TEA COMPOSITION COMPRISING CYCLOCARYA PALIURUS AND PREPARATION METHOD AND USES THEREOF
Compositions and preparation method thereof, said compositions comprise Cyclocarya paliurus leaf and one or more herbs selected from the group consisting of Green Tea, Mori Folium, Siraitiae Fructus, Broadleaf Holly leaf and Polygonati odorati Rhizoma, and their preparation method. Said compositions can treat diabetes, hyperglycemia, hypertension and/or hyperlipidemia.
This application claims priority to People's Republic of China Patent Application No. 201510212607.0 filed Apr. 29, 2015, People's Republic of China Patent Application No. 201510214436.5 filed Apr. 29, 2015, and People's Republic of China Patent Application No. 201510213059.3 filed Apr. 29, 2015, the disclosures of each of which are hereby incorporated herein by reference in their entireties.
FIELD OF THE INVENTIONThe present invention relates to the field of herbal medicine and herbal nutritional composition. In particular, the present invention relates to processed herbal compositions (such as an herbal tea) comprising Cyclocarya paliurus leaves and other herbs (such as Mori Folium and Green Tea), and their use in lowering blood sugar and treating diabetes, hyperglycemia, hypertension and/or hyperlipidemia.
BACKGROUNDHerbal teas are widely consumed by people worldwide, and many cultures have treasured traditions of using herbal teas to promote health, improve bodily functions, and treat illnesses. Owing to the rapid changes in people's diet and lifestyle, most countries today are challenged by epidemics of metabolic conditions, such as diabetes, cardiovascular diseases, hypertension, and obesity. However, many of these metabolic conditions are chronic, and individuals afflicted by the conditions need lifelong and expensive treatment and special dietary regimen.
Particular herbs from Chinese medicine, such as Cyclocarya paliurus, Mori Folium, and Green Tea, have been empirically and experimentally proven to help lower blood sugar, which is beneficial because elevated blood sugar levels can lead to severe damage to the body. High blood sugar level is also the culprit for the devastating health effects of many chronic metabolic diseases, such as diabetes. Therefore, regular consumption of herbal tea compositions comprising herbs with known potentials to lower blood sugar can serve as an effective and sustainable strategy to manage or prevent the long-term metabolic conditions.
All references described herein are incorporated by reference in their entirety.
BRIEF SUMMARY OF THE INVENTIONThe present invention provides a health care composition (such as a pharmaceutical composition or a nutritional composition) comprising (including consisting essentially of or consisting of) Cyclocarya paliurus leaves and one or more herbs selected from the group consisting of Green Tea, Mori Folium, Siraitiae Fructus, Broadleaf Holly leaves and Polygonati odorati Rhizoma.
In some aspects, provided is an herbal tea composition comprising (including consisting essentially of or consisting of) Cyclocarya paliurus leaves and one or more herbs selected from the group consisting of Green Tea, Mori Folium, Siraitiae Fructus, Broadleaf Holly leaves and Polygonati odorati Rhizoma, and a method for preparing the herbal tea composition thereof. An herbal tea bag comprising the herbal tea composition is also provided by the present invention. The herbal tea composition and the herbal tea bag are useful for lowering blood sugar, treating diabetes, hyperglycemia, hypertension, and/or hyperlipidemia in a subject in need thereof.
In some embodiments, provided is an herbal tea composition comprising (including consisting essentially of or consisting of) Cyclocarya paliurus leaves, Green Tea and Mori Folium. In some embodiments, provided is an herbal tea composition comprising (including consisting essentially of or consisting of) Cyclocarya paliurus leaves, Siraitiae Fructus, and Mori Folium. In some embodiments, provided is an herbal tea composition comprising (including consisting essentially of or consisting of) Cyclocarya paliurus leaves and Broadleaf Holly leaves. In some embodiments, provided is an herbal tea composition comprising (including consisting essentially of or consisting of) Cyclocarya paliurus leaves, Mori Folium, Green Tea, and Polygonati odorati Rhizoma.
In one aspect, the present invention provides a method for preparing an herbal tea composition comprising (including consisting essentially of or consisting of) Cyclocarya paliurus leaves, Mori Folium and Green Tea, wherein the method comprises mixing crushed and sieved leaves of Cyclocarya paliurus, Mori Folium and Green Tea, wherein the crushed leaves are sieved to remove particles that are smaller than a certain size (such as 60-mesh) prior to mixing.
En one embodiment, the relative proportion (by weight) of the crushed and sieved leaves of Cyclocarya paliurus, Mori Folium and Green Tea provided in the method for preparing the herbal tea composition is about 1:1:1, respectively.
Another aspect of the present invention provides a method for preparing an herbal tea composition comprising (including consisting essentially of or consisting of) Cyclocarya paliurus, Mori Folium and Green Tea, wherein the method comprises crushing leaves of Cyclocarya paliurus, Mori Folium and Green Tea; sieving the crushed leaves through a mesh (such as 60-mesh to 20-mesh) sieve to remove fine particles; mixing a portion of the crushed and sieved leaves of Cyclocarya paliurus, a portion of the crushed and sieved leaves of Mori Folium and a portion of the crushed and sieved leaves of Green Tea; and packaging at least a portion of the mixture in a package.
Another aspect of the present invention provides a method for preparing an herbal tea composition comprising (including consisting essentially of or consisting of) Cyclocarya paliurus, Mori Folium and Green Tea, wherein the method comprises washing leaves of Cyclocarya paliurus and Mori Folium; drying the washed leaves at about 80-100° C. to less than about 10% water content; crushing the dried leaves to a size of about 0.1 cm to 2 cm; sieving the crushed leaves through a sieve (such as 80-mesh to 20-mesh sieve) to remove fine particles; mixing a portion of the crushed and sieved leaves of Cyclocarya paliurus and Mori Folium, with a portion of Green Tea; and packaging at least a portion of the mixture in a package.
In some embodiments of the methods described above, equal portions (by weight) of the crushed and sieved leaves of Cyclocarya paliurus, Mori Folium and Green Tea are provided to prepare the herbal tea composition.
Yet another aspect of the present invention provides a method for preparing an herbal tea composition comprising (including consisting essentially of or consisting of) Cyclocarya paliurus leaves, Mori Folium and Green Tea, wherein the method comprises separately crushing leaves of Cyclocarya paliurus, Mori Folium and Green Tea; separately sieving the crushed leaves through a mesh (such as 60-mesh to 20-mesh) sieve to remove fine particles; mixing a portion of about 15 times weight (e.g., about 500 g) of the crushed and sieved leaves of Cyclocarya paliurus, a portion of about 15 times weight (e.g., about 500 g) of the crushed and sieved leaves of Mori Folium and a portion of about 15 times weight (e.g., about 500 g) of the crushed and sieved leaves of Green Tea for at least about 10 minutes (such as about 10-30 minutes, or about 20 minutes) to achieve uniform mixing; dividing the mixture into equal portions (e.g., about 1-5 g each, or about 1.5 g each); packing each portion (e.g., about 1-5 g each, or about 1.5 g each) of the mixture into an inner package; and packing the packed inner package into an outer package.
Further provided by the present invention is an herbal tea composition prepared by any of the methods detailed herein.
Still another aspect of the present invention provides an herbal tea composition for lowering blood sugar in a subject in need thereof, comprising Cyclocarya paliurus, Mori Folium and Green Tea, prepared by a method comprising mixing equal portions (by weight) of crushed and sieved leaves of Cyclocarya paliurus, Mori Folium and Green Tea.
Still yet another aspect of the present invention provides an herbal tea composition consisting essentially of or consisting of crushed and sieved leaves of Cyclocarya paliurus, Mori Folium and Green Tea.
In one embodiment, the herbal tea composition consists essentially of or consists of crushed and sieved leaves of Cyclocarya paliurus, Mori Folium and Green Tea in a relative proportion (by weight) of about 1-98%:1-98%:1-98%, about 10-80%:10-80%:10-80%, about 20-60%:20-60%:20-60%, about 30-40%:30-40%:20-40%, about 33.3%:33.3%:33.3%, or about 1:1:1 respectively.
Also provided by the present invention is an herbal tea bag comprising any of the herbal tea compositions described herein, and a packaging.
Further provided is a method for lowering blood sugar or treating diabetes, hyperglycemia, hypertension, and/or hyperlipidemia in a subject in need thereof, comprising administering a therapeutically effective amount of a health care composition, an herbal tea composition, or an herbal extract composition detailed herein.
Also provided is a use of a health care composition, an herbal tea composition, or an herbal extract composition detailed herein in the manufacture of a medicament for the treatment of diabetes, hyperglycemia, hypertension, and/or hyperlipidemia.
Further provided is a kit comprising a health care composition, an herbal tea composition, or an herbal extract composition detailed herein.
The present invention provides a health care composition (or a health-enhancing composition, e.g., a pharmaceutical composition or a nutritional composition) comprising (including consisting essentially of or consisting of) Cyclocarya paliurus leaves and one or more herbs selected from the group consisting of Green Tea, Mori Folium, Siraitiae Fructus, Broadleaf Holly leaves and Polygonati odorati Rhizoma. Also provided are methods of using any of the compositions in lowering blood sugar, treating a disease or condition (e.g., diabetes, hyperglycemia, hypertension or hyperlipidemia), or providing nutritional supplement, to an individual in need thereof. Further provided are methods and processes for preparing or manufacturing the compositions described herein.
As used herein, the singular form “a”, “an”, and “the” includes plural references unless indicated otherwise.
Reference to “about” a value or parameter herein includes (and describes) embodiments that are directed to that value or parameter per se. For example, description referring to “about X” includes description of “X.”
Unless otherwise noted, technical terms are used according to conventional usage.
The compositions and methods of the present invention may comprise, consist of, or consist essentially of the essential elements and limitations of the invention described herein, as well as any additional or optional ingredients, components, or limitations described herein or otherwise useful.
It is understood that aspects and embodiments of the invention described herein include “comprising,” “consisting of,” and “consisting essentially of” aspects and embodiments. For example, for all compositions described herein, and all methods using or making a composition described herein, the compositions can either comprise the listed components or steps, or can “consist essentially of” the listed components or steps. A composition consisting essentially of a list of components contains at least 70% (e.g., by weight) of the listed components. In some embodiments, a composition consisting essentially of a list of components contains at least 75%, 80%, 85%, 90% or 95% (e.g., by weight) of the listed components. In some embodiments, a composition consisting essentially of a list of components contains at least 95%, 96%, 97%, 98% or 99% (e.g., by weight) of the listed components. In some embodiments, a composition consisting essentially of a list of components contains about 99%, about 99.5% or about 99.9% (e.g., by weight) of the listed components. For example, in a pharmaceutical composition consisting essentially of a list of herbal components (e.g., Cyclocarya paliurus leaves, Green Tea and Mori Folium), the listed herbal components account for at least 70% (e.g., by weight) of all of the active ingredients. In some embodiments, the pharmaceutical composition contains at least 85%, 90%, 95%, or 99% (by weight) of list of herbal components (e.g., Cyclocarya paliurus leaves, Green Tea and Mori Folium). In some embodiments, the pharmaceutical composition contains about 99%, about 99.5% or about 99.9% (by weight) of list of herbal components (e.g., Cyclocarya paliurus leaves, Green Tea and Mori Folium).
As used herein, a composition comprising an herb (e.g., Cyclocarya paliurus leaves) means the composition includes (inclusive or open-ended) the herb in its raw form or processed form, for example, crushed and sieved parts or particles, or extracts of the herb. When a percentage (or relative amount) of an herb is stated for a composition obtained by processing a mixture of more than one herbs, the percentage or relative amount indicates the proportion of the herb in the mixture before the mixture is processed. For example, when an herbal extract composition obtained by extracting a mixture of Cyclocarya paliurus leaves and other herbs is stated to comprise about 50% (by weight) of Cyclocarya paliurus leaves, the mixture comprises about 50% (by weight) of Cyclocarya paliurus leaves before extraction.
Health Care Compositions
Cyclocarya paliurus (also known as wheel wingnut, sweet tea tree, or in Traditional Chinese Medicine Qing qian liu) is a native deciduous plant of China and the sole species in the genus of Cyclocarya in the family Juglandaceae. The plant is only found in China, and its leaves contain a soluble heteropolysaccharide consisting of various monosaccaride building blocks, among many other bioactive ingredients, which have experimentally been shown to increase insulin sensitivity and reduce blood sugar in animal models. Having a bitter sweet flavor, the leaves of Cyclocarya paliurus (Qing qian liu ye in Chinese) and their extracts have been used in Chinese folk medicines and herbal tea compositions for treating and preventing conditions associated with elevated blood sugar. In the present invention, the term “Cyclocarya paliurus” refers to the plant or any part of the plant, including but not limited to its leaves, bark, stem, root, buds and flowers. Additionally, the plant parts of Cyclocarya paliurus can be young or old, fresh or dried, raw or processed. Indications and properties of Cyclocarya paliurus leaves as a traditional Chinese medicine include but are not limited to the following: slightly bitter, pungent, neutral; act to tonify spleen and resolve dampness, clear heat and soothe viscera, relieve Qi stagnancy in liver, nourish kidney Yin; effective for relieving obesity due to non-invigorating spleen, phlegm turbidity, preference in fatty, sweet, and heavy-taste food, laziness to move, food retention, liver depression and Qi stagnation.
Mori Folium (also known as Folium Mori, Morus leaves, mulberry leaves, or in Traditional Chinese Medicine Sang ye), is the leaf of an arbor plant Morus alba, or white mulberry, of the family Moraceae. Morus alba is widely found in silkworm breeding regions in south China, Japan, and other subtropical regions in the South East Asia. Mulberry leaves (Mori Folium) commonly used in Traditional Chinese Medicine are collected after early frost, and the leaves have little smell, but a bland, slightly bitter and astringent taste. Among the multitude of bioactive ingredients in Mori Folium, 1-deoxynojirimycin can inhibit the enzyme alpha-glucosidase, which breaks down disaccharides into monosaccharides, thereby reducing intestinal absorption of sugars and stabilizing sugar levels in the blood. Mori Folium has been used in Traditional Chinese Medicine in the form of an herbal tea composition for improving bodily functions. In the present invention, “Mori Folium” refers to the leaves of Morus alba harvested from any geological location, or at any time of the year, young or old, fresh or dried, in raw or processed conditions. Indications and properties of Mori Folium as a traditional Chinese medicine include the following: light smell and bland taste, slightly bitter and astringent; effective in lowering blood pressure, promoting urination, and lowering blood lipid level; capable of inhibiting α-Glucosidase, and competitively block disaccharide hydrolases such as maltase and sucrase in brush border of the small intestinal epithelium; capable of lowering blood sugar.
Camellia sinensis (also known as tea plant and tea shrub) is a flowering evergreen shrub or tree of the family Theaceae. Camellia sinensis is cultivated in many tropical and subtropical areas of the world characterized by rich and moist growing conditions. The Chinese variety of the plant has small leaves that are harvested and processed with various methods to yield different teas of varying levels of oxidation, such as white tea, green tea, and oolong tea. In particular, green tea is rich in antioxidants, such as catechins, which have antibiotic, anti-cancer, anti-diabetic, and anti-inflammation potentials. Green tea and its extracts are widely used worldwide in pharmaceutical compositions, nutritional compositions, cosmetics and beverages to promote health. “Green Tea” as used herein refers to the leaves of Camellia sinensis used in green tea production, and the leaves can be raw or processed, young or old, fresh or dried. Indications and properties of Green Tea as a traditional Chinese medicine include the following: effective in refreshing mind, promoting urination, relieving fatigue, and anti-aging; good for people having too much high-fat diet, hypertension, experiencing difficulty in urination, fever and thirst.
The invention provides a health care composition (or a health-enhancing composition, e.g., a pharmaceutical composition or a nutritional composition) comprising (including consisting essentially of or consisting of) Cyclocarya paliurus leaves and one or more herbs selected from the group consisting of Green Tea, Mori Folium, Siraitiae Fructus, Broadleaf Holly leaves and Polygonati odorati Rhizoma. In some instances, the composition comprises (including consists essentially of or consists of) parts or particles obtained by mechanically processing the herbs. For example, the composition may comprise crushed parts of the herbs mixed together in packet (e.g., a tea bag). In some instances, the composition comprises (including consists essentially of or consists of) substances extracted from Cyclocarya paliurus leaves and the other herbs, for example, by using a method described herein for preparing an herbal extract composition. The health care composition disclosed herein comprising the herbs may provide synergistic effect in lowering blood sugar, while avoiding excessive toxicity often associated with long-term usage of Traditional Chinese Medicine due to factors such as heavy metal contamination and impurities.
In some embodiments, the health care composition comprises (including consists essentially of or consists of) Cyclocarya paliurus leaves and one or more herbs selected from the group consisting of Green Tea, Mori Folium, Siraitiae Fructus, Broadleaf Holly leaves and Polygonati odorati Rhizoma. In some embodiments, the health care composition comprises (including consists essentially of or consists of) Cyclocarya paliurus leaves and one herb selected from the group consisting of Green Tea, Mori Folium, Siraitiae Fructus, Broadleaf Holly leaves and Polygonati odorati Rhizoma. In some embodiments, the health care composition comprises (including consists essentially of or consists of) Cyclocarya paliurus leaves and two herbs selected from the group consisting of Green Tea, Mori Folium, Siraitiae Fructus, Broadleaf Holly leaves and Polygonati odorati Rhizoma. In some embodiments, the health care composition comprises (including consists essentially of or consists of) Cyclocarya paliurus leaves and three or four herbs selected from the group consisting of Green Tea, Mori Folium, Siraitiae Fructus, Broadleaf Holly leaves and Polygonati odorati Rhizoma. In some embodiments, the health care composition comprises (including consists essentially of or consists of) Cyclocarya paliurus leaves, Green Tea, Mori Folium, Siraitiae Fructus, Broadleaf Holly leaves and Polygonati odorati Rhizoma.
In some preferred embodiments, the health care composition (e.g., a pharmaceutical composition or a nutritional composition) comprises (including consists essentially of or consists of) Cyclocarya paliurus leaves, Green Tea, and Mori Folium. In some embodiments, the composition comprises about 1-98% (w) Cyclocarya paliurus leaves, about 1-98% (w) Green Tea and about 1-98% (w) Mori Folium. In some embodiments, the composition comprises about 10-80% (w) Cyclocarya paliurus leaves, about 10-80% (w) Green Tea and about 10-80% (w) Mori Folium. In some embodiments, the composition comprises about 20-60% (w) Cyclocarya paliurus leaves, about 20-60% (w) Green Tea and about 20-60% (w) Mori Folium. In some embodiments, the composition comprises about 30-40% (w) Cyclocarya paliurus leaves, about 30-40% (w) Green Tea and about 20-40% (w) Mori Folium. In some embodiments, the composition comprises about 33.3% (w) Cyclocarya paliurus leaves, about 33.3% (w) Green Tea and about 33.3% (w) Mori Folium. In some embodiments, the health care composition consists essentially of Cyclocarya paliurus leaves, Green Tea and Mori Folium. In some embodiments, the health care composition consists of Cyclocarya paliurus leaves, Green Tea and Mori Folium. In some embodiments, the health care composition consists of Cyclocarya paliurus leaves, Green Tea and Mori Folium at relative proportion (by weight) of about 1:1:1, respectively. In some embodiments, the composition further comprises one or more herbs selected from the group consisting of Citri Reticulatae Pericarpium, Dioscoreae Rhizoma, Paeoniae Radix alba, Poria, and Puerariae lobatae Radix. In some embodiments of any of the compositions, the composition further comprises one or more herbs selected from the group consisting of Polygonati odorati Rhizoma, Lycii Fructus, Polygonati Rhizoma, Laminariae Thallus/Eckloniae Thallus, Mume Fructus, Dendrobii Caulis, Mori Cortex, Ginseng Radix et Rhizoma, Notoginseng Radix et Rhizoma, Ligustri lucidi Fructus, Corni Fructus, Chuanxiong Rhizoma, Atractylodis Rhizoma, Scrophulariae Radix, Rehmanniae Radix, Angelicae sinensis Radix, Rhodiolae Crenulatae Radix et Rhizoma, Panacis Quinquefolii Radix, Aloe, Schisandrae chinensis Fructus, Ophiopogonis Radix, Prepared Rhubarb, Anemarrhenae Rhizoma, Tribuli Fructus, Ginkgo Folium, Astragali Radix, Gynostemma pentaphyllum, Balsam pear, Fagopyrum tataricum, Pumpkin, Konjac, Celery, Corn Stigma, Tremella, Hericium erinaceus, and Garlic.
In some embodiments, the health care composition (e.g., a pharmaceutical composition or a nutritional composition) comprises (including consists essentially of or consists of) Cyclocarya paliurus leaves, Siraitiae Fructus, and Mori Folium. In some embodiments, the composition comprises about 1-98% (w) Cyclocarya paliurus leaves, about 1-98% (w) Siraitiae Fructus and about 1-98% (w) Mori Folium. In some embodiments, the composition comprises about 10-80% (w) Cyclocarya paliurus leaves, about 10-80% (w) Siraitiae Fructus and about 10-80% (w) Mori Folium. In some embodiments, the composition comprises about 20-60% (w) Cyclocarya paliurus leaves, about 20-60% (w) Siraitiae Fructus and about 20-60% (w) Mori Folium. In some embodiments, the health care composition consists essentially of Cyclocarya paliurus leaves, Siraitiae Fructus and Mori Folium. In some embodiments, the health care composition consists of Cyclocarya paliurus leaves, Siraitiae Fructus and Mori Folium. In some embodiments, the composition further comprises one or more herbs selected from the group consisting of Citri Reticulatae Pericarpium, Dioscoreae Rhizoma, Paeoniae Radix alba, Poria, and Puerariae lobatae Radix. In some embodiments of any of the compositions, the composition further comprises one or more herbs selected from the group consisting of Polygonati odorati Rhizoma, Lycii Fructus, Polygonati Rhizoma, Laminariae Thallus/Eckloniae Thallus, Mume Fructus, Dendrobii Caulis, Mori Cortex, Ginseng Radix et Rhizoma, Notoginseng Radix et Rhizoma, Ligustri lucidi Fructus, Corni Fructus, Chuanxiong Rhizoma, Atractylodis Rhizoma, Scrophulariae Radix, Rehmanniae Radix, Angelicae sinensis Radix, Rhodiolae Crenulatae Radix et Rhizoma, Panacis Quinquefolii Radix, Aloe, Schisandrae chinensis Fructus, Ophiopogonis Radix, Prepared Rhubarb, Anemarrhenae Rhizoma, Tribuli Fructus, Ginkgo Folium, Astragali Radix, Gynostemma pentaphyllum, Balsam pear, Fagopyrum tataricum, Pumpkin, Konjac, Celery, Corn Stigma, Tremella, Hericium erinaceus, and Garlic.
In some embodiments, the health care composition (e.g., a pharmaceutical composition or a nutritional composition) comprises (including consists essentially of or consists of) Cyclocarya paliurus leaves and Broadleaf Holly leaves. In some embodiments, the composition comprises about 1-98% (w) Cyclocarya paliurus leaves and about 1-98% (w) Broadleaf Holly leaves. In some embodiments, the composition comprises about 10-80% (w) Cyclocarya paliurus leaves and about 10-80% (w) Broadleaf Holly leaves. In some embodiments, the composition comprises about 20-60% (w) Cyclocarya paliurus leaves and about 20-60% (w) Broadleaf Holly leaves. In some embodiments, the composition comprises about 50% (w) Cyclocarya paliurus leaves and about 50% (w) Broadleaf Holly leaves. In some embodiments, the health care composition consists essentially of Cyclocarya paliurus leaves and Broadleaf Holly leaves. In some embodiments, the health care composition consists of Cyclocarya paliurus leaves and Broadleaf Holly leaves. In some embodiments, the composition further comprises one or more herbs selected from the group consisting of Mori Folium, Green Tea, Polygonati odorati Rhizoma, Sweet Potato leaves, and Lycii Folium. In some embodiments, the composition comprises about 10-90% (w) Cyclocarya paliurus leaves, about 10-90% (w) Broadleaf Holly leaves and about 10-90% (w) of one or more herbs selected from the group consisting of Mori Folium, Green Tea, Polygonati odorati Rhizoma, Sweet Potato leaves, and Lycii Folium. In some embodiments, the composition comprises about 20-60% (w) Cyclocarya paliurus leaves, about 20-60% (w) Broadleaf Holly leaves and about 20-60% (w) of one or more herbs selected from the group consisting of Mori Folium, Green Tea, Polygonati odorati Rhizoma, Sweet Potato leaves, and Lycii Folium. In some embodiments, the composition comprises about 40% (w) Cyclocarya paliurus leaves, about 30% (w) Broadleaf Holly leaves and about 30% (w) of one or more herbs selected from the group consisting of Mori Folium, Green Tea, Polygonati odorati Rhizoma, Sweet Potato leaves, and Lycii Folium. In some embodiments, the composition comprises Cyclocarya paliurus leaves, Broadleaf Holly leaves and Mori Folium. In some embodiments, the composition comprises about 40% (w) Cyclocarya paliurus leaves, about 30% (w) Broadleaf Holly leaves and about 30% (w) Mori Folium. In one variation, the Broadleaf Holly in the composition is a small leaf Broadleaf Holly. In some embodiments of any of the compositions, the composition further comprises one or more herbs selected from the group consisting of Buckwheat leaves, Longan leaves, Myrica rubra leaves, Sweet Potato leaves, Eriobotryae Folium, Lycii Fructus, Polygonati Rhizoma, Laminariae Thallus/Eckloniae Thallus, Mume Fructus, Dendrobii Caulis, Mori Cortex, Ginseng Radix et Rhizoma, Notoginseng Radix et Rhizoma, Ligustri lucidi Fructus, Corni Fructus, Chuanxiong Rhizoma, Atractylodis Rhizoma, Scrophulariae Radix, Rehmanniae Radix, Angelicae sinensis Radix, Rhodiolae Crenulatae Radix et Rhizoma, Panacis Quinquefolii Radix, Aloe, Schisandrae chinensis Fructus, Ophiopogonis Radix, Prepared Rhubarb, Anemarrhenae Rhizoma, Tribuli Fructus, Ginkgo Folium, Astragali Radix, Gynostemma pentaphyllum, Balsam pear, Fagopyrum tataricum, Pumpkin, Konjac, Celery, Corn Stigma, Tremella, Hericium erinaceus, and Garlic.
In some embodiments, the health care composition (e.g., a pharmaceutical composition or a nutritional composition) comprises (including consists essentially of or consists of) Cyclocarya paliurus leaves, Mori Folium, Green Tea, and Polygonati odorati Rhizoma. In some embodiments, the composition comprises about 5-85% (w) Cyclocarya paliurus leaves, about 5-85% (w) Mori Folium, about 5-85% (w) Green Tea, and about 10-85% (w) Polygonati odorati Rhizoma. In some embodiments, the composition comprises about 10-70% (w) Cyclocarya paliurus leaves, about 10-70% (w) Mori Folium, about 10-70% (w) Green Tea, and about 10-70% (w) Polygonati odorati Rhizoma. In some embodiments, the composition comprises about 20-40% (w) Cyclocarya paliurus leaves, about 20-40% (w) Mori Folium, about 20-40% (w) Green Tea, and about 20-40% (w) Polygonati odorati Rhizoma. In some embodiments, the composition comprises about 30% (w) Cyclocarya paliurus leaves, about 25% (w) Mori Folium, about 25% (w) Green Tea, and about 20% Polygonati odorati Rhizoma. In some embodiments, the health care composition consists essentially of Cyclocarya paliurus leaves, Mori Folium, Green Tea, and Polygonati odorati Rhizoma. In some embodiments, the health care composition consists of Cyclocarya paliurus leaves, Mori Folium, Green Tea, and Polygonati odorati Rhizoma. In some embodiments, the health care composition consists of Cyclocarya paliurus leaves, Mori Folium, Green Tea, and Polygonati odorati Rhizoma at relative proportion (by weight) of about 30%:25%:25%:20%, respectively. In some embodiments, the composition further comprises one or more herbs selected from the group consisting of Broadleaf Holly leaves, Black Tea, Lycii Folium, Buckwheat leaves, Longan leaves, Myrica rubra leaves, Sweet Potato leaves, and Eriobotryae Folium. In some embodiments, the composition further comprises one or more herbs selected from the group consisting of Citri Reticulatae Pericarpium, Dioscoreae Rhizoma, Scrophulariae Radix, Panacis Quinquefolii Radix, Ginkgo Folium, Gynostemma pentaphyllum, and Corn Stigma. In some embodiments of any of the compositions, the composition further comprises one or more herbs selected from the group consisting of Polygonati Rhizoma, Laminariae Thallus/Eckloniae Thallus, Siraitiae Fructus, Mume Fructus, Notoginseng Radix et Rhizoma, Ligustri lucidi Fructus, Corni Fructus, Chuanxiong Rhizoma, Atractylodis Rhizoma, Rehmanniae Radix, Paeoniae Radix alba, Aloe, Schisandrae chinensis Fructus, Ophiopogonis Radix, Prepared Rhubarb, Anemarrhenae Rhizoma, Tribuli Fructus, Astragali Radix, Gynostemma pentaphyllum, Balsam pear, Fagopyrum tataricum, Pumpkin, Konjac, Celery, Tremella, Hericium erinaceus, and Garlic.
In some embodiments, the health care composition (e.g., a pharmaceutical composition or a nutritional composition) comprises (including consists essentially of or consists of) Cyclocarya paliurus leaves, Mori Folium, Green Tea, Polygonati odorati Rhizoma, and Broadleaf Holly leaves. In some embodiments, the composition comprises about 20-30% (w) Cyclocarya paliurus leaves, about 20-70% (w) Mori Folium, about 15-25% (w) Green Tea, about 5-15% (w) Polygonati odorati Rhizoma, and about 5-15% (w) Broadleaf Holly leaves. In some embodiments, the composition consists essentially of about 20-30% (w) Cyclocarya paliurus leaves, about 20-70% (w) Mori Folium, about 15-25% (w) Green Tea, about 5-15% (w) Polygonati odorati Rhizoma, and about 5-15% (w) Broadleaf Holly leaves. In some embodiments, the health care composition comprises (including consists essentially of or consists of) Cyclocarya paliurus leaves, Broadleaf Holly leaves, Mori Folium, Black Tea, Polygonati odorati Rhizoma, Green Tea, Eriobotryae Folium, Buckwheat leaves, and Longan leaves. In some embodiments, the composition comprises about 20-30% (w) Cyclocarya paliurus leaves, about 10-20% (w) Broadleaf Holly leaves, about 10-20% (w) Mori Folium, about 10-20% (w) Black Tea, about 10-20% (w) Polygonati odorati Rhizoma, about 10-20% (w) Green Tea, about 10-20% (w) Eriobotryae Folium, about 10-20% (w) Buckwheat leaves, and about 10-20% (w) Longan leaves. In some embodiments, the composition consists essentially of about 20-30% (w) Cyclocarya paliurus leaves, about 10-20% (w) Broadleaf Holly leaves, about 10-20% (w) Mori Folium, about 10-20% (w) Black Tea, about 10-20% (w) Polygonati odorati Rhizoma, about 10-20% (w) Green Tea, about 10-20% (w) Eriobotryae Folium, about 10-20% (w) Buckwheat leaves and about 10-20% (w) Longan leaves. In some embodiments, the health care composition (e.g., a pharmaceutical composition or a nutritional composition) comprises (including consists essentially of or consists of) Cyclocarya paliurus leaves, Green Tea, Citri Reticulatae Pericarpium, Dioscoreae Rhizoma, Black Tea, Scrophulariae Radix, Panacis Quinquefolii Radix, Ginkgo Folium, Gynostemma pentaphyllum, and Corn Stigma. In some embodiments, the composition comprises (including consists essentially of or consists of) about 10-20% (w) Cyclocarya paliurus leaves, about 5-20% (w) Green Tea, about 5-20% (w) Citri Reticulatae Pericarpium, about 5-20% (w) Dioscoreae Rhizoma, about 5-20% (w) Black Tea, about 5-20% (w) Scrophulariae Radix, about 5-20% (w) Panacis Quinquefolii Radix, about 5-20% (w) Ginkgo Folium, about 5-20% (w) Gynostemma pentaphyllum, and about 5-20% (w) Corn Stigma. In some embodiments, the composition consists essentially of about 10% (w) Cyclocarya paliurus leaves, about 10% (w) Green Tea, about 10% (w) Citri Reticulatae Pericarpium, about 10% (w) Dioscoreae Rhizoma, about 10% (w) Black Tea, about 10% (w) Scrophulariae Radix, about 10% (w) Panacis Quinquefolii Radix, about 10% (w) Ginkgo Folium, about 10% (w) Gynostemma pentaphyllum, and about 10% (w) Corn Stigma. In some embodiments, the health care composition (e.g., a pharmaceutical composition or a nutritional composition) comprises (including consists essentially of or consists of) Cyclocarya paliurus leaves, Mori Folium, and Polygonati odorati Rhizoma. In some embodiments of any of the compositions, the composition further comprises one or more herbs selected from the group consisting of Polygonati Rhizoma, Laminariae Thallus/Eckloniae Thallus, Siraitiae Fructus, Mume Fructus, Notoginseng Radix et Rhizoma, Ligustri lucidi Fructus, Corni Fructus, Chuanxiong Rhizoma, Atractylodis Rhizoma, Rehmanniae Radix, Paeoniae Radix alba, Aloe, Schisandrae chinensis Fructus, Ophiopogonis Radix, Prepared Rhubarb, Anemarrhenae Rhizoma, Tribuli Fructus, Astragali Radix, Gynostemma pentaphyllum, Balsam pear, Fagopyrum tataricum, Pumpkin, Konjac, Celery, Tremella, Hericium erinaceus, and Garlic.
The health care composition may be an oral formulation such as a tablet, a capsule, a granule, a powder, an effervescent tablet, or an herbal tea formulation. The health care composition (such as a pharmaceutical composition or a nutritional composition) may further comprise one or more excipients. Examples of pharmaceutically acceptable excipient include but are not limited to pregelatinized starch, β-cyclodextrin, maltodextrin, Carbopol, microcrystalline cellulose, hydroxypropylmethylcellulose, low-substituted hydroxypropylcellulose, polyethylene glycol (PEG), sodium carboxymethyl cellulose, methylcellulose, ethylcellulose, mannitol, cross-linked sodium carboxymethyl cellulose, lactose, polyvinylpyrrolidone (PVP), magnesium stearate, talc, silica powder, aspartame, sodium bicarbonate, and sodium carbonate.
The health care compositions comprising the herbs (e.g., a Chinese herbal medicine) described herein may be prepared by methods known in the art, and methods described herein. For example, an herbal tea composition comprising one or more of the herbs described herein can be prepared by crushing and sieving the herbs, and packaging in a packet (e.g., a tea bag). A granule composition can be prepared by extracting the herbs with a solvent (e.g., hot water) and converting the extracts into granules by using auxiliary agents or excipients such as β-cyclodextrin, microcrystalline cellulose, calcium hydrogen phosphate, or mannitol. A gel capsule composition can be manufactured by enclosure of a granule composition in a gel capsule. An herbal extract composition can be prepared by extracting the herbs, and removing impurities, for example, by filtration and centrifugation. Powders, oral tablets and effervescent tablets can be prepared using the herbal extracts and appropriate auxiliary materials by processes known in the art.
In some embodiments of any of the compositions detailed herein comprising Green Tea, the Green Tea may be substituted with Black Tea. In some embodiments, the Green Tea may be substituted with Siraitiae Fructus.
Herbal Tea Compositions
In one aspect, the present invention provides an herbal tea composition containing Cyclocarya paliurus leaves and other herbal components, for example, Mori Folium, and Green Tea. Both Cyclocarya paliurus leaves and Mori Folium have been treasured as herbal medicines in China since ancient times, and each herb has been used in Traditional Chinese Medicine to treat and prevent high blood sugar levels and diabetes. Camellia sinesis, in the form of Green Tea, gains widespread popularity as a healthy beverage worldwide. The herbal tea composition disclosed herein may enable balanced delivery of biologically active substances from each herb, including polysaccharides, amino acids, vitamins, minerals, antioxidants and fibers, which are useful for lowering blood sugar and providing nutritional supplements to human consumers. Many herbal tea compositions on the market or disclosed by the prior arts comprise other herbs or additive ingredients, which may contain substances that interact with the beneficial active substances in Cyclocarya paliurus leaves, Mori Folium, and Green Tea, thereby undermining the overall efficacy of some herbal tea compositions comprising ingredients other than Cyclocarya paliurus leaves, Mori Folium, and Green Tea. The additional components in some previous herbal tea compositions may also contain toxic substances or substances that can cause undesirable side effects over long-term usage. Also, some methods for preparing similar herbal tea compositions in prior arts involve steps that can disrupt the integrity of the bioactive ingredients in the herbs. The method for preparing the herbal tea composition in the present invention can preserve the active ingredients from the herbs that are useful for reducing blood sugar. The herbal tea composition described herein provides consumers a simple-to-use, cost-effective, and flavorful means for long-term management of their blood sugar and for maintenance of their health.
In some embodiments, provided is an herbal tea composition comprising (including consisting essentially of or consisting of) Cyclocarya paliurus leaves and one or more herbs selected from the group consisting of Green Tea, Mori Folium, Siraitiae Fructus, Broadleaf Holly leaves and Polygonati odorati Rhizoma. In some embodiments, the herbal tea composition comprises (including consists essentially of or consists of) Cyclocarya paliurus leaves and one, two, or three herbs selected from the group consisting of Green Tea, Mori Folium, Siraitiae Fructus, Broadleaf Holly leaves and Polygonati odorati Rhizoma. In some embodiments, the herbal tea composition consists essentially of Cyclocarya paliurus leaves and one, two, or three herbs selected from the group consisting of Green Tea, Mori Folium, Siraitiae Fructus, Broadleaf Holly leaves and Polygonati odorati Rhizoma. In some embodiments, the herbal tea composition further comprises one or more of additional herbs describe herein, for example, herbs described for any of the health care compositions detailed herein.
Herbal tea compositions comprising (including consisting essentially of or consisting of) each and every combinations of herbs detailed herein for the health care compositions are embraced and described as if each and every combinations are explicitly recited. For example, in some embodiments, provided is an herbal tea composition comprising (including consisting essentially of or consisting of) Cyclocarya paliurus leaves, Siraitiae Fructus, and Mori Folium. In some embodiments, provided is an herbal tea composition comprising (including consisting essentially of or consisting of) Cyclocarya paliurus leaves and Broadleaf Holly leaves. In some embodiments, provided is an herbal tea composition comprising (including consisting essentially of or consisting of) Cyclocarya paliurus leaves, Mori Folium, Green Tea, and Polygonati odorati Rhizoma.
In a preferred embodiment, provided is an herbal tea composition comprising (including consisting essentially of or consisting of) Cyclocarya paliurus, Mori Folium and Green Tea, prepared by a method comprising mixing of crushed and sieved leaves of Cyclocarya paliurus, Mori Folium and Green Tea. One aspect of the present invention provides an herbal tea composition consisting essentially of or consisting of crushed and sieved leaves of Cyclocarya paliurus, Mori Folium and Green Tea. The herbal tea compositions described herein are useful for lowering blood sugar in a subject in need thereof.
The relative proportion of Cyclocarya paliurus and other herbs (e.g., Mori Folium and Green Tea) in the herbal tea composition can be important for achieving optimal health benefits. In one embodiment, specifically provided is an herbal tea composition prepared by a method comprising mixing equal portions (by weight) of crushed and sieved leaves of Cyclocarya paliurus, Mori Folium and Green Tea. Accordingly, the ratio by weight of the crushed and sieved leaves of Cyclocarya paliurus, Mori Folium and Green Tea in the herbal tea composition is about 1:1:1 respectively.
The present invention further provides an herbal tea composition consisting essentially of or consisting of crushed and sieved leaves of Cyclocarya paliurus, Mori Folium and Green Tea. In one embodiment, the herbal tea composition consists essentially of or consists of crushed and sieves leaves of Cyclocarya paliurus, Mori Folium and Green Tea in a relative proportion (by weight) of about 1:1:1 respectively. Accordingly, in this embodiment, the percentage by weight of Cyclocarya paliurus in the herbal tea composition is about 33.3%, the percentage by weight of Mori Folium in the herbal tea composition is about 33.3%, and the percentage by weight of Green Tea in the herbal tea composition is about 33.3%.
Any of the herbal tea compositions described herein can further be incorporated in an herbal tea bag, wherein the herbal tea bag comprises the herbal tea composition and a packaging. In one embodiment of the herbal tea bag, the packaging comprises an inner package and an outer package. The inner package can be a sterile package of one layer, two layers or more than two layers of bags made of suitable materials, such as nylon, paper, plastic or composite materials, which can be used in food production. The outer package can be a package made of suitable materials, such as paper, nylon, plastic, metal or composite materials, which can help to preserve the integrity and flavor of the tea bag.
The herbal tea composition and the herbal tea bag disclosed herein are characterized by a low level of heavy metal contents and other toxic elements. Common heavy metals found in herbal tea compositions include manganese, copper, cadmium, lead, iron, mercury, zinc and arsenic. In some embodiments, the herbal tea composition and the herbal tea bag detailed herein each contains a total of about less than 20 ppm (parts per million), less than 15 ppm, less than 10 ppm, less than 5 ppm, less than 1 ppm, or less than 0.5 ppm of combined heavy metal content. In some embodiments, the herbal tea composition and the herbal tea bag detailed herein each contains about less than 5 ppm, less than 2 ppm, less than 1 ppm, less than 0.5 ppm, or less than 0.1 ppm of lead; and/or about less than 3 ppm, less than 2 ppm, less than 1 ppm, less than 0.5 ppm, or less than 0.1 ppm of arsenic; and/or about less than 3 ppm, less than 2 ppm, less than 1 ppm, less than 0.5 ppm, or less than 0.1 ppm of mercury. The low level of heavy metals ensures safety for long-term human consumption of the herbal tea composition and the herbal tea bag.
Method for Preparation
The present invention provides a method for preparing an herbal tea composition comprising herbal combinations detailed herein, the method comprising crushing and sieving the herbs. In some embodiments, provided is a method for preparing an herbal tea composition comprising Cyclocarya paliurus leaves and one or more herbs selected from the group consisting of Green Tea, Mori Folium, Siraitiae Fructus, Broadleaf Holly leaves and Polygonati odorati Rhizoma, the method comprising crushing and sieving leaves of Cyclocarya paliurus and the one or more herbs selected from the group consisting of Green Tea, Mori Folium, Siraitiae Fructus, Broadleaf Holly leaves and Polygonati odorati Rhizoma. In some embodiments, the method further comprises separately crushing leaves of Cyclocarya paliurus and the one or more herbs selected from the group consisting of Green Tea, Mori Folium, Siraitiae Fructus, Broadleaf Holly leaves and Polygonati odorati Rhizoma, and sieving the crushed the leaves through a sieve to remove fine particles prior to mixing. In some embodiments, the method further comprises washing and drying (such as separately washing and drying) the leaves of Cyclocarya paliurus and the one or more herbs selected from the group consisting of Green Tea, Mori Folium, Siraitiae Fructus, Broadleaf Holly leaves and Polygonati odorati Rhizoma to less than about 10% water content prior to mixing.
In some embodiments, provided is a method for preparing an herbal tea composition comprising (including consisting essentially of or consisting of) Cyclocarya paliurus, Mori Folium and Green Tea, wherein the method comprises sieving crushed leaves of Cyclocarya paliurus, Mori Folium and Green Tea through a sieve, and mixing the sieved and crushed leaves. In one embodiment, the method further comprises separately crushing leaves of Cyclocarya paliurus, Mori Folium and Green Tea and sieving the crushed the leaves through a sieve to remove fine particles prior to mixing.
The sieve used in the sieving step can be a mesh-sieve of appropriate pore size, such as a 20-mesh (about 0.841 mm pore size), 24-mesh (about 0.707 mm pore size), 28-mesh (about 0.595 mm pore size), 32-mesh (about 0.5 mm pore size), 35-mesh (about 0.420 mm pore size), 42-mesh (about 0.354 mm pore size), 48-mesh (0.297 mm pore size), 50-mesh (about 0.297 mm pore size), 65-mesh (0.250 mm pore size), 70 mesh (about 0.21 mm pore size), or 80-mesh (about 0.177 mm pore size) sieve. In some embodiments, an about 80-mesh to about 20-mesh, such as about 60-mesh to about 20-mesh sieve is used to sieve the crushed leaves. Fine particles smaller than the pore size of the sieve are discarded to remove undesirable substances from the herbal tea composition, including particles containing heavy metals.
Small amount of heavy metals can normally be found in herbal tea compositions and herbal tea compositions, which can lead to toxicity and undesirable side effects, especially for long term consumption. The heavy metal contents in the crude herbs (i.e. Cyclocarya paliurus leaves, Mori Folium, and Green Tea) that are used to prepare the herbal tea composition can vary significantly depending on their origins of production, thereby affecting the overall heavy metal contents of the herbal tea commotion and its derivate products (e.g. the herbal tea bag). Table 1 lists representative concentrations of lead and arsenic as measured using methods known in the art in crude Cyclocarya paliurus leaves from various origins where the herbs are harvested and optionally processed prior to their use in producing the herbal extract composition. To warrant a desirable heavy metal content, in some embodiments of the method for preparing the herbal tea composition, Cyclocarya paliurus leaves, and the one or more herbs selected from the group consisting of Green Tea, Mori Folium, Siraitiae Fructus, Broadleaf Holly leaves and Polygonati odorati Rhizoma from origins that are associated with a low total heavy metal concentration, or low concentrations of particular heavy metals (such as lead and/or arsenic) are selected. In some embodiments, the leaves of Cyclocarya paliurus, and the one or more herbs selected from the group consisting of Green Tea, Mori Folium, Siraitiae Fructus, Broadleaf Holly leaves and Polygonati odorati Rhizoma are washed and dried prior to mixing to reduce the heavy metal contents. A low total heavy metal concentration can be less than about 10 ppm, less than about 5 ppm, less than about 1 ppm, or less than about 0.5 ppm. A low concentration of a particular heavy metal (such as lead or arsenic) can be less than about 10 ppm, less than about 5 ppm, or less than about 1 ppm, or less than about 0.5 ppm.
The relative ratio of the herbal components (e.g., Cyclocarya paliurus, Mori Folium and Green Tea) in the herbal tea composition is important for achieving optimum health benefits and flavor. In some embodiments, the method further comprises weighing the crushed and sieved leaves of the herbs (e.g., Cyclocarya paliurus, Mori Folium and Green Tea) prior to mixing.
For an herbal tea composition comprising (including consisting essentially of or consisting of) Cyclocarya paliurus leaves, Mori Folium and Green Tea, the relative ratio by weight of Cyclocarya paliurus leaves to Mori Folium can be about 1:4 to about 1:3, about 1:3 to about 1:2, about 1:3 to about 1:1, about 1:1 to about 2:1, about 2:1 to about 3:1, about 3:1 to about 4:1, about 0.8:1 to about 1.2:1, or preferably about 1:1. The relative ratio by weight of Cyclocarya paliurus leaves to Green Tea can be about 1:4 to about 1:3, about 1:3 to about 1:2, about 1:3 to about 1:1, about 1:1 to about 2:1, about 2:1 to about 3:1, about 3:1 to about 4:1, about 0.8:1 to about 1.2:1, or preferably about 1:1. In one preferred embodiment, the relative proportion of the crushed and sieved leaves of Cyclocarya paliurus, Mori Folium and Green Tea used to prepare the herbal tea composition is about 1:1:1 respectively. The percentage by weight of Cyclocarya paliurus leaves in the herbal tea composition can be about 1%-10%, 5%-15%, 10%-20%, 15%-25%, 20%-30%, 25%-35%, 30%-40%, 35%-40%, 40%-50%, 45%-55%, 50%-60%, 55%-65%, 60%-70%, 65%-75%, 70%-80%, 75-85%, 80%-90%, 85%-95%, 90-95%, 1%-40%, 40%-70%, 70%-95%, 30%-36%, or preferably about 33.3%. The percentage by weight of Mori Folium in the herbal tea composition can be 1%-10%, 5%-15%, 10%-20%, 15%-25%, 20%-30%, 25%-35%, 30%-40%, 35%-40%, 40%-50%, 45%-55%, 50%-60%, 55%-65%, 60%-70%, 65%-75%, 70%-80%, 75-85%, 80%-90%, 85%-95%, 90-95%, 1%-40%, 40%-70%, 70%-95%, 30%-36%, or preferably about 33.3%. The percentage by weight of Green Tea in the herbal tea composition can be 1%-10%, 5%-15%, 10%-20%, 15%-25%, 20%-30%, 25%-35%, 30%-40%, 35%-40%, 40%-50%, 45%-55%, 50%-60%, 55%-65%, 60%-70%, 65%-75%, 70%-80%, 75-85%, 80%-90%, 85%-95%, 90-95%, 1%-40%, 40%-70%, 70%-95%, 30%-36%, or preferably about 33.3%. In another preferred embodiment, in the mixture of the crushed and sieved leaves of Cyclocarya paliurus, Mori Folium and Green Tea, the percentage by weight of Cyclocarya paliurus leaves is about 33.3%, the percentage by weight of Mori Folium is about 33.3%, and the percentage by weight of Green Tea is about 33.3%.
The mixing step of the method detailed herein can comprise mixing the crushed and sieved leaves of Cyclocarya paliurus, Mori Folium and Green Tea for at least about any of 10 minutes, 20 minutes, 30 minutes, 40 minutes, or 1 hour, in order to obtain a uniform mixture of the leaves. In one preferred embodiment, the crushed and sieved leaves of Cyclocarya paliurus, Mori Folium and Green Tea are mixed for about 10 minutes to about 30 minutes, such as about 20 minutes. The leaves of Cyclocarya paliurus, Mori Folium and Green Tea can be crushed separately, or they can be crushed together. The size of the crushed leaves is about no more than any of 5 cm, 4 cm, 3 cm, 2 cm, 1.5 cm, 1 cm, 0.5 cm, 0.2 cm, or 0.1 cm. In some embodiments, the crushed leaves have a size of about 0.1 cm to about 2 cm. In some embodiments, the Green Tea is processed Green Tea having a size of about 0.1 cm to about 2 cm.
The leaves of Cyclocarya paliurus, Mori Folium and Green Tea can be mixed together, or the leaves of Cyclocarya paliurus and Mori Folium can be mixed together first, and then mixed with the Green Tea, such as processed Green Tea. In some embodiments, the method comprises mixing leaves of Cyclocarya paliurus and Mori Folium to obtain a first mixture, crushing and sieving the first mixture, and mixing the crushed and sieved leaves of the first mixture with the Green Tea (such as processed Green Tea). In some embodiments, the leaves of Cyclocarya paliurus and Mori Folium are first washed and dried (such as at a temperature of about 80° C. to about 100° C.) to less than about 10% water content, crushed to a size of 0.1-2 cm, and sieved through a sieve (such as about 80-mesh to about 20-mesh) to remove fine particles prior to mixing with the Green Tea.
Additional steps can be added to the method to further enhance the preparation of the herbal tea composition. In some embodiments, the method further comprises testing the mixture for quality control. In some embodiments, the method further comprises packaging at least a portion of the mixture in a package. A portion of about 1-2 g, 0.5-1.5 g, 2-3 g, 1.5-2.5 g, 3-5 g, 1-5 g, or 5-10 g of the mixture can be packed in a package. In one preferred embodiment, a portion of about 1-5 g of the mixture is packed in a package. In another preferred embodiment, a portion of about 1.5 g of the mixture is packed in a package. The package can be a sterile package of one layer, two layers or more than two layers made of suitable materials, such as nylon, paper, plastic or composite materials, which can be used in food production.
Another aspect of the present invention provides a method for preparing an herbal tea composition comprising (including consisting essentially of or consisting of) Cyclocarya paliurus leaves and one or more herbs selected from the group consisting of Green Tea, Mori Folium, Siraitiae Fructus, Broadleaf Holly leaves and Polygonati odorati Rhizoma, wherein the method comprises crushing leaves of Cyclocarya paliurus and the one or more herbs selected from the group consisting of Green Tea, Mori Folium, Siraitiae Fructus, Broadleaf Holly leaves and Polygonati odorati Rhizoma; sieving the crushed herbs or leaves through a mesh (such as 60-mesh to about 20-mesh) sieve to remove fine particles; mixing a portion of the crushed and sieved leaves of Cyclocarya paliurus, a portion of the crushed and sieved herbs or leaves of each of the one or more herbs selected from the group consisting of Green Tea, Mori Folium, Siraitiae Fructus, Broadleaf Holly leaves and Polygonati odorati Rhizoma; and packaging at least a portion of the mixture in a package.
In one aspect, the present invention provides a method for preparing an herbal tea composition comprising (including consisting essentially of or consisting of) Cyclocarya paliurus, Mori Folium and Green Tea, wherein the method comprises crushing leaves of Cyclocarya paliurus, Mori Folium and Green Tea; sieving the crushed leaves through a mesh (such as 60-mesh to 20-mesh) sieve to remove fine particles; mixing a portion of the crushed and sieved leaves of Cyclocarya paliurus, a portion of the crushed and sieved leaves of Mori Folium and a portion of the crushed and sieved leaves of Green Tea; and packaging at least a portion of the mixture in a package.
In one aspect, the present invention provides a method for preparing an herbal tea composition comprising (including consisting essentially of or consisting of) Cyclocarya paliurus, Mori Folium and Green Tea, wherein the method comprises mixing leaves of Cyclocarya paliurus and Mori Folium to obtain a first mixture; crushing the mixed leaves (such as to a size of about 0.1 cm to 2 cm), sieving the crushed leaves through a mesh (such as 80-mesh to 20-mesh) sieve to remove fine particles; and mixing a portion of the crushed and sieved leaves of the first mixture, with a portion of the Green Tea; and packaging at least a portion of the mixture in a package.
In some embodiments, there is provided a method for preparing an herbal tea composition comprising (including consisting essentially of or consisting of) Cyclocarya paliurus, Mori Folium and Green Tea, wherein the method comprises washing leaves of Cyclocarya paliurus and Mori Folium; drying the washed leaves (such as at about 80-100° C.) to less than about 10% water content; crushing the dried leaves (such as to a size of about 0.1 cm to 2 cm); sieving the crushed leaves through a mesh (such as 80-mesh to 20-mesh) sieve to remove fine particles; mixing a portion of the crushed and sieved leaves of Cyclocarya paliurus and Mori Folium, with a portion of Green Tea; and packaging at least a portion of the mixture in a package.
It is intended that any of the steps and parameters described herein for preparing the herbal tea composition comprising (including consisting essentially of or consisting of) Cyclocarya paliurus, Mori Folium and Green Tea can be combined with any of the steps and parameters described herein for preparing the herbal tea bag, as if each and every combination is individually described. For example, one exemplary embodiment of the present invention provides a method for preparing an herbal tea composition comprising (including consisting essentially of or consisting of) Cyclocarya paliurus, Mori Folium and Green Tea, wherein the method comprises separately crushing leaves of Cyclocarya paliurus, Mori Folium and Green Tea; separately sieving the crushed leaves through a 60-mesh to 20-mesh sieve to remove fine particles; mixing a portion of about 500 parts weight (e.g. about 500 grams) of the crushed and sieved leaves of Cyclocarya paliurus, a portion of about 500 parts weight (e.g. about 500 grams) of the crushed and sieved leaves of Mori Folium, and a portion of about 500 parts by weight (e.g. about 500 grams) of the crushed and sieved leaves of Green Tea for at least about 10 (such as about 10-30, or about 20) minutes to achieve uniform mixing; dividing the mixture into equal portions of about 1-5 times weight (e.g. about 1-5 g, or about 1.5 grams) each; packing each portion of the mixture into an inner package; and packing the packed inner package into an outer package. Example 1 illustrates this exemplary method.
Further provided by the present invention is an herbal tea composition prepared by any embodiment of the method detailed herein.
The herbal tea composition and the herbal tea bag provided by the present invention can be used by individuals in need of lowering their blood sugar, for example, those with elevated blood sugar levels, and diabetic patients. Blood sugar refers to the variety of naturally occurring carbohydrates, including monosaccharides, oligosaccharides, and polysaccharides that are normally found in the blood stream, blood or any serological fraction of the blood, such as serum. One monosaccharide species, glucose, is the primary source of energy for cells in all organisms, and therefore, glucose is one of the most abundant and highly regulated sugars in the blood. The herbal tea composition and the herbal tea bag are intended for consumption as a supplement to the normal treatment and dietary regimen of the subjects in need. A recommended serving for the herbal tea composition in packets of about 1.5 g portions is to consume 2 packets per day as a drink or beverage to maintain or lower blood sugar level in a subject in need. Consumers may choose other serving regimens depending on their needs. When packets of larger portions of the herbal tea composition are used, consumers can adjust their serving regimen accordingly. Efficacy of the herbal tea composition and the herbal tea bag can be measured by monitoring a subject's blood glucose level using any of the currently available assays on the market over the course of consumption. Comparison of blood sugar data from a group of subjects (human or animal models) taking the herbal tea composition versus blood sugar data from a group of subjects (human or animal models) taking placebo drinks can help evaluate the efficacy of the herbal tea composition, the herbal tea or the herbal tea bag.
Herbal Extract Compositions and Methods of Making Thereof
The invention further provides an herbal extract composition comprising (including consisting essentially of or consisting of) an extract from any combinations of herbs detailed herein, for example, an extract from Cyclocarya paliurus leaves and one or more herbs selected from the group consisting of Green Tea, Mori Folium, Siraitiae Fructus, Broadleaf Holly leaves and Polygonati odorati Rhizoma. In some embodiments, the herbal extract composition comprises (including consists essentially of or consists of) an extract from Cyclocarya paliurus leaves, Mori Folium and Green Tea.
Herbal extract compositions comprising (including consisting essentially of or consisting of) an extract of each and every combinations of herbs detailed herein for the health care compositions are embraced and described as if each and every combinations are explicitly recited. For example, in some embodiments, provided is an herbal extract composition comprising (including consisting essentially of or consisting of) an extract of Cyclocarya paliurus leaves, Siraitiae Fructus, and Mori Folium. In some embodiments, provided is an herbal extract composition comprising (including consisting essentially of or consisting of) an extract of Cyclocarya paliurus leaves and Broadleaf Holly leaves. In some embodiments, provided is an herbal extract composition comprising (including consisting essentially of or consisting of) an extract of Cyclocarya paliurus leaves, Mori Folium, Green Tea, and Polygonati odorati Rhizoma.
The herbal extract compositions can be prepared by extracting a mixture of the herbal components, concentrating the extract, and drying. The herbal extract compositions can also be prepared by extracting an herbal tea composition detailed herein, for example, using a suitable solvent (e.g., hot water or alcoholic water), concentrating the extract, and drying.
In one embodiment, an herbal extract composition comprising (including consisting essentially of or consisting of) an extract of Cyclocarya paliurus leaves, Mori Folium and Green Tea is prepared using a method comprising the following steps:
-
- i) providing a mixture of Cyclocarya paliurus leaves, Mori Folium and Green Tea;
- ii) extracting said mixture with water (e.g., boiling water) to obtain an aqueous extract;
- iii) concentrating the aqueous extract to obtain a concentrated mixture;
- iv) obtaining a liquid portion of said concentrated mixture; and
- v) drying (e.g., spray-drying) said extract to produce the herbal extract composition.
In some embodiments, the method further comprises mixing the extract with a pharmaceutically acceptable excipient (e.g., β-cyclodextrin, maltodextrin, or lactose) before drying.
The herbal extract compositions used to prepare oral formulations such as a tablet, a capsule, a granule, a powder, an effervescent tablet, or an herbal tea formulation.
Methods for Use
The herbal tea compositions and the herbal extract compositions are useful in lowering blood sugar, treating a disease or condition (e.g., diabetes, hyperglycemia, hypertension or hyperlipidemia), or providing nutritional supplement, to an individual in need thereof.
One aspect of the present invention provides a method of lowering blood sugar in a subject in need thereof comprising administering to the subject a therapeutically effective amount of an herbal tea composition or herbal extract composition detailed herein. Methods for treating diabetes, hyperglycemia, hypertension and/or hyperlipidemia are also provided.
In some embodiments, provided is a method of lowering blood sugar or treating diabetes, hyperglycemia, hypertension and/or hyperlipidemia, in a subject in need thereof comprising administering to the subject a therapeutically effective amount of an herbal tea composition, an herbal extract composition, a nutritional composition, or a pharmaceutical composition described herein, each independently, comprising (including consisting essentially of or consisting of) an herbal combination detailed herein, or an extract of the herbal combinations detailed herein, for example, an herbal combination of Cyclocarya paliurus leaves and one or more herbs selected from the group consisting of Green Tea, Mori Folium, Siraitiae Fructus, Broadleaf Holly leaves and Polygonati odorati Rhizoma, preferably, an herbal combination of Cyclocarya paliurus leaves, Green Tea, and Mori Folium. The subject in need can be a human patient suffering from diabetes, other metabolic diseases, or other conditions associated with an elevated blood sugar level. Blood sugar refers to the variety of naturally occurring carbohydrates, including monosaccharides, oligosaccharides, and polysaccharides that are normally found in the blood stream, blood or any serological fraction of the blood, such as serum. One monosaccharide species, glucose, is the primary source of energy for cells in all organisms, and therefore, glucose is one of the most abundant and highly regulated sugars in the blood. In some but not all embodiments of the present invention, “lowering blood sugar” specifically refers to lowering blood glucose. Lowering of blood sugar levels is an effective strategy to treat and manage human conditions, such as diabetes and other metabolic conditions that are responsive to reduced blood sugar level. Therefore, the method described herein can also be applied to treat any disease or condition responsive to lowering of blood sugar. In some embodiments, provided is a method for treating hyperglycemia, hypertension and/or hyperlipidemia in an individual in need thereof.
Alternatively, the herbal extract composition, the gel capsule or the nutritional composition described herein can be used as a nutritional supplement in a method provided by the present invention to reduce blood sugar in a subject in need thereof. “Nutritional supplement” refers to substance that may have beneficial health effects, but are normally absent or present at insufficient quantities in a person's diet. As a nutritional supplement, the herbal extract composition, the gel capsule, or the nutritional composition should be administered to the subject in need thereof in conjunction with standard and other therapeutic means to help the subject manage his or her blood sugar levels.
“Therapeutically effective amount” or “effective amount” in the present invention refers to an amount of an herbal tea composition, an herbal extract composition, a nutritional composition, or a pharmaceutical composition sufficient to improve the condition of the subject in need thereof, without causing serious side-effects. In a preferred embodiment of the present invention, the herbal tea composition described in Example 1 are administered orally with a dosage regimen of 2 doses per day and 1 tea bag per dose. The dosage of the herbal tea composition, the herbal extract composition, the nutritional composition, or the pharmaceutical composition of the present invention can be adjusted according to actual situation based on knowledge in the art. The efficacy of the herbal extract composition, the herbal extract composition, the nutritional composition, or the pharmaceutical composition can be measured by methods known in the art for assessing blood sugar levels in standard animal models (e.g. mice and rats) or in human subjects, for example, as illustrated in Example 6.
EXAMPLEThe following exemplary embodiment further describes the present invention. Although the description refers to practical embodiments, it will be clear to one skilled in the art that the present invention may be practiced with variation of these specific details. Hence this invention should not be construed as limited to the embodiments set forth herein.
Example 1 Preparation of an Herbal Tea BagA flow chart illustrating an exemplary method for preparing an herbal tea bag comprising Cyclocarya paliurus leaves, Mori Folium and Green Tea is shown in
The herbal tea bag was prepared as follows. Leaves of Cyclocarya paliurus, Mori Folium and Green Tea according to production standards of initial ingredients were provided. Each ingredient was crushed separately, and each crushed leaves were sieved separately through a 60-mesh to 20-mesh (such as 60-mesh) sieve to remove fine particles. About 500 grams of crushed leaves of Cyclocarya paliurus, about 500 grams of crushed Mori Folium, and about 500 grams of crushed Green Tea were weighed out. The weighed crushed leaves of Cyclocarya paliurus, Mori Folium and Green Tea were mixed in a mixer for about 10-30 (such as about 20) minutes to obtain a uniform mixture. The uniform mixture was divided into equal portions of about 1-5 g (such as about 1.5 g) each, and each portion was packaged into a triangular bag made of nylon membrane. Each bag was placed into individual inner package made of composite membrane used in food packaging. The quality of the inner-packaged tea bags was inspected according to company standards. The inner-packaged tea bags were packaged into outer packages according to company standards. The quality of the packaging was inspected. The packaged tea bags that had passed quality inspections were stored in a dry warehouse at ambient room temperature. Up to 1000 tea bags, 1.5 g per bag could be prepared. The parameters of the method described herein can be adjusted according to actual situation.
The tea bags are administered, for example, to a human at a dosage of about 2 bags of 1.5 g/bag per day.
Example 2 Preparation of Test Samples and Control SamplesSample Formulae:
Test Sample 1 (S1): Cyclocarya paliurus leaves: 1.0 kg; Green Tea: 8.0 kg; and Mori Folium: 1.0 kg.
Test Sample 2 (S2): Cyclocarya paliurus leaves 4.0 kg, Mori Folium 4.0 kg, and Broadleaf Holly leaves 2.0 kg.
Test Sample 3 (S3): Cyclocarya paliurus leaves 3.3 kg, Green Tea 3.3 kg, and Mori Folium 3.3 kg.
Test Sample 4 (S4): Cyclocarya paliurus leaves 5.0 kg, Green Tea 1.0 kg, Mori Folium 1.0 kg, Broadleaf Holly leaves 1.0 kg, Polygonatum odoratum 1.0 kg, and Paeoniae Radix alba 1.0 kg.
Test Sample 5 (S5): Cyclocarya paliurus leaves 8.0 kg, Green Tea 0.5 kg, Mori Folium 0.5 kg, Black Tea 0.5 kg, and Puerariae lobatae Radix 0.5 kg.
Test Sample 6 (S6): Cyclocarya paliurus leaves 1.0 kg, Green Tea 1.0 kg, Citri Reticulatae Pericarpium 1.0 kg, Dioscoreae Rhizoma 1.0 kg, Black Tea 1.0 kg, Scrophulariae Radix 1.0 kg, Panacis Quinquefolii Radix 1.0 kg, Ginkgo Folium 1.0 kg, Gynostemma pentaphyllum 1.0 kg, and Corn Stigma 1.0 kg.
Control Sample 1 (D1): Cyclocarya paliurus leaves: 10 kg.
Control Sample 2 (D2): Green Tea: 10 kg.
Control Sample 3 (D3): Mori Folium: 10 kg.
Control Sample 3 (D4): Cyclocarya paliurus leaves 3.5 kg, Green Tea 3.5 kg, and Mori Folium 3.0 kg.
The samples were prepared according to the steps detailed below, and tested for efficacies in lowering blood sugars, blood lipids, and blood pressure in animal models.
Method of Preparation
Step 1. Each herbal medicine was measured precisely according to the above composition, broken into pieces separately, then filtered using 60 mesh to remove fine powders in the raw ingredient.
Step 2. Cyclocarya paliurus leaves and other herbal ingredients were mixed well in a mixer for about 20 mins to obtain a mixture.
Step 3. The mixture was aliquoted into triangle-shaped bags, 1.5 g/bag, and the packing material was nylon membrane.
Example 3 Test of Lowering Blood Sugar1. Materials and Methods
1) Samples and solution: samples from Test Samples 1-6 and Control Samples 1-4 were labeled as S1, S2, S3, S4, S5, S6, and D1, D2, D3, D4, respectively; Streptozotocin (SIGMA), pack size: 1 g/tube, lot#: SLBJ7785V; insulin detection kit, imported and aliquoted, Nanjing Jiancheng Bioengineering Co., 20141022; 0.9% NaCl injection (physiological saline), pack size: 250 mL/bottle, Sichuan Kelun Pharmaceutical Co. Ltd., lot#: C13102005-1; high fat diet formula (79% basal diet+1% cholesterol+15% fresh yolk+5% lard), picric acid, etc.
2) Instruments: W-80A vortex mixer (Shanghai Medical Instruments Co. Ltd.); electronic balance, METTLER TOLEDO (METTLER-TOLEDO group), model: pl303; LDZ5-2 centrifuge (Beijing Medical Centrifuge Factory); Johnson Stable Blood Glucose Meter (Johnson & Johnson (China) Medical Device Co. Ltd.); BECKMAN Synchron CX 5 automatic blood biochemistry analyzer (USA); microplate reader, Bio-Rad (USA), model: iMark; DCA 2000 glycosylated hemoglobin analyzer (Bayer, Germany); others: platform scale, and fixed cage, etc.
3) Experimental animals: SD rats (SPF level), weight 160-180 g, male, provided by Southern Medical University Laboratory Animal Center, Certificate#: SCXK (Guangdong)2011-0015. Animals were raised in SPF level barrier level animal room, animal use license#: SYXK (Guangdong) 2012-0081.
4) Dosage setting: expected dosage for human adults is 3.0 g/60 kg·BW·day. Dosage used for rats was 10 times that of human. The dosage was calculated using raw drug amount.
5) Statistical analysis: data were processed using SPSS 17.0 statistical tool, parameters were displayed as mean±standard deviation (
2. Methods and Results
2.1 Methods
1) Rat diet: Regular diet: cornmeal 80%, flour 15%, soybean flour 5%; High fat diet: 79% basal diet+1% cholesterol+15% fresh yolk+5% lard.
2) Modeling: 120 SPF level SD rats, male, weight 160-180 g, were fed for one week adaptively. 10 rats were selected as normal control group and fed with regular diet, while animals of other groups were fed with high fat diet for one month, after random inspection showing an obvious elevation in blood lipid indexes, STZ was intraperitoneally injected at 35 mg/kg to induce diabetic models (before injecting, STZ was prepared into 6 mg/mL solution using 0.1 mmol/L citric acid/sodium citrate buffer (pH=4.5), and destined to be finished within 60 mins). Fasting venous blood was collected from tails on the 7th day after STZ injection. Blood sugar was measured using blood sugar meter, and successful models were regarded as with blood sugar ≧16.7 mmol/L. After the models were stable, animals were grouped based on blood lipids and blood sugar, orally administered test drugs and control drugs, and all indexes were monitored.
3) Grouping and drug administration: 110 successfully modeled animals in relatively good conditions were evenly separated into 11 groups based on blood sugar levels and weights: 10 rats per group, named as type II diabetes model control group (administered with distilled water), S1 group, S2 group, S3 group, S4 group, S5 group, S6 group, D1 group, D2 group, D3 group, and D4 group. Normal un-modeled SD rats were set as normal control (administered with distilled water). Each group was orally administered with drug according to corresponding dosage, once per day, for a period of 4 weeks (4 W).
2.2 Measurements
1) Regular observation was performed, and weights were recorded every 2 weeks.
2) Blood sugar was measured before, after 2 weeks and after 4 weeks of drug administration, using blood sugar meter.
3) Serum insulin and glycosylated hemoglobin levels were measured.
4) Sugar tolerance test: the test was carried out 2 days before the whole experiment ended. Sugar tolerance test was carried out as following: animals were kept under fasting for about 6 hours, different concentrations of test samples were given to each group, glucose was orally administered at 2.0 g/kg after 15-20 mins, blood sugar levels were measured at 0, 0.5, and 2 hours after administering glucose, and the changes of areas under the blood sugar curve of each time point after administering glucose were studied for both model control group and experimental groups. The area under the blood sugar curve=½×(blood sugar level at 0 h+blood sugar level at 0.5 h)×0.5+½×(blood sugar level at 2 h+blood sugar level at 0.5 h)×1.5=0.25×(blood sugar level at 0 h+4× blood sugar level at 0.5 h+3× blood sugar level at 2 h).
2.3 Results
1) The effect on blood sugar of type II diabetes rat: As shown in Table 2, the rat blood sugar level of each diabetes model group significantly elevated before giving drugs, compared to that of the normal control group, indicating successful modeling. After 2 W of treatment, the blood sugar levels of S1-S6 groups, D1 group and D4 group all decreased, compared to that of model control group. After 4 W of treatment, the blood sugar levels of S1-S6 groups, D1 group and D4 group all decreased.
2) The effects on serum insulin level and glycosylated hemoglobin level of type II diabetes rats: As shown in Table 3, compared to those of the normal control group, rats in model control group showed significantly decreased serum insulin level (p<0.01) and significantly elevated glycosylated hemoglobin level (p<0.01) after fed with high fat diet and modeled for diabetes, indicating hyperlipidemia rat models were successful. Compared to the model control group, rat serum insulin levels of S1-S6 groups, D1 group and D4 group all increased. Compared to the model control group, rat glycosylated hemoglobin levels of S1-S6 groups, D1 group and D4 group all decreased (p<0.05).
3) The sugar tolerance test results of type II diabetes rats: As shown in Table 4, the areas under the blood sugar curves of S1-S6 groups, D1 group and D4 group all decreased, compared to that of model control group.
3. Conclusion
S1-S6, D1 and D4 showed clear effects on lowering blood sugar for diabetes rat models, and the compositions of S1-S6 exhibited synergistic or enhanced effects in lowering blood sugar.
Example 4 Test of Lowering Blood Lipids1. Materials and Methods
1) Samples and solution: samples from Test Samples 1-6 and Control Samples 1-4 were labeled as S1, S2, S3, S4, S5, S6, and D1, D2, D3, D4, respectively; 0.9% NaCl injection (physiological saline), pack size: 250 mL/bottle, Sichuan Kelun Pharmaceutical Co. Ltd., lot#: C13102005-1; high fat diet formula (79% basal diet+1% cholesterol+15% fresh yolk+5% lard), distilled water, and picric acid, etc.
2) Instruments: W-80A vortex mixer (Shanghai Medical Instruments Co. Ltd.); electronic balance, METTLER TOLEDO (METTLER-TOLEDO group), model: pl303; LDZ5-2 centrifuge (Beijing Medical Centrifuge Factory); BECKMAN Synchron CX 5 automatic blood biochemistry analyzer (USA); others: platform scale, and fixed cage, etc.
3) Experimental animals: SD rats (SPF level), weight 160-180 g, male, provided by Southern Medical University Laboratory Animal Center, Certificate#: SCXK (Guangdong)2011-0015. Animals were raised in SPF level barrier level animal room, animal use license#: SYXK (Guangdong) 2012-0081.
4) Dosage setting: expected dosage for human adults is 3.0 g/60 kg·BW·day. Dosage used for rats was 10 times that of human. The dosage was calculated using raw drug amount.
5) Statistical analysis: data were processed using SPSS 17.0 statistical tool, parameters were displayed as mean±standard deviation (
2. Methods and Results
2.1 Grouping and Methods
120 SPF level SD rats, male, weight 160-180 g, were fed for one week adaptively. 10 rats were selected as normal control group and fed with regular diet; the rest animals were fed with high fat diet. After feeding continuously for 4 weeks (blood was drawn at regular intervals to test for the four indexes of blood lipids, in order to determine whether models were successful), 110 successfully modeled animals in relatively good conditions were chosen and evenly separated into 11 groups based on blood lipid levels and weights: 10 rats per group, named as hyperlipidemia model control group (administered with distilled water), S1 group, S2 group, S3 group, S4 group, S5 group, S6 group, D1 group, D2 group, D3 group and D4 group.
After feeding high fat diet for 4 weeks, drugs were administered according to the above grouping with high fat diet continuously provided (the normal control group was fed with normal diet), drugs were administered once per day, for a period of 4 W. After the last drug administration, animals were kept overnight fasting, weighed the next day, then anaesthetized using chloral hydrate, after drawing blood through inferior vena cava, animals were executed. Supernatant was obtained by centrifuging the blood samples, then serum biochemical indexes were measured.
2.2 Measurements
1) Regular observation was performed, and weights were recorded every week.
2) Rat serum lipid indexes of each group: blood was drawn from orbital venous plexus every 2 weeks, serum was separated for the detection of: total cholesterol (TC), triglyceride (TG), high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C).
2.3 Results
The effects on serum TC, TG, HDL-C, LDL-C, and TC/HDL-C are shown in Tables 5-7. As shown in Table 5, after fed with high fat diet for 4 W, the model control group rats showed significantly elevated levels of TC and LDL-C (p<0.01), and significant elevation of TG (p<0.05), compared to those of normal control group, indicating successful modeling of hyperlipidemia rats. Rats were evenly separated into 4 groups according to blood lipid level. As shown in Table 6, after 2 W treatment, drug samples of S1-S6 groups, D1 group and D4 group all functioned to lower TC, TG and LDL-C levels in serum, compared to the model control group. As shown in Table 7, after 4 W treatment, drug samples of S1-S6 groups, D1 group and D4 group could lower TC, TG and LDL-C levels in serum (p<0.05 or p<0.01), compared to the model control group.
3. Conclusion
S1-S6, D1 and D4 showed clear effects in lowering blood lipid levels in hyperlipidemia rat models, and the compositions of S1-S6 exhibited synergistic or enhanced effects in lowering blood lipids.
Example 5 Test of Lowering Blood Pressure1. Materials and Methods
1) Samples and solution: samples from Test Samples 1-6 and Control Samples 1-4 were labeled as S1, S2, S3, S4, S5, S6, and D1, D2, D3, D4, respectively; 0.9% NaCl injection (physiological saline), pack size: 250 mL/bottle, Sichuan Kelun Pharmaceutical Co. Ltd., lot#: C13102005-1; distilled water, and picric acid, etc.
2) Instruments: DKB-501A High Precision Water Bath (Shanghai Senxin Laboratory Apparatus Ltd.); electronic constant temperature drying cabinet (Changsha Medical Devices Ltd.); PowerLab/4SP ML125 non-invasive blood pressure measurement system (ML125/R NIBP, MLT1199 Disposable BP Transducer/Cable Kit; ADInstruments Ltd., Australia); MP120-1 electronic balance (Shanghai Number Two Balance Instrument Factory).
3) Experimental animals: SHR rats (SPF level), weight 190-230 g, male, provided by Beijing Vital River Laboratory Animal Technology Co. Ltd., Certificate#: SCXK (Beijing) 2012-0001. Animals were raised in SPF level barrier level animal room, animal use license#: SYXK (Guangdong) 2012-0081. WISTAR male rats (SPF level) were provided by Beijing Vital River Laboratory Animal Technology Co. Ltd., Certificate#: SCXK (Beijing) 2012-0001.
4) Dosage setting: expected dosage for human adults is 3.0 g/60 kg·BW·day. Dosage used for rats was 10 times that of human. The dosage was calculated using raw drug amount.
5) Statistic analysis: data were processed using SPSS 17.0 statistical tool, parameters were displayed as mean±standard deviation (
2. Methods and Results
9-10 week old male spontaneously hypertensive rats (SHR) were randomly separated into 11 groups, 10 rats per group, named as hypertension model control group (administered with distilled water), S1 group, S2 group, S3 group, S4 group, S5 group, S6 group, D1 group, D2 group, D3 group and D4 group. 10 normal WISTAR rats were selected as normal control group (administered with distilled water). Animals in each group were intragastrically administered with different dosages of drugs, once per day, for a period of 4 W. Rat caudal artery blood pressure (systolic arterial pressure, SAP, mmHg) was measured using non-invasive caudal artery blood pressure measurement system, before, after 2 W, and after 4 W treatment.
Non-invasive tail cuff method (NIBP): a rat was placed into the rat fixer, allowing its tail exposed. Infrared heater was set to be 38° C. Rat tail was heated under radiation for about 10 mins until the tail becoming soft and caudal artery expanding sufficiently. Pressured tail cuff was passed through the rat tail and fixed at the tail root, so that rat caudal artery was in tight contact with the pulse sensor of the PowerLab ML125/R non-invasive caudal artery blood pressure measurement system. The pulse waveform was monitored, and blood pressure could be measured when stable pulse wave appeared. When the animal calmed down, pressure was increased in the tail cuff at 90-420BPM (rat pressure increasing level), pulse wave could be seen to gradually diminish until disappear, then gas was gradually released in the tail cuff, pressure gradually decreased in the tail cuff, and pulse wave reappeared when the pressure reached SAP, the blood pressure of which was defined as the rat tail SAP. The measurement was repeated for 3 times, and average value was obtained. The pressure drop value (blood pressure drop value) was calculated as SAP after treatment minus SAP before treatment. The result is shown in Table 8.
The result showed that, rats in the model control group had significantly elevated blood pressure compared to that of rats in the normal control group, indicating spontaneously hypertensive rats as successful models. Drugs of S1-S6 groups, D1 group and D4 group significantly lowered the blood pressure of SHR rats after 4 W treatment (p<0.05), compared to model control group.
3. Conclusion
S1-S6, D1 and D4 samples showed significant effects in lowering blood pressure, and the compositions of S1-S6 exhibited synergistic or enhanced effects in lowering blood pressure.
Example 6 In Vivo Efficacy DeterminationAnimal subjects or human subjects are assigned randomly into a control group and a treatment group. The treatment group is provided a therapeutically effective amount of the herbal tea composition, the herbal extract composition, the nutritional composition, or the pharmaceutical composition comprising (including consisting essentially of or consisting of) a tea bag or an extract of the herb combinations (e.g., Cyclocarya paliurus leaves, Green Tea, and Mori Folium), with a predetermined dosage regimen over a predetermined period of time. The control group is provided with a placebo with the same dosage regimen and treatment duration. Blood glucose levels in all subjects of both experimental groups are monitored prior to the experiment, during the course of the experiment, and at the end of the experiment. Standard blood glucose kits, such as those relying on the nonspecific reducing property of glucose, and those using glucose specific enzymes, are used to monitor the blood glucose levels of the subjects. Statistical analysis is performed to compare the blood glucose levels at various time points in the course of the experiment between the control group and the treatment group, which is used along with other relevant data to determine the efficacy of the methods of treatment disclosed in the present invention.
The present invention only listed some specific examples. However, the characteristics of one or more of the practical embodiments can be combined with those from one or more of other practical embodiments to obtain combined exemplary embodiments, which are also under the protection scope of the present invention, and should be treated as having been disclosed in the present invention.
Claims
1. A health care composition comprising about 20-60% (w) Cyclocarya paliurus leaves, about 20-60% (w) Green Tea and about 20-60% (w) Mori Folium.
2-3. (canceled)
4. The health care composition of claim 1, wherein the health care composition comprises about 30-40% (w) Cyclocarya paliurus leaves, about 30-40% (w) Green Tea and about 20-40% (w) Mori Folium.
5. The health care composition of claim 1, wherein the health care composition comprises about 33.3% (w) Cyclocarya paliurus leaves, about 33.3% (w) Green Tea and about 33.3% (w) Mori Folium.
6-7. (canceled)
8. A method for preparing an herbal tea composition comprising Cyclocarya paliurus leaves, Mori Folium and Green Tea, wherein the method comprising mixing crushed and sieved leaves of Cyclocarya paliurus, Mori Folium and Green Tea in a relative proportion (by weight) of about 20-60%:20-60%:20-60% respectively, wherein the crushed leaves are sieved to remove particles that are smaller than 60-mesh in size prior to mixing.
9. The method of claim 8, further comprising separately crushing leaves of Cyclocarya paliurus, Mori Folium and Green Tea and sieving the crushed leaves through a 60-mesh to 20-mesh sieve to remove fine particles prior to mixing.
10. The method of claim 8, further comprising mixing leaves of Cyclocarya paliurus and Mori Folium to obtain a first mixture, crushing and sieving the first mixture prior to mixing the crushed and sieved leaves in the first mixture with the Green Tea.
11. The method of claim 10, further comprising washing and drying the leaves of Cyclocarya paliurus and Mori Folium to less than about 10% water content prior to mixing.
12. The method of claim 8, comprising mixing crushed and sieved leaves of Cyclocarya paliurus, Mori Folium and Green Tea in a relative proportion (by weight) of about 1:1:1 respectively.
13. The method of claim 8, further comprising packaging at least a portion of the mixture in a package.
14. The method of claim 8, wherein the method comprises:
- i) crushing leaves of Cyclocarya paliurus, Mori Folium and Green Tea;
- ii) sieving the crushed leaves through a 60-mesh to 20-mesh sieve to remove fine particles;
- iii) mixing a portion of the crushed and sieved leaves of Cyclocarya paliurus, a portion of the crushed and sieved leaves of Mori Folium, and a portion of the crushed and sieved leaves of Green Tea; and
- iv) packaging at least a portion of the mixture in a package.
15. (canceled)
16. The method of claim 8, wherein the method comprises:
- i) washing leaves of Cyclocarya paliurus and Mori Folium;
- ii) drying the washed leaves at about 80-100° C. to less than about 10% water content;
- iii) crushing the dried leaves to a size of about 0.1 cm to 2 cm;
- iv) sieving the crushed leaves through an 80-mesh to 20-mesh sieve to remove fine particles;
- v) mixing a portion of the crushed and sieved leaves of Cyclocarya paliurus and Mori Folium, with a portion of Green Tea; and
- vi) packaging at least a portion of the mixture in a package.
17. The method of claim 8, wherein the method comprising:
- i) separately crushing leaves of Cyclocarya paliurus, Mori Folium and Green Tea;
- ii) separately sieving the crushed leaves through a 60-mesh to 20-mesh sieve to remove fine particles;
- iii) mixing a portion of about 500 g of the crushed and sieved leaves of Cyclocarya paliurus, a portion of about 500 g of the crushed and sieved leaves of Mori Folium and a portion of about 500 g of the crushed and sieved leaves of Green Tea for at least 10 minutes to achieve uniform mixing;
- iv) dividing the mixture into equal portions of about 1 g to about 5 g each;
- v) packing each portion of about 1 g to about 5 g of the mixture into an inner package; and
- vi) packing the packed inner package into an outer package.
18. An herbal tea composition prepared by the method of claim 8.
19. (canceled)
20. An herbal tea composition consisting essentially of crushed and sieved leaves of Cyclocarya paliurus, Mori Folium and Green Tea, wherein the crushed and sieved leaves of Cyclocarya paliurus, Mori Folium and Green Tea are in a relative proportion (by weight) of about 20-60%:20-60%:20-60% respectively.
21. The herbal tea composition of claim 20, wherein the crushed and sieved leaves of Cyclocarya paliurus, Mori Folium and Green Tea are in a relative proportion (by weight) of about 1:1:1 respectively.
22. An herbal tea bag comprising the herbal tea composition of claim 20, and a packaging.
23. The herbal tea bag of claim 22, wherein the packaging comprising an inner package and an outer package.
24. (canceled)
25. A method of lowering blood sugar in a subject in need thereof comprising administering to the subject a therapeutically effective amount of the health care composition of claim 1.
26. A method of lowering blood sugar in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of the herbal tea composition of claim 18.
27. A method of treating hyperglycemia, hypertension, and/or hyperlipidemia in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of the health care composition of claim 1.
Type: Application
Filed: Apr 28, 2016
Publication Date: Jun 22, 2017
Inventors: Zhen LUO (Guangzhou), Xia ZHENG (Guangzhou), Xiaolei GUO (Guangzhou), Chung Wah MA (Guangzhou)
Application Number: 15/128,835
