Abstract: A treatment process of cyclosporine eye gel, comprising the steps of: adding carbomer to water, stirring thoroughly and homogenizing; after the prepared carbomer base swollen, stirring and homogenizing; cooling the carbomer base after moist heat sterilization, performing vacuum degassing, adjusting the pH of the base to 5.0-9.0 with filtered sodium hydroxide solution; mixing polyoxyl 35 castor oil, cyclosporin A raw material, 1,2-propanediol and water in a suitable ratio, preparing into a clear solution under a water bath at 35 to 45° C., and filtering; mixing the filtrate uniformly with the carbomer base, performing vacuum degassing; performing aseptic filling after another filtration. For the process of the present invention, sterilization and filtration is performed before adding carbomer, which is convenient for industrial production.

Abstract: A treatment process of cyclosporine eye gel, comprising the steps of: adding carbomer to water, stirring thoroughly and homogenizing; after the prepared carbomer base swollen, stirring and homogenizing; cooling the carbomer base after moist heat sterilization, performing vacuum degassing, adjusting the pH of the base to 5.0-9.0 with filtered sodium hydroxide solution; mixing polyoxyl 35 castor oil, cyclosporin A raw material, 1,2-propanediol and water in a suitable ratio, preparing into a clear solution under a water bath at 35 to 45° C., and filtering; mixing the filtrate uniformly with the carbomer base, performing vacuum degassing; performing aseptic filling after another filtration. For the process of the present invention, sterilization and filtration is performed before adding carbomer, which is convenient for industrial production.

Abstract: A method of controlling the impurities in a cyclosporin A eye gel. A high performance liquid chromatography is performed, and chromatographic conditions are as follows: the detection wavelength is 210-230 nm; the column temperature is 60-68° C.; the flow rate is 0.8-1 ml/min; and the mobile phase A is: THF-water-phosphoric acid. The method of controlling impurities solves the problem of excipients interference and separation of many impurities at the same time, it also provides an effective method for the formulation of quality standard of impurities in this kind of preparation.