丙酸氯倍他索凝胶剂的制备与质量控制

Preparation and Quality Control of Clobetasol Propionate Gel

目的 :制备丙酸氯倍他索凝胶并建立质量控制方法。方法 :以卡波姆 941 为辅料制备0.05 %丙酸氯倍他索凝胶 ;用紫外分光光度法测定其含量 ,测定波长为241nm。结果 :丙酸氯倍他索在6～24μg/ml范围内线性关系良好 ,回归方程A=0 0324C—0 0863(n=3) ,r=0 9999 ;平均回收率为99 44 % (n=5) ,RSD=1 14 %。结论 :本制剂制备容易 ,质量稳定 ,控制方法快速。

OBJECTIVE:To prepare clobetasol propionate gel and to establish a method for its quality control METHODS:With carbamer941 as veihele,the 0 05% clobetasol propionate gel was prepared;An ultraviolet spectrophotometry at 241nm for the determination of clobetasol propionate in gel was established RESULTS:The calibration curve of clobetasol propionate was linear in the concentration range of 6～24μg/ml,A=0 0 324C-0 0 863(n=3),r=0 9 999 The average recovery rate was 99 44%(n=5),RSD=1 14% CONCLUSION:The preparation of clobetasol propionate gel was simple,its quality was stable;The method of quality control was rapid and accurate