摘要
目的:制备皮炎净乳膏并建立其质量控制方法.方法:采用理化反应对皮炎净乳膏进行定性鉴别;采用高效液相色谱法测定主药丙酸氯倍他索的含量.结果:理化鉴别反应呈阳性;丙酸氯倍他索检测浓度线性范围为4.06~97.49μg/ml,平均加样回收率为98.67%(RSD=0.82%,n=9),在乳膏中的平均含量为0.492mg/g.结论:本处方设计及制备工艺合理,性质稳定,质量控制方法简便、准确、可行.
OBJECTIVE : To prepare Piyanjing cream and to establish a quality control method for it. METHODS : Chemical reactions were performed to identify Piyanjing cream qualitatively. The content of main agent, elobetasol propionate was determined by HPLC. RESULTS: Chemical reactions were positive .The elobetasol propionate linearhy was between 4.06-97.49μg/ml, and the average recovery was 98.67% (RSD = 0.82%, n =9), the average content of elobetasol propionate was 0. 492mg/g. CONCLUSION : The prescription and the preparation technique are reasonable, the cream is stable in quality, the quality control is simple ,accurate and practicable.
出处
《中国药房》
CAS
CSCD
北大核心
2005年第23期1788-1789,共2页
China Pharmacy
关键词
皮炎净乳膏
丙酸氯倍他索
制备
质量控制
Piyanjing cream
Clobetasol propionate
Preparation
Quality control