摘要
[目的]建立复方地塞米松乳膏微生物限度检查法,并对方法进行验证。[方法]采用《中国药典》2005年版二部附录微生物限度包含的方法对复方地塞米松乳膏进行方法验证,通过比较回收率来确定适宜的检查方法。[结果]复方地塞米松乳膏微生物限度细菌检查可采用常规法,霉菌和酵母菌检查宜采用薄膜过滤法。[结论]该方法有效可行,可用于该品种的微生物限度检查。
[Objective]To establish a method of microbial limit test for compound dexamethasone acetate cream and carry out the validation of this method. [ Methods]The methods of microbial limit test in appendices volume Ⅱ of pharmacopoeia of people＇s republic of China（edition 2005 ） were adopted to validate compound dexamethasone acetate cream. [Results] Routine method could be used for the microbial limit detection of compound dexamethasone acetate cream; membrane- filter method was the best one for the detection of fungus and yeast fungus. [Conclusion] It is proved that the method is reliable,and it can be used for the microbial limit test for compound dexamethasone acetate cream.
出处
《广西中医学院学报》
2008年第3期74-76,共3页
Journal of Guangxi Traditional Chinese Medical University
关键词
复方地塞米松乳膏
微生物限度检查
方法验证
Compound dexamethasone acetate cream
Microbial limit test
Validation of the method
