藿胆丸微生物限度检查方法学验证实验

The verified experiment of Huodan pills in microbial limit test methodology

目的探讨藿胆丸的微生物限度检查方法的验证实验。方法按《中华人民共和国药典》2010年版一部微生物限度检查方法进行验证实验。结果藿胆丸对枯草芽孢杆菌、金黄色葡萄球菌具有很强的抑制作用,根据方法验证实验结果采用薄膜过滤法(200ml/膜)进行本品的细菌计数,常规法进行霉菌及酵母菌计数,常规法进行控制菌检查。结论严格按照《中华人民共和国药典》要求,选择5株阳性菌株进行药品的微生物限度检查方法学验证实验极为必要。

Objective To analysis the verified experiment of Huodan pills in microbial limit test methodology. Meth ods Verification test was performed according to microhial limit test methodology of pharmacopoeia of people＇s republic of china ,2010 version,A. Results According to the result,bacterial counts adopted membrane-falter procedure （200 per piece）, the amout of mould and yeast was counted by routine method,the examined of control bacteria adopted routine method. Conclu sion According to the pharmacopoeia of people＇s republic of china,selected five gram-positive bacterias for verification testing of microbial limit test methodology is necessary.