不同企业来源安神丸微生物限度检查方法学验证比较

目的：对不同企业来源安神丸的微生物限度检查进行计数方法的验证及控制菌检查方法的验证比较。方法：按照《中国药典》2005年版一部附录提供的微生物限度检查法的要求进行验证实验;用不同方法测定不同企业来源安神丸对5个规定试验菌株的回收率,并对必检控制菌的检查法进行验证。结果：安神丸1细菌采用培养基稀释法（0.2ml/皿）,霉菌采用常规方法,控制菌检查,大肠埃希菌、大肠菌群、沙门菌均采用常规法（直接接种法）检查;安神丸2细菌采用薄膜过滤法,霉菌采用常规法,控制菌检查,大肠埃希菌、大肠菌群采用薄膜过滤法,沙门菌采用常规法（直接接种法）检查。结论：该研究适合安神丸微生物限度检查方法的验证。

Method verification for microbial limit test of mind tranquilizing pill from different enterprises

Objective：To determine the test condition and method in the microbial limit test of Mind Tranquilizing Pill and to ensure a scientific test method and accurate test results. Methods： The method verification was carried out in accordance with the microbial limit test recorded in the appendix of China Pharmacopeia （2005 edition ,Volume I）. Results： The normal method was determined as microbial limit test method for Mind Tranquilizing Pill. Conclusion： This experiment provided scientific bases for the microbial limit test of Mind Tranquilizing Pill, which is of great practical value for the production and test of this drug.