2种中药制剂微生物限度与控制菌方法验证

Method verification of microbial limit and control bacteria for two kinds of Chinese patent drugs

目的建立六味地黄胶囊与杞菊地黄胶囊微生物限度与控制菌的检查方法。方法采用常规法与培养基稀释法对2种中药制剂进行微生物限度方法验证,采用直接接种法进行控制菌方法验证。结果建立了2种中药制剂的微生物限度与控制菌检查方法。结论六味地黄胶囊采用培养基稀释法(0.5mL/皿)测定细菌数,常规法测定霉菌及酵母菌数;杞菊地黄胶囊采用培养基稀释法(0.2mL/皿)测定细菌数,培养基稀释法(0.5mL/皿)测定霉菌及酵母菌数。采用直接接种法对2种中药制剂进行控制菌(大肠埃希菌与大肠菌群)检测。

Objective To estabilish methods of the microbial limit and control bacteria tests for Liuweidihuang Capsules and Qijudi- huang Capsules. Methods Routine method and medium diluting method were adopted for the verification of microbial methodology, direct inoculation method for control bacteria. Results The methods of the microbial limit and control bacteria tests for two kinds of Chinese patent drugs were estabilished. Conclusion Bacterial count of Liuweidihuang Capsules could adopt the medium diluting method {0.5 mL/plant} ,while yeast and mold count could adopt the routine method. Bacterial count of Qijudihuang Capsules could adopt the medium diluting method （0.2 mL/plant）, while yeast and mold count could adopt the medium diluting method （0. 5 mL/plant）. Direct inoculation method could be adopted for detecting the control bacteria for the two kinds of Chinese patent preparations.