不同厂家通便灵胶囊微生物限度检查方法学验证的探讨

目的：通过对不同厂家同一品种的方法学验证，建立通便灵胶囊微生物限度检查方法。方法按《中国药典》2010版的要求。通过接种代表性的阳性菌株，用常规法及培养基稀释法对五株阳性菌进行回收率测定。结果该品种有抑菌性，采用培养基稀释法对五株阳性菌株回收率均高于70%。结论本样品微生物限度检查中，细菌检查可用培养基稀释法，霉菌酵母菌及控制菌检查可采用常规法。

Study on the validation of microbial limit test method for Tongbianling Capsules of different manufactures

Objective To establish a microbial limit test method of Tongbianling Capsules through the validation of different manufacturers of the same species verification methodology. Methods The recovery percent of five positive bacteria was measured by inoculating representative positive strains using routine method and culture medium dilution method as the requirements of Chinese pharmacopoeia,2010. Results The studied object had antimicrobial properties and the recovery percent of the five positive bacteria are higher than 70% using culture medium dilution method. Conclusion Bacteria detection can be tested by the culture medium dilution method,mold,yeast and control bacteria can be tested by routine method.