熊胆胶囊微生物限度检查方法学验证试验

目的分析研究熊胆胶囊的微生物限度检查方法。方法按《中国药典》2010年版微生物限度检查方法进行验证试验。结果熊胆胶囊对枯草芽孢杆菌具有很强的抑制作用,根据方法验证实验结果,建议采用薄膜过滤法(400 mL/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。

Validation of Methods in Microbial Limit Tests for Xiongdan Capsules

Objective To analyze the necessity of validation of methods in microbial limit tests for Xiongdan capsules. Methods Validation of microbiological limit tests according to "Chinese Pharmacopoeia edition 2010". Results Xiongdan capsules has strong inhibiting effect on Bacillus subtilis in bacterium.The membrane filtration method was used in the test of bacterium.The routine method was used in the test of mold and yeasts.The routine method was used in the test of pathogenic bacterium. Conclusion Strict accordance with the "Chinese Pharmacopoeia" requirement,to select the five positive strains for drugs microbial limit method validation experiments is necessary.