金匮肾气丸微生物限度检查法的研究

Validation of microbiological test for Jinkui Shenqi pills

目的建立金匮肾气丸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法进行验证和试验,细菌计数采用培养基稀释法,霉菌、酵母菌计数及大肠埃希菌和大肠菌群检查采用常规法检查。结果方法学验证中各菌的回收率均>70%,该方法可行。结论经方法学验证试验得出的检查方法可用于金匮肾气丸的微生物限度检查。

Objective To establish the microbial limit test for Jinkui Shenqi pill.Methods According to microbial limit in Edition 2010 of Chinese Pharmacopoeia,medium dilution method was used for bacterium count,and routine method was used for total molds and yeast count,detection of Escherichia coli and Coliform bacteria.Results The recovery of 5 validation strains was 70%.Conclusion The method can be used for microbial limit test for Jinkui Shenqi pills.