金匮肾气丸微生物限度检查法的建立及检验结果分析

目的: 建立金匮肾气丸的微生物限度检查法,并对34个生产企业215个批次的产品的微生物限度检查结果进行分析。 方法: 细菌计数采用培养基稀释法,霉菌和酵母菌计数、大肠埃希菌和大肠菌群检查采用常规法。 结果: 7个生产企业10个批次的产品进行方法验证,各菌的回收率均大于70%,该方法可行。 结论: 34个生产企业215个批次的金匮肾气丸的微生物限度检查结果均符合规定。

Objective: The method of microbial limit test of Jinkuishenqi pills was established,and the test results of 215 batches from 34 manufacturers were analyzed. Methods: Medium dilution method was used for bacterium count,and routine method was used for total combined molds and yeasts count,detection of Escherichia coli and Coliform bacteria. Results: The validation of method test of 10 batches products from 7 manufacturers has been processed,and the recovery of five validation strains was more than 70%. Conclusions:: It is satisfactory that results of microbial limit tests of 215 batches Jinkuishenqi pills from 34 manufacturers were complies.

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