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。

The establishment of microbial limit test for Jinkuishenqi pills and the analysis of the test results

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.