摘要
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 225 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%. Conclnsions：It is satisfactory that results of microbial limit tests of 215 batches Jinkuishenqi pills from 34 manufacturers were complies.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2012年第2期360-364,共5页
Chinese Journal of Pharmaceutical Analysis
关键词
金匮肾气丸
微生物限度检查
方法验证
质量分析
Jinkuishenqi pills
microbial limit test
validation of method
quality analysis
