参苓白术散微生物限度检查法的建立及检验结果分析

摘要

目的 建立参苓白术散的微生物限度检查法,对14个生产厂家37个批次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 选取的3个生产厂家6个批次的产品进行方法验证,五种验证菌的回收率均大于70％.结论 14个生产厂家,37个批次的参苓白术散微生物限度(检查)结果均符合规定,结果较为满意.%Objective The method of microbial limit test of Shenling baizhu powder was established,and the test results of 37 batches from 14 manufacturers were analyzed.Methods Medium dilution method was used for bacterium count,and routine method was used for total combined molds and yests count,detection of Escherichia coli and Coliform bacteria.Results The validation of method test of 6 batchis products from 3 manufacturers had been processed,and the recovery of five validation strains was more than 70％.Conclusion The results of microbial limit tests of 37 batches Shenling baizhu powder from 14 manufacturers were met the specification.