八珍系列制剂微生物限度检查法的建立及检验结果分析

目的:建立八珍系列制剂(八珍丸、八珍颗粒、八珍胶囊、八珍片、八珍口服液)微生物限度检查法,对18个生产企业125批次样品的微生物限度检查结果进行分析,并对污染较严重样品的污染菌进行分离、鉴定。方法:八珍丸和八珍胶囊:细菌计数采用培养基稀释法,霉菌和酵母菌计数采用常规法,大肠埃希菌和大肠菌群检查采用直接接种法;八珍颗粒和八珍口服液:细菌计数、霉菌和酵母菌计数采用常规法,大肠埃希菌检查采用直接接种法;八珍片:细菌计数采用培养基稀释法,霉菌和酵母菌计数采用常规法,大肠埃希菌检查采用直接接种法。细菌和酵母菌鉴定采用VITEK 2全自动微生物鉴定系统。结果:14个生产企业24批次的产品进行方法验证,细菌、霉菌和酵母菌计数验证中各菌的回收率均大于70%,大肠埃希菌和大肠菌群检查验证中可检出验证菌,该方法可行。不同剂型样品间的微生物污染状况差异较大,样品污染的微生物主要是芽孢杆菌。结论:18个生产企业125批次的八珍系列制剂的微生物限度检查结果均符合规定。

Objective: To establish a method for microbial limit test of Bazhen preparations(pills, granules, capsules, tablets and oral liquid), analyze the test results of 125 batches of samples from 18 manufacturers, and isolate and identify the contaminant bacteria and yeast from serious polluted samples.Methods: Pills and capsules: the medium dilution method was used for bacteria count, and the routine pour-plate method was adopted for fungi and yeasts count.The direct inoculation method was applied for the detection of Escherichia coli and coliform count.Granules and oral liquid: routine pour-plate method was used for the bacteria count, fungi and yeasts count.The direct inoculation method was used for the detection of E.coli. Tablets: The medium dilution method was used for bacteria count, and routine pour-plate method was used for the fungi and yeasts count.The direct inoculation method was used for the detection of E.coli.VITEK 2 microorganism identification system was used for bacterial and yeast identification.Results: The method of validation was conducted for 24 batches of samples from 14 manufacturers. The recoveries of five validation strains for the count of bacteria, fungi and yeasts were above 70%.Validation strains were detected in E.coli and coliform count tests.There's significant difference of microbe pollution situation between different preparations.The main contaminant bacteria were Bacillus spp. Conclusion: It is satisfactory that the microbial limit tests of 125 batches of Bazhen preparations from 24 manufacturers all meet the test requirements.