中国药典2015年版八珍胶囊和八珍片微生物限度检查与探讨

Microbiological Quality Analysis and Evaluation of Chinese Pharmacopoeia (2015 Edition) for Bazhen Capsules and Bazhen Tablets

关键词:  八珍胶囊  八珍片  中国药典2015年版  微生物限度检查  耐胆盐革兰阴性菌  方法验证  质量分析

Key words:  Bazhen capsules  Bazhen tablets  Chinese Pharmacopoeia (2015 Edition)  microbial limit test  bile-tolerant gram-negative bacteria  validation of method  quality analysis

摘要:

目的 对八珍胶囊和八珍片微生物限度检查进行方法学验证并对检验结果和污染菌进行分析。方法 八珍胶囊和八珍片采用中国药典2015年版微生物限度检查法进行方法验证，对6家31批次的八珍胶囊和八珍片进行微生物限度检查，细菌和酵母菌鉴定采用VITEK2全自动微生物鉴定系统。结果 需氧菌总数、真菌和酵母菌总数验证中各菌的回收率均>0.5，大肠埃希菌检查、耐胆盐革兰阴性菌检查沙门菌检查各验证组均可检出阳性菌。污染的微生物主要是芽孢杆菌等药材原料和环境中常见的细菌和酵母菌。结论 建立满足中国药典2015年版要求的八珍胶囊和八珍片的微生物限度检查方法，需氧菌总数采用培养基稀释法、真菌和酵母菌总数采用常规法，大肠埃希菌检查、耐胆盐革兰阴性菌检查和沙门菌检查(针对八珍胶囊)都采用直接接种法。31批样品的微生物限度检查结果均符合规定，污染的微生物主要为药材原料和环境中常见的芽孢杆菌等。

Abstract:

OBJECTIVE To establish the method of microbial limit test for Bazhen capsules and Bazhen tablets, analyze the test results and contaminant microbes. METHODS The method validation of Bazhen capsules and Bazhen tablets of microbial limit test of Chinese Pharmacopoeia (2015 Edition) was conducted. Thirty-one batches of Bazhen capsules and Bazhen tablets from 6 manufacturers were tested under the validated method. VITEK 2 Microorganism Identification System was used for bacterial and yeast identification. RESULTS The recoveries of 5 validation strains for the total aerobic microbial count, total yeasts and mold count were more than 0.5. In validation of method tests on Escherichia coli, bile-tolerant gram-negative bacteria and Salmonella enterica subsp., validation strains were detected. The main contaminant microbes were Bacillus spp. and microbe related to the herb material and environment. CONCLUSION The medium dilution method is used for the total aerobic microbial count, routine pour-plate method is used for total yeasts and molds count. The direct inoculation method is used for the detection of Escherichia coli, bile-tolerant gram-negative bacteria and Salmonella enterica subsp. (for the capsule). It is satisfactory that the results of microbial limit tests of 31 batches of samples meet test requirements. The main polluted microbes is Bacillus spp., which are common in the drug material and production environment.