八珍丸的中国药典2015年版微生物学检查结果分析与评价

目的:建立八珍丸微生物限度检查方法,并对其检验结果和污染菌进行分析。方法:采用中国药典2015年版微生物限度检查法对8家10批次的产品进行方法验证试验,用建立的方法对8家30批次的八珍丸进行微生物限度检查,细菌鉴定采用VITEK2全自动微生物鉴定系统和VITEK MS全自动微生物质谱鉴定系统。结果:需氧菌总数、霉菌和酵母菌总数验证中各菌的回收率均为0.5~2.0,大肠埃希菌检查验证组可检出大肠埃希菌,耐胆盐革兰阴性菌检查验证组可检出大肠埃希菌和铜绿假单胞菌,沙门菌检查验证组可检出沙门菌。样品主要污染的微生物是芽孢杆菌和其他根系微生物。结论:建立八珍丸的中国药典2015年版微生物限度检查方法,需氧菌总数采用培养基稀释法,霉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都采用直接接种法。30批样品的微生物限度检查结果均符合规定,污染的主要微生物为药材原料和环境中常见的芽孢杆菌等。

Objective:To establish the method of microbial limit test of Bazhen pills and analyze the test results, and identify contaminant bacteria.Methods:The method validation of the 10 batches of Bazhen pills from 8 manufacturers was conducted by microbial limit test from appendixes in ChP 2015.Totally 30 batches of Bazhen pills from 8 manufacturers were tested under the validated method.VITEK 2 and VITEK MS microorganism identification systems were used for bacterial identification.Results:The recoveries of all kinds of strains in the tests of total aerobic microbial count, total yeast and mold count were 0.5-2.0.In the method validations of Escherichia coli, bile-tolerant gram-negative bacteria and Salmonella enterica subsp., all kinds of strains were respectively detected.The main contaminant bacteria were Bacillus spp.and the bacteria related to the plant root.Conclusion:The medium dilution method was used for the total aerobic microbial counting, and the routine pour-plate method was used for total yeast and mold counting.The direct inoculation method was used for the detection of Escherichia coli, bile-tolerant gram-negative bacteria and Salmonella enterica subsp..It is satisfactory that the results of microbial limit tests of 30 batches of Bazhen pills met test requirements.The main polluted bacteria were Bacillus spp.et al, which were common in the drug material and production environment.

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