川芎茶调丸微生物学质量分析与评价

目的：建立川芎茶调丸微生物限度检查法，对6个生产企业52批次样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：6个生产企业14批次的产品进行方法验证，金黄色葡萄球菌、大肠埃希菌和枯草芽孢杆菌的回收率与样品阿魏酸含量呈负相关，采用培养基稀释法可消除样品的抑菌性，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均可检出验证菌，该方法可行。结论：建立了川芎茶调丸的微生物限度检查方法，6个生产企业52批次的川芎茶调丸微生物限度检查结果均符合规定。

Objective: To establish a microbial limit test method for Chuanxiongchatiao pills evaluation, and analyze the test results of 52 batches samples from 6 manufacturers. Methods: 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 Escherichia coli and coliform count. Results: The method validation of 14 batches samples from 6 manufacturers was conducted. There was negative correlation between the recovery rate of Staphylococcus aureus, Bacillus subtilis, Escherichia coli and the content of ferulic acid, while medium dilution method could remove the antibacterial activity of the samples. The recoveries of five validation strains for the count of bacteria, fungi and yeasts were all above 70%. In method validation of Escherichia coli and coliform count tests, validation strains were detected. Conclusion: The microbial limit test method for the Chuanxiongchatiao pills was established. It is satisfactory that the results of microbial limit tests of 52 batches of Chuanxiongchatiao pills from 6 manufacturers meet test requirements.

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