参苓白术丸微生物学质量分析与评价

目的: 建立参苓白术丸的微生物限度检查法,对11个生产企业45个批次的产品的微生物限度检查结果进行分析,并对不合格产品的污染菌进行分离、鉴定。 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。细菌鉴定采用VITEK2菌种鉴定系统。 结果: 45批次的产品微生物限度检查的合格率为97.8%,1批不合格产品中主要污染的是短小芽孢杆菌和枯草芽孢杆菌。 结论: 药品的微生物学质量分析与评价不仅应包括药品的微生物限度检查结果分析,还应当包括产品污染菌的分离、鉴定和分析,特别是针对不合格产品的污染菌的鉴定与分析。

Objective: To establish a method for microbial limit test of Shenlingbaizhu pills,analyze the test results of 45 batches from 11 manufacturers,and isolate and identify contaminant bacteria of substandard products. Methods: The medium dilution method was used for bacterium count,and the routine method was used for mold and yeast counts,and detection of Escherichia coli and Coliform bacteria.VITEK2 strain identification system was used for bacterial identification. Results: The qualification rate of 45 batches by the microbial limit test was 97.8%,and one batch of the substandard product was mainly contaminated by Bacillus pumilus and Bacillus subtilis. Conclusion: The analysis and evaluation of pharmaceutical microbiological quality not only includes the analysis of results of pharmaceutical microbial limit test,but also the isolation,identification and analysis of contaminant bacteria,especially of the contaminant bacteria in substandard products.

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