消炎止咳片微生物限度检查法研究

Validation of Microbiological Test for Xiaoyan Zhike Tablet

目的:建立消炎止咳片的微生物限度检查方法。方法:按《中华人民共和国药典》2010年版(一部)微生物限度检查法进行验证试验,细菌计数采用薄膜过滤法,霉菌和酵母菌计数及大肠埃希菌和大肠菌群检查采用常规法检查。结果:各菌的回收率均大于70%,该方法可行。结论:经方法学验证得出的检查方法可用于消炎止咳片的微生物限度检查。

Objective：To establish the microbial limit test for Xiaoyan Zhike Tablet. Methods：According to microbial limit in Edition 2010 of Chinese Pharmacopoeia,membrane-filter method was used for bacterum count and routine method was used for total molda and yeast count as well as the detection of Escherichia coil and Coliform bacteria. Results：The recovery of 5 validation strains was more than 70%. Conclusion：The method can be used for microbial limit test for Xiaoyan Zhike Tablet.