去痛片微生物限度检查法的方法学验证

Methodology Verification of Somedon Microbial Limit Examination

去痛片为复方制剂,进行微生物限度检查的方法学验证时应检查细菌、霉菌、酵母菌及大肠埃希菌项目,以确认所采用的方法适用于该药品的检查。文章采用稀释法检查细菌、霉菌及酵母菌含量,采用常规法检查大肠埃希菌含量,结果可靠。

Somedon is compound drugs.When doing the methodology verification of microbial limit examination,bacteria, mould,yeast and Escherichia coli should be inspected in order to make sure the measures are proper for the inspection.The paper adopts dilution methods to inspect the content of bacteria,mould and yeast and normal methods to inspect the content of Escherichia.The results are reliable