妇科止带片微生物限度检查的方法学验证研究

Methodological validation method for microbial limit test of fukezhidai tablets

目的建立妇科止带片微生物限度检查方法。方法采用薄膜过滤法进行细菌数计数,采用平皿法进行霉菌和酵母菌计数,采用常规法进行控制菌的检查。结果大肠埃希菌、白色念珠菌、黑曲霉菌回收率皆在80%以上;金黄色葡萄球菌、枯草芽孢杆菌回收率皆在95%以上;阴性菌对照组均无生长。结论该法可以作为妇科止带片的微生物限度检查方法。

Objective To establish a microbial limit test for fukezhidai tablets. Methods We used membrane filtration method for bacterium,plate method for fungus and yeast test,conventional test method for control bacteria examination. Results The recovery rates of Escherichia coli,Candida albicans and Aspergillus niger were all more than 80% and more than 95% for Staphylococcus aureus and Bacillus subtilis. Negative control group had no growth. Conclusions The method can be used to examine microbial limit of fukezhidai tablets.