清热泻火胶囊微生物限度检查的方法学验证

目的建立清热泻火胶囊的微生物限度检查方法并进行验证。方法按照2010年版《中国药典》规定,分别采用常规法、培养基稀释法、薄膜过滤法对清热泻火胶囊进行微生物限度检查,并根据对5种供试菌株的回收率结果进行方法学验证试验。结果:常规法试验对大肠埃希菌和黑曲霉的回收率均高于70%,白色念珠菌需通过培养基稀释法去除抑菌作用,而金黄色葡萄球菌和枯草芽孢杆菌则需通过薄膜过滤法试验进一步去除抑菌作用,从而使其回收率均达到70%以上。控制菌可按常规法进行检查。结论:清热泻火胶囊微生物限度检查时采用常规法进行霉菌和控制菌计数,采用培养基稀释法进行酵母菌计数,采用薄膜过滤法进行细菌计数,方法准确可靠,重复性好。

Study on Method Validation of Microbial Limit Test for Qingre Xiehuo Capsules

OBJECTIVE：To establish the method of microbial limit test for Qingre xiehuo capsules and validate the method.METHODS：According to Chinese Pharmacopoeia（2010 edition）,conventional method,medium dilution method and membrane filtration method were used for microbial limit test of Qingre xiehuo capsules;methodology validation was conducted according to the results of recovery test for 5 kinds of strains. RESULTS：Recoveries of Escherichia coli and Aspergillus niger were higher than70% by conventional method,and antimicrobial effect of Candida albicans had been removed by medium dilution method. Staphylococcus aureus and Bacillus subtilis were required by the membrane filtration method for further removal of antimicrobial effect,and the recovery rate reached 70% above. The test bacteria had been detected by conventional method of control bacteria. CONCLUSIONS：In microbial limit test of Qingre xiehuo capsules,conventional method is usually used for mold and control bacteria count,medium dilution method for yeast counts and membrane filtration method for bacteria counts. The method is accurate,reliable and reproducible.