异烟肼片微生物限度检查法的建立

Establishment of Microbial Limit Test of Isoniazid Tablets

建立一种适用于异烟肼片的微生物限度检查方法,并对方法进行验证。需氧菌、霉菌和酵母菌总数计数法、控制菌(大肠埃希菌)检查均采用薄膜过滤法,供试液浓度为1∶10。需氧菌总数、霉菌和酵母菌总数计数法方法验证各试验菌的回收试验结果均在0.5~2.0之间,大肠埃希菌检查法适用性试验符合要求。该方法可行性强,适用于异烟肼片的微生物限度检查。

To establish a microbiological limit test method for isoniazid tablets and verify the method.The total count of aerobic microbial,mold and yeasts,as well as the control bacteria test method,used the membrane filtration method.The test liquid concentration was 1∶10.The recoveries of each validation strain for the total aerobic microbiac count,total yeasts and mold count were were between 0.5 and 2.0.The suitability test of Escherichia coli conforms to the requirements.This method is feasible and applicable to the microbial limit test of isoniazid tablets.