双葛止泻口服液微生物限度检查方法学验证

建立了双葛止泻口服液的微生物限度检查方法。根据2015年版《中华人民共和国兽药典(二部)》通则1102非无菌产品微生物限度检查:微生物计数法,以及通则1103非无菌产品微生物限度检查:控制菌检查法和通则1104非无菌兽药微生物限度标准进行方法适用性试验。结果表明,采用薄膜过滤法对样品进行需氧菌总数、霉菌和酵母菌计数方法适用性试验,试验组与菌液对照组的比值为0.5~2,采用常规法进行控制菌检查方法适用性试验,试验组检出阳性试验菌。所建立的方法可作为双葛止泻口服液微生物限度的检查方法。

Methodological Validation of Microbial Limit Test of Shuangge Anti-diarrhea Oral Liquid

To establish a microbial limit test method of Shuangge anti-diarrhea oral liquid,according to the general rule 1102(microbial counting method for microbial limit test of non-sterile products),the general rule 1103(the control bacteria examination method for microbial limit test of non-sterile products),the general rule 1104(the test method for suitability of microbiological limits for non-sterile drugs)of Chinese Veterinary Pharmacopoeia(2015 edition,volumeⅡ),the applicability of the method was tested.Results showed that the applicability of the membrane filtration method to count the total number of aerobic bacteria,molds and yeasts in the samples was tested.The ratio between test group and microorganism solution group were between 0.5 and 2.In the control bacteria tests,the control bacteria was found in the test group.The established method can be used for the microbial limit test of Shuangge anti-diarrhea oral liquid.