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目的:对依癌胶囊微生物限度检查方法进行方法学验证。方法:需氧菌总数测定采用稀释倾注法;霉菌及酵母菌总数测定采用倾注法,通过3次独立的平行试验,分别计算各试验菌每次试验的回收率。控制菌采用相对应的菌株进行常规法试验,其中耐胆盐革兰阴性菌采用大肠埃希菌和铜绿假单胞菌作为试验菌。结果:各试验菌的回收率均在0.5~2.0范围内,控制菌试验组呈阳性。结论:本品的微生物限度检查采用稀释倾注法进行需氧菌总数测定、倾注法进行霉菌及酵母菌总数测定,控制菌采用常规法。
OBJECTIVE: To verify the method of microbial limit test of YiCao capsule. Methods: The total number of aerobic bacteria was determined by dilution method. The total number of molds and yeasts was determined by pour method. The recovery rate of each test was calculated by three independent parallel experiments. The control bacteria used the corresponding strains for routine tests, of which Escherichia coli and Pseudomonas aeruginosa were used as test bacteria. Results: The recovery rate of each test bacteria were in the range of 0.5 ~ 2.0, the control bacteria test group was positive. Conclusion: The microbial limit test of this product is carried out by the method of dilution and pouring to determine the total number of aerobic bacteria, pouring method for the determination of the total number of molds and yeasts, and the control bacteria using the conventional method.