倍芪腹泻贴微生物限度检查方法的适用性试验

目的 建立倍芪腹泻贴微生物限度检查方法。 方法 按照《中国药典》2015年版四部﹝通则1105和通则1106﹞的具体规定,采用平皿法、稀释法、薄膜过滤法及方法联用对倍芪腹泻贴进行微生物限度方法适用性试验。 结果 需氧菌总数、真菌和酵母菌总数计数方法适用性试验中各试验菌回收比值均不小于0.9,控制菌方法适用性试验均检出金黄色葡萄球菌和铜绿假单胞菌。 结论 该试验方法可用于倍芪腹泻贴的微生物限度检查。

Research on applicability test of microbial limit determination for Beiqi Fuxie Tie

Objective To establish method for the microbial limit test of Beiqi Fuxie Tie. Methods According to the guiding principle of the applicability test of microbial limit count method provided by the Chinese Pharmacopoeia (edition 2015,part 4),the microbial limit test of Beiqi Fuxie Tie was conducted using the normal plate method,the dilution method,the membrane filtration method and the union of some test methods. Results The total number of aerobic bacteria,the total number of molds and yeast count methods the recovery ratio of each test bacterium was not less than 0.9,and the applicability test of control bacterium method detected staphylococcus aureus and pseudomonas aeruginosa. Conclusions The established method could apply to the microbial limit test of Beiqi Fuxie Tie.