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目的建立医院制剂肿痛消胶囊《中国药典》2015年版的微生物限度检查方法。方法参照《中国药典》2015年版(四部)微生物限度检查法,采用常规法和培养基稀释法进行方法适用性试验。结果肿痛消胶囊对金黄色葡萄球菌有一定的抑制作用,对其他菌无抑制作用。结论采用培养基稀释法进行需氧菌总数计数;采用常规平皿法进行霉菌和酵母菌总数计数;采用直接接种法进行控制菌的检查。
Objective To establish a microbiological limit inspection method for the 2015 edition of the hospital preparation XiTuxiao capsule “Chinese Pharmacopoeia”. Methods According to the “Chinese Pharmacopoeia” 2015 edition (Part IV) microbial limit test method, the conventional method and the medium dilution method were used for the method suitability test. Results Tutongxiao Capsule had a certain inhibitory effect on Staphylococcus aureus and had no inhibitory effect on other bacteria. [Conclusion] The total number of aerobic bacteria was counted using the medium dilution method; the total number of mold and yeast was counted using the conventional plate method; the control bacteria were checked by direct inoculation method.