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目的:对振源软胶囊微生物限度检查方法可行性进行验证。方法:根据《中国药典》2005年版二部微生物限度检查法验证试验。本品细菌检查采用离心稀释法进行验证、真菌和酵母菌采用常规法进行验证。结果:稀释剂对照组和试验组各试验菌的回收率均大于70%;控制菌采用常规法进行验证,阳性时照菌检出,阴性时照菌未检出。结论:振源软胶囊微生物限度检查方法符合《中国药典》2005年版“微生物限度检查法”的规定。
OBJECTIVE: To verify the feasibility of microbial limit testing of Zhenyuan soft capsule. Methods: According to the Chinese Pharmacopoeia 2005 edition two microbial limit test validation test. The product of bacterial examination using centrifugal dilution method for validation, fungi and yeast using conventional methods to verify. Results: The recoveries of all the test bacteria in the diluent control group and the test group were more than 70%. The control bacteria were verified by the routine method. The positive bacteria were detected as positive bacteria and negative bacteria were not detected. Conclusion: Zhenyuan soft capsule microbial limit test method in line with the “Chinese Pharmacopoeia” 2005 edition of “microbial limit test” requirement.