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目的:建立牛黄上清胶囊的微生物限度检查法,并对方法进行验证。方法:细菌计数法为培养基稀释法;霉菌、酵母菌计数法为培养基稀释法;大肠埃希菌检查和大肠菌群检查均为常规法。结果:在3次独立的平行试验中,5株试验菌回收率均大于70%,符合验证要求。结论:该方法消除了样品的抑菌性,可用于该品种的微生物限度检查。
Objective: To establish a microbial limit test method for Niuhuang Shangqing Capsule and verify the method. Methods: Bacteria counting method is a medium dilution method; mold, yeast count method is a medium dilution method; E. coli examination and coliform group examination are conventional methods. RESULTS: In three independent parallel tests, the recoveries of the five test bacteria were all greater than 70%, which met the verification requirements. Conclusion: This method eliminates the bacteriostatic effect of the sample and can be used for microbial limit testing of the species.