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目的:对六味地黄软胶囊微生物限度检查方法进行方法学验证。方法:采用平皿记数法,分组分别使用5种实验菌验证。试验组取供试液加菌液注入培养基中培养。菌液组分别取各实验菌液注入培养基中培养。稀释剂对照组取稀释剂加菌液注入培养基中培养。供试品对照组取供试液注入培养基中培养。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。采用观察大肠埃希菌、大肠菌群与阴性金黄色葡萄球菌在相同环境下的培养来验证控制菌的检查方法。结果:各试验菌的回收率均高于70%,稀释剂对5种试验菌的回收率均高于70%。结论:采用常规法可以进行本品的微生物限度检查。
Objective: To verify the methodology of microbial limit test of Liuweidihuang soft capsule. Methods: Using the plate counting method, groups were verified using 5 experimental bacteria. The test group took the test solution plus the broth to inject into the culture medium. In the bacterial solution group, each experimental bacterial solution was inoculated into the culture medium. In the diluent control group, the diluent and bacterium were injected into the culture medium. For the control group, the test solution was injected into the culture medium for injection. The recovery of each test for each test was calculated by 3 independent parallel tests. The inspection method for the control bacteria was verified by observing the cultivation of Escherichia coli, coliform bacteria and negative Staphylococcus aureus in the same environment. Results: The recoveries of all test bacteria were higher than 70%, and the recoveries of diluents were higher than 70% for 5 test bacteria. Conclusion: The microbial limit test of this product can be performed by conventional methods.