诺氟沙星胶囊微生物限度检查方法的验证

Validation of Microbial Limit Test Method of Norfloxacin Capsule

目的建立诺氟沙星胶囊微生物限度检查的方法,确保检验的准确性。方法联合采用薄膜过滤和在培养基加入MnSO4的方法,验证诺氟沙星胶囊微生物限度检查方法。结果采用联合方法,可去除诺氟沙星胶囊的杀菌活性,检出样品的污染菌。结论此方法可用作诺氟沙星胶囊微生物限度的检查。

Objective To establish the microbial limit test method of norfloxacin capsule and ensure the accuracy of test.Methods The membrane fi ltration method combined with adding MnSO4 into the medium was used for the microbial limit test of norfloxacin capsule,and the validation of microbial limit test method was performed.Results The joint approach mentioned above removed the bactericidal activity of norfloxacin capsule and detected the bacteria contamination.Conclusion The method can be used for the microbial li...