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目的建立头孢呋辛酯胶囊微生物限度检查方法。方法通过对试验菌活菌数回收测定进行方法选择、确定敏感菌株,采用低速离心沉淀处理供试液与薄膜过滤方法去除头孢呋辛酯的抗菌活性,经验证试验来确认其抑菌活性是否去除。结果枯草芽孢杆菌、金黄色葡萄球菌为敏感菌;经验证本方法达到中国药典2005年版验证试验的要求。结论本方法可有效的控制头孢呋辛酯胶囊质量,可作为头孢呋辛酯胶囊的微生物限度检查方法。
Objective To establish a microbiological limit test method of cefuroxime axetil capsule. Methods The method was used to determine the viable count of test bacteria, and the sensitive strains were identified. The antibacterial activity of cefuroxime axetil was removed by low speed centrifugation for the test solution and membrane filtration. The antibacterial activity was determined by confirmatory test . Results Bacillus subtilis, Staphylococcus aureus is a sensitive strain; this method has been verified by the Chinese Pharmacopoeia 2005 edition validation test requirements. Conclusion This method can effectively control the quality of cefuroxime axetil capsule, which can be used as the limit of microbial test for cefuroxime axetil capsules.