头孢呋辛酯胶囊微生物限度检查方法的验证实验研究

Study on Microbial Limit Test of Cefuroxime Axetil Capsule

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 method for microbial limit test of cefuroxime axetil capsule. METHODS Based on the viable count of test bacteria to choice method and identify the most sensitive strains, by using low-speed centrifugal precipitation test solution and membrane filtration to remove the antibacterial activity of cefuroxime axetil. It was confirmed whether its antibacterial activity had been removed thoroughly. RESULTS The method passed the validation test of Ch. P （2005）. The Bacillus subtilis and Stapbylococcus aureus were the most sensitive strain. CONCLUSION This method can be an effective method for the quality control of the medicines, and can be used in microbial limit test for cefuroxime axetil capsule.