【摘要】 目的:逐步建立统一的注射剂无菌检查方法标准。方法:按2005年版《中国药典》规定,采用薄膜过滤法对15种注射用头孢菌素进行系统的无菌检查方法研究。结果:各头孢菌素有不同程度的抗菌活性,但在冲洗液冲洗500mL·筒-1、加酶量300万IU·筒-1的试验条件下,抑菌活性均可消除。结论:无菌检查方法的验证是必要的,头孢菌素无菌检查方法可以统一,形成标准操作规范。更多还原

【Abstract】 OBJECTIVE: To establish step by step the unified criteria for the sterility test methods of cephalosporins. METHODS: According to the China Pharmacopoeia( 2005 edition) , sterility test methods of 15 cephalosporins were studied by membrane- filter procedure. RESULTS: Various cephalosporins showed different degree of antibacterial activity, but which could be counteracted by the added rinse solution ( at a dosage of 500mL/ cartridge) and enzyme ( at a dosage of 3 000 000 IU/ cartridge) . CONCLUSION: The verification for sterility test methods of cephalosporins is necessary, and the sterility test meth-ods of cephalosporins can be unified to be standardized operation criteria.更多还原