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目的:验证注射用头孢曲松钠的无菌检查方法。方法:照《中国药典》2010年版二部附录“无菌检查法”规范操作,用薄膜过滤法对注射用头孢曲松钠(3个批号)作无菌检查,并对方法进行验证。结果:薄膜过滤法是可溶性药品无菌检查的首选方法,但不同性质药品的操作过程应作相应调整。结论:将分次过滤、分次冲洗应用于薄膜过滤法是注射用头孢曲松钠无菌检查的首选方法
Objective: To verify the sterility of ceftriaxone sodium for injection. Methods: According to the “Chinese Pharmacopoeia” 2010 edition two appendix “sterility test method ” standard operation, using thin-film filter method for injection of ceftriaxone sodium (3 lot) for sterility test and verify the method. Results: Membrane filtration was the preferred method for sterility testing of soluble drugs, but the operation of different types of drugs should be adjusted accordingly. Conclusion: The method of fractional filtration and fractional flushing applied to the membrane filtration method is the preferred method for the sterile examination of ceftriaxone sodium for injection