注射用头孢尼西钠无菌检查方法的优化及关键影响因素  

Optimization of sterility test method and key infl uencing factors of cefonicid sodium for injection

作　　者：肖建光[1] 欧国栋 赖珊[1] 洪建文[1] Xiao Jian-guang;Ou Guo-dong;Lai Shan;Hong Jian-wen(Guangdong Institute of Drug Control,Guangzhou 510663)

机构地区：[1]广东省药品检验所,广州510663

出　　处：《中国抗生素杂志》2021年第4期287-290,共4页Chinese Journal of Antibiotics

摘　　要：目的对2019年国家评价性抽验注射用头孢尼西钠无菌检验情况进行分析,对无菌检验方法进行改进并验证。方法参考《中国药典》2015年版四部,采用薄膜过滤法加头孢菌素酶对注射用头孢尼西钠无菌检查方法进行优化。结果取供试品适量,用0.9%无菌氯化钠溶解,制成约60mg/mL的溶液,采用薄膜过滤法,以0.1%蛋白胨水作冲洗液,加入头孢菌素酶约50万单位/筒,并以金黄色葡萄球菌为阳性对照菌,进行注射用头孢尼西钠的无菌检查。80批次的样品合格率100%。结论注射用头孢尼西钠无菌检查总体质量较好,所建方法可为该品种无菌检查的共性检查方法。Objective To analyze the sterility test of cefonicid sodium for injection in 2019 national evaluation sampling test,and to improve and verify the sterility test method.Methods According to the specification of Chinese Pharmacopoeia(2015 Edition),we used the membrane filtration method and the cephalosporin enzyme approach to improve the sterility method of cefenician sodium for injection.Results Take appropriate amount of the test sample,dissolve it with 0.9%sterile sodium chloride,and prepare a solution of about 60mg/mL.In the membrane fi ltration method,0.1%peptone water was used as the washing solution,about 500,000 units/barrel cephalosporin enzyme was added,and Staphylococcus aureus was used as positive control bacteria for the sterility test of cefonicid sodium for injection.The qualifi ed rate of 80 batches was 100%.Conclusion The quality of the sterility test of cefenicillin sodium for injection is good,and the improved method can provide a reference for the sterility test of cefenicillin sodium for injection.

关 键 词：注射用头孢尼西钠 无菌检查法 方法适用性试验 

分 类 号：R978.1[医药卫生—药品] R917[医药卫生—药学]