替加氟注射液无菌检查方法学研究  

Sterility Test of Tegafur Injection

作　　者：王刚林 周剑 

机构地区：[1]重庆医疗器械质量检验中心,重庆401147 [2]重庆市食品药品检验所,重庆401121

出　　处：《中国药业》2014年第14期61-62,共2页China Pharmaceuticals

摘　　要：目的对替加氟注射液无菌检查的方法进行研究。方法用薄膜过滤冲洗法对替加氟注射液无菌检查的方法进行研究,同时确定最佳冲洗液量。结果采用薄膜过滤法,用pH=7.0氯化钠蛋白胨缓冲液100 mL分2次冲洗过滤,可以有效消除抑菌成分。结论该方法适用于替加氟注射液的无菌检查。Objective To study the sterility test of Tegafur Injection. Methods The membrane filtration irrigation method was used to the study of sterility test of Tegafur Injection and make sure the best flushing dose. Results Adopting the membrane filtration irrigation method and twice flushing by 100 mL of pH =7.0 sodium chloride-albumin peptone could eliminate the antibacterial components. Conclusion The established method is suitable for the sterility test of Tegafur Injection .

关 键 词：替加氟注射液 无菌检查 薄膜过滤法 

分 类 号：R927.11[医药卫生—药学] R979.1