头孢匹胺注射剂国内外质量现状分析  

Analysis on the Quality of Cefpiramide for Injection at Home and Abroad

作　　者：肖慧[1] 武建卓[1] 洪建文[1] Xiao Hui;Wu Jian-zhuo;Hong Jian-wen(Guangdong Institute for Drug Control,Guangzhou 510663)

机构地区：[1]广东省药品检验所,广州510663

出　　处：《国外医药（抗生素分册）》2020年第6期411-415,共5页World Notes on Antibiotics

摘　　要：本文通过对头孢匹胺注射剂的基本信息、国内外上市情况、参比制剂、生产工艺等信息进行了梳理,结合国家评价性抽验质量情况,比较了该品种国内外质量标准和质量情况,探讨了该制剂在仿制过程中关注点,为国内开展该品种的质量与疗效一致性评价提供参考。In this paper,the basic information,domestic and foreign marketing situation,reference preparation,production technology and other information of cefpiramidefor injection were sorted out.Combined with the national evaluation quality situation,the quality standards and quality situation of cefpiramidefor injection at home and abroad were compared,and the focus of the preparation in the process of imitation was discussed,which provided reference for the quality and efficacy consistency evaluation of cefpiramidefor injection in China.

关 键 词：头孢匹胺 国内外现状 一致性评价 

分 类 号：R978.1[医药卫生—药品]