注射用盐酸头孢替安国内外质量现状分析  

Quality Analysis of Cefotiam Hydrochloride for Injection at Home and Abroad

作　　者：彭洁[1] 洪建文[1] Peng Jie;Hong Jian-wen(Guangdong Institute for Drug Control,NMPA Key Laboratory for Rapid Testing Technology of Drugs,Guangzhou)

机构地区：[1]广东省药品检验所,国家药品监督管理局药品快速检验技术重点实验室,广州510663

出　　处：《国外医药（抗生素分册）》2020年第6期430-433,共4页World Notes on Antibiotics

基　　金：广东省科技计划项目(2018B020207008)。

摘　　要：本文通过对注射用盐酸头孢替安的基本信息、国内外上市情况及参比制剂信息的梳理,结合该品种国家评价性抽验情况,在处方工艺、质量标准进行对比,探讨了该制剂在仿制过程中质量控制的关键点,为国内开展该品种的质量与疗效一致性评价提供参考。Based on the basic information of Cefotiam hydrochloride for injection,the marketing situation at home and abroad,and the information of reference preparation,combined with the national evaluation sampling test of Cefotiam hydrochloride for injection,the formulation technology and quality standards were compared,and the key points of quality control in the process of imitation were discussed,which provided reference for the quality and efficacy consistency evaluation of Cefotiam hydrochloride for injection in China.

关 键 词：注射用盐酸头孢替安 国内外现状 一致性评价 

分 类 号：R978.1[医药卫生—药品]