盐酸头孢甲肟无菌粉结晶工艺优化  

Optimization of Aseptic Powder Crystallization Process of Cefmenoxime Hydrochloride

作　　者：刘玲 陈博 刘曈 LIU Ling;CHEN Bo;LIU Tong(Liaoning Haisco Pharmaceutical Co.,Ltd.,Xingcheng 125107,China;Department of Pharmacy,The First Hospital of China Medical University,Shenyang 110001,China)

机构地区：[1]辽宁海思科制药有限公司,辽宁兴城125107 [2]中国医科大学附属第一医院药学部,辽宁沈阳110001

出　　处：《化学与生物工程》2018年第8期63-65,共3页Chemistry & Bioengineering

基　　金：辽宁省高等学校基本科研项目(LQNK201739)

摘　　要：通过对盐酸头孢甲肟无菌粉结晶工艺的优化,使其结晶状态适合采用三合一设备进行批量生产,降低了无菌原料药生产过程中被金属离子污染的风险,保障了工艺的无菌水平,同时有利于粉针剂的混料及分装,保障生产顺利进行。We optimized the aseptic powder crystallization process of cefmenoxime hydrochloride,and the crystallization state is greatly suitable for quantity production using three-in-one equipment.The optimized process of the aseptic powder crystallization reduces the risk of metal ion contamination during the production process of aseptic drug substances,and immensely ensures the level of asepsis.In addition,the optimized process is vastly beneficial for mixing and dispensing powder injections to ensure smooth production.

关 键 词：盐酸头孢甲肟 无菌 结晶 优化 

分 类 号：TQ465.1[化学工程—制药化工] R978.1[医药卫生—药品]