注射剂灭菌工艺研究存在的常见问题及几点思考  

Common problems and related considerations of sterilization process of injection

作　　者：陈晓莉[1] 赵慧玲[2] 

机构地区：[1]国家食品药品监督管理局药品认证中心,北京100061 [2]国家食品药品监督管理局药品审评中心,北京100038

出　　处：《中国新药杂志》2009年第9期780-783,共4页Chinese Journal of New Drugs

摘　　要：总结了注射剂灭菌工艺研究中存在的常见问题,如处方研究前未了解药物的稳定特性,忽视了附加剂和灭菌工艺的筛选、无菌保证值和F0值的考察以及工艺验证研究等,并针对上述问题提出了保证注射剂安全性和稳定性的若干建议。This article summarized the common problems occurring in sterilization process of injection products, such as lacking sufficient knowledge of drug stability, ignoring screening of excipients and sterilization process, neglecting sterilizing ensuring level and F0 study and process validation. It also provided some considerations for ensuring the safety and stability of injection products.

关 键 词：注射剂 无菌保证值 F0值 灭菌工艺 灭菌工艺验证 

分 类 号：R944.11[医药卫生—药剂学]