“质量源于设计”在仿制注射剂处方工艺研究中的应用  

Application of “quality by design” in the formulation and process research of generic injections

作　　者：蒋煜[1] 杨建红[1] 王亚敏[1] 

机构地区：[1]国家食品药品监督管理总局药品审评中心,北京100038

出　　处：《中国新药杂志》2014年第8期921-924,954,共5页Chinese Journal of New Drugs

摘　　要：由于注射剂给药后直接进入血液系统,各国药监机构均将其视为风险程度最高的产品之一。本文基于"质量源于设计"(QbD)的理念,对注射液质量风险来源进行了分析。本文还从注射剂质量概况(QTPP)、关键质量属性(CQA)、基于关键物料属性(CMAs)等方面对注射剂的处方工艺变量进行了风险分析,探讨了关键工艺参数以及潜在的高风险变量,以及相应的控制策略。Injections have been considered highly risky because they are designed to be injected directly into the blood system. Based on the concept of ＂quality by design （QbD） ＂, the sources of quality risks in injec- tions were analyzed; ＂quality target product profile （QTPP）＂ and the ＂critical quality attributes （CQA）＂ of injec- tions were discussed. Besides, risks of injection formulation and process variables were analyzed, and critical process parameters and control strategies were explored on the foundation of critical material attributes （CMAs）.

关 键 词：质量源于设计 仿制注射剂 处方工艺研究 应用 

分 类 号：R95[医药卫生—药学]