原料药工艺开发要点和质量控制措施  

Key Points of Active Pharmaceutical Ingredient(API)Process Development and Quality Control Measures

作　　者：苑晓艳 何伯海 YUAN Xiaoyan;HE Bohai(Lianyungang Runzhong Pharmaceutical Co.,Ltd.,Lianyungang 222000,China)

机构地区：[1]连云港润众制药有限公司,江苏连云港222000

出　　处：《化工管理》2024年第29期158-160,共3页Chemical Management

摘　　要：作为药品研发流程中的核心环节,原料药(API)工艺开发的成功与否直接关乎药品的质量优劣、安全性高低以及生产效率的高低。文章简要分析了原料药工艺开发的基本流程,探究了工艺开发过程中面临的关键问题及挑战。同时,从临床前阶段到临床阶段等不同层面,探讨了原料药工艺开发各阶段的特点。在此基础上,提出了相应的质量控制策略,以确保原料药质量的持续稳定。As the central aspect of the pharmaceutical research and development process,the success of active pharmaceutical ingredient(API)process development directly impacts the quality,safety,and production efficiency of drugs.This paper briefly analyzes the basic procedure of API process development and explores the key issues and challenges faced during the process.Meanwhile,it discusses the characteristics of various stages of API process development,ranging from the preclinical phase to the clinical phase.Based on this,corresponding quality control strategies are proposed to ensure the consistent stability of API quality.

关 键 词：原料药 工艺开发 质量控制 医药化工 

分 类 号：TQ460.6[化学工程—制药化工]