化药原料药当前药学审评技术要求初探  

Thoughts on current chemistry,manufacturing&control (CMC) technical review requirement of chemical active pharmaceutical ingredients

作　　者：操锋[1] 马玉楠[2] 

机构地区：[1]中国药科大学药剂学教研室,南京210009 [2]国家食品药品监督管理总局药品审评中心,北京100038

出　　处：《中国药科大学学报》2014年第3期274-280,共7页Journal of China Pharmaceutical University

摘　　要：回顾近十年来我国药品研发和审评的历程,分析目前我国医药行业形势及国家食品药品监督管理总局药品审评中心(CDE)对化药原料药审评理念和技术要求的变化。结合CDE审评现状详细分析了原料药研发要点,从合成工艺、起始原料和中间体的控制、关键步骤及工艺参数、晶型、批量、结构确证、质量研究、质量标准以及稳定性等多个方面介绍了药品研发中应该注意的问题,供我国新药研发人员参考。This article reviews drug research and evaluation history in China in the last decades, which analyses current status of Chinese pharmaceutical industry and changes of chemical active pharmaceutical ingredient evaluation principles and technical requirement from Center for Drug Evaluation （CDE） of China Food and Drug Administration （CFDA）. Key points during the research and development of active pharmaceutical ingredient are detailed analyzed in connection with the current drug evaluation status and issues should be paid attention during the drug research and development are introduced from synthesis process, control of starting material and intermediate, key steps and processing parameters, crystal form, batch, structural identification, research of quality, quality standard and stability and other perspectives. This article can be considered by persons for drug research and development in China.

关 键 词：化学药 原料药 药学技术审评 新药研发 

分 类 号：F203[经济管理—国民经济] F426.72[化学工程—制药化工] TQ460