复方心血管药物的质量研究与评价  

Quality control research and review of compound cardiovascular drugs

作　　者：张震[1] 张玉琥[1] 康彩练[1] 

机构地区：[1]国家食品药品监督管理局药品审评中心,北京100038

出　　处：《中国临床药理学杂志》2009年第5期471-474,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：复方心血管类药物在化药复方制剂的注册申请中占有相当大的比例;但研究人员在进行该类药物的研究尤其是在质量研究方面,存在设计不合理、研究不规范现象。本文就心血管复方制剂的特点、开发构想及质量研究和评价重点进行阐述,以供研发者进行试验研究时的参考。Nowadays,the registration of the compound cardiovascular drugs are to go up,while there remain many problems in the design and research methods of this kind of drugs in the domestic research. In thearticle,the writer detail with the characteristic,development strategies,the unode of the quality control research and reviewof the compound car-diovascular drugs and hope to give advises to the domestic researchers.

关 键 词：复方心血管药物 质量研究 质量评价 

分 类 号：R972[医药卫生—药品] R954[医药卫生—药学]