复方药品创新研发策略  

Strategy of fixed-dose combination innovative development

作　　者：袁秉祥[1,2] 陈莉娜[1,2] 王冰 

机构地区：[1]西安交通大学医学院药理学系 [2]陕西省新型治疗疫苗工程技术研究中心

出　　处：《中国临床药理学与治疗学》2013年第10期1175-1181,共7页Chinese Journal of Clinical Pharmacology and Therapeutics

基　　金：国家自然科学青年基金项目(30901808);陕西省科技统筹创新工程计划项目(2011KTCL03-20)

摘　　要：固定剂量复方药品研发是创新过程,目前已成为突破药物研究瓶颈的新出路之一。复方药品组方必须基于药物相互作用理论,充分利用与治疗目的相同的作用和效应,进行组方论证,进行多因素多水平分析和临床联合用药验证,确定目标组方,最后进入新药规范化研究和试验。复方药品的创新研发全过程(药学、药效学、药动学、毒理学和临床试验)与全创新药物同样规范和严格,并且必须进行拆方分析。本文从复方药品组方原则、研发策略、研发技术要求规范要点等方面进行了综述。Development of fixed-dose combi nation finished pharmaceutical products （FDC- FPPs, FDCs） is an innovative process and has become one of the breakthrough strategies for removing the bottlenecks in drug discovery. Formulating prescription of FDCs is based on drug interactions theory. The principle of for-mulating prescription is taking full advantage of the drugs＂ effects with a same remedy goal, then proceeding a demonstration of the prescription and multi-factor and multi-level analyses, verif ying of clinical combinations, confirming of the goal prescription, finally accessing the normalize research and trials of new drug development. The whole process of FDCs research and devel-opment （pharmacy, pharmacodynamics, phar macokinetics, toxicology and clinical trials） is as strict as such of the complete innovative drug, and need to optimize the formula and the ratio of prescription. This review summarizes the princi ples of formulating prescription, development strategy, and technical requirements specifica tion of FDCs.

关 键 词：复方药品研发 药物相互作用理论 多因 素多水平分析技术 组方原则 技术要求规范 

分 类 号：R965.1[医药卫生—药理学]