我国中药缓控释制剂的研究状态分析  

R & D Progresses:Sustained-Release TCM Drugs in China

作　　者：陈立兵[1] 葛卫红[1] 张继稳[2] 

机构地区：[1]浙江中医药大学,杭州310053 [2]中国科学院上海药物研究所,上海201203

出　　处：《世界科学技术-中医药现代化》2007年第5期83-90,共8页Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology

基　　金：科技部国家科技支撑计划项目(2006BAI098B08-08):现代制剂技术在中药制剂中应用的适宜性研究

摘　　要：目的:回顾分析我国中药缓控释制剂研究进展和存在的问题,为中药缓控释制剂研发提供思路。方法:系统检索国家食品药品监督管理局的药品注册和审批数据库、国家知识产权局专利数据库和中文文献数据库,统计分析中药缓控释制剂新药注册、专利和文献,进行信息学统计;分析中药缓控释制剂研究若干关键技术领域的进展。结果:中药缓控释制剂论文、专利和药品注册等均呈上升趋势,研究的深度和广度显著加强,针对成型技术、释放度、吸收动力学和体内药动学等关键技术的研究取得进展,但在研究方法学上存在重要缺陷,多局限于单组分评价和套用化学药缓控释制剂评价方法,亟待建立符合中医药整体观的中药缓控释制剂体内外评价方法。结论:中药缓控释制剂研究取得明显进步,但需要加强新药研发和注册,其评价理论亟待创新和发展。This paper reviews the development progress of sustained - release TCM drugs in China, with an analysis of the existing problems in the area. It explores new technical lines for developing sustained -release TCM drugs. Authors searched the State Food and Drug Administration＇s database on drug approval and registration, and the State Intellectual Property Office＇s patent database and Chinese literature database on new drug registrations, in an attempt to analyze the development progress and trends from a statistical point of view. Authors also review the development progress of some key technological areas that contribute to the sustained - release TCM drugs. Drug registration records, patents, and sustained - release TCM drug data show that more efforts have been made in the area, and studies of sustained - release TCM drugs have gone deeper and wider. People have made substantive progresses in studying the molding techniques, releasing rate, absorption kinetics, and pharmacokinetics of sustained - release TCM drugs. Authors also point out that there are some major deficiencies in the methodologies used in the study. Most of the studies are confined to a single - component based evaluation. Authors believe that new methodology is needed to study sustained -release TCM drugs in vitro/vivo. It is concluded that study of sustained - release TCM drugs has made significant progresses, though one has to pay more attention to the development and registration of new drugs. It is also important to create new methodology for studying sustained -release TCM drugs.

关 键 词：中药 缓释制剂 控释制剂 多组分 

分 类 号：R965.1[医药卫生—药理学]