R&D Progresses: Sustained-Release TCM Drugs in China
我国中药缓控释制剂的研究状态分析

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.