临床有效中药单味制剂研究进展

Research progress on clinically effective single preparations of traditional Chinese medicine

中药单味制剂又称“单方成药”,是指由传统单味中药、单味中药有效部位(含有效成分)作为处方,通过现代化研究、生产制成的中成药。其具有历史悠久、疗效确切、副作用少等优点,是中药新药研发中必不可少的一部分。近年来,随着国家政策的优化,中药新药研发动力十足,中药单味制剂的发展也呈现出利好的趋势。但因同时存在构成比例不均衡、适应症有待拓展、基础研究尚待继续深入以及高校科研院所现有专利成果转化率低的情况,尚存在较大开发空间。该文通过统计分析《中华人民共和国药典》中的单味制剂,检索查阅相关临床应用、基础研究、专利申请、产业化等信息,分析研究中药单味制剂发展现状、特点和难点,为中药单味制剂的开发提供方向。

The traditional Chinese medicine(TCM)single preparation refers to the innovative TCM made from the whole or the effective part(including the effective ingredient)extract of a TCM single herb by modern technology.They have a long history of applications,definite effects and few side effects.It is an indispensable part of the research of innovative TCM.In recent years,with the optimization of national policies,the development of TCM single preparation shows a positive trend.However,because of the imbalance in the composition ratio,the need for expansion of indications,the need for further basic research,and the low conversion rate of existing patent achievements in universities and institutes,the TCM single preparation still has significant development space.In this review,we analyze and study the current situation,characteristics and difficulties of TCM single preparation,as well as relevant clinical application,basic research,industrialization and patent application information through statistical analysis of TCM single preparations in the Chinese Pharmacopoeia,which helps to provide direction for the development and research of single preparation of TCM.