医疗机构中药制剂成果转化的现状及难点  

Current Situation and Difficulty of Achievements Transformation of Hospital Traditional Chinese Medicine Preparation

作　　者：何嘉仑[1] 唐洪梅[1] 张建军[2] 丘振文[1] 杨忠奇[1] HE Jialun;TANG Hongmei;ZHANG Jianjun;QIU Zhenwen;YANG Zhongqi(The First Affiliated Hospital of Guangzhou University of Chinese Medicine,Guangdong Guangzhou 510405,China;Guangdong Second Traditional Chinese Medicine Hospital,Guangdong Guangzhou 510095,China)

机构地区：[1]广州中医药大学第一附属医院,广东广州510405 [2]广东省第二中医院,广东广州510095

出　　处：《中国医药导刊》2022年第5期466-469,共4页Chinese Journal of Medicinal Guide

基　　金：广州市科技计划项目(项目编号:202102010013,项目名称:中药早期临床研究重点实验室)。

摘　　要：医疗机构(医院)中药制剂发展至今,有较为丰富的人用经验,而基于人用经验的中药新药研发是中医药的优势,也是发展的趋势。随着新的法规以及针对中药人用经验整理和总结的技术要求进一步明晰,中医临床实践在中药新药注册审评中的作用日益显现。如何有效、充分地开发利用中医药独特优势的原创资源并实现成果转化,是中医药工作者需要深入思考和解决的关键问题。本研究从医院中药制剂转化为中药新药的优势以及新政策等方面,阐述医疗机构中药制剂成果转化的现状,从临床成果转化的观念、临床价值、临床数据、质量标准等方面说明医院中药制剂新药转化的难点并提出建议,以期为日后更多优质的医院中药制剂转化为中药新药提供参考。Medical instiutions(hospital)traditional Chinese medicine(TCM)preparations have rich human use experience developed up to now,and the research and development of TCM new drug based on human use experience is the advantage and development trend of TCM.With the further clarification of new regulations and technical requirements for the collation and summary of human use experience of TCM,the summary of TCM clinical practice will play an increasingly important role in the registration and evaluation of TCM new drug.How to effectively and fully develop and utilize the TCM original resources with unique advantages and realize the transformation of achievements is a key problem that TCM practitioners need to think and solve.Therefore,this paper expounds the current situation of the achievements transformation of hospital TCM preparations from the advantages and new policies of transforming hospital TCM preparations to TCM new drugs,and illustrates the difficulties in the achievements transformation of hospital TCM preparations from the aspects of the concept,clinical value,clinical data and quality standards of the transformation of clinical achievements,and puts forward the suggestions,in order to provide reference for transforming more hospital TCM preparations into TCM new drugs in the future.

关 键 词：医疗机构 中药制剂 成果转化 人用经验 

分 类 号：R288[医药卫生—中药学]