医疗机构制剂在人用经验中药创新药研发的关键问题与思考

Key issues and thoughts on development of innovative Chinese medicines from hospital preparations based on experience of use in clinic

医疗机构制剂作为践行中医药理论、落实临床使用经验、实现中药新药转化中不可或缺的关键环节。以中药医疗机构制剂为基础和源泉,进一步积累人用经验进而研发中药创新药,在中药创新药研发中具有重要意义。医疗机构制剂自身具有转化为新药的土壤,便于开展人用经验证据收集,且部分特色医疗机构制剂品种产生较大的经济和社会价值,使得医疗机构制剂在中药创新药研发中具有明显优势。但是目前临床成果转化的观念和政策相对滞后,医疗机构制剂人用经验证据收集的研究基础相对薄弱,以及医疗机构制剂自身发展受限,制约了医疗机构制剂向中药新药的转化。本文通过对医疗机构制剂的优势及局限性分析,认为应当加强医疗机构制剂知识产权保护意识,完善转化奖励机制;鼓励加强医疗机构制剂研究基础,开展二次开发和再评价;维护好医疗机构制剂的生存和发展空间,形成医院制剂发展的良性循环;修订和完善人用经验证据收集的配套法规和相关技术要求;搭建中药临床人用经验转化平台,加强人用经验的数据的积累和收集。通过解决医疗机构制剂研发和应用问题,推动基于人用经验的中药创新药研发,使临床经验方-医疗机构制剂-中药新药的研发路线更加通畅和高效。

Hospital preparations are the indispensable link in practicing traditional Chinese medicine theory,inheriting clinical experience,and realizing the transformation of new Chinese medicines.Accumulating experience of using hospital preparations in human is of great significance in the development of innovative traditional Chinese medicines.Hospital preparations,with the convenience for collecting clinic experience and great economic and social values for some of them,have the advantage to be converted into innovative drugs.However,as the concepts and policies for the conversion of clinical outcomes are relatively lagging and the basic research on the clinical evidence of some preparations are relatively limited,few hospital preparations have been converted to new traditional Chinese medicines.In this article,we analyzed the advantages and limitations of hospital preparations,and put forward some suggestions as follows:the protection of intellectual property rights of hospital preparations should be strengthened,the reward mechanism should be improved,proceeding research of hospital preparations should be encouraged,and the survival and development space of hospital preparations should also be maintained.Only in this way,a virtuous circle for the development of hospital preparations can be formed.In addition,the supporting regulations and relevant technical requirements for collecting human experience also need to be improved.The platform for the conversion of traditional Chinese medicine with clinical human experience were suggested to be built.By solving the problems of hospital preparations'development and promoting the research of innovative traditional Chinese medicines based on human experience in clinic,the route of converting empirical prescriptions to hospital preparations and then to new drugs is hoped to be more smooth and efficient.