医疗机构中药制剂向中药新药转化的探讨

笔者分析了医疗机构制剂在新药开发中的优势，指出医疗机构中药制剂研发中存在临床评价不规范、医疗机构自身新药开发能力较低、缺少良好的合作研发平台及知识产权保护问题等问题。针对上述问题，笔者提出三点建议：一是规范临床研究，建立信息数据库；二是医疗机构、科研机构和药品生产企业联合创建良好的新药研发平台；三是加强知识产权及研究者利益的保护。全文为医疗结构在新的药品注册法规体系下，促进医疗机构中药制剂向新药转化提供一些思路。

Inquiry on TCM preparation transforming to new TCM drugs in medical institutions

The authors analyzed the advantages of the medical institutions preparation in the development of new drugs,pointed out that medical institutions had problems of non-standard clinical evaluation,low drug development capabilities,lacking good cooperation in research and development platform and intellectual property protection.In response to these problems,the authors put forward three suggestions: 1.standardizing clinical research and establishing an information database;2.medical institutions,research institutions and pharmaceutical manufacturing companies combined to establishing a good drug discovery platform together;3.the intellectual property rights and researcher interests should be protected.The whole text provided some ideas that can promote TCM preparation in medical institutions to convert to new drugs in the new drug registration and regulation system.