中药二次开发的研究思路探讨

将中药二次开发作为中药研发的方向之一,有助于在中药研发领域创造新价值。通过综述近年来药物二次开发的研究热点,分析国内改给药途径、改剂型中药的获批情况,了解中药二次开发中相关的技术方法,提出了中药二次开发的研究思路。当前药物二次开发的研究热点:非抗癌药用于癌症、药物重新定位于罕见病、改变给药途径对呼吸系统疾病再治疗、非呼吸系统疾病药物的吸入疗法再利用。中药的二次开发不完全等同于化学药的老药新用,有其自身特点,可参考的研究思路:(1)优化生产工艺、选择更合适的剂型、优化临床给药途径等;(2)提升中成药的质量控制水平;(3)阐明中药的活性成分与作用机制;(4)进一步聚焦有良好疗效的中药优势病种,如一些疑难疾病、慢病、罕见病的病种。

Discussion on research ideas of secondary development of traditional Chinese medicine

Taking redevelopment of traditional Chinese medicine (TCM) as one of the directions of TCM research and development is helpful to create new value in TCM research and development. In this paper, research hotspots of redevelopment of drugs in recent years were reviewed, and the approval situation of modified administration route and modified dosage form of TCM were analyzed, the relevant technical methods in the redevelopment of TCM were understood, and research ideas of the redevelopment of TCM were put forward. The current research hotspots of drug redevelopment include the use of non-anticancer drugs for cancer, drug reorientation for rare diseases, retreatment of respiratory diseases by changing drug delivery routes, and the reuse of inhalation therapy for non-respiratory diseases. The secondary development of TCM is not exactly the same as the new use of old chemical drugs, but it has its own characteristics. The following research ideas can be referred to: (1) Optimize the production process, choose more appropriate dosage form, and optimize the route of administration, etc.; (2) Improve the quality control level of proprietary Chinese medicines; (3) Elucidate the active ingredients and mechanism of action of TCM; (4) Further focus on dominant TCM diseases with good curative effects, such as some difficult diseases, chronic diseases and rare diseases.