基于名老中医经验方的中药新药研发策略分析

Research and Development of New Traditional Chinese Medicine Based on Experienced Prescriptions of Prestigious Chinese Physicians

名老中医经验方是当代名老中医在临床实践过程中形成的确有疗效的方剂,体现了中医对疾病发生发展规律及核心病机的认识,是组方用药规律的宝贵经验,代表了中医临床最高诊疗水平的治疗方案,是新药研发和科技创新的主要源头。传承名老中医的学术思想和临床经验,挖掘、整理名老中医经验方,开发出中药新药,具有重大的现实意义。基于名老中医经验方的中药新药研发是国家重点鼓励研发的方向,也是目前申报量最大的中药新药类别,但近年来批准上市的此类中药新药却非常少。究其原因,研发人员对国家关于此类中药新药的审评理念及相关技术要求了解不够,导致在中药新药研发策略上存在一定问题,是此类中药新药批准上市数量低的主要原因。为了更好地推进名老中医经验方新药研发工作顺利开展,充分发挥名老中医经验方在中药新药研发中的独特优势,该文针对目前名老中医经验方新药研发中存在的问题,强调以临床价值为导向、重视人用历史、全过程质量控制的中药新药研发理念,并从研发的药学、药效毒理以及临床环节需关注的问题进行了深入地分析和探讨,旨在为广大中药新药研发机构和人员提供借鉴和参考,从而研发出更多满足临床需求的安全、有效、质量可控的中药新药,为实现健康中国战略提供重要保障。

The experienced prescriptions of famous prestigious Chinese physicians are effective prescriptions developed by prestigious Chinese doctors during their long-time clinical practice, which reflect the traditional Chinese medicine (TCM) understanding of the disease development regularity and core pathogenesis. These experienced prescriptions provide valuable experience for medication and prescription regularities, and represent the highest level of TCM treatment and the major sources of new drug research, development and technology innovation. It is of great significance to inherit academic thoughts and clinical experiences of prestigious Chinese physicians, explore and summarize experienced prescriptions, and develop new Chinese drugs. The researches of new drugs based on experienced prescriptions are the major direction encouraged by the government, with the maximum amount of new TCM drug applications but a low approval rate in recent years. The main reason for the low number of approved new TCM drug applications is that researchers know less about evaluation concepts and relevant techniques, leading to problems in research and development strategy. To facilitate a smooth advance of the new drug research and development and take full advantage of the experienced prescriptions, in this paper, we focus on the problems about new drug development of experienced prescriptions, lay emphasis on the new TCM drug research and development concepts of clinical value, history of human application and whole-process quality control, and deeply and systematically analyze concerns in such links as pharmacy, pharmacodynamics, toxicology and clinic application. The purpose of this article is to provide the reference in solving actual problems, the reliable basis of further researches on experienced prescriptions, and the important guarantee for developing more safe, effective and high-quality controllable drugs to meets clinical requirements, so as to achieve the strategy of a healthy China.