精准医学下的中药新药创制与质量评控

Precision Medicine Oriented Drug R&D and Quality Control of Traditional Chinese Medicine

精准医疗已成为国际生物医药发展的重要趋势,从某种意义上讲,注重个体化诊疗的中医药就是精准医疗的先驱。为了更好地满足临床治疗及行业提质增效的重大关切和需求,以精准医疗为导向,以"精准研发,精准质控,精准用药"为核心和目标,将是未来中药现代化发展与研究的重大课题。其中,基于临床精准定位的中药新药创制是精准研发的关键,关联临床功效的中药质量生物评价是精准质控的核心,关联临床病证的中药安全性评价是精准用药的重点。本文简要介绍了有关"精准研发"、"精准质控"的一些想法及做法,供全国同行们参考和商榷。

Precision medicine has become an important trend in the development of international biomedicine. To some extent, traditional Chinese medicine （TCM）, characterized by individual diagnosis and treatment, is the pioneer of precision medicine.Taking ＂Precision R ＆ D, Precision Quality Control and Precision Medicine＂ as the core and target, precision medicine oriented drug research will be a great challenge for the modernization and development of TCM in the future, which is better meet the major concerns and needs in improving quality and performance of clinical treatment and TCM industry. Among them, precise clinical positioning oriented new drug innovation is the key of TCM R ＆ D. Biological assay related to clinical efficiency is the core of precision quality control of TCM. Safety evaluation associated with clinical syndrome is the focus of TCM-based precision medicine. This article is a summary of our views and experiences in precision R ＆ D and precision quality control as a reference.