Zhou Gang, Wang Ting, He Yan-Ping
Zhongguo Zhong Yao Za Zhi. 2014 Aug;39(16):3192-5.
Medicinal materials research and development of new drug of traditional Chinese medicine (TCM) research is the premise and foundation of new drug research and development, it throughout the whole process of new drug research. Medicinal materials research is one of the main content of the pharmaceutical research of new drug of TCM, and it is also the focus of the new medicine pharmaceutical evaluation content. This article through the analysis of the present problems existing in the development of TCM research of new drug of TCM, from medicine research concept, quality stability, quality standard, etc are expounded, including medicine research idea value medicine study should focus on the important role and from the purpose for the top-level design of new drug research problem. Medicinal materials quality stability should pay attention to the original, medicinal part, origin, processing, storage, planting (breeding), and other aspects. Aspect of quality standard of medicinal materials should pay attention to establish the quality standards of conform to the characteristics of new drug of TCM. As the instruction of TCM new drug research and development and the scientific nature of the review, and provide the basis for medicinal material standards.
中药材研究是中药新药研发的前提和基础,贯穿于新药研发的全过程。中药材研究是中药新药药学研究的主要内容之一,也是新药药学评价内容的重点。本文通过分析中药新药研发中中药材研究存在的问题,从药材研究理念、质量稳定性、质量标准等方面进行阐述,包括药材研究思路价值、药材研究应关注的重要作用以及新药研发顶层设计目的问题。中药材质量稳定性应关注产地、药用部位、来源、炮制、贮藏、种植(养殖)等方面。中药材质量标准方面应注重建立符合中药新药特点的质量标准。为中药新药研发及审评的科学性提供指导,并为药材标准提供依据。