【摘要】 中药新药研发中药材研究是新药研发的前提和基础,它贯穿于整个新药研究全过程。药材研究是中药新药药学研究的主要内容之一,也是新药药学评价的重点内容。该文通过分析目前中药新药研发中药材研究资料中存在的问题,分别从药材研究理念、药材质量稳定、药材质量标准等方面进行了阐述,其中药材研究理念方面应关注重视药材研究重要作用和从新药研究的目的进行顶层设计的问题;药材质量稳定方面应关注基原、药用部位、产地、采收加工、贮藏、种植(养殖)等方面问题;药材质量标准方面应关注建立符合中药新药特点的质量标准问题,为指导中药新药研发和审评的科学性,以及为药材标准的制定提供依据。更多还原

【Abstract】 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.更多还原