中文摘要：

中药资源是中医药健康事业可持续发展的基础,也是中药产业可持续发展的物质基础。道地药材是在特定自然条件、生态环境的地域内所生产的药材。其质量又与地域性、多样性、可变性和人文性的＂四性＂特点密不可分,它决定了中药资源发展中所占有的特殊性和规律性。中药的有效性及安全性是中药质量的核心问题,然而现行的中药质量问题、质量评价和控制方法尚存在难以客观反映中药内存在的质量问题,质量标准中测定及鉴别的成分尚不能和中药有效性和安全性直接关联。根据中药化学成分与植物次生代谢物生物合成的关联性,为反映中药材、饮片、提取物、单方或复方制剂中的与功效有关物质与质量的关系,重申定义中药质量标志物的基本条件。着眼于全过程的物质基础的特有、差异、动态变化和质量的传递性、溯源性,建立质量标志物中药产业链全过程控制体系,有利于建立中药全程质量控制及质量溯源体系。

英文摘要：

Chinese medicine resources are the basis of the sustainable development of the health of Chinese medicine, and also the material basis for the sustainable development of Chinese medicine industry. Geoherbs are produced in the specific natural conditions, the ecological environment in the area of medicine. The quality of the medicinal materials is closely related to the characteristics of regional, diversity, variability, and humanity. It determines the particularity and regularity of the development of Chinese medicine resources. The effectiveness and safety of Chinese medicine are the core problems of the quality of Chinese medicine. However, the current Chinese medicine quality issues, quality evaluation, and control methods still exist and cannot objectively reflect the Chinese medicine problems in quality, quality standard in the determination and identification of components is not related with the effectiveness and safety. According to the relevance of the chemical constituents in Chinese medicines and plant secondary metabolite biosynthesis for reaction in herbs, herbal extracts, or compound preparation, and effects on the quality of medicinal materials, the author reiterated markers for defining the quality of traditional Chinese medicine basic conditions. Focus on the material foundation of characteristic, difference, and dynamic change in whole process and quality transfer and traceability, the author believes that to establish quality markers of drug industry chain whole process control system, is conducive to the establishment of a full Chinese medicine quality control and quality traceability system.