从中药资源质量质量标志物认识中药产业的健康发展.docVIP

屮草药 2016,18(47),3149-3154 DOI: 10.7501 /j.issn.0253-2670.2016.18.001 从中药资源-质量-质量标志物认识中药 产业的健康发展 刘昌孝 天津药物研究院新药评价研宄中心 导出/参考文献关注 分享 收藏打印 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 棊础。道地药材是在特定自然条件、生态环境的地域A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冇效性和安全性直 接关联。根据屮药化学成分与植物次生代谢物生物合成的关联性,为反映屮药材、 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 屮药全程质量控制及质量溯源体系。 关键词： 中药资源;中药质量;质量标志物;中药产业;中药产业链;质量溯源; 作者简介：刘昌孝，中国工程院院士。E-mail:liuchangxiao@l63. com 收稿日期：2016-08-18 基金：国家自然科学基金重点项0 Recognizing healthy development of Chinese medicine industry from resourcesquality-quality markers of Chinese medicine LIU Chang-xiao Research Center for New Drug Evaluation，Tianjin Institute of Pharmaceutical Research; Abstract： 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 preparati