天然产物国家标准样品的研制过程、现状及展望

Preparation Process,Status and Prospect of China Certified Reference Material from Natural Products

目的:介绍天然产物国家标准样品的研制过程、现状、展望和主要管理程序,为开展天然产物国家标准样品的研制奠定基础。方法:对天然产物国家标准样品的研制过程和管理程序进行了详细的说明,对目前的研制现状进行了整理和分析,对研制过程中存在的问题进行了总结,对发展趋势进行了展望。结果:天然产物国家标准样品的研制过程主要涉及来源与制备、理化性质和定性分析、纯度分析、分析方法的建立、贮藏与包装、均匀性检验、稳定性检验、定值及申报材料的撰写等9个技术方面,在加强国家标准样品的研制方面提出了要区分标准样品与标准物质的概念、稳定性与加速稳定性的关系、单体与非单体天然产物的方向,提出了研制过程中存在的问题和展望,首次公开了研制的管理程序。结论:天然产物国家标准样品是一种国家级的实物标准,对促进和控制中药的标准和质量、实现中药的产业化和现代化都具有重要的意义。

Objective:To introduce the preparation process,status,prospect,and main management procedures of China certified reference materials (CRMs)from natural products,and lay foundation for the development of China CRMs.Method:The development process and management procedure of China CRMs from natural products were described in detail.The present situation of development was collected and analyzed.The problems in the development process were summarized and the development trend was prospected.Result:The preparation process of China CRMs from natural products mainly involved sources and preparation,physical and chemical properties and qualitative analysis,purity analysis,establishment of analytical methods,storage and packaging,homogeneity test,stability test,quantitative determination,and preparation of declaration materials. In order to strengthen the development of China CRMs from natural products,it was proposed to distinguish the concept of CRMs clearly and to understand the relationships between stability and accelerated stability,as well as the direction of monomer and non-monomer from natural products.The problems and prospects in the preparation process were presented,and the management procedure during the development of China CRMs from naturalproducts was disclosed for the first time.Conclusion: The China CRMs from natural products is a national material standard and has important significance to promote and control the standard and quality of Chinese materia medica and realize both industrialization and modernization of Chinese materia medica.