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 natural products 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.