Non-NICPBP(National Institutes For Food And Drug Control)Source Of Traditional Chinese Medicine Chemical Reference Substance Collection And Its Application Research

Objective:With the development of Chinese medicine chemistry technology,the detection methods of drug standards are constantly improved,the varieties and quantities of the reference substance of demand have increased greatly.However,by the end of 2014,there were only 640 kinds of traditional Chinese medicine chemical reference substance.Its variety and quantity cannot meet the needs of Chinese medicine quality research,detection and the creation of new Chinese medicine.So this paper intends to choose about 60 of chemical reference substance of traditional Chinese medicines that non-NICPBP source for standardization,systematic research,to improve the information of physical and chemical properties,purity analysis and structural identification of each control products,establish the quality standard of each control product,to lay a foundation for the establishment of a database of non-NICPBP source of Chinese medicine chemical reference substance.Methods:We collected about 60 of chemical reference substance of traditional Chinese medicines that non-NICPBP source(For example:Artemisetin,Maackiain,Verbenaloside,Oleuropein,Hederacoside C,etc.)were selected to study,and to describe the physical and chemical properties of the each reference substance(Crystal shape,solubility,melting point,etc.),content determination(Exploration and analysis of the optimum conditions for the determination of its content),purity test(Analysis of silica gel and polyamide by thin layer chromatography?Analysis of high performance liquid chromatography),structure(Study on UV,IR,MS and NMR,determine the chemical structure of the work reference.),and collect the reference substance sources and pharmacological effects,then Improve identification and inspection of operating procedures,and formulate quality standards for each reference substance.Results:In the early stage of this experiment,60 kinds of different work control products were collected and sorted,its molecular formula,molecular weight,source,pharmacological action and physicochemical properties are determined,and the condition of purity identification was analyzed.Finally,the UV spectrum analysis,infrared spectrum analysis and the determination of NMR were carried out,to determine the chemical structure of the work control products,and it lays a certain foundation for the related analysis in the future.Conclusion:The chemical reference substance of traditional Chinese medicines for non-NICPBP sources make up for the shortage of varieties and quantities of traditional Chinese medicine chemical reference substance;Non-NICPBP source of Chinese medicine chemical reference substance and traditional Chinese medicine chemical reference substance jointly meet the needs of current Chinese medicine quality research,detection and the creation of new Chinese medicine.