Objective:To develop the first batch of traditional Chinese medicine chemical reference substance 2-acetate regaloside A used in standard of Baihe(Juandan)Peifang Keli.Methods:The structure was elucidated by nuclear magnetic resonance spectrometry,mass spectrometry,ultraviolet spectroscopy and infrared spectrosco-py.Purity analysis,determination of related substance and investigation of other physical and chemical parameters were carried out by using analytical different techniques such as high performance liquid chromatography,gas chromatography,coulometry and ignition residue method.On the above basis,the mass balance was used for value determination,and the 1H quantitative nuclear magnetic resonance method was applied for further verifica-tion.Results:The structure of the traditional Chinese medicine chemical reference substance was determined as 2-acetate regaloside A,and it was identified as a new compound by SciFinder search.The calibration value by mass balance method was 99.31％,and result of 1H quantitative nuclear magnetic resonance method was 100.06％(n=3,RSD=0.47％).Conclusion:The accurate development and calibration of the first batch of 2-acetate regaloside A fully ensures the implementation of the standard for Baihe(Juandan)Peifang Keli.
关键词
2-乙酰王百合苷A/对照品/结构/鉴定/核磁/纯度/含量
Key words
2-acetate regaloside A/reference substance/structure/identification/nuclear magnetic resonance/purity/assay
维普
万方数据