荷叶的化学对照品2-羟基-1-甲氧基阿朴啡研究

Studies on the chemical reference substance 2-hydroxy-1-methoxyaporphine of Folium Nelumbinis

目的:研究荷叶的化学对照品2-羟基-1-甲氧基阿朴啡的制备方法及其质量标准,为荷叶药材及其相关产品的质量控制提供物质基础。方法:采用溶剂法和色谱法从荷叶中分离、纯化、制备2-羟基-1-甲氧基阿朴啡对照品,以紫外光谱、质谱、核磁共振氢谱和碳谱等方法确认结构,薄层色谱法、高效液相色谱法和差示扫描量热法进行纯度检查,高效液相色谱法进行均匀性检查。结果:2-羟基-1-甲氧基阿朴啡对照品得率0.029%,高效液相色谱法和差示扫描量热法测定纯度均大于98.00%,均匀性合格。结论:2-羟基-1-甲氧基阿朴啡对照品分离制备方法简便可行,纯度和均匀性符合化学对照品的要求,可满足荷叶药材及其相关产品质量控制的需要。

Objective：To investigate the preparation method and quality standard of the chemical reference substance of Folium Nelumbinis,and lay the substances foundation for the quality control of Folium Nelumbinis or its related products.Methods：The chemical reference substance 2-hydroxy-1-methoxyaporphine was isolated and purified by solvent extract and chromatography,which structure was determined by UV,MS,1HNMR and 13CNMR.The purity was analyzed by TLC,HPLC,DSC and the homogeneity was analyzed by HPLC.Results：The yield rate of 2-hydroxy-1-methoxyaporphine was 0.029%.The purity determined by HPLC or DSC was over 98.00%,and the homogeneity was appropriative.Conclusion：Seeing that the method of isolation and purification is simple and feasible,and the purity and homogeneity are in accordance with the demands of chemical reference substance,2-hydroxy-1-methoxyaporphine can meet the needs of the quality control of Folium Nelumbinis and its related products.