桑叶配方颗粒物质基准研究

Research on substance benchmark of Mulberry leaf formula granule

桑叶配方颗粒迄今尚没有统一的质量标准。为提升桑叶配方颗粒的内在质量,对其物质基准评价方法进行了研究。选取具有代表性产地的15批桑叶制备物质基准,采用高效液相色谱法,以芦丁、异槲皮苷、紫云英苷作为评价指标,确定桑叶物质基准的出膏率范围、标志性成分含量及转移率范围,采用超高效液相色谱法,建立物质基准UPLC特征图谱,并对其主要成分进行指认。结果表明:15批物质基准中,芦丁转移率为19.94%~34.05%,异槲皮苷转移率为11.67%~43.58%,紫云英苷转移率为10.73%~43.05%;物质基准特征图谱中,标定了14个共有峰,指认出7个色谱峰,分别为新绿原酸、绿原酸、咖啡酸、芦丁、异槲皮苷、槲皮素-3-O-(6″-O-丙二酰基)-β-D-葡萄糖苷、紫云英苷。所建立的基准评价方法为桑叶配方颗粒质量标准的制定及其后续大规模生产提供了数据基础。

So far,there is no unified quality standard for Mulberry leaf formula granules.In order to improve the intrinsic quality of Mulberry leaf formula granules,the substance benchmark evaluation method is studied.15 batches of Mulberry leaf from representative producing areas are selected to prepare the substance benchmark,and with rutin,isoquercetin,astragalin as evaluation indexes,the extract rate,the iconic component content and the transfer rate range of Mulberry leaf substance benchmark are determined by high performance liquid chromatography.By using the ultra high performance liquid chromatography method,the substance benchmark UPLC feature chromatograms is established,and its main components are identified.The results show that the transfer rates of rutin,isoquercitrin and astragalin are 19.94%~34.05%,11.67%~43.58% and 10 73%~43.05%,respectively.In the substance benchmark feature chromatograms,fourteen common peaks are identified,and seven chromatographic peaks are identified including neochlorogenic acid,chlorogenic acid,caffeic acid,rutin,isoquercetin,quercetin 3-O-(6″-O-malonyl)-beta-D-glucoside and astragalin.The established benchmark evaluation method provides a data basis for the formulation of quality standards of mulberry leaf formula granules and subsequent mass production.