基于HPLC指纹图谱与多成分含量测定结合化学计量学的傣肾宁颗粒质量评价研究

Quality evaluation of Daishenning Granules based on HPLC fingerprint and multi-component content determination combined with chemometrics

目的:建立傣族经方傣肾宁颗粒的HPLC指纹图谱研究,并进行多成分含量测定。方法:采用Diamonsil C_(18)色谱柱(4.6mm×250mm,5μm),以乙腈-0.5%冰乙酸水溶液为流动相进行梯度洗脱,建立傣肾宁颗粒的HPLC指纹图谱,利用化学计量法比较傣肾宁颗粒的质量一致性。采用HPLC法对丹参素、原儿茶酸、原儿茶醛、对香豆酸、迷迭香酸、丹酚酸B6个成分进行多成分含量测定。结果:11批傣肾宁颗粒共标定了32个共有峰,相似度均>0.98。并利用对照品指认了丹参素、原儿茶酸、原儿茶醛、对香豆酸、迷迭香酸、丹酚酸B6个共有峰。同步测定傣肾宁颗粒中6个成分的含量,其中迷迭香酸的含量最高,其次为丹参素和丹酚酸B。结论:建立的指纹图谱方法稳定可靠,多成分同步含量测定方法简便快捷,可用于傣肾宁颗粒的质量控制,为傣肾宁的后续研究奠定了坚实的基础。

Objective:To establish the HPLC fingerprint of Dai medicine classical famous prescription Daishenning Granules,and determine the content of multiple components.Methods:All samples were analyzed by Diamonsil C_(18) chromatographic column(4.6 mm×250 mm,5μm),and eluted with acetonitrile-0.5%acetic acid aqueous solution.High performance liquid chromatography(HPLC)fingerprints were established,to compare the quality consistency of Daishenning Granules by chemometric method.The HPLC method was used to determine the contents of 6 components including Danshensu,protocatechuic acid,protocatechuic aldehyde,p-coumaric acid,rosmarinic acid,and salvianolic acid B.Results:A total of 32 common peaks were calibrated in 11 batches of Daishenning Granules,and the similarities were all greater than 0.98.And the reference substance was used to identify the 6 common peaks of Danshensu,protocatechuic acid,protocatechuic aldehyde,p-coumaric acid,rosmarinic acid,and salvianolic acid B.The contents of 6 components in Daishenning Granules were simultaneously determined,among which rosmarinic acid had the highest content,followed by Danshensu and salvianolic acid B.Conclusion:The fingerprint method established is stable and reliable,and the multi-component simultaneous content determination method is simple and quick.It can be used for the quality control of Daishenning Granules,laying a solid foundation for the follow-up research of Daishenning Granules.