基于一测多评法含量测定及薄层鉴别的经典名方竹茹汤颗粒剂的质量评价研究

Quality evaluation of Zhuru Decoction Granules based on quantitative analysis of multi-components with a single-marker content determination and TLC identification

目的 建立经典名方竹茹汤颗粒(Zhuru Decoction Granules,ZDG)特征图谱及一测多评(quantitative analysis multicomponents by single marker,QAMS)法测定其主要成分,优化薄层色谱条件,建立同时鉴别葛根素和甘草苷的方法。方法优化并确定HPLC最佳色谱条件并建立特征图谱,以葛根素作为参照物,建立葛根素、3′-羟基葛根素、3′-甲氧基葛根素、葛根素芹菜糖苷、大豆苷、甘草苷、甘草酸的QAMS法,建立主要药效成分葛根素及甘草苷同时鉴别的薄层条件。结果 得到15批样品特征图谱与其对照图谱的相似度均大于0.95;15批制剂运用QAMS法和外标法得到的各成分含量无显著性差异,7种成分相对误差均低于5%;通过稳定性考察证明薄层检测条件稳定可行。结论 该方法科学可行,稳定可控,有助于经典名方ZDG质量控制方法的完善和提高,为经典名方的质量控制评价提供参考。

Objective To establish the characteristic chromatogram of Zhuru Decoction Granules(竹茹汤颗粒,ZDG) and determine its main components by quantitative analysis of multi-components with a single-marker(QAMS) method,optimize the TLC conditions,and establish a simultaneous identification method for puerarin and glycyrrhizin.Methods To optimize and determine the best chromatographic conditions of HPLC and establish the characteristic chromatogram.With puerarin as the reference material,establish a QAMS for the identification of puerarin,3′-hydroxypuerarin,3′-methoxy puerarin,puerarin apigenide,daidzin,glycyrrhizin and glycyrrhizic acid,and establish the TLC conditions for the simultaneous identification of the main active ingredients puerarin and glycyrrhizin.Results The similarity between the characteristic profiles of the 15 batches of samples and their control profiles was greater than 0.95;There was no significant difference between the contents of the components obtained by the QAMS method and the external standard method for the 15 batches of preparations,and the relative errors of the seven components were less than 5%;The stability study proved that the thin-layer assay conditions were stable and feasible.Conclusion The method is scientific,feasible,stable and controllable.The study is helpful to improve the quality control method of ZDG,a classic famous prescription,and is expected to provide a reference for the quality control evaluation of the classical prescription.