复方刺五加颗粒HPLC指纹图谱建立及多成分含量测定研究  

Establishment of HPLC Fingerprint and Multi-Component Content Determination of Compound Eleutherococcus Senticosus Granules

作　　者：杨雯雯 杨赛赛 王旭[1] 严妍[1] 刘磊[1] 吴修红[1] YANG Wenwen;YANG Saisai;WANG Xu;YAN Yan;LIU Lei;WU Xiuhong(Heilongjiang University of Chinese Medicine,Harbin 150040,China)

机构地区：[1]黑龙江中医药大学,黑龙江哈尔滨150040

出　　处：《中医药学报》2025年第3期43-51,共9页Acta Chinese Medicine and Pharmacology

基　　金：黑龙江省揭榜挂帅(2023ZXJ02C01);黑龙江省重点研发计划(2024ZX12C16)。

摘　　要：目的:利用高效液相色谱(HPLC)法建立了复方刺五加颗粒的指纹图谱,并测定6种成分的含量,为其质量控制和评价提供参考。方法:采用HPLC法建立10批复方刺五加颗粒指纹图谱,并进行相似度评价、结合化学模式识别分析进行评价,同时对复方刺五加颗粒中紫丁香苷、刺五加苷E、异嗪皮啶、五味子醇甲、五味子甲素、五味子乙素进行多成分含量测定。结果:10批复方刺五加颗粒相似度均>0.921,其中紫丁香苷、刺五加苷E、异嗪皮啶、五味子醇甲、五味子甲素、五味子乙素的线性范围分别为2.92~5.84μg、2.55~5.10μg、0.405~0.81μg、0.095~0.19μg、0.14~0.28μg、0.68~1.36μg线性关系良好,加样回收率为100.2%~101.4%,RSD为1.2%~1.6%,精密度、重复性、稳定性均符合要求。结论:该方法简单、便捷,可为评价复方刺五加颗粒质量提供依据。Objective:To establish the HPLC fingerprint of Compound Eleutherococcus Senticosus Granules and to determine the content of six components,providing a reference for quality control and evaluation.Methods:HPLC was used to establish the fingerprint of Compound Eleutherococcus Senticosus Granules from 10 batches,followed by similarity evaluation and chemical pattern recognition analysis.The contents of the six components in the granules,namely,Syringin,Eleutheroside E,Isohypaphorine,Schisandrin A,Schisandrin B,and Schisandrin C,were also measured.Results:The similarity of the fingerprints from the 10 batches was all>0.921.The linear ranges for Syringin,Eleutheroside E,Isohypaphorine,Schisandrin A,Schisandrin B,and Schisandrin C were 2.92~5.84μg,2.55~5.10μg,0.405~0.81μg,0.095~0.19μg,0.14~0.28μg,and 0.68~1.36μg,respectively,all showing good linear relationships.The recovery rates were 100.2%~101.4%,with RSDs of 1.2%~1.6%.Precision,repeatability,and stability tests all met the required standards.Conclusion:The established method is simple and convenient,providing a basis for evaluating the quality of Compound Eleutherococcus Senticosus Granules.

关 键 词：复方刺五加颗粒 含量测定 指纹图谱 

分 类 号：R284.1[医药卫生—中药学]