经典名方保阴煎HPLC指纹图谱的建立及多成分含量测定方法研究  

HPLC Fingerprint Establishment and Multiple Components Content Determination of Classical Formula of Baoyin Decoction

作　　者：张曼 李秋晗 谢静[1] 王佳慧 吴修红[1] 闫广利[1] 李丹 王喜军[1] ZHANG Man;LI Qiuhan;XIE Jing;WANG Jiahui;WU Xiuhong;YAN Guangli;LI Dan;WANG Xijun(Engineering Research Center of Efficacy Evaluation and Industrial Development of TCM Classic Formulae of Ministry of Education, Heilongjiang University of Chinese Medicine, Harbin 150040, China;Jing-Jin-Ji Joint Innovation Pharmaceutical (Beijing) Co., Ltd., Beijing 100025, China)

机构地区：[1]黑龙江中医药大学教育部经典名方有效性评价及产业化开发工程研究中心,黑龙江哈尔滨150040 [2]京津冀联创药物研究(北京)有限公司,北京100025

出　　处：《中医药学报》2022年第6期45-52,共8页Acta Chinese Medicine and Pharmacology

基　　金：黑龙江省重点研发计划指导类项目(GZ20210125)。

摘　　要：目的:建立经典名方保阴煎HPLC指纹图谱及5-羟甲基糠醛、芍药苷、小檗碱、黄芩苷的同时含量测定方法。方法:按照传统制法制备保阴煎基准样品,利用HPLC-UV法建立化学成分指纹图谱,并进行相似度评价及峰归属;选择组方药物药效相关成分5-羟甲基糠醛、芍药苷、小檗碱、黄芩苷建立多成分同时定量方法。结果:保阴煎指纹图谱中确定20个共有峰,15批保阴煎基准样品指纹图谱的相似度均>0.9;多成分同时定量方法中,5-羟甲基糠醛、芍药苷、小檗碱、黄芩苷的线性范围分别为0.34~10.97μg/mL、5.83~186.70μg/mL、2.64~84.60μg/mL、19.76~632.40μg/mL,线性关系良好,加样回收率分别为87.64~102.03%,RSD为2.00%~3.00%,精密度、稳定性、重复性均符合相应要求。结论:建立的保阴煎HPLC指纹图谱及多成分同时定量方法,能够用于保阴煎质量控制。Objective:To establish the HPLC fingerprint of famous classical formulae of Baoyin Decoction(BYD)and to simultaneously determine the contents of 5-hydroxymethylfurfural,paeoniflorin,berberine and baicalin.Methods:The reference sample of BYD was prepared according to the traditional preparation method.The fingerprint of the reference sample was established by HPLC-UV,and the similarity evaluation and peak attribution were carried out.Four effective components,which were 5-hydroxymethylfurfural,paeoniflorin,berberine and baicalin,were selected to establish the content simultaneous determination method.Results:The similarity of fingerprints of 15 batches of BYD reference samples was more than 0.9,and 20 common peaks were determined.The linear ranges of 5-hydroxymethylfurfural,paeoniflorin,berberine and baicalin were 0.34~10.97μg/mL,5.83~186.70μg/mL,2.64~84.60μg/mL and 19.76~632.40μg/mL,respectively.The recovery rate was 87.64%~102.03%,and the RSD value was between 2.00%and 3.00%.The precision,the stability and the repeatability met the corresponding requirements.Conclusion:This study established a method for the determination of fingerprint and main effective components of BYD,and provided guarantee for the quality standards of BYD.

关 键 词：经典名方 保阴煎 基准样品 指纹图谱 含量测定 

分 类 号：R284.1[医药卫生—中药学]