摘要
目的建立通肠清胰合剂的HPLC指纹图谱,并对5种成分进行含量测定。方法采用Agilent ZORBAX SB?C_(18)色谱柱(250 mm×4.6 mm,5μm),以乙腈?p H 5.0磷酸盐缓冲液为流动相,梯度洗脱,检测波长为230 nm和250 nm,流速为1.0 m L/min,柱温为30℃,进样量为10μL。通过中药色谱指纹图谱相似度评价系统(2012版)建立10个批次的通肠清胰合剂HPLC指纹图谱,同时进行相似度评价。结合软件SPSS 27.0、Origin Pro 2024b进行聚类分析和主成分分析。结果黄芩苷、芍药苷、大黄酸、厚朴酚、和厚朴酚分别在一定浓度范围内线性关系良好(r≥0.9998),平均回收率和RSD分别在96.39%~97.96%、1.54%~2.37%(n=6)之间。10批通肠清胰合剂指纹图谱显示存在12个共有峰,相似度为0.984~1.000。10批样品可聚为3类,其中S1~S7为第一类,S10为第二类,S8和S9为第三类。指认了5个成分,分别为大黄酸、芍药苷、黄芩苷、厚朴酚、和厚朴酚。结论本研究所建立的通肠清胰合剂HPLC指纹图谱及成分含量测定方法准确可靠、重复性强,为通肠清胰合剂的质量控制提供了科学依据。
Objective To establish HPLC fingerprint of Tongchang Qingyi mixture,and to determine the content of 5 components.Methods An Agilent ZORBAX SB-C_(18)chromatographic column(250 mm×4.6 mm,5μm)was used.Acetonitrile-pH 5.0 phosphate buffer solution was taken as the mobile phase with gradient elution.The detection wavelengths were set at 230 nm and 250 nm.The flow rate was 1.0 mL/min,the column temperature was 30°C,and the injection volume was 10μL.The HPLC fingerprints of 10 batches of Tongchang Qingyi mixture were established by the"Similarity Evaluation System for Chromatographic Fingerprints of Traditional Chinese Medicine(2012 version)",and the similarity evaluation was conducted simultaneously.Cluster analysis and principal component analysis were carried out in combination with the software SPSS 27.0 and OriginPro 2024b.Results Baicalin,paeoniflorin,rhein,magnolol and honokiol all had good linear relationships within certain concentration ranges respectively(r≥0.9998).The average recovery rates and RSDs were between 96.39%-97.96%and 1.54%-2.37%(n=6),respectively.The fingerprint chromatograms of 10 batches of Tongchang Qingyi mixture showed that there were 12 common peaks,with the similarities ranging from 0.984 to 1.000.The 10 batches of samples could be clustered into 3 categories.Among them,S1-S7 belonged to the first category,S10 belonged to the second category,and S8 and S9 belonged to the third category.Five components had been identified,namely rhein,paeoniflorin,baicalin,magnolol and honokiol.Conclusion The established HPLC fingerprint and component content measurement method for Tongchang Qingyi mixture in the research are accurate,reliable,and highly reproducible,and provide a scientific basis for the quality control of Tongchang Qingyi mixture.
作者
陈毕琳
胡运莲
李霞
刘梓梵
徐茜
黄志军
CHEN Bilin;HU Yunlian;LI Xia;LIU Zifan;XU Qian;HUANG Zhijun(School of Chemistry,Chemical Engineering and Life Sciences,Wuhan University of Technology,Wuhan 430070,China;Department of Spleen and Stomach,Hubei Provincial Hospital of Traditional Chinese Medicine,Wuhan 430061,China;Hubei Academy of Preventive Medicine Sciences Jianmin Pharmaceutical Group Inc,Wuhan 430053,China)
出处
《药学前沿》
2025年第1期50-58,共9页
China Pharmacist
基金
湖北省重点研发计划项目(2023BCB032)。
关键词
通肠清胰合剂
含量测定
高效液相色谱指纹图谱
聚类分析
主成分分析
质量研究
Tongchang Qingyi mixture
Content determination
High performance liquid chromatography fingerprint
Cluster analysis
Principal component analysis
Quality study
作者简介
通信作者:黄志军,博士,副教授,硕士研究生导师,Email:huangzhijun@whut.edu.cn。
