经典名方泽泻汤基准样品HPLC特征指纹图谱分析研究

HPLC characteristic fingerprint analysis and research of benchmark samples of famous classical prescription Zexie Decoction

关键词:  经典名方  泽泻汤  基准样品  特征指纹图谱  高效液相色谱法

Key words:  famous classical prescription  Zexie Decoction  benchmark sample  characteristic fingerprint  HPLC

摘要:

[目的] 创建经典名方泽泻汤基准样品的高效液相色谱（HPLC）特征指纹图谱，通过对其进行分析与质量评价，为泽泻汤质量控制标准的建立提供科学参考和依据。[方法] 依据传统方法复原至现代煎煮方式制备泽泻汤标准煎液，采用Agilent ZORBAX SB-Aq C₁₈色谱柱（250mm×4.6mm，5μm），流动相选用乙腈-水进行梯度洗脱，创建泽泻汤HPLC特征指纹图谱，利用《中药色谱指纹图谱相似度评价系统软件（2012版）》对18批泽泻汤基准样品进行指纹图谱相似度评价和特征图谱共有峰分析。[结果] 18批泽泻汤基准样品的相似度为0.912~0.997。通过对样品图谱进行数据匹配，确立了11个共有峰。并通过混合对照品比对指认了4个特征峰，分别为泽泻醇A（4号峰）、白术内酯Ⅰ（6号峰）、泽泻醇B（8号峰）、23-乙酰泽泻醇B（9号峰）。以23-乙酰泽泻醇B的色谱峰（9号峰）为S峰，规定11个共有峰的相对保留时间。[结论] 建立的泽泻汤基准样品HPLC特征指纹图谱分析方法灵敏、稳定且数据准确可靠，体现了泽泻汤基准样品的整体化学成分特征，为经典名方泽泻汤基准样品及复方制剂的质量评价提供依据。

Abstract:

[Objective] To establish the HPLC characteristic fingerprint of Zexie Decoction,analyze and evaluate its quality,so as to provide scientific reference and basis for the quality control standard.[Methods] According to the traditional method,the standard decoction of Zexie Decoction was prepared by the way of modern decoction method. The HPLC characteristic fingerprint of Zexie Decoction was established on Agilent ZORBAX SB-Aq C₁₈ column(250 mm×4.6 mm,5 μm) with the mobile phase consisting of acetonitrile and water. The similarity and characteristic peak analysis of 18 batches Zexie Decoction were carried out by the “similarity evaluation system for chromatographic fingerprint of Chinese materia medica 2012 version”.[Results] The similarity of 18 batches of Zexie Decoction benchmark samples was 0.912~0.997,and 11 common peaks were marked. Four peaks were confirmed,they were alisol A(peak 4),atractylode Ⅰ(peak 6),alisol B(peak 8),23-acetyl alisol B(peak 9). The relative retention time of 11 characteristic peaks was specified with 23-acetyl alisol B (peak 10) as the S peak.[Conclusion] The established HPLC characteristic fingerprint analysis method was ingenious,stabilized,accurate and faithful,which could reflect the overall chemical composition characteristics of Zexie Decoction,and be used to provide basis for the quality evaluation of Zexie Decoction preparations.