基于中药质量标志物的四君子汤质量控制研究

Study on quality control of Sijunzi Decoction based on quality markers of Chinese medicine

中文关键词:四君子汤  HPLC  Q-marker  特征图谱  质量控制  含量测定

keywords:Sijunzi Decoction  HPLC  Q-marker  Feature Spectrum  Quality Control  Simultaneous determination

中文摘要:目的 建立四君子汤HPLC的特征图谱和8个中药质量标志物（Q-marker）成分的含量测定方法，为四君子汤质量控制研究提供依据。方法 采用HPLC法，色谱柱Agilent -C18柱（4.6m×250 m，5μm）；采用乙腈-0.1%磷酸水溶液为流动相，梯度洗脱；柱温35 ℃；体积流量0.7 mL/min；检测波长203 nm和220 nm，对四君子汤进行特征图谱建立，并对参皂苷Rg1等8个Q-marker成分进行定量测定。结果 建立了四君子汤HPLC特征图谱，有33个共有峰；通过对照品指认8个特征性成分，分别为人参皂苷Rg1、人参皂苷Re、人参皂苷Rb1、甘草酸、甘草苷、白术内酯Ⅰ、白术内酯Ⅲ、茯苓酸；平均回收率在93.91%~95.77%，RSD均<2%；经测定四君子汤中上述8个成分的含量依次分别为：0.81 mg/g、0.51 mg/g、0.16 mg/g、0.58 mg/g、0.25 mg/g、0.13 mg/g、0.24 mg/g、0.08 mg/g。结论 建立的HPLC特征图谱及定量测定方法适用于四君子汤的质量评价，该方法操作简便、准确可靠、重复性高，为四君子汤的质量控制提供了有效的检测方法。

Abstract:Objective To establish the HPLC feature spectrum of Sijunzi decoction and the content determination methods for eight quality marker components (Q-markers) of traditional Chinese medicine, to provide a basis for the quality control of SJZD. Methods HPLC was used, with an Agilent C18 column (4.6m×250 m, 5μm) as the chromatographic column; acetonitrile-0.1% phosphoric acid aqueous solution was used as the mobile phase, with gradient elution; the column temperature was 35℃, the flow rate was 0.7 mL/min, and the detection wavelengths were 203 nm and 220 nm. The feature spectrum of Sijunzi decoction was determined, and the content of eight Q-markers, including ginsenoside Rg1, was quantified. Results An HPLC feature spectrum of Sijunzi decoction was established, with 33 common peaks; through reference substances, eight characteristic components were identified, namely ginsenoside Rg1, ginsenoside Re, ginsenoside Rb1, glycyrrhizin, glycyrrhizic acid, atractylodes lactone I, atractylodes lactone III, and poria acid; the average recovery rate was between 93.91% and 95.77%, with RSD all <2%; the content of the above eight components in Sijunzi decoction was determined to be 0.81mg/g, 0.51mg/g, 0.16mg/g, 0.58mg/g, 0.25mg/g, 0.13mg/g, 0.24mg/g, 0.08mg/g. Conclusion The HPLC feature and quantitative determination method established is suitable for the quality evaluation of Sijunzi decoction. This method is simple, accurate and reliable, and has high repeatability, which provides an effective detection method for the quality control of Sijunzi decoction.