目的 建立保元汤标准汤剂的超高效液相色谱法（Ultra Performance Liquid Chromatography，UPLC）特征图谱，并建立同时测定人参皂苷Rb1和甘草酸2种指标成分含量的方法，为该经典名方的质量控制及评价提供参考。方法 采用ACQUITY BEH Shied C18 column （2.1 × 100 mm，1.7 μm）色谱柱，以0.01%甲酸水（A）-0.05%甲酸乙腈（B）为流动相梯度洗脱，柱温30℃，流速0.4 mL min^-1，检测波长203 nm、237 nm。建立15批保元汤标准汤剂的UPLC特征图谱，应用“中药色谱指纹图谱相似度评价系统”软件（2012版）进行相似度分析，归属共有峰。采用层次聚类分析（HCA），主成分分析（PCA）等对特征图谱数据进行评价。利用UPLC特征图谱方法测定2种成分含量。结果 建立了15批保元汤标准汤剂的特征图谱，相似度均大于0.85，并确认了21个共有峰，指认出毛蕊异黄酮葡萄糖苷、甘草苷、人参皂苷Rg1、人参皂苷Re、人参皂苷Rb1、甘草酸6个峰。15批保元汤聚为4类，载荷散点图显示毛蕊异黄酮葡萄糖苷、人参皂苷Rg1等7个成分含量对保元汤质量有较大影响。含量测定显示，在一定范围内人参皂苷Rb1、甘草酸线性关系良好（r ≥ 0.997）。标准汤剂中含量测定结果分别在12.62-30.33 μg·mL^-1、63.80-106.67 μg·mL^-1，转移率分别在51.04%-70.06%、54.89%-74.38%；对应实物中含量测定结果分别在0.98-2.27 mg·g^-1、4.42-8.74 mg·g^-1，转移率分别在78.14%-101.19%、89.99%-99.88%。结论 建立的保元汤UPLC特征图谱及双指标成分含量测定方法专属性强、灵敏度高，可为该方剂复方制剂的质量控制与评价提供参考。

Objective To establish the ultra-performance liquid chromatography (UPLC) characteristic mapping of substance benchmark of Baoyuan Decoction and a method for simultaneous determination of the contents of 2 index ingredients, ginsenoside Rb1 and glycyrrhizic acid to provide references for the quality control and evaluation of this classical prescription.Methods The separation was performed on ACQUITY BEH Shied C18 column (2.1 ×100 mm, 1.7 μm) for gradient elution with 0.01% formic acid water (A) - 0.05% formic acid acetonitrile (B) solution, flow rate 0.4 mL·min^-1, column temperature 30 ℃, detection wavelength was 203 nm and 237 nm. The UPLC characteristic mapping of substance benchmark of 15 batches of Baoyuan Decoction were established, and similarity analysis was performed using the software “similarity evaluation system of chromatographic fingerprints of traditional Chinese medicine” (version 2012), and the common peaks were assigned. The characteristic mapping data were evaluated by hierarchical clustering analysis (HCA) and principal component analysis (PCA). The contents of 2 components were determined by UPLC characteristic mapping method.Results The characteristic mapping of substance benchmarks of 15 batches of Baoyuan Decoction were established with similarities > 0.85, and 21 common peaks were confirmed, which referred to six peaks including calycosin-7-O-β-d-glucoside, liquiritin, ginsenoside Rg1, ginsenoside Re, ginsenoside Rb1, glycyrrhizic acid. Fifteen batches of Baoyuan Decoction were clustered into four classes, and the loading scatter plot showed that the contents of seven components, including calycosin-7-O-β-d-glucoside and ginsenoside Rg1, had a large effect on the quality of Baoyuan Decoction. The linearity relationships of ginsenoside Rb1 and glycyrrhizic acid (r ≥0.9997) were good. The results of content determination of substance benchmark respectively were 12.62-30.33 μg·mL^-1, 63.80-106.67 μg·mL^-1. The results of transfer rate were 51.04%-70.06%、54.89%-74.38%. The results of content determination of substance benchmark respectively were 0.98-2.27 mg·g^-1, 4.42-8.74 mg·g^-1. The results of transfer rate were 78.14%-101.19%, 89.99%-99.88%.Conclusion The established UPLC characteristic mapping of Baoyuan Decoction and the determination method of two index components have strong specificity and high sensitivity, which can provide reference for the quality control and evaluation of the compound preparation of Baoyuan Decoction.

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重大新药创制科技重大专项（编号：2019ZX09201005）：基于大数据的中药新药发现关键技术与品种开发等，负责人：徐江 中央级公益性科研院所基本科研业务费（编号：ZXKT17027）：人参中三萜皂苷及其相关调控基因研究，负责人：徐江 优秀青年科技人才（创新类）培养专项（编号：ZZ13-YQ-047）：基于基因组的人参属药用活性物质关键基因挖掘，负责人：徐江