目的 建立竹叶石膏汤（Zhuye Shigao Decoction，ZSD）物质基准的HPLC特征图谱及指标成分含量测定方法，并结合化学模式识别法进行评价，探寻其质量传递规律。方法 制备20批ZSD物质基准，建立HPLC特征图谱，明确共有峰归属，测定全方出膏率、指标成分异荭草苷、人参皂苷Rg₁、人参皂苷Re、人参皂苷Rb₁、甘草苷和甘草酸的含量及转移率，对物质基准进行量值传递分析。结果 20批ZSD物质基准特征图谱的相似度均大于0.90，共确定了21个特征峰，分别来自方中淡竹叶（6个峰）、麦冬（6个峰）、半夏（3个峰）、甘草（6个峰）4个药味；化学模式识别法将20批样品分为4类；各指标成分从饮片到物质基准的转移率分别为异荭草苷31.94%~50.91%，甘草苷35.77%~62.55%，甘草酸13.09%~22.63%，人参皂苷Rg₁ 57.28%~83.95%，人参皂苷Re 42.21%~72.27%，人参皂苷Rb₁ 38.19%~64.57%；出膏率为16.99%~27.06%。结论 采用特征图谱、多指标含量测定以及化学模式识别法对ZSD物质基准进行量值传递分析，该方法科学合理，可为后续制剂开发提供参考。

Objective To establish the HPLC fingerprint and multi-component determination for substance benchmark of Zhuye Shigao Decoction (竹叶石膏汤, ZSD), evaluate its quality in combination with chemical pattern recognition method and explore the mass transfer law of substance benchmark. Methods The substance benchmark of 20 batches of ZSD was prepared based on ancient medical records, the HPLC fingerprint was established, the attribution of common peaks was clarified, and the ointment rate of the whole prescription was determined. The components content and transfer rate of isoorientin, ginsengside Rg₁, ginsenoside Re, ginsenoside Rb₁, liquiritin and glycyrrhizic acid were measured and the transfer analysis of substance benchmark was performed. Results The similarity of the 20 batches of ZSD material benchmark fingerprint were all greater than 0.90, and a total of 21 characteristic peaks were identified, which came from Lophatherum gracile (six peaks), Ophiopogon japonicus (six peaks), Pinellia ternata (three peaks), and Glycyrrhiza uralensis (six peaks). The samples can be divided into four categories by chemical pattern recognition methods. The transfer rate of each index component from the decoction pieces to the substance benchmark was in the range of isoorientin:31.94%-50.91%, glycyrrhizin:35.77%-62.55%, licorice acid:13.09%-22.63%, ginsenoside Rg₁:57.28%-83.95%, ginsenoside Re:42.21%-72.27%, ginsenoside Rb₁:38.19-64.57%; The creaming rate ranges from 16.99% to 27.06%. Conclusion In this study, the fingerprint combined with multi-index content determination and chemical pattern recognition were used to carry out the quantity value transfer analysis of the substance benchmark of ZSD. This method is scientific and reasonable, and can provide a reference for subsequent formulation development.

R286.02

吉林省重点研发项目（2017-SW-KF106）；国家中药标准化项目（ZYBZH-Y-JL-25）