目的 建立经典名方温胆汤基准样品特征图谱,并采用一测多评(quantitative analysis of multi-components by single marker,QAMS)法同时测定5种标志性成分(柚皮苷、橙皮苷、新橙皮苷、甘草酸、6-姜辣素)的含量。方法 制备15批温胆汤基准样品,以橙皮苷为参照峰确定共有峰,建立温胆汤HPLC特征图谱;以橙皮苷为内标参照物,确定其他4种成分的相对校正因子(f_s/i)并计算含量,同时采用外标法测定,比较两者结果差异。结果 建立了温胆汤基准样品的HPLC特征图谱,15批基准样品的特征图谱相似度均大于0.99;以橙皮苷为内参的柚皮苷、新橙皮苷、甘草酸、6-姜辣素的f_s/i分别为0.940 1、0.932 9、0.413 6、0.607 3,QAMS法含量测定结果与外标法无显著差异。结论 建立的HPLC特征图谱结合QAMS法方便、稳定,能较好地对温胆汤基准样品进行整体质量评价。

Objective To establish the characteristic chromatograms of classic prescription Wendan Decoction (温胆汤) and determine five index components (naringin, hesperidin, neohesperidin, glycyrrhizin and 6-gingerol) by quantitative analysis of multi-components by single marker (QAMS) methods. Methods A total of 15 batches of Wendan Decoction benchmark sample were prepared and the HPLC characteristic chromatograms of Wendan Decoction were established to determine common peaks with hesperidin as the reference peak. Hesperidin was used as the internal standard reference to calculate the relative correction factors of naringin, neohesperidin, glycyrrhizin, and 6-gingerol by HPLC and the content determination of five active ingredients were determined using the external standard method (ESM) and QAMS methods respectively. Results The similarity of characteristic chromatograms of the 15 batches of samples were all greater than 0.99. The relative correction factors of naringin, neohesperidin, glycyrrhizin acid and 6-gingerol using hesperidin as the internal reference were 0.940 1, 0.932 9, 0.413 6 and 0.607 3, respectively, and there was no significant difference between the contents of the components determined by the QAMS method and the ESM method. Conclusion The established HPLC characteristic chromatograms combined with QAMS method is convenient and stable, which provides a reference for the overall quality evaluation of Wendan Decoction benchmark sample.

国家中医药管理局中药标准化项目（ZYBZH-C-JS-30）；江苏省研究生科研与实践创新计划项目（KYCX19-1313）