目的 构建芍药甘草汤基准样品HPLC指纹图谱及11种成分定量测定方法，同时建立大类成分总黄酮、总苷、总酚、总多糖的UV含量测定手段，全面评价基准样品的质量，为芍药甘草汤基准样品质量控制提供依据。方法 运用高效液相色谱法（HPLC）构建芍药甘草汤基准样品的HPLC指纹图谱，并同步实现11种指标成分的定量测定，同时，结合化学计量学方法，明确芍药甘草汤基准样品的差异性特征成分；借助紫外-可见分光光度法，对芍药甘草汤基准样品中的总黄酮、总苷、总酚、总多糖含量进行检测分析，在此基础上，深入剖析11个有效成分在总黄酮、总苷、总酚3个大类成分中的占比情况，从而达成对芍药甘草汤基准样品质量的系统性、全面性评价。结果 建立了17批芍药甘草汤基准样品指纹图谱，相似度均大于0.9，标定了13个共有峰，指认了其中11个色谱峰信息；17批芍药甘草汤基准样品中没食子酸、芍药内酯苷、芍药苷、芹糖甘草苷、甘草苷、苯甲酸、1,2,3,4,6-五没食子酰葡萄糖、异甘草素、甘草素、异甘草苷、甘草酸铵的质量分数分别为2.72～4.92、4.82～19.44、29.68～40.98、2.94～6.10、5.47～7.90、1.31～3.44、0.83～1.10、0.67～0.96、0.78～1.52、0.12～0.23、10.16～20.29 mg·g^-1，芍药内酯苷、芍药苷、甘草酸铵为区分不同批次芍药甘草汤基准样品的差异性标志物；17批基准样品总黄酮质量分数为2.25%～3.45%、总苷质量分数为9.40%～14.18%、总酚质量分数为0.97%～2.19%、总多糖质量分数为45.44%～59.47%，大类成分总质量分数为62.64%～75.97%；11个定量指标在黄酮类、酚酸类、苷类成分占比分别为44.20%～54.19%、32.95%～59.76%、43.11%～61.70%。结论 建立的指纹图谱及质量分数测定方法可靠，重复性及准确性良好，结合化学计量学筛选的质量差异物，可为后续质量评价研究提供依据。

Objective HPLC fingerprint chromatogram of the benchmark sample of the Shaoyao Gancao Decoction and the quantitative determination method of 11 components were established. Meanwhile, the UV content determination methods of the major components such as total flavonoids, total glycosides, total phenols and total polysaccharides were developed to comprehensively evaluate the quality of the benchmark sample and provide a basis for the quality control of the benchmark sample of the Shaoyao Gancao Decoction.Methods The HPLC fingerprint chromatogram of the benchmark sample of the Shaoyao Gancao Decoction was constructed by HPLC, and the quantitative determination of 11 index components was simultaneously achieved. In addition, the characteristic components of the benchmark sample of the Shaoyao Gancao Decoction were identified by chemometrics. The contents of total flavonoids, total glycosides, total phenols and total polysaccharides in the benchmark sample of the Shaoyao Gancao Decoction were detected by UV spectrophotometry. On this basis, the proportion of 11 effective components in the three major components of total flavonoids, total glycosides and total phenols was analyzed in depth to achieve a systematic and comprehensive evaluation of the quality of the benchmark sample of the Shaoyao Gancao Decoction.Results The HPLC fingerprint chromatograms of 17 batches of benchmark samples of the Shaoyao Gancao Decoction were established, with similarity greater than 0.9. Thirteen common peaks were identified, and the information of 11 chromatographic peaks was recognized. The mass fractions of gallic acid, paeoniflorin, paeonol, apioside, liquiritin, benzoic acid, 1, 2, 3, 4, 6-pentagalloyl glucose, isoliquiritigenin, liquiritigenin, isoliquiritin and ammonium glycyrrhizinate in 17 batches of benchmark samples of the Shaoyao Gancao Decoction were 2.72—4.92, 4.82—19.44, 29.68—40.98, 2.94—6.10, 5.47—7.90, 1.31—3.44, 0.83—1.10, 0.67—0.96, 0.78—1.52, 0.12—0.23 and 10.16—20.29 mg·g^-1, respectively. Paeoniflorin, paeonol and ammonium glycyrrhizinate were the differential markers for distinguishing different batches of benchmark samples of the Shaoyao Gancao Decoction. The contents of total flavonoids, total glycosides, total phenols and total polysaccharides in 17 batches of benchmark samples were 2.25%—3.45%, 9.40%—14.18%, 0.97%—2.19% and 45.44%—59.47%, respectively. The total content of major components was 62.64%—75.97%. The proportions of 11 quantitative indicators in flavonoids, phenolic acids and glycosides were 44.20%—54.19%, 32.95%—59.76% and 43.11%—61.70%, respectively.Conclusion The established fingerprint chromatogram and content determination method were reliable, with good repeatability and accuracy. Combined with the quality difference substances screened by chemometrics, it can provide a basis for subsequent quality evaluation research.

R283.6

国家工信部产业基础再造和制造业高质量发展专项（2440STCZB2614）