目的 建立黄芪桂枝五物汤（Huangqi Guizhi Wuwu Decoction，HGWD）基准样品的指纹图谱方法，并建立HGWD基准样品中4个关键指标性成分定量测定的HPLC方法，为HGWD基准样品质量控制提供参考。方法 采用HPLC法建立HGWD指纹图谱，通过基准样品与各单味药材的相关性分析进行共有峰归属，以对照品进行共有峰指认，通过各批次间相似度评价结合化学模式识别分析15批HGWD基准样品的质量差异。同时建立指标性成分毛蕊异黄酮葡萄糖苷、芍药苷、肉桂酸、桂皮醛定量测定方法，结合干膏率及定量测定结果进行量值传递研究。结果 建立了15批HGWD基准样品的HPLC指纹图谱，共标定14个共有峰，经对照品比对，确定其中3号峰为芍药内酯苷、4号峰为芍药苷，5号峰为毛蕊异黄酮葡萄糖苷、8号峰为香豆素、11号峰为肉桂酸、12号峰为桂皮醛、14号峰为6-姜辣素；各批次间相似度均≥0.904，可聚为2类，5个主成分累积贡献率达84.205%；毛蕊异黄酮葡萄糖苷、芍药苷、肉桂酸和桂皮醛的质量分数分别为0.503～0.920、16.452～28.520、0.344～0.866、0.842～1.735 mg/g，HGWD饮片-基准样品的转移率分别为23.480%～38.717%、36.468%～53.193%、20.054%～33.694%、2.782%～4.570%。结论 采用指纹图谱及多指标性成分定量测定方法为经典名方HGWD的基准样品量值传递进行分析，为HGWD基准样品质量控制和复方制剂的开发提供依据。

Objective To establish a fingerprint method for the reference samples of Huangqi Guizhi Wuwu Decoction (HGWD, 黄芪桂枝五物汤) and a HPLC method for the determination of three index components in the reference samples, so as to provide reference for the quality control of the reference samples. Methods The fingerprint of HGWD was established by HPLC, the common peak was assigned by correlation analysis between the reference samples and each single flavor of medicinal materials, and the common peak was identified by reference products. The quality difference of 15 batches of reference samples was analyzed by similarity evaluation and chemical pattern recognition. At the same time, the determination method of paeoniflorin and cinnamic acid was established, and the transfer of the quantity value was studied in combination with the determination results of dry paste. Results The fingerprints of 15 batches of HGWD were established, and 14 common peaks were identified, among which peak 3 was albiflorin, peak 4 was paeoniflorin, peak 5 was glucoside of calynoisoflavone, peak 8 was coumarin, peak 11 was cinnamic acid, peak 12 was cinnamaldehyde and peak 14 was 6-gingerol. The similarity of each batch was ≥ 0.904, which could be clustered into two categories, and the cumulative contribution rate of the five principal components was 84.205. The contents of calycosin-7-O-β-D-glucoside, paeoniflorin, cinnamic acid and cinnamic were 0.503—0.920, 16.452—28.520, 0.344—0.866, 0.842—1.735 mg/g, respectively. The transfer rates of decoction slices and reference samples were 23.480%—38.717%, 36.468%—53.193%, 20.054%—33.694%, 2.782%—4.570%, respectively. Conclusion By using the combination of fingerprint and the content determination of the multi-index components, the quality value transfer of benchmark samples in HGWD can be analyzed, which provides a scientific basis for the quality control of the benchmark samples and the development of compound preparations.

R283.6

国家中医药管理局高水平建设学科（zyyzdxk-2023272）