目的 建立经典名方葛根芩连汤（Gegen Qinlian Decoction，GQD）基准样品的HPLC指纹图谱及指标性成分含量测定方法，研究GQD基准样品量质传递规律。方法 根据《伤寒论》记载方法遵古制备了15批GQD基准样品，并建立了15批基准样品的HPLC指纹图谱，明确指纹图谱中峰归属和相似度范围，并对出膏率范围、指标性成分含量范围及转移率范围等量质传递指标进行分析，初步建立GQD基准样品的质量控制体系。结果 15批GQD共标定了34个共有峰，且相似度良好（＞0.99）。基准样品中11种指标性成分质量分数分别为葛根素0.803 1%～1.093 8%，大豆苷0.104 8%～0.178 9%，大豆苷元0.011 7%～0.024 4%，黄芩苷0.470 9%～0.736 9%，汉黄芩苷0.211 2%～0.219 9%，黄芩素0.001 1%～0.002 2%，汉黄芩素0.001 2%～0.002 2%，盐酸小檗碱0.053 2%～0.115 4%，巴马汀0.022 4%～0.042 3%，甘草苷0.118 8%～0.195 4%，甘草酸0.087 6%～0.099 2%。饮片至水煎液、水煎液至基准样品的平均转移率分别为葛根素17.71%～19.69%、84.18%～104.00%，大豆苷10.32%～13.65%、86.90%～105.38%，大豆苷元21.13%～27.65%、64.64%～104.09%，黄芩苷22.46%～23.99%、71.58%～107.61%，汉黄芩苷21.38%～28.16%、82.54%～106.78%，黄芩素2.15%～3.81%、51.85%～83.33%，汉黄芩素4.83%～9.55%、43.75%～73.33%，盐酸小檗碱6.33%～8.70%、60.33%～99.95%，巴马汀11.09%～15.79%、60.56%～76.94%，甘草苷57.82%～76.53%、80.98%～103.70%，甘草酸14.98%～18.08%、87.96%～106.12%。15批基准样品干膏率传递率的均值为81.35%。结论 通过指纹图谱、出膏率及指标性成分含量测定相结合，对经典名方GQD基准样品的量质传递过程进行分析，可为后续GQD经典名方制剂的质量控制研究提供参考。

Objective The HPLC fingerprint and the content determination method of the benchmark sample of Gegen Qinlian Decoction (葛根芩连汤, GQD) were established to study the rule of quantitative transmitting of GQD benchmark sample. Methods Fifteen batches of GQD benchmark samples were prepared according to the record method of “Treatise on Febrile Diseases”, and the HPLC fingerprint of 15 batches of benchmark samples was established. The peak attribution and similarity range in the fingerprint were clarified, and the quality transfer indexes such as the range of extract yield, the content range of index components and the range of transfer rate were analyzed. The quality control system of GQD benchmark samples was preliminarily established. Results A total of 34 common peaks were calibrated for 15 batches of GQD, and the similarity was good (> 0.99). The contents of puerarin, daidzin, daidzein, baicalin, wogonoside, baicalein, wogonin, berberine hydrochloride, palmatine, liquiritin, glycyrrhizic acid in the benchmark sample were 0.803 1%—1.093 8%, 0.104 8%—0.178 9%, 0.011 7%—0.024 4%, 0.470 9%—0.736 9%, 0.211 2%—0.219 9%, 0.001 1%—0.002 2%, 0.001 2%—0.002 2%, 0.053 2%—0.115 4%, 0.022 4%—0.042 3%, 0.118 8%—0.195 4%, 0.087 6%—0.099 2%, respectively. The average transfer rates of decoction pieces to decoction and decoction to benchmark samples were 17.71%—19.69% and 84.18%—104.00% for puerarin, 10.32%—13.65% and 86.90%—105.38% for daidzein, 21.13%—27.65% and 64.64%—104.09% for daidzein, 22.46%—23.99% and 71.58%—107.61% for baicalin, and 21.38%—28.16% and 82.54%—106.78% for wogonoside, 2.15%—3.81% and 51.85%—83.33% for baicalein, 4.83%—9.55% and 43.75%—73.33% for wogonin, 6.33%—8.70% and 60.33%—99.95% for berberine hydrochloride, 11.09%—15.79% and 60.56%—76.94% for palmatine, 57.82%—76.53% and 80.98%—103.70% liquiritin, 14.98%—18.08% and 87.96%—106.12% for glycyrrhizic acid, respectively. The average dry paste rate transfer rate of 15 batches of benchmark samples was 81.35%. Conclusion Through the combination of fingerprint, extract yield and index component content determination, the quality transfer process of the benchmark sample of the classic prescription GQD was analyzed, which can provide reference for the quality control research of the classic prescription preparation of GQD.

国家中医药管理局中医药创新团队及人才支持计划项目（ZYYCXTD-D-202209）；2021年成都市科技人才创新创业项目（2021-RCO5-00020-CG）