目的 建立经典名方黄芪桂枝五物汤（Huangqi Guizhi Wuwu Decoction，HGWD）汤剂和冻干粉的HPLC特征图谱及9种指标成分含量测定方法，表征其量值传递规律。方法 按照《按古代经典名方目录管理的中药复方制剂药学研究技术指导原则（试行）》建立HGWD HPLC特征图谱和8种指标成分含量多波长同时测定方法以及黄芪甲苷含量测定方法，按前期优选工艺制备15批HGWD汤剂和冻干粉，以单位质量复方饮片的特征峰面积（当量特征峰面积）和（或）多指标成分含量，表征其药材-饮片-汤剂-冻干粉的量值传递规律。结果 建立的HPLC法均符合《中国药典》2025年版要求。15批HGWD汤剂和冻干粉的特征图谱批内相似度≥0.983，批间相似度≥0.909，批内和批间样品质量一致性较好。共有的15个特征峰涵盖了HGWD全部饮片，指认了7个特征峰。15批HGWD汤剂中，黄芪甲苷、没食子酸、芍药内酯苷、芍药苷、毛蕊异黄酮葡萄糖苷、肉桂酸、桂皮醛、芒柄花素、6-姜辣素9种质量标志物的质量分数按对应饮片量计算分别为0.14～0.32、1.33～1.84、2.26～7.57、11.57～15.01、0.11～0.26、0.17～0.32、0.45～0.97、0.01～0.02、0.21～0.32 mg/g，含量范围大部分在均值±30%内。15批HGWD的15个当量特征峰面积汤剂-冻干粉的批内转移率，除部分批次的桂皮醛为45%～71%外，其余14个峰为73%～129%；批间转移率均值为62%～101%。结论 确定HGWD基准样品实物形态为汤剂，构建的质控指标较全面合理，增加的当量特征峰面积量值传递表征的方法较为科学，可为其他经典名方基准样品研发提供新的评价和质控指标，为HGWD基准样品质量标准制定和颗粒剂研发提供依据。

Objective To establish the HPLC chromatograms of the classic prescription Huangqi Guizhi Wuwu Decoction (HGWD, 黄芪桂枝五物汤) of its decoction and freeze-dried powder, as well as quantitative determination methods for nine marker components, in order to characterize the law of quantitative transfer. Methods According to the “Technical Guidance for Pharmaceutical Research of Traditional Chinese Compound Preparations Managed According to Ancient Classic Formula Catalogue (Trial)”, HPLC finger printing profiles and a simultaneous quantitative method for eight active components, along with a separate assay for astragaloside A, were developed. Fifteen batches of HGWD decoction and freeze-dried powder were prepared using an optimized process. The value transfer process from medicinal materials to decoction pieces, decoctions, and finally freeze-dried powders was systematically characterized by evaluating the characteristic peak area of the unit mass compound yinpian (equivalent characteristic peak area) and/or quantitative levels of multiple constituents. Results The established HPLC methods both met the requirements stipulated in the 2025 edition of the Chinese Pharmacopoeia. The intra-batch similarity of the characteristic chromatograms for the 15 batches of HGWD and its freeze-dried powder was ≥ 0.983, while the inter-batch similarity was ≥ 0.909, indicating good consistency of sample quality both within and between batches. The 15 characteristic peaks in common covered all the herbal components of HGWD, among which seven peaks were identified. Among the 15 batches of HGWD decoctions, the contents of nine quality indicators-astragaloside IV, gallic acid, albiflorin, paeoniflorin, calycosin-7-O-β-D-glucoside, cinnamic acid, cinnamaldehyde, formononetin, 6-gingerol-were calculated based on the corresponding dosage of the herbs, ranging from 0.14 to 0.32, 1.33 to 1.84, 2.26 to 7.57, 11.57 to 15.01, 0.11 to 0.26, 0.17 to 0.32, 0.45 to 0.97, 0.01 to 0.02, and 0.21 to 0.32 mg/g respectively. The content ranges were mostly within the mean ± 30%. For the 15 equivalent characteristic peaks across the 15 batches of HGWD, the intra-batch transfer rates from decoction to freeze-dried powder ranged from 73% to 129% for 14 peaks, except for cinnamaldehyde in some batches, which showed a transfer rate of 45% to 71%. The mean inter-batch transfer rates ranged from 62% to 101%. Conclusion The decoction form is determined as the reference substance for HGWD. The established quality control indicators are comprehensive and reasonable. The method for characterizing the transfer of equivalent characteristic peak area is relatively scientific. It can provide new evaluation and quality control indicators for the research and development of benchmark samples of other classic prescriptions. These findings provide a basis for establishing quality standards for HGWD reference samples and for supporting the development of granule formulations.

R283.6

厦门市扶持中医药发展专项资助项目（XWZY-2023-0105）；厦门市扶持中医药发展专项资助项目（XWZY-2023-0206）；福建省医学创新课题资助项目（2025CXA073）