目的 建立经典名方泻黄散（Xiehuang Powder，XHP）基准样品HPLC指纹图谱及5种指标性成分含量测定方法，分析药材饮片到基准样品的量值传递特征，为泻黄散质量标准建立及相关制剂开发提供依据。方法 依据国家公布的经典名方关键信息表及古籍记载，收集购自主产区或道地产区、来源于多个产地的处方药材，制备15批泻黄散基准样品。采用HPLC法建立指纹图谱，结合对照品比对和HPLC-MS对特征峰进行指认，并以相似度评价结合化学计量学分析考察批间一致性及差异成分。同时建立栀子苷、升麻素苷、5-O-甲基维斯阿米醇苷、甘草苷和甘草酸5种指标性成分的含量测定方法，并分析其由药材饮片到基准样品的量值传递特征。结果 成功建立15批泻黄散基准样品HPLC指纹图谱，15批样品相似度均≥0.900，共标定44个共有峰，指认14个特征峰。化学计量学分析显示，15批泻黄散基准样品可分为3类，正交偏最小二乘法-判别分析（orthogonal partial least squares-discriminant analysis，OPLS-DA）筛得17个对批间差异贡献较大的成分。5种指标性成分在基准样品中的质量分数分别为栀子苷0.248～0.326 mg/g、升麻素苷2.438～3.812 mg/g、5-O-甲基维斯阿米醇苷0.178～0.292 mg/g、甘草苷2.609～3.121 mg/g、甘草酸8.888～9.481 mg/g；药材饮片到基准样品的转移率分别为栀子苷1.003 5%～1.342 1%、升麻素苷40.558 1%～46.727 7%、5-O-甲基维斯阿米醇苷44.463 4%～52.561 2%、甘草苷34.818 5%～38.229 3%、甘草酸34.214 0%～39.804 1%。结论 建立了泻黄散基准样品HPLC指纹图谱及多指标成分含量测定方法，初步揭示了5种指标性成分由药材饮片到基准样品的量值传递特征，可为泻黄散质量标准建立及相关中药制剂开发提供实验依据。

Objective To establish an HPLC fingerprint of classic prescription Xiehuang Powder (XHP, 泻黄散) benchmark samples and a quantitative method for five marker components, and to analyze quantity value transfer characteristics from decoction pieces to benchmark samples, providing a basis for the establishment of quality standards for Xiehuang Powder and the development of related preparations. Methods Prescription materials were sourced from major producing areas, genuine production areas, as well as from multiple origins based on the official key information table of classical prescriptions and ancient records. A total of 15 batches of XHP benchmark samples were prepared. HPLC fingerprints were established, and characteristic peaks were assigned using reference standards and HPLC-MS. Batch consistency and differential components were assessed via similarity evaluation and chemometric analysis. Quantitative methods were developed for geniposide, prim-O-glucosylcimifugin, 5-O-methylvisammioside, liquiritin, and glycyrrhizic acid. Their transfer characteristics from decoction pieces to benchmark samples were subsequently analyzed. Results HPLC fingerprints were successfully established for 15 batches of XHP benchmark samples. The similarity values across all batches were not less than 0.900. A total of 44 common peaks were marked, and 14 characteristic peaks were identified. The 15 batches were classified into three distinct groups by chemometric analysis. A total of 17 components contributing significantly to batch differences were identified by orthogonal partial least squares discriminant analysis (OPLS-DA). Mass fractions for geniposide, prim-O-glucosylcimifugin, 5-O-methylvisammioside, liquiritin, and glycyrrhizic acid were 0.248—0.326, 2.438—3.812, 0.178—0.292, 2.609—3.121, 8.888—9.481 mg/g, respectively. Their respective transfer rates from decoction pieces to benchmark samples were 1.003 5%—1.342 1%, 40.558 1%—46.727 7%, 44.463 4%—52.561 2%, 34.818 5%—38.229 3%, and 34.214 0%—39.804 1%. Conclusion An HPLC fingerprint and a multicomponent quantitative method were established for XHP benchmark samples. The quantity value transfer characteristics of five marker components were successfully clarified. These findings provide experimental support for the establishment of XHP quality standards and the development of related traditional Chinese medicine formulations.

R283.6

国家自然科学基金资助项目（82373843）；陕西省中医药管理局中医药科研项目（2025-ZY-004）；陕西省科技厅秦创原“科学家＋工程师”队伍建设项目（2025QCY-KXJ-107）；陕西省中医药管理局陕西省中医药科研创新团队项目（2025-CXTD-07）；西安市科技局科学家＋工程师队伍建设项目（2025JH-KXGC-0012）；咸阳市科技局重大科技创新专项项目（L2025-ZDKJ-ZDGG-ZYRGZN-004）；陕西省教育厅重点科学研究计划项目（25JR042）