目的 通过建立HPLC指纹图谱及指标成分含量测定方法，构建经典名方调胃承气汤（Tiaowei Chengqi Decoction，TCD）的质量评价体系，并对其基准样品量值传递规律进行探究。方法 遵循古法制备15批不同产地药材来源的TCD基准样品；采用HPLC法建立其指纹图谱，运用层次聚类分析（hierarchical clustering analysis，HCA）、正交偏最小二乘-判别分析（orthogonalpartial least squares-discriminant analysis，OPLS-DA）和主成分分析（principal component analysis，PCA）等化学计量学方法评价批次间一致性并筛选差异标志物；同时，基于PCA模型计算Hotelling’s T²与DModX，以95%与99%置信界限作为警戒与控制限［T²_Crit (95%)＝31.49，T²_Crit (99%)＝54.15，D_Crit＝1.97］用于TCD基准样品批次一致性评价；建立方法同步测定15批TCD基准样品及其对应药材饮片中没食子酸、甘草苷、芦荟大黄素、大黄酸、甘草酸、大黄素6种指标成分的含量，并计算其从饮片到基准样品的转移率。结果 成功建立了TCD基准样品的HPLC指纹图谱，标定了16个共有峰；化学计量学分析结果显示，不同批次TCD基准样品可被有效区分，并筛选出没食子酸、甘草酸铵等是批次间差异的主要化学标志物；6种指标成分含量测定结果显示，15批TCD基准样品中没食子酸、甘草苷、芦荟大黄素、大黄酸、甘草酸铵、大黄素的质量分数分别为0.521～1.581、0.143～0.711、0.025～0.071、0.016～0.182、0.487～2.740、0.007～0.039 mg/g；量值传递研究结果显示，6种成分的平均转移率分别为17.625%、2.878%、5.929%、5.159%、1.689%和1.088%。结论 结合多成分定量及化学计量学，建立了TCD基准样品的HPLC指纹图谱，探究了其药材-基准样品的成分传递规律，为TCD的质量评价提供了科学依据。

Objective The quality research system of the classic formula Tiaowei Chengqi Decoction (TCD, 调胃承气汤) was constructed by establishing HPLC fingerprinting and index component content determination methods, and the quantity value transfer law of its reference samples were explored. Methods Prepare TCD reference samples from 15 batches of herbal materials sourced from different regions using traditional methods. Establish fingerprint profiles via HPLC and evaluate batch-to-batch consistency using chemometric methods such as hierarchical cluster analysis (HCA) orthogonal partial least squares-discriminant analysis (OPLS-DA) and principal component analysis (PCA) to identify the batch-to-batch consistency and differential markers. Simultaneously, Hotelling’s T² and DModX were calculated based on the PCA model, with 95% and 99% confidence limits serving as the warning and control limits [T²_Crit (95%) = 31.49, T²_Crit (99%) = 54.15, D_Crit = 1.97] for batch consistency evaluation. A method was established to simultaneously determine the content of six target components gallic acid, glycyrrhizin, aloe-emodin, emodin, glycyrrhetic acid, and rhein in 15 batches of samples and their corresponding crude drug slices. The transfer rate of these components from crude drug slices to samples was calculated. Results A robust HPLC fingerprint profile of TCD was successfully established, allowing for the identification of 16 common peaks. Chemometric analysis confirmed effective batch-to-batch differentiation, with gallic acid and glycyrrhizic acid identified as key chemical markers contributing to the discrimination of batch variations. Quantitative analysis of six marker components across 15 batches revealed mass fractions ranging from 0.521 to 1.581 mg/g for gallic acid, 0.143 to 0.711 mg/g for glycyrrhizin, 0.025 to 0.071 mg/g for aloe-emodin, 0.016 to 0.182 mg/g for emodin, 0.487 to 2.740 mg/g for glycyrrhizic acid, and 0.007 to 0.039 mg/g for rhein. Furthermore, component tracking from crude drug to final sample demonstrated average transfer rates of 17.625%,2.878%,5.929%,5.159%,1.689% and 1.088% for these compounds, respectively. Conclusion Combined with multi-component quantitative analysis with chemometric methods to develop an HPLC fingerprint profile for TCD, systematically investigating the compositional variation patterns from herbal materials to reference samples. The findings provide a scientific foundation for quality evaluation research on TCD.

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湖北省中医药管理局药用矿物学重点学科建设项目（鄂中医通2023］ 2号）；国家中医药管理局高水平中医药重点学科建设项日（国中医药人教函2022］ 226号）