目的 基于HPLC指纹图谱和化学模式识别方式建立和胃降逆胶囊的质量评价方法。方法 建立11批和胃降逆胶囊的HPLC指纹图谱，指认共有峰，并进行相似度评价；采用SPSS 26.0、SIMCA14.1软件对和胃降逆胶囊进行聚类分析（HCA）、主成分分析（PCA）和最小偏二乘判别分析（OPLS-DA），以变量重要性投影（VIP）值＞1为标准筛选影响和胃降逆胶囊质量的差异性成分。结果 建立了11批和胃降逆胶囊的指纹图谱，相似度均大于0.90，标定共有峰25个，指认了其中5个，分别是绿原酸、菊苣酸、虎杖苷、大黄素-8-O-β-D-葡萄糖苷和大黄素。由HCA可知，11批和胃降逆胶囊可聚为3类，PCA从25个共有峰中提取了4个主成分，通过OPLS-DA分析筛选了16号峰（大黄素-8-O-β-D-葡萄糖苷）、25号峰（大黄素）、5号峰（虎杖苷）、24号峰和19号峰5个引起不同批次和胃降逆胶囊质量差异的主要标志性成分。结论 建立的HPLC指纹图谱方法稳定可靠，结合化学模式识别技术可用于评价和胃降逆胶囊的整体质量。

Objective To establish a quality evaluation method for Hewei Jiangni Capsules based on HPLC fingerprint and chemical pattern recognition. Methods HPLC fingerprint of 11 batches of Hewei Jiangni Capsules was carried on. The common peaks were identified and similarity evaluation was performed. Hierarchical cluster analysis (HCA), principal components analysis (PCA), and orthogonal patrial least squares discriminant analysis (OPLS-DA) were conducted on Hewei Jiangni Capsules using SPSS 26.0 and SIMCA 14.1 software. Differential components affecting the quality of Hewei Jiangni Capsules were screened based on the criterion of variable importance projection (VIP) value > 1.0. Results HPLC fingerprint of 11 batches of Hewei Jiangni Capsules were established. The similarities of 11 batches of samples were above 0.90, and 25 common peaks were identified, and five components were confirmed, namely chlorogenic acid, cichoric acid, polydatin, emodin-8-O-β-D-pyranoside, and emodin. The results of HCA indicate that 11 batches of Hewei Jiangni Capsules could be classified into three clusters, four principal components from 25 common peaks were extracted by PCA. Five quality differential components were presented in the fingerprints by OPLS-DA, including peak 16 (emodin-8-O-β-D-glucoside), peak 25 (emodin), peak 5 (polydatin), peak 24, and peak 19. Conclusion The established HPLC fingerprint method is stable and reliable, and combined with chemical pattern recognition technology, which can be used to evaluate the overall quality of Hewei Jiangni Capsules.

R285.5

陕西省重点研发计划（2024SF-YBXM-481）；陕西省中医药管理局中医药全省性专款专项项目（2021-QYZL-01）