目的 采用超高效液相色谱法建立生姜总酚软胶囊的指纹图谱，并结合化学计量学评价其质量。方法 以15批生姜总酚软胶囊样品的15个共有峰面积为对象，经Z得分标准化后，采用聚类分析、主成分分析、偏最小二乘判别分析（OPLS-DA）进行多变量统计分析。结果 建立了生姜总酚软胶囊的UPLC指纹图谱，共标定15个共有峰，样品的相似度均大于0.95。15批样品间存在明显质量梯度差异；共提取3个特征值大于1的主成分，累积方差贡献率达95.124%，峰4（6-姜辣素）、峰7（8-姜酚）、峰8（6-姜烯酚）、峰10（10-姜酚）是各主成分的核心相关变量；OPLS-DA模型筛选出8个峰对组别差异贡献最大，其中峰7（8-姜酚）、峰10（10-姜酚）、峰14可作为生姜总酚软胶囊质量控制的关键依据。结论 所建立的UPLC指纹图谱操作简便、结果可靠，可为生姜总酚软胶囊标准化生产、质量管控提供依据。

Objective To establish a fingerprint of Ginger Total Phenol Soft Capsules by UPLC, and evaluate their quality combined with chemometrics. Methods The areas of 15 common peaks from 15 batches of samples were used as research objects. After Z-score standardization, multivariate statistical analysis was performed using hierarchical cluster analysis, principal component analysis and OPLS-DA model. Results UPLC fingerprint of Ginger Total Phenol Soft Capsules was established with 15 common peaks identified. The similarities were all above than 0.95. There was a significant quality gradient difference among 15 batches of samples. Three principal components with eigenvalues greater than 1 were extracted, accounting for a cumulative variance contribution of 95.124%. Peaks 4 (6-gingerol), 7 (8-gingerol), 8 (6-shogaol), and 10 (10-gingerol) were identified as the core correlated variables for each principal component. The OPLS-DA model identified 8 peaks with the greatest contribution to group differences, among which peaks 7 (8-gingerol), 10 (10-gingerol), and 14 could serve as key criteria for quality control of Ginger Total Phenol Soft Capsules.Conclusion The established UPLC fingerprint method is simple to operate and reliable in results, providing a basis for the standardized production and quality control of Ginger Total Phenol Soft Capsules.

国家药监局中药材质量监测与评价重点实验室开放课题（KFKT2022-8）；广西科技重大专项（桂科AA23023035-4）