目的 建立生脉颗粒HPLC指纹图谱和化学模式识别方法评价其质量。方法 采用HPLC法建立10批生脉颗粒的指纹图谱，计算相似度，确定共有峰，进行层次聚类分析和主成分分析，并结合正交偏最小二乘-判别分析进行模式识别，筛选影响生脉颗粒质量的差异性成分。结果 确定了16个共有峰，指认了5个色谱峰，各批次相似度均大于0.940。10批生脉颗粒样品分为3类，3个主成分的累积方差贡献率为93.481%；6个峰所对应的成分可能是导致不同批次之间生脉颗粒样品质量差异的主要标志物。结论 建立的HPLC指纹图谱与化学模式识别方法相结合可对生脉颗粒的质量进行综合评价。

Objective To establish an HPLC fingerprint of Shengmai Granules combined with the chemical pattern recognition method to evaluate quality. Methods HPLC fingerprints of 10 batches of Shengmai Granules were established. The similarity was calculated and the common peaks were confirmed, and the hierarchical clustering analysis (HCA) and principal component analysis (PCA) were carried out. The chemical pattern recognition was carried out by orthogonal partial least squares-discriminant analysis (OPLS-DA) method. The differential components in Shengmai Granules quality were screened. Results There were 16 common peaks of HPLC fingerprint of Shengmai Granules, and five components were identified. The similarities of Shengmai Granules were greater than 0.940. 10 Batches of Shengmai Granules were divided into three categories and the cumulative variance contribution rate of the three principal components was 93.481%. Six common peaks were the main bioactive markers causing differences in the quality of different batches of Shengmai Granules. Conclusion The established method of HPLC fingerprint combined with the chemical pattern recognition method can be used for the systemic evaluation of quality of Shengmai Granules.

R286.02

陕西省科技厅古代经典名方研究与开发创新团队项目（2022TD-50）；陕西省中医药管理局重点研究项目（2023-010）