目的 建立补中益气合剂的高效液相色谱（HPLC）指纹图谱，结合化学模式识别技术对补中益气合剂进行质量评价。方法 采用HPLC法建立10批补中益气合剂HPLC指纹图谱，以层次聚类分析（HCA）和主成分分析（PCA）进行多元统计分析补中益气合剂的质量。结果 10批补中益气合剂相似度均大于0.90，得到31个共有峰，通过对照品指认了其中6个峰对应的成分；HCA将10批样品分为3类，PCA得到6个主成分，累积方差贡献率为96.503%。结论 HPLC指纹图谱结合化学计量学可综合评价补中益气合剂的质量。

Objective To establish a high-performance liquid chromatography (HPLC) fingerprint for Buzhong Yiqi Mixtures, and to evaluate its quality using chemometric pattern recognition techniques. Methods HPLC fingerprints of 10 batches of Buzhong Yiqi Mixtures were established by HPLC method. Hierarchical cluster analysis (HCA) and principal component analysis (PCA) were utilized for multivariate statistical analysis to evaluate the quality of Buzhong Yiqi Mixtures. Results The similarity of 10 batches of Buzhong Yiqi Mixtures was all greater than 0.90, with 31 common peaks identified. Six peaks corresponding to their components were identified through reference substances. HCA allowed the 10 batches of samples to be divided into three categories, and PCA yielded six principal components, with a cumulative variance contribution rate of 96.503%. Conclusion The combination of HPLC fingerprint and chemometrics can comprehensively evaluate the product quality of Buzhong Yiqi Mixtures.

R286.02

山东省重点研发计划（竞争性创新平台）项目（2024CXPT074）；泰山产业领军人才工程专项（tscx202312102）