目的 建立补中益气产品HPLC指纹图谱，并结合化学模式识别对相关产品（口服液、合剂、水丸、蜜丸、浓缩丸）进行质量标志物分析。方法 以Kromasil 100-5-C₁₈柱（250 mm×4.6 mm，5 μm）为色谱柱，流动相为乙腈-0.2%甲酸水溶液，体积流量0.80 mL/min，检测波长260 nm，梯度洗脱；对20批补中益气产品的HPLC指纹图谱进行相似度评价，结合层次聚类分析（hierarchical cluster analysis，HCA）、主成分分析（principal component analysis，PCA）和正交偏最小二乘法-判别分析（orthogonal partial least squares-discriminant analysis，OPLS-DA）对色谱峰进行综合处理和分析。结果 以补中益气产品HPLC指纹图谱中的16个色谱峰为共有峰，20批样品的相似度为0.799～0.933；指认其中10个共有峰。HCA、PCA、OPLS-DA分类结果显示，20批补中益气产品可聚为4类，补中益气浓缩丸聚为一类，补中益气水丸聚为一类，补中益气蜜丸聚为一类，补中益气合剂与11批口服液聚为一类。OPLS-DA筛选出变量投影重要性分析值（variable importance in projection，VIP）大于1的共有峰依次为峰2（肌苷）、3（胸苷）、10（橙皮苷）、15（甘草酸）、6（毛蕊异黄酮-7-O-葡萄糖苷），以上特征峰可作为补中益气产品的质量标志物。结论 建立的HPLC指纹图谱方法简便快捷，专属性、重复性良好；结合化学模式识别分析，为补中益气产品质量评价标准体系的建立提供参考。

Objective To analyze of quality markers for Buzhong Yiqi products (oral liquid, mixture, water pills, honey pills, concentrated pills) by the HPLC fingerprint combined with chemical pattern recognition. Methods Kromasil 100-5-C₁₈ column (250 mm×4.6 mm, 5 μm) was used as the detection column. The mobile phase was acetonitrile and 0.2% formic acid water with the flow rate of 0.80 mL/min under gradient elution, and the detection wavelength was set at 260 nm. The HPLC fingerprints of 20 batches of Buzhong Yiqi products were established and evaluated for similarity. The common peaks were processed and analyzed by combining hierarchical cluster analysis (HCA), principal component analysis (PCA) and orthogonal partial least squares-discriminant analysis (OPLS-DA). Results There were 16 common peaks in 20 batches of Buzhong Yiqi oral products with similarity of 0.799—0.933. Among these, 10 common peaks were identified. The classification results of HCA, PCA and OPLS-DA showed that 20 batches of Buzhong Yiqi products could be clustered into four categories, Buzhong Yiqi concentrated pills were clustered into one category, Buzhong Yiqi water pills were clustered into one category, Buzhong Yiqi honey pills were clustered into one category, and Buzhong Yiqi mixture and 11 batches oral liquid were clustered into one category. The OPLS-DA results showed that the common peaks with variable importance in projection (VIP) value ＞1 were peak 2(inosine), peak 3(thymidine), peak 10(hesperidin), peak 15(glycyrrhizic acid), and peak 6(calycosin-7-O-β-D-glucoside). The above five common peaks were selected as the quality markers in Buzhong Yiqi products.Conclusion The fingerprint established in this study is simple, accurate and reproducible. It provides a reference for the establishment of the quality evaluation standard system of Buzhong Yiqi products by combining with the chemical pattern recognition analysis.

R283.6

浙江省基础公益研究计划项目（LBY22H280003）；浙江工业大学研究生实践基地建设项目（GZ21231160006）；浙江工业大学研究生实践基地建设项目（GZ21881160011）