目的 建立龙生蛭胶囊的HPLC指纹图谱，结合化学模式识别方法进行质量评价。方法 采用HPLC法建立龙生蛭胶囊的指纹图谱，进行相似度评价，确定共有峰；对测定结果进行层次聚类分析和主成分分析，并结合正交偏最小二乘–判别分析对样品进行模式识别，以VIP值大于1为标准筛选影响龙生蛭胶囊质量的差异性成分。结果 19批龙生蛭胶囊样品的HPLC指纹图谱共标定了20个共有峰，相似度均大于0.95，指认了9个共有峰，分别为槲皮素、没食子酸、原儿茶酸、紫丁香苷、绿原酸、芍药苷、刺五加苷E、异嗪皮啶、毛蕊异黄酮葡萄糖苷。19批样品可分为2类；前4个主成分的累积方差贡献率为85.504%；以VIP值大于1为标准，筛选出8个主要峰，13、8、2（没食子酸）、3（原儿茶酸）、1（槲皮素）、14（芍药苷）、10、11号峰。结论 建立了龙生蛭胶囊更全面、系统的质量评价和分析方法，为龙生蛭胶囊的质量标准提高提供理论依据。

Objective To develop an HPLC fingerprint of Longshengzhi Capsules and evaluate its quality consistency by combining with the chemical pattern recognition method for the purpose of its quality control. Methods HPLC fingerprints of Longshengzhi Capsules was establish. The similarity was evaluated to establish the common peaks. The hierarchical clustering analysis (HCA), principal component analysis (PCA), and orthogonal partial least squares-discriminant analysis (OPLS-DA) method were carried out, and the differential components of Longshengzhi Capsules quality were screened by the VIP value greater than 1. Results There were 20 common peaks in HPLC fingerprints of Longshengzhi Capsules and the similarities of 19 batches of Longshengzhi Capsules were above 0.95. Nine common peaks have been identified, namely quercetin, gallic acid, protocatechuic acid, syringin, chlorogenic acid, paeoniflorin, eleutheroside E, isofraxidin, and calycosin-7-O-glucoside. 19 Batches of samples were divided into two categories and the cumulative variance contribution rate of the first four principal components was 85.504%. There were eight common peaks with VIP>1, which were 13, 8, 2(gallic acid), 3(protocatechuic acid), 1(quercetin), 14(paeoniflorin), 10, and 11 peak. Conclusion A more comprehensive and systematic quality evaluation and analysis method for Longshengzhi Capsules has been established to provide theoretical basis for improving the quality standard of Longshengzhi Capsules.

R286.02

陕西省教育厅重点科研协同创新中心项目（21JY001）；陕西省科技厅一般项目（2023-YBSF-365）；陕西省科技厅自然科学研究一般项目（2022JQ-919）；咸阳市重大科技专项计划项目（2018K01-47）