目的 建立黃蛭益腎膠囊HPLC指紋圖譜，采用指紋圖譜并結合化學模式識別技術對黃蛭益腎膠囊進行質量控制。方法 采用Waters XBridge^® Shield RP18（250 mm×4.6 mm，5 μm）色譜柱，以乙腈-0.05%磷酸水溶液為流動相，梯度洗脫，體積流量1.0 mL/min，柱溫30℃，檢測波長210 nm。采用HPLC串聯(lián)四極桿飛行時間質譜（HPLC-Q-TOF-MS/MS）對共有峰定性分析，采用聚類分析（HCA）、主成分分析（PCA）及偏最小二乘法-判別分析（PLS-DA）統(tǒng)計分析。結果 16批樣品中共標定24個共有峰，相似度評價均大于0.9，鑒定了其中24個峰并歸屬于7味藥；HCA及PCA識別方法將樣品分為3類；PLS-DA篩選出包括黃芪異黃烷苷、人參皂苷Rg₁、毛蕊異黃酮葡萄糖苷、7，2'-二羥基-3'，4'-二甲氧基異黃烷、松脂醇二葡萄糖苷、毛蕊異黃酮、芒柄花黃素、綠原酸在內的8種主要差異成分。結論 建立的HPLC指紋圖譜可最大程度反映黃蛭益腎膠囊的藥味組成信息，較全面反映其質量，應用的評價分析技術可合理評價其質量差異并準確尋找出差異成分，為其質量合理控制和標準完善提供依據(jù)。

Objective To establish a high performance liquid chromatography (HPLC) fingerprint of Huangzhi Yishen Capsule, control the quality of Huangzhi Yishen Capsule by fingerprint and chemical pattern recognition technology. Methods Waters XBridge^® Shield RP18 (250 mm×4.6 mm, 5 μm) column was used, mobile phase was consisted of acetonitrile-0.05% phosphoric acid solution, gradient elution, the flow rate was 1.0 mL/min, the column temperature was 30℃ and the detection wavelength was 210 nm. The common peaks in fingerprint were identified by HPLC-Q-TOF-MS/MS, analyzed by cluster analysis (HCA), principal component analysis (PCA) and partial least squares discriminant analysis (PLS-DA). Results The fingerprint of Huangzhi Yishen Capsule was established with 24 common peaks, the similarities of 16 batches of samples were all above 0.9, 24 of them were identified, which come from seven herbs; the samples could be divided into three categories by HCA, PCA and PLS-DA technic, eight components were screened out to cause quality differences, including 2'-hydroxy-3', 4'-dimethoxy-isoflavan-glucoside, Ginsenoside Rg₁, calycosin-glucopyranoside, 7, 2'-dihydroxy-3', 4'-dimethoxy-isoflavan, pinoresinol diglucoside, calycosin, formononetin and chlorogenic acid. Conclusion The established HPLC fingerprint can extremely demonstrate the foumlations of Huangzhiyishen Capsule and reflect its quality comprehensively. The application of evaluation software and recognition technics can reasonably evaluate the quality difference and accurately find out the components that caused the quality difference, therefore provide the basis for reasonable quality control and standard improvement on Huangzhi Yishen Capsule.

R284.1

國家藥典委員會藥品標準制修訂研究課題（2019Z040）