目的 建立龍生蛭膠囊的HPLC指紋圖譜，結(jié)合化學(xué)模式識(shí)別方法進(jìn)行質(zhì)量評(píng)價(jià)。方法 采用HPLC法建立龍生蛭膠囊的指紋圖譜，進(jìn)行相似度評(píng)價(jià)，確定共有峰；對(duì)測定結(jié)果進(jìn)行層次聚類分析和主成分分析，并結(jié)合正交偏最小二乘–判別分析對(duì)樣品進(jìn)行模式識(shí)別，以VIP值大于1為標(biāo)準(zhǔn)篩選影響龍生蛭膠囊質(zhì)量的差異性成分。結(jié)果 19批龍生蛭膠囊樣品的HPLC指紋圖譜共標(biāo)定了20個(gè)共有峰，相似度均大于0.95，指認(rèn)了9個(gè)共有峰，分別為槲皮素、沒食子酸、原兒茶酸、紫丁香苷、綠原酸、芍藥苷、刺五加苷E、異嗪皮啶、毛蕊異黃酮葡萄糖苷。19批樣品可分為2類；前4個(gè)主成分的累積方差貢獻(xiàn)率為85.504%；以VIP值大于1為標(biāo)準(zhǔn)，篩選出8個(gè)主要峰，13、8、2（沒食子酸）、3（原兒茶酸）、1（槲皮素）、14（芍藥苷）、10、11號(hào)峰。結(jié)論 建立了龍生蛭膠囊更全面、系統(tǒng)的質(zhì)量評(píng)價(jià)和分析方法，為龍生蛭膠囊的質(zhì)量標(biāo)準(zhǔn)提高提供理論依據(jù)。

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

陜西省教育廳重點(diǎn)科研協(xié)同創(chuàng)新中心項(xiàng)目（21JY001）；陜西省科技廳一般項(xiàng)目（2023-YBSF-365）；陜西省科技廳自然科學(xué)研究一般項(xiàng)目（2022JQ-919）；咸陽市重大科技專項(xiàng)計(jì)劃項(xiàng)目（2018K01-47）