目的 建立絳糖寧顆粒HPLC指紋圖譜及多成分定量分析方法，為其質(zhì)量控制提供科學(xué)依據(jù)。方法 采用Agilent ZORBAX SB-Aq色譜柱，以乙腈-0.05%磷酸溶液為流動(dòng)相進(jìn)行梯度洗脫，體積流量1.0 mL·min^-1，檢測(cè)波長(zhǎng)260 nm，柱溫30℃，構(gòu)建18批絳糖寧顆粒的HPLC指紋圖譜，結(jié)合聚類分析（CA）、主成分分析（PCA）和正交偏最小二乘判別分析（OPLS-DA），篩選不同批次絳糖寧顆粒的差異成分，并同步對(duì)制劑中毛蕊異黃酮-7-O-β-D-葡萄糖苷、芹糖甘草苷、甘草苷、芒柄花苷、毛蕊異黃酮、甘草素、甘草酸、芒柄花素、五味子醇甲、五味子醇乙共10種成分進(jìn)行含量測(cè)定。結(jié)果 所建立的絳糖寧顆粒指紋圖譜共標(biāo)定了22個(gè)共有成分，經(jīng)對(duì)照品比對(duì)成功指認(rèn)出其中10種成分；18批樣品的相似度均大于0.923，表明批次間整體質(zhì)量一致性良好；CA和PCA結(jié)果相似，18批樣本可被分為2類，且色譜峰可被分為4組；OPLS-DA進(jìn)一步篩選出12個(gè)差異性成分，其中包括五味子醇甲、五味子醇乙、甘草素、芒柄花苷和毛蕊異黃酮-7-O-β-D-葡萄糖苷5種已納入定量分析的成分。結(jié)論 建立的絳糖寧顆粒HPLC指紋圖譜及多指標(biāo)定量分析方法穩(wěn)定、可靠，結(jié)合化學(xué)計(jì)量學(xué)分析適用于絳糖寧顆粒的質(zhì)量評(píng)價(jià)，為質(zhì)量標(biāo)準(zhǔn)的完善與提升提供參考。

Objective To establish the HPLC fingerprint and multi-component quantitative analysis method for Jiangtangning Granules, providing a scientific basis for its quality control. Methods The analysis was carried out on Agilent ZORBAX SB-Aq column with a mobile phase of acetonitrile and 0.05% phosphoric acid solution for gradient elution at a flow rate of 1.0 mL·min^-1, detection wavelength of 260 nm, and column temperature of 30 ℃. The HPLC fingerprint of 18 batches of Jiangtangning Granules was constructed. Cluster analysis（CA）, principal component analysis（PCA）, and orthogonal partial least squares discriminant analysis（OPLS-DA） were combined to screen the differential components among different batches of Jiangtangning Granules. Meanwhile, the contents of calycosin-7-O-β-D-glucoside, liquiritin apioside, liquiritin, ononin, calycosin, liquiritigenin, glycyrrhizic acid, formononetin, schisandrol A, schisandrol B, a total of 10 components, were determined simultaneously. Results A total of 22 common components were identified in the established HPLC fingerprint of Jiangtangning Granules, and 10 of them were successfully identified by comparison with reference substances. The similarity of 18 batches of samples was all greater than 0.923, indicating good consistency in overall quality among batches. The results of CA and PCA were similar, and 18 samples could be divided into two categories, and the chromatographic peaks could be divided into four groups. OPLS-DA further screened out 12 differential components, including five components that had been included in the quantitative analysis, namely schisandrol A, schisandrol B, liquiritigenin, ononin, and calycosin-7-O-β-D-glucoside. Conclusion The established HPLC fingerprint and multi-index quantitative analysis method for Jiangtangning Granules is stable and reliable. Combined with chemometrics analysis, it is suitable for the quality evaluation of Jiangtangning Granules and can provide a reference for the improvement and enhancement of its quality standards.

R284.2

湖北省科技重大專項(xiàng)(2022ACA003)