目的 建立绛糖宁颗粒HPLC指纹图谱及多成分定量分析方法，为其质量控制提供科学依据。方法 采用Agilent ZORBAX SB-Aq色谱柱，以乙腈-0.05%磷酸溶液为流动相进行梯度洗脱，体积流量1.0 mL·min^-1，检测波长260 nm，柱温30℃，构建18批绛糖宁颗粒的HPLC指纹图谱，结合聚类分析（CA）、主成分分析（PCA）和正交偏最小二乘判别分析（OPLS-DA），筛选不同批次绛糖宁颗粒的差异成分，并同步对制剂中毛蕊异黄酮-7-O-β-D-葡萄糖苷、芹糖甘草苷、甘草苷、芒柄花苷、毛蕊异黄酮、甘草素、甘草酸、芒柄花素、五味子醇甲、五味子醇乙共10种成分进行含量测定。结果 所建立的绛糖宁颗粒指纹图谱共标定了22个共有成分，经对照品比对成功指认出其中10种成分；18批样品的相似度均大于0.923，表明批次间整体质量一致性良好；CA和PCA结果相似，18批样本可被分为2类，且色谱峰可被分为4组；OPLS-DA进一步筛选出12个差异性成分，其中包括五味子醇甲、五味子醇乙、甘草素、芒柄花苷和毛蕊异黄酮-7-O-β-D-葡萄糖苷5种已纳入定量分析的成分。结论 建立的绛糖宁颗粒HPLC指纹图谱及多指标定量分析方法稳定、可靠，结合化学计量学分析适用于绛糖宁颗粒的质量评价，为质量标准的完善与提升提供参考。

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

湖北省科技重大专项(2022ACA003)