目的 开发一种基于HPLC-Q-Exactive液质联用技术的通脉降糖胶囊（Tongmai Jiangtang Capsule，TJC）全局定性分析的检测方法，同时应用液相色谱建立TJC的HPLC指纹图谱，并对其主要成分进行定量分析，为TJC的全面质量评价及质量控制提供参考依据。方法 利用Thermo Fisher Q-Exactive液质联用系统对TJC化学信息进行采集，结合数据库、文献检索及对照品比对等手段进行TJC成分鉴定。采用Capcell Pak C₁₈色谱柱（150 mm×4.6 mm，3 μm），以0.5%甲酸水溶液-0.5%甲酸乙腈溶液为流动相进行梯度洗脱，柱温40℃，体积流量0.4 mL/min，对15批次TJC样品进行检测，同时建立指纹图谱，应用中药色谱指纹图谱相似度评价系统（2012版）进行相似度评价和共有峰指认，并对其中8个指标成分进行定量测定。结果 利用高分辨液质联用技术共鉴定出TJC中150种化合物。15批TJC的指纹图谱相似度均在0.97以上，共标定25个共有峰，指认其中8个色谱峰（原儿茶酸、原儿茶醛、葛根素、3'-甲氧基葛根素、葛根素芹菜糖苷、大豆苷、丹酚酸B以及丹参酮II_A），对其进行HPLC定量分析，结果显示所有目标成分均线性良好（R²>0.999），平均回收率均在95.30%~103.56%，质量分数分别为原儿茶酸0.204~0.482 mg/g、原儿茶醛0.345~0.516 mg/g、葛根素5.374~8.805 mg/g、3'-甲氧基葛根素1.148~2.075 mg/g、葛根素芹菜糖苷1.327~2.204 mg/g、大豆苷1.378~2.276 mg/g、丹酚酸B 3.065~4.918 mg/g以及丹参酮II_A 0.412~0.594 mg/g。结论 所建立的成分鉴定、指纹图谱和定量分析方法稳定可行、结果可靠，适用于TJC的综合质量评价，可为TJC产品的质量控制提供参考借鉴。

Objective To establish a set of analytical methods for global qualitative analysis, HPLC fingerprint, and main component quantification of Tongmai Jiangtang Capsule (通脉降糖胶囊, TJC) based on HPLC-Q-Exactive-MS, so as to provide scientific evidence for overall quality evaluation and control of TJC. Methods In the present study, Thermo Fisher LC-Q-Exactive MS system was applied to collect MS information of the TJC components, which was further elucidated with the help of related databases, former publication and standard substances. HPLC analysis of TJC samples from 15 different batches was performed on a Capcell Pak C₁₈ column (150 mm×4.6 mm, 3 μm) using 0.5% formic acid aqueous solution and 0.5% formic acid acetonitrile solution as mobile phases. The column temperature was 40℃, and the flow rate was 0.4 mL/min. Chromatographic fingerprint similarity evaluation system (2012 edition) was applied for similarity evaluation, common peak identification, and simultaneous determination of eight index components was carried out. Results As the result, a total of 150 compounds in TJC were identified with high resolution HPLC-MS. The fingerprint similarities of TJC samples from 15 batches were all above 0.97, and 25 shared peaks were calibrated. Eight chromatographic peaks (representing protocatechuic acid, protocatechualdehyde, puerarin, 3'-methoxypuerarin, puerarin apigenoside, daidzein, salvianolic acid B, and tanshinone II_A) were identified and quantitatively analyzed with HPLC. The results showed that all target components had good linearity (R² > 0.999), and the average recoveries were in the range of 95.30%-103.56%. The contents of protocatechuic acid, protocatechualdehyde, puerarin, 3'-methoxy puerarin, puerarin apigenoside, daidzein, salvianolic acid B and tanshinone II_A were 0.204-0.482 mg/g, 0.345-0.516 mg/g, 5.374-8.805 mg/g, 1.148-2.075 mg/g, 1.327-2.204 mg/g, 1.378-2.276 mg/g, 3.065-4.918 mg/g and 0.412-0.594 mg/g, respectively. Conclusion The integrated method for the qualitative, quantitative and fingerprint analysis of TJC established in this study was proven stable, feasible and reliable. It would be suitable for the comprehensive quality evaluation and control of TJC.

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国家重点研发计划项目（2018YFC1704200）；国家重点研发计划项目（2018YFC1704204）；浙江省中医药科技计划项目（2021ZQ025）；浙江省自然科学基金项目（LR19H280001）