目的 建立香橘乳癖宁胶囊（XRC）的UPLC指纹图谱，利用系统指纹定量法鉴定各批次制剂质量，并采用电喷雾离子源-四极杆-飞行时间质谱（ESI-Q-TOF/MS^E）对其化学成分进行定性分析。方法 采用Acquty UPLC BEH C₁₈（100 mm×2.1 mm，1.7 μm）色谱柱，以0.1%甲酸水溶液-乙腈为流动相进行梯度洗脱，体积流量为0.25 mL/min，柱温为28℃，检测波长为270 nm。以系统指纹定量法的宏定性相似度（S_m）、宏定量相似度（P_m）为评价指标，对10批制剂的整体质量进行评价。并利用UPLC-ESI-Q-TOF/MS^E正、负2种离子模式扫描对共有峰成分进行定性分析。结果 建立10批XRC的UPLC对照指纹图谱，标定33个共有峰，指认其中28个成分，并分别归属药材来源。系统指纹定量法评价结果表明，9批制剂质量在5级以上。结论 建立有效、可靠的XRC制剂质量评价方法，对其质量控制方法进行提升，并为物质基础的进一步研究奠定基础。

Objective To establish fingerprint analysis method by UPLC for quality control of Xiangju Rupining Capsule (XRC), and assess the quality of each sample by systematic quantified fingerprint method, then to identify the compositions by ESI-Q-TOF/MS^E. Methods The Acquty UPLC BEH C₁₈ (100 mm×2.1 mm, 1.7 μm) was used with a mobile phase of acetonitrile-0.1% formic acid in gradient elution. The flow rate was 0.25 mL/min. The column temperature was 28℃, and detection wavelength was 270 nm. Macro qualitative similarities (S_m) and macro quantitative similarities (P_m) were used as the assessing parameters to evaluate the overall quality of 10 batches of XRC. Ultra performance liquid chromatography-quadrupole time-of-flight tandem mass spectrometry (UPLC-ESI-Q-TOF/MS^E) was used for qualitative analysis of common components in the positive and negative ion modes. Results Fingerprints of 10 batches of XRC were established and 33 common peaks were obtained, then 28 of which were identified, belonging to six medicinal herbs. The results of systematic quantified fingerprint method showed that quality of nine batches samples was above grade 5. Conclusion The effective and reliable quality evaluation method of XRC was established, which is beneficial to the study of its material basis.

国家重大科技专项重大新药创制——中医药优势领域的创新中药关键技术开发研究（2017ZX09301005）