目的 建立超高效液相色谱法（UHPLC）同时测定补肺活血胶囊（Bufei Huoxue Capsules，BHC）中12种指标成分没食子酸、氧化芍药苷、芍药内酯苷、补骨脂苷、芍药苷、异补骨脂苷、毛蕊异黄酮苷、芒柄花苷、毛蕊异黄酮、补骨脂素、异补骨脂素、苯甲酰芍药苷的含量。方法 采用Acquity UPLC BEH C₁₈色谱柱（100 mm×2.1 mm，1.7 mm）；流动相为乙腈-0.1%甲酸水溶液，梯度洗脱；体积流量0.4 mL/min，柱温35℃，进样量4 mL，检测波长246 nm。结果 BHC中12种指标成分在18 min内色谱峰分离良好，没食子酸、氧化芍药苷、芍药内酯苷、补骨脂苷、芍药苷、异补骨脂苷、毛蕊异黄酮苷、芒柄花苷、毛蕊异黄酮、补骨脂素、异补骨脂素和苯甲酰芍药苷分别在0.38～195.20（r＝0.999 9）、0.17～21.44（r＝0.999 6）、0.85～433.80（r＝0.999 9）、0.68～345.60（r＝0.999 9）、1.11～566.60（r＝0.999 8）、0.47～241.40（r＝0.999 9）、0.08～39.36（r＝0.999 8）、0.05～26.16（r＝0.999 9）、0.03～16.42（r＝0.999 9）、0.25～129.10（r＝0.999 8）、0.26～133.10（r＝0.999 7）、0.09～47.28 μg/mL（r＝0.999 9）线性关系良好；精密度、稳定性、重复性、加样回收率均符合分析要求。11批补肺活血胶囊中没食子酸、氧化芍药苷、芍药内酯苷、补骨脂苷、芍药苷、异补骨脂苷、毛蕊异黄酮苷、芒柄花苷、毛蕊异黄酮、补骨脂素、异补骨脂素和苯甲酰芍药苷平均质量分数分别为2.624 2、0.222 4、16.409 9、7.459 5、18.974 2、7.887 5、0.505 7、0.109 9、0.170 7、1.364 7、1.170 0、0.203 6 mg/g。结论 所建立的方法分析速度快、准确度高、重复性好，为BHC质量标准提升提供了方法支撑。

Objective An ultra-high performance liquid chromatography (UHPLC) method was established for simultaneous determination of gallic acid, oxypaeoniflora, albiflorin, psoralenoside, paeoniflorin, isopsoraloside, calycosin 7-O-glucoside, ononin, calycosin, psoralen, isopsoralen and benzoylpaeoniflorin in Bufei Huoxue Capsules (BHC). Methods The UHPLC analysis was performed on an Acquity UPLC BEH C₁₈ (100 mm×2.1 mm, 1.7 μm). The mobile phase was acetonitrile-0.1% formic acid aqueous solution, gradient elution at the flow rate of 0.4 mL/min, and detection wavelength of 246 nm. The column temperature and injection volume were 35℃ and 4 μL, respectively. Results The chromatographic peaks of 12 target components in BHC were well separated in 18 min. The linear ranges for gallic acid, oxypaeoniflora, albiflorin, psoralenoside, paeoniflorin, isopsoraloside, calycosin 7-O-glucoside, ononin, calycosin, psoralen, isopsoralen and benzoylpaeoniflorin were 0.38-195.20 (r=0.999 9), 0.17-21.44 (r=0.999 6), 0.85-433.80 (r=0.999 9), 0.68-345.60 (r=0.999 9), 1.11-566.60 (r=0.999 8), 0.47-241.40 (r=0.999 9), 0.08-39.36 (r=0.999 8), 0.05-26.16 (r=0.999 9), 0.03-16.42 (r=0.999 9), 0.25-129.10 (r=0.999 8), 0.26-133.10 (r=0.999 7), 0.09-47.28 μg/mL (r=0.999 9), respectively. The precision, stability repeatability and recovery all met the requirements of analysis. The average contents of gallic acid, oxypaeoniflora, albiflorin, psoralenoside, paeoniflorin, isopsoraloside, calycosin 7-O- glucoside, ononin, calycosin, psoralen, isopsoralen and benzoylpaeoniflorin in 11 batches of BHC were 2.624 2, 0.222 4, 16.409 9, 7.459 5, 18.974 2, 7.887 5, 0.505 7, 0.109 9, 0.170 7, 1.364 7, 1.170 0, 0.203 6 mg/g, respectively. Conclusion The established method has the advantages of fast analysis speed, high accuracy and good repeatability, which provides a reference for the internal quality evaluation of BHC.

R286.02

江苏省高校自然科学研究重大项目(18KJA360006);江苏省研究生科研创新项目(KYCX21_1728)