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期 刊 ：中国中药杂志 2008年 33卷 12期 页码：1398.

关键词：超高效液相色谱；飞行时间质谱；苦参素注射液；苦参碱；氧化苦参碱；

Keywords:ultra high performance liquid chromatography (UPLC), time-of-flight mass spectrometry (TOF-MS), Kushensu Injection, matrine, oxymatrine,

摘 要 ：目的：建立苦参素注射液中苦参碱和氧化苦参碱的含量测定方法。方法：色谱柱为Acquity UPLCBEH C18色谱柱(2.1 mm×100 mm，1.7 μm)；以10 mmol·L^-1醋酸胺水溶液(用氨水调节pH 8)-甲醇为流动相梯度洗脱；流速0.30 mL·min^-1；柱温30 ℃；检测波长210 nm；进样量2 μL。结果：苦参碱和氧化苦参碱分别在0.084～3.36 μg和0.086～3.44 μg呈现良好的线性关系，平均加样回收率分别为103.2%，98.7 %；RSD分别为1.5%，1.2%。结论：本法简便、快速、准确，适用于该药品生产及临床应用中的质量监控。

Abstract:Objective: To develop a method for the determination of matrine and oxymatrine in Kushensu injection by ultra performance liquid chromatography-quadrupole time-of-flight mass spectrometry (UPLC/Q-TOF-MS). Method: The analysis was performed on a Acquity UPLC BEH C18 column (2.1 mm×100 mm，1.7 μm) with the gradient elution of 10 mmol·L^-1 amine acetate (pH 8, adjusted by aqueous ammonia) and methanol. The flow rate was set as 0.30 mL·min^-1. The column temperature was maintained at 30 ℃. The peaks were detected at 210 nm and the injection volume was 2 μL. Result: The calibration curves showed good linearity within the test ranges of 0.084-3.36 μg for matrine and 0.086-3.44 μg for oxymatrine, respectively. The mean recoveries were 103.2%, 98.7 %, and the RSD were 1.5%, 1.2%, respectively. Conclusion: The established method is simple, rapid and sensitive, can be used for the quality control of matrine and oxymatrine in Kushensu injection through the manufacturing process and clinical implement.

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