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作 者:叶茂[1] 谢国祥[2] 赵爱华[1] 张媛媛[1] 贾伟[1]
机构地区:[1]上海交通大学药学院,上海200240 [2]上海交通大学系统生物医学研究院,上海200240
出 处:《中国中药杂志》2008年第12期1398-1401,共4页China Journal of Chinese Materia Medica
基 金:国家科技部国际合作项目(2006DFA02700)
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 UPL- CBEH C18色谱柱(2.1 mm×100 mm,1.7μm);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2μL。结果:苦参碱和氧化苦参碱分别在0.084~3.36μg和0.086~3.44μg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。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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