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目的:建立了参芪益气固本片中6种有效成分的UPLC-MS定量方法。方法:采用C18色谱柱,以乙腈-0.1%甲酸水为流动相梯度洗脱,流速0.5 m L·min-1,采用负离子模式检测,源喷雾电压(IS)-5 000 V,辅助加热气温度450℃,雾化气50 psi,辅助气40 psi,气帘气30 psi,解簇电压-55 V,采集方法 TOF-MS/MS。结果:6种成分芍药苷,人参皂苷Re,人参皂苷Rg1,连翘苷,人参皂苷Rb1,黄芪甲苷在检测的范围内线性良好,r均大于0.999,方法回收率为98%~102%,RSD均小于4.5%。结论:采用本方法测定参芪益气固本中的6种成分方法准确度高、仪器精密度良好,可以用于该制剂的质量控制方法,同时本文使用了UPLC-MS方法,与传统的HPLC-MS比较,具有提高分离度、降低药品的生产成本,可以为其他含有该成分的中成药制剂制定标准提供参考。
OBJECTIVE: To establish an UPLC-MS quantitative method for the determination of six effective components in Shenqi Yiqi Guben Tablet. Methods: C18 column was used to elute acetonitrile-0.1% formic acid as the mobile phase with a flow rate of 0.5 mL · min-1. Negative ion mode was used to detect the source spray voltage (IS) -5 000 V, 450 ° C, atomization gas 50 psi, auxiliary gas 40 psi, curtain gas 30 psi, solution cluster voltage -55 V, collection method TOF-MS / MS. Results: The linearity of the six components, paeoniflorin, ginsenoside Re, ginsenoside Rg1, forsythin, ginsenoside Rb1 and astragaloside in the range of detection was good, all of which were more than 0.999. The recoveries were 98% -102% RSD less than 4.5%. Conclusion: The method of determination of Shenqi Yiqi Guben 6 components with high accuracy, good precision instruments can be used for the preparation of quality control methods, the same time the UPLC-MS method used in this article, and conventional HPLC -MS comparison, with the increase of resolution, reduce the cost of drug production, can provide reference for other standards for the formulation of proprietary Chinese medicines containing the component.