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目的:建立康艾注射液中黄芪甲苷、人参皂苷Rg1、Re、Rf、Rb1和氧化苦参碱的定量分析方法。方法:采用HPLC-ELSD-UV法同时测定康艾注射液中6种活性成分的含量,Waters symmetry C_(18)(4.6 mm×250 mm,5μm)色谱柱,3%磷酸-乙腈梯度洗脱,体积流量为1.0 m L·min~(-1),紫外检测波长为215 nm;ELSD参数:漂移管温度为60℃,氮气体积流量为2.5 m L·min~(-1),雾化温度为36℃,柱温25℃。结果:在选定色谱条件下,黄芪甲苷、人参皂苷Rg1、Re、Rf、Rb1和氧化苦参碱在0.0466~0.2793μg、0.0592~0.3552μg、0.0418~0.25054μg、0.0284~0.1701μg、0.0112~0.0669μg和4.3520~26.1117μg范围内线性关系良好(r=0.9995、0.9996、0.9997、0.9993、0.9997和0.9993),平均回收率分别为99.36%、98.67%、97.43%、98.81%、97.95%和99.31%,RSD值分别为1.17%、1.09%、2.65%、1.54%、1.18%和0.87%(n=3)。结论:方法准确,快速,重复性好,专属性强,可用于康艾注射液的质量控制。
Objective: To establish a quantitative method for the determination of Astragaloside Ⅳ, ginsenoside Rg1, Re, Rf, Rb1 and oxymatrine in Kangai injection. Methods: Simultaneous determination of six active ingredients in Kangai Injection by HPLC-ELSD-UV was performed on a Waters symmetry C18 (4.6 mm × 250 mm, 5 μm) column with a 3% phosphoric acid-acetonitrile gradient. The volume flow rate was 1.0 m L · min -1 and the UV detection wavelength was 215 nm. The ELSD parameters were as follows: drift tube temperature was 60 ℃, nitrogen flow volume was 2.5 m L · min -1, atomization temperature was 36 ℃, column temperature 25 ℃. Results: Under the selected chromatographic conditions, the concentrations of astragaloside Ⅳ, ginsenoside Rg1, Re, Rf, Rb1 and oxymatrine in the range of 0.0466 ~ 0.2793μg, 0.0592 ~ 0.3552μg, 0.0418 ~ 0.25054μg, 0.0284 ~ 0.1701μg, 0.0112 ~ The average recoveries were 99.36%, 98.67%, 97.43%, 98.81%, 97.95% and 99.31% for the range of 0.0669μg and 4.3520μg / ml to 26.1117μg / The RSD values were 1.17%, 1.09%, 2.65%, 1.54%, 1.18% and 0.87%, respectively (n = 3). Conclusion: The method is accurate, rapid, reproducible and specific. It can be used for the quality control of Kangai injection.