知母配方颗粒中4种成分在大鼠体内的药动学研究

Pharmacokinetics of 4 components in dispensing granules of Anemarrhenae Rhizoma in rats

目的建立HPLC-MS/MS法同时测定大鼠血浆中新芒果苷、芒果苷、知母皂苷BⅡ和知母皂苷AⅢ的含量,并用于知母配方颗粒与饮片提取物在健康大鼠体内的药动学行为的比较。方法采用Phenomenex Kinetex C_(18)(75 mm×2.1 mm,2.6 μm)色谱柱,水(0.1%甲酸)-甲醇(0.1%甲酸)为流动相,梯度洗脱,流速为0.4 mL·min^(-1),柱温为30℃。质谱检测器采用电喷雾离子源,在负离子模式下进行多反应监测。结果知母配方颗粒与饮片提取物中新芒果苷、芒果苷、知母皂苷BⅡ和知母皂苷AⅢ的药动学参数差异无统计学意义。结论知母配方颗粒与饮片提取物具有生物等效性,为知母颗粒的临床合理用药提供了参考。

Objective To establish an HPLC-MS/MS method to simultaneously determine neomangiferin,mangiferin,timosaponin BⅡand timosaponin AⅢin rat blood plasma,and to evaluate the pharmacokinetics and bioequivalence of Anemarrhenae Rhizoma granules and pieces.Methods The chromatographic separation was performed on Phenomenex Kinetex C18 column(75 mm×2.1 mm,2.6μm)at 30℃.The mobile phase was composed of 0.1%formic acid water and 0.1%formic acid methanol with gradient elution at a flow rate of 0.4 mL·min^(-1).The detection was performed in multiple reaction-monitoring mode with turbo ion spray source in the negative ion.Results Good linearity over the investigated concentration ranges was observed.The absolute recovery,matrix effect and stability of the four analytes were all satisfactory.No significant difference in the pharmacokinetic parameters of neomangiferin,mangiferin,timosaponin BⅡand timosaponin AⅢwas observed between the two groups.Conclusion The granules and pieces of the Anemarrhenae Rhizoma are bioequivalent,which provides an experimental basis for the rational use of Anemarrhenae Rhizoma granules.