人知降糖胶囊质量标准研究

摘要

目的:对人知降糖胶囊的质量标准进行研究,建立TLC鉴别方法和菝葜皂苷元的含量测定方法.方法:以甲醇-水(94:6)为流动相;流速:1.0 mL/min;采用蒸发光散射检测器:漂移管温度80℃,氮气流速每分钟1.7L.结果:薄层鉴别系统分离度好,专属性强;菝葜皂苷元含量在0.3610～3.610 μg范围内呈良好的线性关系,回归方程:Y=1.514 4X+5.088 3 (r=0.999 8),平均加样回收率为100.15％,RSD为1.26％.结论:该质量标准分离效果好、专属性强、结果准确可靠,可以有效控制人知降糖胶囊质量.%Objective:To study quality standard of RenZhi glucose-lowering capsules,establish TLC identification method and content determination methods for sarsasapogenin.Methods:Methanol-water (94:6) was selected as the mobile phase,flow rate:1.0mL/min;HPLC-ELSD was used;the temperature of drift tube was 80℃,nitrogen flow velocity was 1.7L/min.Results:TLC identification system showed good separation effects and strong specificity,the contents of sarsasapogenin were in the good linear relationship ranged from 0.3610 to 3.610 μg,regression equation:Y=1.514 4X+5.088 3 (r--0.999 8),average recovery rate was 100.15％,RSD was 1.26％.Conclusion:The quality standard,showing good separation effects,strong specificity,accurate and reliable results,could effectively control the quality of RenZhi glucose-lowering capsules.