培元颗粒质量初步研究

A Preliminary Study of Quality Control of Peiyuan Granule

目的建立培元颗粒的质量标准。方法采用薄层色谱法对培元颗粒中人参、黄芪、淫羊藿进行定性鉴别,采用高效液相色谱-蒸发光散射检测法测定培元颗粒中人参皂苷Rb1与黄芪甲苷的含量。色谱柱为Phenomenex C18（250mm×4.6 mm,5μm）,流动相为乙腈-水（梯度洗脱）,流速为1.0 mL/min,柱温为30℃。蒸发光散射检测器的漂移管温度为100℃,雾化温度为30℃。结果薄层色谱法能检出人参、黄芪、淫羊藿,斑点清晰,且阴性对照无干扰;人参皂苷Rb1和黄芪甲苷分别在2.46-20.5μg/mL、1.54-7.69μg/mL范围内与峰面积线性关系良好,平均加样回收率分别为96.84%、97.58%,RSD分别为1.15%、1.34%。结论所建立的方法操作简单,重复性好,可以用于培元颗粒的质量控制。

Objective To establish a quality standard for Peiyuan Granule.Methods The qualitative identification of Panax ginseng,Astragalus membranaceus,and Herba Epimedii in Peiyuan Granule was performed by thin-layer chromatography（TLC）,and the content of ginsenoside Rb1 and astragaloside in Peiyuan Granule was determined by high-performance liquid chromatography-evaporative light-scattering detection.The analysis was carried out on a Phenomenex-C18column（250mm × 4.6mm,5μm）with a mobile phase of acetonitrile-water for gradient elution at a flow rate of 1.0mL/min and a column temperature of 30 ℃.The evaporative light-scattering detector was used at a drift tube temperature of 100 ℃ and an atomizing temperature of 30 ℃.Results The TLC spots of Panax ginseng,Astragalus membranaceus,and Herba Epimedii were clear without interference from the negative control.A good linear relationship with peak area was achieved when the concentrations of ginsenoside Rb1 and astragaloside ranged within 2.46-20.5 μg/mL and 1.54-7.69μg/mL,and the average recovery rates were 96.84% and97.58%,respectively,with relative standard deviations of 1.15% and 1.34%.Conclusion The established method is simple and repeatable to effectively control the quality of Peiyuan Granule.