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目的建立参芪胶囊的质量标准。方法采用薄层色谱法对方中人参、三七、黄芪进行定性鉴别;采用HPLC对制剂中人参皂苷Rg1、黄芪甲苷进行含量测定。采用Odyssil ODS-C18(250 mm×4.6 mm,5μm)柱为色谱柱,乙腈-水为流动相,梯度洗脱,流速为1.0ml·min-1,柱温为35℃,蒸发光散射检测器:漂移管温度90℃,载气流速1.6 L·min-1。结果定性鉴别分离度好、专属性强;人参皂苷Rg1和黄芪甲苷线性范围分别为0.420~8.400μg(r=0.999 0)和0.115~2.300μg(r=0.999 0),平均回收率分别为102.97%(RSD=1.35%)和100.97%(RSD=1.45%)。结论该实验建立的鉴别和含量测定方法简便可行,重复性好,适用于该品质量的控制。
Objective To establish the quality standard of Shenqi capsule. Methods Thin layer chromatography was used to qualitatively identify ginseng, notoginseng and astragalus, and the content of ginsenoside Rg1 and astragaloside were determined by HPLC. A column with Odyssil ODS-C18 (250 mm × 4.6 mm, 5 μm) was used as the column. The mobile phase consisted of acetonitrile-water with gradient elution at a flow rate of 1.0 ml · min-1 and a column temperature of 35 ° C. Evaporative light scattering detector : Drift tube temperature 90 ℃, carrier gas flow rate 1.6 L · min-1. Results The results showed that the linear range of ginsenoside Rg1 and astragaloside Ⅳ were 0.420-8.400μg (r = 0.999 0) and 0.115-2.300μg (r = 0.999 0), respectively. The average recovery was 102.97 % (RSD = 1.35%) and 100.97% (RSD = 1.45%). Conclusion The method of identification and content determination established in this experiment is simple and feasible with good repeatability and is suitable for the quality control of this product.