三棱颗粒的质量标准研究

Quality standard of Sanleng Granules

目的:建立控制三棱颗粒(黄芪,三棱,莪术等)的质量标准。方法:采用薄层色谱法对三棱颗粒中黄芪、三棱、莪术、芫花进行定性鉴别;采用高效液相色谱-蒸发光散射检测器法对三棱颗粒中黄芪甲苷进行定量分析。色谱柱为C18柱(250 mm×4.6 mm,5μm),流动相为甲醇-水(79∶21),流速0.8 mL/m in,ELSD参数中漂移管温度为90℃,气体流速为2.2 L/m in。结果:薄层斑点清晰,阴性对照无干扰;黄芪甲苷对照品在1.018μg^10.18μg范围内,进样量与峰面积呈良好线性关系,平均加样回收率为98.26%,RSD=1.33%(n=6)。结论:方法简便可行,结果准确可靠,可作为本产品的质量控制方法。

AIM： To establish the quality standard of Sanleng Granule （Radix Astragali, Rhizoma Sparganii, Rhizoma Curcumae etc. ） METHODS： Radix Astragali, Rhizoma Sparganii, Rhizoma Curcumae, Flos C, enkwa were identified by TLC. The content of astragaloside Ⅳ was determined by HPLC-ELSD. The separation was performed on C18 column with methanol-water （79：21 ） as a mobile phase. The flow rate was 0.8 mL/min. The temperature of drift tube for measurement was at 90 ℃ and flow rate of N2 was 2.2 L/min. RESULTS ： The TLC sports developed were fairly clear, and the blank test showed no interference. The control content of astragalin IV was within the range of 1. 018 μg-10. 18 μg, and there was the fine linearship between the sample input and the peak area, the average recovery was 98.26%, RSD was 1.33% （n = 6）. CONCLUSION： The method is simple, reliable, accurate and can be applied as the quantity control method of Sanleng Granules.