通窍鼻炎颗粒质量标准研究

Study on Quality Standand of Tongqiaobiyan Granule

目的:建立通窍鼻炎颗粒中欧前胡素和黄芪甲苷的含量测定方法。方法:采用高效液相色谱法。以迪马Diamonsil C18(4.6 mm×250 mm,5μm)色谱柱,流动相甲醇-水(54∶46),检测波长248 nm,测定欧前胡素的含量;以菲罗门100A C18(4.6 mm×150 mm,5μm)色谱柱,蒸发光散射检测器,乙腈-水(32∶68)为流动相测定黄芪甲苷的含量。结果:欧前胡素在0.072 5～0.773 6μg线性关系良好,黄芪甲苷在1.462 8～7.314μg线性关系良好,其精密度、重复性、稳定性均符合要求。结论:方法准确可靠,可用于通窍鼻炎颗粒的质量控制。

Objective： To establish the methods for determination of imperatorin and astragaloside in Tongqiaobiyan granule. Method： The HPLC method was performed on Diamonsil C18 （4.6mm×250mm,5μm）column; a mixture liquid of methanol-water （54： 46） was used as the mobile phase, and the detective wavelength was at 238 nm to determine the content of imperatorin. With Philo door 100A CIS （4.6mm×150mm,5μm）column and evaporative light scattering detector, a mixture liquid of acetonitrile-water （32： 68） was used as the mobile phase to determine the content of astragaloside. Result： The calibration curve of imperatorin and astragaloside were linear in the ranges of 0. 072 5-0. 773 6, 1. 462 8-7. 314μg respectively. Conclusion： It is an accurate and credible quality control method.