丹桂香颗粒的质量标准研究

Study on Quality Standards of Danguixiang Granules

目的完善丹桂香颗粒的质量标准,以控制药品质量。方法采用HPLC-ELSD法,色谱柱为迪马Kromasil C18;流动相为乙腈-水（32∶68）;流速为1.0mL.min-1;漂移管温度为60℃。结果黄芪甲苷进样量在1.245~12.45μg范围内,积分值的对数与进样量的对数线性关系良好,r=0.9999,平均回收率99.2%,RSD为1.48%。结论本方法操作简单、结果准确,能够有效地控制丹桂香颗粒的质量。

Objective To improve the quality standard of Danguixiang Granules.Methods HPLC-ELSD was used to determine directly astragaloside on Kromasil C18 column.Using acetonitrile-water（32 ∶68） as mobile phase,the flow rate was 1.0mL ·min-1.The temperature of drift tube for ELSD was 60℃.Results Good linear relation of logA with logW was achieved when the sample size of astragaloside at 1.245～12.45μg,r=0.9999.The average recovery of astragaloside was 99.2%,RSD was 1.48%.Conclusion The method is simple,accurate and reproducible.It can be used as the quality control method of Danguixiang Granules.