芪蛭固本通脉丸的质量标准研究

Quality Standard of Qizhi Guben Tongmai Pills

目的:建立芪蛭固本通脉丸的质量标准。方法:采用薄层色谱法(TLC)对芪蛭固本通脉丸中的黄芪、党参、川芎、水蛭、金银花进行定性鉴别,采用HPLC法对芪蛭固本通脉丸中黄芪的有效成分黄芪甲苷以及金银花中的绿原酸分别进行含量测定。结果:薄层色谱专属性强,斑点清晰。黄芪甲苷在0.51～10.2μg(r=0.9990)范围内线性关系良好,平均回收率为95.55%(RSD=1.0%,n=9);绿原酸在0.077～2.322μg(r=0.9998)范围内线性关系良好,平均回收率为96.77%(RSD=1.3%,n=9)。结论:该方法简便快速,结果准确,可以有效控制芪蛭固本通脉丸质量。

Objective：To establish the quality control for Qizhi Guben Tongmai pills.Method：Five herbs（Radix Astragalus,Radix Codonopsis Pilosulae,Rhizoma Ligusticum,Hirudo nipponica,and Lonicera japonica）in Qizhi Guben Tongmai pills were identified by TLC.The content of chlorogenic acid was determinted by HPLC-UV,and the content of astragalosideⅣwas quantitatively analyzed through HPLC-ELSD.Result：The TLC identification was highly specific and the spots were clear.The linear ranges and recoveries were 0.077-2.322μg（r=0.999 8）and 96.77%（RSD=1.3%,n=9）for chlorogenic acid and 0.51-10.2μg（r=0.999 0）and 95.55%（RSD=1.0%,n=9）for astragalosideⅣ,respectively.Conclusion：The qualitative and quantitative methods established in this study are simple,feasible,accurate and reproducible,and can be used as the quality standard for Qizhi Guben Tongmai pills.