基于类药成分3,6′-二芥子酰基蔗糖和α-细辛醚的开心散质量控制方法研究

Quality control of Kaixinsan based on drug-like components,3,6′-disinapoylsucrose and α-asarone

目的建立基于类药成分3,6′-二芥子酰基蔗糖和α-细辛醚的开心散质量控制方法。方法采用HPLC-DAD分析方法,Venusil C18柱（4.6 mm×250 mm,5μm）,流动相为乙腈-0.1%磷酸水溶液,梯度洗脱,流速为1 mL/min。3,6′-二芥子酰基蔗糖和α-细辛醚的检测波长分别为330 nm和258 nm,柱温30℃。结果 3,6′-二芥子酰基蔗糖在0.062 28~0.373 68μg范围内线性关系良好（r=0.999 6）,平均回收率为98.50%,RSD为2.62%;α-细辛醚在0.013 632~0.136 320μg（r=0.999 7）范围内线性关系良好,平均回收率为96.65%,RSD为0.80%。结论 3批样品含量测定结果表明,该方法简便、准确,可用于开心散提取物中类药成分3,6′-二芥子酰基蔗糖和α-细辛醚的含量测定,并可作为开心散定量控制方法之一。

Objective To establish a method for quality control of Kaixinsan based on drug-like components,3,6′-disinapoylsucrose and α-asarone.Methods The procedure of HPLC coupled with photodiode array UV detector（HPLC-DAD） were performed on the chromatographic column of Venusil C18（4.6 mm×250 mm,5 μm）,and the mobile phase was acetonitrile-0.1 % of phosphoric acid solution（42∶ 58） in gradient elution program.The flow velocity was 1 mL/min.The detection wavelength of 3,6′-disinapoylsucrose was 330 nm and that of α-asarone was 258 nm.The temperature was 30 ℃.Results 3,6′-Disinapoylsucrose showed a good linear relationship at range of 0.062 28 μg-0.373 68 μg（r=0.999 6） with average recovery as 98.35%（RSD=2.62%）.α-Asarone showed a good linear relationship at range of 0.013 632 μg-0.136 320 μg（r=0.999 7） with average recovery as 96.65%（RSD=0.80%）.Conclusion The quantitative determination of 3 batches of samples shows that the method is simple and accurate,which can be used in the quantitative determination of 3,6′-disinapoylsucrose and α-asarone and can be one of quality control methods for Kaixinsan.