Li Ling, Zhang Xiuwen, Bu Fengjiao, Chen Nianzu, Zhang Hongmei, Gu Jifeng
Department of Pharmacy, Eye & ENT Hospital of Fudan University, Shanghai, China.
Jinan Center for Food and Drug Control, Jinan, Shandong Province, China.
Biomed Chromatogr. 2019 Nov;33(11):e4648. doi: 10.1002/bmc.4648. Epub 2019 Aug 5.
Shejin-liyan Granule (SJLY) is an effective traditional Chinese prescription medicine for the treatment of acute pharyngitis. In this study, a selective and convenient HPLC-MS/MS method was developed and validated for the simultaneous determination of the following eight constituents in the plasma: galuteolin, tectoridin, tectorigenin, iridin, irigenin, irisflorentin, arctiin and arctigenin. The plasma samples were prepared by a protein precipitation method using acetonitrile, and analysis was carried out on a C column using a gradient elution at a flow rate of 0.3 mL/min. The concentration of these analytes was quantified in the positive ion and multiple reaction monitoring modes. The method was validated for selectivity, linearity, accuracy, precision, recovery, matrix effect and sample stability. The obtained results were well within the acceptable limits. The established method was then successfully applied to study the pharmacokinetic profiles of the multiple constituents of Shejin-liyan Granule. According to the area under the curve and maximum concentration data, tectorigenin exhibited the highest exposure followed by arctigenin, irigenin, arctiin and irisflorentin. The concentrations of galuteolin, tectoridin and iridin were low, and a complete concentration-time curve could not be plotted. This research provides useful information for understanding the pharmacokinetics of Shejin-liyan Granule.
射干利咽颗粒是治疗急性咽炎的一种有效的中药方剂。本研究建立了一种选择性好、操作简便的高效液相色谱-串联质谱法(HPLC-MS/MS),并对其进行了验证,可同时测定血浆中的以下8种成分:木犀草素、鸢尾苷、鸢尾黄素、环烯醚萜苷、鸢尾苷元、鸢尾黄酮、牛蒡子苷和牛蒡子苷元。血浆样品采用乙腈蛋白沉淀法制备,在C柱上以0.3 mL/min的流速进行梯度洗脱分析。这些分析物的浓度在正离子和多反应监测模式下进行定量。该方法在选择性、线性、准确性、精密度、回收率、基质效应和样品稳定性方面进行了验证。所得结果均在可接受范围内。所建立的方法随后成功应用于研究射干利咽颗粒多种成分的药代动力学特征。根据曲线下面积和最大浓度数据,鸢尾黄素的暴露量最高,其次是牛蒡子苷元、鸢尾苷元、牛蒡子苷和鸢尾黄酮。木犀草素、鸢尾苷和环烯醚萜苷的浓度较低,无法绘制完整的浓度-时间曲线。本研究为了解射干利咽颗粒的药代动力学提供了有用信息。