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本文建立了简单、快速的HPLC方法测定利巴韦林在人血浆中的含量, 并研究了健康受试者体内利巴韦林片剂的药代动力学。HPLC方法选择C18色谱柱(250mm×4.6mm,5μm), 超纯水为流动相, 柱温为25°C, 检测波长为207nm。在50.4-2016.0ng/mL范围内线性关系良好(r=0.9998), 最低检测浓度为15ng/mL。低、中、高三个浓度的相对回收率大于90%, 日内精密度小于10%, 日间精密度小于15%。用药代动力学软件WinNonlin进行房室模型分析的结果显示:二室模型能更好地模拟利巴韦林在体内的过程。计算得到的AUC0-t、CL/F和Cmax分别是10807.8 h·ng/mL、64879.5 mL和525.1ng/mL。这些结果为药剂工作者开发利用利巴韦林剂型提供了参考。
In this paper, we established a simple and rapid HPLC method for the determination of ribavirin in human plasma and studied the pharmacokinetics of ribavirin tablets in healthy subjects. HPLC method C18 column (250mm × 4.6mm, 5μm), ultrapure water as the mobile phase, the column temperature was 25 ° C, the detection wavelength was 207nm. The linearity was good in the range of 50.4-2016.0 ng / mL (r = 0.9998) with the lowest detection concentration of 15 ng / mL. The relative recoveries of low, medium and high concentrations were over 90%, the intraday precision was less than 10% and the intraday precision was less than 15%. Pharmacokinetics software WinNonlin analysis of the atrioventricular model results show that: two-compartment model to better simulate the process of ribavirin in the body. Calculated AUC0-t, CL / F and Cmax were 10807.8 h · ng / mL, 64879.5 mL and 525.1 ng / mL, respectively. These results provide a reference for pharmaceutical workers to develop and utilize ribavirin dosage forms.