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本文首次建立了测定人血浆中氯雷他定的液质联用方法。本方法采用有机溶剂提取药物后由ODS柱分离 ,质谱检测器测定。该方法的线性范围为 0 .4～ 10 0ng·mL-1,(r=0 .9995 ) ,方法回收率在 95 %～ 10 4 %之间 ,日内和日间精密度都小于 12 %。采用自身对照交叉给药方式 ,单剂量分别给予 18名男性健康志愿者两种国产氯雷他定片 4 0mg ,其主要药动学参数Cmax,AUC0 -t和Tmax分别为 :5 1.89± 2 0 .18ng·mL-1和 5 2 .4 8± 2 2 .35ng·mL-1;14 0 .75± 88.4 2ng·h·mL-1和 14 7.2 4± 92 .33ng·h·mL-1;0 .81± 0 .35h和 0 .81± 0 .2 7h。统计学结果表明 :两种制剂间的主要动力学参数无明显差异 ,为生物等效制剂 ,其相对生物利用度为 97%± 13%。
This article for the first time established a method for the determination of loratadine in human plasma by LC-MS. The method uses organic solvent to extract the drug, separated by ODS column and detected by mass spectrometer. The linear range of the method was 0.4-400 ng · mL-1 (r = 0.9995). The recovery of the method was between 95% and 104%. The intra- and inter-day precision was less than 12%. Using self-controlled cross-over mode, a single dose of two domestic loratadine tablets were given to 18 male volunteers. The main pharmacokinetic parameters Cmax, AUC0-t and Tmax were 5 1.89 ± 20 .18ng · mL-1 and 52.48 ± 2 2 .35ng · mL-1; 14 0 .75 ± 88.4 2ng · h · mL-1 and 14 7.24 ± 92.33ng · h · mL-1; 0 .81 ± 0 .35 h and 0 .81 ± 0 .2 7 h. The statistical results show that there is no significant difference between the two main pharmacokinetic parameters, which is a bioequivalent formulation with a relative bioavailability of 97% ± 13%.