国产兰索拉唑药代动力学研究

目的研究国产兰索拉唑人体内药代动力学参数,寻求测定兰索拉唑血药浓度的更加简便的高效液相色谱法。方法采用乙醚-二氯甲烷萃取样品,应用HypersilBDS C18色谱柱,流动相为水-乙腈-三乙胺。结果兰索拉唑血药浓度的线性范围为0.05～2.0μg/mL,最低检测浓度为0.05μg/mL,日内精密度RSD为1.4%～5.4%,日间精密度RSD为1.5%～7.8%,相对回收率为94%～96%,符合生物样品分析要求。6名健康受试者单剂量口服受试制剂后,测得受试制剂中的AUC0→t、AUC0→∞分别为(3.387±1.225)、(3.533±1.237)h.μg/mL,Cmax为(0.918±0.252)μg/mL,Tmax、T1/2分别为(1.917±0.583)、(2.081±0.771)h。结论受试制剂国产兰索拉唑的药代动力学参数与文献报道一致,方法简便可行。

Investigation on pharmacokinetics of home-made lansoprazole

Objective To study the pharmacokinetics of home-made lansoprazole,explore the effective HPLC method.Methods The samples were extracted by aether-dichlormethane mixed liquor,then dissociated HypersilBDS C18 chromato bar.Water-acetonitrile-triethylamine was used as mobile phase.Results The linear range of lansoprazole was 0.05~2.0 μg/mL.The minimum concentration was 0.05 μg/mL,the within-day RSD was 1.4%~5.4%.The inter-day RSD was 1.5%~7.8%.The relative recovery was 94%~96%.AUC0t and AUC0∞ were(3.387±1.225) and(3.533±1.237) h · μg/mL respectively;Cmax was(0.918±0.252) μg/mL;Tmax and T1/2 were(1.917±0.583) and(2.081±0.771) h respectively.Conclusion The pharmacokinetics of home-made Lansoprazole is accordance with the literatures.This method is convenient and feasible.