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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。
Objective To study the pharmacokinetic parameters of domestic lansoprazole in human and seek a more convenient HPLC method for the determination of plasma concentration of lansoprazole. Methods The samples were extracted with diethyl ether - methylene chloride. Hypersil BDS C18 column was used with the mobile phase of water - acetonitrile - triethylamine. Results The linear range of the plasma concentration of lansoprazole was 0.05-2.0μg / mL, the lowest detection concentration was 0.05μg / mL, the intra-day precision RSD was 1.4% -5.4%, and the intra-day precision RSD was 1.5% -7.8% , The relative recovery was 94% ~ 96%, in line with the biological sample analysis requirements. AUC0 → t and AUC0 → ∞ in the test preparations were (3.387 ± 1.225), (3.533 ± 1.237) h.μg / mL and Cmax were ( 0.918 ± 0.252) μg / mL, Tmax and T1 / 2 were (1.917 ± 0.583) and (2.081 ± 0.771) h, respectively. Conclusions The pharmacokinetic parameters of domestic lansoprazole are consistent with those reported in the literature, and the method is simple and feasible.