HPLC法测定血浆中奥美拉唑及其人体药动学研究

目的建立测定血浆中奥美拉唑的HPLC法 ,并对其进行药代动力学研究。方法以CapcellPak C18柱 ,(4 6mm× 15 0mm ,5 μm,SHISEIDOFINECHEMICALS ,日本 )为色谱柱 ,以乙腈 0 0 5mol·L-1磷酸二氢铵 (V∶V =35∶6 5 )为流动相 ,测定了 18名健康男性志愿受试者单剂量口服奥美拉唑胶囊后的不同时刻血浆中奥美拉唑的质量浓度 ,并根据测定结果求算奥美拉唑的药代动力学参数。结果 18名健康受试者口服奥美拉唑胶囊后 ,血浆中的tmax为 (2 3± 0 8)h ;ρmax为(10 5 0 0± 396 0 ) μg·L-1;t1/ 2 为 (1 3± 0 5 )h ;AUC0 -10 为 (32 4 8 9± 2 15 2 1) μg·h·L-1;AUC0 -∞ 为 (3393 9± 2 342 6 ) μg·h·L-1。结论该方法适合临床药代动力学研究

Determination of Omeprazole in plasma by HPLC and its pharmacokinetics study

Objective To establish a method for the determination of the concentration of Omeprazole in plasma by HPLC,and study its pharmacokinetics.Method The analytical column was Capcell Pak-C 18( 4.6 mm× 150 mm, 5 μm) and the mobile phase consisted of acetonitrile- 0.05 mol·L -1 NH 4H 2PO 4(V∶V=35∶65).The single oral doses of an Omeprazole capsules were given to 18 volunteers to study the pharmacokinetics and Omeprazole concentrations in plasma were determined by the HPLC method.Result The pharmacokinetic parameters were as follows:t max was(2.3±0.8)h;ρ max was( 1 050.0± 396.0)μg·L -1;t 1/2 was (1.3±0.5)h;AUC 0-10 was ( 3 248.9± 2 152.1)μg·h·L -1;AUC 0-∞ was( 3 393.9± 2 342.6)μg·h·L -1.Conclusion The method can be applied to the pharmacokinetics study.