单剂量口服奥扎格雷钠在健康人体的药代动力学

Pharmacokinetics of sodium ozagrel in healthy human subjects after a single dose administration

目的研究健康人体单剂口服奥扎格雷钠口服液的人体药代动力学。方法12名健康志愿者口服奥扎格雷钠口服液200mg,用反相高效液相色谱法—二极管阵列紫外法测定血浆中奥扎格雷钠浓度,并求算其药代动力学参数。结果奥扎格雷钠口服液的药代动力学参数tmax为(0.42±0.12)h、Cmax为(3.10±1.06)mg·L-1、AUC0-t为(3.50±0.91)mg·h·L-1,t1/2β为(0.72±0.26)h。结论单剂量口服奥扎格雷钠,在体内分布及消除较快,且Cmax及AUC与剂量成正比。

Objective To study the pharmacokineties of sodium ozagrel after a single dose administration in human subjects. Methods After oral administration of 200 mg sodium ozagrel oral preparation in 12 voluteers. The blood concentrations of sodium ozagrel in all volunteers were determinated by HPLC - UV. And concentrations - time profile were simulated and pharmacokinetic parameters were calculated with DAS software. Results Pharmacokinetic parameters of sodium ozagrel oral preparation in 12 voluteers were obtained as follows： tmax was （0.42 ± 0.12 ） h,Cmax was （3.10±1.06） mg·L^-1 ,AUC0-t was （3.50±0.91） mg·h·L^-1, t1/2β was （ 0.72±0.26 ） h. Conclusion Sodium ozagrel distributed and eliminated rapidly in volunteers after a single dose of 200 mg administration, and their Cmax and AUC are directly proportion to doses.