吉非罗齐胶囊在健康人体内的相对生物利用度

Relative bioavailability of gemfibrozil capsules in healthy volunteers

目的 :研究吉非罗齐胶囊在健康人体内的相对生物利用度。方法 :采用高效液相色谱 (HPLC)法测定 18名男性健康受试者单剂量交叉口服 90 0mg 2种吉非罗齐胶囊后不同时间血浆中的药物浓度。结果 :二者药 时曲线均符合一房室模型 ,Cmax分别为 (45 .2 4± 10 .15 )mg·L-1和 (43.38± 9.84 )mg·L-1;Tmax分别为 (2 .4 7± 0 .93)h和 (2 .2 5±0 .75 )h ;T1/ 2 分别 (1.5 9± 0 .19)h和 (1.75± 0 .2 9)h ;AUC分别为 (16 5 .79± 37.79)mg·h·L-1和 (15 6 .39± 32 .2 8)mg·h·L-1。被试制剂的相对生物利用度为 (95 .5 5± 11.4 5 ) % (77.0 3%～ 119.4 5 % )。结论 :2种制剂具有生物等效性。

Aim: To study the pharmacokinetics and bioavailability of gemfibrozil in 18 young healthy volunteers. Methods:The gemfibrozil concentrations in plasma were determined by HPLC after a single oral dose of the standard formulation and the tested formulation were given to 18 volunteers respectively in randomized cross over test. Results:The concentration time curves of two formulations fitted to a one compartment open model.The C max was (45.24±10.15)mg·L -1 and (43.38±9.84)mg·L -1 ; T max was (2.47±0.93)h and (2.25±0.75)h; T 1/2 was (1.59±0.19)h and (1.75±0.29)h; AUC was (165.79±37.79) mg·h·L -1 and (156.39±32.28)mg·h·L -1 ,respectively.The pharmacokinetic parameters obtained from our studies showed that there was no significant difference between 2 formulations( P >0.05).The relative bioavailability of the tested formulation was (95.55± 11.45)% (77.03%～119.45%). Conclusion:The results of statistical analysis suggest that the 2 formulations are with bioequivalent.