吉非罗齐胶囊的药动学及相对生物利用度

STUDY ON PHARMACOKINETICS AND BIOEQUIVALENCE OF GEMFIBROZIL CAPSULES

目的 :研究吉非罗齐胶囊在人体内的药代动力学及相对生物利用度。方法 :采用反相高效液相色谱法测定 1 0名受试者单剂量口服 60 0mg吉非罗齐供试胶囊与参比胶囊后的血药浓度变化情况。结果 :药时曲线下面积分别为 (95 .71± 1 0 .0 4 ) μg·h·ml- 1 与 (96 .55± 1 0 .78) μg·h·ml- 1 ,达峰时间分别为 (2 .0 5± 0 .44)h与 (2 1 0±0 39)h ,峰浓度分别为 (2 9.80± 2 .60 ) μg·ml- 1 与 (2 9.35± 4 .47) μg·ml- 1 ,均无显著性差异 (P >0 .0 5) ,供试胶囊的相对生物利用度为 99.72 %± 1 0 .76 %。结论

OBJECTIVE:To study the pharmacokinetics and relative bioavailabilities of two gemfibrozil capsules. METHODS:Gemfibrozil was determined after a single oral dose of two gemfibrozil capsules given to 10 volunteers respectively in an open randomized cross over test. gemfibrozil concentration in serum was assayed by RP HPLC.RESULTS:After taking a single oral dose 600 mg of test and reference gemfibrozil capsules,the AUC 0→∞ of gemfibrozil of the two formulations were (95 71±10 04) μg·h·ml -1 and (96.55±10.78)μg·h·ml -1 ; T max were (2.05±0.44)h and (2.10±0.39)h; C max were (29.80±2.60)μg·ml -1 and (29.35±4.47)μg·ml -1 respectively. CONCLUSION:The result of statistical analysis showed that there were no significant differences of the AUC 0→∞ 、T max and C max of gemfibrozil between the two formulations(P>0 05) and two gemfibrozil capsules were bioequivalent.