论文部分内容阅读
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 :双单侧t检验表明供试品与参比胶囊为生物等效制剂
Objective: To study the pharmacokinetics and relative bioavailability of gemfibrozil capsules in human. Methods: The plasma concentrations of 60 mg gemfibrozil test capsules and reference capsules were determined by reversed-phase high performance liquid chromatography (RP-HPLC). Results: The area under the curve was (95.71 ± 1.04) μg · h · ml-1 and (96.55 ± 1.78) μg · h · ml-1, respectively. The peak time was (2. 05 ± 0.44) h and (2 1 0 ± 0 39) h, the peak concentrations were (2. 9.80 ± 2.60) μg · ml-1 and (2. 9.35 ± 4.47) μg · Ml -1, there was no significant difference (P> 0.05), the relative bioavailability of test capsules was 99.72% ± 1.06%. Conclusion: Double unilateral t test showed that the test and reference capsules were bioequivalent