摘要
目的 考察吉非罗齐在正常人体内的药代动力学过程 ,评价两种胶囊制剂的人体相对生物等效性 .方法 采用标准二阶段交叉设计自身对照试验方法 ,10例健康受试者单剂量口服两种吉非罗齐胶囊后 ,以 HPL C法测定吉非罗齐的血浆浓度 .结果 吉非罗齐的体内过程符合血管外一室开放模型 .吉非罗齐胶囊 A与 B的主要药动学参数 Tmax,Cmax,AUC(0～ 12 h)分别为 :(1.5± 0 .3)和 (1.6± 0 .4) h;(33.2±5 .5 )和 (34 .6± 5 .3) mg· L- 1 ;(134 .5± 11.2 )和 (131.7±17.0 ) m g· h· L- 1 ,经统计学处理 ,两者间无显著性差异 .结论 吉非罗齐胶囊 A相对胶囊 B的平均生物利用度为(10 3.5± 15 .3) % 。
AIM To compare the pharmacokinetics and the relativ e bioeffects between two kinds of gemfibrozil capsules. METHODS G emfibrozil concentrations in plasma were determined by HPLC method after two ki nds of gemfibrozil capsules in a single dose were given orally to 10 healthy vol unteers in a two-period crossover design way. RESULTS Pharmaco kinetics of gemfibrozil could be described by one-compartment open model. The T max, C max and AUC(0-12 h) of capsule A and B were (1.5 ±0.3) and (1.6±0.4) h; (33.2±5.5) and (34.6±5.3) mg·L -1; (134.5±11. 2) and (131.7±17.0) mg·h -1·L -1 respectively. According to a statistical algorithm, there were no signifi cant differences between the two capsules. CONCLUSION Average r elative bioavailability of capsule A compared with capsule B were (103.5±15.3)% and the two kinds of gemfibrozil capsules were bioequivalent.
出处
《第四军医大学学报》
北大核心
2001年第18期1689-1691,共3页
Journal of the Fourth Military Medical University
关键词
吉非罗齐
相对生物学效应
药代动力学
HPLC
gemfibrozil
relative biological effect
pha rmacokinetics
chromatography, high pressure liquid
