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目的:研究单剂量和多剂量口服苯扎贝特缓释片在Beagle犬体内的药动学特征。方法:4只Beagle犬单剂量和多剂量口服苯扎贝特缓释片后,不同时间点采集血样。采用高效液相色谱法测定其血药浓度,应用Topfit2.0软件计算其主要药动学参数。结果:苯扎贝特缓释片给药后主要药动学参数如下:单剂量Cmax为(19.8±6.7)mg.L-1,tmax为(2.3±0.8)h,AUC0-τ为(80.0±35.8)mg.h.L-1,t1/2为(8.5±1.5)h;多剂量Cmax为(21.5±6.0)mg.L-1,tmax为(2.8±1.1)h,AUC0-τ为(114.3±63.0)mg.h.L-1,t1/2为(8.8±4.5)h。结论:本法灵敏度高,简便,分析速度快,专属性强,可用于犬血浆中苯扎贝特的测定。苯扎贝特缓释片口服给药符合二房室模型,多次给药无明显蓄积现象。
OBJECTIVE: To study the pharmacokinetics of bezafibrate sustained-release tablets in Beagle dogs with single and multiple doses. Methods: Four Beagle dogs were given single and multiple doses of oral bezafibrate after sustained release tablets, blood samples were taken at different time points. The plasma concentration was determined by HPLC. Topfit2.0 software was used to calculate the main pharmacokinetic parameters. Results: The main pharmacokinetic parameters of bezafibrate sustained-release tablets were as follows: the single-dose Cmax was (19.8 ± 6.7) mg.L-1, the tmax was (2.3 ± 0.8) h, the AUC0-τ was (80.0 ± 35.8) mg.hL-1, and t1 / 2 was (8.5 ± 1.5) h; Cmax was (21.5 ± 6.0) mg.L-1 for multiple dose and (2.8 ± 1.1) 63.0) mg.hL-1, and t1 / 2 was (8.8 ± 4.5) h. Conclusion: This method is sensitive, simple, rapid analysis, specific and can be used for the determination of bezafibrate in dog plasma. Bezafide sustained-release tablets oral administration consistent with two-compartment model, multiple administration no significant accumulation phenomenon.