论文部分内容阅读
目的 :研究两种国产双氯芬酸钠缓释剂在 12名男性健康志愿者中的药物动力学和相对生物利用度。方法 :根据交叉试验方案po单剂量 10 0 m g及多剂量两种双氯芬酸钠缓释制剂 ,采用反相高效液相色谱法测定血清中双氯芬酸钠的浓度。结果 :po单剂量10 0 mg研制片 AUC、cmax、tmax、T1 /2α、T1 /2β分别为 (5 75 3± 2 16 1) (h· ng) /m l、(6 75 .4± 141.6 ) ng/ml、(2 .2 84± 0 .5 42 ) h、(0 .9430± 0 .5 82 4) h、(6 .713± 2 .2 0 8) h;对照片为 (5 15 0± 2 16 7) (h· ng) /ml、(6 2 0 .1± 187.1) ng/ml、(2 .491± 0 .6 45 ) h、(1.0 6 0 0± 0 .6 82 9) h、(6 .15 9± 2 .372 ) h,研制片的相对生物利用度为 10 7.9%。po多剂量研制片 AUC、cmax、tmax、T1 /2α和 T1 /2β分别为 (5 915± 1112 ) (h· ng) /m l、(76 6 .5± 173.0 ) ng/ml、(2 .6 70± 0 .770 ) h、(1.6 90± 1.0 6 0 ) h、(5 .46 0± 2 .0 70 ) h;对照片为(5 781± 1849) (h· ng) /m l、(75 9.2± 2 16 .3) ng/ml、(2 .310± 0 .5 2 0 ) h、(1.2 0 0± 0 .830 ) h、(6 .16 0± 2 .2 10 ) h,研制片的相对生物利用度为 10 2 .3%。两种国产缓释制剂的所有药物动力学参数经统计学 (SPSS软件 )处理均无显著性差异 (P>0 .0 5 ) ,用双?
Objective: To study the pharmacokinetics and relative bioavailability of two domestic diclofenac sodium sustained-release tablets in 12 male healthy volunteers. Methods: The concentrations of diclofenac sodium in serum were determined by reversed-phase high performance liquid chromatography (RP-HPLC) according to the crossover test protocol po single dose of 10 0 m g and multiple doses of diclofenac sodium sustained-release preparations. Results: AUC, cmax, tmax, T1 / 2α and T1 / 2β were (5 753 ± 2 16 1) (h · ng) / ml and (6 75.4 ± 141.6) ng / ml, (2 .2 84 ± 0 .5 42) h, (0.9430 ± 0.582 4) h, (6.71 ± 2.208) h; (26.1 ± 187.1) ng / ml, (2.491 ± 0.645) h, (1.06 0 0 ± 0.662 9) h, (6.159 ± 2.372) h, the relative bioavailability of the developed tablets was 10 7.9%. (5 591 ± 1112) (h · ng) / ml, (76 6 ± 5 ± 173.0) ng / ml, (2.6 70 ± 0.770) h, (1.690 ± 1.06 0) h and (5.400 ± 2.070) h, respectively. The control group was (5 781 ± 1849) 9.2 ± 2 16.3 ng / ml, (2.30 ± 0.520) h, (1.200 ± 0.838) h, (6.120 ± 2.20) h, The relative bioavailability was 102.3%. All the pharmacokinetic parameters of the two kinds of domestic sustained-release preparations showed no significant difference (P> 0.05) by the statistics (SPSS software)