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目的 比较不同厂家国产吉非罗齐胶囊的生物等效性。方法 12名健康男性志愿受试者随机交叉单剂量口服两种吉非罗齐胶囊各 6 0 0mg,用高效液相色谱法检测血清中药物浓度。结果 血药浓度数据经 3p97拟合 ,两者的体内过程均符合血管外口服给药一室开放模型 ,实测cmax分别为 (2 8.10± 3.79)与 (2 9.0 2± 2 .2 9)mg·L- 1,t( 1/2 )ke分别为 (2 .17±0 .5 0 )与 (2 .10± 0 .6 3)h ,实测tpeak分别为 (1.4 2± 0 .4 5 )与 (1.4 6± 0 .2 9)h ,梯形法计算的AUC0~ 2 4 分别为 (14 0 .2 3± 2 1.94 )与 (14 1.2 2±2 8.6 6 )mg·h·L- 1。两者的主要药代动力学参数经方差分析和双单侧t检验 ,无显著性差异 (P >0 .0 5 )。供试品相对于对照品的生物利用度为(10 0 .6 1± 12 .6 3) %。结论 两制剂体内过程相仿 ,具有生物等效性
Objective To compare the bioequivalence of gemfibrozil capsules made by different manufacturers. Methods Twelve healthy male volunteers were randomized to receive 600 mg of Gemfibrozil capsules orally in randomized crossover doses. Serum drug concentrations were determined by high performance liquid chromatography (HPLC). Results The plasma concentration data were fitted by 3p97, and the in vivo process of the two groups were in accordance with the open-chamber oral administration model. The measured cmax were (2.80 ± 3.79) and (9.02 ± 2.29) mg · The values of L-1 and t (1/2) ke were (2.17 ± 0.50) and (2.10 ± 0.63) h, respectively. The measured tpeaks were (1.4 2 ± 0.45) and (1.4 6 ± 0.29) h, and the AUC0 ~ 2 4 calculated by the trapezoidal method were (14 0 .23 ± 2 1.94) and (14 1.2 2 ± 2. 8.66) mg · h · L -1, respectively. There was no significant difference between the two main pharmacokinetic parameters by means of ANOVA and double unilateral t test (P> 0.05). The bioavailability of the test product relative to the reference substance was (100.61 ± 12.63)%. Conclusion The two preparations have similar in vivo process and bioequivalence