【摘要】 目的 :评价双氯酚酸钾实验制剂和参比制剂的生物等效性。方法 :8名健康男性志愿者交叉单剂量口服双氯酚酸钾实验制剂或参比制剂 50mg ,采用反相高效液相色谱法测定经时过程血药浓度 ,血药浓度时间数据用 3p97药代动力学实用程序拟合 ,计算其药代动力学参数。结果 :实验制剂和参比制剂主要药代动力学参数Ka分别为 (3.0 4 2 ±1.356 )h- 1和 (1.952 ±0 .6 2 4 )h- 1;t1/ 2 分别为 (1.70 2 ±0 .0 82 )h和 (1.74 2±0 .0 71)h ;Cmax分别为 (1.12 3±0 .2 74 )mg/L和 (0 .980 ±0 .2 31)mg/L ;Tpeak分别为 (0 .992 ±0 .2 2 5)h和(1.2 4 0 ±0 .2 98)h ;AUC分别为 (3.894 6 ±1.1391)mg/ (L·h)和 (3.7985±0 .8832 )mg/ (L·h)。双氯酚酸钾实验制剂的生物利用度为 (10 1.79±8.50 ) %。结论 :经统计学处理 ,两制剂的药代动力学参数差异无显著性(P >0 .0 5) ,方差分析及双单侧t检验 ,证明两制剂具有生物等效性更多还原

【Abstract】 Objective:To evaluate the bioequivalence of diclofenac potassium tablets of test and reference. Methods:Plasma diclofenac potassium concentrations of 8 male healthy volunteers after a self alternative single oral dose (50mg) of diclofenac potassium of test and reference preparations were determined by high pressure liquid chromatographic (HPLC) method.The plasma concentraition time cures were fitted and the pharmacokinetic parameters were calculated with 3p97 practical pharmacokinetic program. Results:The K a,t 1/2 ,C max ,T peak ,AUC of test and reference were (3.042[FK(W+3mm。3mm]±1.356)h -1 and (1.952[FK(W+3mm。3mm]±0.624)h -1 ,(1.702[FK(W+3mm。3mm]±0.082)h and (1.742[FK(W+3mm。3mm]±0.071)h,(1.123[FK(W+3mm。3mm]± 0.274 )mg/L and (0.980[FK(W+3mm。3mm]± 0.231 )mg/L,(0 992[FK(W+3mm。3mm]±0.225)h and (1.240[FK(W+3mm。3mm]±0.298)h,(3.8946[FK(W+3mm。3mm]±1.1391)mg/(L·h) and (3.7985[FK(W+3mm。3mm]±0.8832)mg/(L·h),respectively. Conclusion:The pharmacokinetic parameters of test and reference had no significant differences (P>0.05),and the relative bioavailability was (101.79[FK(W+3mm。3mm]±8.50)%.The variance and two one side tests showed that the test and reference were bioequivalent.更多还原