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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
OBJECTIVE: To evaluate the bioequivalence of diclofacate experimental and reference preparations. Methods: Eight healthy male volunteers were crossed with a single oral dose of diclofenac potassium test formulation or reference formulation 50 mg. The plasma concentration of the drug over time was measured by RP-HPLC. Kinetic utility fitting to calculate its pharmacokinetic parameters. RESULTS: The main pharmacokinetic parameters Ka of experimental and reference preparations were (3.04 2 ± 1.356) h-1 and (1.952 ± 0.644) h-1, respectively; t1 / 2 was (1.70 2 ± 0 .0 82) h and (1.74 2 ± 0 .0 71) h respectively; Cmax were (1.12 3 ± 0.224) mg / L and (0.980 ± 0.231) mg / L, respectively; (0.992 ± 0.225) h and (1.2 4 0 ± 0.288) h respectively; AUC were (3.894 6 ± 1.1391) mg / (L · h) and (3.7985 ± 0.8832) mg / (L · h). The bioavailability of the diclofenac test preparation was (10 1.79 ± 8.50)%. Conclusion: There was no significant difference in pharmacokinetic parameters between the two preparations (P> 0.05), analysis of variance and double unilateral t-test, which proved that the two preparations were bioequivalent