目的研究双氯芬酸钠缓释片在健康人体内的药物动力学及其相对生物利用度。方法20名健康男性受试者随机分为2组,根据交叉试验设计方案,单次给予和多次给予两种双氯芬酸钠缓释制剂,采用HPLC法测定其血药浓度,并计算药物动力学参数。结果口服单次给药的药物动力学参数计算结果显示,血浆中受试制剂和参比制剂的AUC0-t分别为(2 103.0±651.7)和(2 264.5±731.9)μg.h.L-1,以AUC0-t计算,受试制剂的相对生物利用度为(95.4±21.8)%。口服多次给药的药物动力学参数计算结果显示,血浆中受试制剂和参比制剂的AUCss分别为(2 922.5±398.6)和(2 843.6±429.4)μg.h.L-1,受试制剂的DF/τ为参比制剂的(102.8±18.0)%,以AUCss计算,受试制剂的相对生物利用度为(103.5±10.3)%。结论统计学分析结果表明受试制剂和参比制剂具有生物等效性。 Objective To study the pharmacokinetics and relative bioavailability of diclofenac sodium sustained-release tablets in healthy volunteers. Methods Twenty healthy male subjects were randomly divided into two groups. According to the crossover design, two diclofenac sodium sustained-release preparations were given either singly or repeatedly. The plasma concentration of diclofenac sodium was determined by HPLC and the pharmacokinetic parameters . Results The calculated pharmacokinetic parameters of single oral administration showed that the AUC0-t of plasma test and reference preparations were (2 103.0 ± 651.7) and (2 264.5 ± 731.9) μg.hL-1, respectively, AUC0-t calculation, the relative bioavailability of the test preparation was (95.4 ± 21.8)%. The results of pharmacokinetic parameters calculation of multiple oral administrations showed that the AUCss of plasma test and reference preparations were (2 922.5 ± 398.6) and (2 843.6 ± 429.4) μg.hL-1, respectively, The DF / τ was (102.8 ± 18.0)% of the reference formulation, and the relative bioavailability of the test formulation was (103.5 ± 10.3)% as calculated by AUCss. Conclusion The results of statistical analysis show that the test preparations and reference preparations have bioequivalence.