双氯芬酸钠缓释片的人体生物等效性考察

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。

Bioequivalence of diclofenac sodium sustained release tablets in human plasma

Objectives To evaluate the bioequivalence of diclofenac sodium sustained release tablets in 20 healthy volunteers. Methods Twenty healthy male volunteers were randomly divided into 2 groups. Double-periodical crossed design was used. diclofenac sodium concentration in plasma was determined by HPLC after a single dose and a multiple doses of diclofenac sodium sustained release tablets. The relative bioavailability and related parameters of pharmacokinetics were calculated by DAS2.0 program. Results The AUC0-t of the test preparation and the reference preparation after single dose were (2103.0±651.7) and (2264.5±731.9) μg·h·L^-1, respectively. The relative bioavailability of the test to reference preparation was (95.4 ± 21.8)%. The AUCss of the test preparation and the reference preparation after multiple doses were (2922.5 ± 398.6) and (2843.6 ± 429.4) μg·h·L^-1, respectively. The DF/τ value of reference formulation was (102.8 ± 18.0) % of test formulation. The relative bioavailability of test to reference preparation was (103.5 ± 10.3) %. Conclusion The results indicate that the reference preparation and the test preparation are bioequivalent.