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目的:研究2种双氯芬酸钾胶囊的人体生物等效性。方法:20名健康男性志愿者随机交叉单剂量口服受试制剂或参比制剂,采用高效液相色谱-质谱法测定血药浓度,计算药动学参数和相对生物利用度。结果:受试制剂与参比制剂的药-时曲线符合一房室模型,AUC0～8分别为(2.27±0.66)、(2.16±0.58)(μg·h)/ml,Cmax分别为(1.27±0.40)、(1.38±0.58)μg/ml,tmax分别为(0.9±0.7)、(1.0±0.7)h;受试制剂的相对生物利用度为(104.9±12.8)%。结论:2种双氯芬酸钾胶囊具有生物等效性。
Objective: To study the bioequivalence of two diclofenac potassium capsules. Methods: Twenty healthy male volunteers were randomized to crossover a single dose of oral test formulation or reference formulation. Plasma concentrations were determined by high performance liquid chromatography-mass spectrometry. Pharmacokinetic parameters and relative bioavailability were calculated. Results: The drug-time curve of the test preparation and the reference preparation conformed to the one-compartment model with AUC0-8 of (2.27 ± 0.66) and (2.16 ± 0.58) μg · h-1, respectively, 0.40), (1.38 ± 0.58) μg / ml, tmax were (0.9 ± 0.7) and (1.0 ± 0.7) h, respectively. The relative bioavailability of the test preparation was (104.9 ± 12.8)%. Conclusions: Two diclofenac potassium capsules are bioequivalent.