关键词: 溴莫普林, hyprim, 生物等效性, 乙萘酚, 高效液相色谱法

Abstract: Aim To evaluate the bioequivalence of demestic brodimoprim capsules and imported hyprim tablets and provide experimental basis for clinical application. Methods A single dosage of Brodimoprim or hyprim was given to 18 healthy volunteers in a randomized 2-way crossover test and the brodimoprim concentrations in plasma were determined by HPLC withβ-naphtol as internal standard. The pharmacokinetic parameters and the relative bioavailability of the two preparations were calculated and their bioequivalence was evaluated. Results The major pharm aco kin etic parameters of test and reference preparations were as follows respectively: t_1/2(α) (2.1 ± 1.0) and (1.9±0.9) h,t_1/2(β) (43.2 ± 4.8) and (42.4 ± 4.3) h, T_peak(3.4 ± 1.6) and (3.1 ± 1.5) h, C_max (5.9 ± 0.9) and (5.9 ± 1.0) μg·ml^-1,AUC_0~132 (360.2 ± 55.3) and (358.7 ± 52.6) μg·ml^-1,AUC_0~∞ (423.8 ± 56.0) and (422.5 ± 51.1) μg·ml^-1. The relative bioavailability (F) of b rod imp rim capsules was (99.7 ± 4.8) %。Conclusion The multi factorial analysis of variance showed that there was no significant difference in AUC_0~132 between the test and reference preparations (P > 0.05). The bioequivalent assumption was proved by further two one-side t-test and (1~2α) confidence interval analysis in individuals, periods and forms of these two preparations

Key words: brodimoprim capsule, hyprim, bioequivalence, naphthol, HPLC