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目的:了解国产去氧氟尿苷胶囊在人体的药物动力学及相对生物利用度.方法:采用随机交叉试验设计,10例男性健康志愿者单剂量po试验品与参比品去氧氟尿苷胶囊400mg,以HPLC法测定血药浓度.结果:试验品与参比胶囊各项动力学参数为T_1/2:(19.35±3.69)与(17.50±3.06)min,t_(max):(38.5±14.7)与(33.5±8.5)min.c_(max):(3.35±0.93)与(3.42±0.98)μg/ml;AUC(o-T):(157.58±41.90)与(154.20±45.36)(μg·min)/ml .经交叉试验方差分析,上述药物动力学参数无统计学显著差异(P>0.05).结论:试验品与参比胶囊生物等效,试验品的相对生物利用度为(104.05±13.97)%.
OBJECTIVE: To understand the pharmacokinetics and relative bioavailability of domestic doxifluridine capsules in human.Methods: A randomized crossover design was used in this study. Ten single-dose po test samples of healthy volunteers and reference samples of doxifluridine Capsule 400mg, HPLC determination of plasma concentration.Results: The experimental parameters and reference capsules of the kinetic parameters T_1 / 2: (19.35 ± 3.69) and (17.50 ± 3.06) min, t max: (38.5 ± 14.7) and (33.5 ± 8.5) min.c max (3.35 ± 0.93) and (3.42 ± 0.98) μg / ml respectively; AUC (oT) :( 157.58 ± 41.90) and (154.20 ± 45.36) ) / ml.According to the cross-test analysis of variance, there was no significant difference in pharmacokinetic parameters between the two groups (P> 0.05) .Conclusion: The relative bioavailability of test and reference capsules was (104.05 ± 13.97 )%.