【摘要】 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T₁/2:（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）%.更多还原

【Abstract】 AIM: To study the pharmacokinetics and relative bioavailability of 5’-deoxy -5-fluorouridine capsule in Chinese healthy volunteers. METHODS: Ten male Chinese healthy volunteers received po 400 mg 5’-deoxy-5-fluorouridine capsule in a random crossover design. Drug concentrations in serum were determined by high performance liquid chromatography. RESULTS: The pharmacokinetic parameters of tested and reference cap-sules were as follows: T_1/2: （19. 35 ± 3.69） vs （17. 50 ± 3. 06）min, t_max: （38. 5 ± 14. 7） vs （33. 5 ± 8. 5）min, c_max: （3. 35 ± 0. 93） vs （3. 42 ± 0. 98）μg/ml, AUC_0-T: （157. 58 ± 41. 90） vs （154. 20 ± 45. 36） （μg · min）/ml, respectively. There were no significant differences in the pharmacokinetic parameters above between the 2 capsules（P>0. 05）. CONCLUSION: The relative bioavailability of 5’-deoxy-5-fluorouridine capsule is （104. 05 ± 13. 97） %. The re-sults suggest the 2 preparations have bioequivalence.更多还原