去氧氟尿苷胶囊的人体药物动力学及相对生物利用度  

Pharmacokinetics and relative bioavailability of 5'-deoxy-5-fluo-rouridine capsule in Chinese healthy volunteers

作　　者：许长江[1] 刘骁 杨香媛 江志强 李端 周仁兴 

机构地区：[1]卫生部上海医科大学临床药理基地临床药理检测中心,上海200032 [2]上海太平洋生物高科技有限公司,上海200233

出　　处：《中国临床药学杂志》1999年第5期284-287,共4页Chinese Journal of Clinical Pharmacy

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)%.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.

关 键 词：去氧氟尿苷 药物动力学 相对生物利用度 

分 类 号：R979.1[医药卫生—药品] R912[医药卫生—药学]