摘要
目的 :以进口去氧氟尿苷胶囊为对照 ,考察国产去氧氟尿苷胶囊的药动学及 2种制剂的生物等效性。方法 :10名肿瘤病人随机双交叉口服 2种胶囊 80 0mg ,采用HPLC法测定药物的血药浓度。结果 :进口和国产去氧氟尿苷胶囊的药动学参数———Cmax分别为 (5 .1± 1.4 )mg·L- 1,(4.6± 1.2 )mg·L- 1;Tmax分别为 (1.0± 0 .4 )h ,(0 .8± 0 .4 )h ;AUC分别为 (6 .5± 1.7)mg·h·L- 1,(6 .0± 1.6 )mg·h·L- 1。国产去氧氟尿苷胶囊相对生物利用度为 (95± 12 ) %。结论
AIM: To study the pharmacokinetics and bioequivalence of domestic vs imported deoxifluridine. METHODS: Ten tumor patients were received two kinds of deoxifluridine capsules 800 mg, po , in a cross over design. The plasma concentrations of drug were determined by HPLC. RESULT:The pharmacokinetic parameters of domestic and imported deoxifluridine capsules were C max (5.1± s 1.4) mg·L -1 ,(4.6±1.2) mg·L -1 ; T max (1.0±0.4)h,(0.8±0.4) h; AUC(6.5±1.7) mg·h·L -1 ,(6.0±1.6) mg·h·L -1 , respectively. The relative bioavailability of domestic deoxifluridine was (95±12)%. CONCLUSION:The result of statistical analysis shows that the two formulations are bioequivalent.
出处
《中国新药与临床杂志》
CAS
CSCD
北大核心
2003年第1期27-29,共3页
Chinese Journal of New Drugs and Clinical Remedies
