【摘要】 采用HPLC法测定Beagle犬单剂量口服含替加氟100mg、尿嘧啶224mg的参比优福定胶囊与受试优福定胶囊后替加氟与其活性代谢产物5氟尿嘧啶的血药浓度,然后进行犬体相对生物利用度与生物等效性研究.结果表明:受试制剂在犬体内替加氟与5氟尿嘧啶的相对生物利用度分别为(106.89±21.74)%与(102.32±24.02)%,两种制剂具有生物等效性.更多还原

【Abstract】 Tegafur [1-(tetrahydro-2-furanyl)-5-fluorouracil](TF), a masked form of 5-fluorouracil (5-FU), is an effective antitumor agent. Oral administration of TF plus uracil (U) (14 mole/mole) (UFT) is more effective than that of TF alone. The relative bioavailability of UFT was studied in beagle dogs. A single oral administration of UFT test capsules or reference capsules containing 100 mg TF and 224 mg U was given to each dog according to a random crossover design. The drug concentrations in plasma were determined by high performance liquid chromatography (HPLC). The relative bioavailabilities of TF and 5-FU were ( 106.89± 21.74)% and ( 102.32± 24.02)%, respectively. The pharmacokinetic parameters, including C_ max, AUC_ 0~t and AUC_ 0~∞, show no significant difference (P> 0.05). Statistical results show that the two preparations are bioequivalent ( P>0.05).更多还原