食物对口服更昔洛韦人体内吸收的影响

 目的研究健康人po更昔洛韦胶囊的生物利用度,并探讨食物对药物体内吸收的影响。方法18名健康志愿者随机交叉单剂量空腹po更昔洛韦国产胶囊或进口胶囊,或餐后po国产胶囊1000mg,采用HPLC测定其血药浓度,3P97程序计算药动学参数,并对餐后与空腹服药的药动学参数进行显著性检验。结果更昔洛韦国产胶囊与进口胶囊比较的相对生物利用度为(96.8±16.9)%,两制剂的AUC,ρ_max和t_max均无显著性差异(P>0.05)。餐后与空腹服药比较,AUC,ρ_max显著增加,t_max明显延长,两者差异极其显著(P<0.01)。结论两种制剂具有生物等效性,食物可显著增加更昔洛韦的体内吸收,提高药物的生物利用度。

Effects of food on absorption of ganciclovir after oral administration in healthy volunteers

OBJECTIVE To study the relative bioavailability of domestic and imported ganciclovir capsules and evaluate the effect of food on absorption of the drug in 18 healthy volunteers. METHODS Subjects received oral ganciclovir at a single dose of 1 000 mg either after an overnight fast or after a breakfast in a randomized three-way crossover study. Plasma concentrations were determined by HPLC and the pharma-cokinetic parameters were calculated by 3P97 program. RESULTS The relative bioavailability of domestic capsules versus imported capsules was (96.8 ± 16.9) % . The results of statistical analysis for AUC, ρ_max and t_max showed that there were no significant differencs between the two formulations(P>0.05) . The AUC and ρ_max of ganciclovir were significantly higher in the fed state than after an overnight fast. The t_max was increased from 1.9 h in the fasting state to 3.3 h in the fed state(P<0.01) .CONCLUSION The study indicated that the two formulations were of bioequivalence and food potentially increased the bioavailability of oral ganciclovir.