健康志愿者单次口服国产泛昔洛韦片后的药代动力学

Pharmacokinetics of famciclovir after single dosing in Chinese healthy volunteers

目的 : 研究我国男性健康志愿者单次口服国产泛昔洛韦片后的药代动力学行为 ,并与英国产同类制剂作比较 ,求得相对生物利用度。方法 : 8例男性健康志愿者以四阶优化拉丁方设计分别交叉单次口服英国产及三个剂量的国产泛昔洛韦片 ,在 0～ 2 4h内 11个时间点采集血浆及分段尿液 ,高效液相法测定血、尿中的喷昔洛韦浓度 ,并用 3P87程序计算药代动力学参数和相对生物利用度。结果 : 口服泛昔洛韦片后 ,药物在体内的动力学表现为二室模型 ,三个受试剂量的药代动力学参数与英国产制剂及文献数据基本一致。结论 : 受试药与对照药的药代动力学基本相同 ,受试药的相对生物利用度平均值为 110 .87%。

Objective:To study the pharmacokinetics of domestic and imported famciclovir after single dosing in Chinese healthy male volunteers, and to calculate the relative bioavailability of domestic famciclovir.Methods:Eight healthy male volunteers received single oral doses of famciclovir made in China or U.K. (125 mg,250 mg,500 mg,250mg) according to a latin square cross over design. The plasma and urine levels of penciclovir were determined by HPLC. The data of plasma concentrations of penciclovir were treated with 3P87, and the pharmacokinetic parameters were obtained.Results:After oral administration pharmacokinetic model was described open two compartmental model. The pharmacokinetic parameters of domestic famciclovir were the same as the impored famciclovir. Conclusion :There was no difference between domestic and impooted famciclovir in pharmacokinetics. The relative bioavailability of famciclovir made in China was 110.87%. [