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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 single-dose domestic famciclovir tablets in male health volunteers in China and to compare the relative bioavailability with similar preparations in the United Kingdom. Methods: Eight healthy male volunteers were enrolled in this study. The fourth-order optimized Latin square design was designed to orally infect single-dose domestic and imported three doses of famciclovir tablets. Plasma and segmental urine samples were collected at 11 time points from 0 to 24 hours. The concentration of penciclovir in blood and urine was measured by liquid phase method, and the pharmacokinetic parameters and relative bioavailability were calculated by 3P87 program. Results: After oral administration of famciclovir tablets, the pharmacokinetics of the drug in vivo was a two-compartment model. The pharmacokinetic parameters of the three doses were basically the same as those of the English-made preparations and the literature data. Conclusion: The pharmacokinetics of the test drug and the reference drug are basically the same, and the relative bioavailability of the test drug is 110.87%.