盐酸伐昔洛韦片的药动学与生物利用度

 目的:研究盐酸伐昔洛韦(万乃洛韦)片在正常人体内的药动学与生物利用度。方法:采用梯度洗脱反相高效液相色谱法测定10名健康志愿受试者PO盐酸伐昔洛韦片和阿昔洛韦片后血中阿昔洛韦浓度；以3P87药动学计算程序处理测定结果，计算药动学参数；用双单侧t检验和配对t检验法对主要药动学参数进行统计分析，评价二者的生物等效性。结果:二者的药时曲线可用一室模型拟合，二者的药时曲线下面积分别为20.69μg·min·l^-1与8.22μg·min·ml^-1；达峰时间分别是2.10h与2.57h；峰浓度分别是2.886μg·ml^-1与1.086μg·ml^-1。结论:统计分析结果表明二者为生物不等效制剂，以阿昔洛韦片为参比制剂计算出盐酸伐昔洛韦片的相对生物利用度为364.04%。

Pharmacokinetics and relative bioavailability of valaciclovir hydrochloride tablet

OBJECTIVE: To study the pharmacokinetics and relative bioavailability of valaciclovir hydrochloride tablet.METHODS: The acyclovir concentration in plasma was assayed by HPLC method following a single oral dose of valaciclovir hydrochloride tablet and acyclovir tablet respectively given to 10 volunteers in a open randomized cross-over test.RESULTS:After a single oral dose 600 mg of valaciclovir hydrochloride tablet, the c_max and t_max was 2.886μg·ml^-1and 2.10 h respectively, the AUC_o→∞was 20.69μg·min·ml^{-1.The concentration-time courves after medication conformed to a one compartment open model with a first order absorption. CONCLUSION: There were significant differences between valaciclovir hydrochloride tablet and acyclovir tablet in the AUC_o→∞,c_max and t_max. The bioavailability of valaciclovir hydrochloride tablet was 364.04%.}