盐酸伐昔洛韦在人体内的药动学和相对生物利用度

目的研究伐昔洛韦在正常人体内药动学和相对生物利用度。方法20名健康志愿者单剂量交叉口服伐昔洛韦300mg和参比片，用高效液相色谱（HPLC）法检测受试者血药浓度，并计算两者的药动学参数。结果受试药与参比药的血药浓度水平一致。其主要药动学参数t1/2分别为（3．81±0．66）h和（4．15±0．74）h；Tmax分别为（1．48±0．58）h和（1.38±0．56）h，Cmax分别为（1．86±0．50）mg／L和（2．07±0．62）mg／L，AUC分别为（7．51±1．71）mg·h／L和（7．03±0．98）mg·h／L，两制剂的药动学参数相近。用AUC估算的伐昔洛韦试验药相对生物利用度为98．0％±11．8％。结论伐昔洛韦片和参比片的AUC、Cmax经方差分析和双向单侧t检验表明两制剂生物等效；Tmax经非参数法检验表明两种制剂差异无统计学意义（P〉0.05）。

Pharmacokinetics and relative bioavailability of valaciclovir in healthy volunteers

Objective To study the pharmacokinetics and relative bioavailability of valaciclovir in healthy volunteers. Methods A single oral dose of 300 mg test valaciclovir or reference drug was given to 20 volunteers according to a randomized crossover study. The drug concentration in plasma was analyzed by HPLC method. Results The main pharmacokinetic parameters of valaciclovir were as follows： t1/2（3.81±0.66）hand （4.15±0.74）h, Tmax（1.48±0.58）hand （1.38±0.56）h, Cmax （1. 86 ± 0. 50） mg/L and （2.07± 0.62） mg/L, AUC0-12 （7.51 ±1.71） mg · h/L and 7.03 ± 0.98 mg·h/L for test and reference drug, respectively. The relative bioavailability of the test drug was 98.0% ± 11.8%. Conclusions Statistical analysis shows that the two preparations were bioequivalent.