两种盐酸伐昔洛韦片在健康志愿者体内的生物等效性研究

目的：评价两种国产盐酸伐昔洛韦片的生物等效性。方法：采用双周期交叉试验的方法，20名男性健康志愿者单剂量口服盐酸伐昔洛韦片试验药或对照药0．3g，采用HPLC方法测定人血浆中伐昔洛韦的活性代谢产物阿昔洛韦的浓度，用DAS2．1软件对两药进行等效性评价。结果：试验药与对照药的主要药动学参数：Cmax分别为（1．837±0．634）μg·ml^-1和（1．842±0．625）μg·ml^-1；tmax分别为（1．063±0．573）h和（1．138±0．559）h，t1／2分别为（2．956±0．403）h和（3．005±0．271）h，AUC0→14分别为（5．528±1．145）μg·ml^-1·h和（5．725±1．304）μg·ml^-1·h。结论：两种盐酸伐昔洛韦片生物等效。

Bioequivanlence of Two Valaciclovir Hydrochloride Tablets in Healthy Volunteers

Objective： To evaluate the bioequivalence between two valaciclovir hydroehloride tablets. Method： Twenty healthy male volunteers were treated with a single close of 0. 3g valaciclovir hydrochloride tablets by a randomized crossover design. Plasma concentrations of aciclovir were determined by HPLC and the bioequivalence between two formulations were evaluated by DAS2. 1 program. Result： The pharmaeokinetie parameters of aciclovir were expressed as following ： Cmax were （ 1. 837± 0. 634 ） μg.ml^-1 and （ 1. 842 ± 0.625） μg.ml^-1;tmax were （1.063±0.573） h and （1.138 ±0.559） h,t1/2 were （2.956 ±0.403） h and （3.005±0.271） h, AUC0-14 were （5. 528 ± 1. 145） μg.ml^-1.h and （5. 725 ± 1. 304） μg.ml^-1 .h,respectively. Conclusion： Two valaciclovir hydroehlo- ride tablets are bioequivalent.