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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0.3 g,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:C_(max)分别为(1.837±0.634)μg·ml~(-1)和(1.842±0.625)μg·ml~(-1);t_(max)分别为(1.063±0.573)h和(1.138±0.559)h,t_(1/2)分别为(2.956±0.403)h和(3.005±0.271)h,AUC_(0→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。
Objective: To evaluate the bioequivalence of two domestic valacyclovir hydrochloride tablets. Methods: A total of 20 healthy male volunteers were given a single oral dose of valacyclovir hydrochloride tablets test drug or control drug 0.3 g. The HPLC method was used to determine the active metabolite of valacyclovir in human plasma. The concentration of lovastatin, with DAS2.1 software equivalent evaluation of the two drugs. Results: The main pharmacokinetic parameters of test drug and control drug were: C max (1.837 ± 0.634) μg · ml -1 and (1.842 ± 0.625) μg · ml -1, respectively; max were 1.063 ± 0.573 h and 1.138 ± 0.559 h respectively, t 1/2 was 2.956 ± 0.403 h and 3.005 ± 0.271 h respectively, AUC 0-15 was 5.528 ± 1.145 μg · ml -1 · h and 5.725 ± 1.304 μg · ml -1 · h respectively. Conclusion: Two kinds of valacyclovir hydrochloride tablets are bioequivalent.