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目的:研究食物对复方缬沙坦片中缬沙坦人体药动学的影响。方法:采用随机交叉试验设计,10名男性健康志愿者禁食12 h后空腹或进食后口服复方缬沙坦片2片(每片含缬沙坦80 mg),反相高效液相色谱法测定血浆中缬沙坦的浓度。结果:受试者空腹和进食后口服复方缬沙坦片,血浆中缬沙坦的主要药动学参数:Cmax分别为(4．238±0．822)和(2．984± 1.230)mg·L-1,Imax分别为(2.70±0．63)和(3．20±1.38)h,AUC0→∞分别为(32．06±7.14)和(25．39±7．60)mg·h·L-1,CL分别为(5.247±1.310)和(6．981±2.623)L·h-1。结论:食物对缬沙坦的药代动力学特征有显著影响。
Objective: To study the effect of food on the pharmacokinetics of valsartan in compound valsartan tablets. Methods: Randomized crossover design was conducted in 10 male healthy volunteers. After fasting for 12 hours or after oral administration, 2 oral valsartan tablets (each containing valsartan 80 mg) were determined by RP-HPLC Valsartan concentration in plasma. Results: The main pharmacokinetic parameters of valsartan were: (4.238 ± 0.822) and (2.984 ± 1.230) mg · L-1 and Imax were (2.70 ± 0.63) and (3.20 ± 1.38) h, AUC0 → ∞ were (32.06 ± 7.14) and (25.39 ± 7.60) mg · h · L-1 and CL were (5.247 ± 1.310) and (6.981 ± 2.623) L · h-1, respectively. Conclusion: Food has a significant effect on the pharmacokinetic profile of valsartan.