摘要
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: The food on influences of the pharmacokinetics of valsartan in compound valsartan tablets was studied. Method: 10 healthy male subjects received two tablets of the compound valsartan (containing valsartan 80 mg per tablet), once after a 12 hour fast, and once following a standard high-fat meal at random crossover design. Plasma samples of valsartan obtained periodically were determined using an RP-HPLC method. Result: Under fasted and fed conditions, the main pharmacokinetic parameters of valsartan was as follows: Cmax were (4. 238 ±0.822) and (2. 984 ± 1. 230) mg·L^-1 ,tmax 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 ,CL were (5. 247 ± 1. 310) and (6. 981 ± 2. 623) L·h^-1. Conclusion: Food had a statistically significant effect on the pharmacokinetics of valsartan.
出处
《中国药师》
CAS
2005年第12期988-990,共3页
China Pharmacist