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食物对复方缬沙坦片中缬沙坦人体药动学特征的影响

Effect of Food on the Pharmacokinetics of Valsartan in Compound Valsartan Tablets

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【作者】 宫文会; 李高; 斯陆勤; 黄建耿;

【Author】 Gong Wenhui, Li Gao, Si Luqin, Huang Jiangeng( Department of Pharmaceutics, Tongji Pharmaceutical College, Huazhong University of Science and Technology, Wuhan 430030, P. R, China)

【机构】 华中科技大学同济医学院药学院药剂系; 华中科技大学同济医学院药学院药剂系 武汉 430030; 武汉 430030;

【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。

【Abstract】 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. Conclu-sion: Food had a statistically significant effect on the pharmacokinetics of valsartan.

【关键词】 食物; 复方缬沙坦片; 药动学;
【Key words】 Food; Valsartan; Pharmacokinetics;
  • 【分类号】R96
  • 【被引频次】5
  • 【下载频次】272
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