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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 被引量:4

Effect of Food on the Pharmacokinetics of Valsartan in Compound Valsartan Tablets
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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
关键词 食物 复方缬沙坦片 药动学 Food Valsartan Pharmacokinetics
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参考文献4

  • 1黄一玲,田蕾,李一石,宋珍,华潞,边文彦,姚康宝.缬沙坦3种制剂的健康人体生物等效性研究[J].中国新药与临床杂志,2003,22(6):341-344. 被引量:12
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二级参考文献5

  • 1黄圣凯,韩可勤.生物等效性评价的几种统计方法[J].中国临床药理学杂志,1993,9(1):43-46. 被引量:125
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