缬沙坦分散片人体生物等效性研究

    Bioequivalence of valsartan dispersible tablets and capsules in healthy volunteers

    • 摘要: 目的:研究缬沙坦分散片与胶囊在健康人体的生物等效性。方法:20名健康志愿者采用双周期交叉试验,单剂量空腹口服缬沙坦分散片和胶囊各80 mg,高效液相色谱法测定其血清中缬沙坦浓度,血药浓度-时间数据经DAS 1.0统计软件处理,计算主要药代动力学参数,并进行两种制剂的生物等效性评价。结果:缬沙坦分散片与胶囊的主要药代动力学参数t1/2、Cmax、Tmax、AUC0-36h分别为:(3.715±1.895) h和(3.585±1.901) h、(1.797±0.539)μg/ml和(1.848±0.647)μg/ml;(2.350±0.489) h和(2.425±0.438) h、(10.786±3.794)μg·h-1·ml-1和(10.52±3.961)μg·h-1·ml-1。分散片与胶囊比较,分散片相对生物利用度为(111.6±40.7)%。结论:两种制剂具有生物等效性。

       

      Abstract: Objective: To investigate the bioequivalence of valsartan dispersible tablets and capsules in healthy volunteers.Methods: Twenty volunteers were randomly divided into two groups(test and reference),with double cross-over design.The concentration of valsartan in serum was determined by high performance liquid chromatography(HPLC) and pharmacokinetic parameters were calculated with DAS2.0 practical pharmacokinetics program.Results: The pharmacokinetic parameters of valsartan dispersible tablets and capsules were as follows:t1/2 were(3.715±1.895)h and(3.585±1.901)h,Cmax were(1.797±0.539)μg/ml and(1.848±0.647)μg/ml,Tmax were(2.350±0.489)h and(2.425±0.438)h,AUC0-36 h were(10.786±3.794) μg·h-1·ml-1 and(10.52±3.96) μg·h-1·ml-1.The relative bioavalibility of valsartan dispersible tablets was(111.6±40.7)%.Conclusions: The statistical analysis showed that the test and reference preparation were bioequivalent.

       

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