固体复合酶活力测定方法检测健康人单次口服果糖二磷酸钠片的药动学预试验

发布时间：2018-04-21 19:09

  本文选题：果糖二磷酸钠 + 固体复合酶　； 参考：《四川大学学报(医学版)》2015年03期

【摘要】：目的研究果糖二磷酸钠片在健康中国人体内的药动学特征。方法采用自身交叉对照的试验设计方法,将6名健康男性受试者随机分为两组,交叉单剂量口服3g安慰剂和果糖二磷酸钠片,建立固体复合酶活力测定方法以测定人血浆中果糖二磷酸的药物浓度。进行果糖二磷酸钠的临床药动学研究。结果本方法的标准曲线方程为:R=0.000 741C-0.000 73(r=0.998)。血浆中果糖二磷酸钠浓度在4.94~78.97μg/mL范围内与果糖二磷酸钠的吸光度差值ΔA’具有良好的线性关系。高、中、低浓度血浆样品的方法回收率分别为(100.08±2.67)%、(99.79±8.14)%、(95.14±8.09)%,提取回收率分别为(93.19±2.49)%、(96.15±7.84)%、(91.80±7.81)%,在室温和冰冻条件(-20℃)下相对标准偏差(RSD)值均在10%以内。单剂量口服3g果糖二磷酸钠片后6名受试者血浆果糖二磷酸浓度无明显峰值,浓度在(60.38±18.19)μg/mL至(71.81±7.65)μg/mL范围内波动;服用等量安慰剂后,6名受试者平均血浆果糖二磷酸浓度在(52.76±17.82)μg/mL至(73.42±9.28)μg/mL之间波动。结论单剂量口服3g果糖二磷酸钠片后其血药浓度较服用等量安慰剂后无明显升高,可能需要加大口服给药剂量。
[Abstract]:Objective to study the pharmacokinetics of fructose sodium diphosphate tablets in healthy Chinese volunteers. Methods six healthy male subjects were randomly divided into two groups: a single oral dose of 3 g placebo and sodium fructose diphosphate tablet. A method for the determination of fructose diphosphate (fructose diphosphate) in human plasma was established. The clinical pharmacokinetics of fructose sodium diphosphate was studied. Results the standard curve equation of this method is 0. 000 741C-0.000. There was a good linear relationship between the concentration of fructose sodium diphosphate in the range of 4.94 渭 g/mL and the absorbance difference 螖 A'of sodium fructose diphosphate. The recoveries of high, medium and low concentrations of plasma samples were 100.08 卤2.67 and 99.79 卤8.14 卤8.09, respectively, and the recoveries were 93.19 卤2.491.15 卤7.841.80 卤7.81, respectively. The relative standard deviations (RSDs) were within 10% at room temperature and freezing conditions (-20 鈩，

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