本文選題：果糖二磷酸鈉 + 固體復(fù)合酶　； 參考：《四川大學(xué)學(xué)報(bào)(醫(yī)學(xué)版)》2015年03期

【摘要】：目的研究果糖二磷酸鈉片在健康中國人體內(nèi)的藥動學(xué)特征。方法采用自身交叉對照的試驗(yàn)設(shè)計(jì)方法,將6名健康男性受試者隨機(jī)分為兩組,交叉單劑量口服3g安慰劑和果糖二磷酸鈉片,建立固體復(fù)合酶活力測定方法以測定人血漿中果糖二磷酸的藥物濃度。進(jìn)行果糖二磷酸鈉的臨床藥動學(xué)研究。結(jié)果本方法的標(biāo)準(zhǔn)曲線方程為:R=0.000 741C-0.000 73(r=0.998)。血漿中果糖二磷酸鈉濃度在4.94~78.97μg/mL范圍內(nèi)與果糖二磷酸鈉的吸光度差值ΔA’具有良好的線性關(guān)系。高、中、低濃度血漿樣品的方法回收率分別為(100.08±2.67)%、(99.79±8.14)%、(95.14±8.09)%,提取回收率分別為(93.19±2.49)%、(96.15±7.84)%、(91.80±7.81)%,在室溫和冰凍條件(-20℃)下相對標(biāo)準(zhǔn)偏差(RSD)值均在10%以內(nèi)。單劑量口服3g果糖二磷酸鈉片后6名受試者血漿果糖二磷酸濃度無明顯峰值,濃度在(60.38±18.19)μg/mL至(71.81±7.65)μg/mL范圍內(nèi)波動;服用等量安慰劑后,6名受試者平均血漿果糖二磷酸濃度在(52.76±17.82)μg/mL至(73.42±9.28)μg/mL之間波動。結(jié)論單劑量口服3g果糖二磷酸鈉片后其血藥濃度較服用等量安慰劑后無明顯升高,可能需要加大口服給藥劑量。
[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 鹵2.67 and 99.79 鹵8.14 鹵8.09, respectively, and the recoveries were 93.19 鹵2.491.15 鹵7.841.80 鹵7.81, respectively. The relative standard deviations (RSDs) were within 10% at room temperature and freezing conditions (-20 鈩，

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