| 依那普利滴丸和片剂在人体内的药动学与生物等效性 |
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| 引用本文： | 张志涛,蒋志文.依那普利滴丸和片剂在人体内的药动学与生物等效性[J].中国新药与临床杂志,2008,27(12). |
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| 作者姓名： | 张志涛 蒋志文 |
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| 作者单位： | 蚌埠医学院药学系,安徽,蚌埠,233030 |
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| 摘 要： | 目的评价依那普利滴丸与片剂2种制剂的生物等效性。方法20名健康男性受试者自身交叉单剂量口服依那普利滴丸和普通片20 mg,以HPLC-MS/MS法测定血浆中依那普利的代谢产物依那普利拉的浓度。采用DAS 2.0软件处理计算主要药动学参数,以方差分析与双向单侧t检验进行统计学分析。结果2种制剂血浆中依那普利拉的t_(1/2)分别为(7±s4)和(7±3)h,c_(max)分别为(61±19)和(64±27)μg·L~(-1),t_(max)分别为(4.1±0.8)和(3.9±0.7)h,AUC_(0～48)分别为(498±139)和(496±228)μg·h·L~(-1),AUC_(0～∞)分别为(515±145)和(520±241)μg·h·L~(-1),以依那普利拉计算的人体相对生物利用度为(114±38)%。结论2种制剂在健康人体内具有生物等效性。
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| 关 键 词： | 依那普利 依那普利拉 色谱法 高压液相 光谱法 质量 电喷雾电离 药动学 生物等效性 |
Pharmacokinetics and bioequivalence of enalapril dripping pill and its tablet in Chinese healthy volunteers |
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| ZHANG Zhi-tao,JIANG Zhi-wen.Pharmacokinetics and bioequivalence of enalapril dripping pill and its tablet in Chinese healthy volunteers[J].Chinese Journal of New Drugs and Clinical Remedies,2008,27(12). |
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| Authors: | ZHANG Zhi-tao JIANG Zhi-wen |
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| Institution: | ZHANG Zhi-tao,JIANG Zhi-wen (Faculty of Pharmacy,Bengbu Medical College,Bengbu A NHUI 233030,China) |
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| Abstract: | AIM To evaluate the bioequivalence of enalapril dripping pill and its tablet in healthy volunteers through HPLC-MS/MS measuring the blood concentration after orally taken enalapril preparation and estimating the pharmacokinetics of enalapril driping pill and its tablets.METHODS A single oral dose of 20 mg enalapril was given to 20 healthy male volunteers according to a randomized crossover design.Plasma concentrations of enalaprilat,the metabolite of enalapril,were detected by HPLC-MS/MS.The pharmacokinetic... |
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| Keywords: | enalapril enalaprilat chromatography high pressure liquid spectrometry mass electrospray ionization pharmacokinetics bioequivalence |
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