【摘要】：目的研究硫酸氫氯吡格雷片在中國(guó)健康人體的藥代動(dòng)力學(xué)和相對(duì)生物利用度。方法 24名健康受試者采用自身對(duì)照、隨機(jī)交叉給藥法,單次空腹口服硫酸氫氯吡格雷片參比和受試藥物各150 mg。用液相色譜-質(zhì)譜聯(lián)用法(LC-MS/MS)測(cè)定血漿中氯吡格雷和氯吡格雷羧酸鹽代謝物的血藥濃度,計(jì)算兩種藥物的藥代動(dòng)力學(xué)參數(shù)和相對(duì)生物利用度。結(jié)果血漿中氯吡格雷受試藥物和參比藥物tmax分別為(1.03±0.36),(1.11±0.41)h;Cmax分別為(2.90±1.68),(3.05±1.63)ng·m L-1;t1/2分別為(3.50±1.19),(3.22±0.66)h;AUC0-t分別為(8.75±5.10),(9.26±5.36)ng·h·m L-1;AUC0-∞分別為(9.52±5.64),(9.97±5.88)ng·h·m L-1;平均相對(duì)生物利用度為(98.40±24.30)%。血漿中氯吡格雷羧酸鹽代謝物,tmax分別為(0.98±0.72),(0.91±0.40)h;Cmax分別為(4799±1569),(4697±1856)ng·m L-1;t1/2分別為(7.24±1.56),(7.25±1.38)h;AUC0-t分別為(13043±3845),(13707±4007)ng·h·m L-1;AUC0-∞分別為(13933±4242),(14596±4172)ng·h·m L-1;平均相對(duì)生物利用度為(95.90±13.50)%。結(jié)論兩種氯吡格雷和氯吡格雷羧酸鹽代謝物具有生物等效性。
[Abstract]:Objective to study the pharmacokinetics and relative bioavailability of hydroclopidogrel sulfate tablets in Chinese healthy volunteers. Methods Twenty-four healthy subjects were randomly divided into two groups: hydroclopidogrel tablets and hydroclopidogrel tablets by oral administration of hydroclopidogrel tablets on an empty stomach for 150 mg. each. The concentrations of clopidogrel and clopidogrel in plasma were determined by liquid chromatography-mass spectrometry (LC-MS/MS). The pharmacokinetics parameters and relative bioavailability of the two drugs were calculated. Results the tmax of clopidogrel and reference drug in plasma was (1.03 鹵0.36), (1.11 鹵0.41) h and (2.90 鹵1.68), (3.05 鹵1.63) ng 路ml 鈮，

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