硫酸氢氯吡格雷片在中国健康人体的药代动力学和相对生物利用度研究

发布时间：2019-08-06 13:33

【摘要】：目的研究硫酸氢氯吡格雷片在中国健康人体的药代动力学和相对生物利用度。方法 24名健康受试者采用自身对照、随机交叉给药法,单次空腹口服硫酸氢氯吡格雷片参比和受试药物各150 mg。用液相色谱-质谱联用法(LC-MS/MS)测定血浆中氯吡格雷和氯吡格雷羧酸盐代谢物的血药浓度,计算两种药物的药代动力学参数和相对生物利用度。结果血浆中氯吡格雷受试药物和参比药物tmax分别为(1.03±0.36),(1.11±0.41)h;Cmax分别为(2.90±1.68),(3.05±1.63)ng·m L-1;t1/2分别为(3.50±1.19),(3.22±0.66)h;AUC0-t分别为(8.75±5.10),(9.26±5.36)ng·h·m L-1;AUC0-∞分别为(9.52±5.64),(9.97±5.88)ng·h·m L-1;平均相对生物利用度为(98.40±24.30)%。血浆中氯吡格雷羧酸盐代谢物,tmax分别为(0.98±0.72),(0.91±0.40)h;Cmax分别为(4799±1569),(4697±1856)ng·m L-1;t1/2分别为(7.24±1.56),(7.25±1.38)h;AUC0-t分别为(13043±3845),(13707±4007)ng·h·m L-1;AUC0-∞分别为(13933±4242),(14596±4172)ng·h·m L-1;平均相对生物利用度为(95.90±13.50)%。结论两种氯吡格雷和氯吡格雷羧酸盐代谢物具有生物等效性。
[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 卤0.36), (1.11 卤0.41) h and (2.90 卤1.68), (3.05 卤1.63) ng 路ml 鈮，

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