| 硫唑嘌呤片在健康人体的生物等效性 |
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| 引用本文： | 师少军,严慧娟,万元胜,陈华庭,曾繁典.硫唑嘌呤片在健康人体的生物等效性[J].中国临床药理学杂志,2010,26(1). |
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| 作者姓名： | 师少军 严慧娟 万元胜 陈华庭 曾繁典 |
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| 作者单位： | 1. 华中科技大学同济医学院附属协和医院药剂科,武汉,430022
2. 华中科技大学,同济医学院临床药理研究所,武汉,430030 |
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| 摘 要： | 目的研究硫唑嘌呤片(免疫抑制剂)在健康人体的相对生物利用度并评价其生物等效性。方法20名健康志愿者自身交叉、单剂量口服硫唑嘌呤受试和参比制剂各100 mg后,用反相高效液相色谱法测定血浆中其代谢物6-巯基嘌呤浓度。应用DAS软件计算药代动力学参数和相对生物利用度。结果6-巯基嘌呤受试制剂和参比制剂的平均药物浓度-时间曲线均符合一室模型,主要药代动力学参数:t1/2分别为(1.30±0.25),(1.30±0.34)h;tmax分别为(1.25±0.16),(1.24±0.21)h;Cmax分别为(48.44±17.09),(52.32±24.37)μg.L-1;AUC0-t分别为(89.49±19.25),(91.90±25.31)μg.h.L-1;AUC0-∞分别为(96.11±19.74),(98.36±24.66)μg.h.L-1。与参比制剂比较,受试制剂的相对生物利用度F0-t为(99.62±15.29)%,F0-∞为(99.39±13.59)%。结论2种硫唑嘌呤制剂具有生物等效性。
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| 关 键 词： | 硫唑嘌呤 6-巯基嘌呤 生物等效性 反相高效液相色谱 |
Bioequivalence of azathioprine tablets in healthy volunteers |
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| SHI Shao-jun,YAN Hui-juan,WAN Yuan-sheng,CHEN Hua-ting,ZENG Fan-dian.Bioequivalence of azathioprine tablets in healthy volunteers[J].The Chinese Journal of Clinical Pharmacology,2010,26(1). |
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| Authors: | SHI Shao-jun YAN Hui-juan WAN Yuan-sheng CHEN Hua-ting ZENG Fan-dian |
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| Institution: | 1.Department of Pharmacy;Union Hospital Affiliated to Tongji Medical College of Huzhong University of Science and Technology;Wuhan 430022;China;2.Institute of Clinical Pharmacology;Tongji Medical College of Huazhong University of Science and Technology;Wuhan 430030;China |
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| Abstract: | Objective To evaluate the relative bioavailability and bioequivalence of azathioprine tablets in healthy volunteers.Methods A single oral dose of 100 mg azathioprine test and reference tablets were given to 20 male healthy volunteers in a randomized crossover study.Plasma metabolite 6-mercaptopurine of azathioprine was determined by RP-HPLC.The pharmacokinetic parameters and relative bioavailability were calculated with DAS program to evaluate the bioequivalence of the two preparations.Results The concentra... |
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| Keywords: | azathioprine 6-mercaptopurine bioequivalence RP-HPLC |
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