| 盐酸安非他酮缓释片人体生物等效性 |
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| 引用本文： | 李国成,余晓霞,伍俊研,温预关. 盐酸安非他酮缓释片人体生物等效性[J]. 中国医院药学杂志, 2011, 0(10) |
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| 作者姓名： | 李国成 余晓霞 伍俊研 温预关 |
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| 作者单位： | 中山大学附属孙逸仙纪念医院;广州市脑科医院国家药品临床研究基地; |
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| 基金项目： | 广东省自然科学研究基金资助项目(编号:8151037001000001); 广东省医学科研基金立项(编号:A2008559) |
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| 摘 要： | 目的:进行受试制剂盐酸安非他酮缓释片与市售参比制剂盐酸安非他酮缓释片的人体生物等效性研究。方法:20例健康男性志愿者采用自身交叉给药方案,分别口服单次给予和连续多次(18例)给予2种盐酸安非他酮缓释制剂,采用HPLC-MS/MS法测定其血药浓度,计算药动学参数,并判定2种制剂的生物等效性。结果:口服单次给予受试制剂和参比制剂安非他酮缓释片的主要药动学参数为Cmax分别为(174.0±55.5),(175.1±56.2)μg.L-1,tmax分别为(2.0±0.5),(2.0±0.6)h,t1/2分别为(11.1±5.0),(11.8±8.2)h,AUC0-72分别为(952.9±423.4),(901.6±372.5)μg.h.L-1,AUC0-∞分别为(968.2±441.0),(918.8±375.8)μg.h.L-1;以AUC0-72计,单次口服受试制剂的相对生物利用度为(106.0±24.3)%。口服连续多次给予的主要药动学参数为Cmax分别为(149.1±45.1),(149.2±38.4)μg.L-1,tmax分别为(2.1±0.9),(1.8±0.3)h,t1/2分别为(12.7±4.6),(1...
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| 关 键 词： | 盐酸安非他酮 高效液相串联质谱法 生物等效性 |
Study on the bioequivalence of bupropion hydrochloride sustained-release tablets in healthy volunteers |
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| LI Guo-cheng,YU Xiao-xia,WU Jun-yan,WEN Yu-guan. Study on the bioequivalence of bupropion hydrochloride sustained-release tablets in healthy volunteers[J]. Chinese Journal of Hospital Pharmacy, 2011, 0(10) |
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| Authors: | LI Guo-cheng YU Xiao-xia WU Jun-yan WEN Yu-guan |
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| Affiliation: | LI Guo-cheng1,YU Xiao-xia1,WU Jun-yan1,WEN Yu-guan2(1.Deptartment of Pharmacy,The Sun Yat-sen Hospital of Sun Yat-sen University,Guangdong Guangzhou 510120,China,2.Department of Clinical Pharmacology,Guangzhou Brain Hospital,Guangdong Guangzhou 510370,China) |
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| Abstract: | OBJECTIVE To study the bioequivalence of bupropion hydrochloride sustained-release tablets.METHODS A single dose and multiple oral doses of bupropion hydrochloride sustained-release tablets(the test and the reference) were given to 20 male healthy volunteers in randomized crossover design for the pharmacokinetic and relative bioavailability study.Plasma concentrations of bupropion hydrochloride were determined by HPLC-MS-MS.RESULTS The main pharmacokinetic parameters for a single oral dose of test and refer... |
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| Keywords: | bupropion hydrochloride HPLC-MS-MS bioequivalence |
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