| 氨酚双氢可待因胶囊在健康人体的生物等效性 |
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| 引用本文： | 邱相君,王淑英,刘涛,袁世英,刘心霞,陈汇. 氨酚双氢可待因胶囊在健康人体的生物等效性[J]. 中国临床药理学杂志, 2011, 27(2) |
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| 作者姓名： | 邱相君 王淑英 刘涛 袁世英 刘心霞 陈汇 |
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| 作者单位： | 1. 河南科技大学,医学院,河南,洛阳,471003
2. 华中科技大学,同济医学院,武汉,430030 |
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| 摘 要： | 目的研究氨酚双氢可待因胶囊(解热镇痛药)在健康人体的生物等效性。方法健康志愿者20名随机双交叉分别单剂量口服氨酚双氢可待因胶囊(试验制剂)和氨酚双氢可待因片(参比制剂);分别于服药后14 h内,多点抽取静脉血;用高效液相色谱法分别测定血浆中对乙酰氨基酚和双氢可待因的浓度;用DAS程序计算相对生物利用度并评价2种制剂生物等效性。结果单剂量口服氨酚双氢可待因胶囊和片剂后,血浆中对乙酰氨基酚的Cm ax分别为(9.06±2.05),(9.15±2.50)mg.L-1;AUC0-14分别为(34.46±7.49),(35.91±7.01)mg.h.L-1;AUC0-∞分别为(35.66±7.86),(37.24±7.56)mg.h.L-1;相对生物利用度为(97.17±19.09)%。双氢可待因的Cm ax分别为(61.84±9.84),(58.33±6.79)μg.L-1;AUC0-14分别为(289.23±31.30),(281.56±25.91)μg.h.L-1;AUC0-∞分别为(304.83±32.95),(298.45±29.15)μg.h.L-1;相对生物利用度为(103.58±15.09)%。结论 2...
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| 关 键 词： | 对乙酰氨基酚 双氢可待因 生物等效性 高效液相色谱法 |
Bioequivalence of paracetamol and dihydrocodeine tatrate capsules in Chinese healthy volunteers |
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| QIU Xiang-jun,WANG Shu-ying,LIU Tao,YUAN Shi-ying,LIU Xin-xia,CHEN Hui. Bioequivalence of paracetamol and dihydrocodeine tatrate capsules in Chinese healthy volunteers[J]. The Chinese Journal of Clinical Pharmacology, 2011, 27(2) |
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| Authors: | QIU Xiang-jun WANG Shu-ying LIU Tao YUAN Shi-ying LIU Xin-xia CHEN Hui |
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| Affiliation: | QIU Xiang-jun1,WANG Shu-ying1,LIU Tao1,YUAN Shi-ying2,LIU Xin-xia2,CHEN Hui2 (1.Medical College of Henan University of Science and Technology,Luoyang 471003,Henan Province,China,2.Tongji Medical College of Huazhong University of Science and Technology,Wuhan 430030,China) |
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| Abstract: | Objective To study the bioequivalence of paracetamol and dihydrocodeine tartrate capsules in healthy volunteers.Methods A single oral dose of tested and reference formulation were given to 20 healthy volunteers in a randomised crossover study.The concentrations of acetaminophen and dihydrocodeine in plasma were determined by HPLC,respectively.The pharmacokinetic parameters were calculated and the bioavailability and bioequivalence of acetaminophen and dihydrocodeine were evaluated by DAS program.Results Aft... |
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| Keywords: | acetaminophen dihydrocodeine bioequivalence HPLC |
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