| 厄贝沙坦氢氯噻嗪胶囊在健康人体的生物等效性 |
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| 引用本文： | 邱相君,刘涛,袁世英,刘心霞,陈汇. 厄贝沙坦氢氯噻嗪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(11) |
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| 作者姓名： | 邱相君 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： | 目的研究厄贝沙坦氢氯噻嗪胶囊(抗高血压药)在健康人体的生物等效性。方法 22名健康志愿者,随机双交叉单剂量口服厄贝沙坦氢氯噻嗪胶囊(试验制剂)和厄贝沙坦氢氯噻嗪片(参比制剂),剂量为厄贝沙坦300 mg、氢氯噻嗪25 mg。分别于服药后36 h内,多点抽取静脉血,用高效液相色谱法分别测定血浆中厄贝沙坦和氢氯噻嗪的浓度。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。结果单剂量口服厄贝沙坦氢氯噻嗪胶囊和片剂后的药代动力学参数,厄贝沙坦:Cmax分别为(2.61±0.62)和(2.57±0.46)mg·L-1;AUC0-36分别为(15.14±3.43)和(15.39±3.91)mg·h·L-1;AUC0-∞分别为(16.37±3.42)和(16.80±4.28)mg·h·L-1;相对生物利用度为(100.75±19.42)%。氢氯噻嗪:Cmax分别为(162.51±27.55)和(168.18±25.71)μg·L-1;AUC0-36分别为(1115.41±147.34)和(1144.15±171.62)μg·h·L-1;AUC0-∞分别为(1212.68±160.77)和(1252.75±211.2...
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| 关 键 词： | 厄贝沙坦 氢氯噻嗪 生物等效性 高效液相色谱法 |
Bioequivalence of irbesartan and hydrochlorothiazide capsules in Chinese healthy volunteers |
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| QIU Xiang-jun,LIU Tao,YUAN Shi-ying,LIU Xin-xia,CHEN Hui. Bioequivalence of irbesartan and hydrochlorothiazide capsules in Chinese healthy volunteers[J]. The Chinese Journal of Clinical Pharmacology, 2011, 27(11) |
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| Authors: | QIU Xiang-jun LIU Tao YUAN Shi-ying LIU Xin-xia CHEN Hui |
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| Affiliation: | QIU Xiang-jun1,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 irbesartan and hydrochlorothiazide capsules in healthy volunteers.Methods A single oral dose of test and reference formulations were given to 22 healthy volunteers in a randomised crossover study.The concentrations of irbesartan and hydrochlorothiazide in plasma were determined by HPLC,respectively.The pharmacokinetic parameters were calculated and the bioavailability and bioequivalence of irbesartan and hydrochlorothiazide were evaluated by DAS program,respectively.... |
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| Keywords: | irbesartan hydrochlorothiazide bioequivalence HPLC |
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