| 盐酸特拉唑嗪口腔崩解片人体生物等效性研究 |
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| 引用本文： | 张 丽,吴玉柱,徐海燕,袁 波. 盐酸特拉唑嗪口腔崩解片人体生物等效性研究[J]. 沈阳药科大学学报, 2011, 28(9): 740-744 |
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| 作者姓名： | 张 丽 吴玉柱 徐海燕 袁 波 |
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| 作者单位： | 1. 沈阳药科大学 药学院，辽宁 沈阳 110016；2. 辽宁省食品药品检验所，辽宁 沈阳 110023；3. 辽宁省药物研究院，辽宁 沈阳 110015 |
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| 摘 要： | 目的研究特拉唑嗪口腔崩解片在健康人体内的药动学行为,并以胶囊剂为参比进行生物等效性评价。方法采用液质联用(LC-MS-MS)法测定服药后受试者血浆中特拉唑嗪的质量浓度并计算主要药动学参数。结果 18名受试者口服含盐酸特拉唑嗪2 mg的受试制剂和参比制剂后,血浆中特拉唑嗪的tmax为(1.3±0.8)、(1.2±0.8)h,ρmax为(62.9±20.4)、(62.0±15.3)μg.L-1,t1/2为(10.2±1.3)、(10.7±1.3)h,AUC0-t为(556.3±162.6)、(584.2±124.2)μg.h.L-1,AUC0-∞为(576.4±169.9)、(611.7±126.5)μg.h.L-1。以AUC0-t计算,盐酸特拉唑嗪口腔崩解片中特拉唑嗪的相对生物利用度为(96.2±22.4)%。结论受试制剂和参比制剂具有生物等效性。
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| 关 键 词： | 特拉唑嗪 液质联用 药动学 生物等效性 |
| 收稿时间： | 2011-01-13 |
| 修稿时间： | 2011-03-13 |
Pharmacokinetics and bioequivalence of terazosin orally disintegrating tablets |
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| Zhang Li,Wu Yu-zhuXu Hai-yan,Yuan Bo. Pharmacokinetics and bioequivalence of terazosin orally disintegrating tablets[J]. Journal of Shenyang Pharmaceutical University, 2011, 28(9): 740-744 |
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| Authors: | Zhang Li Wu Yu-zhuXu Hai-yan Yuan Bo |
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| Affiliation: | 1. School of Pharmacy, Shenyang Pharmaceutical University, Shenyang 110016, China; 2. Liaoning institute for food and drug control, Shenyang 110023, China; 3. Liaoning institute of pharmaceutical research, Shenyang 110015, China |
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| Abstract: | Objective To study the pharmacokinetics and bioequivalence between two kinds of terazosin tablets in healthy volunteers.Methods A single oral dose of two kinds of terazosin tablets was given to 18 healthy volunteers in a randomized two-period crossover study.The concentrations of terazosin in plasma were determined by the liquid chromatography tandem mass spectrometry(LC-MS-MS).The plasma concentration-time curves were plotted and the main pharmacokinetic parameters were calculated.Results The main pharmaco... |
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| Keywords: | terazosin liquid chromatography tandem mass spectrometry pharmacokinetics bioequivalence |
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