| 盐酸曲马多缓释片的相对生物利用度研究 |
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| 引用本文： | 葛庆华,王浩,张小红,刘戈,周臻. 盐酸曲马多缓释片的相对生物利用度研究[J]. 中国医药工业杂志, 2001, 32(1): 14-17 |
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| 作者姓名： | 葛庆华 王浩 张小红 刘戈 周臻 |
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| 作者单位： | 药物制剂国家工程研究中心, |
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| 摘 要： | 18名男性健康受试者，随机交叉口服两种盐酸曲马多缓释片，采用反相高效液相色谱-荧光检测法测定血浆药物浓度。单剂量口服100mg两种缓释片的C
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| 关 键 词： | 盐酸曲马多 缓释片 相对生物利用度 HPLC 镇痛药 |
| 文章编号： | 1001-8255(2001)01-0014-04 |
| 修稿时间： | 1999-11-28 |
Relative Bioavailabilityof Sustained Release Tablets of Tramadol Hydrochloride |
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| GE Qing-hua,WANG Hao,ZHANG Xiao-Hong,LIU Ge,ZHOU Zhen. Relative Bioavailabilityof Sustained Release Tablets of Tramadol Hydrochloride[J]. , 2001, 32(1): 14-17 |
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| Authors: | GE Qing-hua WANG Hao ZHANG Xiao-Hong LIU Ge ZHOU Zhen |
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| Abstract: | The pharmacokinetics and relative bioavailability of two brands of sustained release tramadol hydrochloride tablets administrated orally by 18 healthy male volunteers were investigated, according to a randomized crossover design. The plasma concentration of tramadol hydrochloride was determined by RP-HPLC method with fluorescence detection. The pharmacokinetic parameters for the single oral dose of 100 mg sustained release tramadol hydrochloride tablets were Cmax 205.0±51.3 and 193.5±44.0 ng/ml; Tmax 5.6±2.1 and 5.8±2.6 h;t1/2 7.3±2.6 and 7.3±2.8 h, for tested and reference tablets, respectively. The relative bioavailability for the tested tablets was 97.36±10.01%. For the multiple dosing, the concentration peak-trough ratio (PTR) were 1.42±0.17 and 1.44±0.22, the degree of fluctuation (DF) were 36.09±12.78 and 34.37±14.22%, respectively. The results of two-one-sided t test showed that the tablets of two brands were bioequivalent. |
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| Keywords: | tramadol hydrochloride sustained release tablets bioavailability HPLX |
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