| 伊曲康唑分散片人体生物等效性研究 |
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| 引用本文： | 包丽昕,郭满芳,尹政元.伊曲康唑分散片人体生物等效性研究[J].中国伤残医学,2009,17(6). |
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| 作者姓名： | 包丽昕 郭满芳 尹政元 |
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| 作者单位： | 1. 哈尔滨三联药业有限公司,黑龙江,哈尔滨,150025
2. 哈尔滨世一堂制药厂 |
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| 摘 要： | 目的:评价国产伊曲康唑片人体生物利用度和生物等效性。方法:22名健康男性受试者随机交叉口服伊曲康唑分散片和伊曲康唑胶囊,采用液相色谱-质谱-质谱联用法测定血浆中伊曲康唑的浓度,结果:受试药物和参比药物的药代动力学主要参数分别为:Tmax:4.55±0.83和4.25±1.02h;Cmax:170.7±70.8和155.5±73.3ng/ml;t1/2:19.3±4.6和20.4±11.4h;AUC0-t:2385±1281和2257±1168ng.h/ml,AUC0-∞:2496±1334和2371±1207ng.h/ml。以AUC0-t计算,伊曲康唑分散片的相对生物利用度平均为112.5±39.2%。结论:伊曲康唑分散片和伊曲康唑胶囊生物等效。
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| 关 键 词： | 伊曲康唑 生物等效性 液相色谱-质谱-质谱 |
Study on Relative bioavailalility and bilequiralence of Itraconazsle Dispersible Tablets |
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| BAO Li-xin,GUO Man-fang,YIN Zheng-yuan.Study on Relative bioavailalility and bilequiralence of Itraconazsle Dispersible Tablets[J].Chinese JOurnal of Trauma and Disability Medicine,2009,17(6). |
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| Authors: | BAO Li-xin GUO Man-fang YIN Zheng-yuan |
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| Abstract: | Objective:To evaluate relative bioavailability and bioequivalence of itraconazole dispersible tablets.Methods:The bioavailability and bioequivalence of Itraconazole Dispersible Tablets in cross-over trial in 22 healthy volunteers after oral admintrarion of itraconazole dispersible tablets and itraconazole capsules,drug concentration in plasma was assayed by HPLC/MS/MS.Results:The main pharmacokinetic parameters for the test product and referenc product showed Tmax :4.55±0.83 and 4.25±1.02h;Cmax:170.7±70.8 and 155.5±73.3ng/ml;t1/2:19.3±4.6 and 20.4±11.4h;AUC0-t:2385±1281 and 2257±1168 ng.h/ml,AUC0-∞:2496±1334 and 2371±1207 ng.h/ml。Conclusion:The two formulations should be bioequivalent. |
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| Keywords: | Itraconazole Bioavailability HPLC/MS/MS |
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