| 辛伐他汀片人体药代动力学及相对生物利用度的研究 |
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| 引用本文： | 杨永革,邸晓辉,李广富,许雪廷,刘静.辛伐他汀片人体药代动力学及相对生物利用度的研究[J].华北国防医药,2008,20(3):62-64. |
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| 作者姓名： | 杨永革 邸晓辉 李广富 许雪廷 刘静 |
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| 作者单位： | 北京军区总医院药理科;扬子江药业集团有限公司;北京军区总医院药理科 北京;江苏泰州; |
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| 摘 要： | 目的:评价2种辛伐他汀片的相对生物利用度和生物等效性.方法:选择18名健康受试者随机分为2组,先后予单剂量、交叉口服辛伐他汀受试制剂和参比制剂各40 mg,采用液相色谱-质谱-质谱联用法测定给药后不同时间受试者血浆中辛伐他汀的浓度,对辛伐他汀受试制剂和参比制剂进行生物等效性评价.结果:辛伐他汀受试制剂和参比制剂的主要药代动力学参数:cmax分别为(9.70±6.62)及(10.06±6.29) μg/L;tmax分别为(1.64±1.01)及(1.64±0.68)h;t1/2分别为(3.48±1.16)及(4.15±1.90)h;AUC0～14h分别为(29.96±16.28)及(32.78±18.53)μg·h·L-1;AUC0～∞分别为(31.49±16.65)及(36.39±21.71) μg·h·L-1.受试制剂的相对生物利用度为(97.79±26.63)%.结论:2种制剂具有生物等效性.
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| 关 键 词： | 辛伐他汀 液相色谱-质谱-质谱 生物利用度 药代动力学 |
Pharmacokinetics and Relative Bioavailability of Simvastatin Tablets in Healthy Volunteers |
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| YANG Yong-ge,DI Xiao-hui,LI Guang-fu,XU Xue-ting,LIU Jing.Pharmacokinetics and Relative Bioavailability of Simvastatin Tablets in Healthy Volunteers[J].Medical Journal of Beijing Military Region,2008,20(3):62-64. |
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| Authors: | YANG Yong-ge DI Xiao-hui LI Guang-fu XU Xue-ting LIU Jing |
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| Institution: | YANG Yong-ge1,DI Xiao-hui1,LI Guang-fu2,XU Xue-ting1,LIU Jing1(1.Department of Pharmacology,General Hospital of Beijing Military Area,Beijing 100700,China,2.Yangzijiang Pharmaceutical Corporation LTD,Taizhou,Jiangsu 225321,China) |
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| Abstract: | Objective:To establish LC/MS/MS method for determination of Simvastatin in plasma and to study the pharmacokinetics and relative bioavailability following oral administration of trail Simvastatin tablets and reference simvastatin tablets in Chinese healthy volunteers.Methods:Eighteen volunteers were randomly divided into 2 groups.A LC-MS-MS method was used for the determination of Simvastatin in plasma after a single oral dose of 40 mg Simvastatin trail or reference samples in a crossover design.The pharmac... |
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| Keywords: | Simvastatin LC-MS-MS Bioavailability Pharmacokinetics |
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