| 非那雄胺片人体药代动力学及生物等效性研究 |
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| 引用本文： | 栾蓉,赵旻,刘颖,赵春杰.非那雄胺片人体药代动力学及生物等效性研究[J].中国药业,2011,20(1):15-16. |
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| 作者姓名： | 栾蓉 赵旻 刘颖 赵春杰 |
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| 作者单位： | 1. 山东省济南市卫生局信息化服务中心,山东,济南,250001
2. 沈阳药科大学药学院,辽宁,沈阳,110016 |
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| 摘 要： | 目的 研究单剂量口服非那雄胺片后的血药浓度经时过程,并进行生物等效性评价.方法 采用自身交叉试验方法,18名健康志愿者分别单剂量口服非那雄胺片受试制荆和参比制荆各30 mg,采用高效液相色谱法测定血浆中药物浓度.结果 受试制剂与参比制剂的血药浓度-时间曲线基本一致,主要药代动力学参数达峰时间(Tman)分剐为(3.56±0.51)h和(3.56±0.51)h,峰浓度(Cman)分别为(549.69±48.98)ng/mL和(549.85±70.02)ng/mL,消除半衰期(t1/2)分别为(4.45±0.54)h和(4.58±0.53)h,0～24 h药时曲线下面积(AUC0-24)分别为(3177.57±362.55)ng/(h·mL)和(3223.84±446.14)ng/(h·mL),0～∞药时曲线下面积(AUC0～∞)分别为(3315.42±387.57)ng/(h·mL)和(3372.50±473.23)ng/(h·mL),受试制剂的相对生物利用度为(99.11±7.97)%.结论 两种制剂具有生物等效性.
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| 关 键 词： | 非那雄胺 药代动力学 生物利用度 高效液相色谱法 |
Pharmacokinetics and Relative Bioequivalence of Finasteride Tablets in Healthy Volunteers |
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| Luan Rong,Zhao Min,Liu Ying,Zhao Chunjie.Pharmacokinetics and Relative Bioequivalence of Finasteride Tablets in Healthy Volunteers[J].China Pharmaceuticals,2011,20(1):15-16. |
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| Authors: | Luan Rong Zhao Min Liu Ying Zhao Chunjie |
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| Institution: | Luan Rong1,Zhao Min2,Liu Ying2,Zhao Chunjie2(1.Information Service Center,Jinan Public Health Bureau,Jinan,Shandong,China 250001,2.Pharmacy College,Shenyang Pharmaceutical University,Shenyang,Liaoning,China 110016) |
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| Abstract: | Objective To investigate the concentration-time profile and the relative bioequivalence of test Finasteride Tablets.Methods The test and reference tablets with a single oral dose of 30 mg finasteride were given to 18 healthy volunteers respectively,in a randomized,cross-over study.Serum concentrations of finasteride were determined by HPLC.Results The concentration-time profile of the test tablets was well fitted to that of the reference tablets.The main pharmacokinetic parameters of the test and reference ... |
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| Keywords: | finasteride pharmacokinetics bioavailability HPLC |
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