| 非那雄胺片的人体生物等效性研究 |
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| 引用本文： | 高晨,赵志刚,余立,庞青云,王成刚,李文东,李冬梅,朱立,邵微,王景田.非那雄胺片的人体生物等效性研究[J].中国药房,2005,16(10):760-762. |
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| 作者姓名： | 高晨 赵志刚 余立 庞青云 王成刚 李文东 李冬梅 朱立 邵微 王景田 |
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| 作者单位： | 1. 北京天坛医院药剂科,北京市,100050
2. 北京市药品检验所,北京市,100035 |
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| 摘 要： | 目的:研究国产与进口非那雄胺片的人体生物等效性。方法:采用高效液相色谱法测定18名健康男性志愿者随机交叉单剂量口服非那雄胺片10mg后血清中的药物浓度,计算药动学参数和相对生物利用度,并进行生物等效性评价。结果:国产及进口非那雄胺片的AUC0～t 分别为(990 .80±302. 80)、(1007 .46±333. 65) (μg·h)/L ,Cmax 分别为(119. 22±18. 48)、(114. 08±22 .97) μg/L ,tmax 分别为(2. 89±1. 02)h、(2. 64±0. 54)h ,国产制剂相对于进口制剂的人体生物利用度为(103. 35±29 .75) %。结论:国产与进口非那雄胺片具有生物等效性。
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| 关 键 词： | 非那雄胺 高效液相色谱法 生物等效性 |
| 文章编号： | 1001-0408(2005)10-0760-03 |
| 修稿时间： | 2004年7月9日 |
Study on Bioequivalence of Finasteride Tablets in Human Body |
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| GAO Chen,ZHAO Zhigang,YU Li,PANG Qingyun,WANG Chenggang,Li Wendong,Li Dongmei,ZHU Li,SHAO Wei,WANG Jingtian.Study on Bioequivalence of Finasteride Tablets in Human Body[J].China Pharmacy,2005,16(10):760-762. |
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| Authors: | GAO Chen ZHAO Zhigang YU Li PANG Qingyun WANG Chenggang Li Wendong Li Dongmei ZHU Li SHAO Wei WANG Jingtian |
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| Abstract: | OBJECTIVE:To study the human body bioequivalence of finasteride tablets from both domestic and imˉport.METHODS:The serum concentration of18volunteers were determined by HPLC after a random cross single oral dose of10mg of finasteride tablets,the pharmacokinetic parameters and the relative bioavailability were calculated and the bioequivaˉlence was evaluated as well.RESULTS:For the domestic and the import finasteride tablets,the AUC (0～t) of which were(990.80±302.80)(μg·h)/L and(1007.46±333.65)(μg·h)/L respectively,the C max of which were(119.22±18.48)μg/L and(114.08±22.97)μg/L respectively,the t max of which were(2.89±1.02)h and(2.64±0.54)h respectively,the relative bioavailability of the domestic preparation was(103.35%±29.75)%of the imported one.CONCLUSION:The domestic and import finasteride tablets were of bioequivalence. |
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| Keywords: | Finasteride HPLC Bioequivalence |
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