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| 非那雄胺2种片剂的药动学和相对生物利用度比较 | |
| 引用本文： | 张国庆,柴逸峰,张银娣,王彬,沈建平,王慧,赵亮.非那雄胺2种片剂的药动学和相对生物利用度比较[J].中国新药与临床杂志,2004,23(10):684-686. |
| 作者姓名： | 张国庆 柴逸峰 张银娣 王彬 沈建平 王慧 赵亮 |
| 作者单位： | 1. 中国人民解放军第二军医大学东方肝胆外科医院,药材科,上海,200438 2. 中国人民解放军第二军医大学,药学院,上海,200433 3. 南京医科大学,临床药理室,江苏,南京,210029 4. 中国人民解放军第二军医大学东方肝胆外科医院,药材科,上海,200438;中国人民解放军第二军医大学,药学院,上海,200433 |
| 摘 要： | 目的 :比较非那雄胺 2种片剂在健康受试者体内的药动学和相对生物利用度。方法 :2 0名男性健康受试者随机交叉口服非那雄胺受试片与参比片 ,剂量均为 5mg ,采用液相色谱 质谱联用技术测定血浆中非那雄胺浓度。结果 :非那雄胺受试片和参比片的主要药动学参数Cmax为 (5 0±s 11)和 (5 3± 12 ) μg·L- 1,Tmax为 (2 .4± 0 .8)和 (2 .3± 0 .8)h ,T1/2 为 (6 .2± 0 .9)和 (6 .4± 0 .7)h ,AUC0 2 4 为 (317± 91)和 (30 7± 86 ) μg·h·L- 1。非那雄胺受试片对参比片的相对生物利用度为 (10 4± 14 ) %。结论 :双单侧t检验显示 2种片剂生物等效 |
| 关 键 词： | 非那雄胺 片剂 药动学 生物利用度 液相色谱法 光谱分析 质量 |
| 文章编号： | 1007-7669(2004)10-0684-03 |
Comparison of pharmacokinetics and relative bioavailabilities of two kinds of finasteride tablets |
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| ZHANG Guo-qing ,CHAI Yi-feng ,ZHANG Yin-di ,WANG Bin ,SHEN Jian-ping ,WANG Hui ,ZHAO Liang.Comparison of pharmacokinetics and relative bioavailabilities of two kinds of finasteride tablets[J].Chinese Journal of New Drugs and Clinical Remedies,2004,23(10):684-686. | |
| Authors: | ZHANG Guo-qing CHAI Yi-feng ZHANG Yin-di WANG Bin SHEN Jian-ping WANG Hui ZHAO Liang |
| Institution: | ZHANG Guo-qing 1,CHAI Yi-feng 2,ZHANG Yin-di 3,WANG Bin 1,2,SHEN Jian-ping 3,WANG Hui 1,ZHAO Liang 1 |
| Abstract: | AIM: To compare the bioavailabilities and pharmacokinetics of two kinds of finasteride tablet in healthy volunteers. METHODS: According to the random crossover design, 20 male healthy volunteers administrated two kinds of finasteride tablets 5 mg . The plasma concentrations of finasteride were determined by LC-MSD. RESULTS: The pharmacokinetic parameters of the test and reference tablets were (50±s 11) and (53±12) μg·L -1 for C max,(2.4±0.8) and (2.3±0.8)h for T max, (6.2±0.9) and (6.4±0.7) h for T 1/2,(317±91) and (307±86) μg·h·L -1 for AUC 0-24. The relative bioavailability of the test tablet was (104±14)%. CONCLUSION: Two kinds of finasteride tablets are bioequivalent in healthy volunteers. |
| Keywords: | finasteride tablets pharmacokinetics biological availability liquid chromatography spectrum analysis mass |
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