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目的：建立液质联用方法测定人血浆中非那雄胺的浓度。方法：采用自身对照交叉给药方式,单剂量分别给予20名男性健康志愿者2种非那雄胺片2 mg,用乙酸乙酯提取血浆中非那雄胺后由C_(18)柱分离,质谱检测器测定。结果：该法线性范围为0．3～50μg·L~(-1)(r=0．9992),方法回收率在98．39%～104．76%之间,日内和日间精密度都小于10%。其主要药动学参数c_(max)为(22±4)和(22±5)μg·L~(-1),AUC_(0～24)为(125±27)和(127±30)μg·h·L~(-1),t_(1/2)为(4．4±0．6)和(4．5±0．5)h；t_(max)为(3．0±0．7)和(2．8±0．9)h。结论：2种制剂间的主要动力学参数无明显差异,为生物等效制剂,其相对生物利用度为(99．3±9．2)%。
Objective: To establish a liquid chromatography-mass spectrometry method for the determination of finasteride in human plasma. Methods: Two kinds of finasteride tablets of 20 male healthy volunteers were given 2 mg respectively by self - control cross - administration mode. The plasma finasteride was extracted with ethyl acetate and separated by C18 column. Mass spectrometry detector. Results: The linear range of this method was 0.3 ~ 50μg · L -1 (r = 0.9992). The recoveries of the method ranged from 98.39% to 104.76%. The intra- and inter-day precision Less than 10%. The main pharmacokinetic parameters were (22 ± 4) and (22 ± 5) μg · L -1 and (125 ± 27) and (127 ± 30) μg · L -1 for AUC 0-24. · H · L ~ (-1), t_ (1/2) was (4.4 ± 0.6) and (4.5 ± 0.5) h, t_ (max) was (3.0 ± 0) 7) and (2.8 ± 0.9) h. Conclusion: There is no significant difference in the main kinetic parameters between the two preparations. The bioavailability of the two preparations is (99.3 ± 9.2)%.