国产非那雄胺片剂人体药动学及生物等高效性研究

傅军;李艳艳;张会杰;徐文炜;熊玉卿

中国药学杂志 ›› 2004, Vol. 39 ›› Issue (07) : 533-535.

中国药学杂志 ›› 2004, Vol. 39 ›› Issue (07) : 533-535.
论著

国产非那雄胺片剂人体药动学及生物等高效性研究

  • 傅军;李艳艳;张会杰;徐文炜;熊玉卿
作者信息 +

Studies on the pharmacokinetics and bioquivalence of domestic finasteride tablet in healthy volunteers

  • FU Jun; LI Yan-yan; ZHANG Hui-jie; XU Wen-wei; XIONG Yu-qing
Author information +
文章历史 +

摘要

目的 评价非那雄胺国产片剂和进口片剂在人体内生物等效性。方法 采用高效液相色谱紫外检测法测定20名健康受试者单剂量po10 mg非那雄胺国产或进口片剂后,血浆中非那雄胺的浓度。结果 非那雄胺国产片剂和进口片剂的AUC0~24均值分别为(840.63±140.84)和(847.51±166.96)ng·h·mL-1实测cmax均值分别为(117.17±19.74)和(117.43±18.06)ng·mL-1,实测tmax分别为(1.88 ±0.48)和(1.95±0.43)h,国产非那雄胺片剂的相对生物利用度为(100.73±15.27)%。结论 经统计学分析,供试制剂和参比制剂具有生物等效性。

Abstract

OBJECTIVE To evaluate the bioequivalence of domestic finasteride tablet and imported tablet. METHODS A single oral dose of 10 mg domestic tablet or imported tablet was given to 20 healthy volunteers in a randomized crossover study. The concentrations of finasteride were determined by HPLC method. RESULTS The main pharmacokinetic parameters of the two products were as follows:AUQ0-24(840.63±140.84) and (847.51±166.96) ng-h-mL-1, cmax(117.17±19.74) and (117.43±18.06) ng·mL-1, tmax(1.88±0.48) and (1.95±0.43)h,respectively. The relative bioavailability of domestic tablet to imported tablet was (100.73土15.27)%. There were no significant differences on the pharmacokinetic parameters between the two preparations(P>0.05). CONCLUSION The results demonstrated that the two preparations were bioequivalent.

关键词

非那雄胺 / 高效液相色谱法 / 药动学 / 生物等效性

Key words

finasteride / HPLC / pharmacokinetics / bioequivalence

引用本文

导出引用
傅军;李艳艳;张会杰;徐文炜;熊玉卿. 国产非那雄胺片剂人体药动学及生物等高效性研究[J]. 中国药学杂志, 2004, 39(07): 533-535
FU Jun;LI Yn-yn;ZHNG Hui-jie;XU Wen-wei;XIONG Yu-qing. Studies on the pharmacokinetics and bioquivalence of domestic finasteride tablet in healthy volunteers[J]. Chinese Pharmaceutical Journal, 2004, 39(07): 533-535

参考文献

[1]Constanzer ML, Matuszewski BK, Bayne WF. Highperformance liquid chromatographic method for the determination of finasteride in human plasma at therapeutic doses [J]. J Chromatogr B, 1991,566:127. [2]Giuseppe C, Pietro M. Finasteride in biological fluids:extraction and separation by a graphitized caibon black cartridge and quantification by highperformance liquid chromatography [J]. J Chromatogr B ,1997,693:245. [3]Ptacek P, Meek J, Klima J. Determination of finasteride in human plasma by quid-liquid extraction and hi^i-performance liquid chrom-atogr^jhy [J]. J Chromatogr B,2000,738 :305. [4]Joseph F. Steiner clinical pharmacokinetics and pharmacodynamics of finasteride [J]. Clin Pharmacokinet,1996,30:16.

65

Accesses

0

Citation

Detail

段落导航
相关文章

/