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Volume 33 Issue 5
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Article Navigation >  Journal of Pharmaceutical Practice and Service  > 2015  >  33(5): 419-422

ZHU Leilei, GUO Lixia, ZHAN Yan, QIU Furong, ZHAO Tongfang, YE Yujie, YUAN Wei'an, LI Anping, LI Minghua, SU Shufang, JIANG Jian. Bioequivalence study on two terazosin hydrochloride tablets[J]. Journal of Pharmaceutical Practice and Service, 2015, 33(5): 419-422. doi: 10.3969/j.issn.1006-0111.2015.05.009
Citation: ZHU Leilei, GUO Lixia, ZHAN Yan, QIU Furong, ZHAO Tongfang, YE Yujie, YUAN Wei'an, LI Anping, LI Minghua, SU Shufang, JIANG Jian. Bioequivalence study on two terazosin hydrochloride tablets[J]. Journal of Pharmaceutical Practice and Service, 2015, 33(5): 419-422. doi: 10.3969/j.issn.1006-0111.2015.05.009
shu

Bioequivalence study on two terazosin hydrochloride tablets

doi: 10.3969/j.issn.1006-0111.2015.05.009
  • 1.

    Department of Clinical Pharmacology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China

  • 2.

    Shanghai Center for Drug Metabolism and Pharmacokinetics Research, Shanghai 201203, China

  • 3.

    Shanxi Zhendong Pharmaceutical Co., Ltd., Changzhi 460000, China

  • Received Date: 2014-09-26
  • Rev Recd Date: 2015-03-31
  • Objective To evaluate the bioequivalence of domestic and imported terazosin hydrochloride tablets after single oral dose. Methods It was a single center, randomized, open, cross-over trail design, 21 subjects were fasting oral administered of 2 mg domestic and imported terazosin hydrochloride tablets in different periods, venous blood 4 ml were collected in different time points before and 60 h after administration, plasma concentration of terazosin was determined by LC-MS/MS. Results The main pharmacokinetic parameters of domestic and imported terazosin hydrochloride tablets were as follows:t1/2 : (13.2± 2.39) h vs (12.5±1.93) h, tmax: (1.01±0.83) h vs (1.08±0.69) h, Cmax: (40.1±10.6) ng/ml vs (37.3±9.57) ng/ml; AUC0- ∞: (428±82.1) ng·h/ml vs (426±85.2) ng·h/ml. The relative bioavailability of domestic terazosin hydrochloride tablets was (101.2±14.7)%. 90% CI of domestic and imported terazosin hydrochloride tablets AUC0-t and Cmax geometric mean ratio fell between 80%-125%. Conclusion The domestic tablets are bioequivalent to the imported tablets.
  • [1] 祝凌飞. 特拉唑嗪治疗良性前列腺增生疗效Meta分析[J].中国药房,2013,24(24):2279-2282.
    [2] 国家药典委员会. 中华人民共和国药典2010年版二部[S]. 北京: 中国医药科技出版社,2010: 附录195-199.
    [3] 顾逸敏,姚 蓝,刘艳梅,等.进口和国产盐酸特拉唑嗪片的人体生物等效性研究[J].药学服务与研究,2009,9(5):370-373.
    [4] 陈 钧,陆 伟,史振祺,等.两种盐酸特拉唑嗪片剂人体生物等效性评价[J].中国药学杂志,2003,38(6):446-448.
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Bioequivalence study on two terazosin hydrochloride tablets

doi: 10.3969/j.issn.1006-0111.2015.05.009
  • 1. Department of Clinical Pharmacology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China
  • 2. Shanghai Center for Drug Metabolism and Pharmacokinetics Research, Shanghai 201203, China
  • 3. Shanxi Zhendong Pharmaceutical Co., Ltd., Changzhi 460000, China
  • Received Date: 2014-09-26
  • Rev Recd Date: 2015-03-31

Abstract: Objective To evaluate the bioequivalence of domestic and imported terazosin hydrochloride tablets after single oral dose. Methods It was a single center, randomized, open, cross-over trail design, 21 subjects were fasting oral administered of 2 mg domestic and imported terazosin hydrochloride tablets in different periods, venous blood 4 ml were collected in different time points before and 60 h after administration, plasma concentration of terazosin was determined by LC-MS/MS. Results The main pharmacokinetic parameters of domestic and imported terazosin hydrochloride tablets were as follows:t1/2 : (13.2± 2.39) h vs (12.5±1.93) h, tmax: (1.01±0.83) h vs (1.08±0.69) h, Cmax: (40.1±10.6) ng/ml vs (37.3±9.57) ng/ml; AUC0- ∞: (428±82.1) ng·h/ml vs (426±85.2) ng·h/ml. The relative bioavailability of domestic terazosin hydrochloride tablets was (101.2±14.7)%. 90% CI of domestic and imported terazosin hydrochloride tablets AUC0-t and Cmax geometric mean ratio fell between 80%-125%. Conclusion The domestic tablets are bioequivalent to the imported tablets.

ZHU Leilei, GUO Lixia, ZHAN Yan, QIU Furong, ZHAO Tongfang, YE Yujie, YUAN Wei'an, LI Anping, LI Minghua, SU Shufang, JIANG Jian. Bioequivalence study on two terazosin hydrochloride tablets[J]. Journal of Pharmaceutical Practice and Service, 2015, 33(5): 419-422. doi: 10.3969/j.issn.1006-0111.2015.05.009
Citation: ZHU Leilei, GUO Lixia, ZHAN Yan, QIU Furong, ZHAO Tongfang, YE Yujie, YUAN Wei'an, LI Anping, LI Minghua, SU Shufang, JIANG Jian. Bioequivalence study on two terazosin hydrochloride tablets[J]. Journal of Pharmaceutical Practice and Service, 2015, 33(5): 419-422. doi: 10.3969/j.issn.1006-0111.2015.05.009
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