两种盐酸特拉唑嗪片的人体生物等效性研究

朱蕾蕾; 郭丽霞; 詹燕; 裘福荣; 赵彤芳; 叶宇婕; 元唯安; 李安平; 李明花; 苏淑芳; 蒋健

doi:10.3969/j.issn.1006-0111.2015.05.009

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两种盐酸特拉唑嗪片的人体生物等效性研究

朱蕾蕾, 郭丽霞, 詹燕, 裘福荣, 赵彤芳, 叶宇婕, 元唯安, 李安平, 李明花, 苏淑芳, 蒋健

文章导航 > 药学实践与服务 > 2015 > 33(5): 419-422

朱蕾蕾, 郭丽霞, 詹燕, 裘福荣, 赵彤芳, 叶宇婕, 元唯安, 李安平, 李明花, 苏淑芳, 蒋健. 两种盐酸特拉唑嗪片的人体生物等效性研究[J]. 药学实践与服务, 2015, 33(5): 419-422. doi: 10.3969/j.issn.1006-0111.2015.05.009

引用本文:

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

两种盐酸特拉唑嗪片的人体生物等效性研究

doi: 10.3969/j.issn.1006-0111.2015.05.009

1.
上海中医药大学附属曙光医院临床药理科, 上海 201203
2.
上海药物代谢研究中心, 上海 201203
3.
山西振东制药股份有限公司, 山西长治 460000

基金项目: "十二五"重大新药创制《创新药物研究开发技术平台建设》(2012ZX09303009-001);上海市进一步加快中医药事业发展三年行动计划(2014-2016年)中医药专门人才计划(ZY3-RCPY-3-1059)

Bioequivalence study on two terazosin hydrochloride tablets

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

摘要: 目的评价单剂量口服国产和进口盐酸特拉唑嗪片的人体生物等效性。方法采用单中心、随机、开放、双周期交叉试验设计,21名受试者在不同周期分别空腹口服国产和进口盐酸特拉唑嗪片2 mg,于给药前0 h及给药后60 h内不同时间点采集静脉血4 ml,采用液-质联用(LC-MS/MS)法测定受试者血浆中特拉唑嗪的浓度。结果国产和进口盐酸特拉唑嗪片的t_1/2分别为(13.2±2.39)和(12.5±1.93) h;t_max分别为(1.01±0.83)和(1.08±0.69) h;C_max分别为(40.1±10.6)和(37.3±9.57) ng/ml;AUC_0-∞分别为(428±82.1)和(426±85.2) ng·h/ml。国产盐酸特拉唑嗪片的相对生物利用度为(101.2±14.7)%。国产与进口盐酸特拉唑嗪片AUC_0-t和C_max几何均值比的90%置信区间(CI)均落在80%~125%之间。结论国产和进口盐酸特拉唑嗪片具有生物等效性。
- 盐酸特拉唑嗪 /
- 液-质联用 /
- 生物等效性
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:t_1/2 : (13.2± 2.39) h vs (12.5±1.93) h, t_max: (1.01±0.83) h vs (1.08±0.69) h, C_max: (40.1±10.6) ng/ml vs (37.3±9.57) ng/ml; AUC_{0- ∞}: (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 AUC_0-t and C_max geometric mean ratio fell between 80%-125%. Conclusion The domestic tablets are bioequivalent to the imported tablets.
- terazosin hydrochloride /
- LC-MS/MS /
- bioequivalence

[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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两种盐酸特拉唑嗪片的人体生物等效性研究

doi: 10.3969/j.issn.1006-0111.2015.05.009

1. 上海中医药大学附属曙光医院临床药理科, 上海 201203

2. 上海药物代谢研究中心, 上海 201203

3. 山西振东制药股份有限公司, 山西长治 460000

收稿日期: 2014-09-26
修回日期: 2015-03-31

关键词:

盐酸特拉唑嗪 /

液-质联用 /

生物等效性

摘要: 目的评价单剂量口服国产和进口盐酸特拉唑嗪片的人体生物等效性。方法采用单中心、随机、开放、双周期交叉试验设计,21名受试者在不同周期分别空腹口服国产和进口盐酸特拉唑嗪片2 mg,于给药前0 h及给药后60 h内不同时间点采集静脉血4 ml,采用液-质联用(LC-MS/MS)法测定受试者血浆中特拉唑嗪的浓度。结果国产和进口盐酸特拉唑嗪片的t_1/2分别为(13.2±2.39)和(12.5±1.93) h;t_max分别为(1.01±0.83)和(1.08±0.69) h;C_max分别为(40.1±10.6)和(37.3±9.57) ng/ml;AUC_0-∞分别为(428±82.1)和(426±85.2) ng·h/ml。国产盐酸特拉唑嗪片的相对生物利用度为(101.2±14.7)%。国产与进口盐酸特拉唑嗪片AUC_0-t和C_max几何均值比的90%置信区间(CI)均落在80%~125%之间。结论国产和进口盐酸特拉唑嗪片具有生物等效性。

English Abstract

Bioequivalence study on two terazosin hydrochloride tablets

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

Keywords:

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:t_1/2 : (13.2± 2.39) h vs (12.5±1.93) h, t_max: (1.01±0.83) h vs (1.08±0.69) h, C_max: (40.1±10.6) ng/ml vs (37.3±9.57) ng/ml; AUC_{0- ∞}: (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 AUC_0-t and C_max geometric mean ratio fell between 80%-125%. Conclusion The domestic tablets are bioequivalent to the imported tablets.

引用本文:

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