医药导报2011，Vol.30Issue(11)：1432-1434,3.DOI:10.3870/yydb.2011.11.009
烟酸缓释片的生物等效性研究
Study on Bioequivalence of Nicotinic Acid Sustained-Release Tablets
舒成仁 1邓彬 2周雪苹 1黎维勇2
作者信息
- 1. 湖北省黄石市中心医院药剂科,435000
- 2. 华中科技大学同济医学院附属协和医院药剂科,武汉,430022
- 折叠
摘要
Abstract
Objective To establish a method for determination of nicotinic acid in human plasma and study its bioequivalence in Chinese healthy volunteers. Methods Thirty healthy volunteers were orally administered with 1 500 mg nicotinic acid ( test) tablets in a randomized crossover design. The drug levels in plasma samples were determined by a HPLC-MS/MS method. Results The main pharmacokinetic parameters of the test and reference preparations were as follows: AUC0→15 was ( 20 046. 1 ± 16 286. 8 ), ( 21 605. 0 ± 18 058. 5 ) ng ? H ? Ml/-1 , AUC0→ was ( 20 806. 0 ± 16 300. 7 ) and ( 22 811. 2±18 468.3 ) ng ? H ? Ml/-1 ; Cmax was ( 8 716. 3±6 811. 2 ) and ( 9 570. 2±8 217. 1 ) ng ? Ml/-1 ;tmax was ( 4. 414± 1. 337 ) and ( 4. 310±l. 285 ) h;t1/2 was ( 4. 000±4. 898 ) and ( 2. 906±3. 393 ) h. The relative bioavailability of the test tablet was ( 96. 6±30. 9 ) % . Conclusion The domestically made nicotinic acid tablets and those imported are bioequivalent.关键词
烟酸/药动学/生物等效性/高效液相色谱-质谱串联法Key words
Nicotinic acid/ Pharmacokinetics/ Bioequivalence/ HPLC-MS/MS分类
医药卫生引用本文复制引用
舒成仁,邓彬,周雪苹,黎维勇..烟酸缓释片的生物等效性研究[J].医药导报,2011,30(11):1432-1434,3.
