医药导报2011，Vol.30Issue(5)：584-586,3.DOI:10.3870/yydb.2011.05.009
奥美拉唑肠溶胶囊的人体相对生物利用度与生物等效性研究
Relative Bioavailability and Bioequivalence of Omeprazole Enteric-coated Capsules in Healthy Volunteers
刘红梅 1王智勇 1赵红光 1杜霞 1董迪 1宋笑丹 1吴琳华1
作者信息
- 1. 哈尔滨医科大学附属第二临床医院药学部,150086
- 折叠
摘要
Abstract
Objective To set up a method of content determination for omeprazole in human plasma by HPLC and study the pharmacokinetics and relative bioavailability of omeprazole enteric-coated capsules.Methods A single dose of reference and test omeprazole enteric-coated capsules was given to 20 healthy volunteers, respectively, in a randomized 2-way cross-over study.The plasma concentration of omeprazole was determined by HPLC and their pharmacokinetics as well as relative bioavailability was measured.Results The main pharmacokinetic parameters of two formulations, reference and test ones were as follows: Cmax were( 906.01 ±589.55 )and( 875.87±662.95 )ng · mL -1, tmax were( 2.21±0.88 )and( 2.07±0.87 )h,AUC 0-12 were( 1 778.70±1 164.11 )and( 1 834.25±1 342.25 )ng · h · mL-1; t1/2 Ke were( 0.96±0.25 )and( 0.85±0.18 )h.The relative bioavailability of F0→12 was( 104.02 ± 13.60 )％.Conclusion The two kinds of omeprazole enteric-coated capsules are bioequivalent.关键词
奥美拉唑/生物利用度,相对/生物等效性/色谱法,高效液相分类
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刘红梅,王智勇,赵红光,杜霞,董迪,宋笑丹,吴琳华..奥美拉唑肠溶胶囊的人体相对生物利用度与生物等效性研究[J].医药导报,2011,30(5):584-586,3.
