中国临床药理学杂志2011，Vol.27Issue(11)：859-861,3.
扎鲁司特胶囊在健康人体的生物等效性
Bioequivalence of zafirlukast capsules in healthy volunteers
袭荣刚 1王晓波 1刘丹 1刘玮 2王玉娟 2宋冬梅 3徐鹏久3
作者信息
- 1. 解放军第210医院国家药物临床试验机构,辽宁大连 116021
- 2. 海南通用三洋药业有限公司,海口 570312
- 3. 沈阳亿灵医药科技有限公司,沈阳 110179
- 折叠
摘要
Abstract
Objective To evaluate the bioequivalence of zafirlukast capsules and zafirlukast tablets in healthy volunteers. Methods A single o-ral dose of 20 mg test(capsule) and reference(tablets) preparations were given to 20 healthy volunteers in a randomized crossover study. Zafirlukast concentrations in plasma were determined by HPLC - MS - MS methods. The pharmacokinetic parameters were calculated. Results The main pharmacokinetic parameters of the domestic and imported were as follows: tmax were ( 1. 50 ± 0. 76 ) , (1. 63 ± 0. 48 ) h; Cmax were (505. 34 ±208. 73), (449. 62 ± 191. 80) ng · mL-1; t1/2 were (7. 60 ± 4. 87), (7. 36 ±4. 50) h;AUC0_48 were (1362 ±534),(1260±581) ng · H · mL-1; AUC0-∞ were (1371 ±537),(1268 ±588) ng · H · mL-1, respectively. The relative bioavailability of zafirlukast capsules to imported zafirlukast tablets was (113. 6 ±29. 7)%. Conclusion The results demonstrated that the two preparations were bioequivalent.关键词
扎鲁司特/生物等效性/高效液相色谱-串联质谱Key words
zafirlukast/ bioequivalence/ HPLC - MS - MS分类
医药卫生引用本文复制引用
袭荣刚,王晓波,刘丹,刘玮,王玉娟,宋冬梅,徐鹏久..扎鲁司特胶囊在健康人体的生物等效性[J].中国临床药理学杂志,2011,27(11):859-861,3.
