国产氯雷他定口腔崩解片人体药动学  

Pharmacokinetics of domestic loratadine orally disintegrating tablets in Chinese healthy volunteers

作　　者：温预关[1] 莫玉泉[1] 黄锦雄[1] 马崔[1] 胡号应[1] 陈美婉[2] 刘文宪[1] 陆欣乔[1] 

机构地区：[1]广州市脑科医院国家药品临床研究基地,广东广州510370 [2]广东药学院,2005届毕业生广东广州510224

出　　处：《中国医院药学杂志》2006年第12期1481-1483,共3页Chinese Journal of Hospital Pharmacy

摘　　要：目的:研究国产氯雷他定口腔崩解片在健康人体的药动学。方法:9名健康男性志愿者单剂量口含20mg氯雷他定口腔崩解片后取静脉血,采用液质联用法(LC/MS)测定血浆中氯雷他定质量浓度,并用PKS药动学软件统计处理。结果:氯雷他定口腔崩解片药-时曲线符合二室模型,其Cmax,tmax,t1/2,AUC0-36,AUC0-∞分别为(15.0±4.8)μg.L-1,(0.78±0.19)h,(12.2±7.9)h,(27.2±9.5)μg.L-1.h,(31.4±12.2)μg.L-1.h。结论:本研究结果可为临床用药提供参考。OBJECTIVE To study the pharmacokinetics of loratadine orally disintegrating tablets in Chinese healthy volunteers. METHODS 9 male healthy subjects received a single oral dose of 20 mg loratadine orally disintegrating tablets. The plasma concentrations of loratadine was determined by an improved LC/MS method. Data of plasma level-time was disposed with PKS software. RESULTS The main pharmacokinetics parameters of loratadine was as follow.. Cmax was（15.0±4. 8）μg·L^-1 , twas （0. 78±0. 19） h,t1/2 was（12. 2±7. 9）h, AUG0-36was （27. 2 ± 9. 5） μg·L^-1 ·h,AUG0-∞ was （31.49±12. 2）μg·L^-1·h. CONCLUSION The study provides a useful information for clinical trials.

关 键 词：氧雷他定口腔崩解片 液质联用法 药动学 

分 类 号：R969.1[医药卫生—药理学]