HPLC/MS法研究国产氯雷他定片的人体生物等效性  

Bioequivalence of domestic loratadine tablets in healthy volunteers by HPLC/MS

作　　者：孙春华[1] 刘蕾[1] 赫广威[1] 殷琦[1] 史爱欣[1] 李可欣[1] 

机构地区：[1]卫生部北京医院临床药理基地,北京100730

出　　处：《中国临床药理学杂志》2004年第4期287-290,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：目的评价国产及进口氯雷他定片的生物等效性。方法用随机交叉试验方法,18名受试者按体重指数进行分层,随机服用氯雷他定片试验制剂或参比制剂。结果试验制剂与参比制剂的tmax分别为1.3±0.2和1.3±0.3h,Cmax分别为:38.47±17.41和39.03±18.33mg.L-1,用梯形法计算所得的AUC0-t分别为:139.19±49.03和144.33±65.66ng.h.mL-1,氯雷他定试验制剂的相对生物利用度为(100.7±13.6)%。结论2制剂具有生物等效性。Objective To evaluate bioequivalence of domestic and importedloratadine tablets in healthy male volunteers. Methods A single oral domestic andimported loratadine tablets were given according to a randomized 2 way crossoverdesign. Plasma loratadine was determined by HPLC/MS. Results Thepharmacokinetic parameters of test and reference were as follow: tmax were: 1.3±0.2 and 1.3±0.3h,Cmax were: 38.47±17.41and 39.03±18.33ng.h.mL-1,AUC0-twere : 139.19±49.03 and 144.33±65.66ng.h.mL-1 ,respectively. The relativebioavaiability of domestic were (100.7±13.6)%. Conclusion The result demonstratedthat two formations of loratadine were bioequivalence by analysis of variance,two-one sided test and 90% confidential internal .

关 键 词：氯雷他定 高效液相色谱/质谱 药代动力学 生物等效性 

分 类 号：R969.1[医药卫生—药理学] R972.6[医药卫生—药学]