国产氯雷他定片人体生物等效性研究  

Study on the bioequivalence of domestic loratadine in healthy volunteers

作　　者：刘宇[1] 毛郴[1] 何海霞[1] 周远大[1] 

机构地区：[1]重庆医科大学临床学院药剂科,重庆400016

出　　处：《重庆医科大学学报》2003年第5期614-616,652,共4页Journal of Chongqing Medical University

摘　　要：目的 :2 0名健康男性受试者随机交叉口服 2 0mg西南合成制药总厂研制的氯雷他定片 (LORAX)与上海先灵葆雅制药有限公司生产的氯雷他定片 (开瑞坦 ,LORAS)进行药代动力学和生物等效性研究。方法 :采用高效液相色谱法测定血中氯雷他定浓度。结果 :经 3p97程序拟合和计算 ,LORAX和LORAS的Cmax为 8.5 9± 6 .70和 9.5 9± 8.2 2ng/ml;Tmax为 1.0 8±0 .4 1和 1.2 1± 0 .2 8h ;AUC0 -t为 2 7.2 9± 2 4 .5 4和 2 7.12± 2 0 .6 4ng·h/ml。 结论 :经方差分析和双单侧检验 ,结果表明两者具有生物等效性 ,LORAX片的相对生物利用度为 10 0 .6 3± 14 .2 7%。Objective:To study the bioequivalence and pharmacokinetics of two kinds of loratadine tablets in 20 healthy volunteers.Methods:An oral dose of 20mg of test or reference loratadine tablets was given according to a randomized 2-way cross-over design,blood samples were withdrawn up to 12 hours past administration,and plasma concentration of loratadine was determined by HPLC method.Results:The peak plasma levels (C max ) of loratadine test drug and reference drug were 8.59±6.70 or 9.59±8.22ng/ml respectively. The peak time (T max ) were 1.08±0.41 or 1.21±0.28h respectively,and AUC 0-t were 27.29±25.54 or 27.12±20.64ng·h/ml respectively.Conclusion:The result of statistic analysis and tow one-sided test suggest that the domestic loratadine talbet is bioequivalent to the imported tablet.The relative bioavailability of domestic loratadine tablets is 100.63%±14.27%.

关 键 词：氯雷他定 生物等效性 高效液相色谱法 

分 类 号：R969.1[医药卫生—药理学]