盐酸利托君片在中国健康人体的生物等效性  

Bioequivalence of ritodrine hydrochloride tablets in Chinese healthy volunteers

作　　者：张佳丽[1] 吴华[1] 潘世芬[1] 王鹤尧[1] 

机构地区：[1]首都医科大学附属北京朝阳医院药事部,北京100020

出　　处：《中国临床药理学杂志》2012年第2期128-130,134,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：目的评价2种国产盐酸利托君片在中国健康人体的生物等效性。方法22名健康女性受试者随机交叉单剂量口服盐酸利托君片试验药物或对照药物,各10 mg。用高效液相色谱-串联质谱法测定血浆中盐酸利托君浓度;用DAS2.0软件计算药代动力学参数,并对2种药物进行生物等效性评价。结果试验药物和对照药物的主要药代动力学参数:Cmax分别为(5.71±1.83)和(5.61±2.03)ng.mL-1;Tmax分别为(0.54±0.45)和(0.46±0.24)h;t1/2分别为(3.64±3.99)和(4.25±4.02)h;AUC0-t分别为(12.31±5.20)和(12.01±5.42)h.ng.mL-1。AUC0-t、AUC0-∞、Cmax的90%可信区间分别为95.8%～111.6%、92.3%～118.9%和95.4%～108.2%。试验药物相对于对照药物的生物利用度F为(105.3±19.96)%。结论试验药物和对照药物生物等效。Objective To evaluate the bioequivalence of two preparations of ritodrine hydrochloride tablets.Methods A single oral dose of 10 mg test and reference ritodrine hydrochloride tablets were given to 22 female healthy volunteers in a randomized crossover study.The concentrations of ritodrine hydrochloride were determined by HPLC-MS /MS method.The pharmacokinetic paramters and relative bioavailability were calculated by DAS 2.0 software,then the bioequivalence was judged.Results The main pharmacokinetic parameters of two preparations were as follows： Cmax were（5.71±1.83）,（5.61±2.03） ng·mL-1,Tmax were（0.54±0.45）,（0.46±0.24） h,t1/2 were（3.64±3.99）,（4.25±4.02） h,AUC0-t were（12.31±5.20）,（12.01±5.42） h·ng·mL-1,respectively.The relative bioavailability of test tablets was（105.3±19.96）%.The 90% CIs for the ratios of AUC0-t,Cmax were 95.8%-111.6%,95.4%-108.2%,respectively.Conclusion The results demonstrated that the two preparations were bioequivalent.

关 键 词：盐酸利托君片 生物等效性 药代动力学 高效液相色谱-串联质谱 

分 类 号：R969.1[医药卫生—药理学] R984[医药卫生—药学]