孟鲁斯特钠咀嚼片在健康人体内药动学和生物等效性

目的:研究两种(仿制新药与市售)孟鲁司特钠咀嚼片在人体内生物等效性。方法:采用单中心、随机、开放、双周期自身交叉试验设计,20名健康男性志愿者分2周期分别口服受试制剂和参比制剂各10 mg,HPLC法测定血浆中孟鲁司特钠咀嚼片的浓度,用DAS2.1.1软件计算人体药动学参数并进行生物等效性评价。结果:受试制剂和参比制剂两药的主要药代动力学参数AUC0-t分别为(17.94±6.19)μg h/ml和(17.37±4.73)μg h/ml,AUC0-∞分别为(18.26±6.16)μg h/ml和(17.64±4.66)μg h/ml,Cmax分别为(5.58±1.95)μg/ml和(5.54±1.65)μg/ml,Tmax分别为(2.03±0.97)h和(1.93±0.69)h,t1/2分别为(1.20±0.17)h和(1.19±0.13)h。受试制剂的平均相对生物利用度为(101.5±6.56)%。结论:受试制剂和参比制剂具有生物等效性。

Study On Bioavailability of Montelukast Sodium Chewable Tablets

Objective: To study the bioavailability in two kinds of Montelukast sodium chewable tablets.Methods: In a randomized crossover study,20 healthy male volunteers were given a single oral dose of 10 mg test and reference formulations.The plasma concent ration of Montelukast sodium was determined by an HPLC method.The pharmacokinetic parameters were calculated and the bioequivalence of two formulations were evaluated by DAS 2.1.1 software.Results: The main pharmacokinetic parameters in the test and reference praperations of cefalexin were as follow: AUC0-t were(17.94±6.19)μg h/ml and(17.37±4.73)μg h/ml,AUC0-∞ were(18.26±6.16)μg h/ml and(17.64±4.66)μg h/ml,Cmax were(5.58±1.95)μg/ml and(5.54±1.65)μg/ml,Tmax were(2.03±0.97)h and(1.93±0.69)h,t1/2 were(1.20±0.17)h and(1.19±0.13)h.The relative bioavailability o f the test tablets was(101.5±6.56)%.Concluion: The test and reference preparations are bioequivalent.