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In Vitro Release Behavior of Fexofenadine Capsules and its Pharmacokinetic Studies in Beagle Dogs

YUAN Chun-ping1,PENG Ke-long2,OU Shu-yun2,YIN Chun-ping2(1.Guangdong Medi-world Pharmaceutical Co.,Ltd,Foshan 528303,China;2.School of Pharmacy,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430030,China)  
Objective To evaluate in vitro release behavior of fexofenadine capsules,establish a LC-MS/MS method for the content determination of fexofenadine and study its pharmacokinetics in Beagle dogs.Methods The release behavior was evaluated by using a cup method in four media;a LC-MS/MS method was used to determine drug concentration after a single dose of administration of tablets or capsules in six dogs;pharmacokinetic parameters were calculated with the DAS2.1.1 program.Results The two preparations showed good release behavior;the AUC0-t of fexofenadine capsules and tablets were(20.00±7.48)and(16.42±9.37) mg·L-1·h,AUC0-∞ were(20.30±8.08)and(16.68±9.44) mg·L-1·h,t1/2 were(3.10±1.60)and(4.54±2.03)h,tmax were(1.58±0.49)and(1.67±0.68) h,and Cmax were(4.24±1.69)and(3.68±1.89) mg·L-1,respectively.Conclusion The capsules and tablets of fexofenadine present similar release behavior in vitro.No obvious difference has been found between the main pharmacokinetic parameters of them,which suggests they would have the same therapeutic efficacy.
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