Esomeprazole Magnesium Enteric-capsule In Beagle Pharmacokinetic Study

Objective:Combining with clinical application, single dose oral Esomeprazole Magnesium Enteric-capsule after, through the LC-MS/MS determination of Esomeprazole Magnesium Enteric-capsule(40mg/grain) with relative biof preparation and reference preparation. Determination of blood drug concentration change process, evaluation bioequivaloavailability ence of Esomeprazole Magnesium Enteric-capsule, and to provide the clinical reasonable application to learn related information.Methods:This experiment through the establishment of a LC-MS/MS method, divided6health Beagles into two groups random double cross single dose test, determination of oral Esomeprazole Magnesium Enteric-capsule preparation and reference preparation subjects after the Beagle plasma concentrations of Esomeprazole, adopts the Analyte1.5.1(AB corporation, USA) software for data processing, study the pharmacokinetic process of Esomeprazole Magnesium Enteric-capsule in dogs, and compare two kinds of preparation Tmax, Cmax, AUC in Esomeprazole evaluation parameters to evaluation of Esomeprazole Magnesium Enteric-capsule preparation quality.Results:After the6health fields single dose oral Esomeprazole magnesium enteric capsules, determination of blood drug concentration by the process, when the test product and reference preparation in Esomeprazole respectively at1.417±1.271h and1.500±0.652h peaked at1950.00±525.966ng/ml and1958.333±391.173ng/ml, elimination half-life were1.010±0.539h and0.844±0.344h; The area under the blood drug concentration-time curve AUCo-t were3735.708±985.686ng/ml·h and3448.041±498.486ng/ml·h, blood drug concentration-time curve under the total AUC0-∞were3736.943±987.058ng/ml-h and3448.703±498.150ng/ml-h. According to the area under the blood drug concentration-time curve AUC0-t and AUC0-∞is HeNan topfond pharmaceutical company LTD,The Esomeprazole magnesium enteric capsule was107.8±21.9%the relative bioavailability of F1and F2was107.8±22.0%.Conclusions:Through the Esomeprazole magnesium enteric capsules (40mg/grain) with relative bioavailability of preparation and reference preparation. Single dose oral Esomeprazole Magnesium Enteric-capsule after, through the establishment of a LC-MS/MS method for the6healthy Beagles subjects Esomeprazole blood drug concentration in plasma changes in parameter values was tested, according to the area under the blood drug concentration-time curve AUC0-t and AUCo-∞is HeNan topfond pharmaceutical company LTD. The Esomeprazole magnesium enteric capsule was107.8±21.9%the relative bioavailability of F1and F2was107.8±22.0%. By analysis of variance and double unilateral t test,(1-2a)%confidence during method and Wilcoxon nonparametric test proves that the two preparations Cmax, AUC0-t, AUCo-∞and tmax medicine generation of parameters, such as basic consistent. For Esomeprazole provides relevant to study the clinical application of information and theoretical basis.