Bioequiavailability Investigation Of Omeprazole Enteric Coated Tablet In Human

Purpose: To study bioavailability and bioequiavailability of the experimental drug, Omeprazole enteric coated tablet (The sixth factory of haerbin pharmaceutic group) and the comparison drug, Shenliyu (The limited company of peking sun pharmaceutics). Subjects were male health volunteers. Using random cross method of two periods, HPLC detected the blood drug concentration of Omeprazole in volunteers after taking the experimental drug and the comparison drug (single oral dose 40mg Omeprazole enteric coated tablet).Methods: Establishing the method of HPLC examing the blood drug concentration. The method was single, recycle rate of method was beyond 95%,and recycle rate of extraction was 80%,relative standard difference in day and daytime was below 10%. Accuracy, precision, sensitivity, specificity and quantitate limit etc accorded with the standard of"instructor rule of bioavailability and bioequiavailability of chemical medicine in human".Results: Using trapezia area method calculated AUC of the two drugs after 20 male health volunteers took orally single dose-40mg the experimental drug and the comparison drug of Omeprazole enteric coated tablet in random cross methods of two periods. The relative bioavailability of the experimental drug of Omeprazole enteric coated tablet was 104.8%±39.2%,which was up to the mustard. The half life(t_1/2)of two drugs was 1.609±1.11h and 1.543±0.89h,...