Abstract：Objective To Study on the preparation method of Esomeprazole Magnesium enteric-coated pellets-type tablets.Methods The enteric-coated Esomeprazole Magnesium pellets were prepared by fluid bed bottom spray coating method,the Esomeprazole Magnesium pellets were prepared by direct compression of the enteric-coated pellets and suitable excipients.Results The drug layer contained 7%of the HPC-SSL aqueous solution as the binder,adding 5%of the Esomeprazole Magnesium raw materials and 3%talc as anti-binder agent,prepared into drug-containing pellets.Isolation layer contained 5%HPC-SSL aqueous solution as the coating material,coating weight gain of 15%to 20%.The ratio of enteric materials Eudragit L30D-55/NE30D was 9∶1,the coating weight gain was 40%,enteric-coated pellets/excipients(Lactose/MCC/PVPP=140∶80∶25)was 1∶1,the enteric-coated tablets releasen in 0.1 mol/L hydrochloric acid in 2 h was less than 10%,while in pH 6.8 Phosphate buffer in 45 min was more than 75%.Conclusion The release behavior of Esomeprazole Magnesium enteric-coated pellets prepared by the above method is preferred,and it may be used in industrial production.
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