Omeprazole enteric capsule and preparation method thereof

Abstract

The invention discloses an omeprazole enteric capsule and a preparation method thereof. The omeprazole enteric capsule comprises omeprazole enteric pellets filled into a gelatin capsule shell. Each omeprazole enteric pellet sequentially comprises an omeprazole carrying pellet core, an isolation layer and an enteric layer from inside to outside, wherein the omeprazole carrying pellet core is prepared through an extrusion spheronization method, and the isolation layer and the enteric layer are prepared through a fluidized bed coating method. The omeprazole enteric capsule is different from original products in a way that Tween 80 and low-substituted hydroxypropyl cellulose are added to the omeprazole carrying pellet cores on the basis of omeprazole, lactose anhydrous, microcrystalline cellulose, mannitol, disodium hydrogen phosphate, hydroxypropyl cellulose and lauryl sodium sulfate. The prepared omeprazole enteric capsule does not change the stability and reproducibility of the capsule,increases the in-vitro dissolution rate of the capsule, especially increases capsule homogeneity to allow the blood drug concentration peak reaching time of different health volunteers to be consistent and has a good application value in clinical application.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to an omeprazole enteric-coated pellet, an omeprazole enteric-coated capsule prepared from the enteric-coated pellet, and a preparation method of the omeprazole enteric-coated capsule. Background technique [0002] Proton pump inhibitors are benzimidazole compounds used for the treatment of peptic ulcer, esophageal reflux disease, gastrinoma syndrome and Helicobacter pylori. So far, proton pump inhibitors that have been marketed abroad include omeprazole, esomeprazole, pantoprazole, lansoprazole, rabeprazole, dex-rabeprazole, dex-lansoprazole azoles, etc. The proton pump inhibitors listed in China include omeprazole, esomeprazole, pantoprazole, lansoprazole, rabeprazole, etc., and dex-rabeprazole, Dexlansoprazole, etc. Omeprazole was launched in the United States in 1988 and is the earliest benzimidazole proton pump inhibitor on the market. [0003] According to the Tho...

AI Technical Summary

Problems solved by technology

In general, the speed and ability of this enzyme metabolism causes inter-individual differences, which are difficult to achieve through prescription and process adjustments

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