Omeprazole enteric-coated pellet and preparation process thereof

Abstract

The invention provides an omeprazole enteric-coated pellet and a preparation process thereof. The preparation process comprises the following steps: mixing a modified polylactic acid solution and an ethyl cellulose aqueous dispersion, and stirring to obtain a slow-release protection solution; dissolving mannitol in purified water to obtain a mannitol solution; the preparation method comprises the following steps: dry-mixing omeprazole and microcrystalline cellulose, adding dimeticone, shearing, extruding and rounding to obtain pellet cores; the preparation method comprises the following steps: alternately spraying a sustained-release protective solution and a mannitol solution on a pellet core, drying to obtain a coated pellet core, dissolving hydroxypropyl methyl cellulose and talcum powder in purified water, stirring to obtain an enteric coating solution, spraying the enteric coating solution on the coated pellet core, and drying after spraying to obtain the omeprazole enteric pellet. By adopting the unique omeprazole enteric-coated pellet preparation process, the pellet has the advantages of large drug loading capacity, smooth and round appearance, no fine powder, no cracking, no broken pellet, good pellet formability, high yield, good in-vitro release degree, stable quality, simple production process and controllable product quality.

Description

technical field [0001] The invention relates to the technical field of medicine preparation, in particular to an omeprazole enteric-coated pellet and a preparation process thereof. Background technique [0002] Omeprazole is a proton pump inhibitor developed in Sweden, which can inhibit the excessive secretion of gastric acid, so it is often used to treat peptic ulcer. However, omeprazole has poor stability. Its structure contains the chemical structure of sulfonyl benzimidazole, which is a weakly basic compound, and is easily affected by the external environment to degrade and produce impurities, reducing the content of the main drug. Especially under acidic and light conditions, omeprazole is very easy to decompose quickly, and its hydrophobicity is strong, and its compatibility with reagents such as liquids is poor, resulting in low industrial production yield and difficult quality control in the production process. There are differences in the quality of finished produc...

AI Technical Summary

Problems solved by technology

However, the stability of omeprazole is poor, and its structure contains the chemical structure of sulfonyl benzimidazole, which is a weakly basic compound, which is easily affected by the external environment and degrades to produce impurities, reducing the content of the main drug.

Especially under acidic and light conditions, omeprazole is very easy to decompose quickly, and its hydrophobicity is strong, and its compatibility with reagents such as liquids is poor, resulting in low industrial production yield and difficult quality control in the production process. Causes differences in finished product quality between batches

[0003]Omeprazole is usually prepared by extrusion spheronization method to prepare basic pills or pellet cores, but the extrusion spheronization method has certain limitations. Incompatibility phenomenon exists in the process, prone to loose powder or pellet core cracking, poor fluidity, which affects the dissolution time limit of subsequent pellets, poor disintegration force, which is not conducive to the dissolution of the main drug, and poor formability of pellets

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