Rabeprazole sodium enterosoluble micro-particles and preparation method thereof

Abstract

The invention belongs to the field of pharmaceutical preparations, and particularly relates to novel rabeprazole sodium enterosoluble micro-particles with high stability in an acid medium, and a preparation method thereof. Each rabeprazole sodium enterosoluble micro-particle comprises a blank pill core (1), a medicine-carrying layer (2), an isolation coating layer (3) and an enteric coating layer (4) in sequence from inside to outside. A pH value regulator is used in the medicine-carrying layer, the isolation coating layer is added between the medicine-carrying layer and the enteric coating layer, and particularly, a retarding agent is added into an enteric coating layer combination, so that the acid tolerance of a medicament active ingredient namely rabeprazole sodium which is extremely unstable in acid is well improved. The rabeprazole sodium enterosoluble micro-particles and a preparation thereof can be used for treating diseases such as active duodenal ulcer, benign active gastric ulcer, rodent or ulcerative gastroesophageal reflux accompanied by clinical symptoms and the like.

Description

Technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a novel rabeprazole sodium enteric-coated particle with good stability in an acid medium and a preparation method thereof. The rabeprazole sodium enteric-coated particles and preparations thereof can be used to treat diseases such as active duodenal ulcer, benign active gastric ulcer, erosive or ulcerative gastroesophageal reflux syndrome accompanied by clinical symptoms. Background technique [0002] With the development of my country's society and economy, environmental changes and changes in people's lifestyles, the pressure to survive increases, the incidence of peptic ulcers is gradually increasing, becoming a common and frequently-occurring disease. If such diseases are not actively treated after they are sick, serious complications such as blood, perforation, obstruction, etc. may occur, and even about 2% to 3% of patients may develop cancer. [0003] The m...

AI Technical Summary

Problems solved by technology

Therefore, simply using hydroxypropyl methylcellulose as the coating material for the isolation layer cannot provide a good isolation effect on the drug-loaded layer and the enteric coating layer, resulting in poor acid resistance of the tablet.

[0015] (3) No plasticizer is added to the enteric coating material, which will easily lead to insufficient flexibility of the coating film, and the prepared particles are prone to rupture in the subsequent tableting process, which seriously affects the acid resistance and enteric coating effect of the final preparation

[0016] (4) Acid resistance is an extremely important parameter for evaluating the quality of enteric-coated preparations. Chinese patent application CN200910021345 fails to provide its acid resistance measurement method and results, and cannot judge its acid resistance.

Images