Omeprazole enteric dry suspension and preparation method thereof

Abstract

The invention provides an omeprazole enteric dry suspension and a preparation method thereof, and belongs to the technical field of medicine.The enteric dry suspension is prepared from, by weight, 40%-49% of omeprazole enteric microspheres, 0%-1% of wetting agent, 45%-58% of flavoring agent and 1%-5% of suspending aid.According to the omeprazole enteric dry suspension and the preparation method thereof, a hot-melting spraying method is adopted to prepare omeprazole and a sustained-release skeleton material into sustained-release microspheres A, the sustained-release microspheres A are each sequentially wrapped with an isolation coating layer and an enteric coating layer, the wrapped microspheres A are mixed with the flavoring agent, the wetting agent and the suspending aid, and then the omeprazole enteric dry suspension is obtained; the prepared omeprazole enteric dry suspension is distributed uniformly in the intestinal tract and is not prone to cause initial burst release; compared with tablets and capsules, the omeprazole enteric dry suspension is good in stability, fractional doses are convenient, an oral suspension is formed by adding water to the dry suspension to enable the dry suspension to be dissolved, absorption is good, the efficacy is quick to achieve, the bioavailability is good, the mouthfeel is good, the dry suspension is particularly suitable for patients with dysphagia, specially for child patients and elderly patients to take, compliance of the patients is improved, and the preparation method is simple and suitable for industrial production and application.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to an omeprazole enteric-coated dry suspension and a preparation method thereof. Background technique [0002] Omeprazole, whose chemical name is 5-methoxy-2-{[(4-methoxy-3,5-dimethyl-2-pyridyl)-methyl]-sulfinyl}-1 - Benzimidazole, a proton pump inhibitor, can be used in the treatment of gastric ulcer, duodenal ulcer, rebound ulcer, reflux esophagitis and Zoller-Ellison syndrome. [0003] Omeprazole is protonated under acidic or neutral conditions, is easy to degrade and transform, and is transformed into a compound sulfenamide that inhibits H+ / K+-ATPase activity, and rapidly combines with cysteine ​​on H+ / K+-ATPase The combination of sulfhydryl groups forms disulfide bonds, thereby inactivating the enzyme, specifically inhibiting the activity of H+ / K+-ATPase in gastric parietal cells, thereby inhibiting gastric acid secretion. Because omeprazole is unstable ...

AI Technical Summary

Problems solved by technology

Because omeprazole is unstable to acid, oral preparations containing omeprazole are required to avoid contact with gastric juice and must be transferred to the alkaline intestinal tract as a prototype. Therefore, all omeprazole enteric-coated preparations are used clinically. Omeprazole enteric-coated preparations currently on the market are mainly omeprazole enteric-coated capsules and omeprazole enteric-coated tablets, but these dosage forms are not suitable for patients with swallowing difficulties, such as the elderly and children

And in the course of clinical use, it is inconvenient to divide the dose