Quetiapine fumarate sustained-release tablet and preparation method thereof

Abstract

The invention provides a quetiapine fumarate sustained-release tablet. The sustained-release tablet comprises the following components in percentage by weight: 5%-50% of quetiapine fumarate, 2%-12% of hydroxypropyl methylcellulose K4M, 0.4%-5% of hydroxypropyl methylcellulose K100M, 6%-35% of hydroxypropyl methylcellulose K100LV, 5%-20% of organic acid salt, 10%-60% of a filling agent and 0.2-2% of a lubricant. According to the sustained-release tablet, by adopting hydroxypropyl methylcellulose compositions with different viscosities as a sustained-release framework material, the preparation can reach the expected sustained-release effect. By measuring in-vitro release, results show that the preparation is smoothly released at 6 hours, 12 hours and 20 hours and illustrates that the product has better sustained-release property. The raw materials are easily available, the preparation method is simple and the sustained-release tablet is conductive to scale operation, is suitable for industrial production and has better application value.

Description

technical field [0001] The invention relates to a pharmaceutical preparation, in particular to a drug sustained-release preparation, in particular to a quetiapine fumarate sustained-release tablet for treating adult schizophrenia and a preparation method thereof. Background technique [0002] Schizophrenia is a severe psychiatric disease with unknown etiology. It mainly occurs in young and middle-aged people. Clinically, it is manifested as various obstacles in thinking, emotion, and behavior, as well as incoordination between mental activities and the surrounding environment. Patients generally have clear consciousness and normal intelligence. The course of schizophrenia is often protracted and develops progressively. If it is found early, it should be given reasonable treatment as soon as possible. Due to untimely and unreasonable treatment, a small number of patients delay time, delay diagnosis and treatment, make the disease progress slowly, and even lose the opportunity...

AI Technical Summary

Problems solved by technology

But the embodiment described in above-mentioned patent releases faster in the stomach, 2h in the stomach exceeds 40% of release, may cause the blood drug concentration in the body to be too high; The slower embodiment of release adds too many auxiliary materials, increases the weight of the tablet, and does not Useful for patients

Chinese patent CN200710043404.9 discloses a sustained and controlled release preparation composition composed of quetiapine, organic acid, water-soluble polymer material, enteric material, wax and water-insoluble polymer material, wherein the enteric material is used as the function Sexual coating materials prevent the dissolution of drugs in gastric juice, waxy materials and water-insoluble polymer materials are used to control the dissolution of drugs in gastric juice or intestinal juice, but the polymer materials in the examples described in the patent account for about 50%. Larger, resulting in larger tablet weight and inconvenient administration

Chinese patent CN101754752A discloses a "delayed-release composition comprising quetiapine and its preparation method", and the sustained-release material used is the first hydroxypropylmethylcellulose ( i.e. hydroxypropylmethylcellulose K100LV) and a second hydroxypropylmethylcellulose (i.e. hydroxypropylmethylcellulose K4M) component with an apparent viscosity between about 3000cp and 5600cp, can achieve quetiapine Sustained and stable release, but the sustained-release preparation made is incomplete in the later release (see Example 7 of the present application)

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