Quetiapine sustained release tablet and preparation method thereof

Abstract

The invention relates to a quetiapine sustained release tablet which at least comprises quetiapine taken as active ingredient or pharmaceutically acceptable salt thereof, ethylcellulose taken as sustained release framework material, and water-soluble binding agent with low viscosity, wherein the ethylcellulose has the average grain diameter less than or equal to 80 mu m, and the preferable average grain diameter is less than or equal to 40 mu m. The invention also relates to a preparation method of the quetiapine sustained release tablet. The product of the invention has good sustained release property, and has the advantages of simple production technique, no use of organic solvent in the technique process and easy cleaning of production equipment and field.

Description

technical field The invention relates to the field of pharmaceutical preparations, in particular to quetiapine sustained-release tablets and a preparation method thereof. Background technique Quetiapine is an atypical antipsychotic. Its structure is similar to that of clozapine. It belongs to dibenzodiazepine derivatives. Cell deficiency, obesity, anticholinergic and other adverse reactions. Now marketed under the trade name Seroquel (SEROQUEL) for the treatment of schizophrenia, as monotherapy or as an adjunct to lithium or divalproex (Divalproex), and acute Treatment of manic episodes. Pharmacokinetic studies have shown that quetiapine is rapidly absorbed after oral administration, the plasma concentration reaches its peak in about 1.0-1.8 hours, and the elimination half-life is relatively short. Ordinary quetiapine tablets usually need to be administered 3 times a day to maintain the efficacy. Therefore, it is necessary to provide a sustained-release quetiapine susta...

AI Technical Summary

Problems solved by technology

But on the one hand, the properties of the slow-release matrix materials involved in this patent application are very different, and it is difficult to extend the limited examples to other slow-release matrix materials by reading the instructions and learning examples; on the other hand, the patent application provides Among the 3 quetiapine sustained-release tablet embodiments containing ethyl cellulose (embodiments 5-7), ethyl cellulose was first dissolved in ethanol to form an ethanol solution, and after being absorbed with quetiapine and a filler , then add the povidone-ethanol solution with a concentration of 10%, mix and granulate with other pharmaceutical excipients, and the granulation process using a large amount of ethanol is obviously not economical and environmentally friendly, and use high-concentration ethanol (such as 95% ethanol ) granulation will increase the risk of explosion when the granules are dry, and the requirements for equipment and production workshops will be higher

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