Solid preparation and preparation method thereof

Abstract

The invention discloses a method for preparing a solid risperidone preparation. The method comprises the following steps of: dissolving risperidone into acid solution containing an acidulant to obtain medicament-containing acid solution; and uniformly mixing excipients and the medicament-containing acid solution, and performing wet granulation. The invention also discloses the solid risperidone preparation prepared by the method. The method overcomes the disadvantages of serious pollution, high loss and serious potential safety hazards caused by mechanical pulverization treatment, is convenient and easy to operate, has high safety factor, and is easily applied to industrialized production. The solid risperidone preparation prepared by the method has excellent dissolution characteristic, stability and content uniformity.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a solid preparation and a preparation method thereof. Background technique [0002] Schizophrenia (Schizophrenia) is a group of unknown etiology, the most common type of mental illness characterized by basic personality changes, splits in thinking, emotion, and behavior, and incoordination between mental activities and the environment. In the past two decades, atypical antipsychotic drugs have made great progress. They can effectively improve the cognitive function of psychotic patients as a whole, and have good safety and tolerance. They have become the first choice for the treatment of schizophrenia and psychosis. Peridone is one of the representative drugs, which is widely used clinically. Similar drugs paliperidone and iloperidone have also been listed. [0003] Risperidone, chemical name 3-[2-[4-(6-fluoro-1,2)-benzisoxazol-3-yl-1-piperidine]ethyl]-6,7,8,9 -tetra...

AI Technical Summary

Problems solved by technology

[0009] The technical problem to be solved by the present invention is to overcome the existing methods of preparing risperidone solid preparations by selecting and controlling the particle size of risperidone by means of mechanical or jet crushing, which will cause environmental pollution, large loss, and serious safety hazards. Moreover, the dissolution characteristics of the solid preparation of risperidone are not ideal yet, and a preparation is provided that is easier to operate, has less pollution, does not have the aforementioned safety hazards, and can ensure that the obtained solid preparation has excellent dissolution characteristics, stability and content uniformity. Method, and risperidone solid preparation prepared by the method

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