Solid zopiclone preparation and preparation method thereof

Abstract

The invention discloses a method for preparing a solid zopiclone preparation. The method comprises the following steps of: dissolving zopiclone into acid solution containing an acidulant to obtain medicament-containing acid solution; and uniformly mixing a basifier, excipients and the medicament-containing acid solution, and performing wet granulation, wherein the basifier is a reagent which ensures that the acidity of mixed solution of the basifier and the medicament-containing acid solution is reduced compared with the acidity of the medicament-containing acid solution. The invention also discloses the solid zopiclone 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 zopiclone 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 of zopiclone and a preparation method thereof. Background technique [0002] Zopiclone, with a molecular weight of 388.81, is a weak base compound and slightly soluble in water. It is a fast and short-acting non-benzodiazepine sedative hypnotics, which can be used for the treatment of short-term or chronic insomnia. Clinical studies have proved that taking 3.75-7.5mg zopiclone each time has a good effect on initiating sleep and maintaining sleep quality. [0003] Zopiclone is slightly soluble in water, so it is necessary to pulverize zopiclone to a certain fineness when preparing the solid preparation, so as to ensure that the solid preparation can dissolve rapidly after oral administration. At present, the pulverization of zopiclone generally adopts a mechanical pulverization method. However, the processing method of mechanical crushing has defect...

AI Technical Summary

Problems solved by technology

[0008] The technical problem to be solved by the present invention is to overcome the existing zopiclone solid preparation preparation method through mechanical pulverization to select and control the particle size of zopiclone, which will cause environmental pollution, large loss, and serious safety hazards. The dissolution properties of piconelone solid pharmaceutical preparations are still not ideal, and a kind of more convenient operation, less pollution, no aforementioned safety hazards, and can ensure that the obtained solid preparations have excellent dissolution properties, stability and content uniformity Preparation method, and zopiclone solid preparation prepared by the method

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