Eszopiclone solid preparation and preparation method thereof

Abstract

The invention discloses the preparation method of eszopiclone solid preparation, which comprises the following steps of dissolving eszopiclone into acidic solution containing an acidifying agent to obtain medicine-containing acidic solution; and uniformly mixing alkalinizing agent, accessories and the medicine-containing acidic solution to granulate by a wet method, wherein the alkalinizing agentis agent by which the acidity of mixed solution of the alkalinizing agent and the medicine-containing acidic solution is reduced relative to the acidity of the medicine-containing acidic solution. The invention also discloses eszopiclone solid preparation prepared by the method. According to the method disclosed by the invention, the defects of the serious pollution, high loss and serous potential safety hazards brought by mechanical crushing treatment are avoided; and the method is simple, convenient and feasible for operation and easy for industrial production and has high safety coefficient. The eszopiclone solid preparation prepared by the method has the advantages of excellent dissolution property, stability, and content uniformity.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a solid preparation of eszopiclone and a preparation method thereof. Background technique [0002] Eszopiclone is a single isomer of zopiclone with a molecular weight of 388.81. It is a weak base compound and slightly soluble in water. It is a fast and short-acting non-benzodiazepine sedative hypnotics. It can be used in the treatment of short-term or chronic insomnia. Clinical studies have proved that taking 1-3mg eszopiclone each time has a good effect on initiating sleep and maintaining sleep quality. [0003] Eszopiclone is slightly soluble in water, so it is necessary to pulverize eszopiclone 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 eszopiclone generally adopts a mechanical pulverization method. However, the processing me...

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Problems solved by technology

[0008] The technical problem to be solved by the present invention is to overcome the existing preparation method of eszopiclone solid preparation by selecting and controlling the particle size of eszopiclone by means of mechanical pulverization, which will cause environmental pollution, large loss, and serious safety hazards. hidden dangers, and the dissolution characteristics of eszopiclone solid pharmaceutical preparations are not ideal enough defects, and provide a more convenient operation, less pollution, no aforementioned safety hazards, and can ensure that the obtained solid preparations have excellent dissolution characteristics, stable Preparation method of property and content uniformity, and eszopiclone solid preparation prepared by the method

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