Method for preparing solid preparation and solid preparation

Abstract

The invention discloses a method for preparing a solid preparation. The method comprises the following steps of: dissolving active ingredients of a water-insoluble and / or slightly water-soluble alkaline medicament 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 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 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 easy and convenient to operate, has high safety factor, and is easily applied to industrialized production. The solid preparation prepared by the method has dissolution characteristic which is remarkably improved compared with that in the prior art, and has the stability and content uniformity which are equivalent to or better than those in the prior art.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a preparation method of a solid preparation and the obtained solid preparation. Background technique [0002] In the field of pharmaceutical preparations, the particle size of active pharmaceutical ingredients is closely related to the preparation process and quality of solid preparations. In the preparation process of specific pharmaceutical preparations, the particle size of the active pharmaceutical ingredients is usually selected according to the dissolution characteristics of the medicine and the permeability of the biomembrane. For example, if it is a drug with poor solubility and drug dissolution is the rate-limiting process of absorption, a smaller particle size can be selected to promote drug absorption. For another example, if it is a drug with poor compressibility, its compressibility can be improved by selecting an appropriate particle size and ...

AI Technical Summary

Problems solved by technology

[0008] The technical problem to be solved by the present invention is to overcome the existing solid preparation method to select and control the particle size of the pharmaceutical active ingredient through mechanical pulverization, which will cause environmental pollution, serious safety hazards, large loss, and the resulting solid pharmaceutical preparation However, for water-insoluble or poorly water-soluble basic drugs, it provides a method that is easier to operate, less polluted, without the aforementioned safety hazards, and can ensure that the prepared solid preparation has excellent dissolution The preparation method of characteristic, stability and content uniformity and obtained solid preparation

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