Method for preparing solid preparation and solid preparation

Abstract

The invention discloses a method for preparing a solid preparation, which comprises the following steps of: dissolving active ingredients of water-insoluble and / or lowly water-soluble alkaline medicaments in acidulant-containing acid solution to prepare medicament-containing acid solution; and mixing the medicament-containing acid solution and auxiliary materials uniformly to perform wet-method pelletizing. The invention also discloses the solid preparation prepared by the method. By the method, the defects of serious pollution, large loss and serious potential safety hazard which are caused by mechanical pulverization are overcome, and the method is easy and convenient to operate, has high safety factors and is applied to industrial production easily. The solid preparation prepared by the method has the excellent dissolution characteristic, stability and content uniformity.

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 is easier to operate, less polluted, without the aforementioned safety hazards, and can ensure that the prepared solid preparation has excellent dissolution characteristics. , preparation method of stability and content uniformity and obtained solid preparation

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