Preparation method of medicament solid preparation and obtained medicament solid preparation

Abstract

The invention discloses a preparation method of a medicament solid preparation. The method comprises the following steps of: dissolving active ingredients of a water-insoluble and / or water-poorly-soluble acid medicament into an alkaline solution containing a basifier to obtain a medicament-containing alkaline liquid; and uniformly mixing auxiliary materials with the medicament-containing alkaline liquid, and performing wet process pelletizing. The invention further discloses a medicament solid preparation prepared with the method. Due to the adoption of the preparation method disclosed by the invention, the defects of severe pollution, large loss and severe potential safety hazard caused by mechanical smashing treatment are overcome, and the effects of reducing the particle sizes of the active ingredients of the water-insoluble and / or water-poorly-soluble acid medicament in a pelletizing process is achieved. The method is easy and convenient to operate, is practicable, has high safety coefficient, and is easily applied to industrial production. The solid preparation prepared with the method has excellent dissolving 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 pharmaceutical solid preparation and the obtained pharmaceutical solid preparation. Background technique [0002] In the field of pharmaceutical preparations, the particle size of pharmaceutical active ingredients is closely related to the preparation process and quality of solid preparations. The reduction of particle size is the key to improving the dissolution rate and content uniformity of pharmaceutical 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 dru...

AI Technical Summary

Problems solved by technology

[0009] 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 acidic 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. The preparation method of the pharmaceutical solid preparation of stability and content uniformity and the obtained pharmaceutical solid preparation

Images