Pharmaceutical composition and preparation method thereof

Abstract

The invention relates to a pharmaceutical composition for oral administration, a preparation method and an application of the pharmaceutical composition as well as a modifying method of acid pharmaceutical adjuvants, wherein the pharmaceutical composition consists of a) the pharmaceutically acceptable surface-modified acid pharmaceutical adjuvants, and b) dabigatran etexilate, or pharmaceutically acceptable salt or a hydrate; and the modifying method comprises the following steps: preparing a pharmaceutically acceptable modifying alkaline substance water solution, and adding the water solution to powder particles of the acid pharmaceutical adjuvants, so that a neutral salt layer is each formed on the surface of the powder particles of the acid pharmaceutical adjuvants, so that hydrotropy can be performed by virtue of the acid adjuvants in a preparation prescription of the dabigatran etexilate, and meanwhile, the dabigatran etexilate can be prevented from being broken up by the acid adjuvants. The technology is also applicable to surface modification of alkaline pharmaceutical adjuvants, so that a neutral salt layer is each formed on the surfaces of the alkaline pharmaceutical adjuvants; therefore, the alkaline pharmaceutical adjuvants are prevented from being broken up by pharmaceutical active ingredients.

Description

technical field [0001] The invention relates to a pharmaceutical composition, which contains a pharmaceutically acceptable surface-modified acidic pharmaceutical auxiliary material. Particularly, the present invention relates to a kind of pharmaceutical composition, and it contains dabigatran etexilate (active substance) or its pharmaceutically acceptable salt, hydrate and pharmaceutically acceptable surface-modified acidic pharmaceutical excipients. Background technique [0002] Many drugs will chemically react with acidic or alkaline materials, which will cause the chemical degradation of the drug. Under normal circumstances, these acidic or alkaline materials will be avoided as far as possible in the preparation products of these drugs that are decomposed by acid or alkali. However, in some special cases, these unstable drugs may require some acidic or alkaline materials, so that the preparation products of these drugs meet certain requirements. [0003] One example is ...

AI Technical Summary

Problems solved by technology

The process applies the drug by fluidizing the surface of the organic acid core material, that is, the drug is formulated into a suspension for drug application. This process has the advantages of low drug application rate, large drug loss, uneven drug application, and uncertain drug dosage. The process operation is complex and other disadvantages, and the degree of sphericity of the prepared organic acid pellet core, the degree of perfection of the coating film of the separation layer, and the degree of combination of the active drug and the separation layer need to be strictly controlled, so the production cost is high and the production cycle is long.

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