Ezetimibe medicinal preparation

Abstract

The invention relates to an ezetimibe medicinal preparation. The medicinal preparation specifically comprises an ezetimibe solid dispersion, a filling agent, a disintegrating agent and an adhesive, wherein the ezetimibe solid dispersion comprises ezetimibe, microcrystalline cellulose and a dispersing agent; and the particle size d0.5 of the microcrystalline cellulose is less than or equal to 30 [mu] m. The ezetimibe medicinal preparation prepared by the invention has a relatively good dissolution rate, and has a dissolution effect consistent with that of an original researched sold product; the process is smooth in the preparation process; the quality of the obtained product meets the standard requirements; and the ezetimibe medicinal preparation is suitable for industrial large-scale production.

Description

technical field [0001] The invention relates to a novel pharmaceutical preparation of cholesterol absorption inhibitors, specifically ezetimibe pharmaceutical preparation, and a preparation method of the pharmaceutical preparation. Background technique [0002] Ezetimibe is a new class of cholesterol absorption inhibitors that can be used alone or in combination with HMG-CoA reductase inhibitors (statins) for the treatment of primary (heterozygous familial or nonfamilial) hypercholesterolemia Homozygous familial hypercholesterolemia (HoFH), homozygous sitosterolemia (or phytosterolemia). The mechanism of action of ezetimibe is that it attaches to the brush border of small intestinal villi and inhibits the absorption of cholesterol, thereby reducing the transport of cholesterol from the small intestine to the liver, reducing the storage of cholesterol in the liver and increasing the clearance of cholesterol in the blood. Ezetimibe tablets were first jointly developed by Sche...

AI Technical Summary

Problems solved by technology

[0010] The invention provides a pharmaceutical preparation of ezetimibe, aiming at overcoming the problems of ezetimibe dissolution effect and poor fluidity

The ezetimibe pharmaceutical preparation prepared by the present invention has a better dissolution rate, which can be consistent with the dissolution effect of the original commercially available product, and overcomes the difficulty in preparation of the preparation caused by the poor fluidity of the ezetimibe, The process in the preparation process is smooth, and the quality of the obtained product meets the standard requirements, ensuring the safety and effectiveness of patients taking it, and is suitable for large-scale industrial production.

Images