Ezetimibe medicinal preparation

A technology for ezetimibe and pharmaceutical preparations, which is applied in the field of ezetimibe pharmaceutical preparations, and can solve the problems of ezetimibe's dissolution effect and poor fluidity

Active Publication Date: 2020-10-23
BEIJING WINSUNNY PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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...

Method used

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  • Ezetimibe medicinal preparation
  • Ezetimibe medicinal preparation
  • Ezetimibe medicinal preparation

Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0038] 10 g of ezetimibe, 15 g of calcium hydrogen phosphate, and 20 g of microcrystalline cellulose (d0.5 is 30 μm) were dissolved in 1 L of ethanol to obtain a mixed solution, and the absolute ethanol was removed by spray drying to obtain a solid dispersion of ezetimibe.

experiment example 2

[0040] 10 g of ezetimibe, 15 g of calcium hydrogen phosphate, and 20 g of microcrystalline cellulose (d0.5 is 65 μm) were dissolved in 1 L of ethanol to obtain a mixed solution, and the absolute ethanol was removed by spray drying to obtain a solid dispersion of ezetimibe.

experiment example 3

[0042]10 g of ezetimibe, 15 g of calcium hydrogen phosphate, and 20 g of microcrystalline cellulose (d0.5 is 130 μm) were dissolved in 1 L of ethanol to obtain a mixed solution, which was removed by spray drying to obtain a solid dispersion of ezetimibe.

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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...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K9/14A61K47/38A61K47/20A61K47/02A61K31/397A61P3/06
CPCA61K9/2054A61K9/2013A61K9/2009A61K9/146A61K9/145A61K9/143A61K31/397A61P3/06
Inventor 陈海建刘丽敏白小玉张荣凤耿玉先产运霞
Owner BEIJING WINSUNNY PHARMA CO LTD
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