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Lipid-lowering compound preparation and preparation method thereof

A compound preparation and blood lipid-lowering technology, which is applied in the direction of pill delivery, pharmaceutical formula, medical preparations containing active ingredients, etc., can solve problems such as difficult implementation, achieve reduced drug dosage, lower blood lipid, good stability and dissolution degree of effect

Active Publication Date: 2014-05-14
安徽联创生物医药股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, such treatment has remained elusive and there is a need for improved medical treatments that are very effective in lowering plasma cholesterol levels

Method used

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  • Lipid-lowering compound preparation and preparation method thereof
  • Lipid-lowering compound preparation and preparation method thereof
  • Lipid-lowering compound preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Embodiment 1, a kind of lipid-lowering compound preparation and preparation method thereof

[0024] A lipid-lowering compound preparation, consisting of a first sheet and a second sheet, the first sheet is composed of atorvastatin calcium as an active ingredient and pharmaceutically acceptable excipients or auxiliary materials, and the second sheet is composed of Composition of ezetimibe as an active ingredient and pharmaceutically acceptable excipients or auxiliary materials;

[0025] The first sheet contains:

[0026]

[0027] The second sheet contains:

[0028]

[0029] Step (1), the atorvastatin calcium raw material used in the first sheet layer, direct compression lactose, sodium bicarbonate, microcrystalline cellulose PH102, povidone K-30, sodium carboxymethyl starch , talcum powder and magnesium stearate are evenly mixed for later use;

[0030] Step (2), uniformly mixing the ezetimibe bulk drug, sodium lauryl sulfate, microcrystalline cellulose PH102, t...

Embodiment 2

[0034] Embodiment 2, a kind of lipid-lowering compound preparation and preparation method thereof

[0035] A lipid-lowering compound preparation, consisting of a first sheet and a second sheet, the first sheet is composed of atorvastatin calcium as an active ingredient and pharmaceutically acceptable excipients or auxiliary materials, and the second sheet is composed of Composition of ezetimibe as an active ingredient and pharmaceutically acceptable excipients or auxiliary materials;

[0036] The first sheet contains:

[0037]

[0038] The second sheet contains:

[0039]

[0040] Step (1), the atorvastatin calcium raw material used in the first sheet layer, direct compression lactose, sodium bicarbonate, microcrystalline cellulose PH102, povidone K-30, sodium carboxymethyl starch , talcum powder, and magnesium stearate are mixed evenly and then directly compressed into tablets;

[0041] Step (2), uniformly mixing the ezetimibe bulk drug, sodium lauryl sulfate, micro...

Embodiment 3

[0045] Embodiment 3, a kind of lipid-lowering compound preparation and preparation method thereof

[0046] A lipid-lowering compound preparation, consisting of a first sheet and a second sheet, the first sheet is composed of atorvastatin calcium as an active ingredient and pharmaceutically acceptable excipients or auxiliary materials, and the second sheet is composed of Composition of ezetimibe as an active ingredient and pharmaceutically acceptable excipients or auxiliary materials;

[0047] The first sheet contains:

[0048]

[0049] The second sheet contains:

[0050]

[0051] Step (1), the atorvastatin calcium raw material used in the first sheet layer, direct compression lactose, sodium bicarbonate, microcrystalline cellulose PH102, povidone K-30, sodium carboxymethyl starch , talcum powder and magnesium stearate are evenly mixed for later use;

[0052] Step (2), uniformly mixing the ezetimibe bulk drug, sodium lauryl sulfate, microcrystalline cellulose PH102, ...

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Abstract

The invention provides a lipid-lowering compound preparation and a preparation method thereof. The lipid-lowering compound preparation is composed of a first thin layer and a second lamella, wherein the first thin layer is composed of atorvastatin calcium serving as the active ingredient and pharmaceutically acceptable excipient or accessories, while the second thin layer is composed of ezetimibe serving as the active ingredient and pharmaceutically acceptable excipient or accessories. The preparation method comprises the following steps of forming the first thin layer by directly mixing the raw materials, forming the second thin layer by pelletizing at first by an efficient wet-process pelletizing method, and pressing the two thin layers by a two-layer tablet press to obtain a double-layer tablet. The lipid-lowering compound preparation is prepared with the atorvastatin and the ezetimibe as the major active ingredients, and thus is capable of lowering blood lipid in the two links of intestinal absorption and liver synthesis; when the dosage of one single drug is reduced, negative influence caused by improving the intestinal absorption with the atorvastatin and promoting the liver synthesis with the ezetimibe is overcome; and besides, the lipid-lowering compound preparation has excellent stability and dissolubility.

Description

technical field [0001] The invention relates to a preparation and a preparation method thereof, in particular to a lipid-lowering compound preparation and a preparation method thereof. Background technique [0002] Hypercholesterolemia represents a common pre-existing disease pattern in well-off countries of the Western Hemisphere. Cholesterol can cause "arteriosclerosis," narrowing of the arteries, slowing blood flow to the heart and even blocking it by limiting the oxygen supply to the organ. Hypercholesterolemia is implicated in atherosclerosis, heart attack and stroke and is one of several conditions that can lead to coronary artery disease, the leading cause of death in the United States with approximately 600,000 deaths per year. Risk groups include overweight, smokers, those with a poor diet (eg, high in saturated fat), those with insufficient physical activity, and those suffering from stress. Various treatments have been proposed for such at-risk individuals, as w...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/40A61K9/28A61P3/06A61K31/397
Inventor 葛德培吴其华
Owner 安徽联创生物医药股份有限公司
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