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A kind of ezetimibe atorvastatin calcium tablet and preparation method thereof

A technology of atorvastatin calcium and ezetimibe, which is applied in the field of medicine, can solve problems such as unfavorable industrial production, and achieve the effects of improving uniform distribution, hydrophilicity, rapid release, and high concentration

Active Publication Date: 2018-06-15
ZHEJIANG JUTAI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But the solvent used in this method is diethylene glycol monoethyl ether, a flammable and slightly toxic solvent, which is also unfavorable for suitability for industrialized production

Method used

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  • A kind of ezetimibe atorvastatin calcium tablet and preparation method thereof
  • A kind of ezetimibe atorvastatin calcium tablet and preparation method thereof
  • A kind of ezetimibe atorvastatin calcium tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Ezetimibe Layer Prescription and Preparation

[0029] Element

Dosage (mg)

effect

Ezetimibe

10

active ingredient

Povidone K30

120

Adhesive

Sodium dodecyl sulfate

8

active agent

lactose

50

water soluble filler

Microcrystalline Cellulose 102

50

water insoluble filler

Croscarmellose Sodium

30

disintegrant

Magnesium stearate

2

lubricant

90% ethanol

0.06ml

D

[0030] Mix the above-mentioned ezetimibe, sodium lauryl sulfate, lactose, microcrystalline cellulose 102, croscarmellose sodium, and 3 / 4 amount of povidone K30 according to the prescription ratio, mix well, and use 20% The povidone K30 90% ethanol solution is granulated with 40 meshes, dried, granulated, and magnesium stearate is added to form an ezetimibe layer.

[0031] Prescription and preparation of atorvastatin calcium layer

[0032] Element

Dosage (mg)

effect

...

Embodiment 2

[0036] Ezetimibe Layer Prescription and Preparation

[0037] In the top-drive granulator, ezetimibe and sodium lauryl sulfate are highly dispersed in 20% povidone K30 90% ethanol solution according to the prescription ratio of Example 1, and then lactose is added, slightly Crystalline cellulose 102, croscarmellose sodium, stirred evenly, made into 40-60 mesh wet granules, dried at 40 degrees, granulated, added an appropriate amount of lubricant, ready to serve.

[0038] Atorvastatin calcium layer prescription and preparation are the same as in Example 1

[0039] The two kinds of granules were respectively pressed into upper and lower two-layer tablets with different feed hoppers on a double-layer tablet press, and coated with gastric solution to obtain the double-layer tablet of Example 2.

Embodiment 3

[0041] Ezetimibe Layer Prescription and Preparation

[0042] In the top-drive granulator, ezetimibe and sodium lauryl sulfate were highly dispersed in proportion to a concentration of 20% povidone K30-90% ethanol solution according to the prescription ratio of Example 1, and then gradually added Stir the lactose evenly, add microcrystalline cellulose 102 and croscarmellose sodium, make it into wet granules of 40-60 mesh, dry at 40 degrees, granulate, add an appropriate amount of lubricant, and get ready.

[0043] Atorvastatin calcium layer prescription and preparation are the same as in Example 1

[0044] The two kinds of granules were respectively pressed into upper and lower two-layer tablets with different feed hoppers on a double-layer tablet press, and coated with gastric solution to obtain the double-layer tablet of Example 3.

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Abstract

The invention discloses an ezetimibe and atorvastatin calcium tablet and a preparation method thereof. The tablet is prepared from ezetimibe particles and atorvastatin calcium particles through double-layer tabletting, wherein the ezetimibe particles comprise the following components: ezetimibe, a binder, a surfactant, a water-soluble filling agent, a water-insoluble filling agent, a disintegrating agent and a lubricant; during pelletizing of the ezetimibe particles, the ezetimibe and the surfactant are dissolved or dispersed into a binder solution; the water-soluble filling agent is added to uniformly mix; and other auxiliary materials are added for pelletizing. During the preparation of the ezetimibe layer, the auxiliary materials are added in specific sequence, so that the in-vitro release problem of the ezetimibe is effectively solved.

Description

technical field [0001] The invention relates to an ezetimibe atorvastatin calcium tablet and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Ezetimibe Atorvastatin Calcium Tablets is a compound preparation, which is mainly used to reduce the level of total cholesterol (low-density lipoprotein cholesterol and triglyceride) and can increase the level of high-density lipoprotein cholesterol. It was developed by Merck of the United States The compound lipid-lowering drug, whose trade name is "LIPTRZET", was approved by the FDA on May 3, 2013. The compound preparation generally adopts two active ingredients in a single solid dosage form as separate entities, that is, a bilayer tablet. The two active ingredients have different action mechanisms, and when they are made into a compound formula, they have better curative effect and patient adaptability, and have broad market prospects. [0003] But unexpectedly, in the proce...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/397A61K31/40A61K9/24A61K9/30A61P3/06
CPCA61K9/2086A61K9/282A61K31/397A61K31/40
Inventor 易建勇祝方猛赵能选
Owner ZHEJIANG JUTAI PHARMA
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