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Enteric-coated sustained release composition

A slow-release tablet and enteric-coating technology, which is applied in the field of enteric-coated slow-release compositions, paroxetine hydrochloride enteric-coated slow-release tablets and preparation fields, can solve problems such as drug instability, dissolution phenomenon, etc. The effect of short production time and long shelf life

Inactive Publication Date: 2014-02-05
JILIN DONGMENG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0051] The contriver is used above-mentioned method for paroxetine, and the result of measuring is, the medicine prepared by this method is unstable under accelerated condition, has stripping phenomenon under acidic condition simultaneously, releases too fast in alkali

Method used

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  • Enteric-coated sustained release composition
  • Enteric-coated sustained release composition
  • Enteric-coated sustained release composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0120] 25mg strength tablet

[0121] 1. Tablet Prescription:

[0122]

[0123] 2. Prescription of enteric coating solution:

[0124] Acryl-EZE appropriate amount

Appropriate amount of purified water

[0125] 3. Prescription of film coating solution:

[0126] Gastric-soluble film coating agent

Appropriate amount

purified water

Appropriate amount

[0127] Preparation:

[0128] 1. Prepare an adhesive of 10% PVP (50% w / w ethanol) for the drug-containing layer for use; the preparation method of the adhesive is as follows: 10 g of povidone K30 plus 90 g of 50% (w / w) ethanol.

[0129] 2. Prepare an adhesive of 25% PVP (50% w / w ethanol) for the retarding layer for use; the preparation method of the adhesive is as follows: 25 g of povidone K30 plus 75 g of 50% (w / w) ethanol

[0130] 3. Process of drug-containing layer: Weigh paroxetine hydrochloride, lactose, silicon dioxide and hypromellose K4M according to the prescripti...

Embodiment 2

[0145] 12.5mg strength tablet

[0146] 1. Tablets:

[0147]

[0148]

[0149] 2. Prescription of enteric coating solution:

[0150] Acryl-EZE appropriate amount

Appropriate amount of purified water

[0151] 3. Prescription of gastric soluble coating solution:

[0152] Gastric-soluble film coating agent

Appropriate amount

purified water

Appropriate amount

[0153] Prepared according to the method used in Example 1.

[0154] Examples 1 and 2 are industrial scale-up production, and 100,000 pieces are prepared.

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Abstract

The invention discloses an enteric-coated sustained release preparation and a preparation method thereof. The preparation is in form of a double-layer enteric-coated sustained release tablet containing paroxetine or pharmaceutically applicative salt thereof. According to the preparation, Acryl-EZE is used as the material of an enteric coating, so that the stability of the sustained release tablet in releasing can be improved.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to an enteric-coated sustained-release composition, in particular to a paroxetine hydrochloride enteric-coated sustained-release tablet and a preparation method thereof. Background technique [0002] Paroxetine hydrochloride, English name: paroxetine, structural formula: [0003] [0004] Paroxetine is a new type of antidepressant, which can be used for various types of depression. Miserin and fluoxetine are similar, but they act quickly and are well tolerated. Paroxetine is still effective for patients with severe depression and other antidepressant treatment ineffective. Pregnant women and children generally do not use it. For patients with severe liver, kidney damage or severe heart damage, it should be limited to the lowest therapeutic dose. [0005] Paroxetine needs to be absorbed in the intestinal tract to be effective, and is widely distributed in...

Claims

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Application Information

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IPC IPC(8): A61K9/30A61K31/4525A61K47/38A61K47/32A61K47/14A61P25/24
Inventor 张青贺王景全陈林韩平
Owner JILIN DONGMENG PHARMA
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