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Paroxetine enteric sustained-release preparation and preparation method thereof

A slow-release preparation and preparation technology, which is applied in the directions of pill delivery, pharmaceutical formulations, and non-active ingredients medical preparations

Active Publication Date: 2014-12-03
BEIJING WINSUNNY PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The inventor has developed a kind of paroxetine enteric-coated slow-release preparation through a large number of tests, and this preparation has solved the problem of paroxetine stability and release degree in the above-mentioned paper

Method used

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  • Paroxetine enteric sustained-release preparation and preparation method thereof
  • Paroxetine enteric sustained-release preparation and preparation method thereof
  • Paroxetine enteric sustained-release preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Element Dosage (g) Paroxetine hydrochloride (equivalent to paroxetine 12.5g) 14.22 hypromellose 40.5 lactose 42 microcrystalline cellulose 26.5 Povidone 9

[0030] Preparation:

[0031] (1) Mix and sieve paroxetine hydrochloride and hypromellose to obtain mixed powder a;

[0032] (2) Evenly mix the mixed powder a with lactose and microcrystalline cellulose to obtain the mixed powder b;

[0033] (3) Add povidone ethanol solution into povidone into mixed powder b, granulate and dry;

[0034] (4) Press into tablets, enteric-coated, and the weight gain of the coating is 6-8%.

Embodiment 2

[0036] Element Dosage (g) Paroxetine hydrochloride (equivalent to paroxetine 12.5g) 14.22 hypromellose 20 Methylcellulose 12 lactose 36 microcrystalline cellulose 25 Povidone 7 Magnesium stearate 0.65 Micropowder silica gel 0.65

[0037] Preparation:

[0038] (1) Mix and sieve paroxetine hydrochloride, hypromellose and methylcellulose to obtain mixed powder a;

[0039] (2) Evenly mix the mixed powder a with lactose and microcrystalline cellulose to obtain the mixed powder b;

[0040] (3) Add povidone ethanol solution into povidone into mixed powder b, granulate and dry;

[0041] (4) Add magnesium stearate and micronized silica gel;

[0042] (5) Press into tablets, enteric-coated, and the weight gain of the coating is 6-8%.

Embodiment 3

[0044] Element Dosage (g) Paroxetine hydrochloride (equivalent to paroxetine 12.5g) 14.22 Hydroxyethyl cellulose 20 lactose 30 microcrystalline cellulose 20.5 Povidone 5

[0045] The preparation method is the same as in Example 1.

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PUM

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Abstract

The invention discloses a paroxetine enteric sustained-release preparation and a preparation method thereof. The paroxetine enteric sustained-release preparation comprises a paroxetine tablet core and an enteric coating. The paroxetine tablet core comprises paroxetine or its salt, a hydrophilic gel material, a diluent and a binder. The diluent comprises a mixture of lactose and microcrystalline cellulose or a mixture of lactose and pregelatinized starch. The paroxetine enteric sustained-release preparation has good stability, active components are not influenced by extraneous factors easily, content is not changed basically, a release curve is stable, tablet surface appearance is good, and the preparation method is simple, can be operated easily and is suitable for industrial large-scale production.

Description

technical field [0001] The invention relates to a paroxetine preparation and a preparation method thereof, in particular to a paroxetine enteric-coated sustained-release preparation and a preparation method thereof. Background technique [0002] Depression is a common mood disorder, which can be caused by various reasons. The main clinical feature is marked and persistent low mood, and the low mood is not commensurate with the situation. In severe cases, suicidal thoughts and behaviors may appear. With the accelerated pace of life and increased stress, the incidence of depression is also on the rise. According to the statistics of the World Health Organization, depression has become the fourth largest disease in the world. It is estimated that by 2020, it may become second only to coronary heart disease. the second leading disease. [0003] Paroxetine was developed by Glaxo with the chemical name (3s)trans-3-[(1,3-benzodioxol-5-yloxy)methyl]-4-(4-fluorophenyl ) piperidine,...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4525A61K9/28A61K47/26A61K47/38A61K47/36A61P25/22A61P25/24A61P25/00
Inventor 邹文娟郝艳山苏晓峰胡晓虎李泳陈启龙梅喆
Owner BEIJING WINSUNNY PHARMA CO LTD
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