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Stable paroxetine hydrochloride tablet and preparation method thereof

A technology of paroxetine hydrochloride tablets and paroxetine hydrochloride, which is applied in the field of medicine, can solve the problems of reddening of paroxetine hydrochloride products and deterioration of the hardness of paroxetine hydrochloride tablets, etc., and achieve the goal of solving changes in hardness, inhibiting reddening of products, and complete dissolution Effect

Active Publication Date: 2019-07-23
山东启荣科技有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] The present invention proposes a stable paroxetine hydrochloride tablet and a preparation method thereof, which solves the problem of the reddening of the paroxetine hydrochloride product in the wet granulation process and the problem of paroxetine hydrochloride tablets under high temperature when calcium phosphate dihydrate is used as the main filler. The problem of poor hardness

Method used

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  • Stable paroxetine hydrochloride tablet and preparation method thereof
  • Stable paroxetine hydrochloride tablet and preparation method thereof
  • Stable paroxetine hydrochloride tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] A stabilized tablet of paroxetine hydrochloride containing the following components by weight per 1000 tablets:

[0040] Paroxetine Hydrochloride 22.8g, Calcium Hydrogen Phosphate Dihydrate 245.7g, Povidone K30 15g, Sucrose 9g, Carboxymethyl Starch Sodium 18g, Magnesium Stearate 1.5g, Opadry 9g,

[0041] Its preparation method adopts a wet granulation process, and the wetting agent is purified water, which specifically includes the following steps:

[0042] S1. According to the above formula, weigh each component for later use;

[0043] S2, mixing paroxetine hydrochloride evenly with other components in the formula;

[0044] S3, add wetting agent, continue granulation;

[0045] S4, drying the prepared wet granules, and pressing into tablets;

[0046] S5, coating the tablet core to obtain a stable paroxetine hydrochloride tablet.

Embodiment 2

[0048] A stabilized tablet of paroxetine hydrochloride containing the following components by weight per 1000 tablets:

[0049] Paroxetine Hydrochloride 22.8g, Calcium Hydrogen Phosphate Dihydrate 241.2g, Povidone K30 15g, Sucrose 15g, Carboxymethyl Starch Sodium 18g, Magnesium Stearate 3g, Opadry 9g,

[0050] Its preparation method adopts the wet granulation process, and the wetting agent is an aqueous solution of povidone K30, and the specific steps are the same as in Example 1.

Embodiment 3

[0052] A stabilized tablet of paroxetine hydrochloride containing the following components by weight per 1000 tablets:

[0053] Paroxetine Hydrochloride 22.8g, Calcium Hydrogen Phosphate Dihydrate 229.2g, Povidone K30 9g, Sucrose 18g, Carboxymethyl Starch Sodium 18g, Magnesium Stearate 3g, Opadry 9g,

[0054] Its preparation method adopts the wet granulation process, the wetting agent is purified water, and the specific steps are the same as in Example 1.

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Abstract

The invention belongs to the technical field of medicines, and provides a stable paroxetine hydrochloride tablet and a preparation method thereof. The paroxetine hydrochloride tablet comprises the following components in parts by weight: 7.6 parts of paroxetine hydrochloride, 67.4-81.9 parts of a filler, 2-5 parts of an adhesive, 3-10 parts of a stabilizer, 5-7 parts of a disintegrant and 0.5-3 parts of a lubricant, wherein the stabilizer is sucrose, the filler is calcium hydrogen phosphate dihydrate, the disintegrant is sodium carboxymethyl starch, the adhesive is povidone K30, and the lubricant is magnesium stearate. The preparation method of the paroxetine hydrochloride tablet adopts a wet granulation process. The method solves the problems that paroxetine hydrochloride products turn red in the wet granulation process and the hardness of paroxetine hydrochloride tablets is poor at high temperature when calcium phosphate dihydrate is used as a main filler.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a stable paroxetine hydrochloride tablet and a preparation method thereof. Background technique [0002] Paroxetine Hydrochloride Tablets is a drug for treating depression that was launched in the 1990s. At present, it has been produced and sold by many companies, and it is widely used around the world, bringing good benefits to patients. [0003] Paroxetine hydrochloride chemical name: (1)-(3S,4R)-4-(4-fluorophenyl)-3-[[(3,4-methylenedioxy)phenoxy]methyl]piperidine Hydrochloride hemihydrate, its structural formula is as follows: [0004] [0005] Molecular formula: [0006] Molecular weight: 374.84 [0007] Paroxetine hydrochloride contains aromatic ether and secondary ammonia structure, which is greatly affected by humidity and temperature. Its hydrochloride form is relatively stable, and its stability becomes poor in alkaline environment, and it will degrade under hot ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K31/4525A61K47/36A61K47/32A61K47/02A61K47/26A61P25/24
CPCA61K9/2009A61K9/2018A61K9/2027A61K9/2059A61K9/2866A61K31/4525A61P25/24
Inventor 刘智勇王海东王华宇
Owner 山东启荣科技有限公司
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