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Paroxetine enteric-coated and sustained-release tablet and preparation method thereof

A technology for enteric and sustained-release tablets of paroxetine, which is applied to pharmaceutical formulations, medical preparations with inactive ingredients, and medical preparations containing active ingredients, etc., can solve disadvantages, reduce production costs, drug prices, and difficulty in drug quality control. and risks, so as to enhance the recognition ability and improve the appearance.

Inactive Publication Date: 2014-09-17
ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The paroxetine enteric-coated sustained-release preparation provided by the above prior art uses a relatively complicated multi-particulate system and double-layer tablet process, which is not conducive to reducing production costs and drug prices, and also makes the quality control of drugs more difficult and risky

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-3

[0044]

[0045]

[0046] The particle size of paroxetine hydrochloride hemihydrate is D90=125 μm, D50=45 μm. 14.22mg of paroxetine hydrochloride hemihydrate is equivalent to 12.5mg of paroxetine, and so on for other specifications.

[0047] Both Eudragit NE30D and L30D-55 in the prescription are water dispersions with a solid content of 30%, and 24.0 (7.2) in the prescription indicates The dosage is 24.0mg, of which the solid content is 7.2mg.

[0048] Tablet core preparation method:

[0049] Active components, fillers, slow-release materials, and binders are mixed evenly, added with 5.8:1 (w / w) alcoholic water solution to granulate, dried in a fluidized bed, and colloidal silicon dioxide and stearin are added after granulation Magnesium acid mixed, compressed into tablets.

[0050] Extended Release Coating:

[0051] Disperse 100g of talc powder (D90=3.8μm) in 366.2g of purified water, stir well, then add 333.3g of After continuing to stir evenly, the above-mentio...

Embodiment 4-5

[0056]

Embodiment 6

[0058]

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PUM

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Abstract

The invention relates to a paroxetine enteric-coated and sustained-release tablet, which comprises a single-layer tablet core, a sustained-release coating film and an enteric coating film, wherein the single-layer tablet core contains paroxetine or pharmaceutically acceptable salt and a sustained-release skeleton material; and the invention further provides a preparation method of the paroxetine enteric-coated and sustained-release tablet. The paroxetine enteric-coated and sustained-release tablet is simple in production technology and stable in quality.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to paroxetine enteric-coated sustained-release tablets and a preparation method thereof. Background technique [0002] Paroxetine, a phenylpiperidine derivative, is a selective 5-hydroxytryptamine (5-HT) reuptake inhibitor (SSRIs), widely used clinically to treat depression. According to relevant surveys, the incidence of depression in my country is about 3%-5%, and more than 26 million people have suffered from depression. With the development of society, white-collar workers living in big cities such as Beijing, Shanghai and Guangzhou quickly become a high-risk group of this disease under the environment of high pressure and high competition. [0003] The chemical name of paroxetine (C19H20FNO3) is (-)-(3S,4S)-4-(4-fluorophenyl)-3-[[3,4-(methyleneoxy)phenoxy]methyl]piperidine Pyridine. Has the following chemical structure: [0004] [0005] In medicine, paroxetine...

Claims

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Application Information

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IPC IPC(8): A61K9/32A61K31/4525A61K47/32A61K47/38A61P25/24
Inventor 邱宗杰陈浩李巧霞胡功允
Owner ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD
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