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Ropinirole hydrochloride sustained-release preparation and preparation method thereof

A technology for ropinirole hydrochloride and sustained-release preparations, which is applied in the field of ropinirole hydrochloride sustained-release preparations and their preparation, and can solve the problems of inconvenience of movement, unsuitability of common dosage forms for clinical application, etc.

Inactive Publication Date: 2009-07-29
北京华禧联合科技发展有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The currently marketed ropinirole preparations are mainly ordinary coated tablets, which need to be used three times a day, while Parkinson's patients present with inconvenient mobility. For Parkinson's disease patients who need long-term medication, ordinary dosage forms are no longer suitable for clinical application

Method used

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  • Ropinirole hydrochloride sustained-release preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] (1) 140g ropinirole hydrochloride powder, 40g sodium carboxymethyl starch and 800g lactose are mixed uniformly, granulated with 10% povidone K30 to form drug-containing granules, and the granules are sized to obtain 800g with a particle size of 16 to 30 mesh particles.

[0021] (2) With a fluidized bed coating machine, spray 180g of a coating solution containing the following composition on 300g of the above-mentioned granules to obtain coated granules. and Eudragit L100-

[0022] Composition Weight (%)

[0023] Ethyl cellulose 11.6

[0024] Sodium Lauryl Sulfate 0.5

[0025] Triethyl citrate 4.7

[0026] Methacrylic acid copolymer 2.7

[0027] Distilled water 80.5

[0028] Total 100.0

[0029] (3) Using a fluidized bed coating machine, atomize and spray 180 g of a coating liquid containing the following composition on 300 g of the above-mentioned granules to obtain coated granules.

[0030] Composition Weight (%)

[0031] Ethyl cellulose 12.0

[0032] Sodi...

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PUM

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Abstract

The invention relates to a ropinirole hydrochloride slow-release preparation. At least one layer of a coating membrance containing a hydrophobic substance and a plastic excipient or a coating membrance containing the compositions and an enteric-coated macromolecular substance is used to coat particles containing ropinirole hydrochloride so as to form coated particles; and the coated particles and other excipients and disintegrating agents are encapsulated into a hard capsule or pressed into a tablet together.

Description

Technical field [0001] The invention relates to a sustained-release preparation of ropinirole hydrochloride and a preparation method thereof. The preparation is composed of drug-containing coated granules and excipients, wherein the coating film of the drug-containing granules contains hydrophobic film-forming materials, enteric film-forming materials and plasticizers. By changing the composition of the coating film, coating amount and The ratio of the mixture of coated granules with different coating amounts can adjust the release rate of ropinirole hydrochloride in an appropriate range. The drug can be released continuously and steadily for 24 hours or longer, which is more conducive to the clinical medication and treatment of patients. Background technique [0002] Ropinirole hydrochloride is a dopamine D3 agonist. Clinical trials have shown that ropinirole can be used alone in the treatment of early Parkinson's disease, and can also be used in combination with levodopa ...

Claims

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Application Information

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IPC IPC(8): A61K9/28A61K9/48A61K31/4045A61K47/34A61K47/38A61P25/16
Inventor 谢晓东
Owner 北京华禧联合科技发展有限公司
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