A kind of pramipexole hydrochloride sustained-release pharmaceutical composition and preparation method thereof

A technology of pramipexole hydrochloride and composition, which is applied in the field of pramipexole hydrochloride sustained-release pharmaceutical composition and its preparation, and can solve the problems of slow and stable release of pramipexole hydrochloride and the like

Active Publication Date: 2022-04-08
海思科制药(眉山)有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] Aiming at the deficiencies in the above-mentioned prior art, the present invention adopts the sustained-release preparation technology to solve the problem of slow and steady release of pramipexole hydrochloride while improving the solubility

Method used

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  • A kind of pramipexole hydrochloride sustained-release pharmaceutical composition and preparation method thereof
  • A kind of pramipexole hydrochloride sustained-release pharmaceutical composition and preparation method thereof
  • A kind of pramipexole hydrochloride sustained-release pharmaceutical composition and preparation method thereof

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Embodiment Construction

[0024] The following specific embodiments are a further description of the present invention, and should not be considered as a limitation of the protection scope of the present invention. This is the prescription and process for 10,000 tablets, and the units are in grams.

[0025]

[0026]

[0027] 1. Weigh each raw and auxiliary material according to the theoretical amount for subsequent use;

[0028] 2. Pass through a 80-mesh sieve for pramipexole hydrochloride, take hypromellose, starch, carbomer, and colloidal silicon dioxide and pass through a 60-mesh sieve respectively and mix them. Put the mixed materials in a V-type mixer at 24-36 rpm Minutes, mixed for 30-35min;

[0029]3. Add magnesium stearate to the second step, 24-36 rpm, mix for 10-15min;

[0030] 4. Take the mixed material and press it into tablets.

[0031]

[0032]

[0033] Result evaluation:

[0034] (1) release in pH6.8 medium: after embodiment 1 prescription adjusts hypromellose K4M consumpt...

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Abstract

The invention provides a pramipexole hydrochloride slow-release composition and a preparation method thereof. The slow-release granules are made of the following raw materials in parts by weight: pramipexole hydrochloride, a lubricant, a skeleton slow-release material, and a filler. Pramipexole hydrochloride is a new anti-Parkinson drug with unique dopamine agonist characteristics and neuroprotective effect. This medicine is an aminobenzothiazole compound, non-ergot selective dopamine D 2 Receptor family agonists are used to treat early and advanced PD, either alone or in combination with levodopa. The invention solves the problem of slowly and stably releasing the pramipexole hydrochloride while improving the solubility of the pramipexole hydrochloride.

Description

technical field [0001] The invention relates to a sustained-release pharmaceutical composition, in particular to a sustained-release pramipexole hydrochloride pharmaceutical composition and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Pramipexole Dihydrochloride Monohydrate, Chinese and English chemical name (6S)-6-N-propyl-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diamino Dihydrochloride monohydrate, (6S)-6-N-propyl-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diamino)dihydrochloridemonohydrate; Chemical Abstracts Number CAS: 191217-81 -9. [0003] Pramipexole Hydrochloride (Pramipexole Dihydrochloride) is a non-ergotamine dopamine D2 receptor agonist, developed by Boehringer Ingelheim, Germany, and first listed in the United States on May 10, 1997, with the trade name Mirapex. [0004] Drug therapy remains the mainstay of Parkinson's disease relief. The results of a large number of clinical trials have proved the s...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/22A61K31/428A61K47/38A61K47/26A61K47/36A61K47/32A61P25/16
CPCA61K9/0002A61K9/2018A61K9/2027A61K9/2054A61K9/2059A61K31/428
Inventor 熊小君姚志昂施薛娇李丹陈九龙
Owner 海思科制药(眉山)有限公司
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