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Pramipexole dihydrochloride sustained release preparation and preparation method thereof

A technology of pramipexole hydrochloride and sustained-release preparations, which is applied in the direction of pharmaceutical formulas, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., which can solve the problem of low uniformity of sustained-release preparations and achieve improved release The effect of degree and uniformity

Active Publication Date: 2015-05-13
葛亚伯
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In view of this, the present invention provides a kind of pramipexole hydrochloride slow-release preparation, by setting the ratio of mixed matrix tablet and coating layer, improves the release degree of slow-release preparation, solves the unevenness of sustained-release preparation in the prior art. high problem

Method used

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  • Pramipexole dihydrochloride sustained release preparation and preparation method thereof
  • Pramipexole dihydrochloride sustained release preparation and preparation method thereof

Examples

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Effect test

Embodiment 1

[0019] A kind of pramipexole hydrochloride sustained-release preparation, is made up of mixed matrix tablet and the coating layer that wraps described mixed matrix tablet, and described mixed matrix tablet is made up of following components (parts by weight): 5 parts of pramipexole hydrochloride, hydroxyl 30 parts of propylmethylcellulose, 20 parts of wax, and the coating layer includes the following components (parts by weight): 50 parts of compressible starch, 50 parts of microcrystalline cellulose, and 50 parts of talcum powder. Its preparation method is as follows:

[0020] 1) Mix pramipexole hydrochloride and hydroxypropyl methylcellulose evenly, add 200 parts of purified water, place in a centrifugal pellet machine, and use 100 parts of purified water to centrifugally make pellets by spraying liquid and adding powder, and then use wax 20 parts by weight are skeleton materials to make the mixed skeleton tablet.

[0021] 2) Mix and stir the compressible starch, the talc p...

Embodiment 2

[0024] A kind of pramipexole hydrochloride sustained-release preparation, is made up of mixed matrix tablet and the coating layer that wraps described mixed matrix tablet, and described mixed matrix tablet is made up of following components (parts by weight): 10 parts of pramipexole hydrochloride, hydroxyl 80 parts of propylmethylcellulose, 40 parts of wax, and the coating layer includes the following components (parts by weight): 100 parts of compressible starch, 100 parts of microcrystalline cellulose, and 100 parts of micronized silica gel. Its preparation method is as follows:

[0025] 1) Mix pramipexole hydrochloride and hypromellose evenly, add 200 parts of purified water and 200 parts of ethanol, place in a centrifugal pellet machine, use 150 parts of purified water and 150 parts of ethanol to spray liquid and add powder After centrifugal pelletizing, wax is used as the skeleton material to make the mixed skeleton tablet.

[0026] 2) Mix and stir the compressible starc...

Embodiment 3

[0029] A kind of pramipexole hydrochloride sustained-release preparation, is made up of mixed matrix tablet and the coating layer that wraps described mixed matrix tablet, and described mixed matrix tablet is made up of following components (parts by weight): 25 parts of pramipexole hydrochloride, hydroxyl 150 parts of propylmethylcellulose, 80 parts of wax, and the coating layer includes the following components (parts by weight): 200 parts of compressible starch, 200 parts of microcrystalline cellulose, and 150 parts of talcum powder. Its preparation method is as follows:

[0030] 1) Mix pramipexole hydrochloride and hypromellose, extrude strips through a sieve plate with a pore size of 0.5 mm, and use wax as the skeleton material to make the mixed skeleton tablet.

[0031] 2) Mix and stir the compressible starch, the lubricant, and the microcrystalline cellulose with 400 parts of ethanol to uniformly prepare a suspension.

[0032] 3) Put the mixed matrix tablet into a flui...

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Abstract

The invention discloses a pramipexole dihydrochloride sustained release preparation and a preparation thereof. The pramipexole dihydrochloride sustained release preparation consists of mixed matrix tablets and coatings wrapping the mixed matrix tablets, wherein the mixed matrix tablets comprise the following components in parts by weight: 5-50 parts of pramipexole dihydrochloride, 30-300 parts of hydroxypropyl methyl cellulose, and 20-250 parts of wax; the coatings comprise the following components in parts by weight: 50-400 parts of compressible starch, 50-500 parts of microcrystalline cellulose, and 50-500 parts of a lubricant; the weight of the mixed matrix tablets is 10-60% of that of the coatings. The wax is used as matrix materials, the proportion of the mixed matrix tablets to the coatings is set so as to improve the releasing rate and the uniformity of the sustained release preparation, and the sustained release preparation which is taken once one day is prepared.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a sustained-release preparation of pramipexole acid and a preparation method thereof. Background technique [0002] Parkinson's disease (PD), also known as parkinsonism, is one of the most common neurodegenerative diseases. The incidence group is mainly concentrated in the population over 60 years old, and the incidence rate is 10-21 / 100,000 population / year. The etiology and pathogenesis of PD are not yet clear, and may be related to social factors, drug factors, and patient factors. Clinical symptoms are mainly manifested in bradykinesia, muscle rigidity, resting tremor, abnormal posture and gait, cognitive / mental abnormalities, sleep disturbance, autonomic dysfunction, sensory disturbance, etc. Currently, the drugs for treating Parkinson's disease on the market are mainly pramipexole hydrochloride sustained-release tablets, most of which are three times a ...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K31/428A61K47/44A61K47/38A61K47/36A61P25/16A61K47/06
Inventor 葛亚伯苏东晓
Owner 葛亚伯
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