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Hydrochloric acid pramipexole capsule and preparation method thereof

A technology for pramipexole hydrochloride and pramipexole acid is applied in the field of preparation of pharmaceutical preparations, which can solve the problems of no sample content uniformity detection, extremely high mixing uniformity requirements, and lower hygroscopicity than sifuro.

Active Publication Date: 2013-09-04
北京华睿鼎信科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Focusing on the investigation of the sample's moisture absorption and weight gain within 10 days at 25°C and a relative humidity of 75%, it shows that the moisture absorption of the sample is lower than that of Senfulo. The related substances and dissolution rate did not change significantly, but the inventor measured the average tablet weight and tablet weight difference of the samples but did not detect the content uniformity of the samples
[0012] However, the above-mentioned patent does not mention an important aspect, that is, the uniformity of the content. Because the content of pramipexole hydrochloride in the preparation is extremely low, the preparation method, especially the mixing uniformity, is extremely demanding, which is difficult to achieve with the existing mixing technology. The Chinese Pharmacopoeia requires that the present invention finds a preparation method of pramipexole hydrochloride capsules after research

Method used

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  • Hydrochloric acid pramipexole capsule and preparation method thereof
  • Hydrochloric acid pramipexole capsule and preparation method thereof
  • Hydrochloric acid pramipexole capsule and preparation method thereof

Examples

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Effect test

Embodiment 1

[0050] [Example 1] Preparation of Pramipexole Hydrochloride Capsules

[0051] prescription composition

[0052]

[0053] Preparation Process

[0054] (1) According to the prescription, mannitol, starch, and polylactic acid are passed through an 80-mesh sieve and mixed evenly to obtain a mixed powder;

[0055] (2) Add povidone k30 to the aqueous solution, and dissolve the added pramipexole hydrochloride to obtain an adhesive solution.

[0056] (3) Add the binder solution in step (2) to the powder mixing in step (1), wet sieve and granulate.

[0057] (4) Dry the wet granules in step (3) at 55° C. to 60° C. for 3 hours.

[0058] (5) Take the dried granules and pass through a 16-mesh sieve for sizing, add silicon dioxide and magnesium stearate, and mix well.

[0059] (6) Fill the capsules and get ready.

Embodiment 2

[0060] [Example 2] Preparation of Pramipexole Hydrochloride Capsules

[0061] prescription composition

[0062]

[0063] Preparation Process

[0064] (1) According to the prescription, mannitol, starch, and polylactic acid are passed through an 80-mesh sieve and mixed evenly to obtain a mixed powder;

[0065] (2) Add povidone k30 to the aqueous solution, and dissolve the added pramipexole hydrochloride to obtain an adhesive solution.

[0066] (3) Add the binder solution in step (2) to the powder mixing in step (1), wet sieve and granulate.

[0067] (4) Dry the wet granules in step (3) at 55° C. to 60° C. for 3 hours.

[0068] (5) Take the dried granules and pass through a 16-mesh sieve for sizing, add silicon dioxide and magnesium stearate, and mix well.

[0069] (6) Fill the capsules and get ready.

Embodiment 3

[0070] [Example 3] Preparation of Pramipexole Hydrochloride Capsules

[0071] prescription composition

[0072]

[0073]

[0074] Preparation Process

[0075] (1) According to the prescription, mannitol, starch, and polylactic acid are passed through an 80-mesh sieve and mixed evenly to obtain a mixed powder;

[0076] (2) Add povidone k30 to the aqueous solution, and dissolve the added pramipexole hydrochloride to obtain an adhesive solution.

[0077] (3) Add the binder solution in step (2) to the powder mixing in step (1), and stir quickly to granulate.

[0078] (4) Put the wet granules in step (3) into a fluidized bed for boiling drying, keep the inlet air temperature at 55°C, and the material temperature at 45°C, and boil and dry for 20 minutes.

[0079] (5) Add silicon dioxide and magnesium stearate to the dried granules, and mix well.

[0080] (6) Fill the capsules and get ready.

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Abstract

The invention discloses a hydrochloric acid pramipexole capsule and a preparation method thereof, and belongs to the technical field of pharmaceutical preparations. Each capsule comprises 0.125-0.5mg hydrochloric acid pramipexole, 20-50mg starch, 40-70mg mannitol, 5-10mg polylactic acid, 1.5-3mg povidone K30, 0.5-2mg silicon dioxide and 0.5-2mg magnesium stearate. The preparation method comprises the following steps of uniformly mixing mannitol and the starch at an appropriate amount, adding an adhesive solution dissolved with a main drug, pelletizing, drying, granulating, adding a surplus auxiliary material, encapsulating, and obtaining the capsule.

Description

technical field [0001] The invention relates to the preparation of a pharmaceutical preparation, in particular to a pramipexole hydrochloride capsule and a preparation method thereof. technical background [0002] Pramipexole is a new generation of non-ergot dopamine receptor agonist developed by Boehringer Ingelheim, Germany. It can act on dopamine D2 receptors highly selectively and is used for the treatment of Parkinson's disease. It was first disclosed in US Patent No. 4,731,374, US4843086 and US4886812, and listed in the United States in July 1997, the product name is MIRAPEX and SIFROL . The dosage forms currently on the market include ordinary tablets and sustained-release tablets, and the specifications of ordinary tablets are: 0.125mg, 0.25mg, 0.5mg, 1.0mg, and 1.5mg. The specifications of sustained-release tablets are: 0.375mg, 0.75mg, 1.5mg, 3.0mg, 4.5mg. [0003] The chemical name of pramipexole is S-2-amino-4,5,6,7-tetrahydro-6-(propylamino)-benzothiazole,...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K47/34A61K31/428A61P25/16
Inventor 常珍郑玲玲韩克刚赵优曼
Owner 北京华睿鼎信科技有限公司
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