Pramipexole dihydrochloride sustained-release tablets and preparation method thereof

A technology of pramipexole hydrochloride and sustained-release tablets, applied in the field of pramipexole hydrochloride sustained-release tablets and its preparation, can solve the problems of exacerbating Parkinson's disease in patients, and achieve the effect of strong sustained-release ability

Active Publication Date: 2016-03-09
JIANGSU SHENHUA PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The study analyzed that this abnormality is related to the metabolism of pramipexole hydrochloride by the liver and kidney in the body. When this side effect occurs, the patient has to reduce the dosage of the drug, but with the reduction of the dosage, the patient's Parkinson's disease is aggravated

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Pramipexole hydrochloride passes through a 100-mesh sieve, cornstarch and microcrystalline cellulose pass through a 100-mesh sieve, xanthan gum (molecular weight is 2×10 6 —2×10 7 ) and gum arabic through a 200-mesh sieve, and other auxiliary materials through a 80-mesh sieve. Take by weighing according to prescription quantity, prescription is as follows:

[0027] 1.5 parts by weight of pramipexole hydrochloride, 20 parts by weight of xanthan gum, 10 parts by weight of gum arabic, 180 parts by weight of corn starch, 120 parts by weight of microcrystalline cellulose, 10 parts by weight of micropowder silica gel, and 8 parts by weight of magnesium stearate. Mix evenly to obtain mixture A; the obtained mixture A is compressed into tablets, and the hardness of the tablet is 10kg / cm 2 .

[0028] The dissolution results of the pramipexole hydrochloride sustained-release tablets prepared in Example 1 under different time and medium conditions are shown in Table 1.

[0029...

Embodiment 2

[0032] Pramipexole hydrochloride passes through a 100-mesh sieve, cornstarch and microcrystalline cellulose pass through a 100-mesh sieve, xanthan gum (molecular weight is 2×10 6 —2×10 7 ) and gum arabic through a 200-mesh sieve, and other auxiliary materials through a 80-mesh sieve. Take by weighing according to prescription quantity, prescription is as follows:

[0033] 4.5 parts by weight of pramipexole hydrochloride, 28 parts by weight of xanthan gum, 15 parts by weight of gum arabic, 160 parts by weight of corn starch, 105 parts by weight of microcrystalline cellulose, 8 parts by weight of micronized silica gel, and 10 parts by weight of magnesium stearate. Mix evenly to obtain the mixture, and the obtained mixture is compressed into tablets, and the tablet hardness is 8kg / cm 2 .

[0034] The dissolution results of the pramipexole hydrochloride sustained-release tablets prepared in Example 2 under different time and medium conditions are shown in Table 2.

[0035] Dis...

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Abstract

The invention discloses pramipexole dihydrochloride sustained-release tablets and a preparation method thereof. According to the pramipexole dihydrochloride sustained-release tablets, by adopting a composition of natural high-molecular xanthan gum and Arabic gum as a sustained-release carrier matrix, stable blood concentration can be effectively regulated and controlled, daily administration frequency can be reduced, and damage of pramipexole dihydrochloride to liver and kidney metabolism can be relieved. The pramipexole dihydrochloride sustained-release tablets are moderate in hardness, strong in sustained-release capacity and free of drug burst-release effects.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a pramipexole hydrochloride sustained-release tablet and a preparation method thereof. Background technique [0002] Parkinson's disease (Parkinson's Disease) is a chronic degenerative disorder of the central nervous system, which will impair the patient's motor skills, language ability and other functions. Its cause is still unknown, but it is speculated that it is related to the rapid degeneration of brain cells in the basal ganglia and substantial nigra, which cannot produce enough nerve-guiding substances dopamine and enhanced choline. Dopamine is needed in the brain to command muscle activity, and a lack of sufficient dopamine will result in various activity disorders. [0003] Pramipexole is a dopamine D2 receptor agonist used in the treatment of Parkinson's disease, the chemical name is S(-)-2-amino-6-n-propylamino-4,5,6,7-tetrahydrobenzo Thiazole, the marketed...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K31/428A61K47/36A61P25/16
Inventor 袁兵兵张芙蓉王英燕李荀徐国华
Owner JIANGSU SHENHUA PHARMA
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