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Pramipexole dihydrochloride transdermal patch and preparation method thereof

A technology of pramipexole hydrochloride and transdermal patch is applied to the transdermal patch of pramipexole hydrochloride and its preparation field, and can solve the problems of drugs entering the body and the like

Inactive Publication Date: 2014-03-05
CHINA PHARM UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, multiple administrations are still required, failing to allow the drug to enter the body at a constant rate

Method used

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  • Pramipexole dihydrochloride transdermal patch and preparation method thereof
  • Pramipexole dihydrochloride transdermal patch and preparation method thereof
  • Pramipexole dihydrochloride transdermal patch and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] The composition of the first layer (close to the release layer): 1.2g polyvinyl alcohol (PVA17-88), 0.3g polyvinylpyrrolidone (PVP), 0.2g eucalyptus oil, 0.12g azone, 800.2g Tween, Propylene glycol 0.4g, glycerin 0.2g, edetate disodium 0.1g, pramipexole hydrochloride 20mg.

[0028] The composition of the second layer (middle layer): polyvinyl alcohol (PVA17-88) 2.4g, polyvinylpyrrolidone (PVP) 0.6g, eucalyptus oil 0.4g, azone 0.24g, Tween 800.4g, propylene glycol 0.8g, glycerin 0.4g.

[0029] The composition of the third layer (close to the backing layer): polyvinyl alcohol (PVA17-88) 1.2g, polyvinylpyrrolidone (PVP) 0.3g, eucalyptus oil 0.2g, azone 0.12g, Tween 800.2g, propylene glycol 0.4 g, glycerin 0.2g, disodium 7-diamine tetraacetate 0.1g, pramipexole hydrochloride 60mg.

[0030] Preparation method: fully swell polyvinyl alcohol and polyvinyl pyrrolidone with 50% ethanol, add eucalyptus oil, Tween 80, azone, propylene glycol and glycerin, dissolve and mix with m...

Embodiment 2

[0033] The first layer (close to the anti-adhesive layer) composition: polyvinyl alcohol (PVA17-88) 2.0g, polyvinylpyrrolidone (PVP) 0.4g, N-methylpyrrolidone 0.2g, propylene glycol 0.3g, glycerin 0.3g, vitamin C0.2g, pramipexole hydrochloride 15mg.

[0034]The composition of the second layer (middle layer): polyvinyl alcohol (PVA17-88) 2.8g, polyvinylpyrrolidone (PVP) 0.2g, N-methylpyrrolidone 0.4g, propylene glycol 0.3g, glycerin 0.4g, vitamin C0.2g, hydrochloric acid Pramipexole 30mg.

[0035] The composition of the third layer (close to the backing layer): polyvinyl alcohol (PVA17-88) 1.4g, polyvinylpyrrolidone (PVP) 0.3g, N-methylpyrrolidone 0.2g, propylene glycol 0.2g, glycerin 0.2g, vitamin C0. 3g, pramipexole hydrochloride 45mg.

[0036] Prepared as in Example 1, prepared to contain pramipexole hydrochloride 1.84mg / cm 2 transdermal patch. A modified Franz diffusion cell was used to measure the penetration rate of the transdermal patch in the abdominal skin of the h...

Embodiment 3

[0038] The first layer (close to the anti-adhesive layer) composition: polyvinyl alcohol (PVA17-88) 0.6g, polyvinylpyrrolidone (PVP) 0.2g, menthol 0.2g, Tween 800.1g, glycerin 0.4g, sodium metabisulfite 0.05g, pramipexole hydrochloride 1.6mg.

[0039] The composition of the second layer (middle layer): polyvinyl alcohol (PVA17-88) 1.8g, polyvinylpyrrolidone (PVP) 0.3g, menthol 0.25g, Tween 800.1g, glycerin 0.5g, sodium metabisulfite 0.05g, general hydrochloride Laxole 6.4mg.

[0040] The composition of the third layer (close to the backing layer): polyvinyl alcohol (PVA17-88) 0.8g, polyvinylpyrrolidone (PVP) 0.1g, menthol 0.2g, Tween 800.1g, glycerin 0.4g, sodium metabisulfite 0.05g , pramipexole hydrochloride 3.2mg.

[0041] Prepared as in Example 1, prepared to contain pramipexole hydrochloride 2.04mg / cm 2 transdermal patch. A modified Franz diffusion cell was used to measure the penetration rate of the transdermal patch in the abdominal skin of the hair-free rats, and t...

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Abstract

The invention particularly relates to a pramipexole dihydrochloride transdermal patch and a preparation method thereof, and belongs to the field of medicament preparation. A hydrophilic matrix mixed penetration enhancer is utilized, so that the condition that a medicament quickly releases within a long period of time at a constant speed, and achieves a relatively good permeation rate is guaranteed by adopting a multi-layer patch technology. The invention also discloses a preparation method of the pramipexole dihydrochloride transdermal patch, and the transparent patch which is good in uniformity is prepared.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a transdermal patch of pramipexole hydrochloride and a preparation method thereof. Background technique [0002] Pramipexole is a non-ergot alkaloid dopamine agonist mainly used in the treatment of Parkinson's disease. It can be used alone to treat Parkinson's disease in the early stage, can delay the appearance of motor symptoms, and can improve the quality of life of patients compared with levodopa. In the late stage, it can be used in combination with dopamine to treat Parkinson's disease, which can reduce the dose of levodopa. Pramipexole has a neuroprotective effect on dopamine, and it has unique advantages in the treatment of neuroprotection and restless legs syndrome (RLS), which can significantly delay the development of Parkinson's disease. Compared with other ergot dopamine receptor agonists, it does not cause heart valve damage. In addition to treating mot...

Claims

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Application Information

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IPC IPC(8): A61K9/70A61K31/428A61K47/32A61P25/16
Inventor 刘建平汪铃
Owner CHINA PHARM UNIV
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