Pramipexole transdermal patch and preparing method thereof
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A technology of pramipexole and transdermal patch, applied in the field of medicine
Pending Publication Date: 2019-07-12
大道隆达(北京)医药科技发展有限公司
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Problems solved by technology
Pramipexole patch is a new type of drug delivery system, which can not only improve the poor compliance of injections, but also avoid the stimulation of the gastrointestinal tract by oral dosage forms, slow drug release and reduce drug side effects,
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Embodiment 1
[0019] Dissolve 4,5,6,7-tetrahydrobenzo[d]thiazole-2,6-diamine (250g) in water, resolve with tartaric acid (150g) to obtain 80g of fractions, add propane to Acid anhydride (60g) was stirred and reacted. After the reaction was completed, concentrate under reduced pressure, add water and potassium carbonate to the concentrated residue, extract with ethyl acetate, collect the organic phase and concentrate to obtain a concentrate (100g), add the concentrate to tetrahydrofuran, and add borane solution under nitrogen protection (90ml) to react, after the reaction, extract with n-heptane, and evaporate the organic solvent to obtain pramipexole free base (60g), with a melting point of 117-121°C.
Embodiment 2
[0021]Dissolve 4,5,6,7-tetrahydrobenzo[d]thiazole-2,6-diamine (25g) in water, resolve with tartaric acid (15g) to obtain 8g of fractions, add propane Acid anhydride (6g) was stirred and reacted. After the reaction was completed, concentrate under reduced pressure, add water and potassium carbonate to the concentrated residue, extract with ethyl acetate, collect the organic phase and concentrate to obtain a concentrate (10g), add the concentrate to tetrahydrofuran, and add borane solution under nitrogen protection (10ml) reaction, after the reaction, extraction with ethyl acetate, evaporation of the organic solvent to give pramipexole free base (5.8g), melting point 117 ~ 121 ℃.
Embodiment 3
[0023] Dissolve 4,5,6,7-tetrahydrobenzo[d]thiazole-2,6-diamine (25g) in water, resolve with tartaric acid (15g) to obtain 8g of fractions, add propane Acid anhydride (6g) was stirred and reacted. After the reaction was completed, concentrate under reduced pressure, add water and potassium carbonate to the concentrated residue, extract with ethyl acetate, collect the organic phase and concentrate to obtain a concentrate (10g), add the concentrate to tetrahydrofuran, and add borane solution under nitrogen protection (10ml) to react, after the reaction, extract with dichloromethane, and evaporate the organic solvent to obtain pramipexole free base (6.2g), with a melting point of 117-120°C.
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Abstract
The invention belongs to the technical field of medicine, and discloses a pramipexole transdermal patch and a preparing method thereof. The pramipexole transdermal patch comprises a back lining, a medicine storage library and a binding-prevention layer, wherein the medicine storage library comprises 1-20 wt% of a main medicine pramipexole, 50-90 wt% of a pressure-sensitive adhesive and 0.5-10 wt%of a transdermal absorption accelerator. An inert filler, a tackifier, an antioxidant and the like can also be added, and the dosages of the inert filler, the tackifier, the antioxidant and the like are 0.1-10 wt% separately. The pramipexole transdermal patch is a novel medicine delivery system, the situation that the medicine delivery adaptability of an injection is poor can be avoided, the irritation of the oral dosage form to the gastrointestinal tract can also be avoided, the drug is released slowly, thus the toxic and side effects of the medicine are alleviated, and the curative effect islasting and steady; if medicine delivery needs to be interrupted, what is only needed is to uncover the patch, and thus the patch is convenient to use. The pramipexole transdermal patch also has theadvantages of being good in adhesiveness and flexibility, causing no contamination and the like.
Description
technical field [0001] The invention belongs to the technical field of medicine, and relates to a pramipexole transdermal patch and a preparation method thereof. Background technique [0002] Parkinson's disease (PD) is a common chronic degenerative disease of the central nervous system. The main clinical manifestations are slow movement, resting tremor (extremities and jaw), slow movement and muscle stiffness and other motor symptoms. At the same time, there may be emotional disturbance , sleep disturbance and non-motor symptoms such as autonomic disturbance and restless legs. Along with the increasing attention in patients with Parkinson's disease, the treatment of non-motor symptoms has gradually attracted people's attention. The disease brings great physical and mental pain to the patients, reduces the quality of life and shortens the life expectancy. Parkinson's disease is the second largest neurodegenerative disease after Alzheimer's disease (AD). Epidemiological sur...
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