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A kind of piribedil sustained-release tablet and preparation method thereof

A technology for piribedil and sustained-release tablets, which is applied in the directions of pharmaceutical formulations, medical preparations with inactive ingredients, and medical preparations containing active ingredients, etc. phenomenon and other problems, to achieve a good slow-release effect, overcome difficulties in regulation, and expand production.

Active Publication Date: 2020-07-24
SUZHOU HOMESUN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Since the 1960s, Western medicine has been using levodopa replacement therapy in the treatment of PD. It has been found that the effect of replacement therapy generally begins to decline after 3 to 5 years, and drug-induced movement disorders (dyskinesia) appear as manifestations. Complications, early side effects include nausea, anorexia, dizziness; long-term use can cause end-of-dose phenomenon, on-off phenomenon and movement disorders
Has not been found in piribedil as a hydrophobic matrix material to make extended-release tablets

Method used

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  • A kind of piribedil sustained-release tablet and preparation method thereof
  • A kind of piribedil sustained-release tablet and preparation method thereof
  • A kind of piribedil sustained-release tablet and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0032] Embodiment 1: Preparation of piribedil sustained-release tablets

[0033] Take by weighing 2.5g piribedil, 2.5g glyceryl palmitate stearate, 5g microcrystalline cellulose, cross 80 mesh sieves after mixing uniformly according to the equivalent incremental method, the waxy molten liquid of 2.5g (0.5g white beeswax , 1g palm wax and 1g PEG 6000 Add ethanol, melt at 85°C and dry to remove ethanol) Add the main drug, microcrystalline cellulose and glyceryl palmitate stearate into the mixture, use the ethanol solution of PVPK30 (concentration: 5%wt.) as the binder (solution Use amount 10g) to make soft material, granulate with 30 mesh sieve, dry at 60°C for 1 hour, granulate with 30 mesh sieve, add 0.2g magnesium stearate and 0.3g silicon dioxide, mix well, and press into tablets.

Embodiment 2

[0034] Embodiment 2: Preparation of piribedil sustained-release tablets

[0035] Take by weighing 2.5g piribedil, 5g glyceryl palmitate stearate, 2.5g microcrystalline cellulose, cross 80 mesh sieves after mixing uniformly according to the equivalent incremental method, the waxy molten liquid of 2.5g (0.5g white beeswax , 1g palm wax and 1g PEG 6000 Add ethanol, melt at 85°C and dry to remove ethanol) Add the main drug, microcrystalline cellulose and glyceryl palmitate stearate into the mixture, use the ethanol solution of PVPK30 (concentration: 5%wt.) as the binder (solution Use amount 10g) to make soft material, granulate with 30 mesh sieve, dry at 60°C for 1 hour, granulate with 30 mesh sieve, add 0.2g magnesium stearate and 0.3g silicon dioxide, mix well, and press into tablets.

Embodiment 3

[0036]Embodiment 3: Preparation of piribedil sustained-release tablets (comparative example)

[0037] Take by weighing 2.5g piribedil, 7.5g glyceryl palmitostearate, cross 80 mesh sieves after mixing uniformly according to the equal amount addition method, the waxy molten liquid of 2.5g (0.5g white beeswax, 1g palm wax and 1gPEG 6000 Add ethanol and melt at 85°C) into the mixture of the main drug, microcrystalline cellulose and glyceryl palmitate stearate, and use the ethanol solution of PVP K30 (concentration: 5%wt.) as the binder (the amount of the solution is 10g) To make soft material, granulate with a 30-mesh sieve, dry at 60°C for 1 hour, granulate with a 30-mesh sieve, add 0.2g magnesium stearate and 0.3g silicon dioxide, mix well, and press into tablets.

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Abstract

The invention belongs to the field of pharmaceutical preparations and discloses a piribedil sustained-release tablet and a preparation method thereof. The sustained-release tablet is prepared from, by mass, 10%-40% of piribedil, 50%-80% of a hydrophobic framework material, 1%-5% of an adhesive and 0.5%-5% of a lubricating agent, wherein the hydrophobic framework material is a mixture of microcrystalline cellulose, glyceride, wax and a melting promotion agent, glyceride refers to one or two of glycerin monostearate or glyceryl palmitostearate, and wax refers to one or two of white beeswax or palm wax. The sustained-release tablet which comprises the hydrophobic framework material and the like has advantages of high controllability in medicine release, applicability to treatment of Parkinson's disease, simple process and benefits to production expansion.

Description

technical field [0001] The invention relates to a pharmaceutical preparation and a preparation method thereof, in particular to a piribedil sustained-release tablet and a preparation method thereof. Background technique [0002] Parkinson's disease (PD) is a common degenerative disease of the central nervous system. The main symptoms are decreased movement, muscle rigidity and tremor. DA neurotransmitter decreased, and eosinophilic Lewy bodies formed in 7EC6 cells. The incidence of PD increases with age, and the incidence rate is 0.5% for those over 50 years old, and 1% for those over 60 years old. There are 1.7 million PD patients in my country, and it is estimated that about 100,000 new patients will be added each year. Since the 1960s, Western medicine has been using levodopa replacement therapy in the treatment of PD. It has been found that the effect of replacement therapy generally begins to decline after 3 to 5 years, and drug-induced movement disorders (dyskinesia)...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/22A61K31/506A61K47/38A61K47/14A61K47/44A61P25/16
CPCA61K9/0002A61K9/2013A61K9/2054A61K31/506
Inventor 曹青日张晓雪陆红彬樊超王晓花
Owner SUZHOU HOMESUN PHARMA
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