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Piribedil sustained-release tablet and preparation method thereof

A technology for piribedil and sustained-release tablets, which can be applied to pharmaceutical formulations, medical preparations without active ingredients, and medical preparations containing active ingredients, etc., and can solve problems such as splitting phenomenon, limited types of excipients, and poor compressibility.

Active Publication Date: 2019-12-31
SUZHOU HOMESUN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Pirabedil Sustained-release Tablets have a relatively large content of the main drug. Considering that the weight of the tablet does not change, the types of excipients selected are limited. When pure HPMC is used as the skeleton material, the compressibility is poor and there is a phenomenon of fragmentation. Its dissolution is higher than that of the original preparation. big difference

Method used

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  • Piribedil sustained-release tablet and preparation method thereof
  • Piribedil sustained-release tablet and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0023] Embodiment 1: Preparation of piribedil sustained-release tablets

[0024] Weigh 0.4g piribedil (small particle size < 200µm), 4g hypromellose K15M, 1g lactose, 3g acrylic resin RSPO, mix uniformly according to the method of equal addition, and use 0.5g PVPK30 in 10ml ethanol solution as Adhesive soft material, granulated with 30 mesh sieve, dried at 60°C for 20 minutes, granulated with 30 mesh sieve, added 0.6g piribedil (large particle size 200~600µm), 0.2g magnesium stearate and 0.3g Silica, mixed, compressed into tablets.

Embodiment 2

[0025] Embodiment 2: Preparation of piribedil sustained-release tablets

[0026] Weigh 0.5g piribedil (small particle size < 200μm), 1g hydroxypropyl methylcellulose K4M, 3g microcrystalline cellulose, 2g acrylic resin RSPO, mix uniformly according to the method of equal addition, and use 0.5g PVPK30 10mL ethanol solution is the soft material made of binder, granulate with 30 mesh sieve, dry at 60°C for 20min, after granulation with 30 mesh sieve, add 2.5g piribedil (large particle size 200~600μm), 0.2g stearic acid Magnesium and 0.3g of silicon dioxide, mixed, pressed into tablets.

Embodiment 3

[0027] Embodiment 3: Preparation of piribedil sustained-release tablets

[0028] Weigh 1g of piribedil (small particle size < 200µm), 6g of hydroxypropyl methylcellulose K100M, 4g of a mixture of pregelatinized starch and mannitol, and 4.7g of acrylic resin RSPO, and mix them uniformly according to the method of equal addition. Use 20mL of ethanol solution containing 0.2g PVPK30 as a binder to make soft materials, granulate with a 30-mesh sieve, dry at 60°C for 20min, and granulate with a 30-mesh sieve, add 4g of piribedil (large particle size 200-600µm), 0.05 g magnesium stearate and 0.05 g silicon dioxide, mix well, and compress into tablets.

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Abstract

The invention discloses a piribedil sustained-release tablet that is composed of piribedil particles, a hydrophilic skeleton material, a hydrophobic skeleton material, a filler, a binder and a lubricant. In percentage by weight, the piribedil sustained-release tablet comprises 10%-30% of piribedil particles, 10%-40% of hydrophilic skeleton material, 10%-30% of hydrophobic skeleton material, 10%-40% of filler, 1%-5% of binder and 1%-5% of lubricant. The piribedil particles comprises large-size piribedil and small-size piribedil, wherein the large-size piribedil is 200-600 [mu]m in particle sizeand the small-size piribedil is less than 200 [mu]m in particle size. The piribedil sustained-release tablet of the invention can be used to treat Parkinson disease.

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 relatively common refractory clinical disease, which often causes movement disorders in middle-aged and elderly people. It manifests as resting tremor, bradykinesia, muscle rigidity, and abnormal posture and gait, which greatly affects the quality of life of patients. [0003] Pirabedil is a dopaminergic agonist developed by Servier Pharmaceuticals in France, and its chemical name is 2-(4-piperonyl-1-piperazinyl)pyrimidine. Levodopa preparations are traditional medicines for the treatment of Parkinson's disease by Western medicine. The pathogenesis of Parkinson's is that the dopamine (DA) nervous system in the central nigrostriatum pathway undergoes lesions or necrosis, resulting in the reduction or absence of DA in th...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K47/38A61K47/32A61K31/506A61P25/16
CPCA61K9/2054A61K9/2027A61K31/506A61P25/16
Inventor 曹青日张晓雪陆红彬樊超
Owner SUZHOU HOMESUN PHARMA
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