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Piribedil sustained-release tablet and preparation method thereof

A technology of piribedil and sustained-release tablets, which is applied in the direction of pharmaceutical formulations, medical preparations containing no active ingredients, and medical preparations containing active ingredients, etc., which can solve the problems of difficult drug release and poor correlation between in vivo and in vitro, etc. Achieve the effects of simple process, improved drug efficacy and convenient use

Inactive Publication Date: 2015-06-24
SUZHOU HOMESUN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The skeleton material of the sustained-release preparation is preferably hypromellose from hydrophilic or hydrophobic materials with different solubility characteristics, but there are still poor in vivo and in vitro correlations and difficulty in drug release caused by the use of a single hydrophilic polymer. regulation and other issues

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

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

[0033] Prepare 25g piribedil sustained-release tablets, first take by weighing piribedil that accounts for 38.5% of the quality of piribedil sustained-release tablets, 10% skeleton material, 25% lactose, and 25% microcrystalline cellulose. The skeleton material is a mixture of hydroxypropylmethylcellulose K4M, hydroxypropylmethylcellulose K15M and acrylic resin RS PO; by mass ratio, hydroxypropylmethylcellulose K4M: hydroxypropylmethylcellulose K15M: acrylic resin RS PO is 2:1:1, and the acrylic resin RS PO is a copolymer of ethyl acrylate, methyl methacrylate and trimethylaminoethyl methacrylate chloride, and the molar ratio of the three is 1:2 : 0.1. Then use 1% ethanol with a concentration of 50% as a binder to make a soft material, granulate with a 18-mesh sieve, dry at 60°C for 2 hours, and after granulation with a 18-mesh sieve, add 0.5% magnesium stearate, mix well, and press piece.

Embodiment 2

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

[0035] Prepare 30g piribedil sustained-release tablets, first take by weighing piribedil that accounts for 20% of the quality of piribedil sustained-release tablets, 28.5% skeleton material, 25% lactose, and 23% microcrystalline cellulose. The skeleton material is a mixture of hydroxypropylmethylcellulose K4M, hydroxypropylmethylcellulose K15M and acrylic resin RS PO; by mass ratio, hydroxypropylmethylcellulose K4M: hydroxypropylmethylcellulose K15M: acrylic resin RS PO is 2:1:1, and the acrylic resin RS PO is a copolymer of ethyl acrylate, methyl methacrylate and trimethylaminoethyl methacrylate chloride, and the molar ratio of the three is 1:2 : 0.1. Then use 3% ethanol with a concentration of 50% as a binder to make a soft material, granulate with a 18-mesh sieve, dry at 60°C for 2 hours, and after granulation with a 18-mesh sieve, add 0.5% magnesium stearate, mix well, and press piece.

Embodiment 3

[0036] Embodiment 3: Preparation of piribedil sustained-release tablets

[0037] Prepare 30g piribedil sustained-release tablets, first take by weighing piribedil that accounts for 20% of the quality of piribedil sustained-release tablets, 38.5% skeleton material, 20% lactose, and 20% microcrystalline cellulose. The skeleton material is a mixture of hydroxypropylmethylcellulose K4M, hydroxypropylmethylcellulose K15M and acrylic resin RS PO; by mass ratio, hydroxypropylmethylcellulose K4M: hydroxypropylmethylcellulose K15M: acrylic resin RS PO is 2:1:1, and the acrylic resin RS PO is a copolymer of ethyl acrylate, methyl methacrylate and trimethylaminoethyl methacrylate chloride, and the molar ratio of the three is 1:2 : 0.1. Then use 1% ethanol with a concentration of 50% as a binder to make a soft material, granulate with a 18-mesh sieve, dry at 60°C for 2 hours, and after granulation with a 18-mesh sieve, add 0.5% magnesium stearate, mix well, and press piece.

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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 piribedil sustained-release tablet mainly comprises the following components in percent by mass: 20-40% of piribedil, 10-60% of a framework material, 10-50% of a filling agent, 1-5% of a binding agent and 0.5-4% of a lubricating agent. The piribedil sustained-release tablet comprises a hydrophilic gel framework material and an acrylic resin-like framework material which are used for regulating release rate of main medicines. The prepared piribedil sustained-release tablet can be used for treating Parkinson's disease. The piribedil sustained-release tablet product has the advantages that administration frequency is reduced, medicine taking compliance of a patient is improved and pharmaceutical effect and medicine safety are improved, so that the piribedil sustained-release tablet is more applicable to the patient; and meanwhile, a technique of the piribedil sustained-release tablet is simple, and industrial large-scale production is benefited.

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), also known as paralysis agitans, is a common degenerative disease of the nervous system in middle-aged and elderly people. It is characterized by degeneration and loss of dopaminergic neurons in the substantia nigra and the formation of Lewy bodies. Muscle rigidity and abnormal posture and gait. PD is one of the difficult diseases identified by the World Health Organization. The prevalence rate of the elderly population over 65 years old is 2%, and its clinical incidence tends to increase. There is no radical cure, which seriously endangers the physical and mental health of middle-aged and elderly people, and brings huge burdens to families and society. [0003] Pirabedil is a dopaminergic agonist developed by Servier Phar...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K31/506A61K47/38A61K47/32A61P25/16
Inventor 曹青日陆红彬朱晓音
Owner SUZHOU HOMESUN PHARMA
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