Opicapone pharmaceutical composition and preparation method thereof

The technology of a composition and Opica, applied in the field of medicine, can solve the problems of difficult to achieve industrialized large-scale production, unstable preparations, and high production costs, and achieve the effects of reliable quality, stable product quality, and improved yield.

Inactive Publication Date: 2017-03-29
TIANJIN HANKANG PHARMA BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The applicant has found through research that the oral preparations prepared by referring to the existing methods are not only complicated in process, high in production cost, difficult to realize industrialized large-scale production, but also unstable in preparations, easy to absorb moisture, etc.

Method used

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  • Opicapone pharmaceutical composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] Every 1000 described opicapone pharmaceutical compositions, its formula consists of:

[0045] Opicapone 10g

[0046] Hydroxypropyl Methyl Cellulose 10g

[0047] Mannitol 55g

[0048] Microcrystalline cellulose 20 g

[0049] Magnesium Stearate 3g

[0050] Micronized silica gel 2g

[0051] Preparation process: 1) Pulverize opicapone, hydroxypropyl methylcellulose, mannitol and microcrystalline cellulose through a 100-mesh sieve respectively, and set aside;

[0052] 2) Weigh the above-mentioned materials in the prescription amount, make soft materials with 10% povidone K30 absolute ethanol solution, and granulate with 20 mesh;

[0053] 3) Ventilate and dry in a drying oven for 2-3 hours at a temperature of 50±2°C;

[0054] 4) Add magnesium stearate and micropowder silica gel, and mix well with dry granules;

[0055] 5) Calculate the actual tablet weight, adjust the tablet weight, and press the tablet;

[0056] 6) Prepare the prescribed amount of film coating agent ...

Embodiment 2

[0059] Every 1000 described opicapone pharmaceutical compositions, its formula consists of:

[0060] Opicapone 20g

[0061] Sodium Carboxymethyl Cellulose 20g

[0062] Mannitol 110g

[0063] Microcrystalline Cellulose 40g

[0064] Magnesium Stearate 6g

[0065] Micronized silica gel 4g

[0066] Preparation process: 1) Pulverize opicapone, sodium carboxymethylcellulose, mannitol and microcrystalline cellulose through a 100-mesh sieve, and set aside;

[0067] 2) Weigh the above-mentioned materials in the prescription amount, make soft materials with 10% povidone K30 absolute ethanol solution, and granulate with 20 mesh;

[0068] 3) Ventilate and dry in a drying oven for 2-3 hours at a temperature of 50±2°C;

[0069] 4) Add magnesium stearate and micropowder silica gel, and mix well with dry granules;

[0070] 5) Calculate the actual tablet weight, adjust the tablet weight, and press the tablet;

[0071] 6) Prepare the prescribed amount of film coating agent with 70% etha...

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Abstract

The invention discloses an opicapone pharmaceutical composition. Mannitol and microcrystalline cellulose are used as the filler. The opicapone pharmaceutical composition comprises, by weight, 40%-55% of the mannitol and 20%-30% of the microcrystalline cellulose. The opicapone pharmaceutical composition is good in stability and has more obvious advantages for increasing the product yield, reducing costs, achieving industrialization and being better applied to clinical practice.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to an opicapone pharmaceutical composition and a preparation method thereof. Background technique [0002] Opicapone chemical name: 5-[3-(2,5-dichloro-4,6-dimethyl-1-oxo-pyridin-3-yl)-[1,2,4]oxadiazole -5-yl]-3-nitrobenzene-1,2-diol [0003] Molecular formula: C15H10CL2N4O6. [0004] Molecular weight: 414.17. [0005] After research, the applicant found that the oral preparation prepared by referring to the existing method not only has complicated process, high production cost, and it is difficult to realize industrialized large-scale production, but also has problems such as unstable preparation and easy moisture absorption. At present, there is still a need for a new method to prepare the opicapone pharmaceutical composition. By finding suitable excipients and the ratio of various excipients, it can ensure good fluidity during tablet compression, good dissolution ...

Claims

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Application Information

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IPC IPC(8): A61K9/30A61K31/4439A61K47/38A61K47/10
Inventor严洁
OwnerTIANJIN HANKANG PHARMA BIOTECH