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Process for preparing blonanserin

A preparation process, the technology of blonanserin, which is applied in the field of preparation process of antipsychotic drug blonanserin tablets, can solve the problems of easy adsorption on the container wall, uniform dissolution rate of tablets, obvious static electricity, etc., and achieve increased mixing Uniformity, increase fluidity, and eliminate static electricity

Inactive Publication Date: 2017-11-28
BEIJING SHENLANHAI BIO PHARM TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the prior art, the preparation process of blonanserin tablets often adopts a wet granulation process, and the prepared blonanserin tablets have the following disadvantages: 1) blonanserin is insoluble in water, and the dissolution rate of the tablet is difficult to be consistent with the original research; 2) After blonanserin is crushed, the bulk density is small and the static electricity is obvious. It is not suitable to mix well during the production process, or it is easy to be adsorbed on the container wall

Method used

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  • Process for preparing blonanserin
  • Process for preparing blonanserin
  • Process for preparing blonanserin

Examples

Experimental program
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Effect test

Embodiment 1

[0024]

[0025] Made into 1000 pieces

[0026] Preparation process: Mix micronized blonanserin and part of silicon dioxide and pass through a 60-mesh sieve to form a premix; add the premix, hydroxypropyl cellulose (low substitution) and lactose into a wet granulator and mix 5min; the mixture is made into a soft material with an appropriate amount of hydroxypropyl cellulose aqueous solution, and granulated through a 24-mesh sieve; the wet granules are air-dried at 50°C, passed through a 24-mesh sieve for granulation, and the remaining amount of silicon dioxide, microcrystalline cellulose and hard Magnesium fatty acid was mixed for 5 minutes and compressed into tablets.

Embodiment 2

[0028]

[0029] Made into 1000 pieces

[0030] Preparation process: Mix micronized blonanserin and part of silicon dioxide and pass through a 60-mesh sieve to form a premix; add the premix, hydroxypropyl cellulose (low substitution) and lactose into a wet granulator and mix 15min; the mixture is made into a soft material with an appropriate amount of hydroxypropyl cellulose aqueous solution, and granulated through a 20-mesh sieve; the wet granules are air-dried at 60°C, granulated through a 20-mesh sieve, and the remaining amount of silicon dioxide, microcrystalline cellulose and hard Magnesium fatty acid was mixed for 15 minutes and compressed into tablets.

Embodiment 3

[0032]

[0033] Made into 1000 pieces

[0034] Preparation process: Mix micronized blonanserin and part of silicon dioxide and pass through a 60-mesh sieve to form a premix; add the premix, hydroxypropyl cellulose (low substitution) and lactose into a wet granulator and mix 20min; the mixture is made into a soft material with an appropriate amount of hydroxypropyl cellulose aqueous solution, and granulated through a 24-mesh sieve; the wet granules are air-dried at 80°C, granulated through a 24-mesh sieve, and the remaining amount of silicon dioxide, microcrystalline cellulose and hard Magnesium fatty acid was mixed for 15 minutes and compressed into tablets.

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Abstract

The invention discloses a preparation process of blonanserin tablets. The tablet contains blonanserin, hydroxypropyl cellulose (low substitution), lactose, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, silicon dioxide, and the preparation of the blonanserin tablet The process includes the following steps: 1) blonanserin raw material micropowder is premixed with silicon dioxide; 2) the premix is ​​mixed with hydroxypropyl cellulose (low substitution) and lactose; 3) hydroxypropyl cellulose aqueous solution Make soft materials for binders, granulate, dry, and granulate; 4) Add silicon dioxide, microcrystalline cellulose and magnesium stearate, mix well, and compress into tablets. The blonanserin tablet prepared by the invention has the advantages of simple process operation, easy industrialization, good stability, good dissolution rate and the like.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to a preparation process of an antipsychotic drug blonanserin tablet. Background technique [0002] According to a survey by the Ministry of Health, mental illness ranks first in the total burden of disease in China, accounting for about 20% of the total burden of disease. Schizophrenia is the most common type of mental illness characterized by changes in basic personality, splits in thinking, emotion, and behavior, and incoordination between mental activities and the environment. According to the Ministry of Health report in 2006, there are approximately 8.6 million schizophrenia patients in my country. [0003] Blonanserin was developed by Sumitomo Co., Ltd., and it was launched in Japan in January 2008. It is a new generation of atypical anti-schizophrenia drugs, belonging to serotonin and dopamine antagonists, more selective for the two receptors than other antipsychotic dr...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/496A61K47/38A61K47/04A61K47/26A61P25/18
CPCA61K31/496A61K9/2009A61K9/2018A61K9/2054
Inventor 崔磊
Owner BEIJING SHENLANHAI BIO PHARM TECH
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