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Blonanserin tablet pharmaceutical composition and preparation method thereof

A technology of blonanserin and its composition, which is applied in the field of medicine, can solve the problems of small tablet hardness, large loss of active ingredients, insufficient adhesive viscosity, etc.

Active Publication Date: 2020-03-10
SHENZHEN WANHE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0020] However, the existing blonanserin specification is 4mg, which belongs to the low-dose specification, and the preparation of blonanserin tablets in the prior art usually adopts a wet granulation process. The preparation has the following disadvantages: 1) the loss of the active ingredient is large during the preparation process, which is about 10-20%; 2) the viscosity of the used binder for granulation is not enough, and the obtained granules are relatively fine, so it is difficult to pressurize during tabletting, resulting in less tablet hardness

Method used

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  • Blonanserin tablet pharmaceutical composition and preparation method thereof
  • Blonanserin tablet pharmaceutical composition and preparation method thereof
  • Blonanserin tablet pharmaceutical composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0080] Embodiment 1: blonanserin tablets

[0081] prescription:

[0082] Blonanserin (the main drug) 4.0 parts by weight, lactose (diluent) 60 parts by weight, Microcrystalline Cellulose (Thinner) 45 parts by weight, Hydroxypropyl Cellulose (Binder) 2 parts by weight, Low-substituted hydroxypropyl cellulose (disintegrant) 8 parts by weight, Silicon dioxide (glidant) 0.6 parts by weight, Magnesium Stearate (Lubricant) 0.3 parts by weight, Purified water (binding solvent) Appropriate amount (solvent used in the process and eventually removed).

[0083] Preparation method:

[0084] (i) Pre-crushing various raw materials and auxiliary materials to a fine powder that can pass through 120 mesh;

[0085] (ii) Micronize blonanserin and 1.5 times its weight of microcrystalline cellulose until the particle size is less than 10 μm (more than 90% of the particle diameter is within the range of 3 to 10 μm), and then add ha...

Embodiment 2

[0088] Embodiment 2: blonanserin tablets

[0089] prescription:

[0090]

[0091]

[0092] Preparation method:

[0093] (i) Pre-crushing various raw materials and auxiliary materials to a fine powder that can pass through 120 mesh;

[0094] (ii) Micronize blonanserin and microcrystalline cellulose with 1 times its weight until the particle size is less than 10 μm (more than 90% of the particle diameter is within the range of 3 to 10 μm), and then add half the amount of the prescription Mix disintegrants and continue to crush until the particle size of all particles is less than 25 μm to obtain micronized powder;

[0095] (iii) Mix the micronized powder obtained in step (ii) with the remaining amount of diluent, the remaining amount of disintegrant and half the amount of glidant in the prescription, put it in a fluidized bed granulator, and prepare the binder with water into a binder solution with a concentration of 3%, and use it to carry out fluidized bed granulati...

Embodiment 3

[0097] Embodiment 3: blonanserin tablets

[0098] prescription:

[0099] Blonanserin (the main drug) 4.0 parts by weight, lactose (diluent) 67 parts by weight, Microcrystalline Cellulose (Thinner) 133 parts by weight, Hydroxypropyl Cellulose (Binder) 5 parts by weight, Low-substituted hydroxypropyl cellulose (disintegrant) 20 parts by weight, Silicon dioxide (glidant) 2 parts by weight, Magnesium Stearate (Lubricant) 0.1 parts by weight, Purified water (binding solvent) Appropriate amount (solvent used in the process and eventually removed).

[0100] Preparation method:

[0101] (i) Pre-crushing various raw materials and auxiliary materials to a fine powder that can pass through 120 mesh;

[0102] (ii) Micronize blonanserin and microcrystalline cellulose twice its weight until the particle size is less than 10 μm (more than 90% of the particle diameter is within the range of 3 to 10 μm), and then add half the ...

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PUM

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Abstract

The invention relates to a blonanserin tablet composition and a preparation method thereof. Particularly, the blonanserin tablet composition comprises, by weight, 4 parts of blonanserin, 60-200 parts of diluting agents, 5-20 parts of disintegrating agents, 1-5 parts of adhesives, 0.1-2 parts of flow aids and 0.1-1 part of lubricants. The blonanserin tablet composition has excellent properties such as tablet dissolution performance stated in the specification.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to an antipsychotic drug and a preparation method thereof, in particular to a tablet pharmaceutical composition containing blonanserin and a preparation method thereof. Background technique [0002] Schizophrenia is a disorder characterized by deep cognitive and emotional dissociations that affect the most basic human behaviors, such as language, thought, perception, and self-awareness. Symptoms of the disease include a wide range, the most common being mental disorders, such as hallucinations, paranoia and delusions. [0003] According to statistics, the prevalence rate of schizophrenia in the world is 0.5% to 1.5%, and only 5% of all treated patients can finally fully recover. In addition, because schizophrenia often causes comorbidities, such as anxiety disorders, depression, or psychotropic substance abuse, according to a survey by Datamonitor, more than one-third (38%) of patie...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K47/26A61K47/38A61K47/04A61K47/12A61K31/496A61P25/18
CPCA61K9/2009A61K9/2013A61K9/2018A61K9/2054A61K9/2095A61K31/496
Inventor 刘晓燕胡克余马俊
Owner SHENZHEN WANHE PHARMA
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