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Clozapine tablet pharmaceutical composition and preparation method

A technology of clozapine tablets and compositions, applied in the field of tablet pharmaceutical compositions containing clozapine, can solve problems such as chemical stability defects, and achieve the effects of excellent tablet performance and excellent chemical stability

Active Publication Date: 2021-06-15
HUNAN DONGTING PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The pharmaceutical preparation that clozapine is made still can face the defect of chemical stability in long-term storage process, therefore, this area still expects to have new method to prepare clozapine tablet pharmaceutical composition

Method used

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  • Clozapine tablet pharmaceutical composition and preparation method
  • Clozapine tablet pharmaceutical composition and preparation method
  • Clozapine tablet pharmaceutical composition and preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0130] Embodiment 1: prepare clozapine tablet

[0131] prescription:

[0132] Intragranular part Clozapine 25mg lactose 48mg corn starch 7mg silica 0.95mg Polyvinylpyrrolidone K30 4.5mg extragranular part corn starch 7mg talcum powder 0.9mg Magnesium stearate 0.65mg

[0133] Preparation method: Mix clozapine, diluent, internally added part of disintegrant, and internally added part of glidant; use pre-prepared 25% binder aqueous solution to make wet granules from this mixture; dry the wet granules , 20-mesh sieve for granulation; add part of disintegrant, part of glidant, magnesium stearate, final blend to make all the materials evenly mixed; compress into tablets, to obtain. With the specification of 25mg / tablet, the inspection of relevant projects was carried out.

Embodiment 2

[0134] Embodiment 2: prepare clozapine tablet

[0135] prescription:

[0136] Intragranular part Clozapine 25mg lactose 20mg corn starch 6.7mg silica 1mg Polyvinylpyrrolidone K30 8mg extragranular part corn starch 13.3mg talcum powder 2mg Magnesium stearate 1mg

[0137] Preparation method: mix clozapine, diluent, internally added part of disintegrant, and internally added part of glidant; use pre-prepared 30% binder aqueous solution to prepare wet granules for this mixture; dry the wet granules , 20-mesh sieve for granulation; add part of disintegrant, part of glidant, magnesium stearate, final blend to make all the materials evenly mixed; compress into tablets, to obtain. With the specification of 25mg / tablet, the inspection of relevant projects was carried out.

Embodiment 3

[0138] Embodiment 3: prepare clozapine tablet

[0139] prescription:

[0140] Intragranular part Clozapine 25mg lactose 80mg corn starch 3mg silica 0.6mg Polyvinylpyrrolidone K30 2mg extragranular part corn starch 2mg talcum powder 0.4mg Magnesium stearate 0.2mg

[0141] Preparation method: mix clozapine, diluent, internally added part of disintegrant, and internally added part of glidant; use pre-prepared 20% binder aqueous solution to prepare wet granules for this mixture; dry the wet granules , 20-mesh sieve for granulation; add part of disintegrant, part of glidant, magnesium stearate, final blend to make all the materials evenly mixed; compress into tablets, to obtain. With the specification of 25mg / tablet, the inspection of relevant projects was carried out.

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PUM

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Abstract

The invention relates to a clozapine tablet pharmaceutical composition and a preparation method. On the one hand, the present invention relates to a kind of clozapine tablet pharmaceutical composition, which comprises clozapine, diluent, disintegrant, glidant, binding agent, lubricant; Further, described lubricant is Magnesium stearate. The diluent is selected from microcrystalline cellulose, lactose, dextrin, calcium hydrogen phosphate and combinations thereof. The invention also relates to the preparation method of the tablet pharmaceutical composition, its quality detection method and its use in the preparation of medicines for preventing or treating schizophrenia. The clozapine tablet pharmaceutical composition of the present invention exhibits excellent pharmaceutical properties, for example, exhibits excellent chemical stability and excellent dissolution performance.

Description

technical field [0001] The invention belongs to the technical field of medicine, relates to a pharmaceutical composition for acute and chronic schizophrenia, especially a tablet pharmaceutical composition containing clozapine, a preparation method of the tablet pharmaceutical composition, and their pharmaceutical use. The clozapine tablet pharmaceutical composition of the present invention presents excellent technical effects. Background technique [0002] 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 survey data of six districts in the United States, the annual incidence rate is 0.43‰~0.69‰, 0.30‰~1.20‰ for those over 15 years old (Babigian, 1975), and 0.09‰ in some areas of my country. According to the International Pilot Survey on Schizophrenia ( IPSS) data, 20 centers in 18 countries, surve...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/06G01N30/74A61K9/20A61K47/02A61K31/551A61P25/18
CPCA61K9/2009A61K9/2095A61K31/551A61P25/18G01N30/06G01N30/74
Inventor 侯奇伟李晓云伍忆王波
Owner HUNAN DONGTING PHARMA
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