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Clozapine tablet medicine composition and preparation method

A technology of clozapine tablets and compositions, applied in the field of tablet pharmaceutical compositions containing clozapine, capable of solving problems such as chemical stability defects

Active Publication Date: 2018-12-18
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 medicine composition and preparation method
  • Clozapine tablet medicine composition and preparation method
  • Clozapine tablet medicine composition and preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0135] Embodiment 1: prepare clozapine tablet

[0136] prescription:

[0137] Intragranular part

[0138] 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

[0139] Embodiment 2: prepare clozapine tablet

[0140] prescription:

[0141] Intragranular part

[0142] 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

[0143] Embodiment 3: prepare clozapine tablet

[0144] prescription:

[0145] Intragranular part

[0146] 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 medicine composition and a preparation method. The clozapine tablet medicine composition provided by the invention comprises clozapine, diluent, disintegrant, glidant, binder and lubricant. The lubricant is magnesium stearate. The diluent is selected from microcrystalline cellulose, lactose, calcium hydrogen phosphate and combination thereof. The invention also relates to the preparation method of the clozapine tablet medicine composition, a quality detection method of the clozapine tablet medicine composition and application of the clozapine tabletmedicine composition to preparation of medicine for preventing or treating schizophrenia. The clozapine tablet medicine composition provided by the invention presents excellent pharmaceutical performance, such as excellent chemical stability and excellent digestion 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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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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