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Quetiapine fumarate tablet pharmaceutical composition and preparation method

A quetiapine fumarate tablet and a technology of quetiapine fumarate, which are applied in the field of medicine, can solve problems such as chemical stability defects, and achieve the effects of excellent tablet performance and excellent chemical stability

Active Publication Date: 2021-06-11
HUNAN DONGTING PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The pharmaceutical preparation made by quetiapine still faces the defect of chemical stability in the long-term storage process, therefore, the art still expects a new method to prepare quetiapine fumarate tablet pharmaceutical composition

Method used

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  • Quetiapine fumarate tablet pharmaceutical composition and preparation method
  • Quetiapine fumarate tablet pharmaceutical composition and preparation method
  • Quetiapine fumarate tablet pharmaceutical composition and preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0102] Embodiment 1: preparation quetiapine fumarate tablet

[0103] prescription:

[0104]

[0105]

[0106] Preparation method: mix quetiapine fumarate, diluent, binder, and internally added disintegrant evenly; use water as the wetting agent to make wet granules from the mixed material; dry the wet granules, and sieve through a 20-mesh sieve Granules; add part of the disintegrant, add magnesium stearate, and finally mix all the materials evenly; With the specification of 25mg / tablet, the inspection of relevant projects was carried out. During the preparation process, the amount of wetting agent water is 30% of the weight of the powder material.

Embodiment 2

[0107] Embodiment 2: preparation quetiapine fumarate tablet

[0108] prescription:

[0109] Intragranular part Quetiapine Fumarate 25mg (calculated as quetiapine) Calcium hydrogen phosphate 2mg microcrystalline cellulose 5mg lactose 3mg Povidone K30 5mg Carboxymethyl Starch Sodium 4.7mg extragranular part Carboxymethyl Starch Sodium 1.3mg Magnesium stearate 0.25mg

[0110] Preparation method: mix quetiapine fumarate, diluent, binder, and internally added disintegrant evenly; use water as the wetting agent to make wet granules from the mixed material; dry the wet granules, and sieve through a 20-mesh sieve Granules; add part of the disintegrant, add magnesium stearate, and finally mix all the materials evenly; With the specification of 25mg / tablet, the inspection of relevant projects was carried out. During the preparation process, the amount of wetting agent water is 35% of the weight of the pow...

Embodiment 3

[0111] Embodiment 3: preparation quetiapine fumarate tablet

[0112] prescription:

[0113]

[0114]

[0115] Preparation method: mix quetiapine fumarate, diluent, binder, and internally added disintegrant evenly; use water as the wetting agent to make wet granules from the mixed material; dry the wet granules, and sieve through a 20-mesh sieve Granules; add part of the disintegrant, add magnesium stearate, and finally mix all the materials evenly; With the specification of 25mg / tablet, the inspection of relevant projects was carried out. During the preparation process, the amount of wetting agent water is 25% of the weight of the powder material.

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Abstract

The invention relates to a quetiapine fumarate tablet pharmaceutical composition and a preparation method. On the one hand, the present invention relates to a kind of quetiapine fumarate tablet pharmaceutical composition, which comprises quetiapine fumarate, diluent, binding agent, disintegrant, lubricant, and described lubricant is hard Magnesium fatty acid, the diluent is selected from microcrystalline cellulose, starch, lactose, pregelatinized starch, dextrin, calcium hydrogen phosphate and combinations thereof. The present 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 and treating manic episodes of bipolar affective disorder. The quetiapine fumarate tablet pharmaceutical composition of the present invention exhibits excellent pharmaceutical properties.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a pharmaceutical composition of an antipsychotic drug, in particular to a tablet pharmaceutical composition of the antipsychotic drug quetiapine fumarate, and the invention also relates to a preparation method of the tablet pharmaceutical composition . Further, the present invention also relates to the pharmaceutical use of such pharmaceutical compositions. The quetiapine fumarate tablet pharmaceutical composition of the present invention exhibits excellent properties such as excellent pharmaceutical properties. Background technique [0002] Quetiapine (trade name: Seroquel), developed by AstraZeneca in the United Kingdom, was approved by the US FDA on September 26, 1997. It is clinically used for the treatment of schizophrenia, bipolar disorder, generalized anxiety and Assist in the treatment of mental disorders such as severe depression. Quetiapine is a representative of the ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/06G01N30/74A61K9/28A61K9/20A61K31/554A61P25/18A61P25/28
CPCA61K9/2009A61K9/2095A61K9/28A61K31/554A61P25/18A61P25/28G01N30/06G01N30/74
Inventor 侯奇伟徐晓霞李林郭杰梁伟
Owner HUNAN DONGTING PHARMA
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