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Composition of slow (controled) releasing preparation of Quetiadine Hemifumarate, and application

A technology of quetiapine fumarate and quinolone fumarate, which is applied in the field of quetiapine fumarate oral sustained-release preparations, which can solve the problems of inconvenience to patients and their families, and short action time of preparations.

Inactive Publication Date: 2007-12-26
SHANGHAI MODERN PHARMA ENG INVESTIGATION CENT +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] At present, the domestic common preparation of quetiapine fumarate with a relatively low price is already on the market. It is a non-sustained and controlled release preparation.

Method used

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  • Composition of slow (controled) releasing preparation of Quetiadine Hemifumarate, and application
  • Composition of slow (controled) releasing preparation of Quetiadine Hemifumarate, and application
  • Composition of slow (controled) releasing preparation of Quetiadine Hemifumarate, and application

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0068] Mix 100 grams of quetiapine fumarate, 10 grams of citric acid, 90 grams of water-soluble macromolecular material polyvinylpyrrolidone and 2 grams of waxy stearyl alcohol, and add hydroxypropyl methylcellulose with a weight concentration of 3%. The slurry is made into a soft material, then granulated to obtain the granules, put in a coating machine, use 400ml of enteric-coated material and water-insoluble polymer material for ethanol mixture slurry coating, and dry at 60°C to obtain quetiapine fumarate ( Controlled) release granules.

[0069]The enteric-coated material is hydroxypropylmethylcellulose phthalate (HPMCP-55), the water-insoluble polymer material is ethyl cellulose, the enteric-coated material and the water-insoluble polymer material are in the ethanol mixture slurry, and the enteric-coated material is The content of the water-insoluble polymer material is 0.035g / ml, the content of the water-insoluble polymer material is 0.015g / ml, and the volume concentratio...

Embodiment 2

[0071] Mix 100 grams of quetiapine fumarate, 5 grams of tartaric acid, 50 grams of water-soluble macromolecular material polyvinyl alcohol, and 1 gram of cetyl alcohol, and add 3% hydroxypropyl methylcellulose slurry to make a soft Material, then granulated, to obtain granules, add 1.5 grams of talcum powder and mix evenly, punch a tablet with a shallow concave of 9mm. Take the tablet and place it in a coating pan, coat it with 100ml of ethanol mixture slurry of enteric material and water-insoluble polymer material, and dry at 60°C to obtain a tablet.

[0072] The enteric material is methacrylic acid-methacrylic acid copolymer (II), and the water-insoluble polymer material is trimethylammonium ethyl methacrylate-methacrylate copolymer (RS-100). In the ethanol mixture slurry of the molecular material, the content of the enteric material is 0.075g / ml, and the content of the water-insoluble polymer material is 0.025g / ml. The volume concentration of ethanol used was 85%.

[007...

Embodiment 3

[0075] The granules of Example 1 are packed into capsules to obtain capsules.

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PUM

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Abstract

The present invention discloses a quithiopine fumarate slow (controlled) release preparation and its application. Its preparation composition includes (by wt%) 27-50% of quithiopine fumarate, 2-7% of organic acid, 40-50% of water-soluble macromolecule, 2-7% of enteric solubility material, 0.1-2% of wax and 2-7% of water-insoluble macromolecule. Said preparation can be effectively used for curing schizophrenia.

Description

technical field [0001] The invention relates to a quetiapine fumarate preparation, in particular to an oral slow-controlled release preparation of quetiapine fumarate. Background technique [0002] Quetiapine fumarate is a diphenoxazepine, an atypical antipsychotic. Its structure is similar to that of clozapine and olanzapine, and it is a variety of neurotransmitter receptor antagonists in the brain. It mainly plays an antipsychotic effect by blocking the central dopamine D2 receptor and 5-hydroxytryptamine 2 (5-HT2) receptor . It also has a blocking effect on histamine H receptors and adrenal α1 receptors, but has no affinity for muscarinic and benzodiazepine receptors. [0003] Quetiapine fumarate is clinically used in various types of schizophrenia. It is effective for both positive and negative symptoms of schizophrenia, and can also reduce the symptoms of depression, anxiety and cognitive deficits associated with schizophrenia. [0004] Conventional oral dose for sc...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K9/22A61K9/52A61K31/554A61P25/18
Inventor 贺芬陈昂裘渊
Owner SHANGHAI MODERN PHARMA ENG INVESTIGATION CENT
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