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Pharmaceutical composition containing olanzapine and preparation method thereof

A composition, the technology of olanzapine, applied in the field of medicine, can solve the problems of long heating time of tablet core, long time of water contact, and many process steps, and achieve the effect of avoiding water contact, good industrialization prospect and simple production process

Active Publication Date: 2014-07-16
TIANJIN INSTITUTE OF PHARMA RESEARCH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] There are many processes in this process, and after repeated test verification, it is found that the quality is not good, and because of multiple coatings, the heating time of the tablet core is long, and the contact time with water is long, and the analysis shows that the reason for the instability of olanzapine is Process modification is necessary due to discoloration caused by olanzapine hydrate

Method used

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  • Pharmaceutical composition containing olanzapine and preparation method thereof
  • Pharmaceutical composition containing olanzapine and preparation method thereof
  • Pharmaceutical composition containing olanzapine and preparation method thereof

Examples

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Effect test

Embodiment 1

[0060]

[0061] After the main drug and auxiliary materials are mixed evenly, the intermediates are measured to determine the tablet weight, and the tablets are pressed immediately. Opadry after tableting Coating, coating weight gain 2%-7%.

Embodiment 2

[0063]

[0064] After the main drug and auxiliary materials are mixed evenly, the intermediates are measured to determine the tablet weight, and the tablets are pressed immediately. Opadry after tableting Coating, coating weight gain 2%-7%.

Embodiment 3

[0066]

[0067] After the main drug and auxiliary materials are mixed evenly, the intermediates are measured to determine the tablet weight, and the tablets are pressed immediately. Opadry after tableting Coating, coating weight gain 2%-7%.

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Abstract

The invention belongs to the medical technical field, and particularly provides a pharmaceutical composition containing olanzapine. A preparing way is a direct tabletting process method, and auxiliary materials suitable for olanzapine stability and compatibility are selected through testing; olanzapine tablets obtained through the process preparing way have good quality stability and have the content uniformity and other oral preparation related quality items all according with requirements. The process has the advantages of good reproducibility, strong operability, low process cost, relatively good clinical use value and relatively good social benefits. The oral preparation provided by the invention is used for treating schizophrenia.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a pharmaceutical composition containing olanzapine and a preparation method thereof. The preparation method is a process method of direct compression, and adjuvants suitable for the stability and compatibility of olanzapine are selected through tests. The olanzapine tablets obtained by this process preparation method have good quality stability and uniform content. Relevant quality items of other oral preparations such as degree meet the requirements. The process has good reproducibility, strong operability, low process cost, and good clinical use value and social benefits. The oral preparation provided by the invention is used for treating schizophrenia. Background technique [0002] Olanzapine English name: Olanzapine Chemical name: 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b][1,5]benzodiazepine Miscellaneous. For the acute phase of schizophrenia and o...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/5513A61K9/28A61J3/10A61P25/18
Inventor 吴赟王成港罗振福李玲
Owner TIANJIN INSTITUTE OF PHARMA RESEARCH
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