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Olanzapine tablet composition and preparation method thereof

A technology for olanzapine tablet and composition, applied in the field of olanzapine tablet composition and preparation thereof, can solve the problems of poor powder fluidity, large difference in tablet weight, powder splinter, etc., and achieves the elimination of poor fluidity, qualified quality and properties stable effect

Active Publication Date: 2014-12-17
CHENGDU EASTON BIOPHARMACEUTICALS CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the direct compression process also has some disadvantages, such as poor fluidity of the powder, large differences in tablet weight, and direct powder compression is likely to cause problems such as splits, which limits the application of this process to a certain extent.

Method used

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  • Olanzapine tablet composition and preparation method thereof
  • Olanzapine tablet composition and preparation method thereof
  • Olanzapine tablet composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Preparation Process:

[0027] (1) Ingredients: Weigh the prescribed amount of olanzapine, lactose, microcrystalline cellulose, crospovidone, hydroxypropyl methylcellulose, magnesium stearate, crush and sieve the raw materials if necessary, Make it fit 100 mesh sieve;

[0028] (2) Mixing: Mix lactose, crospovidone, olanzapine, microcrystalline cellulose and hydroxypropyl methylcellulose for 40 minutes to make them uniform;

[0029] (3) Add the prescribed amount of magnesium stearate to the powder mixed uniformly in step (2), and mix for 10 minutes to make it uniform;

[0030] (4) Press the uniformly mixed medicinal powder in step (3) into tablets directly, and control the hardness at 50N-75N;

[0031] (5) Coating: Add the prescribed amount of film coating premix Opadry 85G68918 into the stirring water, and stir evenly to obtain a 20% (w / w) coating solution for later use. Take the vegetarian tablet and put it in the coating pan, control the pan speed to 5-10 revolution...

Embodiment 2

[0033] Preparation process: same as the preparation process of Example 1, mixing in step (2) for 20 minutes to make it uniform, and controlling the hardness at 55N-80N.

Embodiment 3

[0035] Preparation process: same as the preparation process of Example 1, mixing in step (2) for 30 minutes to make it uniform, and controlling the hardness at 50N-80N. Comparative example: According to the prescription and preparation process of 5 mg olanzapine per tablet disclosed in Example 2 of Chinese Patent No. ZL96192778.X, a comparative example sample was obtained.

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PUM

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Abstract

The invention provides a novel olanzapine tablet composition and a preparation method thereof. Lactose and microcrystalline cellulose, which have the advantages of good fluidity and compressive forming ability, are respectively taken as the diluent and dry adhesive. A simple direct powder press method is taken to prepare the olanzapine tablet, the technology is simple, thus time and energy are both saved, moreover the disintegrating or dissolving speed of the tablet is increased, the tablet bio-utilization degree is also improved, the quality of the prepared olanzapine tablet composition is controllable, and the stability of the olanzapine tablet composition is guaranteed.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to an olanzapine tablet composition and a preparation method thereof. Background technique [0002] Olanzapine, chemical name: 2-methyl-10-(4-methyl-1-piperazine)-4H-thieno[2,3-b][1,5]benzodiazepine Miscellaneous, the molecular formula is: C 17 h 20 N 4 S, the molecular weight is 312.43, and the chemical structure formula is: [0003] [0004] Olanzapine is indicated for the acute phase and maintenance treatment of schizophrenia and other psychosis with severe positive and / or negative symptoms. Olanzapine also relieves secondary affective symptoms common in schizophrenia and related disorders. Olanzapine is a non-traditional antipsychotic drug developed by Eli Lilly and Company for short-term and long-term treatment of schizophrenia. It was launched in Europe and the United States in 1996, and in China in 1999. In 2003, it was listed as a first-line drug by the gu...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/5513A61K47/38A61K47/26A61P25/18
Inventor 王颖
Owner CHENGDU EASTON BIOPHARMACEUTICALS CO LTD
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