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Olanzapine tablet and preparation method thereof

A technology of olanzapine tablets and olanzapine, which is applied in the field of pharmaceutical and chemical technology synthesis, can solve the problems of easily causing splits, olanzapine moisture sensitivity, low production efficiency, etc., and achieve good compression moldability, stable preparation quality, The effect of improving productivity

Active Publication Date: 2018-09-07
苏州盛达药业有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] However, due to the nature of olanzapine itself, which is sensitive to moisture, easy to change color, metastable in various crystalline and amorphous forms, and easy to degrade after being made into tablets, it is not suitable to use wet granulation and tableting technology. preparation, and the preparation method disclosed in the above-mentioned patent is relatively cumbersome, thus making the production efficiency lower
The powder direct compression method omits the step of wet granulation, which has the advantages of saving time and energy, simple process, and fewer procedures. The direct compression of powder is easy 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 and preparation method thereof
  • Olanzapine tablet and preparation method thereof
  • Olanzapine tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] 1. Raw material composition:

[0028] Olanzapine 100 grams, lactose 150 grams, povidone K30 15 grams, microcrystalline cellulose 50 grams, mannitol 30 grams, magnesium stearate 3 grams.

[0029] 2. Preparation process:

[0030] (1) Sieve olanzapine, lactose, povidone K30, microcrystalline cellulose, mannitol and magnesium stearate respectively, wherein, olanzapine, lactose and magnesium stearate pass through a 100 mesh sieve respectively; Ketone K30, microcrystalline cellulose and mannitol are respectively passed through an 80-mesh sieve, and set aside;

[0031] (2) Take olanzapine, lactose, povidone K30, microcrystalline cellulose and mannitol and mix in the mixer;

[0032] (3) Add magnesium stearate to the mixed medicine in step (2), sieve and mix, carry out olanzapine content detection, adopt direct compression technology to compress after determining the tablet weight, the tableting environment temperature is 25 ℃, humidity 50% RH, the tablet compression pressure...

Embodiment 2

[0034] 1. Raw material composition:

[0035] Olanzapine 100 grams, lactose 140 grams, povidone K30 20 grams, microcrystalline cellulose 40 grams, mannitol 40 grams, magnesium stearate 2 grams.

[0036] 2. Preparation process:

[0037] The preparation process is the same as in Example 1.

Embodiment 3

[0039] 1. Raw material composition:

[0040] Olanzapine 100 grams, lactose 160 grams, povidone K30 10 grams, microcrystalline cellulose 60 grams, mannitol 20 grams, magnesium stearate 4 grams.

[0041] 2. Preparation process:

[0042] The preparation process is the same as in Example 1.

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Abstract

The invention relates to an olanzapine tablet which contains the following components in parts by weight: 100 parts of olanzapine, 140-160 parts of lactose, 10-20 parts of povidone K30, 40-60 parts ofmicrocrystalline cellulose, 20-40 parts of mannitol, and 2-4 parts of magnesium stearate. The olanzapine tablet prepared by adopting the formula and process disclosed by the invention has the advantages of good dissolubility, high stability, low tablet damage rate and improvement of production efficiency.

Description

technical field [0001] The invention belongs to the technical synthesis field of medicine and chemical industry, and in particular relates to an olanzapine tablet 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. 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 guidelines for the prevention and treat...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K47/26A61K47/32A61K47/38A61K31/551A61P25/18
CPCA61K9/2018A61K9/2027A61K9/2054A61K9/2095A61K31/551A61P25/18
Inventor 胡礼勇刘要武黄军豪周自金
Owner 苏州盛达药业有限公司