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Trimebutine maleate tablet and preparing method thereof

A technology of trimebutine maleate and trimebutine acid tablets is applied in the field of trimebutine maleate tablets and preparation thereof, and can solve the problem of low content of main drug components, unsatisfactory effect, and residual organic solvent. The quantity does not meet the standard, etc.

Inactive Publication Date: 2004-06-30
HAINAN PULIN PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] Obviously, the purpose of the above-mentioned patents is to cover up the bitterness, but the effect is not ideal, and the preparation method is complicated, the production cost is high, and the use of flammable solvents makes it difficult to remove the residual solvents, and the residual organic solvents do not meet the standards; on the other hand , the preparation prepared by the above method has a low content of the main ingredient, and the daily dose of trimebutine maleate for patients is 300-600 mg, but the amount of excipients is several times higher than that of the active ingredient

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] Trimebutine Maleate Tablets (100mg)

[0020] components

[0021] Sieve the trimebutine maleate raw material into a fluidized bed bottom spray device, and coat the raw material with a dispersion of polyacrylic resin E100, polyacrylic resin NE30D and colloidal silicon in ethanol to obtain coated raw material granules .

[0022] Granulate lactose, starch, microcrystalline cellulose, and tartaric acid-dissolved hypromellose, dry, and sub-granulate.

[0023] Take the coated trimebutine maleate raw material and auxiliary material granules, add cross-linked vitamin acid, peppermint flavor and silicon dioxide, mix evenly, compress into tablets, and pack.

[0024] components

[0025] The tablet prepared by this method has no bitter taste in the mouth;

Embodiment 2

[0027] Trimebutine Maleate Tablets (100mg)

[0028] components

[0029] The raw material of trimebutine maleate is sieved and placed in a fluidized bed bottom spraying device, and the raw material is coated with HPMC and a dispersion liquid of colloidal silicon in ethanol to obtain coated raw material granules.

[0030] Granulate lactose, starch, microcrystalline cellulose, and tartaric acid-dissolved hypromellose, dry, and sub-granulate.

[0031] Take the coated trimebutine maleate raw material and auxiliary material granules, add cross-linked vitamin acid, peppermint flavor and silicon dioxide, mix evenly, compress into tablets, and pack.

[0032] components

[0033] Tablets prepared in this way have no bitter taste.

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PUM

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Abstract

The present invention relates to a kind of oral trimebutine tablet and its preparation method. Said invention is characterized by that the trimebutine raw material can be coated with water soluble film-forming agent and plasticizer. The tablet made up by said method can hide the taste of trimebutine, at the same time it does not affect disintegration and does not affect resolution of its main component.

Description

technical field [0001] The invention relates to a trimebutine maleate tablet for oral administration and a preparation method thereof. Background technique [0002] Because trimebutine maleate has a persistent and unbearable astringent taste, if you take a conventional tablet orally, a strong numb taste will be produced when the medicine comes into contact with the tongue, making it impossible for people to continue taking it. [0003] Previously known technologies only relate to the persistent bitter taste of trimebutine maleate or to ensure the stability of trimebutine maleate during preparation and storage of medicines, but are not perfect. [0004] FR2468364, published May 8, 1981, describes a process for the preparation of microcapsules filled with pharmaceutically active compounds, the walls of which are ethylcellulose, carried out in cyclohexane, using phase separation An inducer, preferably a phospholipid phase separation inducer, as an example, trimebutine maleate ...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/235A61P1/06
Inventor 范敏华朱小平楼金芳
Owner HAINAN PULIN PHARMA
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