Racecadotril granules and preparation technology thereof

A technology of racecadotril and its preparation process, which is applied in the field of racecadotril granules and its preparation, and can solve the problems of poor granulation effect and taste, affecting children's compliance, etc.

Inactive Publication Date: 2014-12-24
BEIJING HANMI PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Because racecadotril itself has a bitter taste, which affects children's compliance, and the granulation e...

Method used

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  • Racecadotril granules and preparation technology thereof
  • Racecadotril granules and preparation technology thereof
  • Racecadotril granules and preparation technology thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] The preparation method of embodiment 1 racecadotril granules

[0040]

[0041] Process:

[0042] Sucrose is crushed and passed through an 80-mesh sieve, and set aside; racecadotril is passed through an 80-mesh sieve, set aside;

[0043] Dissolve tartrazine and hypromellose in water, add racecadotril to suspend it, and then add sucrose (binder) to dissolve to obtain a binder solution;

[0044] Take sucrose (excipient) and aspartame and put them in a high-speed wet mixing granulator, and mix evenly; add the above binder, granulate with 18 mesh, dry at 50°C, and granulate with 16 mesh;

[0045] Filling, 1g per bag.

Embodiment 2

[0046] The preparation method of embodiment 2 racecadotril granules

[0047]

[0048]

[0049] Process:

[0050] Sucrose is crushed and passed through an 80-mesh sieve, and set aside; racecadotril is passed through an 80-mesh sieve, set aside;

[0051] Dissolve Sunset Yellow 60 and hydroxypropyl cellulose in water, add racecadotril to suspend it, then add sucrose (adhesive) to dissolve to obtain an adhesive solution;

[0052] Take sucrose (excipient) and sodium saccharin in a high-speed wet mixing granulator, mix evenly; add the above binder, granulate with 18 mesh, dry at 50°C, and granulate with 16 mesh;

[0053] Filling, 1g per bag.

Embodiment 3

[0054] The preparation method of embodiment 3 racecadotril granules

[0055]

[0056] Process:

[0057] Sucrose is crushed and passed through an 80-mesh sieve, and set aside; racecadotril is passed through an 80-mesh sieve, set aside;

[0058] Dissolve tartrazine 85 and povidone in water, add racecadotril to suspend it, and then add sucrose (adhesive) to dissolve to obtain an adhesive solution;

[0059] Take sucrose (excipient) and stevioside in a high-speed wet mixing granulator, and mix evenly; add the above binder, granulate with 18 mesh, dry at 50°C, and granulate with 16 mesh;

[0060] Filling, 1g per bag.

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Abstract

The invention relates to the field of medicinal preparations, and particularly relates to racecadotril granules and a preparation method thereof. The racecadotril granules are prepared from the following raw materials by weight: 0.1-2 parts of racecadotril, 93-99 parts of an excipient, 0.02-2 parts of a corrigent, 0.01-0.1 part of an adhesive and 0.05-1 part of a suspending agent. The racecadotril granules are prepared by suspending racecadotril in the adhesive and dissolving partial sucrose in the adhesive, so that bitter taste of a drug can be covered. The prepared racecadotril granules have relatively good granulation effect, and increase compliance of children.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a racecadotril granule and a preparation process thereof. Background technique [0002] Diarrhea has always been a concern, the most common cause of which is intestinal infection, as many as 3 to 4 million people die from intestinal infection worldwide every year, especially the morbidity and mortality of infants, preschool children and the elderly higher. Racecadotril is an antidiarrheal drug with a new mechanism of action and a high specific antisecretory effect for the treatment of acute diarrhea in adults. In 2001, the indication for diarrhea in children was added. [0003] Racecadotril (racecadotr il) was developed by the French Bioproject company, and was listed under the trade name Tiorfan in 1993, and the dosage form was capsules. Racecadotril is a new type of antidiarrheal drug, suitable for symptomatic treatment of various diarrhea. Compared with other ant...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K31/265A61K47/38A61K47/26A61K47/32A61P1/12
Inventor 张明方翼杨慧君成仁基
Owner BEIJING HANMI PHARMA CO LTD
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