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Trimebutine Maleate suspension and preparation method thereof

A technology of trimebutine maleate and dry suspension, which is applied in the field of pharmaceutical preparations, can solve the problems of unbearable astringent taste, poor swallowing ability, poor compliance and the like, and achieves masking of bad taste and good solubility. Effect

Active Publication Date: 2014-04-02
HAINAN PULIN PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Elderly people generally have poor swallowing ability and clinical compliance is not very good
In addition, trimebutine maleate has a persistent unbearable astringent taste
The current oral trimebutine maleate conventional tablet produces a strong numb taste and bitter taste when the medicine contacts with the tongue, making it impossible for people to continue taking it. Therefore, it is necessary to prepare a trimebutine maleate The preparation can not only overcome the numbness and bitterness produced by the medicine when taken orally, but also overcome the poor swallowing ability of the elderly

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Prescription: Trimebutine Maleate Crystal Granules 400g

[0019] Polyacrylic resin E100 100g

[0020] Mannitol 1077g

[0021] Sucrose 2153g

[0022] Xanthan gum 50g

[0023] Fresh Creamer 70g

[0024] Sodium Carboxymethyl Cellulose 150g

[0025] Preparation process: place trimebutine maleate crystal granules in a fluidized bed, configure 7% polyacrylic acid resin E100 solution with 95% ethanol, and use bottom spraying method for coating. The equipment parameters are controlled as follows: fan frequency 15Hz; air inlet temperature 38°C; liquid supply 5rpm; material temperature 30°C; atomization pressure 0.15MPa; if adhesion occurs, stop, take out the particles if necessary, select a 40-mesh screen to remove the adhesion part, and then continue coating , until the coating material is exhausted, after the coating material is exhausted, continue to dry the granules in the fluidized bed for 30 minutes to obtain the coated granules; cr...

Embodiment 2

[0028] Prescription: trimebutine maleate powder 400g

[0029] Mannitol 400g

[0030] Sodium Carboxymethyl Cellulose 3g

[0031] Polyacrylic resin E100 200g

[0032] Sucrose 1903g

[0033] Xanthan gum 50g

[0034] Fresh Creamer 70g

[0035] Sodium Carboxymethyl Cellulose 150g

[0036] Preparation process: After mixing trimebutine maleate and mannitol evenly, use 1.5% sodium carboxymethylcellulose aqueous solution to make soft materials, pass through a 24-mesh sieve to make wet granules, and dry at 50°C until the weight loss on drying is less than After 3%, granulate with 30 mesh sieves to obtain trimebutine maleate granules; trimebutine maleate granules are placed in a fluidized bed, and 7% polyacrylic acid resin is prepared with 95% ethanol E100 solution is coated by bottom spraying method, and the equipment parameters are controlled as follows: fan frequency 18Hz; air inlet temperature 42°C; liquid supply 4rpm; material temperature 28°C; atomization pressure 0.2MPa; if ...

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PUM

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Abstract

The invention relates to a Trimebutine Maleate suspension, which comprises 7 to 25 percent of Trimebutine Maleate particles, 1.5 to 7.5 percent of coating material, 60 to 85 percent of flavoring agent and 3 to 7 percent of suspending aid, wherein the Trimebutine Maleate particles are Trimebutine Maleate crystal particles or medicine particles containing Trimebutine Maleate. The Trimebutine Maleate suspension provided by the invention can effectively hide the unpleasant odor of a Trimebutine Maleate raw material and improve the obedience in patients; and the preparation is highly soluble, can be taken conveniently and helps to solve the difficult swallowing problem of old patients.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to pharmaceutical preparations for treating gastrointestinal diseases, in particular to trimebutine maleate dry suspension and a preparation method thereof. Background technique [0002] Trimebutine maleate was first listed in Japan in the mid-1970s. It is used as a gastrointestinal motility regulator to treat gastrointestinal disorders, such as irritable bowel syndrome, gastrointestinal dysfunction caused by chronic gastritis, and surgery. It has been used for nearly 40 years in foreign countries and nearly 10 years in China for post-gastrointestinal disorders. Pharmacological studies have shown that trimebutine maleate regulates gastrointestinal motility and lower esophageal sphincter pressure by acting on peripheral opioid receptors, gastrointestinal smooth muscle and affecting the release of gastrointestinal peptides, and induces propulsion in the digestive system. Ex...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/16A61K31/24A61K47/38A61K47/32A61P1/14
Inventor 范敏华刘海刘华朱旭雷
Owner HAINAN PULIN PHARMA
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