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Trimebutine maleate dispersion tablet

A technology of trimebutine maleate and dispersible tablets, which is applied in the field of trimebutine maleate dispersible tablets, can solve problems such as increased production cost, and achieve the effects of convenient administration, rapid disintegration and fast onset of action

Active Publication Date: 2006-10-04
孙伟丰
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

EP 0 076 515, EP 0 076 428, and EP 0 099 109 have successively adjusted the proportion of coating materials, so that the prepared microspheres can ideally mask the bitter taste and improve the stability, while the release effect is improved. However, the particle coating increase production costs

Method used

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  • Trimebutine maleate dispersion tablet
  • Trimebutine maleate dispersion tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Polyvinylpolypyrrolidone (PVPP, specification XL) is a pharmaceutical excipient with strong disintegration. This trimebutine maleate dispersible tablet intends to use PVPP as the disintegrant, but its compressibility is poor. Therefore, An appropriate amount of microcrystalline cellulose is added to the prescription to increase its compressibility, and the prescription screening of this product intends to screen out the appropriate dosage. At the same time, trimebutine maleate tastes bitter and should be adjusted. According to preliminary tests, sweeteners alone cannot completely cover the bitter taste of trimebutine maleate, but adding an appropriate amount of flavoring agent can cover the bitter taste well. , so sweeteners and aromas are screened simultaneously in prescription screening. Different binders were also screened for their effect on the product.

[0022] Orthogonal screening method was used to screen the prescriptions of trimebutine maleate dispersible tab...

Embodiment 2

[0033] Trimebutine Maleate 100g

[0034] Polyvinylpolypyrrolidone (PVPP) XL 80g

[0035] Microcrystalline Cellulose 100g

[0036] Tartaric acid 1.0g

[0037] Aspartame 1.0g

[0038] Orange essence 0.5g

[0039] 8% starch slurry (containing 1% sodium lauryl sulfate) 16.5g

[0040] Magnesium Stearate 1.0g

[0041] A total of 1000 pieces

[0042] Weigh trimebutine maleate in the above prescription amount and pulverize it, mix it with pulverized tartaric acid, PVPP and microcrystalline cellulose, take aspartame and mix it with the above materials in an equal amount incremental method.

[0043] Get 8% starch slurry to make soft material, cross 16 mesh sieves. Dry at 60°C for 60 minutes.

[0044] Take out the granules, whole the granules, add orange essence and magnesium stearate, and mix well.

[0045] Tablet.

Embodiment 3

[0047] prescription:

[0048] Trimebutine Maleate 100g

[0049] Croscarmellose Sodium 80g

[0050] Microcrystalline Cellulose 100g

[0051] Tartaric acid 1.0g

[0052] Aspartame 1.0g

[0053] Orange essence 0.5g

[0054] 8% starch slurry (containing 1% sodium lauryl sulfate) 16.5g

[0055] Magnesium Stearate 1.0g

[0056] A total of 1000 pieces

[0057]Weigh the prescribed amount of trimebutine maleate and pulverize it, mix it with pulverized tartaric acid, croscarmellose sodium and microcrystalline cellulose, take aspartame and mix it with the above-mentioned materials according to the method of equal addition.

[0058] Get 8% starch slurry to make soft material, cross 16 mesh sieves. Dry at 60°C for 60 minutes.

[0059] Take out the granules, whole the granules, add orange essence and magnesium stearate, and mix well.

[0060] Tablet.

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Abstract

The invention relates to a trimebutine maleate dispersible tablet, which comprises trimebutine maleate, highly effective crumbling agent, bulking agent, lubricating agent, tartaric acid, sweetener and flavoring agent. The weight ratio of the trimebutine maleate and the highly effective crumbling agent is 1:0.8-1.2.

Description

technical field [0001] The invention relates to a trimebutine maleate dispersible tablet. Background technique [0002] Trimebutine maleate is a drug for the treatment of gastrointestinal symptoms and irritable bowel syndrome caused by chronic gastritis. It is a non-competitive antispasmodic with mild opioid receptor affinity, has pronounced anti-serotonin effects, modulates spontaneous motility of the gastrointestinal tract, increases electrophysiological stimulation and contraction of the large intestine and ileum of isolated guinea pigs synchronization. Trimebutine maleate does not affect normal gastrointestinal motility, and can regulate abnormal motility in both directions. In recent years, with the in-depth discussion of its mechanism of action, the therapeutic effect of trimebutine maleate on irritable bowel syndrome (IBS) and gastrointestinal dysfunction has gradually been affirmed by the medical community. [0003] As a relatively safe drug, trimebutine maleate c...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/222A61K9/20A61P1/04
Inventor 孙伟丰
Owner 孙伟丰
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