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Mosapride citrate tablet and preparation method thereof

A technology of mosapride citrate and dispersible tablets, which is applied in the field of medical preparations containing organic active ingredients, can solve problems such as difficulty in investigating the optimal process, and achieves the advantages of being conducive to industrialized production, not having strict requirements on particle size, The effect of the universality of the process

Active Publication Date: 2018-03-02
ZHEJIANG ANGLIKANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Sustained-release tablets are affected by many factors such as pressure and powder fluidity during tablet compression, which brings many difficulties to the investigation of the best process in the later stage

Method used

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  • Mosapride citrate tablet and preparation method thereof
  • Mosapride citrate tablet and preparation method thereof
  • Mosapride citrate tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] Mosapride Citrate 26.50g

[0040] Lactose 295.00g

[0041] Starch 160.00g

[0042] Low-substituted hydroxypropyl cellulose 140.00g

[0043] Hypromellose 12.00g

[0044] Purified water 188.00g

[0045] Magnesium Stearate 6.50g

[0046] Micronized silica gel 8.25g.

[0047] Preparation:

[0048] 1) Take raw and auxiliary materials respectively according to the above-mentioned prescription quantity, and the auxiliary materials are passed through a 60-mesh sieve;

[0049] 2) Weigh the purified water of the prescribed amount, add the hypromellose of the prescribed amount, stir and dissolve, and stir and dissolve to form the hypromellose aqueous solution;

[0050]3) transfer lactose, API, starch and the hypromellose aqueous solution formed in step (2) to a wet granulator in sequence, and wet granulation after premixing;

[0051] 4) cross 30 mesh sieves and granulate after drying and mix low-substituted hydroxypropyl cellulose, magnesium stearate and micropowder silica...

Embodiment 2

[0054] Mosapride Citrate 26.50g

[0055] Lactose 300.00g

[0056] Starch 150.00g

[0057] Low-substituted hydroxypropyl cellulose 155.00g

[0058] Hypromellose 15.00g

[0059] Purified water 188.00g

[0060] Magnesium Stearate 6.50g

[0061] Micropowder silica gel 8.00g.

[0062] Preparation:

[0063] 1) Weigh the raw and auxiliary materials respectively according to the above-mentioned recipe quantities, and the auxiliary materials pass through a 60-mesh sieve;

[0064] 2) take by weighing the purified water of recipe quantity, add the hypromellose of recipe quantity, stir and dissolve to form hypromellose aqueous solution;

[0065] 3) transfer lactose, API, starch and the hypromellose aqueous solution formed in step (2) to a wet granulator in sequence, and wet granulation after premixing;

[0066] 4) After drying, pass through a 30-mesh sieve to granulate and mix low-substituted hydroxypropyl cellulose, magnesium stearate and micropowder silica gel; 5) Tablet compres...

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Abstract

The invention relates to a mosapride citrate tablet and a preparation method thereof, and belongs to the technical field of medical preparations which are applied to medical use and contain organic active ingredients. With mosapride citrate as a raw material and lactose, starch and hydroxypropyl methylcellulose as adjuvant materials, and assisted by aids, the mosapride citrate tablet is prepared by conducting wet-process granulation and tabletting. The mosapride citrate tablet provided by the invention, when applied to the preparation of gastric motor drugs, has the characteristics of being rapid in dissolution, good in stability, simple in preparation process, easy for industrial mass production and the like.

Description

technical field [0001] The application relates to a mosapride citrate tablet and a preparation method thereof, belonging to the technical field of medical preparations containing organic active ingredients. Background technique [0002] Mosapride citrate is a third-generation gastric motility drug developed by Nippon Pharmaceutical Co., Ltd. It is a selective 5-HT4 receptor agonist and belongs to the third-generation gastric motility drug, mainly used for the treatment of functional dyspepsia and gastroesophageal reflux disease. The drug can significantly improve symptoms such as sourness and heartburn in patients with functional dyspepsia, and can accelerate gastric emptying and promote gastric and duodenal motility. At the same time, there are no side effects such as extrapyramidal reaction and diarrhea, and the tolerance is good. [0003] The chemical name of mosapride citrate is (±)-4-amino-5-chloro-2-ethoxy-N-{[4-(4-fluorobenzyl)-2-morphinyl]methyl }Toluamide citrate ...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/5375A61K47/38A61K47/36A61K47/26A61P1/14A61P1/04
CPCA61K9/2018A61K9/2054A61K9/2059A61K9/2095A61K31/5375
Inventor 伊骏李欣严立勇徐成苗蒋震山杨国栋方南平
Owner ZHEJIANG ANGLIKANG PHARMA
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