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Preparation for quickly disintegrating fatty amine polymer salt

A uniformly mixed, sevelamer carbonate tablet technology, which is applied in the direction of pill delivery, drug combination, medical preparation of non-active ingredients, etc., can solve the problem of short residence time, restrictive effect, and influence on the stability of sevelamer carbonate And other issues

Active Publication Date: 2013-11-20
CHANGZHOU FANGYUAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0014] The present inventor has carried out research to sevelamer carbonate, finds that in the prepared tablet, sevelamer carbonate is in storage process, and the amount of carbonate radical is reducing, affects the stability of sevelamer carbonate, simultaneously the carbonic acid sevelamer The short residence time of sevelamer in the gastrointestinal tract limits its ability to exert greater phosphorus-binding effects

Method used

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  • Preparation for quickly disintegrating fatty amine polymer salt
  • Preparation for quickly disintegrating fatty amine polymer salt
  • Preparation for quickly disintegrating fatty amine polymer salt

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] Tablets containing sevelamer carbonate are prescribed as follows:

[0045]

[0046] The preparation method comprises the following steps: taking the active ingredient sevelamer carbonate and auxiliary materials and preparing them for use; taking sevelamer carbonate, microcrystalline cellulose, sodium bicarbonate, arginine and polylactic acid and mixing them evenly, adding water and mixing them evenly , dry granulation, then add magnesium stearate, mix evenly, and press into 1000 tablets.

Embodiment 2

[0048] Tablets containing sevelamer carbonate are prescribed as follows:

[0049]

[0050] The preparation method comprises the following steps: taking the active ingredient sevelamer carbonate and auxiliary materials and preparing them for use; taking sevelamer carbonate, microcrystalline cellulose, sodium bicarbonate, arginine and polylactic acid and mixing them evenly, adding water and mixing them evenly , dry granulation, then add magnesium stearate, mix evenly, and press into 1000 tablets.

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Abstract

The invention relates to a preparation for quickly disintegrating fatty amine polymer salt, and particularly relates to a sevelamer carbonate tablet. The formula of the preparation comprises the following components: 400-800g of sevelamer carbonate, 40-80g of microcrystalline cellulose, 40-80g of sodium hydrogen carbonate, 10-20g of arginine, 10-20g of polylactic acid and 1-2g of magnesium stearate. The preparation method comprises the following steps: preparing the active component (sevelamer carbonate) and the auxiliary components for later use; uniformly mixing the sevelamer carbonate, the microcrystalline cellulose, the sodium hydrogen carbonate, the arginine and the polylactic acid; adding water, and uniformly mixing; granulating through a dry method; then adding the magnesium stearate, and uniformly mixing; and tabletting.

Description

technical field [0001] The invention relates to a pharmaceutical preparation, in particular to a fast disintegrating preparation of fatty amine polymer salt and a preparation method thereof. Background technique [0002] Fatty amine polymer salts, such as: sevelamer carbonate, sevelamer hydrochloride, colesevelam hydrochloride, colestipol hydrochloride, cholestyramine hydrochloride, because the structure contains fatty amine polymers, resulting in difficulty in absorption , formulations are particularly difficult to manufacture, so rapidly disintegrating formulations are an important option. [0003] However, while preparing the fast-disintegrating preparation, other problems followed one after another, such as stability, gastrointestinal tract effect, phosphate binding rate and other problems encountered when preparing the fast-disintegrating preparation of sevelamer carbonate. [0004] Sevelamer carbonate, a fatty amine polymer, English name: Sevelamer carbonate, structur...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/785A61K47/38A61K47/02A61K47/18A61K47/34A61P3/12
Inventor 孙国栋王国华葛志敏田景萱李兴刚解亮
Owner CHANGZHOU FANGYUAN PHARMA
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