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A kind of aluminum magnesium carbonate granule and preparation method thereof

A technology of aluminum magnesium carbonate and granules, which is applied in the directions of aluminum/calcium/magnesium active ingredients, pharmaceutical formulations, medical preparations with non-active ingredients, etc. It can avoid the problems of patients with difficulty in taking it, and chewable tablets are not suitable for patients who have difficulty in chewing, so as to avoid the difference in the antacid performance of the drug in vitro, the maintenance time of the antacid in vitro, and the decrease of the stability of the drug.

Active Publication Date: 2021-11-12
HINYE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Chinese patent CN102813634A discloses a aluminum magnesium carbonate tablet. In this solution, the surfactant sodium lauryl sulfate is added to the prescription to promote disintegration, and the antacid effect is improved and the antacid effect is prolonged by adding a weak acid pH regulator. time, and the bulk drug needs to be micronized, the aluminum magnesium carbonate tablet formulation of this scheme is complicated in composition, and the production cost is relatively high, and the addition of a weak acid pH regulator will cause the tablet to increase gas generation during acid neutralization, thereby Worsening bloating from gas trapping
However, too much pregelatinized starch is unfavorable to the strength and dissolution of the tablet, which will cause the tablet to disintegrate quickly but the active ingredient in it cannot be effectively dissolved and reacted with gastric acid, which eventually leads to the dispersible tablet preparation of this scheme. Acidity and acid production rate vary greatly
[0008] In addition, the specifications and single doses of the above drugs are relatively large (specification: 0.5g, single dose 0.5g-1g), ordinary tablets are not conducive to taking solid tablets, and chewable tablets are not conducive to patients with chewing difficulties
Moreover, ordinary tablets usually have a long disintegration time limit, and chewable tablets can only play a therapeutic role in time if they are swallowed after being fully chewed.

Method used

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  • A kind of aluminum magnesium carbonate granule and preparation method thereof
  • A kind of aluminum magnesium carbonate granule and preparation method thereof
  • A kind of aluminum magnesium carbonate granule and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0044] A hydrotalcite granule, in parts by weight, in every 1000 packs (2g / pack) of hydrotalcite granules, the content of each component is as follows:

[0045]

[0046] Preparation method: Weigh the prescription amount of aluminum magnesium carbonate (particle size distribution D(V, 0.9) is 50.5 μm, D(V, 0.5) is 17.9 μm), mannitol, corn starch, banana flavor, mint flavor, pass through 50 mesh Sieve, put it in a wet mixing granulator and mix evenly; prepare hydroxypropyl cellulose into an aqueous solution with a concentration of about 3.1%, and then add sodium saccharin to dissolve it to obtain a granulation solution, and then add the above mixture to the wet method The soft material is produced in the mixing granulator, and the prepared soft material is passed through a 14-mesh screen, dried in a boiling dryer at 50°C-53°C, and sieved with a vibrating sieve with a 10-mesh screen on the upper layer and a 60-mesh screen on the lower layer. Whole grains, mixed evenly, that is...

Embodiment 2

[0048] A hydrotalcite granule, in parts by weight, in every 1000 packs (2g / pack) of hydrotalcite granules, the content of each component is as follows:

[0049]

[0050]

[0051] Preparation method: Weigh the prescription amount of aluminum magnesium carbonate (particle size distribution D(V, 0.9) is 52.5 μm, D(V, 0.5) is 7.0 μm), mannitol, corn starch, banana flavor, mint flavor, pass through 50 mesh Sieve, put it in a wet mixing granulator and mix evenly; prepare hydroxypropyl cellulose into an aqueous solution with a concentration of about 1.7%, and then add sodium saccharin to dissolve it to obtain a granulation solution, and then add the above mixture to the wet method The soft material is produced in the mixing granulator, and the prepared soft material is passed through a 14-mesh sieve, and dried in a boiling dryer at 60°C. The upper layer of the vibrating sieve is equipped with a 10-mesh sieve, and the lower layer is equipped with a 60-mesh sieve. Mix well and se...

Embodiment 3

[0053] A hydrotalcite granule, in parts by weight, in every 1000 packs (2g / pack) of hydrotalcite granules, the content of each component is as follows:

[0054]

[0055] Preparation method: Weigh the prescription amount of aluminum magnesium carbonate (particle size distribution D (V, 0.9) is 52.5 μm, D (V, 0.5) is 7.0 μm), mannitol, and corn starch, pass through a 50-mesh sieve, and set wet method Mix evenly in a mixing granulator; prepare hydroxypropyl cellulose into an aqueous solution with a concentration of about 1.7%, then add sodium saccharin to dissolve it to obtain a granulation solution, and then add the above mixture to a wet mixing granulator to prepare Soft material, the prepared soft material is passed through a 14-mesh sieve, dried in a boiling dryer at 60°C, sieved with a vibrating sieve with a 10-mesh sieve on the upper layer and a 60-mesh sieve on the lower layer, and mixed evenly.

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Abstract

The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to aluminum magnesium carbonate granules and a preparation method thereof. The aluminum magnesium carbonate granules are made of aluminum magnesium carbonate and pharmaceutically acceptable auxiliary materials, wherein the particle size D90 of aluminum aluminum carbonate is distributed in the range of 40-70 μm, and the particle size D50 is distributed in the range of 5-20 μm; The excipients include mannitol, corn starch and hydroxypropyl cellulose. The aluminum magnesium carbonate granules provided by the invention have fast acid-making speed, long in vitro anti-acid maintenance time, and stable in-vitro anti-acid performance. commercial production.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to aluminum magnesium carbonate granules and a preparation method thereof. Background technique [0002] The chemical name of aluminum magnesium carbonate is cetyl dialuminum carbonate hexamagnesium hydrate, and the chemical formula is Al 2 Mg 6 (OH) 16 CO 3 4H 2 O is a water-insoluble crystalline powder with a layered network structure. Aluminum magnesium carbonate is an antacid and pepsin-inhibiting drug, which can effectively resist the attack of endogenous invasion factors on the stomach, and also has a protective effect on the gastrointestinal mucosa. It is currently used for the treatment of gastric ulcer, duodenal Ideal for intestinal ulcers, relief of heartburn (heartburn) caused by excess stomach acid, and chronic gastritis. [0003] At present, although there are many aluminum magnesium carbonate tablets or aluminum magnesium carbonate...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/16A61K33/10A61K47/38A61K47/36A61K47/26A61P1/04
CPCA61K9/1623A61K9/1652A61K33/10A61P1/04
Inventor 刘文利王彬金波王衡新宋志林高玉贺
Owner HINYE PHARM CO LTD