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Hydrotalcite tablet and preparation method thereof

A technology of magnesium carbonate flakes and aluminum magnesium carbonate, applied in the direction of active ingredients of aluminum/calcium/magnesium, pharmaceutical formulas, medical preparations of non-active ingredients, etc., can solve the problems of large loss, complicated process, and high equipment requirements, and achieve The effect of increasing mobility

Active Publication Date: 2011-08-17
四川健能制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In this application, the raw materials and excipients are ultra-micronized, which requires high equipment and a large amount of loss during the preparation process. The granulation process adopts two steps of wet granulation and spray granulation. The process is complicated and not suitable for industrial production. About 10 minutes, the time is too long

Method used

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  • Hydrotalcite tablet and preparation method thereof
  • Hydrotalcite tablet and preparation method thereof
  • Hydrotalcite tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] 1. Prescription:

[0020] Aluminum Magnesium Carbonate 1000g

[0021] Microcrystalline Cellulose 130g

[0022] Xylitol 260g

[0023] Cross-linked sodium carboxymethyl starch 30g

[0024] Menthol 1g

[0025] Stevioside 15g

[0026] Magnesium Stearate 15g

[0027] Silica 45g

[0028]

[0029] Makes 1000 pieces

[0030] 2. Process steps:

[0031] (1) Particle size requirements of raw and auxiliary materials: the particle size of aluminum magnesium carbonate, menthol, magnesium stearate, and silicon dioxide is less than 180 microns; the particle size of microcrystalline cellulose, xylitol, cross-linked sodium carboxymethyl starch, and steviol glycoside 250 microns;

[0032] (2) Add aluminum magnesium carbonate, microcrystalline cellulose, xylitol, cross-linked sodium carboxymethyl starch, menthol, stevioside, magnesium stearate, and silicon dioxide into the two-dimensional mixer , The mixing time was 15-45 minutes to obtain the total mixt...

Embodiment 2

[0043] 1. Prescription:

[0044] Aluminum Magnesium Carbonate 500g

[0045] Microcrystalline Cellulose 100g

[0046] Xylitol 350g

[0047] Cross-linked sodium carboxymethyl starch 40g

[0048] Menthol 0.3g

[0049] Stevioside 3g

[0050] Magnesium Stearate 1g

[0051] Silica 5g

[0052]

[0053] Makes 1000 pieces

[0054] 2. Process steps:

[0055] (1) Particle size requirements of raw and auxiliary materials: the particle size of aluminum magnesium carbonate, menthol, magnesium stearate, and silicon dioxide is less than 180 microns; the particle size of microcrystalline cellulose, xylitol, cross-linked sodium carboxymethyl starch, and steviol glycoside 250 microns;

[0056] (2) Add aluminum magnesium carbonate, microcrystalline cellulose, xylitol, cross-linked sodium carboxymethyl starch, menthol, stevioside, magnesium stearate, and silicon dioxide into the two-dimensional mixer , The mixing time was 15-45 minutes to obtain the total mixtu...

Embodiment 3

[0062] Stability test

[0063] Investigate the samples (embodiment 1, embodiment 2) through long-term (conditions: 25 ℃ ± 2 ℃, RH60% ± 10%) investigation for 60 months, the investigation results are as follows:

[0064]

[0065] The results show that: After 60 months of long-term investigation, there is no obvious change in each index.

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Abstract

The invention discloses a hydrotalcite tablet which comprises the components in every 1000 preparation units: 500-1000g of hydrotalcite, 100-130g of microcrystalline cellulose, 260-350g of xylitol, 30-40g of crosslinking carboxy methyl starch sodium, 0.3-1g of menthol crystal, 3-15g of stevioside, 1-15g of magnesium stearate and 5-45g of silicon dioxide. The hydrotalcite tablet is good in stability and dispersion uniformity, rapid in disintegration and effect and good in mouth feeling. The invention also discloses a preparation method of the hydrotalcite tablet, which adopts the technique of directly compressing powder into the tablet and is simple in technique and low in energy consumption, thus reducing the production cost.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to antacids and gastric mucosa protection drugs, in particular to aluminum magnesium carbonate tablets and a preparation method thereof. Background technique [0002] Aluminum magnesium carbonate is a compound of aluminum hydroxide, magnesium hydroxide, carbonate and water. It is a new type of long-acting antacid. Its active ingredients are arranged in a layered lattice structure, which is a unique network structure and has dual functions. On the one hand, it makes the gastric juice quickly reach the optimum range of pH 3-5, prevents the excessive activity of pepsin, and promotes ulcer healing. At the same time, it can reversibly combine with bile acid and pepsin to eliminate the damage of bile acid to the gastric mucosa. It is used for hyperacidity, acute and chronic gastritis, bile reflux gastritis, reflux esophagitis, duodenal bulb Ulcers, gastric ulcers, various reasons...

Claims

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Application Information

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IPC IPC(8): A61K33/10A61K36/534A61K47/38A61K9/20A61P1/04A61K31/045
Inventor 梅勇王国华刘萍杨莉
Owner 四川健能制药有限公司