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Hydrotalcite dispersible tablet and preparation method thereof

A technology of aluminum magnesium carbonate and dispersible tablets, which is applied in the directions of aluminum/calcium/magnesium active ingredients, medical preparations of non-active ingredients, and pharmaceutical formulations, which can solve the problems of inconvenient storage and transportation of granules and suspensions, and specifications and specifications. The problems of large dosage and large volume of granules can achieve the effect of favorable drug dissolution, rapid drug dissolution and convenient taking.

Active Publication Date: 2010-12-08
HUBEI LIYI PHARM TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Due to the large specifications and dosage of this product (specification: 0.5g, dosage: 1-1.5g), it will cause inconvenience to those who have difficulty swallowing, such as children and elderly patients
Ordinary tablets often have a long disintegration time limit (the Chinese Pharmacopoeia requires disintegration within 15 minutes), and chewable tablets must be chewed and swallowed for a long time before they can exert their therapeutic effects. The storage and transportation of granules and suspensions are not very convenient

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Embodiment 1 per 1000 dosage

[0029] Aluminum Magnesium Carbonate 500g

[0030] 100g pregelatinized starch

[0031] Low-substituted hydroxypropyl cellulose 28g (add half of the inside and outside of the grain)

[0032] Stevia 6g

[0033] povidone k 30 15g

[0034] Menthol 2g

[0035] Talc powder 5g

[0036] Magnesium Stearate 4g

[0037] Preparation of Aluminum Magnesium Carbonate Dispersible Tablets

[0038] Take aluminum magnesium carbonate, pregelatinized starch, stevioside and half the amount of low-substituted hydroxypropyl cellulose, sieve and mix evenly, and mix povidone K 30 Make a 50 g / L solvent aqueous solution, add the above mixture to make a soft material, granulate with a 24-mesh sieve, dry at 60-70°C for 4 hours, granulate with a 24-mesh sieve, add menthol, talcum powder, magnesium stearate and The remaining low-substituted hydroxypropyl cellulose is mixed evenly and pressed into tablets.

Embodiment 2

[0039] Embodiment 2 per 1000 dosage

[0040] Aluminum Magnesium Carbonate 500g

[0041] 80g pregelatinized starch

[0042] Croscarmellose Sodium 28g (add half of each inside and outside the grain)

[0043] Sodium saccharin 3g

[0044] Hypromellose (15cps) 10g

[0045] Talc powder 10g

[0046] Magnesium Stearate 5g

[0047] Preparation of Aluminum Magnesium Carbonate Dispersible Tablets

[0048] Take aluminum magnesium carbonate, pregelatinized starch, croscarmellose sodium, and saccharin sodium in the prescribed amount, sieve and mix well, make hypromellose (15cps) into a 30 g / liter aqueous solution, and add the above mixture The medium-made soft material is granulated through a 30-mesh sieve, dried at 60-70°C for 6 hours, granulated through a 30-mesh sieve, added with talcum powder and magnesium stearate, mixed evenly, and pressed into tablets.

Embodiment 3

[0049] Embodiment 3 per 1000 dosage

[0050] Aluminum Magnesium Carbonate 500g

[0051] 60g pregelatinized starch

[0052] Sodium saccharin 3g

[0053] povidone k 90 12g

[0054] Menthol 1g

[0055] Silica 7g

[0056] Low-substituted hydroxypropyl cellulose 26g (add half of the inside and outside of the grain)

[0057] Magnesium Stearate 5g

[0058] Note: Polyvinylpyrrolidone is formulated as a 100 g / L solvent ethanol solution, and the solvent is 50% ethanol water solution by volume.

[0059] Preparation of Aluminum Magnesium Carbonate Dispersible Tablets

[0060] Take aluminum magnesium carbonate, pregelatinized starch, sodium saccharin, sieve and mix evenly, and mix povidone K 90 Use 50% ethanol by volume to form an ethanol solution of 100 g / L solvent, add the above mixture to make a soft material, pass through a 24 mesh sieve to granulate, dry at 60-65°C for 4 hours, granulate with a 24 mesh sieve, add menthol Silicon dioxide, magnesium stearate and the r...

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Abstract

The invention provides a hydrotalcite dispersible tablet which comprises 75.7-85.5wt% of hydrotalcite, 6.0-17.1wt% of pre-gelatinized starch, 2.4-4.8% of low-substitutive hydroxy propyl cellulose or crosslinking carboxymethylcellulose odium, 0.8-2.6wt% of polyvinylpyrrolidone or hydroxypropyl methylcellulose, 0.2-1.0wt% of saccharin sodium salt or steviosin, 0-0.3 wt% of menthol crystal, 0.6-1.0wt% of magnesium stearate and 0.8-1.7wt% of talcum powder or silicon dioxide. Compared with the common dispersible tablet, the hydrotalcite dispersible tablet has short disintegrating time, and the disintegrated grain water solution is in the state of suspending solution. Compared with the hydrotalcite chewable tablet and the common tablet, the hydrotalcite dispersible tablet is more convenient and flexible in taking, thereby not only being capable of taking by means of sucking and swallowing, but also being capable of taking by means of dispersing after adding water or juice and the like. Compared with the hydrotalcite blending and suspending agent and the grains agent, the hydrotalcite dispersible tablet is more convenient for storing and transporting. The dispersible tablet has good dispersible status, is convenient for taking, can be fast disintegrated after taking, achieves the aim of fast acting after being distributed onto the surface of the gastric mucosa, has the same preparation technology as the common non-coating tablet, does not need special equipment, and has lower preparation cost.

Description

technical field [0001] The invention relates to aluminum magnesium carbonate dispersible tablets for treating digestive system diseases and a preparation method thereof. Background technique [0002] Aluminum magnesium carbonate is basic aluminum magnesium carbonate tetrahydrate, the English name is Hydrotalcite. [0003] Aluminum magnesium carbonate is a new type of antacid that is difficult to absorb. It has obvious antacid effect and also has the function of protecting the gastric mucosa. It also has a certain adsorption effect on bile acid, and its effect is rapid, mild and long-lasting. Because this product contains two kinds of metal ions, aluminum and magnesium, they can offset the side effects of constipation caused by aluminum salts and diarrhea caused by magnesium salts. Mice were orally given this product, its LD 50 >10.0g / kg, intraperitoneally administered LD 50 It is 8.2g / kg, therefore, this product has little acute toxicity and high safety. [0004] This...

Claims

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Application Information

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IPC IPC(8): A61K33/10A61K9/20A61K47/38A61P1/04A61P1/08A61P1/14
Inventor 樊迎春李瑛郭小杰
Owner HUBEI LIYI PHARM TECH CO LTD
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