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Method for preparing compound famotidine chewing tablet

A technology of famotidine tablets and famotidine, which is applied in the field of preparation of compound famotidine chewable tablets, can solve the problems of unfavorable patients, toxicity, side effects, preparation of famotidine, unstable storage, etc.

Active Publication Date: 2006-05-10
四川泰华堂制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] However, famotidine is unstable during preparation and storage, which will not only reduce the therapeutic effect of the drug, but also generate related substances that are unfavorable to patients, resulting in toxicity and side effects.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0110] Get the following components by weight (unit g) ratio

[0111] Main ingredients: famotidine 5.0; calcium carbonate 400; magnesium hydroxide 82.5.

[0112] Excipients: mannitol 100; sucrose 65; starch 15;

[0113] 10% starch slurry 130; stearic acid 6; coating premix 1.2.

[0114] According to the following specific steps to make 1000 pieces

[0115] (1) Grinding the above-mentioned main and auxiliary materials to 100 mesh respectively; (2) Mixing 5.0 g of famotidine, 15 g of starch, 15 g of sucrose, and 15 g of mannitol uniformly by equal-volume incremental mixing; (3) adding 10% 10g of starch slurry is made into 18-mesh granules made from the mixture; (4) the granules are dried at 60°C for 3 hours; (5) 0.5g of stearic acid is added and mixed evenly with the dry granules; (6) (7) Coat the famotidine tablet with the coating premix; (8) Use 400g of calcium carbonate, 82.5g of magnesium hydroxide, 50g of sucrose, and 85g of mannitol, etc. (9) Add 120g of 10% starch slu...

Embodiment 2

[0117] Get the following components by weight (unit g) ratio

[0118] Main ingredients: famotidine 5.0; calcium carbonate 400; magnesium hydroxide 82.5.

[0119] Excipients: mannitol 100; sucrose 65; starch 15; microcrystalline cellulose 10;

[0120] Stearic acid 6; Gum acacia 1.0; 10% polyvinylpyrrolidone 90.

[0121] According to the following specific steps to make 1000 pieces

[0122] (1) Grinding the above-mentioned main and auxiliary materials to 100 mesh respectively; (2) Mixing 5.0 g of famotidine, 15 g of starch, 15 g of sucrose, and 15 g of mannitol uniformly by equal-volume incremental mixing; (3) adding 10% 7g polyvinylpyrrolidone 18 mesh granules made from the mixture; (4) the granules were dried at 65°C for 2 hours; (5) 0.5g of stearic acid was added and mixed evenly with the dry granules; (6) The granules are compressed into tablets with a tablet machine; (7) the famotidine tablets are wrapped with gum arabic; (8) calcium carbonate 400g, magnesium hydro...

Embodiment 3

[0124] Get the following components by weight (unit g) ratio

[0125] Main ingredients: famotidine 5.0; calcium carbonate 400; magnesium hydroxide 82.5.

[0126] Excipients: mannitol 100; sucrose 65; starch 15;

[0127] 10% Starch Slurry 130; Magnesium Stearate 6; Gelatin 1.5.

[0128] According to the following specific steps to make 1000 pieces

[0129] (1) Grinding the above-mentioned main and auxiliary materials to 100 mesh respectively; (2) Mixing 5.0 g of famotidine, 15 g of starch, 15 g of sucrose, and 15 g of mannitol uniformly by equal-volume incremental mixing; (3) adding 10% 10g of starch slurry is made into 18-mesh granules made from the mixture; (4) the granules are dried at 50°C for 5 hours; (5) 0.5g of magnesium stearate is added and mixed evenly with the dry granules; (6) The granules are pressed into tablets with a tablet machine; (7) gelatin wraps the famotidine tablets; (8) 400 g of calcium carbonate, 82.5 g of magnesium hydroxide, 50 g of sucrose, and 85...

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PUM

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Abstract

The invention relates to a process for preparing compound Famotidine chewable tablets, which comprises separating Famotidin from calcium carbonate and magnesium hydroxide, thus no reactions with be produced between the effective compositions, thus the product stability can be improved.

Description

technical field [0001] The invention belongs to a preparation method of medicines, in particular to a preparation method of compound famotidine chewable tablets. Background technique [0002] Compound Famotidine Chewable Tablets is a compound preparation composed of famotidine, calcium carbonate and magnesium hydroxide, which is used for the treatment of gastrointestinal diseases. [0003] Famotidine is an H2 receptor antagonist of the guanylthiazole class. It has the characteristics of high affinity for H2 receptors. It has obvious inhibitory effect on gastric acid secretion, and has a negative effect on basic secretion and gastric acid and pepsin caused by various stimuli. Increase has inhibitory effect, and it has a significant inhibitory effect on gastric acid secretion at night, and can also inhibit gastric acid secretion stimulated by pentagastrin. It is also longer and is a good antacid, while famotidine takes a certain amount of time to start working, usually an hou...

Claims

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Application Information

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IPC IPC(8): A61K31/426A61K9/20A61P1/04
Inventor 俞凯
Owner 四川泰华堂制药有限公司
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