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Amoxicillin potassium clavulanate tablet and method for preparing same

A technology of amoxicillin and clavulanate potassium tablets and clavulanate potassium, which is applied in the field of medicine and can solve problems such as the stability of amoxicillin and clavulanate potassium that are not mentioned

Active Publication Date: 2013-12-04
HAINAN ZHONGJI MEDICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Again, the technology does not mention how to address the stability of amoxicillin and potassium clavulanate

Method used

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  • Amoxicillin potassium clavulanate tablet and method for preparing same
  • Amoxicillin potassium clavulanate tablet and method for preparing same
  • Amoxicillin potassium clavulanate tablet and method for preparing same

Examples

Experimental program
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Effect test

Embodiment 1

[0027] Embodiment 1 amoxicillin-clavulanate potassium tablet and preparation technology thereof

[0028]

[0029] Preparation Process:

[0030] (1) Pass amoxicillin and tartaric acid through a 100-mesh sieve, mix evenly, add absolute ethanol for wet granulation, granulate with a 16-mesh sieve, and dry at 50°C to obtain drug-containing granules for later use;

[0031] (2) Dry the disintegrant at 105°C until the moisture content is 2.6%, cool to room temperature under the condition of relative humidity less than 45%RH, pass through a 80-mesh sieve, and set aside;

[0032] (3) Under the condition that the relative humidity is less than 45%RH, pass potassium clavulanate through an 80-mesh sieve for later use;

[0033] (4) Mix the drug-containing granules with the sieved crospovidone and potassium clavulanate evenly, add magnesium stearate, mix evenly, and directly compress into tablets.

Embodiment 2

[0034] Embodiment 2 Amoxicillin-clavulanate potassium tablet and preparation technology thereof

[0035]

[0036] Preparation Process:

[0037] (1) Pass amoxicillin and tartaric acid through a 80-mesh sieve, mix evenly, add absolute ethanol to wet granulate, granulate with a 18-mesh sieve, and dry at 45°C to obtain drug-containing granules for later use;

[0038] (2) Dry the disintegrant at 105°C until the moisture content is 2.9%, cool to room temperature under the condition of relative humidity less than 45%RH, pass through a 80-mesh sieve, and set aside;

[0039] (3) Under the condition that the relative humidity is less than 45%RH, pass potassium clavulanate through an 80-mesh sieve for later use;

[0040] (4) Mix the drug-containing granules with the sieved crospovidone and potassium clavulanate evenly, add magnesium stearate, mix evenly, and directly compress into tablets.

Embodiment 3

[0041] Embodiment 3 amoxicillin-clavulanate potassium tablet and preparation technology thereof

[0042]

[0043] Preparation Process:

[0044] (1) Pass amoxicillin and tartaric acid through a 100-mesh sieve, mix evenly, add absolute ethanol for wet granulation, granulate with a 18-mesh sieve, and dry at 45°C to obtain drug-containing granules for later use;

[0045] (2) Dry the disintegrant at 105°C until the moisture content is less than 2.8%, cool to room temperature under the condition of relative humidity less than 45%RH, pass through a 80-mesh sieve, and set aside;

[0046] (3) Under the condition that the relative humidity is less than 45%RH, pass potassium clavulanate through an 80-mesh sieve for later use;

[0047] (4) Mix the drug-containing granules with the sieved crospovidone and potassium clavulanate evenly, add magnesium stearate, mix evenly, and directly compress into tablets.

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PUM

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Abstract

The invention discloses an amoxicillin potassium clavulanate tablet. In the tablet, the weight ratio of amoxicillin and potassium clavulanate is 4-8:1. The tablet is formed by even mixing of medicated granules, the potassium clavulanate, a disintegrating agent and a lubricating agent in a direct tablet compressing mode, wherein the disintegrating agent is dried to have the moisture content lower than 3%. The medicated granules comprise amoxicillin and tartaric acid, wherein the weight ratio of the amoxicillin and the tartaric acid is 1:0.1-0.5. The tablet is rapid in dissolution, good in stability, few in auxiliary material kind and simple in preparation technology.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to amoxicillin-clavulanate potassium tablet and a preparation method thereof. Background technique [0002] Amoxicillin, namely amoxicillin, is the most commonly used penicillin β-lactam broad-spectrum antibiotic. It is a white powder with a half-life of about 61.3 minutes. Amoxicillin is stable under acidic conditions, its gastrointestinal absorption rate reaches 90%, its bactericidal effect is strong, and it can quickly penetrate the cell membrane. One of the best medicines. However, amoxicillin is easily hydrolyzed by the attack of β-lactamase in the body, thereby reducing the effective blood concentration of amoxicillin, resulting in the increasing resistance of various bacteria to amoxicillin. Therefore, single use of amoxicillin is less and less effective in treating various diseases. In addition, amoxicillin will undergo the degradation reaction of penicillin...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/43A61K9/20A61K47/12A61K47/32A61P31/04A61K31/424
Inventor 不公告发明人
Owner HAINAN ZHONGJI MEDICAL TECH
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