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Preparation method of amoxicillin and clavulanate potassium tablets

A technology of amoxicillin-clavulanate potassium and clavulanate potassium, which is applied in the direction of non-active ingredient medical preparations, active ingredient-containing medical preparations, pharmaceutical formulas, etc., and can solve poor humidity controllability and product instability and other issues to achieve the effect of ensuring quality, reducing dosage, and reducing side effects

Inactive Publication Date: 2014-08-06
KANGTIAN PHARMA ZHONGSHAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The inventor found in the research process that by improving the production process of amoxicillin-clavulanate potassium tablets, the granulation, tableting, etc., can be improved and strengthened, and the coating technology can be used to solve the problem of amoxicillin. The defects of poor humidity controllability and product instability of potassium clavulanate tablets ensure the quality of medicines and improve production efficiency

Method used

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  • Preparation method of amoxicillin and clavulanate potassium tablets

Examples

Experimental program
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Effect test

Embodiment 1

[0023] A kind of preparation method of amoxicillin-clavulanate potassium tablet, obtain through following steps:

[0024] Prescription of amoxicillin and clavulanate potassium tablets: 875g of amoxicillin, 125g of potassium clavulanate, 226.6g of microcrystalline cellulose, 10.0g of micronized silica gel, 29.0g of croscarmellose sodium, and 14.5g of magnesium stearate. Among them, the internal part of microcrystalline cellulose is 212.1g, and the external part is 14.5g; the internal part of magnesium stearate is 7.25g, and the external part is 7.25g.

[0025] The above raw materials can be used for the production of 1000 amoxicillin and clavulanate potassium tablets. The coating material used to produce amoxicillin-clavulanate potassium tablets is Opadry white OY-C-7000A of Colorcon Company. The coating powder consists of hypromellose 2910 (5CPS), titanium dioxide, ethyl cellulose (10CPS), and diethyl phthalate.

[0026] Concrete preparation process is as follows:

[0027] ...

Embodiment 2

[0036] A kind of preparation method of amoxicillin-clavulanate potassium tablet, obtain through following steps:

[0037] Prescription of amoxicillin and clavulanate potassium tablets: 875g of amoxicillin, 125g of potassium clavulanate, 337.5g of microcrystalline cellulose, 12.5g of micronized silica gel, 12.5g of croscarmellose sodium, and 25g of magnesium stearate. Among them, the internal part of microcrystalline cellulose is 315.9g, and the external part is 21.6g; the internal part of magnesium stearate is 12.5g, and the external part is 12.5g.

[0038] The above raw materials can be used for the production of 1000 amoxicillin and clavulanate potassium tablets. The coating material used to produce amoxicillin-clavulanate potassium tablets is Opadry white OY-C-7000A of Colorcon Company. The coating powder consists of hypromellose 2910 (5CPS), titanium dioxide, ethyl cellulose (10CPS), and diethyl phthalate.

[0039] The specific preparation process is the same as in Examp...

Embodiment 3

[0042] Prescription of amoxicillin and clavulanate potassium tablets: 875g of amoxicillin, 125g of potassium clavulanate, 266.7g of microcrystalline cellulose, 25g of micronized silica gel, 25g of croscarmellose sodium, and 33.3g of magnesium stearate. Among them, the internal part of microcrystalline cellulose is 249.6g, and the external part is 17.1g; the internal part of magnesium stearate is 16.7g, and the external part is 16.6g.

[0043] The above raw materials can be used for the production of 1000 amoxicillin and clavulanate potassium tablets. The coating material used to produce amoxicillin-clavulanate potassium tablets is Opadry white OY-C-7000A of Colorcon Company. The coating powder consists of hypromellose 2910 (5CPS), titanium dioxide, ethyl cellulose (10CPS), and diethyl phthalate.

[0044] The specific preparation process is the same as in Example 1.

[0045] The amoxicillin / potassium clavulanate 7:1 sheet prepared by the above method meets the requirements of...

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Abstract

The invention belongs to the field of chemosynthesis, and particularly relates to a preparation method of amoxicillin and clavulanate potassium tablets. The preparation method comprises the following steps: mixing major ingredients, mixing minor ingredients, pressing particles, sieving, repeatedly pressing particles, tabletting, coating and the like. The preparation method enhances the control to the pelletizing and tabletting processes of the amoxicillin and clavulanate potassium tablets, introduces a novel coating technology to overcome the defects of poor humidity controllability of the amoxicillin and clavulanate potassium tablets and product instability, ensures the quality of drugs, and improves the production efficiency; the steps of crushing, sieving and selecting fine powders to be pressed into particles are repeated.

Description

technical field [0001] The invention belongs to the field of drug synthesis, in particular to a preparation method of amoxicillin-clavulanate potassium tablets. Background technique [0002] Potassium amoxicillin and clavulanate is suitable for lower respiratory tract infection, otitis media, sinusitis, etc. caused by β-lactamase Haemophilus influenzae and Moraxella catarrhalis. Urinary tract and skin and soft tissue infections caused by β-lactamase Staphylococcus aureus and enzyme-producing Enterobacteriaceae such as Escherichia coli and Klebsiella can also be used for mild and moderate infections caused by enterococcus . [0003] β-lactam antibacterial drugs are the most widely used antibacterial drugs in clinical practice because of their good curative effect, safety and reliability, and few adverse reactions. However, long-term use of such antibiotics has developed resistance in bacteria, greatly reducing their efficacy. The resistance to β-lactam antibiotics is due t...

Claims

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Application Information

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IPC IPC(8): A61K31/43A61K9/36A61K47/38A61K31/424
Inventor 李玉祥
Owner KANGTIAN PHARMA ZHONGSHAN
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