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Compound pharmaceutical composition of amoxicillin sodium and potassium clavulanate and preparation method of compound pharmaceutical composition

A technology of amoxicillin sodium clavulanate potassium and amoxicillin sodium, applied in the compound pharmaceutical composition of amoxicillin sodium clavulanate potassium for injection and its preparation field, can solve the problem of amoxicillin sodium clavulanate potassium Problems such as poor stability, high levels of related substances, and unstable compatibility, etc., achieve clinical drug safety and solve the effects of poor stability

Active Publication Date: 2016-03-02
FUAN PHARM (GRP) CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] After long-term in-depth research, the inventor has proved that the amoxicillin sodium clavulanate potassium of 5:1 weight part not only solves the poor stability of amoxicillin sodium clavulanate potassium by controlling the scope of specific pH regulator and pH value, Related to the high level of material problems, and solved the problem of unstable compatibility

Method used

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  • Compound pharmaceutical composition of amoxicillin sodium and potassium clavulanate and preparation method of compound pharmaceutical composition
  • Compound pharmaceutical composition of amoxicillin sodium and potassium clavulanate and preparation method of compound pharmaceutical composition
  • Compound pharmaceutical composition of amoxicillin sodium and potassium clavulanate and preparation method of compound pharmaceutical composition

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] Amoxicillin sodium (calculated as free) 100g

[0050] Potassium clavulanate (calculated as free) 20g

[0051] Appropriate amount of sodium carbonate

[0052] Weigh the prescribed amount of amoxicillin sodium and clavulanate potassium in the aseptic operation room, dissolve them in 1800ml of water for injection, adjust the pH value of the mixture to 8.6-8.8 with sodium carbonate, add 450ml of water for injection, and add Activated carbon absorbs the heat source, sterilizes and filters with membrane filters of 0.45 μm and 0.22 μm pore size respectively, puts the sterile solution into a tray, freezes and dries it, and then packs it to obtain the product.

[0053] The freeze-drying process is as follows: solidify the aliquoted sterile solution at -25°C, then gradually raise the temperature to -15°C, and keep warm until the water line disappears 3 hours after the first drying. Then continue to heat up to 35-40°C to sublimate and dry the product moisture to about 1.0-2.0%, ...

Embodiment 2

[0055] Amoxicillin sodium (calculated as free) 200g

[0056] Potassium clavulanate (calculated as free) 40g

[0057] Appropriate amount of sodium carbonate

[0058] Weigh the prescribed amount of amoxicillin sodium and clavulanate potassium in the aseptic operation room, dissolve them in 3200ml of water for injection, adjust the pH value of the mixture to 8.6-8.8 with sodium carbonate, add 800ml of water for injection, and add Activated carbon absorbs the heat source, sterilizes and filters with membrane filters of 0.45 μm and 0.22 μm pore size respectively, puts the sterile solution into a tray, freezes and dries it, and then packs it to obtain the product.

Embodiment 3

[0060] Amoxicillin sodium (calculated as free) 500g

[0061] Potassium clavulanate (calculated as free) 100g

[0062] Appropriate amount of sodium carbonate

[0063] Weigh the prescribed amount of amoxicillin sodium and clavulanate potassium in the aseptic operation room, dissolve them in 9000ml of water for injection, adjust the pH value of the mixture to 8.6-8.8 with sodium carbonate, then add 2250ml of water for injection, and add Activated carbon absorbs the heat source, sterilizes and filters with membrane filters of 0.45 μm and 0.22 μm pore size respectively, puts the sterile solution into a tray, freezes and dries it, and then packs it to obtain the product.

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Abstract

The invention discloses a compound pharmaceutical composition of amoxicillin sodium and potassium clavulanate. The injection composition consists of amoxicillin sodium, potassium clavulanate and sodium carbonate which serves as a pH value regulator; and the pH value of a mixed solution is regulated to be 8.5-10.0 through the sodium carbonate. In addition, the invention also discloses a preparation method of the compound pharmaceutical composition. The compound pharmaceutical composition disclosed by the invention, through a formula and a process, can solve the problem of poor stability in the prior art, in particular problem of instable compatibility, so that clinical medication is safer.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a compound pharmaceutical composition of amoxicillin sodium and clavulanate potassium for injection and a preparation method thereof. Background technique [0002] Amoxicillin is a β-lactam antibiotic with broad antibacterial spectrum, strong bactericidal power in the body, and good absorption. It has been widely used clinically since it was launched in the 1960s. However, with the emergence of more and more pathogenic strains producing β-lactamase, the pathogenic bacteria can make the β-lactam ring in the amoxicillin molecule easily hydrolyzed and lose its activity, thus producing drug resistance. Clavulanic acid, also known as clavulanic acid, has only weak antibacterial activity, but it has a strong broad-spectrum β-lactamase inhibitory effect, which can protect the antibacterial effect of β-lactam antibiotics that are not resistant to enzymes. ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/43A61K47/02A61P31/04A61K31/424
CPCA61K9/0019A61K9/19A61K31/424A61K31/43A61K47/02A61K2300/00
Inventor 蒋晨
Owner FUAN PHARM (GRP) CO LTD
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