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Novel amoxicillin sodium compound and composition of amoxicillin sodium compound and sulbactam sodium compound

A technology of amoxicillin sodium and sulbactam sodium, applied in the field of amoxicillin sodium compounds and pharmaceutical compositions thereof, can solve the problems of inaccuracy, secondary infection dosage, oxidative decomposition and deterioration of active ingredients and the like

Active Publication Date: 2013-04-03
中山市力恩普制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Amoxicillin sodium sulbactam sodium pharmaceutical composition compound preparation has a large amount of clinical use, definite curative effect, and very good market prospect. Like most cephalosporin antibiotics, it is composed of amoxicillin sodium and sulbactam sodium aseptic raw materials. Subpackaged or freeze-dried, it has a common defect that the stability of the preparation is poor, and it cannot meet the quality requirements of the expiration date
Existing amoxicillin sodium sulbactam sodium compositions are generally lyophilized powder injections, which are mixed and dissolved in sterile powders and used in injection solvents during use, which not only causes the possibility of secondary infection and inaccurate dosage, but also It needs to be prepared at the same time as it is used. If it is left for a long time, the active ingredients will be oxidized and decomposed, which will affect the use of patients.

Method used

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  • Novel amoxicillin sodium compound and composition of amoxicillin sodium compound and sulbactam sodium compound
  • Novel amoxicillin sodium compound and composition of amoxicillin sodium compound and sulbactam sodium compound

Examples

Experimental program
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Effect test

Embodiment 1

[0019] A composition of amoxicillin sodium compound and sulbactam sodium compound, said composition is an injection, and the preparation method of said injection consists of the following steps:

[0020] (1) Take 400ml of water for injection and place it in a container, then add 0.3g of vitamin C, 0.2g of proline, and 0.3g of nicotinamide, dissolve and add activated carbon to filter to form solution A;

[0021] (2) Take 60ml of water for injection and place it in another container, add 5g of amoxicillin sodium, and stir until it is completely dissolved to form solution B;

[0022] (3) Take 40ml of water for injection and place it in another container, add 5g of sulbactam sodium, and stir until it is completely dissolved to form solution C;

[0023] (4) Add solutions B and C to solution A, add water for injection to 1000ml, add activated carbon again, stir and filter to form solution D;

[0024] (5) Detect the contents of amoxicillin sodium and sulbactam sodium in solution D, ...

Embodiment 2

[0026] A composition of amoxicillin sodium compound and sulbactam sodium compound, said composition is an injection, and the preparation method of said injection consists of the following steps:

[0027] (1) Take 400ml of water for injection and place it in a container, then add 0.9g of vitamin C, 0.6g of proline, and 0.8g of nicotinamide, dissolve and add activated carbon to filter to form solution A;

[0028] (2) Take 60ml of water for injection and place it in another container, add 10g of amoxicillin sodium, and stir until it is completely dissolved to form solution B;

[0029] (3) Take 40ml of water for injection and place it in another container, add 2.5g of sulbactam sodium, and stir until it is completely dissolved to form solution C;

[0030] (4) Add solutions B and C to solution A, add water for injection to 1000ml, add activated carbon again, stir and filter to form solution D;

[0031] (5) Detect the contents of amoxicillin sodium and sulbactam sodium in solution ...

Embodiment 3

[0033] A composition of amoxicillin sodium compound and sulbactam sodium compound, said composition is an injection, and the preparation method of said injection consists of the following steps:

[0034] (1) Take 400ml of water for injection and place it in a container, then add 0.45g of vitamin C, 0.3g of proline, and 0.45g of nicotinamide, dissolve and add activated carbon to filter to form solution A;

[0035] (2) Take 60ml of water for injection and place it in another container, add 6g of amoxicillin sodium, and stir until it is completely dissolved to form solution B;

[0036] (3) Take 40ml of water for injection and place it in another container, add 3g of sulbactam sodium, stir until it is completely dissolved, and form solution C;

[0037] (4) Add solutions B and C to solution A, add water for injection to 1000ml, add activated carbon again, stir and filter to form solution D;

[0038] (5) Detect the contents of amoxicillin sodium and sulbactam sodium in solution D, ...

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Abstract

The invention discloses a novel amoxicillin sodium compound. The purity of the amoxicillin sodium compound is more than 99%, the specific rotation of the amoxicillin sodium compound is between +260 degrees and +280 degrees. The invention also discloses a composition of the amoxicillin sodium compound and the sulbactam sodium compound, which comprises the following components in parts by weight: 50-100 parts of amoxicillin sodium, 25-50 parts of sulbactam sodium, 3-9 parts of vitamin C, 1-6 parts of proline, and 2-8 parts of nicotinamide. According to the composition of the amoxicillin sodium compound and the sulbactam sodium compound, the vitamin C, the proline and the nicotinamide are taken as stabilizers and play synergistic effect so as to improve the stability of the composition of the amoxicillin sodium compound and the sulbactam sodium compound effectively, the composition can be prepared into stable injection which is not easy to deteriorate due to oxygenolysis after being laid for a period, and the injection does not need to be prepared when being used, thus being convenient to use.

Description

technical field [0001] The invention relates to an amoxicillin sodium compound and a pharmaceutical composition thereof, in particular to a composition of an amoxicillin sodium compound and a sulbactam sodium compound. Background technique [0002] Amoxicillin sodium is a bactericidal broad-spectrum antibiotic, and sulbactam sodium is an irreversible broad-spectrum β-lactamase inhibitor, which can effectively inhibit the β-lactamase produced by drug-resistant bacteria. Clinically, many Gram-positive and Gram-negative bacteria produce β-lactamase, which can make amoxicillin lose its antibacterial activity. Due to the presence of sulbactam sodium, amoxicillin can be protected from the destruction of β-lactamase, so that the bacteria that have been resistant to amoxicillin and produce β-lactamase are still sensitive to amoxicillin. This product is a bactericidal antibiotic, which can kill a variety of Gram-positive and Gram-negative bacteria in clinical practice, especially fo...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D499/68A61K31/43A61K47/22A61P31/04
Inventor 吴秋萍
Owner 中山市力恩普制药有限公司
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