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Amoxicillin sodium clavulanate potassium preparation for injection and preparation method thereof

A technology of amoxicillin sodium clavulanate potassium and amoxicillin sodium is applied in the field of amoxicillin sodium clavulanate potassium preparation for injection and its preparation, which can solve the problems of poor stability, easy allergy, low purity and the like, and achieves the The effect of improved stability, high purity and less impurities

Active Publication Date: 2019-05-24
NORTH CHINA PHARMA COMPANY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0015] The technical problem to be solved in the present invention is to provide a preparation of amoxicillin sodium and clavulanate potassium for injection and a preparation method thereof. The present invention overcomes the disadvantages of existing injection preparations such as low purity, poor stability, many impurities, and easy allergies. Improve the purity and crystal size of amoxicillin sodium crystals, so that the stability of amoxicillin sodium clavulanate potassium powder injection and injection solution is improved

Method used

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  • Amoxicillin sodium clavulanate potassium preparation for injection and preparation method thereof
  • Amoxicillin sodium clavulanate potassium preparation for injection and preparation method thereof
  • Amoxicillin sodium clavulanate potassium preparation for injection and preparation method thereof

Examples

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Embodiment 1

[0048] Example 1 Preparation of high-purity amoxicillin sodium crystals.

[0049] The preparation method of high-purity amoxicillin sodium crystals comprises five process steps of condensation reaction, hydrolysis reaction, crystallization of amoxicillin, preparation of amoxicillin sodium, and crystallization of amoxicillin sodium, specifically as follows.

[0050] 1) Condensation reaction.

[0051] First prepare a 6-aminopenicillanic acid salt solution. The specific process is, according to the mass ratio of 6-aminopenicillanic acid and dichloromethane is 1:1.5, weigh 200g of reaction raw materials 6-aminopenicillanic acid and 300g of dichloromethane solvent, according to 6-aminopenicillane The mass ratio of acid to water is 1:0.20, 40g of water is weighed, and 98.3g of triethylamine is weighed according to the molar ratio of 6-aminopenicillanic acid to triethylamine is 1:1.05.

[0052] Reduce the temperature of dichloromethane to 0-6°C, stir and dissolve for 20 minutes, th...

Embodiment 2

[0068] Example 2 Preparation of high-purity amoxicillin sodium crystals.

[0069] The preparation method of high-purity amoxicillin sodium crystals comprises five process steps of condensation reaction, hydrolysis reaction, crystallization of amoxicillin, preparation of amoxicillin sodium, and crystallization of amoxicillin sodium, specifically as follows.

[0070] 1) Condensation reaction.

[0071] First prepare a 6-aminopenicillanic acid salt solution. The specific process is, according to the mass ratio of 6-aminopenicillanic acid and dichloromethane is 1:1.75, weigh 200g of reaction raw materials 6-aminopenicillanic acid and 350g of dichloromethane solvent, according to 6-aminopenicillane The mass ratio of acid to water is 1:0.175, 35g of water is weighed, and 103.0g of triethylamine is weighed according to the molar ratio of 6-aminopenicillanic acid to triethylamine is 1:1.10.

[0072] Reduce the temperature of dichloromethane to 0-6°C, stir and dissolve for 10 minutes,...

Embodiment 3

[0088] Example 3 Preparation of Amoxicillin Sodium Clavulanate Potassium Preparation for Injection.

[0089] The amoxicillin sodium and clavulanate potassium preparation for injection in this embodiment comprises amoxicillin sodium crystals and clavulanate potassium in a weight ratio of 5:1. The particle size of the amoxicillin sodium crystal is 25-35 μm, which is obtained by the above-mentioned embodiment 1 or embodiment 2.

[0090] The preparation method of the amoxicillin sodium clavulanate potassium preparation for injection of the present embodiment comprises the following processing steps,

[0091] A) According to the process steps of Example 1 or Example 2, amoxicillin sodium crystals with a particle size of 25-35 μm were obtained.

[0092] B) Amoxicillin sodium crystals and clavulanate potassium are uniformly mixed according to a mass ratio of 5:1.

[0093] C) It is packaged in 25ml vials, and the content of the active ingredient in the amoxicillin sodium and clavula...

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Abstract

The invention relates to an amoxicillin sodium potassium clavulanate preparation for injection and a preparation method of the preparation. The preparation consists of an amoxicillin sodium crystal and potassium clavulanate at mass ratio of (5-10) to 1, wherein the grain size of the amoxicillin sodium crystal is 25-35microns. The preparation method comprises the following steps: preparing the amoxicillin sodium crystal, uniformly mixing the amoxicillin sodium crystal and the potassium clavulanate according to a fixed mass ratio, and packaging an obtained mixture in a small bottle of 25ml so as to obtain amoxicillin sodium potassium clavulanate powder for injection; and in the clinical field, on the basis of a dispensing scheme of dissolving the powder in 20ml of injection water, an amoxicillin sodium potassium clavulanate injection solution is obtained. The amoxicillin sodium crystal disclosed by the invention is high in purity and low in content of impurities; and the amoxicillin sodium potassium clavulanate preparation for injection is good in stability and is not easy for causing allergy.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a preparation of amoxicillin sodium and clavulanate potassium for injection and a preparation method thereof. Background technique [0002] Penicillin is the world's first clinically used anti-infective drug, and is the earliest antibiotic discovered by humans. In 1928, Fleming, a professor of bacteriology at St. Mary's College of Medicine, University of London (now part of Imperial College London), worked in the laboratory Penicillium was found to have a bactericidal effect, and was extracted in 1938 by a team led by Chain, Florey and Heatley (Norman Heatley, 1911-2004) of Oxford University. [0003] Penicillin (Penicillin, or transliteration Penicillin) refers to a class of antibiotics containing penicillin in the molecule, which can destroy the cell wall of bacteria and play a bactericidal effect during the reproduction period of bacterial cells. It is an a...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/43A61K9/14A61K9/08C07D499/68C07D499/10A61P31/04A61K31/424
CPCA61K9/0019A61K9/08A61K9/14A61K31/424A61K31/43C07D499/10C07D499/68A61K2300/00
Inventor 高任龙胡卫国左丽华郝瑞霞严正人仇俊新刘慧勤刘善萍杨京霞王秋颖黄娟陈利明吴琴雪刘丹周捷张艳慧
Owner NORTH CHINA PHARMA COMPANY