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Amoxicillin sodium and sulbactam sodium preparation for injection and preparation method thereof

A technology for amoxicillin sodium sulbactam sodium and amoxicillin sodium, which is applied in the field of medicine, can solve the problems of poor stability, many impurities and low purity, and achieves the advantages of stable preparation, improved reaction yield and increased condensation reaction temperature. Effect

Inactive Publication Date: 2015-05-27
NORTH CHINA PHARMA COMPANY +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] The current amoxicillin sodium sulbactam sodium for injection has the disadvantages of low purity, many impurities, poor stability, and easy allergies.

Method used

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  • Amoxicillin sodium and sulbactam sodium preparation for injection and preparation method thereof
  • Amoxicillin sodium and sulbactam sodium preparation for injection and preparation method thereof
  • Amoxicillin sodium and sulbactam sodium preparation for injection and preparation method thereof

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Effect test

Embodiment 1

[0043] A kind of amoxicillin sodium sulbactam sodium preparation for injection is formed by uniformly mixing high-purity amoxicillin sodium and high-purity sulbactam sodium, and the weight ratio of amoxicillin sodium and sulbactam sodium is 2: 1.

[0044] The amoxicillin sodium sulbactam sodium preparation for injection is prepared by the following steps:

[0045] (1) prepare high-purity amoxicillin sodium; this high-purity amoxicillin sodium is prepared with the following method:

[0046] ①Preparation of mixed acid anhydride: add 906ml of dichloromethane, add 300g of D-p-hydroxyphenylglycine Deng potassium salt (hydroxydeng salt) under rapid stirring, add 130ml of N,N-dimethylacetamide (DMA) at the same time, keep the temperature 10-15°C, cool down, when the temperature drops to 0°C, add 7.5 grams of 2,6-lutidine, continue to cool down to -30°C, add 119 grams of pivaloyl chloride at a uniform speed within 10 minutes, and control the temperature at -15 ℃, keep warm for 60 mi...

Embodiment 2

[0060] A kind of amoxicillin sodium sulbactam sodium preparation for injection is formed by uniformly mixing high-purity amoxicillin sodium and high-purity sulbactam sodium, and the weight ratio of amoxicillin sodium and sulbactam sodium is 3: 1.

[0061] The amoxicillin sodium sulbactam sodium preparation for injection is prepared by the following steps:

[0062] (1) prepare high-purity amoxicillin sodium; this high-purity amoxicillin sodium is prepared with the following method:

[0063] ①Preparation of mixed acid anhydride: Add 1000ml of dichloromethane, add 300g of D-p-hydroxyphenylglycine Deng potassium salt (hydroxydeng salt) under rapid stirring, and add 150ml of N,N-dimethylacetamide (DMA) at the same time, keep the temperature 10-15°C, cool down, when the temperature drops to 0°C, add 8.2 grams of 2,6-lutidine, continue to cool down to -34°C, add 125 grams of pivaloyl chloride at a uniform speed within 10 minutes, and control the temperature at -18 ℃, keep warm for ...

Embodiment 3

[0077] A kind of amoxicillin sodium sulbactam sodium preparation for injection, uniformly mixed by high-purity amoxicillin sodium and high-purity sulbactam sodium, the weight ratio of amoxicillin sodium and sulbactam sodium is 4: 1.

[0078] The amoxicillin sodium sulbactam sodium preparation for injection is prepared by the following steps:

[0079] (1) prepare high-purity amoxicillin sodium; this high-purity amoxicillin sodium is prepared with the following method:

[0080] ①Preparation of mixed acid anhydride: Add 1132ml of dichloromethane, add 300g of D-p-hydroxyphenylglycine Deng potassium salt (hydroxydeng salt) under rapid stirring, add 160ml N,N-dimethylacetamide (DMA) at the same time, keep the temperature 10-15°C, cool down, when the temperature drops to 0°C, add 9.0 grams of 2,6-lutidine, continue to cool down to -38°C, add 131 grams of pivaloyl chloride at a uniform speed within 10 minutes, and control the temperature at -20 °C, keep the reaction for 60 minutes. ...

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Abstract

The invention discloses an amoxicillin sodium and sulbactam sodium preparation for injection and a preparation method thereof. The amoxicillin sodium and sulbactam sodium preparation for injection is formed by uniformly mixing high purity amoxicillin sodium and high purity sulbactam sodium, wherein the weight ratio of amoxicillin sodium to sulbactam sodium is (2-4): 1. The amoxicillin sodium and sulbactam sodium preparation for injection disclosed by the invention has the advantages of being high in purity, few in impurities, high in stability, hard to irritate and the like.

Description

technical field [0001] The invention relates to amoxicillin sodium sulbactam sodium preparation for injection and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Amoxicillin sodium and sulbactam sodium for injection are compound preparations, and its components are sterile powders uniformly mixed with amoxicillin sodium and sulbactam sodium. [0003] Amoxicillin sodium, the chemical name is (2S,5R,6R)-3,3-dimethyl-6-[(R)-(-)-2-amino-2-(4-hydroxyphenyl)acetamido ]-Sodium 7-oxo-4thia-1-azabicyclo(3.2.0)heptane-2-carboxylate. Molecular formula: C 16 h 18 N 3 NaO 5 S, molecular weight: 387.40. Amoxicillin sodium is a semi-synthetic penicillin antibiotic, suitable for the treatment of the following diseases: 1. Otitis media, sinusitis, pharyngitis, tonsillitis, etc. Respiratory infection. 2. Urinary tract infection caused by Escherichia coli, Proteus mirabilis or Enterococcus faecalis. 3. Skin and soft tissue infe...

Claims

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Application Information

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IPC IPC(8): A61K31/43A61P31/04C07D499/86C07D499/16C07D499/18C07D499/68C07D499/12
Inventor 左丽华严正人刘慧勤胡卫国郝瑞霞王利杰杨京霞陈宇东傅苗青胡国胜
Owner NORTH CHINA PHARMA COMPANY
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