Ampicillin sodium sulbactam sodium preparation for injection and preparation method thereof

A technology of ampicillin sodium sulbactam sodium and ampicillin sodium, which is applied in the field of medicine, can solve problems such as poor stability, easy allergies, and many impurities, and achieve the effects of good stability, increased reaction yield, and high purity

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] Current Ampicillin Sodium Sulbactam Sodium for Injection has the disa

Method used

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

Examples

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Effect test

Embodiment 1

[0043] An ampicillin sodium sulbactam sodium preparation for injection is prepared by uniformly mixing high-purity ampicillin sodium and high-purity sulbactam sodium, and the weight ratio of ampicillin sodium to sulbactam sodium is 2:1.

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

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

[0046] ① Preparation of mixed acid anhydride: add 906ml of dichloromethane, add 298 grams of L-phenylglycine ethyl Deng potassium salt (Deng salt) under rapid stirring, add 130ml N, N-dimethylacetamide (DMA) at the same time, keep the temperature at 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°C, The reaction was incubated for 60 m...

Embodiment 2

[0060] An ampicillin sodium sulbactam sodium preparation for injection is prepared by uniformly mixing high-purity ampicillin sodium and high-purity sulbactam sodium, and the weight ratio of ampicillin sodium to sulbactam sodium is 3:1.

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

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

[0063] ① Preparation of mixed acid anhydride: add 1000ml of dichloromethane, add 298 grams of L-phenylglycine ethyl Deng potassium salt (Deng salt) under rapid stirring, and add 150ml N,N-dimethylacetamide (DMA) at the same time, keep the temperature at 10- 15°C, lower the temperature, 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°C, The reaction was in...

Embodiment 3

[0077] An ampicillin sodium sulbactam sodium preparation for injection is prepared by uniformly mixing high-purity ampicillin sodium and high-purity sulbactam sodium, and the weight ratio of ampicillin sodium to sulbactam sodium is 4:1.

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

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

[0080] ① Preparation of mixed acid anhydride: Add 1132ml of dichloromethane, add 298 grams of L-phenylglycine ethyl Deng potassium salt (Deng salt) under rapid stirring, add 160ml N, N-dimethylacetamide (DMA) at the same time, keep the temperature at 10- 15°C, lower the temperature, 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, The reaction was incub...

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Abstract

The invention discloses an ampicillin sodium sulbactam sodium preparation for injection and a preparation method thereof. The ampicillin sodium sulbactam sodium preparation for injection is formed by mixing high-purity ampicillin sodium crystals with high-purity sulbactam sodium uniformly, wherein the weight ratio of ampicillin sodium to sulbactam sodium is (2-4):1. The ampicillin sodium sulbactam sodium preparation for injection has the advantages of high purity, less impurity, high stability, difficult irritability and the like.

Description

technical field [0001] The invention relates to an ampicillin sodium sulbactam sodium preparation for injection and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Ampicillin sodium and sulbactam sodium for injection are compound preparations, and its components are sterile powders uniformly mixed with ampicillin sodium and sulbactam sodium. [0003] Ampicillin sodium, chemical name: (2S, 5R, 6R)-3,3-dimethyl-6[ -2-Amino-2-phenylacetamido]-7-oxo-4-thioxo-1-amobicyclo[3.2.0]heptane-2-potassium acid sodium salt. Molecular formula: C 16 h 18 N 3 NaO 4 S, molecular weight: 371.39. Ampicillin sodium is one of the earliest semi-synthetic penicillin antibiotics, suitable for the treatment of infections caused by sensitive bacteria. Typical indications include: sinusitis, otitis media, epiglottitis, bacterial pneumonia and other upper and lower respiratory tract infections; urinary tract infection, pyelonephritis; per...

Claims

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Application Information

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IPC IPC(8): A61K31/43A61K9/14A61P31/04C07D499/68C07D499/86C07D499/16
Inventor 左丽华严正人胡卫国郝瑞霞王欣王利杰刘丹杨京霞李颜茹陈宇东傅苗青胡国胜
Owner NORTH CHINA PHARMA COMPANY
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