Preparation method of cefoperazone sodium and sulbactam sodium powder injection for injection

A technology of cefoperazone sodium sulbactam sodium powder and cefoperazone sodium, which is applied in the field of medicine, can solve the problems of low solvent content, increased process difficulty, low mass transfer efficiency, etc., and achieve the effect of reduced impurity content and good product stability

Active Publication Date: 2015-05-27
NORTH CHINA PHARMA HEBEI HUAMIN PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0013] The packed tower used in the existing solvent recovery technology in the pharmaceutical industry has low mass transfer efficiency, poor operational stability, low solvent content and high impurities, and thus cannot be directly applied to product reproduction, or the product produced after direct application has low purity, High impurities
Usually the recovered solvent needs to be further processed, which increases the production cost and increases the difficulty of the process

Method used

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  • Preparation method of cefoperazone sodium and sulbactam sodium powder injection for injection
  • Preparation method of cefoperazone sodium and sulbactam sodium powder injection for injection
  • Preparation method of cefoperazone sodium and sulbactam sodium powder injection for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Embodiment 1 (adopting traditional technology to reclaim solvent)

[0030] (1) Preparation of cefoperazone sodium: add 200kg cefoperazone acid, 200L purified water, 400L of traditional technology to reclaim acetone in the dissolving tank, add 30kg of sodium bicarbonate, control the temperature at 15°C, stir and dissolve, then filter into the crystallization tank , control the temperature at 18°C, continue to add 3600L of acetone recovered by traditional technology for crystallization, grow crystals at 0-5°C, filter, and vacuum-dry at 45°C to obtain the finished product of cefoperazone sodium.

[0031] (2) Preparation of sulbactam sodium: add 800L of ethanol reclaimed by traditional technology, 200kg of sulbactam acid, 200kg of sodium acetate, 500L of ethanol reclaimed by traditional technology in a dissolving tank, stir at 40°C for temperature control, dissolve and filter, then temperature control for 40°C Under the condition of 1500°C, add 1500L of ethanol recovered by...

Embodiment 2

[0035] Embodiment 2 (adopt traditional technology to reclaim solvent)

[0036] (1) The preparation of cefoperazone sodium: add 400kg cefoperazone acid in dissolving tank, 400L purified water, the traditional technology of 600L reclaims acetone, adds sodium bicarbonate 70kg, after stirring and dissolving, filter in the crystallization tank, continue to add traditional technology Recover 5000L of acetone for crystallization, grow the crystal, filter, and dry at 40-50°C to obtain the finished product of cefoperazone sodium.

[0037] (2) Preparation of sulbactam sodium: add 800L of ethanol recovered by traditional technology, 200kg of sulbactam acid, 200kg of sodium acetate, 500L of ethanol recovered by traditional technology in a dissolving tank, stir, dissolve and filter, then add 1500L of ethanol recovered by traditional technology to carry out Crystallize, filter and wash, and dry at 40-50°C to obtain sulbactam sodium.

[0038] (3) Preparation of mixed powder of cefoperazone ...

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PUM

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Abstract

The invention discloses a preparation method of a cefoperazone sodium and sulbactam sodium powder injection for injection. A recovered solvent is prepared by a stereo mass transfer tower plate technology, and is directly applied to production of cefoperazone sodium and sulbactam sodium products; the quality indexes such as color grade, clarity and purity of the obtained cefoperazone sodium and sulbactam sodium powder injection product for injection are greatly improved; the cefoperazone sodium and sulbactam sodium powder injection is high in quality stability and few in impurity; and the preparation method is low in production cost and simple in process.

Description

technical field [0001] This product relates to a preparation method of cefoperazone sodium sulbactam sodium powder preparation for injection, belonging to the technical field of medicine. Background technique [0002] Cefoperazone Sodium / Sulbactam Sodium for Injection is a broad-spectrum antibacterial drug composed of cefoperazone sodium (third-generation cephalosporin) and β-lactamase inhibitor sulbactam sodium with partial antibacterial activity. Bacteria and some anaerobic bacteria have antagonistic effects, especially for Gram-negative bacteria, and also have strong antagonistic effects for Pseudomonas aeruginosa. Wide range of clinical applications, mainly for the treatment of respiratory infections caused by sensitive bacteria, urinary tract infections, sepsis and burn infections and other diseases. [0003] Cefoperazone sodium is a third-generation cephalosporin with a molecular weight of 667.66 and a structural formula as follows: [0004] [0005] Its chemical ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/546A61K9/14A61P31/04A61K31/43
Inventor 蒋晓声刘树林张锁庆董伟昌胡少华王智李科贺军利倪福震吴士军米建伟陈宇东傅苗青胡国胜
Owner NORTH CHINA PHARMA HEBEI HUAMIN PHARMA
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