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Cefoxitin sodium powder preparation for injection

A technology of cefoxitin sodium and cetin sodium powder, which is applied in the field of medicine, can solve the problems of many impurities, low purity of active ingredients, obvious side effects, etc., and achieve the effect of less residual solvent, less impurities and high stability

Active Publication Date: 2015-05-20
NORTH CHINA PHARMA HEBEI HUAMIN PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] At present, some methods for preparing cefoxitin sodium preparations have been disclosed at home and abroad, but the cefoxitin sodium preparations made by these methods have problems such as low purity of active ingredients, too many impurities, and obvious side effects caused thereby.

Method used

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  • Cefoxitin sodium powder preparation for injection
  • Cefoxitin sodium powder preparation for injection
  • Cefoxitin sodium powder preparation for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] (1) Add 163kg of weighed methanol and 18kg of anhydrous sodium acetate in a stainless steel reaction tank, control the temperature of the reaction solution at 13-16°C, stir to dissolve all the solid materials, and set aside;

[0031] (2) Add 576kg of acetone and 144kg of methanol in a weighed amount into the cleaned and dried stainless steel reaction tank, and cool the feed liquid to 10°C. Add 90 kg of cefoxitin acid under stirring, and stir until dissolved under nitrogen protection. Add 6 kg of activated carbon into the dissolving tank, and stir and decolorize at 10° C. for 30 minutes. Filter the dissolving and decolorizing solution into a sterile crystallization tank; add the prepared acetone 360kg / methanol 58kg mixed washing liquid into the dissolving tank, and filter the washing liquid into the crystallization tank. ;

[0032] (3) Control the feed liquid in the crystallization tank at 13-16°C, control the stirring speed at 60 rpm, control the nitrogen pressure <0....

Embodiment 2

[0037] (1) Add 172kg of weighed methanol and 19kg of anhydrous sodium acetate into a stainless steel reaction tank, control the temperature of the reaction solution at 13-16°C, and stir to dissolve all the solid materials.

[0038] (2) Add a weighed amount of 569kg of acetone and 140kg of methanol into the cleaned and dried stainless steel reaction tank, and cool the feed liquid to 10°C. Add 90 kg of cefoxitin acid under stirring, and stir until dissolved under nitrogen protection. Add 6 kg of activated carbon into the dissolving tank, and stir and decolorize at 10° C. for 30 minutes. Filter the dissolving and decolorizing solution into a sterile crystallization tank; add the prepared acetone 360kg / methanol 58kg mixed washing liquid into the dissolving tank, and filter the washing liquid into the crystallization tank.

[0039] (3) Control the temperature of the feed liquid in the crystallization tank at 13-16°C, control the stirring speed at 60 rpm, control the nitrogen press...

Embodiment 3

[0045] (1) Add 154kg of weighed methanol and 17kg of sodium isooctanoate into a stainless steel reaction tank, control the temperature of the reaction solution at 13-16°C, and stir to dissolve all the solid materials.

[0046] (2) Add a weighed amount of 544kg of acetone and 136kg of methanol into the cleaned and dried stainless steel reaction tank, and cool the feed liquid to 10°C. Add 85 kg of cefoxitin acid under stirring, and stir until dissolved under nitrogen protection. Add 6 kg of activated carbon into the dissolving tank, and stir and decolorize at 10° C. for 30 minutes. Filter the dissolving and decolorizing solution into a sterile crystallization tank; add the prepared acetone 360kg / methanol 58kg mixed washing liquid into the dissolving tank, and filter the washing liquid into the crystallization tank.

[0047] (3) Control the feed liquid in the crystallization tank at 13-16°C, control the stirring speed at 60 rpm (8Hz), control the nitrogen pressure <0.2MPa, add s...

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Abstract

The invention discloses a cefoxitin sodium powder preparation for injection. The cefoxitin sodium powder preparation is prepared by the following steps: (1) controlling the temperature, and preparing a sodium-forming agent solution; (2) adding acetone and methyl alcohol to a reaction tank, cooling, stirring under nitrogen protection, adding cefoxitin acid until dissolving, adding activated carbon, decolorizing, filtering, mixing a solvent and washing; (3) controlling the temperature of a crystallization tank, the stirring speed and the nitrogen pressure by molecular assembly and shape optimization techniques for crystal products in a grain process by Hebei Huamin Pharmaceutical Co.,Ltd. in North China, dropwise adding the sodium-forming agent solution, and adding acetone according to a feeding rate form; (4) filtering and drying crystalline liquid, detecting and discharging; and (5) carrying out sub-package of preparations with different specifications, and controlling the environment temperature and humidity to obtain cefoxitin sodium for injection. The cefoxitin sodium for injection, prepared by the preparation method, has good hydrodynamics performance, and is perfect in crystalline form and uniform in particle size distribution; and the color grade, the clarity, the purity and the stability are greatly improved.

Description

technical field [0001] The invention relates to a cefoxitin sodium powder injection preparation, which belongs to the technical field of medicine. Background technique [0002] Cefoxitin sodium is a cephalosporin antibiotic. Its nucleus is similar to cephalosporins, and its antibacterial properties are also similar. It is customarily listed as the second-generation cephalosporins. It is characterized by its strong antibacterial effect on Gram-negative bacteria and its high resistance to β-lactamase. The antibacterial spectrum includes Escherichia coli, Klebsiella pneumoniae, indole-positive Proteus and Serratia, Klebsiella, influenza bacillus, Salmonella, Shigella, etc. It also has a good effect on staphylococcus and various streptococci. Clinically, it is mainly used for respiratory tract infection, endocarditis, peritonitis, pyelonephritis, urinary tract infection, sepsis, bone, joint, skin and soft tissue infection caused by sensitive bacteria. [0003] Cefoxitin sodiu...

Claims

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Application Information

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IPC IPC(8): A61J3/02A61K9/14A61K31/546A61P31/04
Inventor 蒋晓声刘树林张锁庆贾全董伟昌张致一张立斌魏阔李敏张文胜王智姜莉莉傅翠连
Owner NORTH CHINA PHARMA HEBEI HUAMIN PHARMA
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