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Cefuroxime sodium powder preparation for injection

A technology of sodium fluorescein powder and cefuroxime acid, applied in the field of medicine, can solve the problems of residual solvent, instability, inclusion and the like, and achieve the effects of less residual solvent, high stability and less impurities

Active Publication Date: 2015-07-15
NORTH CHINA PHARMA HEBEI HUAMIN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The stability of cefuroxime sodium is relatively poor, and it is unstable to heat, acidic environment, and alkaline environment. It is manifested in problems such as easy discoloration of appearance, lower content, and occurrence of degradation products. The reason for the occurrence may be that some impurities, Reasons such as residual solvent in the crystal form

Method used

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  • Cefuroxime sodium powder preparation for injection
  • Cefuroxime sodium powder preparation for injection
  • Cefuroxime sodium powder preparation for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] (1) add weighed methanol 153kg, anhydrous sodium acetate 18kg in the stainless steel reaction tank, stir to make solid material all dissolve, set aside;

[0032] (2) Add 576 kg of acetone and 60 kg of water into a cleaned and dried stainless steel reaction tank, add 85 kg of cefuroxime 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 dissolved and decolorized solution into a sterile crystallization tank; add the prepared acetone and water mixed washing solution into the dissolution tank, and filter the washing solution into the crystallization tank;

[0033] (3) Control the feed liquid in the crystallization tank at 10-15°C, control the stirring speed at 100 rpm, control the nitrogen pressure <0.2MPa, add sodium acetate solution dropwise, and finish adding in 60-80 minutes; flow acceleration rate according to the table Add solvent ...

Embodiment 2

[0038] (1) add weighed ethanol 172kg, anhydrous sodium acetate 22kg in the stainless steel reaction tank, stir to make solid material all dissolve, set aside;

[0039] (2) Add 597kg of ethanol and 60kg of water into a cleaned and dried stainless steel reaction tank, add 78kg of cefuroxime 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 dissolved and decolorized solution into a sterile crystallization tank; add the prepared acetone and water mixed washing solution into the dissolution tank, and filter the washing solution into the crystallization tank;

[0040] (3) Control the feed liquid in the crystallization tank at 10-15°C, control the stirring speed at 100 rpm, control the nitrogen pressure <0.2MPa, add sodium acetate solution dropwise, and finish adding in 60-80 minutes; flow acceleration rate according to the table Add solvent etha...

Embodiment 3

[0045] (1) add weighed ethanol 163kg, anhydrous sodium acetate 20kg in the stainless steel reaction tank, stir to make solid material all dissolve, set aside;

[0046] (2) Add 552 kg of ethanol and 60 kg of water into a cleaned and dried stainless steel reaction tank, add 92 kg of cefuroxime 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 dissolved and decolorized solution into a sterile crystallization tank; add the prepared acetone and water mixed washing solution into the dissolution tank, and filter the washing solution into the crystallization tank;

[0047] (3) Control the feed liquid in the crystallization tank at 10-15°C, control the stirring speed at 100 rpm, control the nitrogen pressure <0.2MPa, add sodium acetate solution dropwise, and finish adding in 60-80 minutes; flow acceleration rate according to the table Add solvent e...

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Abstract

The present invention discloses a cefuroxime sodium powder preparation for injection. The preparation is prepared by the following steps: (1) preparing a sodium acetate solution by dissolving sodium acetate with a solvent for standby; (2) adding the solvent and water, and adding cefuroxime acid with stirring until complete dissolution; adding activated carbon, decolorizing, filtering, mixing with the solvent, washing the residue and a filter bottle, and filling a crystallization tank with the filtrate; (3) applying the particle process morphology and molecular assembly process crystal product molecular assembly and shape-state optimization technology by Hebei Huamin Pharmaceutical Co. Ltd. of North China Pharmaceutical Co. Ltd., controlling the temperature and stirring speed, and dropwise adding sodium acetate solution; and adding a solvent agent according to the flow rate; (4) carrying out pumping filtration, washing, vacuum drying, weighing, and packing; and 5) packing the preparations in different specifications to obtain the cefuroxime sodium for injection. The cefuroxime sodium powder prepared by the method has the advantages of excellent hydrodynamic performance, perfect crystal shape, uniform particle size distribution, and greatly improved color grade, clarification, purity and stability.

Description

technical field [0001] The invention relates to a cefuroxime sodium powder preparation for injection, which belongs to the technical field of medicine. Background technique [0002] Cefuroxime sodium is a second-generation cephalosporin with broad antibacterial spectrum and strong antibacterial activity. It has good antibacterial activity against both Gram-positive and Gram-negative microorganisms. It is highly stable against β-lactamase and has no side effects. Its mechanism of action is to bind to penicillin-binding proteins (PBPs) on the bacterial cell membrane, acylate transpeptidase, inhibit bacterial cell wall synthesis, affect the cross-linking of cell wall mucopeptide components, and inhibit cell division and growth. grows longer, and finally dissolves and dies. Cefuroxime sodium is used for respiratory tract infection, ENT infection, urinary tract infection, skin and soft tissue infection, bone and joint infection, obstetric and gynecological infection, gonorrhea a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/546A61P31/04
Inventor 张锁庆刘树林蒋晓声董伟昌贾全李敏田洪年张立斌胡少华张文胜王智
Owner NORTH CHINA PHARMA HEBEI HUAMIN PHARMA
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