Preparation process of cefotaxime sodium powder-injections

A technology of cefotaxime sodium and preparation process, which is applied in the field of medicine and chemical industry, can solve the problems of reducing the medicinal effect of cefotaxime sodium, and achieve the effects of enhancing injection safety and improving product quality

Inactive Publication Date: 2017-08-18
SICHUAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0005] The technical problem to be solved by the present invention is that the medicinal effect of cefotaxime sodium for injection caused by the existing preparation technology of cefotaxime sodium for injection reduces, and the purpose is

Method used

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Embodiment 1

[0026] The invention provides a preparation process of cefotaxime sodium powder injection for injection, the specific steps are:

[0027] (1) raw material preparation process: under the temperature condition of 15~20 ℃, prepare the mixed solvent of ethanol, acetone and water, the volume fraction of ethanol in the mixed solvent is 20~25%, the volume fraction of acetone is 8~10%, then Add cefotaxime acid to the mixed solvent and carry out stirring reaction to prepare cefotaxime sodium; add activated carbon for decolorization and sterile membrane filtration to obtain a filtrate; then add aseptic cefotaxime sodium seed crystals to the above filtrate, and stir Add ethanol dropwise under conditions, the stirring speed is 50-80r / min, and the dropping speed is 8-12mL / min. After the dropwise addition is completed, the crystal is grown for 35-55 minutes at a temperature of 5-15°C; finally, the raw material of cefotaxime sodium is obtained by vacuum filtration and drying.

[0028] (2) C...

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PUM

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Abstract

The invention discloses a preparation process of cefotaxime sodium powder-injections. The preparation process includes: preparing raw materials, to be more specific, preparing the mixed solvent of ethanol, acetone and water, adding cefotaxime acid into the mixed solvent to perform stirring reaction so as to prepare cefotaxime sodium, adding activated carbon for decoloration, filtering with a sterile membrane to obtain filtrate, adding sterile cefotaxime sodium seed crystals into the filtrate, dropwise adding ethanol under a stirring condition, and performing grain growing, vacuum filtration and drying to obtain the cefotaxime sodium; cleaning soda-lime-glass moulded injection bottles; cleaning rubber plugs; cleaning aluminum covers; performing sterile split charging to obtain the cefotaxime sodium powder-injections. The preparation process has the advantages that the various procedures including the raw material preparation, the bottle cleaning, the plug cleaning and the split charging are strictly controlled, the problem of use effect lowering caused by the performance damage of the cefotaxime sodium during preparation is avoided, product quality is further increased, and the safety of the cefotaxime sodium powder-injections is increased.

Description

technical field [0001] The invention belongs to the field of medicine and chemical industry, in particular to a preparation process of cefotaxime sodium powder for injection. Background technique [0002] The main ingredient of this product is cefotaxime sodium. The chemical name is: (6R,7R)-3-[(acetyloxy)methyl]-7-[2-amino-4-thiazolyl-(methoxyimino)acetamido]-8-oxo-5 - Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid sodium salt. Chemical Structure: [0003] Cefotaxime sodium is also known as cefotaxime, cefotaxime cephalosporin, ceftaxime, cefotaxime, etc. Cefotaxime sodium is used for pneumonia caused by sensitive bacteria and other lower respiratory tract infections, urinary tract infections, meningitis, sepsis, abdominal infections, pelvic infections, skin and soft tissue infections, reproductive tract infections, bone and joint infections, etc. Cefotaxime sodium can be used as the drug of choice for infantile meningitis. [0004] How to improve the effect and s...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K31/546A61P31/04C07D501/34C07D501/04C07D501/12
CPCA61K9/14A61K9/0019A61K31/546C07D501/04C07D501/12C07D501/34
Inventor 朱玮杨敏侯述成
Owner SICHUAN PHARMA
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