Detection method and production process for ceftizoxime sodium preparation

A technology of ceftizoxime sodium and ceftizoxime acid, which is applied in the field of medicine and can solve problems such as uncollected

Inactive Publication Date: 2012-02-15
SUZHOU ERYE PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

The 2005 edition of the Chinese Pharmacopoeia has clearly formulated polymer control indicators for the 13 standards of the 7 antibiotic varieties included in it, but this species is not included in the 2005 edition of the Chinese Pharmacopoeia

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  • Detection method and production process for ceftizoxime sodium preparation
  • Detection method and production process for ceftizoxime sodium preparation
  • Detection method and production process for ceftizoxime sodium preparation

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Embodiment Construction

[0055] 1. The process conditions for preparing ceftizoxime sodium

[0056] Reaction temperature 28°C, anhydrous sodium carbonate: ceftizoxamic acid (mass ratio) = 0.15: 1.0, reaction time 1.5h, control the pH value before crystallization to 6.7, ethanol: ceftizoxamic acid = 30ml: 1.0g, ethanol drops The acceleration is 450ml / h, and the crystal growth time is 2h. The product yield reaches 95.5%, and the product quality meets the Pharmacopoeia standard.

[0057] 2. The process conditions for preparing ceftizoxime sodium

[0058] Reaction temperature 30 ℃, anhydrous sodium carbonate: ceftizoxamic acid (mass ratio) = 0.15: 1.0, reaction time 2h, control pH value before crystallization is 7.0, ethanol: ceftizoxamic acid = 30ml: 1.0g, ethanol drop rate 450ml / h, crystal growth time 2h. The product yield reaches 96%, and the product quality meets the Pharmacopoeia standard.

[0059] 3. Inspection of polymers in ceftizoxime sodium injection preparations

[0060] The chromatographi...

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Abstract

The invention discloses a preparation method and a detection method for ceftizoxime sodium. Various factors which influence the quality and yield of the product in the process of producing the ceftizoxime sodium are subjected to experimental analysis and research, and optimal process conditions for producing the ceftizoxime sodium are obtained; and a method which meets the requirement of a national medicine inspection sample and is used for measuring ceftizoxime sodium high polymer is established.

Description

[0001] technical field [0002] The invention belongs to the technical field of medicine, and in particular relates to a method for preparing and detecting ceftizoxime sodium. Background technique [0003] Ceftizoxime sodium (ceftizoxime sodium) is also known as Yibao Shiling, and its main component and chemical name are {[ 6R-[ 6 ( , 7 ( ( Z ) ) ) ] -7{[ [ 2, 3-dihydro -2-imino-4-thiazolyl](methoxyimino)acetyl]amino]-8-oxo-5-thia-1-azabicyclo[4.2.0]octane-2 -ene-2-carboxylic acid sodium salt. Its structural formula is as follows: [0004] Molecular formula: C 13 h 12 N 5 NaO 5 S 2 [0005] Molecular weight: 405.39 [0006] The third-generation cephalosporin antibiotic developed for Fujisawa Pharmaceutical Co., Ltd. (Fujisawa), Japan, has the characteristics of being stable to β-lactamase, and has a wide antibacterial spectrum, low toxicity, enzyme resistance, low toxicity and permeability It crosses the blood-brain barrier and is widely used clinically. [0007] ...

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D501/20C07D501/04G01N30/02
Inventor 蒋芸朱炜郭顺王宁
Owner SUZHOU ERYE PHARMA CO LTD
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