Cefobutazine sodium compound and pharmaceutical composition made therefrom

A technology of ceftezole sodium and refined products, which is applied in the field of purification of ceftezole sodium, can solve the problems of high polymer content of ceftezole sodium, lower content of active ingredients of the drug, improper control of production process, etc., and achieve simple and easy operation OK, long validity period, and solve the effect of poor liquidity

Inactive Publication Date: 2010-06-30
HAINAN LINGKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, due to the long storage time of expired ceftezole sodium, the content of active ingredients of the drug is often reduced, the color becomes darker, and the polymer content increases.
Moreover, in some cases, due to improper control of the production process, the resulting polymer content of ceftezole sodium was particularly high
When the polymer content is high, it is easy to cause allergic reactions in the human body

Method used

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  • Cefobutazine sodium compound and pharmaceutical composition made therefrom
  • Cefobutazine sodium compound and pharmaceutical composition made therefrom
  • Cefobutazine sodium compound and pharmaceutical composition made therefrom

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Purify ceftezole sodium as follows:

[0034] 1). Dissolve 100g of ceftezole sodium crude product in 1000ml of water, add 2mol / L hydrochloric acid solution, adjust the pH value to 3.0, and stir to precipitate insoluble matter;

[0035] 2). Filter out the insoluble matter, obtain a solid after washing with purified water, then add 1000ml ethanol to the obtained solid to dissolve it, absorb it through D101 macroporous adsorption resin, elute and purify with 500ml chloroform, and collect the eluate ;

[0036] 3). Regulate the pH value of the eluent with 10% sodium hydroxide solution to be 8.0, separate out solids, wash with 300ml ethanol after centrifugation for 30min, and vacuum-dry at 30°C for 10 hours to obtain 95.5g of ceftezole sodium refined product, The yield was 95.5%, and the purity determined by HPLC was 99.5%.

Embodiment 2

[0038] Dissolve 100g of crude ceftezole sodium in 1000ml of water, add 5mol / L formic acid solution, adjust the pH value to 5.0, stir to precipitate insoluble matter, filter, obtain a solid after washing with purified water, and then add 800ml of dichloromethane to the resulting solid Make it dissolve, absorb by AB-8 macroporous resin, elute and purify with 800ml acetone, collect the eluate; then use 20% sodium acetate solution to adjust the pH value of the eluate to 8.0, precipitate solid, centrifuge for 20min and use Washed with 300ml of ethanol and dried in vacuum at 40°C for 8 hours to obtain 94.7g of refined product of ceftezole sodium with a yield of 94.7%, and a purity of 99.7% as determined by HPLC.

Embodiment 3

[0040]Dissolve 100g of crude ceftezole sodium in 1000ml of water, add 5% sodium dihydrogen phosphate solution, adjust the pH value to 4.5, stir to precipitate insoluble matter, filter, wash with purified water to obtain a solid, and then add 1000ml of methanol to the obtained solid Make it dissolve, absorb with AB-8 macroporous resin, elute and purify with 500ml petroleum ether, collect the eluate; then use 10% ammonia solution to adjust the pH value of the eluate to 9.0, precipitate solid, centrifuge for 10min and use Washed with 300ml of ethanol, dried under vacuum at 35°C for 10 hours to obtain 96.3g of refined ceftezole sodium, with a yield of 96.3%, and a purity of 99.6% as determined by HPLC.

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PUM

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Abstract

The invention relates to a cefobutazine sodium compound and a purification method thereof. The invention adopts the combination of pH value adjustment and resin absorption so as to be capable of separating out high molecular polymers contained in the cefobutazine sodium compound and finally obtain high-purity cefobutazine sodium. The invention also relates to a product obtained according to the method and a pharmaceutical composition containing the product.

Description

technical field [0001] The invention relates to a method for purifying ceftezole sodium, a product prepared by the method and a pharmaceutical composition containing the product. Background technique [0002] Ceftezole sodium, also known as ceftezole sodium, English name, ceftezole sodium, chemical name: (6R,7R)-3-[(1,3,4-thiadiazol-2-yl)thio Methyl]-8-oxo-7-[2-(1H-tetrazol-1-yl)acetamido]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2 Sodium formate, molecular formula: C 13 h 11 N 8 NaO 4 S 3 , molecular weight: 462.45, structural formula: [0003] [0004] Ceftezole sodium is a semi-synthetic cephalosporin derivative, and its mechanism of action is to exert antibacterial activity by inhibiting the synthesis of bacterial cell walls. Ceftezole sodium has antibacterial activity against the following bacteria: 1. Aerobic Gram-positive bacteria: Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes. 2. Aerobic Gram-negative bacteria: Escherichia coli, Klebsi...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07D501/36A61P31/04A61K31/546A61K9/14C07D501/12
Inventor 陶灵刚
Owner HAINAN LINGKANG PHARMA CO LTD
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