High-purified cefmetazole sodium compound

A technology of cefmetazole sodium and cefmetazole, applied in the field of medicine, can solve problems such as poor purity, adverse reactions, poor color, etc., and achieve the effects of improving purity and content, optimizing product quality, and ensuring safety

Inactive Publication Date: 2010-07-28
HAINAN LINGKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, domestic manufacturers of cefmetazole sodium preparations mainly rely on imported raw materials for packaging. There are also some manufacturers in China that produce this product, but the products obtained by existing methods have poor purity, poor color, and low content. Defects, which affect the quality effect of its preparation
In particular, cefmetazole sodium is often used as an injection in clinical practice, and its low purity may even lead to unforeseen adverse reactions, thereby limiting the use of the drug
[0006] In the prior art, a simple and effective method has not been proposed to improve the purity of cefmetazole sodium

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] The refining of embodiment 1 cefmetazole sodium

[0032] (1) Dissolve 200g of cefmetazole sodium in 2000ml of water, add 0.5mol / L hydrochloric acid solution to a pH value of 2.2, precipitate insoluble matter, stir and react for 60 minutes, filter, and dry under reduced pressure at 40°C to obtain cefmetazole 180.8 g;

[0033] (2) Dissolve 180.8g cefmetazole in 2000ml of acetonitrile and ethyl acetate solution with a volume ratio of 1:2, add D1300 type macroporous adsorption resin, stir and adsorb at room temperature for 20 minutes, and use acetonitrile with a volume ratio of 1:2 Eluted and purified with ethyl acetate solution, collected the eluate, added 3.01 g of activated carbon, stirred and adsorbed at room temperature for 30 minutes, filtered for decarburization, and collected the filtrate;

[0034] (3) Add dropwise 4% sodium hydroxide solution to pH 8.0 in the filtrate, separate out insolubles, stir and react at room temperature for 60 minutes, filter, and dry und...

Embodiment 2

[0035] The refining of embodiment 2 cefmetazole sodium

[0036] (1) Dissolve 200g of cefmetazole sodium in 2000ml of water, add 2mol / L sulfuric acid solution to a pH value of 2.6, precipitate insoluble matter, stir and react for 30 minutes, filter, and dry under reduced pressure at 50°C to obtain cefmetazole 182.6 g;

[0037] (2) Dissolve 182.6g of cefmetazole in 2000ml of methanol, add BS-55 type macroporous adsorption resin, stir and adsorb at room temperature for 30 minutes, elute and purify with methanol, collect the eluate, add 4.02g of activated carbon, and stir at room temperature Adsorb for 20 minutes, filter for decarburization, and collect the filtrate;

[0038] (3) Add dropwise 10% sodium carbonate solution to the pH value of 7.0 in the filtrate, precipitate insoluble matter, stir and react at room temperature for 30 minutes, filter, and dry under reduced pressure at 50°C to obtain 181.8g of cefmetazole sodium, with a yield of 90.9%, HPLC The purity is 99.6%.

Embodiment 3

[0039] The refining of embodiment 3 cefmetazole sodium

[0040] (1) Dissolve 200g of cefmetazole sodium in 23000ml of water, add 1mol / L formic acid solution until the pH value is 2.7, precipitate insoluble matter, stir and react for 40 minutes, filter, and dry under reduced pressure at 50°C to obtain 181.2g of cefmetazole ;

[0041] (2) Dissolve 181.2g cefmetazole in 2000ml isopropanol, add D1300 type macroporous adsorption resin, stir and adsorb at room temperature for 30 minutes, elute and purify with isopropanol, collect eluent, add 2.08g of gac, Stir and adsorb at room temperature for 30 minutes, filter for decarburization, and collect the filtrate;

[0042] (3) Add 2% sodium acetate solution dropwise to pH 7.5 in the filtrate, precipitate insoluble matter, stir and react at room temperature for 45 minutes, filter, and dry under reduced pressure at 40°C to obtain 183.4g of cefmetazole sodium, yield 91.7%, HPLC The purity is 99.7%.

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Abstract

The invention provides a cefmetazole sodium compound, which is highly purified and finally obtained by the way of achieving the purification purpose through acid-base reaction, macroporous absorption resin and activated carbon adsorption, thus optimizing the quality of preparation products and the safety of clinical medication.

Description

technical field [0001] The invention relates to a high-purity cefmetazole sodium compound, which belongs to the technical field of medicine. Background technique [0002] Cefmetazole sodium, its chemical name is: (6R, 7S)-7-[2-[(cyanomethyl)thio]acetamido]-7-methoxy-3-[[(1-methyl -1H-tetrazol-5-yl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid sodium salt, Molecular formula: C 15 h 16 N 7 NaO 5 S 3 , molecular weight: 493.52, structural formula: [0003] [0004] Cefmetazole sodium is a second-generation cephalosporin, which is clinically used for respiratory system infection, biliary tract infection, urinary system infection, obstetrics and gynecology bacterial infection, skin and soft tissue infection and postoperative infection prevention caused by sensitive bacteria. [0005] The synthetic method of cefmetazole sodium has been reported in the literature to use 7-ACA and p-toluenesulfonyl chloride as the main raw materials, and react in...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D501/57C07D501/12
Inventor 陶灵刚
Owner HAINAN LINGKANG PHARMA CO LTD
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