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Cefamandole nafate hydrate and preparation method thereof

A technology of cefamandole sodium and hydrate, applied in the field of medicine, can solve the problems of inconvenient use and large amount of production, and achieve the effects of good stability, fast dissolution speed and smooth surface

Active Publication Date: 2010-12-15
湖北美林药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, cefamandole sodium is mostly a powder preparation for injection, containing a small amount of cefamandole. Because cefamandole has a low solubility in water, it is necessary to add sodium carbonate in the preparation as a cosolvent, which will produce a large amount of carbon dioxide, which is inconvenient to use

Method used

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  • Cefamandole nafate hydrate and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment example 1

[0013] Take by weighing 200g of cefamandole sodium raw material, place in a 500ml beaker, add 50ml of water to dissolve. Slowly add (completely add within half an hour) 200ml of acetone, stir while adding, control the temperature to 2-8°C, and keep the temperature constant for 3 hours.

[0014] Suction filtration, wash the filter cake with ethanol, and dry under reduced pressure at 50°C for 4 hours to obtain cefamandole sodium pentahydrate.

Embodiment example 2

[0016] Take by weighing 200g of cefamandole sodium raw material, place in a 500ml beaker, add 50ml of water to dissolve. Slowly add (completely add within half an hour) 200ml of eluent, stirring while adding, ethanol 50ml, ethyl acetate 150ml, control the temperature to 2-8°C, and keep the temperature constant for 3 hours.

[0017] Suction filtration, wash the filter cake with ethanol, and dry under reduced pressure at 50°C for 4 hours to obtain cefamandole sodium pentahydrate.

Embodiment example 3

[0019] Take cefamandole sodium raw material 2000g, place in the 5000ml beaker, add 500ml water to dissolve. Add slowly (within 40 minutes) 2000ml of eluting agent, stir while adding, eluting agent is 500ml of dichloromethane, 1500ml of ethyl acetate, control the temperature to 2-8°C, and keep the temperature constant for 3 hours.

[0020] Suction filtration, wash the filter cake with ethanol, and dry under reduced pressure at 50°C for 4 hours to obtain cefamandole sodium pentahydrate.

[0021] Research on the relevant characteristics of cefamandole sodium hydrate:

[0022] 1. Elemental analysis

[0023] Get the cefamandole sodium hydrate prepared above and carry out elemental analysis, the result: C 37.88%; H 4.50%; N 13.87%, agree with the cefamandole sodium pentahydrate theoretical value (theoretical value: C 37.84%; H 4.48%; N 13.94%)

[0024] 2. Differential thermal analysis

[0025] The above-prepared cefamandole sodium hydrate was subjected to differential thermal an...

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Abstract

The invention relates to a cefamandole nafate hydrate. The molecular formula of the cefamandole nafate hydrate is C19H17N6NaO6S25H2O. The preparation method of the cefamandole nafate hydrate comprises the following steps of: dissolving cefamandole nafate crude drug in water and placing the dissolved cefamandole nafate crude drug in a crystallizer; adding 5-15 parts of elution agents, cooling the mixture to 2-8 DEG C, separating out solids and then filtering; and rinsing the solids in the elution agents, drying for 3-5 hours at the drying temperature of 10-50 DEG C under a ventilated or vacuumcondition to obtain the cefamandole nafate hydrate. The invention also provides a cefamandole nafate for injection, which is prepared by using the cefamandole nafate hydrate as the crude drug. The cefamandole nafate hydrate obtained in the method has the advantages of smooth surface, good stability and high dissolving sped in water. After the cefamandole nafate hydrate is dissolved in the water, the action mechanism and the clinical effect of the cefamandole nafate hydrate are the same as those of cefamandole nafate prepared in the traditional process.

Description

technical field [0001] The invention relates to a hydrate of cefamandole sodium, relates to a preparation method of the hydrate and its application in medicine, and belongs to the technical field of medicine. technical background [0002] The chemical formula of cefamandole sodium is 7-D-(2-formyloxyphenylacetamide)-3[(1-methyl-1H-tetrazol-5yl)mercaptomethyl]-3 cephem-4-carboxylate Acid sodium salt, the molecular formula is C 19 h 17 N 6 NaO 6 S 2 , is a second-generation cephalosporin, which is used in infections of the respiratory tract, genitourinary system, skin and soft tissues, bones and joints, pharynx, ear, nose and throat, peritonitis and sepsis caused by sensitive Gram-negative bacteria. It has good curative effect on biliary tract and intestinal infection. [0003] At present, cefamandole sodium is mostly a powder preparation for injection, which contains a small amount of cefamandole. Because cefamandole has a low solubility in water, it is necessary to add...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D501/36C07D501/04A61K31/546A61P31/04
Inventor 曾艺林刚
Owner 湖北美林药业有限公司
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