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Ceftazidime compound prepared by adopting coupling crystallization technology and preparation thereof

A technology of ceftazidime and compound, applied in the field of ceftazidime compound and preparation thereof, can solve problems such as poor stability

Inactive Publication Date: 2017-01-11
海南顿斯医药科技有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The first object of the present invention is to provide a ceftazidime compound, which is prepared by coupling crystallization technology and has the characteristics of high purity, good color grade and good stability, because its specific coupling structure greatly improves its stability, It solves the problem of poor product stability at present, and the impurity control level is far superior to similar products

Method used

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  • Ceftazidime compound prepared by adopting coupling crystallization technology and preparation thereof
  • Ceftazidime compound prepared by adopting coupling crystallization technology and preparation thereof
  • Ceftazidime compound prepared by adopting coupling crystallization technology and preparation thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Embodiment 1: the preparation of ceftazidime compound

[0029] (1) Add 0.547kg of ceftazidime crude product into 5kg of purified water, add 0.09kg of sodium ethylate, stir and dissolve, let stand, and react for 4 hours;

[0030] (2) Add 5kg of isopropanol, stir, lower the temperature to -10°C, let stand for 10 hours, precipitate crystals, filter, wash with ethanol to obtain a filter cake, and dry to obtain 0.592kg of compound;

[0031] (3) Put the above compound in 2kg of purified water, stir and dissolve, add dropwise 2mol / L hydrochloric acid solution, adjust the pH value to 3.53, lower the temperature to 5°C, let it stand for 10 hours, precipitate crystals, filter, and wash with cold water to obtain The filter cake was dried to obtain 0.497 kg of ceftazidime with a yield of 91%.

[0032] Crystal form determination results: the X-ray powder diffraction pattern of ceftazidime in Example 1 shows characteristic diffraction peaks at 9.24°, 18.64°, 25.10°, and 28.42°.

[...

Embodiment 2

[0036] Embodiment 2: the preparation of ceftazidime compound

[0037] (1) Add 1.13kg of ceftazidime crude product into 10kg of purified water, add 0.11kg of sodium carbonate, stir and dissolve, leave standstill, and react for 4 hours;

[0038] (2) Add 15kg of ethanol, stir, lower the temperature to -5°C, let stand for 10 hours, precipitate crystals, filter, wash with ethanol to obtain a filter cake, and dry to obtain 1.22kg of compound;

[0039] (3) Put the above compound in 5 kg of purified water, stir and dissolve, add dropwise 2mol / L nitric acid solution, adjust the pH value to 3.47, lower the temperature to 2°C, let it stand for 10 hours, precipitate crystals, filter, and wash with cold water to obtain The filter cake was dried to obtain 1.02 kg of ceftazidime with a yield of 90%.

Embodiment 3

[0040] Embodiment 3: the preparation of ceftazidime compound

[0041] (1) Add 3.32kg of ceftazime crude product into 20kg of purified water, add 0.4kg of sodium hydroxide, stir and dissolve, leave standstill, and react for 4 hours;

[0042] (2) Add 25kg of ethanol, stir, lower the temperature to 0°C, let stand for 10 hours, precipitate crystals, filter, wash with ethanol to obtain a filter cake, and dry to obtain 3.65kg of compound;

[0043] (3) Put the above compound in 10kg of purified water, stir and dissolve, add dropwise 2mol / L acetic acid solution, adjust the pH value to 3.49, lower the temperature to 0°C, let it stand for 10 hours, precipitate crystals, filter, and wash with cold water to obtain The filter cake was dried to obtain 3.06 kg of ceftazidime with a yield of 92%.

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Abstract

The invention discloses a ceftazidime compound and a preparation thereof, namely ceftazidime for injection. The ceftazidime compound is prepared by adopting a coupling crystallization technology. The 'high-end medicine product refining crystallization technology development and industrialization project' won the second award for national scientific and technological progress in 2015, and the coupling crystallization technology belongs to one of the high-end medicine product refining crystallization technologies. The ceftazidime compound has the advantages of being high in purity, good in color grade and good in stability.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a ceftazidime compound prepared by coupled crystallization technology and a preparation thereof. Background technique [0002] The R&D and industrialization project of refined crystallization technology for high-end pharmaceutical products of one of the inventors, Tianjin University and Xi'an Lijun Pharmaceutical Co., Ltd., won the second prize of the 2015 National Science and Technology Progress Award. [0003] Coupling crystallization technology is one of the refined crystallization technologies for high-end pharmaceutical products. It aims to break through the blockade of related pharmaceutical product crystal forms and crystallization technology patents at home and abroad, and realize the leap in the research and development of new crystal forms of high-end pharmaceutical products and the level of crystallization technology. It has reached the international leadin...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D501/46C07D501/12A61K31/546
CPCC07D501/46C07B2200/13C07D501/12
Inventor 王坤
Owner 海南顿斯医药科技有限公司
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