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Cefotaxime sodium compound prepared by fluid mechanics principle and preparation of cefotaxime sodium compound

A technology of cefotaxime sodium and its compound, which is applied in the field of cefotaxime sodium compound and its preparations, and can solve problems such as poor crystallization state, high impurity and instability of cefotaxime sodium

Inactive Publication Date: 2017-01-04
陕西顿斯制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] At present, cefotaxime sodium has problems such as high impurities, low content, poor crystallization state, difficult packaging, poor stability, etc.
The existence of these problems, on the one hand, leads to poor and unstable product quality, and the sold products are easily required to be returned. On the other hand, this situation will cause a serious waste of manpower, material resources, and financial resources.

Method used

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  • Cefotaxime sodium compound prepared by fluid mechanics principle and preparation of cefotaxime sodium compound
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  • Cefotaxime sodium compound prepared by fluid mechanics principle and preparation of cefotaxime sodium compound

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Effect test

Embodiment 1

[0030] Embodiment 1: the preparation of cefotaxime sodium

[0031] Measure 500ml of ethyl acetate and 100ml of water and add them to the standing wave reactor of the hydrodynamic principle device. The temperature of the water bath is 100°C. Stir and mix well. , slowly add 50.34g of sodium carbonate, adjust the pH value to 4.2, after the pH value is stable, add 0.85g of activated carbon for decolorization for 30min, and filter. Wash the carbon cake successively with acetone 50ml×2 and water 50ml×2. The temperature of the solvent circulation tank is controlled at 18-20°C, the temperature of the standing wave reactor is controlled at 30-35°C, the circulation pump is turned on, and 300ml of ethyl acetone (ratio 1:5) mixture is added dropwise to the standing wave reactor, and the Then continue to circulate for 5 minutes, turn off the circulation pump, and let stand for crystallization for 30 minutes. Slowly lower the temperature of the solvent circulation tank to 5-8°C, turn on t...

Embodiment 2

[0038] Embodiment 2: the preparation of cefotaxime sodium

[0039] Measure 600ml of ethyl acetate and 100ml of water and add them to the standing wave reactor of the hydrodynamic principle device. The temperature of the water bath is 80°C. Stir and mix well. , slowly add 50.50 g of sodium carbonate, adjust the pH value to 5.0, after the pH value is stable, add 0.90 g of activated carbon for decolorization for 30 min, and filter. Wash the carbon cake successively with acetone 50ml×2 and water 50ml×2. The temperature of the solvent circulation tank is controlled at 15-18°C, the temperature of the standing wave reactor is controlled at 30-35°C, the circulation pump is turned on, and 400ml of ethyl acetone (ratio 1:4) mixture is added dropwise to the standing wave reactor. Then continue to circulate for 5 minutes, turn off the circulation pump, and let stand for crystallization for 30 minutes. Slowly lower the temperature of the solvent circulation tank to 6-10°C, turn on the ci...

Embodiment 3

[0040] Embodiment 3: the preparation of cefotaxime sodium

[0041]Measure 400ml of ethyl acetate and 100ml of water and add them to the standing wave reactor of the hydrodynamic principle device. The temperature of the water bath is 105°C. Stir and mix well. , slowly add 50.42g of sodium carbonate, adjust the pH value to 5.5, after the pH value is stable, add 0.84g of activated carbon for decolorization for 30min, and filter. Wash the carbon cake successively with acetone 50ml×2 and water 50ml×2. The temperature of the solvent circulation tank is controlled at 10-16°C, the temperature of the standing wave reactor is controlled at 30-35°C, the circulation pump is turned on, and 400ml of ethyl acetone (ratio 1:4) mixture is added dropwise to the standing wave reactor. Then continue to circulate for 5 minutes, turn off the circulation pump, and let stand for crystallization for 30 minutes. Slowly lower the temperature of the solvent circulation tank to 5-8°C, turn on the circul...

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Abstract

The invention discloses a cefotaxime sodium compound prepared by the fluid mechanics principle and a preparation of the cefotaxime sodium compound, namely efotaxime sodium for injection. A 'research, development and industrialization project of high-end medicine product refining and crystalizing technologies' acquires the second prize of 2015 National Science and Technology Progress Award, and the fluid mechanics principle belongs to one of the high-end medicine product refining and crystalizing technologies. The cefotaxime sodium compound is measured by X-ray powder diffraction, and the main feature peaks indicated by diffraction angles 2theta in the spectrum of the cefotaxime sodium compound is 9.24 degrees, 18.65 degrees, 20.65 degrees, 25.10 degrees and 28.42 degrees. The cefotaxime sodium compound is high in purity, low in impurity content, good in flowability and good in stability.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to a cefotaxime sodium compound prepared by utilizing the principle of fluid mechanics 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] The principle of fluid mechanics belongs to one of the refined crystallization technologies of 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 realizes a leap in the research and development of high-end pharmaceutical products and crystallization technology, reaching an international leading position. The level h...

Claims

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Application Information

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IPC IPC(8): C07D501/34C07D501/12A61K31/546A61K9/14A61P31/04
CPCC07D501/34A61K9/0019A61K9/14A61K31/546C07B2200/13C07D501/12
Inventor 王坤
Owner 陕西顿斯制药有限公司
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