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Cefodizime sodium compound and preparation thereof

A technology for cefodizime sodium and compound, applied in the field of cefodizime sodium, can solve the problems of increase and side reaction conditions, low crystal purity of cefodizime sodium, affecting the stability of compounds, etc., and achieves the effect of good stability.

Active Publication Date: 2013-01-16
HAINAN HERUI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0004] At present, certain research has been done on the crystal form of cefodizime sodium. Patent ZL201010200559.0 discloses a composition of cefodizime sodium, which discloses a crystal form of cefodizime sodium, but the obtained The purity of cefodizime sodium crystals is not high, and the purity will further affect the stability of the compound, and increase and side reaction conditions

Method used

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  • Cefodizime sodium compound and preparation thereof
  • Cefodizime sodium compound and preparation thereof
  • Cefodizime sodium compound and preparation thereof

Examples

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Effect test

Embodiment 1

[0025] Embodiment 1: the preparation of cefodizime sodium crystal

[0026] (1) Dissolve cefodizime sodium solid in distilled water, the weight ratio of cefodizime sodium solid to distilled water is 1:10; under the sound field with a frequency of 25KHz and an output power of 60W, add anhydrous acetone, A mixed solvent of anhydrous methanol and ethyl acetate (volume ratio of 1:1.5:0.15); the volume ratio of the mixed solvent to the cefodizime sodium aqueous solution is 3.5:1; the speed of adding the mixed solvent is 25ml / min, Stirring speed is 30 rpm;

[0027] (2) After adding the mixed solvent, lower the temperature to 5°C at a cooling rate of 0.25°C / min. After the crystals are obtained, stand for crystallization; filter, wash the filter cake with absolute ethanol, and vacuum-dry for 6 hours to obtain cephalosporins Sodium azine crystals.

[0028] The X-ray powder diffraction pattern obtained by Cu-Kα ray measurement is as follows figure 1 As shown; the particle size of the ...

Embodiment 2

[0029] Embodiment 2: the preparation of cefodizime sodium crystal

[0030] (1) Dissolve cefodizime sodium solid in distilled water, the weight ratio of cefodizime sodium solid to distilled water is 1:20; under the sound field with a frequency of 15KHz and an output power of 30W, add anhydrous acetone, A mixed solvent of anhydrous methanol and ethyl acetate (volume ratio 1:1:0.2); the volume ratio of the mixed solvent to the cefodizime sodium aqueous solution is 1.5:1, and the speed of adding the mixed solvent is 20ml / min, Stirring speed is 60 rpm;

[0031] (2) After adding the mixed solvent, lower the temperature to 1°C, and the cooling rate is 1°C / min. After the crystals are obtained, stand for crystallization; filter, wash the filter cake with absolute ethanol, and vacuum dry for 6 hours to obtain cephalosporins Sodium azine crystals.

[0032] The X-ray powder diffraction pattern obtained by Cu-Kα ray measurement is as follows figure 1 As shown; the particle size of the c...

Embodiment 3

[0033] Embodiment 3: the preparation of cefodizime sodium crystal

[0034] (1) Dissolve cefodizime sodium solid in distilled water, the weight ratio of cefodizime sodium solid to distilled water is 8:100; under the sound field with a frequency of 20KHz and an output power of 40W, add anhydrous acetone, A mixed solvent of anhydrous methanol and ethyl acetate (volume ratio 1:0.5:0.25); the volume ratio of the mixed solvent to the cefodizime sodium aqueous solution is 1:1; the speed of adding the mixed solvent is 30ml / min, The stirring speed is 60 rpm.

[0035] (2) After adding the mixed solvent, lower the temperature to 1°C to 5°C to obtain crystals and then stand for crystallization; filter, wash the filter cake with absolute ethanol, and vacuum dry for 1 to 6 hours to obtain cefodizime sodium crystals; The cooling rate is 0.1-1°C / min, preferably 0.1-0.25°C / min.

[0036] The X-ray powder diffraction pattern obtained by Cu-Kα ray measurement is as follows figure 1 As shown; t...

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Abstract

The invention relates to cefodizime sodium, in particular to a compound of the cefodizime sodium and a preparation of the compound. The compound of the cefodizime sodium is crystal, an X-ray powder diffraction diagram obtained by Cu-K alpha ray measurement is shown as a diagram 1, the grain diameter of the compound cefodizime sodium ranges from 70 micrometers to 120 micrometers, distribution width ranges from 50 micrometers to 150 micrometers, preferably, the grain diameter of the compound ranges from 80 micrometers to100 micrometers, and the distribution width ranges from 60 micrometers to140 micrometers. The crystal compound of the cefodizime sodium is good in stability and applicable to being prepared into power injection for clinical applications.

Description

technical field [0001] The invention relates to a cefodizime sodium, in particular to a cefodizime sodium compound and a preparation thereof. Background technique [0002] Cefodizime sodium is a semi-synthetic third-generation cephalosporin whose structural formula is shown in formula I. It has antibacterial activity against Gram-positive bacteria and negative bacteria, is stable to β-lactamase, and is resistant to cephalosporinase and penicillinase. extremely stable. Cefodizime sodium has dual properties of antibacterial and immune regulation, and is widely used clinically. Clinically, it is mainly used for pneumonia, bronchitis, pharyngitis, tonsillitis, pyelonephritis, urinary tract infection, gonococcal urethritis, cholecystitis, cholangitis, gynecological infection, sepsis and Otitis media etc. [0003] [0004] At present, certain research has been done on the crystal form of cefodizime sodium. Patent ZL201010200559.0 discloses a composition of cefodizime sodium,...

Claims

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Application Information

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IPC IPC(8): C07D501/36C07D501/12A61K31/546A61K9/14A61P31/04
Inventor 朱正兵
Owner HAINAN HERUI PHARMA
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