Method for preparing medicine ceftriaxone sodium crystal compound for treating surgical infection

A technology for ceftriaxone sodium and a crystal compound, which is applied in the field of medicine and achieves the effects of high purity, simple process and high yield

Inactive Publication Date: 2017-02-22
临沂草之美医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The quality level of the ceftriaxone sodium product obtained by the prior art basically meets the pharmacopoeia standard as the goal, or only one index is significantly higher than the pharmacopoeia standard, and fails to reach the level where multiple key quality indexes are all higher than the pharmacopoeia standard

Method used

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  • Method for preparing medicine ceftriaxone sodium crystal compound for treating surgical infection
  • Method for preparing medicine ceftriaxone sodium crystal compound for treating surgical infection
  • Method for preparing medicine ceftriaxone sodium crystal compound for treating surgical infection

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Effect test

Embodiment 1

[0044] The preparation of embodiment 1 ceftriaxone sodium crystal compound

[0045] Dissolve ceftriaxone sodium in a mixed solvent of water and dimethyl sulfoxide whose volume is 4 times the weight of ceftriaxone sodium at 35°C. The volume ratio of water to dimethyl sulfoxide is 5:1.5; Add the mixed solvent of ethanol and ether whose volume is 7 times of the weight of ceftriaxone sodium at a speed of 2:2, stir while adding, control the temperature at 35°C, and grow the crystal for 3 hours; then Add isopropanol with a volume 5 times the weight of ceftriaxone sodium at a speed of 20ml / min, and after growing the crystal for 1 hour, cool down to -5°C at a speed of 10°C / hour, then keep stirring at a speed of 90 rev / min and stir to analyze crystallization and crystal growth for 3 hours; filtering, washing, and drying under reduced pressure to obtain ceftriaxone sodium crystalline compound.

[0046] Measured by powder X-ray diffractometry, the X-ray powder diffraction pattern repres...

Embodiment 2

[0049] The preparation of embodiment 2 ceftriaxone sodium crystalline compound

[0050] Dissolve ceftriaxone sodium in a mixed solvent of water and dimethyl sulfoxide whose volume is 5 times the weight of ceftriaxone sodium at 35°C. The volume ratio of water to dimethyl sulfoxide is 5:1.5; Add the mixed solvent of ethanol and ether whose volume is 8 times of the weight of ceftriaxone sodium at a speed of 2:2, stir while adding, control the temperature at 35°C, and grow the crystal for 3 hours; then Add isopropanol with a volume of 6 times the weight of ceftriaxone sodium at a speed of 20ml / min, and after growing the crystal for 1 hour, cool down to -5°C at a speed of 10°C / hour, and then maintain a stirring speed of 90 rpm to stir and analyze crystallization and crystal growth for 3 hours; filtering, washing, and drying under reduced pressure to obtain ceftriaxone sodium crystalline compound.

[0051] Measure with powder X-ray diffractometry, the X-ray powder diffraction patte...

Embodiment 3

[0052] The preparation of embodiment 3 ceftriaxone sodium crystalline compound

[0053] Dissolve ceftriaxone sodium in a mixed solvent of water and dimethyl sulfoxide whose volume is 6 times the weight of ceftriaxone sodium at 35°C. The volume ratio of water to dimethyl sulfoxide is 5:1.5; Add the mixed solvent of ethanol and diethyl ether whose volume is 9 times of the weight of ceftriaxone sodium at a high speed, the volume ratio of ethanol and diethyl ether is 2:2, stir while adding, control the temperature at 35°C, and grow crystals for 3 hours; then Add isopropanol whose volume is 7 times the weight of ceftriaxone sodium at a speed of 20ml / min, and after growing the crystal for 1 hour, cool down to -5°C at a speed of 10°C / hour, then keep stirring at a speed of 90 rev / min and stir to analyze crystallization and crystal growth for 3 hours; filtering, washing, and drying under reduced pressure to obtain ceftriaxone sodium crystalline compound.

[0054] Measure with powder X...

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Abstract

The invention belongs to the technical field of medicine and discloses a method for preparing a medicine ceftriaxone sodium crystal compound for treating surgical infection. The structural formula of the prepared ceftriaxone sodium crystal compound is shown in the formula (I). The crystal compound is measured through an X-ray powder diffraction measuring method, and an X-ray powder diffraction pattern shown by the diffraction angle of 2theta+ / -0.2 degrees is shown in the figure 1. The prepared crystal compound is high in purity, low in polymer content, good in stability, not prone to moisture absorption and good in fluidity. The formula (I) is shown in the specification.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a method for preparing a crystalline ceftriaxone sodium compound for treating surgical infection. Background technique [0002] Molecular formula of ceftriaxone sodium: C 18 h 17 N 8 NaO 7 S 3 Triple hemihydrate, the structural formula is as follows: [0003] [0004] The chemical name of ceftriaxone sodium is (6R,7R)-3-[[(1,2,5,6-tetrahydro-2-methyl-5,6-dioxo-1,2,4-triazine -3-yl)thio]methyl]-7-[[(2-amino-4-thiazolyl)methoxyiminoacetyl]amino]-8-oxo-5-thia-1-aza Bicyclo[4.2.0]oct-2-ene-2-carboxylic acid sodium salt triple hemihydrate. It is white or off-white crystalline powder, odorless and tasteless, hygroscopic, easily soluble in water, slightly soluble in methanol, almost insoluble in chloroform or ether. [0005] Ceftriaxone sodium was developed by Swiss Hoffmann-LaRoche Company and first launched in Switzerland in 1982. Belonging to the third genera...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D501/36C07D501/12A61K31/546A61P31/04A61K9/48A61K47/38
CPCC07D501/36A61K9/4866C07B2200/13C07D501/12
Inventor 苗怡文
Owner 临沂草之美医药科技有限公司
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