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Ceftizoxime sodium compound crystal form, and preparing method and pharmaceutical preparation thereof

A technology for cefizoxime sodium and pharmaceutical preparations, which is applied in the field of drug synthesis, can solve problems such as affecting drug safety and increasing body irritation, so as to improve product stability and drug safety, reduce irritation, and achieve a simple process. Effect

Active Publication Date: 2014-01-22
ZHEJIANG YATAI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This crystal form uses ethanol and acetone as the recrystallization solvent, and finally there is a small amount of organic solvents such as acetone in the preparation, which increases the irritation to the body and affects the safety of the drug.

Method used

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  • Ceftizoxime sodium compound crystal form, and preparing method and pharmaceutical preparation thereof
  • Ceftizoxime sodium compound crystal form, and preparing method and pharmaceutical preparation thereof
  • Ceftizoxime sodium compound crystal form, and preparing method and pharmaceutical preparation thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] The preparation method of a crystal form of ceftizoxime sodium compound of this embodiment comprises the following steps: take 10 g of ceftizoxime sodium raw material (Harbin Pharmaceutical Group Pharmaceutical General Factory, purity 93%), add 60 ml of pure water, stir at room temperature (100 turn / min) to completely dissolve, and control the pH value to 6.5; then slowly add 300ml of absolute ethanol into the above container within 50min, and make it completely precipitate at 25°C, and then filter and dry to constant weight at 45°C ℃, -0.05MPa, dried for 4 hours; 7.8g of fine granular ceftizoxime sodium compound crystal form was obtained.

[0024] The resulting product X-ray powder diffraction pattern prepared in the present embodiment is as follows: figure 1 As shown, it can be seen from the figure that the X-ray powder diffraction spectrum of the ceftizoxime sodium crystal form of the present embodiment is expressed at 4.7 °, 6.3 °, 6.7 °, 8.8 °, 9.4 °, 9.7 ° with th...

Embodiment 2

[0029] The preparation method of a crystal form of ceftizoxime sodium compound in this example comprises the following steps: take 10 g of ceftizoxime sodium raw material, add 65 ml of pure water, stir at room temperature (90 rpm) until completely dissolved, and then add 1.0 g of ceftizoxime sodium Activated carbon is adsorbed and filtered, and the pH value is controlled to be 6.5; then 300ml of absolute ethanol is slowly added to the above container within 50 minutes, and it is completely precipitated at 20°C, and dried to constant weight by suction filtration. -0.03MPa, dried for 4.5h; 7.4g of fine granular ceftizoxime sodium compound crystal form was obtained. The X-ray powder diffraction pattern of the crystal form obtained is the same as in Example 1. When carrying out the stability test, the mass percentage content of related substances is 0.11%, and the mass percentage content of ceftizoxime polymer is 0.05%.

Embodiment 3

[0040] A pharmaceutical preparation for injection prepared by using the crystal form of ceftizoxime sodium compound prepared in Example 1 of this embodiment comprises the following steps: taking 1000 g of the crystal form of ceftizoxime sodium compound prepared in Example 1 (according to ceftizoxime sodium compound crystal form) In the local 100-level clean area, it is divided into 1000 bottles of 10ml molded antibiotic glass bottles, and then stoppered and capped to obtain ceftizoxime sodium for injection, the specification is: 1.0 (according to ceftizoxime ). The obtained product is a pharmaceutical preparation whose active ingredient is the crystal form of the ceftizoxime sodium compound (ie, the crystal form of ceftizoxime sodium).

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PUM

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Abstract

The invention discloses a ceftizoxime sodium compound crystal form. By adopting X-ray powder diffraction determination, the crystal form has the following main characteristic peaks expressed by the diffraction angles of 2 theta + / - 0.2 DEG in a spectrogram: 4.7 DEG, 6.3 DEG, 6.7 DEG, 8.8 DEG, 9.4 DEG, 9.7 DEG, 12.1 DEG, 12.5 DEG, 13.7 DEG, 14.1 DEG, 14.6 DEG, 16.4 DEG, 17.0 DEG, 17.7 DEG, 18.0 DEG, 18.5 DEG, 18.9 DEG, 19.8 DEG, 20.1 DEG, and 21.2 DEG. The invention also discloses a preparation method and a pharmaceutical preparation of the crystal form. Through in-depth study of ceftizoxime sodium, the new ceftizoxime sodium crystal form is obtained after recrystallization, the compound crystal form is obviously of a small granular shape, has uniform particle size distribution and good fluidity, and has the hygroscopicity decreased; and during the production process, no smashing is required, no static electricity is generated, and the stability of the product installed capacity is improved.

Description

technical field [0001] The invention relates to the technical field of drug synthesis, in particular to a crystal form of ceftizoxime sodium compound, a preparation method and a pharmaceutical preparation thereof. Background technique [0002] Ceftizoxime Sodium (Ceftizoxime Sodium) is the third-generation cephalosporin developed by Fujisawa Pharmaceutical Co., Ltd. in the 1980s. The CA registration number is: 68401-82-1, and the molecular formula is: C 13 h 12 N 5 o 5 S 2 Na, molecular weight: 405.39, trade name: Yibaoshiling. The chemical name of this product is (6R,7R)-7-[[2,3-dihydro-2-imino-4-thiazolyl(methoxyimino)acetyl]amino]-8-oxo-5- Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid sodium salt, the structural formula is as follows: [0003] [0004] This product has a strong antibacterial effect on Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and other Enterobacteriaceae bacteria, and has a good antibacterial effect on Haemophilus influenza...

Claims

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Application Information

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IPC IPC(8): C07D501/20C07D501/12A61K31/546A61P31/04
CPCC07D501/12C07D501/20
Inventor 王丽云冯超敏陈洁戴兴祥陈钗萍
Owner ZHEJIANG YATAI PHARMA
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