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Amorphous cefodizime sodium and preparation method thereof and pharmaceutical composition comprising same

An amorphous technology of cefodizime sodium, which is applied in the field of preparation of pharmaceutical compounds, can solve problems such as impracticability, and achieve the effects of reduced irritation, low organic residual value, and very easy to satisfy in the industry

Inactive Publication Date: 2010-06-23
SHENZHEN SALUBRIS PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] There is no report that amorphous cefodizime sodium is studied at present, and the method for preparing crystalline cephalosporin sodium salts by a special freeze-drying method is disclosed in DE2614668. Some people think that the special freeze-drying method described in this patent can Obtaining amorphous cefodizime sodium, the applicant found through experimental research that it cannot be realized, and what is obtained by this method is not amorphous cefodizime sodium

Method used

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  • Amorphous cefodizime sodium and preparation method thereof and pharmaceutical composition comprising same
  • Amorphous cefodizime sodium and preparation method thereof and pharmaceutical composition comprising same
  • Amorphous cefodizime sodium and preparation method thereof and pharmaceutical composition comprising same

Examples

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Effect test

Embodiment 1

[0032] Take 5g of cefodizime sodium sample, add it to 30ml of methanol solvent, and stir at room temperature until it dissolves completely. The solution was then placed in an ice bath and cooled to about 15°C. Slowly drop 200ml of absolute ethanol into the above solution, and at the same time stir at a stirring speed of 250rpm until the solid of cefodizime sodium is completely precipitated, filter with suction, wash the filter cake with absolute ethanol and vacuum dry to constant weight to obtain 3.8g granular Amorphous cefodizime sodium product. Its X-ray diffraction pattern of gained product is as figure 1 As shown, its differential thermal analysis spectrum is shown as figure 2 As shown, its infrared spectrum is shown as image 3 shown.

[0033] The obtained granular amorphous cefodizime sodium sample and the commercially available cefodizime sodium sample are carried out to the residual ethanol test test, and the gas chromatographic analysis results show that the resi...

Embodiment 2

[0035] Take 5 g of cefodizime sodium sample, add it to 40 ml of methanol solvent, and stir at room temperature until it dissolves completely. The solution was then placed in an ice bath and cooled to about 10°C. Slowly drop 300ml of acetone into the above solution, and simultaneously stir at a stirring speed of 200rpm until the solid of cefodizime sodium is completely precipitated, filter with suction, wash the filter cake with acetone, and then vacuum-dry to constant weight to obtain 3.6g of granular amorphous cephalosporins Sodium azine products. Its X-ray diffraction collection of illustrative plates of gained product, differential thermal analysis collection of illustrative plates, infrared spectrum collection of illustrative plates are basically consistent with embodiment 1; Acetone residual content is less than 0.3%, meets the standard established by the technical guidance principle of national chemical medicine residual solvent research (acetone content should be less ...

Embodiment 3

[0037] Take 5 g of cefodizime sodium sample, add it to 25 ml of methanol solvent, and stir at room temperature until it dissolves completely. The solution was then placed in an ice bath and cooled to about 5 °C. Slowly drop 150ml of ethyl acetate into the above solution, and at the same time stir at a stirring speed of 160rpm until the solid of cefodizime sodium is completely precipitated, filter with suction, wash the filter cake with ethyl acetate and vacuum dry to constant weight to obtain 3.5g of granular Amorphous cefodizime sodium product. Its X-ray diffraction collection of illustrative plates of gained product, differential thermal analysis collection of illustrative plates, infrared spectrum collection of illustrative plates are basically consistent with embodiment 1; Ethyl acetate residual content is less than 0.3%, meets the standard that the technical guideline of national chemical drug residual solvent research makes (acetic acid The ethyl ester content should be...

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Abstract

The invention provides an amorphous cefodizime sodium, which is characterized in that an amorphous X-ray diffraction pattern is free from having an X-ray diffraction peak; and in an amorphous differential thermogram, the endothermic peak stays at 57 to 68 DEG C, and the exothermic peak stays at 250 to 258 DEG C. The organic residual value in the cefodizime sodium is low, so the cefodizime sodium is free from entering into a hard lamp during the drying and is easy to operate; the obtained product presents in an apparent granular shape, and the fluidity is good; and when the cefodizime sodium is used for the preparation, the cefodizime sodium is free from being crushed and can be directly homogenized to be prepared, thereby saving device, power and labor cost for the industrialized production, and shortening the production period.

Description

technical field [0001] The invention belongs to the field of preparation of pharmaceutical compounds, in particular to an amorphous cefodizime sodium, a preparation method thereof and a pharmaceutical composition containing the amorphous. Background technique [0002] Cefodizime was invented by Hoechst, Germany, and it is the world's first third-generation cephalosporin with immune enhancing function. Cefodizime can enhance the immune response, and animal models and human studies in vitro and in vivo have shown that the drug can activate macrophages and increase their phagocytic activity and bactericidal rate. Cefodizime has high affinity to proteins involved in cell wall synthesis in sensitive bacteria. Cefodizime has a broad antibacterial spectrum, including most clinically relevant Gram-positive bacteria, Gram-negative bacteria, aerobic bacteria and baroxic bacteria. [0003] Currently commercially available cefodizime sodium products have high residues of ethanol and a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D501/36A61K31/546A61P31/04
Inventor 郑加林邵记
Owner SHENZHEN SALUBRIS PHARMA CO LTD
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