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Cefodizime sodium compound solid, method for preparing same and pharmaceutical preparation of cefodizime sodium compound solid

A technology of cefodizime sodium and pharmaceutical preparations, which is applied in the fields of cefodizime sodium compound entities, cefodizime sodium crystal forms, preparation methods and pharmaceutical preparations, and can solve the problems of unstable product loading, increased vascular irritation, and residual To solve the problem of high quantity, achieve the effect of improving product stability and drug safety, improving drug safety, and simplifying the crystallization process

Active Publication Date: 2012-11-28
ZHEJIANG YATAI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, impurities such as cefodizime sodium related substance Ⅰ and cefodizime sodium polymer have great potential safety hazards in clinical drug use.
[0004] The currently commercially available cefodizime sodium product is in the form of dust, and its density is very low. It is very easy to generate static electricity and agglomerate during the packaging process, resulting in unstable product loading, which seriously affects product quality and production efficiency; and the product The residual amount of ethanol in the medium is very high, and it is extremely difficult to remove, which increases the irritation of the product to human blood vessels
And the organic solvent residue of cefodizime sodium on the market is higher
They usually increase the drying time and drying temperature to reduce the content of organic residual solvents, which also increases the amount of impurities such as cefodizime sodium related substance I and cefodizime sodium polymer, which brings hidden dangers to clinical medication

Method used

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  • Cefodizime sodium compound solid, method for preparing same and pharmaceutical preparation of cefodizime sodium compound solid
  • Cefodizime sodium compound solid, method for preparing same and pharmaceutical preparation of cefodizime sodium compound solid
  • Cefodizime sodium compound solid, method for preparing same and pharmaceutical preparation of cefodizime sodium compound solid

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Effect test

Embodiment 1

[0023] The preparation method of a cefodizime sodium compound entity of the present embodiment comprises the steps of: taking 10 g of crude cefodizime sodium salt, adding 60 ml of acetone aqueous solution with a volume fraction of 35%, and stirring at room temperature until completely dissolved; then adding 1.0 g Activated carbon is used for adsorption and filtration, and the filtered solution is placed in an ice bath to cool down to 10°C, and stirred for 20 minutes until a large amount of crystals are precipitated; slowly add 300ml of acetone solvent with a mass concentration of 95% to the above crystal precipitation container within 50 minutes , to make it all dissolve, place the solution in an ice bath, cool down to about 0°C, stir at a stirring speed of 100rpm until the solids are completely precipitated, and vacuum-dry to constant weight through suction filtration, wherein the drying adopts vacuum drying at a temperature of 43°C , -0.05MPa, dried for 4h; 7.8g fine granular...

Embodiment 2

[0029] The preparation method of a cefodizime sodium compound entity of the present embodiment comprises the following steps: take 10 g of crude cefodizime sodium salt, add 65 ml of acetone aqueous solution with a volume fraction of 40%, stir at room temperature until completely dissolved; then add 1.0 g Activated carbon is used for adsorption and filtration, and the filtered solution is placed in an ice bath to cool down to 10°C, and stirred for 20 minutes until a large amount of crystals are precipitated; slowly add 300ml of acetone solvent with a mass concentration of 95% to the above crystal precipitation container within 50 minutes , to make it all dissolve, put the solution in an ice bath, cool down to 5°C, stir at a stirring speed of 90rpm until the solid is completely precipitated, and vacuum-dry to constant weight through suction filtration, wherein the drying is vacuum drying, the temperature is 45°C, -0.05MPa, dried for 3 hours; 7.4g fine granular cefodizime sodium c...

Embodiment 3

[0032] The preparation method of a kind of cefodizime sodium compound entity of the present embodiment comprises the following steps: take 10 g of crude cefodizime sodium salt, add 50 ml of acetone aqueous solution with a volume fraction of 50%, stir at room temperature until completely dissolved; then add 1.0 g Adsorb and filter the activated carbon, put the filtrate in an ice bath and cool down to 8°C, stir for 20 minutes until a large amount of crystals are precipitated; slowly add 300ml of acetone solvent with a mass concentration of 95% to the crystal precipitation container within 50 minutes , to make it all dissolve, place the solution in an ice bath, cool down to -5°C, stir at a stirring speed of 160rpm until the solids are completely precipitated, and vacuum-dry to constant weight through suction filtration, wherein the drying is vacuum drying at 40°C , -0.05MPa, dried for 5h; 7.0g fine granular cefodizime sodium compound solid product was obtained. The X-ray diffract...

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Abstract

The invention discloses a cefodizime sodium compound solid, a method for preparing the same and a pharmaceutical preparation of the cefodizime sodium compound solid, wherein the method for preparing the cefodizime sodium compound solid comprises the following steps of: first, dissolving crude cefodizime sodium salt in an acetone aqueous solution, then adding activated carbon to adsorb and filter, cooling the filtrate, stirring to separate the solid out, adding an acetone solvent to separate the solid out, filtering and drying, thus obtaining the cefodizime sodium compound solid. The prepared compound solids are fine particles, and have uniform particle size distribution and good liquidity, the crystallization technology is simple, the residual amount of organic solvent is low, and the product stability and pharmaceutical safety are effectively improved.

Description

technical field [0001] The invention relates to a cefodizime sodium compound entity, in particular to a cefodizime sodium crystal form, a preparation method and a pharmaceutical preparation thereof; belonging to the field of pharmaceutical compounds. Background technique [0002] Cefodizime 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 anaerobic bacteria. [0003] At present, the quality of cefodizime sodium is mainly affected by impurities such as cefodizime sodium related substance ...

Claims

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Application Information

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IPC IPC(8): C07D501/36A61K31/546A61K9/14A61P31/04
Inventor 吕旭幸黄春森王丽云王一升冯超敏戴兴祥
Owner ZHEJIANG YATAI PHARMA
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