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Cefodizime sodium preparation method

A technology of cefodizime sodium and n-butanol, which is applied in the field of medicine, can solve the problems of unfavorable mechanical sub-packaging and loading control, increased equipment and power costs, and low critical relative humidity, achieving good application prospects, improving stability, The effect of reducing production cost and difficulty of operation

Inactive Publication Date: 2013-04-03
LIAONING HAISCO PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Most of the currently commercially available cefodizime sodium raw materials are very fine powders with poor fluidity, which is not conducive to mechanical sub-packaging and loading control; and its critical relative humidity is low, usually at RH40% or below, and it is easy to absorb moisture, which requires Additional dehumidification equipment is used to strictly control the humidity level of the sub-packaging workshop below the critical relative humidity, which leads to an increase in equipment and power costs, especially in summer with high humidity; in addition, the sub-packaging speed also needs to be as fast as possible , to reduce the exposure time of raw materials in the air and ensure the quality of finished preparations, thus increasing the difficulty of operation

Method used

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Examples

Experimental program
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Effect test

Embodiment 1

[0024] (1) Add the crude product of cefodizime sodium (commercially available cefodizime sodium) into the mixed solution of water and n-butanol, wherein the weight ratio of the crude product of cefodizime sodium, water and n-butanol is 1:1.5:3. Heat and stir at 45-50°C until dissolved to obtain a water-n-butanol solution of cefodizime sodium;

[0025] (2) Decolorization treatment: adding activated carbon in an amount of 0.3% of the total volume of the solution to the water-n-butanol solution of cefodizime sodium for decolorization treatment, and then filtering out insoluble impurities while hot to obtain a decolorization solution;

[0026] (3) Cool the decolorizing solution to 20-25°C, crystallize at a constant temperature of 20-25°C, filter, and vacuum-dry at 40°C for about 5 hours to obtain the finished product.

Embodiment 2

[0028] (1) Add the crude cefodizime sodium to the mixed solution of water and n-butanol, wherein the weight ratio of the crude cefodizime sodium, water and n-butanol is 1:1.5:3, heat and stir at 45-50°C until dissolved , to obtain the water-n-butanol solution of cefodizime sodium;

[0029] (2) Decolorization treatment: add activated carbon in an amount of 0.5% of the total volume of the solution to the water-n-butanol solution of cefodizime sodium for decolorization treatment, and then filter out insoluble impurities while hot to obtain a decolorization solution;

[0030] (3) Cool the decolorizing solution to 20-25°C, crystallize at a constant temperature of 20-25°C, filter, and vacuum-dry at 40°C for about 5 hours to obtain the finished product.

Embodiment 3

[0032] (1) Add the crude cefodizime sodium to the mixed solution of water and n-butanol, wherein the weight ratio of the crude cefodizime sodium, water and n-butanol is 1:1.5:3, heat and stir at 45-50°C until dissolved , to obtain the water-n-butanol solution of cefodizime sodium;

[0033] (2) Decolorization treatment: add activated carbon in an amount of 0.1% of the total volume of the solution to the water-n-butanol solution of cefodizime sodium for decolorization treatment, and then filter out insoluble impurities while hot to obtain a decolorization solution;

[0034] (3) Cool the decolorizing solution to 20-25°C, crystallize at a constant temperature of 20-25°C, filter, and vacuum-dry at 40°C for about 5 hours to obtain the finished product.

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Abstract

The invention belongs to the technical field of medicines, and in particular relates to a cefodizime sodium preparation method which is suitable for an industrial production of parenteral preparations. Specifically, the invention relates to a method for crystallizing and purifying the cefodizime sodium. According to the method, the purity of the cefodizime sodium is improved and the stability of the cefodizime sodium is improved by a way of crystallizing through a specific solvent and under specific conditions; more importantly, the cefodizime sodium prepared by the method is comparatively excellent in liquidity and high in critical relative humidity, and is specifically suitable for parenteral preparations of the cefodizime sodium prepared through sterile packaging; and the product has a good application prospect.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a preparation method of cefodizime sodium suitable for industrial production of parenteral administration preparations. Background technique [0002] Cefodizime sodium is a third-generation cephalosporin antibiotic for injection jointly developed by Hearst Company of Germany and Russell Company of France. It is also the first third-generation cephalosporin with immune-enhancing function in the world. First launched in Japan in 1990, it is mainly used clinically for infections caused by sensitive bacteria, such as upper and lower urinary tract infections, lower respiratory tract infections, and gonorrhea. The chemical name of cefodizime sodium is: (6R,7R)-7-[(2-amino-4-thiazolyl)-(methoxyimino)acetamido]-3-[[(5-carboxymethyl- 4-Methyl-2-thiazolyl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid disodium salt, molecular formula for C 20 h 18...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D501/36C07D501/12
Inventor 郑伟
Owner LIAONING HAISCO PHARMACEUTICAL CO LTD
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