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Method for purifying cefazolin acid

The technology of a cefazolin acid and its purification method, which is applied in the field of cefazolin acid purification, can solve the problems of high cost of medication for patients, high cost of production enterprises, and increased production cost, and is suitable for large-scale production and application. The effect of product quality improvement and low production cost

Active Publication Date: 2015-05-13
石药集团中诺药业(石家庄)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the commonly used purification method is recrystallization method, which requires the use of a large amount of organic solvents, which has a great pollution pressure on the environment, and the recrystallization effect is poor, often one recrystallization cannot meet the quality requirements, and it needs to be carried out many times, resulting in The product yield decreases, the production cost increases, and the cost of the production enterprise is higher, which eventually leads to the high price of cefazolin sodium, and the high cost of medication for patients
[0004] Chinese patent CN102617607 also discloses a method for decolorizing and purifying cefazolin acid by using an aluminum oxide column. Some organic impurities in cefazolin acid are difficult to be removed by adsorption, and the impurities of cefazolin acid after purification are too high to meet the requirements Directly used in freeze-drying method to prepare the requirement of cefazolin sodium

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Control the temperature at 10-15°C, add 42g of sodium bicarbonate and 22.0g of crude cefazolin acid (97% content) into 500ml of purified water, stir for 20 minutes, all the solids are dissolved, the solution is transparent, and the detected pH value is 6.7, add A little sodium bicarbonate solid, adjust the pH value to 7.0, add 250ml LX-18 macroporous resin, stir and adsorb for 20 minutes, filter, remove the resin, add 10% hydrochloric acid dropwise to the filtrate to adjust the pH value to 2.8, there is solid precipitation, filter with suction , washed with 200ml of acetone and filtered, and then dried at 60±5°C to obtain 20.2g of cefazolinic acid, with a yield of 91.8%.

Embodiment 2

[0025] Control the temperature at 10-15°C, add 42g of sodium bicarbonate and 22.0g of crude cefazolin acid (97% content) into 400ml of purified water, stir for 30 minutes, all the solids are dissolved, the solution is transparent, and the detected pH value is 6.8, add A small amount of sodium bicarbonate to adjust the pH value to 7.5, add 400ml LX-18 type macroporous resin, stir and adsorb for 20 minutes, filter, remove the resin, add 10% hydrochloric acid dropwise to the filtrate to adjust the pH value to 2.5, solids are precipitated, suction filter, and use 200ml of acetone was washed and suction filtered, and dried at 60±5°C to obtain 20.0g of cefazolinic acid with a yield of 90.9%.

Embodiment 3

[0027] Control the temperature at 10-15°C, add 42g of sodium bicarbonate and 22.0g of crude cefazolin acid (97% content) into 600ml of purified water, stir for 20 minutes, all the solids are dissolved, the solution is transparent, and the detected pH value is 6.6, add A small amount of sodium bicarbonate to adjust the pH value to 8.0, add 200ml LX-18 macroporous resin, stir and adsorb for 20 minutes, filter, remove the resin, add 10% hydrochloric acid dropwise to the filtrate to adjust the pH value to 3.0, solids are precipitated, suction filtered, and After washing with 200ml of acetone and suction filtration, drying at a temperature of 60±5°C gave 19.0g of cefazolinic acid with a yield of 86.3%.

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PUM

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Abstract

The invention discloses a method for purifying a cefazolin acid, which is implemented by preparing a crude cefazolin acid product with a content of less than 97% into a sodium salt firstly; then, carrying out adsorption on the sodium salt by using a macroporous resin so as to remove impurities; and finally, reducing the sodium salt to an acid, so that the content, individual impurity and color grade of the obtained cefazolin acid satisfy the demands of being directly used for preparing cefazolin sodium by using a freeze-drying method; and the cefazolin acid can be directly used. The method disclosed by the invention overcomes the defects that single purification in existing purification methods can not meet the requirements of use.

Description

technical field [0001] The invention belongs to the technical field of preparation of cephalosporin antibiotics in the pharmaceutical and chemical industry, and in particular relates to a method for purifying cefazolin acid. Background technique [0002] Cefazolin sodium, also known as cephalosporin Ⅴ, Pioneer 5, etc., is a semi-synthetic first-generation cephalosporin, which has a strong effect on gram-positive bacteria and has a strong effect on gram-negative bacteria, especially Gram-negative bacteria. The role of Lebei pneumoniae is also strong. Cefazolin acid has obvious advantages over the first-generation cephalosporins. It has enzyme resistance, high efficiency and low toxicity, and has a wide range of clinical indications. Abscess, endocarditis, sepsis, ear and soft tissue infection, etc., the treatment effect is better. [0003] Cefazolin sodium for clinical use is injection powder, which is usually prepared by freeze-drying method, and is directly freeze-dried i...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D501/36C07D501/12
CPCC07D501/12C07D501/36
Inventor 徐永龙刘健袁国强郭军臣王永伟赵英杰梅玉龙
Owner 石药集团中诺药业(石家庄)有限公司
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