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Preparation of cefepime hydrochlorice by sodium salt precipitation method

A technology of cefepime hydrochloride and sodium salt, which is applied in the field of preparation of cephalosporin compounds, can solve problems such as increased impurities, deepened color of feed liquid, and influence on product purity, so as to reduce pollution, reduce dosage, and increase production rate effect

Inactive Publication Date: 2007-10-03
SHENZHEN SALUBRIS PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In actual production, this method exposes cefepime to a weakly alkaline environment for a long time, which will easily lead to the deepening of the color of the feed liquid and the increase of impurities, which will eventually affect the purity of the product

Method used

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  • Preparation of cefepime hydrochlorice by sodium salt precipitation method
  • Preparation of cefepime hydrochlorice by sodium salt precipitation method

Examples

Experimental program
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Embodiment 1

[0031] Dissolve 171g of sodium isooctanoate (1.03mol) in 900mL of water and 200mL of acetone at room temperature (15-25°C), and add 300g of cefepime sulfate (0.52mol, weight based on anhydrous substance) in batches under effective stirring to form Good fluidity paste system. After 10 minutes, add 1600 mL of acetone and appropriate amount of activated carbon, and stir for 30 minutes. The solid was isolated by centrifugation or suction filtration. Wash the filter cake with 500 mL of acetone-water 2:1 (v / v) mixed solution, and combine the filtrates. 18% HCl was added to the filtrate with stirring to pH 1.0-1.5. Then 8 L of acetone was added over 1 hour. The temperature of the system was lowered to 5-10° C., and the stirring was continued for 1 hour. Suction. The filter cake was washed with acetone and dried under vacuum at 40° C. to obtain about 270 g of white crystalline powder. The purity is 99.7%, the water content is 3.8% (K-F method), and the residual acetone is 0.25%....

Embodiment 2

[0033] Add 300g of cefepime sulfate (0.52mol, the weight is based on anhydrous matter) to 900mL of water at room temperature (15-25°C), and add about 20% sodium hydroxide aqueous solution dropwise under vigorous stirring until the pH of the system is 5.5-6.5 between. Then add 2100mL acetone and an appropriate amount of activated carbon, and stir for 30 minutes. The solid was isolated by centrifugation or suction filtration. Wash the filter cake with 500 mL of acetone-water 2:1 (v / v) mixed solution, and combine the filtrates. 30% HCl was added to the filtrate with stirring until the pH was 1.0-1.5. Then 8 L of acetone was added over 1 hour. The temperature of the system was lowered to 5-10° C., and the stirring was continued for 1 hour. Suction. The filter cake was washed with acetone and dried under vacuum at 40° C. to obtain about 270 g of white crystalline powder. The purity is above 99.7%, the water content is 3-4%, and the residual acetone is less than 0.4%. The pro...

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Abstract

This invention relates to a preparation method of cefepime muriaficus. It uses water solubility basicity sodium salt ( sodium acetate, sodium lactate isooctanoid acid sodium, sodium carbonate, sodium bicarbonate, sodium hydroxide or rand om hybrid) to regulate sulfuric acid cefepime solution to subacidity or neutrality, add organic solvent to precipitate out sodium sulfate, sodium bisulfate or their hydrate. Then add hydrochloric acid for salification, and obtain cefepime muriaficus. This invention effectively avoide degradation of efepime, advance yield and purity; greatly cut erosion of acidity feed liquid to equipments; significant reduce dosage of organic solvent, advance production efficiency.

Description

technical field [0001] The invention relates to a preparation method of cephalosporin compounds, in particular to a method for preparing cefepime hydrochloride by using cefepime sulfate as a raw material. Background technique [0002] Cefepime (formula I) is a fourth-generation cephalosporin antibiotic for injection, which has good antibacterial activity against Gram-negative bacteria, Gram-positive bacteria and anaerobic bacteria, and has good antibacterial activity against β-lactamase. Compared with the third-generation cephalosporin antibiotics, it has a wider antibacterial spectrum and antibacterial activity. It is clinically used to treat severe infections. The earliest cefepime document is US Patent 4,406,899. [0003] Cefepime is a thermally unstable and highly water-soluble neutral inner salt, its structure is shown in the figure below. Due to the existence of carboxyl negative ions in pure cefepime, it is easy to combine with protons in aqueous solution, which pr...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D501/46
Inventor 谭端明张志国叶澄海
Owner SHENZHEN SALUBRIS PHARMA CO LTD
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