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Preparation method of stable cefuroxime sodium

A technology of cefuroxime sodium and cefuroxime sodium, applied in the field of medicine, can solve the problems of not being able to store conditions in a cool and cool warehouse, slowing product discoloration, poor stability, etc., and achieving high yield, low product impurities, and stability. Good results

Inactive Publication Date: 2012-12-26
SHANXI WEIQIDA PHARMA IND
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Although this product has been on the market for many years, the product has poor stability and is prone to discoloration. Although some domestic preparation manufacturers use nitrogen protection in the preparation process to slow down the discoloration of the product, it does not solve the problem of unstable internal quality of the product. The stability is still very poor, and the manufacturer failed to fundamentally solve the stability problem of the product
At present, domestic cefuroxime sodium products and most foreign products (except "Xilixin" of the original research factory) cannot meet the storage conditions of a cool warehouse. During the validity period, the product color meets the requirements of the Chinese Pharmacopoeia and the European Pharmacopoeia. bring great danger

Method used

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Examples

Experimental program
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Effect test

Embodiment 1

[0017] In a jacketed reaction flask, add 100 g of cefuroxime acid, 300 ml of acetone, and 50 ml of purified water, stir until completely dissolved, add activated carbon, stir and decolorize at room temperature for 30 minutes, and filter; a mixture consisting of acetone and a small amount of purified water The mixture was washed, the filtrate was combined, absolute ethanol was added, the temperature was controlled at 25°C, and sodium lactate (74 g) and sodium acetate (11 g) (dissolved in 100 ml of absolute ethanol) were added dropwise. After the dropwise addition, the reaction was stirred for 30 min. Then, add 800 ml of acetone dropwise within 15min, cool to 10°C and stir to grow crystals, filter, stir and wash with a mixture of acetone+purified water+ethanol; wash with appropriate amount of acetone, measure the pH value of cefuroxime sodium More than 6 is sufficient, and vacuum-drying below 45° C. until the moisture content is qualified to obtain 97 g of cefuroxime sodium with ...

Embodiment 2

[0021] In a jacketed reaction flask, add 100 grams of cefuroxime acid, 500 ml of acetone, and 70 ml of purified water, stir until completely dissolved, add activated carbon, stir and decolorize at room temperature for 30 minutes, and filter; The mixed solution was washed, the filtrate was combined, absolute ethanol was added, the temperature was controlled at 35°C, and sodium lactate (86 g) and sodium acetate (9 g) (dissolved in 100 ml of absolute ethanol) were added dropwise. After the dropwise addition, the reaction was stirred for 30 min. Subsequently, 1000 ml of acetone was added dropwise in 45min, cooled to 10°C, stirred and grown for crystal growth, filtered, and washed with a mixture of acetone+purified water+ethanol; 5. Vacuum drying below 45° C. until the moisture content is qualified to obtain 98 g of cefuroxime sodium with a purity of 99.5%.

Embodiment 3

[0023] In a jacketed reaction flask, add 100 grams of cefuroxime acid, 400 ml of acetone, and 40 ml of purified water, stir until completely dissolved, add activated carbon, stir and decolorize at room temperature for 30 minutes, and filter; The mixed solution was washed, the filtrate was combined, absolute ethanol was added, the temperature was controlled at 15°C, and sodium lactate (70 g) and sodium acetate (22 g) (dissolved in 100 ml of absolute ethanol) were added dropwise. After the dropwise addition, the reaction was stirred for 30 min. Then, add 1200 ml of acetone dropwise within 15min, cool to 10°C and stir to grow crystals, filter, stir and wash with a mixture of acetone+purified water+ethanol; wash with appropriate amount of acetone, measure the pH value of cefuroxime sodium 6.9, vacuum drying below 45°C until the moisture content is qualified to obtain 97 g of cefuroxime sodium with a purity of 99.4%.

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Abstract

The invention belongs to the technical field of medicine, relates to a preparation method of cephalosporin, and more specifically relates to a preparation method of a stable cefuroxime sodium. According to the invention, a process control technique and a multiscale simulation technology are utilized to conduct on-line crystallization control of cefuroxime sodium, so as to obtain a cefuroxime sodium product with stable quality and crystal form, and moderate particles. The quality and especially the stability of the product are improved greatly, and product quality achieves a same level as that of ''Xilixin'' from an original researching factory.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a preparation method of cephalosporins, more particularly, to a preparation method of stable cefuroxime sodium. Background technique [0002] Cefuroxime sodium is a national essential drug and one of the eight cephalosporins that are not restricted for use in the 2011 my country's forthcoming Catalogue of Graded Management of Antibacterial Drug Use. In 2010, the annual output of cefuroxime sodium in China was about 500 tons. The cefuroxime product was developed by Glaxo in the UK and has a wide range of clinical applications. For the treatment of Haemophilus influenzae (including ampicillin-resistant strains), Haemophilus parainfluenzae, Branhamella catarrhalis, Escherichia coli, Klebsiella spp., Proteus mirabilis among Gram-negative aerobic bacteria , Proteus spp., Providencia thaliana, and Neisseria gonorrhoeae (including strains that produce and do not produce penicillase enz...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D501/34C07D501/02
Inventor 李树有蒋远顺
Owner SHANXI WEIQIDA PHARMA IND
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