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Refining method of high-purity cefepime dihydrochloride monohydrate

A technology of cefepime dihydrochloride and monohydrate, which is applied in the field of refining high-purity cefepime dihydrochloride monohydrate, and can solve the problems of products not meeting Chinese quality standards, cefepime with high water solubility, Unable to reduce water content and other issues, to achieve low loss, high purity, and low impact

Inactive Publication Date: 2014-03-26
YIYUAN XINQUAN CHEM
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] There is certain shortcoming in the above-mentioned method that adds organic solvent to separate out cefepime hydrochloride in the aqueous solution, the dihydrate of cefepime dihydrochloride can occur in the product, simultaneously because the water solubility of cefepime is bigger, above-mentioned method can appear relatively Large material loss and no way to reduce moisture content by drying
The prepared product containing cefepime dihydrochloride dihydrate does not meet the Chinese quality standards for this species

Method used

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  • Refining method of high-purity cefepime dihydrochloride monohydrate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Add 5Kg of activated carbon to 500L of acetone, stir for 2h, filter through a filter tank equipped with a 0.01um high-precision filter element, and then cool to below 5°C for use. Add 5Kg of activated carbon to 300L of ethanol, stir for 2h, filter through a filter tank equipped with a 0.01um high-precision filter element, and then cool to below 5°C for use.

[0028] Cefepime internal salt 200Kg and 60Kg concentrated hydrochloric acid, 10Kg sodium bisulfite, 10KgEDTA-Na 2 Add to 900L methanol and heat up to 35℃ to dissolve, add 3Kg activated carbon and stir for 2h, filter through a filter tank equipped with a 0.01um high-precision filter element, transfer the filtrate to a crystallization tank and stir, add 100g seed crystals (cefepime hydrochloride) , Lower the temperature to below 5°C, add 100L of the above acetone dropwise for 3h, maintain the temperature at 0°C during the dropping process, and grow the crystals for 2h after the dropwise addition. After the crystal growt...

Embodiment 2

[0030] Add 8Kg of activated carbon to 800L of acetone, stir for 3h, filter through a filter tank equipped with a 0.01um high-precision filter element, and then cool to below 5°C for use. Add 8Kg of activated carbon to 600L of ethanol, stir for 3h, filter through a filter tank equipped with a 0.01um high-precision filter element, and then cool to below 5°C for use.

[0031] Mix 200Kg of cefepime internal salt and 50Kg of concentrated hydrochloric acid, 15Kg of sodium bisulfite, 15Kg of EDTA-Na 2 Add to 1000L methanol and heat up to 30℃ to dissolve, add 8Kg activated carbon and stir for 3h, filter through a filter tank equipped with a 0.01um high-precision filter element, transfer the filtrate to a crystallization tank and stir, add 200g seed crystals (cefepime hydrochloride) , The temperature is lowered to below 5°C, 200L of the above acetone is added dropwise, the dropping time is 5h, the temperature is maintained at 10°C during the dropping process, and the crystals are grown for...

Embodiment 3

[0033] Add 10Kg of activated carbon to 1000L of acetone, stir for 4h, filter through a filter tank equipped with a 0.01um high-precision filter element, and then cool to below 5°C for use. Add 10Kg of activated carbon to 600L of ethanol, stir for 4h, filter through a filter tank equipped with a 0.01um high-precision filter element, and then cool to below 5°C for use.

[0034] Cefepime internal salt 200Kg and 80Kg concentrated hydrochloric acid, 20Kg sodium bisulfite, 20KgEDTA-Na 2 Add to 1200L methanol and heat to 50℃ to dissolve, add 10Kg activated carbon and stir for 4h, filter through a filter tank equipped with 0.01um high-precision filter element, transfer the filtrate to a crystallization tank and stir, add 200g seed crystals (ceftepime hydrochloride) , Lower the temperature to below 5°C, add 400L of the above acetone dropwise for 6 hours, maintain the temperature at 5°C during the dropping process, and grow the crystals for 5 hours after the drop. After the crystal growth ...

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Abstract

The invention belongs to the field of medicines and in particular relates to a refining method of high-purity cefepime dihydrochloride monohydrate. The refining method comprises the following steps: dissolving cefepime inner salt, concentrated hydrochloric acid, sodium hydrogen sulfite and EDTA-Na2 (ethylene diamine tetraacetic acid-sodium 2) in methanol, adding active carbon, mixing, and filtering; adding acetone into filter liquor, crystallizing, filtering again, and washing a filter cake to obtain cefepime dihydrochloride monohydrate. According to the refining method, the conditions are mild, cefepime is less influenced, and the process is easy to operate; the cefepime loss is low in the reaction process, cefepime dihydrochloride monohydrate is obtained by the method, cefepime dihydrochloride dihydrate is prevented from being generated, the purity of cefepime is improved, and the quality of cefepime is greatly improved.

Description

Technical field [0001] The invention belongs to the field of medicine, and specifically relates to a method for refining high-purity cefepime dihydrochloride monohydrate. Background technique [0002] Cefepime is a fourth-generation cephalosporin. Compared with the third-generation antibiotics, Cefepime has a broader antibacterial spectrum, and it has enhanced activity against Gram-positive bacteria and is more stable to β-lactamase. The drug is highly water-soluble, can quickly penetrate the outer membrane of bacteria and the microporin channel with negative electrons, so that it has the performance of rapidly spreading to the bacterial site, and maintains the high activity of the drug, which can directly affect the bacterial cell wall The anabolism of gram-negative bacteria, gram-positive bacteria and some antibiotic-resistant strains have a good inhibitory effect. It has played a good role in the treatment of lower respiratory tract, skin and bone tissue, urinary system, gyne...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D501/46C07D501/12
CPCC07D501/12C07D501/46
Inventor 周浩张立明
Owner YIYUAN XINQUAN CHEM
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