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Separation extraction method of fondaparinux sodium

A technology of fondaparinux sodium and its extraction method, which is applied in chemical instruments and methods, preparation of sugar derivatives, sugar derivatives, etc.

Active Publication Date: 2014-08-20
NANJING TIANXIANG PHARMA TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

The method of vacuum concentration and water removal consumes a lot of power and energy, and the efficiency is low. After concentration to a certain concentration, a large amount of salt will be precipitated before the product, which is not conducive to further purification; while the method of nanofiltration is expensive and cumbersome to maintain.

Method used

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  • Separation extraction method of fondaparinux sodium
  • Separation extraction method of fondaparinux sodium
  • Separation extraction method of fondaparinux sodium

Examples

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Embodiment 1

[0022] 1. Dissolve 10 g of crude fondaparinux sodium (content 35%) in 100 mL of pure water, add water to dilute to a conductivity of 40 us, and then pump this solution into 400 mL of D254 resin for adsorption. After the adsorption is complete, use 400 mL of 20 % NaCl solution was eluted in circulation for 1 h, and then the eluate was collected. After precipitation treatment, 3.32 g of Fonda product was obtained, with a recovery rate of 94.8%.

[0023] 2. Dilute 50 L of Fonda preparation solution (conductivity 90us) with water to a conductivity of 40-45us, and then pump this solution into 4 L D254 resin for adsorption. After the adsorption is complete, circulate with 2*3 L 20 % NaCl solution After elution for 1 h, the eluents were combined, and 30 g of Fonda product was obtained after precipitation treatment, which took 18 h.

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Abstract

The invention discloses a separation extraction method of fondaparinux sodium. The method includes the following steps: adsorbing a dilute salt solution of a fondaparinux sodium compound by ion exchange resin, then eluting with concentrated brine solution to achieve the purpose of salt removal and concentration, so as to obtain concentrated liquid of fondaparinux sodium. The invention uses ion exchange resin before fondaparinux sodium adsorption, to separate most of the salt and water, and then a small amount of concentrated brine solution is employed to elute the product, and the subsequent precipitation is carried out directly to obtain the product. The method is simple and practical in operation and low in cost and can control processing batch arbitrarily, so as to greatly facilitate the posttreatment process of the fondaparinux sodium product.

Description

technical field [0001] The invention relates to a method for separating and extracting fondaparinux sodium. Background technique [0002] D254 is a macroporous strong basic quaternary ammonium salt type cation exchange resin. Previously, D254 has been widely used in the separation of heparin sodium and protein and other magazines. It is easy to operate, has a high recovery rate of heparin sodium, and the resin can be regenerated and recycled. [0003] Fondaparinux sodium is a highly selective factor Xa inhibitor developed by Sanofi, France. It was launched in China in 2008 under the trade name "Android". Compared with low molecular weight heparin, it is a structurally defined single compound with a lower molecular weight. Compared with enoxaparin, the curative effect is not lower than that of enoxaparin, and the relative risk of bleeding is reduced by 50%. [0004] Although the clinical performance of fondaparinux sodium is very good, its application is limited due to its...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07H15/04C07H1/06
Inventor 李正海
Owner NANJING TIANXIANG PHARMA TECH
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