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The purification method of idaparin sodium

A technology of edaparin sodium and edaparin, which is applied in chemical instruments and methods, organic chemistry, sugar derivatives, etc., and can solve problems such as non-compliance

Active Publication Date: 2021-11-02
AMPHASTAR NANJING PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] Utilize the purity of the edaparin sodium synthesized by the above method (i.e. the crude product of edaparin sodium) is only about 60% to 70%, which does not meet the standard of raw material drug (API) in the pharmaceutical industry (i.e., the purity of API needs to reach 99.0%) )

Method used

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  • The purification method of idaparin sodium
  • The purification method of idaparin sodium
  • The purification method of idaparin sodium

Examples

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Effect test

example 1

[0071] Dissolve 20 g of the crude edaparin sodium product with a purity of 60% to 70% synthesized by the [3+2] synthesis method in 50 ml of deionized water to obtain a solution containing the crude product of edaparin sodium. The solution was injected into a column of sodium ion exchange resin. Described sodium ion exchange resin column can be Mono S 5 / 50GL (chromatography) column or Mono S 10 / 100GL (chromatography) column, and it can all be located in Buckinghamshire, England, General Electric Medical Life Sciences in Little Chalfont Alternatively, the (chromatographic) column can be hand packed with Dowex 50WX8, 100-200 mesh ion exchange resin or Dowex Monosphere 88 resin, both available from DOW Chemical Company, Michigan, USA. The (chromatographic) column is washed with deionized water, the amount of water used may be 1 to 6 column volumes, for example 1 to 3 column volumes. The eluate was collected portion by portion. In other words, successive fractions of the eluate a...

example 2

[0075] 40 g of the crude edaparin sodium product with a purity of 60% to 70% synthesized by the [3+2] synthesis method was dissolved in 50 ml of deionized water to obtain a solution containing the crude product of edaparin sodium. The solution was injected into a column of sodium ion exchange resin. Described sodium ion exchange resin column can be Mono S 5 / 50GL (chromatography) column or Mono S 10 / 100GL (chromatography) column, and it can all be located in Buckinghamshire, England, General Electric Medical Life Sciences in Little Chalfont Alternatively, the (chromatographic) column can be hand packed with Dowex 50WX8, 100-200 mesh ion exchange resin or Dowex Monosphere 88 resin, both available from DOW Chemical Company, Michigan, USA. The (chromatographic) column is washed with deionized water, the amount of water used may be 1 to 6 column volumes, for example 1 to 3 column volumes. The eluate was collected portion by portion. In other words, successive fractions of the elu...

example 3

[0079] Dissolve 10 g of the crude product of edaparin sodium with a purity of 60% to 70% synthesized by the [3+2] synthesis method in 25 ml of deionized water to obtain a solution containing the crude product of edaparin sodium. The solution was injected into a column of sodium ion exchange resin. Described sodium ion exchange resin column can be Mono S 5 / 50GL (chromatography) column or Mono S 10 / 100GL (chromatography) column, and it can all be located in Buckinghamshire, England, General Electric Medical Life Sciences in Little Chalfont Alternatively, the (chromatographic) column can be hand packed with Dowex 50WX8, 100-200 mesh ion exchange resin or Dowex Monosphere 88 resin, both available from DOW Chemical Company, Michigan, USA. The (chromatographic) column is washed with deionized water, the amount of water used may be 1 to 6 column volumes, for example 1 to 3 column volumes. The eluate was collected portion by portion. In other words, successive fractions of the eluat...

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Abstract

A method for purifying edaparin sodium comprising: passing a solution containing crude edaparin sodium through a sodium ion exchange resin column to obtain a first mixture; passing the solution containing the first mixture through a gel chromatography column, obtaining a second mixture; and precipitating purified edaparin sodium from a solution containing the second mixture.

Description

technical field [0001] The following description relates to a purification method of edaparin sodium, which contains methyl 2,3,4-tri-O-methyl-6-O-sulfonic acid group-α-D-glucopyranosyl -(1→4)-2,3-Di-O-methyl-β-D-glucopyranosyl-(1→4)-2,3,6-tri-O-sulfonic acid- α-D-Glucopyranosyl-(1→4)-2,3-di-O-methyl-α-L-iduronyl-(1→4)-2,3,6-tri -O-sulfo-α-D-glucopyranoside Nonyl Sodium. Background technique [0002] Edaparin sodium is an antithrombotic drug chemically related to low molecular weight heparin. Edaparin sodium is a synthetic inhibitor of pentasaccharide factor Xa, which is used as an antithrombotic and antithrombotic drug. One of the advantages of edaparin sodium compared with low molecular weight heparin (LMWH) or unbroken heparin is that the treatment method using edaparin sodium can greatly reduce the risk of heparin-induced thrombocytopenia (HIT). [0003] Edaparinux sodium has a similar chemical structure and mode of action to fondaparinux, a low molecular weight hepa...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07H15/04C07H15/18C07H15/14
CPCC07H1/06C07H15/04
Inventor 孟俊东徐勇刚王文存陈松张昊宁
Owner AMPHASTAR NANJING PHARMA