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Decoloration method for enoxaparin sodium intermediate

A technology of enoxaparin sodium and intermediates, which is applied in the field of decolorization, can solve the problems of safety risks in the finished product, affect the yield, and little difference in electronegativity, and achieve superior use effect, good decolorization effect and little structural damage. Effect

Active Publication Date: 2013-07-24
山东万邦赛诺康生化制药股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The decolorization method disclosed in this document has the following disadvantages: (1), decolorization with activated carbon will absorb some enoxaparin sodium, thereby reducing the yield; (2), it is also easy to produce ultrafine particles that cannot be filtered out, making the finished product security risk
[0006] At present, there are also some processes that use hydrogen peroxide to oxidize and decolorize. These processes often require multiple oxidation processes to make the color meet the requirements, but multiple oxidations will cause damage to the structure of enoxaparin sodium. Will reduce the potency of enoxaparin sodium
At the same time, there will be residual hydrogen peroxide in enoxaparin sodium, which will affect the stability of enoxaparin sodium
[0007] In addition, there is also a method of simply using macroporous anion exchange resins to decolorize the enoxaparin sodium intermediate. At the same time as the pigment, part of the enoxaparin sodium is also eluted, thereby affecting the yield

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] A method for decolorizing an enoxaparin sodium intermediate, comprising the following steps:

[0026] (1) Weigh 100g of enoxaparin sodium intermediate and dissolve it in 1000ml of 4% sodium chloride solution prepared in advance to make a 10% (w / v) enoxaparin sodium intermediate solution;

[0027] (2) Use 40% sodium hydroxide solution to adjust the pH value of the above enoxaparin sodium solution to 10.5±0.5, adjust the temperature to 55°C, and add 1% (v / v) hydrogen peroxide (original The concentration is 30%, before adding, dilute the concentration to 10% according to the ratio of 1:3), add in three times (add once every 30min, add one-third of the amount each time), add in 1 hour, and stir intermittently , starting from the first addition of hydrogen peroxide, oxidized at this temperature for 2 hours in total, then cooled to room temperature, left at this pH value for 10 hours, oxidized and filtered until clarified.

[0028] (3) After adjusting the pH value of the cla...

Embodiment 2

[0034] A method for decolorizing an enoxaparin sodium intermediate, comprising the following steps:

[0035] (1) Weigh 100g of enoxaparin sodium intermediate and dissolve it in 1000ml of 4% sodium chloride solution prepared in advance to form a 15% (w / v) enoxaparin sodium intermediate solution;

[0036] (2) Use 40% sodium hydroxide solution to adjust the pH value of the above enoxaparin sodium solution to 11±0.5, adjust the temperature to 40°C, and add 1.5% (v / v) hydrogen peroxide (original The concentration is 30%, before adding, dilute the concentration to 10% according to the ratio of 1:3), add in three times (add once every 30min, add one-third of the amount each time), add in 1 hour, and stir intermittently , starting from the first addition of hydrogen peroxide, oxidized at this temperature for 2 hours in total, then cooled to room temperature, left at this pH value for 10 hours, oxidized and filtered until clarified.

[0037] (3) After adjusting the pH value of the cla...

Embodiment 3

[0043] A method for decolorizing an enoxaparin sodium intermediate, comprising the following steps:

[0044] (1) Weigh 100g of enoxaparin sodium intermediate and dissolve it in 1000ml of 4% sodium chloride solution prepared in advance to make an 8% (w / v) enoxaparin sodium intermediate solution;

[0045] (2) Use 40% sodium hydroxide solution to adjust the pH value of the above enoxaparin sodium solution to 10±0.5, adjust the temperature to 60°C, and add 0.8% (v / v) hydrogen peroxide (original The concentration is 30%, before adding, dilute the concentration to 10% according to the ratio of 1:3), add in three times (add once every 30min, add one-third of the amount each time), add in 1 hour, and stir intermittently , starting from the first addition of hydrogen peroxide, oxidized at this temperature for 2 hours in total, then cooled to room temperature, left at this pH value for 10 hours, oxidized and filtered until clarified.

[0046] (3) After adjusting the pH value of the clari...

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Abstract

The invention discloses a decoloration method for an enoxaparin sodium intermediate. The decoloration method for the enoxaparin sodium intermediate comprises the following operation steps of: (1) dissolving the enoxaparin sodium intermediate by sodium chloride solution to obtain dissolution solution; (2) adding the dissolution solution obtained in the step (1) in hydrogen peroxide solution, and filtering to obtain filtrate; (3) adsorbing the filtrate obtained in the step (2) by macroporous anion exchange resin, sequentially washing by purified water and low-concentration sodium chloride solution, and eluting by high-concentration sodium chloride solution to obtain eluate after the adsorption is complete; and (4) precipitating the eluate obtained in the step (3) by ethanol, dehydrating, and vacuum-drying to obtain the enoxaparin sodium finished product.

Description

technical field [0001] The invention relates to a decolorization method, in particular to an enoxaparin sodium intermediate decolorization method. Background technique [0002] Enoxaparin sodium is a low-molecular-weight heparin sodium salt, mainly used for the prevention of venous thromboembolic diseases (prevention of thrombosis in veins), especially for the prevention of thrombosis associated with orthopedic or general surgery; treatment of established deep veins Embolism, with or without pulmonary embolism; used together with aspirin to treat unstable angina and non-Q wave myocardial infarction; used in extracorporeal circulation for hemodialysis to prevent thrombosis, etc. [0003] Enoxaparin sodium is obtained by alkaline depolymerization of benzyl ester derivatives of porcine intestinal mucosal heparin. Alkaline depolymerization of heparin benzyl ester, acid neutralization, alcohol precipitation, refining, decolorization, dehydration and drying to obtain the finished...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C08B37/10
Inventor 郑会武石滨丛义国刘清凉
Owner 山东万邦赛诺康生化制药股份有限公司
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