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Enoxaparin sodium purifying method

The technology of enoxaparin sodium and purification method is applied in the field of preparation of biological pharmaceutical raw materials, which can solve the problems of inability to achieve clarity and poor clarity, and achieve the effects of good clarity and simple purification operation.

Inactive Publication Date: 2016-03-23
QINGDAO JIULONG BIO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Among them, the enoxaparin sodium intermediate obtained after acid neutralization and alcohol precipitation often has poor clarity. If it is not refined and purified, it cannot meet the requirements of clarity in the Pharmacopoeia

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment

[0018] Put 1.1 kg of the prepared crude enoxaparin sodium into 5 L of 10% sodium chloride solution, stir and dissolve to obtain a crude enoxaparin sodium solution, and filter to obtain a filtrate. Put the filtrate in a centrifuge at 3000r / min for 30min to obtain supernatant and precipitate. 10L of ethanol was added to the supernatant, stirred for 1 h and then allowed to stand for 3 h to obtain a precipitate. The precipitate was dissolved into a 10wt~15wt% solution with purified water, filtered through a 0.22μm filter membrane, and then spray-dried to obtain 1.02kg of enoxaparin sodium finished product, with a purification yield of 93.5%.

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PUM

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Abstract

The invention relates to an enoxaparin sodium purifying method and belongs to the field of biological engineering. The process is simple in operation, safe, controllable and high in yield. The needs of the pharmaceutical industry can be met.

Description

technical field [0001] The invention relates to a preparation method of biomedicine raw materials, which belongs to the field of biotechnology, in particular to a purification method of enoxaparin sodium. Background technique [0002] Enoxaparin Sodium (Enoxaparin Sodium) belongs to low-molecular-weight heparins, and its main feature is that there is a 4-enpyranuronic acid structure in the molecule. This product has strong antithrombotic effect and low risk of bleeding. It is currently one of the main therapeutic drugs for anticoagulant and antithrombotic formation. In 2006, the global sales amounted to 24.3ML euros. The French Aventis company has developed and applied for a patent on the preparation process in 1993. However, this patent does not involve key processes such as esterification rate, ring formation rate and product purification in the production process. [0003] Using porcine mucosal heparin as the starting material, preparation of heparin quaternary ammonium...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C08B37/10
Inventor 刘冠男夏衬来迟培升
Owner QINGDAO JIULONG BIO PHARMA