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Enoxaparin sodium compound and preparation method thereof

A technology of enoxaparin sodium and enoxaparin, which is applied in the field of enoxaparin sodium and its preparation, can solve the problems of waste water pollution, affecting the esterification rate, and low yield, and achieve high yield, short reaction time, and easy operation. easy effect

Active Publication Date: 2013-02-13
SUZHOU ERYE PHARMA CO LTD
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  • Abstract
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Problems solved by technology

[0019] Another object of the present invention is to provide a novel preparation method of enoxaparin sodium, specifically to provide a new synthetic process for heparin quaternary ammonium salt, more specifically, to provide a solid-phase synthesis method for heparin quaternary ammonium salt, to Overcome the defects of low yield, large amount of waste water pollution and affecting the esterification rate of subsequent steps in the existing aqueous phase synthesis method

Method used

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  • Enoxaparin sodium compound and preparation method thereof
  • Enoxaparin sodium compound and preparation method thereof

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Effect test

Embodiment 1

[0037] Take 10g of heparin sodium, 50mg of sodium chloride, and 25g of benzethonium chloride, mix them evenly, place them in a microwave reactor with a power of 150W, and react at a temperature of 60°C for 30min, then cool to obtain 30g of heparin quaternary ammonium salt;

[0038] Using the method of US Patent No. 5,389,618, the quaternary ammonium salt of heparin was esterified, cracked, and purified to obtain 18.5 g of enoxaparin.

[0039]

[0040] The product tests are as follows:

[0041] Source of reference substance: Imported enoxaparin sodium injection (Kesai, batch number: 110601-J), extracted and refined by Suzhou Erye Pharmaceutical Co., Ltd. according to enoxaparin sodium raw material refining method.

[0042] 1. High resolution mass spectrometry

[0043] Mass spectrometry system: Shimadzu LCMS-IT-TOF

[0044] Off-line positive ion mode, spray voltage 2.0kV, spray gas flow rate 0.5L / min, CDL temperature 200°C, heating module temperature 200°C, detector volta...

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Abstract

The invention provides an enoxaparin sodium compound and a preparation method thereof. Liquaemin and benzethonium chloride are used as raw materials, sodium chloride is used as a neutral reaction medium and a microwave solid-phase synthesis method is carried out to prepare heparin quaternary ammonium salt.

Description

[0001] technical field [0002] The invention relates to enoxaparin sodium and a preparation method thereof, belonging to the technical field of medicine. [0003] Background technique [0004] Enoxaparin sodium is a new type of antithrombotic drug developed by Aventis of France, which was approved by the US FDA in October 2004. Enoxaparin sodium is clinically used to prevent deep vein thrombosis, prevent deep vein thrombosis and pulmonary embolism, treat established deep vein thrombosis, prevent thrombosis in extracorporeal circulation during hemodialysis, and treat unstable angina and non-Q Wave myocardial infarction, etc., are currently the first choice for anticoagulant and antithrombotic treatment drugs. In 2006, the global sales amounted to 24.35 euros. [0005] European Pharmacopoeia version 5.3 defines enoxaparin as follows: it is a low molecular weight heparin sodium produced by alkaline lysis of heparin benzyl ester sodium derivatives obtained from heparin sodium...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C08B37/10C07H11/00C07H1/00
Inventor 陈学文陈洋洋
Owner SUZHOU ERYE PHARMA CO LTD
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