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Preparation method for improving clarity of enoxaparin sodium

A technology for enoxaparin sodium and clarity, which is applied in the field of preparation for improving the clarity of enoxaparin sodium, can solve problems such as poor clarity and failure to meet clarity requirements, and achieve good clarity, simple and easy processing methods, The effect of high product yield

Active Publication Date: 2014-09-03
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

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 clarity requirements of the 2010 edition of the Chinese Pharmacopoeia

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] A preparation method for improving the clarity of enoxaparin sodium, comprising the following steps:

[0023] (1) Weigh 100g of enoxaparin sodium crude product, dissolve it in 1000ml of 4% sodium chloride solution prepared in advance to make a 10% (w / v) enoxaparin sodium crude product solution, and filter;

[0024] (2) Add 6 times (v / v) ethanol or methanol (the temperature of ethanol or methanol is controlled below 10°C) to the above crude enoxaparin sodium solution to obtain a precipitate, which is left to stand for 6 hours, and the precipitate is collected;

[0025] (3) Dissolve the collected precipitate in 1000ml of 4% sodium chloride solution A prepared in advance to make a 10% (w / v) crude solution of enoxaparin sodium, and filter; use quaternary ammonium salt detection test paper to detect quaternary ammonium If the salt concentration is less than 5ppm, the operation of (5) is carried out. If quaternary ammonium salt concentration is greater than 5ppm, just carry ...

Embodiment 2

[0031] A preparation method for improving the clarity of enoxaparin sodium, comprising the following steps:

[0032] (1) Weigh 100g of enoxaparin sodium crude product, dissolve it in 1000ml of 10% (w / v) sodium chloride solution A prepared in advance to make 10% (w / v) enoxaparin sodium crude product solution, filter ;

[0033] (2) Add 8 times (v / v) ethanol or methanol (the temperature of ethanol or methanol is controlled below 10°C) to the above crude enoxaparin sodium solution to obtain a precipitate, which is left to stand for 12 hours, and the precipitate is collected;

[0034] (3) Dissolve the collected precipitate with 1000ml of pre-prepared 10% sodium chloride solution A to make a 10% (w / v) enoxaparin sodium crude product solution, and filter; use quaternary ammonium salt detection test paper to detect quaternary ammonium If the salt concentration is less than 5ppm, the operation of (5) is carried out. If the quaternary ammonium salt concentration is greater than 5ppm, ...

Embodiment 3

[0040] A preparation method for improving the clarity of enoxaparin sodium, comprising the following steps:

[0041] (1) Weigh 100g of enoxaparin sodium crude product, dissolve it in 1000ml of 15% (w / v) sodium chloride solution A prepared in advance to make 10% (w / v) enoxaparin sodium crude product solution, filter ;

[0042] (2) Add 10 times (v / v) ethanol or methanol (the temperature of ethanol or methanol is controlled below 10°C) to the above crude enoxaparin sodium solution to obtain a precipitate, which is left to stand for 20 hours, and the precipitate is collected;

[0043] (3) Dissolve the collected precipitate with 1000ml of 15% sodium chloride solution A prepared in advance to make a 10% (w / v) enoxaparin sodium crude product solution, and filter; use quaternary ammonium salt detection test paper to detect quaternary ammonium If the salt concentration is less than 5ppm, the operation of (5) is carried out. If the quaternary ammonium salt concentration is greater tha...

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PUM

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Abstract

The invention discloses a preparation method for improving the clarity of enoxaparin sodium. The method comprises the following steps: dissolving a crude product of enoxaparin sodium by adopting sodium chloride with concentration of more than 3.5%(w / v), ionizing quaternary ammonium salt bonded with the crude product of enoxaparin sodium through replacement reaction, and precipitating out enoxaparin sodium by using high-quantity ethanol or methanol. Compared with the prior art, the preparation method provided by the invention is easy and feasible, the product yield is high, and the clarity is relatively good.

Description

technical field [0001] The invention relates to the technical field, in particular to a preparation method for improving the clarity of enoxaparin sodium. 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 ...

Claims

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Application Information

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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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