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Method for directly producing enoxaparin sodium from crude product heparin sodium

A technology of enoxaparin sodium and heparin sodium, which is applied in the field of preparation of enoxaparin sodium, can solve the problems of unstrict control of starting materials, high sulfate content in finished products, and large amount of organic solvents used, so as to achieve stable product quality Controllable, stable product quality, and reduced production costs

Active Publication Date: 2013-12-11
DONGYING TIANDONG PHARM CO LTD
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  • Description
  • Claims
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Problems solved by technology

[0006] In order to solve the above-mentioned technical problems existing in the prior art, the object of the present invention is to provide a method for directly producing enoxaparin sodium from crude heparin sodium, which overcomes the large amount of organic solvent used in the original production process and the control of starting materials. It is not strict, the production process is complicated, and the technical problems of high sulfate content in the finished product

Method used

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  • Method for directly producing enoxaparin sodium from crude product heparin sodium

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Embodiment 1

[0029] Such as figure 1 As shown, the process described in this embodiment includes the following steps:

[0030] Take 100Kg of crude product heparin sodium, add purified water to dissolve it into a crude product sodium heparin aqueous solution with a concentration of 10wt%; use hydrochloric acid or sodium hydroxide with a concentration of 4mol / L to adjust the pH value of the solution to 5.2, and then add 0.4 times the volume of the solution for medicinal Ethanol, adjust the temperature to 0.5°C, let it stand for 6 hours, collect the precipitate a, add 5 times the volume of the precipitate a purified water, after it is completely dissolved, add 0.2v% of the solution volume of hydrogen peroxide to oxidize for 6 hours, filter with a filter membrane , add 2 times the volume of ethanol to precipitate the solution, place the precipitate for 6 hours to obtain precipitate b; add purified water to dissolve the precipitate b to form a heparin sodium solution with a concentration of 10 ...

Embodiment 2

[0033] Enoxaparin sodium is realized by the following process. Take 100Kg of crude heparin sodium, add purified water to dissolve it into a crude product heparin sodium aqueous solution with a concentration of 15wt%, use hydrochloric acid or sodium hydroxide with a concentration of 4mol / L to adjust the pH value of the solution to 6.7, Then add medicinal ethanol 0.8 times the volume of the solution, adjust the temperature to 9.5°C, let it stand for 24 hours, collect the precipitate a, add 15 times the volume of purified water of the precipitate a, after completely dissolving, add 1v% hydrogen peroxide of the solution volume Oxidize for 12 hours, filter with a filter membrane, add ethanol in an amount twice the volume of the solution to precipitate, and place the precipitate for 12 hours to obtain precipitate b; add purified water to precipitate b to dissolve it into a heparin sodium solution with a concentration of 15 wt%, and take the precipitate Benzethonium chloride with 4 ti...

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Abstract

The invention relates to a preparation method for directly producing enoxaparin sodium from crude product heparin sodium. The preparation method comprises the following steps of: taking the crude product heparin sodium as a raw material, performing fractionated precipitation through an organic solvent to remove most of impurities in the crude product heparin sodium, and then removing part of residual impurity proteins, pigments and other impurities by oxidation through hydrogen peroxide so as to get the high-purity heparin sodium which is in line with the production requirements of the enoxaparin sodium; and taking the high-purity heparin sodium as an intermediate product, preparing a heparin quaternary ammonium salt, preparing heparin benzyl ester, performing alkaline depolymerization on the heparin benzyl ester, neutralizing with an acid, performing alcohol precipitation, refining, decoloring, dehydrating and drying to get an enoxaparin sodium finished product. By adopting the method disclosed by the invention, the use of the organic solvent is greatly reduced, the production efficiency is improved, the influences on the environment are reduced, the enoxaparin sodium finished product which achieves or is better than European Pharmacopoeia 7.0 version is obtained, and the method is simple to operate and can realize industrialized production.

Description

technical field [0001] The invention relates to a method for preparing enoxaparin sodium, more specifically, the invention relates to a method for directly producing enoxaparin sodium from crude heparin sodium. Background technique [0002] European Pharmacopoeia (EP) version 7.0 defines enoxaparin sodium (enoxaparin sodium) as a sodium salt of low molecular weight heparin, composed of complex oligosaccharides that have not yet been fully characterized, and its structure is characterized by the fact that most components are in the sugar chain The non-reducing end has a 4-enopyranuronic acid structure, and 15%-25% of the components have a 1,6 anhydride structure at the reducing end. EP7.0 stipulates that the average relative molecular weight of enoxaparin sodium ranges from 3800 to 5000, and the characteristic value is about 4500. The proportion of fractions with molecular weights less than 2000D should be 12.0% to 20.0%, and the proportion of fractions from 2000D to 8000D sh...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C08B37/10
Inventor 郭林崔慧斐李荣
Owner DONGYING TIANDONG PHARM CO LTD
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