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Refining method of enoxaparin sodium

A technology of enoxaparin sodium and its refining method, which is applied in the field of medicine, can solve problems such as the clarity of enoxaparin sodium finished products, and achieve the effects of easy product collection and simple production process

Inactive Publication Date: 2015-05-06
JIANGSU WANBANG BIOPHARMLS +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

(3) In the preparation process of enoxaparin sodium finished product, methods such as alcohol precipitation and freeze-drying have been used in relevant literature reports, and the above methods cannot well solve the problem of clarity of enoxaparin sodium finished product

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] Add 20 g of crude enoxaparin sodium and 400 ml of purified water to a dry 1L reaction bottle, stir and dissolve at 10°C to 30°C to form a 5% concentration liquid, adjust the pH value to 7.8 with 1mol / L sodium hydroxide, press Add 1% hydrogen peroxide to the liquid volume, the concentration of hydrogen peroxide is 30%, the concentration here is the mass volume concentration in the usual sense, keep stirring for 12 hours, gradually add 40 g of sodium chloride to the liquid and stir Dissolve, add methanol 2.5 times the volume of the drug solution, precipitate, and filter to obtain the intermediate product of enoxaparin sodium. Repeat this step once.

[0018] Add 15 g of enoxaparin sodium intermediate product and 75 ml of purified water to a dry 250 ml reaction bottle, stir and dissolve at 20°C~30°C to form a 20% concentration liquid medicine, and filter the medicine solution through a 0.1 micron filter membrane, Spray drying, wherein the inlet temperature of the spray-dri...

Embodiment 2

[0020] Add 20 g of enoxaparin sodium crude product and 400 ml of purified water to a dry 1L reaction bottle, stir and dissolve at 10°C to 30°C to form a 5% concentration liquid, adjust the pH value to 8.8 with 1mol / L sodium hydroxide, press Add 0.5% hydrogen peroxide to the volume of the medicinal solution, the concentration of hydrogen peroxide is 30%, and continue to stir for 20 hours. Gradually add 40 g of sodium chloride to the medicinal solution and stir to dissolve, add methanol to 2.5 times the volume of the medicinal solution, and precipitate. Filter to obtain the middle of enoxaparin sodium. Repeat this step once.

[0021] Add 15 g of enoxaparin sodium crude product and 50 ml of purified water to a dry 250 ml reaction bottle, stir and dissolve at 20°C to 30°C to form a 30% concentration liquid medicine, filter the medicine liquid through a 0.1 micron filter membrane, spray Drying, wherein the inlet temperature of the spray-dried medicinal liquid is 140°C, the outlet ...

Embodiment 3

[0023] Add 20 g of crude enoxaparin sodium and 400 ml of purified water to a dry 1L reaction bottle, stir and dissolve at 10°C to 30°C to form a 5% concentration liquid, adjust the pH value to 6.8 with 1mol / L sodium hydroxide, press Add 0.3% hydrogen peroxide to the volume of the medicinal solution, the concentration of hydrogen peroxide is 30%, and continue to stir for 18 hours. Gradually add 40 g of sodium chloride to the medicinal solution and stir to dissolve, add 5 times the volume of the medicinal solution to methanol, and precipitate. The intermediate product of enoxaparin sodium was obtained by filtration. Repeat this step once.

[0024] Add 15 g of enoxaparin sodium crude product and 50 ml of purified water to a dry 250 ml reaction bottle, stir and dissolve at 20°C to 30°C to form a 30% concentration liquid medicine, filter the medicine liquid through a 0.1 micron filter membrane, spray Drying, wherein the inlet temperature of the spray-dried medicinal liquid is 120°...

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Abstract

The invention belongs to the technical field of medicine and relates to a refining method of enoxaparin sodium. The refining method solves the problems of the prior art, utilizes an enoxaparin sodium crude product as a raw material, realizes combination of hydrogen peroxide oxidation decoloring and methanol grading alcohol precipitation, and adopts a two-step decoloring and methanol grading alcohol precipitation method. The decolored agent obtained by the refining method is basically colorless, colored impurities can be effectively removed and an enoxaparin sodium finished product is obtained by spray drying. The refining method realizes synthesis of the enoxaparin sodium finished product satisfying the requirement EP 7.0. The refining method has product collection easiness and is suitable for industrial expanded production. Through integral cooperation of decoloring, grading alcohol precipitation and spray drying, product clarity is less than or equal to that of a turbidimetric liquid 0.5, European pharmacopoeia EP 7.0 requirements are satisfied, production processes are simple, product collection is easy and the refining method is provided for industrial production.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a method for refining enoxaparin sodium. Background technique [0002] The English name of enoxaparin sodium is: enoxaparin sodium, the trade name is Kesai, and its structural formula is: [0003] [0004] Enoxaparin sodium was first approved in France in 1987, and was first approved for marketing in the United States and Canada as low molecular weight heparin in 1993. Now this drug is used to treat 108 million patients with deep venous thrombosis around the world. Regarding the production process of enoxaparin sodium, there have been many reports at home and abroad, for example: US5389618, CN100436483, CN101165071A and so on. However, one of the important production processes, that is, the refining of enoxaparin sodium, is reported differently in relevant literature at home and abroad. (1) For the decolorization of crude enoxaparin sodium, related literatu...

Claims

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Application Information

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IPC IPC(8): C08B37/10
Inventor 乔德水李伟高雪芹
Owner JIANGSU WANBANG BIOPHARMLS
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