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Refining and purification method of enoxaparin

A technology of enoxaparin and purification method, which is applied in the field of refining and purification of enoxaparin and medicine, can solve the problems of unstable product quality, complex production process, high cost, etc., achieve high recrystallization yield and improve product quality. Quality, easy-to-handle results

Inactive Publication Date: 2012-08-01
山东郁茏生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The purpose of the present invention is to provide a method for refining and purifying enoxaparin, so as to solve the deficiencies of the prior art such as complex production process, high cost, unstable product quality, and large pollution, and greatly improve the uniformity of product crystal particles , so that the preparation can well meet the needs of clinical use

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Take 5g of crude enoxaparin, dissolve it with 20g of deionized water, and prepare a homogeneous solution; the solution is irradiated with microwaves under stirring, with a microwave frequency of 400MHz, a power of 170W, and an irradiation time of 6s; g: The temperature of the material is slowly lowered to 5°C, and the crystal is grown for 3 hours; when the residual mother liquor is detected to be lower than 1000ppm, the material is filtered and dried to obtain the product. Yield 98.4%. All indicators of the tested products meet the standards of the European Pharmacopoeia.

[0028] Average molecular weight: 4800 Daltons;

[0029] Molecular weight distribution: the content of polysaccharide molecules with molecular weight less than 2000 Dalton is 11.8.0%, and the content of polysaccharide molecules with molecular weight between 2000-8000 Dalton is 80.3%.

[0030] Anti-Xa / anti-II: 4.6;

[0031] Anti-Xa: 118.4IU / mg;

[0032] 231nm absorption value: 14.56.

Embodiment 2

[0034] Take 5g of crude enoxaparin, dissolve it with 15g of deionized water, and prepare a homogeneous solution; the solution is intermittently irradiated with microwaves under stirring, with a microwave frequency of 400MHz, a power of 170W, and an irradiation time of 6s; g: The temperature of the material is slowly lowered to 5°C, and the crystal is grown for 3 hours; when the residual mother liquor is detected to be lower than 1000ppm, the material is filtered and dried to obtain the product. Yield 97.3%. All indicators of the tested products meet the standards of the European Pharmacopoeia.

[0035] Average molecular weight: 4800 Daltons;

[0036] Molecular weight distribution: the content of polysaccharide molecules with molecular weight less than 2000 Dalton is 10.8.0%, and the content of polysaccharide molecules with molecular weight between 2000-8000 Dalton is 79.0%.

[0037] Anti-Xa / anti-II: 4.6;

[0038] Anti-Xa: 118.4IU / mg;

[0039] 231nm absorption value: 14.56....

Embodiment 3

[0041] Take 5g of crude enoxaparin, dissolve it with 20g of deionized water, and prepare a homogeneous solution; the solution is irradiated with microwaves under stirring, the microwave frequency is 380Mhz, the power is 170W, and the irradiation time is 6s; add 0.001g of pure enoxaparin to the solution The temperature of the material is slowly cooled to 0°C, and the crystal is grown for 3 hours; when the residual mother liquor is detected to be lower than 1000ppm, the material is filtered and dried to obtain the product. Yield 98.0%. All indicators of the tested products meet the standards of the European Pharmacopoeia.

[0042] Average molecular weight: 4800 Daltons;

[0043] Molecular weight distribution: the content of polysaccharide molecules with molecular weight less than 2000 Daltons is 11.3.0%, and the content of polysaccharide molecules with molecular weights between 2000-8000 Daltons is 79.5%.

[0044] Anti-Xa / anti-II: 4.6;

[0045] Anti-Xa: 118.4IU / mg;

[0046] ...

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Abstract

The invention discloses a refining and purification method of enoxaparin, comprising: taking water as a solvent; dissolving the crude product of enoxaparin into water; preparing the crude product into a solution; irradiating the solution of enoxaparin with microwave of proper frequency and power; adding a proper quantity of seed crystals, and culturing the seed crystals at a low temperature for acertain time; and then filtering and drying to obtain the product. The finished product of the enoxaparin prepared with the method conforms to the European Pharmacopoeia standard, the quality of preparation is superior to that of the imported similar product sold in the present market, and the price of the preparation is low. Meanwhile, the method reduces the usage amount of organic solvents, lowers production cost and improves the recrystallization yield of the product.

Description

technical field [0001] The invention relates to a method for refining and purifying a medicine, in particular to a method for refining and purifying enoxaparin, and belongs to the technical field of chemical industry. Background technique [0002] Microwave generally refers to radio waves in the decimeter wave, centimeter wave, and millimeter wave band (frequency 300-300000 MHz). As a transmission medium and heating energy, microwave has been widely used in the field of chemistry, forming microwave chemistry, which has developed rapidly in recent years and has received more and more attention. A review in the famous Nature magazine in early 2003 discussed the advantages and research hotspots of current microwave chemistry. Using computer simulations, researchers at the Massachusetts Institute of Technology have found that microwave heating is a cheap and energy-efficient way to prompt chemical reactions to occur. Their research focused on the separation of mixtures adsorbe...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C08B37/10
Inventor 姚成盛
Owner 山东郁茏生物科技有限公司
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