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Method for protecting and purifying heparin sodium under resin adsorption state

A technology of resin adsorption and heparin sodium, applied in the field of biological purification, can solve the problems of unstable quality of high-quality heparin sodium, unfavorable quality stability of finished heparin preparations and low molecular weight heparin preparations, etc. The effect of efficiency

Active Publication Date: 2018-07-27
黄石市典雅生物科技有限公司
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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 solve the problem that the current purification of crude heparin sodium cannot be separated from the oxidation purification method, and the quality of the obtained high-quality heparin sodium is unstable, which is not conducive to controlling the quality stability of heparin preparations and low-molecular-weight heparin preparations. To provide a resin Method for protecting and purifying heparin sodium in adsorption state

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] A method for protecting and purifying heparin sodium in a resin adsorption state, comprising the following steps:

[0029] (1) Crude heparin sodium dissolution and resin adsorption: Weigh the crude heparin sodium, add purified water to dissolve it into a crude heparin sodium solution with a mass fraction of 1-5%, filter, transfer the filtrate to an adsorption tank, Add 1-3g of activated strong basic ion exchange resin, adjust the pH to 8.0-8.5 with NaOH solution with a mass fraction of 5-8%, add trypsin with a solution volume of 0.03-0.06%, and keep warm at 50-58°C for dynamic After 10-12 hours of enzymatic desorption, the heparin titer of the effluent was detected to be <4IU / ml, and the adsorption was stopped;

[0030] (2) Pure water washing: Drain the solution in the adsorption tank, vacuum dry, transfer the resin adsorbing heparin sodium to the elution tank, add purified water 8-10 times the weight of the resin, keep warm at 35-45 °C and wash twice, 20-60 minutes ea...

Embodiment 2

[0044] A method for protecting and purifying heparin sodium in a state of resin adsorption in this embodiment comprises the following steps:

[0045] (1) Dissolution of crude heparin sodium and resin adsorption: Weigh 6.053kg of crude heparin sodium with a unit potency of 95.8IU / mg, add purified water to dissolve it into a crude heparin sodium solution with a mass fraction of 3%, filter, and transfer the filtrate to the adsorption In the tank, add 2 g of activated German Lewatit MP-500 resin per 10,000 IU of heparin sodium, adjust the pH to 8.2 with a 6% NaOH solution, add 0.03-0.06% of the solution volume trypsin, and keep warm for 52-55 ℃ Dynamic enzymatic desorption for 10 hours, and the heparin titer of the effluent was detected to be <4IU / ml, and the adsorption was stopped;

[0046] (2) Pure water washing: Drain the solution in the adsorption tank, vacuum dry, transfer the resin adsorbing heparin sodium to the elution tank, add purified water 8 times the weight of the res...

Embodiment 3

[0059] A method for protecting and purifying heparin sodium in a state of resin adsorption in this embodiment comprises the following steps:

[0060] (1) Dissolution of crude heparin sodium and resin adsorption: Weigh 7.036kg of crude heparin sodium with a unit potency of 78.5IU / mg, add purified water to dissolve into a crude heparin sodium solution with a mass fraction of 5%, filter, and transfer the filtrate to the adsorption In the tank, add 2.5g of activated American Amberlite IRA-400 resin per 10000IU of heparin sodium, adjust the pH to 8.4 with a 7% NaOH solution, add 0.03-0.06% of the solution volume trypsin, and keep warm for 50- Dynamic enzymatic desorption at 54°C for 11 hours, and the heparin titer in the effluent was detected to be <4IU / ml, and the adsorption was stopped;

[0061] (2) Washing with pure water: Drain the solution in the adsorption tank, vacuum dry, transfer the resin adsorbing heparin sodium to the elution tank, add purified water 9 times the weight ...

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Abstract

The invention discloses a method for protecting and purifying heparin sodium under a resin adsorption state. The method takes a heparin sodium crude product as a raw material, after dissolving, resinadsorption is carried out, under the resin adsorption state, mixed salt solution is employed to remove nucleic acid, salt solution is carried out to remove binding protein, a salt and ethanol mixed solution is employed for performing ultrasonic removing of an ethanol-soluble object, salt is employed for gradient elution and desorption, a methanol and ethanol mixed solution is used for ultrasonic decolouring, absolute ethyl alcohol is used for ultrasonic dehydrating to remove methanol, a sediment is subjected to dissolving and ultrafiltration to remove salt and alcohol, and a fine product heparin sodium is prepared through freeze-drying. The method abandons a traditional heparin sodium chemical oxidation impurity-removing purifying method, the prepared heparin sodium has the advantages of complete molecular structure, less fracture, and good stability, the unit titer is more than 180 IU / mg, and the titer yield is 98-99.5%. The heparin sodium as a raw material is in favor of stability ofa heparin preparation, and is in favor of controlling important quality indexes such as weight average molecular weight and molecular weight distribution of the low molecular heparin preparations such as enoxaparin sodium.

Description

technical field [0001] The invention relates to the technical field of biological purification, in particular to a method for protecting and purifying heparin sodium in a state of resin adsorption. The method of the present invention abandons the traditional method of chemical oxidation, impurity removal and purification of heparin sodium, and the obtained heparin sodium has a relatively complete molecular structure, less breakage, good stability, a unit potency of more than 180 IU / mg, and a potency yield of 98%-99.5 %. Background technique [0002] Heparin is a kind of mucopolysaccharide contained in mammals. It combines with protein and exists in intestinal mucosa, lung, liver and other organs. After heparin is separated and extracted from protein, it has various physiological activities such as anticoagulant, antithrombotic, and hypolipidemic, and is an effective drug for preventing atherosclerosis and cardiovascular and cerebrovascular diseases. The average molecular w...

Claims

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Application Information

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IPC IPC(8): C08B37/10
CPCC08B37/0003
Inventor 吕典吕鉴贵吕兴
Owner 黄石市典雅生物科技有限公司
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