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A kind of ultra-low molecular weight heparin sodium and preparation method thereof

A technology of heparin sodium and molecular weight, applied in the field of biomedicine, can solve the problem of high cost, and achieve the effect of convenient operation, strong practicability and simple method

Active Publication Date: 2022-07-29
山东万邦赛诺康生化制药股份有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0006] However, the inventors found that most of the prior art uses sodium nitrite degradation method, and then obtains it through ethanol molecular weight fractionation, the yield is 20-40%, and the cost is very high

Method used

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  • A kind of ultra-low molecular weight heparin sodium and preparation method thereof
  • A kind of ultra-low molecular weight heparin sodium and preparation method thereof
  • A kind of ultra-low molecular weight heparin sodium and preparation method thereof

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preparation example Construction

[0026] A preparation method of ultra-low molecular weight heparin sodium, comprising the following steps:

[0027] (1) Preparation of solution A: 3-6% sodium chloride (W / V) contains 2-3% sodium nitrite (calculated according to the weight of heparin sodium) aqueous solution (adjust the pH of the solution to 2-3 )

[0028] (2) Take the fine heparin sodium, make it into a 5-15% heparin sodium aqueous solution, add the A solution while stirring at room temperature, and constantly monitor and adjust the pH of the solution to stabilize it at PH to 2.0 to 3.0. After confirming the reaction (after generating a large number of bubbles), use a 3000 Dalton membrane for ultrafiltration, add 4% sodium chloride solution containing 2-3% sodium nitrite aqueous solution while filtering, and keep the volume of the reaction solution in the retention zone unchanged. , maintain the PH of the liquid in the interception zone at 2.0-3.0, and stop the ultrafiltration after no bubbles are produced in ...

Embodiment 1

[0037] (1) get 100g of fine heparin sodium, be made into 10% heparin sodium aqueous solution 1000ml, add 4% sodium chloride containing 2% sodium nitrite (sodium nitrite is calculated according to the weight of the heparin sodium) aqueous solution (the solution of PH is adjusted to 2.2) at room temperature, add 6mol / L hydrochloric acid while stirring to adjust the pH to 2.2, after the reaction produces bubbles, carry out ultrafiltration with a 3000-dalton membrane, add 4% of sodium chloride while filtration Sodium nitrate (sodium nitrite is calculated according to the weight of heparin sodium) aqueous solution, keep the volume of the reaction solution in the interception zone unchanged, and maintain pH 2.2 throughout the process, which should be adjusted at any time. The ultrafiltration was stopped after no bubbles were generated in the reaction solution and no heparin sodium was detected in the solution.

[0038] (2) collect the filtrate obtained in step (1), and adjust the pH...

Embodiment 2

[0059] (1) take 100g of fine heparin sodium and dissolve it into 1000ml of 15% aqueous solution, add 3% sodium chloride containing 3% sodium nitrite aqueous solution (the pH of the solution is adjusted to 2.5), add 6mol / L hydrochloric acid while stirring at room temperature Adjust the pH to 2.5, use a 3000 Dalton membrane for ultrafiltration after the reaction bubbles are generated, add 3% sodium chloride solution containing 3% sodium nitrite aqueous solution while filtering, and keep the pH to 2.5 to keep the reaction in the trapping zone The volume of the solution remained unchanged, and the ultrafiltration was stopped after no bubbles were generated in the reaction solution and no heparin sodium was detected in the solution.

[0060] (2) Collect the filtrate in (1), and adjust the pH to 7.0, then add 1 g of solid sodium borohydride (the amount added is 1% by weight of heparin sodium) to the filtrate after reduction reaction for 12 hours, use 1000 Dalton The membrane was sub...

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Abstract

The invention relates to an ultra-low molecular weight heparin sodium and a preparation method thereof, belonging to the field of biomedicine. Through membrane separation, the low molecular weight heparin sodium is further degraded into heparin fragments. The preparation method has mild degradation conditions, can reduce the detachment of the sulfonic acid group from the heparin, and can realize that almost all the raw materials of the heparin sodium are depolymerized into the ultra-low molecular weight heparin sodium. The ultra-low molecular weight heparin sodium prepared by this method has a high yield, an average molecular weight of less than 3000 Da, and a higher anti-Fxa biological activity.

Description

technical field [0001] The invention belongs to the field of biomedicine, in particular to an ultra-low molecular weight heparin sodium. Background technique [0002] The information disclosed in this Background section is only for enhancement of understanding of the general background of the invention and should not necessarily be taken as an acknowledgement or any form of suggestion that this information forms the prior art already known to a person of ordinary skill in the art. [0003] Low molecular weight heparin is a low molecular weight heparin product obtained by degrading unfractionated heparin. It has the advantages of low molecular weight (molecular weight below 8000Da), high bioavailability, long plasma half-life, etc. In particular, the bleeding side effects caused by it are greatly reduced, and it is widely received by medical care. Workers welcome. Mainly used for the prevention of thromboembolic diseases, such as nephrotic syndrome, venous thrombosis after s...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C08B37/10A61P7/02
CPCC08B37/0078A61P7/02
Inventor 丛义国郑会武李玲
Owner 山东万邦赛诺康生化制药股份有限公司
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