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Separation and purification method of high-quality heparin sodium

A purification method and heparin sodium technology are applied in the field of separation and purification of high-quality heparin sodium, which can solve the problems of many losses in the heparin process, cumbersome operation steps, low yield of heparin sodium, etc. low consumption effect

Inactive Publication Date: 2020-11-24
山东辰龙药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] After analyzing the above-mentioned patents, it is known that most of heparin sodium is refined and purified by resin adsorption or ultrafiltration, which leads to a low or slightly high yield of high-quality heparin sodium, but the quality does not meet the CP and EP standards, and the purification process The operation steps in the process are relatively cumbersome, the heparin process loses more, and the process produces more solid waste and salty wastewater

Method used

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  • Separation and purification method of high-quality heparin sodium

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] 1. Add 20 crude heparin sodium (porcine heparin with a potency of 90 IU / mg) and 140 g of purified water to a clean four-necked glass reaction bottle. During the dissolution process, add 1% sodium chloride to the amount of water until it is stirred and dissolved.

[0033] 2. Add activated trypsin to the solution, raise the temperature to 40°C, and perform enzymatic hydrolysis for 12 hours. During the process, adjust the pH value between 8-12.

[0034] 3. After the enzymatic hydrolysis is completed, heat the feed solution to 85-90°C and filter.

[0035] 4. After the filtration is completed, cool the filtrate to 50°C, add 6g of 2709 strong alkaline enzyme, and perform enzymatic hydrolysis for 10 hours. During the process, adjust the pH value between 8-12.

[0036] 5. After the enzymatic hydrolysis is completed, heat the feed solution to 85-90°C and filter.

[0037] 6. Cool the filtrate to 35-40°C, add 210g of medicinal ethanol to the feed liquid, let it settle with alcoho...

Embodiment 2

[0051] The steps of this embodiment are the same as those in Example 1, except that the enzyme is replaced by 1398 protease and proteolytic enzyme.

[0052] The output of heparin sodium finished product is 8.2g, the potency is 178IU / mg, the potency recovery rate is 82%, and the protein content is 0.52%.

Embodiment 3

[0054] The steps of this embodiment are the same as those in Example 1, except that the enzyme is replaced by trypsin and proteolytic enzyme.

[0055] The output of heparin sodium finished product is 8.8g, the potency is 180IU / mg, the potency recovery rate is 82%, and the protein content is 0.35%.

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Abstract

The invention relates to a separation and purification method of high-quality heparin sodium. The separation and purification method comprises the following steps: S1, dissolving crude heparin sodium:mixing the crude heparin sodium with water, and adding sodium chloride in a dissolving process; S2, carrying out enzymolysis and filtering: selecting two enzymes, firstly hydrolyzing by utilizing thefirst enzyme, and then heating and filtering; adding the second enzyme into filtered filtrate, heating, stirring and filtering; S3, carrying out oxidization and de-coloring: adding purified water into the heparin sodium obtained by step S2 and dissolving; carrying out the oxidization and de-coloring by utilizing hydrogen peroxide; S4, carrying out alcohol precipitation: adding the purified waterinto a heparin sodium sediment obtained by step S3 and dissolving; S5, freeze-drying: adding the purified water and 1 percent of sodium chloride into the heparin sodium sediment obtained by step S4, and adding a solution into a freeze dryer and carrying out freeze-drying treatment; and S6, crushing and packaging: crushing the freeze-dried heparin sodium and packaging after crushing. The separationand purification method provided by the invention has a high titer recovery rate; the quality of a finished product meets CP (content protection) standards and EP (effective concentration) standards;the whole purification method has low energy consumption and the purification cost is effectively reduced.

Description

technical field [0001] The invention relates to a method for separating and purifying high-quality heparin sodium. Background technique [0002] Heparin sodium is a sulfate ester of acidic mucopolysaccharide produced by animal connective tissue. It has a strong anticoagulant effect and is the drug of choice for preventing thromboembolic diseases. Its structural formula is as follows: [0003] [0004] n=4to 50, R=H or SO 3 Na,R'=H or SO 3 Na or CO-CH 3 [0005] R 2 = H and R 3 =CO 2 Na or R 2 =CO 2 Na and R 3 =H [0006] Heparin sodium not only has anticoagulant, antithrombotic and blood lipid adjustment functions, but also has various biological functions such as anti-inflammation, anti-allergy, anti-virus, and anti-cancer. So far, there is no product that can completely replace it, and it is still the most important anticoagulant and antithrombotic biochemical drug. [0007] At present, domestic heparin sodium extraction methods mainly include salt hydrolys...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C08B37/10
CPCC08B37/0075C08B37/0003
Inventor 李兴臣姚洪雷梁祺李浩徐发往翟川川
Owner 山东辰龙药业有限公司