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Method for separating purified heparin sodium

A technology for separation and purification of heparin sodium, applied in the field of separation and purification of heparin sodium, can solve the problems of low removal of nucleic acid and protein impurities, low product titer, and high extraction quality requirements

Active Publication Date: 2013-04-10
QINGDAO JIULONG BIO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Its limitations lie in the low degree of removal of nucleic acid and protein impurities, high requirements for extraction quality (required potency ≥ 80U / mg), long production cycle, low product potency, and low yield

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment Construction

[0017] The following examples illustrate the invention in detail:

[0018] 1. Add 800Kg of water to the reaction tank, and add 100Kg of heparin sodium (60U / mg) into the reaction tank while stirring until completely dissolved.

[0019] 2. Adjust the pH to 6.0, raise the temperature to 55°C and stop heating, add 600g of pepsin and 1200g of trypsin, stir well and keep warm for 3 hours.

[0020] 3. Adjust the pH to 9.0, rapidly raise the temperature to 90°C, and let stand for 30 minutes. Cool down to 55°C, add 160L of 95% ethanol, adjust pH=11.0, and let stand for 12 hours.

[0021] 4. Siphon the supernatant of enzymatic hydrolysis, centrifuge the lower sediment, combine the mother liquor to the supernatant, and discard the solid separation.

[0022] 5. Adjust the pH of the material liquid in 4 to 7.0, raise the temperature to 70°C, add 2.4Kg of flocculation precipitant 1 (calcium carbonate), stir evenly, and let stand for 12 hours. After siphoning the supernatant and centrifug...

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PUM

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Abstract

The invention relates to a method for separating purified heparin sodium. Heparin sodium obtained through extracting porcine intestinal mucosa contains a great amount of protein, nucleic acid and other impurities, so that certain problems are brought to refining and purifying of heparin sodium. The traditional process method is that residual impurities are removed through a salt resolving process or an enzymolysis process, which has the disadvantages that the requirement on extraction quality of heparin sodium is high, the removal efficiency is relatively low, the follow-up oxidation precipitation refining time is long, the consumption of oxidant (hydrogen peroxide) is high, and the yield is low. According to the method provided by the invention, residual impurities in heparin sodium are removed with precipitant through enzymolysis, so that the process design is reasonable, the removal efficiency is high, the follow-up refining time is shortened, the product yield is improved, and the cost is lowered.

Description

technical field [0001] The invention relates to a method for separating and purifying heparin sodium, in particular to a production process for heparin sodium. Background technique [0002] Heparin sodium is a commonly used anticoagulant drug in clinical practice. It is a mucopolysaccharide mainly extracted from pig small intestinal mucosa, which has significant anticoagulant and antithrombotic effects. In recent years, the emergence of low molecular weight heparin sodium has made the application of heparin sodium more and more extensive. The traditional production process method is to carry out salt hydrolysis or enzymatic hydrolysis to the crudely extracted heparin sodium (potency 60-100U / mg), and then carry out oxidative decolorization and refinement. Its limitation is that the degree of removal of nucleic acid and protein impurities is low, the requirements for extraction quality are high (required potency ≥ 80U / mg), the production cycle is long, the product potency is ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C08B37/10
Inventor 夏衬来迟培升刁爱芹
Owner QINGDAO JIULONG BIO PHARMA
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