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Technique for producing ultra-low molecular heparin sodium (calcium)

A molecular heparin sodium, ultra-low technology, applied in the field of biopharmaceuticals, can solve the problems of clinical application limitations, serious side effects of heparin bleeding, etc., and achieve the effect of good clinical safety

Inactive Publication Date: 2009-09-02
SUZHOU FAST BIOLOGICAL PHARMACY TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It has the functions of anticoagulation and blood lipid regulation, and has been widely used in the field of cardiovascular disease prevention and treatment. However, heparin has serious bleeding side effects in clinical practice, and its clinical application is limited.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Embodiment 1: 100g unfractionated heparin (anti-IIa factor potency 143IU / mg, dermatan sulfate content 0.7%), dissolve in 2000ml water for injection, cool to 3 ℃, adjust pH to 3.0 with acetic acid solution, add 150ml 1 % (v / v) sodium nitrite solution, adjust the pH to 2.7 with acetic acid solution, after 6 hours of cracking, add 150ml of 1% (v / v) sodium nitrite solution, after 12 hours of cracking, add 100ml of 1% (v / v) Sodium nitrite solution, after 18 hours of cracking, adjust the pH value of the above cracking solution to 7.5 with sodium hydroxide to stop cracking.

[0019] 2% sodium chloride was added to the lysate, and after dissolving, the solution was passed through an anion exchange column for cyclic adsorption for 2 hours. Wash the exchange column with 4000ml of 2% sodium chloride solution, and elute with 1000ml of 20% sodium chloride solution to obtain a solution of ultra-low molecular weight heparin sodium. After the solution passed through a 5000D ultrafilt...

Embodiment 2

[0021] Embodiment two: 100g unfractionated heparin (anti-IIa factor potency 143IU / mg, dermatan sulfate content 0.7%), be dissolved in 2000ml water for injection, be cooled to 5 ℃, adjust pH to 3.0 with acetic acid solution, add 160ml 1% (v / v) Sodium nitrite solution, adjust the pH to 2.5 with acetic acid solution, after 7 hours of cracking, add 160ml of 1% (v / v) sodium nitrite solution, after 14 hours of cracking, add 120ml of 1% (v / v) v) Sodium nitrite solution, after 20 hours of lysis, adjust the pH value of the above lysis solution to 8.0 with sodium hydroxide to terminate the lysis.

[0022] 2% sodium chloride was added to the lysate, and after dissolving, the solution was passed through an anion exchange column for cyclic adsorption for 2 hours. Wash the exchange column with 6000ml of 1.8% calcium chloride solution, and elute with 1000ml of 24% calcium chloride solution to obtain a solution of ultra-low molecular weight heparin calcium. After the solution passed through...

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PUM

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Abstract

Aiming at the conditions that heparin has severe bleeding side effects in clinical practice and clinical application thereof is restricted, the invention discloses a technique for producing ultra-low molecular heparin sodium (calcium). The technique comprises the following steps of: taking heparin sodium solution, adding sodium nitrite solution for cracking; adjusting the lysis buffer by using alkaline; absorbing impurities by using an anion-exchange column; washing for obtaining ultra-low molecular heparin calcium; carrying out filtration by using an ultrafiltration membrane and obtaining a precipitate by using alcohol; and after desalting, dehydration, re-precipitation, cooling and drying, obtaining a finished product of ultra-low molecular heparin calcium. The product has better and safer antithrombotic effect under low level of anticoagulation, and can be widely used for preventing and treating diseases such as deep vein thrombosis, pulmonary embolism, disseminated intravascular coagulation, and the like.

Description

technical field [0001] The invention relates to a production method of ultra low molecular weight heparin (ultra low molecular weight heparin, ultra LMWH), in particular to a production process of ultra low molecular weight heparin sodium and ultra low molecular weight heparin calcium, belonging to the field of biopharmaceuticals. Background of the invention [0002] Heparin is a kind of mucopolysaccharide, which widely exists in animal organs and tissues such as intestinal mucosa and lung, and becomes medicinal heparin sodium after fat removal and protein removal processes. It has the functions of anticoagulation and blood lipid regulation, and has been widely used in the field of cardiovascular disease prevention and treatment. However, heparin has serious bleeding side effects in clinical practice, and its clinical application is limited. Low molecular weight heparin (LMWH) is an anticoagulant drug developed in the 1980s. It is obtained by splitting unfractionated heparin...

Claims

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Application Information

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IPC IPC(8): C08B37/10
Inventor 陈激
Owner SUZHOU FAST BIOLOGICAL PHARMACY TECH
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