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Preparation method of heparin sodium

A technology of heparin sodium and sodium chloride, which is applied in the field of pharmacy, can solve the problems of destructive effects on the tetrasaccharide junction area and does not meet the requirements of industrial production, and achieve the effect of high potency and complete heparin structure

Inactive Publication Date: 2016-08-24
GANSU LANYAO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The above third method has a destructive effect on the tetrasaccharide linking region of heparin, which does not meet the requirements of industrial production

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] 1) Dissolve crude heparin sodium in purified water at a concentration of 20% (g / mL) at 25°C, add sodium chloride at a concentration of 4% (g / mL), adjust the pH to 10.0 after dissolution, and stir for 3.5 hour, then warm up to 80°C, adjust the pH to 9.5, let stand for 10 minutes, quickly cool down to below 20°C, let stand for 4 hours, filter, and take the filtrate;

[0020] 2) The filtrate obtained in step 1 was warmed up to 45°C, adjusted to pH 8.0 with 18% (g / mL) hydrochloric acid aqueous solution or 20% (g / mL) sodium hydroxide aqueous solution, added trypsin to react for 4 hours, and then Add calcium chloride at a concentration of 2% (g / mL), stir to dissolve, heat up to 80°C, continue stirring for 10 minutes, then cool down to below 40°C, add sodium carbonate at a concentration of 2% (g / mL), and continue Stir for 30 minutes, centrifuge, and take the supernatant;

[0021] 3) Add water to the supernatant obtained in step 2 to the initial volume of the crude heparin sod...

Embodiment 2

[0028] 1) Dissolve crude heparin sodium in purified water at a concentration of 20% (g / mL) at 35°C, add sodium chloride at a concentration of 5% (g / mL), adjust the pH to 10.5 after dissolution, and stir for 4.0 hour, then warm up to 85°C, adjust the pH to 10.0, let stand for 10 minutes, quickly cool down to below 20°C, let stand for 5 hours, filter, and take the filtrate;

[0029] 2) The filtrate obtained in step 1 was warmed up to 50°C, adjusted to pH 9.0 with 18% (g / mL) hydrochloric acid aqueous solution or 20% (g / mL) sodium hydroxide aqueous solution, added trypsin to react for 5 hours, and then Add calcium chloride at a concentration of 2% (g / mL), stir to dissolve, heat up to 85°C, continue to stir for 10 minutes, then cool down to below 40°C, add sodium carbonate at a concentration of 2% (g / mL), and continue Stir for 30 minutes, centrifuge, and take the supernatant;

[0030] 3) Add water to the supernatant obtained in step 2 to the initial volume of the crude heparin sod...

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PUM

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Abstract

The invention provides a preparation method of heparin sodium. The preparation method comprises the following steps: edulcoration of crude products, enzymatic hydrolysis, edulcoration with acid, oxidation, freeze-drying, and pulverizing. Serine in the heparin sodium can be removed, limitation of the preparation method of heparin sodium to large batch production in the prior art is overcome, the process is simple to operate, and structural integrity and titer of heparin are improved.

Description

technical field [0001] The invention belongs to the field of pharmacy, and relates to a heparin and its derivatives, in particular to a preparation method of heparin sodium. Background technique [0002] Heparin is a linear mucopolysaccharide composed of repeating disaccharide units linked by furfuric acid and glucosamine with 1-4 glycosidic bonds. It is widely distributed in mammalian tissues and is expressed by connective tissue mast cells. Heparin exists mostly in the form of heparin sodium-protein complex in animals. Due to the incomplete dissociation of heparin sodium, the heparin extraction method will leave covalently bound proteins and electrostatically bound positively charged proteins. [0003] At present, many methods for removing serine in heparin have been published at home and abroad. For example, Keiichi Takagaki reported in 2002 the method of removing heparin serine by using cellulase with β-endoxylosidase activity; Yu-ki Matsuno reported in 2007 A method f...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C08B37/10
Inventor 杨军
Owner GANSU LANYAO PHARMA CO LTD
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