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Heparin sodium high in clarity

A heparin sodium, high-purity technology, applied in the direction of blood diseases, extracellular fluid diseases, non-central analgesics, etc., can solve the problems of reduced insoluble particles, residual protein and nucleic acid, etc., to achieve reduced insoluble particles, low cost, The effect of simple operation method

Inactive Publication Date: 2020-03-27
山东万邦赛诺康生化制药股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] In order to overcome the above problems, the present invention provides a preparation process of high-purity heparin sodium, which solves the problem of relatively large residual protein and nucleic acid during the refining of existing heparin sodium, and also greatly reduces the insoluble particles in the refining process ,

Method used

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Examples

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Effect test

Embodiment 1

[0039] A preparation process for high-purity heparin sodium, specifically comprising the following steps:

[0040] 1. Enzymatic deproteinization: dilute the crude heparin sodium with purified water to a 10% (w / v) concentration solution, raise the temperature to 45.0°C, adjust the pH value to 7-9, add the dissolved 2709 protease, and keep the temperature and pH, keep stirring for 6 hours, then add calcium chloride solution, keep stirring, and filter with plate and frame filter;

[0041]2. Oxidation: adjust the temperature of the filtrate to room temperature °C, adjust the pH value of the feed liquid to 10-11 with 4mol / L sodium hydroxide solution, and add 30% of the feed liquid volume to 1% of the feed liquid volume under the condition of maintaining pH 10-11. For hydrogen peroxide oxidation, check the pH change of the feed liquid every half hour. If the pH is lower than 10, adjust it to the range of 10-11 in time, and add 0.5% hydrogen peroxide. The overall hydrogen peroxide ad...

Embodiment 2

[0048] A preparation process for high-purity heparin sodium, specifically comprising the following steps:

[0049] 1. Enzymatic deproteinization: Dilute the crude heparin sodium with purified water to a solution with a concentration of 5% (w / v), raise the temperature to 55.0°C, adjust the pH value to 7-9, add dissolved 2709 protease, and keep the temperature and pH, keep stirring for 6 hours, then add calcium chloride solution, keep stirring, and filter with plate and frame filter;

[0050] 2. Oxidation: adjust the temperature of the filtrate to room temperature °C, adjust the pH value of the feed liquid to 10-11 with 4mol / L sodium hydroxide solution, and add 30% of the feed liquid volume to 1% of the feed liquid volume under the condition of maintaining pH 10-11. For hydrogen peroxide oxidation, check the pH change of the feed liquid every half hour. If the pH is lower than 10, adjust it to the range of 10-11 in time, and add 0.5% hydrogen peroxide. The overall hydrogen perox...

Embodiment 3

[0057] A preparation process for high-purity heparin sodium, specifically comprising the following steps:

[0058] 1. Enzymatic deproteinization: dilute the crude heparin sodium with purified water to a solution with a concentration of 15% (w / v), raise the temperature to 35.0°C, adjust the pH value to 7-9, add dissolved 2709 protease, and keep the temperature and pH, after stirring for 6 hours, add calcium chloride solution, continue stirring, and filter with a plate and frame filter;

[0059] 2. Oxidation: adjust the temperature of the filtrate to room temperature °C, adjust the pH value of the feed liquid to 10-11 with 4mol / L sodium hydroxide solution, and add 30% of the feed liquid volume to 1% of the feed liquid volume under the condition of maintaining pH 10-11. For hydrogen peroxide oxidation, check the pH change of the feed liquid every half hour. If the pH is lower than 10, adjust it to the range of 10-11 in time, and add 0.5% hydrogen peroxide. The overall hydrogen pe...

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Abstract

The invention relates to high-clarity heparin sodium, which is prepared by the following steps: carrying out enzymolysis, oxidation, ethanol precipitation and filtration on a heparin sodium crude product, and collecting a feed liquid I; adding a sodium carbonate solution and dichloromethane into the feed liquid I, standing, carrying out secondary filtration, collecting a filtrate, carrying out ethanol precipitation again, and collecting a feed liquid II; and diluting the feed liquid II, acidifying, and filtering again to obtain the high-purity heparin sodium. The method can solve the problemof relatively more residual protein and nucleic acid in the existing heparin sodium refining process, and greatly reduce insoluble particles in the refining process. Therefore, the heparin sodium withhigher purity is obtained.

Description

technical field [0001] The invention relates to a method for refining crude heparin sodium, in particular to a method for producing raw material heparin sodium suitable for low molecular weight heparin production. Background technique [0002] The information disclosed in this background section is only intended to increase the understanding of the general background of the present invention, and is not necessarily to be regarded as an acknowledgment or any form of suggestion that the information constitutes the prior art already known to those skilled in the art. [0003] Heparin sodium is a commonly used clinical anticoagulant drug, widely present in the viscera and intestinal mucosa of mammals, mainly composed of D-glucosamine, L-iduronic acid, M-acetylglucosamine and D-glucosamine Mucopolysaccharide sulfate composed of uronic acid alternately, as a natural anticoagulant substance, has good activity in anticoagulation, promoting protease release and complement cytolytic s...

Claims

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Application Information

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IPC IPC(8): C08B37/10A61P7/02A61P29/00A61P35/00
CPCA61P7/02A61P29/00A61P35/00C08B37/0075
Inventor 丛义国郑会武李玲李正想孔祥翔李齐齐
Owner 山东万邦赛诺康生化制药股份有限公司
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