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Method for improving stability of refined heparin sodium 10% water solution by virtue of stabilizer adding process

A stabilizer, heparin sodium technology, applied in the biological field, can solve the problems such as the separation technology of chondroitin polysulfate that has not been reported

Inactive Publication Date: 2015-05-27
QINGDAO JIULONG BIO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

On April 17-18 and April 24-25, an international symposium on heparin sodium was held in the United States. On May 4, the official website of the US FDA announced that the main cause of death was polychondroitin sulfate, and so far No technique has been reported for the separation of chondroitin polysulfate from heparin sodium

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] 1. Extraction

[0037] 1. Crude product dissolution:

[0038] Open the water valve, add 900L of drinking water, then add 15 billion units of heparin sodium crude product into the reaction tank, add while stirring, after stirring for 6 hours, use a stirring rod to test whether the bottom is completely dissolved;

[0039] 2. Enzyme hydrolysis:

[0040] Adjust the pH of the solution in the previous step to 7.5 with hydrochloric acid solution, add 1500 g of pepsin when the temperature rises to 53 °C, then add 300 g of trypsin, and keep warm at 53 °C for 3 hours;

[0041] 3. Rapid heating:

[0042] Heat the enzymolysis solution from the previous step to 88°C within 35 minutes, stand still for 15 minutes, start stirring, pass in circulating water to cool down, and when the temperature drops to 50°C, adjust the pH to 11.0 with 6mol / L sodium hydroxide solution, stand still Stratification for 24 hours;

[0043] 4. Centrifugation of impurities precipitated at the bottom:

[...

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PUM

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Abstract

The invention discloses a method for improving stability of a refined heparin sodium 10% water solution by virtue of a stabilizer adding process. The method can meet requirements proposed by customers from America on our company that the refined heparin sodium 10% water solution, after boiled in boiling water for 3h, is free from significant change in color, absorbance and active ingredients. The technical scheme is as follows: an appropriate stabilizer is added according to a certain proportion since the intermediate control of a heparin sodium refining process is qualified, so as to protect heparin from being damaged; and the produced 10% water solution, after being boiled in boiling water for 3h, is free from significant change in color, absorbance and active ingredients. Therefore, the method disclosed by the invention, which can meet customer requirements, has promoted export and won a good reputation for our company.

Description

technical field [0001] The invention relates to the field of biotechnology, in particular to a method for protecting heparin from destruction by adding a suitable stabilizer. Background technique [0002] Heparin sodium is a biochemical drug extracted from pig small intestine mucosa. It is an irreplaceable, life-saving drug of choice in surgery, and the market cannot be interrupted. Since it was used clinically in the 1940s, its scope of application has continued to expand, especially since the 1990s, the product is mainly used clinically to prevent thrombosis and treat cardiovascular diseases, blood diseases, uremia, etc. Western countries have begun to study the preventive effect of heparin sodium on cancer, and its new uses are increasing. [0003] Since the 1970s, the production process of heparin sodium in my country has been continuously improved, and China has become the country with the largest output of heparin sodium in the world. More than 70% of heparin sodium ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C08B37/10
Inventor 刘冠男王小凤夏衬来
Owner QINGDAO JIULONG BIO PHARMA