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Process for preparing high-purity dermatan sulfate from heparin sodium leftovers

A technology of dermatan sulfate and leftovers, applied in the field of preparing high-purity dermatan sulfate, can solve the problems of undisclosed important factors such as pH value and precipitation temperature, inability to exert a therapeutic effect, and low purity of dermatan sulfate, and achieve market competition. Power, easy to scale production, low cost effect

Active Publication Date: 2016-12-07
HEBEI CHANGSHAN BIOCHEM PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the good therapeutic effect of this medicine, there is a great market demand. CN100384884C adopts the method of separating and purifying dermatan sulfate and low-molecular weight heparan sulfate from heparin sodium by-products by ethanol fractionation precipitation, although this method is not suitable for fractionation precipitation The drug solution concentration, salt content and ethanol concentration have been studied, but the pH value and precipitation temperature, the important factors that affect the precipitation and separation effect of the drug solution, have not been disclosed.
The test result of the prepared dermatan sulfate is that the specific rotation is -55°~-63°, and the anticoagulant potency is ≤10USPu / mg. Because the higher the purity of the dermatan sulfate, the lower the specific rotation, the lower the anticoagulant potency , indicating that the purity of dermatan sulfate prepared by it is low, so it cannot exert a better therapeutic effect

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Embodiment 1: a. rough classification

[0022] Take 2kg of the leftover wet product of the heparin sodium boutique production, add purified water to dissolve and set the volume to 40L, add 3.2kg of sodium chloride, after the sodium chloride is dissolved, adjust the pH of the solution to 6.0 with 3mol / L hydrochloric acid solution, and then add ethanol, Make the concentration of ethanol in the solution 37.5% L / L, then let it stand for precipitation at 15±1°C, and separate the precipitate and supernatant after precipitation for 8 hours. Collect the supernatant, add ethanol to the supernatant so that the concentration of ethanol in the liquid is 49% L / L, let it stand for precipitation at 15±1°C, collect the precipitate after 8 hours of precipitation to obtain the crude product of dermatan sulfate 1.4 kg;

[0023] b. Refining of dermatan sulfate

[0024] Dissolve the above 1.4kg dermatan sulfate crude product in purified water and set the volume to 10L, adjust the pH of th...

Embodiment 2

[0033] Embodiment 2: the difference between this embodiment and embodiment 1 is that

[0034] a. Rough classification

[0035] Add purified water to dissolve 4kg of the leftover wet product of heparin sodium high-quality goods and make it to 40L, then add 2.0kg of sodium chloride, after the sodium chloride is dissolved, adjust the pH of the solution to 5.8 with 3mol / L hydrochloric acid solution, then add ethanol, Make the concentration of ethanol in the solution 35.4% L / L, then set aside to settle at 11±1°C, and separate the precipitate and supernatant after precipitation for 6 hours. Add ethanol to the collected supernatant so that the concentration of ethanol in the medicinal solution is 45.0% L / L, let it stand for precipitation at 11±1°C, collect the precipitate after 6 hours of precipitation to obtain 2.3 kg of crude dermatan sulfate;

[0036] b. Refining of dermatan sulfate

[0037] Dissolve the above 2.3kg of dermatan sulfate crude product in purified water and set the...

Embodiment 3

[0046] Embodiment 3: The difference between this embodiment and Embodiment 1 and Embodiment 2 is that

[0047] a. Rough classification

[0048] Add purified water to dissolve 10kg of the wet product of the heparin sodium fine product and make it to 40L, then add 0.8kg of sodium chloride, after the sodium chloride is dissolved, adjust the pH of the solution to 5.5 with 3mol / L hydrochloric acid solution, then add ethanol, Make the concentration of ethanol in the solution 32.3% L / L, then let it stand for precipitation at 20±1°C, and separate the precipitate and supernatant after precipitation for 3 hours. Add ethanol to the collected supernatant so that the concentration of ethanol in the medicinal solution is 41.1% L / L, let it stand for precipitation at 20±1°C, and collect the precipitate after 10 hours of precipitation to obtain 5.8 kg of crude dermatan sulfate;

[0049] b. Refining of dermatan sulfate

[0050] Dissolve the above 5.8kg crude product of dermatan sulfate in pur...

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Abstract

The invention relates to a process for preparing high-purity dermatan sulfate from heparin sodium leftovers. The process comprises the following steps: precipitating leftovers produced during production of high-quality heparin sodium serving as a raw material in a grading way by ethanol to obtain a heparinoid crude product and a dermatan sulfate crude product, and precipitating the heparinoid crude product in a grading way by the ethanol and oxidizing by hydrogen peroxide to obtain positive specific rotation heparinoid and negative specific rotation heparinoid; degrading the dermatan sulfate crude product by nitrous acid in order to degrade heparin substances contained in the crude product into low-molecular heparin substances, precipitating by ethanol in a grading way, and oxidizing by hydrogen peroxide to obtain over 98 percent dermatan sulfate. By adopting the process, the problem of low purity of the dermatan sulfate in the market for a long time is solved, the leftovers are changed into treasure, and large extra benefit can be created for an enterprise; the process has the advantages of simple steps, environmental friendliness, no production of toxic and harmful substances, low cost and easiness for scale production.

Description

technical field [0001] The invention relates to a method for preparing high-purity dermatan sulfate from leftovers produced in the process of preparing high-quality heparin sodium, and belongs to the technical field of mucopolysaccharide biopharmaceuticals. Background technique [0002] Dermatan sulfate (DS for short) is a natural glycosaminoglycan composed of repeating disaccharide units. The disaccharides are acetamidogalactose and iduronic acid, mainly N-acetyl Double sugar chain structure composed of galactosamine 4-sulfate and L-iduronic acid. Dermatan sulfate is widely distributed in animal tissues. It has anti-thrombosis, anti-edema, promotes skin renewal, prevents hyperkeratinization and acanthosis of the skin, moisturizes the skin, and maintains moisture. It has been paid more and more attention by domestic and foreign experts in recent years. The therapeutic effect of dermatan sulfate is directly related to its purity. Generally, the higher the purity of dermatan ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C08B37/08
Inventor 赵焕荣田志鹏张素艳白文举王鹏飞高树华
Owner HEBEI CHANGSHAN BIOCHEM PHARMA
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