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Method for separating and purifying sulodexide crude drugs from heparin by-product

A technology of heparin by-products and raw materials, applied in the field of medicine, can solve problems such as high production costs, large internal structure damage, and low pass rate

Active Publication Date: 2019-05-17
HUBEI YINUORUI BIOLOGICAL PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Aiming at the deficiencies of the prior art, the present invention provides a method for separating and purifying sulodexide raw material from heparin by-products, which solves the problem that the existing produced products often have insufficient purity, relatively large damage to the internal structure, and difficulty in confirming the structure. , low qualified rate, high production cost and difficulty in industrial production, lack of ability to remove impurities such as pigment proteins, and the ratio of heparan sulfate component to dermatan sulfate component in the obtained product is uncontrollable, and the appearance of the product is not good.

Method used

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  • Method for separating and purifying sulodexide crude drugs from heparin by-product
  • Method for separating and purifying sulodexide crude drugs from heparin by-product
  • Method for separating and purifying sulodexide crude drugs from heparin by-product

Examples

Experimental program
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Effect test

Embodiment 1

[0047] S1. Pretreatment of heparin by-products: Dissolve heparin by-products heparin 5%, heparan sulfate 45% and dermatan sulfate 47% with a titer of 29 usp u / mg into a solution with a mass fraction of 5%. Dissolve 2% sodium chloride, then add 95% ethanol until the ethanol concentration is 30%, keep it warm for 4 hours, pour out the supernatant, and remove the lower precipitate;

[0048] S2. Separation of heparin: continue to add 95% ethanol to the supernatant obtained in S1 until the ethanol concentration is 50%, keep it warm for 4 hours, precipitate, dehydrate, dry and dry to obtain the crude product after removing heparin;

[0049] S3. Pretreatment of crude heparin: add water to dissolve the crude product in step S1 into a solution with a mass fraction of 10%, raise the temperature to 25° C., dissolve the feed solution with 2% sodium chloride, and then adjust the pH to 11 with sodium hydroxide solution. Then add 2% anhydrous sodium carbonate-sodium bicarbonate buffer soluti...

Embodiment 2

[0053] S1. Pretreatment of heparin by-products: Dissolve heparin by-products heparin 5%, heparan sulfate 45% and dermatan sulfate 47% with a titer of 29 usp u / mg into a solution with a mass fraction of 10%, and heat up to 38°C. Dissolve 2% sodium chloride, then add 95% ethanol until the ethanol concentration is 35%, keep warm for 4 hours, pour out the supernatant, and remove the lower precipitate;

[0054] S2. Separation of heparin: continue to add 95% ethanol to the supernatant obtained in S1 until the ethanol concentration is 50%, keep it warm for 4 hours, precipitate, dehydrate, dry and dry to obtain the crude product after removing heparin;

[0055] S3. Pretreatment of crude heparin: add water to dissolve the crude product in step S1 into a solution with a mass fraction of 10%, raise the temperature to 27°C, dissolve the feed solution with 2% sodium chloride, and then adjust the pH to 11 with sodium hydroxide solution. Then add 2% anhydrous sodium carbonate-sodium bicarbon...

Embodiment 3

[0059] S1. Pretreatment of heparin by-products: Dissolve heparin by-products heparin 5%, heparan sulfate 45% and dermatan sulfate 47% with a titer of 29usp u / mg into a solution with a mass fraction of 15%, and heat up to 40°C. Dissolve 2% sodium chloride, then add 95% ethanol until the ethanol concentration is 30%, keep it warm for 4 hours, pour out the supernatant, and remove the lower precipitate;

[0060] S2. Separation of heparin: continue to add 95% ethanol to the supernatant obtained in S1 until the ethanol concentration is 46%, keep it warm for 4 hours, precipitate, dehydrate, dry and dry to obtain the crude product after removing heparin;

[0061] S3. Pretreatment of crude heparin: add water to dissolve the crude product in step S1 into a solution with a mass fraction of 12%, raise the temperature to 30°C, dissolve the feed solution with 2% sodium chloride, and then adjust the pH to 11 with sodium hydroxide solution. Then add 2% anhydrous sodium carbonate-sodium bicarb...

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Abstract

The invention discloses a method for separating and purifying sulodexide crude drugs from a heparin by-product, and relates to the technical field of medicine. The method for separating and purifyingthe sulodexide crude drugs from the heparin by-product comprises the steps that a heparin sulfate and dermatan sulfate crude product is obtained after the heparin by-product is dissolved by adopting high-temperature precipitation separation; and then, a crude product solution is oxidized, precipitated and dried through a hydrogen peroxide-ozone system to obtain sulodexide. According to the methodfor separating and purifying the sulodexide crude drugs from the heparin by-product, the hydrogen peroxide-ozone system is adopted during oxidation, and the oxidation effect can be improved to effectively remove chromoprotein and impurities. During precipitation, compared with a traditional low-temperature precipitation method, a high-temperature precipitation method is adopted, the titer recoveryrate is increased by 10%, using of a centrifugal machine and ion exchange resin is further reduced, compared with traditional hydrogen peroxide oxidation treatment, 60% time is shortened, the productquality and production efficiency are improved, the method for separating and purifying the sulodexide crude drugs from the heparin by-product is suitable for large-scale industrial production, the period is short, the cost is low, the heparin by-product is sufficiently and effectively used, the product purity is higher, and the stability is higher.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a method for separating and purifying sulodexide crude drug from heparin by-products. Background technique [0002] Sulodide, whose trade name is "Weisu", is a low-molecular-weight heparin drug, which belongs to the glycosaminoglycan class of drugs like heparin. Sulodide contains two main components, heparan sulfate and dermatan sulfate. The principle of action is different but synergistic. Sulodexide can be taken orally, subcutaneously or intravenously, and finally metabolized by the kidneys. It has high bioavailability and has a high affinity with endothelial cells. Among the absorbed drugs, at least 90% It exists in the vascular endothelium and has a good protective effect on the vascular endothelium. As a new type of natural glycosaminoglycan, sulodexide has anticoagulant, thrombolytic, anti-cardiovascular disease, and hypolipidemic effects. It is used in the treatment of pe...

Claims

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Application Information

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IPC IPC(8): C08B37/10
Inventor 干浩董凯周伟韩自江罗慧何锐罗锡川倪爱民徐永保
Owner HUBEI YINUORUI BIOLOGICAL PHARMA
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