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A method for separating and purifying sulodexide bulk drug from heparin by-products

A technology for heparin by-products and raw materials, applied in the field of medicine, can solve the problems of lack of ability to remove impurities such as pigments, proteins, difficulties in industrial production, and poor product appearance.

Active Publication Date: 2021-04-27
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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  • A method for separating and purifying sulodexide bulk drug from heparin by-products
  • A method for separating and purifying sulodexide bulk drug from heparin by-products
  • A method for separating and purifying sulodexide bulk drug from heparin by-products

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: dissolve the crude product in step S1 with water to 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 bicarbon...

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Abstract

The invention discloses a method for separating and purifying sulodexide raw materials from heparin by-products. After dissolving the heparin by-products, high-temperature precipitation is adopted to separate the crude heparan sulfate and dermatan sulfate; then the crude product solution is passed through hydrogen peroxide -Sulodexide is prepared by oxidative precipitation and drying in an ozone system, and the invention relates to the technical field of medicine. In the method for separating and purifying the raw material drug of sulodexide from the by-product of heparin, the hydrogen peroxide-ozone system is adopted in the oxidation, which can improve the oxidation effect and effectively remove the pigment protein and impurities. The high-temperature precipitation method during precipitation increases the titer recovery rate by 10% compared with the traditional low-temperature precipitation method, and also reduces the use of centrifuges and ion exchange resins, saves 60% of the time compared to simple hydrogen peroxide treatment, and improves product quality. and production efficiency, suitable for large-scale industrial production, short cycle, low cost, full and effective utilization of heparin by-products, high product purity and strong stability.

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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Patent Type & Authority Patents(China)
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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