Sulodexide production method

A production method and heparin by-product technology, applied in the field of biopharmaceuticals, can solve problems such as high raw material prices, insufficient purity, difficult process control, etc., achieve the effect of solving financial and material resources, realizing industrialized production, and facilitating industrialized production

Active Publication Date: 2015-03-11
SHANDONG CHENZHONG BIOPHARM +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The international and domestic preparation methods of sulodexide are relatively simple, and the products produced are often not pure enough, the internal structure is greatly damaged, the qualified rate of structure confirmation is low, or the process is often difficult to simply mix fast-moving heparin and dermatan sulfate. control, making it difficult for the final product to meet higher re

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] The production method of sulodexide comprises the following steps:

[0034] a) Oxidation: Take 1000g of heparin by-product, add 10L of purified water to dissolve it completely, adjust the pH value of the feed liquid to 9.4, control the temperature of the feed liquid to 56°C, add 300ml of hydrogen peroxide, and oxidize for 10 hours. After the oxidation is completed, adjust The pH value of the feed liquid is 7.2, high-speed centrifugation at 12000 rpm for 30 minutes, and the centrifugation is completed, the supernatant is filtered with a 0.65 μm filter membrane, and the filtrate is collected;

[0035] b) ultrafiltration: in the filtrate of step a), add the sodium acetate of feed liquid volume 120g, adopt the ultrafiltration membrane that molecular weight cut off is 10KDa to carry out tangential flow circulation ultrafiltration, circulate ultrafiltration 5h, collect retentate 1.9L and Permeate 8.0L;

[0036] c) Precipitation: add feed liquid volume 19g sodium acetate to t...

Embodiment 2

[0047] The production method of sulodexide comprises the following steps:

[0048] a) Oxidation: Take 2000g of heparin by-product, add 18L of purified water to dissolve it completely, adjust the pH value of the feed liquid to 9.6, control the temperature of the feed liquid to 50°C, add 800ml of hydrogen peroxide, and oxidize for 12 hours. After the oxidation is completed, adjust The pH value of the feed liquid is 7.4, high-speed centrifugation at 12000r / min for 30min, and the centrifugation is completed, the supernatant is filtered with a 0.65μm filter membrane, and the filtrate is collected;

[0049] b) ultrafiltration: in the filtrate of step a), add the sodium acetate of feed liquid volume 300g, adopt the ultrafiltration membrane that molecular weight cut off is 10KDa to carry out tangential flow circulation ultrafiltration, circulate ultrafiltration 8h, collect retentate 3.7L and Permeate 15.4L;

[0050] c) Precipitation: Add 37g of sodium acetate into the retained liquid...

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Abstract

The invention discloses a sulodexide production method and belongs to the technical field of bio-pharmaceuticals. The sulodexide production method comprises the following steps: using a heparin byproduct as a raw material, and performing oxidization to obtain an intermediate crude product heparin solution; adding acetate into the intermediate crude product heparin solution, and separating by ultra-filtration to obtain a rapid movement heparin crude product and a dermatan sulfate crude product; then respectively refining a rapid movement heparin crude product and a dermatan sulfate crude product; performing refinement on the rapid movement heparin crude product and the dermatan sulfate crude product; finally mixing and dissolving precipitates obtained by refining, filtering, collecting a filtrate, and carrying out freeze-drying processing to obtain a sulodexide raw material. The method has the advantages that product purity and stability are improved; as the byproduct produced during the production of heparin is used as the raw material, the production cost is reduced, required production equipment is simple, and production conditions are easy to control.

Description

technical field [0001] The invention belongs to the technical field of biopharmaceuticals, and in particular relates to a production method of sulodexide. Background technique [0002] Sulodexide, trade name "Vessel Due F", was first developed by Alfa Wassermann Pharmaceuticals in Italy as a low-molecular-weight heparin drug, which belongs to the same class of glycosaminoglycans as heparin drug. Heparan sulfate and dermatan sulfate, both contained in the drug, work synergistically, giving the drug a different profile than heparin. Compared with heparin, sulodexide has stronger antithrombotic effect and less possibility of causing bleeding. Sulodexide can be taken orally, especially making it suitable for long-term antithrombotic treatment. Sulodexide exerts its pharmacological effects through anticoagulation, fibrinolysis, hemorrheology, antiproliferation and membrane permeability maintenance, which makes sulodexide can be used to prevent and treat thrombotic diseases; A...

Claims

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Application Information

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IPC IPC(8): A61K31/737A61K31/727A61P7/02A61P9/10C08B37/10
CPCA61K31/727A61K31/737C08B37/0075A61K2300/00
Inventor 周霞乔德强雷晓刚郭维林勇郭恩中
Owner SHANDONG CHENZHONG BIOPHARM
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