Method for preparing sulodexide raw material from heparin byproduct by adopting ethanol precipitation process

A technology for heparin by-product and ethanol, which is applied in the field of preparing sulodexide raw materials, can solve the problems of short polysaccharide chain length and low degree of sulfation, and achieves the effects of low cost, simple process and easy amplification

Active Publication Date: 2014-09-03
SHENZHEN HEPALINK PHARMA GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The LMWH part contains the same disaccharide polymer structure as unfractionated heparin,

Method used

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  • Method for preparing sulodexide raw material from heparin byproduct by adopting ethanol precipitation process

Examples

Experimental program
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Effect test

Embodiment 1

[0018] Dissolve heparin by-products (including CS5%, DS50%, fast heparin 25%, slow heparin 20%, titer 41usp u / mg, specific rotation +15°) into a 10% (m / m) solution, and dissolve in 6M hydrogen Adjust the pH to 11.0 with sodium oxide, add ethanol to a mass concentration of 31%, and precipitate at 2-8°C for 2 hours. Centrifuge at 4000rpm for 30min, collect the supernatant to obtain the sulfated polysaccharide solution after removing slow heparin.

[0019] Add water to the obtained sulfated polysaccharide solution to make the ethanol concentration 24%, adjust the pH to 2.0 with 6M hydrochloric acid, add ethanol until the mass concentration is 40%, and precipitate at 2-8°C for 1-2 hours. The supernatant was collected by centrifugation to obtain a sulfated polysaccharide solution after dermatan sulfate was reduced.

[0020] Add water to the obtained solution to make the ethanol concentration 36%, adjust the pH to 7.0 with 6M sodium hydroxide, add solid NaCl to a mass concentration...

Embodiment 2

[0023] Take the raw material of Example 1, the product after the first precipitation, the product after the second precipitation, the product after the third precipitation (final product), etc. for agarose gel electrophoresis analysis, the method refers to the patent "a glass-mounted electrophoresis method Method for analyzing mucopolysaccharides 200910040788.8". The result is as figure 1 As shown, M represents the raw material of heparin by-products. The raw material contains CS, DS, fast heparin, and slow heparin. After the first precipitation, the slow heparin was removed. After the second precipitation, the DS content was reduced, and the third precipitation was removed. CS, to obtain the final product: DS 20-30%, fast heparin 70-80%.

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Abstract

The invention discloses a method for preparing a sulodexide raw material from a heparin byproduct by adopting an ethanol precipitation process. The method comprises the following steps: dissolving the heparin byproduct, adjusting a liquid to have a high pH value by sodium hydroxide, performing low-temperature precipitation by a proper amount of ethanol, and removing precipitate to obtain a sulphated polysaccharide liquid; adjusting the sulphated polysaccharide liquid to have a low pH value by hydrochloric acid, performing low-temperature precipitation by a proper amount of ethanol, and removing precipitate to obtain a sulphated polysaccharide liquid; and adjusting the liquid to be neutral by sodium hydroxide, performing room-temperature precipitation by a proper amount of ethanol, and drying precipitate to obtain the sulodexide raw material. The method is simple in process, low in cost, easy to realize and suitable for industrialized production.

Description

technical field [0001] The invention relates to a method for preparing sulodexide raw material, in particular to a method for separating sulodexide raw material from heparin by-products. Background technique [0002] Sulodexide, whose trade name is VESSEL DUE F, and whose chemical name is glucuronyl glucosaminoglycan sulfate. Originally produced by Alfa Wassermann in Italy, it was first launched in Italy in 1974 and entered the Chinese market in 2003. The indications are vascular diseases with the risk of thrombosis, and it is an orally absorbable anticoagulant drug. In recent years, it has been shown that it is effective in the treatment of diabetic nephropathy. [0003] Sulodexide is extracted from pig intestinal mucosa. It is a highly purified glycosaminoglycan. It is a long-chain negatively charged macromolecule composed of repeated disaccharide structural units. The disaccharide unit contains two modified sugars, namely N- Acetylgalactosamine or N - Acetylglucosamin...

Claims

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Application Information

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IPC IPC(8): C08B37/00
Inventor 马小来李锂张锦黄洪
Owner SHENZHEN HEPALINK PHARMA GRP CO LTD
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