Study On Quality Control Of Sulodexide-A Polysaccharide Drug

Sulodexide, a product developed by Italian Alfa Wassermann in 1974, is an anticoagulant drugs. Up to now, Chinese Local Pharmaceutical Companies have not made copies of the drugs. Compared with the traditional anticlotting drug heparin, Sulodexide has lower risk of bleeding and the oral dosage forms, whose clinical effect is good. Baxter’s heparin drug had caused " the heparin contamination crisis" in 2008, which resulted in nearly 100 deaths. The incident quickly spread to Germany, Britain, France and other European countries. It turned out that the event was caused by the impurities in heparin drug. That is chondroitin sulfate( over sulfated chondroitin sulfats,OSCS). The main production source of heparin is natural animal tissue and quality control is difficult. As a low molecular weight heparin drug, Sulodexide’s quality control is also difficult dueing to the same source from animal tissues. No matter from the perspective of research or quality control, structure analysis is particularly important for Sulodexide. Literature about Sulodexide is more on pharmacological activities and seldom on structure research, which also shows that the structure study of Sulodexide has a challenge.Modern instrumental analytical methods are established to analysis about Sulodexide in this work on sulfate anion、disaccharides analysis、glycosaminoglycans(GAGs)separation 、 qualitative and quantitative. Ion chromatography coupled with electrical conductivity detector(ECD) is used to qualitatively and quantitatively analyze sulfate anion. Ion chromatography coupled with pulsed amperometric detector(PAD) is used to analyze glycosamine qualitatively and quantitatively. Strong anion exchange(SAX) chromatography method is established to qualitatively and quantitatively analysis the HP/HS and CS/DS disaccharide. Methods of molecular sieve chromatography/ agarose gel electrophoresis(AE) is builded to separate two kinds of glycosaminoglycans components. Size exclusion chromatography—multi-angle laser light scattering detector method(SEC—MALLS) measures the molecular weight of the two kinds of glycosaminoglycans components. These methods effectively reveal the properties of Sulodexide’s structure. The application of these methods has significantly high specificity and is positively benefit of the quality control and monitoring of Sulodexide.