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Pharmaceutical grade chondroitin sulfate: Structural analysis and identification of contaminants in different commercial preparations

机译:医药级硫酸软骨素:不同商业制剂中污染物的结构分析和鉴定

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The aim of the present study was to characterize 16 pharmaceutical grade chondroitin sulfate (CS) samples, concerning the structure and presence of contaminants, in comparison to USP and analytical grade CS. Agarose gel electrophoresis has shown that only 5 samples were >90% CS, while 11 contained less than 15% CS. FACE (fluorophore-assisted carbohydrate electrophoresis) revealed that maltodextrin was the main contaminant in nine of them, and lactose in two. Raman spectroscopy corroborated these results. Concerning the structure of the CS present in the five CS-rich samples, the ratios 4-sulfated:6-sulfated disaccharides varied from 0.9 to 1.7, and their modal molecular weight was 20-29 kDa. Also, they were all contaminated by small amounts of keratan sulfate (<1%). In conclusion, our findings indicate that the composition of CS preparations not always corresponds to the manufacturers' descriptions, and indicate that further characterization should be required for the registry and license of pharmaceutical grade CS. (C) 2015 Elsevier Ltd. All rights reserved.
机译:本研究的目的是与USP和分析级CS相比,对16种药用级硫酸软骨素(CS)样品进行表征,涉及污染物的结构和存在。琼脂糖凝胶电泳显示只有5个样品的CS> 90%,而11个样品的CS不到15%。 FACE(荧光辅助糖电泳)表明,麦芽糖糊精是其中的主要污染物,其中九种是乳糖,二种是乳糖。拉曼光谱证实了这些结果。关于在五个富含CS的样品中存在的CS的结构,4-硫酸盐:6-硫酸盐二糖的比率在0.9到1.7之间变化,其模态分子量为20-29 kDa。同样,它们都被少量硫酸角质素污染(<1%)。总之,我们的发现表明CS制剂的成分并不总是与制造商的说明相对应,并表明需要对药用级CS的注册和许可进行进一步的表征。 (C)2015 Elsevier Ltd.保留所有权利。

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