Residual keratan sulfate in chondroitin sulfate formulations for oral administration
Residual keratan sulfate in chondroitin sulfate formulations for oral administration
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DOI：
10.1016/j.carbpol.2012.06.009
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发表时间：
2012-10-01
影响因子：
11.2
通讯作者：
Mourao, Paulo A. S.
中科院分区：
文献类型：
--
作者：
Pomin, Vitor H.;Piquet, Adriana A.;Mourao, Paulo A. S.
硫酸软骨素是一种生物医学糖胺聚糖 (GAG)，主要用作膳食补充剂。我们对一些可口服的硫酸软骨素制剂进行了分析。该分析基于琼脂糖凝胶电泳、强阴离子交换色谱、特定 GAG 裂解酶的消化率、糖醛酸含量、NMR 光谱和尺寸排阻色谱。从鲨鱼软骨中分批检测到硫酸角质素，平均含量相当于 GAG 总量的 16%。硫酸角质素是一种惰性材料，由于其存在于这些配方中而不太可能发生危险影响。然而，其意想不到的高百分比损害了标签声明中指定的真实成分的所需含量，并警告药典更新其专着。他们推荐的技术，尤其是醋酸纤维素电泳，在检测硫酸软骨素配方中的硫酸角质素方面效率低下。此外，这一发现还提醒制造商改进隔离程序，并提醒监管机构进行更好的审核。基于强阴离子交换色谱的分析被证明比标准药典目前建议的方法更可靠。 (C) 2012 Elsevier Ltd. 保留所有权利。
Chondroitin sulfate is a biomedical glycosaminoglycan (GAG) mostly used as a dietary supplement. We undertook analysis on some formulations of chondroitin sulfates available for oral administration. The analysis was based on agarose-gel electrophoresis, strong anion-exchange chromatography, digestibility with specific GAG lyases, uronic acid content, NMR spectroscopy, and size-exclusion chromatography. Keratan sulfate was detected in batches from shark cartilage, averaging similar to 16% of the total GAG. Keratan sulfate is an inert material, and hazardous effects due to its presence in these formulations are unlikely to occur. However, its unexpected high percentage compromises the desired amounts of the real ingredient specified on the label claims, and forewarns the pharmacopeias to update their monographs. The techniques they recommended, especially cellulose acetate electrophoresis, are inefficient in detecting keratan sulfate in chondroitin sulfate formulations. In addition, this finding also alerts the manufacturers for improved isolation procedures as well as the supervisory agencies for better audits. Analysis based on strong anion-exchange chromatography is shown to be more reliable than the methods presently suggested by standard pharmacopeias. (C) 2012 Elsevier Ltd. All rights reserved.