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合成多肽药物中相关结构杂质分析综述Review on Analysis of Related Structure Impurities in Synthetic Peptide Medicines
陈松辉, 李明, 李红梅, 陈妍
多肽药物, 杂质, 质量控制, 质谱, 综述Peptide Medicine, Impurity, Quality Control, Mass Spectrometry, Review
《Advances in Analytical Chemistry》, Vol.6 No.3, 2016-08-09
Peptide medicines have been widely used because of the advantages of relatively low cost, high biological activity, low side effects, target specificity, etc. At present, the peptide drug market is growing twice as fast as other drug markets. Currently, most of the peptides are manufactured by solid-phase peptide synthesis. During synthesis and transportation process, related structure im-purities such as amino acid deletion, amino acid insertion, incomplete removal of protecting groups, oxidation/reduction are easily generated. Many related structure impurities don’t have therapeutic effect; on the contrary they have toxic and side effect. In the paper, the analysis of related structure impurities in synthetic peptide medicines is systematically reviewed. This will be helpful to establish related regulation on quality control of medicine and improve quality of peptide medicine.