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对多肽固相合成中水解杂质和非对映异构体杂质进行研究。介绍了多肽合成中氨基酸水解机制和消旋机制,从合成原料、质量控制、工艺过程控制和检测方法选择等方面为多肽合成研究者提供参考。结果表明:某些氨基酸水解产生的水解杂质和消旋产生的非对映异构体杂质是多肽药物的重要有关物质之一,因此应加强对水解杂质和非对映异构体杂质的研究与控制。
Polysaccharide solid-phase synthesis of impurities in the hydrolysis and diastereomers were studied. The mechanism of amino acid hydrolysis and racemic mechanism in peptide synthesis were introduced. It provided a reference for peptide synthesis researchers from synthetic raw materials, quality control, process control and selection of detection methods. The results show that some of the hydrolysis of amino acids and hydrolysis of racemic diastereomeric impurities is one of the important drug-related substances, it is necessary to strengthen the hydrolysis of impurities and diastereomeric impurities and control.