非对映异构体杂质在合成多肽药物中的相关探究

Related Exploration of Diastereomer Impurities in the Synthesis of Peptide Drugs

探讨非对映异构体杂质在合成多肽药物中的研究及控制。通过研究合成多肽药物氨基酸的消旋的作用机制,观察非对应异构体杂质的产生过程,从合成原料、工艺操作以及检测方法方面提供合理的质控建议。了解部分氨基酸水解后产生的水解杂质以及消旋产生的非对应异构杂质是合成多肽药物的重要物质,应加强对非对映异构体杂质的研究与控制。

The diastereomer research and control of impurities in the synthesis of peptide drugs were investigated.Through research of the mechanism of action of racemic amino acids in synthesis of peptide drugs,observing the corresponding isomer impurity production process,reasonable quality advice was put forward from the aspects of synthesis of raw materials,process operation and test method. After understanding the partial hydrolysis amino acid hydrolysis to produce impurities and despun create the corresponding heterogeneous impurities is important material for the synthesis of peptide drugs,strengthening the diastereomer impurities and control was put forward.