合成多肽药物质量控制研究探讨  

Discussion on Quality Control of Synthetic Peptide

作　　者：戴佳 赵巧君 童玥[1] DAI Jia;ZHAO Qiao-jun;TONG Yue(School of Life Science and Technology,China Pharmaceutical University,Nanjing 210009,China)

机构地区：[1]中国药科大学生命科学与技术学院,江苏南京210009

出　　处：《药物生物技术》2023年第1期69-76,共8页Pharmaceutical Biotechnology

摘　　要：合成多肽药物作为一种介于小分子和生物制品之间的特殊药物形式,既有小分子药物稳定性好和纯度高的特点,又具有生物药物生物活性高和毒副作用低的优势,越来越受到制药行业的关注。多肽是由多个氨基酸通过酰胺键共价连接而成,由于氨基酸异构和侧链修饰导致多肽药物与生物制品一样存在异质性的特点,而化学合成工艺复杂多样,杂质谱的鉴定相比小分子药物更为困难。因此合成多肽药物的质量控制既要满足化学合成药物的质量控制要求,又要兼顾生物制品的特点,对于制药行业存在很大挑战。文章结合国内外合成多肽药物药学研究的相关指导原则及研究进展,从多肽的鉴别、含量测定、杂质谱分析等方面出发,对合成多肽药物的质量控制进行全面的探讨和分析,以期为后续合成多肽类药物的质量控制研究提供参考。As a special drug form between small molecules and biological products,synthetic peptides not only possess the characte-ristics of robust stability and high purity of small molecules,but also have the advantages of strong biological activity and low toxicity of biological products,and get more and more attentions from pharmaceutical industry.Since the peptide is formed through covalent linkage of multiple amino acids by amide bonds,the peptide drugs show heterogeneity due to isoform and modification of amino acids,which is the same as biological products.And the chemical synthetic manufacturing process is complex and diverse,which results in the difficulty of characterization of impurity profiles compared to small molecules.Therefore,the quality control of synthetic peptide drugs should not only meet the quality control requirements of chemical synthetic drugs,but also take into account the characteristics of biological products,which poses great challenges to the pharmaceutical industry.In this review,based on domestic and foreign relevant guidelines on pharmaceutical development of synthetic peptides and research progress,the quality control issues of synthetic peptides are comprehensively discussed and analyzed,expecting for providing reference for the follow-up quality control of synthetic peptide drugs.

关 键 词：合成多肽 异质性 化学合成 质量控制 杂质谱 指导原则 

分 类 号：R927[医药卫生—药学]