蛋白类药物强制降解研究进展

Research Progress on Forced Degradation of Biopharmaceuticals

强制降解试验可以揭示药物可能的降解途径,为蛋白类药物制剂组方的开发、储存、运输提供支持,因此,强制降解研究在蛋白类药物研发中具有重要作用,但目前关于强制条件的选择、作用时间和降解程度尚无标准指南。综述了目前常用的强制降解条件(高温、pH、氧化、光照、反复冻融和震荡或搅拌)及不同强制降解条件对蛋白类药物的影响,并提出了相关设计建议,以期为蛋白类药物的强制降解试验条件的选择提供参考。

The forced degradation studies can reveal the possible degradation pathway of medicine,and provide support for the formulation development,storage and transportation of biopharmaceuticals.Therefore,the forced degradation studies paly important roles in biopharmaceuticals research and development,however,there were no standard guidelines on the selection of forced conditions,action time and degradation degree.The commonly used forced degradation conditions(high temperature,pH,oxidation,light,repeated freezing-thawing and shaking or stirring)and the effects of different forced degradation conditions on protein drugs were summarized in this paper,and reasonable design suggestions were put forward,in order to provide refer‑ence for the selection of forced degradation studies conditions of biopharmaceuticals.