供注射用动植物提取油类原料药研究的考虑

Considerations on the study of oil APIs for injection extracted from animals and plants

供注射用动植物提取油类原料药主要应用于脂肪乳类制剂。现结合相关法规、指导原则的要求以及近年的审评经验,阐述供注射用动植物提取油类原料药研究的一些考虑,包括起始原料及过程控制、杂质控制、病毒灭活/去除工艺验证、质量研究等,旨在为后续研发提供参考。

Oil APIs for injection extracted from animals and plants mainly used in fat emulsions.Based on the requirements of relevant regulations,guidelines,and review experience in recent years,this paper expounds some considerations on the study of oil APIs for injection extracted from animals and plants,including starting materials and process control,impurity control,validation of virus inactivation/removal process,quality research,etc,in order to provide some references for future research.