摘要
脂肪乳/氨基酸/葡萄糖复合型三腔袋产品是一种即开、即混、即用的“全合一”肠外营养液,临床可用于为轻到重度分解代谢且无法经胃肠道喂养、胃肠道喂养不足或胃肠道功能障碍的患者提供每天所需的能量、必需脂肪酸、氨基酸、电解质等。此类包装在平常存放时严格隔离三室,使用时在一定外力下打开,使三室相通,可避免在灭菌和贮藏过程中各组分间发生相互作用,增强药品稳定性,还可避免临床使用时造成的二次污染,改善患者生存质量。本文结合国内外指导原则的要求以及近年的审评经验,阐述脂肪乳/氨基酸/葡萄糖复合型三腔袋产品仿制药药学研究的一些考虑,旨在为后续的研发提供参考。
Fat emulsion/amino acids/glucose triple-chamber bag is an"all-in-one"parenteral nutrition solution supplied as a ready-to use formulation,which is intended for providing daily energy,essential fatty acids,amino acids and electrolytes to patients with mild to severe catabolism who are not candidates for gastrointestinal feeding,have an inadequate response to gastrointestinal feeding,or are diagnosed with gastrointestinal dysfunction.The three chambers of these products are completely isolated prior to use,while connect with each other after applying certain force during treatment.Such design can avoid the interaction between the components during sterilization and storage,increase the stability of the product,minimize the risk of secondary contamination associated with clinical use,and improve the quality of life andprognosis of the patients.This article addressed several considerations for the pharmaceutical study on the generic drugs of triple-chamber bag of fat emulsion/amino acids/glucose based on the requirements in Chinese and international guidelines as well as our recent review experience,with the aim to provide instructions for subsequent research and development.
作者
张歆
王宏亮
吴小飞
许真玉
ZHANG Xin;WANG Hongliang;WU Xiaofei;XU Zhenyu(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)
出处
《药学研究》
CAS
2024年第5期513-515,520,共4页
Journal of Pharmaceutical Research
关键词
脂肪乳/氨基酸/葡萄糖复合型三腔袋
仿制药
药学研究
Triple-chamber bag of fat emulsion/amino acids/glucose injection
Generic drugs
Pharmaceutical study
