吸入制剂辅料安全性评价的共性与个性  

Commonality and Particularity of Safety Evaluation of Inhaled Excipients

作　　者：潘卫松 李克 吴健鸿 陈蓉 PAN Weisong;LI Ke;WU Jianhong;CHEN Rong(NMPA Key Laboratory for Quality Research and Control of Drug Products,Wuhan Institute for Drug and Medical Device Control,Wuhan 430073,China)

机构地区：[1]武汉药品医疗器械检验所,国家药品监督管理局药物制剂质量研究与控制重点实验室,武汉430073

出　　处：《医药导报》2024年第5期752-756,共5页Herald of Medicine

基　　金：湖北省自然科学基金资助项目(2023AFB919)。

摘　　要：该文综述了近年来吸入制剂辅料安全性研究的方法和成果。吸入制剂辅料的安全性评价在遵守毒理学研究基本原则和方法的前提下,具备经由呼吸系统给药特殊性而产生的特殊要求。现代生物技术、体外替代方法和免疫毒理学理论和方法的快速发展为吸入制剂新辅料的研究开发提供了更多的可能,为制药工业迅速发展奠定了基础。该文为深入开展吸入制剂辅料的安评工作提供了理论基础。This article reviewed the methods and achievements of safety research on inhaled excipients in recent years.The safety evaluation of inhaled excipients should not only follow the basic principles and methods of toxicology research,but also has special requirements of administration through the respiratory system.The rapid development of modern biotechnology,in vitro alternative methods and immunotoxicology theories and methods has provided more possibilities for the further research and development of new excipients for inhaled formulations,laying the foundation for the rapid development of the pharmaceutical industry.This article provided theoretical and methodological preparations for safety assessment of inhaled excipients.

关 键 词：吸入制剂 辅料 安全性评价 免疫毒理学 

分 类 号：R943[医药卫生—药剂学] R969.3[医药卫生—药学]