基于各国监管机构相关技术要求的吸入气雾剂质量控制研究进展
Advances in quality control of inhalable aerosols based on technical requirements of regulation agencies worldwide
汪敏 1房兆营 2王雪 2刘阿利3
作者信息
- 1. 山东中医药大学,济南 250100;鲁南贝特制药有限公司,山东 临沂 276006
- 2. 鲁南贝特制药有限公司,山东 临沂 276006;药物新制剂研发山东省工程研究中心,山东 临沂 276006
- 3. 山东中医药大学,济南 250100;鲁南贝特制药有限公司,山东 临沂 276006;药物新制剂研发山东省工程研究中心,山东 临沂 276006
- 折叠
摘要
吸入气雾剂是一种复杂的药物-装置组合产品,广泛用于治疗各种肺部疾病.目前国内外上市的吸入气雾剂品种较少,各国监管机构的质量控制技术要求仍有差别,无法快速开展体外安全性、有效性及质量可控性评价.本文通过文献调研,对比各国监管机构的相关技术要求,对吸入气雾剂的质量研究进行综述,并简要分析存在的问题和挑战,以期为吸入气雾剂的研发提供参考.
Abstract
Inhalation aerosol is a complex drug-device combination product which is utilized extensively for various respiratory conditions.The availability of inhalable aerosols is limited in both domestic and international markets.There are some discrepancies in the quality control technical requirements of regulation agencies in different countries that hindered the efficient conduct of safety,efficacy and quality control in vitro.The article compared the technical requirements established by regulation agencies through literature research,reviewed the quality control research,and briefly analyzed the existing problems and challenges to provide reference for the research and development of inhalable aerosols.
关键词
吸入气雾剂/质量控制/技术要求/空气动力学粒径分布Key words
inhalable aerosol/quality control/technical requirement/aerodynamic particle size distribution引用本文复制引用
出版年
2024
NETL
NSTL
万方数据