摘要
化药注射剂中的不溶性微粒可能从原辅包材料、生产过程、储存运输,以及使用过程中引入。控制注射剂中不溶性微粒的产生是减少输液不良反应、保障用药安全的重要措施。通过参考有关注射剂中不溶性微粒的国内外药典标准、指导原则和研究文献,探讨不溶性微粒产生的主要原因,并提出有效控制策略和相关建议,以期为控制化药注射剂的质量提供相应参考。
Insoluble particles in chemical injections may originate from the drug substance,pharmaceutical excipients,packaging materials,manufacture process,storage,transportation,and clinical application.Controlling the production of insoluble particles in injections is an important measure to reduce adverse reactions and ensure drug safety.Referring to the pharmacopoeias of different countries,relevant regulations and guidances,and research literature on insoluble particles in chemical injections,this paper discusses the causes of insoluble particles,and puts forward effective control strategies and relevant suggestions,so as to provide theoretical supports for controlling the quality of chemical injections.
作者
王宏亮
WANG Hongliang(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)
出处
《药物评价研究》
CAS
2022年第9期1909-1913,共5页
Drug Evaluation Research
关键词
化学药品
注射剂
不溶性微粒
产生原因
控制策略
chemical drug
injection
insoluble particles
cause of occurrence
control strategy
