注射用冷冻干燥用胶塞的生物安全性考察  

Study on Biosafety of Freeze-drying Rubber Plug for Injection

作　　者：洪燕 郑洋滨 艾力奇 龚玮 刘荷英 HONG Yan;ZHENG Yangbin;AI Liqi;GONG Wei;LIU Heying(Jiangxi Institute for Drug Control,NMPA Key Laboratory of Quality Evaluation of Traditional Chinese Patent Medicine,Jiangxi Province Engineering Research Center of Drug and Medical Device Quality,Nanchang Jiangxi 330029,China;The First Affiliated Hospital of Nanchang University,Nanchang Jiangxi 330006,China)

机构地区：[1]江西省药品检验检测研究院,国家药品监督管理局中成药质量评价重点实验室,江西省药品与医疗器械质量工程技术研究中心,江西南昌330029 [2]南昌大学第一附属医院,江西南昌330006

出　　处：《药品评价》2023年第11期1315-1317,共3页Drug Evaluation

基　　金：江西省药品监督管理局科研项目(2019JS02)。

摘　　要：目的考察注射用冷冻干燥用胶塞生物安全性,以确保该品种的安全性及生物相容性。方法收集3家企业注射用冷冻干燥用胶塞,按照《国家药包材标准》进行生物学评价,确定其安全性。结果两种注射用冷冻干燥用胶塞的生物学试验全部符合规定。结论为保证注射用冷冻干燥用胶塞临床应用的安全,减少不良反应的发生,建议在其现行质量标准中增加细胞毒性、皮肤致敏及皮内刺激等三个生物试验检查项。Objective To investigate the biological safety of injection freeze-drying stoppers,in order to ensure the safety and biocompatibility of this variety.Methods Collect freeze-drying stoppers for injection from three enterprises,and conduct biological evaluations according to the National Pharmaceutical Packaging Material Standards to determine their safety.Results The biological tests of both injection freeze-drying stoppers met the requirements.Conclusion To ensure the safety of clinical application of freeze-drying stoppers for injection and reduce the occurrence of adverse reactions,it is recommended to add three biological test items,including cytotoxicity,skin sensitization,and intradermal irritation,to its current quality standards.

关 键 词：药物包装 注射用冷冻干燥用胶塞 生物安全性 细胞毒性 皮肤致敏 皮内刺激 

分 类 号：R96[医药卫生—药理学]