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

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.