聚氯乙烯与非聚氯乙烯药品包装材料对大容量注射液药品质量的影响及发展趋势  

Effect of PVC and Non-PVC Drug Packaging Materials on the Drug Quality of Large-Volume Injection and Development Trend of Drug Packaging Materials

作　　者：那一凡 齐文渊[1] 倪倩[1] 解晨曦 谭玲[1] NA Yifan;QI Wenyuan;NI Qian;XIE Chenxi;TAN Ling(Department of Pharmaceutical Science,Beijing Hospital·Beijing Key Laboratory of Drug Clinical Risk and Personalized Medication Evaluation·National Center of Gerontology·Institute of Geriatric Medicine,Chinese Academy of Medical Science·Clinical Trial Center,Beijing Hospital,Beijing,China 100730)

机构地区：[1]北京医院药学部·药物临床风险与个体化应用评价北京市重点实验室·国家老年医学中心·中国医学科学院老年医学研究所·北京医院临床试验研究中心,北京100730

出　　处：《中国药业》2022年第5期124-127,共4页China Pharmaceuticals

基　　金：国家科技重大专项课题[2017zx09101001]。

摘　　要：目的探讨聚氯乙烯(PVC)与非PVC药品包装材料(简称药包材)对大容量注射液(简称大输液)药品质量的影响。方法查询相关文献、指导原则及法规,从塑化剂迁移、药物吸附性、生物安全性方面比较PVC及非PVC药包材对大输液药品质量的影响,并总结大输液药包材的发展趋势。结果非PVC药包材在塑化剂迁移、药物吸附性、生物安全性方面均优于PVC药包材。结论非PVC多层共挤输液膜材料已成为大输液药包材的发展方向。Objective To investigate the effect of polyvinyl chloride(PVC)and non-PVC drug packaging materials on the quality of large-volume injection(LVI).Methods The relevant literature,guiding principles and regulations were searched,the effects of PVC and non-PVC drug packaging materials on the quality of LVI were compared from the aspects of plasticizer migration,drug adsorption and biological safety,and the development trend of packaging materials of LVI was summarized.Results Non-PVC drug packaging materials were superior to PVC drug packaging materials in plasticizer migration,drug adsorption and biological safety.Conclusion Non-PVC multi-layer co-extruded film material has become the development direction of drug packaging material of LVI.

关 键 词：大容量注射液 药品包装材料 聚氯乙烯 多层共挤膜 药品质量 

分 类 号：R95[医药卫生—药学]