药包材相容性研究中邻苯二甲酸酯类增塑剂的安全性评估  

Assessing Safety of Phthalate in the Compatibility Study Between Pharmaceutical Packing Materials and Drugs

作　　者：张文华 吉丽娜 冯靖 刘言 ZHANG Wen-hua;JI Li-na;FENG Jing;LIU Yan(Tianjin Institute for Drug Control,Tianjin 300070,China)

机构地区：[1]天津市药品检验研究院,天津300070

出　　处：《中国药学杂志》2023年第6期533-536,共4页Chinese Pharmaceutical Journal

摘　　要：目的对含邻苯二甲酸酯类增塑剂药包材的添加剂进行安全性评估,为药包材相容性研究提供帮助。方法从两方面对邻苯二甲酸酯类增塑剂进行安全性研究。一方面,通过检索数据库或收集美国及欧洲官方网站公布的部分邻苯二甲酸酯类增塑剂口服途径的毒理学数据,推测该物质的每日最大暴露量。另一方面,采用毒理学软件Toxtree中“Cramer决策树”对无法获得每日最大暴露量的邻苯二甲酸酯类增塑剂进行安全性研究。结果通过文献收集得到11个邻苯二甲酸酯类增塑剂口服途径的安全性评估数据,采用毒理学软件分析得到8个邻苯二甲酸酯类增塑剂口服途径的安全性评估数据。结论建立了19个邻苯二甲酸酯类物质口服途径的安全性评估数据,为药包材相容性研究提供安全性数据支撑。OBJECTIVE To provide information for the compatibility study between pharmaceutical packing materials and drugs by assessing safety of phthalate esters(PAEs).METHODS This study of phthalate esters was carried out from two aspects.On the one hand,were retrieved databases and searched relevant official literatures of USA and Europe,and then transformed the obtained knowledge to permitted daily exposure(PDE)in oral administration.On the other hand,Toxtree v3.1.0 software was used to get the safety data of those PAEs for which PDE data was not available.RESULTS The PDE values and the safety concern threshold(SCT)were obtained for 11 and 8 PAEs compounds by official literatures and Toxtree software,respectively.CONCLUSION The safety data is established for 19 PAEs given by oral administration,which could provide help for the compatibility study between pharmaceutical packing materials and drugs.

关 键 词：安全性评估 邻苯二甲酸酯 人每日允许最大暴露量 安全性阈值 相容性研究 

分 类 号：R917[医药卫生—药物分析学]