摘要
以2种医药用聚丙烯树脂(国产RP 260和进口W 331)为原料,在(121±2)℃加热30 min的实验条件下,对其进行高温灭菌处理。结果表明:工业生产的RP 260[来源于生产装置中(121±2)℃,经15 min灭菌处理后的样品]的溶出不挥发物主要为抗氧剂1010的降解产物3-(3,5-二叔丁基-4-羟基苯基)丙酸和含有乙烯基团的低聚物;经实验室高温灭菌后,在RP 260或W 331医用注射水中,相应溶出的Mg,Al离子迁移质量浓度(Mg离子为0.025 mg/L,Al离子为0.010 mg/L)相同,抗氧剂1010降解产物质量浓度分别为0.5,0.4 mg/L,均满足YBB 00022002—2015要求。
Two types of polypropylene resins for medicinal infusion items(domestic RP 260 and imported W 331)were adopted as raw materials and sterilized at(121±2)℃for 30 min in the laboratory.The results showed that the dissolved non-volatile matter of industrially produced RP 260[sampled from the industrial production line sterilized at(121±2)℃for 15 min]were mainly 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionic acid,the degradation product of antioxidant 1010,and oligomers containing ethylene groups;After laboratory high temperature sterilization,the mass concentration of Mg and Al ions corresponding dissolved in RP 260 or W 331 medical injection water were the same(both Mg,Al ions of 0.025,0.010 mg/L respectively),and that of the degradation products of their antioxidant 1010 were 0.5,0.4 mg/L respectively,all met the requirements of YBB 00022002—2015.
作者
吴建
刘芸
李广全
王福善
魏钦
WU Jian;LIU yun;LI Guang-quan;WANG Fu-shan;WEI Qin(Lanzhou Petrochemical Research Center,Petrochemical Research Institute,PetroChina,Lanzhou 730060,China;Lanzhou Petrochemical Company,PetroChina,Lanzhou 730060,China;Ethylene Plant of Lanzhou Petrochemical Company,PetroChina,Lanzhou 730060,China)
出处
《石化技术与应用》
CAS
2021年第6期416-418,共3页
Petrochemical Technology & Application
关键词
医药输液用聚丙烯树脂
抗氧剂
医用注射水
溶出物
迁移质量浓度
polypropylene resin for medicinal infusion
antioxidant
medical injection water
dissolved matter
migration mass concentration
