碳酸氢钠林格注射液与非PVC五层共挤膜输液袋的相容性研究  

Compatibility study on Bicarbonated ringer 's injection with non-PVC 5-layer co-extrusion bags

作　　者：王慧洁[1] 陈晨[1] 李明[1] 袁浩宇 毛声俊[1] 

机构地区：[1]四川大学华西药学院靶向药物及释药系统教育部重点实验室,四川成都610041 [2]中国核工业总公司四一六医院药剂科,四川成都610051

出　　处：《华西药学杂志》2017年第6期567-569,共3页West China Journal of Pharmaceutical Sciences

摘　　要：目的考察非PVC五层共挤膜输液袋与碳酸氢钠林格注射液的相容性。方法采用HPLC、GC法对5种抗氧剂和苯乙烯进行检测,分别对包材和供试制剂的提取、迁移及吸附性进行研究。结果提取、迁移试验中,5种抗氧剂和苯乙烯的含量均符合相关要求;吸附试验中,药品的稳定性也符合要求。结论非PVC五层共挤膜输液袋与碳酸氢钠林格注射液的相容性良好,可作为直接接触该药品的包装使用。OBJECTIVE To study the compatibility between the non - PVC 5 - layer co - extrusion bags and Bicarbonated ringer＇ s injection. METHODS Five antioxidants and styrene were determined by HPLC and GC, so as to study the extraction, migration and absorption of the packing materials and the injection. RESULTS In the extraction and migration experiment, the quantitative limit of five antioxidant and styrene complied with the standard requirement. In the absorption experiment, main ingredients in the injection showed no significant change. CONCLUSION Non - PVC 5 - layer co - extrusion bags demonstrated good compatibility with Bicar- bonated ringer＇s injection,they could be used as package that direct contact with Bicarbonated ringer＇s injection.

关 键 词：碳酸氢钠林格注射液 非PVC五层共挤膜输液袋 相容性研究 抗氧剂 苯乙烯 提取试验 迁移试验 吸附试验 

分 类 号：R94[医药卫生—药剂学] R917[医药卫生—药学]