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.
出处
《华西药学杂志》
CAS
CSCD
2017年第6期567-569,共3页
West China Journal of Pharmaceutical Sciences
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
Bicarbonated ringer' s injection
Non - PVC 5 - layer co - extrusion bags
Compatibility study
Antioxidant
Styrene
Extraction experiment
Migration experiment
Absorption experiment