摘要
建立电感耦合等离子体发射光谱仪(ICP)法测定预灌封注射器(PFS)中钨的提取量和迁移量的方法。分别对提取溶剂(4%乙酸溶液、水和0.5%氨水溶液)、提取部位(不锈钢针头、针头连接玻璃尖端和整支注射器)和提取条件(高压灭菌和超声)进行考察,确定提取溶剂为0.5%氨水溶液,对整支注射器进行灌装提取且121℃高压灭菌1 h时,钨提取效率最高。用pH 4.0和pH 7.0乙酸铵缓冲液作为介质模拟迁移试验,测定迁移溶液中的钨含量。本研究建立的方法简单易行且准确可靠,可作为PFS中钨总量的测定方法。
An inductively coupled plasma spectrometry (ICP) method was established for the determination of tungsten which was extracted and migrated from prefilled syringes (PFS). The extraction solvents (4% acetic acid solution, water and 0.5% ammonia solution), extraction sites (stainless steel needle, needle connected with the glass tip and the whole syringe) and extraction conditions (sterilized in the autoclave and ultrasound) were investigated respectively. The results showed the efficiency of tungsten extraction was the highest when extracted with 0.5% ammonia solution to fill the whole syringe and sterilized at the condition of 121℃ for 1 h. The tungsten contents in the migration solutions were determined with pH 4.0 and pH 7.0 ammonium acetate buffer as the media for migration test. The method was simple, feasible, accurate, reliable and suitable for the detection of tungsten in PFS.
作者
侯晴晴
张兵
朱涵超
张毅兰
HOU Qingqing;ZHANG Bing;ZHU Hanchao(China State Institute of Pharmaceutical Industry, Shanghai 201203;CFDA Research and Inspection Center of Pharmaceutical Packaging Materials, Shanghai 201203)
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2019年第4期441-444,共4页
Chinese Journal of Pharmaceuticals
关键词
预灌封注射器
钨
ICP
提取
迁移
prefilled syringes
tungsten
ICP
extraction
migration