摘要
目的检测非PVC五层共挤膜输液袋中的有机溶剂残留量。方法采用气相色谱-质谱联用法对包材浸提液中的残留溶剂进行定性与定量分析。结果 12种供试溶剂的线性范围为0.1145.5 ng（r=0.99970.9999）,回收率为80%100%,检测限为0.041.18μg·m-2;自制的3批输液袋中残留溶剂的检测结果均符合相关规定。结论所用方法灵敏度高、简便可靠,适用于非PVC五层共挤膜输液袋的质量控制与评价。
OBJECTIVE To determine the residual organic solvents in Non-PVC five-layer co-extrusion infusion bags.METHODS The GC-MS method was applied to identify and quantify the residual solvents. RESULTS The linear range of 12 residual organic solvents were 0. 1-145. 5 ng（ r = 0. 9997-0. 9999）,the average recoveries were from 80% to 100%,and the limits of detection range from 0. 04 to 1. 18 μg·m-2. The results of determination of the residual solvents in self-prepared infusion bags met relevant regulations. CONCLUSION The GC-MS method is accurate and sensitive to detect the residual solvents,which is suitable for quality control and evaluation of the Non-PVC five-layer co-extrusion infusion bags.
作者
孙士力
丁宁
甘良春
邹慧熹
毛声俊
SUN Shili;DING Ning;GAN Liangcun;ZOU Huixi;MAO Shengjun(Key Laboratory of Drug Targeting and Drug Delivery System, Ministry of Education, West China School of Pharmacy, Sichuan University, Chengdu , Sichuan , 610041 P. R. China;Sichuan Center for Food and Drug Evaluation, Inspection ＆ Monitoring, Chengdu , Sichuan,610017 P. R. China)
出处
《华西药学杂志》
CAS
CSCD
2018年第3期311-314,共4页
West China Journal of Pharmaceutical Sciences
关键词
气质联用
非PVC五层共挤膜输液袋
残留溶剂
提取试验
相容性研究
质量控制
GC - MS
Non - PVC five - layer co - extrusion infusion bags
Residual organic solvents
Extraction test
Compatibility study
Quality control
