摘要
目的建立以二氯甲烷为溶剂的聚乳酸中丙交酯单体残留的定量检测方法。方法气相色谱法,溶剂为二氯甲烷,内标物为2,6-二甲基-γ-吡喃酮,沉淀剂为丙酮:环己烷=3:16。结果在0.5~10.0μg/ml范围内,峰面积与浓度呈良好的线性关系(r2=0.9990),平均回收率为94.8%。结论本方法准确,重现性好,可用于聚乳酸中残留单体含量的定量检测。
Objective To establish a method for the content determination of residual lactide monomer in the Poly(lactide).Methods GC chromatography internal standard method.Solvent(dichloromethane),internalstandard(2,6-dimethyl-γ-pyranone),precipitant(acetone:cyclohexane=3:16).Results There was a good linear relationship between the concentration and the areas in the range of 0.5 to 10.0μg/ml(r2=0.9990).The average recovery was 94.8%.Conclusion This method is accurate and reproducible.It can be used as the quality control for residual lactide monomer in the Poly(lactide).
作者
马金竹
李沅
董双鹏
闵玥
王翔宇
Ma Jinzhu;Li Yuan;Dong Shuangpeng;Min Yue;Wang Xiangyu(Supervision and Testing Center for Medical Devices of TianJin,Tianjin 300384,China;Center for Medical Device Evaluation.NMPA,Beijing 100081,China)
出处
《医疗装备》
2020年第7期30-32,共3页
Medical Equipment
基金
国家重点研发计划课题(2017YFB1104105,2016YFC1103201,2018YFC1106700)。
