摘要
建立血液透析器中N-甲基吡咯烷酮(NMP)在模拟临床试验过程中溶出量的测定方法,选择乙醇水混合溶液作为浸提模拟溶液,采用气相色谱(GC)检测。结果表明:该方法 NMP的浓度在10~100μg/L范围内线性关系良好(r=0.9993),平均回收率为109.31%(RSD=1.74%,n=9)。方法简单快速,重现性好,回收率高,精密度好,干扰少,定性定量准确,可用于一次性使用空心纤维血液透析器中NMP溶出量的日常监管检测。
Gas chromatography(GC)is developed in the determination of blood dialyzer N-methyl pyrrolidone(NMP)in simulated the dissolubility of the process of clinical trials,choose ethanol water mixture as leaching solution.The results showed that the concentration of NMP was good(r=0.9993)and the average recovery rate was 109.31%(RSD=1.74%,n=9).This method is simple and fast,good reproducibility,high recovery rate,good precision,less disturbance,qualitative quantitative,accurate and can be used for a single-use hollow fiber blood dialyze dissolubility of NMP daily supervision detection.
作者
杨伟芳
李廷鑫
刘晓飞
张治凡
丁雪佳
YANG Wei-fang;LI Ting-xin;LIU Xiao-fei;ZHANG Zhi-fan;DING Xue-jia(Henan Tuoren Medical Instrument Group Co.Ltd.,Henan Xinxiang 453400;Beijing University of Chemical Technology,Beijing 100029)
出处
《中国医疗器械信息》
2018年第7期27-29,共3页
China Medical Device Information