摘要
目的建立药用玻璃包装容器铈(Ce)元素浸出量测定法,测定不同药用玻璃包装容器中Ce元素的浸出量。方法采用标准曲线法,优化电感耦合等离子体质谱(ICP-MS)技术参数,测定39批不同玻璃包装容器中Ce元素的浸出量。结果Ce元素在0~100 ng·mL^(-1)范围内呈良好的线性关系,相关系数为0.9999,加样回收率为103.5%,检出限为0.002 ng·mL^(-1),精密度为0.4%,重复性为3.3%。39批样品中有15批样品Ce元素的浸出量大于10 ng·mL^(-1),无色玻璃容器Ce元素的浸出量明显高于棕色玻璃容器。结论经方法学验证,ICP-MS法可用于药用玻璃容器中Ce元素浸出量的测定,样品测定结果表明CeO_(2)作为澄清剂普遍应用于药用玻璃包装容器中,建议对Ce元素的浸出量进行监控,以保证药品的安全。
Objective To establish a method for the determination of cerium(Ce)leaching in medicinal glass packaging containers and to determine the leaching amount of Ce in different medicinal glass packaging containers.Methods The standard curve method was used to optimize the technical parameters of inductively coupled plasma mass spectrometry(ICP-MS),and the leaching amount of Ce in 39 batches of different glass packaging containers was determined.Results The Ce element showed a good linear relationship in the range of 0,100 ng·mL^(-1),the correlation coefficient was 0.9999,the recovery rate was 103.5%,the detection limit was 0.002 ng·mL^(-1),the precision was 0.4%,and the repeatability was 3.3%.Among the 39 batches of samples,the leaching amount of Ce element in 15 batches of samples was more than 10 ng·mL^(-1),and the leaching amount of Ce element in colorless glass container was significantly higher than that in brown glass container.Conclusion The ICP-MS method can be used to determine the leaching amount of Ce in medicinal glass containers.The results of sample determination show that CeO_(2) is widely used as a clarifier in medicinal glass packaging containers.It is suggested that the leaching amount of Ce should be monitored to ensure the safety of drugs.
出处
《科技创新与应用》
2022年第22期47-50,共4页
Technology Innovation and Application
基金
中国食品药品检定研究院中青年发展基金(2019C8)。
