基于ICP-MS及多元统计方法分析复方西羚解毒制剂中45种元素含量

Analysis of 45 elements in Fufang Xiling Jiedu preparation based on ICP-MS and multivariate statistic method

目的 测定并分析复方西羚解毒制剂中45种无机元素的含量,为复方西羚解毒制剂的安全性检测提供参考。方法 收集16批次复方西羚解毒制剂,采用电感耦合等离子体质谱(ICP-MS)测定锂、硼、铝、钾、锌、砷等45种无机元素的含量,通过绘制含量测定结果的Heatmaps图、Pearson相关性分析图与主成分分析(PCA)散点图、指纹图谱及对照图谱,采用SPSS 21.0对16批样品的含量测定结果进行Pearson相关性分析与PCA分析,评价复方西羚解毒制剂的安全性和质量均一性。结果 复方西羚解毒制剂中无机元素以钾和钙为主,样品中不同元素的含量可以分为5级,不同批次的复方西羚解毒制剂中各元素含量相近,铅、镉、砷、汞、铜均在《中国药典》规定的安全限值内。钴、钇、钐、钆、镝、钍、铝、硅、铁、锑、铊是复方西羚解毒制剂的特征无机元素。结论 该方法操作简单,适合复方西羚解毒制剂中无机元素的含量测定,能为其临床用药安全性提供参考。

Objective To determine and analyze the content of 45 inorganic elements in Fufang Xiling Jiedu preparation and to provide a reference for the safety detection of Fufang Xiling Jiedu preparation.Methods Inductively coupled plasma mass spectrometry(ICP-MS)was used to ascertain the concentrations of 45 inorganic elements,including Li,B,Al,K,Zn and As from 16 batches of Fufang Xiling Jiedu preparation which were gathered.The content determination findings were plotted as heatmaps,Pearson correlation analysis plot,PCA scatter plots,fingerprints,and control maps.The Pearson correlation analysis and PCA analysis were performed on the content determination results of 16 batches using SPSS 21.0,to evaluate the safety and quality uniformity of Fufang Xiling Jiedu preparation.Results The inorganic elements in Fufang Xiling Jiedu preparation were dominated by K and Ca.The content of different elements in the sample could be categorised into 5 levels.The content of various elements in different batches of Fufang Xiling Jiedu preparation was similar.Pb,Cd,As,Hg and Cu were all within the safety limit as those specified in the Chinese Pharmacopoeia.Co,Y,Sm,Gd,Dy,Th,Al,Si,Fe,Sb and Tl were the characteristic inorganic elements of Fufang Xiling Jiedu preparation.Conclusion This method is easy to operate and suitable for the determination of inorganic elements in Fufang Xiling Jiedu preparation,providing references for the clinical medication safety.