注射用油酸钠金属杂质检测及其安全水平分析

Sodium Oleate(for injection)Metal Element Impurity Detection and Safety Level Analysis

为了分析注射用油酸钠金属杂质的安全水平,建立了注射用油酸钠中金属元素杂质的检测方法,对6批样品进行检测。注射用油酸钠使用硝酸进行微波消解,通过ICP-MS法检测Cd、Pb、As、Hg、Co、V、Ni、Li、Sb、Cu、Cr等11种金属元素含量,并对此方法进行方法学考察。结果表明:11种金属元素相关系数≥0.99,一定质量浓度范围内呈均线性关系;精密度在1.1%~7.4%之间;准确度平均值在95.0%~105.0%之间;重复性良好,加标重复RSD在1.1%~8.4%之间。说明方法准确、灵敏度较好,可用于注射用油酸钠中金属杂质的检测。利用此方法对不同来源6批油酸钠样品进行检测,检测样品均未超出控制阈值,研究结果可为注射用油酸钠的金属杂质安全水平评价提供参考。

In order to analyze the safety level of metal element impurities in sodium oleate(for injection),a detection method for metal element impurities in sodium oleate(for injection)was established,and 6 batches of samples were tested and analyzed for their safety level.Sodium oleate(for injection)was microwave-assisted using nitric acid.The content of 11 metal elements,including Cd,Pb,As,Hg,Co,V,Ni,Li,Sb,Cu,and Cr,was detected by ICP-MS,and a methodological study was conducted on this method.The results show that the correlation coefficients of all 11 metal elements are≥0.99,showing a linear relationship within a certain concentration range of quality;The precision is between 1.1% and 7.4%;The average accuracy is between 95.0% and 105.0%;Good repeatability with RSD of 1.1%~8.4%.The above data indicates that this method is accurate and sensitive,and can be used for the detection of metal element impurities in sodium oleate(for injection).This method was used to detect 6 batches of sodium oleate samples from different sources,and the detected samples did not exceed the control threshold.The results of this study can provide reference for the safety level of metal element impurities in sodium oleate(for injection).