ICP-OES法测定口服固体药用陶瓷瓶中26种金属元素的浸出量  

ICP-OES determination of leaching content of 26 metal elements in oral solid medicinal ceramic bottles

作　　者：王悦雯 梁炎 陈蕾 刘言 WANG Yuewen;LIANG Yan;CHEN Lei;LIU Yan(Tianjin Institute of Drug Control,Tianjin 300070,China)

机构地区：[1]天津市药品检验研究院,天津300070

出　　处：《中国药品标准》2023年第3期313-318,共6页Drug Standards of China

摘　　要：目的:建立口服固体药用陶瓷瓶中26种金属元素的测定方法,并对6批口服固体药用陶瓷瓶中的26种金属元素的浸出量进行测定。方法:采用ICP-OES法测定口服固体药用陶瓷瓶中Al、As、B、Ba、Ca、Cd、Co、Cr、Cu、Fe、Hg、K、Li、Mg、Mn、Mo、Na、Ni、Pb、Sb、Se、Si、Sn、Ti、V、Zn共26种元素的浸出量。ICP-OES工作参数:高频功率为1150W,分析谱线分别为:308.2(Al)、193.7(As)、249.6(B)、230.4(Ba)、393.3(Ca)、228.8(Cd)、230.7(Co)、267.7(Cr)、324.7(Cu)、239.5(Fe)、184.9(Hg)、769.8(K)、670.7(Li)、285.2(Mg)、259.3(Mn)、202.0(Mo)、818.3(Na)、221.6(Ni)、220.3(Pb)、217.5(Sb)、196.0(Se)、288.1(Si)、189.9(Sn)、337.2(Ti)、292.4(V)、202.5(Zn)。结果:该方法同时测定Al、As、B、Ba、Ca、Cd、Co、Cr、Cu、Fe、Hg、K、Li、Mg、Mn、Mo、Na、Ni、Pb、Sb、Se、Si、Sn、Ti、V、Zn,各元素在0.02~2μg•mL^(-1)范围内呈良好的线性关系,线性相关系数为0.9978~0.9998;加样回收率为84.7%~107.3%;精密度试验的RSD为0.12%~1.96%;稳定性试验的RSD为0.74%~4.78%;重复性试验的RSD为0.68%~1.87%;检出限为0.33~33.15 ng•mL^(-1)。6批样品中,Al、Ca、Si、Mg、Na、K、Zn七种元素的浸出量较高,检出少量Ba、Fe。结论:本法经方法学验证,可用于测定口服固体药用陶瓷瓶中26种金属元素的浸出量。根据样品测定结果,建议相关标准中增加Cd、Pb、Al、Ca、Mg、Na、K、Zn浸出量的监测。Objective:To establish a method for the determination of 26 metal elements in oral solid medicinal ceramic bottles.The leaching amounts of 26 metal elements in 6 batches of oral solid medicinal ceramic bottles were determined.Methods:The extraction contents of 26 elements(AL,As,B,Ba,Ca,Cd,Co,Cr,Cu,Fe,Hg,k,Li,Mg,Mn,Mo,Na,Ni,Pb,Sb,Se,Si,Sn,Ti,V,Zn)from oral solid medicinal ceramic bottles were determined by ICP-OES.ICP-OES operating parameters:high frequency power of 1150W,the analysis lines were:308.2(Al),193.7(As),249.6(B),230.4(Ba),393.3(Ca),228.8(Cd),230.7(Co),267.7(Cr),324.7(Cu),239.5(Fe),184.9(HG),769.8(K),670.7(Li),285.2(Mg),259.3(Mn),202.0(Mo),818.3(Na),221.6(Ni),220.3(Pb),217.5(Sb),196.0(Se),288.1(Si),189.9(Sn),337.2(Ti),292.4(V),202.5(Zn).Results:A method for the simultaneous determination of Ai,As,B,Ba,Ca,Cd,Co,Cr,Cu,Fe,Hg,k,Li,Mg,Mn,Mo,Na,Ni,Pb,Sb,Se,Si,Sn,Ti,V,Zn were developed,in the range of 0.02-2μg•mL^(-1),the linear correlation coefficient were 0.9978-0.9998,the recovery rate were 84.7%-107.3%,the RSDs were 0.12%-1.96%The RSDs of the stability test were 0.74%-4.78%,the RSDs of the repeatability test were 0.68%-1.87%,and the detection limit were 0.33-33.15 ng•mL^(-1).In 6 batches of samples,the leaching contents of Ai,Ca,Si,Mg,Na,K and Zn were higher,and a small amount of Ba and Fe were detected.Conclusion:The method has been verified by the methodology and can be used for the determination of 26 metal elements in oral solid medicinal ceramic bottles.Based on the results of sample determination,it is suggested that monitoring of leaching amount of Cd,Pb,Al,Ca,Mg,Na,K and Zn should be added to the relevant standards.

关 键 词：电感耦合等离子体发射光谱法(ICP-OES) 口服固体药用陶瓷瓶 金属元素 浸出量 多元素同时测定 

分 类 号：R921.2[医药卫生—药学]