中国药师
中國藥師
중국약사
CHINA PHARMACIST
2014年
12期
2043-2045
,共3页
注射用水%电感耦合等离子体质谱法%金属元素%含量测定
註射用水%電感耦閤等離子體質譜法%金屬元素%含量測定
주사용수%전감우합등리자체질보법%금속원소%함량측정
Water for injection%Inductively coupled plasma mass spectrometry%Metallic elements%Determination
目的::建立电感耦合等离子体质谱法( ICP-MS)测定注射用水中镁、铝、铬、铜、锌、砷、镉、锡、钡、铅、钙、钾、硒、银、钠、汞等16种元素含量的方法。方法:采用ICP-MS法碰撞池技术( CCT),最大程度的减少多原子干扰,通过在线加入锂、钪、锗、铟、铱、铋内标液的方法校正由于基体效应和信号漂移对测量所造成的影响,样品直接酸化测定注射用水中的16种金属元素的含量。结果: ICP-MS技术测定16种金属元素的检测限范围为0.009~0.165 ng·ml-1;标准曲线线性关系良好( r≥0.9990);回收率均在80%~120%范围之内(n=6)。结论:上述方法简便、快速、准确,可用于注射用水中16种金属元素含量的测定,并以此降低注射用水中存在毒性较大金属元素含量超标的潜在风险,为注射用水更严格的质量控制提供参考。
目的::建立電感耦閤等離子體質譜法( ICP-MS)測定註射用水中鎂、鋁、鉻、銅、鋅、砷、鎘、錫、鋇、鉛、鈣、鉀、硒、銀、鈉、汞等16種元素含量的方法。方法:採用ICP-MS法踫撞池技術( CCT),最大程度的減少多原子榦擾,通過在線加入鋰、鈧、鍺、銦、銥、鉍內標液的方法校正由于基體效應和信號漂移對測量所造成的影響,樣品直接痠化測定註射用水中的16種金屬元素的含量。結果: ICP-MS技術測定16種金屬元素的檢測限範圍為0.009~0.165 ng·ml-1;標準麯線線性關繫良好( r≥0.9990);迴收率均在80%~120%範圍之內(n=6)。結論:上述方法簡便、快速、準確,可用于註射用水中16種金屬元素含量的測定,併以此降低註射用水中存在毒性較大金屬元素含量超標的潛在風險,為註射用水更嚴格的質量控製提供參攷。
목적::건립전감우합등리자체질보법( ICP-MS)측정주사용수중미、려、락、동、자、신、력、석、패、연、개、갑、서、은、납、홍등16충원소함량적방법。방법:채용ICP-MS법팽당지기술( CCT),최대정도적감소다원자간우,통과재선가입리、항、타、인、의、필내표액적방법교정유우기체효응화신호표이대측량소조성적영향,양품직접산화측정주사용수중적16충금속원소적함량。결과: ICP-MS기술측정16충금속원소적검측한범위위0.009~0.165 ng·ml-1;표준곡선선성관계량호( r≥0.9990);회수솔균재80%~120%범위지내(n=6)。결론:상술방법간편、쾌속、준학,가용우주사용수중16충금속원소함량적측정,병이차강저주사용수중존재독성교대금속원소함량초표적잠재풍험,위주사용수경엄격적질량공제제공삼고。
Objective:To establish the methods for the determination of Mg,Al,K,Ca,Cr,Cu,Zn,As,Se,Ag,Cd,Sn,Ba,Pb,Na and Hg in water for injection. Methods:The sixteen metallic elements in water for injection were determined by ICP-MS. The collision cell technology ( CCT) was used to minimize the multiple atomic interference, and the matrix effect and signal drift were compensated by using Li, Sc, Ge, In, Ir and Bi as the internal standards and the samples were directly acidified to detect the metallic elements. Results:The detection limit range of the 16 metallic elements were from 0. 009 to 0. 165 ng·ml-1. The calibration curves showed good linearity (r≥0. 999 0). The recoveries were within the range of 80%-120%(n=6). Conclusion:The method is simple, rapid and accurate. It can be used to determine the contents of metallic elements to reduce the potential exceeding limit risk of toxic metal el-ements in water for injection. The methods also can provide reference for the more strict quality evaluation of water for injection.