ICPMS半定量分析某注射剂中的可疑元素.pdf

Drug Standards of Ch ni a 2010, Vo l11 No1 2010 11 1 39 50, 100 mL 3, , R SD 03% , , 70% 25 mL [ 1 2005 [ S : 36 , 2005: 114 [ 1 , , ICPMS 张立雯( , 510 160) : 以分析某注射剂中的可疑元素为例, 将工作中应用 ICPM S 半定量法进行分析的心得 会进行总结, 以展示 ICP M S在帮助查找药品生产异常的原因中所起到的作用, 并探讨如何提高 ICPM S 半定量分析的准确性: 以安捷伦环境校 正标准溶液为校正溶液, 正常样品与异常样品同时采用 ICPM S 半定量法测定: T iCrF eN iBr5 种元素异常样品与正 常样品存在差异, 其中异常样品较正常样品铁含量约 30倍, Br约 5倍: ICPM S 半定量法能为厂家查找生产异常的原因 提供重要参考 : 电感耦合等离子 质谱法; 半定量; 注射剂 : 92 12 : A : 1009- 3656( 2010) - 1- 39- 3 ICPMS Sem iQuantitativeAnalysis ofDoubtfulElements in an Injection Zhang L iw en(G uangz hou In sti tu te f or D rug C on tro,l G uangz hou 5 10 160 ) Abstract Objective: T aking the case o f ana lys is of an injection, ex change v iew s and sha re experiences in ICPM S sem iquantitative ana ly sis, show the function of ICPM S in determ in ing o f abnorm al m anufacture, and d iscu ss how to mi prove the accuracy o f ICPM S sem iquan tita tive ana lysisM ethods: A g ilent Env ironm enta l Ca libration Standards as calibration standa rd, analyze the no rm al sam ple and abno rm al samp le at the same tmi e u sing ICPM S sem i quantitative analysis esults: T i, Cr, Fe, N i, Br f iv e e lem en ts w e re d if fe rent in tw o kinds of sam pleF e conten tw as about 30 tmi es and B r conten tw as about 5 tmi es in abno rm al samp le Conclusion: ICP M S sem i quantitativ e ana lysis can prov ide mi portant reference fo r the o f abno rm al m anu facture KeyW ords: ICPM S; Sem i quantitative A na lysis; In jection ( ICPM S) , ICPM S , ICPM S ( , ) , ICPM S , , , ICPM S ICPM S , , ( , , ), , ! 30% ICPM