注射用血栓通(冻干)中重金属及有害元素的质量控制

目的探索用电感耦合等离子体质谱法测定注射用血栓通(冻干)中的铅、砷、铜、镉、汞。方法微波消解后的注射用血栓通(冻干)样品,加入Sc、In、Ge、Bi等内标元素,以茶叶作为质控标准物质,注入电感耦合等离子体质谱仪测定样品中铅、砷、铜、镉、汞的含量。结果标准曲线相关系数r在0.998以上,回收率为92.7%~100.2%,RSD在3%以内。结论本方法准确迅速,操作性强,干扰少,可以用于注射用血栓通(冻干)中重金属及有害元素的质量控制。

Quality Control of Heavy Metal and Hazard Elements in Efficacious on Freeze-dried Thrombus Scavenger Injection

Objective To approach the quantitative determination of Ph, As, Cu, Cd and Hg in thrombus scavenger injection by inductively coupled plasma mass spectrometry. Method The samples, digested via microwave, calibrated by internal standard elements such as Sc, In, Ge and Bi, with tea leaves as the controlled reference standard, were inlet into ICP-MS to analyze the quantity of Pb, As, Cu, Cd and Hg. Result The correlative coefficients of the standard curves surpasses 0.998, with the recovery at 92.7%-100.2%,while their RSD below3%. Conelusion The method is proved to be accurate and fast, seldom interfered, consultable for determinations of heavy metal elements in freeze-dried thrombus scavenger injection.