清开灵注射液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 Heat Expelling and Enlightening Injection

作　　者：施晓光 陆敏仪 赵庄 刘华钢 甘盛 戴向东 许杨彪 

机构地区：[1]广西壮族自治区食品药品检验所,南宁530021 [2]广西壮族自治区食品药品监督管理局,南宁530021

出　　处：《中国实验方剂学杂志》2013年第6期75-77,共3页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：国家科技重大专项(2009ZX09308-006);科技部十一五支撑项目(2008BAI55B02)

摘　　要：目的:探索用电感耦合等离子体质谱法测定清开灵注射液的铅、砷、铜、镉、汞,探讨其中重金属及有害元素的质量控制。方法:清开灵注射液经微波消解后,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>0.997,回收率为93.2%～100.3%,RSD<2.7%。结论:方法准确迅速,操作性强,干扰少,可以用于清开灵注射液中重金属及有害元素的质量控制。Objective： To approach the quantitative determination of Pb, As, Cu, Cd and Hg in efficacious on Heat Expelling and Enlightening Injection by inductively coupled plasma mass spectrometry.To probe into the quality control of heavy metal and hazard elements in Efficacious on Heat Expelling and Enlightening Injection. 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 0.997, with the recovery at 93.2%-100.3%, while their RSD was below 2.7%. Conclusion： The method is proved to be accurate and fast, seldom interfered, consultable for quality control of heavy metal and hazard elements in Efficacious on Heat Expelling and Enlightening Injection.

关 键 词：清开灵注射液 重金属及有害元素 质量控制 

分 类 号：R284.1[医药卫生—中药学]