电感耦合等离子体质谱法测定培菲康胶囊中4种有害元素

目的：建立培菲康胶囊中铅、砷、镉、汞4种有害元素的测定方法。方法：采用电感耦合等离子体质谱法，样品经微波消解前处理后测定，选择内标法定量以消除基体效应和干扰。结果：在一定的浓度范围内，各元素和内标元素的质量数比值均与浓度呈良好的线性关系，相关系数均大于0.999，加样回收率为73.5%～103.2%，检测限均满足测定的要求。结论：该方法专属性好，灵敏度高，准确快捷，可为同类药品、保健品中有害元素的限量检查提供参考。

Objective: To establish a method for the determination of four harmful elements of lead(Pb),arsenic(As),mercury(Hg)and cadmium(Cd)in Bifico capsules. Methods: Harmful elements were determined by inductively coupled plasma-mass spectrometry,using microwave digestion for sample pretreatment.The internal standard solution was used to eliminate the matrix effect and interference. Results: The mass ratio of each measured element,the corresponding internal standard element and the concentration showed a good linear relationship in a certain concentration range,and the correlation coefficients were all greater than 0.999.The recoveries were from 73.5% to 103.2%,and the detection limits all met the requirements of determination. Conclusion: The method is specific,sensitive,accurate and rapid,and can be used for the limit determination of harmful elements in similar drugs and health products.

[1] YAN Lan(阎澜),ZHANG Jun-dong(张军东).Development of birid triple viable(BIFICO)for clinical application(培菲康临床应用进展)[J].Shanghai Med Pharm J(上海医药),2007,28(3):114
[2] HUANG Jian-quan(黄建权),HU Xin(胡欣),ZHANG Jun-ren(张君仁),et al.Application of ICP-MS technology in pharmaceutical analysis(ICP-MS技术在药物分析中的应用)[J].J China Pharm(中国药房),2006,17(8):624
[3] LI Li-min(李丽敏),WANG Ke(王珂),JI Shen(季申).ICP-MS determination of 5 hazard elements in Shenkang injection(电感耦合等离子质谱法测定肾康注射液中重金属及有害元素)[J].Chin J Pharm Anal(药物分析杂志),2012,32(2):277
[4] HUANG Wen-qi(黄文琦),LUO Yan(罗艳),HUANG Yi-fan(黄一帆),et al.ICP/MS determination of the contents of eight heavy metals in Chinese raw materials(电感耦合等离子体质谱法测定中药材中8种元素含量)[J].Chin J Pharm Anal(药物分析杂志),2012,32(3):437
[5] JIA Ai-ling(贾艾玲),WANG Hong-mei(王红梅),LI Ling-ling(李玲玲).ICP-MS determination of 6 hazard elements in Colla Corii Asini(Ejiao)(电感耦合等离子体质谱法检测阿胶中6种有害元素的含量)[J].Chin J Pharm Anal(药物分析杂志),2012,32(3):434
[6] HU Jun-gao(胡军高),LIANG Xu-xia(梁旭霞),LIU Rui(刘锐),et al.Study on common metal elements in pancreatic extracts by inductively coupled plasma mass spectrometry(胰腺提取物冻干粉中常见金属元素的测定)[J].Chin J Biochem Pharm(中国生化药物杂志),2012,33(6):814
[7] SHI Fang-liang(史芳亮),CHEN Gang(陈钢),CHEN Deng-yun(陈登云).ICP-MS fast determination of trace aluminum in human albumin(应用ICP-MS快速测定人血白蛋白中铝残留量)[J].Chin J Pharm Anal(药物分析杂志),2008,28(10):1602