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

目的: 建立肾康注射液中中铅、砷、汞、镉、铜5种重金属及有害元素的含量测定方法。 方法: 样品以微波消解后经电感耦合质谱测定,选择内标法定量以消除基体效应和干扰。 结果: 5种待测元素的方法检测限在0.002~0.015 mg·L^-1,进样精密度RSD在1.1%~4.8%,重复性RSD在2.6%~5.6%,5种元素高、中、低3种浓度的加样回收率在103.6%~114.9%,样品溶液在消解后2 d内各元素稳定性良好。 结论: 方法灵敏度高,专属性好,可为监控及制订中药注射液中有害元素的限量提供参考。

Objective: To develop a method for the determination of 5 hazard elements such as copper,arsenic,cadmium,mercury and lead in Shenkang injection. Mehtod: The samples were digested by microwaves and then chose appropriate determination parameters of ICP-MS to be detected.The internal standard solution were used to help avoid the interference of matrix elements and spectra. Result: The detection limits of the method were range from 0.002-0.015 mg·L^-1,the RSDs of introduction precision was all less than 5%,the repeatability were all less than 10%.The average recoveries of the 5 elements at three levels (high,medium and low concentration ) were in the range of 103.6%-114.9%,and the solution was stable in two days. Conclusion: The method is simple,accurate and high sensitive,can be used for the determination of rapid monitoring the hazard elements in Shenkang injection.

1 WANG Zhen-tao(王振涛),WANG Ya-hong(王亚红),ZHU Ming-jun(朱明军).The dialectic application of Chinese medicine injection(中药注射液的辨证应用).J Emerg Tradit Chin Med(中国中医急症),2002,11(6):471
2 PAN Feng(潘峰),HUANG Cai-yun(黄彩云).Research progress on cancer therapy of Chinese traditional anticancer injection(常用抗癌中药注射液治疗癌症研究进展).J Shandong Univ Tradit Chin Med(山东中医药大学学报),2002,26(1):73
3 QIAN Cun-rong(钱存荣),YAN Shuang-yin(闫双银).The clinical application of Chinese medicine injection on acute cerebral infarction(中药注射液在急性脑梗塞中的临床应用).China Pharm (中国药业),2006,15(4):63
4 SUN Duan(孙端).The adverse reaction and the prevention on applying Chinese medicine injection(中药注射液不良反应及预防).Chin J Basic Med Tradit Chin Med(中国中医基础医学杂志),2007,13(2):144
5 LIU Wen-qi(刘文启),GUO Wei(郭伟).Analysis on cause of adverse drug reactions(ADRs)of injection of Herba Houttuyniae(鱼腥草注射液不良反应及成因分析).Chin J Pharm Anal(药物分析杂志),2007,27(6):943
6 ZHANG Qing-sheng(张庆生),SHI Shang-mei(石上梅),ZHANG Shu-jie(张树杰).A brief account about the pesticide residue and heavy metal of Chinese medicine in China,Japan and korea(中、日、韩有关中药农药残留与重金属控制概况).China J Tradit Chin Med Pharm(中国医药学报),2005,33(6):1
7 JIANG Wei-dong(姜卫东),HE Ya-ling(贺亚玲),DU Gang(杜刚).Determination of residual Pb Cd As Hg and Cu in Yimucao injection(益母草注射液中铅、镉、砷、汞、铜残留量的测定).Chin J Pharm Anal(药物分析杂志),2008,28(8):1297
8 JIANG Shou-jun(蒋受军),WANG Jin(王瑾),ZHU Bin(朱斌),et al.ICP-MS determination of fifteen microelements in freez-dried Danshen injection.Chin J Pharm Anal(药物分析杂志),2007,27(6):943
9 ChP(中国药典).2005.Vol Ⅱ(二部):59,87,69,152,212