感冒止咳颗粒中重金属的含量测定及其质量评价  

Determination and Quality Evaluation of Heavy Metals in Ganmao Zhike Granules

作　　者：谢莉 严丽 冯春蕾 周洋 于新兰 XIE Li;YAN Li;FENG Chunlei;ZHOU Yang;YU Xinlan(Xinjiang Uygur Autonomous Region Institute for drug Inspection and Research Institute,Key Laboratory of quality control of traditional Chinese medicine(Uygur Medicine)of the State Drug Administration,Urumqi 830054,China)

机构地区：[1]新疆维吾尔自治区药品检验研究院/国家药品监督管理局中药(维药)质量控制重点实验室,新疆乌鲁木齐830054

出　　处：《中国民族民间医药》2023年第20期38-43,共6页Chinese Journal of Ethnomedicine and Ethnopharmacy

摘　　要：目的:建立市售不同厂家的感冒止咳颗粒中铅(Pb)、镉(Cd)、砷(As)、汞(Hg)、铜(Cu)5种重金属元素含量的测定方法,并依据结果评价其质量。方法:供试品经湿法消解后,利用原子吸收分光光度法的测定供试品中Pb、Cd、Cu的含量;利用原子荧光光度法测定供试品中As、Hg的含量,并采用直观分析、聚类分析及相关性分析对所得结果进行分析处理。结果:各重金属元素含量在各自范围内线性关系良好(r>0.9900),重复性、精密度、稳定性的RSD均<3.0%,回收率在88.76%~97.90%之间。不同厂家的感冒止咳颗粒中重金属元素的含量有所差异但均符合《中国药典》相关要求。结论:感冒止咳颗粒的质量总体上安全性较高,但应进一步完善其重金属的限量标准,以确保用药安全。Objective Method for determination of Pb,Cd,As,Hg and Cu in Ganganzhike granules,and to evaluate their quality according to the results.Methods The contents of Pb、Cd and Cu in the samples were determined by atomic absorption spectrophotometry after wet digestion.The contents of As and Hg in the samples were determined by atomic fluorescence spectrophotometry,and the results were analyzed by visual analysis,cluster analysis and correlation analysis to analyze the results.Results The content of each heavy metal element had a good linear relationship in their respective ranges(r>0.9900).The RSDS of repeatability,precision and stability were all<3.0%,and the recoveries were 88.76%-97.90%.The contents of heavy metal elements in Kangzhike granules from different manufacturers are different,but they all meet the relevant requirements of Chinese Pharmacopoeia.Conclusion The quality of Ganganzhike granules is generally safe,but the limit standard of heavy metals should be further improved to ensure drug safety.

关 键 词：感冒止咳颗粒 重金属 聚类分析 

分 类 号：R284.1[医药卫生—中药学]