珍珠层粉中钡的测定及风险评估  

Determination and risk assessment of barium in pearl layer powder

作　　者：冯永刚 熊瑛 吴愫青 FENG Yonggang;XIONG Ying;WU Suqing(Medicine Room,Zhuhai Institute for Food and Drug Control,Guangdong Province,Zhuhai519000,China)

机构地区：[1]珠海市食品药品检验所药品室,广东珠海519000

出　　处：《中国当代医药》2023年第4期48-50,55,共4页China Modern Medicine

摘　　要：目的测定珍珠层粉中钡的残留量,并对其进行风险评估。方法通过电感耦合等离子体质谱法(ICP-MS)测定钡含量,采用ICH Q3D风险评估、健康风险评估(HRA)对珍珠层粉中钡的非致癌性风险进行分析。结果钡元素线性关系良好(r=0.9998);精密度试验的RSD=1.1%(n=6);平均回收率为106.6%,RSD=2.4%(n=6)。5批珍珠层粉中钡残留量范围为4.68~101.75 mg/kg,3批钡的每日摄入量(DI)均大于10%每日允许暴露量(PDE),成人的危害指数(HI)小于1,但10岁以下儿童的HI值接近或大于1,超过标准阈值。结论本研究考察了珍珠层粉中钡的残留情况,为珍珠层粉的质量控制和安全用药尤其是儿童用药提供研究基础。Objective To determine the residual amount of barium in pearl layer powder and carry out risk assessment.Methods The content of barium was determined by inductively coupled plasma mass spectrometry(ICP-MS),and the non-carcinogenic risk of barium in pearl layer powder was analyzed by ICH Q3D risk assessment and health risk assessment(HRA).Results The linear relationship of barium was good(r=0.9998).The relative standard deviation(RSD)of the precision test was 1.1%(n=6),the average recovery was 106.6%,with the RSD=2.4%(n=6).The barium residues in the five batches of pearl layer powder ranged from 4.68 to 101.75 mg/kg.The daily intake(DI)of barium in the three batches were all greater than 10%of permissible daily exposure(PDE).The hazard index(HI)of adults were less than 1,but the HI value of children under 10 years old were close to or greater than 1,exceeding the standard threshold.Conclusion This study investigates the barium residue in pearl layer powder,which provides a research basis for the quality control and safe drug use of pearl layer powder,especially for children.

关 键 词：珍珠层粉 钡 风险评估 电感耦合等离子体质谱法 

分 类 号：R286[医药卫生—中药学]