不同批次还少胶囊重金属元素含量测定及其健康风险评估  

Determination and Health Risk Assessment of Heavy Metal Elements in Different Batches of Huanshao Capsule

作　　者：王丹 杨青山 江春阳 邹隆琼 唐建 周全 周游 周浓 WANG Dan;YANG Qingshan;JIANG Chunyang;ZOU Longqiong;TANG Jian;ZHOU Quan;ZHOU You;ZHOU Nong(The Chongqing Engineering Laboratory for Green Cultivation and Deep Processing of the Three Gorges Reservoir Area’s Medicinal Herbs,College of Food and Biological Engineering,Chongqing Three Gorges University,Chongqing 404120,China;Chongqing Three Gorges Yunhai Pharmaceutical Co.,Ltd.,Chongqing 404500,China)

机构地区：[1]重庆三峡学院生物与食品工程学院,三峡库区道地药材绿色种植与深加工重庆市工程实验室,重庆404120 [2]重庆三峡云海药业股份有限公司,重庆404500

出　　处：《中国中医药信息杂志》2023年第2期118-123,共6页Chinese Journal of Information on Traditional Chinese Medicine

基　　金：重庆市技术创新与应用示范项目(cstc2018jscx-msybX0367)。

摘　　要：目的测定还少胶囊中5种重金属元素含量,建立风险评估模型,为完善还少胶囊质量安全评估标准提供实验基础和数据参考。方法采用微波消解法处理样品,电感耦合等离子体质谱法(ICP-MS)测定11批还少胶囊样品中铜(Cu)、砷(As)、镉(Cd)、汞(Hg)、铅(Pb)5种重金属元素含量,并采用每日暂定最大摄入量(EDI)和靶向危害系数(THQ)对不同批次还少胶囊中重金属污染程度进行健康风险评估。结果5种重金属元素含量测定线性关系良好(r≥0.9991),精密度、重复性试验RSD均小于2.75%,平均回收率为98.33%~101.66%;11批样品中Cu、As、Cd、Hg、Pb含量范围分别为2.575~5.737 mg/kg、0.339~1.299 mg/kg、0.007~0.031 mg/kg、0.007~0.133 mg/kg、0.521~1.688 mg/kg。参考《药用植物及制剂外经贸绿色行业标准》规定,以原料药投料计算,11批样品均未出现重金属元素含量超标现象;健康风险评估结果显示,还少胶囊样品重金属元素含量均不会对成年人健康产生明显影响。结论本研究建立的方法操作简便快速、灵敏度高,可用于还少胶囊中重金属元素含量测定;建立的风险评估模型可进一步完善还少胶囊的安全质量标准。Objective To determine the contents of five heavy metal elements in Huanshao Capsule;To establish the risk assessment model;To provide experimental basis and data reference for improving the quality and safety assessment standard of Huanshao Capsule.Methods The samples were processed by microwave digestion.Inductively coupled plasma mass spectrometry(ICP-MS)was used to determine the contents of five heavy metal elements such as Cu,As,Cd,Hg and Pb in 11 batches of Huanshao Capsule samples.The health risk assessment of heavy metal elements contamination in different batches of Huanshao Capsules was carried out using the estimated daily intake(EDI)and targeted hazard quotients(THQ).Results The content determination of five heavy metal elements showed a good linear relationship(r≥0.9991).The RSD of precision and repeatability experiments was less than 2.75%,and the average recovery of samples was 98.33%–101.66%;the contents of Cu,As,Cd,Hg and Pb in 11 batches of Huanshao Capsule were 2.575–5.737 mg/kg,0.339–1.299 mg/kg,0.007–0.031 mg/kg,0.007–0.133 mg/kg and 0.521-1.688 mg/kg respectively.Referring to the provisions of heavy metal elements in Green Standards of Medicinal Plants and Preparations for Foreign Trade and Economy,calculated by API feeding,the contents of 5 heavy metals in 11 batches of Huanshao Capsule met the standard;the results of health risk assessment showed that the content of 5 heavy metal elements in all batches of Huanshao Capsule would not affect the health of adults.Conclusion The method is simple,rapid and sensitive,and can be used for the determination of heavy metal elements in Huanshao Capsule;the establishment of risk assessment model can further improve the safety and quality standard of Huanshao Capsule.

关 键 词：还少胶囊 电感耦合等离子体质谱法 重金属元素 含量测定 健康风险评估 

分 类 号：R286.02[医药卫生—中药学]