朱砂七药材中重金属残留和相关元素形态价态分析  

Heavy metal residual and related elemental species in Polygonum cillinerve(Nakai)Ohwl

作　　者：李耀磊[1] 王赵[1] 李海亮 昝珂[1] 金红宇[1] 马双成[1] LI Yaolei;WANG Zhao;LI Hailiang;ZAN Ke;JIN Hongyu;MA Shuangcheng(Institute for Control of Chinese Traditional Medicine and Ethnic Medicine,National Institutes for Food and Drug Control,NMPA Key Laboratory for Quality Research and Evaluation of Traditional Chinese Medicine,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院中药民族药检定所,国家药品监督管理局中药质量与评价重点实验室,北京102629

出　　处：《中国药物警戒》2023年第11期1234-1237,共4页Chinese Journal of Pharmacovigilance

基　　金：国家重点研发计划(2022YFC3501500)。

摘　　要：目的探索朱砂七药材中重金属残留水平及其中存在的砷形态价态。方法采用微波消解法结合电感耦合等离子体质谱(ICP-MS)法对朱砂七中铅(Pb)、镉(Cd)、砷(As)、汞(Hg)、铜(Cu)5种重金属及相关元素进行测定,并对含量水平进行分析;另外采用高效液相联用电感耦合等离子体质谱法(HPLC-ICP-MS)对一甲基砷(MMA)、二甲基砷(DMA)、亚砷酸(AsⅢ)、砷酸(AsⅤ)、砷甜菜碱(AsB)、砷胆碱(AsC)等已知6种砷形态价态进行研究。结果参照《中华人民共和国药典》(2020年版)对于植物药限量标准,10批次朱砂七药材中,除1批次药材中的Cd以外,其他元素均未超过限度规定,整体合格率较高。HPLC-ICP-MS研究结果表明,除1批次朱砂七药材检出痕量的AsV外,其他批次朱砂七药材中无机砷与有机砷均未检出。结论朱砂七药材中相关元素安全性较好,为朱砂七重金属及相关元素限量标准制定提供了数据支持,同时通过测定元素形态价态,为未来准确评价相关元素带来的安全性风险提供参考。Objective To explore the residual levels of heavy metals in Polygonum cillinerve(Nakai)Ohwl and the existing arsenic species.Methods Using microwave digestion method combined with inductively coupled plasma mass spectrometry(ICP-MS)method,Pb(lead),Cd(cadmium),As(arsenic),Hg(mercury),Cu(copper)five heavy metals and related elements in Polygonum cillinerve(Nakai)Ohwl Measure were detected,and the content levels were analyzed;in addition,using high performance liquid phase coupled with inductively coupled plasma mass spectrometry(HPLCICP-MS),monomethyl arsenic(MMA),dimethyl arsenic(DMA),and arsenous acid(AsⅢ),arsenic acid(AsⅤ),arsenic betaine(AsB),arsenic choline(AsC)and other six known arsenic species were studied.Results The results of the study showed that according to the 2020 edition of the Chinese Pharmacopoeia for botanical limits,except one batch of Cd in 10batches of Polygonum cillinerve(Nakai)Ohwl,and other elements did not exceed the limit,and the overall pass rate was high.The HPLC-ICP-MS research results showed that,except for the trace amount of AsV detected in the first batch of Polygonum cillinerve(Nakai)Ohwl,the inorganic arsenic and organic arsenic in the other batches of Polygonum cillinerve(Nakai)Ohwl were not detected.Conclusion This study showed the safety risks of heavy metals and related elements in Polygonum cillinerve(Nakai)Ohwl are low.This research provides data support for the formulation of the limit standards for Polygonum cillinerve(Nakai)Ohwl heavy metals and related elements.At the same time,the determination of element species will help to accurately evaluate the safety risks brought by related elements in the future.

关 键 词：朱砂七 重金属 相关元素 电感耦合等离子体质谱 砷 形态 价态 残留 

分 类 号：R973[医药卫生—药品] R994.1[医药卫生—药学]