摘要
目的研究五灵脂中重金属及有害元素和砷形态、价态,并对其安全性进行评价。方法采用微波消解法结合电感耦合等离子体质谱(ICP-MS)法对五灵脂中铅(Pb)、镉(Cd)、砷(As)、汞(Hg)、铜(Cu)5种重金属及有害元素进行测定,参照现行《中国药典》2020年版植物药重金属及有害元素的限量标准、采用单项污染指数法对有害元素潜在的安全性风险进行评价;另外采用高效液相联用电感耦合等离子体质谱(HPLC-ICP-MS)法对一甲基砷(MMA)、二甲基砷(DMA)、亚砷酸(AsⅢ)、砷酸(AsⅤ)、砷甜菜碱(AsB)、砷胆碱(AsC)6种砷形态、价态进行研究。结果2种方法的线性关系、精密度、重复性、回收率均良好。五灵脂中5种重金属及有害元素的安全性较高。HPLC-ICP-MS结果表明,部分药材中检出微量的无机砷(AsⅢ和AsⅤ),结果相对安全可控。结论为五灵脂重金属及有害元素限量标准制定提供了数据支持,同时有助于未来准确评价有害元素带来的安全性风险。
Objective The purpose of this research was to study the heavy metals,harmful elements and arsenic species in the Chinese medicine Trogopterus Xanthipes,and evaluate its safety.Methods Microwave digestion combined with inductively coupled plasma mass spectrometry(ICP-MS)was used to treat five heavy metals and harmful substances in Trogopterus Xanthipes:lead(Pb),cadmium(Cd),arsenic(As),mercury(Hg)and copper(Cu)were determined.With reference to the current limit standards for heavy metals and harmful elements in botanicals in the 2020 edition of the Chinese Pharmacopoeia,the individual pollution index method was used to evaluate the potential safety risks of harmful elements.In addition,high-performance liquid phase coupled with inductively coupled plasma mass spectrometry(HPLC-ICP-MS)was used to analyze methyl arsenic(MMA),methyl arsenic(DMA),arsenous acid(AsⅢ),arsenic acid(AsⅤ),arsenic betaine(AsB),and arsenic choline(AsC).Results The research results showed that the linear relationship,injection precision,repeatability and recovery rate of the two methods were good.The results showed that the five heavy metals and harmful elements in Trogopterus Xanthipes were highly safe.HPLC-ICP-MS results showed that trace amounts of inorganic arsenic(AsⅢand AsⅤ)were detected in some medicinal materials,and the results were relatively safe and controllable.Conclusion This research provides data support for the formulation of the limit standards for Trogopterus Xanthipes heavy metals and harmful elements,and at the same time helps to accurately evaluate the safety risks brought by harmful elements in the future.
作者
李耀磊
李海亮
昝珂
王莹
金红宇
马双成
LI Yaolei;LI Hailiang;ZAN Ke;WANG Ying;JIN Hongyu;MA Shuangcheng(National Institutes for Food and Drug Control,Beijing 100050,China)
出处
《药物评价研究》
CAS
2023年第11期2354-2359,共6页
Drug Evaluation Research
基金
国家重点研发计划(2022YFC3501500)。
