三七片中重金属元素残留量测定及风险评估

Determination and Risk Assessment of Heavy Metals in Sanqi Tablets

目的建立电感耦合等离子体质谱(ICP-MS)测定三七片中6种有害重金属元素残留量的方法,并对服用该药潜在的健康风险进行评估。方法采用微波消解法处理样品,铅(Pb)、汞(Hg)以铋(Bi)作为内标,铜(Cu)、砷(As)以铬(Ge)作为内标,镉(Cd)以铟(In)作为内标,铝(Al)以钪(Sc)作为内标,采用ICP-MS法,同时测定以上6种元素;采用点推定法对各元素的非致癌风险危害商值(HQ)进行评估,并制定了该6种元素在三七片中的残留限量。结果各元素的危害商值大小顺序为As>Pb>Cd>Hg>Cu>Al,三七片中重金属元素的总危害指数小于1;在拟定限度下,Cd、Cu、Hg、Al未超标,Pb、As超标率分别为73%,67%。结论该品种不存在非致癌健康风险,但Pb和As超标情况严重,药材中重金属元素向制剂中的转移应引起重视。

Objective To establish a method for determination of six heavy metals in Sanqi Tablets by microwave digestion-ICP-MS and evaluate the potential health risk of taking the drug.Methods The samples were treated by microwave digestion.Bismuth(Bi)was used as internal standard for lead(Pb)and mercury(Hg),chromium(Ge)was used as internal standard for copper(Cu)and arsenic(As),indium(In)was used as internal standard for cadmium(Cd),and scandium(Sc)was used as internal standard for aluminum(Al).ICP-MS was used to determine the above six metal elements.The non-carcinogenic risk hazard quotient(HQ)of each element was evaluated by point estimation method,and the residue limits of the six elements in Sanqi Tablets were set.Results The HQ of the elements decreased in the following order:As>Pb>Cd>Hg>Cu>Al,and the total hazardous index(HI)of the heavy metals in Sanqi Tablets was less than 1.Levels of Cd,Cu,Hg and Al did not exceed the proposed limit,while standard exceeding rates of Pb and As were 73%and 67%,respectively.Conclusion There is no non-carcinogenic health risk for Sanqi Tablets,but Pb and As exceed the standard seriously.It is necessary to pay attention to the transfer of heavy metals into the preparation.