苦参及其提取液中的重金属污染分析及其初步风险评估

The Safety Evaluation of Heavy Metal Contaminated Radix Sophorae Flavescentis Using Health Risk Assessment Under Different Medication Methods

目的为进一步完善特定药材的质量评价标准,同时弥补其潜在的安全风险评价空缺,以大宗常用中药材苦参为例,深入了解重金属在原药材中的污染水平及其在不同类型制剂中的残留情况,并对服用该药材的潜在危害进行健康风险评估,该研究对评价及提高中药质量及安全方面给出了一定的实验基础及借鉴价值。方法采用微波消解-电感耦合等离子体质谱法(Inductively Coupled Plasma Mass Spectrometry,ICP-MS)法测定了不同产地苦参中铬(Cr)、镍(Ni)、铅(Pb)、镉(Cd)、汞(Hg)、砷(As)、铜(Cu)及锌(Zn)8类有害元素的含量;基于苦参不同提取工艺及人体外消化模型,分别模拟苦参的水提液与醇提液制剂及原粉等3种主要的入药模式,测定其中重金属的转移率,同时使用人体日暴露量及靶标危害系数法(THQ)分别对苦参的重金属健康风险等级进行评估,最终给出特定类型苦参药材中各重金属的最大残留限量推荐值。结果在国际重金属限量标准对比下,12批苦参中6批As超标,1批Cd超标,不合格率为66.76%。然而,水提取工艺对Ni,Cu,As,Zn,Hg及Pb元素具有较高的脱除能力,且醇提工艺可特异性的脱除Cd元素。三种入药方式下THQ总值均低于各项重金属的THQ标准值,而苦参重金属MRL理论值与中国药典MRL值存在较大差异。结论通过研究不同产地苦参中重金属的残留情况及其在不同入药方式下的转移利率发现:苦参药材经提取后,由重金属导致的健康风险等级降低,因此针对不同类型药材中重金属的最大限量值的制定有待进一步修改,本研究为特定类型药材的风险等级评估提供了实验基础与研究思路。

Objective For further improving the quality evaluation criteria of specific medicinal materials and theirsafety control methods,the pollution level of heavy metals in Sophora flavescens and its preparations wascomprehensively analyzed and the potential health risks of taking this medicinal material was also evaluated.The studywas expected to create awareness among the public on the safety of consuming of Sophora flavescens or any other kinds ofmedicinal herbs.Method The heavy metals content(Cr,Ni,Pb,Cd,Hg,As,Cu and Zn)in 12 batches of Radix Sophorae Flavescentis and their preparations were carefully analyzed with inductively coupled plasma mass spectrometry(ICP-MS).Combined with the heavy metal transfer rule under 3 main medication methods,a health risk assessmentmodel for specific medicinal materials and different medication methods was developed based on the parameters ofestimated daily intake(EDI)and target hazard quotients(THQ).In addition,the recommended MRLs of 5 main heavymetals aimed to Sophora flavescen were calculated based on the regulated consumption quantity.Result The test resultwas found that,under the ISO regulation,the unqualified rate was 66.76%for Sophora flavescens including 6 batches ofAs and 1 batch of Cd.Fortunately,the content of heavy metals decreased significantly after extraction process.Such asthe residual level of Ni,Cu,As,Zn,Hg and Pb was low enough after water extraction,while Cd can be specificallyremoved by ethanol extraction process.It was suggested that the total THQ values in raw herbs and three medicationmethods were below the standard THQ value,so the preparation of Radix Sophorae Flavescentis can neglect the non-carcinogenic hazards to human body.Conclusion It can be easily concluded that,after extraction process,theconcentration of heavy metals are significantly decreased and thus leading to low the potential health risk.Above all,thisstudy provided a detailed procedure to assess any other kinds of heavy metal contaminated medicinal herbs and also itspreparations in quality control and safety evaluation,and expected to create awareness among the public on the safety ofconsuming Radix Sophorae Flavescentis and its preparation or any other kinds of medicinal herbs.