作　　者： (左甜甜）; (张磊）; (金红宇）; (马双成）;

机构地区： 中国食品药品检定研究院,北京100050

出　　处： 《药物分析杂志》 2017年第8期1398-1405,共8页

摘　　要： 目的:通过对药材提取前后重金属及有害元素转移率的考察,建立分级别的整合"点评估"模型,为制定限量标准提供参考依据。方法:分别用水煎煮、70%乙醇溶液回流提取和95%乙醇溶液震荡提取川芎、黄连、水蛭、白花蛇舌草和海藻5种药材,浓缩成浸膏,采用电感耦合等离子体质谱法(ICP-MS法)测定浸膏中重金属及有害元素的残留量。并采用分级别的风险评估方法,对于药材提取前后重金属及有害元素残留量进行风险评估。其中第1级采用最大残留限量进行评估,第2级采用监测数据进行评估,第3级在第2级的基础上考虑加工因子等因素进行评估。结果:不同提取方法得到的药材中重金属及有害元素的转移率均值均不足10%。5种药材中重金属及有害元素的提取率大多数符合水煎煮提取大于70%乙醇水回流提取大于95%乙醇水震荡提取的规律。就不同元素而言,砷的提取率普遍高于其他元素。一级风险评估的结果表明川芎和水蛭中的铅和砷,黄连中的铅,海藻中的铅和镉可能对于部分人群具有一定的风险;二级风险评估的结果表明,水蛭中的砷,海藻中的铅、镉和砷可能对于部分人群具有一定的风险;三级风险评估的结果表明海藻中的砷可能对于部分人群具有一定的风险。结论:提取后重金属及有害元素有很大部分减少,转移率不容忽视。本研究建立了中药外源性有害残留物的分级别的整合"点评估"模型。对于较低级别评估模型得到的较高风险的情况,应一步采用更加精确的更高级别的评估模型进行评估。该风险评估模型的建立,为制定限量标准提供参考依据。 Objective： To study the transfer rates of heavy metals and harmful elements in traditional Chinese medicines （ TCMs ） before and after extraction and establishing tiered risk assessment models in order to provide basis for the formulation of standards. Methods： Szechwan lovage rhizome, golden thread, leech, hedyotis diffusa and seaweed were extracted by water, 70% ethanol or 95% ethanol, and were concentrated into extraction. The heavy metals and harmful elements were detected by inductively coupled plasma mass spectrometry （ ICP-MS ） method. Risk assessment for heavy metals and harmful elements in TCMs before and after extraction was done by tiered risk assessment approach. The first tiered risk assessment was assessed by maximum residue limits. The second tiered risk assessment was finished by monitoring data. The third tiered risk assessment was done based on the second tiered risk assessment and the processing factors were considered, Results： The average transfer rates of heavy metals and harmful elements in TCMs obtained by different extraction methods were less than 10%. The extraction rates of heavy metals and harmful elements of 5 kinds of TCMs followed the fact that water decoction extraction rates were larger than 70% ethanol reflux extraction rates. And 70% ethanol reflux extraction rates were larger than 95% ethanol shake extraction rates. For different elements, the extraction rates of arsenic were higher than those of other elements. The first tiered risk assessment results demonstrated that the lead and arsenic in szechwan lovage rhizome and leech, the lead in golden thread and lead and cadmium in seaweed may have certain risks for some people; The second tiered risk assessment results showed that the arsenic in the leech and the lead, cadmium and arsenic in seaweed might have risks for certain people; The third tiered risk assessment results displayed that the arsenic in seaweed might have risks for a part of population. Conclusion： Most of the heavy metals and harmful elements we

关 键 词： 重金属 有害元素 转移率 分级别风险评估 限量标准 川芎 黄连 水蛭 白花蛇舌草 海藻 电感耦合等离子体质谱