基于ICP-MS和对照制剂的牛黄清胃丸中重金属及有害元素残留量测定及风险评估
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摘要
为了解牛黄清胃丸中重金属及有害元素整体残留情况,从全国31个省区抽取了18个厂家的49批次样品,并创新性地将风险评估和对照制剂引入中药外源性污染评价。采用电感耦合等离子体质谱法建立了铅(Pb)、镉(Cd)、砷(As)、汞(Hg)、铜(Cu)的测定方法。按照危害识别、危害特征描述、暴露评估和风险描述的程序进行风险评估,并制定了该品种中铅、镉、砷、汞、铜的残留限量。结果显示,各元素危害伤值大小顺序为铅>砷>铜>汞>镉,牛黄清胃中重金属及有害元素的总危害指数大于1,提示品种存在一定的健康风险.在拟定限度下,对照制剂中5种元素均未超标,样品中镉、铜均未超标,铅、砷、汞超标率分别为12%,12%,14%。首次提出了中成药中重金属及有害元素风险评估的一般步骤,为其他中成药的风险评估和限量制定提供了示范和参考。
To achieve a comprehensive understanding of heavy metals and harmful elements residues in Niuhuang Qingwei Pills,49 samples from 18 manufactures were collected from 31 provinces in China.Risk assessment and control preparations were applied innovatively in evaluation of exogenous pollution in traditional Chinese Medicine.Determination methods for Pb,Cd,As,Hg and Cu were established by inductively coupled plasma mass spectrometry(ICP-MS).Based on the procedures including hazard identification,hazard characterization,exposure assessment and risk characterization,risk assessment was performed and residual limits for Pb,Cd,As,Hg and Cu in the drug were formulated.The results showed that the hazardous quotients(HQ) of the elements were decreased in the following order:Pb>As>Cu>Hg>Cd,and the total hazardous index(HI) of heavy metals and harmful elements in Niuhuang Qingwei Pills was above 1,implying health risk of the drug.Under the proposed limits,5 elements in the control preparation as well as Cd and Cu in the samples were within the limits range,but the excess rates of Pb,As and Hg in the samples were 12%,12% and 14%,respectively.For the first time,basic steps for risk assessment of Chinese patent medicine were established,which provided model and reference for risk assessment and limit formulation of other drugs.
To achieve a comprehensive understanding of heavy metals and harmful elements residues in Niuhuang Qingwei Pills,49 samples from 18 manufactures were collected from 31 provinces in China.Risk assessment and control preparations were applied innovatively in evaluation of exogenous pollution in traditional Chinese Medicine.Determination methods for Pb,Cd,As,Hg and Cu were established by inductively coupled plasma mass spectrometry(ICP-MS).Based on the procedures including hazard identification,hazard characterization,exposure assessment and risk characterization,risk assessment was performed and residual limits for Pb,Cd,As,Hg and Cu in the drug were formulated.The results showed that the hazardous quotients(HQ) of the elements were decreased in the following order:Pb>As>Cu>Hg>Cd,and the total hazardous index(HI) of heavy metals and harmful elements in Niuhuang Qingwei Pills was above 1,implying health risk of the drug.Under the proposed limits,5 elements in the control preparation as well as Cd and Cu in the samples were within the limits range,but the excess rates of Pb,As and Hg in the samples were 12%,12% and 14%,respectively.For the first time,basic steps for risk assessment of Chinese patent medicine were established,which provided model and reference for risk assessment and limit formulation of other drugs.
引文
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[18]周利,杨健,詹志来,等.不同产地黄连中重金属的含量测定及不同用药方式下黄连重金属的风险评估[J].药学学报,2018,53(3):432.
[19]左甜甜,李耀磊,陈沛,等.西洋参、山楂、枸杞子中重金属及有害元素残留量测定及初步风险评估[J].药物分析杂志,2016,36(11):2016.
[20]周骁腾,卢恒,侯静怡,等.当归中4种金属微量元素的检测及其健康风险评价[J].中国环境科学,2013,33(9):1652.
[21]左甜甜,张磊,金红宇,等.中药材提取前后重金属及有害元素转移率和分级别风险评估的研究[J].药物分析杂志,2017,37(8):1398.
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[2]邱学伟,张春辉,吴爱英.不同产地板蓝根中重金属元素的含量测定及分析[J].中国现代应用药学,2018,35(5):715.
[3]张家春,曾宪平,张珍明,等.不同功能区土壤-钩藤系统重金属累计特征及评价[J].中国中药杂志,2016,41(20):3746.
[4]齐耀东,张志鹏,张昭,等.关黄柏产区土壤重金属污染及药材安全性评价[J].中国中药杂志,2016,41(3):383.
[5]周利,郝庆秀,王升,等.微波消解ICP-MS法对冬虫夏草不同部位5种重金属元素的分布研究[J].中国中药杂志,2017,42(15):2934.
[6]侯时季,李涛,蔺阁,等.施用沼液和接种丛枝菌根真菌对甘草生长及重金属累积的影响[J].环境化学,2016,35(8):1465.
[7]郭俊娒,杨俊兴,杨军,等.Cd、Zn交互作用对三七景天根系形态和重金属吸收积累的影响[J].环境科学,2018,doi:10.13227/j.hjkx.201805055.
[8]张亚静,汪涛,郭巧生,等.不同产地野菊花及土壤中重金属元素含量比较研究[J].中国中药杂志,2018,43(14):2908.
[9]甘彦雄,郑勇凤,汪蕾,等.基于ICP-MS分析蓬莪术醋制前后煎液及沉淀物重金属转移率变化[J].中国中药杂志,2016,41(1):65.
[10]彭亮,王媛媛,黄涛,等.ICP-MS法测定陕西不同产地野生茜草中9种重金属[J].中草药,2018,49(6):1418.
[11]范桂强,马国荣,崔婧,等.ICP-MS法测定六味颈康胶囊中的5种重金属元素含量[J].中国现代中药,2018,20(3):337.
[12]张平,马潇,张明童,等.ICP-MS分析不同产地侧柏叶中18种重金属及微量元素[J].中国实验方剂学杂志,2018,24(7):75.
[13]吴建杰,骆骄阳,谷善勇,等.柴胡饮片中重金属生物可给性研究及其风险评估[J].中国中药杂志,2018,43(22):4479.
[14]康国华,张鹏岩,李颜颜,等.黄河下游开封段引黄灌区小麦中重金属污染特征及健康风险评价[J].环境科学,2018,39(8):1465.
[15]田美玲,钟雪梅,张云霞,等.矿业活动影响区稻田土壤和稻米中重金属含量及健康风险[J].环境科学,2018,39(6):2919.
[16]朱美霖,朱新忠,冯宁川.重金属在甘草中的健康风险评估及限量浓度测定[J].中成药,2016,38(8):1771.
[17]曾宪彩,晁思宏,朱美霖,等.中药三七中5种微量元素的含量及健康风险[J].中国环境科学,2016,36(1):293.
[18]周利,杨健,詹志来,等.不同产地黄连中重金属的含量测定及不同用药方式下黄连重金属的风险评估[J].药学学报,2018,53(3):432.
[19]左甜甜,李耀磊,陈沛,等.西洋参、山楂、枸杞子中重金属及有害元素残留量测定及初步风险评估[J].药物分析杂志,2016,36(11):2016.
[20]周骁腾,卢恒,侯静怡,等.当归中4种金属微量元素的检测及其健康风险评价[J].中国环境科学,2013,33(9):1652.
[21]左甜甜,张磊,金红宇,等.中药材提取前后重金属及有害元素转移率和分级别风险评估的研究[J].药物分析杂志,2017,37(8):1398.
[22]Environmental health criteria 240:principles and methods for the risk assessment of chemicals in food[EB/OL].[2018-09-10].http://www.who.int/foodsafety/publications/chemicalfood/en.html,2012-06-15.
[23]Joint FAO/WHO expert committee on food additives.Summary report of the seventy-second meeting of JECFA[EB/OL].[2018-09-10].http://www.who.int/foodsafety/publications/chem/summary72.pdf?ua=1.html,2012-06-04.
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[25]US EPA.Guidelines for performing aggregate exposure and risk assessments[R].Washington DC:U.S.environmental protection agency,Office of Pesticide Programs,1999b.
[26]World Health Organization:Quality control methods for medicinal plant materials[EB/OL].[2018-09-10].http://apps.who.int/iris/bitstream/10665/41986/1/9241545100.pdf.html,2012-05-04.
[27]NSF International:dietary supplement-standard 173:metal contaminant accepted level[S].2003:1.