中成药中重金属及有害元素残留分析、风险评估和限量制定建议  

Analysis and health risk assessment,including recommendation of limits for heavy metals and harmful elements in Chinese patent medicines

作　　者：聂黎行[1] 钱秀玉 蒋沁悦 李翔[3] 李静[1] 左甜甜 常艳[1] 金红宇[1] 戴忠[1] 马双成[1] NIE Li-xing;QIAN Xiu-yu;JIANG Qin-yue;LI Xiang;LI Jing;ZUO Tian-tian;CHANG Yan;JIN Hong-yu;DAI Zhong;MA Shuang-cheng(National Institutes for Food and Drug Control,Beijing 100050,China;Beijing University of Chinese Medicine,Beijing 100029,China;Medical Supplies Center of the PLA General Hospital,Beijing 100048,China)

机构地区：[1]中国食品药品检定研究院,北京100050 [2]北京中医药大学,北京100029 [3]解放军总医院医学保障中心,北京100048

出　　处：《药学学报》2020年第11期2695-2701,共7页Acta Pharmaceutica Sinica

基　　金：国家十三五“重大新药创制”专项(2018ZX09735006);国家自然科学基金资助项目(81303194);中国食品药品检定研究院学科带头人培养基金资助项目(2017X1)。

摘　　要：中药重金属及有害元素残留严重影响公众健康,因此中药材的重金属风险评估日益受到重视,但中成药中重金属及有害元素健康风险评价鲜见报道。为了解中成药中重金属及有害元素整体残留情况及风险,拟定合理限量,基于2010~2018年国家药品抽验大数据,从分布情况、元素和剂型差异、相关性等角度分析了295个品种15054批次中成药中铅、镉、砷、汞、铜、铬的残留特征。按照危害识别、危害特征描述、暴露评估和风险描述的程序,明确了中成药中重金属及有害元素风险评估的基本步骤、计算公式和具体参数,对14787批次样品和276个品种进行了健康风险评估,提出了最大限量的建议制定方法和计算公式。结果显示所有样品各元素残留值和靶标危害系数均呈趋近于0的偏态分布,部分样品Pb、As、Cu、Hg、Cd或Cr残留值超过100 mg·kg^-1,个别样品Pb、As或Cu残留值超过1000 mg·kg^-1,586批次样品靶标危害系数>1,4个品种靶标危害系数>1。中成药丸剂、胶囊剂、片剂、散剂,尤其是原粉制剂中Hg、Pb、As的残留及健康风险应引起关注。Heavy metals and other harmful elements in traditional Chinese medicines inflict serious damage on public health.Therefore,risk assessment of Chinese raw materials has gained increasing attention.To date,few reports have been published on the health risk assessment of heavy metals and harmful elements in Chinese patent medicines.To gain a comprehensive understanding of heavy metals and other harmful elements in Chinese patent medicines and to establish proper limits,residual Pb,Cd,As,Hg,Cu and Cr in 15054 samples of 295 drugs was analyzed with regard to distribution and variation between elements and dosage forms.In addition,in accord with procedures including hazard identification,hazard characterization,exposure assessment and risk characterization,basic procedures and specific parameters for risk assessment of heavy metals and harmful elements in Chinese patent medicines were clarified based on the health risk assessment of 14787 samples and 276 drugs.A method and equation for establishing residual limits is proposed.The results show that content and target hazard quotients(THQs)of the investigated elements in all samples showed a skewed distribution approaching 0.Content of Pb,As,Cu,Hg,Cd or Cr in the samples exceeded 100 mg·kg^-1 and the content of Pb,As,or Cu in individual samples exceeded 1000 mg·kg^-1.THQs of 586 samples and four drugs were above 1.We believe that the health risk of Hg,Pb and As in Chinese patent medicines with dosage forms of pill,capsule,tablet and powder,especially those in raw powder preparations,warrant concern.

关 键 词：中成药 重金属及有害元素 有害残留 风险评估 限量 国家药品抽验 

分 类 号：R917[医药卫生—药物分析学]