人参健脾丸中重金属及有害元素的测定、风险评估及最大限量理论值研究  

Determination,risk assessment and theoretical value of maximum limit of heavy metals and harmful elements in Renshen Jianpi Pills

作　　者：周广涛 黄蒙蒙 栾永福 周倩倩 汪冰 林永强 ZHOU Guang-tao;HUANG Meng-meng;LUAN Yong-fu;ZHOU Qian-qian;WANG Bing;LIN Yong-qiang(National Medical Products Administration Key Laboratory of Rubber Product Quality Evaluation,Shandong Engineering Laboratory for Standard Innovation and Quality Evaluation of Traditional Chinese Medicine,Shandong Institute for Food and Drug Control,Jinan 250101,China;Dong’e Ejiao Co.,Ltd.,Liaocheng 252299,China)

机构地区：[1]山东省食品药品检验研究院,国家药监局胶类产品质量评价重点实验室,山东省中药标准创新与质量评价工程实验室,山东济南250101 [2]东阿阿胶股份有限公司,山东聊城252299

出　　处：《中草药》2023年第16期5225-5232,共8页Chinese Traditional and Herbal Drugs

基　　金：山东省重点研发计划资助项目(重大科技创新工程)(2021CXGC010511);2021年度山东省人文社会科学课题(2021-YYGL-44)。

摘　　要：目的测定人参健脾丸(Renshen Jianpi Pills,RJP)中重金属及有害元素含量,对其进行风险评估并制定限度,为其安全使用提供指导。方法采用电感耦合等离子体质谱法对收集到的30个厂家共135批RJP中的Pb、Cd、As、Hg和Cu5种重金属及有害元素进行测定;采用风险评估的方法对重金属和有害元素的安全性进行评估,计算危害指数(hazard index,HI),并根据评估结果制定最大限量理论值。结果有21批样品Pb元素和55批样品Hg元素的HI值>1,Cd、As和Cu元素HI值均<1。Pb和Hg元素的HI均值分别为0.85和5.32,远高于Cd、As和Cu元素的0.12、0.17和0.04,应予以关注。根据评估结果,结合RJP用法用量,制定Pb、Cd、As、Hg、Cu的最大限量理论值,大蜜丸和小蜜丸为0.5、0.5、1.0、0.1、135 mg/kg;水蜜丸为1.0、0.5、1.5、0.2、200 mg/kg。按制订的限度评价,分别有15批样品的Pb元素和70批样品的Hg元素超标,超标率分别为11.1%和51.9%。结论所建立的风险评估法可有效评估RJP中的重金属及有害元素健康风险,制订的最大限量理论值针对性较强,为其安全用药提供了依据。Objective To determinate the contents of heavy metals and harmful elements in Renshen Jianpi Pills(RJP,人参健脾丸),conduct risk assessments and establish limits,so as to provide guidance for their safe use.Methods ICP-MS was used to determine five heavy metals(Pb,Cd,As,Hg and Cu)and harmful elements in 135 batches of RJP collected from 30 manufacturers.The safety of heavy metals and harmful elements were evaluated by the risk assessment method.The hazard index(HI)was calculated,and the theoretical value of the maximum limit was formulated according to the evaluation results.Results The HI value of Pb in 21 batches samples and Hg in 55 batches samples were all>1,the HI values of Cd,As and Cu were all lower than 1.The average HI values of Pb and Hg were respectively 0.85 and 5.32,it was much higher than 0.12,0.17 and 0.04 of Cd,As and Cu,which should be paid attention to.According to the evaluation results,combined with the usage and dosage of RJP,the theoretical maximum limit values of Pb,Cd,As,Hg and Cu were established,0.5,0.5,1.0,0.1,135 mg/kg for Dami Pills and Xiaomi Pills;1.0,0.5,1.5,0.2 and 200 mg/kg for Water Pills.According to the established limit evaluation,15 batches of Pb and 70 batches of Hg exceeded the standard,the exceeding rate was 11.1% and 51.9%,respectively.Conclusion The risk assessment method established in this study can effectively assess the health risk of heavy metals and harmful elements in RJP,the theoretical maximum limit values formulated are highly targeted and provided a basis for its safe medication.

关 键 词：人参健脾丸 重金属 有害元素 风险评估 最大限量理论值 电感耦合等离子体质谱法 危害指数 Pb Cd As HG Cu 安全性 

分 类 号：R283.6[医药卫生—中药学]