根和根茎类中药材中铅和砷致癌性风险评估研究  

A Study to Carcinogenic Risk Assessment of Pb&As in Root and Rhizome Medicinal Meterials

作　　者：左甜甜 金红宇[1] 张磊 石上梅[3] 申明睿 高飞[1] 马双成[1] Zuo Tiantian;Jin Hongyu;Zhang Lei;Shi Shangmei;Shen Mingrui;Gao Fei;Ma Shuangcheng(National Institutes for Food and Drug Control,Beijing 100050,China;China National Center for Food Safety Risk Assessment,Beijing 100022,China;Chinese Pharmacopoeia Commission,Beijing 100061,China)

机构地区：[1]中国食品药品检定研究院,北京100050 [2]国家食品安全风险评估中心,北京100022 [3]国家药典委员会,北京100061

出　　处：《中国药事》2021年第6期661-665,共5页Chinese Pharmaceutical Affairs

基　　金：国家十三五“重大新药创制”课题(编号2018ZX09735006)。

摘　　要：目的:通过对10种根和根茎类中药材中铅(Pb)和砷(As)的分析、测定及致癌性风险评估,为相关残留限量标准的制修订提供参考依据。方法:采用电感耦合等离子体质谱(ICP-MS)法对全国范围内收集到的巴戟天等883批10种根和根茎类中药材中Pb和As的残留量进行测定和分析。同时,在美国环保署(US EPA)推荐的健康风险评估模型的基础上,结合课题组前期所获得的我国人群(包括高暴露人群和一般暴露人群)的暴露参数,建立符合中药使用特点的根和根茎类品种中致癌性金属元素的致癌风险评估模型。采用致癌风险法(CR)对其Pb和As的致癌性健康风险进行确定性评估。结果:883批根和根茎类中药材中巴戟天的铅的均值超标。致癌性风险评估结果表明,对于一般暴露人群来讲,所有根和根茎类品种中Pb和As的致癌性健康风险均可以被忽略。而对于高暴露人群来讲,当归、三七、巴戟天的致癌性健康风险需要被关注。结论:本研究提出了符合中药使用特点的致癌性金属元素的致癌性健康风险评估模型,为建立符合中药使用特点的风险评估技术体系,以及残留限量标准和相关指导原则的制修订提供了技术支撑。Objective: To provide references for the formulation and revision of related residue limit standards through the analysis, determination and carcinogenicity risk assessment of lead(Pb) and arsenic(As) in 10 kinds of root and rhizome Chinese medicinal materials. Methods: Inductively coupled plasma mass spectrometry(ICP-MS) was used to detect and analyze the residues of lead and arsenic in 10 kinds of root and rhizome Chinese medicinal materials from 883 batches of samples collected nationwide. Moreover, on the basis of the health risk assessment model recommended by US EPA and in combination with the exposure parameters of Chinese population(including the high exposure population and the general exposure population) obtained by our previous study, the carcinogenic risk assessment model of carcinogenic metal elements in root and rhizome materials applicable to traditional Chinese medicines(TCMs) was established. The carcinogenic health risks of lead and arsenic were evaluated by the method of carcinogenic risk(CR). Results: Out of 883 batches of root and rhizome Chinese medicinal materials, the mean value of lead in Morindae Officinalis Radix exceeded the standard. The results of carcinogenic risk assessment indicated that for the general exposure population, the carcinogenic risks of lead and arsenic in all root and rhizome varieties could be ignored. However, for the high exposure population, the carcinogenic health risks of Angelicae Sinensis Radix, Notoginseng Radix Et Rhizoma and Morindae Officinalis Radix were of great concern. Conclusion: A carcinogenic health risk assessment model of metal elements applicable to traditional Chinese medicines is proposed. This study will provide technical help for the establishment of risk assessment technical system applicable to the TCMs, the formulation of residue limit standards, and the revision of related guidelines.

关 键 词：中药材 根和根茎 铅 砷 风险评估 致癌性 

分 类 号：R28[医药卫生—中药学] R995[医药卫生—中医学]