摘要
目的:明确栀子药材中重金属元素的残留水平和健康危害。方法:采用电感耦合等离子质谱法(ICP-MS)测定11个产地33批栀子中铜(Cu)、砷(As)、镉(Cd)、铅(Pb)、汞(Hg)5种重金属的含量,结合聚类分析对重金属残留进行产地评价,采用国际通用的健康风险评估模型计算不同产地及不同给药人群(成人和儿童)的靶标危害系数(THQ)以及重金属推荐最大残留限量值(MRL)。结果:在《中草药重金属限量国际标准(ISO 18664:2015)》(简称ISO标准)以及《药用植物及制剂进出口绿色行业标准》规定下,33批栀子中3批As超标,1批Hg超标,不合格率为12.1%;THQ和累积THQ结果表明,个别产地栀子中的As及重金属总量对人体健康有显著影响;结合THQ值,给出了针对栀子药材的重金属限量理论值MRL。结论:本研究为栀子药材的重金属评估及限量标准的制定奠定了理论基础,也为栀子质量标准的完善以及临床的安全用药提供了科学依据。
Objective: To determine the heavy metal residues in Fructus Gardeniae and risk assessment of heavy metals.Methods: The ICP-MS was used to determine the contents of five heavy metals including Cu, As, Cd, Pb and Hg in 33 batches of Fructus Gardeniae from 11 different habitats. Cluster analysis was applied on the evaluation of heavy metal residues from different habitats. Target hazard quotient(THQ) and the maximum residue limits(MRL) of heavy metals in different producing areas and different dosing populations(adults and children) were calculated by using the international general health risk assessment model. Results: According to the International Standard for Heavy Metal Limits of Chinese Herbal Medicine(ISO 18664:2015)and the Green Industrial Standard for the Import and Export of Medicinal Plants And Preparations, among 33 batches of Fructus Gardeniae, 3 batches of AS exceeded the standard, one batch of Hg exceeded the standard, and the unqualified rate was 12.1%. The results of THQ and total THQ demonstrated that the contents of As and total heavy metal in Fructus Gardeniae from individual habitats had a significant impact on human health. Combined with THQ value, the theoretical value MRL of heavy metal limit for gardenia was given. Conclusion: This research laid a theoretical foundation for the evaluation of heavy metal contents and the establishment of the limit standard of Fructus Gardeniae, and also provided a scientific basis for the improvement of the quality standard of Fructus Gardeniae and the safe use of medicine in clinic.
作者
李晓琦
王琪
陈彦
LI Xiao-qi;WANG Qi;CHEN Yan(Affiliated Hospital of Integrated Traditional Chinese and Western Medicine,Nanjing University of Chinese Medicine,Nanjing 210028,China;Multi-component of Traditional Chinese Medicine and Microecology Research Center,Jiangsu Province Academy of Traditional Chinese Medicine,Nanjing 210028,China)
出处
《中华中医药杂志》
CAS
CSCD
北大核心
2022年第2期1041-1046,共6页
China Journal of Traditional Chinese Medicine and Pharmacy
基金
国家中药标准化项目(No.ZYBZH-C-JS-33)。
作者简介
通信作者:陈彦,江苏省南京市栖霞区红山路十字街100号江苏省中医药研究院中药组分与微生态研究中心,邮编:210028电话:025-52362155,E-mail:ychftn202@hotmail.com。