Article(id=1322922752566493683, tenantId=1146029695717560320, journalId=1255847919539208197, issueId=1322922680609014711, articleNumber=null, orderNo=null, doi=10.13193/j.issn.1673-7717.2025.02.030, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1793338962928, onlineDateStr=2026-10-30, pubDate=1739116800000, pubDateStr=2025-02-10, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793338962928, onlineIssueDateStr=2026-10-30, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793338962928, creator=13701087609, updateTime=1793338962928, updator=13701087609, issue=Issue{id=1322922680609014711, tenantId=1146029695717560320, journalId=1255847919539208197, year='2025', volume='43', issue='2', pageStart='1', pageEnd='258', issueExtLink='null', onlineDate='null', pubDate='1739116800000', pubDateStr='2025-02-10', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=0, createTime=1793338945772, creator='13701087609', updateTime=1793340618065, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322929694785536732, tenantId=1146029695717560320, journalId=1255847919539208197, issueId=1322922680609014711, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322929694785536733, tenantId=1146029695717560320, journalId=1255847919539208197, issueId=1322922680609014711, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=136, endPage=140, ext={EN=ArticleExt(id=1322922752805569012, articleId=1322922752566493683, tenantId=1146029695717560320, journalId=1255847919539208197, language=EN, title=Study on Pharmacopoeia Standard of Residues of Heavy Metals In Plant Medicinal Materials, columnId=1256183361521967297, journalTitle=Chinese Archives of Traditional Chinese Medicine, columnName=Target on National Project, runingTitle=null, highlight=null, articleAbstract=
Objective

This article mainly analyzed and discussed the regulations on heavy metal residue limits for plant medicinal materials in the Pharmacopoeia of The People's Republic of China,understood the existing heavy metal limit regulations in the Pharmacopoeia of The People's Republic of China and provided reference for the revision of heavy metal residue regulations for plant medicinal materials in the future and corresponding countermeasures to promote the development of the medicinal value of plant medicinal materials.

Methods

The main research methods used in this project were literature research,statistical analysis and descriptive research,searching the literature for statistical analysis.

Results

The Pharmacopoeia of The People's Republic of China has been conducting heavy metal testing since2000. The 2005 edition clearly defined the heavy metal content in plant medicinal materials and with the increase of years,we can add other plant medicinal material while maintaining the original heavy metal content. The heavy metal limits in the The Pharmacopoeia of The People's Republic of China are consistent with the Green Industry Standard for the Import and Export of Medicinal Plants and Preparations,and their values are stricter compared to the heavy metal limits of other countries and regions.

Conclusion

The formulation of heavy metal residue limit standards for plant medicinal materials in the Pharmacopoeia of The People's Republic of China is gradually being improved and perfected. The analysis and research of the standards for heavy metal residues in plant medicinal materials is a detailed explanation of the residual amount,stability,accuracy,objectivity and other characteristics of heavy metals in plant medicinal materials as reference indicators for monitoring and national basic medical and health standards.

, authors=Meiling XU, Wanping SUN, Yangon QU, Jianhua WANG, Wenyi SUN, Ming XIE, authorsList=Meiling XU, Wanping SUN, Yangon QU, Jianhua WANG, Wenyi SUN, Ming XIE, authorCompany=null, correspAuthors=Ming XIE, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1322922753443103223, articleId=1322922752566493683, tenantId=1146029695717560320, journalId=1255847919539208197, language=CN, title=植物药材重金属残留药典标准研究, columnId=1256183362172142382, journalTitle=中华中医药学刊, columnName=国家项目点击, runingTitle=null, highlight=null, articleAbstract=
目的

分析探讨《中华人民共和国药典》中涉及到植物药材重金属残留限量规定,了解《中华人民共和国药典》现有的重金属限量规定,进而为之后植物药材重金属残留规定修订工作提供参考依据,促进植物药材药用价值的发展提供相应对策。

方法

采用文献研究法、统计分析法和描述性研究法,搜索文献资料进行统计分析。

结果

《中华人民共和国药典》自2000年起就开始了重金属的检测,2005版《中华人民共和国药典》对植物药材中的重金属含量进行了明确的规定,随着年份的增长,可以在保持原有的重金属含量的基础上添加其他的植物药物,《中华人民共和国药典》规定的重金属限值与《药用植物及制剂进出口绿色行业标准》的规定基本相符,其数值较其他国家和地区的规定更为严格。

结论

我国药典植物药材重金属残留限量标准的制定在逐步改良完善,植物药材重金属残留药典标准分析研究是对植物药材中重金属的残留量,稳定性,以及其作为监测和国家基本医疗保健标准参考指标时应该具有的准确度、客观性等特点进行详细说明。

, authors=徐美玲, 孙婉萍, 曲扬, 王建华, 孙文怡, 谢明, authorsList=徐美玲, 孙婉萍, 曲扬, 王建华, 孙文怡, 谢明, authorCompany=null, correspAuthors=谢明, authorNote=

徐美玲(1983-),女,辽宁大连人,讲师,硕士,研究方向:药事管理。

, correspAuthorsNote=
谢明(1962-),男,辽宁沈阳人,教授,博士,研究方向:药事管理。Email:。
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徐美玲(1983-),女,辽宁大连人,讲师,硕士,研究方向:药事管理。

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徐美玲(1983-),女,辽宁大连人,讲师,硕士,研究方向:药事管理。

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元素每日允许摄入量(ADI)限量最大限量评估值
中国世界卫生组织美国意大利新加坡西洋
参
山楂枸杞子
铅0.003 6051010553.571.781.78
镉0.000 830.30.30.30.10.20.830.420.42
砷0.002 102///32.141.071.07
汞0.000 570.2/30.20.30.570.280.28
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药材(饮片)中铅、砷、汞、镉的各国标准限量与最大限量理论值的比较

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元素每日允许摄入量(ADI)限量最大限量评估值
中国世界卫生组织美国意大利新加坡西洋
参
山楂枸杞子
铅0.003 6051010553.571.781.78
镉0.000 830.30.30.30.10.20.830.420.42
砷0.002 102///32.141.071.07
汞0.000 570.2/30.20.30.570.280.28
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药典版本植物药材重金属限量标准
2005版《中华人民共和国药典》西洋参、甘草、黄芪、丹参、金银花、白芍铅≤5.0,镉≤0.3,汞≤0.2,铜≤20.0,砷≤2.0
2010版《中华人民共和国药典》西洋参、甘草、黄芪、丹参、金银花、白芍铅≤5.0,镉≤0.3,汞≤0.2,铜≤20.0,砷≤2.0
2015版《中华人民共和国药典》西洋参、甘草、黄芪、丹参、金银花、白芍、山楂、枸杞子、海藻、昆布铅≤5.0,镉≤0.3,汞≤0.2,铜≤20.0,砷≤2.0
2020版《中华人民共和国药典》西洋参、甘草、黄芪、丹参、金银花、白芍、山楂、枸杞子、海藻、昆布、白芷、葛根、当归、黄精铅≤5.0,镉≤0.3,汞≤0.2,铜≤20.0,砷≤2.0
), ArticleFig(id=1322922761076736551, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322922752566493683, language=CN, label=表2, caption=

4版《中华人民共和国药典》中新增药材及重金属限量标准

, figureFileSmall=null, figureFileBig=null, tableContent=
药典版本植物药材重金属限量标准
2005版《中华人民共和国药典》西洋参、甘草、黄芪、丹参、金银花、白芍铅≤5.0,镉≤0.3,汞≤0.2,铜≤20.0,砷≤2.0
2010版《中华人民共和国药典》西洋参、甘草、黄芪、丹参、金银花、白芍铅≤5.0,镉≤0.3,汞≤0.2,铜≤20.0,砷≤2.0
2015版《中华人民共和国药典》西洋参、甘草、黄芪、丹参、金银花、白芍、山楂、枸杞子、海藻、昆布铅≤5.0,镉≤0.3,汞≤0.2,铜≤20.0,砷≤2.0
2020版《中华人民共和国药典》西洋参、甘草、黄芪、丹参、金银花、白芍、山楂、枸杞子、海藻、昆布、白芷、葛根、当归、黄精铅≤5.0,镉≤0.3,汞≤0.2,铜≤20.0,砷≤2.0
), ArticleFig(id=1322922761160622632, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322922752566493683, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
不同国家或地区标准标准/授权组织应用对象铜(Cu)(Pb)
铅
(As)砷(Cd)镉(Hg)汞
《中华人民共和国药典》2015版中药材20.05.02.00.30.2
中国绿色行业标准药用植物及制剂的绿色标准法规中药材20.05.02.00.30.2
美国膳食补充标准原料/10.05.00.30.2
日本日本药典中药材/中成药/20.02.0//
英国英国药典中药材/5.05.0//
), ArticleFig(id=1322922761269674537, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322922752566493683, language=CN, label=表3, caption=

各国家的中药重金属限量水平

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不同国家或地区标准标准/授权组织应用对象铜(Cu)(Pb)
铅
(As)砷(Cd)镉(Hg)汞
《中华人民共和国药典》2015版中药材20.05.02.00.30.2
中国绿色行业标准药用植物及制剂的绿色标准法规中药材20.05.02.00.30.2
美国膳食补充标准原料/10.05.00.30.2
日本日本药典中药材/中成药/20.02.0//
英国英国药典中药材/5.05.0//
), ArticleFig(id=1322922761349366314, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322922752566493683, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
药典名称铅的限量标准
《中华人民共和国药典》2005版≤5.0
《中华人民共和国药典》2010版≤5.0
《中华人民共和国药典》2015版≤5.0
《中华人民共和国药典》2020版≤5.0
), ArticleFig(id=1322922761424863787, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322922752566493683, language=CN, label=表4, caption=

4版《中华人民共和国药典》中铅的限量规定变化

, figureFileSmall=null, figureFileBig=null, tableContent=
药典名称铅的限量标准
《中华人民共和国药典》2005版≤5.0
《中华人民共和国药典》2010版≤5.0
《中华人民共和国药典》2015版≤5.0
《中华人民共和国药典》2020版≤5.0
), ArticleFig(id=1322922761491972652, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322922752566493683, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
重金属铅(Pb)镉(Cd)汞(Hg)砷(As)铜(Cu)
限量≤5.0≤0.3≤0.2≤2.0≤20.0
), ArticleFig(id=1322922761575858733, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322922752566493683, language=CN, label=表5, caption=

《药用植物及制剂进出口绿色行业标准》(WM/T2-2004)

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重金属铅(Pb)镉(Cd)汞(Hg)砷(As)铜(Cu)
限量≤5.0≤0.3≤0.2≤2.0≤20.0
), ArticleFig(id=1322922761642967598, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322922752566493683, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
药典名称重金属
铅镉汞铜砷
《中华人民共和国药典》2005版≤5.0≤0.3≤0.2≤20.0≤2.0
《中华人民共和国药典》2010版≤5.0≤0.3≤0.2≤20.0≤2.0
《中华人民共和国药典》2015版≤5.0≤0.3≤0.2≤20.0≤2.0
《中华人民共和国药典》2020版≤5.0≤0.3≤0.2≤20.0≤2.0
), ArticleFig(id=1322922761731047983, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322922752566493683, language=CN, label=表6, caption=

4版《中华人民共和国药典》中重金属限量规定变化

, figureFileSmall=null, figureFileBig=null, tableContent=
药典名称重金属
铅镉汞铜砷
《中华人民共和国药典》2005版≤5.0≤0.3≤0.2≤20.0≤2.0
《中华人民共和国药典》2010版≤5.0≤0.3≤0.2≤20.0≤2.0
《中华人民共和国药典》2015版≤5.0≤0.3≤0.2≤20.0≤2.0
《中华人民共和国药典》2020版≤5.0≤0.3≤0.2≤20.0≤2.0
), ArticleFig(id=1322922761810739760, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322922752566493683, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
元素名称《中华人民共和国药典》药用植物及制剂进出口绿色行业标准
铅≤5.0≤5.0
镉≤0.3≤0.3
砷≤2.0≤2.0
汞≤0.2≤0.2
铜≤20.0≤20.0
), ArticleFig(id=1322922761882042929, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322922752566493683, language=CN, label=表7, caption=

中国植物药材重金属残留限量标准

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元素名称《中华人民共和国药典》药用植物及制剂进出口绿色行业标准
铅≤5.0≤5.0
镉≤0.3≤0.3
砷≤2.0≤2.0
汞≤0.2≤0.2
铜≤20.0≤20.0
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植物药材重金属残留药典标准研究
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徐美玲 , 孙婉萍 , 曲扬 , 王建华 , 孙文怡 , 谢明
中华中医药学刊 | 国家项目点击 2025,43(2): 136-140
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中华中医药学刊 |国家项目点击 2025 , 43 (2) : 136 -140
植物药材重金属残留药典标准研究
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徐美玲, 孙婉萍, 曲扬, 王建华, 孙文怡, 谢明
作者信息
  • 辽宁中医药大学药学院,辽宁 大连 116600
通讯作者:
谢明(1962-),男,辽宁沈阳人,教授,博士,研究方向:药事管理。Email:。
作者简介:

徐美玲(1983-),女,辽宁大连人,讲师,硕士,研究方向:药事管理。

Study on Pharmacopoeia Standard of Residues of Heavy Metals In Plant Medicinal Materials
Meiling XU, Wanping SUN, Yangon QU, Jianhua WANG, Wenyi SUN, Ming XIE
Affiliations
  • College of Pharmacy,Liaoning University of Traditional Chinese Medicine,Dalian 116600,Liaoning,China
出版时间: 2025-02-10 doi: 10.13193/j.issn.1673-7717.2025.02.030
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目的

分析探讨《中华人民共和国药典》中涉及到植物药材重金属残留限量规定,了解《中华人民共和国药典》现有的重金属限量规定,进而为之后植物药材重金属残留规定修订工作提供参考依据,促进植物药材药用价值的发展提供相应对策。

方法

采用文献研究法、统计分析法和描述性研究法,搜索文献资料进行统计分析。

结果

《中华人民共和国药典》自2000年起就开始了重金属的检测,2005版《中华人民共和国药典》对植物药材中的重金属含量进行了明确的规定,随着年份的增长,可以在保持原有的重金属含量的基础上添加其他的植物药物,《中华人民共和国药典》规定的重金属限值与《药用植物及制剂进出口绿色行业标准》的规定基本相符,其数值较其他国家和地区的规定更为严格。

结论

我国药典植物药材重金属残留限量标准的制定在逐步改良完善,植物药材重金属残留药典标准分析研究是对植物药材中重金属的残留量,稳定性,以及其作为监测和国家基本医疗保健标准参考指标时应该具有的准确度、客观性等特点进行详细说明。

植物药材  /  重金属残留  /  药典  /  限量标准
Objective

This article mainly analyzed and discussed the regulations on heavy metal residue limits for plant medicinal materials in the Pharmacopoeia of The People's Republic of China,understood the existing heavy metal limit regulations in the Pharmacopoeia of The People's Republic of China and provided reference for the revision of heavy metal residue regulations for plant medicinal materials in the future and corresponding countermeasures to promote the development of the medicinal value of plant medicinal materials.

Methods

The main research methods used in this project were literature research,statistical analysis and descriptive research,searching the literature for statistical analysis.

Results

The Pharmacopoeia of The People's Republic of China has been conducting heavy metal testing since2000. The 2005 edition clearly defined the heavy metal content in plant medicinal materials and with the increase of years,we can add other plant medicinal material while maintaining the original heavy metal content. The heavy metal limits in the The Pharmacopoeia of The People's Republic of China are consistent with the Green Industry Standard for the Import and Export of Medicinal Plants and Preparations,and their values are stricter compared to the heavy metal limits of other countries and regions.

Conclusion

The formulation of heavy metal residue limit standards for plant medicinal materials in the Pharmacopoeia of The People's Republic of China is gradually being improved and perfected. The analysis and research of the standards for heavy metal residues in plant medicinal materials is a detailed explanation of the residual amount,stability,accuracy,objectivity and other characteristics of heavy metals in plant medicinal materials as reference indicators for monitoring and national basic medical and health standards.

plant medicinal materials  /  heavy metal residue  /  pharmacopoeia  /  standard limit
徐美玲, 孙婉萍, 曲扬, 王建华, 孙文怡, 谢明. 植物药材重金属残留药典标准研究. 中华中医药学刊, 2025 , 43 (2) : 136 -140 . DOI: 10.13193/j.issn.1673-7717.2025.02.030
Meiling XU, Wanping SUN, Yangon QU, Jianhua WANG, Wenyi SUN, Ming XIE. Study on Pharmacopoeia Standard of Residues of Heavy Metals In Plant Medicinal Materials[J]. Chinese Archives of Traditional Chinese Medicine, 2025 , 43 (2) : 136 -140 . DOI: 10.13193/j.issn.1673-7717.2025.02.030
植物药材在我国中药材中占比最大,据相关统计2020版《中华人民共和国药典》共收录了499植物药材[1]在医学上用于防病治病,其植物可用于医药行业或医药行业中的材料。近年来,由于植物药材受生长环境及加工储存过程的影响,其安全问题颇受关注,特别是重金属污染,能与人体中相关物质发生反应,造成人体生化功能的改变,所以我国建立以《中华人民共和国药典》为核心的药品标准体系[2]。植物药材重金属限量标准与我国中药材的用药安全和疗效的发挥有着密切联系,所以为了确保植物药材的安全性与疗效,须了解我国药典中涉及到植物药材重金属残留限量规定,进而为之后植物药材重金属残留规定修订工作提供参考依据,促进植物药材药用价值的发展提供相应对策。
近年来,随着植物药材需求量的逐渐增长,药物安全问题也越来越受到关注,关于植物药材重金属超标的报道屡见不鲜,这类事件的发生影响着我国植物药材用药安全性和疗效,还限制了我国植物药材产业的经济问题。
本课题为药事管理学研究方向,根据《中华人民共和国药典》中有关植物类药材中的重金属元素限量要求,通过分析比较国内各版药典中植物药材重金属限量标准,针对现阶段我国植物药材重金属限量标准提出相关建议。
重金属元素主要有:铜(Cu)、汞(Hg)、砷(As)、镉(Cd)、铅(Pb)、锌(Zn)、银(Ag)、铬(Cr)、铁(Fe)、铂(Pt)等。常见的重金属有:Cu、Hg、As、Cd、Pb等,砷虽然不是真正的重金属,但是它的来源和危害性与重金属类似,故通常列入重金属类进行研究[3]。由于工业的快速发展,农药的频繁使用以及人类过度的城市化活动,导致了重金属在环境中的扩散,从而进入食物链中进行生物蓄积[4-6]。植物对环境的敏感性很高,重金属通过植物的吸收是其进入食物链的重要途径。重金属污染也是全球环境治理的重大挑战之一。
在我国,中药材重金属的污染现状不太乐观。孔丹丹等[7]对51批次的中草药进行了重金属检测与分析,结果显示黄芪中铬的超标率为25%、铜的超标率为5.88%党参中铬的超标率为76.92%、汞的超标率为3.92%。杨春等[8]对通过对几种中草药的重金属元素分析,发现钩藤、何首乌、金银花中的铅、镉超标,均超出了《药用植物及制剂进出口绿色行业标准》[9]中规定的铅和镉含量限制值。重金属污染不仅会影响中药的质量,而且会对人体产生损害。所以,对中药的品质进行监测是非常必要的。
植物药材生产的最根本要素是土壤,土壤有问题,种植的植物也会有问题,人体的身体有问题,就会导致各种病症。因重金属会累积在土壤表面,因此,植物药材中的重金属与土壤中的重金属存在着紧密的关系。
不同的植物需要的金属元素也是不同的,它们会根据一定的比例来吸收不同的金属,所以植物的重金属含量会有很大的差别。
工业“三废”对植物药材的污染较为严重。各种工业企业排放的大量含有各种有毒物质的废气,例如:有色金属冶炼厂、钢铁厂中含有铅、汞、铅、汞等。多种重金属如砷,锡。
重金属的残留药典分析研究植物中存在重金属的残留是一个十分重要而且有意义的重大问题,它不仅可以作为一种分析技术用于植物提取物,在研究其毒性机理方面也有着不可替代作用。
铅会在身体里积累,从而导致中毒,从而引发血液、神经系统、心血管、免疫、内分泌等系统的疾病[10]。世界卫生组织(WHO)建议:成年人的铅摄入量为25μg/kg,正常人为15~40μg/100 g,血铅低于40μg/100 g。铅会抑制血红蛋白的合成,进而引起溶血性贫血;铅对中枢和周边神经系统有一定的毒性;血铅含量升高会影响孩子的认知能力,使其思维能力下降;另外,血液中的血铅含量过高也会引起成年人的血管病变。
汞的形态主要有3种:金属汞、无机汞和有机汞,均对人体会造成神经毒性和肾毒性,有机汞的毒性最大[11]。很多学者认为汞与镉等具有强烈荧光产生癌症相关性,研究植物中重金属残留药典分析结果发现,汞的毒性比镉低,但对植物影响最大,可能有其他重金属中毒等情况出现。
铜是一种身体必需的元素,但若体内的铜含量过高,就会对人体产生一定的毒性,铜过量可导致血红蛋白退化,引起细胞膜的破坏,抑制某些酶的活性,从而影响到身体的正常新陈代谢,还会引起血管系统的疾病。
砷是最常见、最有害于人类健康的污染物。
镉是一种高浓度的累积性重金属污染,对人类的健康有一定的影响。镉对人体的损害主要是通过肾、肝等组织的代谢,减少肾的吸收能力,增强机体的免疫系统,造成骨质疏松、软化,造成关节变形、全身疼痛、关节损伤等。镉不仅具有肾毒性,还会损害骨骼和生殖系统并引起其他健康问题[12]。
《中华人民共和国药典》是中国药品标准体系的核心[13]。《中华人民共和国药典》从2000版开始增加重金属检测方法,从2005版开始,《中华人民共和国药典》收载了丹参、西洋参、金银花、白芍、黄芪、甘草种中药材的重金属限量。《中华人民共和国药典》中的重金属限量值与《药用植物及制剂进出口绿色行业标准》一致,其值与各国与地区的重金属限量标准相比更严格[14]。我国2011年颁布并实施《中国药典污染物排放标准》后到2015年底共检测出多种化合物160余种。其中残留物类型有:含铬、磷汞;含溴化钠(包括利他);含有铅锌铜绿脓液和镉等重金属盐类的物质在植物中含量较高且浓度较大。由表1可见,我国和意大利汞的标准限值都在理论上的最大限值,而铅和砷都超过了理论上的最大限值。
《中华人民共和国药典》2005版一部收载了丹参、西洋参、金银花、白芍、黄芪、甘草等中药材的重金属限量。其中规定了铅不得超过5.0 mg/kg,镉不得超过0.3 mg/kg,汞不得超过0.2 mg/kg,铜不得超过20.0 mg/kg,砷不得超过2.0 mg/kg。
2010版药典中,并无增加植物药材的重金属限量,规定了6种中药中的重金属限量标准:黄芪、甘草、白芍、丹参、金银花、西洋参。限量规定Pb不得超过5.0 mg/kg,Cd不得超过0.3 mg/kg,Hg不得超过0.2 mg/kg,Cu不得超过20.0 mg/kg,As不得超过2.0 mg/kg。
《中华人民共和国药典》2015年版已收录了“中药有害残留物限量制定指导原则”,限量标准是风险评估的核心。此版药典收载了甘草、黄芪、西洋参、白芍、丹参、金银花、山楂、枸杞子、海藻、昆布共10种植物药材的重金属限量。2015版《中华人民共和国药典》对相关有害物质的安全性作了较多的修改,但仅对28种中药及饮片中的重金属进行了严格的控制。
2020年版药典一部新增了白芷、葛根、当归、黄精4种植物药材的重金属限量标准,2005版《中华人民共和国药典》增修丹参等6种植物药材重金属检测标准,2015年版再次新增山楂、枸杞子、海藻、昆布的重金属限量检测,详见表2。
中华人民共和国在国际经济贸易中,对药用植物及其制剂的进出口质量进行了严格的质量标准[15]。中华人民共和国在对外贸易中,对我国药用植物及其制剂的进出口实行了严格的质量标准:重金属总量≤20.0 mg/kg,Pb≤5.0 mg/kg,Cd≤0.3 mg/kg,Hg≤0.2 mg/kg,Cu≤20.0 mg/kg,As≤2.0 mg/kg。
《中华人民共和国药典》公布的各国和地区植物药物中重金属、有害元素限量标准对比如表1、表3,美国、日本等国家均制定了中药材重金属相关标准,但各国对中药材中重金属限量的要求差异较大。《中华人民共和国药典》规定的标准并不是最严格或最宽松的。
2000年版药典开始新增重金属检测方法,直至2005年版《中华人民共和国药典》开始对铅、镉、砷、汞、铜5种重金属进行限量规定。查阅药典发现,在2005年、2010年、2015年、2020年这4版药典中限量规定并无变化,铅含量不超过5 mg/kg。如表4、表5。与我国《药用植物及制剂进出口绿色行业标准》相比,也是处于规定范围内。
镉是各国普遍关心的一种重金属,自我国药典开始对重金属限量进行规定时起,镉含量一直处于不变状态。镉不超过0.3 mg/kg。英国、日本等国家并未对植物药材中重金属镉含量进行明确的规定,详见表3。且镉与WM/T2-2004也处于一致,详见表5。
国家标准中铜含量不超过20 mg/kg,而在美国、日本、英国等国家对铜的限量规定并未提及,详见表3、表5。在我国4版药典中,铜的含量规定一直未变,如表2。
中药材中砷含量,在我国国家标准规定中含量是不超过2 mg/kg,日本美国等国家对砷含量规定与我国一致。
《中华人民共和国药典》2015年版植物药中重金属与有害元素含量标准规定镉和汞的危害相对较低[16]。日本、美国是禁止含有汞元素药材进口的,在我国国家标准规定汞含量是不超过0.2 mg/kg。
人参有百草之王的称号,在2020年《中华人民共和国药典》一部新修订的人参项下,包含了铅、镉、砷、汞、铜5种元素的测定。根据《中华人民共和国药典》2020年版人参项规定[17],铅不得过5 mg/kg,镉不得过1 mg/kg,砷不得过2 mg/kg,汞不得过0.2 mg/kg,铜不得过20 mg/kg,马双欣等[18]利用AFS分析了人参中Pb、Cd、Cu、Hg和As的含量,并达到了国家规定的标准。杜雪等[19]通过微波消解-ICP-MS技术对人参中的重金属进行了分析,500批次样品的样品中,铅、镉、砷、汞、铜的总超标率分别为6.60%,25.20%,1.00%,0.00%,0.40%。
《中华人民共和国药典》2015版对中药材人参进行了测定。结果表明,参素Rb1的指标组分Rb1的合格率较低。同时,因企业大量销往日本,根据《日本药局方》17版的方法,对人参中Rb1的含量进行了检验,结果表明,Rb1的纯度非常高,并以《美国药典》和《欧洲药典》为参考。世界主要药典有《美国药典》《欧洲药典》《日本药局方》,其使用范围和影响范围都很大。详见表5。植物药材中毒标准范围的确定,是研究重金属污染对人体健康所造成危害性以及程度。中药材重金属超标情况严重,需引起重视[20]。因重金属对人体危害极大[21],不少学者对中药材中的重金属现状展开研究[22-24]。药典分析标准的研究,首先从药典上市前后重金属残留量变化中可以看出植物药材重金属含量在逐年降低。但由于植物中药材本身具有毒性较小、生物利用度高和可再生等特点被人们广泛使用,又因为受到水、空气、土壤等因素的影响,中药材在生长过程中可能会存在重金属污染的问题;同时,中药材在仓储、运输及制备过程中也可能会引入重金属离子,影响用药安全[25]。
罗汉果又称汉果或长寿果,是一种独特而宝贵的中药材。罗汉果中各类重金属的平均含量从高到低:铜>铅>砷>镉>汞[26],相关研究表示罗汉果虽存在有害元素,但其指标均在我国规定的指标以下。李斐等[26]研究4个产地的罗汉果并结合国际标准的限量规定,建议将罗汉果中重金属:铅不超过5 mg/kg,镉不超过0.3 mg/kg,铜不超过10 mg/kg,砷不超过2 mg/kg,汞不超过0.1 mg/kg。
4版药典中规定植物药材的数量变化:随着药典的不断修改,植物药材的种类也随之增多,植物药材重金属限量需要引起重视。2015版《中华人民共和国药典》分别对黄芪、海藻、丹参等在内的11种植物药制订了重金属限量值,2020版《中华人民共和国药典》在以上基础上增添了白芷、葛根、当归、黄精等植物药材的重金属限量值。见图1。
药典中规定重金属限量标准的变化:在这4版药典中,每版药典对于铅、镉、砷、汞、铜的限量规定无明显变化,详见表6。我国对重金属限量虽然起步较晚,但在与其他国家相比较时,规定标准也是在安全范围内。
近年来,我国对植物药材中的重金属元素进行了大量的研究,目前以药典为主。现在国内已经出台很多关于这方面的法律文件来规范和完善我国相关立法并取得一定成果。2001年和2005年,我国颁布了《药用植物及制剂进出口绿色行业标准》和《药用植物及制剂外经贸绿色行业标准》,在这些法规中,中药的重金属含量已经有了明确的规定。2015年,ISO国际标准(《中医药-中药材重金属限量》)正式发布,中国中医药研究院中药资源研究中心领导编制,这是首个国际标准化组织关于中药的重金属标准,该标准的颁布使中药材铜、铅、砷、镉、汞超标率分别由20.0%、12.0%、9.7%、28.5%、6.9%下降至1.476%、3.967%、4.819%、1.872%、1.08%。《药用植物及制剂进出口绿色行业标准》对进出口的中药重金属限量实行统一规范,如表7所示。《中华人民共和国药典》对重金属的限量要求与《药用植物及制剂进出口绿色行业标准》的要求基本一致,而该限量值则比其他地方的要求更加严格。
中药材中重金属限量规定与国家标准规定限量标准相比,存在较低风险,但是对中药及其饮片中的一些重金属进行控制,确保中药质量,确保药品的使用安全是必要的。
《中华人民共和国药典》中植物药材重金属残留标准分析研究是对植物药材中重金属的残留量,稳定性,以及其作为监测和国家基本医疗保健标准参考指标时应该具有的准确度、客观性等特点进行详细说明。随着每版药典的新增的中药材数目,可以看出我国对于重金属残留问题在不断加强。
《中华人民共和国药典》的重金属残留检测始于2000年,在2005版药典就对植物药材重金属限量开始规定,逐年增加的药材品种,可发现我国植物药材重金属残留限量规定可在保留已有种类的基础上,增加其他植物药材种类。研究植物重金属标准分析对植物药典的影响,有利于中药材药典规范化和标准化。但作为世界主要的中药出口大国,中国中药材品种数以千计,以上药典中规定中药材只是冰山一角,目前国内有关有害残留物进行相关研究的中药材种类还不到百种。与发达国家相比我国对中药重金属残留研究和标准制定仍较为落后,对中药材种植中重金属残留的控制起步较晚。
中药材中重金属限量规定与国家标准规定限量标准相比,存在较低风险,但是对中药及其饮片中的一些重金属进行控制,确保中药质量,确保药品的使用安全是必要的。
在植物药典分析标准中,对植物重金属的研究是主要部分。重金属被人体吸收后会在体内富集当蓄积到一定量时可引起免疫系统障碍。研究植物重金属标准分析对植物药典的影响,有利于中药材药典规范化和标准化。
  • 国家中医药管理局中药质量保障项目(2022-05)
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doi: 10.13193/j.issn.1673-7717.2025.02.030
  • 首发时间:2026-10-30
  • 出版时间:2025-02-10
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基金
国家中医药管理局中药质量保障项目(2022-05)
作者信息
    辽宁中医药大学药学院,辽宁 大连 116600

通讯作者:

谢明(1962-),男,辽宁沈阳人,教授,博士,研究方向:药事管理。Email:。
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https://castjournals.cast.org.cn/joweb/zhzyyxk/CN/10.13193/j.issn.1673-7717.2025.02.030
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2种不同金属材料的力学参数
科
Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)
属
Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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