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。
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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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articleId=1322922752566493683, language=CN, orderNo=3, keyword=药典), Keyword(id=1322922760447590945, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322922752566493683, language=CN, orderNo=4, keyword=限量标准)], refs=[Reference(id=1322922762142089779, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322922752566493683, doi=null, pmid=null, pmcid=null, year=2022, volume=47, issue=3, pageStart=846, pageEnd=852, url=null, language=null, rfNumber=[1], rfOrder=0, authorNames=蒋洁梅, 郭巧生, 金江群, journalName=中国中药杂志, refType=null, unstructuredReference=蒋洁梅,郭巧生,金江群,
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不同年份版《中华人民共和国药典》规定重金属残留限量的药用植物品种数量变化, figureFileSmall=b6Jkr5R/19lFTNgu6UFWbg==, figureFileBig=i0sG6OhDLiEzs9cXPV/FuQ==, tableContent=null), ArticleFig(id=1322922760854438436, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322922752566493683, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
| 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 60 | 5 | 10 | 10 | 5 | 5 | 3.57 | 1.78 | 1.78 |
| 镉 | 0.000 83 | 0.3 | 0.3 | 0.3 | 0.1 | 0.2 | 0.83 | 0.42 | 0.42 |
| 砷 | 0.002 10 | 2 | / | / | / | 3 | 2.14 | 1.07 | 1.07 |
| 汞 | 0.000 57 | 0.2 | / | 3 | 0.2 | 0.3 | 0.57 | 0.28 | 0.28 |
), ArticleFig(id=1322922760925741605, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322922752566493683, language=CN, label=表1, caption=
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
, figureFileSmall=null, figureFileBig=null, tableContent=
| 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 60 | 5 | 10 | 10 | 5 | 5 | 3.57 | 1.78 | 1.78 |
| 镉 | 0.000 83 | 0.3 | 0.3 | 0.3 | 0.1 | 0.2 | 0.83 | 0.42 | 0.42 |
| 砷 | 0.002 10 | 2 | / | / | / | 3 | 2.14 | 1.07 | 1.07 |
| 汞 | 0.000 57 | 0.2 | / | 3 | 0.2 | 0.3 | 0.57 | 0.28 | 0.28 |
), ArticleFig(id=1322922760992850470, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322922752566493683, language=EN, label=null, caption=null, 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 |
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4版《中华人民共和国药典》中新增药材及重金属限量标准
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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=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 | 20.0 | 5.0 | 2.0 | 0.3 | 0.2 |
| 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 | 20.0 | 5.0 | 2.0 | 0.3 | 0.2 |
| 美国 | 膳食补充标准 | 原料 | / | 10.0 | 5.0 | 0.3 | 0.2 |
| 日本 | 日本药典 | 中药材/中成药 | / | 20.0 | 2.0 | / | / |
| 英国 | 英国药典 | 中药材 | / | 5.0 | 5.0 | / | / |
), 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 | 20.0 | 5.0 | 2.0 | 0.3 | 0.2 |
| 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 | 20.0 | 5.0 | 2.0 | 0.3 | 0.2 |
| 美国 | 膳食补充标准 | 原料 | / | 10.0 | 5.0 | 0.3 | 0.2 |
| 日本 | 日本药典 | 中药材/中成药 | / | 20.0 | 2.0 | / | / |
| 英国 | 英国药典 | 中药材 | / | 5.0 | 5.0 | / | / |
), 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 |
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4版《中华人民共和国药典》中铅的限量规定变化
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| 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 |
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| 《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
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| 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 |
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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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