植物药材重金属残留药典标准研究  

Study on Pharmacopoeia Standard of Residues of Heavy Metals In Plant Medicinal Materials

作　　者：徐美玲[1] 孙婉萍[1] 曲扬[1] 王建华 孙文怡 谢明[1] XU Meiling;SUN Wanping;QU Yangon;WANG Jianhua;SUN Wenyi;XIE Ming(College of Pharmacy,Liaoning University of Traditional Chinese Medicine,Dalian 116600,Liaoning,China)

机构地区：[1]辽宁中医药大学药学院,辽宁大连116600

出　　处：《中华中医药学刊》2025年第2期136-140,共5页Chinese Archives of Traditional Chinese Medicine

基　　金：国家中医药管理局中药质量保障项目(2022-05)。

摘　　要：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。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 since 2000.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.

关 键 词：植物药材 重金属残留 药典 限量标准 

分 类 号：R282.71[医药卫生—中药学]