电感耦合等离子体质谱法在不同药典中的方法体系和在中药无机成分研究中的应用进展
Method System in Different Pharmacopoeias and Application Progress in Study of Inorganic Components of Traditional Chinese Medicine of ICP-MS
摘 要
为科学指导中药安全性标准的建立和合理评价中药的安全性和有效性，通过比较中国、美国及欧洲等药典电感耦合等离子体质谱法[ICP-MS，包括高效液相色谱（HPLC）-ICP-MS]通则方法及技术体系，综述了药典中ICP-MS的方法体系及在中药（动物药、植物药或矿物药）中重金属元素及有害元素、元素形态或价态检测中的技术规范和应用范围；通过相关文献整理，综述了ICP-MS在中药无机成分安全性评价及风险评估、无机元素谱及质量评价和有害元素形态及价态等方面的应用进展，并对ICP-MS新技术和方法在中药研究的应用前景进行了展望（引用文献57篇）。
药典
方法体系
应用进展
无机元素
中药
ICP-MS
pharmacopoeia
method system
application progress
inorganic element
traditional Chinese medicine
Abstract
In order to scientifically guide the establishment of safety standards for traditional Chinese medicines and rationally evaluate the safety and effectiveness of traditional Chinese medicines, method general rules and technical systems about ICP-MS, including HPLC-ICP-MS in the Chinese, American and European pharmacopoeias compared, and method systems in the pharmacopoeias and technical specifications and scopes of application in the analysis of healy metal and harmful elements and their element forms or valences about ICP-MS in traditional Chinese medicines (animal medicine, botanical medicine or mineral medicine) were reviewed. The application progress of ICP-MS in the safety evaluation and risk assessment of the inorganic components of traditional Chinese medicines, the inorganic element spectrum and quality evaluation, and the form and valence of harmful elements were reviewed by the sorting of relevant references. The application prospects of new technologies and methods in traditional Chinese medicine research were prospected (57 references cited).
中图分类号 O657.63 DOI 10.11973/lhjy-hx202107018
所属栏目 专题报道(XRFS)
基金项目 国家重点研发计划（2017YFC1700800）
收稿日期 2021/5/26
修改稿日期
网络出版日期
作者单位点击查看
备注李丽敏,主任药师,博士,主要从事中药质量标准、中药无机元素检测方法与标准的研究,lilimin_sifdc@163.com
引用该论文: LI Limin,ZHOU Rujie,CAO Shuai,MAO Xiuhong,HU Qing,JI Shen. Method System in Different Pharmacopoeias and Application Progress in Study of Inorganic Components of Traditional Chinese Medicine of ICP-MS[J]. Physical Testing and Chemical Analysis part B:Chemical Analysis, 2021, 57(7): 665～672
李丽敏,周如洁,曹帅,毛秀红,胡青,季申. 电感耦合等离子体质谱法在不同药典中的方法体系和在中药无机成分研究中的应用进展[J]. 理化检验－化学分册, 2021, 57(7): 665～672
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参考文献
【1】BULSKA E, WAGNER B. Quantitative aspects of inductively coupled plasma mass spectrometry[J]. Philosophical Transactions of the Royal Society A:Mathematical, Physicaland EngineeringSciences, 2016,374(2079):20150369.
【2】DELAFIORI J, RING G, FUREY A. Clinical applications of HPLC-ICP-MS element speciation:A review[J]. Talanta, 2016,153:306-331.
【3】WYSOCKA I. Determination of rare earth elements concentrations in natural waters - A review of ICP-MS measurement approaches[J]. Talanta, 2021,221:121636.
【4】MITTAL M, KUMAR K, ANGHORE D, et al. ICP-MS:Analytical method for identification and detection of elemental impurities[J]. Current Drug Discovery Technologies, 2017,14(2):106-120.
【5】STEINHOFF B. Challenges in the quality of herbal medicinal products with a specific focus on contaminants[J]. Phytochemical Analysis, 2021,32(2):117-123.
【6】JANCHEVSKA K, STAFILOV T, MEMED-SEJFULAH S, et al. ICH Q3D based elemental impurities study in liquid pharmaceutical dosage form with high daily intake-comparative analysis by ICP-AES and ICP-MS[J]. Drug Development and Industrial Pharmacy, 2020,46(3):456-461.
【7】国家药典委员会.中华人民共和国药典2020年版[M].北京:中国医药科技出版社, 2020.
【8】U. S. Pharmacopeial Convention. U. S. Pharmacopeial:USP 43-NF38[S/OL]. (2019-10-04)[2020-06-29]. https://online.uspnf.com/uspnf/document.
【9】European Pharmacopoeia Commission. European Pharmacopoeia[M]. 10.0 ed. Strasbourg:European Directorate for Quality Medicines, 2019.
【10】吕洪亮,赵旻,李红,等.微波消解-ICP-MS法检测8种药材中8种重金属的含量[J].沈阳药科大学学报, 2020,37(7):618-623.
【11】周利,郝庆秀,王升,等.微波消解ICP-MS法对冬虫夏草不同部位5种重金属元素的分布研究[J].中国中药杂志, 2017,42(15):2934-2938.
【12】李春盈,张玉英.植物类中药材及饮片中18种重金属及有害元素研究[J].分析测试学报, 2016,35(12):1634-1638.
【13】李俊婕,于海英,胡文岳,等.微波消解-ICP-MS法同时测定天麻中15种稀土元素[J].药学研究, 2019,38(6):333-335.
【14】孟珊,邵阳,胡伟杰,等.ICP-MS法同时测定中药类保健食品中22种微量元素[J].中成药, 2019,41(6):1395-1399.
【15】张春华,陈春桃,韩必恺,等.ICP-MS测定5种中药注射液中重金属及有害元素[J].中国测试, 2020,46(1):71-76.
【16】李丽敏,夏晶,张甦,等.电感耦合等离子体质谱法同时测定中药材中的29种元素[J].中国医药工业杂志, 2015,46(9):999-1003.
【17】雷超海,张治军,李沛,等.微波消解-电感耦合等离子体质谱法测定动植物类中药中的5种有害元素[J].中国药师, 2017,20(8):1482-1485.
【18】车静,夏厚林,邓雨娇,等.ICP-MS测定美洲大蠊中5种重金属及有害元素[J].中国药学杂志, 2021,56(1):63-67.
【19】李耀磊,张志成,金红宇,等.ICP-MS法测定复方苦参注射液中铜、砷、镉、汞、铅元素的残留量[J].药物分析杂志, 2018,38(10):1781-1787.
【20】左甜甜,金红宇,余坤子,等.ICP-MS法结合化学计量学用于枸杞子道地性的研究及安全性评价[J].药物分析杂志, 2021,41(3):394-401.
【21】柳臻,苏欣,周衡,等.几种重金属在药材炮制中的含量变化研究[J].科技创新导报, 2015,12(36):252-254.
【22】朱晓东,盛萍,王长健,等.基于化学计量学的青翘和老翘中重金属与有害元素残留规律研究[J].中国中药杂志, 2020,45(15):3694-3699.
【23】聂黎行,钱秀玉,蒋沁悦,等.中成药中重金属及有害元素残留分析、风险评估和限量制定建议[J].药学学报, 2020,55(11):2695-2701.
【24】LUO L, WANG B, JIANG J, et al. Heavy metal contaminations in herbal medicines:Determination, comprehensive risk assessments, and solutions[J]. Frontiersin Pharmacology, 2020,11:595335.
【25】YANG C M, CHIEN M Y, CHAO P C, et al. Investigation of toxic heavy metals content and estimation of potential health risks in Chinese herbal medicine[J]. Journal of Hazardous Materials, 2021,412:125142.
【26】ZUO T T, JIN H Y, ZHANG L, et al. Innovative health risk assessment of heavy metals in Chinese herbal medicines based on extensive data[J]. Pharmacological Research, 2020,159:104987.
【27】左甜甜,罗飞亚,金红宇,等.基于体外消化/MDCK细胞模型测定地龙中镉和砷的生物可给性及风险评估[J].药学学报, 2020,55(5):1004-1009.
【28】左甜甜,申明睿,金红宇,等.累积风险评估方法在5种植物类中药材中铅和镉联合暴露评估中的应用[J].中国药事, 2020,34(9):1020-1027.
【29】周良云,岳红,李璇,等.野生青蒿体内重金属的生物可给性及风险评估[J].中国中药杂志, 2015,40(10):1904-1907.
【30】黄文丽.黄连中重金属Cr和Cd的积累研究[D].杨凌:西北农林科技大学, 2018.
【31】张德林,陈蓉,喻文,等.基于不同川芎种质资源对4种重金属富集特性的研究[J].中药材, 2019,42(2):279-284.
【32】程益清,夏晶,曹帅,等.注射用血栓通中三七元素迁移的规律[J].世界中医药, 2019,14(4):805-808.
【33】卢森华,高源,丘一仙,等.强力枇杷露中20种无机元素的ICP-MS分析与评价[J].现代中药研究与实践, 2020,34(4):53-58.
【34】刘圣金,乔婷婷,马瑜璐,等.正品、伪品治糜康栓的差异特征元素分析及无机元素特征谱[J].中成药, 2019,41(5):1096-1101.
【35】ZHAO Y, MA X, FAN L, et al. Discrimination of geographical origin of cultivated Polygala tenuifolia based on multi-element fingerprinting by inductively coupled plasma mass spectrometry[J]. Scientific Reports, 2017,7(1):12577.
【36】MA X, FAN L, MAO F, et al. Discrimination of three Ephedra species and their geographical origins based on multi-element fingerprinting by inductively coupled plasma mass spectrometry[J]. Scientific Reports, 2018,8(1):10271.
【37】DU H, TANG B B, CAO S R, et al. Discrimination of the species and authenticity of Rhizoma Coptidis based on stable isotope and multielement fingerprinting and multivariate statistical analysis[J]. Analytical and Bioanalytical Chemistry, 2019,411(13):2827-2837.
【38】XIAO Y, LI C, XU W, et al. Arsenic content, speciation, and distribution in wild Cordyceps sinensis[J]. Evidence-Based Complementary and Alternative Medicine, 2021,2021:6651498.
【39】GHULAM G, BEHZAD M, IRSHAD B, et al. Arsenic uptake, toxicity, detoxification, and speciation in plants:Physiological, biochemical, and molecular aspects[J]. International Journal of Environmental Research and Public Health, 2018. 15(1):59-104.
【40】MIELKE H W. Dynamic geochemistry of tetraethyl lead dust during the 20th century:Getting the lead in, out, and translational beyond[J]. International Journal of Environmental Research and Public Health, 2018,15(5):860.
【41】BRANCO V, CAITO S, FARINA M, et al. Biomarkers of mercury toxicity:Past, present, and future trends[J]. Journal of Toxicology and Environmental Health, Part B, 2017,20(3):119-154.
【42】李耀磊,徐健,金红宇,等.冬虫夏草及产区土壤中5种重金属及有害元素污染评价[J].药物分析杂志, 2019,39(4):677-684.
【43】XIAO Y, LI C, XU W, et al. Arsenic content, speciation, and distribution in wild Cordyceps sinensis[J]. Evidence-Based Complementary and Alternative Medicine, 2021,2021:6651498.
【44】骆骄阳,刘好,谷善勇,等.31种动物药中汞、砷元素形态残留分析与限量标准探讨[J].药学学报, 2018,53(11):1879-1886.
【45】LI P, LILM, XIA J, et al. Determination of hexavalent chromium in traditional Chinese medicines by high-performance liquid chromatography with inductively coupled plasma mass spectrometry[J]. Journal of Separation Science, 2015,38(23):4043-4047.
【46】李丽敏,夏晶,王欣美,等.HPLC-ICP-MS法研究5种含雄黄中成药的可溶性砷及其形态[J].中成药, 2012,34(11):2118-2123.
【47】屈蓉,朱琼.6种活血止痛类中成药中微量元素和砷形态含量测定方法学研究[J].中国药品标准, 2020,21(6):555-562.
【48】JIN P F, LIANG X L, XIA L F, et al. Determination of 20 trace elements and arsenic species for a realgar-containing traditional Chinese medicine Niuhuang Jiedu tablets by direct inductively coupled plasma-mass spectrometry and high performance liquid chromatography-inductively coupled plasma-mass spectrometry[J]. Journal of Trace Elements in Medicine and Biology, 2016,33:73-80.
【49】YI Y, GAO S R, XIA J, et al. Study of the accumulation and distribution of arsenic species and association with arsenic toxicity in rats after 30 days of oral realgar administration[J]. Journal of Ethnopharmacology, 2020,247:111576.
【50】张庆丽,吴倩,谢媛媛,等.六神丸和雄黄中砷的组织分布研究[J].药学学报, 2011,46(6):701-706.
【51】王启铮,帕合尔丁·努尔拉江,王丽敏,等.六神丸和雄黄中砷在大鼠体内的药动学研究[J].中国医药工业杂志, 2016,47(9):1177-1182.
【52】姜新,李少元,邓小颖,等.基于高效液相色谱-电感耦合等离子体质谱法的大鼠口服纳米雄黄后体内砷形态分析[J].中草药, 2018,49(22):5328-5333.
【53】马瑜璐,房方,刘圣金,等.金属组学研究概况及其在矿物药研究中的应用前景[J].中国中药杂志, 2021,46(9):2142-2148.
【54】MONTAÑO M D, OLESIK J W, BARBER A G, et al. Single Particle ICP-MS:Advances toward routine analysis of nanomaterials[J]. Analytical and Bioanalytical Chemistry, 2016,408(19):5053-5074.
【55】BECKER J S, MATUSCH A, WU B. Bioimaging mass spectrometry of trace elements-recent advance and applications of LA-ICP-MS:A review[J]. Analytica Chimica Acta, 2014,835:1-18.
【56】SUSSULINI A, BECKER J S, BECKER J S. Laser ablation ICP-MS:Application in biomedical research[J]. Mass Spectrometry Reviews, 2017,36(1):47-57.
【2】DELAFIORI J, RING G, FUREY A. Clinical applications of HPLC-ICP-MS element speciation:A review[J]. Talanta, 2016,153:306-331.
【3】WYSOCKA I. Determination of rare earth elements concentrations in natural waters - A review of ICP-MS measurement approaches[J]. Talanta, 2021,221:121636.
【4】MITTAL M, KUMAR K, ANGHORE D, et al. ICP-MS:Analytical method for identification and detection of elemental impurities[J]. Current Drug Discovery Technologies, 2017,14(2):106-120.
【5】STEINHOFF B. Challenges in the quality of herbal medicinal products with a specific focus on contaminants[J]. Phytochemical Analysis, 2021,32(2):117-123.
【6】JANCHEVSKA K, STAFILOV T, MEMED-SEJFULAH S, et al. ICH Q3D based elemental impurities study in liquid pharmaceutical dosage form with high daily intake-comparative analysis by ICP-AES and ICP-MS[J]. Drug Development and Industrial Pharmacy, 2020,46(3):456-461.
【7】国家药典委员会.中华人民共和国药典2020年版[M].北京:中国医药科技出版社, 2020.
【8】U. S. Pharmacopeial Convention. U. S. Pharmacopeial:USP 43-NF38[S/OL]. (2019-10-04)[2020-06-29]. https://online.uspnf.com/uspnf/document.
【9】European Pharmacopoeia Commission. European Pharmacopoeia[M]. 10.0 ed. Strasbourg:European Directorate for Quality Medicines, 2019.
【10】吕洪亮,赵旻,李红,等.微波消解-ICP-MS法检测8种药材中8种重金属的含量[J].沈阳药科大学学报, 2020,37(7):618-623.
【11】周利,郝庆秀,王升,等.微波消解ICP-MS法对冬虫夏草不同部位5种重金属元素的分布研究[J].中国中药杂志, 2017,42(15):2934-2938.
【12】李春盈,张玉英.植物类中药材及饮片中18种重金属及有害元素研究[J].分析测试学报, 2016,35(12):1634-1638.
【13】李俊婕,于海英,胡文岳,等.微波消解-ICP-MS法同时测定天麻中15种稀土元素[J].药学研究, 2019,38(6):333-335.
【14】孟珊,邵阳,胡伟杰,等.ICP-MS法同时测定中药类保健食品中22种微量元素[J].中成药, 2019,41(6):1395-1399.
【15】张春华,陈春桃,韩必恺,等.ICP-MS测定5种中药注射液中重金属及有害元素[J].中国测试, 2020,46(1):71-76.
【16】李丽敏,夏晶,张甦,等.电感耦合等离子体质谱法同时测定中药材中的29种元素[J].中国医药工业杂志, 2015,46(9):999-1003.
【17】雷超海,张治军,李沛,等.微波消解-电感耦合等离子体质谱法测定动植物类中药中的5种有害元素[J].中国药师, 2017,20(8):1482-1485.
【18】车静,夏厚林,邓雨娇,等.ICP-MS测定美洲大蠊中5种重金属及有害元素[J].中国药学杂志, 2021,56(1):63-67.
【19】李耀磊,张志成,金红宇,等.ICP-MS法测定复方苦参注射液中铜、砷、镉、汞、铅元素的残留量[J].药物分析杂志, 2018,38(10):1781-1787.
【20】左甜甜,金红宇,余坤子,等.ICP-MS法结合化学计量学用于枸杞子道地性的研究及安全性评价[J].药物分析杂志, 2021,41(3):394-401.
【21】柳臻,苏欣,周衡,等.几种重金属在药材炮制中的含量变化研究[J].科技创新导报, 2015,12(36):252-254.
【22】朱晓东,盛萍,王长健,等.基于化学计量学的青翘和老翘中重金属与有害元素残留规律研究[J].中国中药杂志, 2020,45(15):3694-3699.
【23】聂黎行,钱秀玉,蒋沁悦,等.中成药中重金属及有害元素残留分析、风险评估和限量制定建议[J].药学学报, 2020,55(11):2695-2701.
【24】LUO L, WANG B, JIANG J, et al. Heavy metal contaminations in herbal medicines:Determination, comprehensive risk assessments, and solutions[J]. Frontiersin Pharmacology, 2020,11:595335.
【25】YANG C M, CHIEN M Y, CHAO P C, et al. Investigation of toxic heavy metals content and estimation of potential health risks in Chinese herbal medicine[J]. Journal of Hazardous Materials, 2021,412:125142.
【26】ZUO T T, JIN H Y, ZHANG L, et al. Innovative health risk assessment of heavy metals in Chinese herbal medicines based on extensive data[J]. Pharmacological Research, 2020,159:104987.
【27】左甜甜,罗飞亚,金红宇,等.基于体外消化/MDCK细胞模型测定地龙中镉和砷的生物可给性及风险评估[J].药学学报, 2020,55(5):1004-1009.
【28】左甜甜,申明睿,金红宇,等.累积风险评估方法在5种植物类中药材中铅和镉联合暴露评估中的应用[J].中国药事, 2020,34(9):1020-1027.
【29】周良云,岳红,李璇,等.野生青蒿体内重金属的生物可给性及风险评估[J].中国中药杂志, 2015,40(10):1904-1907.
【30】黄文丽.黄连中重金属Cr和Cd的积累研究[D].杨凌:西北农林科技大学, 2018.
【31】张德林,陈蓉,喻文,等.基于不同川芎种质资源对4种重金属富集特性的研究[J].中药材, 2019,42(2):279-284.
【32】程益清,夏晶,曹帅,等.注射用血栓通中三七元素迁移的规律[J].世界中医药, 2019,14(4):805-808.
【33】卢森华,高源,丘一仙,等.强力枇杷露中20种无机元素的ICP-MS分析与评价[J].现代中药研究与实践, 2020,34(4):53-58.
【34】刘圣金,乔婷婷,马瑜璐,等.正品、伪品治糜康栓的差异特征元素分析及无机元素特征谱[J].中成药, 2019,41(5):1096-1101.
【35】ZHAO Y, MA X, FAN L, et al. Discrimination of geographical origin of cultivated Polygala tenuifolia based on multi-element fingerprinting by inductively coupled plasma mass spectrometry[J]. Scientific Reports, 2017,7(1):12577.
【36】MA X, FAN L, MAO F, et al. Discrimination of three Ephedra species and their geographical origins based on multi-element fingerprinting by inductively coupled plasma mass spectrometry[J]. Scientific Reports, 2018,8(1):10271.
【37】DU H, TANG B B, CAO S R, et al. Discrimination of the species and authenticity of Rhizoma Coptidis based on stable isotope and multielement fingerprinting and multivariate statistical analysis[J]. Analytical and Bioanalytical Chemistry, 2019,411(13):2827-2837.
【38】XIAO Y, LI C, XU W, et al. Arsenic content, speciation, and distribution in wild Cordyceps sinensis[J]. Evidence-Based Complementary and Alternative Medicine, 2021,2021:6651498.
【39】GHULAM G, BEHZAD M, IRSHAD B, et al. Arsenic uptake, toxicity, detoxification, and speciation in plants:Physiological, biochemical, and molecular aspects[J]. International Journal of Environmental Research and Public Health, 2018. 15(1):59-104.
【40】MIELKE H W. Dynamic geochemistry of tetraethyl lead dust during the 20th century:Getting the lead in, out, and translational beyond[J]. International Journal of Environmental Research and Public Health, 2018,15(5):860.
【41】BRANCO V, CAITO S, FARINA M, et al. Biomarkers of mercury toxicity:Past, present, and future trends[J]. Journal of Toxicology and Environmental Health, Part B, 2017,20(3):119-154.
【42】李耀磊,徐健,金红宇,等.冬虫夏草及产区土壤中5种重金属及有害元素污染评价[J].药物分析杂志, 2019,39(4):677-684.
【43】XIAO Y, LI C, XU W, et al. Arsenic content, speciation, and distribution in wild Cordyceps sinensis[J]. Evidence-Based Complementary and Alternative Medicine, 2021,2021:6651498.
【44】骆骄阳,刘好,谷善勇,等.31种动物药中汞、砷元素形态残留分析与限量标准探讨[J].药学学报, 2018,53(11):1879-1886.
【45】LI P, LILM, XIA J, et al. Determination of hexavalent chromium in traditional Chinese medicines by high-performance liquid chromatography with inductively coupled plasma mass spectrometry[J]. Journal of Separation Science, 2015,38(23):4043-4047.
【46】李丽敏,夏晶,王欣美,等.HPLC-ICP-MS法研究5种含雄黄中成药的可溶性砷及其形态[J].中成药, 2012,34(11):2118-2123.
【47】屈蓉,朱琼.6种活血止痛类中成药中微量元素和砷形态含量测定方法学研究[J].中国药品标准, 2020,21(6):555-562.
【48】JIN P F, LIANG X L, XIA L F, et al. Determination of 20 trace elements and arsenic species for a realgar-containing traditional Chinese medicine Niuhuang Jiedu tablets by direct inductively coupled plasma-mass spectrometry and high performance liquid chromatography-inductively coupled plasma-mass spectrometry[J]. Journal of Trace Elements in Medicine and Biology, 2016,33:73-80.
【49】YI Y, GAO S R, XIA J, et al. Study of the accumulation and distribution of arsenic species and association with arsenic toxicity in rats after 30 days of oral realgar administration[J]. Journal of Ethnopharmacology, 2020,247:111576.
【50】张庆丽,吴倩,谢媛媛,等.六神丸和雄黄中砷的组织分布研究[J].药学学报, 2011,46(6):701-706.
【51】王启铮,帕合尔丁·努尔拉江,王丽敏,等.六神丸和雄黄中砷在大鼠体内的药动学研究[J].中国医药工业杂志, 2016,47(9):1177-1182.
【52】姜新,李少元,邓小颖,等.基于高效液相色谱-电感耦合等离子体质谱法的大鼠口服纳米雄黄后体内砷形态分析[J].中草药, 2018,49(22):5328-5333.
【53】马瑜璐,房方,刘圣金,等.金属组学研究概况及其在矿物药研究中的应用前景[J].中国中药杂志, 2021,46(9):2142-2148.
【54】MONTAÑO M D, OLESIK J W, BARBER A G, et al. Single Particle ICP-MS:Advances toward routine analysis of nanomaterials[J]. Analytical and Bioanalytical Chemistry, 2016,408(19):5053-5074.
【55】BECKER J S, MATUSCH A, WU B. Bioimaging mass spectrometry of trace elements-recent advance and applications of LA-ICP-MS:A review[J]. Analytica Chimica Acta, 2014,835:1-18.
【56】SUSSULINI A, BECKER J S, BECKER J S. Laser ablation ICP-MS:Application in biomedical research[J]. Mass Spectrometry Reviews, 2017,36(1):47-57.
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