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Article(id=1240709667572216443, tenantId=1146029695717560320, journalId=1205117023404326918, issueId=1240709662501294254, articleNumber=null, orderNo=null, doi=10.16155/j.0254-1793.2024-0434, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1720627200000, receivedDateStr=2024-07-11, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1773737836019, onlineDateStr=2026-03-17, pubDate=1743350400000, pubDateStr=2025-03-31, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1773737836019, onlineIssueDateStr=2026-03-17, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1773737836019, creator=13701087609, updateTime=1773737836019, updator=13701087609, issue=Issue{id=1240709662501294254, tenantId=1146029695717560320, journalId=1205117023404326918, year='2025', volume='45', issue='3', pageStart='361', pageEnd='542', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=0, createTime=1773737834810, creator=13701087609, updateTime=1773737909503, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1240709975845163177, tenantId=1146029695717560320, journalId=1205117023404326918, issueId=1240709662501294254, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1240709975845163178, tenantId=1146029695717560320, journalId=1205117023404326918, issueId=1240709662501294254, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=522, endPage=529, ext={EN=ArticleExt(id=1240709668306219694, articleId=1240709667572216443, tenantId=1146029695717560320, journalId=1205117023404326918, language=EN, title=Determination of 10 kinds of elemental impurities in pharmaceutical excipients sodium succinate by ICP-MS*, columnId=1206272757852074373, journalTitle=Chinese Journal of Pharmaceutical Analysis, columnName=Safety Monitoring, runingTitle=null, highlight=null, articleAbstract=

Objective: To establish an inductively coupled plasma mass spectrometry (ICP-MS) method to determine the contents of 10 elemental impurities in the pharmaceutical excipients sodium succinate according to the ICH Q3D elemental impurity guideline, and to provide a basis for the comprehensive evaluation of potential risks. Methods: According to the types of elements that needed to risk assessment and the permitted daily exposure (PDE) of the injection route, the single-component limit calculation method was used to calculate the limit and control threshold of each element in sodium succinate with 10 g · d-1 as the maximum daily dose.Samples were preprocessed by direct dissolution and the iCAP RQ ICP-MS was used for the simultaneous determination of the residual amounts of 10 impurities in sodium succinate, using Ge, In and Bi as the internal standards. Results: All elemental impurities showed good linear relationship (r>0.99). The limits of detection of Cd, Pb, As, Hg, Co, V, Ni, Li, Sb and Cu were 0.27，19.22，8.86，16.63，0.12，0.28，1.48，6.91，0.35，9.26 ng · g-1, respectively. The recoveries (n=3) of each concentration were between 82.4% and 130.9%, and the RSD (n=6) of the repeatability test was not more than 7.1%, with all findings meeting the requirements for methodological validation. The content of elemental impurities in sodium succinate was less than 30% of the PDE,indicating that the elemental impurities in sodium succinate had no potential safety risk with the medicinal product. Conclusion: The method is simple in sample pretreatment, with high sensitivity and good accuracy. It is suitable for monitoring and risk assessment of elemental impurities in sodium succinate, which is conducive to the quality control. It also provides a reference for the determination of elemental impurities in other products.

, correspAuthors=Xiao-wei WANG, 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, authorCompany=null, fund=null, authors=null, authorsList=Kai-shuang LIU, Mei-fang LI, Xiang ZHANG, Ping WANG, Xiao-wei WANG), CN=ArticleExt(id=1240709668755010255, articleId=1240709667572216443, tenantId=1146029695717560320, journalId=1205117023404326918, language=CN, title=ICP-MS法检测药用辅料琥珀酸钠中10种元素杂质*, columnId=1206272758036623764, journalTitle=药物分析杂志, columnName=安全监测, runingTitle=null, highlight=null, articleAbstract=

目的：根据ICH Q3D元素杂质指导原则，建立了电感耦合等离子体质谱法（ICP-MS法）同时测定药用辅料琥珀酸钠中10种元素杂质含量的方法，为全面评价其潜在风险提供依据。方法：根据注射给药途径需风险评估的元素种类和每日允许暴露量（PDE），采用单组分限度计算法，以10 g · d-1作为最大日剂量，计算琥珀酸钠中各元素的限度和控制阈值。采用iCAP RQ 电感耦合等离子体质谱仪，样品前处理采用直接溶解法，建立了以锗（Ge）、铟（In）、铋（Bi）为内标可同时测定琥珀酸钠中10种元素杂质残留量的分析方法。结果：各元素杂质均呈良好的线性关系（r>0.99），镉（Cd）、铅（Pb）、砷（As）、汞（Hg）、钴（Co）、钒（V）、镍（Ni）、锂（Li）、锑（Sb）和铜（Cu）的检测限分别为0.27、19.22、8.86、16.63、0.12、0.28、1.48、6.91、0.35、9.26 ng · g-1，高、中、低浓度点的回收率（n=3）范围为82.4%~130.9%，重复性试验的RSD（n=6）≤7.1%，均满足方法学验证的要求。琥珀酸钠样品中各元素杂质的含量均低于PDE的30%，表明琥珀酸钠中的元素杂质对药品无潜在的安全性风险。结论：该方法样品前处理简便，灵敏度高，准确性良好，适用于琥珀酸钠中元素杂质的监测和风险评估，有利于质量控制，同时为其他品种元素杂质的测定提供参考。

, correspAuthors=王晓炜, authorNote=null, correspAuthorsNote=
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Tel：（0755）26039315；E-mail：

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unstructuredReference=QI YF，JIA FF，WANG Y，et al．Migration determination and risk assessment of 20 elements in ambroxol hydrochloride injection in glass ampoule packaging［J］．Cent South Pharm，2024，22（1）：194, articleTitle=Migration determination and risk assessment of 20 elements in ambroxol hydrochloride injection in glass ampoule packaging, refAbstract=null), Reference(id=1240722375810019354, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1240709667572216443, doi=null, pmid=null, pmcid=null, year=2023, volume=43, issue=8, pageStart=1446, pageEnd=null, url=null, language=null, rfNumber=［15］, rfOrder=25, authorNames=张凤妹, 陈丹丹, 顾霄, journalName=药物分析杂志, refType=null, unstructuredReference=张凤妹，陈丹丹，顾霄，等．注射用头孢美唑钠中10种ICH控制元素测定方法的建立［J］．药物分析杂志，2023，43（8）：1446, articleTitle=注射用头孢美唑钠中10种ICH控制元素测定方法的建立, refAbstract=null), Reference(id=1240722375889711132, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1240709667572216443, doi=null, pmid=null, pmcid=null, year=2023, volume=43, issue=8, pageStart=1446, pageEnd=null, url=null, language=null, rfNumber=［15］, rfOrder=26, authorNames=ZHANG FM, CHEN DD, GU X, journalName=Chin J Pharm Anal, refType=null, unstructuredReference=ZHANG FM，CHEN DD，GU X，et al．A method for the determination of 10 elemental impurities in cefmetazole sodium for injection according to ICH requirement［J］．Chin J Pharm Anal，2023，43（8）：1446, articleTitle=A method for the determination of 10 elemental impurities in cefmetazole sodium for injection according to ICH requirement, refAbstract=null), Reference(id=1240722375961014303, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1240709667572216443, doi=null, pmid=null, pmcid=null, year=2023, volume=43, issue=5, pageStart=804, pageEnd=null, url=null, language=null, rfNumber=［16］, rfOrder=27, authorNames=郭雅娟, 王彩媚, 胡淑君, journalName=药物分析杂志, refType=null, unstructuredReference=郭雅娟，王彩媚，胡淑君，等．ICP-MS法检测甘露醇中元素杂质的残留量［J］．药物分析杂志，2023，43（5）：804, articleTitle=ICP-MS法检测甘露醇中元素杂质的残留量, refAbstract=null), Reference(id=1240722376057483299, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1240709667572216443, doi=null, pmid=null, pmcid=null, year=2023, volume=43, issue=5, pageStart=804, pageEnd=null, url=null, language=null, rfNumber=［16］, rfOrder=28, authorNames=GUO YJ, WANG CM, HU SJ, journalName=Chin J Pharm Anal, refType=null, unstructuredReference=GUO YJ，WANG CM，HU SJ，et al．Determination of elemental impurities in mannitol by ICP-MS［J］．Chin J Pharm Anal，2023，43（5）：804, articleTitle=Determination of elemental impurities in mannitol by ICP-MS, refAbstract=null), Reference(id=1240722376166535205, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1240709667572216443, doi=null, pmid=null, pmcid=null, year=2015, volume=14, issue=2, pageStart=23, pageEnd=null, url=null, language=null, rfNumber=［17］, rfOrder=29, authorNames=张军红, journalName=济源职业技术学院学报, refType=null, unstructuredReference=张军红．消除ICP-MS测定汞的记忆效应［J］．济源职业技术学院学报，2015，14（2）：23, articleTitle=消除ICP-MS测定汞的记忆效应, refAbstract=null), Reference(id=1240722376242032679, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1240709667572216443, doi=null, pmid=null, pmcid=null, year=2015, volume=14, issue=2, pageStart=23, pageEnd=null, url=null, language=null, rfNumber=［17］, rfOrder=30, authorNames=ZHANG JH, journalName=J Jiyuan Vocat Tech Coll, refType=null, unstructuredReference=ZHANG JH．Eliminating the memory effect of determining mercury by ICP-MS［J］．J Jiyuan Vocat Tech Coll，2015，14（2）：23, articleTitle=Eliminating the memory effect of determining mercury by ICP-MS, refAbstract=null), Reference(id=1240722376334307369, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1240709667572216443, doi=null, pmid=null, pmcid=null, year=2019, volume=54, issue=1, pageStart=53, pageEnd=null, url=null, language=null, rfNumber=［18］, rfOrder=31, authorNames=李耀磊, 金红宇, 韩笑, journalName=中国药学杂志, refType=null, unstructuredReference=李耀磊，金红宇，韩笑．电感耦合等离子体质谱测定法中汞元素记忆效应与稳定性研究［J］．中国药学杂志，2019，54（1）：53, articleTitle=电感耦合等离子体质谱测定法中汞元素记忆效应与稳定性研究, refAbstract=null), Reference(id=1240722376434970667, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1240709667572216443, doi=null, pmid=null, pmcid=null, year=2019, volume=54, issue=1, pageStart=53, pageEnd=null, url=null, language=null, rfNumber=［18］, rfOrder=32, authorNames=LI YL, JIN HY, HAN X, journalName=Chin Pharm J, refType=null, unstructuredReference=LI YL，JIN HY，HAN X．Determination of the memory effect and stability of mercury by ICP-MS［J］．Chin Pharm J，2019，54（1）：53, articleTitle=Determination of the memory effect and stability of mercury by ICP-MS, refAbstract=null), Reference(id=1240722376539828269, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1240709667572216443, doi=null, pmid=null, pmcid=null, year=2023, volume=43, issue=8, pageStart=1423, pageEnd=null, url=null, language=null, rfNumber=［19］, rfOrder=33, authorNames=王玉, 郑淑凤, 贾艾玲, journalName=药物分析杂志, refType=null, unstructuredReference=王玉，郑淑凤，贾艾玲，等．ICP-MS法检测富马酸亚铁中7种元素杂质［J］．药物分析杂志，2023，43（8）：1423, articleTitle=ICP-MS法检测富马酸亚铁中7种元素杂质, refAbstract=null), Reference(id=1240722376648880176, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1240709667572216443, doi=null, pmid=null, pmcid=null, year=2023, volume=43, issue=8, pageStart=1423, pageEnd=null, url=null, language=null, rfNumber=［19］, rfOrder=34, authorNames=WANG Y, ZHENG SF, JIA AL, journalName=Chin J Pharm Anal, refType=null, unstructuredReference=WANG Y，ZHENG SF，JIA AL，et al．ICP-MS determination of 7 kinds of elementalimpurities in ferrous fumarate［J］．Chin J Pharm Anal，2023，43（8）：1423, articleTitle=ICP-MS determination of 7 kinds of elementalimpurities in ferrous fumarate, refAbstract=null)], funds=[Fund(id=1240722373163414454, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1240709667572216443, awardId=2024Y006, language=CN, fundingSource=*2024年度国家药品标准制修订研究课题项目(2024Y006), fundOrder=null, country=null), Fund(id=1240722373255689147, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1240709667572216443, awardId=2024TDB14, language=CN, fundingSource=广东省药品监督管理局2024年科技创新项目(2024TDB14), fundOrder=null, country=null)], companyList=[AuthorCompany(id=1240722368004420202, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1240709667572216443, xref=null, ext=[AuthorCompanyExt(id=1240722368012808810, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1240709667572216443, companyId=1240722368004420202, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1. Shenzhen Institute for Drug Control, Shenzhen Key Laboratory of Drug Quality Standard Research, Shenzhen 518057, China), AuthorCompanyExt(id=1240722368017003115, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1240709667572216443, companyId=1240722368004420202, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1.深圳市药品检验研究院 深圳药品质量标准研究重点实验室，深圳 518057)]), AuthorCompany(id=1240722368084111986, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1240709667572216443, xref=null, ext=[AuthorCompanyExt(id=1240722368092500595, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1240709667572216443, companyId=1240722368084111986, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2. China Pharmaceutical University, Nanjing 211198, China), AuthorCompanyExt(id=1240722368096694900, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1240709667572216443, companyId=1240722368084111986, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2.中国药科大学，南京 211198)])], figs=[ArticleFig(id=1240722371410195291, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1240709667572216443, language=EN, label=Tab. 1, caption=

Sample information of sodium succinate

, figureFileSmall=null, figureFileBig=null, tableContent=
生产企业
（production enterprise）		品名
（sample name）		批号
（batch number）
A（国产）
（domestic）		琥珀酸钠六水合物
（sodium succinate，hexahydrate）		230413039Y
230412037Y
230411035Y
无水琥珀酸钠
（anhydrous sodium succinate）		230506051Y
230505049Y
230505048Y
B（进口）
（imported）		琥珀酸钠六水合物（注射级）
（sodium succinate hexahydrate，injection grade）		37073A
41808A
41820A
), ArticleFig(id=1240722371494081380, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1240709667572216443, language=CN, label=表1, caption=

琥珀酸钠样品信息

, figureFileSmall=null, figureFileBig=null, tableContent=
生产企业
（production enterprise）		品名
（sample name）		批号
（batch number）
A（国产）
（domestic）		琥珀酸钠六水合物
（sodium succinate，hexahydrate）		230413039Y
230412037Y
230411035Y
无水琥珀酸钠
（anhydrous sodium succinate）		230506051Y
230505049Y
230505048Y
B（进口）
（imported）		琥珀酸钠六水合物（注射级）
（sodium succinate hexahydrate，injection grade）		37073A
41808A
41820A
), ArticleFig(id=1240722371573773162, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1240709667572216443, language=EN, label=Tab. 2, caption=

Types, PDE and control limits of evaluated elements in sodium succinate

, figureFileSmall=null, figureFileBig=null, tableContent=
评估元素
（evaluated element）		分类
（class）		PDE/（μg · d-1）通用限度
（general limit）/（μg · g-1）		控制阈值
（control limit）/（μg · g-1）
111Cd120.20.06
208Pb150.50.15
75As1151.50.45
202Hg130.30.09
59Co2A50.50.15
51V2A1010.3
59Ni2A2020.6
7Li3250257.5
122Sb39092.7
65Cu3300309
), ArticleFig(id=1240722371645076335, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1240709667572216443, language=CN, label=表2, caption=

琥珀酸钠评估的元素杂质种类、每日允许暴露量和控制限度

, figureFileSmall=null, figureFileBig=null, tableContent=
评估元素
（evaluated element）		分类
（class）		PDE/（μg · d-1）通用限度
（general limit）/（μg · g-1）		控制阈值
（control limit）/（μg · g-1）
111Cd120.20.06
208Pb150.50.15
75As1151.50.45
202Hg130.30.09
59Co2A50.50.15
51V2A1010.3
59Ni2A2020.6
7Li3250257.5
122Sb39092.7
65Cu3300309
), ArticleFig(id=1240722371745739636, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1240709667572216443, language=EN, label=Tab. 3, caption=

Concentration of linear solution

, figureFileSmall=null, figureFileBig=null, tableContent=
元素
（element）		控制阈值
（control limit）/（μg · g-1）		含量
（content）/（ng · mL-1）
S1S2S3S4S5S6S7
111Cd0.060.20.30.611.21.62
208Pb0.150.50.751.52.5345
75As0.451.52.254.57.591215
59Co0.150.50.751.52.5345
51V0.311.5356810
59Ni0.623610121620
7Li7.52537.575125150200250
122Sb2.7913.52745547290
65Cu9304590150180240300
), ArticleFig(id=1240722371963843452, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1240709667572216443, language=CN, label=表3, caption=

标准曲线溶液浓度

, figureFileSmall=null, figureFileBig=null, tableContent=
元素
（element）		控制阈值
（control limit）/（μg · g-1）		含量
（content）/（ng · mL-1）
S1S2S3S4S5S6S7
111Cd0.060.20.30.611.21.62
208Pb0.150.50.751.52.5345
75As0.451.52.254.57.591215
59Co0.150.50.751.52.5345
51V0.311.5356810
59Ni0.623610121620
7Li7.52537.575125150200250
122Sb2.7913.52745547290
65Cu9304590150180240300
), ArticleFig(id=1240722372035146622, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1240709667572216443, language=EN, label=Tab. 4, caption=

The regression equation, linear equations, precision test, LODs and LOQs for each element

, figureFileSmall=null, figureFileBig=null, tableContent=
元素
（element）		回归方程
（regression equation）		线性范围
（linear range）/（ng · mL-1）		 r精密度试验
（precision test）RSD/%（n=6）		LOD/（ng · g-1）LOQ/（ng · g-1）
111Cd Y=0.008 2X+0.000 10.2~20.999 80.900.267 40.810 3
208Pb Y=0.035 2X+0.007 60.5~50.996 41.019.2258.24
75As Y=0.113 1X+0.003 21.5~151.0000.78.85926.84
202Hg Y=0.005 2X-0.000 10.3~3.60.993 65.116.6350.39
59Co Y=1.996 4X+0.022 20.5~51.0000.70.118 20.358 1
51V Y=0.619 5X-0.000 61~100.999 90.60.278 80.844 9
59Ni Y=1.158 8X+0.067 92~200.999 90.71.4814.487
7Li Y=0.014 1X+0.003 525~2500.999 90.66.91220.95
122Sb Y=0.013 8X-0.002 59~901.0000.40.345 51.047
65Cu Y=0.776 6X-0.907 530~3000.999 90.69.25528.05
), ArticleFig(id=1240722372123227011, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1240709667572216443, language=CN, label=表4, caption=

各元素回归方程、线性范围、精密度、检测限与定量限结果

, figureFileSmall=null, figureFileBig=null, tableContent=
元素
（element）		回归方程
（regression equation）		线性范围
（linear range）/（ng · mL-1）		 r精密度试验
（precision test）RSD/%（n=6）		LOD/（ng · g-1）LOQ/（ng · g-1）
111Cd Y=0.008 2X+0.000 10.2~20.999 80.900.267 40.810 3
208Pb Y=0.035 2X+0.007 60.5~50.996 41.019.2258.24
75As Y=0.113 1X+0.003 21.5~151.0000.78.85926.84
202Hg Y=0.005 2X-0.000 10.3~3.60.993 65.116.6350.39
59Co Y=1.996 4X+0.022 20.5~51.0000.70.118 20.358 1
51V Y=0.619 5X-0.000 61~100.999 90.60.278 80.844 9
59Ni Y=1.158 8X+0.067 92~200.999 90.71.4814.487
7Li Y=0.014 1X+0.003 525~2500.999 90.66.91220.95
122Sb Y=0.013 8X-0.002 59~901.0000.40.345 51.047
65Cu Y=0.776 6X-0.907 530~3000.999 90.69.25528.05
), ArticleFig(id=1240722372228084618, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1240709667572216443, language=EN, label=Tab. 5, caption=

The test results of repeatability test

, figureFileSmall=null, figureFileBig=null, tableContent=
元素
（element）		回收率
（recovery）/%		回收率平均值
（average recovery）/%		RSD/%
123456
111Cd86.889.489.289.488.387.788.51.9
208Pb104.398.898.394.199.87112.6101.36.3
75As111.0110.8111.8109.1110.2110.8110.60.80
202Hg123.9111.0125.0131.0113.1130.9122.57.0
59Co100.9101.1102.6101.1101.1100.5101.30.70
51V129.0127.7130.2127.5130.2127.9128.70.90
59Ni85.585.586.584.686.185.485.60.80
7Li123.4124.3127.9124.8126.2125.9125.41.3
122Sb108.6110.2109.1109.4108.5107.3108.80.90
65Cu81.381.482.780.881.881.481.60.80
), ArticleFig(id=1240722372299387788, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1240709667572216443, language=CN, label=表5, caption=

琥珀酸钠中各元素重复性结果

, figureFileSmall=null, figureFileBig=null, tableContent=
元素
（element）		回收率
（recovery）/%		回收率平均值
（average recovery）/%		RSD/%
123456
111Cd86.889.489.289.488.387.788.51.9
208Pb104.398.898.394.199.87112.6101.36.3
75As111.0110.8111.8109.1110.2110.8110.60.80
202Hg123.9111.0125.0131.0113.1130.9122.57.0
59Co100.9101.1102.6101.1101.1100.5101.30.70
51V129.0127.7130.2127.5130.2127.9128.70.90
59Ni85.585.586.584.686.185.485.60.80
7Li123.4124.3127.9124.8126.2125.9125.41.3
122Sb108.6110.2109.1109.4108.5107.3108.80.90
65Cu81.381.482.780.881.881.481.60.80
), ArticleFig(id=1240722372400051089, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1240709667572216443, language=EN, label=Tab. 6, caption=

The test results of intermediate precision test

, figureFileSmall=null, figureFileBig=null, tableContent=
编号
（No.）		含量（content）/（ng · mL-1）
111Cd208Pb75As202Hg59Co51V59Ni7Li122Sb65Cu
10.868 12.6088.3251.8592.5246.4518.550154.248.89122.0
20.893 82.4708.3091.6652.5286.3878.552155.449.59122.2
30.891 52.4588.3841.8752.5666.5028.649159.949.11124.1
40.893 92.3528.1821.9652.5296.3788.462156.149.22121.2
50.883 12.4978.2661.6972.5276.5128.614157.848.81122.8
60.876 92.8158.3091.9642.5146.3978.539157.448.27122.1
70.896 01.9908.2061.2102.5296.2218.950162.948.41123.8
80.907 62.0188.2321.2342.5446.2918.995164.248.59123.8
90.893 22.0638.2631.2602.5646.4108.992166.047.84124.7
100.880 12.0028.1371.4682.5086.1528.824162.047.52122.4
110.871 12.0728.0311.5402.4856.0648.712158.547.05120.7
120.891 91.9998.1421.2142.5036.1968.843159.547.56121.8
平均值
（average）/（ng · mL-1）		0.887 32.2798.2321.5792.5276.3308.724159.548.41122.6
RSD/%1.312.61.219.00.932.32.22.31.61.0
), ArticleFig(id=1240722372551046038, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1240709667572216443, language=CN, label=表6, caption=

琥珀酸钠中各元素中间精密度含量结果（n=12）

, figureFileSmall=null, figureFileBig=null, tableContent=
编号
（No.）		含量（content）/（ng · mL-1）
111Cd208Pb75As202Hg59Co51V59Ni7Li122Sb65Cu
10.868 12.6088.3251.8592.5246.4518.550154.248.89122.0
20.893 82.4708.3091.6652.5286.3878.552155.449.59122.2
30.891 52.4588.3841.8752.5666.5028.649159.949.11124.1
40.893 92.3528.1821.9652.5296.3788.462156.149.22121.2
50.883 12.4978.2661.6972.5276.5128.614157.848.81122.8
60.876 92.8158.3091.9642.5146.3978.539157.448.27122.1
70.896 01.9908.2061.2102.5296.2218.950162.948.41123.8
80.907 62.0188.2321.2342.5446.2918.995164.248.59123.8
90.893 22.0638.2631.2602.5646.4108.992166.047.84124.7
100.880 12.0028.1371.4682.5086.1528.824162.047.52122.4
110.871 12.0728.0311.5402.4856.0648.712158.547.05120.7
120.891 91.9998.1421.2142.5036.1968.843159.547.56121.8
平均值
（average）/（ng · mL-1）		0.887 32.2798.2321.5792.5276.3308.724159.548.41122.6
RSD/%1.312.61.219.00.932.32.22.31.61.0
), ArticleFig(id=1240722372647515033, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1240709667572216443, language=EN, label=Tab. 7, caption=

The test results of recovery test

, figureFileSmall=null, figureFileBig=null, tableContent=
元素
（element）		回收率（recovery）/%平均回收率
（average recovery）/%		RSD/%
低浓度
（low concentration）		中浓度（medium concentration）高浓度（high concentration）
111Cd91.489.991.590.91.4
208Pb84.981.081.382.46.2
75As111.6109.8109.5110.31.2
202Hg93.582.387.987.97.8
59Co103.1101.8102.0102.31.1
51V128.5126.2125.6126.71.5
59Ni91.089.889.790.21.0
7Li131.2131.5130.1130.91.5
122Sb109.0107.3107.8108.00.92
65Cu84.382.782.983.31.2
), ArticleFig(id=1240722372735595422, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1240709667572216443, language=CN, label=表7, caption=

琥珀酸钠中各元素准确度回收率结果（n=9）

, figureFileSmall=null, figureFileBig=null, tableContent=
元素
（element）		回收率（recovery）/%平均回收率
（average recovery）/%		RSD/%
低浓度
（low concentration）		中浓度（medium concentration）高浓度（high concentration）
111Cd91.489.991.590.91.4
208Pb84.981.081.382.46.2
75As111.6109.8109.5110.31.2
202Hg93.582.387.987.97.8
59Co103.1101.8102.0102.31.1
51V128.5126.2125.6126.71.5
59Ni91.089.889.790.21.0
7Li131.2131.5130.1130.91.5
122Sb109.0107.3107.8108.00.92
65Cu84.382.782.983.31.2
), ArticleFig(id=1240722372823675810, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1240709667572216443, language=EN, label=Tab. 8, caption=

The test results of samples

, figureFileSmall=null, figureFileBig=null, tableContent=
生产企业
（manufacture）		批号
（lot No.）		含量（content）/（ng · g-1）
111Cd208Pb75As202Hg59Co51V59Ni7Li122Sb65Cu
A230413039Y----25.935.7481.99-72.96164.1
230412037Y---66.275.0665.76857.37-63.04166.4
230411035Y---<LOQ8.215.73846.55-74.79158.8
230506051Y---<LOQ35.887.5857.39<LOQ73.04403.8
230505049Y----13.677.91727.37-76.15226
230505048Y---<LOQ14.056.64320.35-65.65227.7
B37073A---<LOQ-5.965<LOQ-63.6144.8
41808A-----5.905--65.74147.5
41820A-----5.584--64.5150.1
), ArticleFig(id=1240722372941116329, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1240709667572216443, language=CN, label=表8, caption=

琥珀酸钠样品测定结果

, figureFileSmall=null, figureFileBig=null, tableContent=
生产企业
（manufacture）		批号
（lot No.）		含量（content）/（ng · g-1）
111Cd208Pb75As202Hg59Co51V59Ni7Li122Sb65Cu
A230413039Y----25.935.7481.99-72.96164.1
230412037Y---66.275.0665.76857.37-63.04166.4
230411035Y---<LOQ8.215.73846.55-74.79158.8
230506051Y---<LOQ35.887.5857.39<LOQ73.04403.8
230505049Y----13.677.91727.37-76.15226
230505048Y---<LOQ14.056.64320.35-65.65227.7
B37073A---<LOQ-5.965<LOQ-63.6144.8
41808A-----5.905--65.74147.5
41820A-----5.584--64.5150.1
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ICP-MS法检测药用辅料琥珀酸钠中10种元素杂质*
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刘凯双 1 , 李美芳 1 , 张翔 2 , 王平 1 , 王晓炜 1, **
药物分析杂志 | 安全监测 2025,45(3): 522-529
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药物分析杂志 | 安全监测 2025, 45(3): 522-529
ICP-MS法检测药用辅料琥珀酸钠中10种元素杂质*
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刘凯双1 , 李美芳1, 张翔2, 王平1, 王晓炜1, **
作者信息
  • 1.深圳市药品检验研究院 深圳药品质量标准研究重点实验室，深圳 518057
  • 2.中国药科大学，南京 211198

    • Tel：（0755）26039315；E-mail：

通讯作者:

**Tel：（0755）26031123；E-mail：
Determination of 10 kinds of elemental impurities in pharmaceutical excipients sodium succinate by ICP-MS*
Kai-shuang LIU1 , Mei-fang LI1, Xiang ZHANG2, Ping WANG1, Xiao-wei WANG1, **
Affiliations
  • 1. Shenzhen Institute for Drug Control, Shenzhen Key Laboratory of Drug Quality Standard Research, Shenzhen 518057, China
  • 2. China Pharmaceutical University, Nanjing 211198, China
出版时间: 2025-03-31 doi: 10.16155/j.0254-1793.2024-0434
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目的：根据ICH Q3D元素杂质指导原则，建立了电感耦合等离子体质谱法（ICP-MS法）同时测定药用辅料琥珀酸钠中10种元素杂质含量的方法，为全面评价其潜在风险提供依据。方法：根据注射给药途径需风险评估的元素种类和每日允许暴露量（PDE），采用单组分限度计算法，以10 g · d-1作为最大日剂量，计算琥珀酸钠中各元素的限度和控制阈值。采用iCAP RQ 电感耦合等离子体质谱仪，样品前处理采用直接溶解法，建立了以锗（Ge）、铟（In）、铋（Bi）为内标可同时测定琥珀酸钠中10种元素杂质残留量的分析方法。结果：各元素杂质均呈良好的线性关系（r>0.99），镉（Cd）、铅（Pb）、砷（As）、汞（Hg）、钴（Co）、钒（V）、镍（Ni）、锂（Li）、锑（Sb）和铜（Cu）的检测限分别为0.27、19.22、8.86、16.63、0.12、0.28、1.48、6.91、0.35、9.26 ng · g-1，高、中、低浓度点的回收率（n=3）范围为82.4%~130.9%，重复性试验的RSD（n=6）≤7.1%，均满足方法学验证的要求。琥珀酸钠样品中各元素杂质的含量均低于PDE的30%，表明琥珀酸钠中的元素杂质对药品无潜在的安全性风险。结论：该方法样品前处理简便，灵敏度高，准确性良好，适用于琥珀酸钠中元素杂质的监测和风险评估，有利于质量控制，同时为其他品种元素杂质的测定提供参考。

琥珀酸钠  /  ICH Q3D  /  电感耦合等离子体质谱（ICP-MS）  /  元素杂质  /  每日允许暴露量（PDE）  /  含量测定  /  内标法  /  风险评估

Objective: To establish an inductively coupled plasma mass spectrometry (ICP-MS) method to determine the contents of 10 elemental impurities in the pharmaceutical excipients sodium succinate according to the ICH Q3D elemental impurity guideline, and to provide a basis for the comprehensive evaluation of potential risks. Methods: According to the types of elements that needed to risk assessment and the permitted daily exposure (PDE) of the injection route, the single-component limit calculation method was used to calculate the limit and control threshold of each element in sodium succinate with 10 g · d-1 as the maximum daily dose.Samples were preprocessed by direct dissolution and the iCAP RQ ICP-MS was used for the simultaneous determination of the residual amounts of 10 impurities in sodium succinate, using Ge, In and Bi as the internal standards. Results: All elemental impurities showed good linear relationship (r>0.99). The limits of detection of Cd, Pb, As, Hg, Co, V, Ni, Li, Sb and Cu were 0.27，19.22，8.86，16.63，0.12，0.28，1.48，6.91，0.35，9.26 ng · g-1, respectively. The recoveries (n=3) of each concentration were between 82.4% and 130.9%, and the RSD (n=6) of the repeatability test was not more than 7.1%, with all findings meeting the requirements for methodological validation. The content of elemental impurities in sodium succinate was less than 30% of the PDE,indicating that the elemental impurities in sodium succinate had no potential safety risk with the medicinal product. Conclusion: The method is simple in sample pretreatment, with high sensitivity and good accuracy. It is suitable for monitoring and risk assessment of elemental impurities in sodium succinate, which is conducive to the quality control. It also provides a reference for the determination of elemental impurities in other products.

sodium succinate  /  ICH Q3D  /  inductively coupled plasma mass spectrometry (ICP-MS)  /  elemental impurities  /  permitted daily exposure（PDE）  /  content determination  /  internal standard method  /  risk assessment
刘凯双, 李美芳, 张翔, 王平, 王晓炜. ICP-MS法检测药用辅料琥珀酸钠中10种元素杂质*. 药物分析杂志, 2025 , 45 (3) : 522 -529 . DOI: 10.16155/j.0254-1793.2024-0434
Kai-shuang LIU, Mei-fang LI, Xiang ZHANG, Ping WANG, Xiao-wei WANG. Determination of 10 kinds of elemental impurities in pharmaceutical excipients sodium succinate by ICP-MS*[J]. Chinese Journal of Pharmaceutical Analysis, 2025 , 45 (3) : 522 -529 . DOI: 10.16155/j.0254-1793.2024-0434
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药用辅料是药物制剂重要的组成部分，决定了药物制剂的性能，包括安全性、有效性、稳定性、均一性等，药用辅料直接或间接影响药品的安全性和有效性[1]。药品的质量控制是保证药品安全有效的重要手段，杂质分析是药品质量控制的重要组成部分[2]。药品元素杂质来源于生产过程中所用的原辅料和制备工艺的每个阶段，也有可能无意引入元素杂质。对元素杂质进行控制是基于安全性和药品稳定性的角度，元素杂质无法为患者提供任何治疗作用，甚至有一定的毒性或可能影响药物的稳定性，因此在药品生产过程中的各个阶段，将元素杂质的限度控制在合理的范围内是保证药品质量的基础和前提[3]。随着国际人用药品注册技术协调会Q3D元素杂质指导原则（ICH Harmonised Guideline For Elemental Impurities Q3D，简称ICH Q3D）对药品中元素杂质的分类和控制提出了要求，通过建立各元素杂质的每日允许暴露量（PDE）来控制药品中的元素杂质的含量，以降低药品中元素杂质的潜在安全风险[4-5]。USP、EP、BP紧随其后，参考ICH Q3D[5]纷纷出台了元素杂质相关检测方法和通则。目前，2020年版《中华人民共和国药典》 （简称《中国药典》）制定了“元素杂质通则”，并面向社会各界公开征求意见，意味着《中国药典》与国际通用标准接轨，通过科学和基于风险的评估，增加对元素杂质的质量控制，弥补了传统湿化学法检测重金属杂质的不足，将更好地保证药品的安全有效[6]。
琥珀酸钠又名丁二酸钠，分子式为C4H4Na2O4 · nH2O（n=0或6），广泛应用于药品和食品工业中。作为药用辅料，琥珀酸钠口服途径一般用作调味剂和pH调节剂，注射用琥珀酸钠一般用作pH缓冲剂或最终产品的制剂成分，如单克隆抗体药和抗体偶联药物的药用辅料。经生产企业调研，琥珀酸钠的生产工艺主要以丁二酸、氢氧化钠和去离子水为原料合成。目前，仅USP[7]有收载琥珀酸钠药品标准，但并未关注元素杂质相关检查法。国内外药典多采用“重金属”和“砷盐”等湿化学法来检测元素杂质[2]，该类检测方法专属性和灵敏度差，定量准确性低，且无法准确测定某种元素杂质的含量，更无法有效评估元素杂质的潜在风险。对于药品中的多种元素杂质的检测，通常采用电感耦合等离子体质谱法（ICP-MS法）[8-11]和电感耦合等离子体原子发射光谱法（ICP-OES法）[12-14]，ICP-MS法和ICP-OES法因其独特优势而成为各国药典推荐的检测方法，并在药品行业得到广泛使用[2]。
本研究以国家药品监督管理局药品审评中心药用辅料登记数据库登记的琥珀酸钠为研究对象。根据琥珀酸钠的工艺和用途，结合ICH Q3D[5]和《中国药典》元素杂质通则（公示稿，公示时间2024-04-23至2024-05-24），采用直接溶解法对样品进行前处理，采用ICP-MS法测定1类元素镉（Cd）、铅（Pb）、砷（As）、汞（Hg），2A类元素钴（Co）、钒（V）、镍（Ni）和3类元素锂（Li）、锑（Sb）、铜（Cu）共计10种元素，建立10种元素杂质的定量分析方法，并进行检测方法适用性的验证，建立的方法专属性强，准确性高，为药用辅料琥珀酸钠的元素杂质风险评估和质量控制提供可靠依据。
1　仪器与试药
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1.1　仪器
MS205DU十万分之一电子天平（梅特勒托利多公司）；Milli-Q Academic纯水器（MILLIPORE公司）；iCAP RQ ICP-MS电感耦合等离子体质谱仪（赛默飞世尔公司）。
1.2　试药
金（Au，批号23A029-1）、锗（Ge，批号23B116）、铟（In，批号23A007）、铋（Bi，批号238024-1）、镉（Cd，批号23A030-2）、铅（Pb，批号23A035-2）、砷（As，批号23B011-5）、汞（Hg，批号23B027-1）、钴（Co，批号23A004-2）、钒（V，批号23A003-2）、镍（Ni，批号23B044-1）、铜（Cu，批号23A041-2）、锂（Li，批号23A031）、锑（Sb，批号238008-2）单元素标准溶液，均由国家有色金属及电子材料分析测试中心提供，单元素标准质量浓度均为1 000 μg · mL-1；65%硝酸（优级纯，批号K53975256），购自默克公司；超纯水（大于18.2 MΩ · cm），实验室自制。
9批琥珀酸钠样品，生产企业、批号信息详见表1。
2　方法与结果
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2.1　ICP-MS仪器参数
KED模式，功率1 600 W，气体高纯氩气，停留时间0.05 s，扫描次数25次。内标元素通过三通管在线混合引入等离子体。
2.2　元素杂质考察种类和限度的选择
根据ICH Q3D[5] 和《中国药典》“元素杂质通则（公示稿） （2024年4月）”。根据元素杂质的分类、是否有意添加引入和给药途径，结合琥珀酸钠的生产原料来源和工艺过程，选择注射给药途径（无意引入）需评估的10种元素进行评估。采用单组分限度计算法，根据注射给药途径各元素的PDE，以10 g · d-1作为最大日剂量，计算琥珀酸钠中各元素的限度和控制阈值[4]，如注射给药途径Cd元素的PDE为2 μg · d-1，将元素杂质PDE的30%定义为控制阈值，按10 g · d-1的最大日剂量计算，通用限度为0.2 μg · g-1，控制阈值0.06 μg · g-1，各元素的限度和控制阈值详见表2。
2.3　溶液的配制
2.3.1　Au稳定剂溶液
精密量取Au单元素标准溶液1.0 mL，置100 mL量瓶中，用2%硝酸稀释制每1 mL含10 μg的溶液。
2.3.2　内标溶液
精密量取Ge、In、Bi单元素标准溶液各1.0 mL，置100 mL量瓶中，加2%硝酸稀释定容至刻度，摇匀；精密量取上述溶液0.4 mL，置200 mL量瓶中，加2%硝酸稀释制成每1 mL中含Ge、In、Bi 20 ng的内标溶液。
2.3.3　供试品溶液
取本品约0.05 g，精密称定，置10 mL量瓶中，加Au稳定剂溶液1.0 mL，用2%硝酸溶解定容至刻度，摇匀，过滤，即得。
2.3.4　空白溶液
精密量取Au稳定剂溶液1.0 mL，置10 mL量瓶中，用2%硝酸定容至刻度，摇匀，过滤，即得。
2.3.5　混合标准品溶液
精密量取Cd、Pb、As、Co、V、Ni、Li、Sb和Cu单元素标准溶液适量，加2%硝酸溶液稀释得到Cd，Pb，As，Co，V，Ni、Li、Sb、Cu质量浓度分别为10、25、75、25、50、100、1 250、450、1 500 ng · mL-1的混合标准品储备液。精密量取混合标准品储备液1.0、1.5、3.0、5.0、6.0、8.0、10.0 mL，分别置于50 mL量瓶中，加2%硝酸稀释制成混合系列标准品溶液，各元素质量浓度见表3。
2.3.6　Hg系列标准品溶液
精密量取Hg单元素标准溶液0.3 mL，置100 mL量瓶中，加2%硝酸稀释定容至刻度，摇匀；精密量取1.0 mL，置100 mL量瓶中，加2%硝酸稀释定容至刻度，摇匀，得Hg标准品储备液。精密量取Hg标准品储备液0.5、0.75、1.5、2.5、3.5、4.5、6.0 mL，分别置50 mL量瓶中，各加入Au稳定剂溶液5.0 mL，用2%硝酸稀释制成含Hg为0.3、0.45、0.9、1.5、2.1、2.7、3.6 ng · mL-1的Hg系列标准品溶液。
2.4　测定方法
取混合系列标准品溶液、Hg系列标准品溶液、供试品溶液，伴随内标溶液进行测定，其中As、Co、V、Ni、Li和Cu以Ge为内标，Cd和Sb以In为内标，Hg和Pb以Bi为内标。按照“2.1”项的条件测定，按内标校正的标准曲线法计算供试品中各元素的含量。
2.5　方法学验证
2.5.1　线性关系考察
取“2.3.5”项的混合系列标准品溶液和“2.3.6”项的Hg系列标准品溶液，分别按“2.1”项的条件测定，以各元素质量浓度（X）为横坐标，以目标元素响应值与内标元素响应值的比值（Y）为纵坐标，绘制标准曲线，得到各元素的线性回归方程，相关系数r在0.993 6~1.000 0，表明各元素线性良好，结果详见表4。
2.5.2　检测限与定量限
测定15份空白样品溶液，计算响应值的标准偏差（SD），以“3.3 SD/S（曲线斜率）”为检测限，以“10 SD/S（曲线斜率）”为定量限，结果见表4。
2.5.3　精密度
取“2.3.5”项下的混合标准品溶液（含Cd，Pb，As，Co，V，Ni、Li、Sb、Cu浓度分别为1、2.5、7.5、2.5、5、10、125、45、150 ng · mL-1）和“2.3.6”项下的Hg标准品溶液（含Hg1.5 ng · mL-1），按“2.1”项下条件，连续测定6次，计算各元素浓度的RSD，均不超过5.1%，表明方法精密度良好，结果见表4。
2.5.4　重复性
取琥珀酸钠样品（批号41820A）0.05 g（6份），精密称定，置10 mL量瓶中，分别精密加入“2.3.5”项下的混合标准品储备液1 mL，加入“2.3.6”项下的Hg标准品储备液0.5 mL和Au稳定剂溶液1 mL，用2%硝酸稀释定容至刻度，摇匀，过滤，测量各元素浓度并计算回收率和RSD，结果见表5。
2.5.5　中间精密度
在不同时间（d），测定“2.5.4”项下的6份加标溶液，计算各元素测定结果的RSD，各元素的RSD均不超过19.0%（小于25%），结果见表6。
2.5.6　回收率
取琥珀酸钠样品（批号41820A）0.05 g，精密称定，置10 mL量瓶中，共9份，平均分为3组，每组分别加入“2.3.5”项下的混合标准品储备液0.5、1.0、1.5 mL，再分别加入“2.3.6”项下的Hg标准品储备液0.25、0.5、0.75 mL和Au稳定剂溶液各1 mL，用2%硝酸稀释至刻度，摇匀，过滤，得到限度水平的150%、100%和50%的各元素加标溶液（n=3）。按“2.4”项下的方法测定并计算各元素回收率，结果见表7。
2.6　琥珀酸钠样品元素杂质测定及数据分析
对收集到的9批琥珀酸钠样品按照“2.3.3”项下的方法制备供试品溶液（每批制备2份），进行元素杂质测定。本实验收集2家企业样品，检出Hg、Co、V、Ni、Li、Sb、Cu元素，但所检出的元素均远小于ICH推荐控制浓度（30%控制阈值）。经评估，该品种的元素杂质风险基本可控，为制剂企业在选择辅料方面提供依据，结果见表8。
3　讨论
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3.1　前处理方法的选择
样品中元素杂质前处理方法一般包括直接测定、直接溶解和间接溶解（消解法）[15]。直接测定一般适用于液体样品。直接溶解法适用于溶解于水的样品，如无机盐类。间接溶解法适用于不能直接溶解于水或有机溶剂的样品，常用微波消解法，样品在强酸、高温高压环境下进行消解，应注意对化学性质不稳定的元素（如Hg）的保护。琥珀酸钠水溶性较好，本实验选择直接溶解并稀释的方法制备供试品溶液。同时，为了减少目标元素Hg的损失，在制备供试品溶液和标准曲线溶液时均加入Au单元素标准品溶液作为稳定剂，形成金汞齐，以降低记忆效应，并提高Hg元素的稳定性和检测的准确性[16-18]。
3.2　样品浓度的选择
ICP-MS实验易受样品基体效应的干扰，样品量在10~100 mg时可以最大程度减少碳含量引起的干扰。为了降低琥珀酸钠样品本身的干扰，本实验分别考察了500、50和20 mg琥珀酸钠样品对测定结果的影响，结果表明当样品量为500 mg时，内标元素的响应值明显被抑制，仅为空白溶液内标响应值的20%。当样品量为50 mg和20 mg时，琥珀酸钠对内标元素的抑制效果明显低于500 mg琥珀酸钠，但当样品量为20 mg时，标准曲线受仪器背景干扰的影响较大，线性较差。样品量为50 mg时，内标元素响应良好，标准曲线不受空白溶液的影响，线性相关系数良好。综上，最终选用50 mg琥珀酸钠进行实验。
3.3　仪器驻留时间的选择
仪器参数的驻留时间的长短，可影响一段时间内到达检测器的粒子的数量，进而影响检测器的相对误差。当ICP-MS仪器参数的驻留时间为0.01 s时，空白溶液中Pb元素响应值较高，且Pb元素标准曲线低浓度点响应值不稳定，标准曲线相关系数r<0.9。当驻留时间为0.05 s时，可提高ICP-MS仪器测量精度并确保Pb元素在低浓度有稳定的响应，标准曲线呈良好的线性关系。
3.4　内标物的选择
琥珀酸钠基体效应较大，会影响内标物的响应，本实验比较了2组内标，分别为Rh和Re，Ge、In和Bi。2组混合内标均受琥珀酸钠基体效应的影响，响应值有不同程度的降低，但质量数接近的元素受基体效应的影响接近，选择质量数相近的元素做内标可以有效地进行校正[19]。因此，选择Ge作为As、Co、V、Ni、Li和Cu的内标，In作为Cd和Sb的内标，Bi作为Hg和Pb的内标，很好地对各元素进行了校正，并降低了基体效应对测定元素响应值的干扰。
4　小结
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本研究建立的测定琥珀酸钠中10种元素杂质含量的ICP-MS法，经方法学验证，具有前处理简便，目标元素损失小，方法准确，灵敏度高等优点，适用于药用辅料琥珀酸钠中元素杂质的检测，为琥珀酸钠元素杂质的质量控制和风险评估提供了有效手段。
基金
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  • *2024年度国家药品标准制修订研究课题项目(2024Y006)
  • 广东省药品监督管理局2024年科技创新项目(2024TDB14)
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2025年第45卷第3期
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doi: 10.16155/j.0254-1793.2024-0434
  • 接收时间：2024-07-11
  • 首发时间：2026-03-17
  • 出版时间：2025-03-31
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  • 收稿日期：2024-07-11
基金
*2024年度国家药品标准制修订研究课题项目(2024Y006)
广东省药品监督管理局2024年科技创新项目(2024TDB14)
作者信息
    1.深圳市药品检验研究院 深圳药品质量标准研究重点实验室，深圳 518057
    2.中国药科大学，南京 211198

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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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