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Article(id=1239250702812377315, tenantId=1146029695717560320, journalId=1205117023404326918, issueId=1239250701583446236, articleNumber=null, orderNo=null, doi=10.16155/j.0254-1793.2024.04.18, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=1711382400000, revisedDateStr=2024-03-26, acceptedDate=null, acceptedDateStr=null, onlineDate=1773389991714, onlineDateStr=2026-03-13, pubDate=1714406400000, pubDateStr=2024-04-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1773389991714, onlineIssueDateStr=2026-03-13, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1773389991714, creator=13701087609, updateTime=1773389991714, updator=13701087609, issue=Issue{id=1239250701583446236, tenantId=1146029695717560320, journalId=1205117023404326918, year='2024', volume='44', issue='4', pageStart='553', pageEnd='736', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1773389991422, creator=13701087609, updateTime=1773390513217, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1239252890213209050, tenantId=1146029695717560320, journalId=1205117023404326918, issueId=1239250701583446236, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1239252890213209051, tenantId=1146029695717560320, journalId=1205117023404326918, issueId=1239250701583446236, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=714, endPage=720, ext={EN=ArticleExt(id=1239250703110172904, articleId=1239250702812377315, tenantId=1146029695717560320, journalId=1205117023404326918, language=EN, title=Risk assessment of combined exposure to cadmium and arsenic in Isatidis Radix based on target-organ toxicity dose modification of HI method*, columnId=1206272758774821315, journalTitle=Chinese Journal of Pharmaceutical Analysis, columnName=Standard Deliberation, runingTitle=null, highlight=null, articleAbstract=
Objective:

To determine the contents of Cd and As in Isatidis Radix and to explore the application of target-organ toxicity dose(TTD) modification of hazard index (HI) method in assessing the risk of combined exposure to heavy metals and harmful elements in traditional Chinese medicines (TCMs).

Methods:

According to the monitoring data of Cd and As in Isatidis Radix, the exposure doses were calculated. The health risk caused by combined exposure to Cd and As was preliminary screened by HI method. Moreover, a more accurate TTD method was used.

Results:

The qualified rates of Cd in 29 batches of Isatidis Radix were 100%. However, 5 batches of As contents exceeded the limit standard. The HQ values of As in 5 batches of Isatidis Radix were more than 1. The results of TTD method showed that for the end points of cardiovascular system, blood, nervous system, the HI values of 5 batches of Isatidis Radix were more than 1, and the health risk was not acceptable.

Conclusion:

The cumulative risk assessment of heavy metals in TCMs is proposed in this study, which offers novel ideas for the development of risk assessment methods of exogenous harmful residues in TCMs, and provides technical support for formulating scientific limit standards.

, correspAuthors=Jian-dong YU, Shuang-cheng MA, 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=Tian-tian ZUO, Yong-li LIU, Hong-yu JIN, Hai-liang LI, Yuan-xi LIU, Jian-dong YU, Shuang-cheng MA), CN=ArticleExt(id=1239250705152798985, articleId=1239250702812377315, tenantId=1146029695717560320, journalId=1205117023404326918, language=CN, title=基于靶器官毒性剂量法的板蓝根中镉和砷的联合暴露评估*, columnId=1206272758971953622, journalTitle=药物分析杂志, columnName=标准研讨, runingTitle=null, highlight=null, articleAbstract=
目的：

对板蓝根中镉(Cd)和砷(As)的残留量进行测定，探索靶器官毒性剂量法在评估中药中重金属及有害元素联合暴露风险中的应用。

方法：

根据板蓝根中Cd和As的残留量监测数据，计算其暴露量。采用危害指数(HI)法对Cd和As联合暴露产生的健康风险进行初步筛查。进一步针对不同毒理学终点，采用靶器官毒性剂量(TTD)法，对Cd和As的累积风险进行更加精确的评估。

结果：

29批板蓝根中Cd的合格率为100%，5批As的含量超过限量标准。HI法的初步评估结果表明，5批板蓝根中As的危害商(HQ)值高于1。TTD法评估结果表明，对于作用终点心血管、血液、神经系统，5批板蓝根的HI值>1，健康风险需要被关注。

结论：

本研究探索了中药材板蓝根中Cd和As的累积风险评估方法，为中药中外源性有害残留物风险评估方法开发提供新的思路，为制定更加科学的限量标准提供技术支撑。

, correspAuthors=于健东, 马双成, authorNote=null, correspAuthorsNote=
** 马双成　Tel：(010)53852076；E-mail：
于健东　Tel：(010)67095452；E-mail：
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左甜甜　Tel：(010)53851453；E-mail：

刘永利　Tel：(0311)67909955；E-mail：

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刘永利　Tel：(0311)67909955；E-mail：

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Current approaches and future strategies, refAbstract=null)], funds=[Fund(id=1239250711297454720, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239250702812377315, awardId=2023Z07, language=CN, fundingSource=*国家药典委员会标准提高课题(2023Z07), fundOrder=null, country=null), Fund(id=1239250711368757893, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239250702812377315, awardId=GJJS-2022-7-1, language=CN, fundingSource=中国食品药品检定研究院关键技术基金(GJJS-2022-7-1), fundOrder=null, country=null)], companyList=[AuthorCompany(id=1239250705438011672, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239250702812377315, xref=1., ext=[AuthorCompanyExt(id=1239250705446400281, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239250702812377315, companyId=1239250705438011672, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1.National Institutes for Food and Drug Control, Beijing 102629, China), AuthorCompanyExt(id=1239250705454788890, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239250702812377315, companyId=1239250705438011672, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1.中国食品药品检定研究院，北京 102629)]), AuthorCompany(id=1239250705513509153, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239250702812377315, xref=2., ext=[AuthorCompanyExt(id=1239250705517703459, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239250702812377315, companyId=1239250705513509153, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2.The Pharmacovigilance Center of Hebei, Shijiazhuang 050090, China), AuthorCompanyExt(id=1239250705526092067, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239250702812377315, companyId=1239250705513509153, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2.河北省药物警戒中心，石家庄 050090)])], figs=[ArticleFig(id=1239250710647337558, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239250702812377315, language=EN, label=Tab.1, caption=

Sample information of and determination results of Cd and As in Isatidis Radix

, figureFileSmall=null, figureFileBig=null, tableContent=
编号
(No.)		产地
(origin)		批号
(batch No.)		含量(content)/(mg·kg-1)
CdAs
1甘肃定西市(Dingxi City，Gansu Province)HB-BLG-010.140.22
2甘肃定西市(Dingxi City，Gansu Province)HB-BLG-020.130.21
3甘肃定西市(Dingxi City，Gansu Province)HB-BLG-030.090.27
4甘肃定西市(Dingxi City，Gansu Province)HB-BLG-040.070.34
5甘肃定西市(Dingxi City，Gansu Province)HB-BLG-050.060.33
6甘肃定西市(Dingxi City，Gansu Province)HB-BLG-060.050.32
7甘肃定西市(Dingxi City，Gansu Province)HB-BLG-070.060.33
8甘肃定西市(Dingxi City，Gansu Province)HB-BLG-080.040.24
9甘肃定西市(Dingxi City，Gansu Province)HB-BLG-090.060.33
10甘肃定西市(Dingxi City，Gansu Province)HB-BLG-100.050.22
11甘肃定西市(Dingxi City，Gansu Province)HB-BLG-110.070.25
12甘肃定西市(Dingxi City，Gansu Province)HB-BLG-120.050.21
13甘肃定西市(Dingxi City，Gansu Province)HB-BLG-130.030.21
14甘肃定西市(Dingxi City，Gansu Province)HB-BLG-140.050.23
15甘肃定西市(Dingxi City，Gansu Province)HB-BLG-150.050.20
16甘肃定西市(Dingxi City，Gansu Province)HB-BLG-160.060.25
17甘肃定西市(Dingxi City，Gansu Province)HB-BLG-170.120.25
18甘肃张掖市(Zhangye City，Gansu Province)HB-BLG-180.1418.35
19甘肃张掖市(Zhangye City，Gansu Province)HB-BLG-190.1717.45
20甘肃张掖市(Zhangye City，Gansu Province)HB-BLG-200.1618.65
21甘肃张掖市(Zhangye City，Gansu Province)HB-BLG-210.1623.64
22甘肃张掖市(Zhangye City，Gansu Province)HB-BLG-220.1724.26
24甘肃张掖市(Zhangye City，Gansu Province)HB-BLG-230.220.55
25甘肃张掖市(Zhangye City，Gansu Province)HB-BLG-250.230.57
26甘肃张掖市(Zhangye City，Gansu Province)HB-BLG-260.210.56
27甘肃张掖市(Zhangye City，Gansu Province)HB-BLG-280.190.40
28甘肃张掖市(Zhangye City，Gansu Province)HB-BLG-290.080.26
29甘肃张掖市(Zhangye City，Gansu Province)HB-BLG-210.080.26
), ArticleFig(id=1239250710727029342, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239250702812377315, language=CN, label=表1, caption=

板蓝根样品信息及Cd和As的测定结果

, figureFileSmall=null, figureFileBig=null, tableContent=
编号
(No.)		产地
(origin)		批号
(batch No.)		含量(content)/(mg·kg-1)
CdAs
1甘肃定西市(Dingxi City，Gansu Province)HB-BLG-010.140.22
2甘肃定西市(Dingxi City，Gansu Province)HB-BLG-020.130.21
3甘肃定西市(Dingxi City，Gansu Province)HB-BLG-030.090.27
4甘肃定西市(Dingxi City，Gansu Province)HB-BLG-040.070.34
5甘肃定西市(Dingxi City，Gansu Province)HB-BLG-050.060.33
6甘肃定西市(Dingxi City，Gansu Province)HB-BLG-060.050.32
7甘肃定西市(Dingxi City，Gansu Province)HB-BLG-070.060.33
8甘肃定西市(Dingxi City，Gansu Province)HB-BLG-080.040.24
9甘肃定西市(Dingxi City，Gansu Province)HB-BLG-090.060.33
10甘肃定西市(Dingxi City，Gansu Province)HB-BLG-100.050.22
11甘肃定西市(Dingxi City，Gansu Province)HB-BLG-110.070.25
12甘肃定西市(Dingxi City，Gansu Province)HB-BLG-120.050.21
13甘肃定西市(Dingxi City，Gansu Province)HB-BLG-130.030.21
14甘肃定西市(Dingxi City，Gansu Province)HB-BLG-140.050.23
15甘肃定西市(Dingxi City，Gansu Province)HB-BLG-150.050.20
16甘肃定西市(Dingxi City，Gansu Province)HB-BLG-160.060.25
17甘肃定西市(Dingxi City，Gansu Province)HB-BLG-170.120.25
18甘肃张掖市(Zhangye City，Gansu Province)HB-BLG-180.1418.35
19甘肃张掖市(Zhangye City，Gansu Province)HB-BLG-190.1717.45
20甘肃张掖市(Zhangye City，Gansu Province)HB-BLG-200.1618.65
21甘肃张掖市(Zhangye City，Gansu Province)HB-BLG-210.1623.64
22甘肃张掖市(Zhangye City，Gansu Province)HB-BLG-220.1724.26
24甘肃张掖市(Zhangye City，Gansu Province)HB-BLG-230.220.55
25甘肃张掖市(Zhangye City，Gansu Province)HB-BLG-250.230.57
26甘肃张掖市(Zhangye City，Gansu Province)HB-BLG-260.210.56
27甘肃张掖市(Zhangye City，Gansu Province)HB-BLG-280.190.40
28甘肃张掖市(Zhangye City，Gansu Province)HB-BLG-290.080.26
29甘肃张掖市(Zhangye City，Gansu Province)HB-BLG-210.080.26
), ArticleFig(id=1239250710819304038, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239250702812377315, language=EN, label=Tab.2, caption=

Daily exposure and HI values of Cd and As in Isatidis Radix

, figureFileSmall=null, figureFileBig=null, tableContent=
批号
(batch No.)		CdAsHI
日暴露量
(daily exposure)/(μg·kg-1)		HQ日暴露量
(daily exposure)/(μg·kg-1)		HQ
HB-BLG-013.17×10-40.0030.0010.0380.042
HB-BLG-023.01×10-40.0030.0010.0370.041
HB-BLG-031.96×10-40.0020.0010.0480.051
HB-BLG-041.47×10-40.0010.0020.0600.063
HB-BLG-051.40×10-40.0010.0020.0580.060
HB-BLG-061.19×10-40.0010.0020.0560.059
HB-BLG-071.46×10-40.0010.0020.0580.060
HB-BLG-088.47×10-50.0010.0010.0430.044
HB-BLG-091.25×10-40.0010.0020.0590.061
HB-BLG-101.08×10-40.0010.0010.0390.041
HB-BLG-111.66×10-40.0020.0010.0440.046
HB-BLG-121.07×10-40.0010.0010.0370.039
HB-BLG-137.27×10-50.0010.0010.0360.037
HB-BLG-141.20×10-40.0010.0010.0410.043
HB-BLG-151.04×10-40.0010.0010.0350.037
HB-BLG-161.35×10-40.0010.0010.0430.045
HB-BLG-172.66×10-40.0030.0010.0440.048
HB-BLG-183.26×10-40.0030.0963.2113.215
HB-BLG-193.80×10-40.0040.0923.0543.058
HB-BLG-203.65×10-40.0040.0983.2643.269
HB-BLG-213.65×10-40.0040.1244.1384.143
HB-BLG-223.84×10-40.0040.1274.2464.251
HB-BLG-234.89×10-40.0050.0030.0960.103
HB-BLG-255.11×10-40.0050.0030.1000.108
HB-BLG-264.80×10-40.0050.0030.0970.104
HB-BLG-284.34×10-40.0040.0020.0700.081
HB-BLG-291.78×10-40.0020.0010.0460.048
), ArticleFig(id=1239250710961910379, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239250702812377315, language=CN, label=表2, caption=

板蓝根中Cd和As的日暴露量及HI值

, figureFileSmall=null, figureFileBig=null, tableContent=
批号
(batch No.)		CdAsHI
日暴露量
(daily exposure)/(μg·kg-1)		HQ日暴露量
(daily exposure)/(μg·kg-1)		HQ
HB-BLG-013.17×10-40.0030.0010.0380.042
HB-BLG-023.01×10-40.0030.0010.0370.041
HB-BLG-031.96×10-40.0020.0010.0480.051
HB-BLG-041.47×10-40.0010.0020.0600.063
HB-BLG-051.40×10-40.0010.0020.0580.060
HB-BLG-061.19×10-40.0010.0020.0560.059
HB-BLG-071.46×10-40.0010.0020.0580.060
HB-BLG-088.47×10-50.0010.0010.0430.044
HB-BLG-091.25×10-40.0010.0020.0590.061
HB-BLG-101.08×10-40.0010.0010.0390.041
HB-BLG-111.66×10-40.0020.0010.0440.046
HB-BLG-121.07×10-40.0010.0010.0370.039
HB-BLG-137.27×10-50.0010.0010.0360.037
HB-BLG-141.20×10-40.0010.0010.0410.043
HB-BLG-151.04×10-40.0010.0010.0350.037
HB-BLG-161.35×10-40.0010.0010.0430.045
HB-BLG-172.66×10-40.0030.0010.0440.048
HB-BLG-183.26×10-40.0030.0963.2113.215
HB-BLG-193.80×10-40.0040.0923.0543.058
HB-BLG-203.65×10-40.0040.0983.2643.269
HB-BLG-213.65×10-40.0040.1244.1384.143
HB-BLG-223.84×10-40.0040.1274.2464.251
HB-BLG-234.89×10-40.0050.0030.0960.103
HB-BLG-255.11×10-40.0050.0030.1000.108
HB-BLG-264.80×10-40.0050.0030.0970.104
HB-BLG-284.34×10-40.0040.0020.0700.081
HB-BLG-291.78×10-40.0020.0010.0460.048
), ArticleFig(id=1239250711066767986, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239250702812377315, language=EN, label=Tab.3, caption=

Cumulative exposure assessment results of Cd and As in Isatidis Radix based on TTD method

, figureFileSmall=null, figureFileBig=null, tableContent=
批号
(batch No.)		Cd的HQ值(HQ of Cd)As的HQ值(HQ of As)HI
心血管
(cardiovascular)		神经
(nerve)		肾脏
(kidney)		血液
(blood)		心血管
(cardiovascular)		神经
(nerve)		肾脏
(kidney)		血液
(blood)		心血管
(cardiovascular)		神经
(nerve)		肾脏
(kidney)		血液
(blood)
HB-BLG-016.34×10-40.0163.82×10-33.96×10-30.0380.0381.27×10-40.0190.0410.0548.33×10-30.024
HB-BLG-026.02×10-40.0153.62×10-33.76×10-30.0370.0371.24×10-40.0190.0410.0539.49×10-30.023
HB-BLG-033.93×10-40.0102.36×10-32.45×10-30.0480.0481.59×10-40.0240.0510.0588.54×10-30.027
HB-BLG-042.95×10-40.0071.77×10-31.84×10-30.0600.0602.00×10-40.0300.0630.0688.34×10-30.033
HB-BLG-052.80×10-40.0071.68×10-31.75×10-30.0580.0581.92×10-40.0290.0610.0668.16×10-30.031
HB-BLG-062.39×10-40.0061.44×10-31.49×10-30.0560.0561.88×10-40.0280.0600.0638.15×10-30.031
HB-BLG-072.91×10-40.0071.75×10-31.82×10-30.0580.0581.92×10-40.0290.0600.0667.72×10-30.031
HB-BLG-081.69×10-40.0041.02×10-31.06×10-30.0430.0431.42×10-40.0210.0450.0486.05×10-30.023
HB-BLG-092.49×10-40.0061.50×10-31.56×10-30.0590.0591.95×10-40.0290.0620.0668.56×10-30.032
HB-BLG-102.16×10-40.0051.30×10-31.35×10-30.0390.0391.31×10-40.0200.0410.0455.22×10-30.022
HB-BLG-113.33×10-40.0082.00×10-32.08×10-30.0440.0441.46×10-40.0220.0470.0537.58×10-30.025
HB-BLG-122.14×10-40.0051.29×10-31.34×10-30.0370.0371.24×10-40.0190.0390.0434.32×10-30.020
HB-BLG-131.45×10-40.0048.76×10-49.08×10-40.0360.0361.20×10-40.0180.0380.0404.57×10-30.019
HB-BLG-142.40×10-40.0061.44×10-31.50×10-30.0410.0411.36×10-40.0200.0430.0476.03×10-30.022
HB-BLG-152.07×10-40.0051.25×10-31.30×10-30.0350.0351.17×10-40.0180.0370.0415.48×10-30.019
HB-BLG-162.69×10-40.0071.62×10-31.68×10-30.0430.0431.44×10-40.0220.0460.0506.40×10-30.024
HB-BLG-175.32×10-40.0133.20×10-33.32×10-30.0440.0441.47×10-40.0220.0480.0589.90×10-30.026
HB-BLG-186.52×10-40.0163.93×10-34.07×10-33.2113.2111.07×10-21.6053.2133.2280.0171.610
HB-BLG-197.60×10-40.0194.58×10-34.75×10-33.0543.0541.02×10-21.5273.0563.0730.0181.532
HB-BLG-207.30×10-40.0184.40×10-34.56×10-33.2643.2641.09×10-21.6323.2673.2830.0201.637
HB-BLG-217.30×10-40.0184.40×10-34.56×10-34.1384.1381.38×10-22.0694.1434.1570.0272.075
HB-BLG-227.68×10-40.0194.63×10-34.80×10-34.2464.2461.42×10-22.1234.2504.2660.0262.129
HB-BLG-239.78×10-40.0245.89×10-36.11×10-30.0960.0963.20×10-40.0480.1020.1220.0180.056
HB-BLG-251.02×10-30.0266.16×10-36.39×10-30.1000.1003.35×10-40.0500.1070.1280.0180.058
HB-BLG-269.60×10-40.0245.78×10-36.00×10-30.0970.0973.24×10-40.0490.1030.1230.0170.056
HB-BLG-288.67×10-40.0225.22×10-35.42×10-30.0700.0702.33×10-40.0350.0890.0970.0440.046
HB-BLG-293.55×10-40.0092.14×10-32.22×10-30.0460.0461.53×10-40.0230.0470.0554.87×10-30.026
HB-BLG-013.66×10-40.0092.21×10-32.29×10-30.0460.0461.53×10-40.0230.0480.0565.09×10-30.026
HB-BLG-023.84×10-40.0102.31×10-32.40×10-30.0430.0431.45×10-40.0220.0450.0534.86×10-30.024
), ArticleFig(id=1239250711163236984, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239250702812377315, language=CN, label=表3, caption=

基于TTD法的板蓝根中Cd和As的累积暴露评估结果

, figureFileSmall=null, figureFileBig=null, tableContent=
批号
(batch No.)		Cd的HQ值(HQ of Cd)As的HQ值(HQ of As)HI
心血管
(cardiovascular)		神经
(nerve)		肾脏
(kidney)		血液
(blood)		心血管
(cardiovascular)		神经
(nerve)		肾脏
(kidney)		血液
(blood)		心血管
(cardiovascular)		神经
(nerve)		肾脏
(kidney)		血液
(blood)
HB-BLG-016.34×10-40.0163.82×10-33.96×10-30.0380.0381.27×10-40.0190.0410.0548.33×10-30.024
HB-BLG-026.02×10-40.0153.62×10-33.76×10-30.0370.0371.24×10-40.0190.0410.0539.49×10-30.023
HB-BLG-033.93×10-40.0102.36×10-32.45×10-30.0480.0481.59×10-40.0240.0510.0588.54×10-30.027
HB-BLG-042.95×10-40.0071.77×10-31.84×10-30.0600.0602.00×10-40.0300.0630.0688.34×10-30.033
HB-BLG-052.80×10-40.0071.68×10-31.75×10-30.0580.0581.92×10-40.0290.0610.0668.16×10-30.031
HB-BLG-062.39×10-40.0061.44×10-31.49×10-30.0560.0561.88×10-40.0280.0600.0638.15×10-30.031
HB-BLG-072.91×10-40.0071.75×10-31.82×10-30.0580.0581.92×10-40.0290.0600.0667.72×10-30.031
HB-BLG-081.69×10-40.0041.02×10-31.06×10-30.0430.0431.42×10-40.0210.0450.0486.05×10-30.023
HB-BLG-092.49×10-40.0061.50×10-31.56×10-30.0590.0591.95×10-40.0290.0620.0668.56×10-30.032
HB-BLG-102.16×10-40.0051.30×10-31.35×10-30.0390.0391.31×10-40.0200.0410.0455.22×10-30.022
HB-BLG-113.33×10-40.0082.00×10-32.08×10-30.0440.0441.46×10-40.0220.0470.0537.58×10-30.025
HB-BLG-122.14×10-40.0051.29×10-31.34×10-30.0370.0371.24×10-40.0190.0390.0434.32×10-30.020
HB-BLG-131.45×10-40.0048.76×10-49.08×10-40.0360.0361.20×10-40.0180.0380.0404.57×10-30.019
HB-BLG-142.40×10-40.0061.44×10-31.50×10-30.0410.0411.36×10-40.0200.0430.0476.03×10-30.022
HB-BLG-152.07×10-40.0051.25×10-31.30×10-30.0350.0351.17×10-40.0180.0370.0415.48×10-30.019
HB-BLG-162.69×10-40.0071.62×10-31.68×10-30.0430.0431.44×10-40.0220.0460.0506.40×10-30.024
HB-BLG-175.32×10-40.0133.20×10-33.32×10-30.0440.0441.47×10-40.0220.0480.0589.90×10-30.026
HB-BLG-186.52×10-40.0163.93×10-34.07×10-33.2113.2111.07×10-21.6053.2133.2280.0171.610
HB-BLG-197.60×10-40.0194.58×10-34.75×10-33.0543.0541.02×10-21.5273.0563.0730.0181.532
HB-BLG-207.30×10-40.0184.40×10-34.56×10-33.2643.2641.09×10-21.6323.2673.2830.0201.637
HB-BLG-217.30×10-40.0184.40×10-34.56×10-34.1384.1381.38×10-22.0694.1434.1570.0272.075
HB-BLG-227.68×10-40.0194.63×10-34.80×10-34.2464.2461.42×10-22.1234.2504.2660.0262.129
HB-BLG-239.78×10-40.0245.89×10-36.11×10-30.0960.0963.20×10-40.0480.1020.1220.0180.056
HB-BLG-251.02×10-30.0266.16×10-36.39×10-30.1000.1003.35×10-40.0500.1070.1280.0180.058
HB-BLG-269.60×10-40.0245.78×10-36.00×10-30.0970.0973.24×10-40.0490.1030.1230.0170.056
HB-BLG-288.67×10-40.0225.22×10-35.42×10-30.0700.0702.33×10-40.0350.0890.0970.0440.046
HB-BLG-293.55×10-40.0092.14×10-32.22×10-30.0460.0461.53×10-40.0230.0470.0554.87×10-30.026
HB-BLG-013.66×10-40.0092.21×10-32.29×10-30.0460.0461.53×10-40.0230.0480.0565.09×10-30.026
HB-BLG-023.84×10-40.0102.31×10-32.40×10-30.0430.0431.45×10-40.0220.0450.0534.86×10-30.024
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基于靶器官毒性剂量法的板蓝根中镉和砷的联合暴露评估*
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左甜甜 1 , 刘永利 2 , 金红宇 1 , 李海亮 1 , 刘芫汐 1 , 于健东 1, ** , 马双成 1, **
药物分析杂志 | 标准研讨 2024,44(4): 714-720
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药物分析杂志 | 标准研讨 2024, 44(4): 714-720
基于靶器官毒性剂量法的板蓝根中镉和砷的联合暴露评估*
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左甜甜1 , 刘永利2 , 金红宇1, 李海亮1, 刘芫汐1, 于健东1, ** , 马双成1, **
作者信息
  • 1.中国食品药品检定研究院，北京 102629
  • 2.河北省药物警戒中心，石家庄 050090

    • 左甜甜　Tel：(010)53851453；E-mail：

    刘永利　Tel：(0311)67909955；E-mail：

通讯作者:

** 马双成　Tel：(010)53852076；E-mail：
于健东　Tel：(010)67095452；E-mail：
Risk assessment of combined exposure to cadmium and arsenic in Isatidis Radix based on target-organ toxicity dose modification of HI method*
Tian-tian ZUO1 , Yong-li LIU2 , Hong-yu JIN1, Hai-liang LI1, Yuan-xi LIU1, Jian-dong YU1, ** , Shuang-cheng MA1, **
Affiliations
  • 1.National Institutes for Food and Drug Control, Beijing 102629, China
  • 2.The Pharmacovigilance Center of Hebei, Shijiazhuang 050090, China
出版时间: 2024-04-30 doi: 10.16155/j.0254-1793.2024.04.18
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摘要
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目的：

对板蓝根中镉(Cd)和砷(As)的残留量进行测定，探索靶器官毒性剂量法在评估中药中重金属及有害元素联合暴露风险中的应用。

方法：

根据板蓝根中Cd和As的残留量监测数据，计算其暴露量。采用危害指数(HI)法对Cd和As联合暴露产生的健康风险进行初步筛查。进一步针对不同毒理学终点，采用靶器官毒性剂量(TTD)法，对Cd和As的累积风险进行更加精确的评估。

结果：

29批板蓝根中Cd的合格率为100%，5批As的含量超过限量标准。HI法的初步评估结果表明，5批板蓝根中As的危害商(HQ)值高于1。TTD法评估结果表明，对于作用终点心血管、血液、神经系统，5批板蓝根的HI值>1，健康风险需要被关注。

结论：

本研究探索了中药材板蓝根中Cd和As的累积风险评估方法，为中药中外源性有害残留物风险评估方法开发提供新的思路，为制定更加科学的限量标准提供技术支撑。

靶器官毒性剂量(TTD)法  /  镉  /  砷  /  板蓝根  /  联合暴露  /  累积风险评估  /  中药
Objective:

To determine the contents of Cd and As in Isatidis Radix and to explore the application of target-organ toxicity dose(TTD) modification of hazard index (HI) method in assessing the risk of combined exposure to heavy metals and harmful elements in traditional Chinese medicines (TCMs).

Methods:

According to the monitoring data of Cd and As in Isatidis Radix, the exposure doses were calculated. The health risk caused by combined exposure to Cd and As was preliminary screened by HI method. Moreover, a more accurate TTD method was used.

Results:

The qualified rates of Cd in 29 batches of Isatidis Radix were 100%. However, 5 batches of As contents exceeded the limit standard. The HQ values of As in 5 batches of Isatidis Radix were more than 1. The results of TTD method showed that for the end points of cardiovascular system, blood, nervous system, the HI values of 5 batches of Isatidis Radix were more than 1, and the health risk was not acceptable.

Conclusion:

The cumulative risk assessment of heavy metals in TCMs is proposed in this study, which offers novel ideas for the development of risk assessment methods of exogenous harmful residues in TCMs, and provides technical support for formulating scientific limit standards.

target-organ toxicity dose(TTD) modification of HI method  /  cadmium  /  arsenic  /  Isatidis Radix  /  combined exposure  /  cumulative risk assessment  /  traditional Chinese medicine
左甜甜, 刘永利, 金红宇, 李海亮, 刘芫汐, 于健东, 马双成. 基于靶器官毒性剂量法的板蓝根中镉和砷的联合暴露评估*. 药物分析杂志, 2024 , 44 (4) : 714 -720 . DOI: 10.16155/j.0254-1793.2024.04.18
Tian-tian ZUO, Yong-li LIU, Hong-yu JIN, Hai-liang LI, Yuan-xi LIU, Jian-dong YU, Shuang-cheng MA. Risk assessment of combined exposure to cadmium and arsenic in Isatidis Radix based on target-organ toxicity dose modification of HI method*[J]. Chinese Journal of Pharmaceutical Analysis, 2024 , 44 (4) : 714 -720 . DOI: 10.16155/j.0254-1793.2024.04.18
正文
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板蓝根为十字花科植物菘蓝Isatis indigotica Fort.的干燥根，含核苷、蒽醌、木脂素、β-谷甾醇、氨基酸等类化合物[1]。板蓝根是一味具有广谱疗效的抗病毒中药，具有清热解毒、凉血利咽之功效，用于治疗温毒发斑、舌绛紫暗、烂喉丹痧、大头瘟疫等症状[2]。目前，对板蓝根的研究主要集中在化学成分和药理学活性，以及基于指纹图谱、谱效关系等相关研究。
中药在种植、采收、加工、贮存等过程中可能被外源性有害残留物污染。重金属为外源性有害残留物，中药一旦被重金属及有害元素污染，在人体中产生蓄积毒性作用，可能会严重损害人体的新陈代谢和人体健康。课题组在前期研究中，发现部分根类中药材中重金属及有害元素残留量较高，建议对根类中药材中重金属及有害元素的残留情况予以重视[3]。目前，对于重金属及有害元素的健康风险评估主要是基于单一金属的单一途径暴露[4-6]，然而在实际生活中，人们每天都会通过多种途径暴露于多种污染物，2种或多种污染物通过不同途径和媒介共同引起的总暴露称为累积暴露，对于累积暴露所产生健康风险的评估，称为累积风险评估。近年来，通过食物和环境同时暴露于多种化学物的健康风险受到更多的关注[7]。即使单独暴露于一类中药材的任何一种化合物没有健康风险，联合暴露于这类化学物的风险，可能需要引起关注。本研究以全国范围内收集到的29批根类药材板蓝根为研究对象，测定其镉(Cd)和砷(As)的残留量，探索靶器官毒性剂量(TTD)法在Cd和As联合暴露评估中的应用，为中药中重金属及有害元素的风险评估方法提供新的思路，为制定更加科学的外源性有害残留物的限量标准提供技术储备。
1　样品收集
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本次抽样年份为2018—2020年，涉及板蓝根样品29批次，分别来自甘肃省定西市魏源县和甘肃省张掖市民乐县，抽样单位涉及中药材及中药饮片生产、经营和流通环节，具体样品信息见表1。
2　样品测定和质量控制
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中药材中Cd和As残留量的测定由河北省药品医疗器械检验研究院完成，根据2020年版《中华人民共和国药典》四部收录的“电感耦合等离子体质谱法(ICP-MS)”进行测定分析。
2.1　仪器工作参数
等离子气流量：15.0 L·min-1；雾化室温度：2 ℃；蠕动泵转速：0.20 r·s-1；He气流量：5 mL·min-1；辅助气流量：0.8 L·min-1；载气流量：0.8 L·min-1；射频功率：1 550 W；采样深度：10 mm；重复次数：3次；描次数：100次。
2.2　随行质量控制
由于所采用的方法为2020年版《中华人民共和国药典》通则2321“铅、镉、砷、汞、铜测定法”，属通用方法，故仅以随行质量控制(包括随行空白试验、同位素内标试验和随行回收试验)来评估方法的可行性。
2.2.1　空白溶液
按2020年版《中华人民共和国药典》“铅、镉、砷、汞、铜测定法”中“电感耦合等离子体质谱法”中仅取硝酸8 mL，“在同样的分析条件下进行空白试验”项下操作。
2.2.2　同位素内标
对整个测定过程的质量稳定性进行监控与评估。75As以72Ge为内标，114Cd以115In为内标。内标回收率均在80%~120%，结果符合残留检测要求。
2.2.3　随行回收率试验
精密称取样品粉末0.5 g(批号HB-BLG-01)，精密加入混合标准溶液(每1 mL含Cd和As分别为1 μg和5 μg)1 mL，按2020年版《中华人民共和国药典》通则2321“铅、镉、砷、汞、铜测定法”中“供试品溶液的制备”项下方法操作，Cd和As的回收率分别为(92.7±3.9)%和(106.2±4.3)%，符合残留检测要求。
3　结果分析
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参照2020年版《中华人民共和国药典》一部对植物类中药材中Cd和As的限量标准(Cd限量≤1 mg·kg-1；As限量≤2 mg·kg-1)，29批板蓝根中Cd的合格率为100%，5批As的含量超过限量标准，建议进一步监测和评估。
4　风险评估
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4.1　暴露量的计算
每人每千克体重中药材中Cd和As日暴露量的计算公式如下
公式(1)中Exp为每人每千克体质量单一重金属及有害元素的日暴露量，单位为μg·kg-1；其中，EF为中药材的服用频率，Ed为服用中药的年限。根据国家食品安全风险评估中心在我国11个省份20 917名调查者的有效消费调查数据[8]，EF的P95值为每年90 d，Ed为20 a；IR为处方中药材的日暴露量，根据2020年版《中华人民共和国药典》规定的最大日用量为15 g；t为经过煎煮等方式提取后重金属及有害元素的转移率，综合文献和课题组的研究结果，在水煎的条件下，Cd和As的t值分别为14%和35%[8]；C为板蓝根中重金属及有害元素的残留量，单位为mg·kg-1；W为人体体质量，以70 kg计；AT为平均寿命天数(365×70=25 550)。
4.2　风险特征描述
单一重金属及有害元素风险的高低由危害商(HQ)来描述，其计算公式如公式(2)：
其中，安全因子SF为10[9]。本研究所采用的健康指导值(HBGV)是美国环保署(US EPA)所建议的Cd和As的口服参考剂量，分别为每日每千克体质量0.001和0.000 3 mg·kg-1[10]。若HQ≤1，那么单一重金属及有害元素暴露所产生的健康风险较低，风险可以被接受；若HQ>1，风险较高，不容忽视。
4.3　累积风险评估
采用分级别的原则对于板蓝根中Cd和As累积暴露所产生的风险进行评估。先从低级别的累积风险评估方法即危害指数(HI)法进行评估，对于风险进行初步筛查，再采用更加精确的TTD法，对于Cd和As的累积风险进行评估。
4.3.1　HI法
HI是各化学物HQ之和，HI的计算公式为
公式(3)中，HQCd和HQCd分别为Cd和As的HQ值。若HI<1，则认为Cd和As联合暴露所产生的风险可以被接受；若HI>1，则认为风险不可接受。
4.3.2　TTD法
TTD法是HI法的改进方法，是针对特定毒理作用终点风险特征描述的方法。TTD法需考虑每一污染物质基于每一作用终点的毒理效应，计算基于每一特定作用终点效应的HQ和HI值[11]。TTD法中HI的计算公式同公式(3)，所不同的是参比值HBGV代入每一毒理效应终点的健康指导值。根据美国环保署(US EPA)发布的指南[12]，针对心血管、血液、神经系统、肾脏、睾丸这5种不同毒理终点Cd的每日允许暴露量(ADI)分别为每千克体质量0.005、0.000 8、0.000 2、0.000 83、0.003 mg·kg-1。针对心血管、血液、神经系统、肾脏这4种不同毒理终点As的ADI分别为每千克体质量0.000 3、0.000 6、0.000 3、0.09 mg·kg-1。若HI<1，则认为风险可以被接受；若HI>1，则认为风险不可接受。
5　结果
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5.1　HI法初步评估结果
计算每千克体质量板蓝根中Cd和As的日暴露量，结果如表2所示。针对Cd和As的最敏感毒理作用终点，分别计算其HQ值，并计算其HI值，HQ结果(表2)说明，5批板蓝根中As的HQ值>1，有必要对其健康风险进行更加精确的评估。
5.2　TTD法修正的HI结果
Cd和As的作用终点主要包括心血管系统、神经系统、肾脏、血液，针对每一种靶器官的毒性剂量，分别计算出Cd和As相应的HQ值，进一步计算出TTD法修正的HI值(表3)。结果对于作用终点心血管、血液、神经系统，均有5批次板蓝根的HI值>1，健康风险需要被关注。
6　讨论和结语
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US EPA认为发起累积性评估的起始因素有3个，一为多种污染物来源或者释放；二为化合物在环境监控或者生物监控中浓度增加；三为该区域病例增加[13]。累积性暴露评估旨在评估某一人群在一定时间区内通过多种途径对不同化合物的暴露，因此一方面需要分析相关化学品的毒性终点，另一方面评估应该综合考虑不同化合物的暴露时间和暴露强度。采用的暴露评估模型一般分为2类，一是以风险初筛为目的，另外是以精确化评估为目的。不同累积风险评估方法所需要的毒理学参数及适用范围有所不同，HI法简便快速，但各重金属及有害元素的健康指导值的确定并非基于共同的观察终点，因此，HI法适用于风险的初步筛查[14-18]。对于更加精确的风险评估，US EPA建议把化合物按照作用机制或者靶标一致性进行进一步分组(包括所有可能产生的效应或者影响的靶器官)[19-20]。本研究首先采用HI法对板蓝根中重金属及有害元素的联合暴露风险进行初筛，进一步探索性地采用更高级别的TTD法对Cd和As可能产生的健康风险做出更加精确的评估。TTD法评估结果表明，对于作用终点心血管、血液、神经系统，5批板蓝根的HI值>1，健康风险需要被关注。污染物的累积风险评估在国际上环境、食品等领域仍然是一个全新的课题，中药中外源性有害残留物的累积风险评估更是刚刚起步。本研究尝试采用TTD法对中药材中重金属及有害元素的累积暴露风险进行评估，以期为中药材中外源性有害残留物风险评估的方法开发提供新思路，为中药材中重金属及有害元素限量标准的制、修订提供科学依据。
基金
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  • *国家药典委员会标准提高课题(2023Z07)
  • 中国食品药品检定研究院关键技术基金(GJJS-2022-7-1)
文献
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2024年第44卷第4期
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doi: 10.16155/j.0254-1793.2024.04.18
  • 首发时间：2026-03-13
  • 出版时间：2024-04-30
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  • 修回日期：2024-03-26
基金
*国家药典委员会标准提高课题(2023Z07)
中国食品药品检定研究院关键技术基金(GJJS-2022-7-1)
作者信息
    1.中国食品药品检定研究院，北京 102629
    2.河北省药物警戒中心，石家庄 050090

通讯作者:

** 马双成　Tel：(010)53852076；E-mail：
于健东　Tel：(010)67095452；E-mail：
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2种不同金属材料的力学参数
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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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