重金属健康危害与中药中重金属限量标准之修订.pdf

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1、11217200617264-2751991100 ppm5 ppm2 ppm0.3 ppm0.2 ppm()(Chinese herbal medicine)(Heavy metal)(Limits of toxic metal)602651)2)3)12001110(“65”)2001912(GMP,Good ManufacturePractice)2034,5()()()(perceptual integration)()()Fanconi syn-drome()()()4,54,5()(266-)()(Itai-itai disease)()()()4,5()4,5()()(ereth

2、ism)(intentional tre-mor)()()()()()()4,5,6()Mees Line()()4,5(kwashior-kor)()(sprue)(Menkes disease)()()267(Vineyard Sprayers Lung)(Wilsons Disease)(ceruloplasmin)(chromium picolinate)4,5()5()25751.6157025070501615070.10.28(World Health Organization,WHO)7*WHO 199925 g/kg b.w.1750 g250 gWHO 1989,20007

3、 g/kg b.w.490 g70 gWHO 1978,1988,19993.3 g/kg b.w.231 g33 gWHO 20031.6 g/kg b.w.112 g16 gWHO 19905 g/kg b.w.350 g50 gWHO 198915 g/kg b.w.1050 g150 g*70b.w.(body weight)2689,1020 ppm2 ppm0.2 ppm0.5ppm0.05 ppm2 ppm0.5ppm1 ppm0.5 ppm0.5 ppm1 ppm1 ppm0.5 ppm0.5ppm0.4 ppm(0.3 ppm)0.3 ppm80.05 ppm0.005 pp

4、m0.01ppm0.002 ppm0.01 ppm0.05ppm0.1 ppm2 ppm0.01 ppm0.05 ppm1 ppm5 ppm0.05 ppm0.3 ppm110.01 ppm0.015 ppm3,129,10(ppm g/g)()PbCdAsHgCu882028240103902027540103734033900.35930.20.50.059220.20.20.12820.10.10.050.48240103930.394()32930.5812/0.5*751.5250880.30.2552500.15880.050.0050.050.00115920.050.0050.

5、010.00115*2 ppm0.5 ppm26930 ppm20 ppm10 ppm40 ppm20 ppm10ppm13,1430 ppm3 10 ppm3 ppm3ppm142001(raw dietarysupplement)10 ppm0.3ppm0.2 ppm5 ppm2 ppm(finished dietary supplement)20 620102015,162001200110 ppm200220063 ppm200720111 ppm20120.8 ppm()17 50 ppm2 ppm1,2211,12-ppbg/L-1ppbg/L-2ppbg/L()Pb 50 15

6、0.5*Cd 5 5 5As 10 10 2Hg 2 2 2Se 10 50 50Cr 50 100 100Ni 100 100 100Ba 2000 2000 2000Sb 10 6 3Tl 2 0.5Be 4 0.8()Mn 50 50 50Cu 1000 1300 1000Zn 5000 5000 5000Ag 50 100 100Fe 300 300 300Al 50-200 501(EPA)(maximum contaminant levels)2(EPA)(health advisory level)*(maximum contaminant limit level)17 2001

7、10 ppm200220063 ppm10 ppm200720111 ppm 5 ppm20120.8 ppm2.5 ppm27015 ppm2 ppm20 ppm10 ppm1ppm40 ppm13,182001()2610 ppm0.3ppm13,191 9 9 15ppm0.2 ppm0.1 ppm(Saint Johnswort)20,21200210 ppm1ppm0.1 ppm5 ppm10 ppm40 ppm2019952 0ppm0.5 ppm5 ppm150 ppm221995()10 ppm0.5 ppm5 ppm20050.3 ppm15,21200110 ppm0.3

8、ppm0.2 ppm5ppm(ppm g/g)1991100a199150.20.1b20021010.14019952050.51501995 1050.52005100.350.5c20012050.320.220200120 g/6 g/10 g/20 g/100.350.2d200126100.3e2004730222005 3050.330.2f2005850.320.2abcdef(9)()2005927120 6201020150.15 ppm20 ppm232001720 ppm5 ppm0.2 ppm2 ppm0.3ppm20 ppm2420055 ppm0.2ppm2 pp

9、m0.3 ppm20 ppm256 ppm0.5ppm1.4 ppm262005(9)()5ppm0.2 ppm2 ppm0.3 ppm20ppm272005 5 ppm 3 ppm 0.2 ppm0.3 ppm 3 ppm30 ppm28791280100 ppm1,13939321()30 ppm2 ppm2 ppm298094429(0940002424)94517244,000 ppm308080Chu JF28033.0931Cheng TJ319322.62.73.03.410.925.633272()20017200592()130.6 ppm5 ppm0.5 ppm34()2

10、ppm30 ppm2 ppm29100 ppm150 ppm2735 ppm2 ppm0.3 ppm0.2ppm()10 ppm2 ppm1 ppm0.5 ppm()5 ppm2 ppm0.3 ppm0.2 ppm1.2005;149-752.California Prop 65,2001,http:/ Priority List for 1999:Top 20 HazardousSubstances,Agency for Toxic Substances and Disease Registry,U.S.Department of Health and Human Services,http

11、:/www.ats-dr.cdc.gov/99list.html;&U.S.CDC,National Center forEnvironmental Health,National Report on Human Exposure toEnvironmental Chemicals,2001.www.cdc.gov/nceh/dls/re-port/Highlights.htm4.Dart R.C.Medical Toxicology,3rd ed.Philadelphia:LippincottWiliams&Wilkins;2004,1393-401,1411-4,1423-31,1437-

12、48.5.Poisendex:Arsenic,Lead,Cadmium.Mercury.1974-2006Thomson MICROMEDEX.MICROMEDEX(R)HealthcareSeries Vol.129,2006.6.Counter SA,Buchanan LH.Mercury exposure in children:a re-view.Toxicol Appl Pharmacol 2004;198:209-30.7.Reports on tasks for scientific cooperatiom.Assessment of thedietary exposure to

13、 arsenic,cadmium,lead and mercury of thepopulation of the EU member sites,2004.8.UNEP.Global Mercury assessment.http:/www.chem.unep.ch/mercury/report/chapter4.htm9.10.94121311.560758692412.Drinking water information from the Environmental ProtectionAgency,USA,http:/www.epa.gov/safewater/regs.html.13

14、.()2004;22:141-7014.USP the United States Pharmacopeial Conventions,Inc.,meet-ing at Washington,D.C.,2003,26.15.WHO:Quality control methods for medicinal plant materials-Revised draft uptate,September,2005,World HealthOrganization,2005.16.Dietary supplements-NSF National draft Standard(DraftStandard

15、 173-2001).National Sanitation FoundationInternational,Am Arbor,Michigan,USA,2001.17.Dharmananda S.Lead Content of Soil,Plants,Foods,Air,andChinese Herb Formulas,2001.http:/www.itmonline.org/arts/lead.htm.18.200119.http:/ L,Sievers H.Contaminants of medicinal and foodherbs with a view to EU regulati

16、ons.Innov Food Technol 2004;25-7.21.22.Koh HL,Woo SO.Chinese proprietary medicine in Singapore.Drug safety 2000;23:351-62.23.2000.24.2001425.200526.2000http:/cc.informac.gov.mo/c/news/c_beauty_news.htm27.200528.2005http:/29.093000021130.1998;39:10-9.31.Chu JF,Liou SH,Wu TN,Ko KN,Chang PY.Risk factor

17、s forhigh blood lead levels among the general population in Taiwan.274Eur J Epidemiol 1998;14:775-81.32.Cheng TJ,Wong RH,Lin YP,Hwang YH,Horng JJ.Wang JD.Chinese herbal medicine,sibship,and blood lead in children.Occup Environ Med 1998;55:573-6.33.9134.0920001269275Health Hazard of Heavy Metal and P

18、rovisionsfor the Standard of Maximum Allowable Levelof Toxic Metal in Herbal Drugs Ming-Ling Wu,and Jou-Fang DengThe incidence and prevalence of end stage renal disease in Taiwan have been highest in the world.Environment pollution and drug misuse are the major risk factors.The presence of toxic hea

19、vy metals can behazardous to the health of patients;especially lead,arsenic,mercury,cadmium.Many countries have abandonedthe import of metal containg herbal drugs.In Taiwan,the standard of toxic metal content in herbal medicine wasfirst established in 1991.The legal limit of toxic heavy metal in her

20、bal medicine is less than 100 ppm.This regu-lation cannot guarantee the safety of herbal user.We suggest the limits of toxic metals in finished herbal pro-ducts and dietary supplemtnts to be as follows:lead 5 ppm,arsenic 2 ppm,cadmium 0.3 ppm,mercury 0.2 ppm.(J Intern Med Taiwan 2006;17:264-275)Division of Clinical Toxicology,Department of Medicine,Taipei Veterans General Hospital&Department of Medicine,Faculty of Medicine,National Yang-Ming University.