重金屬健康危害與中藥中重金屬限量標準之修訂

(1)

11217

1991 100 ppm

5 ppm 2 ppm 0.3 ppm 0.2 ppm

( )

( Chinese herbal medicine ) ( Heavy metal )

( Limits of toxic metal )

6 0

(2)

1 )

2) 3)

1

2001 110

( “65 ” ) 2001 9 1

2

( GMP, Good Manufacture Practice )

20

3

4,5

( ) ( )

( )

( perceptual integration ) ( )

( )

Fanconi syn- drome (

)

( )

4,5

( )

(

(3)

- )

( ) ( Itai-itai disease )

( )

4,5

( )

4,5

( )

( ) ( e r e t h i s m

) ( intentional tre- mor )

( ) (

) ( )

( ) ( )

( )

4,5,6

(

)

Mee's Line

( ) (

)

4,5

( kwashior- k o r

) (

) ( sprue

)

( Menke's disease )

( )

(

)

(4)

( Vineyard Sprayer's Lung ) ( Wilson's Disease )

( ceruloplasmin )

( chromium picolinate )

4,5

( )

5

( )

2 5

7 5

1.6 15

7 0

2 5 0 7 0 5 0

16 150

⁷

0.1

0.2

⁸

(World Health Organization, WHO)

⁷

* *

WHO 1999 25 g/kg b.w. 1750 g 250 g

WHO 1989, 2000 7 g/kg b.w. 490 g 70 g

WHO 1978, 1988, 1999 3.3 g/kg b.w. 231 g 33 g

WHO 2003 1.6 g/kg b.w. 112 g 16 g

WHO 1990 5 g/kg b.w. 350 g 50 g

WHO 1989 15 g/kg b.w. 1050 g 150 g

*

70 b.w. ( body weight )

(5)

9 , 1 0

20 ppm 2 ppm 0.2 ppm 0.5

ppm 0.05 ppm

2 ppm 0.5

ppm

1 ppm 0.5 ppm

0.5 ppm

1 ppm

1 ppm 0.5 ppm

0 . 5

ppm 0.4 ppm

( 0.3 ppm )

0.3 ppm

⁸

0.05 ppm 0.005 ppm 0.01 p p m 0 . 0 0 2 p p m 0 . 0 1 p p m 0 . 0 5

ppm 0.1 ppm 2 ppm 0.01 ppm

0.05 ppm 1 ppm 5 ppm 0.05 ppm 0.3 ppm

¹¹

0.01 ppm 0.015 ppm

3,12

9,10

( ppm g/g )

( ) Pb Cd As Hg Cu

88 20 2

82 40 10 3

90 20 2

75 40 10 3

73 40 3 3

90 0.3 5

93 0.2 0.5 0.05

92 2 0.2 0.2 0.1 2

82 0.1 0.1 0.05 0.4

82 40 10 3

93 0.3

94 ( ) 3 2

93 0.5

81 2/0.5*

75 1.5 250

88 0.3 0.2 5 5

250 0.15

88 0.05 0.005 0.05 0.001 1 5

92 0.05 0.005 0.01 0.001 1 5

*

2 ppm 0.5 ppm

(6)

3 0 p p m 20 ppm 10 ppm

40 ppm 20 ppm 10

p p m

^{1 3 , 1 4}

30 ppm

3 ~10 ppm 3 ppm 3

ppm

¹⁴

2001

( raw dietary

supplement ) 10 ppm 0.3

ppm 0.2 ppm 5 ppm 2 ppm

( finished dietary supplement )

2 0 6

20 10 20

^15,16

2 0 0 1

2001 10 ppm 2002~2006

3 ppm 2007~2011 1 ppm 2012 0.8 ppm ( )

¹⁷

50 ppm 2 ppm

^1,22

11,12

- ppb g/L -

¹

ppb g/L -

²

ppb g/L

( )

Pb < 50 < 15 < 0.5

^*

Cd < 5 < 5 < 5

As < 10 < 10 < 2

Hg < 2 < 2 < 2

Se < 10 < 50 < 50

Cr < 50 < 100 < 100

Ni < 100 < 100 < 100

Ba < 2000 < 2000 < 2000

Sb < 10 < 6 < 3

Tl < 2 < 0.5

Be < 4 < 0.8

( )

Mn < 50 < 50 < 50

Cu < 1000 < 1300 < 1000

Zn < 5000 < 5000 < 5000

Ag < 50 < 100 < 100

Fe < 300 < 300 < 300

Al < 50-200 < 50

1

( EPA ) ( maximum contaminant levels )

2

( EPA ) ( health advisory level )

*

( maximum contaminant limit level )

17

2001 10 ppm

2002~2006 3 ppm

10 ppm

2007~2011 1 ppm

5 ppm

2012 0.8 ppm

2.5 ppm

(7)

15 ppm 2 ppm 20 ppm

1 0 p p m 1

ppm

40 ppm

13,18

2001

( )

2 6

10 ppm 0.3

ppm

^13,19

1 9 9 1 5

ppm 0.2 ppm 0.1 ppm

( S a i n t J o h n s

wort )

^20,21

2002

10 ppm 1

ppm 0.1 ppm 5 ppm

10 ppm 40 ppm

²⁰

1995

2 0

ppm 0.5 ppm 5 ppm

150 ppm

²²

1995

( )

10 ppm 0.5 ppm 5 ppm

2005 0.3 ppm

^15,21

2001 10 ppm

0 . 3 p p m 0 . 2 p p m 5 p p m

( ppm g/g )

1991 100

a

1991 5 0.2 0.1

b

2002 10 1 0.1 40

1995 20 5 0.5 150

1995 10 5 0.5

2005 10 0.3 5 0.5

c

2001 20 5 0.3 2 0.2 20

2001 20 g/ 6 g/ 10 g/ 20 g/

10 0.3 5 0.2

d

2001 26 10 0.3

e

2004 7 30 2 2

2005 30

5 0.3 3 0.2

f

2005 8 5 0.3 2 0.2

a

b c d

e

f

( 9 ) ( ) 2005 9

(8)

20 6 20 10

20

¹⁵

0.15 ppm 20 ppm

²³

2 0 0 1 7

20 ppm 5 ppm

0 . 2 p p m 2 p p m 0 . 3

ppm 20 ppm

²⁴

2005

5 p p m 0 . 2 ppm 2 ppm 0.3 ppm 20 ppm

²⁵

6 ppm 0.5

p p m 1 . 4 p p m

^{2 6}

2 0 0 5

( 9 )

( )

5 ppm 0.2 ppm 2 ppm 0.3 ppm 20

ppm

²⁷

2005

5 ppm 3 ppm 0.2 ppm

0.3 ppm 3 ppm

30 ppm

²⁸

79 12 8 0

100 ppm

1 , 1 3

93 93

2 1

( ) 30 ppm

2 ppm 2 ppm

²⁹

8 0

94 4 29

( 0940002424 ) 94 5 1

72 44,000 ppm

³⁰

80

80 Chu JF 2803

3.09

³¹

Cheng TJ 319

3 2

2.6 2 . 7 3 . 0 3 . 4

10.9 25.6

33

(9)

( )

2 0 0 1 7

2005

92 ( )

¹³

0.6 ppm

5 ppm 0.5 ppm

³⁴

( )

2 ppm 30 ppm

2 p p m

^{2 9}

100 ppm

1

50 ppm

(10)

5 ppm 2 ppm 0.3 ppm 0.2 ppm

( )

10 ppm 2 ppm 1 ppm

0.5 ppm

( )

5 ppm 2 ppm 0.3 ppm 0.2 ppm

1 . 2 0 0 5 ;

149-75

2 . C a l i f o r n i a P r o p 6 5 , 2 0 0 1 , h t t p : / / w w w. c a l p r o p 6 5 . com/ 01regs.html

3.ATSDR/EPA Priority List for 1999: Top 20 Hazardous Substances, Agency for Toxic Substances and Disease Registry, U.S. Department of Health and Human Services, http://www.ats- dr.cdc.gov/99list.html; & U.S. CDC, National Center for Environmental Health, National Report on Human Exposure to Environmental Chemicals, 2001. www.cdc.gov/nceh/dls/re- port/Highlights.htm

4.Dart R.C. Medical Toxicology, 3rd ed. Philadelphia: Lippincott Wiliams & Wilkins; 2004, 1393-401, 1411-4, 1423-31, 1437-48.

5.Poisendex: Arsenic, Lead, Cadmium. Mercury. 1974-2006 Thomson MICROMEDEX. MICROMEDEX(R) Healthcare Series 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 the dietary exposure to arsenic, cadmium, lead and mercury of the population of the EU member sites, 2004.

8.UNEP. Global Mercury assessment. http://www.chem.unep.

ch/mercury/report/chapter4.htm 9.

10. 94 12 13

11. 56075

86 9 24

12.Drinking water information from the Environmental Protection Agency, USA, http://www.epa.gov/safewater/regs.html.

13. ( )

2004; 22: 141-70

14.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 Health Organization, 2005.

16.Dietary supplements - NSF National draft Standard (Draft Standard 173-2001). National Sanitation Foundation International, Am Arbor, Michigan, USA, 2001.

17.Dharmananda S. Lead Content of Soil, Plants, Foods, Air, and Chinese Herb Formulas, 2001. http:/www.itmonline.org/

arts/lead.htm.

18. 2001

19. http://www.cpba.org.

cn/page/BusinessPlatform/zhongcaoyao-6.htm

20.Klabelitz L, Sievers H. Contaminants of medicinal and food herbs with a view to EU regulations. Innov Food Technol 2004;

25-7.

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Drug safety 2000; 23: 351-62.

2 3 .

2000.

2 4 . 2 0 0 1 4

2 5 .

2005

26. 2000 http://

cc.informac.gov.mo/c/news/c_beauty_news.htm 2 7 .

2005

28. 2005

http://finance.sina.cn

2 9 . 0 9 3 0 0 0 0 2 11

30. 1998; 39: 10-9.

31.Chu JF, Liou SH, Wu TN, Ko KN, Chang PY. Risk factors for

high blood lead levels among the general population in Taiwan.

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Eur 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.

91 3 4 . 0 9 2 0 0 0 1 2 6 9

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Health Hazard of Heavy Metal and Provisions for the Standard of Maximum Allowable Level

of Toxic Metal in Herbal Drugs

Ming-Ling Wu, and Jou-Fang Deng

The 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 heavy metals can be hazardous to the health of patients; especially lead, arsenic, mercury, cadmium. Many countries have abandoned the import of metal containg herbal drugs. In Taiwan, the standard of toxic metal content in herbal medicine was first established in 1991. The legal limit of toxic heavy metal in herbal 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.