IF MR 63 2 IF 10 3 IF IF IF A4 9 IF IF IF 11 1 IF IF IF MR IF IF MR Drug Safety Update IF

2009 2 1 872612 IF 1998 9 IODINE M DISINFECTANT SOLUTION 10 10w/v 100mL 10g( 1g) PovidoneIodine 2008 10 15 2008 12 19 2009 1 6 IF 2008 12

IF MR 63 2 IF 10 3 IF IF IF A4 9 IF IF IF 11 1 IF IF IF MR IF IF MR Drug Safety Update IF

1. 1 2. 1 1. 2 2. 2 3. 2 4. 2 5. 2 6. 2 7. CAS 2 1. 3 2. 3 3. 3 4. 3 5. 4 1. 5 2. 5 3. 5 4. 5 5. 5 6. 5 7. 6 8. 6 9. 6 1. 8 2. 8 3. 8 1. 10 2. 10

1. 12 2. 12 3. 12 4. 13 5. 13 6. 14 7. 14 1. 15 2. 15 3. 15 4. 15 5. 15 6. 15 7. 15 8. 16 9. 16 10. 16 11. 16 12. 17 13. 17 14. 17 15. 17 16. 17 1. 18 2. 18 1. 20 2. 20 3. 20 4. 20 5. 20 6. 20 7. 20 8. 20 9. 21 10. 21 11. 21 12. 21

13. 21 14. 21 15. 21 1. 22 2. 23 24 25

Burkholderia cepacia 1) ph 2,3) M 10 10w/v 0602009 16 6 2 M 1 2 3 4 5 6 7 1

M 10 IODINE M DISINFECTANT SOLUTION 10 PovidoneIodine Iodine JAN PovidoneIodineJANUSAN PolyvidoneINN (C6H9NO)nI Poly2-oxopyrrolidin-1-ylethyleneiodineIUPAC Iodinated povidonebpep 2-Pyrrolidinone1-ethenyl-homopolymercompound with iodine PVPI 25655-41-8 2

99.5 ph 1.0g 100mL ph 1.53.5 65 3 4) 1 2 3

1 0.02mol/L 0.02molL 1mL 2.538mg I 2 4

100mL 10g 1g 100mL 10g 1g 2Na ph 4075RH 6 3 ph 5) 4 5

51 250mL 500mL M 10 6) M 10 10 2,3) M 10 1 0.1mL 168 10 Draize 7) M 10 15.010 20.3 Kay and Calandra 8) M 10 10 6

0.5 1 3 6 24 48 72 96 168Draize 7) A) B) 0 1 2 3 1/4 0 1/4 1/2 1/2 3/4 3/4 0 1 2 3 4 4 AB5 80 A) 0 1 2 A5 10 A) B) C) 0 1 2 3 1/2 1/2 0 1 2 3 4 0 1 2 3 ABC2 20 110 n3 Kay and Calandra 8) 40 35 30 0.0 0.5 25 0.5 2.5 20 2.5 15 15 15 25 10 25 50 5 50 80 0 80 100 hr) 100 110 M M 10 10 7

V1 8

9

1 2M 10in vitro 6) M 10 clean dirty clean 0.2 dirty 15 2 dirty MRSAE. coli C. albicans 6 15 clean dirty (2) dirty (0.2) Staphylococcus aureus IFO 12732 15 15 15 Staphylococcus aureusmrsa-01 15 60 15 Staphylococcus epidermidis ATCC 12228 15 15 15 Escherichia coli IFO 3806 15 30 15 Proteus vulgaris IFO 3988 15 15 15 Pseudomonas aeruginosa IFO 13275 15 15 15 Burkholderia cepacia IFO 15124 15 15 15 Serratia marcescens IFO 12648 15 15 15 Candida albicans IFO 1594 15 30 15 99.999 10

3MICin vitro 9) MIC MIC M 10 MIC Staphylococcus aureus IFO 12732 7500 7500 Escherichia coli IFO 3806 11000 11000 Proteus vulgaris IFO 3988 5000 5000 Pseudomonas aeruginosa IFO 13275 10000 10000 MIC M 10µg/mL 4 in vitro 9) Escherichia coli IFO 3806 M 10 0.7 0.7 5 Kelsey-Sykesin vitro 9) Escherichia coli IFO 3806 Kelsey-Sykes M 10 0.08 0.08 1.0 1.0 M 10 w/v 11

10) 12

13

14

1 11) 2 10) 15

T3T4 1 2 12) 16

13) 1 14) 2 3 4 5 1 15) 2 16) 3 17) 4 18) 11) 17

LD50, TDL0 mg/kg 19) LD50 TDL0 3400mg/kg/24 480 8100 4100 640 8000 3450 LD5050TDL0 4) 1 102550100mg/kg 35 5102550mg/kg 35 25mg/kg 25mg/kg BUN Na 2 220200mg/kg SD 10 28 200mg/kg 3Wistar 10 182 5500mg/kg 18

4) 1 21050mg/kg PBI 2mg/kg 50mg/kg 2 440400mgkg PBI 4mgkg 40mg/kg 400mg/kg 52080mg/kg PBI 20mg/kg 80mg/kg 3 6.2550400mg/kg 6.25mg/kgPBI T3 6.25mg/kg3 PBI 6.25mg/kg 400mg/kg 50mg/kg 19

3 1 2 3 4 5 250mL 500mL 10 142030 10 1216 2008 10 15 22000AMX02401000 20

2008 12 19 2612701Q3342 21

1 Burkholderia cepasiapseudomonas cepacia 10236391995 2 medical corner 93125281993 3 EBM QA p5556p602004 4 2006p17351739 2006 5 M 10 6 5421671742005 7DraizeJHAppraisal of the safety of chemicals in foods,drugs and cosmeticsdermal toxicity p46591959 8KayJHInterpretation of eye irritation testjsoccosmetchem13281 2891962 9 p3240p1381431999 10 M 10 11 977 124712501987 12DanzigerYet altransient congenital hypothyroidism after topical iodine in pregnancy and lactationarchdischild 622952961987 13BarOrDet alfalsepositive Haem Detection Due To Povidone Iodine Lancet 82465891981 14OkanoMIrritant contact dermatitis caused by PovidoneIodineJAmAcad Derm 20 (5)8601989 15JacksonHJet aleffect Of PovidoneIodine On Neonatal Thyroid FunctionLancet (8253)9921981 16VorherrHet alvaginal Absorption of PovidoneIodineJAMA 244 (23)2628 26291980 17 30 (4)7651994 18 (ODA)ProgMed 7 (5)1031 10341987 19REGISTRY of TOXIC EFFECTS of CHEMICAL SUBSTANCESSTN2008.12 22

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BETADINE INADINE VIDENE TRAUMASEPT 24

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