鶏伝染性気管支炎生ワクチン(“京都微研“ポールセーバーIB)の
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- いっけい わしあし
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3 (1) 4710 (6) 1L50100mg11kg 510mg()35 7 () (2) EMEAFDAJECFA ADIMRL (2) Medline (2) 1,629,946 MRL ADI ADI 0.005mg/kg/ - 2 -
4 - 3 -
5 () (1) (1),(2) (Ofloxacin) C 18 H 20 FN 3 O () 2 g/l (20) nonvolatile (2) a b DNA DNA (3) 2 (S)-(-)-(R)-(+)- (S)-(-)- (Levofloxacin) (3) a 6 b DNADNA
6 2-1. (4), (5) ICR( 5 )(5mg/kg)T max 0.5 C max 1.3µg/mlT 1/2 () 1.0 (4) ICR( 8 /) 40mg/kg 180 C max 14.5µg/mL 16.8µg/mLT 1/2 () AUC µh/mL 64% % 35.1% (5) (4) Wistar(5)(5mg/kg)T max 0.5 C max 1.7µg/mlT 1/2 () 1.8 Wistar (3 )(10mg/kg ) (6) (3 /)(51020mg/kg) 7 7 T max C max T 1/2 () T max C max µg/mLT 1/2 () T max C max µg/mLT 1/2 () (7) ( 5 /) ( mg/kg) T max C max µg/mLT 1/2 () (0.8ppm) 25mg/kg T max 2 1 C max µg/gT 1/2 () SPFS(3) 100mg/kg24 c TLCN- 2HPLCN- c
7 (8), (9), (10), (11) 6 ( 5 1) 200mg ( 7 ) T max 1.9 ( )C max 2.96µg/mL( µg/mL) T 1/2 ()6.6 ( ) (8) mg ( 7 ) T max 1.5 C max 4.5µg/mLT 1/2 () T max 1.8 C max 6.5µg/mLT 1/2 () 6.5 (9) 6 600mgT max 1.2 C max 10.7µg/mLT 1/2 () % (10) 10 ( 5 ) mg T 1/2 () AUC mgh/L % mg T max C max µg/mLT 1/2 () AUC mgh/l % AUC 200mg % %N % 3.9% (11) 7 200ppm ppm 10.6ppm 5.3ppm 2.4ppm 2.0ppm 0.6ppm 5 (0.02ppm) (12) ppm ppm 3.3ppm 3.2ppm 0.88ppm 0.62ppm 0.29ppm 0.21ppm 3 (0.05ppm)200ppm 6.5ppm 5.5ppm 4.8ppm 0.95ppm 0.54ppm 0.40ppm 3 (0.05ppm) (13) 2-2. (1) (14), (15), (16) LD 50 (Std:ddY) 5290mg/kg 5450mg/kg
8 (Wistar) 3750mg/kg 3590mg/kg()200mg d mg/kg e (Std:ddy) 233mg/kg 208mg/kg(Wistar) 276mg/kg 273mg/kg() 70mg f (Std:ddy)10000mg/kg(Wistar) 9000mg/kg 7070mg/kg g (14) N-(Slc:ddY)LD mg/kg 38.5mg/kg (15) LD 50 (Std:ddY) 1803mg/kg 1881mg/kg (SD) 1507mg/kg 1478mg/kg250mg/kg (16) (2) 4 (17) 6 SlcSprague-Dawley ( 5 /) ( mg/kg /) 4 810mg 1 270mg 270mg 90mg 270mg 270mg 270mg () h 810mg Hb / 90mg 810mg 810mgAPCl - BUNTcho 4 270mgNa + d 200, 400mg2 (1/22/2) e 500mg(0/3)1000mg(4/4) f 50, 70mg(0/2)100mg1 (1/2) g h Preyer s
9 90mg 810mg 270mg 270mg 810mg 810mg 270mg 810mg NOAEL 90mg/kg 26 (18) 5 SlcSprague-Dawley ( 15 / 25 /) ( mg/kg /) mg 270mg 1 270mg 270mg 1 270mg () i QRS mg 26 30mg 270mg WBC mg AP mg ASTTcho 30mg / i Preyer s
10 mgNa + 10mg mg26 90mgpHCl mg 30mg 270mg 26 30mg 90mg 90mg 270mg mg 90mg 26 30mg 30mg 90mg mg NOAEL 10mg/kg 26 (19) 5 CD(SD)(20 /) ( mg/kg/) 26 80mg 320mg 1 80mg 26 WBC LDHCa + 80mgA/G 320mg AP 26 80mg ph ()80mg 80mg 320mg
11 (elongated) 80mg 320mg (glandular mucosa) mg 320mg 4 NOAEL 20mg/kg 26 (19) 2-4 ( 4 /) ( mg/kg /) 26 () (3) 3 (DENdiethylnitrosamineMNUN-methylnitrosoureaDHPN dihydroxy-di-n-propylnitrosamine)(dmd)(f344/du Crj1 15 j )( (LV0.9%) 16 (20) (4) 2 (21) SlcSD ( 24 /) ( mg/kg /) j LVLV 16
12 360mg 10 mg 60 mg 360mg NOAEL 10mg/kg / 360 mg/kg / () (22) SlcSD( 36 /) ( mg/kg/) F F 0 F F 1 21 F 2 F 0 810mg 810mg F 0 810mg 90 mgf 1 90mg 810mg 13 F 1 810mgF F 1 k 810 mg F 1 / F 1 /F 2 NOAEL 90mg/kg / 10mg/kg / 810mg/kg / (23) SD( /) ( mg/kg/) F F 0 F 1 F 1 F 1 F 2 60mgF 0 360mg
13 F 0 / F 1 F 1 / F 2 NOAEL 10mg/kg/ 360 mg/kg/ (23) SD ( 5-10 /) 810mg/kg / (23) SD ( /)( mg/kg /) (23) SD 0810 mg/kg / () (23) (10-15/)( mg/kg/) mg 160mg / NOAEL 40 mg/kg / 160mg/kg /
14 (5) in vitro in vivo in vitro DNA WI µg/ml (24) (UDS ) Ames S. typhimurium TA1535, TA1537,TA1538, TA98, TA100, E. coli WP2 uvra µg/plate(s9) 1 (24) Rec-assay Bacillus subtilis M45(Rec - ) 3.125µg/mL (24) Bacillus subtilis H17(Rec + ) µg/ml(-s922h) (24) CHL µg/ml µg/plate 2 100µg/mL µg/mL 4 100µg/mL µg/ml 4 (24) (24) in vivo 600 mg/kg (24) (in vivo / in vitro) mg/kg mg/kg/, (24) 1 /5 SLC-BDF mg/kg (25) mg/kg/ (25) 1 /5 (24) in vitro Rec-assay UDS in vitro/in vivo in vivo Rec-assay in vivo / in vitro in vitro in vivo
15 R- () R- in vitro Ames S. typhimurium TA1535, TA1537, TA98, µg/plate 1 TA100, E. coli WP2 uvra (S9) (26) CHO(K-1/Hprt) mg/ml (26) (S9) CHL µg/ml (S96h) 2 (26) µg/ml(-s924h) (26) µg/mL (26) (-S948h) CHL µg/mL(-S9) (26) µg/mL (+S9) 250 (26) µg/plate (+S9 TA1537TA µg/plate ) µg/ml in vivo UDS (in vivo/in vitro) F344/N mg/kg mg/kg mg/kg mg/kg/ 1 /5 SLC-BDF mg/kg/ 1 / mg 1 (26) (26) (26) 2 (26) (26) CHL CHL in vivo
16 R- in vitro Ames S. typhimurium TA1535, TA1537, TA98, TA100, E. coli WP2 uvra CHL µg/plate µg/mL µg/plate (S9) µg/mL (S96h) µg/ml(-s924h) µg/mL (-S948h) 1 (26) 2 (26) (26) (26) in vivo mg/kg 1 400mg mg/kg/ 1 /5 (26) 1 (26) R- CHL in vivo (7) (27), (28) CDSD( 10 /) 7 (OFLX) (NA)(OFLX mg/kg /NA100300mg/kg /) OFLX 900mg NA OFLX 300mg 6/10OFLX 900mg NA 10/10 (27) NOAEL 30 mg/kg / CRCD (7 / 3 /) OFLX 900mg/kg / 7 6 1/7 2/7
17 8 (28) 8 (6) 3 ( 3 /20mg 6 /)(051020mg/kg /) 8 20mg 32 20mg 2 (2/3) 7-8 (humerus)(femur) 10mg 10mg 20mg NOAEL 5 mg/kg / (7) ( µg/mL) 15 ERG l 180µgB108µg36µg µg/mL 124 ERG4 VEP m VEP 100µgABC4 VEP50µg (29) (8) (30) Irwin () 300mg/kg 1000mg/kg mg/kg l Electroretinogram m Visual evoked potential
18 (EEGECG n ) 10mg/kg (3mg/kg)(wheel cage) 300mg/kg (100mg/kg)() 1000mg/kg(300mg/kg)( writhing) 100mg/kg writhing300mg/kg ( 30100mg/kg)() 1000mg/kg(300mg/kg) ()( )(shuttle box) () ((NE)(Ach))NE 30mg/kgAch 10mg/kg ( 103mg/kg ) ()() ()10-3 g/ml NE (10-4 g/ml) 10-4 g/ml o () 10-3 g/ml 10-4 g/ml p ( ) 300mg/kg(100mg/kg) (ph) 300mg/kg ph(100mg/kg) ()3mg/kg(1mg/kg ) ()() 3mg/kg () n ElectroencephalogramElectrocardiogram o 10-3 g/ml 10-4 g/ml p 10-3 g/ml 10-4 g/ml
19 10mg/kg 30mg/kg () 1g/kg () 30mg/kg (10mg/kg )( Na + K + Cl ) 300mg/kg Na + Cl () 0.11% (9) in vitro MIC (MIC) MIC ADIMIC 50 (µg/ml) MIC 50 MIC 90 Bacteroides bivius Bacteroides caccae > Bacteroides distasonis Bacteroides fragilis > >
20 Bacteroides fragilis group Bacteroides melaninogenicuss Bacteroides ovatus Bacteroides thetaiotaomicrom Bacteroides uniformis Bacteroides ureolyticus group < Bacteroides vulgatus Bacteroides spp.(fragilis ) < Bifidobacterium spp Clostridium perfringens Clostridium ramosum / innocuum / clostridiiforme Clostridium spp. Eubacterium spp > > Fusobacterium nucleatum Fusobacterium nucleatum / necrophorum Fusobacterium mortiferum / varium Fusobacterium varium / ulcerans / gonidiaformans Fusobacterium spp. Peptococcus spp. Peptostreptococcus spp
21 Peptococcus / Peptostreptococcus Prevotella bivia Prevotella spp. (pigmented) Prevotella spp. (nonpigmented) Prevotella spp Enterococcus faecalis Enterococcus faecium Enterococci Escherichia coli Lactobacillus spp Propionibacterium acnes Propionibacterium granulosum Propionibacterium spp CFU/spot q CFU/spot (34) (S)-(-) CFU/spot MIC (41) MIC 50 Escherichia coli 0.05µ/mL Bacteroides ureolyticus group 0.125µg/mL Clostridium perfringens 0.39µg/mL Eubacterium spp.peptostreptococcus spp.propionibacterium spp. 0.5µg/mLMIC 50 q
22 ATCCMIC 50 ATCC Bacteroides fragilis ATCC25285 Bacteroides thetaiotaomicron ATCC29741 Eubacterium lentum ATCC43055MIC1-2(2)8-8(8)1-1(1) r (32) ph MIC ph ( ) MIC Bacteroides fragilis(6 ) ph MIC()Bacteroides spp.(7 ) Fusobacterium spp.(2 )Clostridium spp.(4 )PeptococcusPeptostreptococcus spp.(5 ) ph7.3 MIC ph (36) 5 200mg Staphylococci D Staphylococci 4 4 MIC 50 MIC 90 D Staphylococci 2/5 4 Candida sp. Candida sp. µg/gin vitro MIC 50 1µg/mLin vitro (44) MIC 8 7 (Enterobacter aerogenesescherichia coliklebsiella pneumoniaepseudomonas aeruginosastaphylococcus aureusprovidencia stuartiiserratia marcescens) (S. marcescens) (P. stuartii) (37) 24 ( 12 )400mg r
23 /(5/5 s )(2/3)(2/3)3 (3/9) (3/9) (45) 13, (1 )(1 )(1 )(2 ) (46) (S)-(-)- 14 C 20 (47) 100µg/mL ERG 50µg/mL ERGVEP 26 (62.5mg/kg /) 8 NOAEL s /
24 F 1 F 2 / UDS Rec-assay in vivo / in vitro R- () DENMNUDHPN 6 ADI 1990 DNA (48) 8 1 in vivo in vitro CHLV79 UV (49) (50) UV UV (48) UV 1 100mg1 3 (51) 1/1,800,000 (52) 5
25 10mg/kg / NOAEL 8 NOAEL 5.0mg/kg / 90 8 ADI in vitro MIC 50 in vivo (200mg/1 2 ) 2/5 Candida spp mg// NOEL in vitro Bacteroides BifidobacteriumClostridiumEubacteriumFusobacteriumPeptococcus / Peptostreptococcus R-plasmidEnterococcusE. coli LactobacillusADIMIC MIC g/mleubacteriumpeptostreptococcuspropionibacterium MIC 50 E. coli E. coli (0.1%)
26 ADI MIC 50 (53),(54) Bacteroides ureolyticus group g/ml Clostridium perfringens () 0.39 g/mlmic Bacteroides 1µg/mL Bacteroides ADI ADI EubacteriumPeptostreptococcusPropionibacteriumMIC µg/mL (ADI) ADI 8 NOAEL 5mg/kg / ADI / 10 ADI 0.005mg/kg / in vitro MIC g 30%() 1 60kg ADI (mg/kg /) (mg/ml) 220 (g) (kg) mg/kg / ADI ADI ADI mg/kg / ADI mg/kg /
27
28 1. ()() 2. () 3. William 2001 () T-3761 (1995) Jap J Antibiotics1995(48), J. Fung-Tomc, et al. (1989)In vitro and in vivo antibacterial activities of BMY 40062, a new fluoronaphtyridone Antimicrob Agents Chemother.1989 (33), No.6, Yabe K, et al. (2001)A non-arthropathic dose and its disposition following repeated oral administration of ofloxacin, a new quinolone antimicrobial agent, to juvenile dogs J Vet Med Sci2001 (63), No.8, DP-1764(Ofloxacin)() 8. R. Warlich, et al. (1990)Multiple-dose pharmacokinetics of ofloxacin in serum, saliva, and skin blister fluid of healthy volunteers Antimicrob Agents Chemother.1990 (34), No.1, D. Israel, et al. (1993)Pharmacokinetics and serum bactericidal titers of ciprofloxacin and ofloxacin following multiple oral doses in healthy volunteers Antimicrob Agents Chemother.1993 (37), No.10, Lockley MR, et al. (1984)The pharmacokinetics and tissue penetration of ofloxacin J Antimicrob Chemother.1984 (14), No.6, H. Lode, et al. (1987)Pharmacokinetics of ofloxacin after parenteral and oral administration Antimicrob Agents Chemother.1987 (31), No.9, DP-1764()( 1)() 13. DP-1764()( 2)() 14. DL-8280 (1984) Chemotherapy1984(32), S-1, DL-8280 () 16. M. Kato, et. al. (1992)Acute oral toxicity of the new quinolone antibacterial agent levofloxacin in mice, rats and monkeys Arzneim-Forsch1992 (42), 3a, DL (1984) Chemotherapy1984(32), S-1, DL (1984) Chemotherapy1984(32), S-1, M. Kato, et. al. (1992)Twenty-six-week oral toxicity of the new quinolone antibacterial agent levofloxacin in rats and cynomolgus monkeys Arzneim-Forsch1992 (42), 3a, T. Kajimura, et. al. (1992)Effect of the new quinolone antibacterial agent levofloxacin on multiple organ carcinogenesis initiated with wide-spectrum carcinogens in rats Arzneim-Forsch1992 (42), 3a, DL-8280 () 22. DL-8280 () 23. S. Takayama, et. al. (1986)Reproductive toxicity of Ofloxacin
29 Arzneim-Forsch1986 (36(II)), Nr. 8, DL-8280 (1984) Chemotherapy1984(32), S-1, DL-8280 () 26. H. Shimada, et. al. (1992)Mutagenicity of the new quinolone antibacterial agent levofloxacin Arzneim-Forsch1992 (42), 3a, DL () 28. DL () 29. H. Sakai, et. al. (1994)Nontoxic intravitreal dose of ofloxacin for rabbit retina Ophthalmic res1994 (26), DL-8280 (1984) Chemotherapy1984(32), S-1, MG Martens, et al (1991)Susceptibility of female pelvic pathogens to oral antibiotic agents in patients who develop postpartum endometritis Am J Obset Gynecol1991 (164), EJ C Goldstein and DM Citron (1991)Comparative activity of ciprofloxacin, ofloxacin, sparfloxacin, Temafloxacin, CI-960, CI-990, and WIN against anaerobic bacteria Antimicrob Agents Chemother.1992 (36), No.5, EJ C Goldstein and DM Citron (1991)Susceptibility of anaerobic bacteria isolated from intra-abdominal infections to ofloxacin and interaction of ofloxacin with metronidazole Antimicrob Agents Chemother.1991 (35), No.11, K. Sato, et al. (1982)In vitro and in vivo activity of DL-8280, a new oxazine derivative Antimicrob Agents Chemother.1982 (22), No.4, Dirk L VC and Stefan RP (1984)In vitro activity of ciprofloxacin compared with those of other new fluorinated piperazinyl-substituted quinolone derivatives Antimicrob Agents Chemother.1984 (25), No.4, Prabhavathi BF, et al. (1986)In-vitro and in-vivo potency of five new fluoroquinolones against anaerobic bacteria J Antimicrobial Chemother.1986 (18), Lisa H and Harold CN (1987)In vitro activity of two new aryl-fluoroquinolone antimicrobial agents, difloxacin (A-56619) and A compared to that of other antimicrobial agents Chemotherapy1987 (33), Asbjrn D and William LD (1988)In vitro activity of A (difloxacin) and A-56620, two aryl fluoroquinolones Chemotherapy1988 (34), RN Gruneberg, et al. (1988)The comparative in-vitro activity of ofloxacin J Antimicrobial Chemotherapy1988 (22), Suppl. C, AM Espinoza, et al (1988)Comparative in vitro activity of a new fluorinated 4-quinolone, T-3262 (A-60969) Antimicrob Agents Chemother.1988 (32), No.5, T Une, et al (1988)In vitro activity of DR-3355, an optically active ofloxacin Antimicrob Agents Chemother.1988 (32), No.9, L. Dubreuil, et al (1996)Activé in vitro D une nouvelle fluoroquinolone, la marbofloxacine (RO ) sur les anaérobies strcts et quelques bactéries de la flore fécale humaine
30 Path Biol1996 (44), Y Fukuoka, et al (1993)In vitro and in vivo antibacterial activities of T-3761, an new quinolone derivative Antimicrob Agents Chemother.1993 (37), No.3, S Pecquet, et al (1987)Effect of oral ofloxacin on fecal bacteria in human volunteers Antimicrob Agents Chemother.1987 (31), No.1, Stein GE, et al (1991)Safety of multiple doses of ofloxacin in healthy volunteers Drugs Exptl Clin Res1991 (XVII), 10/11, RBlomer,et al (1986)Safety of ofloxacin adverse drug reactions reported during phase-ii studies in Europe and in Japan Infection1986 (14), Suppl. 4, S332-S M Tanaka, et al. (2004)Absorption, distribution and excretion of 14 C-levofloxacin after single oral administration in albino and pigmented rats: binding characteristics of levofloxacin-related radioactivity to melanin in vivo. J Pharm Pharmacol.2004 Apr; 56(4), K Marutani, et al. (1993)Reduced phototoxicity of a fluoroquinolone antibacterial agent with a methoxy group at the 8 position in mice irradiated with long-wavelength UV light Antimicrob Agents Chemother.1993 (37), No.10, Zhang T, et al. (2004) Compare two methods of measuring DNA damage induced by photogenotoxicity of fluoroquinolones. Acta Pharmacol Sin.2004 Feb, 25(2), Ronald et, al. (1999) Photogenotoxicity of fluoroquinolones in Chinese hamster V79 cells: dependency on active topoisomerase II. Photochem Photobiol.1999 Mar; 69(3), Scheife RT et, al.photosensitizing potential of ofloxacin Int J Dermatol Jun, 32(6) Yagawa K.Latest industry information on the safety profile of levofloxacin in Japan. Chemotherapy.2001 (47) Suppl 3, 38-43, discussion WHO TRS 893 (2000) 54. EMEA (2002)REVISED GUIDELINE ON SAFETY EVALUATION OF ANTIMICROBIAL SUBSTANCES REGARDING THE EFFECTS ON HUMAN GUT FLORA
Clostridium difficile ciprofloxacin, ofloxacin, norfloxacin Bifidobacterium Lactobacillus Lactobacillus Bacteroides fragilis B. fragilis C. difficile
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