2011 11 4 871319 1mL 5mg 5mg15 1g 5mg 5mg15 JAN JAN Erythromycin LactobionateJAN Colistin Sodium MethanesulfonateJAN 1970 3 31 1970 8 1 1970 7 20 TEL0120-921-839 06-6321-7056 9 17 https://www.santen.co.jp/medical/admin/a300.jsp 2007 12 2007 12 http://www.info.pmda.go.jp 29106 08
1. -------------------------------------1 2. -------------1 1. -------------------------------------------2 2. -------------------------------------------2 3. ----------------------------- 2 4.----------------------------- 2 5. ------------------------------- 3 6.--------------- 3 7.CAS ---------------------------------- 3 1. ------------------------------- 4 2.----- 4 3. ----------------------- 4 4. ----------------------------- 4 1.---------------------------------------------- 5 2. ------------------------------------- 5 3. -------- 6 4. -------- 6 5. ---------- 6 6.-------------------------------- 6 7. ------- 6 8. ------------------------------------------- 7 9. ------------------------------- 7 10. ------------ 7 11.------------------ 7 12.---------------------------------------------- 7 13.----------------- 7 14.----- 7 15. ------------------------------------------- 7 16.-------------------------------------------- 7 1.----------------------------------- 8 2. ---------------------------------- 8 3. ---------------------------------------- 8 1. ---------------------------------------11 2. ---------------------------------------11 1.-------------------- 13 2.--------------------- 13 3.---------------------------------------------13 4.---------------------------------------------13 5.---------------------------------------------14 6.---------------------------------------------14 7. --------------------------14 1. --------------------------15 2. ----------------------------15 3. ----------------------------------------15 4. ----------------------------------------15 5. --------------------15 6. ---------------------------------------15 7. ---------------------------------------15 8.------------------------------------------15 9.-------------------------------16 10. -------------16 11.-------------------------------16 12.-----------------16 13. ---------------------------------------16 14. ---------------------------------16 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. ------------------------------20 10.--------20 11.-------------------------20 12. ---------------------- 20 13. ----------------------------------21 14. ------------------------------------21 15.---------21 16.--------------------------------------21 17. ----------------------------21 1. ---------------------------------------22 2.-----------------------------22 1. -----------------------23 2.------------------23 1.-----------------------------24
1970331 20049-1 -
Ecolicin ophthalmic solution Ecolicin ophthalmic ointment JAN JAN Erythromycin LactobionateJAN Colistin Sodium MethanesulfonateJAN -mycin C 37 H 67 NO 13 C 12 H 22 O 12 1092.22 A C 58 H 105 N 16 Na 5 O 28 S 5 1749.82 B C 57 H 103 N 16 Na 5 O 28 S 5 1735.80-2 -
(2R, 3S, 4S, 5R, 6R, 8R, 10R, 11R, 12S, 13R)-5- (3, 4, 6-trideoxy-3- dimethylamino-β-d-xylo-hexopyranosyloxy)-3-(2,6-dideoxy-3-c-methyl-3- O-methyl-α-L-ribo-hexopyranosyloxy)-6, 11, 12-trihydroxy-2, 4, 6, 8, 10, 12-hexamethyl-9-oxopentadecan-13-olide mono (4-O-β-Dgalactopyranosyl-D-gluconate) IUPAC EM CL 3847-29-8 8068-28-8 3
95 99.5 ph0.5g10mlph5.07.5 ph0.1g10ml30ph6.5 8.5 24 4075%RH 6 60-4 -
- 5-1mL 5mg 5mg15 1g 5mg 5mg 15 ph4.57.0 1 ph6.08.0 1 1mL 5mg 5mg15 1g 5mg 5mg15 5mL
24 2560%RH 50 7 25500lx 30 3 4075%RH 6 25 7 6
Staphylococcus aureus ATCC 6538 P Escherichia coli NIHJ C 37 H 67 NO 13 733.93 A C 53 H 100 N 16 O 13 1168.46300 100mg 7
2 1 323 1-7) 7 143 97.993/95 83.310/12 64.39/14 85.76/7 86.713/15 91.6131/143-8 -
9 14387 93.529/31 100.04/4 100.011/11 100.02/2 100.01/1 100.01/1 81.89/11 100.020/20 100.01/1 80.04/5 94.382/87 1,8) 19 100.03/3 100.06/6 100.05/5 100.01/1 100.04/4 100.019/19 1917 100.010/10 100.03/3 100.03/3 100.01/1 100.017/17
n=143 0.5 0.5 1 23 1 36 1 10 1 91.6131/143 1-7) n=19 0.5 0.5 1 2 30 2 100.019/19 1,8) 10
9) MIC µg/ml * Staphylococcus aureus 209-P Bacillus subtilis PCI-219 Escherichia coli NIHJ JC2 Salmonella typhimurium OUB Shigella sonnei OUB Proteus vulgaris SRL Pseudomonas aeruginosa SRL Pseudomonas aeruginosa SOC&STC 0.10 0.39 3.13 3.13 3.13 >200 25.0 25 * mgmg 10) Chlamydia trachomatis D/UW-3/Cx Chlamydia trachomatis F/UW-6/Cx MIC µg/ml EM OFLX 0.125 1.0 0.125 0.5 10 4 /ml EMOFLX 8) MIC EM CL EM CL EM CL EM CL EM CL EM CL EM CL 4 7 8 4 1 4 5 2.0 7.8112.5 1.04.0 12.515.6 0.100.08 >500 0.010.03 >500 0.08 >500 0.0050.01 500>500 0.040.16 400>500 EM >100 2 CL 100 EMµg/mLCL/mL20uµg - 11 -
3) 0.5 0.5 1533 4 60.5 0.5 154 3 21 12
0.5 0.5 15 4 15 1 11) - 13 -
57n=23500mg 12) 500mg hr 1 2 4 6 µg/ml trace 1.0 1.2 1.1 µg/ml 4.3 3.3 1.3 0.8 0.5 0.5 15 4 15 3.04.6µg/mL 1.253.15µg/mL 2.03.0µg/mL 0.66 1.83µg/mL 11) 14
- 15 -
66 1140.50.5 1361 1 1-7) 4 411 0.5 0.5 1 2 420 8) 1) 2) (1) (2) 3)7 16
1) 2) (1)1 (2) 3)7 17
13) mg 14) mg LD 50 mg/kg 149.0 150.2 58.6 62.0 14) 50mg/kg/day 1 0.424.225mg/kg/day 3 25mg/kg/day 4.2,25mg/kg/day - 18 -
15) 0.5 1 0.5 1 1 0.1mL1 16 4 1 Draize 0.5 5 0.5 5 1 0.1g1 1 1 19
2 5mL105mL 3.5g10 19703 31 14500AMZ01585000 14500AMZ01583000 1970 8 1-20 -
2004930 97 20 3 19 HOT 1022537010101 1319801Q1020 661310032 1022513010101 1319800M1023 661310031 21
119,661(1968)51308 262,397(1968)51309 363, 860(1969)51310 463, 54(1969)51311 563, 661(1969)51312 66, 555(1969)51313 7 51319 861, 281(1967)51307 9 p567,p.707 (1973) 51314 1056, 461(1994)57823 11 51316 12S. MatsudaBiological Research in Pregnancy 5,57(1984)57824 13 51320 14 51322 15 51318-22 -
20116 Ecolicin Taejoon Pharm. Co., Ltd. 1993 Elicocin Croma Medic Inc. 2000 Ecolicin Taejoon Pharm. Co., Ltd. 1993 Elicocin Croma Medic Inc. 2000-23 -
- 24 -