2006 8 3 873999 871319 IF 1998 9 FAX 1 200mL 300mL 500mL 20g 30g 50g 10g 15g 25g 1.8g 2.7g 4.5g 0.9W/V 200mL500mL 1979 3 13 2004 7 9 1979 5 15 2006 8 300mL 1979 3 13 2004 7 9 1982 11 1
IF 1 MR 63 IF 10 IF 2IF IF IF 3IF 4 9 IF IF IF 11 1 IF IF 4IF IF MR IF IF MR Drug Safety Update IF
1961 Virno 1970 Baylor Meyer 1979 3 1982 6 1988 1 1 2 31.06%625,829 33 0.57% 10 0.17% 6 0.10% 6 0.10% () 1 2 3.37%952,821 57 2.02% 16 0.57% 15 0.53% 11 0.39%() 1
GLYCEOL Injection glycerin INN glycerol (JAN)(JAN) Concentrated Glycerin(JAN)Fructose(JAN) NaCl C3H8O3 MW92.09 C6H12O6 MW180.16 NaCl MW58.44 Propane1,2,3triolIUPAC DFructopyranoseIUPAC Sodium ChlorideIUPAC 2
CGA3O CAS 56-81-5 57-48-7 7647-14-5 3
1) 2) 1) 1) (99.5) 2) (95) 1g 1.05mL(96w/v) 40mL(2.4w/v) 1) (99.5) 1g 2.8mL 2.7mL (99.5)(95)100mL 0.17g75% 0.7g 1,2) 100 2) 15 70%1 0.24 1) 4
mp.18 2) mp.102~104() 2) 1) 2) 20 D1.470 20 201.258 2) ph 4.0g 20mL ph 4.0~6.5 1,2) ph 1.0g 10mL ph 4.5~7.0 2.17 3. 1) 14 2) 14 (1)(120)23 5mL (2) 5
1) 14 (1)(120) (2)(120) 1) 14 0.2g 50mL 50mL 30 (11)10mL 20 100mL 0.1molL : 2 0.1mol / L 1mL9.209mg C3H8O3 2) 14 4g 0.2mL 80mL 30 100mL 20 100mm D (C6H12O6)(mg)D1087.0 1) 14 50mg 50mL 0.1molL 0.1mol /L 1mL5.844mg NaCl 6
1 200mL300mL500mL ph ph ph3.06.0 7 1 200mL 300mL 500mL 20g 30g 50g 10g 15g 25g 1.8g 2.7g 4.5g 0.9W/V 7
25 60%RH 40 75%RH 30 3 200mL PE 300mL PE 500mL PE 200mL PE 300mL PE 500mL PE ph 5 ph 5 NaCl 102.6 103.9 101.5 103.1 101.6 102.7 100.1 100.9 100.0 100.4 100.0 100.7 102.0 102.8 100.2 102.3 100.8 102.5 99.4 99.7 99.2 99.5 99.1 99.8 0.92 0.93 0.91 0.93 0.91 0.92 ()ph(5-) 90110% 95105%NaCl 0.850.95w/v% 0.90 0.90 0.90 25 60%RH 30 200mL PE 300mL PE 500mL PE ph 5 NaCl 104.1 104.2 102.9 103.5 102.6 102.7 103.4 103.6 102.1 102.5 101.8 102.0 ph(5-) 90110% 95105%NaCl 0.850.95w/v% 0.93 0.93 0.92 8
3) 1)2) 90 () 24 1)2)pH 0.5 3) 90 9 (AC17) S 25- K.C.L. S 0.9w/v%Na,Cl154Eq/L 5 (1) (2) (3) (4) 9
10mL 100mL 1.000g 0.500g 100mL 5L AT(G)AT(F)AS(G) AS(F) A T(G) () 100 A S(G) AT(G) AS(G) A T(F) () 100 A S(F) AT(F) AS(F) 8mm 300mm 40 0.001mol/L 6 5L (Rs) 2 6 1.0 5mL 30mL 0.1mol/L () 0.1mol /L 1mL5.844mg NaCl 10
() 1 200500mL 1 12 500mL 23 12 1 500mL 30 1 300500mL 4590 (61) 500mL 2 4) 41.41229 (17 253 ) 1 500mL 1000mL 61.7 5) (118 215 ) 500mL 6090 6) 87.75057 3 500mL 120 vital signs( ) 500mL 60 120 11
(61 ) 15w/v (5w/v)500mL 2 4) 79.3 118 (215 ) 20w/v 500mL 6090 6) 1) 104.8173.3 86.8 140.7 2) 10 9 31 16 3 3) 12
4) 7) 8) 9) 10) baloon cold-injury 11) 12,13) 4,14) 1517) 16,18,19) 20) 6,21) 13
3 10%500mL 2 4.2 ml/min 43.284.22mg/dL 3 22) No. 1 2 3 S.E. (0 ) 4.11 0.87 0.77 (2 ) 49.08 45.69 35.06 1 (3 ) 22.00 28.77 14.02 3 (5 ) 1.07 0.53 0.48 1.921.10 43.28±4.22 21.604.26 0.690.19 14
15
14 C 23) 0.750.04 0.400.02 0.570.16 6.740.89 1.640.09 0.150.01 2.700.57 65.881.13 (hr) a) 0.5 4 24 48 0.430.08 0.200.02 0.150.03 0.080.01 0.220.02 0.130.00 4.030.49 0.930.09 0.340.01 0.210.01 0.110.01 0.060.00 1.090.09 0.370.02 29.061.40 15.620.54 10.250.56 14.231.56 1.310.13 0.160.00 0.070.01 0.110.01 0.700.09 0.160.01 0.040.00 0.280.03 10.210.87 13.251.06 0.640.04 78.831.66 45.661.33 33.132.13 25.600.84 a) S.E. ATP 3 DHAP 3 16) 16
5 17
14 C 65% 14 CO2 48 TCA cycle ATP 13% 9% 1% 23) (hr) a) 01 04 024 048 b) 8.101.22 10.250.56 0 38.182.06 14.231.56 01.310.13 59.891.04 13.251.06 00.640.04 65.471.24 8.101.22 48.431.83 75.432.47 79.361.95 S.E. a) b) 14 (hr) 024 048 8.380.53 trace 60.171.16 8.870.58 trace 64.561.02 68.551.16 73.430.85 S.E. a) 4 (7,14,56,89w/v) 14 C 14 CO2 56w/v 14 CO2 56w/v 89w/v 14 CO2 23) 18
14 19
1. 2. 20
-1,6-FBPase 24) FBPase 25) 8,650 157 1.82 184 1988 1995 0.15 0.1 21
() (1979.3.13 1982.4.18) 623 5,206 5,829 9 53 62 () 1.44 1.02 1.06 9 53 62 (%) ( ) 7(1.12) 26(0.50) 33(0.57) 0(0.00) 10(0.19) 10(0.17) 0(0.00) 6(0.12) 6(0.10) 1(0.16) 5(0.10) 6(0.10) 0(0.00) 4(0.08) 4(0.07) 0(0.00) 1(0.02) 1(0.02) 0(0.00) 1(0.02) 1(0.02) 1(0.16) 0(0.00) 1(0.02) () (1982.6.15 1986.6.14) 326 2,495 2,821 14 81 95 () 4.29 3.25 3.37 15 107 122 (%) 14(4.29) 43(1.72) 57(2.02) 0(0.00) 16(0.64) 16(0.57) 0(0.00) 15(0.60) 15(0.53) 1(0.31) 10(0.40) 11(0.39) 0(0.00) 7(0.28) 7(0.25) 0(0.00) 4(0.16) 4(0.14) 0(0.00) 3(0.12) 3(0.11) 0(0.00) 2(0.08) 2(0.07) 0(0.00) 2(0.08) 2(0.07) 0(0.00) 2(0.08) 2(0.07) 0(0.00) 1(0.04) 1(0.04) 0(0.00) 1(0.04) 1(0.04) 0(0.00) 1(0.04) 1(0.04) 22
() () 615 1,811 69 2,495 48 29 4 81 63 38 6 107 () 7.80 1.60 5.80 3.25 23
24
26) LD50 8g/kg 3.0g/kg 6.0g/kg 3.0g/kg 10%30% 6.0g/kg 23 3.0g/kg 6.0g/kg 6.0g/kg ()rotarod 6.0g/kg 26) 6.0g/kg 3.0g/kg 26) 0.3570.75g/kg 10100mg 1g/kg 13 1.5g/kg 1 1.5g/kg 3.0g/kg Na,Cl K Na K 1.5g/kg K 25
26) 10 2g/mL BaCl2 310 3g/mL 310 4g/mL 3 10100mg 0.3750.75g/kg 1.5g/kg 26) 10% 2 4g/kg 4 27) in vitro in vivo in vitro 20.8mg/mL Ca 2.5 g/kg Ca 8 1.0g/kg14 28) 65mg/ kg S.D. 30 2.4g/kg 4 500mL 26) 84 75 57.669.1 65 58 53 63 68 78 75 91 95 110 100 60 60 60 60 60 60 26
26,27) 10mL/kg1 10mL/kg3 26) 24g/kg 1g/kg 26,27,29) 1020L/kg 1 2 7 5,26,27,3033) 31 20% 21 10% 27
2 6 (1) (2)U 2 Y (3) (4) 200mL10 20 300mL10 20 500mL10 20 D 1979 3 13 1982 6 15 300mL 1995 8 1 2003 6 9 15400AMZ00241 28
() 200mL 1979 4 19 2004 7 9 300mL 1982 8 12 2004 7 9 500mL 1979 4 19 2004 7 9 1982 6 15 1988 1 4 14 2 4 1982 6 15 1986 6 14 200mL2190501A4084 300mL2190501A6087 500mL2190501A5064 29
1 14 2003 2 14 2001 3 426(10)1791(1977) 555(7)2327(1978) 675(4)476(1981) 757(6)2017(1980) 817(7)635(1989) 972(4)408(1968) 1026(4)765(1977) 11 26(10)1817(1977) 12Neurol. Med. Chir.22(12)963(1982) 13Neurol. Med. Chir.22(12)972(1982) 1446(6)731(1977) 15 54(9)3068(1977) 16Meyer, J. S. et al.circulation, 51701(1975) 17Ott, E. O. et al.neurology, 241117(1974) 18Sloviter, H. A. et al.nature,2101334(1966) 19Meyer, J. S. et al.stroke, 3168(1972) 20 82(12)932(1978) 21 76(8)1068(1982) 22 (1977) 23 15(2)307(1978) 24Hasegawa,Y. et alpediatrics International,45(1)5(2003) 25Yazaki, M. et alintern. Med., 44(3)188(2005) 26 (1972,1973,1977) 27 (1973,1976) 2826(9)1745(1977) 29 (1976) 30 54(4)1373(1977) 3155(3)929(1978) 3273541(1977) 3374(5)521(1980) 30
Glyceol Inj 1993 6 Glyceol Inj Fandasy Company Limited 1994 8 Glyceol Inj Siam Pharmaceutical Co.LTD 1995 3 31
http://www.chugai-pharm.co.jp 32