Code 290-21941

Limulus J Test Wako

50

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j ,g %K{WCihm i 3qL X^"#

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1956 #F. B. Bang K#D}t j),?j\@_

m 3 V1)#T*j# #J. Levin g F. B. Bang K#

Limulus Amebocyte Lysate m K<)]\AK)j

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X$ n#E. coli UKT-B J*i;b.! 3)4)j)be

# V^~q (Lipopolysaccharide, LPS) 500ngj

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/ml fF! V}X$

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K) n

m EU/ml m m f

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f "*-^ <)]\AK) JPSE m

3 Table 1 m j Ve# EU/mlmf jcL m + Vf\AKbu.S.j)+Tg3

V}X$ n jcL m + Vf C}X$

j log JPSE conc. EU/ml g log Tg min. m

log Tg min A log JPSEconc. EU/ml B A, B ;3 j)be "# gV}X$Rm #

m K fA,Rg3 V}X$}^ V^

JPSEm g jIP,\-]-m Tg m m

KRm m gi+}X$

m r

d86!m jcCe Table 2 j V^ j 3

V}X$ n m + Vf C#Tg m

Tg mean 3 "}X$Rm # V^ mE‘

K JPSE mTgm jnC*iP-oi+}Z

4$

m m

m m<)]\AK) ng/ml jIP,Tg me-an m d86!fm 3 "}X$ $f "^ JPSE m

3 jR-3<)]\AK) #EU/mlj V}X$

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Table m 3 VeN_TC$

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+m<)]\AK) EU/ng # X, KA

+}Xmf# VeN_TC$ m jn f

Z^#W\m f V^ K gVe Ve

A+}X$

Table 1 JPSE m

JPSE soln. (ml ) H2O (ml ) final JPSE conc. (EU/ml )

0.5 (10000 EU/ml ) 4.5 10000.5 (1000 EU/ml ) 4.5 1000.5 (100 EU/ml ) 4.5 101.0 (10 EU/ml ) 4.0 2.02.0 (2.0 EU/ml ) 2.0 1.02.0 (1.0 EU/ml ) 2.0 0.52.0 (0.5 EU/ml ) 2.0 0.252.0 (0.25 EU/ml ) 2.0 0.1252.0 (0.125 EU/ml ) 2.0 0.0625

Table 2 CSE m

CSE soln. (ml ) H2O (ml ) final CSE conc. (ng/ml )

0.5 (100 ng/ml ) 4.5 100.5 (10 ng/ml ) 4.5 1.00.5 (1.0 ng/ml ) 4.5 0.102.0 (0.1 ng/ml ) 2.0 0.052.0 (0.05 ng/ml ) 2.0 0.0252.0 (0.0025 ng/ml ) 2.0 0.001252.0 (0.00125 ng/ml ) 2.0 0.00625

CSE m EU m

Table 3 JPSE m EU/ml g Tg min.

JPSE (EU/ml ) Tg (min.)

0.0625 50.8 49.20.0125 42.8 42.20.025 35.0 34.80.5 30.0 29.81.0 24.8 24.42.0 21.0 21.4

log (Tg (min.) ) 0.251 log (JPSE conc. (EU/ml ) ) 1.397r 0.9989

Table 4 CSE m ng/ml g Tg mean min.

CSE (ng/ml )Tg mean (min)

vial 1 vial 2 vial 3 vial 4

0.00625 49.5 50.1 57.8 51.30.0125 40.2 42.2 43.1 42.00.025 34.8 35.4 36.3 36.70.05 29.9 31.2 31.2 30.00.1 24.6 24.2 24.8 24.5

Table 5 CSE m EU

CSE d86!m Tg EU EU(ng/ml ) (min) (EU/ml ) (EU/ng)

0.00625 52.1 0.0532 8.510.0125 41.9 0.1268 10.140.025 35.8 0.2375 9.500.05 30.6 0.4439 8.880.1 24.5 1.0772 10.77

EU 9.56 (EU/ng)

500 (ng/vial) 9.56 (EU/ng) 4780 (EU/vial)beRm fn CSE m n 4800 (EU/vial) gi+}X"

$Bang, F. B. : Bull. Johns Hopkins Hosp., 98, 325 (1956).

$Levin, J. and Bang, F. B. : Bull. Johns Hopkins Hosp., 115,

265 (1964).

$Westphal, O., L ›uderitz, O., Eichenberger, E. and Keiderling,

W. : Z. Naturforsch., 7b, 536 (1952).

$Akama, K., Kuratsuka, K., and Homma, R., Kanoh, S.,

Niwa, M., Iwanaga, S. and Nakahara, C. : Bacterial En-

dotoxin, eds. Homma, J.Y. et al., p395, Verlag Chemie (1984).

$ # # # #

#38 (6), 781 (1983).

$The United States Parmacopeia 22th, The National Formulary

17th, p1493, U.S. Pharmacoperial Conversion Inc (1990).

$Oishi, H., Takaoka, A., Hatayama, Y., Matsuo, T. and

Sakata, Y. : J. Parenter. Sci. Technol., 39 (5), 194 (1985).

STUVWXYZ[\

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