A quantitative in vitro assay for detecting biological activity of endotoxin using rabbit peripheral blood.

Abstract:

:The pyrogen test or the endotoxin test has been playing a crucial role in detecting endotoxin in parenteral drugs. The current test methods, however, have disadvantages such as requiring a relatively high number of animals or an inadequacy in direct evaluation of in vivo activity. We made an attempt to establish a new in vitro assay method that can overcome the shortcomings of the current assay methods. We standardized the system of tumor necrosis factor-alpha (TNF-alpha) induction from the peripheral blood of rabbits for assaying endotoxin activity. This in vitro assay showed a linear dose-response regression between 0.1 and 5.0 endotoxin units per milliliter of endotoxin and a definite homogeneity of variance by logarithmically transforming the endotoxin and TNF-alpha concentrations in the reaction mixtures at 5 h of incubation at 37 degrees C. The assay showed a definite correlation with the pyrogen test but not with the endotoxin test when endotoxins from various bacteria were tested.

journal_name

Jpn J Infect Dis

authors

Ochiai M,Kataoka M,Toyoizumi H,Yamamoto A,Horiuchi Y

subject

Has Abstract

pub_date

2001-08-01 00:00:00

pages

131-6

issue

4

eissn

1344-6304

issn

1884-2836

journal_volume

54

pub_type

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