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 Disjournal_title
Japanese journal of infectious diseasesauthors
Ochiai M,Kataoka M,Toyoizumi H,Yamamoto A,Horiuchi Ysubject
Has Abstractpub_date
2001-08-01 00:00:00pages
131-6issue
4eissn
1344-6304issn
1884-2836journal_volume
54pub_type
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