Document Detail

A quantitative in vitro assay method for detecting biological activity of endotoxin using prostaglandin E2 induction in rabbit peripheral blood.
MedLine Citation:
PMID:  14524619     Owner:  NLM     Status:  MEDLINE    
The pyrogen test and the endotoxin test (the LAL test) have been playing crucial roles in detecting endotoxin in parenteral drugs. The current test methods, however, have disadvantages such as requiring a large number of animals or an inadequacy in evaluation of in vivo endotoxin activity. We attempted to establish a new assay method that can overcome the shortcomings of the current methods. We standardized the in vitro assay method by the use of prostaglandin E2 (PGE2) induction from peripheral blood of rabbits for detecting endotoxin activity. A linear dose-response regression was attained from approximately 0.15 to 5 endotoxin units/ml of Japanese national reference standard endotoxin by the in vitro assay. The assay showed a fine correlation with the pyrogen test but not with the LAL test, when endotoxins from various bacterial sources were tested. The in vitro assay was also shown to have the capability of detecting a synergistic effect of endotoxin and parenteral drugs. The in vitro PGE2 induction test using rabbit blood was, therefore, suggested to be the appropriate test method for guaranteeing the same level of safety of parenteral drugs as the pyrogen test does.
Masaki Ochiai; Michiyo Kataoka; Hiromi Toyoizumi; Akihiko Yamamoto; Kazunari Kamachi; Yoshinobu Horiuchi
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Publication Detail:
Type:  In Vitro; Journal Article    
Journal Detail:
Title:  Microbiology and immunology     Volume:  47     ISSN:  0385-5600     ISO Abbreviation:  Microbiol. Immunol.     Publication Date:  2003  
Date Detail:
Created Date:  2003-10-03     Completed Date:  2003-12-16     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  7703966     Medline TA:  Microbiol Immunol     Country:  Japan    
Other Details:
Languages:  eng     Pagination:  585-90     Citation Subset:  IM    
Department of Bacterial Pathogenesis and Infection Control, National Institute of Infectious Diseases, Musashimurayama, Tokyo 208-0011, Japan.
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MeSH Terms
Bacteriological Techniques / methods*,  standards
Blood Cells / drug effects*
Dinoprostone / blood*,  metabolism
Endotoxins / toxicity*
Reg. No./Substance:
0/Endotoxins; 363-24-6/Dinoprostone

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