[Endotoxin contents of phytopharmaceuticals: correlation with clinically observed side effects].
Four phytopharmaceutics (Carnivora, Pascotox forte-Injectopas, Esberitox N, Iascador M), which sometimes cause side effects after parenteral administration (fever, rigor, nausea), were examined for their endotoxin content by the kinetic turbidometric Limulus-amebocyte-lysate (LAL) microtitre test. Contaminations of over 10(5) EU/ml (endotoxin units; 1 EU = 0.1 ng of the FDA standard EC-5) were found in correlation with the clinical picture. In one preparation (Carnivora) very high endotoxin levels were always found; contaminations were only occasionally found in the others. These endotoxin measurements are supported by tests of endotoxin-dependent parameters in in-vivo experiments (reduction in leukocytes, acute death in hyperreactive mice). These findings underline the urgent need for a widening of the regulations on testing for pyrogens to include those parenteral preparations which now do not have to be tested because of their small volume (less than 15 ml).
Becker
K P
KP
Abteilung für Immunologie und Serologie, Klinikum Mannheim, Universität Heidelberg.
Ditter
B
B
Nimsky
C
C
Urbaschek
R
R
Urbaschek
B
B
D000818:Animals; D031257:Droseraceae; D004340:Drug Contamination; D004731:Endotoxins / Q000032:analysis*; D006801:Humans; D007958:Leukocyte Count / Q000187:drug effects; D008033:Limulus Test; D051379:Mice; D010936:Plant Extracts / Q000009:adverse effects* / Q000032:analysis*; D010940:Plant Proteins
C047078:Carnivora (Dionaea); D004731:Endotoxins; C054736:Pascotox; D010936:Plant Extracts; D010940:Plant Proteins; C026057:Esberitox; C077177:viscum album peptide
Untersuchungen zum Endotoxingehalt von Phytopharmaka. Korrelation zu klinisch beobachteten Nebenwirkungen.