Untersuchungen zum Endotoxingehalt von Phytopharmaka. Korrelation zu klinisch beobachteten Nebenwirkungen

Journal/Book: Dtsch. Med. Wochenschrift 113 (3), 83-87. 1988;

Abstract: Four phytopharmaceutics (Carnivora, Pascotox forte-Injectopas, EsberitoxN, Iascador M), which sometimes cause side effects after parenteraladministration (fever, rigor, nausea), were examined for their endotoxincontent by the kinetic turbidometric Limulus-amebocyte-lysate (LAL)microtitre test. Contaminations of over 10(5) EU/ml (endotoxin units; 1EU = 0.1 ng of the FDA standard EC-5) were found in correlation with theclinical picture. In one preparation (Carnivora) very high endotoxinlevels were always found; contaminations were only occasionally found inthe others. These endotoxin measurements are supported by tests ofendotoxin-dependent parameters in in-vivo experiments (reduction inleukocytes, acute death in hyperreactive mice). These findings underlinethe urgent need for a widening of the regulations on testing forpyrogens to include those parenteral preparations which now do not haveto be tested because of their small volume (less than 15 ml). Author.

Keyword(s): ANIMAL

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