Extrakte in pflanzlichen Arzneimitteln
Beiträge zur Vergleichbarkeit von Extraktionsverfahren
europharm
Abstract
Extracts used in herbal medicinal products: contributions to the comparability of extraction processes
The European Pharmacopoeia describes basic requirements for extracts in its general monograph “Herbal Drug Extracts”. They have to be adhered to in industrial production, the extract manufacturers generally being highly specialised in their extraction methods. Methods commonly used for the production of extracts for medicinal use are percolation and maceration with smooth transitions between both these methods. In order to be able to react on supply bottlenecks, pharmaceutical companies depend on the availability of more than one extract manufacturer. Moreover, a certain flexibility is required in case the only manufacturer indicated during the marketing authorisation procedure wishes to utilise different equipment or to exchange facilities. This might result in a change of the manufacturing process, e.g. in a modified extraction process. During application and variation procedures, individual health authorities more and more consider herbal extracts with an identical drug-extract-ratio produced with the same extraction solvent but different extraction methods, not comparable. This article intends to demonstrate under which conditions a comparability of extraction methods can be assumed. This applies – according to the relevant legislation for herbal medicinal products – in case the same extraction solvent is used, the specifications of the respective monographs are met, both methods lead to the same drug extract ratio (DER) and stability of the extract (active substance) and the final medicinal product is given.
Zusammenfassung
Das Europäische Arzneibuch beschreibt in der allgemeinen Monographie „Herbal Drug Extracts“ grundlegende Anforderungen an Extrakte. Diese sind in der industriellen Herstellung zu beachten, wobei Hersteller von Extrakten im Allgemeinen in ihren Extraktionsmethoden sehr
