Clarification of the Borderline between “Herbal preparations” and “Isolated Herbal Constituents”
Contribution to the discussion of the “Reflection paper on level of purification of extracts to be considered as herbal preparations” (EMEA/HMPC/186645/08)
Dr. Frauke Gaedcke
Finzelberg GmbH & Co. KG., Andernach (Germany)
Herbal medicinal products contain as herbal preparation not only simply processed preparations such as herbal drugs and herbal extracts as active substances but also purified and concentrated extracts like “refined extracts”. In some cases, however, the purification is so substantial that the question arises whether the resulting preparation has still to be considered as highly purified herbal preparation or whether it should be regarded as an isolated herbal constituent or a mixture of closely related herbal constituents as e. g. sennosides, aescin or silymarin.
pharmind 2009, Nr. 3, Seite 430