Abstract
HMPs derived from Hypericum perforatum , herba (St. Johnʼs wort) play an important role in treating mild to moderate depressive
episodes and mental exhaustion, for example. The genotoxic safety of these HMPs has
already been assessed and reviewed in recent years. However, further data on the genotoxic
potential of Hypericum perforatum , herba preparations would allow the evaluation of the therapeutic safety of the herbal
drug and preparations thereof in accordance with the genotoxicity guideline of the
HMPC of the EMA. Accordingly, their genotoxic potential was tested using the “bracketing
and matrixing” concept, whereby extracts are tested at and between the extremes of
their extraction solvents (ranging in strength from polar to non-polar) to cover the
entire spectrum of the drugʼs constituents. In the present study, five dry extracts
of Hypericum perforatum , herba, representing the full range of potential extraction solvent polarities (water,
ethanol
50% (v/v), methanol 80% (v/v), ethanol 80% (v/v), and n -heptane) were tested using the Ames test, according to the OECD and HMPC guidelines.
No mutagenic effects were observed for any of the five test strains in two independent
experiments (plate incorporation test and pre-incubation test) each carried out with
and without metabolic activation, even at the highest concentrations (5000 µg/plate),
in accordance with the OECD guideline No. 471.
Keywords
Hypericum perforatum
- Hypericaceae - plant extracts - herbal medicines - mutagenesis - genotoxicity tests
