Focus on Alternative and Complementary Therapies
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Focus Alternat Complement Ther©2005 Pharmaceutical Press
Focus Altern Complement Ther 1997; 2: 192–3
The present pharmacokinetic data from comparable studies with horse chestnut seed extracts show niveau differences in the concentration-time curves of ß-escin of a factor ≥ 1.5.
In a prospective, randomised, double-blind study with a double cross-over design, the radioimmunologically measured bioavailability (ß-escin) of an established, retarded reference preparation of a horse chestnut seed extract was compared with a non-retarded preparation under steady-state conditions in 30 volunteers. Additionally, the biopharmaceutical properties of the two extracts were examined with a validated HPLC method, whereby the amount and composition of the active component, escin (triterpene oligoglycoside mixture), was determined.
In contrast to biopharmaceutical equivalence of the two escin preparations, neither an identical bioavailability, nor conformity of the pharmacokinetic parameters of the reference substance with other comparable studies could be shown. The HPLC extract analysis revealed significant differences in the quantitative and qualitative each composition within and between various batches of the two differently prepare extracts.
The high specifity of a radioimmunoassay and the intermolecular variety of the structural related saponin analogs will only allow reliable quantification of ß-escin with an assay validated for a specific escin composition. Measuring different extracts with this specific RIA consequentially will lead to different/inconsistent pharmacokinetic data.
