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Evidence for the absorption of a Cimicifuga/Hypericum fixed combination after oral administration by determination of specific marker substances in rat plasma
Cimicifuga racemosa as an alternative to hormone therapy is the most extensively studied medicinal herb used for the alleviation of menopausal symptoms. Cimicifuga/Hypericum film-coated tablets (CHF) is a fixed combination containing extracts from the herbal substances Hypericum perforatum and C. racemosa. The absorption of constituents from H. perforatum has already been demonstrated after oral intake of monopreparations. Only few data are available for the absorption of Cimicifuga-components. No data at all exist for the fixed combination [1,2,3]. The purpose of this study was to prove the absorption of CHF after oral administration, using valid analytical methods. Hypericin was selected as biomarker for H. perforatum and caffeic acid derivatives (ferulic acid, cimicifugic acid B) as marker substances for C. racemosa. Wistar rats received single, 10-fold und 100-fold human equivalent dosages (HED) of CHF-granulate via gavage. At defined time points blood plasma samples were taken and analysed by HPLC with fluorescence detection. The absorption of the Hypericum-specific marker hypericin was demonstrated after application of the single and 10-fold HED of CHF. Ferulic acid, a marker compound of C. racemosa, could be quantified in the plasma samples in the case of the 10- and 100-fold HED. An enzymatic pretreatment of the plasma samples enabled the determination of cimicifugic acid B, another Cimicifuga-specific compound. The resulting plasma concentrations of all three marker compounds were dependent from the administered dosage. These results prove the absorption of CHF by the detection of specific marker compounds in the plasma of rats after oral application of CHF.
References: 1. Schulz, H.U. et al. (2005) Arzneimittelforschung 55:15–22.
2. Si, D. et al. (2008)J Pharm Biomed Anal 47: 140–145.
3. Einbond, L.S. et al. (2009) Fundam Clin Pharmacol 23:311–321.