Batch-to-Batch Reproducibility of St. John's Wort Preparations

Over the last few years, St. John's Wort products have enjoyed a tremendous surge in interest and sales for the therapy of mild to moderate depression. Although the complete spectrum of active substances in this herbal extract has not yet been elucidated, it is certain that hyperforin is an important component [7] [8]. Further, it appears that the hypericins may also contribute to the antidepressive activity [2]. In this study, the content uniformity of eleven St. John's Wort products sold exclusively in pharmacies was determined. The main objective was to determine the batch-to-batch reproducibility of the various products. The hyperforin was analysed according to a previously published HPLC method [4], while the total hypericin content was determined by an electrochemical method [6]. The results indicate that some, but not all, products show very reproducible batch-to-batch properties. Also, individual products have different hypericin and hyperforin levels, and are therefore not switchable - even when products are manufactured under similar extraction and processing conditions, have the same raw material: extract ratios (on a dry basis) and contain the same amount of extract per unit dosage form.

References

• 1 Butterweck V, Jurgenliemk G, Nahrstedt A, Winterhoff H. Flavonoids from Hypericum perforatum show antidepressant activity in the forced swimming test.  Planta Med. 2000;  66 ((1)) 3-6
• 2 Butterweck V, Petereit F, Winterhoff H, Nahrstedt A. Solubilized hypericin and pseudohypericin from Hypericum perforatum exert antidepressant activity in the forced swimming test.  Planta Med. 1998;  64 291-294
• 3 Hiller K .O., Schmidt A .H.. Chargenkonformität von Phytopharmaka.  Dtsch Apoth Ztg. 2000;  140 ((25)) 109-115
• 4 Maisenbacher P, Kovar K A. Analysis and stability of Hyperici oleum.  Planta Med. 1992;  58 ((4)) 351-354
• 5 Melzer M, Fuhrken D, Kolkmann R. Hyperforin im Johanniskraut.  Dtsch Apoth Ztg. 1998;  138 ((49)) 56-62
• 6 Michelitsch A, Biza M, Wurglics M, Schubert-Zsilavecz M, Baumeister A, Likussar W. Determination of Hypericin in Herbal Medicinal Products by Differential Pulse Polarography (DPP).  Phytochem Anal. 2000;  11 ((1)) 41-44
• 7 Müller W E, Rolli M, Schäfer C, Häfner U. Effects of hypericum extract (LI 160) in biochemical models of antidepressant activity.  Pharmacopsychiatry. 1997;  30 102-107
• 8 Müller W E, Singer A, Wonnemann M, Häfner U, Rolli M. Hyperforin represents the neurotransmitter reuptake inhibiting constituent of hypericum extract.  Pharmacopsychiatry. 1998;  31 16-21
• 9 Pharmacopeial Forum. 1999 25 (2): 7758-7760
• 10 Wurglics M, Westerhoff K, Kaunzinger A, Wilke A, Baumeister A, Schubert-Zsilavecz M. Johanniskrautextrakt-Präparate.  Dtsch Apoth Ztg. 2000;  140 ((34)) 44-50
• 11 Wurglics M, Westerhoff K, Kaunzinger A, Wilke A, Baumeister A, Dressman J B, Schubert-Zsilavecz M. Comparison of German St. John's Wort Products According to Hyperforin and Total Hypericin Content. Journal of the American Pharmaceutical Association 2001, in press
• 12 Zündorf I, Dingermann T. Qualitätsbewertung - Bewertung der Qualität von Phytopharmaka.  Dtsch Apoth Ztg. 1997;  137 ((36)) 61-72