Absence of Penicillin- derivatives in preparations from Penicillium species used in homeopathic medicinal products

Homeopathic medicinal products produced from preparations of Penicillium chrysogenum (Notakehl), P. glabrum (Quentakehl), P. roquefortii (Fortakehl) or P. brevicompactum (Stolonikehl) have been used for over 30 years without reports of any serious or major adverse events. Safety studies and other available data gave no indications for immunotoxic or sensitizing effects. While some species of the genus Penicillium do produce antibiotic substances, they are unwanted by-products in the homeopathic use of active substances derived from the Penicillium species. The aim of this study was to check for the presence of antibiotic substances in these active substances.

For the production of the Penicillium species active substance, the biomass yielded by fermentation is purified and then mechanically opened by a cell mill. The liquid phase is separated and the insoluble components are filtered. The filtrate then undergoes multiple filtration and washing steps prior to sterile filtration and i freeze drying. The resulting starting material is named „e volumine cellulae (lyophil., steril.)“ [1] and is raised to homeopathic potencies (D3, D4, D5).

HPLC-ESI-MS data is presented to prove the absence of Penicillin- derivatives and precursors (Penicillin G, m/e 335 [M+H]+ and 6-Aminopenicillanic acid, m/e 217 [M+H]+) in used active substances. Whilst being found in the fermented culture broth of e.g. Penicillium chrysogenum, Penicillium G and 6-Aminopenicillanic acid are no longer present in the active substance after processing. During the manufacture of the active substances, unwanted antibiotic compounds are eliminated whilst preserving the products high quality.

Acknowledgement: HPLC-ESI-MS analysis was taken out at Phytos GmbH & Co. KG in Neu-Ulm

References: [1] Bader G, Akkoyun A, Wiethoff K (2010) Planta Med 76: 1262