Immunotoxicological safety of preparations obtained from cells of Mucor species

The cell biomass of Mucor racemosus Fresen. (DSM 2845) and M. mucedo L.: Fr. (minus strain: DSM 4885 and plus strain DSM 4886) gained after fermentation is purified from culture medium components and then mechanically opened through a cell mill. After different purification steps, the water-soluble filtrate undergoes sterile filtration and is freeze-dried. The resulting lyophilisate is characterized by electrophoresis (SDS-PAGE), carbohydrate composition of polysaccharides and content of total proteins. The resulted starting material is named “e volumine cellulae (lyophil., steril.)” (evc) and potentised to homeopathic dilutions or triturations used for the homeopathic treatment of disorders of blood circulatory system (Mucor racemosus) [1] or some chronic inflammations and nervous disorders (Mucor mucedo) [1]. Possible immunotoxic effects after repeated oral and rectal, intradermal/dermal or subcutaneous application were tested in various guideline studies with GLP compliance in genetic defined mice and guinea pigs. These studies include general immunotoxicity, mitogenic effects of naive T-cells, proliferation of antigen-stimulated T-cells, delayed type hypersensitivity reactivity, antigen-specific antibody production, acute systemic anaphylaxis induction, and skin sensitisation studies.

It can be concluded that Mucor racemosus evc (Mucokehl®, Vetokehl Muc®) and Mucor mucedo evc (Mucedokehl®) can be regarded as safe in potency D3, D4 and D5, respectively. The immunotoxicological safety data are valid only for the investigated fungi strains as well as for the specific, GMP controlled manufacturing process.

Reference:

[1] Package leaflet Mucokehl and Mucedokehl, Swissmedic-Arzneimittelinformation, www.swissmedicinfo.ch