Characterization and specification finding of Mucor racemosus preparation used as homeopathic starting material

Homeopathic medicinal products produced from preparations of Mucor racemosus Fresen. (DSM 2845) have been used for over 30 years (Mucokehl®, Vetokehl Muc ®).

For the production of the Mucor racemosus starting material, 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 freeze drying. The resulting starting material is named “e volumine cellulae (lyophil., steril.)” evc [1].

For many years a Capillary Electrophoresis (CE) method is used for identity characterization of the homeopathic starting material [2]. Due to the variability of the biological material and even though the process is strictly GMP controlled to have a batch to batch consistency, peaks differ in their height. Sometimes small peaks disappear. It is obvious that used CE method alone is to detailed to indicate identity of Mucor racemosus evc for GMP purposes. Also a very exact rational has to be defined for assessment during batch release. In lack of this a more robust method for specification is demanded. A SDS-PAGE method has been developed and validated with the homeopathic starting material Mucor racemosus evc.

Calculations are shown to constitute a specification via SDS-PAGE. Relative standard deviation is tabulated and demonstrates an excellent value in respect to this biological material. Different analytical methods (e.g. protein content, carbohydrate composition of polysaccharides) are presented to characterize the homeopathic starting material Mucor racemosus evc. Due to the GMP- controlled process of many years and the presented analytical data a good justification of specification can be concluded.

References:

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

[2] Wiethoff, K., Irmer, A., Bader, G., (2010) Planta Med. 76:1331