Clinical Studies on Silybin Phytosome

Clinical Study – Ref12P19

Japan. J. Pharmacol. 60, 315-321 (1992)

Protective Activity of Silipide (Silybin Phytosome) on Liver Damage in Rodents

Marisa Conti, Salvatore Malandrino and Maria Jose Magistretti

Inverni della Beffa Research and Development Laboratiories, via Ripamonti 99, Milan Italy

See National Library of Medicine Citation

The aim of this study was to assess the effect of the silipide (Silybin Phytosome) against liver damage induced by different agents.

The results of this study showed a significant and dose related protective activity against liver damage induced by toxic agents with different mechanisms of action. One of the poisons tested against was galactosomine which mimics hepatitis in its effect on the liver.

The constituents of silipide (Silybin Phytosome), on their own, were devoid of any significant activity at doses equivalent to those contained in the active doses of silipide (Silybin Phytosome).

The oral efficacy of silipide (Silybin Phytosome) and the lack of activity of the uncomplexed silybin indicate that silybin reaches active concentrations at the site of action only when administered as a complex. (1, 2)

Favorable results of preliminary clinical trials (3,4) indicate that silipide (Silybin Phytosome) can be considered as a promising new therapeutic agent for the treatment of hepatic disorders.

Morazzoni, P, Magistretti, M.J., Giachetti, C. and Zanolo, G.: Comparative bioavailability of IdB 1016 (Silybin Phytosome), a new flavanolignan complex , in rats. Eur. J. Drug Metab. Parmacokinet. 17, 39-44 (1992)

Barzaghi, N., Crema, F., Gatti, G., Pifferi, G. and Perucca, E.: Pharmacokinetic studies on IdB 1016, a silybiin-phosphatidylcholine complex, in healthy human subjects. Eur. J. Drug Metab. Pharmacokinet. 15, 333-338 (1990)

Marena, C. And Lampertico, M.: Preliminary clinical development of silipide (Silybin Phytosome): a new complex of silybin in toxic liver disorders. Planta Med. 57, A124-A125 (1991)

Buzzelli, G., Mascarella, S., Giusti, A., Marra, F., Pifferi, G., Marena, C. and Gentilini, P.: Free radical scavenging effects of silybin-phosphatidylcholine (Silybin Phytosome) in pationes with chronic liver disease, preliminary results. Abstracts of 26th meeting “European Association for the Study of the Liver”, September 1991, Palma de Mallorca (Spain), S103 (1991)