Clinical Studies on Silybin Phytosome

Clinical Study – Ref9C8

Med. Sci Res., 1991′ 19, 827-828

Pharacokinetic studies of silybin-phosphatidylcholine complex (Silybin Phytosome) in liver cirrhosis after multiple doses

Rocco Orlando, Annalisa Fragasso, Mario Lampertico1 and Carlo Marena1

Institute of Internal Medicine, University of Padua, Italy, and 1Medical Department, Inverni della Beffa, Milan, Italy

Journal not found on Medline

Introduction: Silybin is the main active component of silymarin, a standardized extract from the seeds of Silybum marianum Gaertn. (Silybin Phytosome) is a complex between silybin and soybean phosphatidylcholine, which exerts protective effects against hepatic lesions induced by toxic agents such as alcohol and phalloidin (1,2).

The data obtained in cirrhotic patients after multiple doses of IdB 1016 (Silybin Phytosome) did not show significant differences from those reported after a single dose. They clearly show that the drug does not accumulate in cirrhotic patients.

Furthermore the results indicate no significant difference from healthy control subjects.

It is therefore posited that this substance can be safely employed in long-term treatment of chronic liver patients.

1. Ferenci, P., Dragosics, B., Frank, H. et al. 1985. Abstr. J. Hepatol., 1, S229

2. Salmi, H.A. and Sarna, S. 1982, Scand. J. Gastroenterol., 17, 517-521