Patent ID: 6280774
Filing Date: 2001-08-28
Classification: A61K,A61P,C07K

Abstract:
A process for preparing a composition for use as an immunomodulator comprising small molecular weight components of less than 3000 daltons, and having the following properties:a) is extracted from bile of animals;b) is capable of stimulating monocytes and macrophages in vitro;c) is capable of modulating tumor necrosis factor production;d) contains no measurable level of IL-1, IL-1b, TNF, IL-6, IL-8, IL-4, GM-CSF or IFN-gamma;e) shows no cytotoxicity to human peripheral blood mononuclear cells; andf) is not an endotoxin,said process comprising (a) mixing bile from an animal with an equal volume of an alcohol to produce a bile/alcohol solution; (b) separating out the alcohol soluble fraction and isolating a solution substantially free of alcohol; (c) removing bile pigments from the solution to obtain a colorless liquid; (d) treating the colorless liquid to substantially remove any residual alcohol; (e) extracting the colorless liquid with ether and isolating the aqueous phase; and (f) removing residual ether from the aqueous phase.