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 Methods of treatment using a soya extract

Details
Inventors: Bombardelli, Ezio; Gabetta, Bruno;
Assignee: Indena S.p.A. (Milan, IT)
Primary Examiner: Flood; Michele
Assistant Examiner:
Attorney, Agent or Firm: Jones Day

A soya extract having a content of glucoside isoflavones of at least 13% by weight and a content of 0.6 to 1.5 parts by weight of group 3 soya saponins per 1 part by weight of glucoside isoflavones. Also, pharmaceutical compositions containing this extract and methods of administering the extract to treat conditions such as pre- or post-menopausal symptoms, cancer, such as breast or prostate cancer, or alcoholism. The extracts are made by a process which includes the steps of treating ripe whole soya beans or oil-free soya flour with an aliphatic alcohol to obtain a first extract; concentrating the first extract to form a concentrated first extract; purifying the concentrated first extract by treatment with at least one aliphatic hydrocarbon; and extracting active components from the purified concentrated first extract with a water-immiscible aliphatic alcohol to obtain a second extract. Preferably, the final extract is concentrated dried to form the desired soya extract.

DETAILED DESCRIPTION Suprisingly, it has now been found that extracts containing glucoside isoflavones and group B soya saponins in defined ratios can be used with success to reduce deliberate alcohol consumption These extracts are significantly more effective than the isoflavones alone and act via a mechanism which is different from that of the inhibition of alcohol dehydrogenase, since the plasma alcohol level remains unchanged.
Thus, the invention relates to a soya extract having a content of glucoside isoflavones of at least 13% by weight and a content of 0.
6 to 1.
5 parts by weight of group 3 soya saponins per 1 part by weight of glucoside isoflavones.
Preferably, the content of group B soya saponins is 1 part by weight per 1 part by weight of glucoside isoflavones.
The invention also relates to a pharmaceutical composition containing, as an active component, one of these soya extracts and a pharmaceutically acceptable carrier or diluent.
Another embodiment of the invention relates to methods for treating various conditions, such as pre- or post-menopausal symptoms in a female subject, cancer, such as breast cancer in a female subject or prostate cancer in a male subject, or alcoholism.
The method step includes administering to a subject in need of such treatment a therapeutically effective amount of one of these soya extracts.
Yet another embodiment of the invention relates to a process for producing these soya extracts.
This process comprises the steps of treating ripe whole soya beans or oil-free soya flour with an aliphatic alcohol to obtain a first extract; concentrating the first extract to form a concentrated first extract; purifying the concentrated first extract by treatment with at least one aliphatic hydrocarbon; and extracting active components from the purified concentrated first extract with a water-immiscible aliphatic alcohol to obtain a second extract.
Preferably, the process further comprises concentrating the second extract followed by drying to form the desired soya extract



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