Therapeutical use of sophora flavescens or sophora subprostrata extracts

#The present invention relates to the use of extracts of Sophora flavescens or Sophora subprostrata for the prophylaxis and treatment of pathological conditions caused by oestrogen deficiency or by dysregulations to sex-hormone-related metabolism, in particular oestrogen metabolism.

#Irregular menstrual cycles appear in women from around the age of 40, marking the onset of the menopause. This phase of changes in the endocrine system, known as the climacteric, may persist for a decade or more. It results from the exhaustion of follicle growth and reduced responses to gonadotrophin. As a consequence of this follicle deficit, production of oestrogen declines and eventually stops altogether. In association with this, a variety of symptoms may develop, such as hot flushes, depression, anxiety, mental confusion, insomnia etc. In addition to these, serious health problems may arise as a result of the decline in oestrogen production, such as osteoporosis, cardiac insufficiency, cerebral infarction (strokes) and cancer.

#Although hormone replacement therapy with oestrogens for the relief of climacteric-related complaints is highly effective, numerous studies show that an increased risk of breast cancer and cancer of the womb, cardiovascular diseases and changes to liver metabolism can be linked to this. The risk of cancer can be reduced by administering progestines. However, the protective effect of progestines appears to fade with long-term use and it is thought that hormone replacement therapy (HRT) is linked with a 35-40% increased risk of breast cancer. Given the side effects, also distinct doubts as to the reliability of this type of treatment, the use of HRT medicine in post-menopausal women over age 40 tends to be refused. It is estimated that only around 20% of post-menopausal American women receive HRT, of whom just 40% continue with the treatment for longer than one year.

#Production of an Extract from Sophora flavescens

#a) Extraction

#2 kg of ground Sophora flavescens roots were mixed with 14 kg 70% [v/v] (62% [w/w]) ethanol, extracted by spinning (Ultraturrax) for 5 min and then stirred intensively for 1 hr at 50° C. Then it was filtered with suction over a Supra Seitz 1500 filter and the drug residue was then extracted for a second time in the same way. Both the extract solutions were combined and the dry extract content was determined using an aliquot. It turned out that there was a dry residue of 475.6 g, corresponding to a yield of 23.8%.