Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Tablets – lozenges – or pills
Reexamination Certificate
1999-08-31
2001-05-01
Spear, James M. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Tablets, lozenges, or pills
C424S195110, C424S451000, C424S455000, C424S489000, C514S937000
Reexamination Certificate
active
06224906
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to St. John's wort compositions, and, more particularly, to such compositions in the form of a stable, free-flowing powder having effective antidepressant properties, characterized by having essentially no hypericin therein, and pharmaceutical and nutritional use formulations thereof.
2. Description of the Prior Art
St. John's wort is the common name for the plants
Hypericum perforatum
and
Hypericum augustifolia
; however,
Hypericum augustifolia
is rarely used in commercial products. Accordingly, the term as used herein refers to
Hypericum perforatum
, as its whole fresh or dried plant, and compositions and use formulations derived therefrom.
St. John's wort has been used externally to treat wounds, muscle aches and burns, and, internally, for relieving psychogenic disturbances, including depressive states, sleep disorders, anxiety and/or nervous excitement, particularly those associated with menopause. An advantage of treatment of certain cases of depression with St. John's wort is that it is rarely accompanied by sexual dysfunction, as with many prescription antidepressants. However, the art does not fully understand what chemical or chemicals in St. John's wort are responsible for its anti-depressant effect.
Accordingly, it is an object of this invention to provide a St. John's wort composition, and use formulations thereof, which have particularly effective antidepressant properties.
A feature of the invention is the provision of a stable, free-flowing St. John's wort powder composition which has essentially no hypericin therein.
Another feature of the invention is the provision of such composition with large amounts of phloroglucinols, xanthones and flavonoids therein.
These and other objects and features of the invention will be made apparent from the following description of the invention.
SUMMARY OF THE INVENTION
What is described herein is a composition of St. John's Wort, in the form of a stable, free-flowing, powder, having effective antidepressant properties, characterized by containing essentially no hypericin therein.
The composition includes a synergistic combination of at least 3% phloroglucinols and at least 3% xanthones therein and which also includes at least 7% flavonoids.
The composition comprises about 3-7% phloroglucinols including hyperforins, about 3-5% xanthones and about 7-12% flavonoids and is about 60% water soluble and about 70% ethanol soluble and has a total ash content of about 15%.
A pharmaceutical or nutritional formulation in the form of a tablet, capsule or liquid is provided for the composition herein. The formulation is present in suitable dosage form for oral administration.
A process of making the composition comprises (a) providing the freshly harvested upper one-third portion of the
Hypericum perforatum
plant at the time of flowering, (b) coarsely crushing the plant, (c) extracting exhaustively with 80% aqueous methanol or ethanol at 50° to 60° C., (d) concentrating the extract under vacuum below 60° C. to provide the dry solid, and (e) pulverizing the solid under controlled temperature and humidity conditions. Alternately, the coarsely crushed plant material is macerated before extraction with a solution of an antioxidant in order to improve the yield and stability of hyperforins.
DETAILED DESCRIPTION OF THE INVENTION
The St. John's wort powder composition of the invention is obtained by a process which comprises: (a) obtaining freshly harvested upper one-third portion of
Hypericum perforatum
plant at the time of flowering, (b) coarsely crushing the plant, (c) extracting exhaustively with 80% aqueous methanol or ethanol at 50° to 60° C., (d) concentrating the extract under vacuum below 60° C. to provide the dry solid, and (e) pulverizing the solid under controlled temperature and humidity.
The following are representative examples of the invention.
REFERENCES:
patent: 5820867 (1998-10-01), Bewicke
patent: 6113907 (2000-09-01), Khwaja et al.
Katz Walter
Natreon Inc.
Spear James M.
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