Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution... – Containing or obtained from scutallaria
Reexamination Certificate
2002-09-17
2004-05-25
Lankford, Jr., Leon B. (Department: 1654)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
Containing or obtained from scutallaria
C424S725000
Reexamination Certificate
active
06740343
ABSTRACT:
FIELD OF THE INVENTION
The present invention is related to novel standardized extracts of
Scutellaria lateriflora
; methods for preparing the same; compositions containing these standardized extracts; and the treatment of anxiety, insomnia, convulsions, muscle tension and spasm, and related manifestations and disorders in humans and other mammals through the administration of compositions containing these standardized extracts.
BACKGROUND OF THE INVENTION
Anxiety is one of the most frequent psychological problems that humans experience. It is estimated that anxiety related psychiatric disorders affect over 13% of the population each year in the United States. The cost of this individual suffering and the social burden of anxiety are significant. Effective treatment of anxiety and related disorders can significantly alleviate the suffering and distress associated with such disorders.
Treatment of anxiety and the related conditions of insomnia and convulsions is as old as recorded history, and the interventions are encyclopedic. While there are effective treatments, there is much need for improvement. The search for new anxiolytic medicines that meet acceptable standards of efficacy and safety continues.
In recent years this search has broadened to include an assessment of herbal sedatives and anxiolytics. These have been used in both folk medicine and phytotherapy for centuries, and continue to have widespread use in many cultures.
Scutellaria lateriflora
, also known as Blue Skullcap or American Skullcap, (hereinafter
S. lateriflora
) is a perennial herb indigenous to North America and Europe. Long used as a traditional herbal remedy for a variety of indications, it is known to exhibit anxiolytic, sedative, and anticonvulsant effects. The use of
S. lateriflora
to treat anxiety, insomnia and related disorders has been one of its major therapeutic applications. The herb is typically used in the form of teas and tinctures. It can also be ingested in fresh or dried forms.
The leaves, stems and flowers of
S. lateriflora
contain a number of biologically active compounds. Nishikawa, et al. analyzed
S. lateriflora
, and found the principle phenolics in leaves, stems, and roots were baicalein and wogonin (Nishikawa, et al. Phenolics in tissue cultures of Scutellaria.
Natural Medicines
53:209-213, 1999). Gafner, et al. screened dried aboveground parts of
S. lateriflora
and identified the flavones baicalin and baicalein, as well as 5,6,7-trihydroxy-2′-methoxyflavone and its 7-0-glucuronide. (Analysis of
Scutellaria lateriflora
and its adulterant
Teucrium canadense
by HPLC-UV and HPLC-UV/MS, Tom's of Maine, PO Box 710, Kennebunk, Me. 04043, USA). Finally, a number of the flavones found in
S. lateriflora
have been reported to selectively bind with high affinity to central benzodiazepine receptor sites, leading to the view that the flavones exerts powerful anxiolytic and other benzodizepine effects in rats. (Medina, et. al., Overview-Flavonoids: A new family of benzodiazapine receptor ligands.
Neurochem Res.
1997 22(4):419.)
While the prior art identifies certain compounds in
S.lateriflora
, it has not been demonstrated which compounds are therapeutically effective. Further, none of the known
S. lateriflora
extracts are standardized. In addition, the currently available commercial
S. lateriflora
preparations do not have adequate therapeutic effects, principally because concentrations of the therapeutically effective components are too low or are not sufficiently bioavailable.
There is a great need, therefore, for extracts of
S. lateriflora
that have rigorous standardization based on the presence of specific markers, and good quality control. There is also a need for extracts of
S. lateriflora
that have higher levels of therapeutically active components, better bioavailability, and demonstrated therapeutic efficacy. Further there is a need for methods of preparing these extracts, as well as for compositions containing these extracts. There is also a need for treatments for anxiety, insomnia, convulsions, muscle tension and spasm, and related manifestations and disorders using these extracts.
SUMMARY OF THE INVENTION
The present invention is directed generally to novel standardized extracts of
Scutellaria lateriflora
for the treatment of symptoms of anxiety, insomnia, convulsions, muscle tension and spasm, and related manifestations and disorders in humans and other mammals.
The present invention is further directed to methods of preparing such extracts.
In one particular aspect of the present invention, there is provided an extract of
S. lateriflora
which comprises an active component for treatment of symptoms of anxiety, insomnia, convulsions, muscle tension and spasm, and related manifestations and disorders that includes at least one specific phenolic marker in an amount of at least 8% by weight based on the total weight of the extract.
In another particular aspect of the present invention, there is provided a method of preparing the extract, which comprises:
treating a mass of
S. lateriflora
with a solvent suitable for extracting at least one active phenolic component to yield an extract solution;
concentrating the extract solution to an extent necessary to provide a minimum desirable concentration of the active component for the treatment of anxiety, insomnia, convulsions, muscle tension and spasm, and related manifestations and disorders, and;
standardizing the extract to yield a known amount of at least one specific phenolic marker.
The present invention is further directed to a pharmaceutical composition useful for treating anxiety, insomnia, convulsions, muscle tension and spasm, and their related manifestations and disorders, comprising as an active component an effective amount of at least one specific phenolic marker extracted from
S. lateriflora
, and a pharmaceutically acceptable carrier, and methods of using the same.
The present invention is further directed to methods of treating anxiety, insomnia, convulsions, muscle tension and spasm, and their related manifestations and disorders by administering the novel standardized extracts of this invention.
REFERENCES:
patent: 6200594 (2001-03-01), Ernest et al.
Nishikawa et al. (Natural Medicines (1999), vol., 53, No. 4, pp. 209-213).*
Medina, et al., Overview Flavonoids: A new family of benzodiazapine receptor ligands.Neurochem Res.1997 22(4) :419.
Hoffmann David Ludwig
Wolfson Philip E.
Coe Susan D.
Lankford , Jr. Leon B.
Litman Richard C.
Phytos, Inc.
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