Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution... – Containing or obtained from palmaceae
Reexamination Certificate
2000-02-25
2001-07-17
Naff, David M. (Department: 1651)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
Containing or obtained from palmaceae
C424S756000, C424S758000, C424S777000, C424S702000
Reexamination Certificate
active
06261607
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention relates to herbal compositions. More particularly, this invention relates to an herbal composition which can be used to promote healthy prostate function in men. The present invention also relates to methods of using such compositions to promote prostate health.
In men, the prostate gland is the source of several common disorders including prostatitis and benign prostatic hypertrophy (BPH), wherein the prostate gland becomes inflamed or enlarged. BPH can cause many uncomfortable and annoying symptoms including: difficulty in starting to urinate; increased urge to urinate; a weak or interrupted stream when urinating; a feeling that the bladder cannot be emptied completely; a feeling of decay when urination is started; a need to urinate often, especially at night; and frequent or continuous lower back pain.
Drug therapies exist which can help offset some of the symptoms of BPH but these are associated with significant side effects such as, e.g., impotence.
Recent scientific studies, including one published in the
Proceedings of the National Academy of Sciences
, demonstrate that the enzyme, 5-lipoxygenase (5-LO), is specifically involved in prostate cancer cell proliferation. Inhibition of this enzyme can lead to massive and rapid apoptosis of prostate cancer cells. Drugs are being developed which inhibit 5-LO and prostate cancer cell proliferation. Unfortunately, these drugs can have significant side effects, including, e.g., eosinophilia, compromised liver function, and cardiomyopathy.
Herbs like saw palmetto and nettle have been associated with relief of BPH symptoms but these herbs have not been commercially identified as 5-LO inhibitors or for the application of reducing prostate cancer cell proliferation.
Research from databases combing international studies indicates that ginger contains the highest number of constituents which can inhibit 5LO. See also, e.g., U.S. Pat. No. 5,763,673;
Chem Pharm Bull
(Tokyo) 1992 Feb;40(2):387-91
Inhibition of prostaglandin and leukotriene biosynthesis by gingerols and diarylheptanoids
, Kiuchi, F, Iwakani S, Shibuya M, Hanaoka F, Sankawa U Faculty of Pharmaceutical Sciences, University of Tokyo, Japan; and Nippon Yakurigaku Zasshi 1986 Oct.;88(4):263-9 [
Pharmacological studies on ginger, IV, Effect of (
6)-
shogaol on the arachidonic cascade
].Suekawa M, Yuasa K, Isono M, Sone H, Ikeya Y, Sakakibara I, Aburada M, Hosoya E.
Olive oil also possesses the ability to inhibit 5-LO. See, e.g.,
Biosci Biotechnol Biochem
1997 Feb;61(2).347-50
Inhibition of arachidonate lipoxygenase activities by
2-(3,4-
dihydroxyphenyl)ethanol, aphenolic compound from olives
. Kohyana N, Nagata T, Fujimoto S, Sekiya K Shikoku National Agricultural Experiment Station, Kagawa, Japan; and
Biochem Pharmacol
1999 Feb 15;57(4):445-9
Inhibition of leukocyte
5-lipoxygenase by phenolics from virgin olive oil, de la Puerta R, Ruiz Gutierrez V, Hoult J R Pharmacology Group, King's College London, UK.
Ursolic acid and carnosol, constituents in rosemary, have also been determined to be inhibitors of 5-LO. See, e.g.,
Biochim Biophys Acta
1992 Apr 8;1125(1):68-72
Inhibition of lipoxygenase activity and HL
60
leukemic cell proliferation by ursolic acid isolated from heather flowers
(
Calhora vulgaris
). Simon A, Najid A, Chulia A J, Delage C, Rigaud M
CJF INSERM
88-03
, Faculte de Medecine, Limoges, France; and
Biochem Pharmacol
1991 Oct 9;42(9); 1673-81
Inhibition of mammaliam
5-lipoxgenase and cydo-oxgenase by flavnoids and phenolic dietary additives. Relationship to antioxidant activity and to iron ion-
reducing ability
. Laughton M J, Evans P J, Moroney M A, Hoult J R, Halliwell B Department of Biochemistry, King's College London, U.K.
As mentioned hereinabove, saw palmetto also has been found to possess 5-ipoxygenase-inhibiting abilities. See, e.g.,
Arzneimittelforschung
1992 Apr;42(4):547-51[Anti-inflammatory activity of sabal fruit extracts prepared with supercritical carbon dioxide. In vitro antagonists of cydoxygenase and
5
-lipoxygnease metabolism]. Breu W, Hagenlocher M, Redl K, Tittel G, Stadler F, Wagner H Institut fur Pharmazeutische Biologie, Ludwig-Maximilians-Universitat Munchen; and
Prostaglandins Leukot Essent Fatty Acids
1997 Sep;57(3):299-304
Effect of the lipidic lipidosterolic extract of Serenoa repens
(
Permixon
)
on the ionophore A
23187-
stimulated production of leukotriene B
4 (
LTB
4)
from human polymorphonuclear neutrophils
. Paubert-Braquet M, Mencia Hueta JM, Cousse H, Braquet P Bio-Inova, Life Sciences International, Plaisir, France.
Nettle root extract and its phenolic components caffeic acid are also inhibitors of 5-lipoxygenase. See, e.g., Arzneimittelforschung 1996 Jan;46(1):52-6 [
Anti-inflammatory effect of Urtica diaica folia extract in comparison to caffeic malic acid
]. Obertreis B, Giller K, Teucher T, Behnke B, Schmitz H Strathmann A G, Hamburg.
Other references which teach the use of herbs to relieve symptoms associated with various prostate disorders (including, e.g., prostate enlargement, benign prostatic hyperplasia, and prostate cancer) is disclosed, for example, in U.S. Pat. Nos. 5,543,146; 5,264,428; 5,910,308; and 5,858,700.
It is continually desirable to provide alternative herbal compositions which are capable of promoting not only prostate health (including normal prostate cell growth) but also healthy sexual functioning and performance and antioxidant activity.
A primary object of this invention is to provide an herbal composition which is capable of inhibiting 5-lipoxygenase, thereby promoting normal cell activity and vitality in the prostate gland and thus significantly supporting prostate health.
A further object of this invention is to provide an herbal composition which, in addition to promoting prostate health, also promotes healthy sexual functioning and performance and provides antioxidant benefits.
A still further object of this invention is to provide an orally or parenterally administered herbal composition capable of providing the therapeutic benefits recited in the preceding objects.
Another object of this invention is to provide methods of promoting prostate health in men, using an herbal composition having the characteristics set forth in the preceding objects.
These and other objects are achieved in the present invention.
SUMMARY OF THE INVENTION
The present invention provides a unique formation which is designed to provide an herbal polyphytonutrient approach to the inhibition of 5-lipoxygenase and the promotion of prostate health in men.
The herbal composition of the present invention contains extracts taken from saw palmetto, green tea, pumpkin seed oil, ginger, dual urtica root extracts, selenium, watermelon and rosemary. More specifically, the herbal composition of this invention contains therapeutically effective amounts of supercritical extracts of saw palmetto, ginger, and rosemary, and either regular or supercritical (preferably regular) extracts of green tea, pumpkin seed oil, and urtica root. The composition further contains selenium and watermelon. In preferred embodiments of the present invention, the ginger supercritical extract is a supercritical extract of certified organic ginger.
In addition to promoting prostate health, the herbal composition of this invention normalizes urine flow, promotes healthy sexual function and performance and scavenges oxygen free radicals, thereby exhibiting antioxidant activity.
Another novel feature of the present invention is that supercritical-solvent free extraction technology is used in association with 5-lipoxygenase inhibition. This technology allows for highest potency of active compounds, as much as 250 times the potency of original fresh plant material.
REFERENCES:
patent: 4843069 (1989-06-01), Keller et al.
patent: 4886665 (1989-12-01), Kovacs
patent: 5002939 (1991-03-01), Streber
patent: 5120558 (1992-06-01), Nguyen et al.
patent: 5264428 (1993-11-01), Streber
patent: 5543146 (1996-08-01), Perez
patent: 5565214 (1996-10-01), Zambo et a
Newmark Thomas
Schulick Paul
Meller Mike
Naff David M.
Patton & Boggs LLP
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