Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution... – Containing or obtained from panax or acanthopanax
Reexamination Certificate
1999-10-01
2002-04-09
Weber, Jon P. (Department: 1651)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
Containing or obtained from panax or acanthopanax
C424S752000, C424S725000
Reexamination Certificate
active
06368640
ABSTRACT:
INTRODUCTION
1. Technical Field
This invention relates to the maintenance of a state of wellness in which sexual health is improved.
2. Background
Quality of life is increasingly valued in today's society. Proper nutrition and exercise, and healthy sexual function contribute to maintain an overall state of wellbeing, which can serve to manage stress, maintain a properly functioning immune system, protect against disease, maintain a positive mental outlook, and generally to enable one to feel good and enjoy life.
SUMMARY OF THE INVENTION
It has been found that the combination of L-arginine, ginseng, and optionally, ginkgo biloba when administered to a human in combination improves the blood circulation and improves the sexual, mental, and cardiac health of an individual. The invention provides methods and compositions for maintaining a state of wellness in an animal by providing a dietary supplement comprising L-arginine, in combination with ginseng and optionally ginkgo biloba and/or additional nutritional supplements. The invention provides a unique blend of components that, in combination, synergistically bestow sexual wellness upon an animal when taken regularly as a dietary supplement alone, or in combination with a pharmaceutical composition which facilitates smooth muscle relaxation and vascular dilatation.
One aspect of the invention is a composition for improving sexual fitness in an animal. The composition comprises (a) a metabolic precursor to nitric oxide, (b) a material for increasing nitric oxide synthase activity, and optionally (c) a material to promote vascular circulation, particularly microvascular circulation. Additional dietary supplements such as vitamins and minerals can also be included.
Another aspect of the invention is a method for improving sexual function in an animal. The method comprises administering the composition described above.
A third aspect of the invention is a method of treating sexual dysfunction in a male or female, e.g., erectile dysfunction in the male. The method comprises administering the composition described above.
Yet another aspect of the invention is a method for preparing a composition useful for improving sexual fitness. The process comprises combining the components of the composition described above, preferably into unit dosage forms.
A fifth aspect of the invention is an article of manufacture comprising the composition described above in combination with labeling that the composition is to be taken for sexual fitness.
DESCRIPTION OF SPECIFIC EMBODIMENTS
The compositions and methods of the invention provide a dietary supplement useful for maintaining a state of wellness in an animal, preferably a laboratory animal or domesticated animal, even more preferably a human, whether male or female.
The composition and method of the invention are particularly useful for improving sexual fitness in both males and females. The composition and method are particularly useful for people who want to remain sexually active as they grow older.
The composition of the invention comprises two, and preferably three, components: (a) a metabolic precursor to nitric oxide, (b) a material for increasing nitric oxide synthase activity, and optionally (c) a material to promote vascular circulation, particularly microvascular circulation. Preferably, the composition is a dietary supplement that is delivered over time to achieve the desired results.
A preferred dietary supplement of the invention comprises a combination of arginine, ginseng, and optionally ginkgo biloba, which is useful for improving blood flow and circulation. Improved blood flow is important for maintaining good sexual health. The compositions and methods of the invention improve sexual wellness without any undesirable side effects such as headache, nausea, gastric upset, chest pain, dizziness, vision disturbance, or change in blood pressure.
The Composition
The main component of the composition of this invention is a metabolic precursor to nitric oxide (NO), such as, for example, organic nitrates and nitrites and other compounds that are capable of conversion to nitric oxide. Many of such precursors are also called nitrovasodilators. Examples of organic nitrates include isoamyl nitrate, nitroglycerin, isosorbide dinitrate, erythrityl tetranitrate and pentaerythritol. Preferably, the precursor to NO is arginine. Arginine is an essential amino acid having the chemical name 2-amino-5-guanidinovaleric acid. It is preferably used in the physiologically active form which is designated as the “L” form. The compound is readily available from various sources in the commercial market place such as from Sigma Chemical Company or Aldrich Chemical Company in a pharmaceutical grade. It generally is available as a powder that generally is associated with two moles of water and forms monoclinic plates. Preferably the L-arginine in the composition is free of other amino acids, peptides and proteins that would interfere with the uptake of L-arginine into the animal's system.
The second component present in the composition is a material that increases nitric oxide synthase (NOS) activity. The increase in NOS activity may result from the increase in the quantity of NOS in the system or from an improvement in the level of activity of NOS or by some other manner. A preferred material is ginseng. Ginseng is material extracted from the root of a plant that is a member of the ginseng family (Araliaceae), genus Panax. Ginseng plants grow in Asia and North America.
P. ginseng
grows in Northern China (Chinese ginseng) and Korea (Korean ginseng). The material extracted from the root is referred to as white ginseng or red ginseng. The former is dried
P. ginseng
root, while the latter is
P. ginseng
root steamed in caramel. American ginseng (
P. quinquefolium
) generally grows in the northern U.S. and Canada. Other relatives include Japanese ginseng (
P. japonicum
), San-Chi ginseng (
P. notoginseng
), Himalayan ginseng (
P. pseudoginseng,
ssp.
himalaicus
var
argustifolius
), and Siberian ginseng (
Eleutherococcus senticosus
).
The ginseng component in the composition is usually standardized ginseng obtained from plants originating from one or more geographical areas, and comprises, in total, about 1% to about 50% ginsenosides, preferably about 10% to about 35% ginsenosides, more preferably about 15% to about 20% ginsenosides, most preferably about 17.5% ginsenosides. Preferably the ginseng component comprises American ginseng and Korean ginseng. The American ginseng comprises about 1% to about 50% ginsenosides, preferably about 1% to about 10% ginsenosides, more preferably about 5% ginsenosides. The Korean ginseng comprises about 1% to about 50% ginsenosides, preferably about 10% to about 40% ginsenosides, more preferably about 30% ginsenosides. The ginseng component in a liquid or tonic is usually one or more extracts of ginseng from various geographical areas having a ratio of herb to solvent when extracted of about 1:2 to about 1:10, preferably about 1:5.
The various types of ginseng are available on the commercial market and are available from various sources, such as, for example, East Earth Herb and Natural Sourcing Solutions, Inc. The types and relative abundance of the chemical constituents of ginseng depend on the species, the part of the plant, the place of origin, the method of cultivation, and the technique of extraction used to obtain the ginseng. Different types of ginseng may have slightly different constituent profiles, but the type of ginseng used in this composition will be the material extracted from
Panax ginseng
or
Panax quinquefolius.
Preferably a mixture of American ginseng and Korean ginseng is employed.
The composition of the ginseng extracted from the roots of the various plants is quite similar among the different species used. Generally the ginseng will contain typical ginsenosides. A further discussion of the constituents of the various types of ginseng may be found in the American Chemical Society publication entitled “Folk Medicine: The Art and the Scienc
Kwock Denny W.
Trant Aileen S.
Wuh Hank C. K.
Creighton Wray James
Narasimhan Meera P.
Patten Patricia D
The Daily Wellness Company
Weber Jon P.
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