Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector – Conjugate or complex
Reexamination Certificate
1999-03-01
2001-06-05
Tate, Christopher R. (Department: 1651)
Drug, bio-affecting and body treating compositions
Antigen, epitope, or other immunospecific immunoeffector
Conjugate or complex
C424S451000, C426S648000
Reexamination Certificate
active
06241987
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to a dietary supplement for use in supporting and maintaining normal prostrate gland function. Specifically, the dietary supplement includes an effective amount of saw palmetto extract, pumpkin seed oil extract and nettle root extract.
The use of plants or plant extracts in dietary supplements has long been used to prevent or control disorders of the human body. The prostrate gland is the source of several common disorders for men. These disorders include prostatitis and benign prostatic hyperplasia (BPH). BPH is a condition associated with aging which affects a large percentage of men over the age of fifty. The symptoms associated with BPH are many and varied. These symptoms include frequent, painful urination, an increased need to urinate, a need to urinate often, especially at night, difficulty in starting to urinate, and a weak or interrupted stream of urination, among others.
A number of plants and plant extracts are known for alleviating the symptoms of BPH. U.S. Pat. No. 5,543,146 to Perez describes treatment of BPH with tablet compositions containing both pumpkin seed and saw palmetto extract. A German reference, W. Vahlensieck, Jr., et al., Drug Treatment of Benign Prostatic Hyperplasia, FORTSCHR-MED., Nov. 10, 1996, at 407—11, also teaches the combination of pumpkin seed and saw palmetto. U.S. Pat. No. 4,886,665 to Kovacs describes the use of an oat extract and a nettle extract in a food supplement for the treatment or prevention of various disfunctions of the human body, including BPH.
While a number of plants and plant extracts are known for preventing or treating the symptoms of BPH, none of the known dietary supplements include a comprehensive combination of plant extracts which address many of the symptoms associated with BPH. Consequently, there is a need for a comprehensive combination of plant extracts and phytochemicals which address many of symptoms associated with BPH and therefore, can be beneficial in supporting or maintaining prostrate gland health.
SUMMARY OF THE INVENTION
The present invention provides a comprehensive combination of plant extracts and phytochemicals in a dietary supplement for use in supporting and maintaining normal prostrate gland function. The dietary supplement contains about 5% to about 25% by weight saw palmetto oil extract, about 12% to about 32% by weight pumpkin seed oil extract and about 1% to about 21% by weight nettle root extract. Additionally, the dietary supplement may include Vitamin A and other antioxidants.
All percentages referred to in the specification and appended claims are by weight unless otherwise stated.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
This invention is directed to a dietary supplement for use in supporting and maintaining normal prostrate gland function. The dietary supplement of the present invention provides a unique combination of herbal extracts including saw palmetto, pumpkin seed, and nettle root, which synergistically combine to help maintain prostrate gland health. In a preferred embodiment of the invention, the dietary supplement includes about 5% to about 25% by weight saw palmetto oil extract, about 12% to about 32% by weight pumpkin seed oil extract, and about 1 % to about 21% by weight nettle root extract.
The saw palmetto for use in this invention may be derived from the
Serenoa repens
plant species. In general, these plants are fan palms which grow in the South Central and South Eastern regions of the United States. The plant matures to approximately 10 feet with leaf clusters attaining a length of two or more feet. The brownish-black berry is harvested commercially for use in the dietary supplement and pharmaceutical industry. Other common names for saw palmetto include sabal, American Dwarf palm tree, and cabbage palm.
Saw palmetto is available commercially from a number of sources. Commercial extracts of the saw palmetto berry typically contain mostly free fatty acids with smaller amounts of fatty alcohols, and sterols, including &bgr;-sitosterol. Preferably, the saw palmetto for use in this invention is extracted from the fruit of the saw palmetto plant. In addition, it is preferred that the saw palmetto extract contains about 80% to about 95% fatty acids.
The pumpkin seed for use in this invention may be derived from various species including, but not limited to,
Cucurbita pepo, Cucurbita maxima, Cucurbita moshata, Cucurbita argyro
-
sperma,
and
Cucurbita ficifolia.
Preferably, the pumpkin seed used in this invention is derived from the
Cucurbita pepo
species. Pumpkin seed is native to America but is also cultivated worldwide. Imports are available from the former USSR, Yugoslavia, China, Austria, Hungary, and Mexico. Synonymous names include
Semen peponis
(Latin), Kurbissamen (Germany) Graine de pepon, Graine de courge, and Graine de citroulle (France).
In general, pumpkin seeds are greenish to earth colored with a flattened oval shape. Each seed is approximately 7-15 mm long with the micropyle recognizable at the narrow pointed end. Commercial pumpkin seed is primarily obtained from cultivated varieties which do not have a testa.
Cucurbita pepo
is an annual with prostrate shoots up to 10 meters long. The leaves are very large and generally have five distinct lobes. The plant also contains yellow dioecious flowers with a funnel shaped corolla. The seeds are housed within the huge spherical berries of the plant.
Pumpkin seed is available commercially from a number of sources. The constituents in fresh pumpkin seed typically include fixed oils, free fatty acids, steroids, phosphatic acid, fiber, pectins, protein, tocopherols, and trace elements such as phosphorus, potassium, magnesium, calcium, sodium, selenium, manganese, zinc, and copper. The amounts and types of these constituents may be influenced by location, year, variety and location/year interactions. Two types of fatty acids which are found in pumpkin seed include, but are not limited to, Oleic and Linoleic acids. Preferably, the pumpkin seed extract used in this invention includes about 80% to about 95% free fatty acids. Steroids that may be found in pumpkin seed include 24&bgr;-ethyl-5&agr;-cholestra-7,25(27)-dien-3&bgr;-ol and 24&bgr;-ethyl-5 &agr;-cholestra-7-trans22,25(27)-trien-3&bgr;-ol. Smaller quantities of sterol glucosides and &Dgr;
5
and &Dgr;
8
-sterols are also found in pumpkin seed.
The nettle root for use in this invention may be derived from various species including, but not limited to,
Urtica dioca
and
Urtica urens.
Nettles are plants which are native to Europe and are found in the United States and Canada. These perennials have an erect stalk and can attain a height up to three feet. The dark green serrated leaves grow opposite each other along the stalk. The constituents in nettle include flavonoids, lectins, amines, minerals, and other plant substances such as chlorophylls, carotenoids, vitamins, triterpenes, sterols, and carboxylic acids such as formic and citric acids. Important flavonoids found in nettles include glycosides of quercetin (isoquercitrin and rutin), kaempferol, and isorhamnetin. The amines are usually found in small amounts and include histamine, choline, acetylcholine and serotonin. The amines are primarily found in the stinging bristles of the plant. Important carotenoids found in nettle include &bgr;-carotene and xanthophylls. Important sterols found in nettle include &bgr;-sitosterol. Preferably, the nettle used in this invention includes about 0.2% to about 1.2% by weight &bgr;-sitosterol. In addition, the nettle root extract is preferably provided in a powdered form.
The saw palmetto, pumpkin seed, and nettle may be isolated from their plant sources by any means available. Preferably, these constituents are isolated through solvent extraction. The extract may be further purified through chromatography or other purification methods.
The dietary supplement of the present invention may also include other dietary needs such as vitamins, minerals, antioxidants and other natural elements. Preferably
Amway Corporation
Amway Corporation
Tate Christopher R.
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