Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution... – Containing or obtained from aloe
Reexamination Certificate
1999-09-21
2002-03-26
Tate, Christopher R. (Department: 1651)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
Containing or obtained from aloe
C424S725000, C514S824000, C514S944000, C514S969000
Reexamination Certificate
active
06361807
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Area of the Art
The invention relates generally to Pomegranate Extracts and Methods of Using Thereof.
2. Description of the Prior Art
Throughout this application, various references are referred to within parentheses. Disclosures of these publications in their entireties are hereby incorporated by reference into this application to more fully describe the state of the art to which this invention pertains. Full bibliographic citation for these references may be found at the end of this application, preceding the claims.
Major risk factors for atherosclerosis include increased plasma low density lipoprotein (LDL) levels, as well as LDL modifications such as its retention, oxidation and aggregation (1-5). Blood platelets activation also contribute to accelerated atherosclerosis (6-8). Oxidative modification of LDL is thought to play a key role during early atherogenesis. Oxidized LDL (Ox-LDL) is taken up by macrophages at enhanced rates via their scavenger receptors (9), leading to the formation of lipid-laden foam cells, the hallmark of early atherosclerosis (10). Cells of the arterial wall (including endothelial cells, smooth muscle cells and macrophages) can oxidize LDL in vitro in the presence of catalytic amounts of transition metal ions (11-13).
Although increased resistance of LDL to oxidation was observed after treatment with various synthetic pharmaceutical agents (14-17), an effort is made to identify natural food products which can offer antioxidant protection against LDL oxidation. The previous study has demonstrated the beneficial effects against LDL oxidation of dietary supplementation of &bgr;-carotene (18, 19), lycopene (20), vitamin E (21) and flavonoids from red wine (22, 23), licorice (24) or olive oil (25).
The pomegranate tree, which is said to have flourished in the Garden of Eden, has been extensively used as a folk medicine in many cultures. In ancient Greek mythology, pomegranates are known as the “fruit of the dead,” and in the ancient Hebrew tradition, pomegranates adorned the vestments of the high priest. The Babylonians regarded its seeds as an agent of resurrection, the Persians as conferring invincibility on the battlefield, and for ancient Chinese it symbolized longevity and immortality.
Edible parts of pomegranate fruits (about 50% of total fruit weight) comprise 80% juice and 20% seeds. Fresh juice contains 85% moisture, 10% total sugars, 1.5% pectin, ascorbic acid and polyphenolic flavonoids. Pomegranate seeds are a rich source of lipids, proteins, crude fibers, pectin and sugars.
The dried pomegranate seeds contain the steroidal estrogen estrone (26, 27), the isoflavonic phytoestrogens genistein and daidzein and the phytoestrogenic coumestrol (28). In pomegranate juice, fructose and glucose are present in similar quantities, calcium is 50% of its ash content and the principal amino acids are glutamic and aspartic acid (29, 30). Content of soluble polyphenols in pomegranate juice varied within the limits of 0.2% to 1.0%, depending on variety, and include mainly anthocyanins (such as cyanidin-3-glycoside, cyanidin-3, 3-diglycoside and delphindin-3-glucosid), catechins, ellagic tannins, and gallic and ellagic acids (31).
Constitutes of pomegranate have been studied for their antiviral and antifungal effects. For example, U.S. Pat. No. 5,840,308 (61) describes an antiviral and antifungal composition comprising a mixture of a ferrous salt and an extract of a plant including, inter alia, pomegranate rind. U.S. Pat. No. 5,411,733 (32) describes an antiviral agent containing a crude drug from, inter alia, the root bark and fruit peel of pomegranate.
Prior to the present invention, however, no one has studied the effects of pomegranate extracts on LDL atherogenic modifications, including its retention, oxidation and aggregation. No one has used pomegranate extracts for the purpose of treating or ameliorating atherosclerosis.
SUMMARY OF THE INVENTION
It is an object of the present invention to study any effects of pomegranate extract, particularly the effect as an antioxidant. It is also an object of the present invention to provide methods of using pomegranate extract, for example, as an antioxidant. It is further an object of the present invention to provide a method of preventing or ameliorating atherosclerosis.
Accordingly, one aspect of the present invention provides a composition, the biologically active component of the composition consisting essentially of an extract from pomegranate, and the composition comprising a carrier. The composition may be used as nutritional supplements, pharmaceutical preparations, vitamin supplements, food additives or foods supplements. The composition may be used in a dosage unit as tablets, suspensions, implants, solutions, emulsions, capsules, powders, syrups, liquid compositions, ointments, lotions, creams, pastes, gels, and the like. According to embodiments of the invention, the extract may be an extract of juice or the inner or outer peel of pomegranate, or a mixture thereof.
Another aspect of the present invention provides an antioxidative composition for treating disorders associated with conditions including lipoprotein oxidation, aggregation, retention; macrophage atherogenicity, platelet activation and atheroscleorosis. The biologically active component of the composition consists essentially of an effective amount of an extract from pomegranate. The examples of disorders include arteriosclerotic heart disease and its associated complications, including myocardial infarction; cerebral vascular disease (including cerebral insufficiency or stroke); peripheral vascular disease (including peripheral vascular disease in the aorta and femoral and corotid arteries); abdominal aortic aneurysms; renal artery stenosis; arteriosclerotic disease, disorders associated with transplant complications; disorders associated with post-operative heart valve replacement; disorders associated with the complications of diabetes mellitus; thrombophlebitis; and other disorders associated with increased platelets and increased platelet activation.
A further aspect of the present invention provides a method of ameliorating disorders associated with conditions including lipoprotein oxidation, aggregation, retention; macrophage atherogenicity, platelet activation and atheroscleorosis. The method comprises administering to a subject in need thereof a therapeutically effective amount of a composition comprising an extract from pomegranate.
Yet another aspect of the present invention provides a method of ameliorating in a sample conditions including lipoprotein oxidation, aggregation, retention; macrophage atherogenicity and platelet activation. The method comprises a step of contacting the sample with a sufficient amount of an extract from pomegranate.
The invention is defined in its fullest scope in the appended claims and is described below in its preferred embodiments.
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[Search R
Aviram Michael
Dornfeld Leslie
Stewart and Lynda Resnick Revocable Trust
Tate Christopher R.
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