Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution...
Reexamination Certificate
1999-12-22
2001-12-04
Henley, III, Raymond (Department: 1614)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
C514S002600, C514S351000, C514S458000, C514S474000, C514S725000
Reexamination Certificate
active
06326034
ABSTRACT:
The present invention is directed to processes of isolating purified compositions with or without chromium from a variety of natural sources including, but not limited to, a yeast strain
S. carlsbergensis, S. cereveisiae
or any commercial yeast extract, or a Saltbush,
Atriplex halimus,
growing in the Mediterranean area. The invention also comprises synthetic sources of chromium, or chromium salts including, but not limited to CrCl
3
, chromium sulfate, chromium gluconate, chromium-cysteine, chromium-glutathione, chromium-N-acetyl cysteine or chromium tartarate. The invention is also directed to formulations of the antioxidants, with or without chromium, which specifically regulate glucose and lipid metabolism, and insulin and antioxidant activities in mammals at enhanced risk for, or having, a diabetic condition, cardiovascular diseases and hyperlipidemia. In the practice of the method of treating diabetes, compositions containing the chromium containing antioxidants are used to regulate the diabetes related metabolic disregulation without general cytotoxic effects.
1. BACKGROUND OF THE INVENTION
Chromium (Cr) has been known as an essential trace element in animal and human nutrition. Cr deficiency may result in various symptoms including increased concentrations of circulating insulin, elevated blood glucose and cholesterol, decreased insulin receptor number, elevated triglyceride and free fatty acid levels and reduced high-density lipoprotein (HDL) cholesterol levels. Chromium levels in most organs decline with age and in diabetics its levels are even lower-than in healthy adults. Anderson, R. A., Clin. Physiol. Biochem. 4: 31-41 (1986).
Chromium deficiency may also produce hypercholesterolemia. The intake of dietary chromium probably varies considerably. In United States, it probably averages 60-90 mg/day with 20-60% of individuals tested consuming below the proposed recommendation of 50-200 mg/day. Refinement of whole grains removes most of the chromium and it has been proposed that chromium deficiency in the developed world is partly because of the reliance on refined and processed food products.
Inorganic Chromium Salts, are absorbed very poorly (about 1%). In biologic systems, chromium is found primarily in the +3 ionic state, although the +2 and +6 states also occur.
The present invention relates to compositions of natural extracted with or without chromium and synthetic antioxidant chromium compounds, for application to individuals to inhibit oxidative injury within the target cells. In the practice of the invention, the natural and synthetic antioxidant compounds, can be applied to supplement traditional pharmaceutical, hormonal and/or nutritional therapies for various diseases.
2. SUMMARY OF INVENTION
In accordance with the invention, processes of isolating from natural sources, compositions of natural antioxidants are provided for the production of improved and more purified compositions. The natural sources used include, but are not limited to the yeast strains
S. carlsbergensis, S. cerevisiae
and commercial yeast extract, and the saltbush
Atriplex halimus
growing in the Mediterranean.
The present invention also provides chromium salts and synthetic sources of chromium complexes, including, but not limited to chromium chloride, chromium gluconate, chromium sulfate, chromium-cysteine, chromium-glutathione, chromium-N-acetyl cysteine or chromium tartarate.
The present invention provides formulations of natural and synthetic compositions for application in a variety of diseases or abnormal conditions including, hyperlipidemia, hypercholesterolemia, obesity, vascular and fibrotic proliferative diseases, cancer, skin warts, skin lesions, UV-induced skin damage, diabetes and diabetic complications or to regulate abnormal metabolic processes.
The present invention provides formulations of natural and synthetic antioxidants with or without chromium, which can be applied in combination with an effective amount of one or more additional antioxidants including vitamin C, vitamin E, reduced glutathione, manganese, beta-carotene, ergothioneine, zinc, selenium, cysteine, N-acetyl cysteine, methionine or 2-mercaptoethanol.
According to an additional aspect of the present invention, there is provided a method to regulate lipid peroxidation, lipid oxidation and metabolism and antioxidant activities by applying formulations of an effective amount of natural with or without chromium and/or synthetic chromium compositions.
According to yet another aspect of the invention, there is provided a method to regulate hyperlipidemia, hypercholesterolemia, obesity, vascular and fibrotic proliferative diseases, cancer, skin warts, skin lesions, UV-induced skin damage, diabetic neuropathy or to regulate lipid metabolism and antioxidant activities by applying formulations of natural and/or synthetic compositions with or without chromium containing compounds, in combination with an effective amount of one or more antioxidants including vitamin C, vitamin E, reduced glutathione, manganese, beta-carotene, ergothioneine, zinc, selenium, cysteine, N-acetyl cysteine, methionine or 2-mercaptoethanol.
The present invention also provides a method to regulate lipid peroxidation, free radical generation, lipid metabolism and antioxidant activities, including application of formulations of natural and/or synthetic compositions with or without chromium in combination with a conventional therapeutic regimen including hormonal therapy or one or more pharmaceutical agents.
The present invention is based on the discovery of improved process to produce more purified compositions of natural and/or synthetic antioxidants with or without chromium.
The present invention is based on the discovery of improved processes to produce synthetic compositions of chromium complexes.
The present invention is also based on the discovery of improved formulations of natural and/or synthetic compositions with or without chromium containing compounds, which exhibit a greater potency in regulating metabolic abnormalities associated with generation of or failure in removal of oxygen free radicals.
It is also the object of the present invention to provide formulations of natural and/or synthetic compositions with or without chromium containing compounds, which are effective when used alone or in combination with antioxidants or conventional therapies.
It is another object of the present invention to provide methods for prevention and treatment of inflammatory diseases, specifically abnormalities in oxygen radicals and lipid metabolism, arachidonic acid metabolism, cyclooxygenase activity or antioxidant activities.
Still other objects and advantages of the invention will in part be obvious and will in part be apparent from the specification.
The invention accordingly comprises the several steps and the relation of one or more of such steps with respect to each of the others, and the product embodying properties, which are adapted to effect such steps and methods, all as exemplified in the following detailed disclosure, and the scope of the invention will be indicated in the claims.
REFERENCES:
patent: 4976960 (1990-12-01), Grossman et al.
patent: 5145674 (1992-09-01), Lane et al.
patent: 5567424 (1996-10-01), Hastings
The Nutritional Desk Reference, Garrison et al., published 1985 by Keats Publications (CT), pp 61-62.
Mirsky Nitsa
Schachter Alona
Sussan Sherbel
Henley III Raymond
Karmali Rashida A.
Natural Compounds LTD
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