Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution... – Containing or obtained from panax or acanthopanax
Reexamination Certificate
1999-12-28
2002-01-22
Tate, Christopher R. (Department: 1651)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
Containing or obtained from panax or acanthopanax
C424S727000, C424S752000, C424S777000, C514S565000, C514S887000, C514S929000
Reexamination Certificate
active
06340480
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to the treatment of circulatory conditions and, more particularly, to an improved natural composition for treatment of an array of conditions by dilation of blood vessels, said conditions including skin wounds, hypertension, etc. The natural composition uses various combinations of L-arginine, ginseng and Zizyphi fructus in a topically or orally administered dosage.
2. Description of the Background
It has been found that an array of conditions can be successfully treated by increasing blood flow to the affected area. The goal of most injury treatments is to accelerate the healing process by increasing the circulation of blood flow to an affected area. This is the recommended treatment for skin wounds, tendonitis, muscular sprains and other injuries to the musculoskeletal system. As a result, there have been a number of studies to determine the most effective compounds and methods for increasing blood flow. There have also been a number of studies to determine the full range of conditions that are amenable to this form of treatment. Many of these studies have cited the vasodilator functions of nitric oxide (NO) as a key factor in the endothelial-mediated microvascular homeostasis that is exhibited in cutaneous tissue.
One example of such a condition plus a useful treatment compound is set forth in co-pending U.S. utility patent application No. 09/255,587 (now issued as U.S. Pat. No. 6,007,824 to the inventors named herein). A composition and method for treating sexual dysfunction was therein disclosed, the natural composition including a combination of L-arginine, ginseng and Zizyphi fructus in an orally administered dosage. The combination acts synergistically to alleviate erectile dysfunction by stimulating enough release of NO in the corpus cavernosum to produce and sustain smooth muscle relaxation, thereby allowing the inflow of blood and alleviating erectile dysfunction. The '587 patent effectively provides a natural medicinal alternative to Viagra® for the treatment of erectile dysfunction.
Further studies have broadened the merits of stimulating NO. Two particular applications include treatment of skin wounds, and treatment of hypertension.
Wound healing is a cooperative process involving platelets, fibroblasts, neutrophils; macrophages, cytokines, growth factors, cellular migration, collagen and matrix deposition, angiogenesis and remodeling. A well-oxygenated vascularized connective tissue compartment is crucial to facilitate the healing process at the wound site.
by 1986, research identified nitric oxide as the endothelium-derived relaxing factor responsible for the maintenance of vascular tone, thus implicating nitric oxide as a potential wound-healing agent. Studies have since confirmed this. See, for example, Schaffer et al.,
Acute Protein-calorie Malnutrition Impairs Wound Healing: a Possible Role of Decreased Wound Nitric Oxide Synthesis
, J Am Coll Surg, Jan. 1997 184:1, 37-43.
Nitric oxide regulation of wound repair invokes the following relationships: wound oxygen availability is enhanced by the vasodilator functions of nitric oxide (this is a key factor in the endothelial-mediated microvascular homeostasis that is exhibited in cutaneous tissue); nitric oxide has been demonstrated to be a significant component of the neurogenic vascular response; local random flap survival is dependent upon sustained nitric oxide activity and nitric oxide deficiency has been clinically and experimentally associated with the neuropathic (ischemic) alterations observed in diabetes; the inflammatory mediation of wound repair is enhanced by nitric oxide mediated antimicrobial cytotoxicity and immunomodulation; wound angiogenesis is enhanced through nitric oxide mediated mechanisms; intravascular cellular adhesion (neutrophilendothelial) is inhibited by the action of nitric oxide on the integrins pathway; nitric oxide activity also decreases extravascular free radical cellular peroxidation by integrins inhibition. In addition, wound matrix development and remodeling are enhanced by the increased collagen deposition and wound tensile strength mediated by nitric oxide. Fibroblast chemotaxis and migration are enhanced by nitric oxide activity, endothelial and epithelial cell proliferation and apoptosis regulation may also be correlated to wound nitric oxide activity. Boykin, J. V.,
Nitric Oxide in Wound Healing
. See, also, Bauer J. A., Hvdroxocobalamins as Biologically Compatible Donors of Nitric Oxide Implicated in the Acceleration of Wound Healing, Med Hypotheses, Jul. 1998 51:1, 65-7.
Nitric oxide regulation of hypertension is another promising direction. The cause of hypertension is not well-understood. At least one study suggests that hypertension can result from impaired endothelial NO activity, e.g., an inability to synthesize NO. Cardillo et al., Selective Defect in Nitric Oxide Synthesis May Explain the Impaired Endothelial-Dependent Vasodilation in Patients with Essential Hypertension, American Heart Association, Inc., 1998. Other studies with anti-oxidants such as Ginko Biloba and Ginsenosides have shown a direct relation with cerebral vasorelaxation, suggesting that increasing blood flow to the brain may be useful in treating ischaemia-induced cerebral dysfunction. See Chen et al., Extracts of Ginkgo Biloba and Ginsenosides Exert Cerebral Vasorelaxation via a Nitric Oxide Pathway, Clin. & Exp. Pharmacology and Physiology, v 24, 958-959 (1997). Of course, blood flow to the brain is most likely a contributing cause of hypertension. It is equally likely that an impaired endothelial NO activity in the kidneys, heart, etc., also contribute.
Unfortunately, known organic Nitric Oxide stimulants such as Ginseng and Ginkgo Biloba, taken orally, result in marginal increases in blood flow and are not viable treatment options for most conditions. They simply do not make up for the impaired endothelial NO activity. More powerful synthetic nitric oxide donors have been developed, but most have proven antagonistic to the immune system. Therefore, a significant demand exists for an effective nitric-oxide donor which is biologically friendly. Based on research, the present inventors have concluded that it would be greatly advantageous to combine the use of L-arginine with other natural and organic constituents as described above to stimulate enough release of NO to serve as a healing catalyst in both applications.
SUMMARY OF THE INVENTION
It is, therefore, an object of the present invention to provide a natural catalyst for the topical and/or oral treatment of wounds.
It is another object to combine the use of L-arginine with other natural and organic constituents to stimulate increased release of NO in the wound compartment to increase the speed and quality of healing.
It is another object to provide a natural relaxant for the treatment of hypertension. It is still another object to combine the use of L-arginine with other natural and organic constituents to stimulate increased release of NO to reduce hypertension.
According to the present invention, the above-described and other objects are accomplished by adapting the compound of L-arginine, ginseng and Zizyphi fructus as described in the '824 patent, and proving its efficacy in an orally or topically administered dosage for effective treatment for wound care and/or hypertension. In the wound-care context, the foregoing ingredients act synergistically to stimulate enough release of NO in the wound compartment. In the hypertension context, the ingredients act synergistically to stimulate enough release of NO to promote vasorelaxation, thereby increasing blood flow to the NO-synthesase impaired area and reducing hypertension.
The combination of ingredients, when administered in proper concentration, works to maintain a critical threshold level of NO in either the wound compartment or NO-synthesase impaired area in order to promote the healing process. The effect is sufficient to increase the speed and quality of systemic vascular relaxation a
Duckett Melvin J.
Moore Kyle
Law Office of Royal W. Craig
Tate Christopher R.
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