The present invention relates generally to herbal extracts. The present invention is more particularly, though not exclusively, useful as an herbal extract and method of manufacturing an extract, for use in the treatment of warm blooded animals, including humans.
Benign Prostatic Hyperplasia (BPH) is a very common disease, affecting about 30% of men aged fifty plus, 50% of men in their sixties and as many as 90% in their seventies and eighties (Source: US Department of Health & Human Services). By 2006, approximately 115 million men in the 50+ age bracket will suffer from BPH.
Historically, treatment of BPH has been attempted using traditional pharmaceutical treatments. For instance, currently there are two main classes of drugs are prescribed for BPH: alpha-blockers and 5-alpha-reductase inhibitors.
Alpha-blockers (or alpha-1 antagonists) work by relaxing the muscles at the neck of the bladder and in the prostate. In this way they reduce the pressure on the urethra and help increase the flow of urine. They do not cure BPH but help to alleviate some of its symptoms. Around 60% of men find symptoms improve significantly after 2-3 weeks of treatment with an alpha-blocker, which are also used for hypertension. Common side-effects include tiredness, dizziness and headaches.
Major drugs in this class include:
Despite their possible benefits, it is important to note that there are a number of severe side effects from pharmaceutical drugs. These include the following:
In light of the above, it would be advantageous to provide a non-pharmaceutical alternative to the treatment of BPH. This alternative treatment would have little or no side effects, be generally well tolerated, relatively uncomplicated to manufacture, and reasonably cost effective.
Epilobium is an edible plant indigenous to the Americas, Europe, Africa, West Asia and India. In traditional herbal medicine, epilobium has proven to have antibacterial, anti-inflammatory, antimicrobial and antioxidant properties. It has been used successfully for bladder health maintenance, male health maintenance, hormonal imbalances, and urinary system health. Certain species have been identified as particularly beneficial in inhibiting the enzyme 5alpha-reductase [Lesuisse, 1996] and serving as an anti-inflammatory inhibitor [Juan et al 1988].
In 2003, The Journal of Pharmacy and Pharmacology published results of a epilobium-relevant study led by Annabella Vitalone, MD, a medical advisor for Phytoceutical, Inc. The study specifically addresses the use of epilobium in treating benign prostatic hyperplasia (BPH). A noncancerous enlargement of the prostate gland, BPH is generally considered to be a normal part of the male aging process with cell proliferation traced to age-related changes in hormone balance and cell-growth factors.
The present invention includes the selection of a particular species of Epilobium, and the production of an efficacious Epilobium extract. The method of extraction utilized in the present invention includes the selection and separation of parts of Epilobium Parviflorum plant to be used, excluding the use of solid stems and roots.
Once selected, the plant parts are combined with a solvent and water for the extraction process. In one embodiment of the present invention, the Epilobium plant parts are combined at room temperature, such as between 71 to 81 degrees (F.) or 20 to 25 degrees (C.), with 196 proof Sugar Cane Alcohol (without denaturalization process), stirred, and allowed to rest, such as for 72 hours. Next, an additional amount of Sugar Cane Alcohol and water is added, stirred, and allowed to rest, such as for 24 hours. Next, water is added, stirred, and allowed to rest, such as for 48 hours; and this step may be repeated. Next, additional sugar cane alcohol is added for stabilization, and the mixture is allowed to rest, such as for 96 hours. The mixture is then filtered.
In a preferred embodiment of the method of extraction, all exposure to daylight is avoided. Once filtered, Pollen and Urtica Dioica extract are added to the final extract. Utilizing the method of the present invention, the final mixture is in the range of 37 to 38 percent alcohol.
The nature, objects, and advantages of the present invention will become more apparent to those skilled in the art after considering the following detailed description in connection with the accompanying drawings, in which like reference numerals designate like parts throughout, and wherein:
An explanation of the benefits of the use of Epilobium extracts for mammals is advantageous to the description of the present invention. The chemical composition for Epilobium is shown in
Treatment of cells with Epilobium extracts did not result in a formation of DNA fragments (evaluated by the TUNEL assay) or chromatin condensation (assessed by Hoechst staining). Flow cytometry analysis indicated that Epilobium extracts inhibit the progression of the cell cycle from the G0/G1 phase.
These results suggest that extracts of Epilobium inhibit proliferation of human PZ-HPV-7 cells in-vitro by affecting progression of the cell cycle.
This study provides some initial biological plausibility for the use of Epilobium extracts in benign prostatic hyperplasia (BPH). More specifically, use of an Epilobium extract has been shown to be: more cell-specific in its action; significantly more potent in BPH treatment than alternative herbal extracts, such as saw palmetto; and more powerful in blocking dihydrotestosterone (DHT), the common cause of hair loss.
Moreover, epilobium's ability to inhibit aromatase production yields a market potential that crosses gender lines. (Aromatase, an enzyme found in the liver, is key to converting androgens androstenedione and testosterone into the estrogens estrone and estradiol.) In addition to BPH management and hair growth, as discussed previously, aromatase inhibitors are currently prescribed/used to: treat clinical conditions linked with hormonal balance (i.e., estrogen and testosterone); increase lean muscle mass; and decrease body fat.
Given these factors, Epilobium is useful for the following: Prostate health in men, hair growth in adults, and menopausal management (hormonal balance) in women.
The physiology of Benign Prostatic Hyperplasia (BPH) is shown in
BPH rarely causes symptoms before age 40, but more than half of men in their sixties and as many as 90 percent in their seventies and eighties have some symptoms of BPH (Source: National Institutes of Health)
The precise cause of BPH—benign prostatic hyperplasia—is still being researched. It is commonly believed, however, that the levels of two hormones produced by the testes (testosterone, which is converted into dihydrotestosterone or DHT, and estradiol, or estrogen) rise as men age. This leads to growth (hyperplasia) in benign (non-cancerous) prostate cells.
As the prostate enlarges, the layer of tissue surrounding it stops it from expanding, causing the gland to press against the urethra like a clamp on a garden hose. The bladder wall becomes thicker and irritable. The bladder begins to contract even when it contains small amounts of urine, causing more frequent urination. Eventually, the bladder weakens and loses the ability to empty itself. Urine remains in the bladder. The narrowing of the urethra and partial emptying of the bladder cause many of the problems associated with BPH.
While men are affected differently, common symptoms of BPH include:
Many people feel uncomfortable talking about the prostate, since the gland plays a role in both sex and urination. Still, prostate enlargement is as common a part of aging as gray hair. As life expectancy rises, so does the occurrence of BPH. In the United States in 2000, despite the hesitancy to seek treatment, there were 4.5 million visits to a physician for treatment of BPH.
In light of the growing incidences of of BPH, and the increasing reluctance to rely solely on pharmaceutical treatment regimens, it has been clinically clear that there are significant advantages to the of Epilobium extracts into the BPH treatment regimen.
The present invention includes the treatment of BPH using an extract of Epilobium having improved effectiveness, and the method of manufacturing that extract.
In each of the extraction processes outlined below, the process begins with the selection of various parts of Epilobium Parviflorum plant to be used, such as selection of aerial parts as leaves and new stems. It is advantageous to avoid the use of solid stems and roots. In a preferred embodiment, the Epilobium plant can be crushed as much as possible to facilitate the extraction process. It is also advantageous to maintain the temperature for the extraction process at approximately room temperature, such as between 71 to 81 degrees (F.) or 20 to 25 degrees (C.).
The process of extraction of the present invention includes a combination of the use of a Sugar Cane Alcohol, such as 196 proof and without the denaturalization process, and water. This combination of alcohol and water extraction provides for a resultant extract having a more significant level of Epilobium.
The process of extraction of the present invention includes a delay, or “resting time” in or between method steps. It is to be appreciated that this delay is exemplary of one or more preferred embodiments, and longer or shorter delays are fully contemplated herein.
Referring now to
Epilobium Extract Production—Standard
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Epilobium Extract Production—20 percent Alcohol “Shortened”
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Epilobium Extract Production—30 percent Alcohol “Shortened”
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Epilobium Extract Production—40 percent Alcohol “Shortened”
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While there have been shown what are presently considered to be preferred embodiments of the present invention, it will be apparent to those skilled in the art that various changes and modifications can be made herein without departing from the scope and spirit of the invention.
This application claims the benefit of priority to co-pending U.S. Provisional Application Ser. No. 60/824,775 entitled “Process of Epilobium Species for Treatment of Hormone Balance in Warm Blooded Animals” filed Sep. 7, 2006, and co-pending U.S. Provisional Application Ser. No. 60/856,962 entitled “Process of Epilobium Species for Treatment of Hormone Balance in Warm Blooded Animals” filed Nov. 6, 2006.
Number | Date | Country | |
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60824775 | Sep 2006 | US | |
60856962 | Nov 2006 | US |