Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector – Conjugate or complex
Reexamination Certificate
1998-01-05
2001-03-06
Lankford, Jr., Leon B. (Department: 1651)
Drug, bio-affecting and body treating compositions
Antigen, epitope, or other immunospecific immunoeffector
Conjugate or complex
C424S404000, C424S405000, C424S435000, C424S539000
Reexamination Certificate
active
06197305
ABSTRACT:
FIELD AND BACKGROUND OF THE INVENTION
The present invention relates to a combination of an herbal extract and an essential oil which shows unexpected prolonged anti-fungal activity and, more particularly, to such a combination which can exert anti-fungal activity on mucosal membranes or skin as a topical application, or within the gastrointestinal tract.
Recently, interest has been displayed in the medicinal properties of herbal preparations. Herbal preparations are considered “more natural” and are therefore viewed as less toxic by the consumer. These preparations are being sold for a number of medical indications.
For example, a combination of Echinacea (
Echinaceae angustifoliae radix
) and Plantago (
Plantago major
) is available from Dolisos Laboratoires, Israel, as “Plantspray”. Plantspray is intended as a composition for oral hygiene. According to the product literature, Plantspray has anti-bacterial activity in the oral cavity and can therefore promote the general health of oral tissues, as well as cosmetic concerns such as malodorous breath. Another herbal combination, Echinacea and Propolis, is also available from Dolisos Laboratoires as “Echinacea Propolis Tabs”. Propolis wax is the resinous substance found in beehives. The Echinacea and Propolis wax combination is also intended for oral hygiene.
However, although combinations of herbal extracts have enjoyed commercial success, relatively few of these combinations have demonstrated proven anti-fungal activity. Furthermore, these combinations have not displayed both prolonged anti-fungal and anti-bacterial activity. The ability to inhibit both fungal and bacterial activity is important for the control of commonly occurring multiple and mixed infections. Finally, currently available herbal preparations also lack significant anti-inflammatory activity. However, inflammation is frequently the cause of extensive discomfort in patients with either fungal or mixed fungal and bacterial infections. Thus, currently available herbal preparations lack the ability to control or alleviate both the microbial causes, as well as the symptoms, of single or mixed infections.
Fungal infections are very common in all populations of both humans and lower animals such as livestock and pets. Indeed, the natural flora in all animals includes many fungi. Fungi grow well in a neutral to slightly alkaline, humid environment. For example, many fungal disorders are associated with an increase of the normal human skin pH from about 5.5 to a higher, more alkaline value. Similarly, many mucosal membranes such as the vagina have a slightly acidic environment when healthy, which tends to become basic when infected with fungi. Thus, normally fungal populations do not grow in an uncontrolled manner because of natural checks on their growth, such as acidity of the environment.
Such fungi are only problematic when they grow in an uncontrolled manner, causing various diseases as well as extreme discomfort for the human or lower animal infected. Unfortunately, uncontrolled fungal growth often occurs for the reasons described above, making topical anti-fungal preparations the largest segment of the market for topical external products.
Once fungal populations have become uncontrolled, the resultant infection is difficult to treat successfully. Such infections are recurrent and require a prolonged treatment regimen. Furthermore, currently available anti-fungal medications do not show prolonged activity against fungal infections, which is another drawback.
There is thus a widely recognized need for, and it would be highly advantageous to have, a herbal preparation with proven prolonged anti-fungal activity, particularly for topical skin, mucosal, oral and vaginal hygiene, and with the concomitant ability to inhibit bacterial growth and relieve inflammation, which are frequently apparent in mixed and multiple microbial infections.
SUMMARY OF THE INVENTION
It is one object of the present invention to provide specific compositions with at least one essential oil with at least one herbal extract with strong anti-fungal activity. It is a further object of the present invention to provide compositions which have highly prolonged anti-fungal activity. It is yet a further object of the present invention to provide compositions which also have good anti-bacterial activity.
Unexpectedly, it has been found that specific combinations of essential oils with an herbal extract provide strong anti-fungal activity. Also unexpectedly, it has been found that the activity is highly prolonged, particularly when compared to popular or leading commercially available anti-fungal preparations. Furthermore, these compositions also have good anti-bacterial activity, thereby providing balanced total therapy against microbial infections. The prior art neither taught nor suggested that such compositions would display such strong, prolonged anti-fungal activity, nor was it taught or suggested that such compositions would additionally display strong anti-bacterial activity.
According to the present invention, there is provided an anti-fungal composition, comprising a herbal extract and an essential oil in a ratio. Preferably, the herbal extract is a tincture. More preferably, a suitable pharmaceutical carrier is included.
Preferably, the essential oil is selected from the group consisting of cinnamon oil, cajeput oil, citronella oil, eucalyptus oil, fennel oil, geranium oil, girofle oil, lavender oil, lemon oil, spearmint oil, myrte oil, origano oil, pine oil, rosemary oil, sarriette oil, thyme oil, and tea-tree oil. More preferably, the essential oil is selected from the group consisting of tea-tree oil, thyme oil and lavander oil. Even more preferably, the essential oil is present in a concentration of from about 0.1 to about 5 percent weight per weight. Most preferably, the essential oil is present at a concentration of from about 0.2 to about 2.0 percent weight per weight.
Preferably, the herbal extract includes a material selected from the group consisting of Plantago, Hypericum, Echinacea, Baptisia, Calendula, Myrrah, Phytolacca, Salvia, Catechu black, Coneflower, Krameria, Tsuga, Rosmarinus, Styrax, Crataegus, Glycerrhiza, Angelica, Krameria, Matricaria, Mallow, Propolis and Sage. More preferably, the herbal extract includes a mixture of Calendula, poke root, Echinacea and Propolis. Most preferably, the herbal extract is present in a concentration in a range of from about 1 to about 10 percent weight per weight.
According to a preferred embodiment of the present invention, the herbal extract includes a mixture of Phytolacca extract, Coneflower extract, Symphytum extract, Canendula extract, Hamamelis extract and Propolis extract, and the essential oil includes a mixture of Thyme oil and Lavender oil. Preferably, the Phytolacca extract, the Coneflower extract, the Symphytum extract, the Calendula extract, and the Hamamelis extract are each present in an amount in a range of from about 1 percent to about 10 percent weight per weight, the Propolis extract is present in an amount in a range of from about 0.1 percent to about 5 percent weight per weight, and the Thyme oil and the Lavander oil are each present in an amount in a range of from about 0.2 percent to about 2.0 percent weight per weight.
According to another embodiment of the present invention, there is provided a method of treating a subject with a fungal infection, comprising the step of administering an anti-fungal composition to the subject, the composition including a herbal extract and an essential oil in an appropriate ratio. Preferably, the fungal infection is present in a tissue selected from the group consisting of gastrointestinal tract, mucosal tissues and skin. More preferably, the mucosal tissue is selected from the group consisting of oral cavity and vagina.
According to yet another embodiment of the present invention, there is provided a mouthwash for treating a fungal infection, including: (a) a herbal extract and an essential oil in an appropriate ratio; and (b) a pharmaceutical carrier.
According to still anot
Forman Yochanan
Friedman Doron
Friedman Michael
Levin Orna
Farmo-Nat Ltd.
Friedman Mark M.
Lankford , Jr. Leon B.
Tate Christopher K.
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