Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution...
Reexamination Certificate
2000-09-11
2001-07-03
Prats, Francisco (Department: 1651)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
C514S828000, C514S858000, C424S547000
Reexamination Certificate
active
06254897
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to a novel herbal composition having antimycotic activity effective against tinea infections comprising plant substances as main ingredients, a method of manufacture and method of treating a patient having a tinea infection. More particularly, the present invention relates to an antimycotic composition effective against tinea infections utilizing natural substances obtained from a combination of
Angelicae Pubescentis Radix, Notopterygium Radix
and
Haliotis Diversicolor Reeve
, and in some embodiments further comprising
Pheretima Aspergillum
(Perrier).
The body normally serves as host for a variety of bacteria and fungi. Most of the time, the balance between the body as host and the microorganisms is maintained. Sometimes, however, conditions exist that permit the microorganisms to tip that balance, causing an infection.
Certain fungal infections of the skin known as tinea infections are caused by dermatophytes, which are members of the Trichophyton, Microsporum and Epidermophyton species. These mold-like fungi thrive in warm, moist areas, thriving on the dead tissues of hair, nails, and outer skin layers. Tinea infections include tinea pedis, known as athlete's foot; tinea corporis, known as ringworm; tinea capitis which is a fungal infection of the scalp that can cause hair loss; tinea cruris known as jock itch or tinea of the groin; tinea unguum which is tinea of the nails; and tinea versicolor, a superficial fungal infection that produces brown, tan, or white spots on the trunk of the body. Tinea infections are contagious and can be passed through direct contact or by contact with clothing, from shower and pool surfaces, and even from pets.
Athlete's foot or tinea pedis is by far the most common form, with more than
900
million people in the world suffering from the disease. It presents with redness, itching, burning, cracking, scaling, swelling and occassionally bleeding. The nails may show thickening, pitting and subungal debris. Local antifungals include imidazoles, such as miconazole nitrate and clotrimazole, tolnaftate, and terbinafine hydrochloride. As the common fungicidal and fungistatic chemical treatments frequently fail to contact the fungi in the horny layers of the skin, athlete's foot seldom clears with local antifungal therapy and systemic antifungals, including terbinafine hydrochloride taken in tablet form, may be required to be taken for considerable lengths of time, potentially for months. Common treatments for athlete's foot using local antifungals require treatment two or three times a day for at least 10 to 14 days, and for some medications, for up to four weeks. It is common treatment to apply the topical antifungal for two weeks after the skin is healed, to eradicate all remaining fungal spores.
Reoccurrences of the infection are frequent, however. For some patients, such as those also afflicted with diabetes or circulatory problems, tinea infections and their treatment can be quite serious. Ringworm presents with lesions that are characterized by central clearing and fine peripheral scales. The lesions may be itchy. There may be deep inflammatory nodules. Systemic therapy is required in severe cases with widespread lesions. Systemic therapy almost always includes griseofulvin. Nausea and gastrointestinal disturbances are common side effects of the drug, but long term use may lead to hepatic or bone marrow failure.
Methods for reducing toxicity of treatments include use of herbal formulations rather than purified pharmaceuticals. Herbs have long been known and used throughout the world for treatment of many conditions, including skin conditions, and there is at least some evidence that herbal remedies may tend to have less deleterious side effects than corresponding pharmaceuticals.
Increasingly, herbal remedies are sought due to concerns caused by antibiotic-resistant and other drug-resistant infectious agents. Even with herbal treatments, however, numerous difficulties are encountered in the treatment of medical conditions. A single herb may contain numerous active, and sometimes conflicting, components. The common herb, rhubarb, for example, may be used in small doses for treating constipation due to its tannic acid component, but is a potent laxative in larger doses because of other components. Other herbs, however, such as black walnut extract which is used to treat athlete's foot, related fungal infections and cancers, as well as to lower blood pressure and cholesterol, can be toxic if taken inappropriately. Additional potential difficulties arise from plant-to-plant variation in the concentration and efficacy of active components. Such difficulties are considerably exacerbated with respect to herbal compositions. In addition to those difficulties mentioned in connection with single herbs, combinations raise the possibility of synergistic effects among components in the various herbs, and increase the difficulties associated with anticipating and analyzing side effects.
Many herbs are reported to have substantial effects on skin ailments. Herbs within this group include, for example
Angelicae Pubescentis Radix
for treatment of psoriasis. Herbs traditionally known or used for treating athlete's foot specifically, include tea tree, garlic, goldenseal and various parts of the black walnut tree, which is known to be toxic when taken inappropriately. Combinations of herbs are also known to have substantial effects on skin ailments. For example, one herbal treatment for tinea infections uses herbal extracts from Aloe vera, Chicory root, Catnip, St. John's wort, vitamins A and E, in a cream base. This treatment is recommended for application 3 to 4 times daily for 2 to 3 days after all lesions are healed and completely gone.
While many effects of individual herbs are known, it is often unclear in the art which herbs to combine, and in which percentages, to achieve improved results.
REFERENCES:
patent: 1214261 (1999-04-01), None
Prats Francisco
Srivastava Kailash C.
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