Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution...
Reexamination Certificate
2000-02-25
2001-07-24
Weber, Jon P. (Department: 1651)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
C424S729000, C424S756000
Reexamination Certificate
active
06264995
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention relates to herbal compositions. More particularly, this invention relates to an herbal composition capable of reducing inflammation in bones and joints. The present invention further relates to methods of using such herbal composition to reduce inflammation.
Arthritic disorders, including rheumatism, osteoarthritis, dysplasia, lupus, bursitis, and gout, are all characterized by inflammation and pain in bones, joints, muscles, and related connective tissues. Most of the forms are progressive. Bone and joint inflammation is a scourge of both animals and humans. Those who suffer from inflammation experience pain and discomfort and may, in advanced cases, lose the effective use of inflamed joints. Thus, the goal of therapeutic methods for treating bone or joint inflammation is the relief of pain and discomfort and the restoration of use of inflamed joints.
Certain enzymes appear to play a role in causing inflammation. One of the features of inflammation is increased oxygenation of arachidonic acid which is metabolized by two enzymic pathways—the cyclooxygenase (CO) and the 5-lipoxygenase (5-LO) pathways—leading to the production of prostaglandins and leukotrienes, respectively. Prostaglandins and leukotrienes are mediators of inflammation. Therapies designed to inhibit cydooxygenase and/or lipoxygenase activity are therefore of great interest.
There are two forms of the cyclooxygenase enzyme: cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2). The latter form, i.e., COX-2, appears to play a key role in inflammatory processes. Recent scientific studies suggest that inhibiting the COX-2 enzyme may be an effective wayto reduce inflammation without the side effects associated with irreversible COX-1 inhibition. In addition, recent scientific studies also suggest that COX-2 inhibition may serve an important function in promoting normal cell growth in the colon, pancreas, breast tissue and other organ systems.
Drugs are being developed which are intended to selectively inhibit COX-2 with minimal effect on COX-1. However, despite the emphasis on COX-2 inhibition, these drugs appear to have serious side effects, e.g., a breakdown in digestive protective mucus and prevention of normal healing processes. For example, non-steroidal anti-inflammatory drugs (NSAIDS) can have a variety of toxic side effects such as, e.g., gastric erosion and adverse effects on kidneys and liver, and may inadequately regulate the cellular immune functions and secretions of various cytokines.
Natural ingredients, e.g., herbs, have also been used to treat bone and joint inflammation, especially in eastern countries, and, increasingly, in western countries. Compositions composed of natural ingredients and said to be useful in reducing inflammation are disclosed, e.g., in U.S. Pat. Nos. 5,494,668, 5,683,698, 5,916,565, 5,888,514, 5,908,628; 5,788,971; 5,854,291; and 5,910,307.
U.S. Pat. No. 5,494,668 (Patwardhan) discloses a method of treating degenerative musculoskeletal diseases such as rheumatoid arthritis and osteoarthritis in an animal, typically a human, involving administering to the animal, typically enterally, in a convenient dosage form, a therapeutically effective amount of the beneficiated extracts of the plants Ashwagandha, Sallai Guggul, Turmeric, and Ginger, in a predetermined proportion relative to each other with or without other biologically active inorganic ingredients.
U.S. Pat. No. 5,683,698 (Chavali et al.) discloses an herbal formulation and its use for reducing/alleviating symptoms associated with rheumatoid arthritis, osteoarthritis, and reactive arthritis and for reducing the production of pro-inflammatory cytokines. The formulation contains an herbal extract from the roots, rhizomes and/or vegetation of six herbal plant varieties, specifically, the species of Alpinia, Smilax, Tinospora, Tribulus, Withania, and Zingiber. The patent further discloses foods, beverages and medicaments in the form of capsules, tablets, liquids, and the like, containing the herbal formulation.
U.S. Pat. No. 5,916,565 (Rose et al.) discloses an orally administered composition for prophylaxis and therapy of joint and connective tissue disorders in vertebrates, wherein the composition contains metabolic precursors, herbal phytochemicals, and palatability agents. Suitable herbal phytochemicals are said to include cayenne, ginger, turmeric, yucca, Devil's claw, nettle leaf, Black Cohosh, alfalfa and celery seeds.
U.S. Pat. No. 5,888,514 (Weisman) discloses a composition for treating bone or joint inflammation in mammals, wherein the composition contains a systemically absorbable cartilage and an amninosaccharide and may optionally contain, among other ingredients, one or more extracts of an herb of the genus Withenia, of the bark of an herb of the genus Salix, or of a root of an herb of the genus Panax.
U.S. Pat. No. 5,908,628 (Hou) discloses compositions for treating osteoarthritis and rheumatoid arthritis, containing talc, silkworm excrement, and ingredients of plants of species of the genera Stephania, Coix, Pinellia, Prunus, Phellodendron, Sophora, Tetrapanax, Stemona, Glycyrrhiza, Tripterygium, Forsythia, and Siegesbeckia.
U.S. Pat. No. 5,788,971 (Togasaki) discloses an active oxygen free radical scavenging agent composed of green tea leaf extract containing epigallo catechin gallate and sunflower seed extract containing chlorogenic acid.
U.S. Pat. No. 5,854,291 (Laughlin, et al.) discloses a topically-applied pain reliever composition for treating such discomforts as arthritis pain, composed of capsaicin and, optionally, a plant extract selected from the group consisting of nettle extract, yarrow extract, coltsfoot extract, birch extract, rosemary extract, horsetail extract, ginger extract, chamomile extract, comfrey extract, lavender extract, and bergamot extract.
U.S. Pat. No. 5,910,307 (Kwak, et al.) discloses a combined medicinal plant composition for alleviating acute/chronic inflammation, composed of
Clematis Radix
, Trichosanthes root, and
Prunella Herba
(which contains oleanolic acid ursolic acid) in a certain ratio. The composition is also useful for inhibiting platelet/whole blood aggregation and inflammation-inducing enzymes (5-lipoxgenase, cylooxygenase-1 and cylooxygenase-2) and for scavenging toxic active oxygen species.
According to various studies,
ocimum sanctum
(holy basil) possesses significat anti-inflammatory properties and is capable of blocking both the cyclooxygenase and lipoxygenase pathways of arachidonate metablism. See e.g.,
J. Ethnopharmacol
. April 1999; 65(1);13-9
, Evaluation of the Gastric Antiulcer Activity of Fixed Oil of Ocimun Sanctum
(
Holy Basil
), Singh, S. Majundar DK College of Pharmacy, University of Delhi, India;
Indian J. Exp. Biol
. October 1998; 36(10): 1028-31,
Comparative Evaluation of Antiinflammatory Potential of Fixed Oil of Different Species of Ocimun and Its Possible Mechanism of Action
, Singh S. College of Pharmacy (University of Delhi), Pushp Vihar, India;
J. Ethnopharmacol
. October 1996; 54(1):19-26, and
Evaluation of Anti
-
Inflammatory Potential of Fixed Oil of Ocimum Santum
(
Holy Basil
)
and Its Possible Mechanism of Action
, Singh, S., Majunbar D K, Rehan H M College of Pharmacy (University of Delhi), New Delhi, India. The marker constituents of
ocimum sanctum
, i.e., ursolic acid and oleanolic acid (less active) have been found to a significant COX-2 inhibitory effect. See, for example,
Indian J. Exp. Biol
. April 1997, 35(4):380-3
, Evaluation of Antiinflammatory Activity of Fatty Acids of Ocinum Sanctum Fixed Oil
, Singh S., Majumdar DK College of Pharmacy (University of Delhi) Pushp Vihar, New Delhi, India; and
FEBS Lett
. Mar. 16, 1992; 299(3):213-7
, Characterization of Uroslic Acid as a Lipoxygenase and Cyclooxygenase Inhibitor Using Macrophages, Platelets and Differentiated HL
60
Leukemic Cells
, Najid A., Simon A., Cook J., Chable-Rabinovitch H., Delage C., Chulia A J, Rigaud M.
CJF INSERM
88-03, Faculte de Medecine, Universite de Limoges, France;
J. Nat. Prod
. Octobe
Newmark Thomas
Schulick Paul
Patten Patrice A.
Patton & Boggs LLP
Weber Jon P.
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