Herbal compositions and their use as anti-inflammatory...

Details Herbal compositions and their use as anti-inflammatory... Herbal compositions and their use as anti-inflammatory...

1999-07-01

2001-08-14

Prats, Francisco (Department: 1651)

Drug, bio-affecting and body treating compositions

Plant material or plant extract of undetermined constitution...

C424S733000, C424S756000, C424S764000

Reexamination Certificate

active

06274176

ABSTRACT:

FIELD OF THE INVENTION
The present invention is directed to an edible composition for use as an anti-inflammatory agent for alleviation of arthritis and gout in mammals. The composition comprises a synergistic mixture of at least three herbs selected from a group of ten herbs identified below.
BACKGROUND OF THE INVENTION
The prior art is replete with references to herbal medicines for treatment of a variety of ailments in mammals. Typically, such herbal medicines are obtained as the active compound(s) by extraction from plant tissues. Although the use of various herbs have been described in related areas, the synergistic combination of the herbs in the edible composition of the invention has never previously been described.
Japanese Patent Publication No. 4,005,237 discloses a combination of
Cinnamomum sieboldii
and
Allium sativum
for superoxide scavenging in the treatment of inflammatory disorders. German patent Publication No. 3,724,341 discloses a combination of
Cinnamomum zeylanicum, Pumica granitum
cortex,
Cardamon zingiberaceie
fruit and
Piper longum
fruit.
U.S. Pat. No. 5,494,668 is directed to a method of treating degenerative musculoskeletal diseases such as rheumatoid arthritis and osteoarthritis in an animal, typically a human, by enteric administration of a therapeutically effective amount of the beneficiated extracts of the plants
Withania somnifera, Boswellia serrata, Curcuma longa
and
Zingiber officinale
in a predetermined proportion to each other.
U.S. Pat. No. 5,120,538 is directed to a method of treating inflammation in a patient by administration of an effective dose of a pharmaceutical composition comprising essential oils extracted from tissues of
Curcuma domestica,
or
Curcuma xanthorrhiza
or both oils and curcuminoid substantially free of bis-desmethoxycurcumin.
U.S. Pat. No. 5,707,631 is directed to a therapeutic herbal composition including
Trigonella foenum-graecum
seed,
Syzygium aromaticum
fruit,
Allilum sativum
bulb,
Cinnamomum zeylanicum
bark,
Saussurea costus
root and
Euphorbia lathyris
bud together with sodium chloride (preferably sea salt).
Arthritis is a chronic syndrome characterized by inflammation of the peripheral joints, while gout manifests itself as an inflammation of the lower leg. For the sake of brevity, whenever reference hereinbelow is made to arthritis, it should be understood as encompassing gout, since the principal difference between arthritis and gout is the location of the inflamed joints. There is a wide spectrum of disease severity but many patients run a course of intermittent relapses and remissions with an overall pattern of slowly progressive joint destruction and deformity. Persistent inflammation produces symptoms and damages tissue causing loss of cartilage, erosion of bone matter and subluxation of the joint. This results in a high degree of morbidity resulting in disturbed daily life of the patient. Diagnosis of arthritis is typically carried out by determination of rheumatoid factor in the blood and radiological changes in the peripheral joints.
Present treatment of arthritis includes first line drugs for control of pain and inflammation classified as non-steroidal anti-inflammatory drugs (NSAIDs), e.g., aspirin, ibuprofen, naproxen, methotrexate, etc. Secondary treatments include corticosteroids, slow acting antirheumatic drugs (SAARDs) or disease modifying drugs (DMs), e.g., penicillinamine, cyclophosphamide, gold salts, azothipprine, levamisole, etc.
All of the foregoing drugs have a variety of toxic side effects and most of them are cytotoxic. These drugs have limited advantages and their effects are mainly of short term duration. The side effects they produce, e.g., gastric erosion, and adverse effects on the kidneys and liver, dictate against their use over extended periods of time. Further the drugs used at present are costly and have low benefit-risk ratios. There still remains a need for alternative therapies for the management of arthritis which are moderate in cost, safe, efficacious and which eliminate the need for traditional drugs and their associated side effects, particularly over prolonged daily use.
SUMMARY OF THE INVENTION
This invention describes an edible composition for use as an anti-inflammatory agent for alleviation of arthritis and gout in mammals. Since the composition comprises a mixture of herbs as described below, the composition meets all of the criteria set forth above, i.e., it is relatively inexpensive, produces no adverse side effects, may be taken in multiple daily doses over prolonged periods of time and it results in the alleviation of arthritis (and gout) in the patient within a few weeks after commencement of ingestion of the composition.
DETAILS OF THE INVENTION
The edible composition of the invention comprises a mixture of at least three herbs selected from the group consisting of the following ten herbs:
TABLE
Stream
200
220
217
213
Composition, Mol %
H2
42.50
47.48
0.00
0.00
CO
47.80
50.69
23.18
23.18
CH4
9.40
1.50
76.77
76.77
N2
0.30
0.33
0.05
0.05
Total:
100.00
100.00
100.00
100.00
Flow, lb. mol/hr.
1000.0
894.9
105.1
457.0
Temp. ° F.
104
84
104
84
Pressure, psig
363
350
140
5.0
Preferably, the mixture contains at least seven of the above-listed ten herbs. More preferably, the mixture will contain at least the following three herbs:
Tanacetum parthenium, Zingibar officinale
and
Curcuma longa.
The ratio of the herbs in the edible composition is not critical, e.g. each herb may be present in amounts as low as 10 wt. %, based on the weight of the composition, with the balance being the other herbs. However, as a matter of convenience, it is preferable that the composition contain approximately equal amounts of each herb.
Preferably, the compositions contain no fillers or enhancing agents, since such materials are unnecessary and merely serve to dilute the effective concentration of the herbs and to decrease the absorption rate into the blood-stream after ingestion.
The individual herbs, obtained from the preferable sources indicated above, may be used in the form of extracts using aqueous and non-aqueous solvents (e.g. ethanol, isopropanol, acetone, etc., which are evaporated off prior to use). Preferably, the herbs are milled and mixed as fine, dry powders. The dry powder mix may then be further processed into the form of compressed tablets, caplets or lozenges or processed into pouches (i.e. “tea” bags) from which water infusions are ingested.
The preferable method of processing the compositions of the invention for ingestion is to package the powdered herbal mixture into gelatin capsules (preferably hard gelatin) of a size preferably of the order of zero or double zero. Such capsules would then contain about 300-600 mg of the powdered herbal mixture per capsule. It has been found that hard gelatin capsules represent the most efficient, economical form of packaging of the edible composition for ingestion.
The dosage of the herbal compositions of the invention to be ingested will vary, depending on factors such as severity of the arthritis, age, physical condition and body weight of the patient, diet, etc. As a general guide, it is expected that patients with a body weight in the range of 60-90 kg would ingest about 1,000-5,000 mg/day of the herbal compositions (corresponding to 2-12 zero or double zero size hard gelatin capsules per day). Typically, a human patient would ingest about 40 mg of the composition per kg of body weight. It is to be understood that these dosage levels are only general guides and the proper dosage level for individual patients may vary considerably depending on the factors indicated above. However, one benefit of the edible compositions of the present invention is that the dosage is not “critical” as is the case with administration of synthetic pharmaceutical medications such as those mentioned above. Since the edible compositions of the present invention are holistic in nature and represent dietary supplements in their own right, “overdosing” is not a problem. The individual patient with a particular body weigh

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