Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution...
Reexamination Certificate
2000-06-21
2002-07-09
Tate, Christopher R. (Department: 1651)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
C424S405000
Reexamination Certificate
active
06416792
ABSTRACT:
FIELD OF THE INVENTION
The present invention is directed to compositions and methods that are useful in alleviating the symptoms associated with mycoplasma infection. The compositions and methods involve the use of a combination of any herb in the genus Symphytum together with any herb in the genus Equisetum. In preferred embodiments, compositions and methods utilize
Symphytum officinale
(comfrey) and
Equisetum hyemale
(horsetail).
BACKGROUND OF THE INVENTION
There are a variety of newly characterized diseases that have been associated with infection by polymorphic mycoplasmas which may have a crystalline form, particularly
Mycoplasma fermentans
. Clear links have been established for AIDS and chronic fatigue syndrome (Lo, et al., Clin. Inf. Dis. 3:S259-263 (1993); Lo, et al., Am. J. Trop. Hyg. 41:364-376 (1989)). Other diseases that have been associated with such infections include human bovine spongiform encephalopathy (Rhodes,
Deadly Feasts
, Simon & Schuster, N.Y., N.Y., p. 197 (1997)) and Gulf War syndrome (Nicholson, et al.,
Chronic Fatigue Illnesses
and
Operation Desert Storm
, Institute for Molecular Medicine, Irvine, Calif.). Among the many symptoms associated with these diseases are memory loss, dementia, neuropathy, paralysis, loss of motor control and wasting. The mycoplasma infections undoubtedly contribute to these symptoms in at least some patients, and the development of new therapeutic agents for treating such infections is therefore of clear value.
SUMMARY OF THE INVENTION
In its first aspect, the present invention is directed to an herbal mixture that can be used in the preparation of a therapeutic composition for the treatment of subjects suffering from symptoms associated with mycoplasma infection, particularly when such infection occurs in a patient with AIDS, chronic fatigue syndrome, human bovine spongiform encephalopathy, or Gulf War syndrome. The mixture consists essentially of any herb of the genus Symphytum together with any herb of the genus Equisetum. Preferably, the mixture contains
Symphytum officinale
and
Equisetum hyemale
. The herbs used in mixtures may be in any form, but the cut form of the Symphytum herb and the powdered form of the Equisetum herb are generally preferred. Typically, the Symphytum herb should be present at a ratio of about 4.7 parts by weight for each part by weight of Equisetum herb. If desired, an antibiotic may also be added to mixtures.
The mixtures discussed above can be used in a method for preparing a therapeutic composition for administration to a human subject suffering from one or more of the symptoms associated with mycoplasma infection. An aqueous suspension is formed by adding water to the mixture, the suspension is incubated, and undissolved material is then removed to form the final composition. Any herb of the genus Symphylum and any herb of the genus Equisetum may be used in the method but the preferred herbs are
Symphytum officinale
and
Equisetum hyemale
. The Symphytum herb should generally be present at about 4.7 parts by weight for each part by weight of the Equisetum herb. A single unit dose may be obtained by extracting approximately 1.56 g of the herb from the genus Symphytum (e.g.,
Symphytum officinale
) and about 0.33 g of the herb from the genus Equisetum (e.g.,
Equisetum hyemale
) with 4 to 6 ounces of water at a temperature near its boiling point (e.g., at a temperature of greater than 70 degrees centigrade) for a period of about 10 to 15 minutes. Larger preparations may be prepared as long as the ratio of the various components are kept the same, e.g., there should be about 4 to 6 ounces of water for each 1.5 g of dry Symphytum herb in the mixture. After incubation, any method can be used for clearing preparations of undissolved material but simple filtration will usually be the most convenient. If desired, an antibiotic may be included in the dry mixture of herbs extracted with water or, alternatively, an antibiotic may be added after extraction and filtration.
In addition to being directed to a method for preparing a therapeutic composition, the present invention is also directed to the composition itself and to the use of the composition in treating a human subject for one or more symptoms associated with mycoplasma infection. Typically, subjects will be selected who have AIDS, chronic fatigue syndrome, Gulf War syndrome, or human bovine spongiform encephalopathy and who are also suspected of being infected with mycoplasma. The therapeutic composition should be administered orally in an amount and for a duration sufficient to reduce or eliminate one or more of the subject's symptoms. Preferably, this treatment will also be accompanied by the administration of one or more antibiotics. The mycoplasma symptoms treatable with the composition include enlarged lymph nodes, recurrent headaches, chronic fatigue, persistent weight loss, musculoskeletal pain, recurrent fever, pharyngitis, depression, blurred vision, dizziness, loss of memory and inability to concentrate. Typically, effective treatment will require that the subject take a daily regimen of four to five unit doses of the therapeutic composition for a period of weeks to months and, in some cases, effective therapy may require continued administration for years. The ingestion of the composition for a prolonged period of time will sometimes cause dernatitis. This may be alleviated or avoided by subjects taking dietary supplements of lecithin and maintaining a high daily intake of water.
DETAILED DESCRIPTION OF THE INVENTION
Plants and herbs have long been recognized for their therapeutic properties. Many are known to contain compounds with potent pharmacological actions and medicines have often been developed using plants or herbs as starting material. In the case of the present invention, herbs of the genus Symphytum (e.g.,
Symphytum officinale
or
Symphytum uplandicum
) are known to contain allantoin, alkaloids and lithospermic acid. Herbs of the genus Equisetum, (e.g.,
Equisetum hyemale
) are known to contain silica. It has been found that a mixture of these herbs may be extracted with water and the extract used to help alleviate certain of the symptoms associated with mycoplasma infection, particularly when the extract is used in conjunction with an antibiotic.
A single unit dose of the composition may be made by combining about 1.56 g of Symphytum herb, preferably in its cut form, with approximately 0.33 g of Equisetum herb, preferably in its powdered form. The dry herbs are placed in an appropriate container and water, heated to a temperature near its boiling point (e.g., to a temperature of greater than 70 degrees centigrade), is then added to a final volume of about 240 ml. The resulting suspension should be covered and incubated for a period of between 10 and 15 minutes. At the end of the incubation, the undissolved herbal material may be removed by straining and the recovered fluid can then be taken orally by patients. This therapeutic composition may be prepared immediately before administration, or, alternatively, one or more preparations may be stored either frozen or lyophilized until use.
One particularly desirable means for preparing the present therapeutic composition is to store premeasured unit dose amounts of dry herbs in porous disposable containers similar to those presently used in teas. Alternatively, dried extract can be incorporated into traditional oral dosage forms such as tablets or capsules. Typically, these would also contain one or more pharmaceutically acceptable excipients.
Patients suffering from symptoms associated with mycoplasma infection should take between four and five unit doses of the composition described above, roughly 960 to 1200 ml, daily. Preferably, this dosage should be spread out relatively evenly throughout the day. Individuals taking other medications may find it desirable to begin with a lower dosage and gradually increase the amount taken over a period of time. This should minimize the chance of their experiencing any severe side effects due to interaction betw
Ingram Teresa J.
Tate Christopher R.
Vinson & Elkins L.L.P.
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