| United States Patent Application |
20040091556
|
| Kind Code
|
A1
|
|
Tigunait, Rajmani
; et al.
|
May 13, 2004
|
Nasal irrigation solutions and methods of using same
Abstract
A nasal irrigation solution comprising is disclosed comprising water and
hydrastine extracted from one or more plants. Another solution comprises
water and berberine extracted from one or more plants. These solutions
are provided from an extract of goldenseal plant. Solutions are also
disclosed having canadine, canadaline, and hydrastidine, all extracted
from the goldenseal plant. More general solutions are disclosed including
alkaloids extracted from one or more plants. The alkaloids are selected
from one or more of the group consisting of: berberine, oxyberberine,
berbamine, palmatine, magnoflorine, phellodendrine, jateorrhizine,
candicine, menisperine, coptisine, worenine, columbamine, epiberberine,
hydrastine, canadine, canadaline, hydrastidine, oxycyanthine,
berberrubine, and isotetrandine. Alkaloids are provided from plant from
the group consisting of: Oregon grape root, yellow root, phellodendron
bark, coptis rhizome, barberry root, and Indian barberry root bark. Other
constituents may include extract of grapefruit seed, vegetable glycerine,
salt, and water soluble zinc. A method for using these solutions is
disclosed which includes flowing the solution through desired portions of
nasal cavities.
| Inventors: |
Tigunait, Rajmani; (Honesdale, PA)
; Miles, James L.; (Honesdale, PA)
|
| Correspondence Name and Address:
|
Michael D. Lake
WALLENSTEIN & WAGNER, LTD.
311 South Wacker Drive - 5300
Chicago
IL
60606
US
|
| Serial No.:
|
630166 |
| Series Code:
|
10
|
| Filed:
|
July 30, 2003 |
| U.S. Current Class: |
424/725; 128/898 |
| U.S. Class at Publication: |
424/725; 128/898 |
| Intern'l Class: |
A01N 065/00 |
Claims
We claim:
1. A nasal irrigation solution comprising: water; and, alkaloids extracted
from one or more plants.
2. The nasal irrigation solution of claim 2 wherein the alkaloids are
selected from one or more of the group consisting of: berberine,
oxyberberine, berbamine, palmatine, magnoflorine, phellodendrine,
jateorrhizine, candicine, menisperine, coptisine, worenine, columbamine,
epiberberine, hydrastine, canadine, canadaline, hydrastidine,
oxycyanthine, berberrubine, and isotetrandine.
3. The solution of claim 2 wherein at least hydrastine is extracted from a
Goldenseal plant.
4. The solution of claim 1 wherein the extract including canadine,
canadaline, and hydrastidine, all extracted from the goldenseal plant.
5. The nasal irrigation solution of claim 1 wherein the one or more plants
are selected from the group consisting of: Oregon grape root, yellow
root, phellodendron bark, coptis rhizome, barberry root, and Indian
barberry root bark.
6. The nasal irrigation solution of claim 2 wherein the one or more plants
are selected from the group consisting of: Oregon grape root, yellow
root, phellodendron bark, coptis rhizome, barberry root, and Indian
barberry root bark.
7. The nasal irrigation solution of claim 1 further comprising an extract
of grapefruit seed.
8. The nasal irrigation solution of claim 2 further comprising an extract
of grapefruit seed.
9. The nasal irrigation solution of claim 6 further comprising an extract
of grapefruit seed.
10. The nasal irrigation solution of claim 1 further comprising vegetable
glycerine.
11. The nasal irrigation solution of claim 2 further comprising vegetable
glycerine.
12. The nasal irrigation solution of claim 6 further comprising vegetable
glycerine.
13. The nasal irrigation solution of claim 9 further comprising vegetable
glycerine.
14. The nasal irrigation solution of claim 1 further comprising salt.
15. The nasal irrigation solution of claim 2 further comprising salt.
16. The nasal irrigation solution of claim 6 further comprising salt.
17. The nasal irrigation solution of claim 14 further comprising salt.
18. The nasal irrigation solution of claim 1 further comprising water
soluble zinc preferably zinc acetate dihydrate.
19. The nasal irrigation solution of claim 2 further comprising water
soluble zinc preferably zinc acetate dihydrate.
20. The nasal irrigation solution of claim 6 further comprising water
soluble zinc preferably zinc acetate dihydrate.
21. The nasal irrigation solution of claim 17 further comprising water
soluble zinc preferably zinc acetate dihydrate.
22. The nasal irrigation solution of claim 19 wherein the zinc acetate is
in the range of about 2 to about 12 mg/ml.
23. The solution of claim 5 wherein the concentrations are: about 0.0001
to about 0.002 ml/ml for grapefruit seed extract; about 1 to about 10
mg/ml for Phellodendron bark; about 1 to about 10 mg/ml for goldenseal
root; about 1 to about 10 mg/ml for barberry root; and, about 1 to about
10 mg/ml for coptis rhizome.
24. The solution of claim 6 wherein the concentrations are: about 0.0001
to about 0.002 ml/ml for grapefruit seed extract; about 1 to about 10
mg/ml for Phellodendron bark; about 1 to about 10 mg/ml for goldenseal
root; about 1 to about 10 mg/ml for barberry root; and, about 1 to about
10 mg/ml for coptis rhizome.
25. The solution of claim 21 wherein the concentrations are: about 0.0001
to about 0.002 ml/ml for grapefruit seed extract; about 1 to about 10
mg/ml for Phellodendron bark; about 1 to about 10 mg/ml for goldenseal
root; about 1 to about 10 mg/ml for barberry root; and, about 1 to about
10 mg/ml for coptis rhizome.
26. The solution of claim 6 wherein the family of alkaloids are those
extracted by ethyl alcohol.
27. The solution of claim 1 wherein the solution contains one or more of
the group of constituents consisting of
: colloidal silver; an essential
oil; and extracts of echinacea.
28. The solution of claim 2 wherein the solution contains one or more of
the group of constituents consisting of
: colloidal silver; an essential
oil; and extracts of one or more of the group consisting of
echinacea-angustifolia, echinacea-purpurea, and echinacea-pallida.
29. A method of treating nasal cavities comprising: providing a solution
having one or more constituents selected from the group consisting of: a
family of alkaloids extracted from one or more plants; essential oils;
zinc; salt; glycerine; colloidial silver; extracts of echinacea; and
grapefruit seed; and, flowing the solution through at least a portion of
the nasal cavities.
30. The method of claim 29 including the step of first diluting the
solution as desired into water or a saline solution to form a dilute
solution and flowing the dilute solution through a desired portion of the
nasal cavities.
31. The method of claims 29 wherein the flowing step includes feeding the
solution into a first nostril while discharging the solution through a
second nostril.
32. The method of claim 31 further comprising placing the solution into a
vessel having a port which cooperates with a nostril to provide an
acceptable degree of sealing between the vessel and the first nostril,
and, positioning the nostril and the vessel with respect to each other
such that either gravity or ambient air pressure will flow the solution
from the vessel into the first nostril and out of the second nostril.
33. The method of claims 29 wherein the flowing step includes flowing
about 4 to about 16 ounces, and more preferably about the 8 ounces of
solution, are flowed through the nasal cavities.
34. The method of claim 29 wherein the alkaloid are selected from the
group consisting of berberine, oxyberberine, berbamine, palmatine,
magnoflorine, phellodendrine, jateorrhizine, candicine, menisperine,
coptisine, worenine, columbamine, epiberberine, hydrastine, canadine,
canadaline, hydrastidine, oxycyanthine, berberrubine, and isotetrandine.
35. The method of claim 34 wherein the plants from which the alkaloids are
extracted are selected from the group consisting of Oregon grape root,
yellow root, phellodendron bark, coptis rhizome, barberry root, and
Indian barberry root bark.
Description
SUMMARY OF THE INVENTION
[0001] According to one aspect of the invention, a nasal irrigation
solution is provided including water and hydrastine extracted from one or
more plants.
[0002] According to another aspect of the invention a nasal irrigation
solution is provided having water and berberine extracted from one or
more plants.
[0003] According to another aspect of the invention, the alkaloids for
these solutions is extracted from the Goldenseal plant. Advantageously,
the extract of goldenseal may also provide canadine and canadaline, to
the solutions.
[0004] According to another aspect of the invention, a nasal irrigation
solution is provided to include water and alkaloids extracted from one or
more plants.
[0005] According to another aspect of the invention, the alkaloids are
selected from one or more of the group consisting of: berberine,
oxyberberine, berbamine, palmatine, magnoflorine, phellodendrine,
jateorrhizine, candicine, menisperine, coptisine, worenine, columbamine,
epiberberine, hydrastine, canadine, canadaline, hydrastidine,
oxycyanthine, berberrubine, and isotetrandine.
[0006] According to another aspect of the invention, the plants from which
alkaloids are extracted are one or more of the group consisting of:
Oregon grape root, yellow root, phellodendron bark, coptis rhizome,
barberry root, and Indian barberry root bark.
[0007] According to another aspect of the invention, the solutions may
include an extract of grapefruit seed, vegetable glycerine, or salt.
[0008] According to another aspect of the invention, any of the solutions
may include water soluble zinc, preferably zinc acetate dihydrate,
preferably in the range of about 2 to about 12 mg/ml.
[0009] According to another aspect of the invention, solutions are
provided wherein the concentration of the solution for the plant extracts
are: about 0.0001 to about 0.002 ml/ml for grapefruit seed extract; about
1 to about 10 mg/ml for phellodendron bark; about 1 to about 10 mg/ml for
goldenseal root; about 1 to about 10 mg/ml for barberry root; and, about
1 to about 10 mg/ml for coptis rhizome.
[0010] According to another aspect of the invention, it was found
beneficial to provide solutions having a family of alkaloids naturally
occurring in plants. The family can comprise alkaloids collected from
different plants. A family may also be defined from a group of alkaloids
naturally occurring in a single plant. A family may be defined by a
combination of inter and intra plant alkaloids.
[0011] According to another aspect of the invention, a family of alkaloids
may be defined and provided as those alkaloids extracted by ethyl alcohol
from one or more of the group of plants comprising: Oregon grape root,
yellow root, phellodendron bark, coptis rhizome, goldenseal root,
barberry root, and Indian barberry root bark.
[0012] According to another aspect of the invention a method of using
these solutions to treat desired portions of a nasal passage or cavities
is provided.
[0013] According to one method of the invention, any one of the solutions
of the invention are flowed through at least a portion of the nasal
cavities.
[0014] According to another aspect of the invention, the methods include
diluting the solutions as desired into water or a saline solution to form
a dilute solution and flowing the dilute solution through a desired
portion of the nasal cavities.
[0015] According to another aspect of the invention, the flowing step
includes feeding the solution into a first nostril while discharging the
solution through a second nostril.
[0016] According to another aspect of the invention, the method includes
placing the solution into a vessel having a port which cooperates with a
first nostril to provide an acceptable degree of sealing between the
vessel and the first nostril, and, positioning the nostril and the vessel
with respect to each other such that either gravity or ambient air
pressure will flow the solution from the vessel into the first nostril
and out of a second nostril. In preferred embodiments, the flowing step
includes flowing about 4 to about 16 ounces, and more preferably about
the 8 ounces of solution, through the nasal cavities.
DESCRIPTION OF THE DRAWINGS
[0017] FIG. 1 is a side perspective or elevation view of a vessel for
carrying out a method according to the invention: and,
[0018] FIG. 2 is a side perspective or elevation view of the vessel of
FIG. 1 in use according to the invention.
DETAILED DESCRIPTION OF A PREFERRED EMBODIMENT OF THE INVENTION
[0019] Preferred aqueous solutions according to the invention are
disclosed. The solutions can be packaged in any size according to desire.
However, according to the methods of the invention concentrated solutions
are preferred. In the preferred example herein a two-ounce bottle is
selected for distribution to consumers. The bottle contains 59
milliliters (ml) of solution. The concentrations for the preferred
constituents will be given for the concentrated 59 ml solution. These
concentrations will of course be different when and if a consumer dilutes
the original solution according to preferred methods of use.
[0020] An exemplary solution contains 465 milligrams of Zinc Acetate
U.S.P. or about 7.88 mg/ml of aqueous solution. The aqueous solution also
contains: about 0.115 ml. of phellodendron bark (phellodendron amurense)
extract which is about 2:1 weight to volume or 0.001955 ml/ml of
solution; about 0.0385 ml of cultivated goldenseal root (hydrastis
canadensis) extract (about 2:1 weight/volume) or 0.00065 ml/ml of
solution; 0.0385 ml of barberry root bark (berberis vulgaris) extract
(about 2:1 weight/volume) or about 0.00065 ml./ml.; about 0.0385 ml of
coptis root (coptis chinensis) extract (2:1 weight/volume) or about
0.00065 ml/ml of solution; 0.05369 ml of grapefruit seed extract or about
0.00130 ml/ml of solution; about 0.02301 ml of glycerol (from
vegetables); and, about 0.00039 ml/ml of solution.
[0021] The herbs or plants listed above are preferably, initially
extracted with a hydro-alcoholic base (purified water and U.S.P. grade
ethyl alcohol from corn) at a weight/volume ratio of about 1:4. The
weight/volume ratio determines the strength of the herbal extract. A
ratio of 1:4 is classified as a tincture. The tincture is then filtered
and concentrated using a low-heat static process which removes all of the
alcohol to a weight/volume ratio of 2:1. Then these extracts are blended
(optionally with the other ingredients, such as zinc acetate dihydrate)
very thoroughly in the base carrier ingredient which is preferably
distilled, micro-filtered, ozonated water.
[0022] It will be understood by those of ordinary skill in the art that,
the weight to volume ratio is a standard scale used to indicate the
strength of a tincture or extract. Technically an extract is stronger
than a tincture. The standard is represented by weight, which indicates
the amount of herb material used to volume, which indicates the amount of
menstrum or solvent (usually a mixture of water and grain alcohol of
which the proportions are determined the sought after plant
constituents). For example, a 1:1 weight to volume ratio indicates that
8.33 pounds of herb or botanical material is used per gallon of solvent,
while a 2:1 weight to volume ratio indicates 16.33 pounds of herb is used
per gallon of solvent. A 1:4 weight to volume ratio indicates that 8.33
pounds of herb is used per 4 gallons of solvent and so on.
[0023] Families of beneficial alkaloids for the solution may be derived
(such as extracted by the above or other known means) according to the
following naturally occurring families per plant, or combinations of
alkaloids between plants (that is, their combination between alkaloids of
different plants or "herbs"). For example, a naturally occurring family
of alkaloids exist in each of the following plants (or herbs): Oregon
grape root contains berberine, oxyberberine, and berbamine; yellow root
contains berberine; phellodendron bark contains berberine, palmatine,
magnoflorine, phellodendrine, jateorrhizine, candicine, and menisperine;
coptis rhizome contains berberine, coptisine, palmatine, jateorrhizine,
worenine, magnoflorine, columbamine, and epiberberine alkaloids;
goldenseal root contains hydrastine, berberine, canadine, canadaline, and
hydrastidine; barberry root contains berberine, oxycyanthine, berbamine,
berberrubine, palmatine, isotetrandine, jateorrhizine, and columbamine;
and, Indian barberry root bark contains berberine alkaloid.
[0024] Each of these plants contains its own family of alkaloids, and
therefore according to the invention can provide a beneficial family on
its own. Also, according to the invention, a mixture or family of
alkaloids comprised of the alkaloids from differing plants can provide
beneficial solutions.
[0025] It is also contemplated that the following constituents in various
combinations with those claimed and disclosed herein would provide
further advantages according to the invention for nasal treatment and
solutions therefore
: colloidal silver (at least 30-100 parts per million
with a micron size of 0.001), pure sodium chloride (99.99% pure); and,
essential oils of peppermint, eucalyptus, oregano, thyme, lemon, lime,
orange, grapefruit, lemon grass, geranium, palma rosa, lavender,
bergamot, pine, tea tree, sandalwood, and rosemary. Other herbs or their
extracts such as echinacea angustifolia, echinacea purpurea, and
echinacea pallida are also contemplated.
[0026] Numerous reports and studies show support for the antimicrobial
activity of the major berberine containing plants. The berberine alkaloid
has been shown to be active in vitro against the growth of organisms like
streptococci, staphylococci, and pneumococci. Ethanol extracts of
berberine containing plants have shown strong anti-inflammatory
properties in many clinical investigations. Results from various clinical
investigations into the major isolated alkaloids of Goldenseal root have
provided a rational basis for the traditional antibacterial uses of this
root.
[0027] While berberine and hydrastine, provide benefits according to the
invention, it was discovered that the constituents disclosed herein
provide synergistic compositions in which all of the ingredients
compliment each other and work more effectively together than alone by
themselves. For example, in the formulation and development of solutions
according to the invention, it was also noted that with the addition of
the Berberine containing herbs, the astringent qualities of the solutions
increased. Subsequent inclusion of grapefruit seed extract in
compositions incrementally increased the astringency level of the
previous formula. In fact, each of the individual ingredients were used
at one point individually during the earlier research stages and were
empirically found to be less effective when used alone as opposed to a
composition of two or more of the ingredients.
[0028] Various forms of Zinc were investigated in order to best scrutinize
this element against human health ailments as well as effectiveness and
stability in solutions according to the invention.
[0029] In certain preferred solutions according to the invention, Zinc
plays several major roles functionally in the composition. Studies have
shown that various types of Zinc help the body and immune system shorten
the duration of common colds and reduce common cold symptoms while aiding
in overall immune function. Zinc also assists and enhances the bodies'
ability to heal wounds and maintain overall health and well being.
[0030] Much research has been done on zinc in variously administered forms
and has demonstrated that zinc can cut the duration of common cold
symptoms by half in many cases. This body of research on zinc has shown
to speed the recovery of the physiology when invaded by a cold or flu.
In-vitro laboratory studies have shown that zinc may interfere with the
reproductive process of various viruses known to cause colds (i.e.
rhinoviruses). Similar in-vitro inspections with zinc have shown that it
may interfere with the ability of certain viruses to enter the cells of
the body.
[0031] In use with the present invention, it was shown that zinc acetate
in combination with the other constituents is more effective than other
means of administration due to the direct topical application and
saturation of portions of sinus physiology, which is achieved for at
least 30 seconds when applied according to the methods of this invention.
This direct saturation leads to greater astringency and mucosal
absorption of zinc and the other components in the solution.
[0032] It was also discovered during the development of solution
compositions according to the invention that having zinc in the solution
and particularly zinc acetate, showed (through organolapetic means,
primarily taste), that the solution was exceptionally astringent and
drying.
[0033] Others have provided means for delivering various beneficial
components to the nasal passages via sprays, inhalants, and the like.
These methods are deficient at reaching many portions of the sinus and do
not provide optimal exposure of the active ingredients to nasal tissue.
Accordingly it was proposed to provide solutions according to the
invention to the nasal passages by streaming the solutions into an out of
the passages. It is proposed that, for a given total amount of active
ingredient to be dosed to a nasal passage, exposure to the tissue is
increased by diluting the amount in a solvent but then streaming the
entire amount (as the dilute solution) over the desired nasal tissue.
[0034] FIG. 1 discloses a vessel 10 for practicing methods according to
the invention. According to a preferred method of the invention, vessel
10 is filled with a diluent or carrier such as water or saline solution,
and a desired amount of a solutions according to the invention is added.
The resulting dilute solution is then flowed through at least a desired
portion the nasal cavities.
[0035] As disclosed in FIG. 2, a preferred method of irrigation includes
flowing the solution into a first nostril while discharging the solution
through a second nostril. The vessel 10 has a port or spout 12 which
cooperates with a nostril to provide an acceptable degree of sealing
between the vessel and the first nostril. The method includes positioning
the nostril and the vessel 10, with respect to each other such that
either gravity or ambient air pressure will flow the solution from the
vessel 10 into the first nostril and out of the second nostril. The
vessel 10 preferably hold about 8 oz of dilute solution, all of which is
flowed through the nasal cavities. Using solutions of the concentrations
disclosed herein, it is preferable to add between 1-10 ml, and more
preferably about 3-5 ml, per 8 oz of diluent, such as for vessel 10.
[0036] Either larger vessels or repeated applications may be desired for
additional irrigation.
