Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution... – Containing or obtained from a tree having matured height of...
Reexamination Certificate
1999-09-01
2001-07-03
Tate, Christopher R. (Department: 1651)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
Containing or obtained from a tree having matured height of...
C424S630000, C424S631000, C424S641000, C424S682000, C424S764000, C514S159000
Reexamination Certificate
active
06254899
ABSTRACT:
The present invention relates to new compositions of plant extracts, their preparation process, their use as medicaments and the pharmaceutical compositions containing them.
Migraines affect approximately 10% of the French population on a regular basis. This illness predominantly affects women (two women to every one man).
Treatments for migraine are essentially symptomatic; none is actually curative. Several reasons explain the lack of discovery of an effective anti-migrainous medicament. The main difficulty is that the intimate factors triggering the onset of migraine are not fully known. However, hypotheses have been put forward with regard to the role of
neuronal receptors (serotonin, dopamine, histamine),
prostaglandins,
noradrenergic receptors (central and peripheral),
stress, diet, the effects of pollution.
All these elements probably contribute to the triggering of a migrainous attack, but do not in themselves explain the phenomenon. In the absence of scientific data on the migraine mechanism, the treatment can only be symptomatic for the moment.
Dihydro-ergotamine, prostaglandin inhibitors (aspirin), analgesics (paracetemol), calcium channel blockers, &bgr;-blockers and the other inhibitory molecules of the 5HT receptor such as sumatriptan constitute the symptomatic treatments for this illness.
These medicaments, of chemical origin, are known to have undesirable or even toxic effects (for example the hepatotoxic effect of paracetemol and aspirin), in particular in the case of chronic use. Moreover, because of their effectiveness and their low toxicity, the new coming products are usually expensive.
Active compounds for combatting migraine are always being sought. Moreover, sufferers are increasingly favouring products of natural origin.
The barks of white willows (
Salix alba
) are used, particularly in France, for the treatment by oral route of light fevers and colds, in the case of pain, and by oral and local route for pains in joints, tendinitis and sprains. The active ingredients concerned would be salicoids.
The aerial part of the Feverfew (
Tanacetum parthenium
) is used for the treatment by oral route of painful periods and in the prevention of migrainous attacks. The active ingredients concerned would be parthenoids.
Thus the Applicant discovered with astonishment that compositions of salicoids (i.e. salicin and its derivatives) and parthenoids, or plants or plant extracts containing these two active ingredients, in particular combined with a metal chosen preferably from copper, zinc or magnesium in a trace element state, or with riboflavin, were endowed with remarkable anti-inflammatory, analgesic and anti-migrainous properties.
For this reason, a subject of the present invention is a new composition of a salicoid and a parthenoid, or plants or plant extracts containing these two active ingredients. A preferred composition comprises a plant extract of the Tanacetum genus and a plant extract of the Salix genus.
“Plant extract” is understood in general to mean both plants and parts of plants, for example and preferably dried or dehydrated and ground, or also extracts of such plants or parts of plants obtained using at least one aqueous and/or organic solvent and being present in a standard liquid or in particular solid form used in pharmacy or dietetics.
The plant of the Tanacetum genus can be for example
Matricaria pyrethrum, Leucanthenum parthenium
and preferably
Tanacetum parthenium
also called
Matricaria chamomilla
. The aerial parts of this plant, dried and ground, are preferably used; such extracts are for example those marketed by the company BIOSPHERE 99 (Vic le Comte—FRANCE) under the reference BIO 3010.
The plant of the Salix genus can be
Salix cinerea
for example and preferably
Salix alba
. The bark of this plant, dried and ground, is preferably used; such extracts are for example those marketed by the company BIOSPHERE 99 under the reference BIO 3021.
A preferred composition above is characterized in that it contains in addition riboflavin, zinc, magnesium or preferably copper in a trace element state, i.e. the metal is used in low or very low proportions for example less than 1 part per 100, preferably less than 1 part per 300, in particular less than 1 part per 1000 relative to the weight of the other constituents.
The copper used can be presented in particular in the form of copper salts, in particular cupric salts (Cu
++
), for example in the form of mineral salts such as copper sulphate, and very particularly salified in the form of organic salts, preferably in the form of gluconates. The same applies for zinc and magnesium.
The above compositions in which the plant of the Tanacetum genus is
Tanacetum parthenium
and the plant of the Salix genus is
Salix alba
are particularly preferred.
Among the compositions of the invention, those in which the extracts used are the dry extracts of parts of plants, dried and ground, in particular those in which the extracts used are the aerial parts of
Tanacetum parthenium
, dried and ground and those in which the extracts used are the bark of
Salix alba
, dried and ground, can also be mentioned.
A preferred composition above is characterized in that it contains, if referring to extracts of the above type and taking only the said extracts into account, 10 to 90% by weight of Tanacetum parthenium extract and 10 to 90% by weight of
Salix alba
extract.
The compositions which are a subject of the present invention have very useful pharmacological properties. They are endowed in particular with remarkable anti-inflammatory, analgesic and anti-migrainous properties.
These properties are illustrated hereafter in the experimental part. They justify the use of the compositions described above as medicaments.
For this reason, a subject of the invention is also the compositions of a plant extract of the Tanacetum genus and a plant extract of the Salix genus, for their use in a method for the therapeutic treatment of the human or animal body, i.e. as a medicament.
The medicaments according to the present invention are used for example in both the curative and preventative treatment of rheumatisms, anti-inflammatory pathologies, vascular pathologies, in particular arterial hypertension or vascular spasms and cardiac pathologies, in particular tachycardias.
They are also used in both the curative and preventative treatment of migraines.
The usual dose, variable according to the patient treated and the affection in question can be, for example, 100 mg to 1000 mg per day, by oral route in man, of the aerial parts, dried and ground, of
Tanacetum parthenium
with 300 mg to 1000 mg of the bark, dried and ground, of
Salix alba
and with 0.05 mg to 2.50 mg of copper in state of copper ions, administered for 7 to 30 days for the curative or preventative treatment of migraines.
A subject of the invention is also the pharmaceutical compositions which contain at least one previously-mentioned composition as an active ingredient.
In these compositions, the active ingredient is advantageously present in effective physiological doses; the previously-mentioned compositions contain in particular an effective anti-migrainous dose of at least one of the above active ingredients.
As medicaments, the above compositions can be incorporated in pharmaceutical compositions intended for digestive route.
These pharmaceutical compositions can be, for example, solid or liquid and be present in the pharmaceutical forms commonly used in human medicine, such as for example, plain or sugar-coated tablets, gelatin capsules, granules, caramels, suppositories; they are prepared according to the usual methods. The active ingredient or ingredients can be incorporated with excipients usually employed in these pharmaceutical compositions such as talc, gum arabic, lactose, starch, magnesium stearate, cocoa butter, aqueous or non-aqueous vehicles, fatty substances of animal or vegetable origin, paraffin derivatives, glycols, various wetting, dispersing or emulsifying agents, preservatives.
Another subject of the present invention is a p
Browdy and Neimark
Laboratoires Remilea
Tate Christopher R.
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