EP4093418A1

EP4093418A1 - Plant-based composition in a form suitable for topical administration and associated production method

Info

Publication number: EP4093418A1
Application number: EP21701269.9A
Authority: EP
Inventors: Alain CASMEZE
Original assignee: Menelik
Current assignee: Menelik
Priority date: 2020-01-20
Filing date: 2021-01-19
Publication date: 2022-11-30
Also published as: FR3106276A1; US20230035038A1; WO2021148366A1; CN115361964A

Abstract

The invention relates to a composition in a form suitable for topical administration comprising, in a cosmetically and/or pharmaceutically acceptable carrier, at least one Urtica extract. The invention is characterized in that it further comprises a mixture of at least five plant extracts. The invention further relates to a method for producing such a composition. Such a composition is particularly useful for the prevention, treatment, relief and calming of symptoms of hemorrhoidal illness and as an aide for healing wounds and calming burns.

Description

COMPOSITION IN A FORM SUITABLE FOR TOPICAL PLANT-BASED ADMINISTRATION, AND ASSOCIATED MANUFACTURING PROCESS

The present invention relates to a composition in a form suitable for topical herbal administration, as well as its method of manufacture. The invention also relates to such a composition for its use in the treatment or prevention of symptoms in the event of dermatological or gasfroenferological conditions, in particular of procfological conditions such as hemorrhoidal disease.

Hemorrhoids are normal vascular formations located around e † inside the anus e † of the rectum, which are present in all individuals and are painless. Internal hemorrhoids are † located inside the anal canal under the lining of the intestinal lining. It is a question of a system of organization of the vessels which is particularly complex: it comprises venous sacs covered with arterioles, therefore the blood content can vary very quickly. The volume of hemorrhoidal packets contributes 10 to 20% to anal tightness. External hemorrhoids are † located under the skin rim of the anus (anal margin). These two systems have vascular connections under the anal mucosa.

These vascular formations are circumferential but are concentrated in hemorrhoidal "bundles" according to the number of arterial pedicles which supply them. These bundles are usually three in number: anferro-droif, posferro-droop and left lateral bundle. They also have a role of cushioning cushion during rectal evacuation. They maintain their anatomical position (in particular during the evacuation of the stool) thanks to elastic fibers coming from the sphincter apparatus. Thus in the normal state, we do not perceive the presence of hemorrhoids.

Hemorrhoidal disease is a mild disease and the symptoms are very bothersome. The main symptoms of hemorrhoidal disease are bleeding, pain, and swelling. There are generally four grades of anatomical changes on procfologic examination.

- Grade 1: Hemorrhoidal symptoms without any externalization.

- Grade 2: Fleeting exteriorization during defecation.

- Grade 3: Frank exteriorization upon defecation or exertion, followed by slow spontaneous reduction or aided by finger pressure. - Grade 4: permanent externalization (hemorrhoidal prolapse).

The medical treatment which is based on the regularization of the intestinal transit by treating constipation, on the administration of drugs having a venous tonic effect e † local topicals (creams and suppositories) e † the instrumental treatment carried out in the consultation cabin † ( infrared, elastic ligation ...) are generally no longer effective when there is a significant proportion. At this stage, hemorrhoidal surgery is generally indicated depending on the patient's request. Only 10% to 15% of patients require surgical treatment.

Current operating techniques are based on two different principles: self † it is a question of hemorrhoidectomy (or Millligan & Morgan technique), i.e. the removal of internal and external hemorrhoidal bundles, self † hemorrhoidopexy (or Longo's intervention) which consists of repositioning and fixing the internal hemorrhoids in the anal canal.

Hemorrhoidopexy is indicated when the incidence of internal hemorrhoids is symmetrical on the three main bundles or almost circumferential e † of grade 3. It is † particularly adapted to patients who must exert efforts during defecation e † in whom it is often observed on examination carried out with an anoscope, that the prolapse of the hemorrhoids is accompanied by an internal prolapse of the lining of the lower rectum. The interest of this †† intervention is † the maintenance of the integrity of the anal canal and the anal margin with a technique that avoids an operative wound. Longo's intervention is less painful postoperatively and allows rapid resumption of activities.

Hemorrhoidectomy is a possible intervention in all circumstances. It is necessary when only one or two hemorrhoidal bundles are pathological e † can be excised with little painful operative consequences. It is used to treat an external hemorrhoidal disease (repeated thrombosis, residual skin marisks or excess). It guarantees † the result † in the event of permanently exteriorized hemorrhoids (grade 4). It is most suitable in grade 3 hemorrhoids in the absence of rectal mucosal prolapse e † when the external hemorrhoidal component is clear.

Surgical treatments such as above are however relatively heavy, painful and require postoperative monitoring before resuming normal urination. In addition, such interventions require a work stoppage modulated according to the findings of the first postoperative visit e † of the type professional activity. The average duration of stoppages is † one to two weeks after hemorrhoidopexy and three to four weeks after hemorrhoidectomy.

There is therefore a need today to develop effective alternative solutions making it possible to act in addition to a surgical intervention. Numerous compositions for the treatment of hemorrhoidal disease have been proposed to date.

The HEMAPRO ™ composition is † a hemorrhoid cream based on a formula that contains a plant complex formed from goldenrod, lemon and butcher's broom which are † known for their edema reducing, calming and stimulating properties. blood circulation, e † tonics. Together with flavonoids and tannins from other natural components, this †† composition improves blood circulation and helps heal wounds.

DIEPHARMEX ™ Laboratories have also designed an an † i-hemorrhoidal gel: MICRO H ™. This gel, packaged in particular in single doses of 5 ml, lines the mucous membranes of the anal canal with a soothing protective gel, promoting natural healing.

SEDORRHOIDE ™ HEMORROIDAL CRISIS rectal cream is an anti-inflammatory and local anesthetic. This medication is recommended in certain anal pathologies accompanied by pain and / or itching, in particular in hemorrhoidal crisis.

Document EP0391905 describes a topical composition based on the aluminum salt of sucrose octasulfate useful for the prevention and treatment of hemorrhoidal disease in addition to its healing action.

Document FR3026948 describes a topical cosmetic and / or dermatological composition, in particular useful for preventing or treating hemorrhoidal disease comprising, in a physiologically acceptable carrier, at least an effective amount of potassium salt of synthetic polysulfated oligosaccharide having 1 to 4 units of 'dares.

However, the use of existing compositions is not without limitation or controversy regarding their effectiveness.

The present invention relates to a composition in a form suitable for topical herbal administration, as well as its method of manufacture. The invention also relates to such a composition for its use in the treatment or prevention of symptoms in the event of dermatological or gastroenterological conditions, in particular proctological conditions such as hemorrhoidal disease. In general, there is a need to search for new compositions which have improved soothing and calming properties for the treatment or prevention of symptoms in the event of dermatological or gasfroenferological conditions, in particular of procfological conditions such as hemorrhoidal disease. There is therefore a need to develop such new compositions as well as alternative methods making it possible to obtain such compositions comprising plant extracts with improved soothing and calming properties.

Considering the foregoing, a problem which the present invention proposes to solve consists in particular in developing compositions which are easy and quick to apply, simple to use, and which exhibit improved efficacy (over time, both quantitative and qualitative. ) crazy † while limiting the impact on the environment.

The first object of the solution to this problem is a composition in a form suitable for topical administration comprising, in a cosmetically and / or pharmaceutically acceptable vehicle, at least one nettle extract (Urtica), characterized in that that it also comprises a mixture of at least five among the twenty-three following plant extracts:

- marigold (Calendula);

- dandelion (Taraxacum);

- elderberry (Sambucus);

- rosemary (Rosmarinus officinalis);

- sage (Salvia officinalis);

- wormwood (Artemisia absinthium L.);

- burdock (Arctium lappa);

- wild thyme (Thymus serpyllum);

- willow (Salix);

- plantago (Plantago lanceolata);

- sweet flag (Acorus calamus);

- aloe (Asphodeloideae);

- blackberry (Morus);

- gaille † scraper (Galium aparine L.);

- yellow gentian (Gentiana lutea);

- angelica (Angelica archangelica);

- yarrow (Achillea millefolium L.);

- basil (Ocimum basilicum); - ground ivy glechoma (Glechoma hederacea);

- comfrey (Symphyfum officinale);

- ivy (Hedera helix L.);

- lemon balm (Melissa officinalis); Where

- walnuts (Juglans regia).

Its second object is a process for preparing a composition according to the invention, characterized in that it comprises the following steps of:

- preparation of the different plants or parts of plants (flowers, flowering tops, aerial parts, leaves, stems, buds, roots, bulbs, rhizomes, barks, seeds, fruits, stones, berries, sap, nothing, latex ef / or thallus) following: marigold (Calendula), dandelion (Taraxacum), elderberry (Sambucus), rosemary (Rosmarinus officinalis), sage (Salvia officinalis), wormwood (Artemisia absinfhium L.), burdock (Arcfium lappa), wild thyme (Thymus serpyllum), willow (Salix), planfago (Planfago lanceolafa), sweet flag (Acorus calamus), aloe (Asphodeloideae), blackberry (Morus), nettle (Urfica), gaillef grafferon (Galium aparine L.), yellow gentian (Genfiana lutea), yarrow (Achillea millefolium L.), basil (Ocimum basilicum), glechoma ground ivy (Glechoma hederacea), comfrey (Symphyfum officinale), ivy (Hedera helix L.), lemon balm (Melissa officinalis), walnuts (Juglans regia), ef possibly angelica (Angelica archangelica);

- Heating and melting of the lipophilic phase;

- Incorporation of the various plants or parts of plants in said liquid lipophilic phase;

- stirring and stirring of the mixture thus obtained for a period of at least one hour;

- filtration of the mixture through a sieve don † the mesh is † less than or equal to

0.2 mm, so as to remove the solid part of the mixture;

- heating of the filter thus obtained;

- possibly adding yellow gentian brandy;

- boiling of the mixture;

- removal of the fire and possible addition of white wax

- cooling and recovery of the composition thus obtained.

Its third subject is a composition according to the invention, for its use in the prevention and / or treatment of symptoms in the event of dermatological conditions, in particular human conditions. Finally, its fourth subject is a composition according to the invention, for the prevention or treatment of the symptoms of hemorrhoidal disease.

The invention and the advantages resulting therefrom will be better understood on reading the description and the non-limiting embodiments which follow.

The Applicant has been able to demonstrate that the composition which is the subject of the invention makes it possible to increase the effectiveness of the compositions for the treatment or prevention of dermatological or gastroenterological conditions, in particular of proctological conditions such as hemorrhoidal disease.

More particularly, the Applicant has been able to demonstrate that the composition according to the invention comprising at least one extract of nettle (Urtica) and at least one mixture of at least five other plant extracts, applied topically, presents in particular one or more of the following benefits:

- an anti-inflammatory effect;

- a healing effect;

- a soothing effect on burns;

- a soothing effect on itching;

- a preventive effect on hemorrhoidal disease;

- a curative effect on hemorrhoidal disease.

This increase in efficacy makes it possible to improve the treatment or prevention of dermatological or gastroenterological conditions.

In addition, the pharmaceutical composition developed by the Applicant is stable and well tolerated.

Advantageously, certain compositions according to the invention allow prolonged release of the active component (s). This results in a longer duration of action and a better safety profile.

In this description, unless otherwise specified, it is understood that, when an interval is given, it includes the upper and lower bounds of said interval. Likewise, when referring to a compound, it includes any pharmaceutically acceptable form and in particular isomers, salts, solvates and polymorphs. In particular if a compound exhibits optical activity, the referenced compound will include the racemic mixture of the different isomers.

The subject of the invention is a pharmaceutical or cosmetic composition. It is in a form suitable for topical application, in particular suitable for its place of administration (skin, scalp, hair, etc.), preferably skin lesions or hemorrhoids. The composition comprises, in a cosmetically and / or pharmaceutically acceptable vehicle, at least one extract of nettle (Urtica).

The term “cosmetically and / or pharmaceutically acceptable vehicle” denotes a non-toxic support capable of being applied to at least one keratin material of human beings. The cosmetic and / or dermatological composition is advantageously a composition for topical application, comprising a cosmetically or dermatologically acceptable medium, that is to say which has a pleasant color, odor and feel and which does not generate unacceptable discomfort. (tingling, tightness, redness), likely to distract consumers from the use of this composition.

The composition according to the invention further comprises a mixture of at least five from the following twenty-three plant extracts:

- wormwood (Artemisia absinthium L.);

- sweet flag (Acorus calamus);

- yarrow (Achillea millefolium L.);

- aloe (Asphodeloideae);

- angelica (Angelica archangelica);

- burdock (Arctium lappa);

- basil (Ocimum basilicum);

- comfrey (Symphyfum officinale);

- gaille † grafferon (Galium aparine L.);

- yellow gentian (Genfiana lufea);

- ground ivy glechoma (Glechoma hederacea);

- ivy (Hedera helix L.);

- lemon balm (Melissa officinalis);

- blackberry (Morus);

- walnuts (Juglans regia).

- dandelion (Taraxacum);

- planfago (Planfago lanceolafa);

- rosemary (Rosmarinus officinalis);

- sage (Salvia officinalis);

- willow (Salix);

- wild thyme (Thymus serpyllum);

- marigold (Calendula); Where

- elderberry (Sambucus); The Applicant has been able to demonstrate that such a composition is particularly effective for the treatment or prevention of dermatological or gasfroenferological conditions, in particular of procfological conditions such as hemorrhoidal disease.

When the composition comprises five of the twenty-two plant extracts listed above, it is preferably the following mixtures:

- marigold, dandelion, elderberry, rosemary, sage;

- dandelion, elderberry, rosemary, sage, wormwood;

- elderberry, rosemary, sage, burdock, wild thyme;

- rosemary, sage, burdock, wild thyme, willow;

- sage, burdock, wild thyme, willow, plantago;

Preferably, the composition according to the invention comprises more than five among the twenty-three plant extracts listed above, preferably ten, twelve, fifteen or twenty plant extracts.

Among the ten preferred plant extracts, we can mention:

- marigold (Calendula);

- dandelion (Taraxacum);

- elderberry (Sambucus);

- rosemary (Rosmarinus officinalis);

- sage (Salvia officinalis);

- wormwood (Artemisia absinthium L.);

- burdock (Arctium lappa);

- wild thyme (Thymus serpyllum);

- willow (Salix); e †

- plantago (Plantago lanceolata).

Among the twelve preferred plant extracts, we can mention:

- marigold (Calendula);

- dandelion (Taraxacum);

- elderberry (Sambucus);

- rosemary (Rosmarinus officinalis);

- sage (Salvia officinalis);

- wormwood (Artemisia absinthium L.);

- burdock (Arctium lappa);

- wild thyme (Thymus serpyllum);

- willow (Salix);

- plantago (Plantago lanceolata); - sweet flag (Acorus calamus); and

- aloe (Asphodeloideae).

Among the fifteen preferred plant extracts, we can mention:

- marigold (Calendula);

- dandelion (Taraxacum);

- elderberry (Sambucus);

- rosemary (Rosmarinus officinalis);

- sage (Salvia officinalis);

- wormwood (Artemisia absinthium L.);

- burdock (Arctium lappa);

- wild thyme (Thymus serpyllum);

- willow (Salix);

- plantago (Plantago lanceolata);

- sweet flag (Acorus calamus);

- aloe (Asphodeloideae);

- blackberry (Morus);

- gaille † scraper (Galium aparine L.); e †

- yellow gentian (Gentiana lutea);

Among the twenty preferred plant extracts, we can mention:

- marigold (Calendula);

- dandelion (Taraxacum);

- elderberry (Sambucus);

- rosemary (Rosmarinus officinalis);

- sage (Salvia officinalis);

- wormwood (Artemisia absinthium L.);

- burdock (Arctium lappa);

- wild thyme (Thymus serpyllum);

- willow (Salix);

- plantago (Plantago lanceolata);

- sweet flag (Acorus calamus);

- aloe (Asphodeloideae);

- blackberry (Morus);

- gaille † scraper (Galium aparine L.);

- yellow gentian (Gentiana lutea);

- yarrow (Achillea millefolium L.);

- basil (Ocimum basilicum); - ground ivy glechoma (Glechoma hederacea);

- comfrey (Symphyfum officinale); and

- ivy (Hedera helix L.);

Preferably, the composition according to the invention comprises a nettle extract (Urfica) and all the following plant extracts: marigold (Calendula), dandelion (Taraxacum), elderberry (Sambucus), rosemary ( Rosmarinus officinalis), sage (Salvia officinalis), wormwood (Arfemisia absinfhium L.), burdock (Arcfium lappa), thyme (Thymus serpyllum), willow (Salix), planfago (Planfago lanceolafa), l ' sweet flag (Acorus calamus), aloe (Asphodeloideae), blackberry (Morus), grafferon gaillef (Galium aparine L.), yellow gentian (Genfiana lufea), yarrow (Achillea millefolium L.), basil (Ocimum basilicum), glechoma ground ivy (Glechoma hederacea), comfrey (Symphyfum officinale), ivy (Hedera helix L.), lemon balm (Melissa officinalis), walnut (Juglans regia) and possibly l ' angelica (Angelica archangelica).

The various extracts are preferentially dispersed in a lipophilic phase composed of oils, fats and / or waxes, of plant, animal, mineral or synthetic origin.

By way of nonlimiting example of vegetable oils that can be used, mention may in particular be made of olive oil, almond oil, peanut oil, soybean oil and olive oil. sunflower, taken alone or in a mixture. Preferably, the vegetable oil is olive oil.

By way of nonlimiting example of usable vegetable fats, mention may in particular be made of shea butter, cocoa butter and mango butter, taken alone or as a mixture. Preferably, the vegetable fat is shea butter.

By way of nonlimiting example of usable plant waxes, mention may in particular be made of carnauba (cactus) wax, soybean wax, jojoba wax and candela (palm) wax, taken alone or as a mixture. Preferably, the vegetable wax is soy wax.

By way of nonlimiting example of animal oils which can be used, mention may in particular be made of whale oil, sperm whale oil, shark liver oil, mink oil and cod oil. , taken alone or as a mixture. Preferably, the animal oil is cod oil.

By way of nonlimiting example of animal fats which can be used, mention may in particular be made of lanolin, seal milk, whale milk, lard and tallow, taken alone or as a mixture. Preferably, the animal fat is lard. By way of nonlimiting example of animal waxes which can be used, mention may in particular be made of beeswax or whale white, taken alone or as a mixture. Preferably, the animal wax is beeswax.

By way of nonlimiting example of oils, fats or mineral waxes which can be used, mention may in particular be made of petroleum jelly and paraffin, taken alone or as a mixture.

By way of nonlimiting example of oils, fats or synthetic waxes which can be used, mention may in particular be made of silicone oil or silicone wax, fatty esters and fatty alcohols, taken alone or as a mixture.

The lipophilic phase is preferably an animal fatty phase, more preferably lard.

According to the invention, the fatty phase represents at least 10% by weight of the total weight of the composition (w / w).

Preferably, the fatty phase representing between 10% and 99% by weight of the total weight of the composition (w / w). More preferably, the fatty phase represents between 50% and 90% by weight of the total weight of the composition (w / w). In fact, for such a range of fatty phase proportions, a good compromise is observed between a stable emulsion containing sufficient fatty phase for application in dermatology (in particular for dry skin) and good tissue tolerance.

A high level of fatty phase is particularly advantageous for dermatological compositions intended for the care of the skin, and in particular for dry skin.

The composition according to the invention may further comprise one or more additives compatible with cosmetic and / or dermatological use.

Of course, those skilled in the art will take care to choose the optional adjuvant (s) to be added to the compositions according to the invention, as well as their concentration, so that the advantageous properties inherently attached to the compositions in accordance with the invention are not , or not substantially altered by the intended addition.

In particular, these adjuvants must not harm the properties of the composition according to the invention, that is to say in particular the absence of irritability of the skin.

According to an advantageous embodiment of the invention, the pharmaceutical composition according to the invention may contain other additional ingredients such as an adjuvant, an † i-oxydan †, a chelating agent, a † ensio-ac † if, a foaming agent, a wetting agent, an emulsifying agent, a viscosifian †, a buffering agent or a preservative, preferably a preservative.

According to another advantageous embodiment, the pharmaceutical composition according to the invention may contain an agent which improves permeation or penetration.

The term “permeation or penetration enhancer” is intended to mean a compound which makes it possible to significantly improve the skin penetration of the active ingredient according to the invention.

By way of illustrative example of an agen † improving permeation or penetration, we can mention oleic acid, oleic alcohol, ethoxydiglycol, laurocapram, alkanecarboxylic acid, dimethylsulfoxide, polar lipids or N-methyl-2-pyrrolidone.

According to an advantageous embodiment, the pharmaceutical composition according to the invention may contain a hydrotropic agent which disrupts the structure of the stratum corneum e † thus making it possible to further increase penetration through the surface layer of the skin.

By way of illustrative example of hydrotropic agen, we can mention sodium xylene sulfonate, isopropyl alcohol, and preferably propylene glycol.

According to a particular embodiment of the invention, the composition further comprises at least one pharmaceutically active ingredient chosen from soothing agents, agents for promoting healing and / or restructuring of the skin, antiallergic agents, antibacterial agents. , depigmenting agents, moisturizing agents, kerato lytic agents analgesics, anesthetics, analgesics, antibiotics, antifungals, painkillers, an † i-inflammatory, antiparasitics, antipruritics antiseptics, antivirals , acne drugs, corticosteroids, vasoconstrictors, venotonics and / or a mixture of these.

By way of nonlimiting example of a pharmaceutically active ingredient that can be used according to the invention, we can mention, without this list being limiting: acetaminophen, fluocinolone acetonide, acetylsalicylic acid, acitretin, clavulanic acid, azelaic acid, acyclovir, adapalene, alclometasone, alpha-tocopherol, amcinonide, amorolfine, amphotericin B, tetracycline, peroxide benzoyl, betamethasone, calcipotriol, calcitriol, ciclopirox, clindamycin, codeine, crisaborole, clobetasol, crotamiton, cyproheptadine, dapsone, desonide, diosmine, dicniflifenluolac, , dioxyanthranol, econazole, efinaconazole, erythromycin, estradiol, etretinate, fluticasone, fusidic acid, mometasone, glycolic acid, glycyrrhetinic acid, halobetasol, G hydrocortisone, hydroquinone, ibuprofen, imiquimod, isotretinoin, ivermectin, ketoconazole, kojic acid, lactic acid, lidocaine, malic acid, mequinol, methoxsalene, metronidazole, miconazole, minocycline, minoxidil, la morphine, octopirox, oxymetazoline, paracetamol, penicillins (amoxyciline), pilocaine, pyridoxine, progesterone, retinol, pimecrolimus, resiquimod, rucinol, tacrolimus, tazarotene, terbinafine, tetracaine, thenaldine, travopost, tretinoin, trimeprazine, trifarotene, troxerutin, zinc pyrithione, as well as the salts or derivatives of these active ingredients, taken alone or as a mixture.

The compositions according to the invention can be provided in all the galenic forms normally used by the unsuspecting man.

Preferably, the compositions according to the invention are intended for topical administration and are provided in the form of a solution, of a dispersion, of an emulsion of liquid or semi-liquid consistency, of a suspension. , an aqueous or lipophilic gel, a microemulsion, a microcapsule, a vesicular dispersion, a dressing or an impregnated compression article.

Particularly advantageously, the composition according to the invention is in the form of an ointment.

According to a preferred embodiment of the invention, the composition is in the form of an ointment comprising:

- a lipophilic phase comprising all the extracts of the following plants: marigold (Calendula), dandelion (Taraxacum), elderberry (Sambucus), rosemary (Rosmarinus officinalis), sage (Salvia officinalis), wormwood (Artemisia absinthium L.), burdock (Arctium lappa), wild thyme (Thymus serpyllum), willow (Salix), plantago (Plantago lanceolata), sweet flag (Acorus calamus), aloe (Asphodeloideae), blackberry (Morus), nettle (Urtica), gaille † gratteron (Galium aparine) L.), yellow gentian (Gentiana lutea), yarrow (Achillea millefolium L.), basil (Ocimum basilicum), ground ivy glechoma (Glechoma hederacea), comfrey (Symphytum officinale), ivy (Hedera helix L.), lemon balm officinale (Melissa officinalis), walnut (Juglans regia), e † possibly angelica (Angelica archangelica); e †

- a hydrophilic phase comprising yellow gentian brandy (Gentiana lutea). A subject of the invention is also a process for preparing a composition according to one of the preceding claims.

Advantageously, the preparation process comprises the following steps of:

- preparation of the different plants or parts of plants (flowers, flowering tops, aerial parts, leaves, stems, buds, roots, bulbs, rhizomes, barks, seeds, fruits, stones, berries, sap, nothing, latex ef / or thallus) following: marigold (Calendula), dandelion (Taraxacum), elderberry (Sambucus), rosemary (Rosmarinus officinalis), sage (Salvia officinalis), wormwood (Arfemisia absinfhium L.), burdock (Arcfium lappa), wild thyme (Thymus serpyllum), willow (Salix), planfago (Planfago lanceolafa), sweet flag (Acorus calamus), aloe (Asphodeloideae), blackberry (Morus), nettle (Urfica), gaillef grafferon (Galium aparine L.), yellow gentian (Genfiana lutea), yarrow (Achillea millefolium L.), basil (Ocimum basilicum), glechoma ground ivy (Glechoma hederacea), comfrey (Symphyfum officinale), ivy (Hedera helix L.), lemon balm (Melissa officinalis), walnuts (Juglans regia), and possibly angelica (Angelica archangelica);

- heating and melting of the lipophilic phase;

- agitation and stirring of the mixture thus obtained for a period of at least one hour; preferably two hours minimum; more preferably between two and three hours;

- filtration of the mixture through a sieve with a mesh † less than or equal to 0.2 mm, so as to remove the solid part of the mixture;

- heating of the filter thus obtained;

- possibly adding yellow gentian brandy;

- boiling of the mixture;

- removal of the fire and possible addition of white wax

- cooling and recovery of the composition thus obtained.

The effective amounts of usable plants can be adjusted depending on the end use of the product.

For the purposes of the present invention, the term “effective amount” means an amount sufficient to obtain the expected effect.

Preferably, the amount of plant or plant extract incorporated into the liquid lipophilic phase is between: - 0.1% e † 30%, preferably between 5% and 25% and more preferably still between 10% and 20% for nettle;

- 0% and 15%, preferably between 1% and 10% and more preferably still between 1.5% and 3% for the marigold;

- 0% and 5%, preferably between 0.1% and 2% and more preferably still between 0.4% and 1% for the dandelion;

- 0% and 10%, preferably between 1% and 7% and more preferably still between 2% and 6% for elderberry;

- 0% and 10%, preferably between 1% and 5% and more preferably still between 2% and 4% for rosemary;

- 0% and 10%, preferably between 0.5% and 5% and more preferably still between 1% and 3% for sage;

- 0% and 2%, preferably between 0.05% and 1% and more preferably still between 0.1% and 0.5% for absinthe;

- 0% and 5%, preferably between 0.3% and 3% and more preferably still between 0.5% and 1.5% for the barda ne;

- 0% and 3%, preferably between 0.1% and 2% and more preferably still between 0.3% and 1% for thistle;

- 0% and 5%, preferably between 1% and 3% and more preferably still between 1.5% and 2.6% for willow;

- 0% and 3%, preferably between 0.2% and 2.5% and more preferably still between 0.4% and 2% for plantago;

- 0% and 5%, preferably between 1% and 3% and more preferably still between 1.5% and 2% for the sweet flag;

- 0% and 2%, preferably between 0.2% and 1% and more preferably still between 0.3% and 0.7% for aloe;

- 0% and 2%, preferably between 0.1% and 1% and more preferably still between 0.2% and 0.8% for blackberries;

- 0% and 3%, preferably between 0.4% and 1.5% and more preferably still between 0.6% and 1.2% for the cleavers;

- 0% and 10%, preferably between 1% and 5% and more preferably still between 1.5% and 3% for the yellow gentian;

- 0% and 10%, preferably between 2% and 8% and more preferably still between 3% and 6% for yarrow;

- 0% and 1%, preferably between 0.01% and 0.5% and more preferably still between 0.05% and 0.3% for basil; - 0% e † 2%, preferably between 0.05% and 1% and more preferably still between 0.1% and 0.7% for ivy glechoma;

- 0% and 3%, preferably between 1% and 2.5% and more preferably still between 1, 2% and 2% for comfrey;

- 0% and 2%, preferably between 0.05% and 1% and more preferably still between 0.1% and 0.4% for ivy;

- 0% and 6%, preferably between 1.5% and 5% and more preferably still between 2% and 4% for lemon balm;

- 0% and 2%, preferably between 0.1% and 1% and more preferably still between 0.3% and 0.6% for the walnut; and

- 0% and 2%, preferably between 0% and 1% and more preferably still between 0% and 0.2% for angelica.

The pharmaceutical composition which is the subject of the invention is particularly indicated for its use in the prevention and / or treatment of dermatological conditions, in particular human conditions.

More particularly, the pharmaceutical composition which is the subject of the invention is suitable for use in the prevention and / or treatment of dermatological conditions, in particular human conditions.

By way of example of dermatological conditions, we can cite in particular:

1) dermatological conditions linked to a keratinization disorder relating to differentiation and cell proliferation, in particular to treat common acnes, comedones, polymorphs, rosacea, nodulocystic acnes, conglobata, senile acnes, secondary acnes such as sun acne, medicated or occupational;

2) keratinization disorders, in particular ichthyosis, ichthyosiform states, lamellar ichthyosis, Darrier's disease, palmoplantar keratoderma, leukoplakia, pityriasis rubra pilaris and leukoplasiform states, cutaneous or mucous (buccal) lichen ;

3) dermatological conditions with an inflammatory immuno-allergic component, with or without cell proliferation disorder, and in particular all forms of psoriasis, whether cutaneous, mucous or ungual, and even psoriatic arthritis, or even dermatitis atopic and the various forms of eczema;

4) skin disorders due to exposure to UV radiation as well as to repair or fight against aging of the skin, whether photo- induced or chronological or to reduce pigmentations and actinic keratoses, or any pathologies associated with chronological or actinic aging, such as xerosis, pigmentations and wrinkles;

5) any condition linked to benign dermal or epidermal proliferation, whether or not of viral origin such as common warts, flat warts, molluscum contagiosum and verruciform epidermodysplasia, oral or florid papillomatosis;

6) dermatological disorders such as immune dermatoses such as lupus erythematosus, bullous immune diseases and collagen diseases such as scleroderma;

7) the stigmata of epidermal and / or dermal atrophy induced by local or systemic corticosteroids, or any other form of skin atrophy,

8) healing disorders, or to prevent or repair vergefures, or to promote healing,

In other words, the invention relates to a pharmaceutical composition according to the invention for its use as a medicament in the treatment of dermatological conditions, in particular human, as defined above.

Finally, as emerges from the examples below, the composition which is the subject of the invention is particularly indicated for its use in the prevention and / or treatment of gastroenterological conditions, in particular human conditions, particularly proctological conditions such as the prevention or treatment of hemorrhoidal disease.

By "prevention or treatment" is meant both any action on the symptoms of hemorrhoids, that is to say concerning the aesthetic appearance of said hemorrhoids as any action on the cause, that is to say any action. on the longitudinal muscles of the rectum forming the ligament of Parks and / or on the opening of arteriovenous shunts, but also any action on the consequences of said hemorrhoids, namely, the scars resulting from said hemorrhoids.

The composition is also suitable for relieving burns, helping healing, relieving hemorrhoidal crises and has an anti-inflammatory effect.

The present invention will now be illustrated by means of the following examples:

Example 1: List of the various plants or parts of plants which can be used for the manufacture of a composition according to the invention: The various ingredients listed below are advantageously used in amounts for the preparation of approximately 5 kg of finished product:

1. Marigold or officinal marigold fCalendula including Calendula officinalisl

For the preparation of the composition according to the invention, which is advantageously an ointment, 200 g of fresh marigold leaves are advantageously used. You can replace fresh marigold leaves with dried marigold leaves. Marigold is particularly useful for the treatment of wounds and cuts.

2. Dandelion, or lion's tooth fTaraxacum including Taraxacum albiduml

For the preparation of the ointment according to the invention, 50g to 100g of fresh dandelion roots, finely chopped, are advantageously used.

Dandelion is particularly useful for the treatment of wounds and cuts and promotes good breathing.

3. Elderberry fSambucusl

For the preparation of the ointment according to the invention, approximately 200 g of fresh, uncompacted elder flowers are advantageously used, as well as approximately 50 g of fine (green and soft) elderberry bark.

It is possible to replace fresh elder flowers with dried elder flowers. It is then preferable to add three times the amount.

Elder flowers are particularly useful for treating wounds and healing the skin.

4. Rosemary or officinal rosemary (Rosmarinus officinalis)

For the preparation of the ointment according to the invention, approximately 200 g of fresh rosemary needles are advantageously used. You can replace fresh rosemary needles with dried rosemary needles. It is then better to use twice as much.

5. Sage or officinal sage (Salvia officinalis)

For the preparation of the ointment according to the invention, approximately 100g to 150g of fresh sage leaves are advantageously used. You can replace the fresh sage leaves with dried sage leaves. It is then better to use twice as much.

Sage is especially useful for the lungs, breathing, and treating inflammation.

6. Absinthe or grand wormwood (Artemisia absinthium L.)

For the preparation of the ointment according to the invention, use is advantageously made of fresh wormwood leaves from two branches of approximately 30 to 40 cm long. You can replace the fresh wormwood leaves with dried wormwood leaves. It is then preferable to add the same quantity (fresh or dry). Absinthe is particularly useful for its antiseptic properties.

7. Burdock (Arctium lappa)

For the preparation of the ointment according to the invention, fresh, medium-sized burdock leaves are advantageously used. You can replace the fresh burdock leaves with dried burdock leaves. It is therefore preferable to use three times the amount. Burdock leaves are particularly useful for treating joint injuries. For the preparation of the ointment according to the invention, it is also recommended to include two fresh burdock roots of medium size, obtained from young and finely chopped plants. Burdock roots are particularly useful for the rapid healing of wounds.

8. Wild thyme or thyme thyme (Thymus serpyllum)

For the preparation of the ointment according to the invention, advantageously about 40 g to 50 g of fresh thyme leaves are used. You can replace fresh thyme leaves with dried thyme leaves. It is then preferable to use twice the amount.

9. Willow (Salix)

For the preparation of the ointment according to the invention, approximately 200 g of fresh, chopped curly willow leaves are used. Sheets are generally available year round.

10. Plantaao or lanceolate plantain (Plantaao lanceolata)

For the preparation of the ointment according to the invention, approximately 50 g to 100 g of young, juicy and fresh leaves are advantageously used, ie approximately 40 leaves of plantago, more preferably a mixture of male and female plants. You can replace fresh plantago leaves with dried plantago leaves. It is then preferable to use twice the amount. Plantago leaves are particularly useful for the treatment of many conditions, especially ear infections and inflammation.

1 1. Sweet flag or sweet rush (Acorus calamus)

For the preparation of the ointment according to the invention, use is advantageously made of approximately 150 g to 200 g of roots (approximately two roots) of fresh fragrant Acore, finely chopped and well cleaned. The roots of Core son † especially useful for the treatment of many ailments. The roots are generally available year round.

12. Aloe fAsphodeloideae)

For the preparation of the ointment according to the invention, advantageously about one medium-sized cluster of small fresh aloe leaves and / or flowers is used. Sheets are generally available year round.

13. Blackberry fMorusl

For the preparation of the ointment according to the invention, approximately 20 to 30 fresh mulberry leaves are advantageously used, ie approximately 30 to 40 g. You can replace the fresh mulberry leaves with dried mulberry / bramble leaves. It is then preferable to use twice the amount.

14. Nettle furtica)

For the preparation of the ointment according to the invention, advantageously about 1 kg of aerial parts of fresh nettles is used. You can replace fresh nettles with dried nettles. It is then preferable to use twice the amount. The aerial parts of nettle are the basis of the preparation.

15. Gaillet aratteron (Galium aparine L.)

For the preparation of the ointment according to the invention, advantageously about two long branches of cleavers, so about 60g, roughly chopped are used. It is preferable not to use wood but rather soft branches. The branches of cleavers are particularly useful for the treatment of many skin conditions. It is possible but difficult to use dried branches. If necessary, replace fresh branches with dried ones. It is then preferable to use twice the amount.

16. Yellow gentian ÎGentiana lutea)

For the preparation of the ointment according to the invention, approximately 200 g of clean, fresh roots of yellow gentian, approximately 1 year old, are advantageously used. The roots are preferably finely chopped and fresh. The roots of yellow gentian are particularly useful for the treatment of many ailments. They have in particular a protective effect on the blood vessels, the liver and allow the cleansing of the organism. They also have an antiseptic effect. 17. Angelica yraie, archanaéliaue or officinal angelica (Anaelica archanqelica)

For the preparation of the ointment according to the invention, approximately 20 g of angelica flowers and / or roots are advantageously used. The addition of angelica in the preparation is optional.

18. Achillea millefolium or Millefeuille (Achillea millefolium L.l

For the preparation of the ointment according to the invention, approximately 300 g of fresh yarrow flowers are advantageously used. You can replace fresh yarrow flowers with dried yarrow flowers. It is then preferable to use twice the amount. Yarrow leaves are particularly useful for the treatment of wounds and lung diseases.

19. Basil or Roman Basil ÎOcimum basilicuml

For the preparation of the ointment according to the invention, approximately 10 g of fresh basil leaves are advantageously used, ie approximately 15 leaves.

Sheets are generally available year round.

20. Glechoma Ground Ivy or Common Ground Ivy (Glechoma hederacea)

For the preparation of the ointment according to the invention, approximately 20g to 30g of fresh glechoma are advantageously used, in pieces of about 15 cm from the top, with a flower, chopped into pieces. It is possible to replace fresh glechoma with dried terrestrial glechoma. It is then preferable to use twice the amount.

21. Comfrey (Svmphvtum officinale)

For the preparation of the ointment according to the invention, advantageously used approximately 150 g of fresh roots of comfrey, unpeeled, well washed, cut into small pieces. The fresh roots of comfrey are particularly useful for bone strengthening.

22. Ivy or climbing ivy (Hedera helix L.l

For the preparation of the ointment according to the invention, approximately 30 g of fresh ivy leaves are advantageously used, ie approximately 20 small young leaves.

23. Lemon balm (Melissa officinalisl

For the preparation of the ointment according to the invention, approximately 200 g of fresh lemon balm leaves (tips) are advantageously used. It is possible replace the fresh lemon balm leaves with dried lemon balm leaves. It is therefore preferable to add twice the quantity.

24. Walnut leaf

For the preparation of the ointment according to the invention, approximately 50 g of young leaves of common walnut (tips) are used advantageously. It is possible to replace the fresh leaves of common walnut (Jugions regia), about 10 to 12 leaves, cut into small pieces.

In general, if you are using ingredients in a dried form, you should double the amounts used and not use ingredients that have been dried for more than two years.

Example 2: Process for manufacturing a composition according to the invention in a lard base

The basis of the composition includes pork fat (lard) and nettles. The different preparation steps are detailed below:

- Preparation of all or part of the ingredients described in Example 1 above;

- heating and melting of about 5 kg of lipophilic phase, which is lard;

- stirring and stirring of the mixture thus obtained for a period of two to three hours over low heat;

- filtration of the mixture, for example through a sieve with a mesh size of 0.2 mm or less, or through gauze placed on a colander;

- elimination of the solid part of the mixture;

- Heating of the filtrate thus obtained;

- add about 50 ml of yellow gentian brandy;

- boiling of the mixture;

- removal from the heat and possible addition of about 1 kg of beeswax;

- cooling and recovery of the composition thus obtained; and

- distribution of the composition in suitable containers.

Example 3 Efficacy test of the composition according to the invention

The composition based on plant extracts according to the invention was tested on a panel of three people exhibiting symptoms of hemorrhoidal disease. These symptoms include itching, burning and irritation, and hemorrhoidal episodes. After using the composition based on plant extracts, these different people observed a marked decrease in the symptoms associated with hemorrhoidal disease and an improvement in their comfort.

The main effects observed are, in particular, soothing during itching, soothing during burns, aid in healing and soothing during hemorrhoidal episodes.

These effects are observed by all of the people tested, regardless of themselves † on the first day of application of the composition based on plant extracts.

However, the effects are more effective and faster if the first day of application occurs as soon as the first symptoms of hemorrhoidal disease appear.

Claims

1. Composition in a form suitable for topical administration comprising, in a cosmetically acceptable vehicle and / or pharmaceufiquemen †, at least one nettle extract (Urtica), characterized in that it further comprises a mixture of '' at least five of the following twenty-three plant extracts:

- marigold (Calendula);

- dandelion (Taraxacum);

- elderberry (Sambucus);

- rosemary (Rosmarinus officinalis);

- sage (Salvia officinalis);

- wormwood (Arfemisia absinfhium L.);

- burdock (Arcfium lappa);

- wild thyme (Thymus serpyllum);

- willow (Salix);

- planfago (Planfago lanceolafa);

- sweet flag (Acorus calamus);

- aloe (Asphodeloideae);

- blackberry (Morus);

- gaillef grafferon (Galium aparine L.);

- yellow gentian (Genfiana lufea);

- angelica (Angelica archangelica);

- yarrow (Achillea millefolium L.);

- basil (Ocimum basilicum);

- ground ivy glechoma (Glechoma hederacea);

- comfrey (Symphyfum officinale);

- ivy (Hedera helix L.);

- lemon balm (Melissa officinalis); Where

- walnuts (Juglans regia).

2. Composition according to claim 1, characterized in that it comprises an exfrai † of nettle (Urtica) and all extracts of the following plants: marigold (Calendula), dandelion (Taraxacum), elderberry (Sambucus ), rosemary (Rosmarinus officinalis), sage (Salvia officinalis), wormwood (Artemisia absinthium L), burdock (Arctium lappa), wild thyme (Thymus serpyllum), willow (Salix), plantago (Plantago lanceolata), sweet flag (Acorus calamus), aloe (Asphodeloideae), blackberry (Morus), bedstraw (Galium aparine L.), yellow gentian (Gentiana lutea), yarrow (Achillea millefolium L.), basil (Ocimum basilicum), ground ivy glechoma (Glechoma hederacea), comfrey (Symphyfum officinale), ivy (Hedera helix L.), lemon balm (Melissa officinalis), walnut (Jugions regia) and possibly angelica ( Angelica archangelica).

3. Composition according to one of claims 1 or 2, characterized in that the various extracts are dispersed in a lipophilic phase composed of oils, fats and / or waxes, of plant, animal, mineral or synthetic origin. .

4. Composition according to claim 3, characterized in that the lipophilic phase is an animal fatty phase, preferably lard.

5. Composition according to one of the preceding claims, characterized in that it further comprises at least one pharmaceutically active ingredient chosen from soothing agents, agents promoting healing and / or restructuring of the skin, antiallergic agents. , antibacterial agents, depigmenting agents, moisturizing agents, keratolytic agents analgesics, anesthetics, analgesics, antibiotics, antifungals, painkillers, an † i-inflammatory agents, antiparasitics, antipruritics antiseptics , antivirals, acne drugs, corticosteroids, vasoconstrictors, venotonics and / or a mixture of these.

6. Composition according to one of the preceding claims, characterized in that it is in the form of a solution, a dispersion, an emulsion of liquid or semi-liquid consistency, a suspension, d an aqueous or lipophilic gel, a microemulsion, a microcapsule, a vesicular dispersion, a dressing or an impregnated restraint article, preferably in the form of an ointment.

7. Composition according to one of the preceding claims, characterized in that it is in the form of an ointment comprising:

- a lipophilic phase comprising all the extracts of the following plants: marigold (Calendula), dandelion (Taraxacum), elderberry (Sambucus), rosemary (Rosmarinus officinalis), sage (Salvia officinalis), wormwood (Artemisia absinthium L), burdock ( Arctium lappa), wild thyme (Thymus serpyllum), willow (Salix), plantago (Plantago lanceolata), sweet flag (Acorus calamus), aloe (Asphodeloideae), blackberry (Morus), nettle (Urtica), gaille † gratteron (Galium aparine L .), yellow gentian (Gentiana lutea), yarrow (Achillea millefolium L.), basil (Ocimum basilicum), ground ivy glechoma (Glechoma hederacea), comfrey (Symphyfum officinale), ivy (Hedera helix L.), lemon balm (Melissa officinalis), walnut (Juglans regia), and possibly angelica (Angelica archangelica); and

- a hydrophilic phase comprising yellow gentian brandy (Gentiana lutea).

8. Process for preparing a composition according to one of the preceding claims, characterized in that it comprises the following steps of:

- preparation of the different plants or parts of plants (flowers, flowering tops, aerial parts, leaves, stems, buds, roots, bulbs, rhizomes, barks, seeds, fruits, stones, berries, sap, nothing, latex ef / or thallus) following: marigold (Calendula), dandelion (Taraxacum), elderberry (Sambucus), rosemary (Rosmarinus officinalis), sage (Salvia officinalis), wormwood (Artemisia absinthium L.), burdock (Arctium lappa), wild thyme (Thymus serpyllum), willow (Salix), plantago (Plantago lanceolata), sweet flag (Acorus calamus), aloe (Asphodeloideae), blackberry (Morus), nettle (Urfica), gaille † gratteron (Galium aparine L.), yellow gentian (Gentiana lutea), yarrow yarrow (Achillea millefolium L.), basil (Ocimum basilicum), glechoma ground ivy (Glechoma hederacea), comfrey (Symphytum officinale), ivy (Hedera helix L.), lemon balm (Melissa officinalis), walnut (Juglans regia), e † possibly angelica (Angelica archangelica);

- heating and melting of the lipophilic phase; - Incorporation of the various plants or parts of plants in said liquid lipophilic phase;

- agitation and stirring of the mixture thus obtained for a period of at least one hour; - filtration of the mixture preferably through a sieve with the mesh size being less than or equal to 0.2 mm, so as to remove the solid part of the mixture;

- heating of the filter thus obtained;

- possibly adding yellow gentian brandy; - boiling of the mixture;

- removal of the heat and possible addition of beeswax;

- cooling and recovery of the composition thus obtained.

9. Composition according to one of claims 1 to 7, for its use in the prevention and / or treatment of symptoms in dermatological conditions, in particular human conditions.

10. Composition according to one of claims 1 to 7, for the prevention or treatment of symptoms of hemorrhoidal disease.