WO2002066041A1 - Natural composition - Google Patents

Abstract

The present invention relates to a natural drug composition comprising active constituents from at least three different plants, a method for producing said composition, the use of said composition for producing a drug for treating detoxification symptoms as well as a method for treating detoxification symptoms. The composition comprising at least one active constituent from a plant of the family Apiceae, preferable from the plant Angelica archangelica, at least one active constituent from a plant of the family Passifloraceae, preferable from the plant Passiflora incarnata, and at least one active constituent from a plant of the family Lamiaceae, preferable from the plant Leonurus cardiacea. In another composition, the composition comprising at least one active constituent from each of the plants Angelica archangelica, Passiflora incarnata, Leonurus cardiacea, Salix alba, Valeriana officinalis, Citrus aurantium, Glycyrrhiza glabra, Cinnamomum cassia verum, Piper nigrum, and Mentha piperita.

Description

Natural composition

The present invention relates to a natural drug composition comprising active constituents from at least three different plants, a method for producing said composition, the use of said composition for producing a drug for treating detoxification symptoms as well as a method for treating detoxification symptoms.

Background of the invention

Abuse of alcohol

Abuse of alcohol (ethanol) is a disorder characterised by continued excessive or compulsive ingestion of alcoholic beverages and this behaviour is believed by many to overlay a complex chronic psychological and nutritional disorder. It should be ap- preciated that abuse of alcohol is a disorder affecting a large number of people and exacts a high cost in both physical and mental anguish. It has been estimated by The National Institute on Alcohol Abuse and Alcoholism that there are as many as 10 million alcoholics and problem drinkers in the U.S. alone. World estimates are several times as many.

There is at present no treatment which is accepted as being broadly effective for this group of patients. Treatments that are used may be classified as either psychotherapy or psychopharmacology. Counselling, participation in self-help groups such as Alcoholics Anonymous, and the like comprise psychotherapy. Use of pharmacologi- cal agents to treat alcohol abuse mainly involves administration of an adversative agent to ethanol such as disulfiram which causes nausea, flushing, and so forth when alcohol is ingested or the administration of an alcohol substitute such as the euphoria-producing benzodiazepines in the acute treatment of the alcohol withdrawal syndrome. A further problem with the benzodiazepines is that they interact with alcohol to potentiate its effects, thereby exacerbating the patient's condition if alcohol is ingested concomitantly. This would result initially in a much greater impairment of the alcohol abuser's faculties and enhancement of intoxication side- effects with accompanying risks. Disulfiram (Antabuse.RTM.) is one of the approved drug treatment for chronic alcohol abuse. It causes a highly unpleasant reaction to alcohol ingestion but provides no other benefit to the chronic abuser of alcohol. Benzodiazepine anxiolytics are used in acute alcohol withdrawal treatment. However, these agents are not useful for definitive treatment of alcohol abuse since they substitute quite nicely for alcohol and can lead to a new dependence. It should be understood that no drug which actually treats the disorder of alcohol abuse per se is available. There is in fact, no really satisfactory drug treatment for abuse of alcohol at the present time.

US 4,582,705 (April 15, 1986) describes series of compositions and a method to detoxifying chronic alcoholics and hard-line drug addicts. The composition was composed of magnesium salt, potassium salt, and at least one salt selected from the group of salts of calcium, sodium, zinc, copper and lithium. Other ingredients was selected among vitamins, nutrients, sugar, flavouring agents or colouring agents. The composition was provided in powder form and was administered orally dissolved in a suitable diluent preferably water. By using the composition major symptoms associated with alcohol and/or drug withdrawal was avoided.

Summary of the invention

An objective of the present invention is to provide a composition for and a method for detoxification and thereby for treating the symptoms related to cessation of alcohol abuse and drug abuse.

In one aspect the present invention relates to a composition comprising at least one active constituent from the plant Angelica archangelica, at least one active constituent from the plant Passiflora incarnata, and at least one active constituent from the plant Leonurus cardiacea. The composition has proven effective against a variety of the symptoms associated with cessation of abuse with alcohol, narcotics, smoking and medicine. In a preferred embodiment the composition comprises constituents from at least five plants or herbs, such as at least one active constituent from the plant Angelica archangelica, at least one active constituent from the plant Passiflora incarnata, at least one active constituent from the plant Leonurus cardiacea, at least one active constituent from the plant Salix alba, and at least one active constituent from the plant Valeriana officinalis.

In yet a further preferred embodiment the composition comprises constituents from at least one active constituent from the plant Angelica archangelica, at least one active constituent from the plant Passiflora incarnata, at least one active constituent from the plant Leonurus cardiacea, at least one active constituent from the plant Salix alba, at least one active constituent from the plant Valeriana officinalis, at least one active constituent from the plant Citrus aurantium, at least one active constituent from the plant Glycyrrhiza glabra, at least one active constituent from the plant Cinnamomum cassia verum, at least one active constituent from the plant Piper nigrum, and at least one active constituent from the plant Mentha piperita.

In another aspect the invention relates to a method of producing said composition.

In yet a further aspect the invention relates to the use of the composition for the preparation of a natural drug for the treatment of symptoms associated with cessation of abuse with alcohol, narcotics, smoking and medicine.

Furthermore, the invention relates to a method of treating one or more symptoms associated with cessation of abuse with alcohol, narcotics, smoking and medicine comprising administering an effective amount of the composition. Normally the treatment is initiated with a high initial dose, which is reduced during a period of for example 5 days to zero or to a lower stabilising dose.

Detailed description of the invention

As discussed above the present invention relates to a composition useful for treating detoxification symptoms in animals, such as mammals, including humans, in particular in humans. The detoxification symptoms relates to profound physiological effects arising when individuals normally intoxicating themselves with alcohol, narcotics, nicotine, or medicaments, suddenly ceases the intoxication, often in order to stop the abuse. During the first few days after stop of the abuse the individual is normally subject to a wide variety of symptoms, such as headache, nausea, stomachache, uneasiness in legs, sneezing, runny nose and eyes, trembling, sweating, stress, sleeping disorders, palpitations, on and off palpitations, digestive disorders, shivering fits, diarrhoea and sweating plams.

Although detoxification symptoms have been tried to be treated for decades, it has not been possible to provide a medicament capable of reducing or even eliminating the symptoms without sedating the individuals, thereby giving them another medicament of which there exists a potential risk of abuse. Due to the seriousity of the symptoms it is important that they are treated, since otherwise it may be difficult to successfully withdraw the individuals from their abuse.

It has now been found that a natural drug composition is capable of reducing and in many instances fully eliminating the symptoms related to detoxification as described above. By the term "natural drug" is meant a composition produced from natural ingredients, i.e. plants and plant parts by using the active constituents from the plant itself. Natural drugs is also denoted 'herbal medicinal drugs' and 'herbal remedies'.

Accordingly, in a first embodiment the invention relates to a composition comprising at least one active constituent from the plant Angelica archangelica, at least one active constituent from the plant Passiflora incarnata, and at least one active constituent from the plant Leonurus cardiacea. Said active constituent may be any active constituent suitable for natural pharmacy.

Angelica archangelica is a herb from the Apiceae (Umbelifferae) family. Other members of the family are Angelica officinalis and Angelica sativa. In a preferred embodiment Angelica archangelica is Angelica archangelica (L).

Passiflora incarnata, is a herb from the Passifloraceae family. Another member of the family is Passiflora idulis. In a preferred embodiment Passiflora incarnata is Passiflora incarnata (L).

Leonurus cardiacea is a herb from the Lamiaceae (Labiatae) family. Another member of the family is Leonurus lanatus. In a preferred embodiment Leonurus cardiacea is Leonurus cardiacea (L). Each of the plants mentioned above comprises a variety of active constituents. In the present context the term "active constituent" is used in its normal meaning, i.e. a constituent that is detectable in the plant, by for example HPLC, and thereby is extractable from the plant, and furthermore is having an effect when administered to an animal, such as a human being.

Preferably the active constituents from Angelica archangelica comprise at least one active constituent selected from angelicin, archangelicin, apterin, furanocoumarin, flavones and organic aromatic acids from Angelica archangelica. The active constituents of Angelica archangelica may be in an extract from any plant part of Angelica archangelica, in which any plant part means from leaves, petioles, inflorescences, stems or roots. Preferably the active constituents of Angelica archangelica is in an extract from Angelica archangelica leaves.

In another embodiment the active constituent from Passiflora incarnata is preferably at least one active constituent selected from vitexin, chrysin, tecto chrysin, galangin, apigenin, flavones and organic aromatic acids from Passiflora incarnata. The active constituents of the Passiflora incarnata may be in an extract from any plant part of Passiflora incarnata, in which any plant part means from leaves, petioles, flowers, inflorescences, stems or roots. Preferably the active constituent is in an extract from

Passiflora incarnata flowers.

In yet another embodiment the active constituent from Leonurus cardiacea is preferably at least one active constituent selected from leonurin, stachydrin, flavones and organic aromatic acids from Leonurus cardiacea. The active constituents of Leonurus cardiacea can be in an extract from any plant part of Leonurus cardiacea, any plant part means leaves, petioles, inflorescences, stems or roots. Preferably the active constituent of the Leonurus cardiacea is in an extract from Leonurus cardiacea leaves.

In a more preferred embodiment the active constituents comprise at least one active constituent selected from angelicin, archangelicin, apterin, furanocoumarin, flavones and organic aromatic acids from Angelica archangelica, at least one active constituent selected from vitexin, chrysin, tecto chrysin, galangin, apigenin, flavones and organic aromatic acids from Passiflora incarnata, and at least one active constituent selected from leonurin, stachydrin, flavones and organic aromatic acids from Leonurus cardiacea.

The names of the constituents mentioned herein are the names normally used in the natural drug pharmacy in relation to the specific plants. The names are listed in the books among others H. A. Hoppe. Taschenbuch der Drogenkunde' and 'Deutsche Arzneibuch (D.A.B10).

By the term "flavones" is generally meant any flavones from said plant apart from the flavones specifically mentioned by name. Examples of preferred flavones are chrysin, tectochrysin, galargin, apigenin and pinocinbrin.

By the term "organic aromatic acids or OAA" is generally meant any organic aromatic acids from said plant apart from the aromatic acids specifically mentioned by name. Examples of organic aromatic acids are caffeic acid, vanillin, ferulic acid, isoferulic acid, 3,4-dimethoxy-cinnamic acid and cinnamic acid.

In a more preferred embodiment the active constituents comprise at least one active constituent selected from angelicin, archangelicin, at least vitexin, and at least leonurin.

In another embodiment the composition comprises active constituent from at least four different plants, wherein the other plant(s) may be selected from any suitable herb plant, such as Salix alba, Valeriana officinalis, Citrus aurantium, Glycyrrhiza glabra, Cinnamomum cassia verum, Piper nigrum, or Mentha piperita.

Salix alba is a herb from the Salicaceae family. Other members of the family are Salicaceae purpureae, Salicaceae capreae, Salicaceae senericea and Salicaceae fragilis. In a preferred embodiment Salix alba is Salix alba (L).

Valeriana officinalis is a herb from the Valerianeceae family. Other members of the family are Valeriana sambucifukia, Valeriana repens and Valeriana wallrothii. In a preferred embodiment Valeriana officinalis is Valeriana officinalis (L). Citrus aurantium is a herb from the Rotaceae family. Other members of the family are Citrus aurantiifolia, Citrus decumana, Citrus limoni, Citrus medicae, Citrus reticulata, Citrus sinensis and Citrus spartofora. In a preferred embodiment Citrus aurantium is Citrus aurantium (L).

Glycyrrhiza glabra is a herb from the Fabaceae (Liguminoceae) family. Other members of the family are Glycyrrhiza uralensis, Glycyrrhiza triphylla, Glycyrrhiza macedonika, Glycyrrhiza ecenata and Glycyrrhiza pallidiflora. In a preferred embodiment Glycyrrhiza glabra is Glycyrrhiza glabra (L).

Cinnamomum cassia verum is a herb from the Lauraceae family. Other members of the family are Cinnamomum camphora, Cinnamomum auromatikum, Cinnamomum massoia, Cinnamomum ceylandieum, Cinnamomum burmaneii and Cinnamomum loureirii. In a preferred embodiment Cinnamomum cassia verum is Cinnamomum cassia verum (L).

Piper nigrum is a herb from the Piperaceae family. Other members of the family are Piper angustifolium, Piper betle, Piper cubeba, Piper quineense, Piper longum, Piper methysticum and Piper erythrina. In a preferred embodiment Piper nigrum is Piper nigrum (L).

Mentha piperita is a herb from the Laminaceae (Labiatae) family. Other members of the family are Mentha aquatica, Mentha arvensis, Mentha crispa, Mentha puleqium and Mentha spicata. In a preferred embodiment Mentha piperita is Mentha piperita (L).

It is within the scope of the invention to include active constituents from the plants or plant parts as mentioned above. Said plants or plant parts can be collected all over the world which means in areas where one or more of said plants grow natural or in areas where said plants can be cultivated by humans either in greenhouses or in the land, as part of a horticultural or agricultural practice. The plants preferred to utilise have grown under tropical conditions or sub-tropical conditions either outdoor in tropical or sub-tropical countries or under similar conditions in greenhouses in other countries. The plants preferred to utilise have grown under conditions where fungicides, insecticides, pesticide and other chemicals used to eliminate or minimise pathogenic organism has been used as little as possible or has been avoided totally.

It is thus within the scope of the invention to include a composition further comprising at least one active constituent from the plant Salix alba. Said active constituent may be any suitable constituent from the plant, such as a constituent suitable for natural pharmacy. In particular the at least one active constituent is selected from salicin, flavones and organic aromatic acids from Salix alba. The active constituents of Salix alba can be in an extract from any plant part of Salix alba, any plant part means leaves, petioles, inflorescences, stems or roots.

Preferably the active constituent of the Salix alba is in an extract from Salix alba leaves.

Another composition which can be included comprising at least one active constituent from the plant Valeriana officinalis. Said active constitution may be any suitable constituent from the plant. In particular the at least one active constituent is selected from valereneacid, alkaloids, volatile oil, valepotriates, faurinone, flavones and organic aromatic acids from Valeriana officinalis. The active constituents of Valeriana officinalis can be in an extract from any plant part of Valeriana officinalis, any plant part means leaves, petioles, inflorescences, stems or roots. Preferably the active constituent of the Valeriana officinalis is in an extract from Valeriana officinalis roots.

When the composition comprising at least one active constituent from the plant Citrus aurantium, said active constituent may be any active component from the plant. In particular the at least one active constituent is selected from limonene, citral, hesperidin, naringin, limonin, flavones and organic aromatic acids from Citrus aurantium. Yet the composition can also comprise at least one active constituent selected from hesperidin, naringin. The active constituents of Citrus aurantium can be in an extract from any plant part of Citrus aurantium, any plant part means leaves, petioles, inflorescences, fruits, stems or roots. Preferably the active constituent of the Citrus aurantium is in an extract from Citrus aurantium peels.

A further composition comprises at least one active constituent from the plant Glycyrrhiza glabra, said active constituent may be any suitable component from the plant. In particular the at least one active constituent selected from Glycyrrhizin, Glycyrrhetinic acid, liquiritigenin, isoliquiritigenin, liquiritin, glycyrans, flavones and organic aromatic acids from Glycyrrhiza glabra. In particular the at least one active constituent is selected from Glycyrrhizin, liquiritin. The active constituents of Glycyrrhiza glabra can be in an extract from any plant part of Glycyrrhiza glabra, any plant part means leaves, petioles, inflorescences, stems or roots. Preferably the active constituent of the Glycyrrhiza glabra is in an extract from Glycyrrhiza glabra roots.

The composition may including at least one active constituent from the plant

Cinnamomum cassia verum, said active constituent may be any active component from the plant. In particular the at least one active constituent selected from eugenol, cinnamaldehyde, cinnezeylanine, procyanidins, cinnamtannins, flavones and organic aromatic acids from Cinnamomum cassia verum. In particular the composition comprises at least eugenol. The active constituents of Cinnamomum cassia verum can be in an extract from any plant part of Cinnamomum cassia verum, any plant part means leaves, petioles, inflorescences, stems or roots. Preferably the active constituent of the Cinnamomum cassia verum is in an extract from Cinnamomum cassia verum cortex.

The mentioned composition may include at least one active constituent from the plant Piper nigrum, said active constituent may be any suitable constituent from the plant, such as a constituent suitable for natural pharmacy. In particular the suitable constituent is selected from (alfa-)- and (beta-)-pinene, phellandrene, dipentene, sesquiterpenes, piperine alkaloid, piperettine alkaloid, resin, flavones and organic aromatic acids from Piper nigrum. In particular the composition comprises at least piperine alkaloid. The active constituents of Piper nigrum can be in an extract from any plant part of Piper nigrum, any plant part means leaves, petioles, inflorescences, seeds, stems or roots. Preferably the active constituent of the Piper nigrum is in an extract from Piper nigrum seeds.

When the composition comprises at least one active constituent from the plant Mentha piperita, said active constituent may be any active component from the plant. In particular the at least one active constituent is selected from menthol, menthyl acetate, neomentol, menthone, flavones and organic aromatic acids from Mentha piperita. In particular said active constituent may be selected from menthol or menthone. The active constituents of Mentha piperita can be in an extract from any plant part of Mentha piperita, any plant part means leaves, petioles, inflorescences, stems or roots. Preferably the active constituent of the Mentha piperita is in an extract from Mentha piperita leaves.

In yet a further embodiment the composition according to the invention comprises active constituents from at least five different plants, wherein the other plant(s) may be selected from any suitable herb plant, such as Salix alba, Valeriana officinalis, Citrus aurantium, Glycyrrhiza glabra, Cinnamomum cassia verum, Piper nigrum and

Mentha piperita. In a preferred embodiment the composition comprises at least one active constituent from the plant Angelica archangelica, at least one active constituent from the plant Passiflora incarnata, at least one active constituent from the plant Leonurus cardiacea, at least one active constituent from the plant Salix alba, and at least one active constituent from the plant Valeriana officinalis.

In another preferred embodiment the composition comprises at least one active constituent from the plant Angelica archangelica, at least one active constituent from the plant Passiflora incarnata, at least one active constituent from the plant Leonurus cardiacea, at least one active constituent from the plant Citrus aurantium, and at least one constituent from the plant Cinnamomum cassia verum.

In another preferred embodiment the composition comprises at least one active constituent from the plant Angelica archangelica, at least one active constituent from the plant Passiflora incarnata, at least one active constituent from the plant

Leonurus cardiacea, at least one active constituent from the plant Glycyrrhiza glabra and at least one constituent from the plant Piper nigrum.

In another preferred embodiment the composition comprises at least one active constituent from the plant Angelica archangelica, at least one active constituent from the plant Passiflora incarnata, at least one active constituent from the plant Leonurus cardiacea, at least one active constituent from the plant Salix alba, and at least one active constituent from the plant Mentha piperita. In another preferred embodiment the composition comprises at least one active constituent from the plant Angelica archangelica, at least one active constituent from the plant Passiflora incarnata, at least one active constituent from the plant Leonurus cardiacea, at least one active constituent from the plant Valeriana officinalis, and at least one active constituent from the plant Cinnamomum cassia verum.

In another preferred embodiment the composition comprises at least one active constituent from the plant Angelica archangelica, at least one active constituent from the plant Passiflora incarnata, at least one active constituent from the plant

Leonurus cardiacea, at least one active constituent from the plant Citrus aurantium, and at least one active constituent from the plant Piper nigrum.

In another preferred embodiment the composition comprises at least one active constituent from the plant Angelica archangelica, at least one active constituent from the plant Passiflora incarnata, at least one active constituent from the plant Leonurus cardiacea, at least one active constituent from the plant Glycyrrhiza glabra and at least one active constituent from the plant Mentha piperita.

In another embodiment the composition according to the invention comprises active constituents from at least six different plants, wherein the active constituents are at least one active component of each of the five plants Angelica archangelica, Passiflora incarnata, Leonurus cardiacea, Salix alba and Valeriana officinalis, the other active constituent(s) may be selected from any suitable herb plant, such as, Citrus aurantium, Glycyrrhiza glabra, Cinnamomum cassia verum, Piper nigrum, or

Mentha piperita. In a preferred embodiment the composition comprises at least one active constituent from the plant Angelica archangelica, at least one active constituent from the plant Passiflora incarnata, at least one active constituent from the plant Leonurus cardiacea, at least one active constituent from the plant Salix alba, at least one active constituent from the plant Valeriana officinalis, and at least one active constituent from the plant Citrus aurantium.

In another preferred embodiment the composition comprises at least one active constituent from the plant Angelica archangelica, at least one active constituent from the plant Passiflora incarnata, at least one active constituent from the plant Leonurus cardiacea, at least one active constituent from the plant Salix alba, at least one active constituent from the plant Valeriana officinalis, and at least one active constituent from the plant Glycyrrhiza glabra.

In another preferred embodiment the composition comprises at least one active constituent from the plant Angelica archangelica, at least one active constituent from the plant Passiflora incarnata, at least one active constituent from the plant Leonurus cardiacea, at least one active constituent from the plant Salix alba, at least one active constituent from the plant Valeriana officinalis, and at least one active constituent from the plant Cinnamomum cassia verum.

In another preferred embodiment the composition comprises at least one active constituent from the plant Angelica archangelica, at least one active constituent from the plant Passiflora incarnata, at least one active constituent from the plant Leonurus cardiacea, at least one active constituent from the plant Salix alba, at least one active constituent from the plant Valeriana officinalis, and at least one active constituent from the plant Piper nigrum.

In another preferred embodiment the composition comprises at least one active constituent from the plant Angelica archangelica, at least one active constituent from the plant Passiflora incarnata, at least one active constituent from the plant Leonurus cardiacea, at least one active constituent from the plant Salix alba, at least one active constituent from the plant Valeriana officinalis, and at least one active constituent from the plant Mentha piperita.

In yet a further embodiment the composition according to the invention comprises active constituents from at least seven different plants, wherein the active constituents are at least one active component of each of the five plants Angelica archangelica, Passiflora incarnata, Leonurus cardiacea, Salix alba and Valeriana officinalis, the other active constituents may be selected from any suitable herb plant, such as, Citrus aurantium, Glycyrrhiza glabra, Cinnamomum cassia verum, Piper nigrum, or Mentha piperita. In a preferred embodiment the composition comprises at least one active constituent from the plant Angelica archangelica, at least one active constituent from the plant Passiflora incarnata, at least one active constituent from the plant Leonurus cardiacea, at least one active constituent from the plant Salix alba, at least one active constituent from the plant Valeriana officinalis, at least one active constituent from the plant Citrus aurantium, and at least one active constituent from the plant Glycyrrhiza glabra.

In another preferred embodiment the composition comprises at least one active constituent from the plant Angelica archangelica, at least one active constituent from the plant Passiflora incarnata, at least one active constituent from the plant Leonurus cardiacea, at least one active constituent from the plant Salix alba, at least one active constituent from the plant Valeriana officinalis, at least one active constituent from the plant Cinnamomum cassia verum and at least one active constituent from the plant Piper nigrum.

In another preferred embodiment the composition comprises at least one active constituent from the plant Angelica archangelica, at least one active constituent from the plant Passiflora incarnata, at least one active constituent from the plant

Leonurus cardiacea, at least one active constituent from the plant Salix alba, at least one active constituent from the plant Valeriana officinalis, at least one active constituent from the plant Glycyrrhiza glabra, and at least one active constituent from the plant Mentha piperita.

In another preferred embodiment the composition comprises at least one active constituent from the plant Angelica archangelica, at least one active constituent from the plant Passiflora incarnata, at least one active constituent from the plant Leonurus cardiacea, at least one active constituent from the plant Salix alba, at least one active constituent from the plant Valeriana officinalis, at least one active constituent from the plant Citrus aurantium, and at least one active constituent from the plant Piper nigrum.

In yet another preferred embodiment the composition comprises at least one active constituent from the plant Angelica archangelica, at least one active constituent from the plant Passiflora incarnata, at least one active constituent from the plant Leonurus cardiacea, at least one active constituent from the plant Salix alba, at least one active constituent from the plant Valeriana officinalis, at least one active constituent from the plant Cinnamomum cassia verum, and at least one active constituent from the plant Glycyrrhiza glabra. In another preferred embodiment the composition comprises at least one active constituent from the plant Angelica archangelica, at least one active constituent from the plant Passiflora incarnata, at least one active constituent from the plant Leonurus cardiacea, at least one active constituent from the plant Salix alba, at least one active constituent from the plant Valeriana officinalis, at least one active constituent from the plant Piper nigrum, and at least one active constituent from the plant Mentha piperita.

In a preferred embodiment the composition comprises at least one active constituent from the plant Angelica archangelica, at least one active constituent from the plant Passiflora incarnata, at least one active constituent from the plant Leonurus cardiacea, at least one active constituent from the plant Salix alba, at least one active constituent from the plant Valeriana officinalis, at least one active constituent from the plant Cinnamomum cassia verum, and at least one active constituent from the plant Mentha piperita.

In yet a further embodiment the composition according to the invention comprises active constituents from at least eight different plants, wherein the active constituents are at least one active component of each of the five plants Angelica archangelica, Passiflora incarnata, Leonurus cardiacea, Salix alba and Valeriana officinalis, the other active constituents may be selected from any suitable herb plant, such as, Citrus aurantium, Glycyrrhiza glabra, Cinnamomum cassia verum, Piper nigrum, or Mentha piperita. In a preferred embodiment the composition comprises at least one active constituent from the plant Angelica archangelica, at least one active constituent from the plant Passiflora incarnata, at least one active constituent from the plant Leonurus cardiacea, at least one active constituent from the plant Salix alba, at least one active constituent from the plant Valeriana officinalis, at least one active constituent from the plant Citrus aurantium, at least one active constituent from the plant Glycyrrhiza glabra and at least one active constituent from the plant Cinnamomum cassia verum.

In another preferred embodiment the composition comprises at least one active constituent from the plant Angelica archangelica, at least one active constituent from the plant Passiflora incarnata, at least one active constituent from the plant Leonurus cardiacea, at least one active constituent from the plant Salix alba, at least one active constituent from the plant Valeriana officinalis, at least one active constituent from the plant Cinnamomum cassia verum, at least one active constituent from the plant Piper nigrum and at least one active constituent from the plant Mentha piperita.

In another preferred embodiment the composition comprises at least one active constituent from the plant Angelica archangelica, at least one active constituent from the plant Passiflora incarnata, at least one active constituent from the plant Leonurus cardiacea, at least one active constituent from the plant Salix alba, at least one active constituent from the plant Valeriana officinalis, at least one active constituent from the plant Glycyrrhiza glabra, at least one active constituent from the plant Cinnamomum cassia verum and at least one active constituent from the plant Piper nigrum.

In another preferred embodiment the composition comprises at least one active constituent from the plant Angelica archangelica, at least one active constituent from the plant Passiflora incarnata, at least one active constituent from the plant Leonurus cardiacea, at least one active constituent from the plant Salix alba, at least one active constituent from the plant Valeriana officinalis, at least one active constituent from the plant Citrus aurantium, at least one active constituent from the plant Piper nigrum and at least one active constituent from the plant Mentha piperita.

In another preferred embodiment the composition comprises at least one active constituent from the plant Angelica archangelica, at least one active constituent from the plant Passiflora incarnata, at least one active constituent from the plant Leonurus cardiacea, at least one active constituent from the plant Salix alba, at least one active constituent from the plant Valeriana officinalis, at least one active constituent from the plant Citrus aurantium, at least one active constituent from the plant Cinnamomum cassia verum and at least one active constituent from the plant

Mentha piperita.

In another preferred embodiment the composition comprises at least one active constituent from the plant Angelica archangelica, at least one active constituent from the plant Passiflora incarnata, at least one active constituent from the plant Leonurus cardiacea, at least one active constituent from the plant Salix alba, at least one active constituent from the plant Valeriana officinalis, at least one active constituent from the plant Cinnamomum cassia verum, at least one active constituent from the plant Glycyrrhiza glabra and at least one active constituent from the plant Mentha piperita.

In yet a further embodiment the composition according to the invention comprises active constituents from at least nine different plants, wherein the active constituents are at least one active component of each of the five plants Angelica archangelica, Passiflora incarnata, Leonurus cardiacea, Salix alba and Valeriana officinalis, the other active constituents may be selected from any suitable herb plant, such as, Citrus aurantium, Glycyrrhiza glabra, Cinnamomum cassia verum, Piper nigrum, or Mentha piperita. In a preferred embodiment the composition comprises at least one active constituent from the plant Angelica archangelica, at least one active constituent from the plant Passiflora incarnata, at least one active constituent from the plant Leonurus cardiacea, at least one active constituent from the plant Salix alba, at least one active constituent from the plant Valeriana officinalis, at least one active constituent from the plant Citrus aurantium, at least one active constituent from the plant Glycyrrhiza glabra, at least one active constituent from the plant Cinnamomum cassia verum and at least one active constituent from the plant Piper nigrum.

In another preferred embodiment the composition comprises at least one active constituent from the plant Angelica archangelica, at least one active constituent from the plant Passiflora incarnata, at least one active constituent from the plant

Leonurus cardiacea, at least one active constituent from the plant Salix alba, at least one active constituent from the plant Valeriana officinalis, at least one active constituent from the plant Mentha piperita, at least one active constituent from the plant Glycyrrhiza glabra, at least one active constituent from the plant Cinnamomum cassia verum and at least one active constituent from the plant Piper nigrum.

In another preferred embodiment the composition comprises at least one active constituent from the plant Angelica archangelica, at least one active constituent from the plant Passiflora incarnata, at least one active constituent from the plant Leonurus cardiacea, at least one active constituent from the plant Salix alba, at least one active constituent from the plant Valeriana officinalis, at least one active constituent from the plant Citrus aurantium, at least one active constituent from the plant Mentha piperita, at least one active constituent from the plant Cinnamomum cassia verum and at least one active constituent from the plant Piper nigrum

In another preferred embodiment the composition comprises at least one active constituent from the plant Angelica archangelica, at least one active constituent from the plant Passiflora incarnata, at least one active constituent from the plant Leonurus cardiacea, at least one active constituent from the plant Salix alba, at least one active constituent from the plant Valeriana officinalis, at least one active constituent from the plant Citrus aurantium, at least one active constituent from the plant Glycyrrhiza glabra, at least one active constituent from the plant Mentha piperita and at least one active constituent from the plant Piper nigrum.

In another preferred embodiment the composition comprises at least one active constituent from the plant Angelica archangelica, at least one active constituent from the plant Passiflora incarnata, at least one active constituent from the plant Leonurus cardiacea, at least one active constituent from the plant Salix alba, at least one active constituent from the plant Valeriana officinalis, at least one active constituent from the plant Citrus aurantium, at least one active constituent from the plant Glycyrrhiza glabra, at least one active constituent from the plant Cinnamomum cassia verum and at least one active constituent from the plant or Mentha piperita.

In a preferred embodiment the component comprises at least one active constituent from the plant Angelica archangelica, at least one active constituent from the plant Passiflora incarnata, at least one active constituent from the plant Leonurus cardiacea, at least one active constituent from the plant Salix alba, at least one active constituent from the plant Valeriana officinalis, at least one active constituent from the plant Citrus aurantium, at least one active constituent from the plant Glycyrrhiza glabra, at least one active constituent from the plant Cinnamomum cassia verum, at least one active constituent from the plant Piper nigrum, and at least one active constituent from the plant Mentha piperita.

In a preferred embodiment the component comprises at least one active constituent from three plants, where these plants are selected among the species Angelica archangelica, Passiflora incarnata, Leonurus cardiacea, Salix alba, Valeriana officinalis, Citrus aurantium, Glycyrrhiza glabra, Cinnamomum cassia verum, Piper nigrum, and Mentha piperita.

In each of the mentioned embodiments comprising active components from different plant species, said active components are in an extract from the plant or plant parts mentioned above for each plant species. Valid for each plant species is that the active components from the plant organs mentioned can be in extracts from fresh or dried plant materials, with 'dried' means solar dried, air dried, freeze dried or said plant material is dried with another drying method.

From the plants the active components of both aerial plant parts as well as from underground plant parts can be used, the preferred plant parts of each plant species are those as mentioned above. When the active components are in an extract from leaves, where the leaf types include scale leaves, leaves and bracts, said leaf types can include petioles and lamina, and said active components can be in an extract from fresh leaves or dried leaves. When the active components are in an extract from roots, where roots include main roots, adventitious roots, aerial roots, stele or cortex of the roots, said active components can be in an extract from fresh or dried roots or root parts. When the active components are in an extract from stems it can include an extract from all of the stem or part of the stems e.g. pith, vascular tissue, cortical tissue or peels. The active components from said stem or stem parts may be in an extract from fresh plant material or in an extract from dried plant material. When the active components are in an extract from inflorescences it can include an extract from all part of the inflorescence or part of the inflorescences such as peduncles, sepals, petals, stamens, nectaries, ovaries or seeds. The active components from said inflorescences or said parts of inflorescences can be in an extract from fresh plant material or in an extract from dried plant material.

Methods of drying plant material

As used herein, dry matter is a term of art typically referring to the material remaining after harvesting fresh plants or plant parts, and heating the harvested material until all the water is removed. Principal components of dry material typically include, but are not limited to, cell membrane polysaccharides and lignin, and protoplasmic components, such as proteins, lipids, amino acids, organic acids, and certain elements that exist as ions but form no essential part of an organic compound (e.g., potassium, among others).

As used herein, material derived from Angelica, Passiflora, Leonurus, Valeriana, Glycyrrhiza, Piper, and Mentha refers to plant material derived from any part of the plant at any stage of its growth. Preferable material includes but is not limited to roots, leaves or extracts thereof. Plant material derived from Salix, Citrus and Cinnamomum refers to material derived from any part of the trees at any stage of its growth. Preferable material includes but is not limited to the peel, seeds or extracts thereof.

Leaves of the plants Angelica, Passiflora, Leonurus, Salix, and Mentha axe harvested during the growing season. Roots of the plants Valeriana and Glycyrrhiza, are harvested during the growing season, seeds of the plant Piper are harvested when the seeds are mature, and peel of the plants Citrus and Cinnamomum can be collected in all seasons.

To facilitate even drying, the collected plant material preferable leaf, root and peel material was in convenient chopped into small pieces, 2-5 cm in length. Many herbal/medicinal plant materials and parts thereof are unstable as they are harvested and must be dehydrated to render them sufficiently stable to be marketed or further processed. Drying methods comprises but are not limited to methods based on solar drying, air drying, microwave power drying, or freeze drying. Extraction of plant components can also be done with fresh plant material as described below.

Dehydration may take the form of simple solar drying in the field but this practice renders the products susceptible to contamination by insects, micro-organisms and general filth as well as the vagaries of weather.

Commercial hot-air dehydrators powered by fossil fuels or electricity provide a more controlled and reliable drying option. None the less, a substantial portion of the active chemical constituents may be lost during the drying process due to the combination of high temperatures and atmospheric oxygen in the drying environment. These factors promote chemical oxidation of the active constituents, rendering them inactive. Alkamides of the plants, being unsaturated, that is containing double carbon bonds within their molecular structure, are likewise susceptible to destruction by interaction with oxygen. Elevated temperatures also promote oxidative reactions. For air drying, a sufficient sample of the plant material was air-dried at constant temperature of a temperature between 50 degree C. and δO.degree. O, according to common industrial practice by using an air dryer with an airflow rate of about 900-1200 L/min. After 10-15 hours in the dryer, final moisture content of 2-10% was obtained.

Another drying method comprises microwave power drying, in which the herbal/medicine plants are dried by applying microwave power to plant materials in a chamber under reduced pressure to reduce the moisture content of the plant materials without significantly reducing (oxidizing) the concentration of active medicinal component in the dried plant materials and thereby produce a dried herbal/medicinal plant product which more closely approaches the medicinal properties of the fresh plant than those of dried products produced by conventional air drying processes. Broadly the process comprises but is not limited to loading of fresh plant materials of a sufficient amount into a vacuum microwave chamber, reducing the pressure in said chamber to a low absolute pressure below 8 inches of mercury (<0.27 atmospheres), applying microwave power at a first rate of between 1 and 12 kilowatts (kW) per kilogram of said plant material for a time period of 2 to 35 minutes to a moisture content of less than 10% based on the dry weight of the plant material without permitting significant oxidation of the non-volatile, large molecular weight active ingredients or damaging the material with excess heat.

Another microwave power drying process is for the dehydrating culinary herbs in which retention of volatile flavour compounds is desirable, wherein vacuum microwave drying is employed to reduce the drying temperature and increase drying rate. In that process rapid, low temperature dehydration results in improved retention of volatile, low molecular weight flavour compounds because low temperature reduces evaporation rate of the flavour compounds and low temperature and short drying times do not allow time for the volatile compounds to diffuse out of the herb tissue into the drying chamber from hence they are lost. For freeze drying, a sufficient sample of the plant material is freeze-dried under vacuum to final moisture content of 2-10%. The chamber and condenser temperatures is selected between 15 to 25.degree. C. and -40 to -δO.degree. C, respectively. Freeze drying is known to result in negligible oxidative losses because of the very low absolute pressure in the drying chamber and the fact that the products are sublimated dry directly from the frozen state. It is known by experts in the field of drying that most biologically active compounds, aside from some dehydration-sensitive proteins, are retained immediately after freeze drying.

Sterilisation of plant material

Sterilisation of the plant material can be necessary to avoid any complications with insects, fungi, bacterias, or other micro-organisms. Traditional methods for the sterilisation of ground herbs and extracts involve the use of extremely toxic substances such as ethylene oxide or methyl bromide, non-edible solvents which are inherently difficult to remove from the plant solids, irradiation, or steam and moisture treatment to reduce plate counts to acceptable levels for use in foods and beverages. Chemical sterilisation, irradiation, and non-edible solvent extraction of herbs are disagreeable to the consumer because of the perceived risks of residual chemicals and/or radiation remaining in the plant matter and, as a result, several processes using added moisture, such as water or steam, at elevated pressures have been developed as alternatives.

Extraction of plant components

Components of the herbs can be extracted with different methods based on fresh or dried plant material, some of the methods are described below, but the extraction methods are not limited to these methods. In the extraction methods described below, the plant components are extracted with one or more solvents. The solvent can be, but are not limited to the groups of organic solvents such as ethanol, ethyl alcohol, ether, chloroform, hexane, acetone and the like, and non-organic solvents such as, but not limited to glycerine, water, and edible solvents such as vegetable oils or lard.

When the extraction processes are performed with organic solvents, the solvent is usually removed from the extract containing the extracted plant components, thereby leaving an active component that can be placed in a tablet, capsule, tonic, or other form as described above. Alternatively following extraction and desolventi- zation, the concentrated extract is standardised with edible solvents and emulsifiers to provide a concentrate with reproducible levels of the active or principal compounds of interest to the user.

In one extraction method, fresh green plant material consisting essentially of the leaves and stems, but not limited to said plant organs is squeezed into a green plant juice, this plant juice is recovered, the pH is adjusted to a pH of 6.2 to 9.5. The plant juice is spray-dried or freeze-dried to obtain a green plant powder. In a further proc- ess, the green plant powder obtained is water extracted by contacting the powder with water at a ratio of 2 to 50 litres of water per kilogram of green plant juice powder to extract water-soluble components from the green juice powder and recovering water-insoluble green plant powder components comprising chlorophyll, lipids, water-insoluble proteins, polysaccharides, fat-soluble vitamins, protein- or sugar-bound minerals, and other compounds. Solvent extracting the water-insoluble components by contact with a polar organic solvent consisting essentially of a mixture of ethanol and acetone in which the weight ratio of ethanol to acetone is 2/1 to 1/10 and the amount of the solvent mixture to the water-insoluble component is 500 to 5000 ml per 100 g of the water-insoluble component of the green plant juice.

In a simple extraction method, the fresh or dried plant material of a sufficient amount are macerated with a solvent. The solvent is allowed to remain in contact with the plant materials for an appropriate period of time and is then filtered to remove solid or particulate material in order to form a filtered extract. If desired, additional solvent can be added to the filtered extract to bring it to a final volume. Alternatively, solvent can be evaporated to increase the concentration of the active constituents of the extract.

In another extraction method, the fresh or dried plant materials are percolated with a solvent. The plant materials which preferable are in sections of a sufficient size including macerated plant materials, are placed in a column, known as a percolator. The solvent is then allowed to flow through the column, contacting the plant material, and the solvent is collected. The collected solvent forms the extract. Percolation has the advantage of allowing a minimal volume of solvent to be used during the extraction process. The volume of solvent required can be partially controlled by the rate of fluid flow through the column, allowing for greater control over the final volume of extract. Preferably, the flow of solvent out of the column is stopped entirely during extraction, so that the efficiency of extraction is increased.

Another extraction method is based on simultaneously extracting and concentrating in a series of high pressure countercurrent mechanical presses using relatively small amounts of vegetable oil as the solvent in an attempt to overcome the problem of dilution inherent in earlier processes. Contact times must be for up to 16-24 hours.

In yet another method, the plant material of a sufficient size and a sufficient amount together with the solvent are added in an extract processor for processing. The supernatant liquid of solvent and solids is drained into a holding/settling tank where the volume is measured and the solids content is determined by analysis. The supernatant liquid is pumped through a 100 mesh liquid filter into a sanitising vessel. The liquid is processed for a minimum of four hours at the temperature of about 75-

ΘO.degree. C. The volume of the liquid is measured and a solids analysis is done. A sample is drawn for microbiologic testing. The liquid is pumped through a 100 mesh filter and sprayed into the vacuum dryer, using volume and solids data to adjust the product to the desired concentration for the finished product. The resulting material is dried. The processor is emptied into sanitary bulk bins or barrels and transported to milling. A pre-grind sample is drawn for biologic testing. The material is milled in a sanitary stainless steel milling system. The material is unloaded from the mill system into fibre drums.

In another extraction method it is possible to make use of the essential oil of herb for the extraction of a herb solid. The essential oil is obtained in the first instance by the steam distillation of the herb. This process generally involves contacting freshly ground herb with an essential oil or oleoresin of herb in a sealed container at elevated temperatures (75-90.degree. C.) and perhaps under a pressure for one hour to extract oleoresin from the herb. The supplemented essential oil of herb is recovered from the extracted herb solids by filtration and the herb cake residue washed with vegetable oil at about 95-110.degree. C. The first supplemented essential oil extract obtained as a filtrate is then used for a second extraction of fresh ground herb, and after separation by filtration, the residual herb cake is again extracted with vegetable oil. The vegetable oil washings may be combined with the essential oil extracts, if desired.

One preferred extraction method comprises preparing the extracts of the herbs by a maceration process involving an alcohol (ethanol, ethyl alcohol, and not methanol) treatment, as is known in the art. Alternatively, the glycerine and water extraction process is particularly useful because glycerine may be used as a solvent in a liquid core of a capsule. Liquid filtrate which is obtained in a conventional extraction process after filtering the extractant liquid may then be further refined by removing any solvents with sufficiently low boiling points such as an alcohol by using standard evaporation techniques until the composition is substantially free from such solvents.

Another extraction method comprises a herbal extraction and concentration system wherein one or more types of medicinal herbs are boiled in an extraction vessel, during a first process phase, at a temperature in the preferable range of 60 to

70.degree. C. to protect the active ingredients in the medicinal herbs from thermal destruction. The boiling process produces an herbal vapour and a herbal liquid. The herbal vapour is conducted from the extraction vessel to a collection tank for collection of the resulting herbal condensate. Herbal condensate from the collection tank is periodically fed back into the herbal liquid in the extraction vessel as the herbs are boiled. After a time, a second process phase begins with a portion of the herbal liquid being conducted from the extraction vessel to a concentration tank. The herbal liquid conducted into the concentration tank includes condensate which has theretofore been re-introduced into the extraction vessel. During the second phase, both the concentration and extraction processes are occurring; that is, the herbs and re-introduced condensate continue to be boiled in the extraction vessel, and the herbal vapour continues to be collected as condensate for periodic reintroduction into the extraction vessel. A third phase of the process is subsequently entered, during which the extraction process ceases, and only concentration occurs. The third phase commences with a final batch of herbal liquid from the extraction vessel being conducted to the concentration tank. Again, the herbal liquid includes herbal condensate which has been periodically fed back to the extraction vessel. The herbal liquid in the concentration tank is concentrated to complete the production process. Another preferable extraction method is super critical extraction by using CO sub2 or another inert gas.

The herbs or plants are preferably processed, i.e. dried, extracted, and the like, before they are combined in the composition.

A preferable extraction method is maceration in 16 hours by approx. 20.degree.C, using a combination of 80% ethanol and 20% water. The liquid part is after filtration, spray dried using solid calcium phosphate o.o., in order to adjust the dry extract to the desired concentration. This solid and standardised extract is used for production of tablets, capsules a.o.

The raw material as well as the composition is controlled quantitatively and qualitatively by identity assay such as HPLC, TLC or gas chromatography by standard proceedings with or without special separation material and/or eluents.

The method of production of tablets, is generally either WG-technology (wet granulation) or DC-technology (direct compression), using standard tabletting equipment (Killian, Manasty, Fette a.o.).

The composition according to any of the preceding claims, said composition comprising one or more fractions derived from the plant Angelica archangelica leaves, at least one active constituent from the plant Passiflora incarnata leaves and at least one active constituent from the plant Leonurus cardiacea leaves exhibiting peaks on HPLC. The term "exhibiting peaks" is used in its conventional meaning, i.e. constituents giving rise to a visual and separable peak on HPLC.

In a further embodiment the amount of the active components expressed as weight percent in the mixtures comprising the plant extracts, can be as follows for each plant species regardless of the number of plant species being a constituent part of the mixture: Angelica archangelica about 6% -11%, Passiflora incarnata about 4% - 8%, Leonurus cardiacea about 4% -8%, Salix alba about 5% -9%, Valeriana officinalis about 4% -6%, Citrus aurantium about 8% -12%, Glycyrrhiza glabra about 4% -6%, Cinnamomum cassia verum about 1% -3%, Piper nigrum about 1% -3%, and/or Mentha piperita about 1 % -3%. In a preferred embodiment, the composition comprises a mixture expressed in weight percent as follows: Angelica archangelica about 7% -8%, Passiflora incarnata about 4.5% -5.5%, Leonurus cardiacea about 4% -5%, Salix alba about 6% -7%, Valeriana officinalis about 3.5% -4.5%, Citrus aurantium about 10% -11%, Glycyrrhiza glabra about 4% -5%, Cinnamomum cassia verum about 1.5% -2.5%,

Piper nigrum about 1.5% -2.5%, and Mentha piperita about 1% -2%.

In a preferred embodiment, the composition comprises a mixture expressed in weight percent as follows: Angelica archangelica about 6% -11%, Passiflora incarnata about 4% -8%, Leonurus cardiacea about 4% -8%, Salix alba about 5% -

9%, Valeriana officinalis about 4% -6%.

In another preferred embodiment, the composition comprises a mixture expressed in weight percent as follows: Angelica archangelica about 9% -10%, Passiflora incarnata about 6% -7%, Leonurus cardiacea about 6% -7%, Salix alba about 7.5%

-8.5%, Valeriana officinalis about 4.5% -5.5%.

In another preferred embodiment, the composition comprises a mixture expressed in weight percent as follows: Angelica archangelica about 6% -11%, Passiflora incarnata about 4% -8% and Leonurus cardiacea about 4% -8%.

In yet a further preferred embodiment, the composition comprises a mixture expressed in weight percent as follows: Angelica archangelica about 10% -11%, Passiflora incarnata about 7% -8% and Leonurus cardiacea about 7% -8%.

In another embodiment the composition according to the invention comprises active constituents from the herbs as mentioned above in addition the embodiment comprise one or more additives selected from calcium carbonate, microcrystalline cellulose, talc, silicium dioxide, magnesium stearate, calcium phosphate, potato starch, macrogolum, flavours.

In a preferred embodiment said additives are selected from calcium carbonate, microcrystalline cellulose, talc, silicium dioxide and magnesium stearate. In yet another embodiment the composition according to the invention comprises active constituents from the herbs as mentioned above, in addition the embodiment comprise one or more additives selected from from colorants, flavors, stabilisers, buffers, artificial and natural sweeteners, dispersants, thickeners, solubilizing agents, and the like, and/or one or more additives selected from BHA (tert- butylhydroxyanisole), BHT (butylhydroxytoluene), c-vitamin, rosemary or propolis.

In another preferred embodiment said additives are utilised in the weight percent as follows: calcium carbonate 22%-35%, microcrystalline cellulose 22%-35%, talc 1%- 5%, silicium dioxide 0.4%-2% and magnesium stearate 0.1 %-1.5%.

In a preferred embodiment, the composition comprises a mixture expressed in weight percent as follows: Angelica archangelica about 7% -8%, Passiflora incarnata about 4.5% -5.5%, Leonurus cardiacea about 4% -5%, Salix alba about 6% -7%, Valeriana officinalis about 3.5% -4.5%, Citrus aurantium about 10% -11 %,

Glycyrrhiza glabra about 4% -5%, Cinnamomum cassia verum about 1.5% -2.5%, Piper nigrum about 1.5% -2.5%, Mentha piperita about 1% -2%, and the additives calcium carbonate 23%-24%, microcrystalline cellulose 23%-24%, talc 2%-3%, silicium dioxide 0.5%-1.5% and magnesium stearate 0.1%-1%.

It is within the scope of the invention to include a method for producing compositions as described above. In a preferred embodiment the method comprises a method of extracting at least one active constituent from the plant Angelica archangelica, at least one active constituent from the plant Passiflora incarnata, and at least one active constituent from the plant Leonurus cardiacea in accordance with the details described above herein included the type of plant materials utilised, a potential drying method performed on said plant materials, the amount of active components utilised and the amount of additives utilised.

Treatment

It is within the scope of the invention to include the use of a composition as described above for the preparation of a natural drug for the treatment of symptoms related to detoxification or cessation of abuse, where the abuse can be alcohol intake, smoking, narcotics intake, Marihuana, Ecstasy, amphetamine, heroin or benzodiazipenes (tranquillizers). In this context smoking means any kind of smoking, such as smoking of cigarettes, cigars or hash.

The composition is useful when treating the variety of symptoms that is normally seen in individuals ceasing an abuse. However, the composition may of course be likewise suitable for treating one or a few of the symptoms in question.

A preferred embodiment of the invention is the use of a composition as described above for the preparation of a natural drug for the treatment of symptoms related to detoxification or cessation of alcohol intake, such as for the treatment of symptoms related to detoxification of alcohol intake.

Another preferred embodiment of the invention is the use of a composition as described above for the preparation of a natural drug for the treatment of symptoms related to abuse of cigarettes or hash, such as for the treatment of symptoms related to abuse of hash.

Another embodiment of the invention is the use of a composition as described above for the preparation of a natural drug for the treatment of one or more symptoms selected from symptoms related to sleep disorder, eating disorder, anxiety, digestive disorders, such as obstipation, ulcers, pain, infections, sedative disorders or diuretic disorders, independent of their cause of origin.

The composition as described above may be used for the preparation of a natural drug with systemic effects in animals such as mammals, including humans, and in particular in humans.

The composition may be formulated for systemic treatment, such as peroral or parenteral treatment. The compounds of the present invention may be formulated in a wide variety of oral administration dosage forms. The pharmaceutical compositions and dosage forms may comprise the constituents of the invention. The acceptable carriers can be either solid or liquid.

Another preferred embodiment of the composition as described above may be for the preparation of a natural drug for peroral administration, such as a composition selected from powder, granules, pellets, capsules, tablets, aerosols, solutions, suspensions, sachets, chewing gum and tea.

A preferred embodiment is the use of a composition as described above for the preparation of a natural drug in a composition as tablets.

Another preferred embodiment is the use of a composition as described above for the preparation of a natural drug in a composition as sachets.

In another embodiment of the invention the composition as described above may be for the preparation of a natural drug for parenteral administration, such as a natural drug for sublingual, intranasal, subcutaneous, intramuscular, intravenous or rectal administration.

No reasons for health make a patient unsuitable for starting a detoxification diet, only one has to be aware of a risk of hypersensitivity to some of the constituents extracted from the herbs.

Another aspect of the invention is a time schedule of the detoxification diet comprising intake of a composition as described above, the administration is in the form of tablets, and the diet is an intensive diet. An example may be when an alcohol abuser begins to feel need of alcohol, said diet is started. Said diet is initially an intensive diet comprising the intake of the composition up to 6 time at day 1 and day 2 and then reducing the amount and frequency to zero or a lower stabilising diet or dose within a period of about 5 days. The number of tablets at each intake time can be lowered according to the patients symptoms of adverse effects, and the therapy can be fulfilled within a shorter period than the 5 days therapy as described above.

The terms 'detoxification' and 'intensive diet or dose' is used to describe the first 5 days of treating alcohol or drug abusers, who has an amount of abuse of said alcohol or drug, which can not be treated with lower doses of the composition described above. The term 'stabilisation diet or dose' is used to describe a period of time in which an abuser following the intensive diet has an intake of the composition described above at a lower dose than in the time of the intensive diet, or in case the abuser has a lesser intake of alcohol and/or drugs, the intensive diet is omitted, and a stabilisation diet with a lower dose of said composition is performed

An embodiment of the invention is that the abuser along with the tablets will receive an instruction, which gives said abuser advise on: the intake of the tablets, the diet, sleep, exercise, day to day living, habits, family and self help groups. To receive a maximal effect it is important for the abuser to follow the instructions very precise.

Another embodiment of the invention is a time schedule of the stabilising diet comprising intake of a composition as described above, the administration is in the form of tablets. Said stabilising diet can be continued immediately after the 5 day intensive diet as described above. When said intensive diet is stopped after 5 days, said stabilising diet comprise the intake for the next 25 days of 5 tablets each time at the time after breakfast, after lunch and before bedtime.

An embodiment of the invention is a time schedule to detoxify and stabilise abusers of narcotic. Marihuana abusers are recommended to take a longer detoxification diet period of approximately three months but on a lower dose than mentioned above concerning alcohol abusers. Ecstasy abusers are recommended to take a three month detoxification period with a high dose in the first month and thereafter a lower regular dose. Abusers of amphetamine are recommended a three month detoxification period with a high dose in the first month and thereafter a lower regular dose. Abusers of heroin who has no other additional forms of abuse can go through detoxification with an extra high dose within the first 5 days. Detoxification of heroin abusers should be combined with intensive therapy, which acts as a holding point during the period of detoxification. Abusers of benzodiazipines and other doctor prescribed medicaments, mood changing medicine are recommended to take a detoxification periods of at least three months, however the chances of a longer period is probable.

An embodiment of the invention is the effectiveness of the composition as described above for the following abstinence symptoms. High pulse: intake of said composition according to the doses described above reduces the abusers or patients pulse substantially from the first dose.

- Sleeplessness: intake of said composition makes the abuser or patients to sleep effortlessly and calmly from the first night. - Restlessness: intake of said composition makes the abuser or patients able to concentrate during conversation and under therapy.

- Physical uneasiness: intake of said composition makes the abuser or patients to have a feeling of being relaxed and comfortable in their bodies.

- Loss of appetite: intake of said composition makes the abuser or patients to eat normally from the first day.

Diarrhoea and vomiting: intake of said composition makes the abuser or patients to experience diarrhoea in detoxification but considered it more as a cleansing of the body. Nausea can occur but not to a serious or intolerable level. It is possible to regulate this nausea with food and drink or by adjusting the dosage of the product.

Intense mental activity about alcohol: intake of said composition makes the abuser or patients symptoms of intensive craving for alcohol both physically and psychologically, absent or at a much lesser level when said composition is used for detoxification.

- The urge to drink: intake of said composition makes the abuser or patients urge/obsession to drink alcohol, which they normally suffer from, during detoxification as not so overwhelming or completely absent. The patients will not become ill if they choose to drink alcohol after consumption of said composition.

Examples

Example of production of a tablet

All ingredients in the ratios specified below are mixed 20-40 minutes in a sufficient powder mixer (a conus mixer), to an homogeneous bulk powder in the order listed from the recipe, except that the magnesium stearate was added finally after the basic mixing (20-40 minutes), and then the mixing procedure was continued for 1-5 minutes. The bulk tablet powder was compressed in a suitable tablet machinery, and the finished tablets had to comply to standard food and drug specifications, as well as the internal specifications of the active constituents from the herbal powder, analysed by HPLC.

The released tablets were packed in boxes, or blister packed.

Example of treatment

Tablets comprising the following constituents were prepared as described above:

Citrus aurantium, peels from fruit 83 mg

Angelica archangelica, leaves 60 mg

Salix alba, leaves 50 mg Passiflora incarnata, flowers 40 mg

Glycyrrhiza glabra, roots 40 mg

Leonurus cardiacea, leaves 40 mg

Valeriana officinalis, roots 33 mg

Cinnamomum cassia verum, cortex 17 mg Piper nigrum, seeds 17 mg

Mentha piperita, leaves 10 mg

Calcium carbonate 190 mg

Cellulose, microcrystallic 190 mg

Talc, asbestos-free 20 mg Silicum dioxid 6 mg

Magnesium stearate 4 mg

Total amount of each tablet 800 mg

It is a part of the invention that the daily intake of tablets is lowered along with the detoxification of the patients. In this experiment the patients had an average intake of 76.5 tablets at the first day, this declined to 16.0 tablets at day 5. Also the number of intake times decline as the intensity of the symptoms weakened. The maximum intake times a day was 6 times that is every 4^th hour. The average intake times at the first day was 5.2, with an average intake of 14.7 tablets at each time. At the 5^th day the patients intook tablets in average 2.4 times with an average intake of 6.8 tablets each time. Some patients stopped the tablet intake at day 4 due to only weak symptoms of adverse effects in combination of no urge of alcohol or drugs.

The results of the trial has been grouped into four groups denoted 'female alcohol', 'female drug', 'male alcohol' and 'male drug'. The group 'female alcohol' consist of 15 female patients only with an alcohol abuse. The group 'female drug' consist of 7 female patients with an abuse of drugs and a possible abuse of alcohol. The group 'male alcohol' consist of 14 male patients only with an alcohol abuse. The group 'male drug' consist of 9 male patients with an abuse of drugs and a possible abuse of alcohol.

The data is listed in the tables described below.

Table 1 shows the daily intake of tablets, no. of intake times and average of tablets/intake time. The table is separated for patients of the four groups mentioned above, and total for all patients.

Table 1 Tablet intake

The averages are calculated from the total number of patients in each group

Group Female, Female, Male, alMale, Total alcohol drug cohol drug

Number of patients 15 7 14 9 45

Day 1

Total no tablets 1067,0 556,0 1212,0 609,0 3444,0

Avg. intake of tab71 ,1 79,4 86,6 67,7 76,5 lets

No. Intake times 74,0 39,0 76,0 45,0 234,0

Avg. intake times 4,9 5,6 5,4 5,0 5,2

Avg. tablets/intake 14,4 14,3 15,9 13,5 14,7

Day 2

Total no tablets 836,0 514,0 924,0 494,0 2768,0

Avg. intake of tab55,7 73,4 66,0 54,9 61 ,5 lets

No. Intake times 76,0 38,0 70,0 43,0 227,0

Avg. intake times 5,1 5,4 5,0 4,8 5,0

Avg. tablets/intake 11 ,0 13,5 13,2 11 ,5 12,2

Day 3

Total no tablets 492,0 404,0 692,0 366,0 1954,0

Avg. intake of tab32,8 57,7 49,4 40,7 43,4 lets

No. Intake times 51 ,0 35,0 66,0 35,0 187,0 Avg. intake times 3,4 5,0 4,7 3,9 4,2 Avg. tablets/intake 9,6 11 ,5 10,5 10,5 10,4

Day 4

Total no tablets 310,0 264,0 328,0 250,0 1152,0 Avg. intake of tab20,7 37,7 23,4 27,8 25,6 lets

No. Intake times 40,0 27,0 39,0 32,0 138,0

Avg. intake times 2,7 3,9 2,8 3,6 3,1

Avg. tablets/intake 7,8 9,8 8,4 7,8 8,3

Day 5

Total no tablets 152,0 202,0 192,0 174,0 720,0 Avg. intake of tab10,1 28,9 13,7 19,3 16,0 lets

No. Intake times 27,0 22,0 30,0 27,0 106,0

Avg. intake times 1 ,8 3,1 2,1 3,0 2,4

Avg. tablets/intake 5,6 9,2 6,4 6,4 6,8

Table 2 is an overview of symptoms of adverse effects when the patients were treated with the detoxification tablets. The table is separated for each of the five days and for patients of the four groups mentioned above, and total for all patients. An adverse effect is registered at present for a patient at a certain day if the adverse effect is registered at least one time at that particular day of the treatment.

Table 2

No. of patients with adverse effect shown for each day of treatment

Female alFemale drug Male, alcoMale drug All pa cohol hol tients

15 patients 7 patients 14 patients 9 patients 45 patients

Day 1 No. Avg. No. Avg. No. Avg. No. Avg. No. Avg.

Headache 5 0,33 2 0,29 4 0,29 2 0,22 13 0,29

Nausea 12 0,80 6 0,86 8 0,57 7 0,78 33 0,73

Stomach9 0,60 4 0,57 6 0,43 2 0,22 21 0,47 ache

Uneasi2 0,13 3 0,43 3 0,21 3 0,33 11 0,24 ness in legs

Sneezing 1 0,07 3 0,43 2 0,14 3 0,33 9 0,20

Runny 1 0,07 4 0,57 2 0,14 2 0,22 9 0,20 nose and eyes

On and off 10 0,67 4 0,57 9 0,64 8 0,89 31 0,69 palpitation

Palpitation 10 0,67 5 0,71 10 0,71 6 0,67 31 0,69

Sweating 13 0,87 6 0,86 14 1 ,00 9 1 ,00 42 0,93

Shivering 4 0,27 6 0,86 2 0,14 4 0,44 16 0,36 fits 3£

Diarrhoea 11 0,73 5 0,71 12 0,86 7 0,78 35 0,78

Sweating 9 0,60 3 0,43 7 0,50 4 0,44 23 0,51 plams

Day 2 No. Avg. No. Avg. No. Avg. No. Avg. No. Avg.

Headache 6 0,40 0 4 0,29 2 0,22 12 0,27

Nausea 10 0,67 4 0,57 11 0,79 7 0,78 32 0,71

Stomach8 0,53 2 0,29 7 0,50 3 0,33 20 0,44 ache

Uneasi1 0,07 2 0,29 1 0,07 1 0,11 5 0,11 ness in legs

Sneezing 0 3 0,43 1 0,07 4 0,44 8 0,18

Runny 0 2 0,29 1 0,07 4 0,44 7 0,16 nose and eyes

On and off 10 0,67 4 0,57 7 0,50 7 0,78 28 0,62 palpitation

Palpitation 8 0,53 6 0,86 10 0,71 5 0,56 29 0,64

Sweating 13 0,87 6 0,86 12 0,86 8 0,89 39 0,87

Shivering 1 0,07 2 0,29 0 2 0,22 5 0,11 fits

Diarrhoea 12 0,80 6 0,86 13 0,93 9 1 ,00 40 0,89

Sweating 8 0,53 3 0,43 9 0,64 5 0,56 25 0,56 plams

Day 3 No. Avg. No. Avg. No. Avg. No. Avg. No. Avg.

Headache 1 0,07 1 0,14 1 0,07 2 0,22 5 0,11

Nausea 5 0,33 3 0,43 7 0,50 2 0,22 17 0,38

Stomach2 0,13 4 0,57 4 0,29 1 0,11 11 0,24 ache

Uneasi0 0 0 0 0 ness in legs

Sneezing 0 1 0,14 0 3 0,33 4 0,09

Runny 0 2 0,29 1 0,07 1 0,11 4 0,09 nose and eyes

On and off 10 0,67 5 0,71 8 0,57 4 0,44 27 0,60 palpitation

Palpitation 3 0,20 2 0,29 4 0,29 4 0,44 13 0,29

Sweating 9 0,60 5 0,71 8 0,57 8 0,89 30 0,67

Shivering 0 0,00 0 0 1 0,11 1 0,02 fits

Diarrhoea 11 0,73 7 1 ,00 8 0,57 8 0,89 34 0,76

Sweating 8 0,53 1 0,14 9 0,64 5 0,56 23 0,51 plams

Day 4 No. Avg. No. Avg. No. Avg. No. Avg. No. Avg.

Headace 4 0,27 0 1 0,07 1 0,11 6 0,13

Nausea 3 0,20 4 0,57 1 0,07 4 0,44 12 0,27

Stomach2 0,13 2 0,29 0 0 4 0,09 ache Uneasi- 1 0,11 1 0,02 ness in legs

Sneezing 0 0 0 2 0,22 2 0,04

Runny 0 0 1 0,07 1 0,11 2 0,04 nose and eyes

On and off 9 0,60 5 0,71 9 0,64 5 0,56 28 0,62 palpitation

Palpitation 1 0,07 1 0,14 1 0,07 1 0,11 4 0,09

Sweating 6 0,40 4 0,57 6 0,43 6 0,67 22 0,49

Shivering 0 0,00 2 0,29 0 2 0,22 4 0,09 fits

Diarrhoea 5 0,33 2 0,29 4 0,29 5 0,56 16 0,36

Sweating 8 0,53 3 0,43 9 0,64 6 0,67 26 0,58 plams

Day 5 No. Avg. No. Avg. No. Avg. No. Avg. No. Avg.

Headache 3 0,20 1 0,14 3 0,21 1 0,11 8 0,18

Nausea 1 0,07 3 0,43 2 0,14 2 0,22 8 0,18

Stomach0 2 0,29 0 0 2 0,04 ache

Uneasi0 0 0 1 0,11 1 0,02 ness in legs

Sneezing 0 0 0 0 0

Runny 0 0 1 0,07 1 0,11 2 0,04 nose and eyes

On and off 5 0,33 5 0,71 5 0,36 5 0,56 20 0,44 palpitation

Palpitation 1 0,07 0 3 0,21 0 4 0,09

Sweating 6 0,40 4 0,57 2 0,14 3 0,33 15 0,33

Shivering 0 0 0 1 0,11 1 0,02 fits

Diarrhoea 0 2 0,29 0 3 0,33 5 0,11

Sweating 7 0,47 1 0,14 5 0,36 7 0,78 20 0,44 plams

Figure 1 shows an example of the registration of tablet intake and of adverse effects for a patient.

Patients in the group 'female drug' had a higher daily intake of tablets than patients in the group 'female alcohol'. The patients in the group 'female drug' in average in- took 79.4 tablets distributed on 5.6 intake times at the first day with an average of 14.3 tablets pr. intake time. The patients in the group 'female alcohol' in average intook 71.1 tablets distributed on 4.9 intake times at the first day with an average of 14.4 tablets pr. intake time. At day 5 the patients in the group 'female drug' in average intook 28.9 tablets distributed on 3.1 intake times with an average of 9.2 tablets pr. intake time. The patients in the group 'female alcohol' in average intook 10.1 tablets distributed on 1.8 intake times at the fifth day with an average of 5.6 tablets pr. intake time

Patients in the group 'male alcohol' had a higher daily intake of tablets than patients in the group 'male drug', except at day 5. Patients in the group 'female drug' had a higher daily intake of tablets than patients in the group 'male drug'.

Patients in the group 'male alcohol' had a higher daily intake of tablets than patients in the group 'female alcohol'.

In general the patients had lesser symptoms at the end of the detoxification treatment period of five days than in the beginning of the detoxification treatment period.

Headache

The frequency of patients with headache decreased in general from 29% to 18% at day 5.

Nausea

The frequency of patients with nausea decreased in general from 73% to 18%, the decrease was especially observed from day 2 to day 3. Patients in the groups 'female drug' and 'male drug' had nausea for a longer period then patients in the other two groups. This was especially observed from day 3 to day 4.

Stomach-ache The frequency of patients with stomach-ache decreased in general from 47% to 4%, the decrease was especially observed from day 2 to day 3, but also from day 3 to day 4. Uneasiness in legs

The frequency of patients with uneasiness in legs decreased in general from 24% to nearly absent from day 3.

Sneezing

The frequency of patients with sneezing decreased in general from 20% to absent. The groups of 'female drug' and 'male drug' had the highest frequency of sneezing, and in these groups the decrease was observed later than for 'female alcohol' and 'male alcohol'.

Runny nose and eyes

The frequency of patients with runny nose and eyes decreased in general from 20% to nearly absent at day 4.

The groups of 'female drug' and 'male drug' had the highest frequency of runny nose and eyes, and the decrease was observed later in these groups than for 'female alcohol' and 'male alcohol'.

On and off palpitation

The frequency of patients with 'on and off palpitation' decreased in general from 69% to 44% at day 5.

Palpitation

The frequency of patients with palpitation decreased in general from 69% to 9%, especially from day 3 the decrease was observed.

Sweating

The frequency of patients with sweating decreased in general from 93% to 33%, the decrease in the frequency was especially observed from day 3 and until day 5.

Shivering fits

In general the frequency of patients with shivering fits decreased from 36% at day 1 to nearly absent at day 5. Especially in the group 'female drug' (86%), the frequency of shivering fits was high at day 1 , in the group 'male drug' the frequency was lower (44%), but still higher than the two groups 'female alcohol' (27%) and 'male alcohol' (14%). Only a single patient had shivering fits at day 5. Diarrhoea

In general the frequency of patients with diarrhoea was high the first three days (76%-89%), but decreased to 11% at day 5.

Sweating plams

The frequency of patients with sweating plams was nearly constant with a frequency about 50% within the five days of detoxification. In the group 'male, drug' the frequency of patients with sweating plams increased from 44% at day 1 to 78% at day 5, while the frequency in the group 'female, drug' decreased from 43% at day 1 and

2 to 14% at day 5.

Evaluation of the experiments

There are no problems in using the tablets, patients will not become ill if they choose to drink alcohol after consumption of the product. The patients are highly motivated to use the tablets as an alternative to doctor prescribed medicine, they describe it as a better alternative due to the absence of drowsiness, euphoria and other mood changing effects. They experience the feeling of being cleaned out, purged, and feel much better very quickly. They consider it a benefit that they can, from the first day, both eat and sleep at the normal regular times of the day. They also thrive by feeling refreshed during the daytime. Normal detoxification with doctor prescribed medicine gives the patients the feeling of being lethargic, dizzy and doped. They describe their condition under this detoxification as feeling comfortable and well. The patients have explained, that under earlier detoxification therapies, that is, with doctor pre- scribed medicine, they thought constantly about alcohol, they described it as a craving for alcohol. Said craving has either not been experienced at all or experienced only at a very low level in detoxification with the tablets claimed.

Those patients who desire detoxification due to the influence of taking doctor pre- scribed medicine complete detoxification very quickly with the tablets claimed. The patients experience either no withdrawal symptoms at all, or only slight discomfort, there is no feeling of intoxication.

Patients, which have completed detoxification at a therapy clinic have been able to participate in the daily therapy sessions from day one. From day two they have been able to participate in the daily cleaning and food preparation. Patients can also complete detoxification at home, these patients have often taken lesser doses of the tablets than patients completing detoxification at a therapy clinic.

Claims

Claims:

1. A composition comprising

- at least one active constituent from a plant of the family Apiceae, - at least one active constituent from a plant of the family Passifloraceae, and

- at least one active constituent from a plant of the family Lamiaceae.

2. The composition according to claim 1 , comprising

- at least one active constituent from the plant Angelica archangelica, - at least one active constituent from the plant Passiflora incarnata, and at least one active constituent from the plant Leonurus cardiacea.

3. The composition according to claim 2, comprising

- at least one active constituent selected from angelicin, archangelicin, apterin, furanocoumarin, flavones and organic aromatic acids from Angelica archangelica, at least one active constituent selected from vitexin, chrysin, tecto chrysin, galangin, apigenin, flavones and organic aromatic acids from Passiflora incarnata, and - at least one active constituent selected from leonurin, stachydrin, flavones and organic aromatic acids from Leonurus cardiacea.

4. The composition according to claim 3, comprising at least one active constituent selected from angelicin, archangelicin, and - at least vitexin, and

- at least leonurin.

5. The composition according to any of the preceding claims, comprising at least one active constituent from a plant of the family Salicaceae.

6. The composition according to claim 5, comprising at least one active constituent from the plant Salix alba.

7. The composition according to claim 6, comprising - at least one active constituent selected from salicin, flavones and organic aromatic acids from Salix alba.

8. The composition according to any of the preceding claims, comprising at least one active constituent from a plant of the family Valerianeceae.

9. The composition according to claim 8, comprising at least one active constituent from the plant Valeriana officinalis.

10. The composition according to claim 9, comprising at least one active constituent selected from groups of valereneacid, alkaloids, volatile oil, valepotriates, faurinone, flavones and organic aromatic acids from Valeriana officinalis.

11. The composition according to any of the preceding claims, comprising at least one active constituent from a plant of the family Rotaceae.

12. The composition according to claim 11 , comprising at least one active constituent from the plant Citrus aurantium.

13. The composition according to claim 12, comprising at least one active constituent selected from limonene, citral, hesperidin, naringin, li onin, flavones and organic aromatic acids from Citrus aurantium.

14. The composition according to claim 12, comprising at least one active constituent selected from hesperidin or naringin.

15. The composition according to any of the preceding claims, comprising at least one active constituent from a plant of the family Fabaceae.

16. The composition according to claim 15, comprising at least one active constituent from the plant Glycyrrhiza glabra.

17. The composition according to claim 16, comprising at least one active constituent selected from Glycyrrhizin, Glycyrrhetinic acid, liquiritigenin, isoliquiritigenin, liquiritin, glycyrans, flavones and organic aromatic acids from Glycyrrhiza glabra.

18. The composition according to claim 16, comprising at least one active constituent selected from Glycyrrhizin, liquiritin.

19. The composition according to claim 16, comprising at least Glycyrrhizin.

20. The composition according to any of the preceding claims, comprising at least one active constituent from a plant of the family Lauraceae.

21. The composition according to claim 20, comprising at least one active constituent from the plant Cinnamomum cassia verum.

22. The composition according to claim 21 , comprising at least one active constituent selected from eugenol, cinnamaldehyde, cinnezeylanine, procyanidins, cinnamtannins, flavones and organic aromatic acids from Cinnamomum cassia verum.

23. The composition according to claim 21 , comprising at least eugenol.

24. The composition according to any of the preceding claims, comprising at least one active constituent from a plant of the family Piperaceae.

25. The composition according to claim 24, comprising at least one active constituent from the plant Piper nigrum.

26. The composition according to claim 25, comprising at least one active constituent selected from (alfa-)- and (beta-)-pinene, phellandrene, dipentene, sesquiterpenes, piperine alkaloid, piperettine alkaloid, resin, flavones and organic aromatic acids from Piper nigrum.

27. The composition according to claim 25, comprising at least piperine alkaloid.

28. The composition according to any of the preceding claims, comprising at least one active constituent from a plant of the family Laminaceae.

29. The composition according to claim 28, comprising at least one active constituent from the plant Mentha piperita.

30. The composition according to claim 29, comprising at least one active constituent selected from menthol, menthyl acetate, neomentol, menthone, flavones and organic aromatic acids from Mentha piperita.

31. The composition according to claim 29, comprising at least one active constituent selected from menthol, menthone.

32. The composition according to claim 2, comprising - at least one active constituent from the plant Angelica archangelica,

- at least one active constituent from the plant Passiflora incarnata,

- at least one active constituent from the plant Leonurus cardiacea,

- at least one active constituent from the plant Salix alba, and at least one active constituent from the plant Valeriana officinalis.

33. The composition according to claim 2, comprising

- at least one active constituent from the plant Angelica archangelica,

- at least one active constituent from the plant Passiflora incarnata, at least one active constituent from the plant Leonurus cardiacea, - at least one active constituent from the plant Salix alba, at least one active constituent from the plant Valeriana officinalis,

- at least one active constituent from the plant Citrus aurantium,

- at least one active constituent from the plant Glycyrrhiza glabra, at least one active constituent from the plant Cinnamomum cassia verum, - at least one active constituent from the plant Piper nigrum, and

- at least one active constituent from the plant Mentha piperita.

34. The composition according to claim 2, wherein the at least one Angelica archangelica active constituent is in an extract from Angelica archangelica leaves.

35. The composition according to claim 2, wherein the at least one Passiflora incarnata active constituent is in an extract from Passiflora incarnata flowers.

36. The composition according to claim 2, wherein the at least one Leonurus cardiacea active constituent is in an extract from Leonurus cardiacea leaves.

37. The composition according to claim 2, wherein the

- at least one Angelica archangelica active constituent is in an extract from Angelica archangelica leaves,

- at least one Passiflora incarnata active constituent is in an extract from Passiflora incarnata leaves, and

- at least one Leonurus cardiacea active constituent is in an extract from Leonurus cardiacea leaves.

38. The composition according to claim 6, wherein the at least one Salix alba active constituent is in an extract from Salix alba leaves.

39. The composition according to claim 9, wherein the at least one Valeriana officinalis active constituent is in an extract from Valeriana officinalis roots.

40. The composition according to claim 32, wherein the at least one Angelica archangelica active constituent is in an extract from Angelica archangelica leaves, - at least one Passiflora incarnata active constituent is in an extract from

Passiflora incarnata leaves,

- at least one Leonurus cardiacea active constituent is in an extract from Leonurus cardiacea leaves,

- at least one Salix alba active constituent is in an extract from Salix alba leaves, and

- at least one Valeriana officinalis active constituent is in an extract from Valeriana officinalis roots.

41. The composition according to claim 12, wherein the at least one Citrus aurantium active constituent is in an extract from Citrus aurantium peels.

42. The composition according to claim 16, wherein the at least one Glycyrrhiza glabra active constituent is in an extract from Glycyrrhiza glabra roots.

43. The composition according to claim 21 , wherein the at least one Cinnamomum cassia verum active constituent is in an extract from Cinnamomum cassia verum cortex.

44. The composition according to claim 25, wherein the at least one Piper nigrum active constituent is in an extract from Piper nigrum seeds.

45. The composition according to claim 29, wherein the at least one Mentha piperita active constituent is in an extract from Mentha piperita leaves.

46. The composition according to claim 33, wherein the at least one Angelica archangelica active constituent is in an extract from Angelica archangelica leaves,

- at least one Passiflora incarnata active constituent is in an extract from Passiflora incarnata leaves, - at least one Leonurus cardiacea active constituent is in an extract from Leonurus cardiacea leaves, at least one Salix alba active constituent is in an extract from Salix alba leaves,

- at least one Valeriana officinalis active constituent is in an extract from Valeriana officinalis roots, - at least one Citrus aurantium active constituent is in an extract from Citrus aurantium peels, at least one Glycyrrhiza glabra active constituent is in an extract from Glycyrrhiza glabra roots,

- at least one Cinnamomum cassia verum active constituent is in an extract from Cinnamomum cassia verum cortex,

- at least one Piper nigrum active constituent is in an extract from Piper nigrum seeds, and

- at least one Mentha piperita active constituent is in an extract from Mentha piperita leaves.

47. The composition according to claim 2 wherein the

- at least one active constituent from the plant Angelica archangelica, is from freeze dried leaves,

- at least one active constituent from the plant Passiflora incarnata, is from freeze dried flowers and

- at least one active constituent from the plant Leonurus cardiacea is from freeze dried leaves.

48. The composition according to claim 6, wherein the at least one Salix alba active constituent is from freeze dried leaves from Salix alba.

49. The composition according to claim 9, wherein the at least one Valeriana officinalis active constituent is from freeze dried roots from Valeriana officinalis.

50. The composition according to claim 32 wherein the

- at least one active constituent from the plant Angelica archangelica, is from freeze dried leaves,

- at least one active constituent from the plant Passiflora incarnata, is from freeze dried flowers, - at least one active constituent from the plant Leonurus cardiacea is from freeze dried leaves

- at least one active constituent from the plant Salix alba is from freeze dried leaves, and

- at least one active constituent from the plant Valeriana officinalis is from freeze dried leaves.

51. The composition according to claim 12, wherein the at least one Citrus aurantium active constituent is from freeze dried peels from Citrus aurantium.

52. The composition according to claim 16, wherein the at least one Glycyrrhiza glabra active constituent is from freeze dried roots from Glycyrrhiza glabra.

53. The composition according to claim 21 , wherein the at least one Cinnamomum cassia verum active constituent is from freeze dried peels from Cinnamomum cassia verum.

54. The composition according to claim 25, wherein the at least one Piper nigrum active constituent is from freeze dried seeds from Piper nigrum.

55. The composition according to claim 29, wherein the at least one Mentha piperita active constituent is from freeze dried leaves from Mentha piperita.

56. The composition according to claim 33 wherein the

- at least one active constituent from the plant Angelica archangelica, is from freeze dried leaves,

- at least one active constituent from the plant Passiflora incarnata, is from freeze dried flowers,

- at least one active constituent from the plant Leonurus cardiacea is from freeze dried leaves - at least one active constituent from the plant Salix alba is from freeze dried leaves,

- at least one active constituent from the plant Valeriana officinalis is from freeze dried leaves,

- at least one active constituent from the plant Citrus aurantium, is from freeze dried peels,

- at least one active constituent from the plant Glycyrrhiza glabra is from freeze dried roots,

- at least one active constituent from the plant Cinnamomum cassia verum is from freeze dried peels, - at least one active constituent from the plant Piper nigrum is from freeze dried seeds, and

- at least one active constituent from the plant Mentha piperita is from freeze dried leaves.

57. The composition according to any of the preceding claims, said composition comprising one or more fractions derived from the plant Angelica archangelica leaves, at least one active constituent from the plant Passiflora incarnata leaves, and at least one active constituent from the plant Leonurus cardiacea leaves exhibiting peaks on HPLC.

58. The composition according to any of the preceding claims, said composition comprising one or more fractions derived from the plant Angelica archangelica leaves, at least one active constituent from Passiflora incarnata leaves, at least one active constituent from Leonurus cardiacea leaves, at least one active constituent from Salix alba leaves and at least one active constituent from

Valeriana officinalis roots exhibiting peaks on HPLC.

59. The composition according to any of the preceding claims, said composition comprising one or more fractions derived from the plant Angelica archangelica leaves, at least one active constituent from Passiflora incarnata leaves, at least one active constituent from Leonurus cardiacea leaves, at least one active constituent from Salix alba leaves, at least one active constituent from Valeriana officinalis roots, at least one active constituent from Citrus aurantium peels, at least one active constituent from Glycyrrhiza glabra roots, at least one active constituent from Cinnamomum cassia verum cortes, at least one active constituent from Piper nigrum seeds, and at least one active constituent from Mentha piperita leaves exhibiting peaks on HPLC.

60. The composition according to any of the preceding claims, said composition comprising a mixture expressed in weight percent as follows:

Angelica archangelica about 6% -11 %,

Passiflora incarnata about 4% -8%, and

Leonurus cardiacea about 4% -8%.

61. The composition according to any of the preceding claims, said composition comprising a mixture expressed in weight percent as follows:

Angelica archangelica about 6% -11 %, Passiflora incarnata about 4% -8%,

Leonurus cardiacea about 4% -8%,

Salix alba about 5% -9%, and

Valeriana officinalis about 4% -6%.

62. The composition according to any of the preceding claims, said composition comprising a mixture expressed in weight percent as follows:

Angelica archangelica about 6% -11 %, Passiflora incarnata about 4% -8%,

Leonurus cardiacea about 4% -8%,

Salix alba about 5% -9%,

Valeriana officinalis about 4% -6%,

Citrus aurantium about 8% -12%, Glycyrrhiza glabra about 4% -6%,

Cinnamomum cassia verum about 1% -3%,

Piper nigrum about 1 % -3%, and

Mentha piperita about 1 % -3%.

63. The composition according to any of the preceding claims, comprising one or more additives selected from calcium carbonate, microcrystalline cellulose, talc, silicium dioxide, magnesium stearate, calcium phosphate, potato starch, macrogolum.

64. The composition according to any of the preceding claims, comprising one or more additives selected from colorants, flavors, stabilisers, buffers, artificial and natural sweeteners, dispersants, thickeners, solubilizing agents, and the like.

65. The composition according to any of the preceding claims, comprising one or more additives selected from BHA, BHT, c-vitamin, rosemary or propolis.

66. A method for producing a composition as defined in any of the preceding claims, comprising the steps of

- obtaining at least one active constituent from a plant of the family Apiceae,

- at least one active constituent from a plant of the family Passifloraceae, and

- at least one active constituent from a plant of the family Lamiaceae,

- mixing said constituents, - forming a composition of said constituents.

67. A method for producing a composition as defined in any of the preceding claims, comprising the steps of

- obtaining

- at least one active constituent from a plant of the family Apiceae,

- at least one active constituent from a plant of the family Passifloraceae, - at least one active constituent from a plant of the family Lamiaceae,

- at least one active constituent from a plant of the family Salicaceae, and

- at least one active constituent from a plant of the family Valerianeceae,

- mixing said constituents,

- forming a composition of said constituents.

68. A method for producing a composition as defined in any of the preceding claims, comprising the steps of

obtain ing

- at least one active constituent from a plant of the family Apiceae,

- at least one active constituent from a plant of the family Passifloraceae,

- at least one active constituent from a plant of the family Lamiaceae,

- at least one active constituent from a plant of the family Salicaceae,

- at least one active constituent from a plant of the family Valerianeceae,

- at least one active constituent from a plant of the family Rotaceae

- at least one active constituent from a plant of the family Fabaceae

- at least one active constituent from a plant of the family Lauraceae

- at least one active constituent from a plant of the family Piperaceae, and

_ at least one active constituent from a plant of the family Laminaceae,

mixing said constituents,

forming a composition of said constituents.

69. A method according to claim 66, for producing a composition, comprising the steps of

- Obtaining

- at least one active constituent from the plant Angelica archangelica, at least one active constituent from the plant Passiflora incarnata, and

- at least one active constituent from the plant Leonurus cardiacea,

mixing said constituents,

- forming a composition of said constituents.

70. A method according to claim 67, for producing a composition, comprising the steps of

- Obtaining

- at least one active constituent from the plant Angelica archangelica, - at least one active constituent from the plant Passiflora incarnata,

- at least one active constituent from the plant Leonurus cardiacea,

- at least one active constituent from the plant Salix alba, and

- at least one active constituent from the plant Valeriana officinalis

- mixing said constituents,

- forming a composition of said constituents.

71. A method according to claim 68, for producing a composition, comprising the steps of

- Obtaining at least one active constituent from the plant Angelica archangelica, at least one active constituent from the plant Passiflora incarnata, - at least one active constituent from the plant Leonurus cardiacea, - at least one active constituent from the plant Salix alba,

- at least one active constituent from the plant Valeriana officinalis,

- at least one active constituent from the plant Citrus aurantium,

- at least one active constituent from the plant Glycyrrhiza glabra, - at least one active constituent from the plant Cinnamomum cassia verum,

- at least one active constituent from the plant Piper nigrum, and

- at least one active constituent from the plant Mentha piperita.

mixing said constituents,

- forming a composition of said constituents.

72. Use of a composition as defined in any of claims 1-71 , for the preparation of a natural drug.

73. Use of a composition as defined in any of claims 1-71 , for the preparation of a natural drug for the treatment of symptoms related to cessation of smoking.

74. Use of a composition as defined in any of claims 1-71 , for the preparation of a natural drug for the treatment of symptoms related to cessation of alcohol intake.

75. Use of a composition as defined in any of claims 1 -71 , for the preparation of a natural drug for the treatment of symptoms related to cessation of narcotics intake, such as but not limited to Marihuana, Ecstasy, amphetamine, heroin and/or benzodiazipenes (tranquillizers)

76. Use of a composition as defined in any of claims 1-71 , for the preparation of a natural drug for the treatment of sleep and/or eating disorder.

77. Use of a composition as defined in any of claims 1-71 , for the preparation of a natural drug for the treatment of anxiety.

78. Use of a composition as defined in any of claims 1-71 , for the preparation of a natural drug for the treatment of digestive disorders, such as obstipation.

79. Use of a composition as defined in any of claims 1-71 , for the preparation of a natural drug for the treatment of ulcers.

80. Use of a composition as defined in any of claims 1-71 , for the preparation of a natural drug for the treatment of pain.

81. Use of a composition as defined in any of claims 1-71 , for the preparation of a natural drug for the treatment of infections.

82. Use of a composition as defined in any of claims 1-71 , for the preparation of a natural drug for the treatment of sedative disorders.

83. Use of a composition as defined in any of claims 1-71 , for the preparation of a natural drug for the treatment of diuretic disorders.

84. Use of a composition as defined in any of claims 1-71 , for the preparation of a natural drug for sublingual, intranasal, topical, intra dermal, subcutaneous, intramuscular or rectal administration.

85. Use of a composition as defined in any of claims 1-71 , for the preparation of a natural drug for parenteral administration.

86. Use of a composition as defined in any of claims 1-71 , for the preparation of a natural drug for peroral administration.

87. Use of a composition as defined in any of claims 1-71 , for the preparation of a natural drug in a composition selected from powder, granules, pellets, capsules, tablets, aerosols, solutions, suspensions, sachets, chewing gum and tea.

88. Use of a composition as defined in any of claims 1-71 , for the preparation of a natural drug in a composition as tablets.

89. Use of a composition as defined in any of claims 1-71 , for the preparation of a natural drug in a composition as sachets.

90. Use of a composition as defined in any of claims 1-71 , for the preparation of a natural drug with systemic effects in the human organism.

91. Use of a composition as defined in any of claims 1-71 , for the preparation of a natural drug with tonic effects in the human organism.

92. A method for treating a disease, a condition or a symptom, comprising administering an effective amount of a natural drug comprising the composition according to any of claims 1-71 or claim 87-89.

93. The method according to claim 92, wherein the disease, condition or symptom is as defined in any of claims 73-83.

94. The method according to claim 92, wherein the natural drug administration is as defined in any of claims 84-86.

95. The method according to claim 92, wherein the natural drug has effects in the human organism as defined in any of claims 90-91.

Figure la

Client description

O c

CD O

m co m m σ>

7i

C m

Figure lb

CO c

CD CO

m co m m

7i c m

3/6

Figure Id

co c

CD CO

m co m m * c m

Figure le

o c

CD O

m o σ5 m m

c m ro

Figure if

o c

CD CO

m co σ> m m σ>

73 c m ro