EP2509613A1

EP2509613A1 - Compound for treating gastrointestinal problems

Info

Publication number: EP2509613A1
Application number: EP10785455A
Authority: EP
Inventors: Reiner Rittinghausen
Original assignee: Individual
Current assignee: Individual
Priority date: 2009-12-10
Filing date: 2010-12-09
Publication date: 2012-10-17
Also published as: WO2011070096A1

Abstract

The invention relates to a compound which is in particular suitable for treating gastrointestinal problems, the compound comprising extracts, essences and/or tinctures of plants and/or plant parts of Chamomilla recutica, Melissa officinalis, Mentha x piperita, Carum carvi and Centaurium erythraea.

Description

Composition for the treatment of gastrointestinal complaints

The present invention relates to a composition suitable for the treatment of gastrointestinal disorders, in particular flatulence and mild spasmodic gastrointestinal disorders.

Gastric and intestinal complaints are widespread health problems with multiple causes. Often stomach / bowel problems occur after eating and are with

Pain, feeling of fullness and nausea associated. It is usually an overload of the stomach due to too hasty, lush, too fatty or too sweet food. Even stressful situations and hectic situations can trigger unpleasant gastrointestinal reactions. Another consequence of digestive problems is bloating, which, if they are particularly severe, can also cause pain. Furthermore, certain foods can cause indigestion and abdominal pain, as well as lead to gas formation in the intestine, which can be accompanied by stinging pain in the abdomen.

Because of the many possible causes of gastrointestinal discomfort therapy is difficult, with many known remedies for gastrointestinal complaints are directed to the treatment of individual causes, such as hyperacidity of the stomach.

Known in the art are not only drug therapies but also herbal medicines, which often combine a high number of ingredients to combat as many causes. Also known are agents containing basic substances which are said to calm the stomach. The disadvantage is that active ingredients are taken, which can be particularly afflicted with chemical preparations with numerous side effects or at least unnecessarily influence the body's stomach / intestinal function.

There is therefore a need for an agent that has been specifically developed for the treatment of mild gastrointestinal complaints such as flatulence and mild spasmodic gastrointestinal disorders. In addition, there is a need for an agent which as such does not cause any harmful side effects and is therefore safe to use for a long time.

It is therefore the object of the present invention to provide a means that overcomes at least one of the aforementioned disadvantages of the prior art.

In particular, it is the object of the present invention to provide a composition which is useful in mild gastrointestinal disorders.

The object is achieved by a composition containing extracts, tinctures and / or extracts of plants and / or plant parts of Chamomilla recutica (chamomile), Melissa officinalis (lemon balm), Mentha x piperita (peppermint), Carum carvi (caraway) and

Centaurium erythraea (centaury). The composition particularly suitable for the treatment of gastrointestinal disorders comprises, based on the

Total volume of the composition:

in the range of> 0.1 vol .-% to <10 vol .-% extract, tincture and / or extract of

Plants and / or plant parts of Centaurium erythraea;

in the range of> 5 vol .-% to <50 vol .-% extract, tincture and / or extract of

Plants and / or plant parts of Chamomilla recutica;

in the range of> 5% by volume to <50% by volume extract, tincture and / or extract of plants and / or plant parts of Melissa officinalis; in the range of> 5 vol .-% to <50 vol .-% extract, tincture and / or extract of plants and / or plant parts of Mentha x piperita;

in the range of> 5 vol .-% to <50 vol .-% extract, tincture and / or extract of

Plants and / or plant parts of Carum carvi,

wherein the volume contents of the respective components are chosen such that the

Total volume of components does not exceed 100% by volume.

Advantageous embodiments of the composition of the invention are in the

Subclaims specified.

For the purposes of the present invention, the term "tincture" is understood to mean drug extracts which are prepared using alcohol, in particular ethanol of suitable concentration The term "tincture" for the purposes of the present invention also includes so-called "mother tinctures" and mixtures of vegetable press juices with alcohol In particular, the term "tincture" includes drug extracts according to the Homeopathic Pharmacopoeia (HAB) from fresh or dried plants and / or plant parts, especially fresh plants and / or plant parts.

For the purposes of this invention, the term "extract" means extracts of plants and / or plants, optionally adjusted to a certain active substance content

Plant parts of liquid, viscous or dry nature, which are obtained, for example, using alcohol, especially ethanol, understood.

In preferred embodiments, homeopathic tinctures and extracts, in particular liquid alcoholic plant extracts, alcoholic and in particular ethanolic tinctures are used. The composition is preferably a herbal composition. For the purposes of this invention, the term "herbal composition" is used

Compositions understood that are made on a vegetable basis, in particular based on extracts of plants and / or plant parts.

For the purposes of the present invention, the term "gastrointestinal complaints" is understood to mean findings which can have a variety of causes and impairments of the patient

Health and well-being such as feeling unwell, nausea, vomiting, feeling of fullness, abdominal pain, cramps or flatulence after eating accompanied, preferably without serious organic damage or disease. For the purposes of the present invention, the term "gastrointestinal complaints" is also understood to mean nervous stomach / intestinal disorders and motility disorders of the gastrointestinal tract.

Surprisingly, it has been found that compositions of the invention, in addition to extracts, tinctures and / or extracts of plants and / or plant parts of Chamomilla recutica (chamomile), Melissa officinalis (lemon balm), Mentha x piperita

(Peppermint), Carum carvi (caraway), extracts, tinctures and / or extracts of

Centaurium erythraea (centaury) has an improved action in the treatment of gastrointestinal discomfort, especially mild spasmodic

Show gastrointestinal disturbances and flatulence.

In particular, it has surprisingly been found that the composition according to the invention can be obtained by extracts, tinctures and / or extracts of Centaurium erythraea both in

prophylactic as well as therapeutic treatment of gastrointestinal discomfort, especially with regard to convulsive gastrointestinal disorders and flatulence can improve an effect. Without being bound to a particular theory, it is believed that the surprisingly good effect of the invention Composition is supported by synergistic effects due to the contained extracts, tinctures and / or extracts of Centaurium erythraea.

In particular, it is advantageous that a good effect on gastrointestinal discomfort can be achieved solely by the medicinal plants Chamomilla recutica, Melissa officinalis, Mentha x piperita, Carum carvi and Centaurium erythraea, so that on a variety of

Components can be dispensed with. This is particularly advantageous since supplied

Active substances may be associated with side effects or at least have an unnecessary effect on the gastrointestinal function. In preferred embodiments, the composition comprises only extracts, tinctures and / or extracts of Chamomilla recutica, Melissa officinalis, Mentha x piperita, Carum carvi and Centaurium erythraea as effective components.

A significant advantage of the composition is realized by the fact that the

Composition comprising Centaurium erythraea, Chamomilla recutica (chamomile), Melissa officinalis (lemon balm), Mentha x piperita (peppermint) and Carum carvi (cumin) due to the low number of effective medicinal plants preferably little or no allergies triggers. An increasing number of people suffer from allergies or

Hypersensitivity to pollen or other ingredients of one or more plants. Hypersensitivity reactions may also occur when taking herbal

Compositions occur and manifest themselves, for example, in the form of skin rash, itching or difficulty in breathing. It is therefore of great advantage that the composition according to the invention reduces the risk of such reactions due to the small number of effective medicinal plants. In particular, for persons with a tendency to allergies, this can result in advantages in use.

The composition of the invention is excellent for the treatment of

Suitable for gastrointestinal complaints. In particular, the composition may continue characterized in that it does not cause photosensitivity of the skin and / or dermatitis. In particularly advantageous embodiments of the

Composition, this has no extracts, tinctures and / or extracts of plants, which can cause photosensitivity of the skin and / or dermatitis, such as angelica root. The use of angelica root can increase the photosensitivity of the skin due to the furocumarine contained and lead to skin inflammation in connection with UV irradiation.

In further particularly advantageous embodiments of the composition, it has no extracts, tinctures and / or extracts from plants which have toxic alkaloids, such as celandine. In celandine, for example, more than 30 different alkaloids have been detected. Alkoloids are very complex and difficult to remove from plant extracts. Alkaloids are already considered to be of concern in small quantities and can cause carcinogens and lead to harmful poisoning.

Investigations by the Applicant have shown that, contrary to the prejudice that celandine is an important component for remedies for complaints of the stomach and intestine, the composition according to the invention can have a corresponding effect even without celandine. In particular, it has been found that in the composition according to the invention without celandine no irritation to the stomach and intestine occur. The composition according to the invention can, contrary to the aforementioned prejudice, also without celandine, have an effect on gastrointestinal complaints, in particular with regard to convulsive gastrointestinal disorders and flatulence.

Furthermore, hepatotoxic effects of celandine are known. It is therefore a particular advantage of the present invention that there is no hepatotoxic risk with good tolerability and high efficacy. Also, the composition of the invention has no extracts, tinctures and / or extracts of the also commonly used milk thistle. Another advantage of the composition is realized by the fact that the composition is able to produce an equally good effect in the treatment of gastrointestinal discomfort as compositions containing milk thistle

In particular, the composition according to the invention has no extracts, tinctures and / or extracts from licorice. Extracts from licorice root are attributed a soothing and spasmolytic effect on the stomach, as well as a preventive and healing effect on gastric ulcers. However, licorice root has been shown to have glucocorticoid side effects, causing blood pressure increase,

Headache and edema. Investigations by the Applicant have shown that, contrary to the prejudice that extracts of licorice root are an important component of remedies for complaints of the stomach and intestine, the composition according to the invention may also have a corresponding effect without licorice.

Inasmuch as the composition of the present invention is as effective in treating gastrointestinal disorders as compositions containing angelica root, celandine and / or licorice, the present invention overcomes a long-standing prejudice in the art.

In particular, the composition according to the invention without extracts, tinctures and / or extracts of angelica root, celandine and / or licorice opens the possibility that the composition can be dosed higher and longer. It is particularly advantageous that there is no danger of unintentional overdosing. A particular advantage of the composition is realized in that the

Composition including Centaurium erythraea, ChamomiUa recutica (chamomile), Melissa officinalis (lemon balm), Mentha x piperita (peppermint) and Carum carvi (caraway) is as effective in the treatment of gastrointestinal discomfort as cuneiform compositions and / or angelica root, but the risk of side effects is significantly reduced.

Of particular advantage here is that it was surprisingly found that when using the composition according to the invention compared with preparations containing a higher number of effective medicinal plants comparable good effect in the treatment of gastrointestinal complaints can be achieved.

It is furthermore of particular advantage that the composition according to the invention can be used in migraine-related gastrointestinal complaints. Migraine sufferers are considered to be particularly difficult to treat, as they often already suffer from migraines due to malaise, nausea or vomiting, and on the other hand often continue to show a disturbance of the gastrointestinal motility. Again, it is believed that the good effect in migraine patients on the interaction of Centaurium erythraea with ChamomiUa recutica (chamomile), Melissa officinalis (lemon balm), Mentha x piperita

(Peppermint) and Carum carvi (caraway) can be traced.

Advantageously, the composition according to the invention contains active substances obtainable from plants and / or plant parts of ChamomiUa recutica, Melissa officinalis, Mentha x piperita, Carum carvi and Centaurium erythraea. The composition according to the invention is particularly distinguished over known plant-based agents in that the composition comprises a special selection of extracts, tinctures and / or extracts of certain plants and / or plant parts, namely ChamomiUa recutica, Melissa officinalis, Mentha x piperita, Carum carvi and Centaurium erythraea, as effective Ingredients has. As a result, the composition according to the invention is particularly suitable for the prophylactic or therapeutic treatment of gastrointestinal complaints and flatulence.

In preferred embodiments, the composition comprises

Total volume of the composition, in the range of> 0.5 vol .-% to <10 vol .-%, preferably in the range of> 1 vol .-% to <8 vol .-%, more preferably in the range of> 2 vol. % to <6% by volume, more preferably in the range from> 4% by volume to <5% by volume, extract, tincture and / or extract of plants and / or plant parts of Centaurium erythraea.

Centaurium erythraea is also referred to as centaury, Chamomilla recutica, Melissa officinalis, Mentha x piperita and Carum carvi are also referred to as chamomile, lemon balm, peppermint and caraway.

In particular, contents of extract, tincture and / or extract in the range of> 1 vol .-% to <10 vol .-%, preferably in the range of> 2 vol .-% to <8 vol .-%, particularly preferably in the range of > 4 vol .-% to <5 vol .-%, based on the total volume of

Composition, on plants and / or plant parts of Centaurium erythraea, can advantageously improve the effectiveness of the composition especially in case of feeling of fullness and flatulence.

Unless stated otherwise, the volume contents of the respective components are chosen such that the total volume of the respective components does not exceed 100% by volume, based on the total composition.

Further advantages of the composition according to the invention will be apparent from the

Concentration profile of the composition. For example, it was found that a higher levels of lemon balm, peppermint and cumin can significantly improve the effectiveness of stomach pain and nausea.

In preferred embodiments, the composition comprises in the range of> 10% by volume to <30% by volume, preferably in the range of> 15% by volume to <25% by volume, particularly preferably in the range of> 20% by volume. % to <22 vol .-%, based on the total volume of the composition, extract, tincture and / or extract of plants and / or plant parts of Chamomilla recutica.

In also preferred embodiments, the composition comprises in the range of> 15 vol.% To <35 vol.%, Preferably in the range of> 20 vol.% To <30 vol.%,

preferably in the range from> 23% by volume to <25% by volume, based on the total volume of the composition, extract, tincture and / or extract of plants and / or

Plant parts of Melissa officinalis.

In further preferred embodiments, the composition comprises in the range of> 20 vol.% To <40 vol.%, Preferably in the range of> 25 vol.% To <35 vol.%, Preferably in the range of> 28 vol. % to <30% by volume, based on the total volume of the composition, extract, tincture and / or extract of plants and / or

Plant parts of Mentha x piperita.

In also preferred embodiments, the composition comprises in the range of> 15 vol.% To <40 vol.%, Preferably in the range of> 20 vol.% To <35 vol.%,

preferably in the range from> 25% by volume to <30% by volume, based on the total volume of the composition, extract, tincture and / or extract of plants and / or

Plant parts of Carum carvi. The composition of the invention is characterized by a surprisingly improved compatibility. In particular, the combination of Chamomilla recutica, Melissa officinalis, Mentha x piperita, Carum carvi and Centaurium erythraea can be characterized by a good efficacy in gastrointestinal complaints and at the same time good tolerability.

In particularly preferred embodiments, the composition comprises, based on the total volume of the composition:

4 vol .-% extract, tincture and / or extract of plants and / or plant parts of

Centaurium erythraea; and or

20 vol.% Extract, tincture and / or extract of plants and / or plant parts of Chamomilla recutica; and or

23 vol .-% extract, tincture and / or extract of plants and / or plant parts of Melissa officinalis; and or

28 vol .-% extract, tincture and / or extract of plants and / or plant parts of Mentha x piperita; and or

25 vol.% Extract, tincture and / or extract of plants and / or plant parts of Carum carvi,

Total volume of components does not exceed 100% by volume.

Extracts, tinctures and extracts can be prepared from whole plants, preferably extracts, tinctures and extracts of plant parts, for example, from flowers, leaves, stems, roots or seeds of plants can be produced. Extracts, tinctures and extracts of Centaurium erythraea from the aboveground parts of plants, in particular from the herbaceous parts of plants, can preferably be produced. Extracts, tinctures and extracts of Chamomilla recutica from the flowers are preferably produced. Preferably, extracts, tinctures and extracts of Melissa officinalis can be produced from the leaves. Extracts, tinctures and extracts of Mentha x piperita are preferably preparable for the leaves. Extracts, tinctures and extracts of Carum carvi from the fruits are preferably producible.

In preferred embodiments, the composition comprises extracts, tinctures and / or extracts of chamomile flowers, lemon balm leaves, peppermint leaves,

Caraway fruits and / or the herbaceous parts of the plant of centaury.

In a particularly preferred embodiment, the composition comprises, based on the total volume of the composition:

4 vol.% Extract, tincture and / or extract of Centaurium erythraea herba;

20 vol.% Extract, tincture and / or extract of Chamomilla recutica flos;

23 vol.% Extract, tincture and / or extract of Melissa officinalis folium;

28 vol.% Extract, tincture and / or extract of Mentha x piperita folium; and

25 vol .-% extract, tincture and / or extract of Carum carvi fructum.

In preferred embodiments, the composition comprises alcoholic, aqueous, or aqueous-alcoholic extracts of plants and / or plant parts of Chamomilla recutica and Carum carvi. Particularly preferred are extracts of liquid nature, so-called fluid extracts.

In also preferred embodiments, the composition comprises alcoholic, aqueous, or aqueous-alcoholic tinctures of plants and / or plant parts of Melissa officinalis, Mentha x piperita and Centaurium erythraea. In further preferred

Embodiments, the composition comprises alcoholic, aqueous, or

aqueous-alcoholic extracts of plants and / or plant parts of Chamomilla recutica and Carum carvi and alcoholic, aqueous, or aqueous-alcoholic tinctures Plants and / or Pnanzenteilen of Melissa officinalis, Mentha x piperita and Centaurium erythraea on.

The weight ratio of the macerated or percolated plant parts of Centaurium erythraea to the extract is preferably in the range from 1: 4.2 to 1: 5 (w / w), preferably in the range from 1: 4.5 to 1: 4.8 (w / w). w), more preferably at 1: 5 (w / w). Preferably, the weight ratio of the macerated or percolored plant parts of ChamomiUa recutica to the extract is in the range of 1: 2 to 1: 4 (w / w). This is preferably

Weight ratio of the macerated or percolated plant parts of Melissa officinalis to the extract in the range of 1: 4-5 (w / w), preferably in the range of 1: 4.5-5 (w / w), particularly preferably 1: 5 (w / w). Preferably, the weight ratio of the macerated or percolored plant parts of Mentha x piperita to the extract is in the range of in the range of 1: 4-5 (w / w), more preferably in the range of 1: 4.5-5 (w / w) preferably at 1: 5 (w / w). Preferably, the weight ratio of the macerated or percolated plant parts of Carum carvi to the extract is in the range of 1: 2 to 1: 3 (w / w).

Preferably, extracts and tinctures by means of alcoholic, aqueous or

aqueous alcoholic extractants produced. Extracts and tinctures according to pharmacopoeia are preferably preparable by means of ethanol-water mixtures.

In preferred embodiments, aqueous-alcoholic extracts of plants and / or plant parts of Chamomiua recutica, Melissa officinalis, Mentha x piperita, Carum carvi and / or Centaurium erythraea are aqueous-ethanolic extracts. Preferably, the extractant used is an ethanol-water mixture, the concentration of ethanol preferably being in the range of 30% (v / v) to 90% (v / v), preferably in the range of 45% (v / v) to 70 % (v / v) is. Preferably, the ethanol concentration of the aqueous ethanolic tincture of Centaurium erythraea is 45% (v / v) or 70% (v / v). Preferably, the concentration of ethanol of the aqueous-ethanolic tinctures of Melissa officinalis and Mentha x piperita is 45% (v / v). Preferably, the ethanol concentration of the aqueous ethanolic extracts of Chamomilla recutica and Carum carvi is 45% (v / v).

The composition is in preferred embodiments a drug,

pharmaceutical preparation, medical device, dietary supplement, dietary

Food and / or a complementary balanced diet. An object of the invention thus relates to a pharmaceutical, pharmaceutical preparation, medical device,

Nutritional supplement, dietetic food and / or supplemental balanced diet comprising a composition according to the invention. Preferably, the

Composition in the form of a drug or a pharmaceutical preparation. In particularly preferred embodiments, the composition is useful as a drug, most preferably the composition is a drug. The

Composition may more preferably be in the form of a dietetic food.

The composition may be solid, liquid and / or gel. Preferably, the composition is in liquid dosage form, preferably selected from the group comprising solution, tincture, juice and / or suspension.

Preferably, the composition is a liquid dosage form. Preferably, the liquid composition is formulated for oral administration. The advantage of

Liquids is their quick onset and easy intake. In particular, liquid dosage forms in the form of drops or small volumes can be administered. This is particularly advantageous when due to gastrointestinal discomfort

Swallowing solid forms of administration is perceived as unpleasant or the The ability to swallow is restricted. Furthermore, liquid dosage forms can be easily and reliably dosed by volume.

In further preferred embodiments, the composition is in the form of a solid dosage form, preferably selected from the group comprising powder and / or granules. Powders and / or granules contain extracts, tinctures and / or extracts of plants and / or plant parts of Chamomilla recutica (chamomile), Melissa officinalis (lemon balm), Mentha x piperita (peppermint), Carum carvi (caraway) and

Centaurium erythraea (centaury), preferably in dried form. A powder or granules can be used in particular for the preparation of a beverage, for example a tea, in particular a stomach infusion. In particularly preferred

In embodiments, the composition is in the form of a gelatinous dosage form, for example in the form of a carbohydrate-based gel. A gel may be in a gel form for direct administration or, more preferably, may be useful in the preparation of a beverage. The advantage of a gelatinous administration form lies in the easy swallowability of the gel and in particular in a comparably small amount

Volume that facilitates administration, especially in patients with a feeling of fullness.

Preferred dosages of a liquid composition according to the invention for oral administration to humans are in the range of> 0.5 ml / day to <25 ml / day, preferably in the range of> 5 ml / day to <20 ml / day, still preferably in the range from> 10 ml / day to <15 ml / day. The dosages per day are administrable in the form of a single dose, preferably the dosages are in the form of several doses

administrable, for example, 5 ml of composition three times a day. Preferably, a dosage in the range of> 0.5 ml / day to <25 ml / day, preferably in the range of> 5 ml / day to <20 ml / day, more preferably in the range of> 10 ml / day to <15 ml / day of a composition comprising:

in the range from> 0.1% by volume to <10% by volume, preferably in the range from> 0.5% by volume to <10% by volume, also preferably in the range of> 1% by volume to <8% by volume, more preferably in the range from> 2% by volume to <6% by volume, particularly preferably in the range from> 4% by volume to <5% by volume, based on the total volume of the

Composition, extract, tincture and / or extract of plants and / or

Parts of plants of Centaurium erythraea; and or

in the range of> 5 vol.% to <50 vol.%, preferably in the range of> 10 vol.% to <30 vol.%, preferably in the range of> 15 vol.% to <25 vol. %, more preferably in the range of> 20 vol .-% to <22 vol .-%, based on the

Total volume of the composition, extract, tincture and / or extract of plants and / or plant parts of Chamomilla recutica; and or

in the range of> 5 vol.% to <50 vol.%, preferably in the range of> 15 vol.% to <35 vol.%, preferably in the range of> 20 vol.% to <30 vol. %, more preferably in the range of> 23 vol .-% to <25 vol .-%, based on the

Total volume of the composition, extract, tincture and / or extract of plants and / or parts of plants of Melissa officinalis; and or

in the range of> 5 vol.% to <50 vol.%, preferably in the range of> 20 vol.% to <40 vol.%, preferably in the range of> 25 vol.% to <35 vol. %, more preferably in the range of> 28 vol .-% to <30 vol .-%, based on the

Total volume of the composition, extract, tincture and / or extract of plants and / or parts of plants of Mentha x piperita; and or

in the range of> 5 vol.% to <50 vol.%, preferably in the range of> 15 vol.% to <40 vol.%, preferably in the range of> 20 vol.% to <35 vol. %, more preferably in the range of> 25 vol .-% to <30 vol .-%, based on the Total volume of the composition, extract, tincture and / or extract of

Plants and / or plant parts of Carum carvi,

Total volume of components does not exceed 100% by volume.

Solid and gelatinous administration forms are preferably in the form of sachets which preferably contain a single dose.

In preferred embodiments, the composition consists of extracts, tinctures and / or extracts of Chamomilla recutica, Melissa officinalis, Mentha x piperita, Carum carvi and Centaurium erythraea, as active ingredients and usual excipients of the formulation.

Another object of the present invention relates to an inventive

A composition for use in the prophylactic and / or therapeutic treatment of gastrointestinal disorders, in particular selected from the group comprising flatulence, convulsive gastrointestinal disorders, gastrointestinal influenza,

Travel sickness and / or stomach pain in migraine.

The term "gastrointestinal flu" or gastroenteritis is to be understood as one of the most prevalent and common diseases of the gastrointestinal tract, which is associated with abdominal pain and abdominal cramps, vomiting and diarrhea. The term "motion sickness" or kinetosis is understood to mean so-called movement diseases, which are caused by unusual movement and acceleration of means of transport, for example cars, ships (seasickness), trains or airplanes. Symptoms are dizziness or vomiting, especially nausea. Advantageously, the composition of the invention, in addition to extracts, tinctures and / or extracts of plants and / or plant parts of Chamomilla recutica (chamomile), Melissa officinalis (lemon balm), Mentha x piperita (peppermint), Carum carvi (caraway), extracts , Tinctures and / or extracts of Centaurium erythraea

(Centaury), have a good effect in the treatment of gastrointestinal discomfort, especially mild spasmodic gastrointestinal disorders and flatulence.

Of particular advantage is that it was surprisingly found that at

Use of the composition according to the invention compared to preparations containing a higher number of effective medicinal plants comparable good effect in the treatment of gastrointestinal discomfort can be achieved without angelica root, celandine and / or licorice are included, which can develop side effects. Thus, the composition of the invention allows a comparable effect with significantly better safety and lower risk for patients.

Surprisingly, it has been found in particular that the inventive

Composition in migraine-related stomach pain and dysmotility is useful. Migraine sufferers are considered to be particularly difficult to treat, as they often already suffer from migraines due to malaise, nausea or vomiting, and on the other hand often continue to show a disturbance of the gastrointestinal motility. Due to the lack of intestinal motility, the patients are orally untreatable over the duration of this disorder, which is a particularly severe limitation of the acute therapy for the patient and may require the visit of a physician for the performance of a parenteral therapy. It is therefore of particular advantage that it was surprisingly found that by administering the composition according to the invention, migraine patients can again show an intestinal motility. Since migraine therapeutics almost without any hepatotoxic potential, the present composition without hepatotoxic potential of particular importance for migraineurs.

It is particularly advantageous that by avoiding the occurrence of side effects a longer-term administration of the composition according to the invention and / or administration in higher doses is made possible. This allows in particular the

Administration of the composition of the invention in an acute treatment as a single and / or multiple, time-limited administration, not before

Occurrence of a disease must be started or used in the long term to achieve an effect.

For the purposes of this invention, an "acute treatment" is understood to mean administration with the effect of producing an advantageous effect at the time shortly before, during or after the onset of the disease, without any preceding long-term administration being independent of disease states, ie. H. over several days, weeks or months, is necessary. In an "acute treatment" in the context of this invention thus comes to relieve the symptoms, without this one of disease states

independent, prophylactic administration and / or a long-term treatment is necessary.

Another object of the present invention therefore relates to a composition according to the invention for use in the acute treatment of gastrointestinal complaints, in particular selected from the group comprising flatulence, convulsive gastrointestinal disorders, gastrointestinal influenza, motion sickness and / or stomach pain Migraines, especially the acute treatment of gastrointestinal influenza and / or motion sickness.

In particular, in acute treatment of gastrointestinal influenza and motion sickness rapid onset is beneficial. Furthermore, a longer-term administration of the inventive

Composition with comparable effect with significantly better safety and thus lower risk for patients allows.

Another object of the present invention relates to a pharmaceutical

pharmaceutical preparation, medical device, dietary supplement, dietary

Food and / or supplementary balanced diet comprising a composition according to the invention.

The composition of the invention for use in the prophylactic and / or therapeutic treatment of gastrointestinal disorders, especially selected from the group comprising flatulence, convulsive gastrointestinal disorders, gastrointestinal influenza, motion sickness and / or stomach pain in migraine, the Composition according to the invention for use in the acute treatment of gastrointestinal disorders and of the medicament, pharmaceutical preparation, medical device,

Dietary supplement, dietetic food and / or supplemental balanced diet comprising a composition of the invention, based on the

Total volume of the composition:

Plants and / or plant parts of Centaurium erythraea;

in the range of> 5 vol .-% to <50 vol .-% extract, tincture and / or extract of

Plants and / or plant parts of Chamomilla recutica;

in the range of> 5% by volume to <50% by volume extract, tincture and / or extract of plants and / or plant parts of Melissa officinalis;

in the range of> 5 vol .-% to <50 vol .-% extract, tincture and / or extract of plants and / or plant parts of Mentha x piperita; in the range of> 5 vol .-% to <50 vol .-% extract, tincture and / or extract of

Plants and / or plant parts of Carum carvi,

Total volume of components does not exceed 100% by volume.

Advantageously, the composition contains active ingredients obtainable from plants and / or plant parts of Chamomilla recutica, Melissa officinalis, Mentha x piperita, Carum carvi and Centaurium erythraea.

In preferred embodiments, the composition comprises

Plant parts of Melissa officinalis. In further preferred embodiments, the composition comprises in the range of> 20 vol.% To <40 vol.%, Preferably in the range of> 25 vol.% To <35 vol.%, Preferably in the range of> 28 vol. % to <30% by volume, based on the total volume of the composition, extract, tincture and / or extract of plants and / or

Plant parts of Mentha x piperita.

In also preferred embodiments, the composition comprises in the range of> 15 vol.% To <40 vol.%, Preferably in the range of> 20 vol.% To <35 vol.%, Preferably in the range of> 25 vol. % to <30% by volume, based on the total volume of the composition, extract, tincture and / or extract of plants and / or

Plant parts of Carum carvi.

4 vol .-% extract, tincture and / or extract of plants and / or plant parts of

Centaurium erythraea; and or

Total volume of components does not exceed 100% by volume. Extracts, tinctures and extracts of Centaurium erythraea from the aboveground parts of plants, in particular from the herbaceous parts of plants, can preferably be produced. Extracts, tinctures and extracts of Chamomilla recutica from the flowers are preferably produced. Preferably, extracts, tinctures and extracts of Melissa officinalis can be produced from the leaves. Extracts, tinctures and extracts of Mentha x piperita are preferably preparable for the leaves. Extracts, tinctures and extracts of Carum carvi from the fruits are preferably producible. In preferred embodiments, the composition comprises extracts, tinctures and / or extracts of chamomile flowers, lemon balm leaves,

Peppermint leaves, caraway fruits and / or the herbaceous parts of plants

Centaury flower on.

4 vol.% Extract, tincture and / or extract of Centaurium erythraea herba;

20 vol.% Extract, tincture and / or extract of Chamomilla recutica flos;

23 vol.% Extract, tincture and / or extract of Melissa officinalis folium;

28 vol.% Extract, tincture and / or extract of Mentha x piperita folium; and

25 vol .-% extract, tincture and / or extract of Carum carvi fructum.

In preferred embodiments, the composition comprises alcoholic, aqueous, or aqueous-alcoholic extracts of plants and / or plant parts of Chamomilla recutica and Carum carvi. Particularly preferred are extracts of liquid nature, so-called fluid extracts. In also preferred embodiments, the

Composition of alcoholic, aqueous, or aqueous-alcoholic tinctures of plants and / or plant parts of Melissa officinalis, Mentha x piperita and Centaurium erythraea on. In further preferred embodiments, the composition comprises alcoholic, aqueous, or aqueous-alcoholic extracts of plants and / or plant parts of Chamomilla recutica and Carum carvi and alcoholic, aqueous, or aqueous-alcoholic Tinctures of plants and / or plant parts of Melissa officinalis, Mentha x piperita and Centaurium erythraea on.

In preferred embodiments, aqueous-alcoholic extracts of plants and / or plant parts of Chamomiua recutica, Melissa officinalis, Mentha x piperita, Carum carvi and / or Centaurium erythraea are aqueous-ethanolic extracts. Preferably, the extractant used is an ethanol-water mixture, the concentration of ethanol preferably being in the range of 30% (v / v) to 90% (v / v), preferably in the range of 45% (v / v) to 70 % (v / v) is.

Preferably, the ethanol concentration of the aqueous ethanolic tincture of Centaurium erythraea is 45% (v / v) or 70% (v / v). Preferably, the concentration of ethanol of the aqueous-ethanolic tinctures of Melissa officinalis and Mentha x piperita is 45% (v / v). Preferably, the ethanol concentration of the aqueous ethanolic extracts of ChamomiUa recutica and Carum carvi is 45% (v / v). The composition may be solid, liquid and / or gel. Preferably, the composition is in liquid dosage form, preferably selected from the group comprising solution, tincture, juice and / or suspension.

Preferably, the composition is a liquid dosage form. Preferably, the liquid composition is formulated for oral administration. In further preferred embodiments, the composition is in the form of a solid

Dosage form before, preferably selected from the group comprising powder and / or granules. Powders and / or granules contain extracts, tinctures and / or extracts of plants and / or plant parts of Chamomilla recutica (chamomile), Melissa officinalis (lemon balm), Mentha x piperita (peppermint), Carum carvi (caraway) and Centaurium erythraea (centaury) preferably in dried form. A powder or granules can be used in particular for the preparation of a beverage, for example a tea, in particular a stomach infusion. In particularly preferred embodiments, the composition is in the form of a gelatinous dosage form, for example in the form of a carbohydrate-based gel. A gel may be in a gel form for direct administration or, more preferably, may be useful in the preparation of a beverage.

Composition, extract, tincture and / or extract of plants and / or

Parts of plants of Centaurium erythraea; and or

in the range of> 5 vol.% to <50 vol.%, preferably in the range of> 10 VoL% to <30 vol.%, preferably in the range of> 15 vol.% to <25 vol. %, more preferably in the range of> 20 vol .-% to <22 vol .-%, based on the

Plants and / or plant parts of Carum carvi,

Total volume of components does not exceed 100% by volume.

In preferred embodiments, the composition consists of extracts, tinctures and / or extracts of Chamomilla recutica, Melissa officinalis, Mentha x piperita, Carum carvi and Centaurium erythraea as effective components and excipients of the

Formulation.

Another aspect of the present invention relates to the use of a

composition according to the invention for the manufacture of a medicament,

pharmaceutical preparation, medical device, nutritional supplement, dietetic food and / or a supplemental balanced diet.

The composition is useful for the treatment of gastrointestinal disorders, in particular flatulence and spasmodic gastrointestinal disorders.

Further, the composition may be used for the preparation of an agent for the prophylactic and / or therapeutic treatment of gastrointestinal disorders, in particular selected from the group consisting of flatulence and / or convulsive gastrointestinal disorders. The composition is particularly suitable for the preparation of a medicament, pharmaceutical preparation, medical device,

Nutritional supplement, dietetic food and / or a supplementary balanced diet for the prophylactic and / or therapeutic treatment of Gastrointestinal complaints, in particular selected from the group comprising flatulence and / or convulsive gastrointestinal disorders.

It has been shown that in particular flatulence and / or mild spasmodic gastrointestinal disturbances can be positively influenced.

Examples of compositions which serve to illustrate the present invention are given below.

Example 1 :

Formulation for a composition for oral administration in gastrointestinal disorders

The formulation included ethanolic tinctures of Centaurium erythraea, Melissa officinalis and Mentha x piperita as well as ethanolic extracts of Chamomilla recutica and Carum carvi.

Example 2 The effect of the composition of the invention on flatulence and mild spasmodic gastrointestinal disturbances was observed. It was found that the administration of the composition of the invention according to Example 1, a significant reduction of stomach cramps was achieved. In particular, it could be shown that the perceived pain and the resulting flatulence could be significantly improved by the composition. Even with repeated and / or long-term intake no contraindications or side effects were observed, in particular no allergies or increased photosensitivity of the skin occurred.

Example 3

The effect of the invention described in Example 1 above

Composition on flatulence and mild spasmodic gastrointestinal disturbances was observed in a comparative experiment, in which 5 ml of the composition according to Example 1 were administered three times daily.

Table I shows a comparison of the effect of various agents on nausea and gastric pressures in gastrointestinal complaints. It can be seen from Table I that a significant reduction in nausea and gastric pressures was achieved by the administration of the composition according to the invention. In particular, it has been shown that the effects were better than administration of chamomile, peppermint and cumin only ingredients and as well as administration of

additional active ingredients from angelica root, celandine and licorice root, whereby the side effects of these medicinal plants could be avoided. Even with a high dosage, no contraindications or side effects were observed. In particular, no irritations in the area of the stomach and intestine, increased blood pressure or

Headache up. Table I

(A) - (B): Comparative Preparations of the Prior Art:

(A) Pascoventral® available from Pascoe Pharmaceuticals GmbH, Glessen

(B) Iberogast® available from Steigerwald Arzneimittelwerk GmbH, Darmstadt (C): Composition according to the invention

Thus, a comparably good effect in the treatment of gastrointestinal complaints could be achieved compared with known preparations, with lower

Side effects occurred.

Claims

Composition particularly suitable for the treatment of gastrointestinal complaints, characterized in that the composition, based on the total volume of the composition, comprises:

in the range of> 0.1% by volume to <10% by volume extract, tincture and / or extract of plants and / or percentages of centaurium erythraea;

in the range of> 5% by volume to <50% by volume extract, tincture and / or extract of plants and / or percentages of Chamomilla recutica;

in the range of> 5% by volume to <50% by volume extract, tincture and / or extract of plants and / or percentages of pepper of Melissa officinalis;

in the range of> 5% by volume to <50% by volume extract, tincture and / or extract of plants and / or pesticidal parts of Mentha x piperita;

in the range of> 5 vol .-% to <50 vol .-% extract, tincture and / or extract of

Plants and / or parts of carrots of Carum carvi,

Total volume of components does not exceed 100% by volume.

2. Composition according to claim 1, characterized in that the

Composition, based on the total volume of the composition, in the range of> 0.5 vol .-% to <10 vol .-%, preferably in the range of> 1 vol .-% to <8 vol .-%, preferably in the range of > 2 vol .-% to <6 vol .-%, particularly preferably in the range of> 4 vol .-% to <5 vol .-%, extract, tincture and / or extract of plants and / or Pfianzenteilen of Centaurium erythraea ,

3. Composition according to claim 1 or 2, characterized in that the composition in the range of> 10 vol .-% to <30 vol .-%, preferably in the range of> 15 vol .-% to <25 vol .-%, preferably in the range of> 20% by volume to <22% by volume, based on the total volume of the composition, extract, tincture and / or extract of plants and / or plant parts of Chamomilla recutica

4. Composition according to one of the preceding claims, characterized in that the composition in the range of> 15 vol .-% to <35 vol .-%, preferably in the range of> 20 vol .-% to <30 vol .-%, preferably in the range of> 23% by volume to <25% by volume, based on the total volume of the composition, extract, tincture and / or extract of plants and / or plant parts of Melissa officinalis.

5. Composition according to one of the preceding claims, characterized in that the composition in the range of> 20 vol .-% to <40 vol .-%, preferably in the range of> 25 vol .-% to <35 vol .-%, preferably in the range of> 28% by volume to <30% by volume, based on the total volume of the composition, extract, tincture and / or extract of plants and / or plant parts of Mentha x piperita.

6. Composition according to one of the preceding claims, characterized in that the composition in the range of> 15 vol .-% to <40 vol .-%, preferably in the range of> 20 vol .-% to <35 vol .-%, preferably in the range of> 25% by volume to <30% by volume, based on the total volume of the composition, extract, tincture and / or extract of plants and / or plant parts of Carum carvi.

7. Composition according to one of the preceding claims, characterized in that the composition extracts, tinctures and / or extracts of chamomile flowers, Melissa leaves, peppermint leaves, caraway fruits and / or the herbaceous parts of the plant of centaury.

8. Composition according to one of the preceding claims, characterized in that the composition comprises alcoholic, aqueous or aqueous-alcoholic extracts of plants and / or plant parts of Chamomilla recutica and Carum carvi, and / or alcoholic, aqueous, or aqueous-alcoholic tinctures of plants and / or plant parts of Melissa officinalis, Mentha x piperita and Centaurium erythraea.

9. Composition according to one of the preceding claims, characterized in that the composition is a drug, pharmaceutical preparation, medical device, dietary supplement, dietary food and / or a supplementary balanced diet, in particular a drug.

Composition according to any one of the preceding claims, characterized in that the dosage of a liquid composition for oral administration to humans is in the range of> 0.5 ml / day to <25 ml / day, preferably in the range of> 5 ml / Day to <20 ml / day, more preferably in the range of> 10 ml / day to <15 ml / day.

11. Composition according to one of the preceding claims for use in the prophylactic and / or therapeutic treatment of gastrointestinal complaints, in particular selected from the group comprising flatulence, spasmodic gastrointestinal disorders, gastrointestinal influenza, motion sickness and / or Stomach pain in migraine.

12. A composition according to any one of the preceding claims for use in the acute treatment of gastrointestinal disorders, in particular selected from the group comprising flatulence, convulsive gastrointestinal disorders, gastrointestinal influenza, Travel sickness and / or stomach pain in migraine, especially in the acute treatment of gastrointestinal influenza and / or motion sickness.

13. Use of a composition according to one of the preceding claims for the production of a pharmaceutical, pharmaceutical preparation, medical device,

Dietary supplement, dietetic food and / or a supplemental balanced diet.

14. Use of a composition according to one of the preceding claims for the production of a medicament, pharmaceutical preparation, medical device,

Nutritional supplement, dietetic food and / or a supplementary balanced diet for the prophylactic and / or therapeutic treatment of

Gastrointestinal complaints, in particular selected from the group comprising flatulence and / or convulsive gastrointestinal disorders.

15. Medicament, pharmaceutical preparation, medical device, dietary supplement, dietetic food and / or supplementary balanced diet comprising a

Composition according to one of the preceding claims.