Composition effective against Borrelia and method for its preparation

Description

[0001] TBE and FME were described in the 1980s. Early summer meningoencephalitis is a disease caused by the TBE virus that presents with symptoms similar to those of Lyme disease, namely fever and partial meningoencephalitis, an inflammation of the brain and meninges.

[0002] Lyme disease is caused by bacteria, not viruses like TBE. "Back then," the risk of transmission existed only in one in 10,000 or 100,000 tick bites. Today, it can be assumed that Borrelia is transmitted with every tick bite. The danger of Borrelia and its connection to rheumatic diseases went unrecognized for a long time, partly because the time between a tick bite and the onset of the disease can take up to 40 years. It usually takes months or years after a tick bite for the disease to develop. Presumably due to the generally weaker immune systems of the "modern" population and the general environmental pollution, the disease often breaks out much more quickly today, with more severe outcomes.We are convinced that most of the rheumatic complaints that occurred in the past, especially among the rural population, and that still occur today, are actually due to Borrelia infections.

[0003] Lyme disease initially manifests with nonspecific general symptoms such as fever, headache, or gastrointestinal discomfort. Skin reddening (erythema migrans or erythema wandering) is a clear symptom of a Lyme infection, but it does not occur in all Lyme disease infections. The absence of erythema wandering after a tick bite does not automatically mean that Lyme disease is not present.

[0004] Symptoms such as flu, fever, and headaches make the disease difficult to detect. It can affect organs, joints, and muscles, as well as the central and peripheral nervous system. At this stage, the immune system is often no longer able to combat the infection. Borrelia bacteria only remain in the blood for a short time and settle in connective tissue and cell walls, living a hidden life. Here, they are difficult to detect, and therefore, long-term treatment is necessary.

[0005] Current treatment techniques: If the infection is not yet advanced, antibiotics can be used. Treatment with pure penicillin G (C16H18N2O4S) has been shown to be most effective. Whether other antibiotics have a lasting and sustained effect has not yet been confirmed and is currently questionable. However, treatment with penicillin can be helpful if the right moment (before the bacteria "hide" in the tissue) is identified by chance; however, identifying this moment is virtually impossible. From the moment the pathogen is transmitted, after a varying incubation period, a local skin infection can develop, which becomes visible as reddening at the site of the bite. The incubation period can last several years in some cases, which is why the associated joint pain was long considered rheumatic and was unsuccessfully treated with cortisone ointment.We are convinced that most of the rheumatic complaints that occurred in the past, especially among the rural population, and that still occur today, are caused by Borrelia.

[0006] Problems with diagnosis and treatment: Contrary to popular belief, Borrelia can spread very quickly. There is no absolutely predictable course for Lyme disease, as the classic classification into three stages suggests; the progression does not follow a regular pattern. If the affected person's symptoms do not fit the conventional medical classification of Lyme disease, Lyme disease is often ruled out and the symptoms are treated incorrectly. A Lyme infection (Lyme disease) does not follow a pattern! How Lyme disease will develop cannot be predicted. Symptoms can develop quickly and severely, or they can manifest gradually and gradually.

[0007] If Lyme disease is not treated promptly, it can become chronic. This means the disease repeatedly recurs or worsens. Even years of symptom-free latency followed by reactivation are possible. The pathogens trigger various clinical pictures. Joints are most commonly affected, but it can also lead to heart problems and vascular inflammation. Mixed forms of the disease are also possible. Many Lyme disease patients complain of exhaustion and chronic fatigue that cannot be compensated for by adequate sleep.

[0008] A Lyme disease vaccine suitable for humans is not expected in the near future. In the United States, a corresponding vaccine was withdrawn from the market in 2002 due to alleged complications. However, this vaccine was only suitable for the American strain of the pathogen and therefore not applicable in Europe. Clinical trials for another vaccine (VLA15) are underway in the United States and Europe.

[0009] The only truly effective antibiotic is pure biological penicillin. In our experience, this must be administered no later than six weeks after infection. This only happens in very rare cases. Lyme disease currently:

[0010] The latest studies show that today, around one in seven people worldwide has been infected with Lyme disease at least once. According to a study published in BMJ Global Health, Central Europe has the highest infection rate at 20%. Therefore, the subject of this invention is to develop an effective therapy for Lyme disease. With patent WO2007060252A3, we have had a therapeutic agent for Lyme disease since 2006, which has also been positively evaluated within the framework of permissible medical therapeutic trials. Here, we discovered and developed active ingredients from total toxin cocktails of various Myriapoda. The disadvantage of this treatment option is the relatively poor availability of the active ingredients. The present proposal is a treatment option for Lyme disease with the best availability of the active ingredients. Camphor oil and the oil of Salvia triloba showed an antimicrobial effect against Borrelia burgdorferii and Borrelia garinii. This effect is significantly surpassed by chamomile oil and cinnamon oil (A. Goc et al. BMC Complementary and Alternative Medicine 2019, 19, 1-11). Mixtures of various plant extracts and oils are also said to have an effect on Borrelia sp. own (US10238619).

[0011] It is therefore an object of the present invention to propose a method for producing a composition having an effect against Borrelia and the composition.

[0012] The problem is solved by the independent claims. Further advantageous embodiments are specified in the subclaims.

[0013] Inventive composition and preparation: The inventors have now discovered substances in a sage, Salvia pisidica Boiss. & Heldr., that can kill Borrelia spp. and Yersinia spp. in vitro and in vivo. Until now, it has been assumed that a methanol extract, or rather the oil of Silvia pisidica, has antimicrobial effects against Gram (+) bacteria. Hardly any effect has been detected against Gram (-) bacteria. Our experiments to date confirm this current scientific opinion.

[0014] The inventors have now discovered that an ethanol extract of the fresh leaves of Salvia pisidica, when incorporated into honey, can kill gram (-) bacteria, especially Borrelia spp. and / or Yersinia spp.

[0015] Thus, an ethanolic extract of Salvia pisidica incorporated into honey is suitable for the treatment of Lyme disease.

[0016] Approximately 900 species of sage are known worldwide. Many contain pharmaceutically interesting substances. Only a few species have been studied to date. We investigated extracts of the following sage species for their Borrelia-killing effects: Salvia mellifera Salvia nevadensis Salvia fruticosa Salvia cinerea Salvia pisidica Salvia lavandulifolia

[0017] Only extracts of Salvia pisidica showed a demonstrable effect against Borrelia according to the invention: The composition according to the invention is prepared according to one aspect of the present invention in the following manner: a) A specific amount of Salvia pisidica leaves, preferably fresh leaves, is added to a specific amount of 96% ethanol, or preferably 100% ethanol. b) The extraction mixture according to a) is allowed to stand for at least 24 hours at a temperature of preferably 25 degrees Celsius. The leaves are then filtered off. c) This active extract from b) is incorporated into 150 mL of liquefied organic blossom honey with constant stirring.

[0018] Culture of Salvia pisidica for optimal active ingredient synthesis: In order for plants, especially the species Salvia pisidica required for the use according to the invention, to be able to produce relevant amounts of their active ingredients, it is important to have the right culture substrates / soils for the plants.

[0019] The inventors discovered that Salvia pisidica not only requires permeable soil, but also requires calcareous soil for active ingredient synthesis. We prefer to use calcareous soil from flora montana with approximately 20% weathered limestone.

[0020] More than 35 different components can be detected in the ethanol extract of Salvia pisidica. Bile acid equivalents, rutin equivalents, and catechin equivalents can be increased through the correct use of substrate. Cultivation in plant containers is more efficient than cultivation directly in soil. For the application according to the invention, it is important to use the fresh leaves of the plants without stems. We observed effects at the following concentrations:

[0021] Therefore, the higher concentrations and the extracts with 100% ethanol are the most effective. Dosage forms:

[0022] It is described, but not claimed, that the extracts can be taken orally. The active ingredients are absorbed through the digestive tract. The ethanolic extract dissolves particularly well in honey, so in addition to taking the ethanolic extract directly, it can also be dissolved in honey.

[0023] The aspects of the present invention are a composition according to claims 1-4 and a process for producing a composition according to claims 1-4 according to claims 5-9. A composition comprising an ethanolic extract of the leaves of Salvia pisidica, comprising: an extract of leaves of Salvia pisidica; with at least 96% ethanol; and at least bee honey. A composition comprising an ethanolic extract of the leaves of Salvia pisidica with the following components: a) an extract of at least young leaves of Salvia pisidica with at least 96% ethanol, and b) at least bee honey. A composition comprising an ethanolic extract of the leaves of Salvia pisidica with the following components: a) an extract of leaves of Salvia pisidica with at least 100% ethanol, and b) at least bee honey. A composition comprising an ethanolic extract of the leaves of Salvia pisidica according to any one of claims 1 to 4, characterized in that the bee honey has the quality of organic blossom honey.A process for producing a composition according to any one of claims 1 to 4, characterized in that the following measures are taken: A specific amount of leaves, preferably fresh leaves, of Salvia pisidica is introduced into a specific amount of 96% ethanol, or preferably 100% ethanol. The extraction mixture according to a) is left to stand for at least 24 hours at temperatures of preferably 25 degrees Celsius. The leaves are then filtered off. This active extract from b) is incorporated into 150 ml of liquefied organic blossom honey with constant stirring.

[0024] The leaves of Salvia pisidica, for use according to the invention, are the most nutritious, measuring approximately 1.7 to 2.1 cm long and 0.9 to 1.3 cm wide (individual leaflets 0.3 to 0.5 cm). Fresh leaves of Salvia pisidica, not necessarily young leaves, are used. This means they are leaves directly from the plant and should be processed immediately after harvesting, or at the latest after 50 hours. "Direct" means without further processing steps. If they are not processed immediately, they should be stored in a dark place at temperatures of 15 to 22 degrees Celsius. Fresh, young, light-green leaves, for use according to the invention, contain even more active ingredients. These leaves are up to 30 days old, depending on the location of the respective plant.

Claims

1. A composition: - an extract made with at least 96% ethanol from the leaves of Salvia pisidica grown on permeable calcareous soil; - and - Bee honey.

2. The composition according to claim 1, wherein the leaves have a length of 1.7 to 2.1 cm and a width of 0.9 to 1.3 cm.

3. The composition according to claim 1 or 2, wherein the ethanol is 100% ethanol.

4. The composition according to any one of claims 1 to 3, characterized in that the bee honey has the quality of organic blossom honey.

5. A process for the preparation of a therapeutic composition according to any one of claims 1 to 4, comprising the steps of: - Incorporating a predetermined amount of leaves of the plant Salvia pisidica grown on permeable calcareous soil into a predetermined amount of at least 96% ethanol to produce a decoction; - Leave the brew to stand for at least 24 hours - Filtering the leaves from the brew; and - Stir the decoction into liquefied blossom honey.

6. The process according to claim 5, characterized in that the ethanol is 100% ethanol.

7. A method according to one of claims 5 or 6, characterized in that fresh leaves are used.

8. The process according to any one of claims 5 to 7, characterized in that the brew is left to stand at at least 25 degrees Celsius.

9. The process according to one of claims 5 to 8, characterized in that the blossom honey is of organic quality.