Ethanolic extract from leaves of the plant salvia pisidica for the treatment of borreliosis caused by borrelia spp

Abstract

The inventors discovered in a sage, Salvia pisidica Boiss. & Heldr., substances which can kill Borrelia spp. and Yersinia spp. in vitro and in vivo. It has previously been assumed that a methanol extract, or the oil from Salvia pisidica has antimicrobial effects against gram (+) bacteria. Previous tests confirmed this current scientific view.

Description

[0001] ETHANOLIC EXTRACT OF LEAVES OF THE PLANT SALVIA PISIDICA FOR THE TREATMENT OF LYME DISEASE CAUSED BY BORRELLIA SPP

[0002] In the 1980s, TBE and FME were described. The early summer

[0003] Meningoencephalitis is a disease caused by the TBE virus that occurs with symptoms similar to those of Lyme disease, i.e. fever and partial meningoencephalitis, the inflammation of the brain and meninges.

[0004] Lyme disease is caused by bacteria, not viruses like TBE. "Back then," the risk of transmission only existed in one in 10,000 or 100,000 tick bites. Today, it can be assumed that every tick bite transmits Borrelia. 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 with pollutants, the disease often breaks out much more quickly today, and the course of the disease is more severe.We are convinced that most of the rheumatic complaints that previously occurred, especially among the rural population, and which still occur today, are actually due to Lyme disease infections.

[0005] 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 infection has not occurred.

[0006] Symptoms such as flu, fever, and headaches make the disease difficult to recognize. 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.

[0007] State of the art treatment:

[0008] If the infection is not yet very advanced, it can be treated with antibiotics. Treatment with pure penicillin (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 doubtful. However, treatment with penicillin can be helpful if the right moment (before the bacteria "hide" in the tissue) is accidentally identified; however, identifying this moment is almost impossible. From the moment of transmission of the pathogen, after a varying incubation period,

[0009] Local skin infection can occur, manifesting as reddening at the bite site. 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 believe that most of the rheumatic complaints that previously occurred, especially among rural populations, and which still occur today, are caused by Borrelia.

[0010] Problems with diagnosis and therapy:

[0011] Contrary to popular belief, Lyme bacteria 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 disease infection does not follow a pattern! How Lyme disease develops cannot be predicted. Symptoms can develop quickly and severely, or they can manifest gradually and insidiously. If Lyme disease is not treated in time, it can become chronic. This means that the disease repeatedly recurs or progressively worsens. Even years of symptom-free latency followed by reactivation are possible.The pathogens trigger various symptoms. Joints are most commonly affected, but they 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, which cannot be remedied by sufficient sleep.

[0012] 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.

[0013] 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.

[0014] Lyme disease currently:

[0015] The latest studies show that 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 W02007060252A3, we have had a therapeutic agent for Lyme disease since 2006, which has also been positively evaluated in 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. In the present invention, we describe an effective treatment option for Lyme disease with the best availability of the active ingredients.It is therefore an object of the present invention to propose a method for producing a therapeutic composition as well as the composition and a device for producing it.

[0016] The problem is solved by the independent claims. Further advantageous embodiments are specified in the subclaims.

[0017] Composition and preparation according to the invention:

[0018] 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 demonstrated against gram (-) bacteria. Our experiments to date confirm this current scientific view.

[0019] 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.

[0020] Thus, an ethanolic extract of Salvia pisidica incorporated into honey is suitable for the treatment of Lyme disease.

[0021] 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:

[0022] Salvia mellifera

[0023] Salvia nevadensis

[0024] Salvia fruticosa

[0025] Salvia cinerea Salvia pisidica

[0026] Salvia lavandulifolia

[0027] Only extracts of Salvia pisidica showed a proven effect against Borrelia:

[0028] The composition according to the invention is prepared according to one aspect of the present invention in the following way: a) A certain amount of leaves, preferably fresh leaves of Salvia pisidica, is introduced into a certain amount of 96% ethanol, or preferably 100% ethanol. b) The extract from a) is stored for at least 24 hours at temperatures of preferably

[0029] Allow to stand at 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, stirring continuously. Culture of Salvia pisidica for optimal active ingredient synthesis:

[0030] In order for plants, especially the species required for the use according to the invention

[0031] For Salvia pisidica to produce relevant amounts of its active ingredients, it is important to have the right growing media / soil for the plants. The inventors discovered that Salvia pisidica not only requires permeable soil, but also that the species requires calcareous soil for active ingredient synthesis. We prefer to use calcareous soil from flora montana with approximately 20% weathered limestone.

[0032] 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 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 the stems. We observed effects at the following concentrations:

[0033] Therefore, the higher concentrations and the extracts in 100% ethanol are the most effective.

[0034] Dosage forms:

[0035] The invention demonstrates that the extracts can be taken orally. The active ingredient is absorbed via 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.

[0036] Aspects of the present invention: Ethanolic extract of the leaves of Salvia pisidica for combating

[0037] Lyme disease:

[0038] - At least leaves of Salvia pisidica;

[0039] - At least 96% ethanol; and

[0040] - At least bee honey.

[0041] - Ethanolic extract of the leaves of Salvia pisidica to combat Lyme disease with the following components: a) At least young leaves of Salvia pisidica b) At least 96% ethanol c) At least bee honey

[0042] - Ethanolic extract of the leaves of Salvia pisidica to combat Lyme disease with the following components: a) At least leaves of Salvia pisidica b) At least 100% ethanol c) At least honey

[0043] - Ethanolic extract of the leaves of Salvia pisidica for combating Lyme disease according to one of claims 1 to 4, characterized in that the bee honey has the quality of organic flower honey.

[0044] - Process for the preparation of a therapeutic composition according to one of claims 1 to 5, characterized in that the following measures are taken:

[0045] - A certain amount of leaves, preferably fresh leaves of Salvia pisidica, is placed in a certain amount of 96% ethanol, or preferably 100% ethanol.

[0046] - The extract from a) is allowed to stand for at least 24 hours at a temperature 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, stirring continuously.

[0047] 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 are used, not necessarily young leaves. This means they are leaves directly from the plant and should be processed immediately after harvesting, or at the latest after 50 hours. Direct here means without further processing steps. If they are not processed immediately, they should be stored in a dark place at temperatures between 15 and 22 degrees Celsius. Fresh, young, light green leaves, for use according to the invention, have even more active ingredients. These leaves are up to 30 days old - depending on the location of the respective plant.

[0048] Kit of parts can be in the form of a kit, a device and / or a system arrangement according to the invention.

[0049] According to the invention, it is particularly advantageous that the method can be used to operate the proposed devices and units. Furthermore, the proposed devices and units are suitable for implementing the method according to the invention. Thus, each device implements structural features suitable for executing the corresponding method. However, the structural features can also be configured as method steps. The proposed method also provides steps for implementing the function of the structural features.

Claims

Patent claims 1 . Ethanolic extract of leaves of Salvia pisidica for combating Lyme disease, comprising: - At least leaves of Salvia pisidica; - At least 96% ethanol; and - At least bee honey.

2. Ethanolic extract of leaves of Salvia pisidica for combating Lyme disease 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. Ethanolic extract of the leaves of Salvia pisidica for combating Lyme disease according to claim 1 or 2, comprising 100% ethanol.

4. Ethanolic extract of leaves of Salvia pisidica for combating Lyme disease according to one of claims 1 to 3, characterized in that the bee honey has the quality of organic flower honey.

5. A process for preparing a therapeutic composition according to any one of claims 1 to 4, comprising the steps of: - Introducing a certain quantity of Salvia pisidica leaves into a predetermined quantity of 96% ethanol to prepare a decoction; - Let the brew stand for at least 24 hours; - Filtering the leaves from the brew; and - Stir the broth into liquefied flower honey.

6. Process according to claim 5, characterized in that the ethanol content is 100%.

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

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

9. A process according to any one of claims 5 to 8, characterized in that the amount of liquefied blossom honey is 150 ml.

10. Method according to one of claims 5 to 9, characterized in that the blossom honey is of organic quality. 11 . Device adapted to carry out the method according to one of claims 5 to 10.

12. System arrangement configured to carry out the method according to one of claims 5 to 10.

13. Device adapted to produce the drawer according to one of claims 1 to 4.

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