Ethanol extract of Salvia pisidica plant leaves for the treatment of borreliosis caused by Borrelia sp.

Abstract

The present inventors have discovered a substance in Salvia pisidica (Boiss. & Heldr.), a type of sage, that can kill Borrelia and Yersinia bacteria in vitro and in vivo. Until now, it has been thought that the ethanol extract or oil of Salvia pisidica has antibacterial effects against gram-positive bacteria. Previous experiments support this scientific view.

Description

[Technical Field]

[0001] TBE and FME were reported in the 1980s. Tick-borne encephalitis is a disease caused by the TBE virus and causes symptoms similar to those of Lyme disease: 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 infection was only about one case per 10,000 or 100,000 tick bites / stings. Today, it's conceivable that every tick bite carries the Borrelia bacteria. The link between Borrelia risk and rheumatic diseases was long unrecognized because up to 40 years can pass between a tick bite and the onset of disease. The time between a tick bite and the onset of disease is usually months to years. Perhaps due to a generally weakened immune system in "modern" humans and general environmental pollution with toxic substances, the onset of disease is often earlier and more severe today. We believe that most of the rheumatic conditions that were once common in rural areas and still occur today are in fact due to Borrelia infection.

[0003] Lyme disease initially presents with nonspecific general symptoms such as fever, headache, or gastrointestinal symptoms. Skin redness (erythema migrans or erythema migrans) is a defining symptom of Borrelia infection, but it does not occur in all Lyme disease infections. The absence of erythema migrans after a tick bite does not necessarily mean that a person is not infected with Lyme disease.

[0004] Flu-like symptoms, fever, and headache make the disease difficult to diagnose. Organs, joints, and muscles can be affected, as can the central and peripheral nervous systems. At this stage, the immune system is often unable to cope with the infection. Borrelia bacteria only last a short time in the blood, living in connective tissues and cell walls, essentially hiding. Here, they are difficult to detect and require prolonged treatment. [Background technology]

[0005] Conventional techniques of treatment If the infection has not yet progressed, it can be treated with antibiotics. The most effective treatment is pure penicillin (C16H18N2O4S). Whether other antibiotics have a lasting effect has not yet been established and is still questionable. However, if the right timing (before the bacteria "hide" in tissues) is found by chance, penicillin treatment may be effective, but this timing is nearly impossible to confirm. After transmission of the pathogen, a localized skin infection develops after a variable incubation period, visible as redness at the bite site. In some cases, the incubation period can last several years, so the associated joint pain is often misdiagnosed as rheumatic symptoms, and treatment with cortisone ointment is unsuccessful. We are confident that most rheumatic symptoms, both past and present, especially in rural areas, are caused by Borrelia.

[0006] Diagnostic and treatment issues Contrary to conventional wisdom, borreliosis can spread extremely rapidly. There is no absolutely predictable course for Lyme disease, as indicated by the classic three-stage classification, and the course of the disease does not proceed in an orderly fashion. If a patient's symptoms do not fit into the traditional medical classification of Lyme disease, Lyme disease is often ruled out and the symptoms are incorrectly treated. Lyme disease infection does not follow any pattern. It is not possible to predict how Lyme disease will progress. Symptoms can become severe rapidly or appear gradually.

[0007] If Lyme disease is not treated in time, it can become a chronic infection. This means that the disease recurs or gradually worsens. Relapses are possible even after a symptom-free incubation period of several years. The pathogen causes a variety of clinical manifestations. Joints are usually affected, but it can also lead to heart disease and vascular inflammation. Mixed forms of the disease are also possible. Many Lyme disease patients complain of fatigue and chronic malaise that does not improve with adequate sleep.

[0008] A Lyme disease vaccine suitable for humans is unlikely to be developed in the near future. In the United States, a corresponding vaccine was withdrawn from the market in 2002 after reports of complications from vaccination. However, this vaccine was only suitable for the US strain of the pathogen and was therefore not available in Europe.

[0009] The only antibiotics that are sufficiently effective are pure biological penicillins, which in our experience should be administered up to six weeks after infection, but only in extremely rare cases. Summary of the Invention

[0010] Current Lyme disease According to recent research, approximately one in seven people worldwide has been infected with Lyme disease at least once. According to a study published in BMJ Global Health, the infection rate is highest in Central Europe, at 20%. Therefore, the objective of this invention is to develop an effective treatment for Lyme disease. In patent specification WO2007060252A3, we have had a treatment for Lyme disease since 2006, and it has performed well in recognized clinical trials. Here, we discovered and developed an active substance from a mixture of the whole venom of various myriapods. The drawback of this treatment is the relative difficulty in obtaining the active ingredient. In this invention, we describe an effective treatment for Lyme disease with the highest availability of the active ingredient.

[0011] It is therefore an object of the present invention to provide a method for producing a therapeutic composition, said composition, and an apparatus for producing said composition.

[0012] This problem is solved by the independent claims. Further advantageous embodiments are described in the dependent claims.

[0013] Compositions and Preparations of the Invention The inventors have discovered a substance in Salvia pisidica (Boiss. & Heldr.), a type of sage, that can kill Borrelia and Yersinia bacteria in vitro and in vivo. Until now, it has been thought that ethanol extracts or oils of Salvia pisidica have antibacterial effects against gram-positive bacteria. There is little evidence of its effectiveness against gram-negative bacteria. Our tests to date support this scientific view.

[0014] The inventors have discovered that an ethanol extract of fresh leaves of Salvia pisidica mixed with honey can kill gram-negative bacteria, particularly Borrelia and / or Yersinia bacteria.

[0015] Therefore, the ethanol extract of Salvia pisidica mixed with honey is suitable for the treatment of Lyme disease.

[0016] Approximately 900 species of sage are known worldwide. Many contain substances of pharmaceutical and medical interest. To date, only a few species have been studied. We have tested extracts of the following sage species for their anti-Borrelia activity: Salvia mellifera (black sage) Salvia nevadensis Salvia fruticosa (Greek sage) Salvia cinerea Salvia pisidica Salvia lavandulifolia (Spanish sage)

[0017] [Table 1]

[0018] Only the extract of Salvia pisidica showed a clear effect against Borrelia bacteria described in this invention.

[0019] According to one aspect of the present invention, the composition of the present invention is prepared by the following method. a) A specific amount of Salvia pisidica leaves, preferably fresh leaves, is placed in a specific amount of 96% ethanol, preferably 100% ethanol. b) The extract from a) is allowed to stand for at least 24 hours, preferably at a temperature of 25 degrees Celsius, after which the leaves are filtered off. c) The active extract from b) is mixed into 150 mL of liquid organic blossom honey with constant stirring.

[0020] Cultivation of Salvia pisidica for optimal synthesis of active ingredients In order for the plants, particularly the Salvia pisidica required for use in the present invention, to produce the appropriate amount of active ingredients, it is important that the medium / soil is suitable for growing the plants.

[0021] We have found that Salvia pisidica not only requires well-drained soil, but also calcareous soil for the synthesis of its active ingredients. We prefer to use the calcareous soil of Flora Montana, which contains approximately 20% weathered limestone.

[0022] 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 by using the appropriate substrate. Cultivation in containers is more efficient than cultivation directly in soil. For this application, it is important to use fresh leaves without stems. We observed effects at the following concentrations:

[0023] [Table 2]

[0024] Therefore, higher concentrations and 100% ethanol extracts are most effective.

[0025] Dosage form According to the present invention, it has been shown that the extract can be administered orally. The active ingredients are absorbed through the digestive tract. Since the ethanol extract is particularly soluble in honey, it is effective not only to administer the ethanol extract directly and pure, but also to dissolve it in honey. DETAILED DESCRIPTION OF THE INVENTION

[0026] Aspects of the present invention 1. An ethanol extract of Salvia pisidica leaves for treating Lyme disease, At least Salvia pisidica leaves, At least 96% ethanol, An ethanol extract containing at least honey.

[0027] 1. An ethanol extract of Salvia pisidica leaves for treating Lyme disease, a) At least young salvia leaves; b) at least 96% ethanol; c) an ethanol extract containing at least honey;

[0028] 1. An ethanol extract of Salvia pisidica leaves for treating Lyme disease, a) at least Salvia pisidica leaves, b) at least 100% ethanol; c) an ethanol extract containing at least honey;

[0029] 5. An ethanol extract of Salvia pisidica leaves for treating Lyme disease according to any one of claims 1 to 4, characterized in that the honey has the quality of organic blossom honey.

[0030] A method for producing the therapeutic composition of any one of claims 1 to 5, comprising: introducing a specific amount of Salvia pisidica leaves, preferably fresh leaves, into a specific amount of 96% ethanol, preferably 100% ethanol; a) leaving the extract from a) for at least 24 hours, preferably at a temperature of 25 degrees Celsius, after which the leaves are removed by filtration; b) into 150 mL of liquid organic blossom honey while stirring at a constant speed.

[0031] For use in this invention, Salvia pisidica leaves approximately 1.7-2.1 cm long and 0.9-1.3 cm wide (individual leaf segments 0.3-0.5 cm) have the highest content. Fresh Salvia pisidica leaves are used, but they do not need to be young. This means that the leaves must be harvested directly from the plant and processed immediately after harvest or at the latest 50 hours after harvest. "Direct" means no additional processing. If not processed immediately, they should be stored in the dark at temperatures between 15-22 degrees Celsius. Fresh, young, light-green leaves contain more active ingredients for use in this invention. These leaves can be up to 30 days old, depending on the plant's location.

[0032] In accordance with the present invention, the kit of parts may exist as a kit, device and / or system arrangement.

[0033] According to the invention, it is particularly advantageous that the methods can be used to operate the proposed devices and units. Furthermore, the proposed devices and units are suitable for carrying out the methods of the invention. Thus, in each case, the devices fulfill structural features that are suitable for carrying out the corresponding methods. However, the structural features can also be designed as method steps. The proposed methods also provide steps for carrying out the functions of the structural features.

Claims

1. 1. An ethanol extract of Salvia pisidica leaves for treating Lyme disease, comprising: At least the leaves of Salvia pisidica, At least 96% ethanol; An ethanol extract containing at least honey.

2. The ethanol extract of Salvia pisidica leaves for treating Lyme disease according to claim 1, wherein the length of the leaves is 1.7-2.1 cm and the width is 0.9-1.3 cm.

3. 3. The ethanol extract of Salvia pisidica leaves for treating Lyme disease according to claim 1 or 2, comprising 100% ethanol.

4. 4. Ethanol extract of Salvia pisidica leaves for treating Lyme disease according to one of claims 1 to 3, characterized in that the honey has the quality of organic blossom honey.

5. A method for producing the therapeutic composition of any one of claims 1 to 4, comprising: A step of mixing a predetermined amount of Salvia pisidica leaves with a predetermined amount of 96% ethanol to obtain an infusion; Allowing the leachate to stand for at least 24 hours; filtering the leaves from the exudate; and stirring the infusion into liquid blossom honey.

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

7. 7. The method according to claim 5 or 6, characterized in that fresh leaves are used.

8. 8. A method according to any one of claims 5 to 7, characterized in that the infusion is left at a temperature of at least 25 degrees Celsius.

9. 9. The method according to any one of claims 5 to 8, characterized in that the amount of liquid blossom honey is 150 ml.

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

11. Apparatus adapted to carry out the method according to any one of claims 5 to 10.

12. A system arrangement adapted for carrying out the method according to any one of claims 5 to 10.

13. An apparatus adapted for the production of an extract according to any one of claims 1 to 4.

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