EP3474873A1 - Solution huileuse de gynura procumbens pour le traitement d'une polyneuropathie périphérique diabétique, des tendinopathies, et des gingivites et parodontites et procédé correspondant - Google Patents

Solution huileuse de gynura procumbens pour le traitement d'une polyneuropathie périphérique diabétique, des tendinopathies, et des gingivites et parodontites et procédé correspondant

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Publication number
EP3474873A1
EP3474873A1 EP16784381.2A EP16784381A EP3474873A1 EP 3474873 A1 EP3474873 A1 EP 3474873A1 EP 16784381 A EP16784381 A EP 16784381A EP 3474873 A1 EP3474873 A1 EP 3474873A1
Authority
EP
European Patent Office
Prior art keywords
leaves
cells
treatment
gingivitis
gynura
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP16784381.2A
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German (de)
English (en)
Inventor
Kostas GRIGORIOU
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Individual
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Individual
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Filing date
Publication date
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Publication of EP3474873A1 publication Critical patent/EP3474873A1/fr
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/02—Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/02—Drugs for disorders of the nervous system for peripheral neuropathies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine

Definitions

  • the present invention discloses an innovate and safe method for effective and safe treatment of peripheral diabetic polyneuritis, tendinopathies, and gingivitis - periodontitis, via the topical administration of the gynura procumbens oil solution.
  • the whole invention is based on the cells rejuvenation by the said solution.
  • the study provided in this invention disclose the preparation of the Gynura oil solution and the use of it in the treatment of several medical disorders based on the free radical scavenging activity of the polyphenols contained in the said solution and created for this purpose.
  • the micro molecular properties of the polyphenols contained in gynura procumbens oil solution allow them to penetrate cell membranes of the peripheral nervous system (PNS), tendons and gum tissues, thus becoming able to recover and protect the cells from the destructive free radical activity.
  • PNS peripheral nervous system
  • Oxidative stress reflects an imbalance between the systemic manifestations of reactive oxygen species and a biological system ability to readily detoxify the reactive intermediates or to repair the resulting damage. Disturbances in the normal redox state of cells can cause toxic effects through the production of peroxides and free radicals that damage all compounds of the cell, including proteins, lipids, and DNA. Oxidative stress from oxidative metabolism cause base damage as well as strand breaks in DNA. Further some reactive oxidative species act as cellular messengers in redox signaling. Thus, oxidative stress can cause oxidative disruption in normal mechanisms in cellular signaling.
  • the cells function is regulated, the protective mechanisms of the cells are activated and the cells are rejuvenated, thus becoming able to operate as fully functioned cells.
  • the present invention provides an innovative, safe, and effective method for treating peripheral diabetic neuropathy, tendonitis and tendinosis, gingivitis and periodontitis by using the oil solution provided from gynura procumbens leaves as topical administration.
  • the said composition is prepared from semi dried leaves collected from a plantation in Limassol Cyprus, created for this purpose.
  • the whole invention is based on the free radical scavenging activity of the polyphenols contained in gynura procumbens oil solution.
  • gynura procumbens oil solution By neutralizing the destructive action of the free radicals on cells, their functions recovers, they rejuvenate and multiply, protective mechanisms activate thus becoming fully functioned cells.
  • the method introduced herein for the preparation of the gynura procumbens oil solution comprises of drying the leaves in a certain amount of time, heating the leaves in ester for a certain amount of time followed by filtration.
  • the temperatures selected for the for the 1 st variable were 35°C, 50T, 65°C, 80°C and 100°C.
  • the time selected for the 2 nd variable was 2 ; 4,6,8, 12 hours. Each of these was tested separately. The sample with the greatest potency and an efficient oil infusion was observed when the sample was heated for 8 hours at 65°C.
  • Sample A had very little medicinal properties when applied topically where sample B had close to 90% cure rate. Based on the above information and results, the final method for creating a gynura procumbens oil solution was formulated along with a clinical study to screen its efficiency.
  • Merkel cell endings are mechanoreceptors found in the basal epidermis and hair follicles. They are large myelinated nerve endings. They provide information of pressure, position and deep static features such as shapes and edges. Merkel cells in the basal epidermis of the skin store neuropeptides which they release to associate nerve endings in response to pressure. In burns Merkel endings are commonly lost. Each ending consists of a Merkel cell in close opposition with an enlarged nerve terminal. A single afferent nerve fiber branches to innervate up to 90 such endings. Merkel cells are associated with their receptive fields. The receptive field of an individual sensory neuron is the particular region of the sensory space in which a stimulus will trigger the firing of the neuron. Schwan cells are involved in many important aspects of peripheral nerve biology - the conduction of nervous impulses along axons, nerve development, and regeneration, trophic support for nervous, production of the nervous extracellular matrix, and modulation of neuromuscular synaptic activity.
  • an afferent nerve fiber is the nerve fiber (axon) of a sensory neuron. It is a long process extending far from the nerve cell body that carries nerve impulses from sensory receptors towards the central nervous system. The opposite direction of neural activity is efferent conduction.”" "Afferent neurons have a single long axon with a short central and a long peripheral branch. Outside the spinal cord, thousands of afferent neuronal cell bodies are aggregated in a swelling dorsal root known as the dorsal root ganglion. IW All the axons in that dorsal root, which contains afferent neuron fibers, are used in the transduction of somatosensory information.
  • Epineurium is the outermost layer of dense irregular connective tissue surrounding a peripheral nerve"' it usually surrounds multiple nerve fascicles as well as blood vessels which supply the nerve. Lymphocytes and fibroblasts are also present and contribute to the production of collagen fibers that form the back born of the epineurium. In addition to providing structural support lymphocytes and fibroblasts play a vital role in maintenance and repair of surrounding tissues.”
  • Capillars surrounded by epineurium are the smallest of the body's blood vessels that make up the microcirculation. Their endothelial linings are only one layer cell thick. They connect arterioles and veins, and they help to enable the water, oxygen, carbon, dioxide and many other nutrients and waste substances between the blood and the tissues"'" surrounding them.
  • Capillars are protected from the basal lamina, a layer of anchoring fibrils composed of type-VII collagen.
  • Diabetic neuropathies are nerve damaging disorders associated with diabetes mellitus. These conditions are thought to result from diabetic microvascular injury involving blood vessels that supply nerves in addition to macrovascular conditions that can culminate in diabetic neuropathy.
  • Vascular and neural diseases are closely related and intertwined. Blood vessels depend on normal function and nerve depends on adequate nerve flow. The first pathological change in the small blood vessels is narrowing of the blood vessels. As the disease progresses, neural dysfunction correlates closely with blood vessel abnormalities, such as capillary basement membrane thickening and endothelial hyperplasia, which contribute to diminished oxygen tension and hypoxia.
  • Neural ischemia is a well-established characteristic of diabetic neuropathies.
  • the present study shows that free radical destructive activity causing oxidative stress of the PNS cells, contributes in the development of peripheral diabetic neuropathy.
  • the clinical study as shown below proves that oxidative stress of the cells and tissue of the peripheral nervous system is also involved in the etiology and development of the said disease. Elimination of the oxidative stress caused by the free radicals in several levels of the peripheral nervous system play a critical role in the treatment of the said diabetic complication.
  • Factors causing oxidative stress due to the multiplication of free radicals present in the peripheral nervous system can be:
  • Oxidative stress can damage the PNS in the following levels.
  • Oxidative stress causes oxidative disruption in normal mechanisms in cellular signaling.
  • Affected from oxidative stress Schwan cells become unable to function properly.
  • Affected afferent nerve fibers (axon) transmit false information from the sensory neurons towards the central nervous system.
  • Affected epineurium cells and tissues become unable to carry their function which is to repair and maintain the afferent nerves surrounding tissues.
  • Affected capillars and their endothelial cells become unable to function properly, causing disturbances in their function which is the microcirculation of the nerves.
  • Dysfunction of the peripheral nervous system in different levels as prescribed causes the main symptoms of diabetic polyneuritis which are: Numbness or reduced ability to feel pain or temperature changes, burning sensation, sharp pains or cramps, increased sensitivity to touch, loss of reflexes, loss of balance and coordination and serious foot complications such as ulcers and infections, conditions that can lead to amputation.
  • peripheral diabetic neuropathy Prior to the treatment of peripheral diabetic neuropathy was rated by the majority of the patients at the severe domain. After the treatment (lasting approximately 12 days) a percentage of 90% rated the symptoms domain at none and a 10% rated the symptoms domain at mild.
  • Reappearance of the symptoms of diabetic polyneuritis occurs in a period of a week after discontinuance of the treatment, so patients where advice to follow supporting treatment via the administration of the said solution once daily.
  • a tendon is a band of fibrous connective tissue that usually connects muscle to bone and is capable of withstanding tension.
  • the collagen portion is made of 97-98% type I collagen with small quantities of other types of collagen.
  • the main cells of the tendon are the tenocytes (elongated fibroblast type cells). Tenocytes produce the collagen molecules which aggregate end-to-end and
  • Fibril bundles are organized to form fibers with the elongated tenocytes closely packed between them.
  • the cells communicate with each other through gap junctions, and this signaling gives them the ability to detect and respond to the mechanical loading.”
  • Fibroblast is a type of cell that synthesizes the extracellular matrix and collagen", the structural framework and plays a critical role in wound healing. Fibroblasts are the most common cells in connective tissue. Fibroblasts produce collagen, glycosaminoglycans, reticular and elastic fibers, glycoproteins found in the extracellular matrix and cytokine TSLP. TSLP has been shown to activate the maturation of a specific subset of dendritic cells located within epidermis and called Langerhans cells/' Growing individuals' fibroblasts are dividing and synthesizing ground substance. Tissue damage stimulates fibrocytes and induces the mitosis of fibroblasts.
  • ECM extracellular matrix
  • Fibroblasts are the most common cell type in connective tissue ECM in which they synthesize maintain and provide a structural framework. Due to its diverse nature and composition the ECM can serve many functions, such as providing support, segregating tissues from one another, and regulating intercellular communication.
  • the ECM can exist in varying degrees of stiffness and elasticity. The elasticity of the ECM can differ by several orders of magnitudes. This property is primary depended on collagen and elastin concentration"'" and has recently been shown to play an influential role in regulating numerous cell functions.
  • proteoglycans The collagen in tendons is held together with proteoglycans components. Proteoglycans interwoven with the collagen fibrils showing that proteoglycans are important structurally in the interconnection of the fibrils. 1 TM
  • the protein component of proteoglycans is synthesized by tenocytes ribosomes and translocated into the lumen of the rough endoplasmic reticulum. Glycosylation of the proteoglycans occurs in the Golgi apparatus in multiple enzymatic steps. The completed proteoglycan is then exported to the extracellular matrix of the tissue.
  • the proteoglycans components of tendons are very important to the mechanical properties. While collagen fibrils allow tendon to resist tensile stress, proteoglycans allow them to resist compressive stress.
  • Tendons are subject to many types of injury. There are various forms of tendinopathies or tendon injuries due to overuse. These types of injuries generally result in inflammation and degeneration or weakening of the tendons which may eventually lead to tendon rupture. 1 TM
  • Tendinitis is the inflammation of the tendon and results from micro-tears and that happen when the musculotendinous unit is acutely overload with a tensile force that is too heavy and/or too sudden.
  • Tendinosis is a chronic degeneration of the tendons collagen in response to chronic overuse; when overuse is continued without giving the tendon time to rest such as with repetitive strain injury, tendinosis results.
  • a microscopic view of tendinosis reveals an increase of immature type III collagen fibers. (Mature type I fibers dominate in healthy tendon tissue), loss of collagen continuity so that collagen fibers are no longer aligned with each other and sometimes fail to line together.
  • Topical administrations of the gynura oil solution on the tendon's area release the cells and the tissue of the tendon from free radicals catastrophic activity. Tenocytes recover thus becoming fully functioned cells.
  • Efficacy of the treatment of tendinitis via topical administration of gynura solution is shown below in figure2.
  • the said treatment was administrated in 65 patients suffering from tendinitis.
  • the said treatment was comprised of topically applying the gynural oil solution 3 times daily followed by light massage to the affected area for 5 minutes.
  • Gynura solution was used via topical administration for the treatment of tendinosis. It was administrated 3 times daily, light massage on the affected area for 5 minutes followed.
  • Tendinosis was rated by the majority of the patients at the moderate to severe domain.
  • Gingiva is part of the soft tissue lining of the mouth. They surround the teeth and provide a seal around them. Most of the gingiva are tightly bound to them underling bond which helps resist the friction of food passing over them. Gingiva consists of two layers: The surface stratified squamous epithelium, and the deeper Lamina Propria.
  • Lamina intestinal fibroblasts are responsible for the production of the fibers as well as the extracellular matrix.
  • Periodontium refers to specialized tissues that both surround and support the teeth, maintaining them in the maxillary and mandibular bones. It provides the support necessary to maintain teeth in function. The periodontium exists for the purpose of supporting teeth during their function and it depends of the stimulation it receives from the function for preservation of its structure. A constant state of balance always exists between the periodontal structure and the external forces. xvl ;
  • Periodontal ligament is a group of specialized connective tissue fibers that essentially attach a tooth to the alveolar bone within which it sits x " periodontal ligament undergoes drastic changes with chronic periodontal diseases that involve the deeper structure of the periodontium with periodontitis. The fibers of the periodontium becomes disorganized and their attachments to the alveolar bond proper or cementum are lost because of the resorption of these two hard dental tissues.
  • TM Factors causing multiplication of the free radicals and oxidative stress involved in gingivitis- periodontitis.
  • Gingivitis (inflammation of the gum tissue) is a non-destructive periodontal disease.”
  • gingivitis inflammation of the gum tissue
  • gingivitis is a non-destructive periodontal disease.
  • the most common form of gingivitis and periodontal disease is the response to bacterial biofilms (plaque) adherent to tooth surface.
  • plaque bacterial biofilms
  • gingivitis can progress to periodontitis, where the inflammation result in tissue destruction and alveolar bon resorption which can ultimately lead to tooth loss.
  • Main symptoms of gingivitis are: swollen gums, bright red gums, painful gums, bleeding or bleeding after brush gums, bad breath called halitosis). When gingiva is swollen the epithelial crevice becomes ulcerated-that condition is called ulcerative gingivitis.
  • Plaque induced gingivitis is by far the most common form of gingival diseases.
  • the etiology of plaque induced gingivitis is bacterial plague which acts to initiate the body's host response. This in turn can lead to destruction of the periodontal attachment apparatus"' the plaque accumulates in the small gaps between the teeth; the bacteria in them produce chemicals and toxins that promote an inflammatory response in the gum tissue.
  • the gingiva tissue When the gingiva tissue is not healthy, it can provide a gateway for periodontal disease to advance into the deeper tissue of periodontium, leading to a poorer prognosis for long-term retention of the teeth.
  • Olive oil gynura solution was used for the treatment of the above conditions via topical administration in spray form. It was used on 62 patients suffering from gingivitis and on 13 patients suffering from ulcerative gingivitis. It was administrated twice daily after tooth brushing, very light finger massage followed. Results from the said treatment are illustrated in figures 4 and 5.
  • Gingivitis Prior to the treatment, Gingivitis was rated by the majority of the patients at the Moderate to severe domain. After the treatment (lasting approximately 7 days) a percentage of 95% of the patients rated the symptoms and pain domain at none and a 5% rated the pain domain at mild.
  • Gum recession starts to recover in about 1 month and continuous to recover at all treatment period (3-6 months according to the degree of the damage).
  • Moving teeth starts to recover in 1 month and continuous its recover during treatment.
  • the treatment lasts approximately 3-6 months, according the degree of the damage.
  • Periodontal ligament surrounding and supporting the teeth recover, thus becoming able to maintain them in the maxillary and mandibular bones and also start to recover ih about 15-20 days.
  • the present invention can cause fundamental changes in the approach of the treatment of serious medical conditions and diseases like peripheral diabetic polyneuritis, tendonitis - tendinosis and gingivitis - periodontitis.
  • the present invention can also change our understanding about the pathogenesis of the said conditions.
  • This invention proves the recovering and rejuvenating ability of the human cells after the neutralization of the free radicals from which are affected. Released from free radicals destructive action cells rejuvenate, thus becoming able to neutralize pathogenic factors from which are affected.
  • the use of tricyclic antidepressants, SSNRIs, SSRIs, NSAIDs, opioids, synthetic cannabinoids, antiepileptic drugs and anticonvulsants used for the treatment of diabetic polyneuritis can be limited or even avoided and by that, medication toxicities can be avoided.
  • the use of antibiotics can also be limited since the use of gynura solution can prevent the appearance of ulcerations in diabetic patients and prevent amputations.
  • gynura solution can also be useful in athletes by keeping tendons and muscles in good condition. By using the said solution tendon ruptures can be avoided.

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Abstract

La présente invention divulgue une innovation et méthode sans danger de traitement sûr et efficace d'une polyneuropathie périphérique diabétique, des tendinopathies, et des gingivites – parodontites via l'administration topique de la solution huileuse de GYNURA PROCUMBENS. La présente invention est basée sur le rajeunissement des cellules par ladite solution.
EP16784381.2A 2016-06-28 2016-06-28 Solution huileuse de gynura procumbens pour le traitement d'une polyneuropathie périphérique diabétique, des tendinopathies, et des gingivites et parodontites et procédé correspondant Withdrawn EP3474873A1 (fr)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/CY2016/000002 WO2018001391A1 (fr) 2016-06-28 2016-06-28 Solution huileuse de gynura procumbens pour le traitement d'une polyneuropathie périphérique diabétique, des tendinopathies, et des gingivites et parodontites et procédé correspondant

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EP3474873A1 true EP3474873A1 (fr) 2019-05-01

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Publication number Priority date Publication date Assignee Title
CN100490780C (zh) * 2007-04-08 2009-05-27 谢平 平卧菊三七护肤霜及其制作方法
CN101032539B (zh) * 2007-04-08 2010-05-19 谢平 复方平卧菊三七口腔喷雾剂
CN103191039B (zh) * 2013-04-10 2014-12-31 翡林谷生物科技（上海）有限公司 一种漱口水及其制备方法和用途
CN103961301B (zh) * 2014-05-30 2016-02-17 袁丁 一种平卧菊三七即效多元修护天然复方面膜及其制备方法

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