Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K9/00—Medicinal preparations characterised by special physical form
  • A61K9/0012—Galenical forms characterised by the site of application
  • A61K9/0043—Nose
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K9/00—Medicinal preparations characterised by special physical form
  • A61K9/0012—Galenical forms characterised by the site of application
  • A61K9/0048—Eye, e.g. artificial tears
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K9/00—Medicinal preparations characterised by special physical form
  • A61K9/0012—Galenical forms characterised by the site of application
  • A61K9/007—Pulmonary tract; Aromatherapy
  • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
  • A61K9/0078—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a nebulizer such as a jet nebulizer, ultrasonic nebulizer, e.g. in the form of aqueous drug solutions or dispersions
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K9/00—Medicinal preparations characterised by special physical form
  • A61K9/08—Solutions
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K9/00—Medicinal preparations characterised by special physical form
  • A61K9/10—Dispersions; Emulsions
  • A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
  • A61K9/1075—Microemulsions or submicron emulsions; Preconcentrates or solids thereof; Micelles, e.g. made of phospholipids or block copolymers
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
  • A61P31/12—Antivirals
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
  • A61P31/12—Antivirals
  • A61P31/14—Antivirals for RNA viruses
  • A61P31/16—Antivirals for RNA viruses for influenza or rhinoviruses

Definitions

• the present invention relates to a preparation for the prevention and / or treatment and / or prevention of the spread of respiratory diseases, which are induced by viruses and may be accompanied by bacterial infections.
• the present invention also relates to the use of an extract of at least one Echinacea species or its sub-species for the preparation of a preparation for the prevention and / or treatment and / or prevention of the spread of respiratory diseases which are induced by viruses and may be accompanied by bacterial infections ,
• Respiratory diseases which are induced by pathogenic viruses and may be accompanied by bacterial infections, NEN to serious complications, such as high fever, pneumonia, pulmonary edema, hemorrhagic pneumonia, the acute respiratory distress syndrome (ARDS), sepsis, respiratory distress, Short of breath ⁇ ness , and even lead to cardiac arrest and death.
• ARDS acute respiratory distress syndrome
• a particularly high risk is based on novel viral influenza strains, as these are unknown to the human and animal immune system. These viruses have a very high mutability, so they escape the Iiranunabwehr and can proliferate unrestrained in the respiratory tract, for example in the lungs.
• Such viruses are capable of causing epidemics or pandemics.
• the Spanish flu mentioned which fell in the years 1918-1920 about 30 million people. Pulmonary edema and severe inflammation in the lungs caused suffocation or circulatory collapse; see Taubenberger J. and Morens D., "1918 Influenza: the mother of all pandemics". Emerg Infect Dis 2006; 12 (1): 15-22.
• pandemic Another example of a pandemic is the Asian flu, which succumbed to about 1.5 million people in 1957.
• oseltamivir Tamiflu ®
• zanamivir Relenza ®
• Amantadine sym- METREL ®
• CHMP Committee for Medicinal Products for Human Use
• viruses which can cause epidemics or pandemics in humans and animals include the lower respiratory tract, especially the bronchi, the bronchioles and alveoli, the lung tissue, as well as the upper respiratory tract, especially the nose, nasal cavity and nasal passages. Throat area, infect. Likewise, these viruses can infect the eyes.
• Therapeutic contains herbal ingredients from Echinacea species. This nose remedy is used exclusively for acute illnesses. Colds of allergic or viral origin are called diseases.
• This preparation should simultaneously have an antiviral, an anti-inflammatory and an antibacterial active principle.
• This preparation is said to be effective locally when administered appropriately in the respiratory tract, especially in the epithelial tissue and in the mucosa of the respiratory tract, including the bronchi, bronchioles and alveoli, as well as in lung tissue and in the oral cavity.
• This preparation should also develop its antiviral and antibacterial activity locally at those points outside the human or animal body where viruses can settle, for example on palms, nasal tampons, nasal tampons, protective masks, medical masks, door traps, medical devices , Air filters, for example in air conditioners.
• This preparation is said to exert its antiviral, anti-inflammatory and antibacterial effect even on suspicion of viral respiratory tract infections, especially in the case of imminent epidemics and pandemics caused, for example, by parainfluenza viruses, respiratory syncytial viruses, corona viruses and influenza viruses.
• Such suspicions may include rapidly rising fever, chills, cough, limb and muscle pain, headache and fatigue, pneumonia, shortness of breath, accompanied, if necessary, by nausea.
• This preparation should have a broad spectrum of activity against the most diverse viruses and bacteria involved in respiratory diseases. This preparation should prevent or at least substantially suppress the formation of resistant viruses and equally inactivate known virus strains and subtypes derived therefrom.
• This preparation should also be used for the prophylaxis of
• Respiratory diseases can be used, especially taken, for example, in the case of impending epidemics and pandemics.
• the preparation according to the invention for the prevention and / or treatment and / or prevention of the spread of respiratory diseases which are induced by viruses and may be accompanied by bacterial infections
• this preparation contains as active component an extract of at least one echinacea species or its subspecies, and that this preparation is either
• Inhalation and / or for pulmonary and / or nasal and / or buccal and / or ocular and / or parenteral, especially intravenous or subcutaneous, administration is suitable, or
• the present invention also relates to the use of an extract of at least one Echinacea species or its sub-species for the preparation of a preparation for the prevention and / or treatment and / or prevention of the spread of respiratory diseases which are induced by viruses and may be accompanied by bacterial infections this preparation either
• - is in a form suitable for inhalation and / or for pulmonary and / or nasal and / or buccal and / or ocular and / or parenteral administration, in particular intravenous or subcutaneous administration, or
• nasal administration of this preparation in the form of nasal drops, nasal sprays, dosage sprays and nasal ointments is excluded for the treatment of nasopharyngeal viral infections.
• a possible preparation according to the invention may contain as the sole active component an extract of at least one Echinacea species or its sub-species, optionally mixed with excipients / formulation substances.
• a possible preparation according to the invention can also be combined with at least one further active substance, for example with a Cistus incanus extract, a neuraminidase inhibitor and / or an M2 inhibitor.
• a preferred preparation according to the invention is preferably administered in a daily dose of up to 12 g, based on the dry matter of the fresh plant as a drug, preferably Echinacea purpurea.
• This preparation preferably contains a mixture of - 99 wt .-% to 75 wt .-%, in particular 95 Gew.-I, of an aqueous ethanolic extract of fresh, not dried aboveground plant parts of Echinacea purpurea and
• the extract of the aerial plant parts is obtainable by a maceration in a ratio of drug to extractant of 1:12 (m / m), wherein the dry matter of the fresh plant is defined as a drug, and at an ethane content of 57.3% (m / m ), including the water of the plant as a constituent of the solvent mixture.
• the extract of the underground plant parts is obtainable by a maceration in a ratio of drug to extractant of 1:11 (m / m), wherein the dry matter of the fresh plant is defined as a drug, and at an ethanol content of 57.3% (m / m ), Including the water of the plant as a component of the solvent mixture.
• This preparation is in such a form, which for inhalation and / or for the pulmonary and / or nasal and / or buccal and / or ocular and / or parenteral, especially intravenous or subcutaneous, administration.
• This preparation may be in the form of a nasal spray, nasal rinse, nasal ointment, nasal powder, eye wash, bronchial lavage, pulmonary spray, inhaler spray, pump sprayer, inhaler, for example, a powder inhaler, a nebulizer or an aerosol.
• Such preparations are suitable for human and animal use, for example in domestic animals and livestock, in particular pigs, cows, horses and poultry, for example chickens, birds, in particular waterfowl, such as ducks, geese.
• This preparation can also be used in one
• Such a preparation can be used to treat surfaces on which viruses can settle, for example on the palms, nasal tampons, nasal tampons, protective masks, medical masks, door traps, medical devices, air filters, for example in air conditioning systems.
• a preparation according to the invention With the local administration of a preparation according to the invention, inter alia, the treatment of a virus-induced respiratory disease, which may be accompanied by bacterial infections, made possible.
• This treatment is based on the three different principles of action described above.
• the aerial parts of the Echinacea purpurea were harvested mechanically during the flowering period on 31st of June 2007 near Roggwil in Switzerland, with as little mechanical stress as possible. In doing so, the 5 to 10 cm above the ground. The roots remained in the soil after harvesting the aerial parts. The roots of the Echinacea purpurea were taken by machine on October 17-18, 2007 from the ground.
• a commercial paper towel with 2.71 g weight was moistened with 7 g of extract mixture and packaged in an aluminum-coated bag, which was then sealed. This moistened handkerchief can be used for direct desi- Felement of hands, keyboards, telephone handsets, door handles, etc. can be used.
• the resulting extract mixture can be processed into a solution / microemulsion for various applications as follows:
• the extract mixture was concentrated by distillation of the ethanol under vacuum (25-75 mbar) and at a temperature of 45 ° C with a rotary evaporator to 10% of the initial amount.
• the concentrate thus obtained was mixed with 5% Cremophor RH 40 and stirred in a concentration of 0.1% in a physiological sodium chloride solution.
• the slightly opalescent, brown-yellow liquid was sterile-filtered through a 0.22 ⁇ m filter.
• the sterile solution thus obtained can be filled into a dropper bottle for ocular application.
• This sterile solution can also be processed into a spray for nasal application.
• This sterile solution can also be filled in glass bottles for pulmonary administration with the aid of an ultrasonic nebulizer.
• HSV-I herpes simplex virus
• this preparation inhibited 65% of avian influenza (H5N1) viruses.
• this preparation inhibited avian influenza (H5N1) viruses by about 98%. No resistance of these H5N1 viruses to treatment appears to occur.
• this preparation showed, especially at high dilutions, for example 1: 1 * 650 to 1: 165 * 000, strong inhibitory effects on the influenza viruses H7N7 and H5N1.
• This preparation of 95% above-ground and underground parts of 5% was investigated in in vitro virus infection ⁇ model in the production of inflammatory cytokines by epithelial cells.
• this preparation inhibited the production of inflammatory cytokines, such as interleukin-6, interleukin-8, after prior infection of human epithelial cells with influenza (H3N2) viruses, with respiratory syncytial viruses, with adenoviruses (AdIl), or with rhinoviruses ,
• H3N2 influenza
• AdIl adenoviruses
• Anti-inflammatory activity was maintained at dilutions of up to 1: 800.
• TNF- ⁇ tumor necrosis factor- ⁇
• interleukin-10 interleukin-10
• Streptococcus pyogenes Hemophilus influenzae, Legionella pneumophila, Propionibacterium acnes, Staphylococcus aureus, Clostridium difficile and Mycobacterium smegmatis.
• Antibacterial activity was maintained at dilutions of up to 1: 400.
• the term “contains” - in English: “contingening” or “comprising” - means that other compounds or components may be present.

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• 2009
  • 2009-07-07 CH CH01053/09A patent/CH699471B1/de unknown
  • 2009-09-07 WO PCT/CH2009/000299 patent/WO2010025577A2/de active Application Filing

Patent Citations (4)

Non-Patent Citations (5)

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