WO2021198940A1 - Composition for preventing or treating chronic or acute virus infection and/or sepsis in humans or animals - Google Patents

Composition for preventing or treating chronic or acute virus infection and/or sepsis in humans or animals Download PDF

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Publication number
WO2021198940A1
WO2021198940A1 PCT/IB2021/052677 IB2021052677W WO2021198940A1 WO 2021198940 A1 WO2021198940 A1 WO 2021198940A1 IB 2021052677 W IB2021052677 W IB 2021052677W WO 2021198940 A1 WO2021198940 A1 WO 2021198940A1
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Prior art keywords
iodine
iodide
zinc
salt
source
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PCT/IB2021/052677
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French (fr)
Japanese (ja)
Inventor
ズアンバー ホアン
ハンボー
クワンタイ グエン
Original Assignee
タイ ミン ファーマシューティカルズ ジェイエスシー
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Priority claimed from JP2020118675A external-priority patent/JP2021161105A/en
Application filed by タイ ミン ファーマシューティカルズ ジェイエスシー filed Critical タイ ミン ファーマシューティカルズ ジェイエスシー
Publication of WO2021198940A1 publication Critical patent/WO2021198940A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/095Sulfur, selenium, or tellurium compounds, e.g. thiols
    • A61K31/10Sulfides; Sulfoxides; Sulfones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/74Synthetic polymeric materials
    • A61K31/785Polymers containing nitrogen
    • A61K31/787Polymers containing nitrogen containing heterocyclic rings having nitrogen as a ring hetero atom
    • A61K31/79Polymers of vinyl pyrrolidone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/18Iodine; Compounds thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • A61K9/12Aerosols; Foams
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • A61P31/14Antivirals for RNA viruses
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Definitions

  • the present invention relates to compositions for the prevention or treatment of chronic or acute viral infections and / or sepsis in humans or animals.
  • Non-Patent Document 1 Non-Patent Document 1
  • This study can contribute to airway antiviral protection by activating the lactoperoxidase / I 2 / H 2 O 2 system with iodide compounds, and the innate antivirus by delivering I ⁇ to the airway mucosa. It suggests that it may enhance immunity.
  • Zinc (Zn) is an important trace element and plays an important role in initiating and maintaining a strong immune response. Furthermore, Zn is a hitrinovirus (Korant and Butterworth, 1976, Geist et al., 1987), a simple herpes virus (Kuempel, Arens and Travis, 2000), a human immunodeficiency virus (Haraguchi et al., 1999), C.I. Hepatitis virus (Yusa et al., 2006), respiratory symptom virus [RS virus] (Suara and Crowe, 2004), vaccinia virus (Katz and Margarith, 1981), picorna virus (Krenn, B et al. 2009). ), Coronavirus and Arterivirus (Te Vertiis AJ et al. 2010), and porcine coronavirus (Wei, Z, M et al. 2012), which have a direct inhibitory effect on various viruses.
  • DMSO Dimethyl sulfoxide
  • the present invention relates to a composition comprising an iodine source and a sulfur source for treating and preventing chronic and acute viral infections and sepsis in humans and animals, in particular in the pharmaceutical field, eg, as a therapeutic agent for these symptoms.
  • a composition comprising an iodine source and a sulfur source for treating and preventing chronic and acute viral infections and sepsis in humans and animals, in particular in the pharmaceutical field, eg, as a therapeutic agent for these symptoms.
  • iodine and dimethylsulfoxide compositions With respect to iodine and dimethylsulfoxide compositions.
  • the present invention exhibits a composition or drug for the treatment of COVID-19, as well as a predominantly human chronic antiviral effect that is superior to the conventionally known antiviral effects of I 2 and DMSO.
  • the purpose is to provide a drug for treating acute viral infection and / or septicemia.
  • the present inventors have found that chronic or acute viral infection and / or sepsis in humans or animals can be treated by using a specific iodine source in combination with a specific sulfur source, and complete the present invention. I arrived.
  • the present invention is as follows.
  • a substance that produces iodine ions by dissolution in water and / or after administration at least one iodine source selected from the group consisting of povidone iodine, and at least selected from the group consisting of dimethyl sulfoxide and methylsulfonylmethane.
  • Chronic human or animal including at least one iodine source selected from the group consisting of iodide salts and povidone iodine, and at least one sulfur source selected from the group consisting of dimethyl sulfoxide and methylsulfonylmethane.
  • a composition for the prevention or treatment of acute viral infection and / or septicemia includes at least one iodine source selected from the group consisting of iodide salts and povidone iodine, which is characterized by being used in combination with at least one sulfur source selected from the group consisting of dimethyl sulfoxide and methylsulfonylmethane.
  • a composition for the prevention or treatment of chronic or acute viral infections and / or septicemia in humans or animals Containing at least one sulfur source selected from the group consisting of dimethyl sulfoxide and methylsulfonylmethane, which is characterized by being used in combination with at least one iodine source selected from the group consisting of iodide salts and povidone iodine. , A composition for the prevention or treatment of chronic or acute viral infections and / or septicemia in humans or animals. [5] The composition according to any one of [1] to [4], wherein the sulfur source is combined with the iodine source to enhance the therapeutic effect of the sulfur source.
  • the daily dose of the iodine source and the sulfur source per kg of human or animal body weight is 20 mol or more of sulfur atoms contained in the sulfur source per mol of iodine atoms contained in the iodine source.
  • the dose of the iodine source per day of human or animal body weight is 1 part by mass with respect to 1 part by mass of the daily dose of the iodine source of human or animal.
  • the iodine source is an iodide salt, it is 5 parts by mass or more and 100 parts by mass or less.
  • the daily dose of the iodine source per kg of human or animal body weight is When the iodine source is an iodide salt, it is 0.5 mg to 10 mg. When the iodine source is povidone iodine, it is 0.5 mg to 50 mg.
  • the daily dose of the iodine source per kg of human or animal body weight is When the iodine source is an iodide salt, it is 1 mg to 5 mg. When the iodine source is povidone iodine, it is 1 mg to 40 mg.
  • the iodine source is an iodide salt, the iodide salt is a metal salt other than zinc iodide (ZnI 2 ), and the metal salt is used together with a zinc salt other than zinc iodide.
  • Composition. [11]
  • the iodine source is an iodide salt, the iodide salt is a metal salt other than zinc iodide (ZnI 2 ), and the metal salt is used together with a zinc salt other than zinc iodide.
  • the iodine source is an iodide salt.
  • the iodide salt is at least one selected from the group consisting of ZnI 2 , CuI 2 , FeI 2 , NaI, Ga 2 I 6 and KI, according to any one of [1] to [11].
  • the iodine source is an iodide salt.
  • the iodide salt is at least one selected from the group consisting of CuI 2 , FeI 2 , NaI, Ga 2 I 6 and KI, and is used together with zinc acetate ((CH 3 COO) 2 Zn).
  • At least one pharmaceutically acceptable dosage form selected from the group consisting of oral, parenteral, rectal, nasal spray, oral spray, transdermal, infusion, and aerosol spray, [1]-[ 14] The composition according to any one of the items.
  • composition according to any one of [1] to [15] for the prevention or treatment of COVID-19 [17] The composition according to any one of [1] to [16], which comprises iodine and dimethyl sulfoxide for the treatment for the prevention and treatment of chronic and acute viral infections and sepsis in humans and animals. .. [18] A therapeutic composition comprising iodine and dimethyl sulfoxide for the prevention and treatment of chronic and acute viral infections and sepsis in humans and animals. [19] The therapeutic composition according to [17] or [18], wherein dimethyl sulfoxide is combined with an iodine compound to enhance the therapeutic effect of dimethyl sulfoxide.
  • iodine refers to molecular iodine (I 2 ), iodide salts (ZnI 2 , CuI 2 , NaI or KI), iodate (NaIO), and / or iodotyrosine or iodolactone or methionine-iodine, providone-. Represents any form of molecule, including lipids or proteins that contain an iodine (iodine) moiety such as iodine, iodoacetic acid.
  • the dose of the component in the therapeutic composition according to any one of [17] to [19] is: Zinc iodide: 0.5 mg to 10 mg / kg body weight, preferably 1 to 5 mg / kg body weight
  • the mixture of zinc salt and iodide can be used in a ratio of 1 part zinc salt to 2-20 parts iodide salt, preferably 1 part zinc salt to 3-10 parts iodide salt (eg, 1 part zinc acetate and iodide).
  • Molecular iodine (I 2 ) or derivative 0.05 mg to 10 mg / kg body weight
  • DMSO dimethyl sulfoxide
  • An agent comprising at least one iodine source selected from the group consisting of an iodide salt and povidone iodine, and constituting the composition according to any one of [1] to [21].
  • An agent comprising at least one sulfur source selected from the group consisting of dimethyl sulfoxide and methylsulfonylmethane, and constituting the composition according to any one of [1] to [21].
  • a method for preventing or treating chronic or acute viral infection and / or sepsis which comprises administering the composition according to any one of [1] to [21] to humans or animals.
  • Pharmaceuticals for treating viral infections and / or septicemia can be provided.
  • the therapeutic combination of the present invention has a wide range of virucidal effects on DNA and RNA-containing viruses.
  • the therapeutic compositions of the present invention also exhibit anti-inflammatory, immunomodulatory and antioxidant effects.
  • the compositions of the present invention can be used as effective and safe sterile and disinfectants for humans and animals.
  • a first aspect of the present invention is a composition for the prevention or treatment of viral infection and / or sepsis.
  • the composition may be a composition for the prevention or treatment of chronic or acute viral infections and / or septicemia in humans or animals, preferably for chronic or acute viral infections and / or septicemia in humans. It is a composition for prevention or treatment, and more preferably a composition for treatment of chronic or acute viral infection and / or septicemia in humans.
  • the first aspect of the present invention is characterized in that a specific iodine source and a specific sulfur source are used in combination.
  • the particular iodine source is at least one selected from the group consisting of substances that produce iodine ions upon dissolution in water and / or after administration, and povidone iodine.
  • the substance that produces iodide ions by dissolution in water may be any substance that can generate iodide ions when mixed with a medium containing water.
  • the "medium containing water” may be water alone, not only water, or a medium containing components other than water, typically in the form of a liquid.
  • substances that generate iodine ions after administration include substances that can generate iodine ions after administration to humans or animals. Specifically, specifically, after administration to a living body, body fluids (blood, lymph, digestion) in the living body (blood, lymph, digestion). Liquids, tissue fluids, liquids present in cells, tissues, organs, etc., water present in the living body, etc.) and water derived from foods and drinks in the living body, which can generate iodine ions, and the like can be mentioned.
  • the specific iodine source may be a substance that produces iodide ions by dissolution in water, and may be a substance that produces iodide ions after administration.
  • a substance that produces iodine ions by dissolution in water and / or after administration is typically an iodide salt, and examples of the iodide salt include those described below.
  • Povidone iodine may also be a substance that produces iodide ions upon dissolution in water and / or after administration.
  • the particular iodine source may also be at least one selected from the group consisting of iodide salts and povidone iodine.
  • the iodide salt and povidone iodine do not have to be substances that generate iodine ions by dissolution in water and / or after administration, but substances that generate iodine ions by dissolution in water and / or after administration. May be preferred.
  • the iodide salt examples include a metal salt of iodine, which is at least one selected from the group consisting of ZnI 2 , CuI 2 , FeI 2 , NaI, gallium iodide (Ga 2 I 6) and KI. Preferably, it is at least one selected from the group consisting of ZnI 2 , NaI and KI, and even more preferably at least one selected from the group consisting of ZnI 2 and NaI.
  • a metal salt of iodine which is at least one selected from the group consisting of ZnI 2 , CuI 2 , FeI 2 , NaI, gallium iodide (Ga 2 I 6) and KI.
  • it is at least one selected from the group consisting of ZnI 2 , NaI and KI, and even more preferably at least one selected from the group consisting of ZnI 2 and NaI.
  • a specific iodine source is a substance that supplies zinc elements (including zinc atoms and zinc ions).
  • Zinc sources include substances that produce zinc ions upon dissolution in water and / or after administration.
  • the substance that produces zinc ions by dissolution in water and / or after administration is referred to as "iodine ion" in the above description of "a substance that produces iodine ions by dissolution in water and / or after administration”. It can be applied by replacing it with "zinc ion”.
  • Zinc sources and / or substances that produce zinc ions upon dissolution in water and / or after administration typically include zinc salts, which contain anions or anions that have little or no potential for adverse effects on the body. Salts of substances (elements, atoms, compounds) that can be produced and zinc are preferable, and salts of carboxylic acids such as zinc iodide (ZnI 2 ) and acetic acid and zinc are more preferable, and zinc iodide and zinc acetate ((CH)). 3 COO) 2 Zn) is more preferable. Since zinc iodide is the above-mentioned specific iodine source and also a zinc source, it can serve as both of them. Therefore, zinc iodide can be used as a specific iodine source and zinc source.
  • the iodide salt is a metal salt other than zinc iodide (ZnI 2 ), it is preferably used together with a zinc salt other than zinc iodide.
  • ZnI 2 zinc iodide
  • the iodide salt is at least one selected from the group consisting of CuI 2 , FeI 2 , NaI, Ga 2 I 6 and KI, it is preferably used with zinc acetate ((CH 3 COO) 2 Zn). stomach.
  • the combination of CuI 2 and zinc acetate, the combination of FeI 2 and zinc acetate, the combination of NaI and zinc acetate, the combination of Ga 2 I 6 and zinc acetate, and the combination of KI and zinc acetate is preferable, and the combination of NaI and zinc acetate is more preferable.
  • an iodine element or an iodine ion may be simply referred to as “iodine”, and an iodide ion (I ⁇ ) may be referred to as “iodine ion”.
  • the term "zinc salt” may specifically refer to a zinc salt other than zinc iodide (ZnI 2).
  • the specific sulfur source is at least one selected from the group consisting of dimethyl sulfoxide (DMSO) and methylsulfonylmethane (MSM). Only one of DMSO or MSM may be used, preferably DMSO. The description of DMSO in this specification can also be applied to MSM.
  • DMSO dimethyl sulfoxide
  • MSM methylsulfonylmethane
  • composition of this embodiment uses a specific iodine source and a specific sulfur source in combination as a pharmacologically active ingredient (medicinal ingredient, activator), and typically iodine (iodine element, iodide ion) and dimethyl. Contains sulfoxide. It is believed that a particular sulfur source is combined with a particular iodine source to enhance the therapeutic effect of the sulfur source.
  • a specific iodine source and a specific sulfur source functioning and exerting an effect is not clear, but a specific iodine source or a part thereof or an iodine element produced from the iodine source or
  • iodine ions and a specific sulfur source act together, the possibility that iodine ions generated from a specific iodine source act (for example, the possibility of exerting an antiviral effect)
  • the specific sulfur source is an iodine ion, It may act as a stabilizer and / or carrier for the iodine element or iodine source, and even if there may be some adverse effects (side effects, etc.) due to the iodide ion, iodine element or iodine source, a specific sulfur source may be affected by the adverse effects.
  • current treatment plans typically include a combination of zinc iodide (ZnI 2 ) or a mixture of zinc and iodide salts (preferably zinc acetate and iodine). Potassium or sodium iodide), iodine crystals, or iodine derivatives (specifically, povidone iodine (also referred to as providone iodine, povidone-iodine), methionine-iodine, iodoacetic acid, etc.) with dimethylsulfoxide (DMSO). I'm using it.
  • compositions combine DMSO with the two components described above, namely ZnI 2, zinc salt / iodide salt or iodine or iodine derivative, to suppress, prevent, and prevent symptoms of all types of viral infections and septicemia. It showed a strong synergistic effect in treatment.
  • Viral infections to which the composition of this embodiment can be effective include SARS-COV-2 infections or COVID-19 (eg, Cases 8 and 9 below), viral pneumonia (eg, Case 1 below), and A.
  • Influenza such as type influenza (for example, case 7 below), respiratory virus infection for which a virus such as a general cold has not been identified (for example, cases 2, 3 and 6 below), genital herpes (for example, case below). 4)
  • herpes infection case 5 described later may be the case
  • hepatitis B, hepatitis C, HIV infection, RSV infection, human papillomavirus infection (HPV) and the like can be mentioned.
  • Viral infections and / or septicemia for which the compositions of this embodiment may be effective include dry cough, severe dry cough, throat pain, squeezing (severe squeezing, etc.), chest and nose stuffiness, headache, chest pain (chest).
  • Pain Pain), muscle pain, body pain, shortness of breath, dyspnea, respiratory insufficiency (acute respiratory insufficiency, etc.), respiratory function limitation, acute bronchitis, fatigue (extreme fatigue, etc.), malaise, cold, pneumonia (inflammatory reaction, etc.) Bilateral lower lobe pneumonia, etc.), chest congestion, pleural effusion, abdominal distension, abdominal pain, heart failure, dyspnea with a heart rate of 114 to 115 per minute, dyspnea such as 32 to 36 breaths per minute, 72 to 86%, etc.
  • Oxygen saturation (SpO 2 ; 72%, 75%, 86%, etc.), fever of about 38-40 ° C (including 38 ° C, 38.7 ° C, 39 ° C, 39.5 ° C, etc.), liver disease, Elevated liver enzymes and blood lactate levels, increased serum creatine, thrombocytopenia, leukocytopenia, congestive heart failure, stage II renal failure, hypotension, type II insulin-dependent diabetes, acute burning pain, With symptoms and conditions such as genital blisters, painful blisters on both sides of the face and in the mouth, blisters, watery secretions, rectal cancer, loss of appetite, bloody diarrhea (bloody diarrhea), olfactory dysfunction, etc. It may be a thing.
  • Patients with viral infections and / or septicemia for which the composition of this embodiment may be effective include lung cancer, breast cancer, prostate cancer, cancer such as prostate cancer with metastasis to bone, lung, lymph nodes, gastric inflammation, gastric ulcer, etc.
  • Patients may have a history of chronic active hepatitis B, Crohn's disease, asthma, COPD (chronic obstructive lung disease), smoking history, and the like.
  • composition of this embodiment is also considered to have effects such as antiviral, anti-inflammatory, antifungal, antibacterial, immunomodulatory, antifibrosis, antithrombotic, cardiac and respiratory assisting activities, and these activities allow patients and animals. These symptoms of the virus can also be alleviated.
  • compositions of this embodiment also include antibiotics such as penem, vancomycin, solmedrol, paracetamol, dexamethasone, tamiflu, acyclovir, corticosteroids, cough suppressants, bronchial dilators, antipyretics, Ringer-lactate. (Solution), nutritional supplements, Chinese herbs, administration of other drugs such as other antiviral drugs, treatment such as oxygen therapy (patients, etc.), or when these treatments do not improve the symptoms Even (patients, etc.) can alleviate these symptoms of patients and animals.
  • antibiotics such as penem, vancomycin, solmedrol, paracetamol, dexamethasone, tamiflu, acyclovir, corticosteroids, cough suppressants, bronchial dilators, antipyretics, Ringer-lactate. (Solution), nutritional supplements, Chinese herbs, administration of other drugs such as other antiviral drugs, treatment such as oxygen therapy (patients, etc.), or when these treatments do not improve the symptoms Even (patient
  • the daily dose of a particular iodine source and a particular sulfur source per kg of human or animal body weight is the ratio of sulfur atoms contained in the sulfur source to 1 mole of iodine atoms contained in the iodine source.
  • 20 mol% or more and 200 mol% or less are mentioned, and the lower limit value is preferably 25 mol% or more, more preferably 30 mol% or more, and the upper limit value is preferably 180 mol% or less, more preferably. Is less than 30 mol%.
  • the daily dose of a specific iodine source per kg of human or animal to 1 part by mass of the dose per kg of body weight of a specific iodine source is that the specific iodine source is an iodide salt.
  • the lower limit value is preferably 10 parts by mass or more, more preferably 20 parts by mass or more
  • the upper limit value is preferably 90 parts by mass. It is less than or equal to parts by mass, more preferably 80 parts by mass or less.
  • the daily dose of a specific iodine source per kg of human or animal to 1 part by mass of the dose per kg of body weight of a specific iodine source is when the specific iodine source is povidone iodine.
  • a range of 5 parts by mass or more and 100 parts by mass or less can be mentioned, and the lower limit value is preferably 10 parts by mass or more, more preferably 20 parts by mass or more, and the upper limit value is preferably 90 parts by mass or more.
  • it is more preferably 80 parts by mass or less.
  • the daily dose of a particular iodine source per kg of human or animal body weight is as follows.
  • the specific iodine source is an iodide salt
  • the range is 0.5 mg to 10 mg, and the lower limit is preferably 1 mg or more, more preferably 2 mg or more, and the upper limit is. It is preferably 7 mg or less, more preferably 5 mg or less.
  • the specific iodine source is an iodide salt
  • the iodide salt is a metal salt other than zinc iodide (ZnI 2 ), and the metal salt is used together with a zinc salt other than zinc iodide.
  • the iodide salt which is a metal salt other than zinc iodide, has a ratio of, for example, 2 to 5 mol with respect to 1 mol of the zinc salt other than zinc iodide, and the zinc salt other than zinc iodide.
  • the iodide salt, which is a metal salt other than zinc iodide has a range of, for example, 1 to 20 parts by mass with respect to 1 part by mass, and the lower limit is preferably 2 parts by mass or more, more preferably 3 parts by mass. It is more than parts by mass, and the upper limit is preferably 10 parts by mass or less, more preferably 5 parts by mass or less.
  • the range is 0.5 mg to 50 mg, the lower limit is preferably 1 mg or more, more preferably 2 mg or more, and the upper limit is preferably. Is 40 mg or less, more preferably 30 mg or less.
  • the daily dose of a particular sulfur source per kg of human or animal body weight may range, for example, from 10 to 1000 g (10 to 1000 ml), with a lower limit of preferably 100 g (100 ml) or more, more preferably. Is 200 g (200 ml) or more, and the upper limit value is preferably 700 g (700 ml) or less, more preferably 500 g (500 ml) or less.
  • DMSO can be replaced with methylsulfonylmethane (MSM), preferably at a dose of 10 mg to 150 mg (10 to 150 ml) per kg body weight per day.
  • MSM methylsulfonylmethane
  • the current therapeutic composition component doses are preferably, for example: Zinc iodide: 0.5-10 mg / kg body weight, preferably 1-5 mg / kg body weight
  • the mixture of zinc salt and iodide can be used in a ratio of 1 part zinc salt to 2 to 20 parts iodide salt, preferably 1 part zinc salt to 3 to 10 parts iodide salt (eg, 1 part zinc acetate and iodide). 5 parts of potassium or 1 part of zinc acetate and 5 parts of sodium iodide).
  • Molecular iodine (molecular iodine; I 2 ) or derivative: 0.05-10 mg / kg body weight
  • Dosage forms of the compositions of this embodiment include, for example, oral liquids, softgels, suspensions, aerosols, gels, oral creams, transdermal agents, nasal and oral sprays and other sprays, eye drops or ears.
  • injections such as preparations, parenteral preparations, rectal suppositories (suppositories), infusions, intramuscular injections, and intravenous injections, powders, powders, granules, tablets, capsules, pills, and liquids.
  • composition of this embodiment may contain other components as long as the desired action is not impaired.
  • Other components include, for example, sweeteners, flavors (flavors), excipients, bases, emulsifiers, solvents (eg, water), stabilizers, pH adjusters and the like.
  • the composition of this embodiment may be a composition in which a specific iodine source, a specific sulfur source, and in some cases a zinc source are further combined at the time of provision of sale or the like, or the composition of the sale or the like may be provided. At the time, at least one selected from the group consisting of a specific iodine source, a specific sulfur source, and an arbitrary zinc source is separated (as a separate agent or composition) and is used in clinical settings such as at the time of administration. It may be mixed.
  • Examples of the administration method of the composition of this embodiment include oral administration, nasal administration, spray administration, transdermal administration, eye drops, ear drops, via injection, intramuscular injection, intravenous administration, and intraperitoneal administration.
  • Enteral administration such as a rectal suppository can be mentioned, and oral administration, nasal administration, spray administration, and intravenous administration are preferable.
  • oral administration it can be administered once to several times a day (for example, two or three times).
  • the administration period of the composition of this embodiment is preferably until the symptoms of viral infection and / or sepsis are alleviated or subsided, for example, 1 hour to 24 hours, for example, 1 hour to 12 hours, 1 hour to after the first administration.
  • Symptom relief such as fever relief (body temperature drop) and pain relief may be seen in a short time such as 6 hours, 1 hour to 3 hours, and 1 hour to 2 hours.
  • administration of the composition of this embodiment may be continued for 1 day or longer, for example, preferably 2 days or longer, more preferably 3 days or longer.
  • the upper limit of the number of days of continuous administration is not particularly limited, and examples thereof include January (within 30 to 31 days), for example, within 15 days, within 12 days, within 10 days, within 5 days, and within 3 days. May be.
  • a second aspect of the present invention comprises an iodide salt and at least one iodine source selected from the group consisting of povidone iodine, and is an agent for constituting the composition of the first aspect.
  • the agent of the second aspect is an agent containing a specific iodine source used for forming, preparing or producing the composition of the first aspect.
  • the agent is prepared and manufactured, for example, as an agent or composition separate from or separated from the agent or composition containing a specific sulfur source and an arbitrary zinc source at the time of provision such as sale or offer for sale. It may be supplied or mixed in clinical settings such as when administered to humans or animals, or it may be a specific iodine source or a specific sulfur source at the time of sale, offer of sale, etc. , And may be used to compose, prepare or produce a single composition of the first aspect comprising any zinc source.
  • the above-mentioned matters concerning the first aspect also apply to the second aspect.
  • a third aspect of the present invention comprises at least one sulfur source selected from the group consisting of dimethyl sulfoxide and methylsulfonylmethane, and is an agent for constructing the composition of the first aspect.
  • the agent of the third aspect is an agent containing a specific sulfur source used for forming, preparing or producing the composition of the first aspect.
  • the agent is prepared and manufactured, for example, as an agent or composition separate from or separated from the agent or composition containing a specific iodine source and an arbitrary zinc source at the time of provision such as sale or offer for sale. It may be supplied or mixed in clinical settings such as when administered to humans or animals, or it may be a specific iodine source or a specific sulfur source at the time of sale, offer of sale, etc. , And may be used to compose, prepare or produce a single composition of the first aspect comprising any zinc source. Within the scope of this purpose, the above-mentioned matters concerning the first aspect also apply to the third aspect.
  • compositions for oral administration can be formulated as follows: 5 g (5000 mg) of zinc iodide with a purity of 99.4% to 99.9% (or 5 g of zinc acetate and 25 g of potassium iodide or 1 part of zinc acetate and 3 to 15 parts (eg, 3 or 3 parts) 5 parts or more, 5 parts or more, 10 parts or 10 parts or less, 15 parts or 15 parts or less) of sodium iodide or potassium iodide) is mixed with 1000 ml of a 99.8% dimethyl sulfoxide solution. (Composition ZnDM-O)
  • compositions for intravenous administration can be formulated as follows: 5 g (5000 mg) of zinc iodide with a purity of 99.8% to 99.9% (or 99.8% 5 g of zinc acetate and 99.8% 25 g of sodium iodide) in 1000 ml of a 99.9% pharmaceutical grade solution of dimethyl sulfoxide. Mix with. (Composition ZnDM-IV)
  • compositions for oral administration can be formulated as follows: 1000-5000 mg povidone iodine, 50 ml water for injection and 50 ml DMSO (Composition PVI-DM)
  • Composition PVI-DM Prescription example 3-1
  • Compositions for oral administration can be formulated as follows: 5000 mg of iodine crystals (or providone-iodine or methionine-iodine), 50 ml of water for injection and 50 ml of DMSO (Composition PVI-DM-1)
  • compositions for nasal and oral sprayers can be formulated as follows: Zinc iodide: 2000 mg, DMSO pharmaceutical grade (98.8-99.9%): 150 ml, water 900 ml (Composition ZnDM-SP)
  • compositions for aerosols or sprays can be formulated as follows: Zinc iodide 1000-2000 mg, DMSO pharmaceutical grade (98.8-99.8%) 200 ml and water for injection 800 ml (Composition ZnDM-AN)
  • compositions for oral administration can be formulated as follows: One part of zinc iodide can be blended with 5 to 50 parts of methylsulfonylmethane (MSM), for example 5 to 10 parts. The mixture is prepared in capsules or tablets with a total weight of 200-1000 mg, eg 300-500 mg. The daily dose is 1 to 3 capsules, 3 times daily for the treatment of viral infections and sepsis, including SARS-CoV-2 (COVID-19).
  • MSM methylsulfonylmethane
  • Example 1 The composition for oral administration was formulated as follows. 5 g (5000 mg) of zinc acetate and 15 g (15000 mg) of sodium iodide were mixed with 1000 ml of a 99.8% pure dimethyl sulfoxide solution (composition ZnDM-O).
  • Example 2 The composition for intravenous administration was formulated as follows. 5 g of 99.8% pure zinc acetate and 25 g of 99.8% pure sodium iodide were mixed with 1000 ml of a 99.9% pure pharmaceutical grade dimethyl sulfoxide solution (composition ZnDM-IV).
  • Example 3 The composition for oral administration was prepared by mixing with the following formulation. 3750 mg of povidone iodine, 50 ml of water for injection and 50 ml of DMSO (composition PVI-DM). The daily dose was 2 mg of povidone iodine per kg of patient body weight (or 150 mg for adult patients).
  • Example 4 Compositions for nasal and oral sprayers were mixed and prepared according to the following formulations.
  • Zinc iodide 2000 mg, DMSO pharmaceutical grade (purity 98.8-99.9%): 150 ml, water 900 ml (composition ZnDM-SP)
  • Example 5 Compositions for aerosols or sprays were prepared by mixing with the following formulations.
  • Example 6 The composition for oral administration can be prepared with the following formulation.
  • One part of zinc iodide can be blended with 5 to 50 parts of methylsulfonylmethane (MSM), for example 5 to 10 parts.
  • MSM methylsulfonylmethane
  • the mixture is formulated in capsules or tablets with a total weight of 200-1000 mg, eg 300-500 mg.
  • the daily dose is 1 to 3 capsules, 3 times daily for the treatment of viral infections and sepsis, including SARS-CoV-2 (COVID-19).
  • Case 1 A 65-year-old male patient with a history of lung cancer was hospitalized with dry cough, sneezing, headache, chest pain, muscle pain, and dyspnea. He showed tachycardia with a heart rate of 115 per minute, a respiratory rate of 36 breaths per minute, 86% oxygen saturation with oxygen therapy, and a fever of 38-39 ° C over the last three days. The patient had been taking antibiotics (penem and vancomycin), cough medicine, and antipyretics for the past three days, but his condition and symptoms did not improve.
  • antibiotics penem and vancomycin
  • Chest X-ray showed right pneumonia and pleural effusion on the left and right sides of the lungs.
  • Patients were treated with penem and vancomycin, given daily dexamethasone 20 mg orally, and Tamiflu, despite normal white blood cell counts at admission. After 24 hours, the patient's general condition and symptoms did not improve. His liver enzymes and blood lactate levels were elevated and serum creatine was elevated. The patient also developed thrombocytopenia and leukopenia. The patient was diagnosed with viral pneumonia and a potentially septic condition. His fever was 39.5 ° C. 3 hours after intravenous injection of 1000 mg of paracetamol.
  • Chest X-ray examination 15 days after treatment with ZnDM-IV showed a reduction of 80% or more in pneumonia on the left side and a 60% reduction in pleural effusion on both sides.
  • the white blood cell count and blood lactate level were in the normal range.
  • Patients with thrombocytopenia, liver enzymes, and creatine were all reduced compared to data prior to ZnDM-IV treatment.
  • Case 2 A 43 year old man. He showed fever of 38.5 ° C, dyspnea, myalgia, dry cough, and severe sneezing. His symptoms started 12 hours ago and were significantly worse. The patient had a history of gastritis, gastric ulcer, and chronic active hepatitis B. The patient has been taking antiviral drugs for the past two years. Due to his liver disease, the patient is unable to take antipyretics for the current symptoms. The patient was diagnosed with a respiratory viral infection and began treatment every 8 hours with 5 ml of ZnDM-O mixed with 150 ml of water. After 6 hours of treatment with ZnDM-O, all symptoms associated with the current illness improved significantly and his fever dropped to 37.6 ° C. without antipyretic therapy. Patients continued to take 5 ml of ZnDM-O 3 times daily for 6 days. His symptoms associated with respiratory viral infections were completely controlled in 72 hours. The patient's health was normalized 5 days after the start of treatment with ZnDM-O.
  • Case 3 An 82-year-old woman with a history of breast cancer and no specific treatment history presented with congestive heart failure, stage II renal failure, hypotension, and type II insulin-dependent diabetes mellitus. On admission, the patient exhibited a fever of 39 ° C., a severe dry cough, a sore throat, muscle aches, chest and stuffy nose, a tachycardia with a heart rate of 114 minutes per minute, and a respiratory rate of 32 breaths per minute. Despite previous treatment with paracetamol with a total dose of 3000 mg, the patient's symptoms did not improve.
  • the patient's blood cell count was normal and the biochemical panel showed a significant increase in C-reactive protein to 146 mg / L, SGPT to 121 IU / L, and SGOT to 114 IU / L.
  • a chest x-ray of the patient showed no signs of pneumonia and no reduction in lung volume.
  • the patient started treatment with 4 ml ZnDM-O every 6 hours with 100 ml of water.
  • Her symptoms were alleviated, and after 24 hours of treatment with ZnDM-O, the patient's fever dropped to 37.4 ° C., with a heart rate of 98 beats per minute and a respiratory rate of 28 breaths per minute.
  • Case 4 A 51 year old woman. He complained of acute burning pain due to blisters on the vulva. The patient was diagnosed with genital herpes, and taking acyclovir 400 mg three times daily for the past three days did not significantly improve symptoms, but the size of the vulvar blisters was minimized. Patients started treatment with 5 ml ZnDM-O mixed with 150 ml of water three times daily.
  • Case 5 A 76 year old woman. There were painful blisters on both sides of the face and in the mouth, and a fever of 38 ° C. Despite administration of 400 mg of acyclovir three times daily for 3 days, the number of blisters increased and secretions were formed on the face and mouth. Patients started treatment with 5 ml of ZnDM-O mixed with 150 ml of water three times daily. Her pain level decreased significantly 6 hours after the start of treatment and was completely suppressed at 72 hours. Blisters and watery secretions were significantly reduced 24 hours after treatment with ZnDM-O. The blisters healed after 12 days of treatment.
  • Case 6 A 74-year-old male patient suffered from end-stage rectal cancer. He developed fatigue, chills, cough, chest pain, and high fever for 3 days before admission. The patient was diagnosed with a respiratory viral infection and acute bronchitis. At admission, the patient's temperature rose to 39.8 ° C. After 24 hours of treatment consisting of antibiotic treatment, oxygen therapy, antipyretic therapy, and infusion of Ringer-lacte solution, the patient's fever maintained a temperature of 39.5 ° C and his condition. Exacerbated with symptoms of extreme fatigue, headache, dyspnea, abdominal distension, and heart failure.
  • Patients began treatment with oral administration of 1 ml of PVI-DM composition mixed with 150 ml of water every 6 hours. The patient's condition improved rapidly 2 hours after starting PVI-DM treatment, and his temperature dropped to 38.3 ° C. His symptoms of heart failure and dyspnea gradually improved during the 10 days of treatment. Patients continued oral treatment with 1 ml PVI-DM mixed with 150 ml of water three times daily without antibiotics for the next 9 days. The symptoms of his pathogenic disease were controlled after 4 days and his general health improved significantly. The patient was discharged 11 days later.
  • Case 7 A 69-year-old man had a high fever, sore throat, and dry cough that lasted for 5 days.
  • the patient was diagnosed with influenza A infection.
  • the patient had a long history of smoking and COPD. He did not receive any specific treatment, but used dietary supplements and herbal medicines to control his COPD symptoms.
  • Patients received antibiotics, solmedrol injections, oral paracetamol, bronchodilator sprays and Tamiflu. Despite the treatment, his fever and cough remained three days after starting the treatment. On the fourth day, the patient developed a SpO 2 87% of acute respiratory failure in 6L / min oxygen mask.
  • a chest x-ray detected signs of pathogen-related pneumonia in the sputum.
  • Example 7 The composition for oral administration was prepared by mixing with the following formulation.
  • Zinc iodide 10 grams (10,000 mg) Purity 98.0% -99.8% Dimethyl sulfoxide pharmaceutical grade 98.8% -99.9% 400ml 600 ml of water (Composition ZnDM-COVID-O)
  • Example 8 Compositions for intravenous administration can be formulated as follows: Zinc iodide 5 grams (5,000 mg) Purity 98.0% -99.8% Dimethyl sulfoxide pharmaceutical grade 98.8% -99.9% 600ml 400 ml of water (Composition ZnDM-COVID-IV)
  • Example 9 Compositions for nasal passages, oral sprays and sprays were prepared by mixing with the following formulations.
  • Zinc iodide 2,000 mg Purity 98.0% -99.8% Dimethyl sulfoxide pharmaceutical grade 98.8% -99.9% 200 ml 800 ml of water (Composition ZnDM-COVID-SN)
  • Case 8 A 76 year old man. With a history of prostate cancer with metastases to bones, lungs and lymph nodes and a history of moderate smoking for 51 years, a fever of 38.7 ° C, muscle and body pain, a severe dry cough with dyspnea, Appeared in the clinic with sore throat, abdominal pain, and extreme fatigue. The patient's symptoms developed and worsened within 6 days and were COVID-19 positive in the RT-PCR test of the nasopharyngeal swab material. The patient underwent x-ray examination and the results showed bilateral lower lobe pneumonia. The patient's SpO 2 level was 72% and the pulse rate was 120 per minute.
  • Patients began treatment with bronchodilator inhalation, parasetamol 1000 mg IV, and oxygen therapy with 10 ml ZnDM-COVID-O mixed with 200 ml water via a mask at 6 liters per minute. Two hours after the first treatment, the patient's condition improved significantly. His muscle and body aches were dramatically reduced, SpO 2 increased to 92% with 3 liters of oxygen therapy per minute, pulse rate was 98 per minute, and fever decreased to 36.7 ° C. .. Patients were receiving 10 ml of ZnDM-COVID-O with 200 ml of water 6 hours after the first treatment without other therapeutic agents.
  • Case 9 A 54-year-old man with a history of Crohn's disease and asthma has a high fever of 39.5 ° C, severe shortness of breath, dry cough, congestion and pain in the chest, bloody diarrhea, extreme fatigue, pain and anosmia. He visited the hospital complaining of anosmia. Chest X-ray confirmed bilateral pneumonia with haze. The patient was diagnosed with suspected COVID-19 by close contact with a close relative who was confirmed to have COVID-19 infection 7 days ago. The patient's SpO 2 was 75%, oxygen therapy was given at 5 liters per minute through a mask, and the pulse rate was 110 per minute.

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Abstract

Provided is a composition or medicine for treating Covid-19, and a medicine for treating chronic or acute virus infection and/or sepsis mainly in humans, said medicine indicating a superior antiviral effect to the antiviral effect of conventionally known DMSO or I2. This composition for preventing or treating chronic or acute virus infection and/or sepsis in humans or animals contains at least one iodine source selected from the group consisting of iodide salts and povidone-iodine, and at least one sulfur source selected from the group consisting of dimethyl sulfoxide and methylsulfonylmethane.

Description

ヒト又は動物の慢性若しくは急性のウイルス感染症及び/又は敗血症の予防若しくは治療のための組成物Compositions for the prevention or treatment of chronic or acute viral infections and / or sepsis in humans or animals
 本発明は、ヒト又は動物の慢性若しくは急性のウイルス感染症及び/又は敗血症の予防若しくは治療のための組成物に関する。 The present invention relates to compositions for the prevention or treatment of chronic or acute viral infections and / or sepsis in humans or animals.
 SARS(重症急性呼吸器症候群)、ノロウイルス、鳥インフルエンザなどのウイルス感染による死亡率は、最近の歴史の中で増加している。2019年12月8日以降、原因不明の肺炎のいくつかの症例が中国湖北省武漢で報告されている(Lu h 2020)。コロナウイルスのこの最近の流行は、後にCOVID−19と命名され、その高い感染力と病原性により世界的な脅威となっている。 Mortality from viral infections such as SARS (Severe Acute Respiratory Syndrome), norovirus, and bird flu has increased in recent history. Since December 8, 2019, several cases of pneumonia of unknown cause have been reported in Wuhan, Hubei Province, China (Luh 2020). This recent epidemic of coronavirus, later named COVID-19, poses a global threat due to its high infectivity and pathogenicity.
 新しいインフルエンザウイルスの出現は、早急な対応が必要な緊急の問題である。抗ウイルスワクチンの開発はこれらの問題の解決策だが、ワクチンは特定のウイルスの感染を防ぐことにおいてのみ効果的である。ワクチンの研究、開発、および製造も、かなりの時間と経済的資源を必要とし、失敗のリスクが高い。COVID−19を引き起こすものを含む新しいコロナウイルスがいかに速く広がっているかを考えると、予防および治療薬としての先天的および適応的な(adaptive)抗ウイルス防御を高める一方で、幅広いウイルスに対して有効な抗ウイルス剤が緊急に必要とされている。 The emergence of a new influenza virus is an urgent issue that requires immediate attention. The development of antiviral vaccines is a solution to these problems, but vaccines are only effective in preventing the transmission of certain viruses. Vaccine research, development, and production also require considerable time and financial resources and is at high risk of failure. Given how fast new coronaviruses, including those that cause COVID-19, are spreading, they are effective against a wide range of viruses while enhancing innate and adaptive antiviral protection as prophylactic and therapeutic agents. Antiviral agents are in urgent need.
 ウイルス性気道感染症は、世界中の罹患率と死亡率の重要な原因である。フィッシャーらは、LPO/I/H酸化的宿主防御システムが2つの主要な呼吸器ウイルス性病原体であるアデノウイルス、およびRSVに対する強力な活性があることを示している。さらに、ラクトペルオキシダーゼ/I/Hシステムは、気道粘膜へのIの送達により、気道抗ウイルス防御に貢献し、生得の抗ウイルス免疫を増強する可能性がある(非特許文献1)。この研究は、ヨウ化物化合物を使用してラクトペルオキシダーゼ/I/Hシステムを活性化することにより、気道抗ウイルス防御に貢献でき、気道粘膜へのIの送達により生得の抗ウイルス免疫を増強する可能性があることを示唆している。 Viral respiratory tract infections are an important cause of morbidity and mortality worldwide. Fisher et al. Show that the LPO / I 2 / H 2 O 2 oxidative host defense system has potent activity against two major respiratory viral pathogens, adenovirus and RSV. In addition, the lactoperoxidase / I 2 / H 2 O 2 system may contribute to airway antiviral protection and enhance innate antiviral immunity by delivering I − to the airway mucosa (Non-Patent Document 1). ). This study can contribute to airway antiviral protection by activating the lactoperoxidase / I 2 / H 2 O 2 system with iodide compounds, and the innate antivirus by delivering I − to the airway mucosa. It suggests that it may enhance immunity.
 亜鉛(Zn)は重要な微量元素であり、強力な免疫応答の開始と維持に重要な役割を果たす。さらに、Znは、ヒトライノウイルス(Korant and Butterworth,1976,Geist et al.,1987)、単純ヘルペスウイルス(Kuempel,Arens and Travis,2000)、ヒト免疫不全ウイルス(Haraguchi et al.,1999)、C型肝炎ウイルス(Yuasa et al.,2006)、呼吸器合胞体ウイルス[RSウイルス](Suara and Crowe,2004)、ワクシニアウイルス(Katz and Margalith,1981)、ピコルナウイルス(Krenn,B et al.2009)、コロナウイルスおよびアルテリウイルス(Te Velthuiis A J et al.2010)、並びにブタコロナウイルス(Wei,Z,M et al.2012)を含むさまざまなウイルスに対して直接阻害効果を示す。 Zinc (Zn) is an important trace element and plays an important role in initiating and maintaining a strong immune response. Furthermore, Zn is a hitrinovirus (Korant and Butterworth, 1976, Geist et al., 1987), a simple herpes virus (Kuempel, Arens and Travis, 2000), a human immunodeficiency virus (Haraguchi et al., 1999), C.I. Hepatitis virus (Yusa et al., 2006), respiratory symptom virus [RS virus] (Suara and Crowe, 2004), vaccinia virus (Katz and Margarith, 1981), picorna virus (Krenn, B et al. 2009). ), Coronavirus and Arterivirus (Te Vertiis AJ et al. 2010), and porcine coronavirus (Wei, Z, M et al. 2012), which have a direct inhibitory effect on various viruses.
 ジメチルスルホキシド(DMSO)は、木材パルプに由来するすべて天然の物質である。1963年に、この化合物が皮膚や他の膜に損傷を与えることなく浸透することができ、成分を生体系に運ぶことができることが発見された。DMSOは酸化ストレスを容易に誘発し、酸素レベルを上昇させ、抗ウイルス剤として作用することができる。この化合物は、ウイルス感染によって誘発される免疫炎症反応の調節不全に関連する敗血症状態を修正することが示されている(非特許文献)。機構的に、DMSOは、敗血症動物の転写因子の活性化を調節し、他の薬物の担体として機能することができる強力な抗酸化物質である。
臨床現場でDMSOを安全に使用してきた長い歴史がある。
Dimethyl sulfoxide (DMSO) is an all-natural substance derived from wood pulp. In 1963, it was discovered that the compound could penetrate without damaging the skin or other membranes and could carry the component into the biological system. DMSO can easily induce oxidative stress, increase oxygen levels and act as an antiviral agent. This compound has been shown to correct septic conditions associated with dysregulation of the immunoinflammatory response induced by viral infection (Non-Patent Document). Mechanically, DMSO is a potent antioxidant that can regulate the activation of transcription factors in septic animals and act as a carrier for other drugs.
There is a long history of safe use of DMSO in clinical practice.
 本発明は、医薬分野、特に、ヒトおよび動物の慢性および急性ウイルス感染並びに敗血症を治療および予防するための、ヨウ素源とイオウ源とを含む組成物に関し、例えば、これらの症状の治療薬としてのヨウ素およびジメチルスルホキシド組成物に関する。 The present invention relates to a composition comprising an iodine source and a sulfur source for treating and preventing chronic and acute viral infections and sepsis in humans and animals, in particular in the pharmaceutical field, eg, as a therapeutic agent for these symptoms. With respect to iodine and dimethylsulfoxide compositions.
 具体的には、本発明は、COVID−19の治療のための組成物ないし医薬、並びに、従来公知のIやDMSOの抗ウイルス効果よりも優れた抗ウイルス効果を示す、主にヒトの慢性若しくは急性のウイルス感染及び/又は敗血症を治療するための医薬を提供することを目的とする。 Specifically, the present invention exhibits a composition or drug for the treatment of COVID-19, as well as a predominantly human chronic antiviral effect that is superior to the conventionally known antiviral effects of I 2 and DMSO. Alternatively, the purpose is to provide a drug for treating acute viral infection and / or septicemia.
 本発明者らは、特定のヨウ素源と、特定のイオウ源とを組み合わせて用いることにより、ヒト若しくは動物の慢性若しくは急性のウイルス感染及び/又は敗血症を治療できることを見出し、本発明を完成するに至った。 The present inventors have found that chronic or acute viral infection and / or sepsis in humans or animals can be treated by using a specific iodine source in combination with a specific sulfur source, and complete the present invention. I arrived.
 すなわち、本発明は以下の通りである。
 [1] 水への溶解により及び/又は投与後にヨウ素イオンを生成する物質、及びポビドンヨードからなる群より選択される少なくとも1つのヨウ素源と、ジメチルスルホキシド及びメチルスルホニルメタンからなる群より選択される少なくとも1つのイオウ源とを含む、ヒト又は動物の慢性若しくは急性のウイルス感染及び/又は敗血症の予防若しくは治療のための組成物。
 [2] ヨウ化物塩、及びポビドンヨードからなる群より選択される少なくとも1つのヨウ素源と、ジメチルスルホキシド及びメチルスルホニルメタンからなる群より選択される少なくとも1つのイオウ源とを含む、ヒト又は動物の慢性若しくは急性のウイルス感染及び/又は敗血症の予防若しくは治療のための組成物。
 [3] ジメチルスルホキシド及びメチルスルホニルメタンからなる群より選択される少なくとも1つのイオウ源と併用することを特徴とする、ヨウ化物塩、及びポビドンヨードからなる群より選択される少なくとも1つのヨウ素源を含む、ヒト又は動物の慢性若しくは急性のウイルス感染及び/又は敗血症の予防若しくは治療のための組成物。
 [4] ヨウ化物塩、及びポビドンヨードからなる群より選択される少なくとも1つのヨウ素源と併用することを特徴とする、ジメチルスルホキシド及びメチルスルホニルメタンからなる群より選択される少なくとも1つのイオウ源を含む、ヒト又は動物の慢性若しくは急性のウイルス感染及び/又は敗血症の予防若しくは治療のための組成物。
 [5] 前記イオウ源が前記ヨウ素源と組み合わされて、前記イオウ源の治療効果が高められる、[1]~[4]の何れか1項に記載の組成物。
 [6] 前記ヨウ素源及び前記イオウ源の1日当りのヒト又は動物の体重1kgあたりの用量は、前記ヨウ素源に含まれるヨウ素原子1モルあたり、前記イオウ源に含まれるイオウ原子が20モル以上、200モル以下の比率である、[1]~[5]の何れか1項に記載の組成物。
 [7] 前記ヨウ素源の1日当りのヒト又は動物の体重1kgあたりの用量1質量部に対する、前記イオウ源の1日当りのヒト又は動物の体重1kgあたりの用量は、
 前記ヨウ素源がヨウ化物塩であるとき、5質量部以上、100質量部以下であり、
 前記ヨウ素源がポビドンヨードであるとき、5質量部以上、100質量部以下である、[1]~[6]の何れか1項に記載の組成物。
 [8] 前記ヨウ素源の1日当りのヒト又は動物の体重1kgあたりの用量は、
 前記ヨウ素源がヨウ化物塩であるとき、0.5mg~10mgであり、
 前記ヨウ素源がポビドンヨードであるとき、0.5mg~50mgであり、
 前記イオウ源の1日当りのヒト又は動物の体重1kgあたりの用量は、10~1000mgである、[1]~[7]の何れか1項に記載の組成物。
 [9] 前記ヨウ素源の1日当りのヒト又は動物の体重1kgあたりの用量は、
 前記ヨウ素源がヨウ化物塩であるとき、1mg~5mgであり、
 前記ヨウ素源がポビドンヨードであるとき、1mg~40mgであり、
 前記イオウ源の1日当りのヒト又は動物の体重1kgあたりの用量は、100~500mgである、[1]~[8]の何れか1項に記載の組成物。
 [10] 前記ヨウ素源がヨウ化物塩であり、該ヨウ化物塩がヨウ化亜鉛(ZnI)以外の金属塩であり、該金属塩がヨウ化亜鉛以外の亜鉛塩とともに用いられ、
 前記ヨウ化亜鉛以外の亜鉛塩1質量部に対し、前記ヨウ化亜鉛以外の金属塩であるヨウ化物塩が2~20質量部である、[1]~[9]の何れか1項に記載の組成物。
 [11] 前記ヨウ素源がヨウ化物塩であり、該ヨウ化物塩がヨウ化亜鉛(ZnI)以外の金属塩であり、該金属塩がヨウ化亜鉛以外の亜鉛塩とともに用いられ、
 前記ヨウ化亜鉛以外の亜鉛塩1質量部に対し、前記ヨウ化亜鉛以外の金属塩であるヨウ化物塩が3~10質量部である、[1]~[9]の何れか1項に記載の組成物。
 [12] 前記ヨウ素源は、ヨウ化物塩であり、
 該ヨウ化物塩は、ZnI、CuI、FeI、NaI、Ga及びKIからなる群より選択される少なくとも1つである、[1]~[11]の何れか1項に記載の組成物。
 [13] 前記ヨウ素源は、ヨウ化物塩であり、
 該ヨウ化物塩はヨウ化亜鉛(ZnI)以外の金属塩であり、ヨウ化亜鉛以外の亜鉛塩とともに用いられる、[1]~[12]何れか1項に記載の組成物。
 [14] 前記ヨウ化物塩はCuI、FeI、NaI、Ga及びKIからなる群より選択される少なくとも1つであり、酢酸亜鉛((CHCOO)Zn)とともに用いられる、[13]に記載の組成物。
 [15] 経口、非経口、直腸、経鼻スプレー、経口スプレー、経皮、点滴、及びエアロゾル噴霧からなる群より選択される少なくとも1つの製薬上許容可能な剤形である、[1]~[14]の何れか1項に記載の組成物。
 [16] COVID−19の予防若しくは治療のための、[1]~[15]の何れか1項に記載の組成物。
 [17] ヨウ素とジメチルスルホキシドを含む、ヒトと動物の慢性および急性ウイルス感染並びに敗血症の予防と治療のための治療のための、[1]~[16]の何れか1項に記載の組成物。
 [18] ヨウ素とジメチルスルホキシドを含む、ヒトと動物の慢性および急性ウイルス感染並びに敗血症の予防と治療のための治療組成物。
 [19] ジメチルスルホキシドがヨウ素化合物と組み合わされて、ジメチルスルホキシドの治療効果を高める、[17]又は[18]に記載の治療用組成物。ヨウ素という用語は、分子ヨウ素(I)、ヨウ化物塩(ZnI、CuI、NaIまたはKI)、ヨウ素酸塩(NaIO)、および/あるいは、ヨードチロシン若しくはヨードラクトン若しくはメチオニン−ヨウ素、プロビドン−ヨウ素、ヨード酢酸などのヨウ素(ヨード)部分を含む脂質またはタンパク質を含む、分子の任意の形態を表す。
 [20] [17]~[19]のいずれか一項に記載の治療用組成物中の成分の用量は:
 ヨウ化亜鉛:体重1kgあたり0.5mg~10mg、好ましくは体重1kgあたり1~5mg
 亜鉛塩とヨウ化物の混合物は、亜鉛塩1部対ヨウ化物塩2−20部、好ましくは亜鉛塩1部対ヨウ化物塩3−10部の比率で使用できる(例:酢酸亜鉛1部とヨウ化カリウム5部、または、酢酸亜鉛1部とヨウ化ナトリウム5部)
 分子状ヨウ素(I)または誘導体:体重1kgあたり0.05mg~10mg
 ジメチルスルホキシド(DMSO):体重1kgあたり10~1000mg、好ましくは体重1kgあたり100~500mg。
 [21] 経口、非経口、直腸、経鼻および経口スプレー、経皮または点滴またはエアロゾル噴霧による、製薬上許容可能な処方の適用による、ヒトおよび動物における急性および慢性ウイルス感染の予防および治療のための、[17]~[20]のいずれか一項に記載の治療用組成物。
 [22] ヨウ化物塩、及びポビドンヨードからなる群より選択される少なくとも1つのヨウ素源からなり、[1]~[21]の何れか1項に記載の組成物を構成するための剤。
 [23] ジメチルスルホキシド及びメチルスルホニルメタンからなる群より選択される少なくとも1つのイオウ源からなり、[1]~[21]の何れか1項に記載の組成物を構成するための剤。
 [24] [1]~[21]の何れか1項に記載の組成物をヒト又は動物に投与することを含む、慢性若しくは急性のウイルス感染及び/又は敗血症の予防若しくは治療の方法。
That is, the present invention is as follows.
[1] A substance that produces iodine ions by dissolution in water and / or after administration, at least one iodine source selected from the group consisting of povidone iodine, and at least selected from the group consisting of dimethyl sulfoxide and methylsulfonylmethane. A composition for the prevention or treatment of chronic or acute viral infections and / or septicemia in humans or animals, comprising one source of iodine.
[2] Chronic human or animal, including at least one iodine source selected from the group consisting of iodide salts and povidone iodine, and at least one sulfur source selected from the group consisting of dimethyl sulfoxide and methylsulfonylmethane. Or a composition for the prevention or treatment of acute viral infection and / or septicemia.
[3] Includes at least one iodine source selected from the group consisting of iodide salts and povidone iodine, which is characterized by being used in combination with at least one sulfur source selected from the group consisting of dimethyl sulfoxide and methylsulfonylmethane. , A composition for the prevention or treatment of chronic or acute viral infections and / or septicemia in humans or animals.
[4] Containing at least one sulfur source selected from the group consisting of dimethyl sulfoxide and methylsulfonylmethane, which is characterized by being used in combination with at least one iodine source selected from the group consisting of iodide salts and povidone iodine. , A composition for the prevention or treatment of chronic or acute viral infections and / or septicemia in humans or animals.
[5] The composition according to any one of [1] to [4], wherein the sulfur source is combined with the iodine source to enhance the therapeutic effect of the sulfur source.
[6] The daily dose of the iodine source and the sulfur source per kg of human or animal body weight is 20 mol or more of sulfur atoms contained in the sulfur source per mol of iodine atoms contained in the iodine source. The composition according to any one of [1] to [5], which has a ratio of 200 mol or less.
[7] The dose of the iodine source per day of human or animal body weight is 1 part by mass with respect to 1 part by mass of the daily dose of the iodine source of human or animal.
When the iodine source is an iodide salt, it is 5 parts by mass or more and 100 parts by mass or less.
The composition according to any one of [1] to [6], wherein the iodine source is povidone iodine, which is 5 parts by mass or more and 100 parts by mass or less.
[8] The daily dose of the iodine source per kg of human or animal body weight is
When the iodine source is an iodide salt, it is 0.5 mg to 10 mg.
When the iodine source is povidone iodine, it is 0.5 mg to 50 mg.
The composition according to any one of [1] to [7], wherein the daily dose of the sulfur source per 1 kg of human or animal body weight is 10 to 1000 mg.
[9] The daily dose of the iodine source per kg of human or animal body weight is
When the iodine source is an iodide salt, it is 1 mg to 5 mg.
When the iodine source is povidone iodine, it is 1 mg to 40 mg.
The composition according to any one of [1] to [8], wherein the daily dose of the sulfur source per 1 kg of human or animal body weight is 100 to 500 mg.
[10] The iodine source is an iodide salt, the iodide salt is a metal salt other than zinc iodide (ZnI 2 ), and the metal salt is used together with a zinc salt other than zinc iodide.
The item according to any one of [1] to [9], wherein the iodide salt, which is a metal salt other than zinc iodide, is 2 to 20 parts by mass with respect to 1 part by mass of the zinc salt other than zinc iodide. Composition.
[11] The iodine source is an iodide salt, the iodide salt is a metal salt other than zinc iodide (ZnI 2 ), and the metal salt is used together with a zinc salt other than zinc iodide.
The item according to any one of [1] to [9], wherein the iodide salt, which is a metal salt other than zinc iodide, is 3 to 10 parts by mass with respect to 1 part by mass of the zinc salt other than zinc iodide. Composition.
[12] The iodine source is an iodide salt.
The iodide salt is at least one selected from the group consisting of ZnI 2 , CuI 2 , FeI 2 , NaI, Ga 2 I 6 and KI, according to any one of [1] to [11]. Composition.
[13] The iodine source is an iodide salt.
The composition according to any one of [1] to [12], wherein the iodide salt is a metal salt other than zinc iodide (ZnI 2) and is used together with a zinc salt other than zinc iodide.
[14] The iodide salt is at least one selected from the group consisting of CuI 2 , FeI 2 , NaI, Ga 2 I 6 and KI, and is used together with zinc acetate ((CH 3 COO) 2 Zn). The composition according to [13].
[15] At least one pharmaceutically acceptable dosage form selected from the group consisting of oral, parenteral, rectal, nasal spray, oral spray, transdermal, infusion, and aerosol spray, [1]-[ 14] The composition according to any one of the items.
[16] The composition according to any one of [1] to [15] for the prevention or treatment of COVID-19.
[17] The composition according to any one of [1] to [16], which comprises iodine and dimethyl sulfoxide for the treatment for the prevention and treatment of chronic and acute viral infections and sepsis in humans and animals. ..
[18] A therapeutic composition comprising iodine and dimethyl sulfoxide for the prevention and treatment of chronic and acute viral infections and sepsis in humans and animals.
[19] The therapeutic composition according to [17] or [18], wherein dimethyl sulfoxide is combined with an iodine compound to enhance the therapeutic effect of dimethyl sulfoxide. The term iodine refers to molecular iodine (I 2 ), iodide salts (ZnI 2 , CuI 2 , NaI or KI), iodate (NaIO), and / or iodotyrosine or iodolactone or methionine-iodine, providone-. Represents any form of molecule, including lipids or proteins that contain an iodine (iodine) moiety such as iodine, iodoacetic acid.
[20] The dose of the component in the therapeutic composition according to any one of [17] to [19] is:
Zinc iodide: 0.5 mg to 10 mg / kg body weight, preferably 1 to 5 mg / kg body weight
The mixture of zinc salt and iodide can be used in a ratio of 1 part zinc salt to 2-20 parts iodide salt, preferably 1 part zinc salt to 3-10 parts iodide salt (eg, 1 part zinc acetate and iodide). 5 parts of potassium or 1 part of zinc acetate and 5 parts of sodium iodide)
Molecular iodine (I 2 ) or derivative: 0.05 mg to 10 mg / kg body weight
Dimethyl sulfoxide (DMSO): 10-1000 mg / kg body weight, preferably 100-500 mg / kg body weight.
[21] For the prevention and treatment of acute and chronic viral infections in humans and animals by the application of pharmaceutically acceptable formulations by oral, parenteral, rectal, nasal and oral sprays, transdermal or infusion or aerosol sprays. The therapeutic composition according to any one of [17] to [20].
[22] An agent comprising at least one iodine source selected from the group consisting of an iodide salt and povidone iodine, and constituting the composition according to any one of [1] to [21].
[23] An agent comprising at least one sulfur source selected from the group consisting of dimethyl sulfoxide and methylsulfonylmethane, and constituting the composition according to any one of [1] to [21].
[24] A method for preventing or treating chronic or acute viral infection and / or sepsis, which comprises administering the composition according to any one of [1] to [21] to humans or animals.
 本発明によれば、COVID−19の治療のための組成物ないし医薬、並びに、従来公知のIやDMSOの抗ウイルス効果よりも優れた抗ウイルス効果を示す、主にヒトの慢性若しくは急性のウイルス感染及び/又は敗血症を治療するための医薬を提供することができる。 According to the present invention, compositions or pharmaceuticals for the treatment of COVID-19, as well as predominantly human chronic or acute, exhibiting antiviral effects superior to those of conventionally known I 2 and DMSO. Pharmaceuticals for treating viral infections and / or septicemia can be provided.
 具体的には、本発明の治療的組み合わせは、DNAおよびRNA含有ウイルスに対して広範な殺ウイルス効果を有する。殺ウイルス効果に加えて、本発明の治療組成物はまた、抗炎症、免疫調節および抗酸化効果を示す。本発明の組成物は、ヒトおよび動物のための有効かつ安全な無菌および消毒剤として使用することができる。 Specifically, the therapeutic combination of the present invention has a wide range of virucidal effects on DNA and RNA-containing viruses. In addition to the virus-killing effect, the therapeutic compositions of the present invention also exhibit anti-inflammatory, immunomodulatory and antioxidant effects. The compositions of the present invention can be used as effective and safe sterile and disinfectants for humans and animals.
 以下、本発明の実施態様について詳細に説明するが、本発明は、以下の実施態様に何ら限定されるものではなく、本発明の目的の範囲内において、適宜変更を加えて実施することができる。 Hereinafter, embodiments of the present invention will be described in detail, but the present invention is not limited to the following embodiments, and can be carried out with appropriate modifications within the scope of the object of the present invention. ..
<ウイルス感染及び/又は敗血症の予防若しくは治療のための組成物>
 本発明の第1の態様は、ウイルス感染及び/又は敗血症の予防若しくは治療のための組成物である。当該組成物は、ヒト又は動物の慢性若しくは急性のウイルス感染及び/又は敗血症の予防若しくは治療のための組成物であってもよく、好ましくは、ヒトの慢性若しくは急性のウイルス感染及び/又は敗血症の予防若しくは治療のための組成物であり、より好ましくは、ヒトの慢性若しくは急性のウイルス感染及び/又は敗血症の治療のための組成物である。
<Composition for prevention or treatment of viral infection and / or sepsis>
A first aspect of the present invention is a composition for the prevention or treatment of viral infection and / or sepsis. The composition may be a composition for the prevention or treatment of chronic or acute viral infections and / or septicemia in humans or animals, preferably for chronic or acute viral infections and / or septicemia in humans. It is a composition for prevention or treatment, and more preferably a composition for treatment of chronic or acute viral infection and / or septicemia in humans.
 本発明の第1の態様は、特定のヨウ素源と、特定のイオウ源とを組み合わせて用いることを特徴とする。
 特定のヨウ素源とは、水への溶解により及び/又は投与後にヨウ素イオンを生成する物質、及びポビドンヨードからなる群より選択される少なくとも1つである。
The first aspect of the present invention is characterized in that a specific iodine source and a specific sulfur source are used in combination.
The particular iodine source is at least one selected from the group consisting of substances that produce iodine ions upon dissolution in water and / or after administration, and povidone iodine.
 水への溶解によりヨウ素イオンを生成する物質は、水を含む媒体に混合するとヨウ素イオンを生じ得るものであればよい。ここで、「水を含む媒体」は、水のみであってもよいし、水のみでなくてもよく、水以外の成分を含む媒体であってもよく、典型的には、液体の剤形、例えば、液剤、注射剤、点滴、エアロゾル、ゲル、経鼻スプレー、経口スプレー、噴霧剤等が挙げられ、また、販売時若しくは提供時には散剤(粉末)、顆粒、錠剤、カプセル剤、丸剤等の固体であって、投与に際して水を含む媒体に混合するための剤形であってもよい。 The substance that produces iodide ions by dissolution in water may be any substance that can generate iodide ions when mixed with a medium containing water. Here, the "medium containing water" may be water alone, not only water, or a medium containing components other than water, typically in the form of a liquid. For example, liquids, injections, infusions, aerosols, gels, nasal sprays, oral sprays, sprays, etc., and powders (powder), granules, tablets, capsules, pills, etc. at the time of sale or provision. It may be a solid of the above, and may be in a dosage form for mixing with a medium containing water at the time of administration.
 投与後にヨウ素イオンを生成する物質は、例えば、ヒト又は動物に投与後にヨウ素イオンを生じ得るものが挙げられ、具体的には、少なくとも生体に投与した後、生体内の体液(血液、リンパ液、消化液、組織液、細胞や組織や臓器等に存在する液、生体内に存在する水分、等)や、生体内における飲食物に由来する水分においてヨウ素イオンを生じ得るもの等が挙げられる。 Examples of substances that generate iodine ions after administration include substances that can generate iodine ions after administration to humans or animals. Specifically, specifically, after administration to a living body, body fluids (blood, lymph, digestion) in the living body (blood, lymph, digestion). Liquids, tissue fluids, liquids present in cells, tissues, organs, etc., water present in the living body, etc.) and water derived from foods and drinks in the living body, which can generate iodine ions, and the like can be mentioned.
 特定のヨウ素源は、水への溶解によりヨウ素イオンを生成する物質であり、且つ、投与後にヨウ素イオンを生成する物質であってもよい。
 水への溶解により及び/又は投与後にヨウ素イオンを生成する物質は、典型的には、ヨウ化物塩が挙げられ、該ヨウ化物塩としては後述のものが挙げられる。ポビドンヨードも、水への溶解により及び/又は投与後にヨウ素イオンを生成する物質に該当する可能性がある。
The specific iodine source may be a substance that produces iodide ions by dissolution in water, and may be a substance that produces iodide ions after administration.
A substance that produces iodine ions by dissolution in water and / or after administration is typically an iodide salt, and examples of the iodide salt include those described below. Povidone iodine may also be a substance that produces iodide ions upon dissolution in water and / or after administration.
 特定のヨウ素源は、また、ヨウ化物塩、及びポビドンヨードからなる群より選択される少なくとも1つであってもよい。ここで、ヨウ化物塩、及びポビドンヨードは、水への溶解により及び/又は投与後にヨウ素イオンを生成する物質でなくてもよいが、水への溶解により及び/又は投与後にヨウ素イオンを生成する物質であるものが好ましい可能性がある。 The particular iodine source may also be at least one selected from the group consisting of iodide salts and povidone iodine. Here, the iodide salt and povidone iodine do not have to be substances that generate iodine ions by dissolution in water and / or after administration, but substances that generate iodine ions by dissolution in water and / or after administration. May be preferred.
 ヨウ化物塩としては、ヨウ素の金属塩が挙げられ、ZnI、CuI、FeI、NaI、ヨウ化ガリウム(Ga)及びKIからなる群より選択される少なくとも1つであることが好ましく、ZnI、NaI及びKIからなる群より選択される少なくとも1つであることがより好ましく、ZnI、及びNaIからなる群より選択される少なくとも1つであることが更により好ましい。 Examples of the iodide salt include a metal salt of iodine, which is at least one selected from the group consisting of ZnI 2 , CuI 2 , FeI 2 , NaI, gallium iodide (Ga 2 I 6) and KI. Preferably, it is at least one selected from the group consisting of ZnI 2 , NaI and KI, and even more preferably at least one selected from the group consisting of ZnI 2 and NaI.
 本発明の第1の態様は、特定のヨウ素源と、特定のイオウ源と、更に亜鉛源とを組み合わせることが好ましい。
 亜鉛源とは、亜鉛元素(亜鉛原子、亜鉛イオンを含む。)を供給する物質である。亜鉛源としては、水への溶解により及び/又は投与後に亜鉛イオンを生成する物質が挙げられる。ここで、水への溶解により及び/又は投与後に亜鉛イオンを生成する物質は、「水への溶解により及び/又は投与後にヨウ素イオンを生成する物質」についての上記説明における「ヨウ素イオン」を「亜鉛イオン」に読み替えて適用することができる。
In the first aspect of the present invention, it is preferable to combine a specific iodine source, a specific sulfur source, and further a zinc source.
The zinc source is a substance that supplies zinc elements (including zinc atoms and zinc ions). Zinc sources include substances that produce zinc ions upon dissolution in water and / or after administration. Here, the substance that produces zinc ions by dissolution in water and / or after administration is referred to as "iodine ion" in the above description of "a substance that produces iodine ions by dissolution in water and / or after administration". It can be applied by replacing it with "zinc ion".
 亜鉛源、ないし、水への溶解により及び/又は投与後に亜鉛イオンを生成する物質としては、典型的には、亜鉛塩が挙げられ、生体に悪影響を及ぼす可能性が無いか低いアニオン又はアニオンを生成し得る物質(元素、原子、化合物)と亜鉛との塩が好ましく、ヨウ化亜鉛(ZnI)、酢酸等のカルボン酸と亜鉛との塩がより好ましく、ヨウ化亜鉛、酢酸亜鉛((CHCOO)Zn)が更に好ましい。
 ヨウ化亜鉛は、上述の特定のヨウ素源であり、且つ、亜鉛源でもあるから、これら両者を兼ねることができる。従って、特定のヨウ素源及び亜鉛源として、ヨウ化亜鉛を用いることができる。
Zinc sources and / or substances that produce zinc ions upon dissolution in water and / or after administration typically include zinc salts, which contain anions or anions that have little or no potential for adverse effects on the body. Salts of substances (elements, atoms, compounds) that can be produced and zinc are preferable, and salts of carboxylic acids such as zinc iodide (ZnI 2 ) and acetic acid and zinc are more preferable, and zinc iodide and zinc acetate ((CH)). 3 COO) 2 Zn) is more preferable.
Since zinc iodide is the above-mentioned specific iodine source and also a zinc source, it can serve as both of them. Therefore, zinc iodide can be used as a specific iodine source and zinc source.
 ヨウ化物塩が、ヨウ化亜鉛(ZnI)以外の金属塩である場合、ヨウ化亜鉛以外の亜鉛塩とともに用いることが好ましい。例えば、ヨウ化物塩がCuI、FeI、NaI、Ga及びKIからなる群より選択される少なくとも1つである場合、酢酸亜鉛((CHCOO)Zn)とともに用いることが好ましくい。具体的には、CuIと酢酸亜鉛との組合せ、FeIと酢酸亜鉛との組合せ、NaIと酢酸亜鉛との組合せ、Gaと酢酸亜鉛との組合せ、KIと酢酸亜鉛との組合せが挙げられ、NaIと酢酸亜鉛との組合せ、KIと酢酸亜鉛との組合せが好ましく、NaIと酢酸亜鉛との組合せがより好ましい。 When the iodide salt is a metal salt other than zinc iodide (ZnI 2 ), it is preferably used together with a zinc salt other than zinc iodide. For example, if the iodide salt is at least one selected from the group consisting of CuI 2 , FeI 2 , NaI, Ga 2 I 6 and KI, it is preferably used with zinc acetate ((CH 3 COO) 2 Zn). stomach. Specifically, the combination of CuI 2 and zinc acetate, the combination of FeI 2 and zinc acetate, the combination of NaI and zinc acetate, the combination of Ga 2 I 6 and zinc acetate, and the combination of KI and zinc acetate The combination of NaI and zinc acetate, the combination of KI and zinc acetate are preferable, and the combination of NaI and zinc acetate is more preferable.
 本明細書において、ヨウ素元素又はヨウ素イオン(ヨウ化物イオン;I)を単に「ヨウ素」と称することがあり、ヨウ化物イオン(I)を「ヨウ素イオン」と称することがある。また、本明細書において、「亜鉛塩」は、具体的には、ヨウ化亜鉛(ZnI)以外の亜鉛塩のことを省略して指すことがある。 In the present specification, an iodine element or an iodine ion (iodide ion; I ) may be simply referred to as “iodine”, and an iodide ion (I ) may be referred to as “iodine ion”. Further, in the present specification, the term "zinc salt" may specifically refer to a zinc salt other than zinc iodide (ZnI 2).
 特定のイオウ源とは、ジメチルスルホキシド(DMSO)及びメチルスルホニルメタン(MSM)からなる群より選択される少なくとも1つである。DMSO又はMSMの何れか一方のみでもよく、DMSOが好ましい。尚、本明細書におけるDMSOについての説明はMSMにも適用することができる。 The specific sulfur source is at least one selected from the group consisting of dimethyl sulfoxide (DMSO) and methylsulfonylmethane (MSM). Only one of DMSO or MSM may be used, preferably DMSO. The description of DMSO in this specification can also be applied to MSM.
 本態様の組成物は、薬理活性成分(薬効成分、活性剤)として、特定のヨウ素源と、特定のイオウ源とを組み合わせて用い、代表的には、ヨウ素(ヨウ素元素、ヨウ素イオン)およびジメチルスルホキシドを含む。特定のイオウ源が特定のヨウ素源と組み合わされて、該イオウ源の治療効果が高められると考えられる。 The composition of this embodiment uses a specific iodine source and a specific sulfur source in combination as a pharmacologically active ingredient (medicinal ingredient, activator), and typically iodine (iodine element, iodide ion) and dimethyl. Contains sulfoxide. It is believed that a particular sulfur source is combined with a particular iodine source to enhance the therapeutic effect of the sulfur source.
 特定のヨウ素源と、特定のイオウ源とがどのように機能して効果を奏するか、作用機序は明らかではないが、特定のヨウ素源あるいはその一部若しくは該ヨウ素源から生成するヨウ素元素又はヨウ素イオンと、特定のイオウ源とがともに作用する可能性、特定のヨウ素源から生成するヨウ素イオンが作用する可能性(例えば、抗ウイルス効果を奏する可能性)、特定のイオウ源がヨウ素イオン、
ヨウ素元素若しくはヨウ素源の安定剤及び/又は担体として作用する可能性、また、ヨウ素イオン、ヨウ素元素若しくはヨウ素源による何らかの悪影響(副作用等)が仮にあり得るとしても、特定のイオウ源が該悪影響から生体を守る可能性等が考えられる。例えば、ヨウ化亜鉛により十分な治療効果が得られるのと同時に、そのヨウ素イオンないしヨウ素元素が何らかの悪影響(副作用等)を仮に及ぼすとしても、DMSO等の特定のイオウ源が該悪影響から生体を守る可能性が考えられる。
The mechanism of action of a specific iodine source and a specific sulfur source functioning and exerting an effect is not clear, but a specific iodine source or a part thereof or an iodine element produced from the iodine source or The possibility that iodine ions and a specific sulfur source act together, the possibility that iodine ions generated from a specific iodine source act (for example, the possibility of exerting an antiviral effect), the specific sulfur source is an iodine ion,
It may act as a stabilizer and / or carrier for the iodine element or iodine source, and even if there may be some adverse effects (side effects, etc.) due to the iodide ion, iodine element or iodine source, a specific sulfur source may be affected by the adverse effects. There is a possibility of protecting the living body. For example, even if zinc iodide has a sufficient therapeutic effect and at the same time its iodine ion or iodine element has some adverse effects (side effects, etc.), a specific sulfur source such as DMSO protects the living body from the adverse effects. There is a possibility.
 ウイルス感染症や敗血症の予防と治療のため、現在の治療計画では、典型的には、ヨウ化亜鉛(ZnI)の組み合わせ、または亜鉛塩とヨウ化物塩との混合物(好ましくは酢酸亜鉛とヨウ化カリウムまたはヨウ化ナトリウム)、ヨウ素結晶、またはヨウ素誘導体(具体的にはポビドンヨード(プロビドンヨード、ポビドン−ヨウ素とも称され得る。)、メチオニン−ヨウ素、ヨード酢酸など)をジメチルスルホキシド(DMSO)と使用している。治療用組成物は、前述の2つの成分、即ち、ZnIまたは亜鉛塩/ヨウ化物塩またはヨウ素またはヨウ素誘導体とDMSOとを組み合わせ、あらゆる種類のウイルス感染症と敗血症の症状の抑制、予防、および治療において強力な相乗効果を示した。 For the prevention and treatment of viral infections and septicemia, current treatment plans typically include a combination of zinc iodide (ZnI 2 ) or a mixture of zinc and iodide salts (preferably zinc acetate and iodine). Potassium or sodium iodide), iodine crystals, or iodine derivatives (specifically, povidone iodine (also referred to as providone iodine, povidone-iodine), methionine-iodine, iodoacetic acid, etc.) with dimethylsulfoxide (DMSO). I'm using it. Therapeutic compositions combine DMSO with the two components described above, namely ZnI 2, zinc salt / iodide salt or iodine or iodine derivative, to suppress, prevent, and prevent symptoms of all types of viral infections and septicemia. It showed a strong synergistic effect in treatment.
 本態様の組成物が効果を示し得るウイルス感染症としては、SARS−COV−2による感染症ないしCOVID−19(例えば後記の事例8、9)、ウイルス性肺炎(例えば後記の事例1)、A型インフルエンザ等のインフルエンザ(例えば後記の事例7)、一般的な風邪のようなウイルスが特定されていない呼吸器ウイルス感染症(例えば後記の事例2、3、6)、性器ヘルペス(例えば後記の事例4)、ヘルペス感染症(後記の事例5がその可能性がある。)のほか、B型肝炎、C型肝炎、HIV感染、RSV感染、ヒトパピローマウイルス感染(HPV)等が挙げられる。 Viral infections to which the composition of this embodiment can be effective include SARS-COV-2 infections or COVID-19 (eg, Cases 8 and 9 below), viral pneumonia (eg, Case 1 below), and A. Influenza such as type influenza (for example, case 7 below), respiratory virus infection for which a virus such as a general cold has not been identified (for example, cases 2, 3 and 6 below), genital herpes (for example, case below). 4) In addition to herpes infection (case 5 described later may be the case), hepatitis B, hepatitis C, HIV infection, RSV infection, human papillomavirus infection (HPV) and the like can be mentioned.
 本態様の組成物が効果を示し得るウイルス感染症及び/又は敗血症は、乾性咳嗽、激しい乾いた咳、喉の痛み、くしゃみ(重度のくしゃみ等)、胸部および鼻づまり、頭痛、胸痛(胸の痛み)、筋肉痛、体の痛み、息切れ、呼吸困難、呼吸不全(急性呼吸不全等)、呼吸機能制限、急性気管支炎、疲労(極度の疲労等)、倦怠感、悪寒、肺炎(炎症反応等。両側下葉肺炎等)、胸部の鬱血、胸水、腹部膨満、腹痛、心不全、心拍数が毎分114~115等の頻脈、毎分32~36呼吸等の呼吸数、72~86%等の酸素飽和度(SpO;72%、75%、86%等)、38~40℃程度(38℃、38.7℃、39℃、39.5℃等を含む)の発熱、肝疾患、肝臓酵素と血中乳酸(lactate)値の上昇、血清クレアチンの増加、血小板減少症、白血球減少症、うっ血性心不全、ステージII腎不全、低血圧、II型インスリン依存型糖尿病、急性の灼熱痛、外陰部水疱、顔の両側や口の中に痛みを伴う水ぶくれ、水疱、水様分泌物、直腸癌、食欲不振、血性下痢(血の混じった下痢)、無嗅覚症等の症状や状態を伴うものであってもよい。 Viral infections and / or septicemia for which the compositions of this embodiment may be effective include dry cough, severe dry cough, throat pain, squeezing (severe squeezing, etc.), chest and nose stuffiness, headache, chest pain (chest). Pain), muscle pain, body pain, shortness of breath, dyspnea, respiratory insufficiency (acute respiratory insufficiency, etc.), respiratory function limitation, acute bronchitis, fatigue (extreme fatigue, etc.), malaise, cold, pneumonia (inflammatory reaction, etc.) Bilateral lower lobe pneumonia, etc.), chest congestion, pleural effusion, abdominal distension, abdominal pain, heart failure, dyspnea with a heart rate of 114 to 115 per minute, dyspnea such as 32 to 36 breaths per minute, 72 to 86%, etc. Oxygen saturation (SpO 2 ; 72%, 75%, 86%, etc.), fever of about 38-40 ° C (including 38 ° C, 38.7 ° C, 39 ° C, 39.5 ° C, etc.), liver disease, Elevated liver enzymes and blood lactate levels, increased serum creatine, thrombocytopenia, leukocytopenia, congestive heart failure, stage II renal failure, hypotension, type II insulin-dependent diabetes, acute burning pain, With symptoms and conditions such as genital blisters, painful blisters on both sides of the face and in the mouth, blisters, watery secretions, rectal cancer, loss of appetite, bloody diarrhea (bloody diarrhea), olfactory dysfunction, etc. It may be a thing.
 本態様の組成物が効果を示し得るウイルス感染症及び/又は敗血症の患者は、肺癌、乳がん、前立腺癌、骨、肺、リンパ節等への転移を伴う前立腺癌等の癌、胃炎、胃潰瘍、慢性活動性B型肝炎、クローン病、喘息、COPD(慢性閉塞性肺疾患)等の既往歴、喫煙歴等がある患者であってもよい。 Patients with viral infections and / or septicemia for which the composition of this embodiment may be effective include lung cancer, breast cancer, prostate cancer, cancer such as prostate cancer with metastasis to bone, lung, lymph nodes, gastric inflammation, gastric ulcer, etc. Patients may have a history of chronic active hepatitis B, Crohn's disease, asthma, COPD (chronic obstructive lung disease), smoking history, and the like.
 本態様の組成物は、抗ウイルス、抗炎症、抗真菌、抗菌、免疫調節、抗線維症、抗血栓、心臓および呼吸補助活性等の効果もあると考えられ、これらの活性により、患者や動物のこれらの症状を緩和することもできる。 The composition of this embodiment is also considered to have effects such as antiviral, anti-inflammatory, antifungal, antibacterial, immunomodulatory, antifibrosis, antithrombotic, cardiac and respiratory assisting activities, and these activities allow patients and animals. These symptoms of the virus can also be alleviated.
 本態様の組成物は、また、ペネム、バンコマイシン、ソルメドロール、パラセタモール、デキサメタゾン、タミフル、アシクロビル、コルチコステロイド等の抗生物質、咳止め薬、気管支拡張剤、解熱剤、リンゲル乳酸塩溶液(Ringer−lactate solution)、栄養補助食品、漢方薬、他の抗ウイルス薬等の他の薬物等の投与、酸素療法等の治療を行った場合(患者等)や、これらの治療を行っても症状が改善しない場合(患者等)であっても、患者や動物のこれらの症状を緩和することもできる。 The compositions of this embodiment also include antibiotics such as penem, vancomycin, solmedrol, paracetamol, dexamethasone, tamiflu, acyclovir, corticosteroids, cough suppressants, bronchial dilators, antipyretics, Ringer-lactate. (Solution), nutritional supplements, Chinese herbs, administration of other drugs such as other antiviral drugs, treatment such as oxygen therapy (patients, etc.), or when these treatments do not improve the symptoms Even (patients, etc.) can alleviate these symptoms of patients and animals.
 特定のヨウ素源及び特定のイオウ源の1日当りのヒト又は動物の体重1kgあたりの用量としては、該ヨウ素源に含まれるヨウ素原子1モルあたりの、該イオウ源に含まれるイオウ原子の比率として、例えば20モル%以上、200モル%以下が挙げられ、下限値としては、好ましくは25モル%以上、より好ましくは30モル%以上であり、上限値としては、好ましくは180モル%以下、より好ましくは30モル%以下である。 The daily dose of a particular iodine source and a particular sulfur source per kg of human or animal body weight is the ratio of sulfur atoms contained in the sulfur source to 1 mole of iodine atoms contained in the iodine source. For example, 20 mol% or more and 200 mol% or less are mentioned, and the lower limit value is preferably 25 mol% or more, more preferably 30 mol% or more, and the upper limit value is preferably 180 mol% or less, more preferably. Is less than 30 mol%.
 特定のヨウ素源の1日当りのヒト又は動物の体重1kgあたりの用量1質量部に対する、特定のイオウ源の1日当りのヒト又は動物の体重1kgあたりの用量は、特定のヨウ素源がヨウ化物塩であるとき、例えば、5質量部以上、100質量部以下の範囲が挙げられ、下限値としては、好ましくは10質量部以上、より好ましくは20質量部以上であり、上限値としては、好ましくは90質量部以下、より好ましくは80質量部以下である。 The daily dose of a specific iodine source per kg of human or animal to 1 part by mass of the dose per kg of body weight of a specific iodine source is that the specific iodine source is an iodide salt. At one time, for example, a range of 5 parts by mass or more and 100 parts by mass or less can be mentioned, and the lower limit value is preferably 10 parts by mass or more, more preferably 20 parts by mass or more, and the upper limit value is preferably 90 parts by mass. It is less than or equal to parts by mass, more preferably 80 parts by mass or less.
 特定のヨウ素源の1日当りのヒト又は動物の体重1kgあたりの用量1質量部に対する、特定のイオウ源の1日当りのヒト又は動物の体重1kgあたりの用量は、特定のヨウ素源がポビドンヨードであるとき、例えば、5質量部以上、100質量部以下の範囲が挙げられ、下限値としては、好ましくは10質量部以上、より好ましくは20質量部以上であり、上限値としては、好ましくは90質量部以下、より好ましくは80質量部以下である。 The daily dose of a specific iodine source per kg of human or animal to 1 part by mass of the dose per kg of body weight of a specific iodine source is when the specific iodine source is povidone iodine. For example, a range of 5 parts by mass or more and 100 parts by mass or less can be mentioned, and the lower limit value is preferably 10 parts by mass or more, more preferably 20 parts by mass or more, and the upper limit value is preferably 90 parts by mass or more. Hereinafter, it is more preferably 80 parts by mass or less.
 特定のヨウ素源の1日当りのヒト又は動物の体重1kgあたりの用量は、下記のとおりである。
(1)特定のヨウ素源がヨウ化物塩であるとき、例えば、0.5mg~10mgの範囲が挙げられ、下限値としては、好ましくは1mg以上、より好ましくは2mg以上であり、上限値としては、好ましくは7mg以下、より好ましくは5mg以下である。
(1−1)特定のヨウ素源がヨウ化物塩であり、該ヨウ化物塩がヨウ化亜鉛(ZnI)以外の金属塩であり、該金属塩がヨウ化亜鉛以外の亜鉛塩とともに用いられるとき、該ヨウ化亜鉛以外の亜鉛塩1モルに対し、該ヨウ化亜鉛以外の金属塩であるヨウ化物塩は、例えば、2~5モルの比率であり、また、該ヨウ化亜鉛以外の亜鉛塩1質量部に対し、該ヨウ化亜鉛以外の金属塩であるヨウ化物塩は、例えば、1~20質量部の範囲が挙げられ、下限値としては、好ましくは2質量部以上、より好ましくは3質量部以上であり、上限値としては、好ましくは10質量部以下、より好ましくは5質量部以下である。
(2)特定のヨウ素源がポビドンヨードであるとき、例えば、0.5mg~50mgの範囲が挙げられ、下限値としては、好ましくは1mg以上、より好ましくは2mg以上であり、上限値としては、好ましくは40mg以下、より好ましくは30mg以下である。
The daily dose of a particular iodine source per kg of human or animal body weight is as follows.
(1) When the specific iodine source is an iodide salt, for example, the range is 0.5 mg to 10 mg, and the lower limit is preferably 1 mg or more, more preferably 2 mg or more, and the upper limit is. It is preferably 7 mg or less, more preferably 5 mg or less.
(1-1) When the specific iodine source is an iodide salt, the iodide salt is a metal salt other than zinc iodide (ZnI 2 ), and the metal salt is used together with a zinc salt other than zinc iodide. The iodide salt, which is a metal salt other than zinc iodide, has a ratio of, for example, 2 to 5 mol with respect to 1 mol of the zinc salt other than zinc iodide, and the zinc salt other than zinc iodide. The iodide salt, which is a metal salt other than zinc iodide, has a range of, for example, 1 to 20 parts by mass with respect to 1 part by mass, and the lower limit is preferably 2 parts by mass or more, more preferably 3 parts by mass. It is more than parts by mass, and the upper limit is preferably 10 parts by mass or less, more preferably 5 parts by mass or less.
(2) When the specific iodine source is povidone iodine, for example, the range is 0.5 mg to 50 mg, the lower limit is preferably 1 mg or more, more preferably 2 mg or more, and the upper limit is preferably. Is 40 mg or less, more preferably 30 mg or less.
 特定のイオウ源の1日当りのヒト又は動物の体重1kgあたりの用量は、例えば、10~1000g(10~1000ml)の範囲が挙げられ、下限値としては、好ましくは100g(100ml)以上、より好ましくは200g(200ml)以上であり、上限値としては、好ましくは700g(700ml)以下、より好ましくは500g(500ml)以下である。これらの用量は特にDMSOに好適である。DMSOは、メチルスルホニルメタン(MSM)で置換することができ、その場合、好ましくは、1日体重1kgあたり10mg~150mg(10~150ml)の用量である。 The daily dose of a particular sulfur source per kg of human or animal body weight may range, for example, from 10 to 1000 g (10 to 1000 ml), with a lower limit of preferably 100 g (100 ml) or more, more preferably. Is 200 g (200 ml) or more, and the upper limit value is preferably 700 g (700 ml) or less, more preferably 500 g (500 ml) or less. These doses are particularly suitable for DMSO. DMSO can be replaced with methylsulfonylmethane (MSM), preferably at a dose of 10 mg to 150 mg (10 to 150 ml) per kg body weight per day.
 現在の治療用組成物の成分の用量
 現在の治療用組成物の成分の用量としては、例えば下記が好ましい。
 ヨウ化亜鉛:体重1kgあたり0.5~10mg、好ましくは体重1kgあたり1~5mg
 亜鉛塩とヨウ化物の混合物は、亜鉛塩1部対ヨウ化物塩2~20部、好ましくは亜鉛塩1部対ヨウ化物塩3~10部の比率で使用できる(例:酢酸亜鉛1部とヨウ化カリウム5部、または、酢酸亜鉛1部とヨウ化ナトリウム5部)。
 分子状ヨウ素(分子ヨウ素;I)または誘導体:体重1kgあたり0.05~10mg
 ジメチルスルホキシド(DMSO):体重1kgあたり10~1000mg(10~1000ml)、好ましくは体重1kgあたり100~500mg(100~500ml)。
Current therapeutic composition component doses The current therapeutic composition component doses are preferably, for example:
Zinc iodide: 0.5-10 mg / kg body weight, preferably 1-5 mg / kg body weight
The mixture of zinc salt and iodide can be used in a ratio of 1 part zinc salt to 2 to 20 parts iodide salt, preferably 1 part zinc salt to 3 to 10 parts iodide salt (eg, 1 part zinc acetate and iodide). 5 parts of potassium or 1 part of zinc acetate and 5 parts of sodium iodide).
Molecular iodine (molecular iodine; I 2 ) or derivative: 0.05-10 mg / kg body weight
Dimethyl sulfoxide (DMSO): 10-1000 mg (10-1000 ml) per kg body weight, preferably 100-500 mg (100-500 ml) per kg body weight.
 本態様の組成物の剤形としては、例えば、経口用液体、ソフトゲル、懸濁液、エアロゾル、ゲル、経口用クリーム、経皮剤、経鼻および経口スプレー等の噴霧剤、点眼または点耳剤、非経口剤、直腸坐剤(坐剤)、点滴、筋肉内注射、静脈内注射等の注射剤、散剤、粉剤、顆粒剤、錠剤、カプセル剤、丸剤、液剤等が挙げられる。 Dosage forms of the compositions of this embodiment include, for example, oral liquids, softgels, suspensions, aerosols, gels, oral creams, transdermal agents, nasal and oral sprays and other sprays, eye drops or ears. Examples thereof include injections such as preparations, parenteral preparations, rectal suppositories (suppositories), infusions, intramuscular injections, and intravenous injections, powders, powders, granules, tablets, capsules, pills, and liquids.
 本態様の組成物は、目的とする作用を損なわない範囲において、他の成分を含有していてもよい。他の成分として、例えば、甘味料、香味料(フレーバー)、賦形剤、基剤、乳化剤、溶剤(例えば、水)、安定剤、pH調整剤等が挙げられる。 The composition of this embodiment may contain other components as long as the desired action is not impaired. Other components include, for example, sweeteners, flavors (flavors), excipients, bases, emulsifiers, solvents (eg, water), stabilizers, pH adjusters and the like.
 本態様の組成物は、販売等の提供の時点において、特定のヨウ素源と、特定のイオウ源と、場合により更に亜鉛源とを組み合わせた組成物であってもよいし、販売等の提供の時点においては特定のヨウ素源、特定のイオウ源、及び任意の亜鉛源からなる群より選択される少なくとも1つが分けられて(別個の剤ないし組成物として)おり、投与時等の臨床の場において混合されるものであってもよい。 The composition of this embodiment may be a composition in which a specific iodine source, a specific sulfur source, and in some cases a zinc source are further combined at the time of provision of sale or the like, or the composition of the sale or the like may be provided. At the time, at least one selected from the group consisting of a specific iodine source, a specific sulfur source, and an arbitrary zinc source is separated (as a separate agent or composition) and is used in clinical settings such as at the time of administration. It may be mixed.
 本態様の組成物の投与方法としては、例えば、経口投与、経鼻投与、噴霧投与、経皮投与、点眼、点耳、点滴(via installation)、筋肉内注射、静脈内投与、腹腔内投与、直腸坐剤等の経腸投与等が挙げられ、経口投与、経鼻投与、噴霧投与、静脈内投与が好ましい。例えば、経口投与の場合、1日1回~数回(例えば、2回又は3回)投与することができる。 Examples of the administration method of the composition of this embodiment include oral administration, nasal administration, spray administration, transdermal administration, eye drops, ear drops, via injection, intramuscular injection, intravenous administration, and intraperitoneal administration. Enteral administration such as a rectal suppository can be mentioned, and oral administration, nasal administration, spray administration, and intravenous administration are preferable. For example, in the case of oral administration, it can be administered once to several times a day (for example, two or three times).
本態様の組成物の投与期間としては、ウイルス感染症及び/又は敗血症の症状が緩和ないし治まるまでが好ましく、例えば、最初の投与後1時間~24時間、例えば1時間~12時間、1時間~6時間、1時間~3時間、1時間~2時間のような短時間で発熱の緩和(体温低下)、痛みの緩和等の症状緩和がみられる場合もある。更なる症状緩和のために、本態様の組成物の投与を1日以上継続してもよく、例えば、好ましくは2日以上、より好ましくは3日以上投与する。
 継続投与日数の上限値としては特に制限はないが、例えば、1月(30~31日以内)が挙げられ、例えば、15日以内、12日以内、10日以内、5日以内、3日以内であってもよい。
The administration period of the composition of this embodiment is preferably until the symptoms of viral infection and / or sepsis are alleviated or subsided, for example, 1 hour to 24 hours, for example, 1 hour to 12 hours, 1 hour to after the first administration. Symptom relief such as fever relief (body temperature drop) and pain relief may be seen in a short time such as 6 hours, 1 hour to 3 hours, and 1 hour to 2 hours. For further symptom relief, administration of the composition of this embodiment may be continued for 1 day or longer, for example, preferably 2 days or longer, more preferably 3 days or longer.
The upper limit of the number of days of continuous administration is not particularly limited, and examples thereof include January (within 30 to 31 days), for example, within 15 days, within 12 days, within 10 days, within 5 days, and within 3 days. May be.
<特定のヨウ素源からなり、第1の態様の組成物を構成するための剤>
 本発明の第2の態様は、ヨウ化物塩、及びポビドンヨードからなる群より選択される少なくとも1つのヨウ素源からなり、第1の態様の組成物を構成するための剤である。
<An agent consisting of a specific iodine source and constituting the composition of the first aspect>
A second aspect of the present invention comprises an iodide salt and at least one iodine source selected from the group consisting of povidone iodine, and is an agent for constituting the composition of the first aspect.
 第2の態様の剤は、第1の態様の組成物を構成、調製ないし製造するために用いられる、特定のヨウ素源を含む剤である。該剤としては、例えば、販売、販売の申出等の提供の時点においては特定のイオウ源、及び任意の亜鉛源を含む剤や組成物とは別個ないし分けられた剤や組成物として調製、製造ないし供給され、ヒト又は動物への投与時等の臨床の場において混合されるものであってもよいし、また、販売、販売の申出等の提供の時点において特定のヨウ素源、特定のイオウ源、及び任意の亜鉛源を含む第1の態様の単一の組成物を構成、調製ないし製造するために用いられるものであってもよい。この趣旨の範囲において、第1の態様について上述した事項が第2の態様にもあてはまる。 The agent of the second aspect is an agent containing a specific iodine source used for forming, preparing or producing the composition of the first aspect. The agent is prepared and manufactured, for example, as an agent or composition separate from or separated from the agent or composition containing a specific sulfur source and an arbitrary zinc source at the time of provision such as sale or offer for sale. It may be supplied or mixed in clinical settings such as when administered to humans or animals, or it may be a specific iodine source or a specific sulfur source at the time of sale, offer of sale, etc. , And may be used to compose, prepare or produce a single composition of the first aspect comprising any zinc source. Within the scope of this purpose, the above-mentioned matters concerning the first aspect also apply to the second aspect.
<特定のイオウ源からなり、第1の態様の組成物を構成するための剤>
 本発明の第3の態様は、ジメチルスルホキシド及びメチルスルホニルメタンからなる群より選択される少なくとも1つのイオウ源からなり、第1の態様の組成物を構成するための剤である。
<An agent consisting of a specific sulfur source and constituting the composition of the first aspect>
A third aspect of the present invention comprises at least one sulfur source selected from the group consisting of dimethyl sulfoxide and methylsulfonylmethane, and is an agent for constructing the composition of the first aspect.
 第3の態様の剤は、第1の態様の組成物を構成、調製ないし製造するために用いられる、特定のイオウ源を含む剤である。該剤としては、例えば、販売、販売の申出等の提供の時点においては特定のヨウ素源、及び任意の亜鉛源を含む剤や組成物とは別個ないし分けられた剤や組成物として調製、製造ないし供給され、ヒト又は動物への投与時等の臨床の場において混合されるものであってもよいし、また、販売、販売の申出等の提供の時点において特定のヨウ素源、特定のイオウ源、及び任意の亜鉛源を含む第1の態様の単一の組成物を構成、調製ないし製造するために用いられるものであってもよい。この趣旨の範囲において、第1の態様について上述した事項が第3の態様にもあてはまる。 The agent of the third aspect is an agent containing a specific sulfur source used for forming, preparing or producing the composition of the first aspect. The agent is prepared and manufactured, for example, as an agent or composition separate from or separated from the agent or composition containing a specific iodine source and an arbitrary zinc source at the time of provision such as sale or offer for sale. It may be supplied or mixed in clinical settings such as when administered to humans or animals, or it may be a specific iodine source or a specific sulfur source at the time of sale, offer of sale, etc. , And may be used to compose, prepare or produce a single composition of the first aspect comprising any zinc source. Within the scope of this purpose, the above-mentioned matters concerning the first aspect also apply to the third aspect.
<処方例>
処方例1
 経口投与用の組成物は、以下のように処方され得る:
 純度99.4%から99.9%の5g(5000mg)のヨウ化亜鉛(または5gの酢酸亜鉛と25gのヨウ化カリウムまたは1部の酢酸亜鉛と3~15部(例えば、3部又は3部以上、5部又は5部以上、10部又は10部以下、15部又は15部以下)のヨウ化ナトリウム若しくはヨウ化カリウム)を1000mlの99.8%ジメチルスルホキシド溶液と混合する。
(組成物ZnDM−O)
<Prescription example>
Prescription example 1
Compositions for oral administration can be formulated as follows:
5 g (5000 mg) of zinc iodide with a purity of 99.4% to 99.9% (or 5 g of zinc acetate and 25 g of potassium iodide or 1 part of zinc acetate and 3 to 15 parts (eg, 3 or 3 parts) 5 parts or more, 5 parts or more, 10 parts or 10 parts or less, 15 parts or 15 parts or less) of sodium iodide or potassium iodide) is mixed with 1000 ml of a 99.8% dimethyl sulfoxide solution.
(Composition ZnDM-O)
処方例2
 静脈内投与のための組成物は、以下のように処方され得る:
 純度99.8%~99.9%のヨウ化亜鉛5g(5000mg)(または酢酸亜鉛99.8%5gとヨウ化ナトリウム99.8%25g)を1000mlのジメチルスルホキシド99.9%医薬品グレードの溶液と混合する。
(組成物ZnDM−IV)
Prescription example 2
Compositions for intravenous administration can be formulated as follows:
5 g (5000 mg) of zinc iodide with a purity of 99.8% to 99.9% (or 99.8% 5 g of zinc acetate and 99.8% 25 g of sodium iodide) in 1000 ml of a 99.9% pharmaceutical grade solution of dimethyl sulfoxide. Mix with.
(Composition ZnDM-IV)
処方例3
 経口投与用の組成物は次のように処方され得る:
 1000~5000mgのポビドンヨード、注射用水50mlおよびDMSO50ml
(組成物PVI−DM)
処方例3−1
 経口投与用の組成物は次のように処方され得る:
 ヨウ素結晶5000mg(またはプロビドン−ヨウ素またはメチオニン−ヨウ素)、注射用水50mlおよびDMSO50ml
(組成物PVI−DM−1)
Prescription example 3
Compositions for oral administration can be formulated as follows:
1000-5000 mg povidone iodine, 50 ml water for injection and 50 ml DMSO
(Composition PVI-DM)
Prescription example 3-1
Compositions for oral administration can be formulated as follows:
5000 mg of iodine crystals (or providone-iodine or methionine-iodine), 50 ml of water for injection and 50 ml of DMSO
(Composition PVI-DM-1)
処方例4
 経鼻、経口噴霧器用の組成物は、次のように処方され得る:
 ヨウ化亜鉛:2000mg、DMSO医薬品グレード(98.8~99.9%):150ml、水900ml
(組成物ZnDM−SP)
Prescription example 4
Compositions for nasal and oral sprayers can be formulated as follows:
Zinc iodide: 2000 mg, DMSO pharmaceutical grade (98.8-99.9%): 150 ml, water 900 ml
(Composition ZnDM-SP)
処方例5
 エアロゾル用または噴霧による組成物は、以下のように処方され得る:
 ヨウ化亜鉛1000~2000mg、DMSO医薬品グレード(98.8~99.8%)200mlおよび注射用水800ml
(組成物ZnDM−AN)
Prescription example 5
Compositions for aerosols or sprays can be formulated as follows:
Zinc iodide 1000-2000 mg, DMSO pharmaceutical grade (98.8-99.8%) 200 ml and water for injection 800 ml
(Composition ZnDM-AN)
処方例6
 経口投与用の組成物は、以下のように処方され得る:
 ヨウ化亜鉛1部をメチルスルホニルメタン(MSM)5~50部、例えば5~10部とブレンド(混合)できる。混合物は、総重量が200~1000mg、例えば300~500mgのカプセルまたは錠剤に調製される。1日の投与量は1~3カプセルで、SARS−CoV−2(COVID−19)を含むウイルス感染や敗血症の治療には1日3回である。
Prescription example 6
Compositions for oral administration can be formulated as follows:
One part of zinc iodide can be blended with 5 to 50 parts of methylsulfonylmethane (MSM), for example 5 to 10 parts. The mixture is prepared in capsules or tablets with a total weight of 200-1000 mg, eg 300-500 mg. The daily dose is 1 to 3 capsules, 3 times daily for the treatment of viral infections and sepsis, including SARS-CoV-2 (COVID-19).
 以下、実施例を示して本発明の詳細を具体的に説明するが、本発明はこれに限定されるものではない。 Hereinafter, the details of the present invention will be specifically described with reference to Examples, but the present invention is not limited thereto.
<種々剤形の組成物の調製例>
実施例1
 経口投与用の組成物を以下のように処方した。
 5g(5000mg)の酢酸亜鉛と15g(15000mg)のヨウ化ナトリウムを1000mlの純度99.8%ジメチルスルホキシド溶液と混合した(組成物ZnDM−O)。
<Examples of preparation of compositions in various dosage forms>
Example 1
The composition for oral administration was formulated as follows.
5 g (5000 mg) of zinc acetate and 15 g (15000 mg) of sodium iodide were mixed with 1000 ml of a 99.8% pure dimethyl sulfoxide solution (composition ZnDM-O).
実施例2
 静脈内投与のための組成物を以下のように処方した。
 純度99.8%の酢酸亜鉛5gと純度99.8%のヨウ化ナトリウム25gとを1000mlの純度99.9%の医薬品グレードのジメチルスルホキシド溶液と混合した(組成物ZnDM−IV)。
Example 2
The composition for intravenous administration was formulated as follows.
5 g of 99.8% pure zinc acetate and 25 g of 99.8% pure sodium iodide were mixed with 1000 ml of a 99.9% pure pharmaceutical grade dimethyl sulfoxide solution (composition ZnDM-IV).
実施例3
 経口投与用の組成物を下記の処方で混合して調製した。
 3750mgのポビドンヨードと、注射用水50mlおよびDMSO50ml(組成物PVI−DM)。
 1日当りの用量が患者の体重1kg当りポビドンヨード2mg(又は大人の患者に150mg)となる量で投与した。
Example 3
The composition for oral administration was prepared by mixing with the following formulation.
3750 mg of povidone iodine, 50 ml of water for injection and 50 ml of DMSO (composition PVI-DM).
The daily dose was 2 mg of povidone iodine per kg of patient body weight (or 150 mg for adult patients).
実施例4
 経鼻、経口噴霧器用の組成物を下記の処方で混合して調製した。
 ヨウ化亜鉛:2000mg、DMSO医薬品グレード(純度98.8~99.9%):150ml、水900ml(組成物ZnDM−SP)
Example 4
Compositions for nasal and oral sprayers were mixed and prepared according to the following formulations.
Zinc iodide: 2000 mg, DMSO pharmaceutical grade (purity 98.8-99.9%): 150 ml, water 900 ml (composition ZnDM-SP)
実施例5
 エアロゾル用または噴霧による組成物を下記の処方で混合して調製した。
 ヨウ化亜鉛2000mg、DMSO医薬品グレード(純度98.8~99.8%)200mlおよび注射用水800ml(組成物ZnDM−AN)
 ZnDM−ANは、1回当りのヨウ化亜鉛の用量が10mg、又は1日当りのヨウ化亜鉛の用量が40mgとなる量で投与した。
Example 5
Compositions for aerosols or sprays were prepared by mixing with the following formulations.
Zinc iodide 2000 mg, DMSO pharmaceutical grade (purity 98.8-99.8%) 200 ml and water for injection 800 ml (composition ZnDM-AN)
ZnDM-AN was administered in an amount such that the dose of zinc iodide per dose was 10 mg or the dose of zinc iodide per day was 40 mg.
実施例6:経口投与用の組成物は下記の処方で調製し得る。
 ヨウ化亜鉛1部をメチルスルホニルメタン(MSM)5~50部、例えば5~10部とブレンド(混合)できる。混合物は、総重量が200~1000mg、例えば300~500mgのカプセルまたは錠剤に配合される。1日の投与量は1~3カプセルで、SARS−CoV−2(COVID−19)を含むウイルス感染や敗血症の治療には1日3回である。
Example 6: The composition for oral administration can be prepared with the following formulation.
One part of zinc iodide can be blended with 5 to 50 parts of methylsulfonylmethane (MSM), for example 5 to 10 parts. The mixture is formulated in capsules or tablets with a total weight of 200-1000 mg, eg 300-500 mg. The daily dose is 1 to 3 capsules, 3 times daily for the treatment of viral infections and sepsis, including SARS-CoV-2 (COVID-19).
<ウイルス感染症及び/又は敗血症の治療の臨床事例>
事例1
 肺癌の既往歴のある65歳の男性患者は、乾性咳嗽、くしゃみ、頭痛、胸痛、筋肉痛、呼吸困難を訴えて入院した。彼は、心拍数が毎分115の頻脈、毎分36呼吸の呼吸数、酸素療法で86%の酸素飽和度、そして過去3日間で38~39℃の発熱を示した。患者は過去3日間抗生物質(ペネムとバンコマイシン)、咳止め薬、解熱剤を服用していたが、彼の状態と症状は改善されなかった。
<Clinical cases of treatment of viral infections and / or sepsis>
Case 1
A 65-year-old male patient with a history of lung cancer was hospitalized with dry cough, sneezing, headache, chest pain, muscle pain, and dyspnea. He showed tachycardia with a heart rate of 115 per minute, a respiratory rate of 36 breaths per minute, 86% oxygen saturation with oxygen therapy, and a fever of 38-39 ° C over the last three days. The patient had been taking antibiotics (penem and vancomycin), cough medicine, and antipyretics for the past three days, but his condition and symptoms did not improve.
 胸部X線検査では、右側肺炎と肺の左側と右側の胸水が認められた。患者は入院時に白血球数が正常であるにも関わらず、ペネムとバンコマイシンで治療され、毎日デキサメタゾン20mgを経口投与し、タミフルを経口投与された。24時間後、患者の全身状態と症状は改善されなかった。彼の肝臓酵素と血中乳酸(lactate)値は上昇し、血清クレアチンは増加した。患者はまた、血小板減少症と白血球減少症を発症していた。患者はウイルス性肺炎と診断され、および敗血症の可能性のある状態と診断された。彼の発熱は、1000mgのパラセタモール静脈内注入後3時間で39.5℃であった。 Chest X-ray showed right pneumonia and pleural effusion on the left and right sides of the lungs. Patients were treated with penem and vancomycin, given daily dexamethasone 20 mg orally, and Tamiflu, despite normal white blood cell counts at admission. After 24 hours, the patient's general condition and symptoms did not improve. His liver enzymes and blood lactate levels were elevated and serum creatine was elevated. The patient also developed thrombocytopenia and leukopenia. The patient was diagnosed with viral pneumonia and a potentially septic condition. His fever was 39.5 ° C. 3 hours after intravenous injection of 1000 mg of paracetamol.
 患者は、500mlの塩化ナトリウム0.9%と混合した20mlの組成物ZnDM−IVを注入し、1分間に50滴の速度で治療を開始した。注入後5時間で、患者の発熱は解熱剤なしで37.6℃に下がった。その後、患者は抗生物質治療、デキサメタゾン、タミフルを中止し、次の4日間、12時間ごとに500mlの塩化ナトリウムと混合した15mlのZnDM−IV溶液を継続するよう勧められた。彼の症状は治療後48時間で著しく改善し、咳、胸痛、呼吸困難、疲労が50%以上減少した。彼の熱は72時間で完全にコントロールされた。 The patient infused 20 ml of the composition ZnDM-IV mixed with 500 ml of 0.9% sodium chloride and started treatment at a rate of 50 drops per minute. Five hours after injection, the patient's fever dropped to 37.6 ° C. without antipyretics. Patients were then advised to discontinue antibiotic treatment, dexamethasone, Tamiflu and continue with 15 ml ZnDM-IV solution mixed with 500 ml sodium chloride every 12 hours for the next 4 days. His symptoms improved significantly 48 hours after treatment, and cough, chest pain, dyspnea, and fatigue were reduced by more than 50%. His fever was completely controlled in 72 hours.
 患者は、さらに10日間、24時間ごとに0.9%塩化ナトリウム500mlと混合したZnDM−IV 20mlによる治療を継続した。このZnDM−IVによる治療期間中、彼の症状は改善し続け、全身状態も改善した。 The patient continued treatment with 20 ml of ZnDM-IV mixed with 500 ml of 0.9% sodium chloride every 24 hours for an additional 10 days. During this treatment with ZnDM-IV, his symptoms continued to improve and his general condition also improved.
 ZnDM−IVによる治療の15日後の胸部X線検査では、左側の肺炎が80%以上減少し、両側の胸水が60%減少した。白血球数と血中乳酸値は正常範囲であった。患者の血小板減少症、肝臓酵素、およびクレアチンはすべて、ZnDM−IV治療前のデータと比較して減少していた。 Chest X-ray examination 15 days after treatment with ZnDM-IV showed a reduction of 80% or more in pneumonia on the left side and a 60% reduction in pleural effusion on both sides. The white blood cell count and blood lactate level were in the normal range. Patients with thrombocytopenia, liver enzymes, and creatine were all reduced compared to data prior to ZnDM-IV treatment.
事例2
 43歳の男性。38.5℃の発熱、呼吸困難、筋肉痛、乾いた咳、重度のくしゃみを示した。彼の症状は12時間前に始まり、著しく悪化していた。患者は、胃炎、胃潰瘍、慢性活動性B型肝炎の既往歴があった。患者は過去2年間抗ウイルス薬を服用していた。彼の肝疾患のため、患者は現在の症状のための解熱剤を服用することができない。患者は呼吸器ウイルス感染症と診断され、150mlの水と混合したZnDM−O 5mlによる8時間ごとの治療を開始した。ZnDM−Oによる6時間の治療後、現在の疾患に関連するすべての症状が大幅に改善し、解熱療法なしで彼の熱は37.6℃に低下した。患者はZnDM−O 5mlを1日3回6日間服用し続けた。呼吸器ウイルス感染に関連する彼の症状は、72時間で完全に制御された。患者の健康状態は、ZnDM−Oによる治療を開始してから5日で正常化した。
Case 2
A 43 year old man. He showed fever of 38.5 ° C, dyspnea, myalgia, dry cough, and severe sneezing. His symptoms started 12 hours ago and were significantly worse. The patient had a history of gastritis, gastric ulcer, and chronic active hepatitis B. The patient has been taking antiviral drugs for the past two years. Due to his liver disease, the patient is unable to take antipyretics for the current symptoms. The patient was diagnosed with a respiratory viral infection and began treatment every 8 hours with 5 ml of ZnDM-O mixed with 150 ml of water. After 6 hours of treatment with ZnDM-O, all symptoms associated with the current illness improved significantly and his fever dropped to 37.6 ° C. without antipyretic therapy. Patients continued to take 5 ml of ZnDM-O 3 times daily for 6 days. His symptoms associated with respiratory viral infections were completely controlled in 72 hours. The patient's health was normalized 5 days after the start of treatment with ZnDM-O.
事例3
 乳がんの病歴があり、特定の治療歴のない82歳の女性は、うっ血性心不全、ステージII腎不全、低血圧、およびII型インスリン依存型糖尿病を示した。入院時、患者は39℃の発熱、激しい乾いた咳、喉の痛み、筋肉痛、胸部および鼻づまり、心拍数が毎分114の頻脈、および毎分32呼吸の呼吸数を示した。総投与量が3000mgのパラセタモールによる以前の治療にもかかわらず、患者の症状は改善していなかった。患者の血球数は正常であり、生化学パネルは、C反応性タンパク質が146mg/L、SGPTが121 IU/L、SGOTが114 IU/Lにまで著しく上昇したことを示した。患者の胸部X線検査では、肺炎の兆候はなく、肺容量の減少も見られなかった。
Case 3
An 82-year-old woman with a history of breast cancer and no specific treatment history presented with congestive heart failure, stage II renal failure, hypotension, and type II insulin-dependent diabetes mellitus. On admission, the patient exhibited a fever of 39 ° C., a severe dry cough, a sore throat, muscle aches, chest and stuffy nose, a tachycardia with a heart rate of 114 minutes per minute, and a respiratory rate of 32 breaths per minute. Despite previous treatment with paracetamol with a total dose of 3000 mg, the patient's symptoms did not improve. The patient's blood cell count was normal and the biochemical panel showed a significant increase in C-reactive protein to 146 mg / L, SGPT to 121 IU / L, and SGOT to 114 IU / L. A chest x-ray of the patient showed no signs of pneumonia and no reduction in lung volume.
 患者は、100mlの水で6時間ごとに4mlのZnDM−Oによる治療を開始した。治療の6時間後、解熱剤なしで患者の熱は37.8℃に低下した。彼女の症状は軽減され、ZnDM−Oによる治療を24時間行った後、患者の発熱は37.4℃まで下がり、心拍数は毎分98拍、呼吸数は毎分28呼吸であった。 The patient started treatment with 4 ml ZnDM-O every 6 hours with 100 ml of water. Six hours after treatment, the patient's fever dropped to 37.8 ° C. without antipyretics. Her symptoms were alleviated, and after 24 hours of treatment with ZnDM-O, the patient's fever dropped to 37.4 ° C., with a heart rate of 98 beats per minute and a respiratory rate of 28 breaths per minute.
 患者は、次の9日間、毎日3回、100mlの水と混合したZnDM−O 4mlによる治療を継続した。彼女の発熱は、72時間の治療で完全に回復し、現在のウイルス感染に関連する彼女の症状は、治療の5日目までに著しく減少した。ZnDM−Oで10日間治療した後、患者は呼吸器ウイルス感染に関連する重大な症状を示していない。 The patient continued treatment with 4 ml of ZnDM-O mixed with 100 ml of water three times daily for the next 9 days. Her fever completely recovered after 72 hours of treatment, and her symptoms associated with the current viral infection were significantly reduced by the 5th day of treatment. After 10 days of treatment with ZnDM-O, the patient showed no significant symptoms associated with respiratory viral infection.
事例4
 51歳の女性。外陰部の水疱が原因で急性の灼熱痛を訴えた。患者は性器ヘルペスと診断され、過去3日間、アシクロビル400mgを1日3回服用したところ、症状は大幅に改善されなかったが、外陰部の水疱の大きさは最小限の減少に抑えられた。
 患者は、1日3回、150mlの水と混合した5mlのZnDM−Oによる治療を開始した。
Case 4
A 51 year old woman. He complained of acute burning pain due to blisters on the vulva. The patient was diagnosed with genital herpes, and taking acyclovir 400 mg three times daily for the past three days did not significantly improve symptoms, but the size of the vulvar blisters was minimized.
Patients started treatment with 5 ml ZnDM-O mixed with 150 ml of water three times daily.
 ZnDM−Oの最初の治療から6時間後、患者の痛みのレベルは50%以上減少した。患者はアシクロビルの服用を中止し、次の9日間、150mlの水と混合してZnDM−O 5mlを1日3回服用し続けた。彼女の痛みは3日で完全に治まり、外陰部水疱はZnDM−Oの治療後6日以内に治癒した。 Six hours after the initial treatment of ZnDM-O, the patient's pain level decreased by more than 50%. The patient stopped taking acyclovir and continued to take 5 ml of ZnDM-O 3 times a day, mixed with 150 ml of water for the next 9 days. Her pain completely subsided in 3 days and the vulvar blisters healed within 6 days after treatment with ZnDM-O.
事例5
 76歳の女性。顔の両側と口の中に痛みを伴う水ぶくれがあり、38℃の発熱があった。アシクロビル400mgを1日3回3日間投与したにもかかわらず、水疱は数が増え、顔面と口に分泌物ができた。患者は、150mlの水と混合したZnDM−O 5mlによる1日3回の治療を開始した。彼女の痛みのレベルは、治療を開始してから6時間後に大幅に減少し、72時間で完全に抑制された。水疱と水様分泌物は、ZnDM−Oによる治療後24時間で著しく減少した。水疱は、12日間の治療で治癒した。
Case 5
A 76 year old woman. There were painful blisters on both sides of the face and in the mouth, and a fever of 38 ° C. Despite administration of 400 mg of acyclovir three times daily for 3 days, the number of blisters increased and secretions were formed on the face and mouth. Patients started treatment with 5 ml of ZnDM-O mixed with 150 ml of water three times daily. Her pain level decreased significantly 6 hours after the start of treatment and was completely suppressed at 72 hours. Blisters and watery secretions were significantly reduced 24 hours after treatment with ZnDM-O. The blisters healed after 12 days of treatment.
事例6
 74歳の男性患者は直腸癌の末期に苦しんでいた。入院前の3日間、倦怠感、悪寒、咳、胸痛、高熱を発症した。患者は呼吸器ウイルス感染症と急性気管支炎と診断されていた。入院時に患者の体温は39.8℃に上昇した。抗生物質治療、酸素療法、解熱療法、およびリンゲル乳酸塩溶液(Ringer−lactate solution)の注入からなる治療を24時間行った後、患者の熱は39.5℃の温度を維持し、彼の状態は極度の疲労、頭痛、呼吸困難、腹部膨満、および心不全の症状で悪化した。
Case 6
A 74-year-old male patient suffered from end-stage rectal cancer. He developed fatigue, chills, cough, chest pain, and high fever for 3 days before admission. The patient was diagnosed with a respiratory viral infection and acute bronchitis. At admission, the patient's temperature rose to 39.8 ° C. After 24 hours of treatment consisting of antibiotic treatment, oxygen therapy, antipyretic therapy, and infusion of Ringer-lacte solution, the patient's fever maintained a temperature of 39.5 ° C and his condition. Exacerbated with symptoms of extreme fatigue, headache, dyspnea, abdominal distension, and heart failure.
 患者は、6時間ごとに150mlの水と混合した1mlのPVI−DM組成物の経口投与による治療を開始した。患者の状態はPVI−DM治療を開始して2時間後に急速に改善し、彼の体温は38.3℃に低下した。彼の心不全と呼吸困難の症状は、10日間の治療の間に徐々に改善した。
 患者は、次の9日間、抗生物質なしで1日3回150mlの水と混合した1mlのPVI−DMによる経口治療を続けた。彼の病原性疾患の症状は4日後に制御され、彼の一般的な健康状態は著しく改善された。患者は11日後に退院した。
Patients began treatment with oral administration of 1 ml of PVI-DM composition mixed with 150 ml of water every 6 hours. The patient's condition improved rapidly 2 hours after starting PVI-DM treatment, and his temperature dropped to 38.3 ° C. His symptoms of heart failure and dyspnea gradually improved during the 10 days of treatment.
Patients continued oral treatment with 1 ml PVI-DM mixed with 150 ml of water three times daily without antibiotics for the next 9 days. The symptoms of his pathogenic disease were controlled after 4 days and his general health improved significantly. The patient was discharged 11 days later.
事例7
 69歳の男性は5日間続く高熱、喉の痛み、乾性咳嗽を呈していた。患者はインフルエンザA型感染症と診断されていた。患者は喫煙とCOPDの長い歴史を持っていた。彼は特定の治療をしなかったが、彼のCOPD症状を制御するために栄養補助食品と漢方薬を使用していた。患者は抗生物質、ソルメドロールの注入、パラセタモールの経口投与、気管支拡張剤の噴霧とタミフルを受けていた。その治療にもかかわらず、彼の発熱と咳は治療を開始してから3日後に残っていた。4日目に、患者は6L/分の酸素マスクでSpO 87%の急性呼吸不全を発症した。胸部X線検査では、喀痰中に病原体を伴う肺炎の徴候が検出された。患者は、4時間ごとに5mlのZnDM−ANを酸素で噴霧して治療を開始した。ZnDM−ANによる2回の治療後、彼の発熱、咳は著しく改善され、SpOは3L/分の酸素マスクで94%に上昇した。ZnDM−ANによる4回の治療後、患者は発熱がなく、解熱剤をこれ以上必要としなかった。ソルメドロールの用量は50%に減らされ、薬物は治療の8日後に完全に排除された。
Case 7
A 69-year-old man had a high fever, sore throat, and dry cough that lasted for 5 days. The patient was diagnosed with influenza A infection. The patient had a long history of smoking and COPD. He did not receive any specific treatment, but used dietary supplements and herbal medicines to control his COPD symptoms. Patients received antibiotics, solmedrol injections, oral paracetamol, bronchodilator sprays and Tamiflu. Despite the treatment, his fever and cough remained three days after starting the treatment. On the fourth day, the patient developed a SpO 2 87% of acute respiratory failure in 6L / min oxygen mask. A chest x-ray detected signs of pathogen-related pneumonia in the sputum. Patients started treatment by spraying 5 ml ZnDM-AN with oxygen every 4 hours. After two treatments with ZnDM-AN, his fever and cough improved significantly and SpO 2 increased to 94% with an oxygen mask of 3 L / min. After 4 treatments with ZnDM-AN, the patient had no fever and did not need any more antipyretics. The dose of solmedrol was reduced to 50% and the drug was completely eliminated 8 days after treatment.
 患者は1日4回ZnDM−AN噴霧による治療を継続し、治療開始後5日後には酸素療法とコルチコステロイドから解放された。治療7日後の胸部X線検査では、肺炎(炎症反応)と肺の呼吸能力の著しい改善が見られた。ZnDM−AN投与開始から21日で肺炎の症状もなく、肺機能も良好で退院した。 The patient continued treatment with ZnDM-AN spray 4 times a day and was released from oxygen therapy and corticosteroids 5 days after the start of treatment. A chest x-ray 7 days after treatment showed a marked improvement in pneumonia (inflammatory response) and lung respiratory capacity. Twenty-one days after the start of ZnDM-AN administration, he was discharged from the hospital with no symptoms of pneumonia and good lung function.
<COVID−19(SARS−COV−2)の治療用組成物の調製例>
実施例7
 経口投与用の組成物は、以下の処方で混合して調製した。
ヨウ化亜鉛10グラム(10,000mg) 純度98.0%−99.8%
ジメチルスルホキシド医薬品グレード98.8%−99.9% 400ml
水600ml
(組成物ZnDM−COVID−O)
<Preparation example of therapeutic composition of COVID-19 (SARS-COV-2)>
Example 7
The composition for oral administration was prepared by mixing with the following formulation.
Zinc iodide 10 grams (10,000 mg) Purity 98.0% -99.8%
Dimethyl sulfoxide pharmaceutical grade 98.8% -99.9% 400ml
600 ml of water
(Composition ZnDM-COVID-O)
実施例8
 静脈内投与用の組成物は、次のように処方され得る:
ヨウ化亜鉛5グラム(5,000mg) 純度98.0%−99.8%
ジメチルスルホキシド医薬品グレード98.8%−99.9% 600ml
水400ml
(組成物ZnDM−COVID−IV)
Example 8
Compositions for intravenous administration can be formulated as follows:
Zinc iodide 5 grams (5,000 mg) Purity 98.0% -99.8%
Dimethyl sulfoxide pharmaceutical grade 98.8% -99.9% 600ml
400 ml of water
(Composition ZnDM-COVID-IV)
実施例9
 鼻腔、経口スプレーおよび噴霧用の組成物は、次の処方で混合して調製した。
ヨウ化亜鉛2,000mg 純度98.0%−99.8%
ジメチルスルホキシド医薬品グレード98.8%−99.9% 200ml
水800ml
(組成物ZnDM−COVID−SN)
Example 9
Compositions for nasal passages, oral sprays and sprays were prepared by mixing with the following formulations.
Zinc iodide 2,000 mg Purity 98.0% -99.8%
Dimethyl sulfoxide pharmaceutical grade 98.8% -99.9% 200 ml
800 ml of water
(Composition ZnDM-COVID-SN)
<COVID−19治療の臨床事例>
事例8
 76歳の男性。骨、肺およびリンパ節への転移を伴う前立腺癌の病歴と51年間の中程度の喫煙歴とを持ち、38.7℃の発熱、筋肉および体の痛み、呼吸困難を伴う激しい乾いた咳、喉の痛み、腹痛、極度の疲労を伴ってクリニックに現れた。患者の症状は発現し6日間で悪化し、鼻咽頭スワブ材料のRT−PCR試験でCOVID−19陽性であった。患者はX線検査を受け、結果は両側下葉肺炎を示した。患者のSpOレベルは72%で、脈拍数は1分あたり120であった。患者は、気管支拡張薬の吸入、パラセタモール1000mgIV、および200mlの水と混合した10mlのZnDM−COVID−Oを毎分6リットルのマスクを介した酸素療法による治療を開始した。最初の治療から2時間で、患者の状態は著しく改善された。彼の筋肉と体の痛みは劇的に減少し、SpOは毎分3リットルの酸素療法で92%に増加し、脈拍数は1分あたり98であり、発熱は36.7℃に低下した。患者は、他の治療薬を使用しない最初の治療から6時間で、水200mlとともにZnDM−COVID−O 10mlを投与していた。治療開始から10時間後、患者の痛み、呼吸パターン、エネルギーはすべて改善され、体温は正常に保たれ、SpOは94%で酸素療法の必要がなく、乾いた咳は70%以上減少した。3日ぶりに3時間寝て、前日と比べて2倍の飲食ができた。患者は、次の48時間の間、8時間ごとに10mlのZnDM−COVID−Oで治療された。彼が訴える病状や症候の全てにおいて臨床的に改善を続けた。治療開始から72時間後、患者の体温は正常で、夜5時間眠り、食欲、エネルギー、息切れが70%以上改善し、乾いた咳がなくなり、COVID−19診断の前に経験した前立腺癌に関連していた体や胸の痛みさえもなくなった。彼のSpOは95%で、脈拍数は1分あたり86であった。
<Clinical case of COVID-19 treatment>
Case 8
A 76 year old man. With a history of prostate cancer with metastases to bones, lungs and lymph nodes and a history of moderate smoking for 51 years, a fever of 38.7 ° C, muscle and body pain, a severe dry cough with dyspnea, Appeared in the clinic with sore throat, abdominal pain, and extreme fatigue. The patient's symptoms developed and worsened within 6 days and were COVID-19 positive in the RT-PCR test of the nasopharyngeal swab material. The patient underwent x-ray examination and the results showed bilateral lower lobe pneumonia. The patient's SpO 2 level was 72% and the pulse rate was 120 per minute. Patients began treatment with bronchodilator inhalation, parasetamol 1000 mg IV, and oxygen therapy with 10 ml ZnDM-COVID-O mixed with 200 ml water via a mask at 6 liters per minute. Two hours after the first treatment, the patient's condition improved significantly. His muscle and body aches were dramatically reduced, SpO 2 increased to 92% with 3 liters of oxygen therapy per minute, pulse rate was 98 per minute, and fever decreased to 36.7 ° C. .. Patients were receiving 10 ml of ZnDM-COVID-O with 200 ml of water 6 hours after the first treatment without other therapeutic agents. Ten hours after the start of treatment, the patient's pain, respiratory pattern, and energy all improved, body temperature remained normal, SpO 2 was 94%, no oxygen therapy was needed, and dry cough was reduced by more than 70%. I slept for 3 hours for the first time in 3 days and was able to eat and drink twice as much as the day before. Patients were treated with 10 ml ZnDM-COVID-O every 8 hours for the next 48 hours. He continued to improve clinically in all of the medical conditions and symptoms he complained of. 72 hours after the start of treatment, the patient's body temperature was normal, he slept for 5 hours at night, his appetite, energy, and shortness of breath improved by more than 70%, his dry cough disappeared, and it was associated with prostate cancer experienced before the diagnosis of COVID-19. I didn't even have the pain in my body and chest. His SpO 2 was 95% and his pulse rate was 86 per minute.
 患者はZnDM−COVID−O 10mlを1日3回、さらに7日間服用し続けた。治療開始から10日目までに、COVID−19に関連する彼の症状はすべて解消され、彼の一般的な健康状態は著しく改善された。11日目までに行われたX線検査では、両側低葉肺炎が完全に解消したことが示された。患者はZnDM−COVID−O 5mlを1日3回、さらに5日間服用し続け、その後16日目にクリニックを退院した。14日目と16日目の鼻咽頭スワブ材料のRT−PCRによるCOVID−19テストは、SARS−CoV−2 RNAに対して陰性を示した。 The patient continued to take 10 ml of ZnDM-COVID-O 3 times a day for another 7 days. By the 10th day of treatment, all his symptoms associated with COVID-19 had disappeared and his general health had improved significantly. X-ray examinations performed by day 11 showed that bilateral hypolobe pneumonia had completely disappeared. The patient continued to take ZnDM-COVID-O 5 ml 3 times a day for another 5 days, after which he was discharged from the clinic on the 16th day. The COVID-19 test by RT-PCR of the nasopharyngeal swab material on the 14th and 16th days showed a negative result for SARS-CoV-2 RNA.
事例9
 クローン病と喘息の既往歴をもつ54歳の男性が、39.5℃の高熱、激しい息切れ、乾いた咳、胸部の鬱血と痛み、血の混じった下痢、極度の疲労、体の痛みと無嗅覚症を訴えて来院した。胸部X線検査で霞みを伴う両側性肺炎を確認した。患者は、7日前にCOVID−19感染が確認された近親者との密接な接触により、COVID−19が疑われると診断された。患者のSpOは75%で、マスクを介して毎分5リットルの酸素療法を行い、脈拍数は毎分110であった。
Case 9
A 54-year-old man with a history of Crohn's disease and asthma has a high fever of 39.5 ° C, severe shortness of breath, dry cough, congestion and pain in the chest, bloody diarrhea, extreme fatigue, pain and anosmia. He visited the hospital complaining of anosmia. Chest X-ray confirmed bilateral pneumonia with haze. The patient was diagnosed with suspected COVID-19 by close contact with a close relative who was confirmed to have COVID-19 infection 7 days ago. The patient's SpO 2 was 75%, oxygen therapy was given at 5 liters per minute through a mask, and the pulse rate was 110 per minute.
 患者はZnDM−COVID−Oを5mlの用量で6時間毎に200mlの水と投与し、5mlのZnDM−COVID−SNを8時間毎に噴霧し、パラセタモール1000mgを静脈内投与し、気管支拡張剤を吸入して、72時間治療された。最初の治療の4時間後、乾いた咳、息切れ、疲労、胸の痛みが著しく減少し、患者の症状は改善した。SpOの読み取り値は3リットル/分の酸素療法で92%であり、脈拍数は毎分92に低下した。彼の体温は37.2℃であった。ZnDM−COVIDによる治療開始から72時間で、現在の疾患に関連する患者のすべての症状が改善され、酸素療法と気管支拡張薬の治療をしなくても、著しい息切れや胸の痛みもなく呼吸できるようになった。
彼の体温は正常範囲であり、SpOは96%で、脈拍数は1分あたり85であった。
患者は12日間、噴霧と酸素治療を行わずに、ZnDM−COVID−O 5mlを6時間ごとに投与する治療を継続した。治療開始から6日間で、現在の疾患と呼吸機能制限に関連する症状はなかった。彼の血性下痢は、治療の4日目から完全に回復した。4日目に、入院時に採取した鼻咽頭スワブ材料のRT−PCR検査でCOVID−19の診断が確認された。
 15日目のX線検査では、肺炎の兆候は見られなかった。14日目と16日目の鼻咽頭スワブ材料のRT−PCRテストでは、SARS−CoV−2 RNAは陰性であった。
Patients administer ZnDM-COVID-O at a dose of 5 ml with 200 ml of water every 6 hours, spray 5 ml of ZnDM-COVID-SN every 8 hours, administer 1000 mg of paracetamol intravenously, and administer a bronchodilator. It was inhaled and treated for 72 hours. Four hours after the first treatment, dry cough, shortness of breath, fatigue, and chest pain were significantly reduced and the patient's symptoms improved. The SpO 2 reading was 92% with oxygen therapy at 3 liters / minute, and the pulse rate dropped to 92 per minute. His body temperature was 37.2 ° C. 72 hours after the start of treatment with ZnDM-COVID, all symptoms of patients associated with the current disease improved and they could breathe without significant shortness of breath or chest pain without oxygen therapy and bronchodilator treatment. It became so.
His body temperature was in the normal range, SpO 2 was 96%, and his pulse rate was 85 per minute.
The patient continued treatment with 5 ml of ZnDM-COVID-O every 6 hours without spraying and oxygen treatment for 12 days. Six days after the start of treatment, there were no symptoms associated with the current illness and respiratory restriction. His bloody diarrhea was completely recovered from the 4th day of treatment. On the 4th day, the diagnosis of COVID-19 was confirmed by RT-PCR examination of the nasopharyngeal swab material collected at the time of admission.
X-ray examination on day 15 showed no signs of pneumonia. The RT-PCR test of nasopharyngeal swab material on days 14 and 16 was negative for SARS-CoV-2 RNA.

Claims (21)

  1.  ヨウ化物塩、及びポビドンヨードからなる群より選択される少なくとも1つのヨウ素源と、ジメチルスルホキシド及びメチルスルホニルメタンからなる群より選択される少なくとも1つのイオウ源とを含む、ヒト又は動物の慢性若しくは急性のウイルス感染及び/又は敗血症の予防若しくは治療のための組成物。 Chronic or acute human or animal sources containing at least one iodine source selected from the group consisting of iodide salts and povidone iodine and at least one source of sulfur selected from the group consisting of dimethyl sulfoxide and methylsulfonylmethane. Compositions for the prevention or treatment of viral infections and / or septicemia.
  2.  水への溶解により及び/又は投与後にヨウ素イオンを生成する物質、及びポビドンヨードからなる群より選択される少なくとも1つのヨウ素源と、ジメチルスルホキシド及びメチルスルホニルメタンからなる群より選択される少なくとも1つのイオウ源とを含む、ヒト又は動物の慢性若しくは急性のウイルス感染及び/又は敗血症の予防若しくは治療のための組成物。 A substance that produces iodine ions by dissolution in water and / or after administration, and at least one iodine source selected from the group consisting of povidone iodine, and at least one sulfur selected from the group consisting of dimethyl sulfoxide and methylsulfonylmethane. Compositions for the prevention or treatment of chronic or acute viral infections and / or septicemia in humans or animals, including sources.
  3.  前記イオウ源が前記ヨウ素源と組み合わされて、前記イオウ源の治療効果が高められる、請求項1又は2に記載の組成物。 The composition according to claim 1 or 2, wherein the sulfur source is combined with the iodine source to enhance the therapeutic effect of the sulfur source.
  4.  前記ヨウ素源及び前記イオウ源の1日当りのヒト又は動物の体重1kgあたりの用量は、前記ヨウ素源に含まれるヨウ素原子1モルあたり、前記イオウ源に含まれるイオウ原子が20モル以上、200モル以下の比率である、請求項1~3の何れか1項に記載の組成物。 The daily dose of the iodine source and the sulfur source per kg of human or animal body weight is 20 mol or more and 200 mol or less of sulfur atoms contained in the sulfur source per 1 mol of iodine atoms contained in the iodine source. The composition according to any one of claims 1 to 3, which is the ratio of.
  5.  前記ヨウ素源の1日当りのヒト又は動物の体重1kgあたりの用量1質量部に対する、前記イオウ源の1日当りのヒト又は動物の体重1kgあたりの用量は、
     前記ヨウ素源がヨウ化物塩であるとき、5質量部以上、100質量部以下であり、
     前記ヨウ素源がポビドンヨードであるとき、5質量部以上、100質量部以下である、請求項1~4の何れか1項に記載の組成物。
    The daily dose of the iodine source for humans or animals per kg of body weight is 1 part by mass, relative to the dose of the iodine source per day for 1 kg of human or animal body weight.
    When the iodine source is an iodide salt, it is 5 parts by mass or more and 100 parts by mass or less.
    The composition according to any one of claims 1 to 4, wherein when the iodine source is povidone iodine, the amount is 5 parts by mass or more and 100 parts by mass or less.
  6.  前記ヨウ素源の1日当りのヒト又は動物の体重1kgあたりの用量は、
     前記ヨウ素源がヨウ化物塩であるとき、0.5mg~10mgであり、
     前記ヨウ素源がポビドンヨードであるとき、0.5mg~50mgであり、
     前記イオウ源の1日当りのヒト又は動物の体重1kgあたりの用量は、10~1000mgである、請求項1~4の何れか1項に記載の組成物。
    The daily dose of the iodine source per kg of human or animal body weight is
    When the iodine source is an iodide salt, it is 0.5 mg to 10 mg.
    When the iodine source is povidone iodine, it is 0.5 mg to 50 mg.
    The composition according to any one of claims 1 to 4, wherein the daily dose of the sulfur source per 1 kg of human or animal body weight is 10 to 1000 mg.
  7.  前記ヨウ素源の1日当りのヒト又は動物の体重1kgあたりの用量は、
     前記ヨウ素源がヨウ化物塩であるとき、1mg~5mgであり、
     前記ヨウ素源がポビドンヨードであるとき、1mg~40mgであり、
     前記イオウ源の1日当りのヒト又は動物の体重1kgあたりの用量は、100~500mgである、請求項1~5の何れか1項に記載の組成物。
    The daily dose of the iodine source per kg of human or animal body weight is
    When the iodine source is an iodide salt, it is 1 mg to 5 mg.
    When the iodine source is povidone iodine, it is 1 mg to 40 mg.
    The composition according to any one of claims 1 to 5, wherein the daily dose of the sulfur source per 1 kg of human or animal body weight is 100 to 500 mg.
  8.  前記ヨウ素源がヨウ化物塩であり、該ヨウ化物塩がヨウ化亜鉛(ZnI)以外の金属塩であり、該金属塩がヨウ化亜鉛以外の亜鉛塩とともに用いられ、
     前記ヨウ化亜鉛以外の亜鉛塩1質量部に対し、前記ヨウ化亜鉛以外の金属塩であるヨウ化物塩が2~20質量部である、請求項1~7の何れか1項に記載の組成物。
    The iodine source is an iodide salt, the iodide salt is a metal salt other than zinc iodide (ZnI 2 ), and the metal salt is used together with a zinc salt other than zinc iodide.
    The composition according to any one of claims 1 to 7, wherein the iodide salt, which is a metal salt other than zinc iodide, is 2 to 20 parts by mass with respect to 1 part by mass of the zinc salt other than zinc iodide. thing.
  9.  前記ヨウ素源がヨウ化物塩であり、該ヨウ化物塩がヨウ化亜鉛(ZnI)以外の金属塩であり、該金属塩がヨウ化亜鉛以外の亜鉛塩とともに用いられ、
     前記ヨウ化亜鉛以外の亜鉛塩1質量部に対し、前記ヨウ化亜鉛以外の金属塩であるヨウ化物塩が3~10質量部である、請求項1~7の何れか1項に記載の組成物。
    The iodine source is an iodide salt, the iodide salt is a metal salt other than zinc iodide (ZnI 2 ), and the metal salt is used together with a zinc salt other than zinc iodide.
    The composition according to any one of claims 1 to 7, wherein the iodide salt, which is a metal salt other than zinc iodide, is 3 to 10 parts by mass with respect to 1 part by mass of the zinc salt other than zinc iodide. thing.
  10.  前記ヨウ素源は、ヨウ化物塩であり、
     該ヨウ化物塩は、ZnI、CuI、FeI、NaI、Ga及びKIからなる群より選択される少なくとも1つである、請求項1~7の何れか1項に記載の組成物。
    The iodine source is an iodide salt,
    The composition according to any one of claims 1 to 7, wherein the iodide salt is at least one selected from the group consisting of ZnI 2 , CuI 2 , FeI 2 , NaI, Ga 2 I 6 and KI. thing.
  11.  前記ヨウ素源は、ヨウ化物塩であり、
     該ヨウ化物塩はヨウ化亜鉛(ZnI)以外の金属塩であり、ヨウ化亜鉛以外の亜鉛塩とともに用いられる、請求項1~7の何れか1項に記載の組成物。
    The iodine source is an iodide salt,
    The composition according to any one of claims 1 to 7, wherein the iodide salt is a metal salt other than zinc iodide (ZnI 2 ) and is used together with a zinc salt other than zinc iodide.
  12.  前記ヨウ化物塩はCuI、FeI、NaI、Ga及びKIからなる群より選択される少なくとも1つであり、酢酸亜鉛((CHCOO)Zn)とともに用いられる、請求項11に記載の組成物。 The iodide salt is at least one selected from the group consisting of CuI 2 , FeI 2 , NaI, Ga 2 I 6 and KI, and is used together with zinc acetate ((CH 3 COO) 2 Zn). The composition according to.
  13.  経口、非経口、直腸、経鼻スプレー、経口スプレー、経皮、点滴、及びエアロゾル噴霧からなる群より選択される少なくとも1つの製薬上許容可能な剤形である、請求項1~12の何れか1項に記載の組成物。 Any of claims 1-12, which is at least one pharmaceutically acceptable dosage form selected from the group consisting of oral, parenteral, rectal, nasal spray, oral spray, transdermal, infusion, and aerosol spray. The composition according to item 1.
  14.  COVID−19の予防若しくは治療のための、請求項1~13の何れか1項に記載の組成物。 The composition according to any one of claims 1 to 13, for the prevention or treatment of COVID-19.
  15.  ヨウ素とジメチルスルホキシドを含む、ヒトと動物の慢性および急性ウイルス感染並びに敗血症の予防と治療のための、請求項1~14の何れか1項に記載の組成物。 The composition according to any one of claims 1 to 14, which comprises iodine and dimethyl sulfoxide for the prevention and treatment of chronic and acute viral infections and sepsis in humans and animals.
  16.  ヨウ素とジメチルスルホキシドを含む、ヒトと動物の慢性および急性ウイルス感染並びに敗血症の予防と治療のための治療用組成物。 A therapeutic composition containing iodine and dimethyl sulfoxide for the prevention and treatment of chronic and acute viral infections and sepsis in humans and animals.
  17.  ジメチルスルホキシドがヨウ素化合物と組み合わされて、ジメチルスルホキシドの治療効果を高める、請求項15又は16に記載の治療用組成物。ヨウ素という用語は、分子ヨウ素(I)、ヨウ化物塩(ZnI、CuI、NaIまたはKI)、ヨウ素酸塩(NaIO)、および/あるいは、ヨードチロシン若しくはヨードラクトン若しくはメチオニン−ヨウ素、プロビドン−ヨウ素、ヨード酢酸などのヨウ素(ヨード)部分を含む脂質またはタンパク質を含む、分子の任意の形態を表す。 The therapeutic composition according to claim 15 or 16, wherein dimethyl sulfoxide is combined with an iodine compound to enhance the therapeutic effect of dimethyl sulfoxide. The term iodine refers to molecular iodine (I 2 ), iodide salts (ZnI 2 , CuI 2 , NaI or KI), iodate (NaIO), and / or iodotyrosine or iodolactone or methionine-iodine, providone-. Represents any form of molecule, including lipids or proteins that contain an iodine (iodine) moiety such as iodine, iodoacetic acid.
  18.  請求項15~17のいずれか一項に記載の治療用組成物中の成分の用量は:
     ヨウ化亜鉛:体重1kgあたり0.5mg~10mg、好ましくは体重1kgあたり1~5mg
     亜鉛塩とヨウ化物の混合物は、亜鉛塩1部対ヨウ化物塩2−20部、好ましくは亜鉛塩1部対ヨウ化物塩3−10部の比率で使用できる(例:酢酸亜鉛1部とヨウ化カリウム5部、または、酢酸亜鉛1部とヨウ化ナトリウム5部)
     分子状ヨウ素(I)または誘導体:体重1kgあたり0.05mg~10mg
     ジメチルスルホキシド(DMSO):体重1kgあたり10~1000mg、好ましくは体重1kgあたり100~500mg。
    The dose of the component in the therapeutic composition according to any one of claims 15 to 17 is:
    Zinc iodide: 0.5 mg to 10 mg / kg body weight, preferably 1 to 5 mg / kg body weight
    The mixture of zinc salt and iodide can be used in a ratio of 1 part zinc salt to 2-20 parts iodide salt, preferably 1 part zinc salt to 3-10 parts iodide salt (eg, 1 part zinc acetate and iodide). 5 parts of potassium or 1 part of zinc acetate and 5 parts of sodium iodide)
    Molecular iodine (I 2 ) or derivative: 0.05 mg to 10 mg / kg body weight
    Dimethyl sulfoxide (DMSO): 10-1000 mg / kg body weight, preferably 100-500 mg / kg body weight.
  19.  経口、非経口、直腸、経鼻および経口スプレー、経皮または点滴またはエアロゾル噴霧による、製薬上許容可能な処方の適用による、ヒトおよび動物における急性および慢性ウイルス感染の予防および治療のための、請求項15~18のいずれか一項に記載の治療用組成物。 Claims for the prevention and treatment of acute and chronic viral infections in humans and animals by the application of pharmaceutically acceptable formulations by oral, parenteral, rectal, nasal and oral sprays, transdermal or infusion or aerosol sprays. Item 8. The therapeutic composition according to any one of Items 15 to 18.
  20.  ヨウ化物塩、及びポビドンヨードからなる群より選択される少なくとも1つのヨウ素源からなり、請求項1~19の何れか1項に記載の組成物を構成するための剤。 An agent for constituting the composition according to any one of claims 1 to 19, which comprises at least one iodine source selected from the group consisting of an iodide salt and povidone iodine.
  21.  ジメチルスルホキシド及びメチルスルホニルメタンからなる群より選択される少なくとも1つのイオウ源からなり、請求項1~19の何れか1項に記載の組成物を構成するための剤。 An agent comprising at least one sulfur source selected from the group consisting of dimethyl sulfoxide and methylsulfonylmethane, and constituting the composition according to any one of claims 1 to 19.
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