WO2021198940A1 - Composition destinée à prévenir ou soigner une infection virale chronique ou aiguë et/ou une septicémie chez l'être humain ou chez l'animal - Google Patents

Composition destinée à prévenir ou soigner une infection virale chronique ou aiguë et/ou une septicémie chez l'être humain ou chez l'animal Download PDF

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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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English (en)
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/ja
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Publication of WO2021198940A1 publication Critical patent/WO2021198940A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/095—Sulfur, selenium, or tellurium compounds, e.g. thiols
    • A61K31/10—Sulfides; Sulfoxides; Sulfones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/74—Synthetic polymeric materials
    • A61K31/785—Polymers containing nitrogen
    • A61K31/787—Polymers containing nitrogen containing heterocyclic rings having nitrogen as a ring hetero atom
    • A61K31/79—Polymers of vinyl pyrrolidone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/18—Iodine; Compounds thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A61K9/12—Aerosols; Foams
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/14—Antivirals for RNA viruses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs 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

L'invention concerne une composition ou un médicament pour soigner la COVID-19, ainsi qu'un médicament, lequel a des effets antiviraux excellents, supérieurs aux effets antiviraux de I2 ou DMSO par exemple, et lequel est destiné à soigner une infection virale chronique ou aiguë et/ou une septicémie principalement chez l'être humain. Plus spécifiquement, l'invention concerne une composition contenant: au moins une source d'iode choisie dans le groupe comprenant sels d'iodure et providone-iode; et au moins une source de soufre choisie dans le groupe comprenant diméthylsulfoxyde et méthyl-sufonyl-méthane; cette composition étant destinée à prévenir ou soigner une infection virale chronique ou aiguë et/ou une septicémie chez l'être humain ou chez l'animal.
PCT/IB2021/052677 2020-03-31 2021-03-31 Composition destinée à prévenir ou soigner une infection virale chronique ou aiguë et/ou une septicémie chez l'être humain ou chez l'animal WO2021198940A1 (fr)

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WO2023100080A1 (fr) * 2021-11-30 2023-06-08 Quifarmedical Company S.A.S. Composition pharmaceutique liquide antivirale contre le sars-cov-2

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WO2022147585A1 (fr) * 2020-12-31 2022-07-07 Ntby Moss Llc Formulations d'un spray nasal prophylactique et ses procédés d'utilisation et de fabrication
WO2023100080A1 (fr) * 2021-11-30 2023-06-08 Quifarmedical Company S.A.S. Composition pharmaceutique liquide antivirale contre le sars-cov-2

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