WO2021249579A2 - 预防及治疗感冒或病毒性疾病的药物 - Google Patents

预防及治疗感冒或病毒性疾病的药物 Download PDF

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WO2021249579A2
WO2021249579A2 PCT/CN2021/111368 CN2021111368W WO2021249579A2 WO 2021249579 A2 WO2021249579 A2 WO 2021249579A2 CN 2021111368 W CN2021111368 W CN 2021111368W WO 2021249579 A2 WO2021249579 A2 WO 2021249579A2
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aspirin
salicylic acid
pharmaceutically acceptable
point
injection
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PCT/CN2021/111368
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English (en)
French (fr)
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WO2021249579A3 (zh
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刘力
陆红
胡梨芳
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刘力
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61K31/60—Salicylic acid; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/04—Drugs for disorders of the respiratory system for throat disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • 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
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/14—Antivirals for RNA viruses
    • A61P31/16—Antivirals for RNA viruses for influenza or rhinoviruses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Definitions

  • the present invention relates to the field of medical and medicine, specifically to provide aspirin and its derivatives in providing drugs for the prevention or treatment of mammalian or human diseases caused by colds or viral colds or influenza or coronaviruses or avian flu or tonsillitis. Method of application.
  • Influenza is an acute respiratory infectious disease caused by influenza virus.
  • the virus is present in the respiratory tract of the patient, and it is transmitted to others through droplets when the patient coughs or sneezes.
  • Influenza is very contagious. Because this virus is easy to mutate, even a person who has had the flu will still be infected when he encounters the flu next time, so the flu is likely to cause an outbreak. Generally, there are more chances of epidemics in winter and spring, and 20-40% of people may be infected with influenza each time.
  • Symptoms of simple influenza include: sudden chills, fever, headache, body aches, nasal congestion, runny nose, dry cough, chest pain, nausea, loss of appetite, etc.
  • infants and the elderly may be complicated by pneumonia or heart failure.
  • Poisoned flu patients manifest as: high fever, nonsense, coma, convulsions, and sometimes death. Therefore, the disease is very easy to spread, so it should be isolated and treated as soon as possible.
  • the common cold commonly known as the cold, is caused by rhinovirus, coronavirus, and parainfluenza viruses. These viruses are present in the respiratory tract of patients and spread to others through droplets.
  • the common cold is much less contagious than influenza. Most people are prone to get the disease after being exposed to cold, rain, or excessive fatigue. Therefore, the common cold often appears individually, and rarely occurs in batches when it is like influenza.
  • Human avian influenza (human avian influenza) is an acute respiratory infectious disease caused by some strains of certain avian subtypes of influenza A virus. It can also infect humans. It is designated as a category A infectious disease by the OIE, also known as True chicken disease or European chicken disease.
  • OIE also known as True chicken disease or European chicken disease.
  • the symptoms of human infection mainly include high fever, cough, runny nose, myalgia, etc., most of which are accompanied by severe pneumonia. In severe cases, the heart, kidney and other organ failures lead to death, and the fatality rate is high.
  • humans are infected with avian influenza. The mortality rate is about 33%. Most people infected with H5N1 virus have an acute onset. The early manifestations are similar to common flu or flu of unknown cause, mainly fever.
  • Varicella is an acute infectious disease caused by the first infection of varicella-zoster virus. It mainly occurs in infants, young children and preschool children. Adults have more severe symptoms than children.
  • Herpes zoster zoster is caused by the varicella-zoster virus (herpes varicella-zoster Virus, VZV) caused by acute skin and mucosal infections. Clinically, it is characterized by herpes that occurs suddenly, distributed along the nerve band, unilaterally distributed, and densely clustered. The pain is obvious, and it rarely recurs after healing. The disease is very contagious.
  • herpes zoster cannot directly transmit the herpes zoster virus, but it can cause chickenpox epidemics in susceptible people. The route of transmission is still "skin-air-respiratory tract". Children with VZV (initial infection) are clinically manifested as chickenpox, and adults are manifested as herpes zoster. If shingles complicated by neuralgia takes a long time, it is very difficult to treat.
  • antiviral drugs such as acyclovir, ganciclovir, and vanaiclovir (0.3g, 2 times/d orally, 6-9 days in a row), valganciclovir and other antiviral drugs are used for treatment, and acyclovir and more During the treatment of ciclovir, the adverse reactions are prominent, and the patients are prone to pain and phlebitis in the blood vessels.
  • neuraminidase inhibitors oseltamivir, peramivir, zanamivir, etc.
  • ganciclovir acyclovir
  • ribavirin ribavirin and other drugs It is invalid for 2019-nCoV.
  • drugs that may be effective include: Remdesivir, lopinavir/ritonavir, lopinavir/ritonavir combined with interferon- ⁇ , convalescent plasma, and monoclonal antibodies.
  • the antiviral drugs for the treatment of COVID-19 patients mainly include interferon- ⁇ 2b, lopinavir/ Ritonavir, Ribavirin, Chloroquine Phosphate and Arbidol (Reference: Cao Jun, Song Quan, Niu Guanghao, Yang Wei, etc., Current status of antiviral drugs for new coronavirus pneumonia[J].Anti-infective pharmacy , 2020,17(03):459-462.), there is no antipyretic and analgesic drug.
  • the clinical symptoms of patients with new coronary pneumonia mainly include cough and sputum, dyspnea, fever, diarrhea, and muscle aches. Imaging can be manifested as chest radiograph/chest CT with interstitial lung lesions. All patients were treated with drugs and oxygen therapy.
  • the drug treatment options include hormone + antibacterial treatment, antiviral + hormone treatment, antiviral + antibacterial treatment, antiviral + hormone + antibacterial treatment, including antiviral + hormone + antibacterial treatment. It accounts for the highest proportion, reaching 72% (Du Yi, Wu Weidong, Wang Xiaocheng, etc., analysis of clinical characteristics and treatment plans of 50 critically ill cases of novel coronavirus pneumonia[J/OL]. Chinese Journal of Nosocomial Infection: 1-4[2020- 05-10]. http://kns. cnki.net/kcms/detail/11.3456.R.20200506.0854.002.html.).
  • Salicylic acid and aspirin have been used for a century and become one of the three classic drugs in the history of medicine. So far, it is still the most widely used antipyretic, analgesic and anti-inflammatory drug in the world, as well as a standard preparation for comparing and evaluating other drugs. It has an anti-thrombotic effect in the body. It can inhibit the release reaction of platelets and inhibit platelet aggregation, which is related to the reduction of TXA2 production. It is used to prevent and treat ischemic heart disease, angina pectoris, cardiopulmonary infarction, and cerebral thrombosis.
  • the administration method is oral or intramuscular injection or intravenous injection.
  • Aspirin arginine salt is a soluble salt made of acetylsalicylic acid and arginine.
  • Lysine aspirin is a double salt of aspirin and lysine. It has antipyretic, analgesic and anti-inflammatory effects, which are basically the same as aspirin. Indications: Mainly used for fever, headache, neuralgia, toothache, muscle pain and active rheumatism, rheumatoid arthritis, trauma and postoperative pain. There is currently no cure for viral colds, and there is no low-dose treatment for colds or upper respiratory tract infections or flu or viral infections. There are currently no low-dose preparations. Aspirin-like drugs can cause gastrointestinal irritation, and nausea is more common.
  • the antipyretic and analgesic dose of aspirin is usually 0.3-0.6g once, 3 times a day, if necessary, once every 4 hours; the anti-rheumatic dose is 3-5g a day (acute rheumatic fever can be up to 7-8g) , Oral in 4 times.
  • the current dosage and usage of arginine aspirin intramuscular injection: 1g each time, 1 to 2 times a day, or according to the doctor's prescription. Children: 10 ⁇ 25mg/kg body weight. Before use, add 0.9% isotonic saline to each bottle or add 2 ⁇ 4ml of sterile water for injection to dissolve and inject.
  • lysine aspirin intramuscular or intravenous injection: 0.9 ⁇ 1.8g each time, 2 times a day. Children 10-25mg/kg body weight per day. Dissolve in 4ml water for injection or isotonic saline and inject. The dosages mentioned above are all very large.
  • the present invention relates to the field of medical technology, in particular to provide applications for the prevention or treatment of mammals or humans caused by viral influenza or coronavirus or new coronavirus or adenovirus or avian influenza or for therapeutic purposes.
  • a long time under the usual route of administration, such as oral or intravenous or intramuscular injection, salicylic acid, salicylamine, acetylsalicylic acid, aspirin, arginine aspirin, and lysine aspirin did not show anti-inflammatory effects.
  • Viral effects but the present invention has found that under special circumstances, it unexpectedly exhibits therapeutic or preventive effects at lower doses than conventional oral or injection administration.
  • acetylsalicylic acid, salicylic acid or its pharmaceutically acceptable salts, double salts or esters and their derivatives, or pharmaceutical compositions containing any of them have the performance of viral diseases Obvious antiviral effect, or change the course of the disease, can prevent or treat or cure the above-mentioned related viral diseases; the above-mentioned applications include cold or influenza, coronavirus, adenovirus or avian influenza virus, chickenpox or herpes zoster virus or tonsils Treatment and prevention of inflammation, etc.
  • the present invention found that salicylic acid or aspirin derivatives or their prodrugs, pharmaceutically acceptable salts, double salts, solvates or their pharmaceutically acceptable esters or ethers or their pharmaceutically acceptable inclusion complexes Drugs, or pharmaceutical compositions containing any of them, under a special administration mode, show obvious antiviral effects on viral diseases, or change the course of the disease, and can prevent or treat or cure the above-mentioned related viral diseases. disease.
  • prodrugs in pharmacology is to modify the structure of drugs that are known to have biological activity but have certain shortcomings (such as: poor bioavailability, unstable properties, short action time, peculiar smell, etc.) into new drugs That is, the prodrug, the latter is inactive in vitro, and is decomposed in the body to release the original drug to produce the drug effect. Compared with the original drug, the prodrug maintains or enhances the efficacy of the original drug and overcomes the shortcomings of the original drug.
  • Prodrugs are biologically reversible derivatives of drug molecules that release active original drugs through enzymatic or chemical action in the body, thereby exerting the expected pharmacological effects (Li Min. The principle of prodrug design and its clinical application[J].Modern China Drug Application, 2009, 3(15): 193-195.). The same is true for salicylic acid or aspirin derivatives or their prodrugs.
  • the drug is selected from but not limited to salicylic acid or aspirin or aspirin derivatives or their prodrugs, pharmaceutically acceptable salts, double salts, solvates or their pharmaceutically acceptable amides or esters or ethers or their pharmaceutically acceptable Accepted clathrates, or pharmaceutical compositions containing any of them, and compositions with pharmaceutically acceptable excipients.
  • Salicylic acid or aspirin derivatives are selected from but not limited to salicylamine, salicylic acid, pharmaceutically acceptable salts of aspirin (selected from but not limited to sodium, potassium, or magnesium, or amino acid, or organic ammonium salts, etc., And pharmaceutically acceptable pharmaceutical compositions or preparations containing them; inclusion compounds include urea, thiourea, and cyclodextrin inclusion compounds, and the cyclodextrins are selected from ⁇ -cyclodextrin, ⁇ -cyclodextrin, and ⁇ -Cyclodextrin, hydroxypropyl- ⁇ -cyclodextrin, sulfobutyl- ⁇ -cyclodextrin, etc.
  • the drug for treating and preventing human viral diseases is: the drug is salicylic acid or aspirin derivative or its prodrug, pharmaceutically acceptable salt, double salt, solvate or pharmaceutically acceptable ester thereof Or ether or a pharmaceutically acceptable clathrate thereof, or a pharmaceutical composition containing any of them, and a pharmaceutically acceptable carrier.
  • the drug for treating and preventing human viral diseases is: the drug is salicylic acid or aspirin or aspirin derivative or its prodrug, pharmaceutically acceptable salt, double salt, solvate or pharmaceutically acceptable
  • the esters or ethers or their pharmaceutically acceptable clathrates, or pharmaceutical compositions containing any of them, salicylic acid or aspirin derivatives are selected from but not limited to salicylamine, salicylic acid, aspirin and Its pharmaceutically acceptable salts (including amino acid salts or organic amine salts, etc.), acetylsalicylic acid or sodium salicylate, salicylic acid L-arginine, salicylic acid arginine, salicylic acid L-group Amino acid, salicylic acid L-lysine, salicylic acid DL-lysine, meglumine salicylate, ethylenediamine salicylate, acetylsalicylic acid or L-citrulline salicylate , Acetylsalicylic acid or diisopropy
  • the drug for treating and preventing human viral diseases is: the drug is salicylic acid or aspirin derivative or its prodrug, pharmaceutically acceptable salt, double salt, solvate or pharmaceutically acceptable ester thereof Or ether or its pharmaceutically acceptable clathrate, or a pharmaceutical composition containing any of them, and a composition with pharmaceutically acceptable excipients, the route of administration is acupoint administration, small Water injection preparations can be administered directly according to the dose.
  • Powder injection preparations can be administered at acupoints after dilution in one or more of normal saline, sterile water or glucose water, and more preferably 0.9% normal saline or sterile water or injection Diluted with water or 5% or 10% glucose water, etc., can be administered at acupoints, and can be administered at one or more acupoints.
  • the dosage is selected from but not limited to 0.1-30mg/acupuncture point (which can be converted to salicylic acid or aspirin). By weight), the more preferred dosage is 0.2-20mg/acupoint, and the more preferred dosage is 0.3-10mg/acupoint.
  • It can be aspirin or acetylsalicylic acid or acetylsalicylic acid arginine or acetylsalicylic acid.
  • Acid lysine or salicylic acid or converted acetylsalicylic acid or salicylic acid is calculated based on the weight of administration; the amount of liquid to be administered is usually selected from but not limited to 0.01-2.5ml/point, more preferably but not limited to 0.02- 1.5ml/acupuncture point, more preferably the dosage of liquid is 0.04-0.8ml/acupuncture point.
  • the above prevention or treatment can be administered alone or in combination with other drugs.
  • the combined administration is selected from but not limited to vitamin C tablets or capsules or granules or injections, vitamin C sodium tablets or injections, snake gall and chuanbei Chinese Traditional Chinese patent medicine preparations (according to the names and standards of the Chinese Pharmacopoeia or drug specifications), the above includes pharmaceutically acceptable drug formulations, combined with antibiotics or antibacterial drugs can be used for combined bacterial infections; the above drugs can be administered in different ways Combined administration, or intravenous or intramuscular injection, oral, spray, inhalation, topical or point injection, etc.
  • the medicine for treating and preventing human viral diseases is characterized by the administration of acupoints in the meridian system, and the acupoints are selected from, but not limited to, the meridian system meridian or collaterals or twelve meridians, odd meridians, eight meridians, and twelve meridians of traditional Chinese medicine.
  • the frequency or interval of administration is selected from but not limited to 1-2 injections per day or every other day, and can also be selected from but not limited to once every 2-5 days or once every one to two weeks or once every 3 weeks or once every month Or 1 time/5 weeks or 1 time/6 weeks or 1 time/8 weeks or 1 time/9 weeks or 1 time/10 weeks or longer.
  • Acupoint injection should be operated in accordance with the conventional requirements of acupoint injection.
  • the injection administration in the present invention is operated according to the usual acupoint administration disinfection procedures, and sterile or sterilized syringes and needles should be used.
  • the operating procedure select the appropriate syringe and needle according to the selected acupuncture points and the amount of medication. After the local skin is routinely disinfected, the needle is pierced into the subcutaneous tissue with a painless quick-introduction method. Aseptic operation is strictly followed to prevent infection. Generally, a needle is replaced for each injection point.
  • the commercially available aspirin and derivative injections are all high-dose (0.5g, 1g/bottle).
  • the commercially available arginine aspirin for injection is produced by many companies (Bayer, Hainan Lingkang Pharmaceutical, Ruiyang Pharmaceutical, Hainan General Kangli, Hope Pharmaceutical, Gourd Baby Pharmaceutical, etc.), lysine for injection (manufacturing companies include Bayer, Shanxi Pude Pharmaceutical, Shenzhen Huayao Nrushing Pharmaceutical, Chongqing Yaoyou, Fengyuan Tushan Pharmaceutical , Hainan Meixilin Biology, Sichuan Meidakang Huakang, Hainan Lingkang Pharmaceutical, Ruiyang Pharmaceutical, Hainan General Kangli, Hope Pharmaceutical, etc.); in clinical practice, it is troublesome to only dilute to prepare about 1% content, or Lower content is more troublesome, it is difficult to convert aseptic operation, waste is also large, waste a lot of time, and it is easy to be contaminated when cross-use with
  • the method for preparing small-dose injections of salicylic acid or aspirin and its derivatives can prepare sterile powder injections or freeze-dried powder injections or small water injections or infusions.
  • Sterile powder injection can directly dispense sterile raw materials into vials, stopper and cap.
  • the preparation of lyophilized powder injection can dissolve salicylic acid or aspirin and its derivatives or aspirin and arginine or lysine or histidine or meglumine in water for injection or in a solvent or in a cosolvent.
  • the single dose of aspirin or salicylic acid in the prior art is too large, wastes too much, and is inconvenient to use.
  • the present invention prepares injections of salicylic acid or aspirin or its derivatives. It is salicylic acid or aspirin or its prodrugs, pharmaceutically acceptable salts, double salts, solvates, or pharmaceutically acceptable esters or ethers or pharmaceutically acceptable clathrates thereof, or contains any of them The corresponding low-dose injections of various pharmaceutical compositions.
  • the prescription specifications based on the weight of salicylic acid or aspirin are selected from but not limited to 3-50mg/bottle or bottle, more preferably from but not limited to 3-30mg/bottle or bottle, and more Preferably but not limited to 5-25mg/bottle or tube.
  • composition refers to a pharmaceutical composition, and the pharmaceutical composition may contain at least one pharmaceutically acceptable carrier or excipient.
  • “Pharmaceutically acceptable excipient” as used herein refers to a pharmaceutically acceptable carrier or vehicle suitable for the administration of the compound provided herein, and includes any such carrier known to those skilled in the art as being suitable for a particular mode of administration .
  • the physiological saline in the present invention usually refers to 0.9% physiological saline or about 0.9% physiological saline.
  • Example 1-A Preparation of L-arginine aspirin powder injection (prescription specification 30mg/bottle, based on L-arginine aspirin)
  • Prescription process Take 3.00g of sterile L-arginine aspirin and 0.30g of glycine, and pack 30mg per bottle into 10ml sterile vials, stopper and press the cap to get it.
  • Example 1-B Preparation of aspirin lysine injection (prescription specification 50mg/bottle, calculated as containing aspirin lysine)
  • Prescription process aseptic aspirin lysine 5.00g, glycine 0.50g, each 0.050g aliquoted into 10ml sterile vials, stoppered, press the cap to get it.
  • Example 1-C Preparation of salicylic acid DL-lysine injection (prescription specification 10mg/bottle, based on salicylic acid)
  • Prescription process In a clean room, weigh 40.0 g of medicinal salicylic acid, add 42.65 g of DL-lysine, 1 g of calcium sodium EDTA, place in 2 liters of water for injection, stir to dissolve, use an appropriate amount of 1 mol/L hydrogen Adjust the pH of the solution to about 7.2 with sodium oxide solution or 1mol/L hydrochloric acid solution, add 0.05% medicinal activated carbon and stir for 30 minutes (weight to volume ratio g/L), add water for injection to make the volume to 4 liters, filter, 0.22 micropores Filter by membrane, fill in sterilized 5ml vials according to specifications, pre-freeze at -40°C for 4 hours, sublimate and dry from -30°C to 0°C, then dry at 5°C to 35°C for 6 hours, keep warm at 35°C It is made by rolling in 3 hours.
  • Example 1-D Preparation of salicylic acid L-arginine injection (prescription: salicylic acid 15mg/bottle, based on salicylic acid)
  • Prescription process In a clean room, weigh 30.0g medicinal salicylic acid, 42.62g meglumine meglumine, 1.0g calcium sodium EDTA 4-hydrate, and place them in 2.2 liters of water for injection, stir to dissolve, and use an appropriate amount of 1mol /L sodium hydroxide solution and or 1mol/L hydrochloric acid solution to adjust the pH value of the solution to about 7.2, add water for injection to 3 liters, add 0.05% medicinal activated carbon (weight to volume ratio g/L), stir for 30 minutes, filter, Filter with 0.22 microporous membrane, fill in sterilized 10ml vials by volume, pre-freeze at -40°C for 4 hours, sublimate and dry from -30°C to 0°C, and then dry at 5°C to 35°C for 7 hours ,Hold at 35°C for 3 hours and roll the lid.
  • 1mol /L sodium hydroxide solution and or 1mol/L hydrochloric acid solution to adjust the pH value of the solution to about
  • Example 1-G Preparation of salicylic acid lysine small water injection (prescription specification: salicylic acid 15mg/3ml/bottle)
  • Example 1-J Preparation of aspirin L-arginine powder injection (prescription 60mg/bottle, based on aspirin L-arginine)
  • Prescription process Take 6.00g of sterile aspirin L-arginine and 0.60g of glycine, divide 60mg per bottle into 10ml sterile vials, stopper and press the cap to get it.
  • Prescription process Take 9.00g of sterile aspirin L-arginine and 0.90g of glycine, divide 90mg per bottle into 15ml sterile vials, stopper and press the cap to get it.
  • Example 1-L Preparation of lysine aspirin injection (prescription 30mg/bottle, based on aspirin-containing lysine)
  • Prescription process Aseptic lysine aspirin 3.00g and glycine 0.30g, each 0.030g aliquoted into 10ml sterile vials, stoppered and capped.
  • Example 1-M Preparation of aspirin lysine injection (prescription specification 60mg/bottle, calculated as containing aspirin lysine)
  • Prescription process sterile aspirin lysine 6.00g, glycine 0.70g, each 0.060g aliquoted into 10ml sterile vials, stoppered, press the cap to get it.
  • Example 1-M Preparation of aspirin lysine injection (prescription specification 90mg/bottle, calculated as containing aspirin lysine)
  • Prescription process Take 12.00g of sterile aspirin L-arginine and 0.90g of glycine, divide 120mg per bottle into 15ml sterile vials, stopper and press the cap to get it.
  • Patient A a 34-year-old male, suffered from cold symptoms such as runny nose, cough, headache, and body aches and weakness. He was clinically diagnosed with a viral cold and injected aspirin L-arginine at Yingxiang acupoint the next day after symptoms appeared. Acid (1%) 0.9% saline solution 0.3ml/time, once a day (qd), for 2 consecutive days, Dazhui, Futu, Feishu points were injected with 0.9% of L-arginine aspirin (1%) % Physiological saline solution 0.5ml/time, qd, for 5 consecutive days. On the second day, give 7.5g of vitamin C in 500ml of 5% glucose at the same time.
  • Patient B male, 42 years old, with flu, sore throat, dry itchy throat, cough, malaise, headache and other symptoms. He also developed fever the next day. The temperature was measured at 38.3°C during the period. Influenza A/B virus antigen
  • the test kit (colloidal gold method) quickly detects influenza A.
  • Patient C male, 45 years old, viral cold, sore throat, dry itchy throat, nasal congestion, cough, headache, chest tightness, malaise, muscle aches, and fever. During the period, the body temperature was measured at 37.8°C.
  • sore throat, nasal congestion, cough, chest tightness, headache and other symptoms alleviated and body temperature returned to normal.
  • Patient D female, 62 years old, had a viral cold, with symptoms such as fever, runny nose, headache, and body weakness. During the test, the temperature was 38.8°C.
  • Tiantu, Tanzhong, and Feishu points were injected with 0.4ml of salicylic acid lysine injection prepared by the method of Example 1-G per time, qd, for 4 consecutive days, and vitamin C 5g was administered at the same time on the first day.
  • Patient E male, age 64, new coronavirus infection, self-infected with sore throat, nasal congestion, cough, headache, sore limbs, hyposmia, chest tightness and other symptoms after the onset, the new coronavirus nucleic acid test was positive, the next day after the symptoms appeared Inject the L-arginine salicylic acid injection prepared by the method of Example 1-H into each Dazhui point, Futu point, Tiantu point, and Feishu point of the patient, once a day at each point 0.5ml, for 10 consecutive days, each Yingxiang point inject 0.2ml/time of the above injection for 7 consecutive days.
  • Patient F female, 57 years old, developed fever after the onset of symptoms, during which the body temperature was 38.6°C, sore throat, runny nose, nasal congestion, dry cough, headache, chest tightness, limb weakness and other symptoms.
  • the new coronavirus antibody test was positive for IgM and negative for IgG.
  • the course of the disease is about three days.
  • Patient G male, 49 years old, was in contact with a patient with the new crown, and developed fever after the onset of symptoms. During the period, he took a body temperature of 38.3°C, sore throat, runny nose, nasal congestion, dry cough, headache, diarrhea, weakened sense of smell, etc., new coronavirus nucleic acid The test was positive, and each of the patients’ Dazhui points, Futu points, Tiantu points, Feishu points, and Kongzu points were injected with 0.5ml of arginine aspirin (1%) in approximately 0.9% physiological saline solution once a day.
  • Patient H female, 55 years old, had a viral cold, with symptoms such as fever, runny nose, headache, and weakness. During the period, the body temperature was measured at 37.9°C, and the influenza A/B virus antigen detection kit (colloidal gold method) was used for rapid detection. Influenza B. On the day of the onset of symptoms, each Yingxiang, Dazhui, Futu, Tiantu, and Feishu points were injected with arginine aspirin 1% physiological saline solution 0.5ml/time, qd , For 6 consecutive days, qd. On the first day, give 5g of vitamin C in 500ml of 5% glucose by intravenous injection.
  • Patient I male, 40 years old, after contact with bird flu poultry, the patient developed flu symptoms, nasal congestion, sore throat, headache, chest pain, general fatigue, muscle aches, and fever.
  • the temperature was measured at 38.1°C, and the course of disease was 2 Day, the patient’s Dazhui point, Futu point, Tiantu point, Feishu point were injected with aspirin arginine (1.2%) of physiological saline solution 0.5m/time, qd, each Quchi point was injected with sperm Aspirin acid (1%) in physiological saline solution 0.2m/time, qd, for 5 consecutive days.
  • symptoms such as nasal congestion, sore throat, headache, chest pain, malaise, muscle aches, etc.
  • influenza A/B virus antigen detection kit colloidal gold method
  • the body temperature was measured at 37.5-38.9°C, and lysine (1%) physiological saline solution 0.3ml/day was injected into each Yingxiang point of the patient for 2 consecutive days; Dazhui point and Tiantu point were injected separately 0.6ml of the above injection solution, for 6 consecutive days, each Futu point and Feishu point were injected with 0.5ml of approximately 0.9% saline of lysine (1%) for 6 consecutive days, once a day; after the day of administration Symptoms of fever were alleviated. On the second day, symptoms such as sore throat, cough and headache were alleviated significantly. The fever symptoms disappeared. On the third day, sore throat and headache symptoms disappeared, and cough alleviated.
  • herpes zoster There are 4 people with herpes zoster, half male and half, in the age range 18-55 years old, 1 case of herpes zoster on the chest and back (two locations), 1 case of herpes zoster on the waist and abdomen (1 location), and 2 cases on the limbs.
  • the patients were on the right palm, wrist, forearm, finger, and thigh.

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Abstract

本发明提供治疗和预防人或哺乳动物的感冒或病毒性疾病的药物或药物组合物的新用途和新方案，该药物为水杨酸或阿司匹林或其前药、或其药学上可接受的盐、复盐、溶剂化物或其药学上可接受的酯或醚或其药学上可接受的包合物，或含有它们中任何一种的药用组合物等，该药物可通过经络系统的穴位给药等来实现治疗或预防。

Description

预防及治疗感冒或病毒性疾病的药物 技术领域
本发明涉及医疗医药领域，具体地说是提供阿司匹林及其衍生物在提供预防或治疗在感冒或病毒性感冒或流感或冠状病毒或禽流感或扁桃体炎等导致的哺乳动物或人疾病的药物和方法中的应用。
 背景技术
感冒习惯上分为病毒性感冒和细菌性感冒，或者普通感冒和流行性感冒。流行性感冒，是由流感病毒引起的急性呼吸道传染病。病毒存在于病人的呼吸道中，在病人咳嗽、打喷嚏时经飞沫传染给别人。流感的传染性很强，由于这种病毒容易变异，即使是患过流感的人，当下次再遇上流感流行，他仍然会感染，所以流感容易引起暴发性流行。一般在冬春季流行的机会较多，每次可能有20～40%的人会传染上流感。单纯型流感的症状包括：突然畏寒、发热、头痛、全身酸痛、鼻塞、流涕、干咳、胸痛、恶心、食欲不振等一种或多种，婴幼儿或老年人可能并发肺炎或心力衰竭。中毒型流感病人则表现为：高热、说胡话、昏迷、抽搐，有时能致人死命。因此病极易传播，故应及早隔离和治疗。
普通感冒，俗称伤风，是由鼻病毒、冠状病毒及副流感病毒等引起，这些病毒存在于病人的呼吸道中，经飞沫传染给别人。普通感冒较流行性感冒传染性要弱得多，一般人在受凉、淋雨、过度疲劳后，因抵抗力下降，才容易得病。所以普通感冒往往是个别出现，很少象流行性感冒流行时，病人成批出现。
人禽流感（human avian influenza）是由甲型流感病毒某些感染禽类亚型中的一些毒株引起的急性呼吸道传染病,也能感染人类，被国际兽疫局定为甲类传染病，又称真性鸡瘟或欧洲鸡瘟。人感染后的症状主要表现为高热、咳嗽、流涕、肌痛等，多数伴有严重的肺炎，严重者心、肾等多种脏器衰竭导致死亡，病死率很高，通常人感染禽流感死亡率约为33%。H5N1病毒感染者多呈急性起病，早期表现类似普通型流感或为不明原因流感，主要为发热，体温大多持续在39℃以上，热程1～7天，一般为3～4天，可伴有流涕、鼻塞、咳嗽、咽痛、头痛、肌肉酸痛和全身不适。部分患者可有恶心、腹痛、腹泻、稀水样便等消化道症状。
水痘（varicella，chickenpox）是由水痘-带状疱疹病毒初次感染引起的急性传染病。主要发生在婴幼儿和学龄前儿童，成人发病症状比儿童更严重。带状疱疹(herpes zoster)是由水痘-带状疱疹病毒(herpes varicella-zoster Virus，VZV)所致的急性皮肤黏膜感染性疾病。临床上以突然发生的、沿神经带状分布、单侧分布、密集成群的疱疹为特点，疼痛明显，愈后极少复发。本病传染性很小，带状疱疹患者不能直接传播带状疱疹病毒，但能在易感人群中造成水痘流行。其传播途径仍为“皮肤-空气-呼吸道”。小儿感染VZV(初发感染)临床表现为水痘，成人表现为带状疱疹。带状疱疹并发神经痛如果发病的时间较长，治疗起来十分困难。目前多用阿昔洛韦、更昔洛韦、万乃洛韦（0.3g，2次/d口服，连用6～9d）、缬更昔洛韦等抗病毒药物治疗，注射阿昔洛韦、更昔洛韦治疗时不良反应突出，患者血管易出现疼痛、静脉炎等。或用可待因(30mg，每日2次)、卡马西平(100mg，每日3次);苯妥英钠(每天300mg)，严重可用阿米替林(amitriptyline)、曲马多、加巴喷丁、普瑞巴林等治疗，新一代的普瑞巴林的疗程达4周。多模式镇痛（口服镇痛药物，局部浸润麻醉和神经阻滞）治疗4周后依然有疼痛（张薇薇,詹玮玮,石波,等.早期多模式镇痛治疗带状疱疹及预防带状疱疹后遗神经痛57例[J].医药导报,2019,38(04):461-464.），还有的患者甚至疼痛数月不愈。
目前临床上常用的抗病毒药物，包括神经氨酸酶抑制剂(奥司他韦、帕拉米韦、扎那米韦等)、更昔洛韦、阿昔洛韦、利巴韦林等药物对2019-nCoV均无效。目前研究证实可能有效的药物包括：瑞德西韦、洛匹那韦/利托那韦、洛匹那韦/利托那韦联合干扰素-β、恢复期血浆、单克隆抗体。
新型冠状病毒肺炎最常见的临床症状是发热(91.6%)和咳嗽(64.5%),其次是呼吸困难(32.8%)和咳痰(28.1%)，而头痛(10.5%)、咽痛(11.2%)、咯血(3.2%)及腹泻(6.6%)等症状相对少见。而解热镇痛药物传统给药方式并未显示改变病情进程。2020年3月3日，国家卫生健康委员会发布的《新型冠状病毒肺炎诊疗方案(试行第7版)》中，治疗COVID-19患者的抗病毒药物主要有干扰素-α2b、洛匹那韦/利托那韦、利巴韦林、磷酸氯喹和阿比多尔(文献：曹俊,宋全,牛广豪,杨薇,等，新型冠状病毒肺炎抗病毒药物的治疗现状[J].抗感染药学, 2020,17(03):459-462.)，其中并无解热镇痛药物。
新型冠状肺炎患者临床症状主要包括咳嗽咳痰、呼吸困难、发热、腹泻、肌肉酸痛等。影像学可表现为胸片/胸部CT双肺间质性病变。所有患者均采取药物治疗以及氧疗支持，药物治疗方案包括激素+抗菌治疗、抗病毒+激素治疗、抗病毒+抗菌治疗、抗病毒+激素+抗菌治疗，其中应用抗病毒+激素+抗菌治疗方案占比最高，达72%(杜艺,武卫东,王晓成,等，50例新型冠状病毒肺炎危重症病例临床特点及治疗方案分析[J/OL].中华医院感染学杂志:1-4[2020-05-10]. http://kns. cnki.net/kcms/detail/11.3456.R.20200506.0854.002.html.)。
水杨酸和阿司匹林已应用百年，成为医药史上三大经典药物之一，至今它仍是世界上应用最广泛的解热、镇痛和抗炎药，也是作为比较和评价其他药物的标准制剂。在体内具有抗血栓的作用，它能抑制血小板的释放反应，抑制血小板的聚集，这与TXA2生成的减少有关。用于预防和治疗缺血性心脏病、心绞痛、心肺梗塞、脑血栓形成，给药方式为口服或肌注或静注。
阿司匹林于1898年上市，近年来发现它还具有抗血小板凝聚的作用，于是重新引起了人们极大的兴趣。将阿司匹林及其他水杨酸衍生物与聚乙烯醇、醋酸纤维素等含羟基聚合物进行熔融酯化，使其高分子化，所得产物的抗炎性和解热止痛性比游离的阿司匹林更为长效或外用软膏。
阿司匹林精氨酸盐为乙酰水杨酸与精氨酸制成的可溶性盐，赖氨酸阿司匹林为阿司匹林和赖氨酸复盐，具有解热，镇痛及抗炎作用，与阿司匹林基本相同。适应症：主要用于发热、头痛、神经痛、牙痛、肌肉痛及活动性风湿病、类风湿性关节炎、创伤及手术后疼痛。目前无法治愈病毒性感冒，更无在低剂量下治疗感冒或上呼吸道感染或流感或病毒性感染疾病，目前也无低剂量的制剂，阿司匹林类药物的胃肠道刺激大，较常见的有恶心、呕吐、上腹部不适或疼痛或胃溃疡，较易出现过敏反应，支气管痉挛性过敏反应，肾损害等，此外，尤其有发热及脱水者，阿司匹林类药物易出现毒性反应。急性发热性疾病，尤其是流感及水痘患儿应用该品，可能与发生瑞氏综合征（Reye’s syndrome）有关。
阿司匹林的解热、镇痛的剂量，通常一次0.3—0.6g，一日3次，必要时每4小时1次；抗风湿的剂量，一日3—5g（急性风湿热可用到7～8g），分 4次口服。精氨酸阿司匹林目前的用量用法：肌注：每次1ｇ，每日1～2次，或依病情按医嘱用药。儿童：10～25mg/kg体重。临用时，每瓶内加入0.9％等渗盐水或加入灭菌注射用水2～4ml溶解后注入。赖氨酸阿司匹林目前的用量用法：肌注或静注：每次0.9～1.8g，每日2次。儿童1日10～25mg/kg体重。以4ml注射用水或等渗盐水溶解后注射。上述给药剂量都很大。
目前公开文献报道阿司匹林水杨酸盐及药学上可接受的盐、复盐或前药或其药学上可接受的酯并不能用于预防或治疗人或动物的病毒性感冒或流感或冠状病毒或禽流感或扁桃体炎等，尽管在常规大剂量和或通常给药途径下才仅能用于退热、镇痛、消炎、抗风湿、抗血栓等或改善症状等，却无法预防或治疗感冒或病毒性感冒或一些病毒性疾病等，特别在低剂量或很低剂量下，公知现有技术是口服或静脉是无效的或无治疗价值的或未有公开文献报道能实现预防或治疗的，哪怕是感冒。
 技术问题
本发明涉及医药技术领域，具体地说是提供预防或治疗病毒性感冒或冠状病毒或新冠病毒或腺病毒或禽流感导致的哺乳动物或人的药物或治疗用途中的应用。长期以来，在通常的给药途径下，譬如口服或静脉或肌肉注射等下，水杨酸、水杨胺、乙酰水杨酸、阿司匹林、精氨酸阿司匹林、赖氨酸阿司匹林并未体现出抗病毒作用，但本发明却发现在特殊情况下，在低于常规口服或注射给药剂量下，却出乎意料的表现出治疗或预防作用。本发明出乎意料的发现乙酰水杨酸、水杨酸或其药学上可接受的盐、复盐或其酯它们的衍生物 或含有它们中任何一种的药用组合物对病毒性疾病表现出明显的抗病毒作用，或改变疾病的进程，能够预防或治疗或治愈上述的相关病毒性疾病；上述应用包括感冒或流感、冠状病毒、腺病毒或禽流感病毒水痘或带状疱疹病毒或扁桃体炎感染等的治疗与预防等。
 技术解决方案
更多的，本发明发现水杨酸或阿司匹林衍生物或其前药、药学上可接受的盐、复盐、溶剂化物或其药学上可接受的酯或醚或其药学上可接受的包合物，或含有它们中任何一种的药用组合物在特殊的给药方式下对病毒性疾病表现出明显的抗病毒作用，或改变疾病的进程，能够预防或治疗或治愈上述的相关病毒性疾病。
药物学上公知的前药原理是将已知有生物活性而又存在某些缺点(如: 生物利用度差、性质不稳定、作用时间短、有异味等。)的药物经结构修饰制成新药即前药，后者体外无活性，在体内分解释放出原药产生药效。与原药相比，前药保持或增强原药的药效，又克服原药的缺点。前药是药物分子的生物可逆的衍生物，在体内经酶或化学作用释放具有活性的原药，从而发挥预期的药理作用（李敏.前药设计原理及其临床应用[J].中国现代药物应用,2009,3(15):193-195.）。水杨酸或阿司匹林衍生物或其前药也是一样。
该药物选自但不仅限于水杨酸或阿司匹林或阿司匹林衍生物或其前药、药学上可接受的盐、复盐、溶剂化物或其药学上可接受的酰胺或酯或醚或其药学上可接受的包合物，或含有它们中任何一种的药用组合物，以及与药学上可接受的赋形剂的组合物。水杨酸或阿司匹林衍生物选自但不仅限于水杨胺、水杨酸、阿司匹林药学上可接受的盐（选自但不仅限于钠盐或钾盐或镁盐或氨基酸盐或有机铵盐等，以及含有其的药学上可接受的药物组合物或制剂等；包合物包括尿素、硫脲、环糊精包合物，环糊精选自α-环糊精，β-环糊精，γ-环糊精，羟丙基- β-环糊精，磺丁基- β-环糊精等中的一种或两种的混合物，其中优选羟丙基-β-环糊精等；包合物溶解于水中易释放药物，效果可预见（黄正佳,黄芳,谢雅.正交试验设计优化阿司匹林环糊精包合物的合成[J].化工时刊,2019,33(05):1-4.）。另外，还包括复方水杨酸钠注射液、水杨酸钠碘化钠注射液（10ml：水杨酸钠0.5g、碘化钠0.5g）、撒溴葡萄糖注射剂、复方柳安咖注射液等。
所述的治疗和预防人的病毒性疾病的药物为：该药物为水杨酸或阿司匹林衍生物或其前药、药学上可接受的盐、复盐、溶剂化物或其药学上可接受的酯或醚或其药学上可接受的包合物，或含有它们中任何一种的药用组合物，和药学上可接受的载体。所述的治疗和预防人的病毒性疾病的药物为：该药物为水杨酸或阿司匹林或阿司匹林衍生物或其前药、药学上可接受的盐、复盐、溶剂化物或其药学上可接受的酯或醚或其药学上可接受的包合物，或含有它们中任何一种的药用组合物，水杨酸或阿司匹林衍生物选自但不仅限于水杨胺、水杨酸、阿司匹林及其药学上可接受的盐（包括氨基酸盐或有机胺盐等）、乙酰水杨酸或水杨酸钠、水杨酸L-精氨酸、水杨酸精氨酸、水杨酸L-组氨酸、水杨酸L-赖氨酸、水杨酸DL-赖氨酸、水杨酸葡甲胺盐、水杨酸乙二胺盐、乙酰水杨酸或水杨酸L-瓜氨酸、乙酰水杨酸或水杨酸双异丙胺、水杨酸胆碱镁、乙酰水杨酸或水杨酸镁、水杨酸镁4水合物、水杨酸葡乙胺）、乙酰水杨胺、沙利芬saliphen、水杨酸萘酯、水杨丙磺酸、双水杨酯、最著酸、水杨吗啉、水杨胺、水杨各可酯、水杨酸甲酯、乙基水杨胺、阿司匹林L-精氨酸、D-精氨酸阿司匹林、精氨酸阿司匹林、赖氨酸阿司匹林、L-赖氨酸阿司匹林、D-赖氨酸阿司匹林、阿司匹林葡甲胺盐等。
所述的治疗和预防人的病毒性疾病的药物为：该药物为水杨酸或阿司匹林衍生物 或其前药、药学上可接受的盐、复盐、溶剂化物或其药学上可接受的酯或醚或其药学上可接受的包合物，或含有它们中任何一种的药用组合物，以及与药学上可接受的赋形剂的组合物，其给药途径为穴位给药，小水针制剂可视剂量直接给药，粉针制剂可以生理盐水或无菌用水或葡萄糖水等中的一种或几种稀释后穴位给药，较优选以0.9%生理盐水或无菌用水或注射用水或5%或10%的葡萄糖水等稀释后穴位给药，可一个或多个穴位给药，给药剂量选自但不仅限于0.1-30mg/个穴位（可以换算为水杨酸或阿司匹林的重量计），较优选给药剂量为0.2-20mg/个穴位，更较优选给药剂量为0.3-10mg/个穴位，可以阿司匹林或乙酰水杨酸或乙酰水杨酸精氨酸或乙酰水杨酸赖氨酸或水杨酸或折算乙酰水杨酸或水杨酸为计给药重量；给药液体量通常选自但不仅限于0.01-2.5ml/个穴位，较优选自但不仅限于0.02-1.5ml/个穴位，更较优选给药液体量为0.04-0.8ml/个穴位。以上的预防或治疗可以是单独给药或与其它药物联合给药，联合给药，选自但不仅限于维生素C片或胶囊或颗粒剂或注射液、维生素C钠片或注射液、蛇胆川贝枇杷膏、川贝枇杷膏或川贝枇杷颗粒、止咳枇杷颗粒、急支糖浆、甘草酸二胺肠溶片或胶囊、复方甘草片、玉屏风颗粒或口服液、藿香正气丸或颗粒等中国传统的中成药制剂（按照中国药典或药品规范的名称及标准），以上包括药学上可接受的药物剂型，联合抗生素或抗菌药给药可以用于合并细菌感染；上述药物的可以不同给药途径进行联合给药，或静脉注射或肌肉注射或口服或喷雾或吸入或外用或穴位注射等。
所述的治疗和预防人的病毒性疾病的药物：以经络系统的穴位给药为特征，穴位选自但不仅限于中医的经络系统经脉或络脉或十二经脉、奇经八脉、十二经别、十二经筋、十二皮部、十五脉络、孙络浮络或足太阳经、足太阴脾经的穴位或阿是穴或奇穴（中国针灸穴位辞典，主编：王守东，出版社：中国医药科技出版社，北京，1999-07出版），选自但不仅限于大椎穴、太阳穴、百会穴、迎香穴、肺俞穴、扶突穴、中府穴、天突穴、天容穴、颈百劳穴、天溪穴、膻中穴、气海穴、背俞穴、肾俞穴、脾俞穴、膈腧穴、血海穴、列缺穴、尺泽穴、太渊穴、合谷穴、丰隆穴、印堂穴、足三里、曲池穴、风池穴、天枢穴、内庭穴、孔最穴、鱼际穴、膏肓穴、夹脊穴、膻中穴、外关穴、风门穴、尺泽穴、定喘穴、阴陵穴、扁桃体穴、阿是穴或奇穴等中的一个或多个。在上述穴位或其临近可单点或左右两侧或多点注射给药。给药次数或间隔选自但不仅限于每日或隔日注射1-2次，亦可选自但不仅限于隔2-5日一次或一到两周一次或1次/3周或1次/月或1次/5周或1次/6周或1次/8周或1次/9周或1次/10周或更长。
穴位注射应按照穴位注射的常规要求操作，本发明中的注射给药均按通常的穴位给药消毒程序操作，应使用无菌或消毒的注射器和针头。根据使用药物的剂量大小及针刺的深度选用不同的注射器和针头。常用的注射器为1ml、2.5ml，操作程序：根据所选穴位及用药量的不同选择合适的注射器和针头。局部皮肤常规消毒后，用无痛快速进针法将针刺入皮下组织，严格遵守无菌操作、防止感染，一般每注射一个穴位换一个针头。
目前，市售的阿司匹林及衍生物注射剂都是大剂量的（0.5g，1g/瓶），譬如市售注射用精氨酸阿司匹林有多家公司生产（拜耳、海南灵康制药、瑞阳制药、海南通用康力、荷普药业、葫芦娃药业等），注射用赖氨匹林（生产公司有拜耳、山西普德药业、深圳华药南方制药、重庆药友、丰原涂山制药、海南美好西林生物、四川美大康华康、海南灵康制药、瑞阳制药、海南通用康力、荷普药业等）；临床实际操作中仅稀释制备约1%含量的很麻烦，或更低含量的更麻烦，无菌操作转换很困难，浪费也大，浪费大量时间，剂量大交叉使用时易污染等，增加临床用药的不安全因素，因此，需要制备其低剂量或小剂量的注射剂。
小剂量的水杨酸或阿司匹林及衍生物注射剂的制备方法，可以制备无菌粉针或冻干粉针或小水针或输液剂等。无菌粉针可以将无菌原料直接分装到西林瓶中，加塞压盖。冻干粉针的制备可将水杨酸或阿司匹林及衍生物或阿司匹林与精氨酸或赖氨酸或组氨酸或葡甲胺等在注射用水或和溶剂中或和助溶剂中溶解，可再加入适量的药学上可接受的抗氧剂、pH调节剂、赋形剂、助溶剂、或其它药学上可接受的组分等，无菌过滤，分装，冷冻干燥、冷冻干燥后无菌分装、减压干燥后无菌分装、喷雾干燥后无菌分装，加塞，压盖，包装。小水针的制备可将水杨酸或阿司匹林及衍生物或阿司匹林与精氨酸或赖氨酸或组氨酸或葡甲胺等在注射用水或和溶剂中或和助溶剂中溶解，可再加入适量的药学上可接受的抗氧剂、pH调节剂、填充剂、助溶剂或其它组分等，加注射用水定容，无菌过滤，定量灌封，灭菌，检验，包装。药用辅料及制剂可参见：《药用辅料手册》，化学工业出版社，2005年出版，作者 (美)舍斯基、(英)韦勒、郑俊民；《药用辅料应用技术》(第二版) 侯惠民等主编；上海医药工业研究院药物制剂部，药物制剂国家工程研究中心编著/2002年。
对于单个患者的临床用药，现有技术的阿司匹林或水杨酸的单支剂量规格太大，浪费太多，使用很不方便，本发明制备水杨酸或阿司匹林或其衍生物的注射剂，该药物为水杨酸或阿司匹林或其前药、药学上可接受的盐、复盐、溶剂化物或其药学上可接受的酯或醚或其药学上可接受的包合物，或含有它们中任何一种的药用组合物的相应低剂量的注射剂。对于本发明药物的注射剂，譬如注射用精氨酸阿司匹林、阿司匹林L-精氨酸、阿司匹林赖氨酸注射剂、注射用赖氨匹林、水杨酸葡甲胺注射剂、或水杨酸L-精氨酸注射剂等衍生物注射剂中，以折算为含水杨酸或阿司匹林重量处方规格选自但不仅限于3-50mg/瓶或支计，较优选自但不仅限于3-30mg/瓶或支，更较优选自但不仅限于5-25mg/瓶或支。
 本发明的实施方式
除了在实施例中以及另有指示时，说明书和权利要求书中所用的所有的数值应被理解为在所有的实例中以术语“约”进行修饰，因此，除非有相反的指示，本说明书和所附的权利要求书中所给出的数值参数是近似值，其可以根据通过本公开内容所寻求的所需要性质而改变，最起码地，并且不是意欲限制等同原则权利要求范围的应用，每个数值参数应考虑有效数字的数和常规四舍五入方法来解释。
虽然设定公开内容的宽范围的数值范围和参数是近似值。但是在具体实施例中所给出的数值被尽可能精确地报道，任意数值本质上包含某些由在它们各自的测试中发现的标准偏差所必然产生的误差。
需要指出的是，除非文中明确地另外说明，在本说明书和附加的权利要求中使用的单数形式“一个”、“一种”以及“该”包括指代物的复数形式，所以，例如。如果提及含有“一种化合物”的组合物时包括两种或多种化合物的混合物，另外需要注意的是，除非本文明确地另外说明，术语“或”通常包括“和/或”。
药物组合物，本文所用“药物组合物”是指药物的组合物，所述的药物组合物可以含有至少一种药学上可接受的载体或赋形剂。
本文所用“药学上可接受的赋形剂”是指适用于本文所偶提供的化合物给药的药用载体或溶媒，其包括本领域技术人员公知的适用于特定给药方式的任何此类载体。本发明中的生理盐水通常是指0.9%生理盐水或约0.9%生理盐水。
为了进一步了解本发明，下面结合实施例对本发明优选实施方案进行描述，但是应当理解，这些描述只是为进一步说明本发明的特征和优点，而不是对本发明权利要求的限制。
以下以具体实施例说明本发明的效果，但本发明的保护范围不受以下实施例的限制。
实施例1-A  L-精氨酸阿司匹林粉针剂的制备（处方规格30mg/瓶，以含L-精氨酸阿司匹林计）
处方工艺：取无菌L-精氨酸阿司匹林3.00g，甘氨酸0.30g，按每瓶30mg分装于10ml无菌的西林瓶中，加塞，压盖即得。
实施例1-B  阿司匹林赖氨酸注射剂的制备（处方规格50mg/瓶，以含阿司匹林赖氨酸计）
处方工艺：无菌阿司匹林赖氨酸5.00g，甘氨酸0.50g，按每瓶0.050g分装于10ml无菌的西林瓶中，加塞，压盖即得。
实施例1-C  水杨酸DL-赖氨酸注射剂的制备（处方规格10mg/瓶，以含水杨酸计）
处方工艺：在洁净室中，称取药用水杨酸 40.0g，加DL-赖氨酸42.65g，EDTA钙钠1g，置于2升注射用水中，搅拌溶解，用适量的1mol/L氢氧化钠溶液或1mol/L盐酸溶液调节溶液pH值至约7.2左右，加入0.05%药用活性炭搅拌30分钟（重量体积比g/L），加注射用水定容至4升，过滤，0.22微孔滤膜过滤，按规格灌装于已灭菌的5ml西林瓶中，在-40℃预冻4小时，从-30℃～0℃升华干燥， 5℃～35℃再干燥6小时，35℃保温3小时，轧盖制得。
 实施例1-D 水杨酸L-精氨酸注射剂的制备（处方：水杨酸15mg/瓶，以含水杨酸计）
在洁净室中，称取药用水杨酸 30.0g，L-精氨酸38.10g，EDTA钙钠1.0g，置于1.5升注射用水中，搅拌使溶，用适量的1mol/L氢氧化钠溶液和或1mol/L硫酸溶液调节溶液pH值至约7.2左右，加注射用水定容至2升，加入0.05%药用活性炭搅拌30分钟（重量体积比g/L），过滤，0.22微孔滤膜过滤，按体积分别灌装于已灭菌的10ml西林瓶中，在-40℃预冻4小时，从-30℃～0℃升华干燥， 5℃～35℃再干燥7小时，35℃保温3小时，轧盖制得。
实施例1-E 水杨酸葡甲胺注射剂的制备（处方规格10mg/瓶，以含水杨酸计）
处方工艺：在洁净室中，称取药用水杨酸 30.0g，药用葡甲胺42.62g，EDTA钙钠4水合物1.0g，置于2.2升注射用水中，搅拌溶解，用适量的1mol/L氢氧化钠溶液和或1mol/L盐酸溶液调节溶液pH值至约7.2左右，加注射用水至3升，加入0.05%药用活性炭（重量体积比g/L），搅拌30分钟，过滤，0.22微孔滤膜过滤，按体积分别灌装于已灭菌的10ml西林瓶中，在-40℃预冻4小时，从-30℃～0℃升华干燥， 5℃～35℃再干燥7小时，35℃保温3小时，轧盖制得。
实施例1-F  水杨酸L-赖氨酸小水针注射液的制备（处方规格：水杨酸6mg/3ml/支）
在洁净室中，称取药用水杨酸 3.00g，L-赖氨酸3.195g，置于1升注射用水中，搅拌溶解，加入EDTA钙钠4水合物3.0g，搅拌溶解，用适量的1mol/L氢氧化钠溶液和或1mol/L盐酸溶液调节溶液pH值至约7.3左右，加注射用水定容至1.5升，加入0.03%药用活性炭（重量体积比g/L），搅拌40分钟，过滤，0.22微孔滤膜过滤过滤两次，按体积分别灌封于已灭菌的安培瓶中，115℃灭菌30分钟，取出冷却至室温，灯检后即得。
实施例1-G  水杨酸赖氨酸小水针注射液的制备（处方规格：水杨酸15mg/3ml/支）
在洁净室中，称取药用水杨酸 30.00g，赖氨酸31.95g，置于5升注射用水中，搅拌溶解，加入EDTA钙钠3.0g，搅拌溶解，用适量的1mol/L氢氧化钠溶液和或1mol/L盐酸溶液调节溶液pH值至约7.2左右，加注射用水定容至6升，加入0.04%药用活性炭（重量体积比g/L），搅拌35分钟，过滤，0.22微孔滤膜过滤两次，按体积分别灌封于已灭菌的安培瓶中，115℃灭菌30分钟，取出冷却至室温，灯检后即得。
实施例1-H 水杨酸L-精氨酸注射液的制备（处方规格：水杨酸11.68mg/3ml/支）
处方：药用水杨酸 11.68g，L-精氨酸14.80g，EDTA钙钠4水合物3.0g，1mol/L氢氧化钠溶液或1mol/L盐酸溶液 适量 加注射用水定容至3.0升
在洁净室中，称取处方量的药用水杨酸，L-精氨酸，EDTA钙钠4水合物，置于2升注射用水中，搅拌溶解，用适量的1mol/L氢氧化钠溶液和或1mol/L盐酸溶液调节溶液pH值至约7.0左右，加注射用水定容至3.0升，加入0.06%药用活性炭（重量体积比g/L），搅拌30分钟，过滤，0.22微孔滤膜过滤两次，按体积分别灌封于已灭菌的安培瓶中，115℃灭菌30分钟，取出冷却至室温，灯检后即得。
实施例1-I  水杨酸钠小水针注射液的制备（处方规格：水杨酸15mg/3ml/支）
处方：药用水杨酸 15.00g，维生素C 10g，EDTA钙钠4水合物3.0g，氢氧化钠 适量，注射用水加到3.0升
 在洁净室中，称取处方量的药用水杨酸，维生素C，EDTA钙钠4水合物，氢氧化钠 适量，置于2.5升注射用水中，加适量的氢氧化钠，搅拌溶解，用适量的1mol/L氢氧化钠溶液或1mol/L盐酸溶液调节溶液pH值至约7.2左右，加注射用水定容至3.0升，加入为0.01%药用活性炭（重量体积比g/L），搅拌25分钟，过滤，0.22微孔滤膜过滤两次，按体积分别灌封于已灭菌的安培瓶中，115℃灭菌30分钟，取出冷却至室温，灯检后即得。
实施例1-J  阿司匹林L-精氨酸粉针剂的制备（处方60mg/瓶，以含阿司匹林L-精氨酸计）
处方工艺：取无菌阿司匹林L-精氨酸6.00g，甘氨酸0.60g，按每瓶60mg分装于10ml无菌的西林瓶中，加塞，压盖即得。
实施例1-K  阿司匹林L-精氨酸粉针剂的制备（处方90mg/瓶，以含阿司匹林L-精氨酸计）
处方工艺：取无菌阿司匹林L-精氨酸9.00g，甘氨酸0.90g，按每瓶90mg分装于15ml无菌的西林瓶中，加塞，压盖即得。
实施例1-L  赖氨酸阿司匹林注射剂的制备（处方30mg/瓶，以含阿司匹林赖氨酸计）
处方工艺：无菌赖氨酸阿司匹林3.00g，甘氨酸0.30g，按每瓶0.030g分装于10ml无菌的西林瓶中，加塞，压盖即得。
实施例1-M  阿司匹林赖氨酸注射剂的制备（处方规格60mg/瓶，以含阿司匹林赖氨酸计）
处方工艺：无菌阿司匹林赖氨酸6.00g，甘氨酸0.70g，按每瓶0.060g分装于10ml无菌的西林瓶中，加塞，压盖即得。
实施例1-M  阿司匹林赖氨酸注射剂的制备（处方规格90mg/瓶，以含阿司匹林赖氨酸计）
处方工艺：无菌阿司匹林赖氨酸9.00g，甘氨酸0.90g，按每瓶0.090g分装于15ml无菌的西林瓶中，加塞，压盖即得。
实施例1-N  阿司匹林L-精氨酸粉针剂的制备（处方规格120mg/瓶，以含阿司匹林L-精氨酸计）
处方工艺：取无菌阿司匹林L-精氨酸12.00g，甘氨酸0.90g，按每瓶120mg分装于15ml无菌的西林瓶中，加塞，压盖即得。
实施例1-O 水杨酸L-精氨酸小水针注射液的制备（处方：水杨酸23.37mg/3ml/支）
处方：药用水杨酸 23.37g，L-精氨酸29.8g，EDTA钙钠4水合物3.0g，1mol/L氢氧化钠溶液或1mol/L盐酸溶液 适量 加注射用水定容至3.0升
    在洁净室中，称取处方量的药用水杨酸，L-精氨酸，EDTA钙钠4水合物，置于2升注射用水中，搅拌溶解，用适量的1mol/L氢氧化钠溶液和或1mol/L盐酸溶液调节溶液pH值至约7.4左右，加注射用水定容至3.0升，加入0.01%药用活性炭（重量体积比g/L），搅拌30分钟，过滤，0.22微孔滤膜过滤两次，按体积分别灌封于已灭菌的安培瓶中，115℃灭菌30分钟，取出冷却至室温，灯检后即得。
实施例1-P 水杨酸L-精氨酸小水针注射液的制备（处方：水杨酸23.37mg/6ml/支）
处方：药用水杨酸 23.37g，L-精氨酸29.8g，EDTA钙钠4水合物3.0g，1mol/L氢氧化钠溶液或1mol/L       硫酸溶液 适量 加注射用水定容至6.0升
在洁净室中，称取处方量的药用水杨酸，L-精氨酸，EDTA钙钠4水合物，置于2升注射用水中，搅拌溶解，用适量的1mol/L氢氧化钠溶液和或1mol/L硫酸溶液调节溶液pH值至约7.2左右，加注射用水定容至6.0升，加入0.04%药用活性炭（重量体积比g/L），搅拌30分钟，过滤，0.22微孔滤膜过滤两次，按体积分别灌封于已灭菌的安培瓶中，115℃灭菌30分钟，取出冷却至室温，灯检后即得。
实施例2
患者A 男性，年龄 34岁，因受凉后出现流涕、咳嗽、头痛、浑身痛无力等感冒症状，临床诊断病毒性感冒，出现症状后第二天于患者的迎香穴注射阿司匹林L-精氨酸（1%）的0.9%生理盐水溶液0.3ml/次，每天一次（qd），连续2天，大椎穴、扶突穴、肺俞穴分别注射L-精氨酸阿司匹林（1%）的0.9%生理盐水溶液0.5ml/次，qd，连续5天，第二天同时给予维生素C7.5g于5%的葡萄糖500ml中静脉注射一次，第三天就自感流涕、咳嗽、头痛、浑身痛无力等症状减轻，第四天，流涕、头痛、浑身痛无力症状消失，第六天，全部症状消失，身体康复，除注射时局部轻微疼痛外，耐受良好，未见其它明显副作用，观察三周，期间虽与其它感冒患者接触过，未见复发，患者身体健康。
实施例3
患者B ，男性，年龄 42岁，流感，出现咽痛、咽部干痒、咳嗽、全身乏力、头痛等症状，第二天并出现发烧，期间测体温38.3℃，甲型/乙型流感病毒抗原检测试剂盒(胶体金法)快速检测为甲型流感，出现症状后第二天，于患者的迎香穴注射赖氨匹林（1%）的生理盐水溶液0.3ml/次，qd，连续2天，同时大椎穴、天突穴分别注射赖氨匹林1%的注射用水溶液0.5ml/次，qd，连续6天，风门穴、定喘穴分别注射赖氨匹林1%的注射用水溶液0.2 ml/次，qd，连续6天，每个扶突穴、肺俞穴分别注射赖氨匹林1%的注射用水溶液0.4ml/次，qd，连续6天；给药当天后发烧症状减轻，第二天就自感咽痛、咽部干痒、咳嗽、全身乏力、头痛等症状明显减轻，发烧症状消失，第三天，咽痛、咽部干痒、头痛症状消失，咳嗽减轻，第三天后，加服中成药复方甘草片3片/次，tid，连续两天，到第六天，全部症状消失，身体康复，除注射时局部轻微疼痛外，耐受良好，未见其它明显副作用，观察三周，期间虽与其它流感患者接触过，未见复发。
实施例4
患者C ，男性，年龄 45岁，病毒性感冒，出现咽痛、咽部干痒、鼻塞、咳嗽、头痛、胸闷、全身乏力、肌肉酸痛症状，并发烧症状，期间测体温37.8℃，出现症状当天，于患者的每个大椎穴、扶突穴、天突穴、肺俞穴分别注射精氨酸阿司匹林（1.5%）的生理盐水溶液0.5m/次，连续5天，每天注射一次(qd)，第二天咽痛、鼻塞、咳嗽、胸闷、头痛等症状减轻，体温恢复正常，第三天，咽痛、咽部干痒、鼻塞、咳嗽、头痛等症状减轻，但当天与核酸阳性的新冠病毒感染患者发生密切接触，第四天，无咽痛、咽部干痒、鼻塞、头痛症状，第五天，症状消失，患者身体康复，隔天再继续给患者的大椎穴、扶突穴、肺俞穴分别注射阿司匹林精氨酸（0.5%）的生理盐水溶液0.5ml给药一次，如此连续给药三次，除注射时局部轻微疼痛外，耐受良好，未见其它明显副作用，继续观察三周，未见复发，也未见出现新冠感染疾病症状，患者身体健康。
实施例5  病毒感染感冒疾病的预防与治疗
患者D， 女性，年龄 62岁，病毒性感冒，出现发热、流涕、头痛、浑身无力等症状，期间测38.8℃，出现症状的当天于患者的每个迎香穴、大椎穴、扶突穴、天突穴、膻中穴、肺俞穴分别注射实施例1-G法制备的水杨酸赖氨酸注射剂0.4ml/次，qd，连续4天，第一天同时给予维生素C 5g于5%的葡萄糖500ml中静脉滴注一次，第二天就自感流涕、头痛、浑身无力等症状减轻，体温恢复正常，第三天，头痛、浑身无力症状消失，第四天全部症状消失，身体康复，除注射时局部轻微疼痛外，耐受良好，未见其它明显副作用，之后观察两周，未见复发，患者身体健康。
实施例6  新冠病毒感染疾病的预防与治疗
患者E， 男性，年龄 64岁，新冠病毒感染，发病后自感出现咽痛、鼻塞、咳嗽、头痛、四肢酸痛、嗅觉减退、胸闷等症状，新冠病毒核酸检测为阳性，出现症状后第二天，于患者的每个大椎穴、扶突穴、天突穴、肺俞穴分别注射实施例1-H 法制备的水杨酸L-精氨酸小水针注射液，每天每个穴位一次注射0.5ml，连续10天，每个迎香穴注射上述注射液0.2ml/次，连续7天，第二天开始自感咽痛、鼻塞、咳嗽、头痛、四肢酸痛等症状减轻，第二天给予加服中成药川贝枇杷颗粒，一次3克，tid，连续四天，甘草酸二胺胶囊150mg/次，tid，连续5天，第十天，全部症状消失，患者身体康复，然后改为隔三天于患者的大椎穴、扶突穴、肺俞穴注射上述注射液0.3ml一次，连续给药3次，除注射时局部轻微疼痛外，耐受良好，未见其它明显副作用，之后观察四周，未见复发，患者身体健康。
实施例7新冠病毒感染疾病的预防与治疗
患者F， 女性，年龄 57岁，发病后出现发烧症状，期间测体温38.6℃、咽痛、流涕、鼻塞、干咳、头痛、胸闷、四肢无力等症状等，新冠病毒抗体检测IgM阳性，IgG阴性，病程约三天，期间曾口服布洛芬片，但未见明显效果，发烧反复；于患者的每个迎香穴注射精氨酸阿司匹林（1%）的0.9%生理盐水溶液0.3ml，连续3天，于患者的每个大椎穴、天突穴、肺俞穴、风池穴分别注射精氨酸阿司匹林（1%）的生理盐水溶液0.5ml/次，qd，连续6天；第一和第二天给予维生素C 5g于5%的葡萄糖500ml中静脉滴注一次；第三天自感咽痛、流涕、鼻塞、干咳、头痛等症状减轻，体温恢复正常，第六天，咽痛、流涕、鼻塞、头痛症状基本消失，然后改为隔天于患者的大椎穴、扶突穴、肺俞穴注射阿司匹林精氨酸（1%）的生理盐水溶液0.5ml/次，qd，连续给药四次，全部症状消失，身体康复，除注射时局部轻微疼痛外，耐受性良好，未见其它明显副作用，观察四周，未见复发。
实施例8  新冠病毒感染疾病的预防与治疗
患者G ，男性，年龄 49岁，与新冠患者接触感染，发病后出现发烧症状，期间测体温38.3℃、咽痛、流涕、鼻塞、干咳、头痛、腹泻、嗅觉减弱等症状等，新冠病毒核酸检测呈阳性，于患者的每个大椎穴、扶突穴、天突穴、肺俞穴、孔最穴分别注射精氨酸阿司匹林（1%）的约0.9%生理盐水溶液0.5ml次/天，qd，连续给药8天，于患者的每个迎香穴、孔最穴分别注射精氨酸阿司匹林（1%）的约0.9%生理盐水溶液0.3ml次，每隔一天一次，连续4次；第一天同时服用中药藿香正气丸，剂量为一天三次，一次两袋，连用三天后停药；第二天就自感咽痛、流涕、鼻塞、咳嗽、头痛等症状减轻，不再腹泻，体温恢复正常，第五天，咽痛、流涕、鼻塞、头痛、腹泻症状消失，第八天全部症状消失，然后从第九天开始于患者的大椎穴、肺俞穴分别注射上述注射溶液0.5ml次/天，隔三天一次，如此连续给药3次，除注射时局部轻微疼痛外，耐受良好，未见其它明显副作用，身体康复，之后观察三周，未见复发，患者身体健康。
实施例9  流感病毒感染疾病的预防与治疗
患者H ，女性，年龄 55岁，病毒性感冒，出现发热、流涕、头痛、浑身无力等症状，期间测体温37.9℃，甲型/乙型流感病毒抗原检测试剂盒(胶体金法)快速检测为乙型流感，出现症状的当天于患者的每个迎香穴、大椎穴、扶突穴、天突穴、肺俞穴分别注射精氨酸阿司匹林1%的生理盐水溶液0.5ml/次，qd，连续6天，qd，第一天同时给予维生素C 5g于5%的葡萄糖500ml中静脉注射，第二天就自感流涕、头痛、浑身无力等症状减轻，体温恢复正常，第三天，头痛、浑身无力症状消失，第五天流涕症状消失，身体康复，除注射时局部轻微疼痛外，耐受良好，未见其它明显副作用，之后观察三周，未见复发，患者身体健康。
实施例10
患者I，男性，年龄 40岁，患者与禽流感家禽有接触后出现流感症状，出现鼻塞、咽痛、头痛、胸痛、全身乏力、肌肉酸痛症状，并发烧症状，期间测体温38.1℃，病程2天，于患者的每个大椎穴、扶突穴、天突穴、肺俞穴分别注射阿司匹林精氨酸（1.2%）的的生理盐水溶液0.5m/次，qd，每个曲池穴注射精氨酸阿司匹林（1%）的的生理盐水溶液0.2m/次，qd，连续5天，第二天鼻塞、咽痛、头痛、胸痛、全身乏力、肌肉酸痛等症状减轻，体温恢复正常，第三天，鼻塞、咽痛、头痛、胸痛、全身乏力、肌肉酸痛等症状减轻，但患者却与新冠肺炎患者发生密切接触，第四天鼻塞、咽痛、头痛、胸痛、全身乏力、肌肉酸痛症状消失，第五天，患者身体康复，但第五天患者又与新冠肺炎患者发生密切接触，感冒治愈后，隔两天再继续给患者的每个大椎穴、扶突穴、肺俞穴分别注射阿司匹林精氨酸（0.5%）的生理盐水溶液0.5ml/次，qd，患者身体康复，如此连续给药四次，停止给药后继续观察四周，患者未见复发，除注射时局部轻微疼痛外，耐受良好，未见其它明显副作用，也未见出现新冠感染疾病症状，患者身体健康。
实施例11  新冠病毒感染疾病的预防与治疗
健康人六人，男性4人，女性2人，年龄28- 50岁，身体健康，但分别均与核酸阳性的新冠病毒感染患者发生密切接触，在发生密切接触的当天，于其的每个大椎穴、扶突穴、肺俞穴、风池穴分别注射精氨酸阿司匹林（1 %）的生理盐水溶液0.5ml/次，qd，连续3天，然后隔两天再继续给患者的每个大椎穴、扶突穴、肺俞穴分别注射精氨酸阿司匹林（0.5%）的生理盐水溶液0.4ml/次/天，如此连续给药两次，除注射时局部轻微疼痛外，耐受良好，未见其它明显副作用，停止给药后继续观察六周，处置过程中未用其它药物，均未见出现新冠感染疾病症状，均身体健康。
实施例12  流感病毒感染疾病的预防与治疗
健康人5人，男性3人，女性2人，年龄32- 60岁，身体健康，但分别均与流感患者和有感冒症状的患者发生密切接触，于发生密切接触的当天，于其的每个大椎穴、扶突穴、肺俞穴分别注射精氨酸阿司匹林（0.8 %）的生理盐水溶液0.5ml/次，隔天一次，qd，连续3次，每个足三里、合谷穴分别注射精氨酸阿司匹林（0.5%）的生理盐水溶液约0.08ml/次，qd，隔天一次，连续2次，除注射时局部轻微疼痛外，耐受良好，未见其它明显副作用，处置过程中未用其它药物，停药后继续观察两周，均未见出现流感或感冒症状，均身体健康。
实施例13  流感病毒感染疾病的预防与治疗
患者共6人 男女各半，年龄范围在 19-61岁，分别用甲型/乙型流感病毒抗原检测试剂盒(胶体金法)快速检测为甲型流感和乙型流感各半，分别先出现发烧、咽痛、咳嗽、头痛、食欲不振等症状，期间测体温为37.5-38.9℃，于患者的每个迎香穴注射赖氨匹林（1%）的生理盐水溶液0.3ml/天，连续2天；大椎穴、天突穴分别注射上述注射溶液0.6ml，连续6天，每个扶突穴、肺俞穴分别注射赖氨匹林（1%）的约0.9%生理盐水0.5ml，连续6天，每天注射一次；给药当天后发烧症状减轻，第二天就自感咽痛、咳嗽、头痛等症状明显减轻，发烧症状消失，第三天，咽痛、头痛症状消失，咳嗽减轻，第三天后，加服中成药川贝枇杷颗粒，一次3克，tid，连续给药两天；到第六天，咳嗽症状消失，除注射时局部轻微疼痛外，耐受良好，未见其它明显副作用，身体康复，停止治疗后继续观察四周，未见复发。
实施例14  疱疹病毒感染疾病
带状疱疹患者共4人 男女各半，年龄范围在 18-55岁，分别为胸背部带状疱疹 1例（两处），腰腹部带状疱疹1例（1处）, 四肢 2例，四肢患者分别在右手掌、手腕、小臂、手指、大腿带状疱疹后神经痛病人，具有典型带状疱疹的临床症状和体征，病程在1周内，未合并细菌感染，已口服镇痛药物未见明显效果，大部分夜不能寐，治疗期间停用其他镇痛药和之前服药抗病毒药物；分别于患者的每个大椎穴、夹脊穴、肺俞穴、曲池穴分别注射精氨酸阿司匹林（1 %）的生理盐水溶液0.5ml/次，每天一次，连续5天，在其每个风池穴、肝俞穴、外关穴分别注射精氨酸阿司匹林（1 %）的生理盐水溶液0.3ml/次，每天一次；同时，第一天给药时，对于特别疼痛的部位选择一个阿是穴注射0.3ml/次；然后，隔两天再继续给患者的每个夹脊穴、大椎穴、扶突穴、肺俞穴分别注射注射精氨酸阿司匹林（1%）的生理盐水溶液0.5ml/次/天，如此连续给药两次，然后，再如此模式隔三天给药一次，并如此连续给药三次。在首次如此治疗后24小时后，患者的疼痛均有所缓解，夜里睡眠改善，之后患者均感觉逐日好转，治疗后分别约在7-9日左右，患者已不感觉到有明显疼痛，除注射时局部轻微疼痛外，耐受良好，未见其它明显副作用，治疗结束时，患者已不觉得疼痛，正常睡眠，疱疹处已结痂，停止给药后继续观察三周，虽有接触其它水痘或带状疱疹患者，处置过程中未用其它药物，均未见复发，均身体健康。
实施例15  扁桃体炎疾病治疗
患者共3人 男性，年龄范围在 18-33岁，均为扁桃体Ⅰ到Ⅱ度肿大，扁桃体炎，体温为37.3-38.4℃之间，病程2-4天之间；于患者的每个大椎穴、天突穴分别注射赖氨匹林（1 %）的生理盐水溶液0.4ml/天，qd，连续3天；每个扁桃体穴分别注射上述注射液0.4ml/天，qd，连续3天；每个合谷穴、尺泽穴分别注射上述注射液0.2ml/天，qd，连续3天；每个扶突穴、肺俞穴分别注射上述注射液0.3ml/天，qd，连续6天；给药第二天后发烧和疼痛症状减轻，第三天退烧，第六天，症状消失，除注射时局部轻微疼痛外，耐受良好，未见其它明显副作用，身体康复，处置过程中未用其它药物，停药后继续观察1个月，未见复发。
以上通过具体实施方式和实施例对本发明进行了详细说明，不过应理解，这些说明并不对本发明的范围构成任何限制，相关技术人员明显能在在不偏离本发明的精神和保护范围的情况下，可以对本发明的技术方案及其实施方式进行多种修饰、改进和替换与组合，来实现本发明技术，这些均因落入本发明的保护范围内。特别需要指出的是，可以理解，很多细节的变化是可能的，所有相类似的替换和改动对本领域技术人员来说是显而易见的，它们都被视为包括在本发明的精神、范围和内容中，本发明并不限于上述实施例。

Claims (8)

  1. 治疗和预防哺乳动物或人的感冒或病毒性疾病的药物，其特征为：该药物为水杨酸或阿司匹林或其前药、药学上可接受的盐、复盐、溶剂化物或其药学上可接受的酯或醚或其药学上可接受的包合物，或含有它们中任何一种的药用组合物。
  2. 根据权利要求1所述的治疗和预防哺乳动物或人的感冒或病毒性疾病的药物，其特征为：该药物为水杨酸或阿司匹林或其前药、药学上可接受的盐、复盐、溶剂化物或其药学上可接受的酯或醚或其药学上可接受的包合物，或含有它们中任何一种的药用组合物，和药学上可接受的载体。
  3. 根据权利要求1、2任一所述的治疗和预防哺乳动物或人的感冒或病毒性疾病的药物，其特征为：该药物为水杨酸或阿司匹林或其前药、药学上可接受的盐、复盐、溶剂化物或其药学上可接受的酯或醚或其药学上可接受的包合物，或含有它们中任何一种的药用组合物，水杨酸或阿司匹林衍生物选自但不仅限于水杨胺、水杨酸、阿司匹林及其药学上可接受的盐，选自但不仅限于乙酰水杨酸或水杨酸钠、水杨酸L-精氨酸、水杨酸精氨酸、水杨酸L-组氨酸、水杨酸L-赖氨酸、水杨酸DL-赖氨酸、水杨酸葡甲胺盐、水杨酸乙二胺盐、乙酰水杨酸或水杨酸L-瓜氨酸、乙酰水杨酸或水杨酸双异丙胺、水杨酸胆碱镁、乙酰水杨酸或水杨酸镁、水杨酸镁4水合物、水杨酸葡乙胺、乙酰水杨胺、沙利芬saliphen、水杨酸萘酯、水杨丙磺酸、双水杨酯、最著酸、水杨吗啉、水杨胺、水杨各可酯、水杨酸甲酯、乙基水杨胺、阿司匹林L-精氨酸、D-精氨酸阿司匹林、精氨酸阿司匹林、赖氨酸阿司匹林、L-赖氨酸阿司匹林、D-赖氨酸阿司匹林、阿司匹林葡甲胺盐中的一种或多种。
  4. 根据权利要求1-3任一所述的治疗和预防哺乳动物或人的感冒或病毒性疾病的药物，其特征为：该药物为水杨酸或阿司匹林或其前药、药学上可接受的盐、复盐、溶剂化物或其药学上可接受的酯或醚或其药学上可接受的包合物，或含有它们中任何一种的药用组合物，其给药途径为穴位给药，粉针制剂以生理盐水或无菌用水或葡萄糖水中的一种或几种稀释后穴位给药，给药剂量选自但不仅限于0.1-30mg/个穴位，可以阿司匹林或乙酰水杨酸或乙酰水杨酸精氨酸或乙酰水杨酸赖氨酸或水杨酸或折算为乙酰水杨酸或水杨酸计给药重量；给药液体量选自但不仅限于0.01-2.5ml/个穴位。
  5. 根据权利要求1-4任一所述的治疗和预防哺乳动物或人的感冒或病毒性疾病的药物，其特征为：该药物可以是单独给药或与其它药物联合给药，联合给药，选自但不仅限于维生素C片或胶囊或颗粒剂或注射液、维生素C钠片或注射液、蛇胆川贝枇杷膏、川贝枇杷膏或川贝枇杷颗粒、止咳枇杷颗粒、急支糖浆、甘草酸二胺肠溶片或胶囊、复方甘草片、玉屏风颗粒或口服液、藿香正气丸或颗粒中国传统的中成药制剂，以上包括药学上可接受的药物剂型，联合抗生素或抗菌药给药可以用于合并细菌感染。
  6. 根据权利要求1-5任一所述的治疗和预防哺乳动物或人的感冒或病毒性疾病的药物，其特征为：以经络系统的穴位给药，穴位选自但不仅限于中医的经络系统经脉或络脉或十二经脉、奇经八脉、十二经别、十二经筋、十二皮部、十五脉络、孙络浮络或足太阳经、足太阴脾经的穴位或阿是穴或奇穴，选自但不仅限于大椎穴、太阳穴、百会穴、迎香穴、肺俞穴、扶突穴、中府穴、天突穴、天容穴、颈百劳穴、天溪穴、膻中穴、气海穴、背俞穴、肾俞穴、脾俞穴、膈腧穴、血海穴、列缺穴、尺泽穴、太渊穴、合谷穴、丰隆穴、印堂穴、足三里、曲池穴、风池穴、天枢穴、内庭穴、孔最穴、鱼际穴、膏肓穴、夹脊穴、膻中穴、外关穴、风门穴、尺泽穴、定喘穴、阴陵穴、扁桃体穴、阿是穴或奇穴中的一个或多个；在上述穴位或其临近可单点或左右两侧或多点注射给药；给药次数或间隔选自但不仅限于每日或隔日注射1-2次，亦可选自但不仅限于隔2-5日一次或一到两周一次或1次/3周或1次/月或1次/5周或1次/6周或1次/8周或1次/9周或1次/10周或更长。
  7. 根据权利要求1-6任一所述的治疗和预防哺乳动物或人的感冒或及病毒性疾病的药物，其特征为：病毒性疾病选自病毒性感冒或流感或冠状病毒或禽流感或水痘或带状疱疹病毒或扁桃体炎等导致的哺乳动物或人疾病。
  8. 根据权利要求1-7任一所述的治疗和预防人或哺乳动物的感冒或及病毒性疾病的药物，其特征为：该药物为水杨酸或阿司匹林或其前药、药学上可接受的盐、复盐、溶剂化物或其药学上可接受的酯或醚或其药学上可接受的包合物，或含有它们中任何一种的药用组合物的相应低剂量的注射剂；对于本发明药物的注射剂，譬如注射用精氨酸阿司匹林、阿司匹林L-精氨酸、阿司匹林赖氨酸注射剂、注射用赖氨匹林、水杨酸葡甲胺注射剂、或水杨酸L-精氨酸注射剂等衍生物注射剂中，以折算为含水杨酸或阿司匹林重量处方规格选自但不仅限于3-50mg/瓶或支计，较优选自但不仅限于3-30mg/瓶或支，更较优选自但不仅限于5-25mg/瓶或支。
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