Inhalation preparation for relieving or treating upper respiratory tract infection as well as preparation method and application of inhalation preparation

Abstract

The invention relates to the technical field of inhalation preparations, in particular to an inhalation preparation for relieving or treating upper respiratory tract infection and a preparation method and application thereof. The inhalation preparation comprises an active pharmaceutical ingredient, and the active pharmaceutical ingredient is andrographolide; the inhalation preparation also comprises pharmaceutically acceptable auxiliary materials; the pharmaceutically acceptable auxiliary materials comprise one or more of a solvent, a cosolvent, a propellant, a carrier / diluent, a pH regulator, an antistatic agent and a stabilizer. The prescriptions and the preparation methods of the aerosol, the dry powder inhalation and the spray are suitable for industrial production, and clinical tests prove that the prepared inhalation preparation has a remarkable relieving or treating effect on upper respiratory tract infection.

Description

Technical Field

[0001] This invention relates to the field of inhaled preparations, specifically to an inhaled preparation for relieving or treating upper respiratory tract infections, its preparation method, and its application. Background Technology

[0002] The respiratory tract is an open cavity connecting the human body to the external environment. It is constantly stimulated by non-self substances and various microorganisms, serving as a habitat for diverse microbial flora within the body. The respiratory tract is divided into the upper and lower respiratory tracts. The upper respiratory tract, composed of the nose, pharynx, and larynx, is the initial passage for ambient air to enter the lungs and is constantly exposed to various substances such as symbiotic bacteria, pathogens, environmental chemicals, and allergen particles. Therefore, upper respiratory tract infections caused by viruses and bacteria, especially viruses, are common. After a viral infection, the upper respiratory tract mucosa loses its resistance, allowing bacteria to invade and causing acute upper respiratory tract inflammation. Clinically, acute pharyngitis, acute tonsillitis, acute nasopharyngitis, and acute catarrhal inflammation are common manifestations. Chronic pharyngitis can also develop acute infection symptoms after viral or bacterial infection.

[0003] Inhaled preparations are liquid or solid formulations in which the active pharmaceutical ingredient is dissolved or dispersed in a suitable medium and delivered to the lungs in the form of an aerosol or vapor to exert local or systemic effects. Inhaled preparations are generally classified into three types: inhaled aerosols, powder inhalers, and sprays.

[0004] Compared to oral formulations, inhaled formulations have the advantages of rapid onset of action and high bioavailability. However, current research on inhaled formulations mainly focuses on lung-related diseases, and there are very few reports on inhaled formulations that relieve or treat upper respiratory tract infections.

[0005] Currently, commercially available andrographolide preparations are mainly available in injection, tablet, capsule, and drop form. In the field of inhaled formulations, commercially available products generally aim for high lung deposition rates, with their core technical characteristic being a high proportion of particles with a diameter of 1-5 μm. They are primarily used for the treatment of lower respiratory tract diseases such as asthma and chronic obstructive pulmonary disease (COPD). To date, there are no reports of andrographolide being formulated into inhaled formulations for the treatment of upper respiratory tract infections. Summary of the Invention

[0006] This invention provides an inhaled preparation for relieving or treating upper respiratory tract infections, its preparation method, and its application. The preparation process of this inhaled preparation is simple and portable, and it has the effect of relieving or treating upper respiratory tract infections.

[0007] In a first aspect, the present invention provides an inhaled formulation for relieving or treating upper respiratory tract infections, comprising: a pharmaceutically active ingredient and pharmaceutically acceptable excipients; The active ingredient in the drug is andrographolide; The pharmaceutically acceptable excipients include one or more of solvents, cosolvents, propellants, carriers / diluents, pH adjusters, antistatic agents, and stabilizers.

[0008] In one alternative embodiment, the inhaled formulation includes an aerosol, a powder inhaler, or a spray.

[0009] In one optional embodiment, the aerosol formulation comprises: 250-750 parts by weight of andrographolide, 50,000-60,000 parts by volume of solvent, 3,000-4,000 parts by volume of cosolvent, and 80,000-120,000 parts by weight of propellant; the ratio of parts by weight to parts by volume is g / mL or kg / L.

[0010] In one optional embodiment, the formulation of the powder spray includes: 100-400 parts by weight of andrographolide, 80-200 parts by weight of carrier / diluent, 10-15 parts by weight of antistatic agent, 20,000-30,000 parts by weight of solvent, and an appropriate amount of pH adjuster; the ratio of parts by weight to parts by volume is g / mL or kg / L.

[0011] In one optional embodiment, the formulation of the spray includes: 100-400 parts by weight of andrographolide, 40,000-60,000 parts by volume of solvent, 8-10 parts by volume of stabilizer and 10-15 parts by weight of antistatic agent; the ratio of parts by weight to parts by volume is g / mL or kg / L.

[0012] In one optional embodiment, the solvent includes any one of ethanol, 30%~60% aqueous ethanol solution, water, and propylene glycol; The co-solvent is glycerol; The propellant includes any one of dichlorodifluoromethane, tetrafluoroethane (HFA134), and heptafluoropropane (HFA227); The carrier / diluent includes any one of lactose and mannitol; The pH adjuster includes any one of sodium hydroxide, disodium hydrogen phosphate, sodium dihydrogen phosphate, and sodium chloride; The antistatic agent is poloxamer 188; The stabilizer includes any one of EDTA-2Na and ascorbic acid.

[0013] Secondly, the present invention also provides a method for preparing an inhaled preparation for relieving or treating upper respiratory tract infections, wherein the inhaled preparation is prepared according to a formula.

[0014] In one optional embodiment, the method for preparing the inhaled formulation for relieving or treating upper respiratory tract infections includes the following steps: S1. First, take part of the prescribed amount of solvent, andrographolide, and solubilizer, mix and dissolve them, then add the remaining solvent and make it completely and evenly dissolved; S2. Filter and fill the drug prepared in step S1, and then press in the prescribed amount of propellant.

[0015] In one optional embodiment, the method for preparing the inhaled formulation for relieving or treating upper respiratory tract infections includes the following steps: S1. Take the prescribed amount of andrographolide, solvent and other excipients, and dissolve them completely and evenly. In one optional embodiment, a portion of the solvent is first used to dissolve the raw materials and auxiliary materials, and then the remaining portion of the solvent is added to dissolve them completely and uniformly. In an optional embodiment, step S1 further includes adding a pH adjuster after dissolution to adjust the pH to 4.5-5.5; In an optional embodiment, step S1 further includes a step of spray drying the drug solution after dissolution. The spray drying conditions are: inlet temperature 80~100℃, vacuum pump power 100%, feed rate 9~10mL / min, atomizing gas flow rate 600~800L / h, and atomizing gas flow pressure 0.6~0.8MPa. S2. Fill and package the medicine prepared in step S1.

[0016] Thirdly, the present invention also provides the use of the above-mentioned inhaled preparation for relieving or treating upper respiratory tract infections or the inhaled preparation prepared by the above-mentioned preparation method in the treatment of upper respiratory tract infections.

[0017] The technical solution of this invention has the following advantages: 1. This invention provides an inhaled formulation for relieving or treating upper respiratory tract infections, the inhaled formulation comprising andrographolide and pharmaceutically acceptable excipients; the pharmaceutically acceptable excipients include one or more of solvents, solubilizers, propellants, carriers / diluents, pH adjusters, antistatic agents, and stabilizers. The aerosol, powder, and spray formulations provided by this invention, based on a volume of 10,000 vials, exhibit stable processes, good reproducibility, and controllable key quality attributes, significantly superior to laboratory-level small-batch preparations.

[0018] 2. The present invention provides a method for preparing an inhaled preparation for relieving or treating upper respiratory tract infections. The inhaled preparation is prepared according to the formula and acts on the upper respiratory tract infection. By utilizing the local administration route, a high concentration and rapid distribution of the drug at the lesion site are achieved, thereby achieving excellent therapeutic effects while minimizing systemic side effects.

[0019] 3. The application of the inhaled formulation for relieving or treating upper respiratory tract infections and its preparation method provided by this invention in relieving or treating upper respiratory tract infections. Clinical trials have shown that the andrographolide inhalation aerosol prepared according to the described formula has a significant therapeutic effect on upper respiratory tract infections. This formulation not only effectively reduces fever and pain, but also exerts anti-inflammatory and antiviral effects, and has good safety in clinical application, with no obvious toxic side effects observed. Detailed Implementation

[0020] The following embodiments are provided to better understand the present invention, but the following embodiments do not constitute a limitation on the content and scope of protection of the present invention. Any product that is the same as or similar to the present invention, derived by any person under the guidance of the present invention or by combining the features of the present invention with other prior art, falls within the scope of protection of the present invention.

[0021] Unless otherwise specified, all experimental steps or conditions in the examples were performed according to conventional experimental procedures and conditions in the art. Reagents or instruments whose manufacturers are not specified are all commercially available products.

[0022] Example 1: Formulation and preparation method of andrographolide aerosol 1. Andrographolide aerosol formulation The formulation for 10,000 bottles of andrographolide aerosol is shown in Table 1.

[0023] Table 1. Andrographolide Aerosol Formulation

[0024] 2. Preparation process of andrographolide aerosol (1) Preparation: Add half of the prescribed amount of ethanol, andrographolide and glycerol to the mixing tank in sequence, stir until completely dissolved, then add more ethanol to dilute to the full amount, stir for 20 to 45 minutes to make it completely uniform, and the preparation process is complete.

[0025] (2) Intermediate product inspection: Take samples of the prepared drug solution for inspection, and release it after passing the inspection.

[0026] (3) Filtration: Filter with sand filter rod and No. 3 sintered glass filter ball respectively, and record the results.

[0027] (4) Washing and drying bottles: Wash and dry the molded bottles, and record the results after completion.

[0028] (5) Filling and capping: Use clean molded bottles for dispensing and capping (dispensing pressure: 0.5-0.6MPa), and check the filling volume and appearance after capping at any time during the process.

[0029] (6) Coating and Dichlorodifluoromethane filling: Perform the coating process and then fill in the propellant dichlorodifluoromethane (9.5-11.0g / bottle) at a pressure of 0.5-0.6MPa. During this process, check the filling amount of dichlorodifluoromethane at any time.

[0030] (7) Leak detection and explosion test: Place the glass bottle after pressing dichlorodifluoromethane in water at 40-42°C for 2 hours to test for leaks and explosion, let it cool naturally, and remove unqualified products.

[0031] (8) Install the press valve: Install the press valve on the qualified products, and put the material label on the intermediate products after inspection and store them in the intermediate station according to the regulations.

[0032] (9) Packaging: The qualified intermediate products are sent to the packaging room and packaged according to regulations. After packaging, they are placed in the inspection area and sampled by the sampler and sent to the inspection room for inspection. After passing the inspection, they are put into the warehouse.

[0033] Example 2: Formulation and preparation method of andrographolide powder spray 1. Andrographolide Powder Inhalation Formula The formulation for andrographolide powder spray, prepared in quantities of 10,000 bottles, is shown in Table 2.

[0034] Table 2. Andrographolide Powder Inhalation Formulation

[0035] 2. Preparation process of andrographolide powder inhaler (1) Preparation: Add 2 / 3 of the prescribed amount of ethanol aqueous solution, andrographolide, poloxamer 188 and lactose into the mixing tank in sequence, stir until completely dissolved, then add ethanol aqueous solution to dilute to the full amount, stir for 20 to 45 minutes to make it completely and evenly dissolved, then add sodium hydroxide while stirring, adjust the pH to 5.0 to complete the preparation process.

[0036] (2) Filtration: Filter with sand filter rods and No. 3 sintered glass filter balls respectively, and record the results. (3) Intermediate product inspection: Take samples of the prepared drug solution for inspection, and release it after passing the inspection.

[0037] (4) Spray drying: The spray drying process is as follows: inlet temperature 80℃, pump power 100%, feed rate 9mL / min, atomizing airflow speed 800L / h, atomizing airflow pressure 0.8MPa.

[0038] (5) Filling and capping: Use clean molded bottles for dispensing, and conduct appearance inspections after filling at any time during the process.

[0039] (6) The qualified intermediate products are sent to the packaging room, packaged according to regulations, and placed in the inspection area. The sampler takes a sample and sends it to the inspection room for inspection. After passing the inspection, the product is put into the warehouse.

[0040] Example 3: Formulation and preparation method of andrographolide aerosol 1. Andrographolide aerosol formulation The formulation for andrographolide aerosol prepared in 10,000 bottles is shown in Table 3.

[0041] Table 3. Andrographolide Aerosol Formulation

[0042] 2. Preparation process of andrographolide aerosol The preparation process of andrographolide aerosol is the same as in Example 1.

[0043] Example 4: Formulation and preparation method of andrographolide spray 1. Andrographolide spray formulation The formulation for andrographolide spray, prepared in quantities of 10,000 bottles, is shown in Table 4.

[0044] Table 4. Andrographolide Spray Formula

[0045] 2. Preparation process of andrographolide spray (1) Preparation: Add half of the prescription amount of 30% ethanol, andrographolide, EDTA-2Na, and poloxamer 188 to the mixing tank in sequence, stir until completely dissolved, then add 30% ethanol to dilute to the full amount, stir for 20-45 minutes to make it completely uniform, and the preparation process is complete.

[0046] (2) Intermediate product inspection: Take samples of the prepared drug solution for inspection, and release it after passing the inspection.

[0047] (3) Filtration: Filter with a cartridge filter and record the results.

[0048] (4) Filling: This includes the following two steps, 1) Filling the spray bottle: The prepared spray solution is delivered into the spray bottle manually or mechanically. The bottle must be sealed during the filling process to ensure that the spray solution does not leak. 2) Nozzle assembly: The spray bottle, already filled with liquid medicine, is assembled with nozzles using automated equipment to ensure a tight and reliable connection of the nozzles.

[0049] (5) Printing labels: Spray bottles usually need to have labels printed on their surface to indicate the brand, drug name, usage instructions and other text information to distinguish them from other similar products.

[0050] (6) Packaging the finished product: Pack the assembled spray bottles into boxes or affix sealing stickers for packaging. The final product can then be put on the market for sale.

[0051] Example 5: Formulation and preparation method of andrographolide powder spray 1. Andrographolide Powder Inhalation Formula The formulation for andrographolide powder spray, prepared in quantities of 10,000 bottles, is shown in Table 5.

[0052] Table 5. Andrographolide Powder Inhalation Formulation

[0053] 2. Preparation process of andrographolide powder inhaler (1) Preparation: Add 2 / 3 of the prescribed amount of ethanol aqueous solution, andrographolide, poloxamer 188 and lactose into the mixing tank in sequence, stir until completely dissolved, then add ethanol aqueous solution to dilute to the full amount, stir for 20 to 45 minutes to make it completely and evenly dissolved, then add sodium hydroxide while stirring, adjust the pH to 5.0 to complete the preparation process.

[0054] (2) Filtration: Filter with sand filter rods and No. 3 sintered glass filter balls respectively, and record the results. (3) Intermediate product inspection: Take samples of the prepared drug solution for inspection, and release it after passing the inspection.

[0055] (4) Spray drying: The spray drying process is as follows: The inlet temperature is 100℃, the vacuum pump power is 100%, the feed rate is 10mL / min, the atomizing gas flow rate is 600L / h, and the atomizing gas flow pressure is 0.6MPa.

[0056] (5) Filling and capping: Use clean molded bottles for dispensing, and conduct appearance inspections after filling at any time during the process.

[0057] (6) The qualified intermediate products are sent to the packaging room, packaged according to regulations, and placed in the inspection area. The sampler takes a sample and sends it to the inspection room for inspection. After passing the inspection, the product is put into the warehouse.

[0058] Example 6: Formulation and preparation method of andrographolide spray 1. Andrographolide spray formulation The formulation for andrographolide spray, prepared in quantities of 10,000 bottles, is shown in Table 6.

[0059] Table 6. Andrographolide Spray Formula

[0060] 2. Preparation process of andrographolide spray The preparation process of andrographolide spray is the same as in Example 4.

[0061] Example 7: Formulation and preparation method of andrographolide spray 1. Andrographolide spray formulation The formulation for andrographolide spray, prepared in quantities of 10,000 bottles, is shown in Table 7.

[0062] Table 7. Andrographolide Spray Formula

[0063] 2. Preparation process of andrographolide spray The preparation process of andrographolide spray is the same as in Example 4.

[0064] Example 8: Formulation and preparation method of andrographolide powder spray 1. Andrographolide Powder Inhalation Formula The formulation for andrographolide powder spray, prepared in quantities of 10,000 bottles, is shown in Table 8.

[0065] Table 8. Andrographolide Powder Inhalation Formulation

[0066] 2. Preparation process of andrographolide powder inhaler The preparation process of andrographolide powder mist is the same as in Example 2.

[0067] Example 9: Formulation and preparation method of andrographolide aerosol 1. Andrographolide aerosol formulation The formulation for andrographolide aerosol prepared in 10,000 bottles is shown in Table 9.

[0068] Table 9. Andrographolide Aerosol Formulation

[0069] 2. Preparation process of andrographolide aerosol The preparation process of andrographolide aerosol is the same as in Example 1.

[0070] Comparative Example 1 The difference between this comparative example and the embodiment is that the preparation used is oral andrographolide tablets (Henan Furentang Pharmaceutical Co., Ltd.).

[0071] Experimental Example 1: Particle Size Determination Due to the specific nature of respiratory drug administration, appropriate particle size is necessary for better action on the upper respiratory tract. The particle size of Examples 1-9 was determined using a two-stage impactor (TSI) according to Method 0951 of the 2025 edition of the Chinese Pharmacopoeia, Part IV. The experimental results are shown in Table 10.

[0072] Table 10 Particle size distribution of the inhalation formulations of each embodiment (unit: μm)

[0073] As mentioned above, the particle size corresponding to D90, i.e., particles larger than it, accounts for 90%, and 90% of the particles have a diameter greater than 5 μm. This invention has found that the deposition of andrographolide inhaled formulations in different parts of the respiratory tract generally depends on the following: particles >5 μm typically deposit in the upper respiratory tract (e.g., oropharynx, larynx). Particles with diameters of 1-5 μm are more likely to reach the lower respiratory tract and deeper parts of the lungs. Particles <1 μm, although they may reach the alveoli, are mostly exhaled, resulting in a low deposition rate. The andrographolide inhaled formulation obtained through the process of this invention can control the particle size distribution D90 to above 5 μm, enabling better deposition in the upper respiratory tract and exerting therapeutic effects on upper respiratory tract-related diseases.

[0074] Experimental Example 2: Clinical Trial of the Therapeutic Effect of Inhaled Formulations on Upper Respiratory Tract Infections 1. Clinical trial grouping The patients were randomly divided into two groups: a treatment group of 70 patients, including 40 males and 30 females; 43 patients had fever for 1 day, 18 patients for 2 days, and 9 patients for 3 days; 12 patients had a body temperature of 37.1-38℃, 37 patients had a body temperature of 38.1-39℃, and 21 patients had a body temperature above 39.1℃; 12 patients had mild symptoms, 37 patients had moderate symptoms, and 21 patients had severe symptoms.

[0075] The control group consisted of 30 patients, including 18 males and 12 females; 13 patients had fever for 1 day, 11 patients for 2 days, and 6 patients for 3 days; 7 patients had a body temperature of 37.1-38℃, 13 patients had a body temperature of 38.1-39℃, and 10 patients had a body temperature above 39.1℃; 7 patients had mild symptoms, 13 patients had moderate symptoms, and 10 patients had severe symptoms.

[0076] There were no significant differences between the two groups in terms of gender, age, course of disease, fever severity, and clinical symptoms (P>0.05), making them comparable.

[0077] 2. Method of administration and observation indicators The treatment group received andrographolide aerosol (prepared in Example 1), 3 sprays (60 μg per spray), 3 times a day. The control group received andrographolide tablets 50 mg / tablet (Comparative Example 1), 2 tablets, 3 times a day. The dosage was adjusted according to body weight and age, and 3 days constituted one course of treatment.

[0078] 3. Observation Indicators Both groups recorded their main symptoms, signs, and blood routine examinations before and after treatment. For temperature changes, the onset time of the medication, the time it took for the temperature to return to normal, and any recurrence of temperature changes were recorded, with a temperature decrease of ≥0.5℃ considered as the criterion for effectiveness.

[0079] 4. Criteria for judging overall therapeutic effect (1) Recovery: Body temperature returns to normal (body temperature drops below 37℃ and does not rise again) within 24-48 hours of taking the medicine, clinical symptoms and signs disappear, abnormal physical and chemical indicators return to normal, and the score value decreases by ≥95%; (2) Significant effect: Body temperature returns to normal within 24-48 hours after medication, and the scores of major clinical symptoms and signs decrease by ≥70%; (3) Effective: Body temperature returns to normal within 48–72 hours after medication, and the scores of major clinical symptoms and signs decrease by ≥30%; (4) Invalid: Those who fail to meet the above standards will have their points reduced by less than 30%.

[0080] 5. Assessment of treatment efficacy for main symptoms (1) Cured: The main symptoms have completely disappeared and the score has decreased by ≥95%; (2) Significant effect: The scores of main symptoms and signs decreased by ≥70%; (3) Effective: The scores of main symptoms and signs decreased by ≥30%; (4) Invalid: Those who fail to meet the above standards will have their points reduced by less than 30%.

[0081] 6. Statistical methods Use t-test, rank-sum test, and χ² test. 2 test.

[0082] 7. Treatment Results (1) Overall effective rate: The overall efficacy of the two groups was compared. In the treatment group, 66 cases were cured, 2 cases showed significant improvement, and 2 cases were ineffective, with an overall effective rate of 97.14%. In the control group, 21 cases were cured, 4 cases showed significant improvement, 3 cases showed improvement, and 2 cases were ineffective, with an overall effective rate of 93.33%. There was no significant difference in the overall effective rate between the two groups (P>0.05).

[0083] (2) Comparison of antipyretic effects: The antipyretic effects of the two groups are shown in Table 11.

[0084] Table 11 Comparison of antipyretic effects between the two groups [n (%)]

[0085] Note: * indicates P<0.05 between the treatment group and the control group.

[0086] Comparison of the onset time of fever reduction and the recovery of body temperature between the two groups: The average onset time of fever reduction after medication was (6.19±3.26) h in the treatment group and (2.63±1.88) h in the control group. The control group was shorter than the treatment group, with a significant difference (P<0.05). After fever reduction, 100% of patients in the treatment group did not experience a return of body temperature, compared to 60% in the control group. The treatment group showed a significant advantage over the control group (P<0.05). The control group had the advantage of faster fever reduction, but more patients experienced a return of body temperature. Although the onset time of fever reduction in the treatment group was relatively slower than that in the control group, the fever reduction effect was stable, and no return of body temperature was observed.

[0087] (3) Comparison of disease condition and efficacy: Comparison of the main symptoms before and after treatment in the two groups. After treatment, the symptoms of nasal congestion, runny nose, sore throat, loose stools, cough and other symptoms in both groups improved, and there was no significant difference between the two groups (P>0.05); the treatment group was better than the control group in terms of nausea, poor appetite, abdominal pain, fatigue, constipation and changes in tongue coating, with significant differences (P<0.05).

[0088] The comparison of the two groups of conditions and treatment effects is shown in Table 12.

[0089] Table 12 Comparison of disease condition and efficacy between the treatment group and the control group

[0090] 8. Conclusion Common cold and fever are frequent respiratory illnesses, ranking first among clinical diseases. Modern medicine refers to it as acute upper respiratory tract infection (ALI), and etiological studies have confirmed that it is primarily caused by viruses, accounting for over 90% of primary ALI infections. ALI is characterized by rapid onset, rapid progression, and numerous complications.

[0091] Clinical observations have shown that andrographolide aerosol has significant antipyretic, analgesic, anti-inflammatory, antibacterial and antiviral effects, with no obvious toxic side effects. It has significant therapeutic effects on bacterial infections, viral infections and mixed infections.

[0092] Obviously, the above embodiments are merely illustrative examples for clear explanation and are not intended to limit the implementation. Those skilled in the art will recognize that other variations or modifications can be made based on the above description. It is neither necessary nor possible to exhaustively list all possible implementations here. However, obvious variations or modifications derived therefrom are still within the scope of protection of this invention.

Claims

1. An inhaled preparation for relieving or treating upper respiratory tract infections, characterized in that, include: The active pharmaceutical ingredient and pharmaceutically acceptable excipients; The active pharmaceutical ingredient is andrographolide; The pharmaceutically acceptable excipients include one or more of solvents, cosolvents, propellants, carriers / diluents, pH adjusters, antistatic agents, and stabilizers.

2. The inhalation formulation according to claim 1, characterized in that, The inhaled preparations include aerosols, powder inhalers, and sprays.

3. The inhalation formulation according to claim 2, characterized in that, The formulation of the aerosol includes: 250-750 parts by weight of andrographolide, 50,000-60,000 parts by volume of solvent, 3,000-4,000 parts by volume of cosolvent, and 80,000-120,000 parts by weight of propellant; the ratio of parts by weight to parts by volume is g / mL or kg / L.

4. The inhalation formulation according to claim 2, characterized in that, The formulation of the powder mist includes: 100-400 parts by weight of andrographolide, 80-200 parts by weight of carrier / diluent, 10-15 parts by weight of antistatic agent, 20,000-30,000 parts by volume of solvent, and an appropriate amount of pH adjuster; the ratio of parts by weight to parts by volume is g / mL or kg / L.

5. The powder atomizer according to claim 2, characterized in that, The formulation of the spray includes: 100-400 parts by weight of andrographolide, 40,000-60,000 parts by volume of solvent, 8-10 parts by weight of stabilizer and 10-15 parts by weight of antistatic agent; the ratio of parts by weight to parts by volume is g / mL or kg / L.

6. The inhalation formulation according to any one of claims 1-5, characterized in that, The solvent includes any one of ethanol, 30%~60% aqueous ethanol solution, water, and propylene glycol; The co-solvent is glycerol; The propellant includes any one of dichlorodifluoromethane, tetrafluoroethane (HFA134), and heptafluoropropane (HFA227); The carrier / diluent includes any one of lactose and mannitol; The pH adjuster includes any one of sodium hydroxide, disodium hydrogen phosphate, sodium dihydrogen phosphate, and sodium chloride; The antistatic agent is poloxamer 188; The stabilizer includes any one of EDTA-2Na and ascorbic acid.

7. A method for preparing an inhaled formulation for relieving or treating upper respiratory tract infections as described in any one of claims 1-6, characterized in that, The inhalation formulation was prepared according to the formula.

8. The method for preparing an inhaled formulation for relieving or treating upper respiratory tract infections according to claim 7, characterized in that, Includes the following steps: S1. First, take part of the prescribed amount of solvent, andrographolide, and solubilizer, mix and dissolve them, then add the remaining solvent and make it completely and evenly dissolved; S2. Filter and fill the drug prepared in step S1, and then press in the prescribed amount of propellant.

9. The method for preparing an inhaled formulation for relieving or treating upper respiratory tract infections according to claim 7, characterized in that, Includes the following steps: S1. Take the prescribed amount of andrographolide, solvent and other excipients, and dissolve them completely and evenly. Optionally, a portion of the solvent can be used to dissolve the raw materials and excipients first, and then the remaining solvent can be added to dissolve them completely and uniformly. Optionally, step S1 may also include adding a pH adjuster after dissolution to adjust the pH to 4.5-5.5; Optionally, step S1 may also include a step of spray drying the drug solution after dissolution. The spray drying conditions are: inlet temperature 80~100℃, vacuum pump power 100%, feed rate 9~10mL / min, atomizing gas flow rate 600~800L / h, and atomizing gas flow pressure 0.6~0.8MPa. S2. Fill and package the medicine prepared in step S1.

10. Use of an inhaled formulation for relieving or treating upper respiratory tract infections as described in any one of claims 1-6, or an inhaled formulation prepared by the method described in any one of claims 7-9, in the treatment of upper respiratory tract infections.

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