A throat clearing and larynx benefiting composition and its use

Abstract

The application discloses a throat clearing and larynx relieving composition and application thereof. The throat clearing and larynx relieving composition is mainly composed of raw oils of vitex oil, rhododendron oil, patchouli oil, eucalyptus oil, mint oil and star anise oil and optional added oil and diluent, is stirred and mixed, and has the main function of clearing throat and relieving larynx, and can also achieve the effects of freshening breath, refreshing brain, detoxifying and moistening lung, swelling and pain relieving, and phlegm and cough relieving.

Description

Technical Field

[0001] This invention belongs to the field of medicine and health care, and in particular relates to a throat-clearing and throat-soothing composition and its application. Background Technology

[0002] Throat diseases are common and frequently occurring, but they are also difficult to cure and have a very high recurrence rate. They are slow to take effect, have a long course, and significant side effects. They are divided into acute and chronic pharyngitis. Chronic pharyngitis mainly results from incomplete treatment of acute pharyngitis, leading to repeated relapses and becoming chronic. There are more patients with chronic pharyngitis than those with acute pharyngitis, and it is difficult to cure completely, affecting a wide range of people. Throat discomfort mainly manifests as sore or itchy throat, difficulty swallowing, a foreign body sensation, dryness and burning, cough with excessive phlegm, sticky phlegm that is difficult to expectorate, and hoarseness. Environmental pollution, an unhealthy diet, long-term work pressure, frequent social interactions and engagements, and smoking and passive smoking have led to a year-on-year increase in the incidence of throat diseases, seriously affecting people's quality of life, work, and study. Treatment for pharyngitis generally involves antibiotics to reduce inflammation and relieve symptoms temporarily, but this cannot cure the root cause. This not only leads to antibiotic overuse but also causes recurrence or further deterioration of pharyngitis. Therefore, traditional Chinese medicine currently accounts for more than 80% of the throat product market, with dosage forms mainly including pills, tablets (including throat lozenges and lozenges), oral liquids, granules, powder sprays, capsules, etc. However, the therapeutic effect of traditional Chinese medicine is not ideal, and long-term use can produce certain toxic side effects on the human body. Therefore, it is of great significance to develop a throat-clearing and throat-soothing product with advantages such as simple operation, direct drug delivery to the lesion, high drug concentration at the local lesion, good safety, and few toxic side effects. Summary of the Invention

[0003] One object of the present invention is to provide a throat-clearing and throat-soothing composition, and another object is to provide applications of the throat-clearing and throat-soothing composition, including its use as a pharmaceutical raw material and as a core material for nebulized inhalation therapy, e-cigarette liquids, and heated non-combustible smoke-generating products.

[0004] Many existing medicinal materials have similar effects to clearing the throat and relieving sore throat.

[0005] Vitex negundo oil: This volatile oil is extracted from the fresh leaves of Vitex negundo L. var. cannabifolia (Sieb. et Zucc.) Hand.-Mazz., a plant in the Verbenaceae family, through steam distillation. It has expectorant, antitussive, and antiasthmatic effects. It is used for cough with excessive phlegm and is often used for chronic bronchitis.

[0006] Manshanhong Oil: This is a volatile oil extracted from the leaves of Rhododendron dauricum L., a plant in the Ericaceae family, through steam distillation. It has the effects of relieving cough and expectorating phlegm, and is used for cough, wheezing and excessive phlegm. It is often used for acute and chronic bronchitis.

[0007] Patchouli oil: This volatile oil is extracted by steam distillation of the dried aerial parts of *Pogostemon cablin* (Blanco) Benth., a plant in the Lamiaceae family. It has aromatic and purifying properties, and can also relieve nausea and vomiting, as well as promote sweating and relieve summer heat. It is used for dampness obstructing the middle jiao, epigastric fullness and vomiting, summer-dampness syndrome, early stage of damp-heat syndrome, fever and fatigue, chest tightness, cold-dampness causing summer heat, abdominal pain and vomiting, diarrhea, nasal congestion and headache.

[0008] Eucalyptus oil: It is a volatile oil extracted by steam distillation from Eucalyptus globulus Labill. (family Myrtaceae), Cinnamomum camphora (L.) Presl. (family Lauraceae), or other plants of the same genus in the above two families. It has the effects of dispelling wind and relieving pain, and is used for skin itching and neuralgia.

[0009] Peppermint oil: a volatile oil extracted from the fresh stems and leaves of *Mentha haplocalyx* Briq. (a plant in the Lamiaceae family) through steam distillation, freezing, and partial de-branching. It is a colorless or pale yellow clear liquid with the effects of dispersing wind-heat, clearing the head and eyes, relieving sore throat, promoting rash eruption, and soothing the liver and regulating qi. It is used for wind-heat colds, early stages of wind-heat syndrome, headache, red eyes, sore throat, mouth ulcers, urticaria, measles, and chest and rib distension. It is an aromatic, flavoring, and carminative agent, and can be used on the skin or mucous membranes to produce a cooling sensation to relieve discomfort and pain. It also has liver-soothing, qi-regulating, and bile-promoting effects.

[0010] Star anise oil: It is a volatile oil extracted by steam distillation from the fresh branches, leaves or mature fruits of the star anise plant (Illicium verum Hook.f.) of the Magnoliaceae family. It has the effects of warming the yang and dispelling cold, regulating qi and relieving pain. It is used for abdominal pain due to cold hernia, lower back pain due to kidney deficiency, vomiting due to stomach cold, and cold pain in the epigastrium and abdomen.

[0011] Wild chrysanthemum oil: Chrysanthemum has a sweet and bitter taste, and is slightly cold in nature. It has the effects of dispelling wind and clearing heat, calming the liver and improving eyesight, and clearing heat and detoxifying. Chrysanthemum mainly contains volatile oils, flavonoids, triterpenes and organic acids, which have pharmacological effects such as antibacterial, antioxidant, antitumor and immune-boosting effects. Among them, volatile oil is the main pharmacological basis for the antibacterial effect of chrysanthemum.

[0012] Myrtle oil, also known as standard myrtle oil, is a standard volatile oil extracted from the plant Rhodomyrtumentosa (Ait.) Hassk. of the Myrtaceae family. It is mainly composed of three monoterpenes: 1,8-cineole, α-pinene, and limonene. It helps to expel sputum by promoting the movement of airway mucosal cilia and improving mucus clearance dynamics. With its good safety and definite efficacy, it is widely used for various respiratory diseases.

[0013] Dried tangerine peel oil: Dried tangerine peel is the mature, dried peel of the citrus fruit (Citrus reticulata) and its cultivated varieties, belonging to the Rutaceae family. It possesses various physiological functions such as regulating qi and strengthening the spleen, drying dampness and resolving phlegm. It is one of my country's traditional medicinal materials, with a long history of both edible and medicinal use, combining the characteristics of both food and medicine. Dried tangerine peel mainly contains volatile oils and flavonoids. The volatile oil of dried tangerine peel has the effects of regulating qi, resolving phlegm, and relieving asthma. Its main component is limonene, which has the effects of regulating qi, reducing inflammation, antibacterial properties, suppressing cough, relieving pain, and dissolving cholesterol stones.

[0014] Rhododendron simsii oil: Rhododendron simsii is a wild evergreen shrub belonging to the genus Rhododendron in the family Ericaceae. It is a plant source for Tibetan medicine, Dali. Rhododendron simsii has a unique fragrance, which is related to its high content of volatile oils. Rhododendron simsii oil mainly contains some monoterpenes, sesquiterpenes, and oxygenated derivatives, and has antitussive, antiasthmatic, antispasmodic, carminative, and expectorant effects.

[0015] Cinnamon oil: a phenolic mixture obtained by dry distillation of beech or similar plants, mainly composed of guaiacol, cinnamon oleol, and other phenols, possessing antibacterial, preservative, and deodorizing properties. In small doses, it is taken internally as an expectorant for chronic bronchitis and bronchiectasis, and can also be inhaled via steam. Externally, it is used as a local analgesic; applying it to cavities can relieve pain.

[0016] Litsea cubeba oil: Litsea cubeba oil is a volatile oil obtained by steam distillation of the dried, mature fruit of Cinnamomummigao HWLi, a plant of the Lauraceae family. It is pungent and warm in nature, and enters the liver and stomach meridians. It has the effects of warming the middle and dispelling cold, regulating qi and relieving pain. It is mainly used to treat stomach pain, abdominal pain, chest tightness and other symptoms.

[0017] To achieve the purpose of clearing the throat and relieving sore throat, the technical solution adopted by this invention is as follows:

[0018] A throat-soothing and throat-relieving composition, comprising two components:

[0019] 1) Plant volatile oil, mass fraction 5%–100%,

[0020] 2) Diluent, mass fraction 0%–95%;

[0021] The plant volatile oil consists of a mandatory crude oil and an optional additive oil.

[0022] The crude oil is composed of Vitex negundo oil, Rhododendron simsii oil, Patchouli oil, Eucalyptus oil, Peppermint oil, and Star anise oil. The added oil is selected from any one or more of the following: Chrysanthemum indicum oil, Myrtle oil, Tangerine peel oil, Rhododendron sibiricum volatile oil, Pomegranate oil, and Litsea cubeba oil.

[0023] The crude oil contains the following components by mass fraction: 20-45% Vitex trifolia oil, 20-45% Amaranthus urinaria oil, 10-22.5% Patchouli oil, 5-11% Eucalyptus oil, 5-11% Menthol oil, and 2.5-5.5% Star anise oil.

[0024] The crude oil contains the following components by mass fraction: 33.3% Vitex negundo oil, 33.3% Amaranthus chinensis oil, 16.7% Patchouli oil, 6.7% Eucalyptus oil, 6.7% Menthol oil, and 3.3% Star anise oil.

[0025] The added oil mass fraction is 0% to 100% of the crude oil mass fraction.

[0026] The throat-clearing and throat-soothing composition is prepared by weighing each component according to the formula, stirring evenly, and filtering.

[0027] Based on crude oil, various dosage forms of the throat-clearing and throat-soothing composition were prepared as follows:

[0028] 1) Crude oil preparation method: Weigh each volatile oil according to the formula, stir evenly, and the crude oil is obtained.

[0029] 2) Preparation method of spray: After diluting the mixed volatile oil with a diluent, stir evenly, filter, and package to obtain the spray.

[0030] 3) Preparation method of aerosol: After diluting the mixed volatile oil with a diluent, stir evenly, filter, fill into a pressure-resistant container, cap, and fill with propellant to obtain the aerosol.

[0031] 4) Preparation method of atomizing agent: Mix volatile oils, stir evenly, filter, and fill to obtain atomizing agent.

[0032] The diluent includes any one or more of medium-chain triglycerides, 70-98% alcohol, anhydrous ethanol, propylene glycol, glycerin, or edible oils.

[0033] The edible oils may include hemp seed oil, sacha inchi oil, olive oil, coconut oil, pomegranate seed oil, wheat germ oil, walnut oil, avocado oil, flaxseed oil, grapeseed oil, tea seed oil, perilla seed oil, pumpkin seed oil, sunflower seed oil, canola seed oil, cranberry seed oil, astaxanthin oil, deep-sea fish oil, soybean oil, peanut oil, sesame oil, camellia oil, corn oil, sea buckthorn oil, borage oil, evening primrose oil, palm oil, etc.

[0034] The propellant includes any one or more of nitrogen, carbon dioxide, heptafluoropropane, tetrafluoroethane, 1,3,3,3-tetrafluoropropylene, 2,3,3,3-tetrafluoropropylene, or compressed air.

[0035] 5) Preparation method of e-cigarette liquid: dilute volatile oil or volatile oil with diluent, stir evenly, filter, and obtain the liquid; or dilute volatile oil or volatile oil with diluent, add smoke-generating agent, stir evenly, filter, and obtain the liquid.

[0036] In the preparation method of e-cigarette liquid, the vapor-generating agent is at least one of propylene glycol or glycerin. The e-cigarette liquid formulation also includes flavoring.

[0037] 6) Preparation method of the core material of heated non-combustible smoke-generating products: After the volatile oil or volatile oil is diluted with a diluent, it is stirred evenly and added to the carrier to form thin sheets, solid particles or micro pellets, thus obtaining the core material.

[0038] The carrier is at least one of the following: sheet, flower stalk, porous material particles, silica gel, macroporous resin, C18 reverse phase material, ceramic particles, microcrystalline cellulose, starch, dextrin, CMC, and CMC-Na.

[0039] The main uses of the throat-clearing and throat-soothing composition of the present invention include:

[0040] 1. Drug therapeutic effect: Dosage forms include sprays and aerosols. When used, the contents are released as a mist and sprayed directly onto the oral mucosa. It has the advantages of simple operation and direct drug delivery to the lesion.

[0041] 2. Nebulized Inhalation Therapy: Nebulized inhalation therapy is a clinically effective method combining physical and chemical treatments for anti-inflammatory and expectorant effects. It boasts advantages such as simple operation, direct drug delivery to the lesion, high local drug concentration, good safety, and minimal side effects. The rational application of nebulized inhalation therapy is an important measure in the treatment of many laryngeal diseases. In recent years, it has been widely used in the clinical treatment of patients with acute and chronic pharyngitis. This product acts directly on the pharynx through ultrasonic nebulization, accelerating local blood circulation, resulting in significant therapeutic effects and no toxic side effects.

[0042] Nebulizers use oxygen, compressed air, or ultrasonic power to break down volatile oil formulations or solutions made from volatile oil formulations into small aerosol droplets, which can be inhaled directly from the device's mouthpiece and can be used for local drug delivery for throat ailments. Drug delivery devices include jet nebulizers, ultrasonic nebulizers, and vibrating sieve nebulizers.

[0043] 3. E-cigarette liquid: Currently, e-cigarette liquids on the market mainly focus on aroma, flavor, and taste, without offering other potential benefits. The e-cigarette liquid provided by this invention is cool and fragrant, with a moderate taste, and has a significant effect on clearing the throat and relieving sore throat, making it easier to cough up phlegm. It is especially suitable for smokers who have long suffered from respiratory diseases such as cough, pharyngitis, and bronchitis.

[0044] 4. Core material of heated tobacco products: Current low-temperature heated tobacco products mostly focus on consumers' taste preferences and smoking experience, while failing to consider reducing harm to consumers' health. The low-temperature heated tobacco product provided by this invention not only satisfies consumers' taste preferences and smoking experience, but also reduces the irritation of tobacco products to consumers' throats, achieving the effect of clearing the throat and relieving sore throat.

[0045] Compared with the prior art, the beneficial effects of this invention are as follows:

[0046] Adhering to the principles of traditional Chinese aromatherapy, this invention utilizes aromatic herbs such as Vitex negundo oil, Rhododendron simsii oil, Patchouli oil, Eucalyptus oil, Peppermint oil, and Star anise oil. Through the formulation of these volatile oils, the medicine is applied to the oral cavity and nasal cavity for local absorption, safely and quickly reaching the affected area to treat throat ailments. The composition of this invention primarily functions to clear the throat and soothe the throat, while also freshening breath and refreshing the mind. It quickly relieves symptoms such as dryness, itching, pain, tightness, astringency, foreign body sensation, cough, phlegm, hoarseness, and halitosis caused by upper respiratory tract infections, excessive smoking and drinking, overuse of the voice, internal heat, and pharyngitis. It also detoxifies and moisturizes the lungs, reduces swelling and relieves pain, eliminates phlegm and stops coughing, protects throat health, and effectively reduces the harm of smoking to the respiratory system, making it especially suitable for long-term use by smokers. Detailed Implementation

[0047] The present invention will be further explained in detail below with reference to the embodiments.

[0048] Those skilled in the art will understand that the following embodiments are for illustrative purposes only and should not be considered as limiting the invention. Where specific techniques or conditions are not specified in the embodiments, they are performed according to the techniques or conditions described in the literature in the art, or according to the product manual. Where the manufacturer of the equipment or instruments used is not specified, they are all conventional products that can be obtained by purchase.

[0049] Example 1

[0050] The formulation 1 of the composition of the present invention is shown below. Weigh each component according to the formulation, stir evenly, and filter to obtain the final product.

[0051]

[0052] Example 2

[0053] Formula 2 of the composition of the present invention is shown below. Weigh each component according to the formula, stir evenly, filter, and the product is obtained.

[0054]

[0055]

[0056] Example 3

[0057] Formula 3 of the composition of the present invention is shown below. Weigh each component according to the formula, stir evenly, and filter to obtain the final product.

[0058]

[0059] Example 4

[0060] Formula 4 of the composition of the present invention is shown below. Weigh each component according to the formula, stir evenly, filter, and the product is obtained.

[0061]

[0062] Example 5

[0063] The formulation 5 of the composition of the present invention is shown below. Weigh each component according to the formulation, stir evenly, and filter to obtain the final product.

[0064]

[0065] Example 6

[0066] The formulation 6 of the composition of the present invention is shown below. Weigh each component according to the formulation, stir evenly, and filter to obtain the final product.

[0067]

[0068] Example 7

[0069] The formulation 7 of the composition of the present invention is shown below. Weigh each component according to the formulation, stir evenly, and filter to obtain the final product.

[0070]

[0071] Example 8

[0072] The formulation 8 of the composition of the present invention is shown below. Weigh each component according to the formulation, stir evenly, and filter to obtain the final product.

[0073]

[0074] Example 9

[0075] The formulation 9 of the composition of the present invention is shown below. Weigh each component according to the formulation, stir evenly, and filter to obtain the final product.

[0076]

[0077] Example 10

[0078] The formulation 10 of the composition of the present invention is shown below. Weigh each component according to the formulation, stir evenly, and filter to obtain the final product.

[0079]

[0080]

[0081] Example 11

[0082] The formulation 11 of the composition of the present invention is shown below. Weigh each component according to the formulation, stir evenly, and filter to obtain the final product.

[0083]

[0084] Example 12

[0085] The formulation 12 of the composition of the present invention is shown below. Weigh each component according to the formulation, stir evenly, and filter to obtain the final product.

[0086]

[0087] Example 13

[0088] The formulation 13 of the composition of the present invention is shown in the table below. Weigh each component according to the formulation, stir evenly, and filter to obtain the final product.

[0089]

[0090]

[0091] Example 14

[0092] The formulation 14 of the composition of the present invention is shown below. Weigh each component according to the formulation, stir evenly, and filter to obtain the final product.

[0093]

[0094] Example 15

[0095] The formulation 15 of the composition of the present invention is shown below. Weigh each component according to the formulation, stir evenly, and filter to obtain the final product.

[0096]

[0097]

[0098] Example 16

[0099] The formulation 16 of the composition of the present invention is shown below. Weigh each component according to the formulation, stir evenly, and filter to obtain the final product.

[0100]

[0101] Example 17 Rat paw swelling test

[0102] 1 Experimental materials

[0103] 1.1 Preparation of samples and test solutions: See Example 4.

[0104] 1.2 Test animals: 48 SPF-grade SD rats, weighing 180 - 200 g, provided by Beijing Huafukang Biotechnology Co., Ltd., with the experimental animal license number: SCXK(Beijing)2020 - 0004, and the experimental animal use license of our unit: SCXK(Yunnan)K2017 - 0004. The temperature in the animal room is 22 - 25°C, and the relative humidity is 55% - 70%.

[0105] 1.3 Dose selection: According to the daily recommended dose for humans, three dose groups of 5, 10, and 20 mg / kg BW (equivalent to 5, 10, and 20 times the human recommended dose respectively) were set, and medium-chain triglyceride was set as the negative control group.

[0106] 1.4 Instruments and reagents

[0107] Instruments: Toe volume measuring instrument, 0.25 mL syringe.

[0108] Inflammatory agent: Dextran 40,000, batch number: F20101219, provided by China National Pharmaceutical Corporation (Shanghai) Chemical Reagent Company. When conducting the test, prepare a 1% dextran solution with sterilized distilled water for standby.

[0109] 2 Test methods

[0110] 2.1 Rat toe swelling experiment was adopted: The SD rats were randomly divided into a negative control group, and test substances at doses of 5, 10, and 20 mg / kg, with 12 rats in each group, according to their body weights. Each dose group was orally administered the test solution by gavage at a dose of 5, 10, and 20 mg / kg BW, and the negative control group was given an equal amount of medium-chain triglyceride. Gavage was performed once a day for 30 consecutive days. The body weights of the rats were measured every day, and the gavage volume was adjusted according to the body weights. One hour after administering the test substance on the 31st day, the volume of the right hind toe of each group of rats was measured using a toe volume measuring instrument as the toe volume at 0 hour. Then, 0.1 mL of 1% dextran 40,000 was injected subcutaneously into the right hind toe of the rats, and the toe volumes of the rats were measured at 1, 3, and 6 hours respectively. The measurement was taken 3 times at the same site, and the average value was taken. The difference between the toe volume measured at different times and the toe volume before the action of the inflammatory agent was used as the swelling value, and the toe swelling rate at each time period was calculated.

[0111] Swelling rate (%) = Swelling value / Toe volume before inflammation × 100%

[0112] Compared with the negative control group, the toe volume swelling rate before and after stimulation at any time point in the test group was significantly reduced, and the difference was significant. It can be determined that the result of the rat toe swelling experiment of the test sample was positive.

[0113] 2.2 The test data generally adopt analysis of variance. If the variances are homogeneous, the F value is calculated. If the F value < F0.05, the conclusion is that there is no significant difference among the means of each group; if the F value ≥ F0.05 (i.e., P ≤ 0.05), the conclusion is that there is a significant difference among the means of each group, and pairwise comparison methods for the means between multiple experimental groups and one control group need to be further used for statistical analysis. For data that are not normally distributed or have unequal variances, appropriate variable transformations need to be performed. After meeting the requirements of normal distribution or homogeneous variances, the transformed data are used for statistical analysis; if the purpose of normal distribution or homogeneous variances still cannot be achieved after variable transformation, the rank sum test is used for statistical analysis.

[0114] 3 Test results

[0115] 3.1 Effects of the sample on the body weight of rats

[0116] The effects of the sample on the body weight of rats are shown in Table 1. Compared with the negative control group, there were no significant differences in the body weight and weight gain of rats in each dose group before the test and at each stage during the test process (P > 0.05), indicating that the sample has no adverse effect on the body weight gain of rats.

[0117] Table 1 Effects of the sample on the body weight gain of rats

[0118]

[0119] 3.2 Effects of the sample on the swelling of rat toes before and after injection of the inflammatory agent

[0120] The effects of the sample on the swelling of rat toes before and after injection of the inflammatory agent are shown in Table 2. Rats were continuously intragastrically administered with three doses of the test substance at 5, 10, and 20 mg / kg BW (equivalent to 5, 10, and 20 times the human recommended dose, respectively) for 30 days, which could significantly reduce the swelling of the volume of the right hind toes of rats caused by the inflammatory agent, indicating that the sample has the effect of reducing the inflammatory swelling of rat toes and suggesting that the sample has the efficacy of clearing the throat.

[0121] Table 2 Effects of the sample on the swelling of rat toes before and after injection of the inflammatory agent

[0122]

[0123] Example 18 Rat cotton ball granuloma test

[0124] 1 Experimental materials

[0125] 1.1 Preparation of the sample and test solution: See Example 4.

[0126] 1.2 Test animals: 48 SPF-grade SD rats, weighing 180 - 200 g, provided by Beijing Huafukang Biotechnology Co., Ltd., with the experimental animal license number: SCXK(Beijing)2020 - 0004, and the experimental animal use license of our unit: SCXK(Yunnan)K2017 - 0004. The temperature in the animal room was 22 - 25 °C, and the relative humidity was 55% - 70%.

[0127] 1.3 Dose selection: According to the recommended daily dose for humans, three dose groups of 5, 10, and 20 mg / kg BW (equivalent to 5, 10, and 20 times the recommended human dose respectively) were set, and medium-chain triglyceride was set as the negative control group.

[0128] 1.4 Instruments and reagents

[0129] Instruments: Constant temperature drying oven, analytical balance, hair remover

[0130] Reagents: Isoflurane, iodophor

[0131] 2 Test methods

[0132] 2.1 The rat cotton ball granuloma test was used: The SD rats were randomly divided into a negative control group, and test groups of 5, 10, and 20 mg / kg of the test substance, with 12 rats in each group. Each dose group was orally administered the test solution at a dose of 5, 10, and 20 mg / kg BW, and the negative control group was given an equal amount of medium-chain triglyceride. The rats were gavaged once a day for 30 consecutive days. The body weight of the rats was measured every day, and the gavage volume was adjusted according to the body weight. 8 days before the end of the experiment, the hair on both sides of the groin of the rats was removed with a hair remover, the rats were lightly anesthetized with ether, disinfected with iodophor, the skin on both sides of the groin of the rats was incised under sterile conditions, the prepared cotton balls were implanted, the incision was sutured, and the test substance was continued to be given. On the day of the end of the experiment, 1 hour after giving the test substance, the rats were decapitated and sacrificed. The skin was cut open at the original suture, the cotton ball granulation tissue was dissected and removed, placed in a clean weighing petri dish that had been weighed, dried in a constant temperature drying oven at 60 °C with the lid open for 1 hour, and then weighed.

[0133] Net weight of granuloma (mg) = weight of cotton ball granuloma after drying - weight of original cotton ball

[0134] 2.2 Generally, analysis of variance is used for test data. If the variances are homogeneous, the F value is calculated. If the F value < F0.05, the conclusion is that there is no significant difference between the means of each group; if the F value ≥ F0.05 (i.e., P ≤ 0.05), the conclusion is that there is a significant difference between the means of each group, and further statistical analysis needs to be carried out using the pairwise comparison method between the means of multiple experimental groups and one control group. For data that are not normally distributed or have heterogeneous variances, appropriate variable transformations need to be carried out. After meeting the requirements of normal distribution or homogeneous variances, the transformed data are used for statistical analysis; if the purpose of normal distribution or homogeneous variances still cannot be achieved after variable transformation, the rank sum test is used for statistical analysis.

[0135] 3 Test Results

[0136] The net weight of cotton ball granulation tissue in each dose group of the sample is shown in Table 3. The cotton ball granulation tissue was peeled off and taken out, and after drying in an oven at 60 °C with the lid open for 1 hour and weighing, the calculated net weight results showed that each dose group of the sample could significantly reduce the net weight of cotton ball granulation tissue.

[0137] Table 3 Net Weight of Cotton Ball Granulation Tissue in Each Dose Group of the Sample

[0138]

[0139] Note: *P<0.05, **P<0.01

[0140] The rats were continuously intragastrically administered with three doses of the test product at 5, 10, and 20 mg / kg BW (equivalent to 5, 10, and 20 times the human recommended dose, respectively) for 30 days. Each dose group of the sample could significantly reduce the net amount of cotton ball granuloma, indicating that the sample has the effect of clearing the throat.

[0141] Example 19 Mouse Ear Swelling Experiment

[0142] 1 Experimental Materials

[0143] 1.1 Preparation of Sample and Test Solution: See Example 4.

[0144] 1.2 Test Animals: 48 SPF-grade KM male mice, weighing 18 - 20 g, provided by Beijing Huafukang Biotechnology Co., Ltd., with the animal license number: SCXK (Beijing) 2020-0004, and the animal use license of our unit: SCXK (Yunnan) K2017-0004. The temperature in the animal room was 22 - 25 °C, and the relative humidity was 55% - 70%.

[0145] 1.3 Dose Selection: Three dose groups of 5, 10, and 20 mg / kg BW (equivalent to 5, 10, and 20 times the human recommended dose, respectively) were set according to the human daily recommended dose, and medium-chain triglyceride was set as the negative control group.

[0146] 1.4 Instruments and Reagents

[0147] Instruments: Micropipette, puncher with a diameter of 9 mm, analytical balance

[0148] Reagents: Xylene

[0149] 2 Test Methods

[0150] 2.1 Xylene-induced ear swelling in mice: KM mice were randomly divided into a negative control group and a control group (n=12 per group) according to body weight. The test solution was administered orally at doses of 5, 10, and 20 mg / kg BW. The negative control group received an equal amount of medium-chain triglycerides. Administration was once daily for 30 days, with daily weight checks and adjustments made accordingly. One hour after the last administration, 40 μL of xylene was applied to both the anterior and posterior surfaces of the left ear of each mouse. The right ear served as a control. Mice were sacrificed 30 minutes later, and both ears were cut off along the auricular baseline. Circular ear pieces were punched at the same location on both ears using a 9 mm diameter hole. The ear weights were then recorded to determine the ear swelling rate.

[0151] Auricular swelling rate (%) = Auricular swelling value / Weight of control ear film × 100%

[0152] 2.2 Experimental data are generally analyzed using ANOVA. If the variances are homogeneous, then the F-value is calculated. If the F-value... <F 0.05 The conclusion is that there is no significant difference between the means of each group; if the F value ≥ F 0.05 (i.e., P≤0.05), indicating a significant difference between the means of each group. Further statistical analysis is needed using pairwise comparisons of the means among multiple experimental groups and one control group. For non-normally distributed or unequal variance data, appropriate variable transformations are required. After achieving a normal distribution or homogeneous variance, the transformed data should be used for statistical analysis. If variable transformation still fails to achieve a normal distribution or homogeneous variance, the rank-sum test should be used for statistical analysis.

[0153] 3. Experimental Results

[0154] Table 4 shows the inhibition of xylene-induced ear swelling in mice by different dosage groups of the samples.

[0155]

[0156] Note: *P<0.05, **P<0.01

[0157] The inhibition of xylene-induced ear swelling in mice by each dose group of the sample is shown in Table 4. After 30 minutes, the mice were sacrificed, and both ears were cut off along the auricle baseline. Circular ear pieces were punched at the same position on both ears with a diameter of 9 mm. The ears were weighed separately, and the ear swelling rate was calculated by counting the ear weight. The results showed that each dose group of the sample could significantly inhibit xylene-induced ear swelling in mice.

[0158] Mice were administered the test sample by gavage for 30 consecutive days at three doses: 5, 10, and 20 mg / kg BW (equivalent to 5, 10, and 20 times the recommended human dose, respectively). Each dose group of the sample significantly reduced xylene-induced ear swelling in mice, suggesting that the sample has a throat-clearing effect.

[0159] Example 20: The preparation method of the spray is as follows:

[0160] 150g of mixed volatile oil raw material was prepared according to the method in Example 4, 850g of medium-chain triglycerides were added, stirred evenly, filtered, and packaged to obtain a spray.

[0161] Example 21: The preparation method of the aerosol is as follows:

[0162] 150g of mixed volatile oil raw material was prepared according to the method in Example 4, 850g of medium-chain triglycerides were added, stirred evenly, filtered, filled into a pressure-resistant container, capped, and filled with heptafluoropropane as a propellant to obtain an aerosol.

[0163] Example 22: The preparation method of the atomizing agent is as follows:

[0164] Prepare 150g of mixed volatile oil raw material according to the method in Example 4, add 850g of medium-chain triglycerides as solvent, stir evenly, filter, dispense into nebulizer, and use for nebulization inhalation.

[0165] Example 23: The method for preparing electronic cigarettes is as follows:

[0166] Prepare 150g of mixed volatile oil raw material according to the method in Example 4, add 850g of medium-chain triglycerides in solvent, stir evenly, filter, and package into electronic cigarette devices to obtain the final product.

[0167] Example 24: The preparation method of the heated non-combustible tobacco product is as follows:

[0168] Prepare 150g of mixed volatile oil raw material according to the method in Example 4, add 850g of medium-chain triglycerides in solvent, stir evenly, add to macroporous resin to form solid particles, add to the cigarette cartridge, and the product is obtained.

[0169] The embodiments described above are merely some, not all, embodiments of the present invention. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without inventive effort are within the scope of protection of the present invention.

Claims

1. A throat-soothing and throat-relieving composition, characterized in that, The composition consists of the following components: 1) Plant volatile oil, mass fraction 5%–100%, 2) Diluent, mass fraction 0%–95%; The plant volatile oil is composed of crude oil, which is composed of Vitex negundo oil, Rhododendron simsii oil, Patchouli oil, Eucalyptus oil, Menthol oil, and Star anise oil. The content of each component in the crude oil is 20-45% Vitex negundo oil, 20-45% Rhododendron simsii oil, 10-22.5% Patchouli oil, 5-11% Eucalyptus oil, 5-11% Menthol oil, and 2.5-5.5% Star anise oil by mass fraction.

2. The throat-soothing and throat-relieving composition as described in claim 1, characterized in that, The crude oil contains the following components by mass fraction: 33.3% Vitex negundo oil, 33.3% Amaranthus chinensis oil, 16.7% Patchouli oil, 6.7% Eucalyptus oil, 6.7% Menthol oil, and 3.3% Star anise oil.

3. The throat-soothing and throat-relieving composition as described in claim 1, characterized in that, The diluent is any one or more selected from medium-chain triglycerides, 70-98% alcohol, anhydrous ethanol, propylene glycol, glycerin, or edible oils.

4. The method for preparing the throat-clearing and soothing composition according to claim 1, characterized in that, Weigh each component according to the formula, stir evenly, and filter to obtain the final product.

5. The use of the throat-soothing and throat-relieving composition as described in claim 1, characterized in that, This composition is used to prepare the liquid form of sprays and aerosols.

6. The use of the throat-soothing and throat-relieving composition as described in claim 1, characterized in that, This composition is used to prepare a liquid for atomizing agents.

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