A myrobalan composition spray for treating chronic pharyngitis and a preparation method thereof

Abstract

The present application relates to the technical field of traditional Chinese medicine, in particular to a kind of composition of Terminalia chebula for treating chronic pharyngitis spray and its preparation method.The spray is prepared from 30-40 parts of Terminalia chebula flesh, 14-22 parts of fried Arctium lappa seed, 12-20 parts of Huangqi, 10-16 parts of Forsythia fruit and 14-22 parts of licorice by weight ratio.The preparation steps of the spray are as follows:Terminalia chebula medicinal material is crushed to obtain flesh, and the above-mentioned raw materials are mixed according to weight ratio and crushed;the crushed raw medicinal materials are extracted twice by refluxing with water, and the two times of extraction liquid are combined;the obtained extraction liquid is concentrated under reduced pressure, and when the relative density of the concentrated liquid is 1.05, spray drying is carried out to obtain Terminalia chebula composition powder;the Terminalia chebula composition powder is taken, a cosolvent is added, and stirred uniformly;flavoring agent and preservative are added, and dissolved in appropriate amount of water, stirred uniformly to obtain Terminalia chebula composition spray material liquid, and then placed;the supernatant of the placed material liquid is poured, sterilized and filtered, and the filtrate is filled in a spray bottle to obtain the Terminalia chebula composition spray.The spray has good relieving and treating effects on sore throat, dry cough, dry throat, itching throat, and throat discomfort of chronic pharyngitis.The spray is convenient to carry, has quick effect, stable effect and small side effects.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine, in particular to a Terminalia chebula composition spray for treating chronic pharyngitis and a preparation method thereof. BACKGROUND

[0002] Chronic pharyngitis is a common and frequently-occurring disease of the upper respiratory tract, which is formed by chronic inflammation of the pharyngeal mucosa, submucosa and pharyngeal lymphoid tissue, etc. The main feature of the disease is pharyngeal mucosa hypertrophy or atrophy. The main clinical symptoms are redness and pain in the throat, dry throat, discomfort when swallowing, dry cough with little sputum, easy fatigue when speaking, and easy nausea and vomiting when brushing teeth and gargling. Epidemiological studies have shown that the incidence of chronic pharyngitis has been increasing in recent years. Among them, the main reasons for patients suffering from chronic pharyngitis are high work pressure, irregular life, more alcohol and tobacco intake, and lack of exercise leading to decreased physical resistance; in addition, some special occupations, such as teachers, singers, and network anchors, etc., cause pharyngeal congestion and edema due to long-term overuse of the voice, and the resistance is reduced, thereby causing the occurrence of chronic pharyngitis. Since the disease is easily affected by many factors, it is difficult to treat in clinical practice, mainly in the high recurrence rate, long duration, and further restriction of diet, speaking and other social activities, which continuously reduces the quality of life of patients.

[0003] In the clinical treatment of chronic pharyngitis, modern medicine often uses antibiotic drugs such as amoxicillin, supplemented by hormone preparations such as dexamethasone; some drugs are also used to relieve specific symptoms, such as ambroxol hydrochloride, which is used to dissolve pharyngeal mucus, making it easier to expel purulent sputum; or various gargling liquids, such as compound borax gargling liquid, chlorhexidine gargling liquid, etc. to relieve local symptoms. These western medicines can improve the symptoms of chronic pharyngitis in the short term, but in the long-term application, not only the patient's immune internal environment and oral ecology are destroyed, but also drug resistance is easily produced, the side effects are large, and the long-term treatment effect is not ideal. In order to overcome the problems existing in the treatment of chronic pharyngitis at present, the present application provides a Terminalia chebula composition spray for treating chronic pharyngitis and a preparation method thereof. SUMMARY

[0004] The purpose of the present application is to provide a Terminalia chebula composition spray for treating chronic pharyngitis and a preparation method thereof. The spray takes Terminalia chebula as the main drug, and is matched with fried Arctium lappa seed, alcohol yellow sophora, forsythia leaf and licorice, which has the effects of astringing lung and benefiting throat, clearing heat and dispelling wind, relieving cough and eliminating phlegm, and detoxifying and resolving mass. It has good relieving and treating effects on the swollen throat, dry cough, dry throat, itching throat, and uncomfortable throat of chronic pharyngitis. The spray is convenient to carry, has quick effect, stable effect, and small side effects.

[0005] In order to achieve the above-mentioned purpose of the application, the present application provides the following technical solutions.

[0006] This invention provides a traditional Chinese medicine composition for treating chronic pharyngitis, characterized in that the raw materials of the composition include the following components: Terminalia chebula pulp, stir-fried burdock seed, wine-processed Scutellaria baicalensis, Forsythia suspensa leaf, and licorice.

[0007] Furthermore, the raw materials of the composition include the following components in parts by weight: 30-40 parts of Terminalia chebula pulp, 14-22 parts of stir-fried burdock seed, 12-20 parts of wine-processed Scutellaria baicalensis, 10-16 parts of Forsythia suspensa leaf, and 14-22 parts of licorice.

[0008] Furthermore, the raw materials of the composition include the following parts by weight of raw materials: 36 parts of Terminalia chebula pulp, 18 parts of stir-fried burdock seed, 16 parts of wine-processed Scutellaria baicalensis, 12 parts of Forsythia suspensa leaf, and 18 parts of licorice.

[0009] The present invention also provides the application of any one of the above-mentioned traditional Chinese medicine compositions in the preparation of a medicament for treating chronic pharyngitis.

[0010] The present invention also provides a spray for treating chronic pharyngitis, comprising any of the above-described traditional Chinese medicine compositions for treating chronic pharyngitis.

[0011] Furthermore, the preparation method of the spray for treating chronic pharyngitis includes the following steps:

[0012] S1. Take the Terminalia chebula medicinal material and crush the pulp. Take the Terminalia chebula pulp, stir-fried burdock seed, wine-processed Scutellaria baicalensis, Forsythia suspensa leaf, and licorice, mix them together, and crush them.

[0013] S2. Take the raw material obtained in S1, add water and reflux extract twice, and combine the two extracts; concentrate the obtained extract under reduced pressure, and spray dry when the relative density of the concentrate is 1.05 to obtain the Terminalia chebula composition powder;

[0014] S3. Take the Terminalia chebula composition powder obtained in S2, add a solubilizer, stir evenly, add flavoring agent and preservative, dissolve in an appropriate amount of water, stir evenly, and obtain Terminalia chebula composition spray liquid, let stand.

[0015] S4. Pour off the supernatant from the material liquid obtained in S3 after it has been left to stand, filter it sterile, and fill the filtrate into a spray bottle to obtain the spray.

[0016] Preferably, in step S2, the amount of water added for the two extractions is 10 times and 8 times the weight of the raw material, respectively, and the extraction time is 0.5 h for both extractions, wherein the raw material needs to be soaked for 1 h before the first extraction.

[0017] Preferably, in step S3, the cosolvent is polysorbate 80(II), and the addition amount is 1% (mL / mL); the flavoring agent is steviol glycoside, and the addition amount is 0.05% (g / mL); the preservative is potassium sorbate, and the addition amount is 0.15% (g / mL); the amount of water added is to make the concentration of the drug solution reach 0.8~1.2 g / mL (weight of raw drug / volume of liquid material); and the standing time is more than 12 h.

[0018] Preferably, in step S4, the supernatant of the settled material liquid is first filtered through a 0.45 μm PES membrane to remove insoluble particles, and then filtered through a 0.22 μm PES membrane for sterilization; and then dispensed into 20 mL spray bottles.

[0019] This invention provides a Terminalia chebula composition spray for treating chronic pharyngitis, the raw materials of which are Terminalia chebula pulp, stir-fried burdock seed, wine-processed Scutellaria baicalensis, Forsythia suspensa leaf, and licorice. Terminalia chebula is the principal herb in the formula, entering the lung and large intestine meridians, and has the effects of astringing the lungs and relieving cough, lowering qi and reducing fire, and benefiting the throat and restoring voice. It is an essential medicine for treating sore throat and loss of voice. The *Illustrated Materia Medica* states, "It treats phlegm cough and sore throat. Holding three or four pieces in the mouth is extremely effective." This indicates that Terminalia chebula alone has excellent effects in treating sore throat. Modern research shows that the chemical components contained in Terminalia chebula include tannins, flavonoids, polysaccharides, etc., among which tannins such as chebulic acid, chebulic acid, gallic acid, and ellagic acid are the main components, possessing good antioxidant, anti-inflammatory, and antibacterial effects. Burdock seed is used as an assistant herb, entering the lung and stomach meridians. It has the effects of dispersing wind-heat, clearing the lungs and relieving sore throat, detoxifying and promoting rash eruption, and reducing swelling and healing sores. Modern research shows that burdock seed contains various chemical components such as lignans, volatile oils, fatty oils, and terpenes. Among them, lignans are the main active ingredients, represented by arctiin and arctigenin, which have numerous pharmacological effects such as antibacterial, antiviral, and antitumor properties. Raw burdock seed is rich in volatile oils and fatty oils, and has a strong cold and slippery nature. Stir-frying can reduce the content of these components, moderate the cold and slippery nature, and enhance its dispersing and dispersing power. In addition, burdock seed has a high content of arctiin. The 2020 edition of the Pharmacopoeia stipulates that its content should not be less than 5.0%. The applicant's previous research found that burdock seeds contain a certain enzyme. When burdock seeds are extracted with water, arctiin will be hydrolyzed into arctigenin. Arctigenin has low polarity and low transfer rate during water extraction, resulting in the loss of effective ingredients. After burdock seeds are stir-fried, they can play a role in killing the enzyme and preserving the glycosides. Since arctiin has greater polarity than arctigenin, the transfer rate of arctiin is high during water extraction. In view of this, in order to ensure that the effective ingredients are fully extracted by water and at the same time mitigate the cold and slippery nature of raw burdock seeds, this invention selects stir-fried burdock seeds in the formulation. Scutellaria baicalensis and Forsythia suspensa leaves are used as adjuvant herbs. Scutellaria baicalensis enters the lung, stomach, gallbladder, and large intestine meridians, and has the effects of clearing heat and drying dampness, purging fire and detoxifying, mainly clearing damp heat in the upper burner. Modern research shows that flavonoids in Scutellaria baicalensis are the main components that exert its pharmacological activity, represented by baicalin, baicalein, wogonin and wogonin, which have a variety of biological activities such as anti-inflammatory, antibacterial, antiviral and antioxidant effects. After being processed with wine, the upward ascending power of Scutellaria baicalensis is enhanced, making it more suitable for diseases of the neck and head in the upper burner. Zhang Yuansu's "Pearl Bag" points out that "stir-fried Scutellaria baicalensis with wine is mainly for blood accumulation in the upper part of the neck" and "those with sores in the upper burner should be washed with Scutellaria baicalensis wine". In this invention, Scutellaria baicalensis with wine is used to mitigate its bitter and cold nature and to promote its upward ascending effect with the power of wine. When combined with Arctium lappa, which clears heat, detoxifies and soothes the throat, it has a good effect in treating red, swollen, hot and painful throat.Forsythia leaves are the dried leaves of the whole Forsythia plant. Their medicinal properties and effects are similar to those of Forsythia suspensa. They are slightly cold in nature, bitter in taste, and enter the heart, lung, and small intestine meridians. They are good at clearing heat, purging fire, detoxifying, promoting body fluid production, quenching thirst, reducing swelling, and dissipating nodules. Modern research shows that Forsythia leaves are rich in chemical components such as forsythoside, forsythoside A, forsythoside A, and rutin, which have antiviral and antioxidant effects. They are often used as a tea and are especially suitable for people with sore throat, fever, acne, and pimples. In this invention, Forsythia leaves are used in the formula, taking advantage of their light and ascending nature to reach the head and neck, relieving the dry throat, sore throat, and foreign body sensation of chronic pharyngitis. Licorice is used as the guiding herb in this formula. It is sweet in taste and neutral in nature, and enters the heart, lung, spleen, and stomach meridians. It has the functions of invigorating qi and tonifying the middle jiao, resolving phlegm and relieving cough, relieving spasms and pain, detoxifying, and moderating the properties of other herbs. Clinically, it is often used to treat sore throat, chronic cough, and asthma. Modern research shows that the main chemical components of licorice are triterpenoid saponins, flavonoids, and polysaccharides, which have anti-inflammatory, antibacterial, antiviral, antioxidant, antitumor, and immunomodulatory effects. Among them, glycyrrhizic acid has a special sweet taste, about 200 times sweeter than sucrose, and is a commonly used flavoring agent. Licorice is used in this formula to replenish qi and relieve pain, harmonize the effects of other herbs, and improve the taste of this spray due to its special sweet taste, thereby enhancing palatability and patient compliance. In traditional Chinese medicine, chronic pharyngitis falls under the category of "throat obstruction." The *Suwen Yin Yang Bie Lun* states, "When one yin and one yang are bound together, it is called throat obstruction." The *Zhu Bing Yuan Hou Lun* mentions, "The yin and yang qi of a person originate from the lungs and circulate up and down the throat. When wind and toxins invade the throat, qi stagnates and accumulates, generating heat, leading to swelling, obstruction, and pain in the throat." The *Si Sheng Xin Yuan* states, "The throat connects to the six fu organs, with the stomach as its master; the throat connects to the five zang organs, with the lungs as its origin." This indicates that the internal cause of throat obstruction is weakness of the lungs, spleen, and stomach, while the external cause is invasion by wind-evil, with toxins invading the throat. This aligns with modern medical understanding of the causes of chronic pharyngitis: high work pressure, worry damaging the spleen, irregular lifestyle and diet depleting stomach qi, and excessive talking inevitably damaging lung qi. Under these conditions of weakened organs, external pathogens easily invade, causing imbalance of qi and yin-yang, leading to chronic pharyngitis. The ingredients of this invention consist of Terminalia chebula pulp, stir-fried burdock seed, wine-processed Scutellaria baicalensis, Forsythia suspensa leaf, and licorice. All five ingredients are associated with the lung meridian. Terminalia chebula pulp astringes the lungs, lowers qi, reduces fire, and soothes the throat. Stir-fried burdock seed disperses wind-heat, clears the lungs, and soothes the throat. Wine-processed Scutellaria baicalensis clears lung heat, detoxifies, and soothes the throat. Forsythia suspensa leaf clears heart fire, detoxifies sores, and disperses carbuncles and swellings to soothe the throat. Licorice tonifies the qi of the spleen and lungs, eliminates phlegm, stops cough, detoxifies, and soothes the throat. The five ingredients are also associated with the heart, spleen, stomach, intestines, and gallbladder meridians, regulating the six fu organs to benefit the throat. The combined effects of these herbs astringe the lungs and soothe the throat, clear heat and dispel wind, stop cough and eliminate phlegm, and detoxify and disperse nodules.

[0020] Currently, there is considerable research on traditional Chinese medicine formulas for treating chronic pharyngitis, but the dosage forms used are mostly decoctions, mixtures, pills, and lozenges. It is well known that orally administered drugs must be metabolized by the liver before being absorbed into the bloodstream to produce therapeutic effects. During this process, some active ingredients are inactivated by the liver and lose their efficacy. Simultaneously, because orally administered drugs are transported to the lesion site through blood circulation, the drug concentration is significantly reduced, and the drug that does not reach the lesion site acts systemically, potentially causing other side effects. The spray provided by this invention can act directly on the patient's throat, absorbed through the pharyngeal mucosa, and take effect directly, to some extent avoiding the weakening of efficacy due to liver metabolism. The spray acts directly on the throat, resulting in a high local drug concentration and faster onset of action. Because the drug does not undergo systemic distribution, the possibility of systemic side effects can be reduced. Furthermore, the drug is packaged in a spray bottle, effectively avoiding contact with the external environment, reducing the possibility of drug contamination, and is less affected by air and light, thus improving drug stability. The spray provided by this invention uses polysorbate 80(II) as a cosolvent to improve drug solubility and increase the concentration of active ingredients. Stevioside is used as a flavoring agent, which is about 300 times sweeter than sucrose and has a good flavoring effect, improving the bitter taste of the drug aqueous extract and enhancing the palatability of the preparation. In addition, steviol itself has anti-inflammatory and antibacterial effects, which can kill harmful bacteria in the oral cavity and play an auxiliary role in the treatment of chronic pharyngitis. A small amount of potassium sorbate is added to the formula as a preservative to delay the mold growth and deterioration of the raw drug aqueous extract, improve the stability of the preparation, and extend the shelf life.

[0021] Based on the above analysis, the beneficial effects of the present invention compared with the prior art are as follows.

[0022] (1) Formulating prescriptions based on the holistic view of traditional Chinese medicine to seek a method that treats both the symptoms and the root cause of chronic pharyngitis. Targeting the root cause of throat obstruction caused by imbalance of Qi and Yin in the body, and invasion of external pathogens, a prescription is made with Terminalia chebula, stir-fried burdock seed, Scutellaria baicalensis (processed with wine), Forsythia suspensa leaf, and Glycyrrhiza uralensis. The five ingredients work together to regulate the six Fu organs to benefit the throat, exerting the functions of astringing the lungs and benefiting the throat, clearing heat and dispelling wind, relieving cough and eliminating phlegm, and detoxifying and dispersing nodules. It has a good relieving and therapeutic effect on the symptoms of sore throat, dry cough, dry throat, itchy throat, and throat discomfort in chronic pharyngitis.

[0023] (2) The spray obtained by the present invention can directly apply the drug to the throat, has a fast onset of action, requires a small amount, is easy to carry, has a stable effect, and has few side effects. Attached Figure Description

[0024] Figure 1These are microscopic images of the pharyngeal and lung tissues of rats in each group, where A: Pharyngeal tissue of the blank group; B: Pharyngeal tissue of the model group; C: Pharyngeal tissue of the positive drug group; D: Pharyngeal tissue of the Example 1 group; E: Pharyngeal tissue of the Example 2 group; F: Pharyngeal tissue of the Example 3 group (observed under a 20× microscope); G: Lung tissue of the blank group; H: Lung tissue of the model group; I: Lung tissue of the positive drug group; J: Lung tissue of the Example 1 group; K: Lung tissue of the Example 2 group; L: Lung tissue of the Example 3 group (observed under a 10× microscope). Detailed Implementation

[0025] To enable those skilled in the art to better understand the present invention, the preparation method of a Terminalia chebula composition spray for treating chronic pharyngitis provided by the present invention is further described below with reference to specific embodiments, but this is not intended to limit the present invention.

[0026] Unless otherwise specified, all reagents and materials used in this invention are commercially available.

[0027] Example 1: A Terminalia chebula composition spray for treating chronic pharyngitis and its preparation method, comprising the following steps.

[0028] S1. Take the Terminalia chebula fruit and crush the pulp. Take 30 g of Terminalia chebula pulp, 14 g of stir-fried burdock fruit, 12 g of wine-processed Scutellaria baicalensis, 10 g of Forsythia suspensa leaf, and 14 g of licorice root. Mix them together and crush them.

[0029] S2. Take an appropriate amount of the crushed raw material, add 800 mL of water and soak for 1 h, reflux extract for 0.5 h, filter, add 640 mL of water to the residue and continue reflux extract for 0.5 h, filter, combine the two extracts; concentrate the obtained extract under reduced pressure at 70~80℃, and spray dry when the relative density of the concentrate is 1.05 to obtain the Terminalia chebula compound powder.

[0030] S3. Take the Terminalia chebula composition powder, add 1 mL of polysorbate 80 (II), stir evenly, add 0.05 g of steviol glycoside and 0.15 g of potassium sorbate, dissolve in 100 mL of water, stir evenly to obtain the Terminalia chebula composition spray liquid, and let stand for 12 h.

[0031] S4. After the material liquid has been allowed to stand, the supernatant is poured out and filtered through a 0.45 μm PES membrane to remove insoluble particles, and then filtered through a 0.22 μm PES membrane for sterilization. The solution is dispensed into 20 ml spray bottles to obtain the Terminalia chebula composition spray for treating chronic pharyngitis.

[0032] Example 2: A Terminalia chebula composition spray for treating chronic pharyngitis and its preparation method, comprising the following steps.

[0033] S1. Take the Terminalia chebula fruit and crush the pulp. Take 36 g of Terminalia chebula pulp, 18 g of stir-fried burdock fruit, 16 g of wine-processed Scutellaria baicalensis, 12 g of Forsythia suspensa leaf, and 18 g of licorice root. Mix them together and crush them.

[0034] S2. Take an appropriate amount of the crushed raw material, add 1000 mL of water and soak for 1 h, reflux extract for 0.5 h, filter, add 800 mL of water to the residue and continue reflux extract for 0.5 h, filter, combine the two extracts; concentrate the obtained extract under reduced pressure at 70~80℃, and spray dry when the relative density of the concentrate is 1.05 to obtain the Terminalia chebula compound powder.

[0035] S3. Take the Terminalia chebula composition powder, add 1 mL of polysorbate 80 (II), stir evenly, add 0.05 g of steviol glycoside and 0.15 g of potassium sorbate, dissolve in 100 mL of water, stir evenly to obtain the Terminalia chebula composition spray liquid, and let stand for 12 h.

[0036] S4. After the material liquid has been allowed to stand, the supernatant is poured out and filtered through a 0.45 μm PES membrane to remove insoluble particles, and then filtered through a 0.22 μm PES membrane for sterilization. The solution is dispensed into 20 ml spray bottles to obtain the Terminalia chebula composition spray for treating chronic pharyngitis.

[0037] Example 3: A Terminalia chebula composition spray for treating chronic pharyngitis and its preparation method, comprising the following steps.

[0038] S1. Take the Terminalia chebula fruit and crush the pulp. Take 40 g of Terminalia chebula pulp, 22 g of stir-fried burdock fruit, 20 g of wine-processed Scutellaria baicalensis, 16 g of Forsythia suspensa leaves, and 22 g of licorice root, mix them together, and crush them.

[0039] S2. Take an appropriate amount of the crushed raw material, add 1200 mL of water and soak for 1 h, reflux extract for 0.5 h, filter, add 960 mL of water to the residue and continue reflux extract for 0.5 h, filter, combine the two extracts; concentrate the obtained extract under reduced pressure at 70~80℃, and spray dry when the relative density of the concentrate is 1.05 to obtain the Terminalia chebula compound powder.

[0040] S3. Take the Terminalia chebula composition powder, add 1 mL of polysorbate 80 (II), stir evenly, add 0.05 g of steviol glycoside and 0.15 g of potassium sorbate, dissolve in 100 mL of water, stir evenly to obtain the Terminalia chebula composition spray liquid, and let stand for 12 h.

[0041] S4. After the material liquid has been allowed to stand, the supernatant is poured out and filtered through a 0.45 μm PES membrane to remove insoluble particles, and then filtered through a 0.22 μm PES membrane for sterilization. The solution is dispensed into 20 ml spray bottles to obtain the Terminalia chebula composition spray for treating chronic pharyngitis.

[0042] Experimental Example 1: Study on the therapeutic effect of a Terminalia chebula composition spray for treating chronic pharyngitis on a rat pharyngitis model.

[0043] Thirty-six SD rats were randomly divided into four groups: a blank control group, a model group, a throat-opening spray group (positive control group), Example 1 group, Example 2 group, and Example 3 group, with six rats in each group. Except for the blank control group, all other groups were sprayed with 2.5% ammonia solution into the pharynx, twice each time, three times a day for 14 consecutive days, ensuring no droplets flowed into the trachea. The blank control group was treated with distilled water instead of 2.5% ammonia solution, with the other procedures the same. Successful modeling was indicated by frequent scratching of the mouth by the rats or congestion and swelling of the pharynx. Each treatment group received the corresponding oral spray according to the dosage of the example, while the blank control group and model group were sprayed with the same volume of distilled water using the same spray bottle. Three sprays were given each time, three times a day for 7 consecutive days.

[0044] The body weight of rats was observed and recorded before modeling, after successful modeling, and at the end of drug administration. The relative body weight percentage was calculated (relative body weight percentage = rat's body weight on the day of the experiment / rat's body weight on day 1 of the experiment × 100%). Diet and activity were observed throughout the experiment. Twelve hours after the last drug administration, rats in each group were anesthetized and sacrificed. Pharyngeal tissue and the right lung were harvested and fixed in 4% paraformaldehyde solution. The fixed pharyngeal tissue and right lung underwent routine dehydration, paraffin embedding, sectioning, and HE staining. The proliferation of squamous epithelium and submucosal connective tissue, vascular congestion, and inflammatory cell infiltration of the pharyngeal mucosa were observed under a light microscope. Alveolar morphology and interalveolar structure were also observed. The spleen and thymus were harvested, weighed (wet weight), and the organ coefficient was calculated. A separate portion of pharyngeal tissue was taken, and the levels of TNF-α, IL-1β, IL-6, and IL-10 in the pharyngeal tissue were measured using enzyme-linked immunosorbent assay (ELISA), following the kit instructions. Statistical analysis was performed using SPSS 17.0 software. Data are expressed as mean ± standard deviation. One-way ANOVA was used for comparisons between groups. The significance level was set at α = 0.05.

[0045] The results showed no significant difference in body weight among the groups before the experiment. During the modeling period, rats in each modeling group experienced weight loss, increased oral secretions, head rubbing against the bedding, and scratching of the lips. Water intake was significantly increased compared to the control group, and some rats developed lip ulcers, indicating successful modeling. After 7 days of experimentation, the activity level of rats in each treatment group returned to normal, oral secretions decreased, water intake decreased, and body weight increased. The relative body weight percentages of each group are shown in Table 1.

[0046] .

[0047] Pathological examination of the sections showed that the pharyngeal mucosa of the control group rats was intact, with clear demarcation between different layers of the mucosa, and no obvious inflammatory cell infiltration or hyperplasia was observed. Compared with the control group, the pharyngeal mucosa of the model group rats was damaged, with mucosal epithelial hyperplasia, congestion and edema of the lamina propria, and obvious inflammatory cell infiltration. Compared with the model group, the above phenomena in each treatment group were reversed, indicating that the sprays obtained in each example group had different degrees of therapeutic effect on pharyngitis model rats. The alveolar walls of the lung tissue of the control group rats were intact, with no inflammatory damage and no thickening of the alveolar septa. Compared with the control group, the lung tissue of the model group rats showed alveolar edema and collapse, a large amount of inflammatory cell infiltration, thickening of the alveolar septa, and capillary congestion in the lung tissue. Compared with the model group, the lung tissue damage of the rats in each treatment group was significantly repaired and tended to be normal, with only a small amount of inflammatory cell infiltration and thinning of the alveolar septa. Morphological observation of the pharynx and lungs of each group of rats is shown in the figure. Figure 1 .

[0048] The results of inflammatory factor assays showed that, compared with the control group, the levels of pro-inflammatory factors TNF-α, IL-1β, and IL-6 in the pharyngeal tissue of rats in the model group were significantly increased. P <0.01), the level of the anti-inflammatory factor IL-10 was significantly reduced ( P <0.01); compared with the model group, the levels of TNF-α, IL-1β, and IL-6 in the pharyngeal tissue of rats in each treatment group were significantly reduced ( P <0.01), IL-10 levels were significantly elevated ( P <0.01), indicating that the spray obtained in this invention has a certain therapeutic effect on rats with pharyngitis, as shown in Table 2.

[0049] .

[0050] Experimental Case 2: A typical case of the therapeutic effect on chronic pharyngitis.

[0051] 1. Ms. Wang, female, 46 years old, a teacher, had suffered from throat discomfort and dry cough for more than 10 years. Recently, due to increased teaching workload, her throat discomfort worsened, affecting her classroom teaching. She went to a hospital for treatment, where examination showed pharyngeal swelling and diffuse congestion, and she was diagnosed with chronic pharyngitis. The doctor prescribed amoxicillin and pharyngitis tablets, which she took for one week, but her symptoms did not improve significantly. She used this spray several times a day, 2-3 sprays each time. She reported that her throat felt refreshed after spraying, and her dry cough was slightly reduced. After one week, her throat discomfort was relieved, and her dry cough was significantly reduced. She continued to use it for one month, and her throat discomfort disappeared. A follow-up six months later showed no recurrence.

[0052] 2. Mr. Ju, male, 43 years old, reported experiencing throat discomfort for over ten years, frequently experiencing a foreign body sensation in his throat requiring throat clearing, nausea and dry heaving when brushing his teeth in the morning, and throat itching and dry cough when speaking for extended periods. Recently, due to work stress, irregular eating habits, and occasional drinking at social events, his throat discomfort worsened. He tried self-medicating with watermelon frost throat lozenges and pear syrup candies, but neither provided significant relief. He used this spray several times daily, 2-3 sprays each time. He reported a reduction in the foreign body sensation in his throat after use, and colleagues reported a decrease in the frequency of throat clearing. After one week, the nausea and dry heaving while brushing his teeth were also suppressed. He continued use for one month, and his throat discomfort disappeared. A follow-up six months later showed no recurrence.

[0053] As can be seen from the above experimental examples, the Terminalia chebula composition spray for treating chronic pharyngitis provided by the present invention can effectively relieve and treat chronic pharyngitis. The product has a fast onset of action, few side effects, and is not prone to recurrence.

[0054] The above description is only a part of the embodiments of the present invention and is not intended to limit the present invention. For those skilled in the art, modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating chronic pharyngitis, characterized in that, The composition is made from the following raw materials in parts by weight: 30-40 parts of Terminalia chebula pulp, 14-22 parts of stir-fried burdock fruit, 12-20 parts of wine-processed Scutellaria baicalensis, 10-16 parts of Forsythia suspensa leaf, and 14-22 parts of licorice.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The composition is made from the following raw materials in parts by weight: 36 parts Terminalia chebula pulp, 18 parts stir-fried burdock fruit, 16 parts wine-processed Scutellaria baicalensis, 12 parts Forsythia suspensa leaf, and 18 parts licorice.

3. The use of the traditional Chinese medicine composition according to any one of claims 1 to 2 in the preparation of a medicament for treating chronic pharyngitis.

4. A spray for treating chronic pharyngitis, made from the traditional Chinese medicine composition for treating chronic pharyngitis as described in any one of claims 1 to 2.

5. The spray for treating chronic pharyngitis according to claim 4, characterized in that, The preparation method steps are as follows: S1. Take the Terminalia chebula medicinal material and crush the pulp. Take the Terminalia chebula pulp, stir-fried burdock seed, wine-processed Scutellaria baicalensis, Forsythia suspensa leaf, and licorice, mix them together, and crush them. S2. Take the raw material obtained in S1, add water and reflux to extract twice, and combine the two extracts; concentrate the obtained extract under reduced pressure, and spray dry when the relative density of the concentrate is 1.05 to obtain powder; the amount of water added for the two extractions is 10 times and 8 times the weight of the raw material, respectively, and the extraction time is 0.5h for both, of which soaking for 1h is required before the first extraction; S3. Take the powder obtained in S2, add a co-solvent, stir evenly, add flavoring agent and preservative, dissolve in an appropriate amount of water, stir evenly to obtain a spray material liquid, and let stand; the co-solvent is selected as polysorbate 80(II), and the amount added is 1% (mL / mL); the flavoring agent is selected as steviol glycoside, and the amount added is 0.05% (g / mL); the preservative is selected as potassium sorbate, and the amount added is 0.15% (g / mL); the amount of water added is to make the concentration of the drug solution reach 0.8~1.2 g / mL (weight of raw drug / volume of material liquid); the standing time is more than 12 hours; S4. Pour off the supernatant from the material liquid obtained in S3 after standing, filter it sterile, and fill the filtrate into a spray bottle to obtain the spray. The specific operation of the supernatant of the material liquid after standing is as follows: first filter it through a 0.45 μm PES filter membrane to remove insoluble particles, and then filter it through a 0.22 μm PES filter membrane for sterilization; dispense it into 20 mL spray bottles.

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