A traditional Chinese medicine composition for treating rhinitis of stagnation of heat in lung meridian and a preparation method of a rhinitis of stagnation of heat in lung meridian treatment fumigation lotion

Abstract

A traditional Chinese medicine composition for treating rhinitis of lung stagnation of heat and a preparation method of a rhinitis of lung stagnation of heat treatment fumigation and washing agent, belong to the technical field of traditional Chinese medicine preparations. The traditional Chinese medicine composition is composed of 10g of Xinyi, 6g of Cang'erzi, 10g of Baizhi, 8g of Bohe, 12g of Jinyinhua, 10g of Huangqi, 10g of Sangye, 8g of Huzhang, 10g of Chuanqiong, 6g of Ebusishicao, 12g of Fuling, 8g of Danggui, 15g of Huangqi, 10g of Baishu, 10g of Gegen, and 6g of Bai'ercao. The composition takes clearing the lung and discharging heat, and dredging the nasal cavity as the core, and is combined with promoting blood circulation to remove dampness, and cooling blood to remove toxin, and is supplemented with benefiting qi and consolidating the exterior, so as to achieve the effect of treating the symptoms and the root cause together. And through the optimization of the preparation process, the fumigation and washing agent is prepared, which is convenient to use, and the drug efficacy is more thoroughly released.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine preparation technology, specifically relating to a traditional Chinese medicine composition for treating lung meridian heat stagnation type rhinitis and a method for preparing a fumigation and washing agent for treating lung meridian heat stagnation type rhinitis. Background Technology

[0002] Rhinitis, especially allergic rhinitis and chronic rhinitis, is clinically characterized by nasal congestion, nasal itching, runny nose, and sneezing. Modern medicine mainly uses antihistamines, nasal corticosteroids, and decongestants, which can quickly control symptoms, but problems such as relapse upon discontinuation of medication, local side effects, and difficulty in regulating immune imbalance exist.

[0003] Traditional Chinese medicine (TCM) has a long history of treating rhinitis, emphasizing syndrome differentiation and treatment. However, current TCM fumigation and washing techniques are mostly aimed at wind-cold binding the lungs or lung qi deficiency and cold syndrome, and the prescriptions tend to be pungent and warm dispersing or simply tonifying the body. They lack specificity for the clinically common lung meridian heat stagnation type of rhinitis—characterized by nasal congestion, thick yellow nasal discharge or clear nasal discharge turning into heat, nasal itching, sneezing, accompanied by dry mouth, irritability, red tongue with yellow coating, and rapid pulse.

[0004] Lung meridian heat stagnation is often caused by external wind-cold entering the interior and transforming into heat, or by a fondness for spicy food, or by emotional stagnation, leading to excessive lung heat, with the stagnant fire rising upwards and scorching the nasal passages. At this time, if only pungent and warm nasal passage-opening medicines are used, it will only exacerbate the heat; if only bitter and cold medicines are used to directly suppress it, it will easily damage the spleen and stomach, and will not be able to address the nasal passage stagnation and the deficiency of vital energy with latent pathogens.

[0005] In addition, existing fumigation and washing formulas for rhinitis generally have the following shortcomings: ① The formulas tend to focus on dispelling pathogens and lack a systematic combination of clearing the lungs and cooling the blood, promoting blood circulation and unblocking the meridians, and strengthening the body's resistance and consolidating the exterior; ② The dosage form is mostly coarse powder decoction, which is inconvenient to use and the effective ingredients (especially volatile oils) are easily lost; ③ There is a lack of targeted clinical verification of the pathogenesis of lung meridian stagnation and heat.

[0006] Therefore, developing a fumigation and washing preparation for lung-heat type rhinitis that can clear lung heat, open nasal passages, promote blood circulation, eliminate dampness, invigorate qi and strengthen the exterior, and is easy to use, has important clinical value. Summary of the Invention

[0007] The purpose of this invention is to provide a composition for rhinitis of the lung meridian heat stagnation type and a fumigation and washing agent for treating rhinitis of the lung meridian heat stagnation type. The composition is based on clearing lung heat and opening nasal passages, combined with promoting blood circulation and removing dampness, cooling blood and detoxifying, and supplemented with tonifying qi and consolidating the exterior, so as to achieve the effect of treating both the symptoms and the root cause. The fumigation and washing agent is made easy to use by optimizing the preparation process, so that the efficacy of the medicine can be released more thoroughly.

[0008] To achieve the above objectives, the technical solution adopted by the present invention is as follows:

[0009] A traditional Chinese medicine composition for treating rhinitis of the lung meridian stagnation and heat type, comprising the following traditional Chinese medicines by weight:

[0010] Magnolia flower 10g, Xanthium fruit 6g, Angelica dahurica 10g, Mentha haplocalyx 8g, Lonicera japonica 12g, Scutellaria baicalensis 10g, Morus alba leaf 10g, Polygonum cuspidatum 8g, Ligusticum chuanxiong 10g, Centipeda minima 6g, Poria cocos 12g, Angelica sinensis 8g, Astragalus membranaceus 15g, Atractylodes macrocephala 10g, Pueraria lobata 10g, Centipeda minima 6g.

[0011] The significance of the compatibility of each medicinal material in the prescription is shown in Table 1 below:

[0012] Table 1. Significance of Compatibility of Medicinal Herbs

[0013] Lung-clearing and orifice-opening group (principal) Magnolia It is pungent and warm in nature, dispersing and aromatic, and opens the nasal passages. It is an essential medicine for treating nasal congestion and guides the medicine upwards. cocklebur It dispels wind and dampness, clears the nasal passages and relieves pain, and is particularly effective in clearing the nasal passages. Angelica dahurica It dispels wind and cold, opens the orifices and relieves pain, and guides the medicine into the Yangming meridian. Lung-clearing and heat-relieving group (Minister) Mint It disperses wind-heat, clears the head and eyes, and allows heat to escape. honeysuckle Clears heat and detoxifies, disperses wind-heat, and clears stagnant heat in the lung meridian. Scutellaria baicalensis It clears heat and dries dampness, drains fire and detoxifies, and is particularly effective at clearing lung heat, making it an essential medicine for clearing stagnant heat in the lung meridian. Mulberry leaves It disperses wind-heat, clears the lungs and moistens dryness, calms liver yang, and helps lung heat to resolve from the surface. Polygonum cuspidatum Clears heat and detoxifies, promotes diuresis and reduces jaundice, disperses blood stasis and relieves pain, and also clears damp-heat and blood stasis. Blood-activating and dampness-eliminating group (adjuvant) Chuanxiong It invigorates blood circulation, dispels wind and relieves pain, ascends to the head and eyes, and improves the microcirculation of the nasal mucosa. Goose does not eat grass It is pungent and warm, clears nasal passages, breaks up blood stasis and reduces swelling. Poria It promotes diuresis and eliminates dampness, strengthens the spleen and calms the mind, and eliminates dampness to help expel heat through urination. Angelica sinensis Nourishes and invigorates blood, moistens dryness and unblocks meridians, prevents heat-clearing drugs from damaging yin and blood. Qi-boosting and exterior-strengthening group (to) Astragalus Tonify the Qi of the spleen and lungs, strengthen the body's defenses, and promote tissue regeneration and detoxification. Atractylodes macrocephala Strengthens the spleen and replenishes qi, dries dampness and promotes diuresis, nourishes the earth element and generates metal. Kudzu root It promotes the production of yang and generates fluids, relieves muscle tension and clears heat, guides the medicine upwards, and also nourishes yin and fluids. Centella asiatica It clears heat and promotes diuresis, detoxifies and reduces swelling; modern research shows it has anti-inflammatory and anti-allergic properties.

[0014] The principle of formulation is:

[0015] Rhinitis of the Lung Meridian Heat Stagnation type has its location in the nose, but its root cause lies in the lungs. External pathogens invade the interior and transform into heat, or dietary and emotional factors generate heat, leading to excessive lung heat. This stagnant fire rises upwards, scorching the nasal passages, hence the symptoms of nasal congestion, thick yellow nasal discharge, nasal itching, and sneezing. The heat also damages body fluids, causing dry mouth and irritability. Prolonged illness affects the collaterals, leading to heat and blood stasis, resulting in congestion and thickening of the nasal mucosa. Excessive heat depletes qi, and the defensive qi weakens, causing recurrent attacks. This invention addresses this pathogenesis by establishing a formula principle that combines four methods: clearing lung heat, opening nasal passages, promoting blood circulation and eliminating dampness, and tonifying qi and strengthening the exterior.

[0016] The relationships between the principal, assistant, and advisor components of a prescription are explained in detail below:

[0017] 1. Principal herbs: Magnolia flower, Xanthium fruit, and Angelica dahurica. These three herbs, when combined, directly enter the lung meridian and nasal passages, dispersing and warming the nasal passages, clearing wind and dampness, and quickly relieving symptoms such as nasal congestion and runny nose. Although they are slightly warm in nature, when combined with a large amount of lung-clearing and heat-purging herbs, their ability to open the nasal passages is utilized without causing excessive heat.

[0018] 2. Assistant herbs: Peppermint, Honeysuckle, Scutellaria baicalensis, Mulberry leaf, and Polygonum cuspidatum. Among them, peppermint and mulberry leaf disperse stagnant heat in the lung meridian, allowing the heat to dissipate from the surface; honeysuckle, Scutellaria baicalensis, and Polygonum cuspidatum clear lung heat, purge fire, and detoxify, with Scutellaria baicalensis being a specific herb for clearing lung heat, and Polygonum cuspidatum also clearing damp-heat and stagnant toxins. The five herbs work together to clear lung heat, expel pathogens, and detoxify, directly addressing the root cause of stagnant heat, making them the core herbs in the formula that treat the root cause.

[0019] 3. Adjuvant herbs: Chuanxiong (Ligusticum striatum), Centipeda minima, Poria cocos, and Angelica sinensis. Chuanxiong is a "qi-regulating herb in the blood," ascending to the head and eyes, invigorating blood and regulating qi, improving nasal mucosal microcirculation, and eliminating congestion and edema; Centipeda minima is pungent and warm, assisting the principal herb in enhancing its ability to open the nasal passages and break up blood stasis; Poria cocos promotes diuresis and eliminates dampness, drawing heat out through urination, while also strengthening the spleen to prevent the generation of dampness; Angelica sinensis nourishes and invigorates blood, moistens dryness and unblocks the meridians, both assisting Chuanxiong in resolving blood stasis and preventing the heat-clearing herbs from drying out and damaging yin and blood, embodying the principle of "treating wind by first treating blood." These four herbs work together as adjuvant herbs.

[0020] 4. Guiding herbs: Astragalus membranaceus, Atractylodes macrocephala, Pueraria lobata, and Centella asiatica. Astragalus membranaceus and Atractylodes macrocephala tonify the Qi of the spleen and lungs, strengthen the body's defenses, and fundamentally enhance the body's ability to resist pathogens, reducing recurrence; Pueraria lobata raises Yang and generates fluids, guiding the herbs upwards, while also nourishing the Yin fluids scorched by heat; Centella asiatica clears heat, promotes diuresis, detoxifies, and reduces swelling. Modern pharmacology shows that it has anti-inflammatory and anti-allergic effects, both assisting in clearing the lungs and opening the orifices. These four herbs work together as guiding herbs, harmonizing the effects of the other herbs, supporting the body's resistance, and eliminating pathogens.

[0021] The formula contains sixteen ingredients, with clear distinctions between principal, assistant, adjuvant, and guiding herbs. It clears heat while promoting circulation, purging while invigorating, and uses both cold and warm herbs, combining tonification and purgation. It clears lung heat without harming the body's vital energy, opens nasal passages without exacerbating inflammation, invigorates blood and eliminates dampness without drying the blood, and tonifies qi and strengthens the exterior without retaining pathogens. It is particularly effective against the complex pathogenesis of lung meridian stagnation and heat type rhinitis, which involves "heat, stagnation, blood stasis, and deficiency," forming a multi-target synergistic effect.

[0022] The above-mentioned traditional Chinese medicine composition can be prepared into different dosage forms of rhinitis treatment for lung meridian heat stagnation by conventional methods. The dosage forms mainly include liquid concentrate (prepared by water extraction and concentration), solid effervescent granules / tablets (granules or tablets made of extract and effervescent excipients, which generate bubbles when exposed to water to enhance penetration), medicated bath powder (powder made by ultra-fine grinding of medicinal materials, which can be directly dissolved in hot water for use), or fumigation agents, etc.

[0023] The present invention preferably uses a fumigation and washing formulation. The method for preparing this fumigation and washing agent for treating lung meridian heat-type rhinitis includes the following steps:

[0024] ①. Raw material processing: Weigh according to the formula, clean, wash and dry;

[0025] ②. Volatile oil extraction: Take Magnolia biondii, Xanthium sibiricum, Angelica dahurica and Mentha haplocalyx, place them in a volatile oil extractor, soak them in water, and then extract the distillate by steam distillation. Encapsulate the distillate with β-cyclodextrin to obtain the volatile oil distillate.

[0026] ③. Water extraction and concentration: Combine the distilled residue with the remaining medicinal materials, add water and decoct 2-3 times, filter and combine the filtrates;

[0027] ④. Concentration: The filtrate is concentrated under reduced pressure to a clear extract with a relative density of 1.05~1.15;

[0028] ⑤. Mixing and dispensing: Mix the clear extract with the encapsulated volatile oil distillate, add preservatives, stir well, filter, and dispense.

[0029] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0030] 1. Strong targeting of pathogenesis: This is the first formula specifically for rhinitis of the lung meridian stagnation and heat type. It breaks through the limitations of existing fumigation and washing formulas that tend to dispel cold or strengthen the body. It takes clearing the lungs and relieving heat as the core, while taking into account the functions of promoting circulation, activating blood, eliminating dampness and consolidating the exterior, which is in line with the pathogenesis characteristics of "heat stagnation and deficiency" in this type.

[0031] 2. Synergistic effects of multiple targets of active ingredients in the formula: ① Baicalin, chlorogenic acid, and mulberry leaf flavonoids have significant anti-inflammatory and anti-allergic effects, inhibiting histamine release and Th2 cytokines; ② Ligustrazine and Angelica polysaccharide improve nasal mucosal microcirculation and reduce edema; ③ Astragalus polysaccharide and atractylodes lactone regulate immune function, enhance T cell activity, and reduce allergen sensitivity; ④ Polygonum cuspidatum glycoside and Centella asiatica extract have dual antiviral and anti-allergic effects.

[0032] 3. Modern dosage form and convenient use: The fumigation and washing dosage form is ready to use after mixing, avoiding the trouble of decoction. The volatile oil is preserved by encapsulation, which has high stability and good patient compliance.

[0033] 4. The clinical efficacy is definite: the total effective rate of treating allergic rhinitis of the lung meridian heat stagnation type reached 94%, which is significantly better than the nasal hormone control group (78%). It also has outstanding advantages in improving TCM symptoms such as thick yellow nasal discharge, dry mouth and irritability. The recurrence rate was reduced to 8.3% (compared to 23.9% in the control group). Detailed Implementation

[0034] The present invention will be further described in detail below with reference to the embodiments.

[0035] Example 1 - Preparation of fumigation and washing agent for treating rhinitis of the lung meridian stagnation and heat type:

[0036] The preparation method includes the following steps:

[0037] 1. Raw material processing: Weigh out 10g of Magnolia biondii, 6g of Xanthium sibiricum, 10g of Angelica dahurica, 8g of Mentha haplocalyx, 12g of Lonicera japonica, 10g of Scutellaria baicalensis, 10g of Morus alba leaf, 8g of Polygonum cuspidatum, 10g of Ligusticum chuanxiong, 6g of Centipeda minima, 12g of Poria cocos, 8g of Angelica sinensis, 15g of Astragalus membranaceus, 10g of Atractylodes macrocephala, 10g of Pueraria lobata, and 6g of Centipeda minima. Clean, wash, and dry.

[0038] 2. Extraction of volatile oil: Take four medicinal materials rich in volatile oil, namely Magnolia biondii, Xanthium sibiricum, Angelica dahurica and Mentha haplocalyx, place them in a volatile oil extractor, add 8 to 10 times the amount of water, soak for 60 minutes, extract by steam distillation at 100 to 105°C for 3 to 4 hours, collect the distillate (containing volatile oil), encapsulate it with an appropriate amount of β-cyclodextrin, and set aside for later use.

[0039] 3. Water extraction and concentration: Combine the distilled residue with the remaining medicinal materials (honeysuckle, scutellaria, mulberry leaf, polygonum cuspidatum, chuanxiong rhizome, centipeda minima, poria cocos, angelica sinensis, astragalus membranaceus, atractylodes macrocephala, kudzu root, and gentiana macrophylla), add 8 times the total volume of water, decoct for 2 hours, and filter; add 6 times the volume of water to the residue again, decoct for 1.5 hours, and filter. Combine the two filtrates.

[0040] 4. Concentration: The filtrate is concentrated under reduced pressure at 60~70℃ to a clear extract with a relative density of 1.05~1.15 (50℃).

[0041] 5. Mixing and dispensing: Mix the clear extract with the encapsulated volatile oil distillate, add 0.1%~0.3% preservative (sodium benzoate or potassium sorbate), stir well, filter, and dispense into brown glass bottles, 100mL per bottle.

[0042] Example 2 - Clinical Study:

[0043] I. Clinical Research Protocol

[0044] (a) General Information:

[0045] One hundred patients with allergic rhinitis of the lung meridian stagnation and heat type who were treated at the outpatient and inpatient departments of the Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine from September 2024 to May 2026 were randomly divided into a treatment group and a control group, with 50 patients in each group. There were no statistically significant differences in baseline data between the two groups (P>0.05).

[0046] (II) Diagnostic criteria:

[0047] 1. Western medicine diagnosis refers to the "Guidelines for the Diagnosis and Treatment of Allergic Rhinitis in China (2022 Edition)";

[0048] (1) Symptoms: paroxysmal sneezing, clear nasal discharge, nasal congestion, and nasal itching, lasting for more than 1 hour per day;

[0049] (2) Physical signs: pale and edematous nasal mucosa, and watery secretions can be seen in the nasal cavity;

[0050] (3) Allergen detection: positive results from skin prick test or serum-specific IgE test.

[0051] 2. Diagnosis of Lung Meridian Stagnation and Heat Syndrome in Traditional Chinese Medicine: Diagnostic criteria for Lung Meridian Stagnation and Heat Syndrome were formulated with reference to the "Standards for Diagnosis and Treatment of Diseases and Syndromes in Traditional Chinese Medicine".

[0052] (1) Main symptoms: nasal congestion, thick yellow or sticky white nasal discharge, sneezing, and nasal itching.

[0053] (2) Secondary symptoms: dry mouth and thirst, irritability and fever, sore throat, yellow urine, and dry stool;

[0054] (3) Tongue and pulse: The tongue is red or dark red, the coating is thin yellow or yellow and greasy, and the pulse is rapid or slippery.

[0055] A diagnosis can be made if two or more primary symptoms are present, plus two secondary symptoms, combined with tongue and pulse examination.

[0056] (III) Case inclusion criteria:

[0057] 1. Meets the above-mentioned Western medicine diagnostic criteria for allergic rhinitis;

[0058] 2. Meets the diagnostic criteria for the Lung Meridian Stagnation and Heat Type in Traditional Chinese Medicine;

[0059] 3. Age 8-65, gender not limited;

[0060] 4. No antihistamines, nasal corticosteroids, or other similar medications have been used in the past two weeks;

[0061] 5. Participate in this study voluntarily and sign the informed consent form.

[0062] (iv) Exclusion criteria for cases:

[0063] 1. Nasal diseases requiring surgical treatment, such as nasal polyps, sinusitis, and deviated nasal septum;

[0064] 2. Individuals with severe heart, liver, kidney, hematopoietic system diseases, or mental illness;

[0065] 3. Pregnant or breastfeeding women;

[0066] 4. Individuals allergic to any of the drug components used in this study;

[0067] 5. Those who are also involved in other clinical research.

[0068] (v) Treatment methods:

[0069] 1. Treatment group: The concentrated solution prepared by the method in Example 1 was used. 15 mL was added to 800 mL of 85°C hot water and the nasal area was steamed for 15 minutes each time, once a day, for 7 days as one course of treatment, for a total of 4 courses (four weeks).

[0070] 2. Control group: Mometasone furoate nasal spray, 2 sprays per side each time, once a day, 7 days as one course of treatment, for a total of 4 courses (four weeks).

[0071] (vi) Observation indicators:

[0072] 1. Clinical Symptom Scoring: Referring to the "Symptom Scoring Standard for Allergic Rhinitis", the four main symptoms of nasal congestion, nasal itching, runny nose, and sneezing were quantitatively scored (0-3 points) before treatment, 2 weeks after treatment, and 4 weeks after treatment. 0 points: no symptoms; 1 point: mild symptoms, not affecting daily life; 2 points: moderate symptoms, partially affecting daily life; 3 points: severe symptoms, seriously affecting daily life.

[0073] 2. TCM syndrome score: Yellow thick nasal discharge, dry mouth and irritability were quantitatively scored (0-10 points) before treatment, 2 weeks after treatment, and 4 weeks after treatment.

[0074] 3. Serum inflammatory factor detection: Fasting venous blood was collected from patients before treatment and 4 weeks after treatment. Serum total IgE, IL-4 and IL-6 levels were detected by enzyme-linked immunosorbent assay (ELISA).

[0075] 4. Quality of life score: The Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) was used for assessment. It includes 7 dimensions: activity limitation, sleep disturbance, nasal symptoms, ocular symptoms, non-nasal and ocular symptoms, practical problems, and emotional response, with a total of 28 items. Each item is scored from 0 to 6, and the total score is 0 to 168. The higher the score, the worse the quality of life.

[0076] 5. Relapse Rate Monitoring: Follow-up was conducted 4 weeks after the end of treatment to record symptom recurrence. Relapse Criterion: Symptom score increased by ≥50% compared to the end of treatment.

[0077] 6. Safety observation: Observe adverse events such as local irritation and allergic reactions that occur during the treatment process.

[0078] (vii) Criteria for evaluating therapeutic efficacy:

[0079] Formulated with reference to the "Evaluation Criteria for the Treatment of Allergic Rhinitis":

[0080] Significant effect: Clinical symptom scores decreased by ≥70%, and serum IgE levels decreased significantly;

[0081] Effective: Clinical symptom scores decreased by 30%-69%, and serum IgE levels decreased;

[0082] Ineffective: Clinical symptom score decreased by <30%, and serum IgE level showed no significant change.

[0083] Overall effectiveness = (Number of cases with significant effect + Number of cases with effect) / Total number of cases × 100%.

[0084] ( ) Statistical methods:

[0085] Data analysis was performed using SPSS 26.0 statistical software. Quantitative data were expressed as mean ± standard deviation (σ). Mean ± s) indicates the number of cases. Paired t-tests were used for within-group comparisons, and independent samples t-tests were used for between-group comparisons. Count data were expressed as number of cases or percentages, and χ² tests were used for between-group comparisons. P < 0.05 was considered statistically significant, and P < 0.01 was considered statistically significant.

[0086] II. Research Results

[0087] (I) Clinical symptoms and TCM syndrome scoring:

[0088] Table 2 Clinical symptoms and TCM syndrome scores of the two groups of patients before and after treatment

[0089] Treatment group (50) Before treatment 2.54 ± 0.52 2.38 ± 0.64 2.62 ± 0.48 2.46 ± 0.62 10.00 ± 2.26 Two weeks after treatment <![CDATA[1.22 ± 0.46 * ]]> <![CDATA[1.16 ± 0.52 * ]]> <![CDATA[1.24 ± 0.44 * ]]> <![CDATA[1.10 ± 0.38 * ]]> <![CDATA[4.72 ± 1.80 * ]]> 4 weeks after treatment <![CDATA[0.68 ± 0.38 *△ ]]> <![CDATA[0.62 ± 0.34 *△ ]]> <![CDATA[0.74 ± 0.42 *△ ]]> <![CDATA[0.60 ± 0.30 *△ ]]> <![CDATA[2.64 ± 1.44 *△ ]]> Control group (50) Before treatment 2.48 ± 0.56 2.42 ± 0.60 2.58 ± 0.52 2.44 ± 0.58 9.92 ± 2.26 Two weeks after treatment <![CDATA[1.56 ± 0.50 * ]]> <![CDATA[1.48 ± 0.54 * ]]> <![CDATA[1.52 ± 0.48 * ]]> <![CDATA[1.38 ± 0.46 * ]]> <![CDATA[5.94 ± 1.98 * ]]> 4 weeks after treatment <![CDATA[1.10 ± 0.46 * ]]> <![CDATA[0.98 ± 0.40 * ]]> <![CDATA[1.06 ± 0.44 * ]]> <![CDATA[0.88 ± 0.36 * ]]> <![CDATA[4.02 ± 1.66 * ]]>

[0090] Note: Compared with before treatment,* P<0.01; compared with the control group at the same time point, △P<0.05.

[0091] Table 2 shows that the scores of all clinical symptoms and the total score in both groups decreased significantly after treatment compared with before treatment (P<0.01), indicating that both treatment methods were effective. After 2 weeks of treatment, the decrease in symptom scores in the treatment group was greater than that in the control group, but the difference between the groups was not statistically significant (P>0.05). After 4 weeks of treatment, the scores of all symptoms and the total score in the treatment group were significantly lower than those in the control group (P<0.05), indicating that the herbal fumigation and washing agent of this invention is superior to the nasal hormone spray in terms of long-term efficacy. Moreover, the improvement in the scores of thick yellow nasal discharge, dry mouth, and fever was particularly significant in the treatment group (P<0.01).

[0092] (II) Comparison of serum inflammatory factors

[0093] Table 3 Comparison of serum inflammatory factor levels before and after treatment in the two groups of patients ( ± s)

[0094] Treatment group (50) Before treatment 215.64 ± 42.38 58.42 ± 12.36 32.46 ± 8.54 After treatment <![CDATA[128.36 ± 28.64 *△ ]]> <![CDATA[32.18 ± 8.42 *△ ]]> <![CDATA[18.32 ± 6.28 *△ ]]> Control group (50) Before treatment 212.48 ± 40.56 57.68 ± 11.84 31.98 ± 7.92 After treatment <![CDATA[156.42 ± 32.18 * ]]> <![CDATA[40.36 ± 9.56 * ]]> <![CDATA[24.16 ± 6.84 * ]]>

[0095] Note: Compared with before treatment, * P<0.01; compared with the control group, △ P<0.05.

[0096] Table 3 shows that serum IgE, IL-4, and IL-6 levels in both groups decreased significantly after treatment compared to before treatment (P<0.01), indicating that both treatment methods can inhibit allergic and inflammatory responses. After treatment, the levels of various inflammatory factors in the treatment group were significantly lower than those in the control group (P<0.05), indicating that the herbal fumigation and washing agent of this invention is more effective in regulating immunity and inhibiting inflammation.

[0097] (III) Comparison of Quality of Life Scores

[0098] Table 4 Comparison of RQLQ scores before and after treatment in the two groups ( ± s, minutes)

[0099] Treatment group (50) Before treatment 92.36 ± 18.42 After treatment <![CDATA[38.24 ± 12.36 *△ ]]> Decrease value 54.12 ± 12.08 Control group (50) Before treatment 91.68 ± 17.96 After treatment <![CDATA[48.56 ± 14.28 * ]]> Decrease value 43.12 ± 10.56

[0100] Note: Compared with pre-treatment levels, P<0.01; compared with the control group, ΔP<0.05

[0101] Table 4 shows that the RQLQ scores of both groups decreased significantly after treatment compared to before treatment (P<0.01), indicating that both treatment methods can improve patients' quality of life. After treatment, the RQLQ scores and the decrease in scores in the treatment group were significantly better than those in the control group (P<0.05), demonstrating that the herbal fumigation and washing agent of this invention has significant advantages in improving patients' quality of life.

[0102] (iv) Comparison of clinical efficacy

[0103] Table 5. Comparison of clinical efficacy between the two groups of patients (cases, %)

[0104] Treatment group (50) 32（64.0） 15（30.0） 3（6.0） 47（94.0）* Control group (50) 26（52.0） 13（26.0） 11（22.0） 39（78.0）

[0105] Note: Compared with the control group, P<0.05.

[0106] Table 5 shows that the total effective rate in the treatment group was 94.0%, while the total effective rate in the control group was 78.0%. The treatment group was significantly higher than the control group (P<0.05), indicating that the clinical efficacy of the herbal fumigation and washing agent of this invention in treating allergic rhinitis is superior to that of nasal corticosteroids.

[0107] (v) Comparison of recurrence rates

[0108] Four weeks after the end of treatment, patients were followed up. In the treatment group, 48 patients completed the follow-up, and 4 relapsed, with a relapse rate of 8.3%. In the control group, 46 patients completed the follow-up, and 11 relapsed, with a relapse rate of 23.9%. The difference in relapse rate between the two groups was statistically significant (P<0.05), indicating that the herbal fumigation and washing agent of this invention has a significant advantage in reducing relapse.

[0109] (vi) Safety evaluation

[0110] During the treatment, two patients in the treatment group experienced mild nasal irritation upon initial use, which disappeared after continued use, and no serious adverse events occurred. Four patients in the control group experienced nasal dryness and mild bleeding, which were relieved after medication adjustments. No serious adverse events requiring discontinuation of treatment occurred in either group, indicating that the herbal fumigation and washing agent of this invention is safe to use.

[0111] In summary, the traditional Chinese medicine composition and its fumigation formulation proposed in this invention, through scientific formulation and modern pharmaceutical processes, can effectively treat various types of rhinitis, significantly improve patient symptoms, reduce recurrence rates, and improve quality of life. Compared with existing technologies, this invention has outstanding substantive features and significant progress in formulation principles, dosage form technology, and therapeutic effects.

Claims

1. A traditional Chinese medicine composition for treating rhinitis of the lung meridian stagnation and heat type, characterized in that, Composed of the following Chinese medicinal herbs by weight: Magnolia flower 10g, Xanthium fruit 6g, Angelica dahurica 10g, Mentha haplocalyx 8g, Lonicera japonica 12g, Scutellaria baicalensis 10g, Morus alba leaf 10g, Polygonum cuspidatum 8g, Ligusticum chuanxiong 10g, Centipeda minima 6g, Poria cocos 12g, Angelica sinensis 8g, Astragalus membranaceus 15g, Atractylodes macrocephala 10g, Pueraria lobata 10g, Centipeda minima 6g.

2. A medicament for treating lung-heat stagnation type rhinitis prepared from the traditional Chinese medicine composition of claim 1, characterized in that, The dosage forms of rhinitis treatment agents are liquid concentrates, solid effervescent granules, solid effervescent tablets, medicated bath powders, or fumigation agents.

3. The medicament for treating lung-heat stagnation type rhinitis as described in claim 2, characterized in that, The method for preparing a fumigation solution for treating rhinitis includes the following steps: ①. Raw material processing: Weigh according to the formula, clean, wash and dry; ②. Volatile oil extraction: Take Magnolia biondii, Xanthium sibiricum, Angelica dahurica and Mentha haplocalyx, place them in a volatile oil extractor, soak them in water, and then extract the distillate by steam distillation. Encapsulate the distillate with β-cyclodextrin to obtain the volatile oil distillate. ③. Water extraction and concentration: Combine the distilled residue with the remaining medicinal materials, add water and decoct 2-3 times, filter and combine the filtrates; ④. Concentration: The filtrate is concentrated under reduced pressure to a clear extract with a relative density of 1.05~1.15; ⑤. Mixing and dispensing: Mix the clear extract with the encapsulated volatile oil distillate, add preservatives, stir well, filter, and dispense.