A traditional Chinese medicine composition for treating nasal obstruction and a preparation method and application thereof

Abstract

The application provides a traditional Chinese medicine composition for treating nasal obstruction and a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicine compositions. According to the application, the following raw materials are included by weight: wild chrysanthemum 10-20 parts, xanthium 10-30 parts, spica prunellae 3-10 parts, gentiana 5-15 parts, agastache 10-20 parts, zanthoxylum 5-15 parts and codonopsis 3-10 parts. The wild chrysanthemum is the monarch drug in the prescription, which disperses wind-heat, eliminates inflammation and detoxifies; the agastache and the xanthium are the ministerial drugs, the agastache resolves exterior, removes dampness, regulates qi and harmonizes the center, and the xanthium opens the nasal orifice and dispels wind-cold; the zanthoxylum, the spica prunellae, the codonopsis and the gentiana are the auxiliary drugs, which assist the wild chrysanthemum in eliminating inflammation and detoxifying, and enhance the prescription in tonifying qi and invigorating the spleen, enhancing the transportation and transformation function of the spleen, supporting defensive qi, enhancing immunity, preventing external evil invasion and dampness reproduction, and the seven drugs are used together to achieve the effect.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine composition technology, and particularly relates to a traditional Chinese medicine composition for treating nasal obstruction, its preparation method and application. Background Technology

[0002] Chronic rhinitis falls under the category of "nasal obstruction" in Traditional Chinese Medicine (TCM). The earliest record of this disease is found in the *Suwen* (Plain Questions) chapter "On the Five Constant Principles of Governance": "During the Great Heat, coughing, sneezing, nosebleeds, and nasal obstruction occur." The *Suwen* chapter "On the Six Qi as Diseases" states: "Nasal obstruction, obstruction means blockage." The lungs open into the nose, which is located above, connecting to the throat and lungs, assisting the lungs in circulating qi and governing respiration; it is the external orifice of the lungs. The nose and lungs are connected, sharing the function of ventilation, serving as the passage for breath and also as a pathway for pathogenic factors to invade the lungs. *Medical Insights* also states that "the tip of the nose belongs to the spleen (earth element)." The nose is located in the center of the face, and the spleen and stomach, belonging to the earth element in the Five Elements theory, reside in the center, governing the transformation and transportation of the essence of food and water, and being the gathering place of blood vessels throughout the body; therefore, the nose is an external manifestation of the spleen and stomach. The nose is the pathway for clear qi; the spleen governs blood, ascending the clear and descending the turbid. When the spleen qi is strong, the clear ascends and the turbid descends, the clear pathway is unobstructed, and the nasal passages are clear. Zheng Meijian's *Sheyu Yiyu* states, "When the vital energy is severely damaged, external pathogens can easily invade." The generation of vital energy originates from the innate essence in the kidneys and relies on the nourishment of acquired energy. The lungs are the pivot of vital energy, and the spleen is the source of vital energy; the two influence and promote each other to form acquired energy. Therefore, deficiency of lung and spleen qi easily leads to insufficient vital energy, making one susceptible to invasion by external pathogens. Director Li Sicai believes that the nose is the orifice of the lungs; insufficient lung qi makes it easy for pathogens to invade, resulting in weakened defensive qi, impaired nasal function, and obstruction of the nasal passages. Spleen deficiency impairs the transformation and transportation of fluids, leading to dysfunction of ascending and descending qi, internal retention of fluids, and obstruction of the nasal passages.

[0003] Nasal congestion is a chronic nasal disease characterized by long-term nasal obstruction and runny nose. Currently, the use of antibiotics, nasal corticosteroids, and antihistamines can only temporarily relieve some symptoms and cannot cure the disease. Worse still, long-term use of some Western medicines (such as vasoconstrictors) may lead to rebound nasal congestion; especially in eosinophilic sinusitis, traditional drugs are difficult to block the immune cascade, resulting in a high recurrence rate; furthermore, the efficacy of single drugs is limited, and it is often necessary to combine them with surgery (such as endoscopic sinus surgery) or physical therapy (such as nasal irrigation).

[0004] Therefore, it is particularly important to seek a safe, effective, and curative Chinese medicine composition and preparation for rhinitis. Summary of the Invention

[0005] In view of this, the purpose of the present invention is to provide a traditional Chinese medicine composition for treating nasal obstruction, with clear formulation and significant efficacy, in which the various herbs work together to treat damp-heat syndrome of the liver and gallbladder.

[0006] To achieve the above-mentioned objectives, the present invention provides the following technical solution:

[0007] A traditional Chinese medicine composition for treating nasal congestion, comprising the following ingredients by weight: 10-20 parts of wild chrysanthemum, 10-30 parts of cocklebur, 3-10 parts of prunella vulgaris, 5-15 parts of gentian, 10-20 parts of patchouli, 5-15 parts of nemesis nidus, and 3-10 parts of codonopsis pilosula.

[0008] Preferably, by weight, the ingredients include the following: 13-17 parts wild chrysanthemum, 15-25 parts cocklebur, 6-9 parts prunella vulgaris, 8-12 parts gentian, 13-17 parts patchouli, 8-12 parts Zanthoxylum nitidum, and 4-6 parts codonopsis.

[0009] Preferably, by weight, the ingredients include the following: 16 parts wild chrysanthemum, 16 parts cocklebur, 8 parts prunella vulgaris, 10 parts gentian, 16 parts patchouli, 10 parts zephyranthes bidentata, and 5 parts codonopsis pilosula.

[0010] Another object of the present invention is to provide a method for preparing the aforementioned traditional Chinese medicine composition, comprising the following steps: weighing each raw material according to a certain proportion, mixing the mixture into a mixture 1, and then soaking the mixture 1 with water; after soaking, decocting the mixture in water and collecting the decoction; concentrating the decoction to a relative density of 1.20–1.25 g / cm³. 3 , to obtain extract.

[0011] Preferably, mixture 1 is mixed with water at a mass ratio of 1:(5-10); the soaking time is 12-48h.

[0012] Preferably, the decoction time is 1 to 3 hours.

[0013] Preferably, the extract is mixed with pregelatinized starch, microcrystalline cellulose, sodium carboxymethyl starch and povidone, dried, and pulverized to obtain a dry extract powder; the dry extract powder is mixed with 70% ethanol by volume and dried to obtain dry granules; the dry granules are mixed with magnesium stearate, compressed into tablets, and coated.

[0014] Another object of the present invention is to provide the application of the traditional Chinese medicine composition or the preparation method described herein in the preparation of a medicament for treating nasal obstruction.

[0015] Preferably, the nasal obstruction includes chronic rhinitis, chronic sinusitis, and nasopharyngitis.

[0016] Another object of the present invention is to provide a medicament for treating nasal obstruction, the medicament comprising the aforementioned traditional Chinese medicine composition.

[0017] Compared with the prior art, the present invention has the following beneficial effects:

[0018] This invention provides a traditional Chinese medicine composition for treating nasal congestion, primarily for treating damp-heat syndrome of the liver and gallbladder, characterized by symptoms such as heaviness and dizziness in the head, fatigue, poor appetite, loose stools, or accompanied by bitter taste in the mouth, dry throat, nasal congestion that fluctuates in severity (worsened by wind), copious yellow and sticky nasal discharge, or purulent nasal discharge, and decreased sense of smell. The tongue is pale red or has teeth marks on the edges, with a yellow and greasy coating or a thin white and slightly yellow coating, and the pulse is thready and slippery or wiry and slippery. The formula uses wild chrysanthemum as the principal ingredient, which disperses wind-heat, reduces inflammation, and detoxifies. The assistant ingredients are agastache and cocklebur. Agastache relieves exterior symptoms, resolves dampness, regulates qi, and harmonizes the middle jiao, while cocklebur clears nasal passages and disperses wind-cold. Zanthoxylum nitidum, prunella vulgaris, codonopsis, and gentian are used as adjuvant ingredients. Zanthoxylum nitidum clears heat, detoxifies, and has antibacterial and anti-inflammatory properties, which assists the principal ingredient, wild chrysanthemum, in reducing inflammation and further enhances the therapeutic effect on nasal inflammation. Gentian and prunella vulgaris have the effects of clearing liver and gallbladder fire, drying dampness, reducing swelling, and detoxifying, which assists the principal ingredient in clearing heat and detoxifying. Codonopsis pilosula tonifies qi and strengthens the spleen, enhances the spleen's digestive function, supports defensive qi, enhances immunity, and prevents external pathogens from invading and dampness from regenerating. The seven ingredients work together to achieve the desired effect. Attached Figure Description

[0019] Figure 1 This is a flowchart of the preparation method; the shaded areas indicate that the preparation is carried out in a Class D clean area, and * indicates a quality control point. Detailed Implementation

[0020] This invention provides a traditional Chinese medicine composition for treating nasal congestion, comprising, by weight, the following ingredients: 10-20 parts of wild chrysanthemum, 10-30 parts of cocklebur, 3-10 parts of prunella vulgaris, 5-15 parts of gentian, 10-20 parts of patchouli, 5-15 parts of zephyranthes bidentata, and 3-10 parts of codonopsis pilosula. Preferably, by weight, it comprises: 13-17 parts of wild chrysanthemum, 15-25 parts of cocklebur, 6-9 parts of prunella vulgaris, 8-12 parts of gentian, 13-17 parts of patchouli, 8-12 parts of zephyranthes bidentata, and 4-6 parts of codonopsis pilosula. More preferably, by weight, it comprises: 16 parts of wild chrysanthemum, 16 parts of cocklebur, 8 parts of prunella vulgaris, 10 parts of gentian, 16 parts of patchouli, 10 parts of zephyranthes bidentata, and 5 parts of codonopsis pilosula. This invention does not specifically limit the source of the above ingredients; commercially available products in the art are acceptable.

[0021] In the traditional Chinese medicine composition of this invention, wild chrysanthemum is the principal ingredient. Wild chrysanthemum has the effects of clearing heat and detoxifying, dispelling wind and calming the liver. It is often used for symptoms such as wind-heat cold, red and swollen eyes, and boils and carbuncles. It plays a major role in the whole formula, giving the whole formula the effects of dispelling wind-heat and reducing inflammation and detoxifying.

[0022] In this invention's traditional Chinese medicine composition, the assistant herbs are agastache rugosa and cocklebur. Agastache rugosa dispels dampness, invigorates the spleen, dispels foulness, harmonizes the middle jiao, relieves summer heat, and releases exterior pathogens. It is used for symptoms such as dampness obstructing the spleen and stomach, abdominal distension, early stage of damp-heat syndrome, vomiting, diarrhea, summer-heat dampness, fever and chills, chills and fever, and chest and abdominal fullness. Cocklebur has the effects of dispersing wind-cold, dispelling dampness, and relieving pain. Its medicinal effects are mild and long-lasting. It helps to clear nasal congestion through the lung meridian and relieve joint pain and skin itching through the spleen and liver meridians. It can relieve runny nose from colds and improve skin problems. Agastache rugosa and cocklebur work together to assist the principal herbs in exerting their effects, so that the whole formula has the effects of relieving exterior pathogens and dispelling dampness, regulating qi and harmonizing the middle jiao, clearing nasal passages, and dispelling wind-cold.

[0023] In this invention's herbal composition, Zanthoxylum nitidum, Prunella vulgaris, Codonopsis pilosula, and Gentiana scabra are used as adjuvant herbs. Zanthoxylum nitidum has the effects of promoting blood circulation and removing blood stasis, regulating qi and relieving pain, dispelling wind and unblocking collaterals, and detoxifying and reducing swelling. It is used to treat injuries from falls and blows, rheumatic pain, toothache, stomachache, and other ailments. Zanthoxylum nitidum clears heat and detoxifies, and has antibacterial and anti-inflammatory properties, assisting the principal herb, Chrysanthemum indicum, in reducing inflammation and further enhancing the therapeutic effect on nasal inflammation. Gentiana scabra is a heat-clearing and dampness-drying herb. It has the effect of clearing damp-heat toxins from the body, improving symptoms of liver and gallbladder fire such as red, swollen, and painful eyes, bitter taste in the mouth, and tinnitus. It is often used to treat jaundice, eczema, and various discomforts caused by liver and gallbladder problems. Prunella vulgaris, through its bitter taste to clear heat, its pungent and dispersing properties, and its cold and fire-clearing properties, regulates liver problems. It can clear liver fire, dissipate stagnation, nourish blood, and calm liver yang excess. It is suitable for liver fire excess, high blood pressure, and nodules and lumps. Both gentian and prunella vulgaris have the effects of clearing heat from the liver and gallbladder, drying dampness, reducing swelling and detoxifying, thus assisting the principal herb in clearing heat and detoxifying. Codonopsis pilosula is a traditional Chinese medicine that tonifies qi and strengthens the spleen. It enhances physical strength, improves fatigue, promotes digestion and absorption, and improves immunity. It is often used to relieve symptoms such as fatigue, poor appetite, and pale complexion caused by qi and blood deficiency. Codonopsis pilosula tonifies qi and strengthens the spleen, enhances the spleen's digestive function, supports defensive qi, strengthens immunity, and prevents external pathogens from invading and dampness from regenerating. Zanthoxylum nitidum, prunella vulgaris, codonopsis pilosula, and gentian serve as adjuvant herbs to further enhance the efficacy of the formula.

[0024] The traditional Chinese medicine composition provided by this invention utilizes seven herbs in combination to achieve synergistic effects. The entire formula integrates the principles of lightness and dispersion with the concept of strengthening the body's resistance. It uses wild chrysanthemum and agastache to disperse the stagnant heat in the upper burner, while codonopsis strengthens the spleen and consolidates the body's foundation, implicitly aligning with the principle of "tonifying the earth to generate metal." In particular, the combination of prunella vulgaris and gentian clears liver fire without harming the stomach, addressing both the symptoms and the root cause.

[0025] This invention is a pure traditional Chinese medicine preparation with significant efficacy, mild medicinal properties, no irritation, and no obvious toxic side effects. Compared with traditional decoctions, it has advantages such as being easy to take, easy to carry, and easy to store. Furthermore, the preparation method is simple and the cost is low.

[0026] The present invention also provides a method for preparing the aforementioned traditional Chinese medicine composition, comprising the following steps: weighing each raw material according to a ratio, mixing the resulting mixture 1, and then soaking the mixture 1 after mixing it with water; after soaking, decocting the mixture in water and collecting the decoction; concentrating the decoction to a relative density of 1.20–1.25 g / cm³. 3 , to obtain extract.

[0027] In the preparation method of the present invention, it is preferred to mix mixture 1 with water at a mass ratio of 1:(5-10), more preferably at a mass ratio of 1-8; the soaking time is preferably 12-48 h, more preferably 20-30 h, and even more preferably 24-26 h; after soaking, the decoction time is preferably 1-3 h. Preferably, after collecting the decoction, the remaining medicinal residue is mixed with water again and decocted again for extraction, with the same method used each time. After combining the extracts, it is preferred to filter using a 100-mesh filter, and then concentrate the solution, preferably to a relative density (80°C) of 1.22-1.24 g / cm³. 3 The concentrated extract is preferably mixed with pregelatinized starch, microcrystalline cellulose, sodium carboxymethyl starch, and povidone in a mass ratio of 20:(4.8–5.2):(2.8–3.2):(1–1.2):(0.18–0.22). After mixing, the mixture is dried, preferably at 75–80°C, preferably for 8 hours (until the moisture content is 1%–3%). It is preferably pulverized to a fine powder that can pass through an 80-mesh sieve to obtain a dry extract powder. The dry extract powder is mixed with 70% ethanol by volume and then dried, preferably at 60°C, preferably until the moisture content is 2%–6%, to obtain dry granules. The dry granules are mixed with magnesium stearate, preferably 0.2% of the mass of the dry granules. The mixture is then compressed into tablets and coated.

[0028] The present invention also provides the application of the traditional Chinese medicine composition or the preparation method described herein in the preparation of a medicament for treating nasal obstruction, wherein nasal obstruction includes chronic rhinitis, chronic sinusitis and nasopharyngitis.

[0029] The present invention also provides a medicament for treating nasal obstruction, the medicament comprising the traditional Chinese medicine composition, wherein the traditional Chinese medicine composition is the sole effective ingredient or one of the effective ingredients of the medicament.

[0030] The technical solutions provided by the present invention will be described in detail below with reference to the embodiments, but they should not be construed as limiting the scope of protection of the present invention.

[0031] Example 1

[0032] A traditional Chinese medicine composition for treating nasal congestion, comprising the following raw materials by weight:

[0033] Wild chrysanthemum 16 parts, cocklebur 16 parts, prunella vulgaris 8 parts, gentian 10 parts, patchouli 16 parts, nemesis 10 parts, codonopsis pilosula 5 parts.

[0034] The preparation method is as follows:

[0035] Weigh each raw material according to the proportion, mix the raw materials and put them into the extraction tank. After soaking for 24 hours, decoct and extract twice with water. Each time, add drinking water in a volume of 5 times the mass of the raw material mixture and decoct and extract for 2 hours each time. Collect the extract each time.

[0036] The combined extracts were filtered through a 100-mesh sieve and concentrated to a relative density of 1.25 g / cm³. 3 At 80℃, an extract is obtained.

[0037] Add 9.49 kg of pregelatinized starch, 5.69 kg of microcrystalline cellulose, 2.09 kg of sodium carboxymethyl starch, and 0.36 kg of povidone (K30) to the extract, mix for 30 minutes, dry at 80°C for 8 hours until the moisture content is 1%, pulverize, and pass 98% of the fine powder through an 80-mesh sieve to obtain dry extract powder.

[0038] Add the dry powder to a trough mixer and mix with 70% ethanol at a ratio of 100g dry powder to 5mL 70% ethanol for 25 minutes. Granulate the mixture using a gyratory granulator with a 24-mesh sieve. Place the wet granules in a hot air circulating oven at 60℃ and dry until the moisture content is 2%. Then, granulate the granules using a 24-mesh granulator.

[0039] Perform the total mixing operation according to the "Standard Operating Procedures for Multi-directional Motion Mixers". Add 0.2% magnesium stearate by weight of the sized dry granules into the mixer for total mixing. Set the mixing speed to 25 Hz and mix for 25 minutes before discharging.

[0040] After installing an 8.5mm diameter circular deep-drawing die and adjusting the tablet press, the granules are loaded into the hopper and tableting begins to produce unprocessed tablets with a weight of 0.2g / tablet. The tablet weight variation is controlled within ±5.0%, and the unprocessed tablet hardness is ≥4kg.

[0041] Pour the uncoated tablets into the coating pan and turn on the coating machine. Follow the "Standard Operating Procedures for Sugar Coating" to perform the sugar coating. Place the batch of uncoated tablets into the sugar coating pan, turn it on, and set the tablet bed temperature to 50℃~55℃. Begin adding simple sugar syrup and talcum powder in batches. Add 600~800mL of simple sugar syrup and 200g of talcum powder per 36kg of uncoated tablets. After the tablets are rounded, add colored sugar syrup. Ensure the tablets have a uniform color, then polish with beeswax until they meet the intermediate product standards for sugar-coated tablets, completing the entire coating process.

[0042] The slices are dried, packaged, and then tablets of the traditional Chinese medicine composition are obtained.

[0043] Example 2

[0044] A traditional Chinese medicine composition for treating nasal congestion, comprising the following raw materials by weight:

[0045] Wild chrysanthemum 12 parts, cocklebur 12 parts, prunella vulgaris 3 parts, gentian 5 parts, patchouli 10 parts, nemesis 6 parts, codonopsis 5 parts.

[0046] The preparation method is the same as in Example 1.

[0047] Example 3

[0048] A traditional Chinese medicine composition for treating nasal congestion, comprising the following raw materials by weight:

[0049] Wild chrysanthemum 20 parts, cocklebur 15 parts, prunella vulgaris 10 parts, gentian 12 parts, patchouli 18 parts, nemesis 12 parts, codonopsis pilosula 10 parts.

[0050] The preparation method is the same as in Example 1.

[0051] Example 4

[0052] A traditional Chinese medicine composition for treating nasal congestion, comprising the following raw materials by weight:

[0053] Wild chrysanthemum 18 parts, cocklebur 20 parts, prunella vulgaris 6 parts, gentian 10 parts, patchouli 15 parts, nemesis 5 parts, codonopsis pilosula 3 parts.

[0054] The preparation method is the same as in Example 1.

[0055] Comparative Example 1

[0056] A traditional Chinese medicine composition for treating nasal congestion, comprising the following raw materials by weight:

[0057] 16 parts of Xanthium sibiricum, 8 parts of Prunella vulgaris, 5 parts of Gentiana scabra, 16 parts of Pogostemon cablin, 8 parts of Zanthoxylum nitidum, and 5 parts of Codonopsis pilosula.

[0058] The preparation method is the same as in Example 1.

[0059] Comparative Example 2

[0060] A traditional Chinese medicine composition for treating nasal congestion, comprising the following raw materials by weight:

[0061] Wild chrysanthemum 16 parts, Prunella vulgaris 8 parts, Gentiana scabra 5 parts, Zanthoxylum nitidum 8 parts, Codonopsis pilosula 5 parts.

[0062] The preparation method is the same as in Example 1.

[0063] Comparative Example 3

[0064] A traditional Chinese medicine composition for treating nasal congestion, comprising the following raw materials by weight:

[0065] Wild chrysanthemum 5 parts, cocklebur 16 parts, prunella vulgaris 8 parts, gentian 5 parts, patchouli 16 parts, nemesis 8 parts, codonopsis 5 parts.

[0066] The preparation method is the same as in Example 1.

[0067] Comparative Example 4

[0068] A traditional Chinese medicine composition for treating nasal congestion, comprising the following raw materials by weight:

[0069] Wild chrysanthemum 25 parts, cocklebur 16 parts, prunella vulgaris 8 parts, gentian 5 parts, patchouli 16 parts, nemesis 8 parts, codonopsis 5 parts.

[0070] The preparation method is the same as in Example 1.

[0071] Comparative Example 5

[0072] A traditional Chinese medicine composition for treating nasal congestion, comprising the following raw materials by weight:

[0073] Wild chrysanthemum 16 parts, cocklebur 5 parts, prunella vulgaris 8 parts, gentian 5 parts, patchouli 5 parts, nemesis 8 parts, codonopsis pilosula 5 parts.

[0074] The preparation method is the same as in Example 1.

[0075] Example 5

[0076] Efficacy verification.

[0077] 1. Experimental Design

[0078] (1) Case selection:

[0079] This study included 270 patients aged 18-65 years who met the diagnostic criteria for "nasal obstruction" (damp-heat syndrome of liver and gallbladder) in the "Guidelines for the Diagnosis and Treatment of Chronic Sinusitis" and the "Standards for Diagnosis and Efficacy of Traditional Chinese Medicine Diseases and Syndromes." The duration of illness was ≥3 months. The main symptoms included nasal congestion, thick yellow nasal discharge, and dizziness / heaviness in the head; secondary symptoms included bitter taste in the mouth, dry throat, fatigue, loss of appetite, and loose stools. Patients with severe cardiopulmonary diseases, malignant tumors, pregnancy, or allergy to this drug were excluded.

[0080] (2) Grouping and administration:

[0081] 270 patients were randomly divided into 9 groups and each group took 4 tablets orally three times a day, prepared according to Examples 1 to 4 and Comparative Examples 1 to 5.

[0082] The treatment course lasts for 4 weeks, with a follow-up period of 3 months to observe the recurrence rate.

[0083] 2. Observation Indicators

[0084] (1) Symptom scoring: A scoring table was developed based on the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines". The scoring table included the degree of nasal congestion, the amount / color of nasal discharge, the decrease in sense of smell, and the feeling of heaviness in the head. Each item was graded as none (0 points), mild (1 point), moderate (2 points), and severe (3 points). The sum of the scores of each item was the total symptom score.

[0085] (2) TCM syndrome scoring: tongue appearance (yellow and greasy coating), pulse appearance (wiry and slippery) and changes in systemic symptoms.

[0086] (3) Safety indicators: blood routine, liver and kidney function and adverse event records.

[0087] 3. Evaluation of therapeutic effect

[0088] (1) Evaluation criteria for therapeutic efficacy:

[0089] Cure: Symptoms have completely disappeared, and the total symptom score is 0.

[0090] Significant effect: Symptoms are significantly reduced, and the total symptom score decreases by ≥70%;

[0091] Effective: Symptoms are alleviated, and the total symptom score decreases by ≥30% and <70%.

[0092] Ineffective: Total symptom score decreases by <30% or total symptom score increases

[0093] (2) Overall effective rate (%) = (number of cured cases + number of cases with significant improvement + number of effective cases) / total number of cases × 100%, significant effective rate = number of cases with significant improvement / total number of cases × 100%. The results are shown in Table 1.

[0094] Table 1 Evaluation of therapeutic effects

[0095]

[0096]

[0097] According to the results in Table 1, the composition provided in Example 1 of this application has the best therapeutic effect, with a total effective rate of 93% and a cure rate of 10%. This confirms that through the synergistic effect of wild chrysanthemum clearing heat and detoxifying (principal drug), cocklebur dispelling wind and opening the orifices (assistant drug), agastache resolving dampness and invigorating the spleen (assistant drug), and other herbs, it significantly improves the core symptoms of damp-heat syndrome such as nasal congestion and yellow sticky nasal discharge.

[0098] The efficacy of the formula decreased sharply when key drugs were missing: the efficacy rate of Comparative Example 1 (lacking Chrysanthemum indicum) dropped sharply to 23%, while that of Comparative Example 2 (lacking Pogostemon cablin and Xanthium sibiricum) was only 30%, which proves that the principal and assistant drugs are indispensable.

[0099] Deviations in the compatibility ratio significantly reduced efficacy: in Comparative Example 3, the effective rate dropped to 50% after reducing the dosage of wild chrysanthemum, indicating insufficient heat-clearing power; in Comparative Example 4, although the effective rate was 83% after exceeding the dosage of wild chrysanthemum, the significant efficacy rate was only 40%, suggesting that excessive dosage disrupted the balance of medicinal properties; in Comparative Example 5, the effective rate was 77% after reducing the dosage of cocklebur and agastache, reflecting a weakened ability to clear the orifices and resolve dampness. In addition, in Example 4, the significant efficacy rate was 47% when the dosage of codonopsis was reduced and the dosage of gentian was increased, which was lower than that of Example 1, indicating that insufficient tonifying herbs may weaken the long-term efficacy.

[0100] Regarding safety, no abnormalities were observed in blood routine tests, liver and kidney function, or adverse event records in any of the patients participating in the trial, indicating that the traditional Chinese medicine composition of this invention has good safety.

[0101] In summary, clinical trial data show that the efficacy of the traditional Chinese medicine composition (nasopharyngeal anti-inflammatory tablets) of this invention is highly dependent on the integrity of the formulation and the accuracy of the compatibility ratio.

[0102] Typical Case:

[0103] Case 1: Patient Li, male, 32 years old, with a 5-year history of chronic sinusitis. Chief complaints: persistent nasal congestion, yellow purulent nasal discharge, headache, dizziness; pale red tongue with teeth marks, yellow and greasy tongue coating; wiry pulse. After taking the herbal composition of Example 1 for 4 weeks (4 tablets each time, 3 times a day, orally), the nasal congestion was relieved, the nasal discharge became clear and thin, and the headache and dizziness disappeared. No recurrence was observed during a 3-month follow-up.

[0104] Case 2: Patient Zhang, female, 48 years old, with a 1-year history of chronic rhinitis. Chief complaint: persistent nasal congestion, yellow purulent nasal discharge, accompanied by heaviness and fatigue in the head and body; pale red tongue with yellow greasy coating; slippery pulse. After taking the traditional Chinese medicine composition of Example 2 for 4 weeks (4 tablets each time, 3 times a day, orally), the patient had no adverse symptoms. No recurrence was observed during a 3-month follow-up.

[0105] Case 3: Patient Tan, female, 18 years old, with a six-month history of chronic rhinitis. Chief complaint: persistent nasal congestion and yellow purulent nasal discharge; pale red tongue with yellow, greasy coating; slippery pulse. After taking the herbal composition of Example 3 for 4 weeks (4 tablets each time, 3 times a day, orally), the nasal congestion and nasal discharge symptoms disappeared. No recurrence was observed during a 3-month follow-up.

[0106] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition for treating nasal obstruction due to damp-heat in the liver and gallbladder, characterized in that, By weight, it consists of the following ingredients: 10-20 parts wild chrysanthemum, 10-30 parts cocklebur, 3-10 parts prunella vulgaris, 5-15 parts gentian, 10-20 parts patchouli, 5-15 parts zephyranthes bidentata, and 3-10 parts codonopsis pilosula. The preparation method of the traditional Chinese medicine composition includes the following steps: Weigh out the raw materials according to the proportions, mix them to obtain mixture 1, mix mixture 1 with water and then soak; after soaking, decoct in water and collect the decoction; concentrate the decoction to a relative density of 1.20-1.25 g / cm³. 3 , to obtain extract.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, By weight, it consists of the following ingredients: 13-17 parts wild chrysanthemum, 15-25 parts cocklebur, 6-9 parts prunella vulgaris, 8-12 parts gentian, 13-17 parts patchouli, 8-12 parts Zanthoxylum nitidum, and 4-6 parts codonopsis pilosula.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, By weight, it consists of the following ingredients: 16 parts wild chrysanthemum, 16 parts cocklebur, 8 parts prunella vulgaris, 10 parts gentian, 16 parts patchouli, 10 parts zephyranthes bidentata, and 5 parts codonopsis pilosula.

4. A method for preparing the traditional Chinese medicine composition according to any one of claims 1 to 3, characterized in that, The process includes the following steps: weighing each raw material according to the proportions, mixing them to obtain mixture 1, mixing mixture 1 with water and then soaking the mixture; after soaking, boiling the mixture in water and collecting the decoction; concentrating the decoction to a relative density of 1.20–1.25 g / cm³. 3 , to obtain extract.

5. The preparation method according to claim 4, characterized in that, Mixture 1 is mixed with water at a mass ratio of 1:(5~10); the soaking time is 12~48h.

6. The preparation method according to claim 4, characterized in that, The boiling time is 1 to 3 hours.

7. The preparation method according to claim 4, characterized in that, The extract is mixed with pregelatinized starch, microcrystalline cellulose, sodium carboxymethyl starch and povidone, dried and pulverized to obtain a dry extract powder; the dry extract powder is mixed with 70% ethanol by volume and dried to obtain dry granules; the dry granules are mixed with magnesium stearate, compressed into tablets and coated.

8. The use of the traditional Chinese medicine composition according to any one of claims 1 to 3 or the preparation method according to any one of claims 4 to 7 in the preparation of a medicine for treating nasal obstruction due to damp-heat in the liver and gallbladder.

9. The application according to claim 8, characterized in that, The nasal obstruction includes chronic rhinitis, chronic sinusitis, and nasopharyngitis.

10. A medicine for treating nasal obstruction due to damp-heat in the liver and gallbladder, characterized in that, The drug comprises the traditional Chinese medicine composition according to any one of claims 1 to 3.

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