Traditional Chinese medicine composition for treating nasosinusitis as well as preparation method and application thereof

Abstract

The invention discloses a traditional Chinese medicine composition for treating nasosinusitis as well as a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition for treating nasosinusitis caused by gall-viscera stagnated heat is prepared from the following components in parts by weight: 20 to 30 parts of herba houttuyniae, 15 to 30 parts of herba patriniae, 8 to 20 parts of spina gleditsiae, 25 to 35 parts of gypsum, 10 to 20 parts of rhizoma chuanxiong and 10 to 20 parts of radix angelicae dahuricae. The invention further discloses a preparation method and application of the traditional Chinese medicine composition for treating nasosinusitis caused by gall-viscera stagnated heat syndrome. According to the traditional Chinese medicine composition for treating the nasosinusitis caused by the gallbladder stagnated heat syndrome, the compatibility follows the theory of monarch, minister, assistant and guide, the whole formula has the effects of clearing away heat and toxic materials, expelling pus, opening orifices, promoting blood circulation and relieving pain, and both symptoms and root causes of the nasosinusitis caused by the gallbladder stagnated heat syndrome are treated according to the core pathogenesis of the nasosinusitis caused by the gallbladder stagnated heat syndrome.

Description

Technical Field

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

[0002] Sinusitis caused by gallbladder heat stagnation is a common clinical type of sinusitis. Its onset is often related to three factors: first, emotional imbalance, such as prolonged depression or sudden anger, which easily leads to dysfunction of the liver and gallbladder; second, pathogenic factors invading the gallbladder, such as incomplete elimination of external pathogens that disturb the gallbladder along the meridians; and third, stagnation of Qi in the gallbladder itself, which over time transforms into heat. Once the heat from the gallbladder is generated, it ascends along the meridians to the nasal passages, burning the sinus mucosa and ultimately causing sinusitis. The core pathogenesis of this syndrome is "gallbladder heat invading the nasal passages," and its pathological evolution is directly related to both liver and gallbladder dysfunction (due to impaired Qi flow and difficulty in dispersing stagnant heat) and internal damp-heat in the spleen and stomach (due to impaired spleen and stomach function generating dampness, which, combined with heat, further aggravates nasal congestion, jointly influencing the progression of the disease. Its clinical features include: nasal congestion and headache, thick yellow-green nasal discharge, copious and foul-smelling discharge, accompanied by bitter taste in the mouth, dry throat, irritability, dizziness, tinnitus, red tongue, yellow coating, and wiry and rapid pulse.

[0003] Modern medical treatment for sinusitis primarily relies on antibiotics for infection control, nasal corticosteroids for inflammation, and decongestants to relieve nasal congestion. While these methods can provide short-term symptom relief, they have significant limitations: First, long-term antibiotic use easily leads to bacterial resistance, especially in patients with chronic sinusitis, where efficacy gradually declines. Second, symptomatic treatment cannot address the core pathogenesis of "gallbladder and visceral heat stagnation syndrome," resulting in a high relapse rate after discontinuation of medication. Third, long-term use of nasal decongestants can easily induce drug-induced rhinitis, exacerbating nasal congestion. Fourth, there is a lack of targeted treatments for patients with concurrent headaches and decreased sense of smell; some patients require surgery, but the risk of recurrence remains post-surgery. Clinically, many patients with sinusitis caused by gallbladder and visceral heat stagnation syndrome suffer from poor response to Western medicine treatment, recurrent attacks, and long-term nasal congestion and headaches, even developing psychological problems such as anxiety and depression.

[0004] There are various traditional Chinese medicines available for treating sinusitis, and they are often chosen by patients due to their unique efficacy and fewer side effects, but they also have various shortcomings. For example, a drug preparation and its preparation method for treating purulent sinusitis (patent number CN201510447328.2) and a fish sauce detox spray for treating sinusitis (patent number CN202410922288.1) are both prepared from houttuynia cordata, patrinia scabiosaefolia, magnolia biondii, gleditsia sinensis thorns, chuanxiong rhizome, scutellaria baicalensis, angelica dahurica, gypsum powder, and licorice. However, in practical applications, it has been found that the decoction formed by combining Magnolia biondii, Scutellaria baicalensis, and Glycyrrhiza uralensis has a bitter and pungent taste. This is because the bitterness and coldness of Scutellaria baicalensis and the pungent and fishy taste of Magnolia biondii cannot be completely balanced by the sweetness of Glycyrrhiza uralensis. This can irritate the oral mucosa and gastrointestinal tract, causing symptoms such as nausea and stomach discomfort. This poses a certain challenge to the taste and physical tolerance of different groups of people, increases the "discomfort" of patients taking the medicine, reduces patients' medication compliance, and thus affects the treatment effect.

[0005] Therefore, developing a traditional Chinese medicine preparation that can treat both the symptoms and the root cause, has a low recurrence rate, and is highly safe has become a key need to solve this disease. Summary of the Invention

[0006] One of the objectives of this invention is to provide a traditional Chinese medicine composition for treating sinusitis caused by stagnation of heat in the gallbladder and viscera.

[0007] The technical solution of the present invention to solve the above-mentioned technical problems is as follows: A traditional Chinese medicine composition for treating sinusitis caused by stagnation of heat in the gallbladder and viscera, comprising the following components in parts by weight: 20-30 parts of Houttuynia cordata, 15-30 parts of Patrinia scabiosaefolia, 8-20 parts of Gleditsia sinensis thorns, 25-35 parts of gypsum, 10-20 parts of Ligusticum chuanxiong and 10-20 parts of Angelica dahurica.

[0008] Explanation of the traditional Chinese medicine formula in this invention: Houttuynia cordata: It has a pungent taste and slightly cold nature, and enters the lung meridian. It has the effects of clearing heat and detoxifying, reducing swelling and draining pus, and promoting urination. Modern pharmacology has confirmed that Houttuynia cordata contains volatile oil (mainly decanoyl acetaldehyde), flavonoids, alkaloids, etc., and has a significant inhibitory effect on common pathogenic bacteria of sinusitis such as Staphylococcus aureus, Streptococcus pneumoniae, and Haemophilus influenzae; it can reduce nasal mucosal inflammation and purulent nasal discharge; it also has antipyretic and analgesic effects, relieving systemic discomfort and headaches.

[0009] Patrinia scabiosifolia: It has a pungent and bitter taste, is slightly cold in nature, and enters the stomach, large intestine, and liver meridians. It has the effects of clearing heat and detoxifying, removing blood stasis and draining pus. Modern pharmacology has confirmed that it contains saponins, alkaloids, and flavonoids, which can enhance the phagocytic function of white blood cells and improve the body's anti-inflammatory ability; at the same time, it can improve local blood circulation in the nasal mucosa, promote the dissipation of blood stasis, accelerate the discharge of purulent nasal discharge, and has a targeted therapeutic effect on the persistent inflammation of chronic sinusitis.

[0010] Gypsum: It has a sweet and pungent taste, is very cold in nature, and enters the lung and stomach meridians. It has the effects of clearing away excess heat in the lungs and stomach, relieving irritability, and quenching thirst. Modern pharmacology shows that the main component of gypsum is calcium sulfate dihydrate, which can inhibit the thermoregulatory center and exert an antipyretic effect; at the same time, it can reduce the permeability of nasal mucosal capillaries, reduce mucosal congestion and edema, and relieve nasal congestion; its "clearing stomach fire" effect can improve the increased purulent nasal discharge caused by accumulated heat in the spleen and stomach.

[0011] Chuanxiong (Ligusticum striatum): pungent and warm in nature, it enters the liver, gallbladder, and pericardium meridians. It has the effects of promoting blood circulation, regulating qi, dispelling wind, and relieving pain. Modern pharmacology has confirmed that Chuanxiong contains volatile oil (ligustrazine), alkaloids, etc., which can dilate cerebral and nasal mucosal blood vessels, improve local microcirculation, and relieve headaches and nasal congestion caused by qi and blood stagnation; at the same time, it can inhibit platelet aggregation, prevent thrombosis at inflamed sites, and promote the absorption of inflammation.

[0012] Angelica dahurica: pungent in taste and warm in nature, it enters the lung and stomach meridians. It has the effects of relieving exterior syndromes and dispelling wind, clearing the nasal passages and relieving pain, reducing swelling and draining pus. Modern pharmacology has confirmed that Angelica dahurica contains volatile oils and coumarins, which have a mild stimulating effect on the nasal mucosa, promoting the movement of nasal mucosal cilia and accelerating the drainage of purulent nasal discharge. Its analgesic effect is significant, especially for pain in the forehead and brow ridge (characteristic pain sites of sinusitis); at the same time, it can inhibit the release of inflammatory mediators and reduce nasal mucosal inflammation.

[0013] Gleditsia sinensis thorns: pungent and warm in nature, they enter the liver and stomach meridians, and have the effects of promoting pus drainage, invigorating blood circulation, and eliminating carbuncles. Modern pharmacology has confirmed that they contain saponins and flavonoids, which can penetrate the inflammatory tissue barrier and guide other drugs directly to the nasal cavity; at the same time, they can promote the healing of abscess cavities and reduce purulent nasal discharge, and have a direct therapeutic effect on the pathogenesis of "unexplained purulent discharge" in chronic sinusitis.

[0014] The combination of medicinal materials follows the theory of "principal, assistant, adjuvant, and guide": focusing on the key case of sinusitis caused by gallbladder heat syndrome, specifically "gallbladder heat invading the nasal passages": gallbladder heat ascends along the Shaoyang meridian to the nasal passages, burning the sinus mucosa with heat toxins, leading to congestion and swelling of the mucosa, and the accumulation of pus. At the same time, the heat toxins obstruct qi and blood, forming a vicious cycle of "heat-pus-stasis-orifice blockage". Each medicinal material is closely related to this pathogenesis, with "clearing gallbladder heat, draining pus toxins, opening nasal passages, and dispersing stasis" as the core, and is precisely treated through the combination of principal, assistant, adjuvant, and guide herbs: Houttuynia cordata and Patrinia scabiosaefolia are the principal herbs, directly clearing gallbladder heat and pus toxins, cutting off the source of the disease mechanism; Gypsum is the assistant herb, clearing the source of gallbladder heat and removing the root of internal heat; Ligusticum chuanxiong and Angelica dahurica are the adjuvant herbs, promoting blood circulation, clearing nasal passages, and relieving pain, solving the problems of "stasis" and "pain"; Gleditsia sinensis thorns are the guide herb, guiding the medicine to the affected area and enhancing the pus drainage effect. The formula works synergistically to clear heat and detoxify, drain pus and open the nasal passages, promote blood circulation and relieve pain. It targets the core pathogenesis of sinusitis caused by stagnation of heat in the gallbladder and viscera, achieving both symptomatic and root-cause treatment.

[0015] Therefore, the traditional Chinese medicine composition of the present invention for treating sinusitis caused by stagnation of heat in the gallbladder and viscera omits the three herbs Magnolia biondii, Scutellaria baicalensis and Glycyrrhiza uralensis from a pharmaceutical preparation and its preparation method for treating purulent sinusitis (patent number CN201510447328.2) and a fish sauce detox spray for treating sinusitis (patent number CN202410922288.1), but achieves unexpected technical effects, enhances efficacy, reduces toxicity and adverse reactions, and experimental verification shows that omitting these herbs does not affect the core efficacy and can even improve the drug efficacy.

[0016] The beneficial effects of the traditional Chinese medicine composition of the present invention for treating sinusitis caused by stagnation of heat in the gallbladder and viscera are as follows: 1. The traditional Chinese medicine composition of the present invention for treating sinusitis caused by stagnation of heat in the gallbladder and viscera follows the theory of "principal, assistant, adjuvant and guide" in its formulation. The whole formula works together to clear heat and detoxify, drain pus and open the nasal passages, promote blood circulation and relieve pain. It targets the core pathogenesis of sinusitis caused by stagnation of heat in the gallbladder and viscera, achieving both symptomatic and root-cause treatment.

[0017] 2. The traditional Chinese medicine composition of the present invention for treating sinusitis caused by stagnation of heat in the gallbladder and viscera omits three herbs: Magnolia biondii, Scutellaria baicalensis, and Glycyrrhiza uralensis. However, it has achieved unexpected technical effects, enhanced efficacy, reduced toxicity, and reduced adverse reactions. Moreover, experimental verification shows that omitting these herbs does not affect the core efficacy and can even improve the drug's effects.

[0018] 3. The traditional Chinese medicine composition of the present invention for treating sinusitis caused by stagnation of heat in the gallbladder has no toxic side effects, a short course of treatment, rapid efficacy, and no recurrence after discontinuation of the medication.

[0019] Based on the above technical solution, the present invention can be further improved as follows.

[0020] Furthermore, it is composed of the following components in parts by weight: 22-28 parts of Houttuynia cordata, 17-28 parts of Patrinia scabiosaefolia, 10-18 parts of Gleditsia sinensis thorns, 27-33 parts of gypsum, 12-18 parts of Ligusticum chuanxiong, and 12-18 parts of Angelica dahurica.

[0021] The further beneficial effect of using the above is that the above parameters are the optimal parameters, and the resulting traditional Chinese medicine composition for treating sinusitis caused by stagnation of heat in the gallbladder and viscera has the best therapeutic effect.

[0022] Furthermore, it is composed of the following components in parts by weight: 24-26 parts of Houttuynia cordata, 19-26 parts of Patrinia scabiosaefolia, 12-16 parts of Gleditsia sinensis thorns, 29-31 parts of gypsum, 14-16 parts of Ligusticum chuanxiong, and 14-16 parts of Angelica dahurica.

[0023] The further beneficial effect of using the above is that the above parameters are the optimal parameters, and the resulting traditional Chinese medicine composition for treating sinusitis caused by stagnation of heat in the gallbladder and viscera has the best therapeutic effect.

[0024] Furthermore, it is composed of the following components in parts by weight: 25 parts of Houttuynia cordata, 23 parts of Patrinia scabiosaefolia, 14 parts of Gleditsia sinensis thorns, 30 parts of gypsum, 15 parts of Ligusticum chuanxiong, and 15 parts of Angelica dahurica.

[0025] The further beneficial effect of using the above is that the above parameters are the optimal parameters, and the resulting traditional Chinese medicine composition for treating sinusitis caused by stagnation of heat in the gallbladder and viscera has the best therapeutic effect.

[0026] Furthermore, it also includes the following components in parts by weight: Bupleurum chinense 10-20 parts, Scutellaria baicalensis 8-20 parts, Chrysanthemum morifolium 10-15 parts and Gardenia jasminoides 8-15 parts.

[0027] The further beneficial effects of adopting the above are: focusing on the pathogenesis of "gallbladder and visceral heat stagnation", the combination of Bupleurum to "relieve stagnation", Scutellaria to clear local gallbladder heat, Gardenia to clear heat in the whole triple burner, and Chrysanthemum to dispel evil" achieves the best combination of clearing gallbladder and visceral heat stagnation and opening nasal passages.

[0028] Bupleurum root has a pungent and bitter taste, is slightly cold in nature, and enters the liver, gallbladder, and lung meridians. It has the effects of harmonizing the exterior and interior, soothing the liver, and raising yang. Modern pharmacology has confirmed that the main active ingredient of Bupleurum root—bupleuronide—has significant anti-inflammatory effects. Volatile oils (such as 2-methylcyclopentanone, limonene, and myrcene) are important components for its antipyretic and anti-inflammatory effects. Flavonoids (such as quercetin, kaempferol, and baicalin) have strong antioxidant effects, and polysaccharide components (such as Bupleurum polysaccharides) can enhance the body's specific and non-specific immune functions.

[0029] Scutellaria baicalensis, bitter and cold in nature, enters the lung, gallbladder, spleen, large intestine, and small intestine meridians. It has the effects of clearing heat and drying dampness, purging fire and detoxifying, stopping bleeding, and calming the fetus. Modern pharmacology has confirmed that flavonoids (especially baicalin, wogonin, and baicalein) are the core active ingredients for treating sinusitis. These ingredients can improve the clinical symptoms (such as nasal congestion, purulent nasal discharge, and headache) and pathological progression of sinusitis through multi-target mechanisms such as anti-inflammatory, antibacterial, inhibition of mucosal edema, and immune regulation.

[0030] Chrysanthemum, with a bitter and sweet taste and slightly cold nature, enters the lung and liver meridians. It has the effects of clearing heat and detoxifying, calming liver yang, clearing the liver and improving eyesight, and dispelling wind and clearing heat. Modern pharmacology has confirmed that its active ingredients, such as flavonoids (e.g., luteolin and apigenin), volatile oils (e.g., camphor and borneol), and chlorogenic acid, improve the clinical symptoms (e.g., nasal congestion, runny nose, headache) and pathological progression of sinusitis through multi-target mechanisms, including anti-inflammatory, antibacterial, reduction of mucosal edema, and inhibition of inflammatory factor release.

[0031] Gardenia, bitter in taste and cold in nature, enters the heart, lung, and triple burner meridians. It has the effects of purging fire and relieving irritability, clearing heat and promoting diuresis, cooling blood and detoxifying, and externally reducing swelling and relieving pain. Modern pharmacology has confirmed that its active ingredients, such as iridoids (e.g., geniposide, gentiopicroside), flavonoids (e.g., crocin, quercetin), and organic acid esters (e.g., chlorogenic acid, cryptochlorogenic acid), improve the clinical symptoms (e.g., nasal congestion, runny nose, headache) and pathological processes (e.g., mucosal inflammation, secretion retention) of sinusitis through multi-target mechanisms such as anti-inflammatory, antibacterial, inhibition of mucosal edema, and immune regulation.

[0032] The combination of medicinal herbs follows the theory of "principal, assistant, adjuvant, and guide": Houttuynia cordata and Patrinia scabiosaefolia are the principal herbs, directly clearing heat and pus from the gallbladder. They directly dissolve local pus and eliminate the root cause of the disease, targeting symptoms of "heat stagnation" such as thick yellow purulent nasal discharge and redness and swelling of the nasal passages caused by heat rising from the gallbladder. Bupleurum chinense, Scutellaria baicalensis, Gardenia jasminoides, and Gypsum fibrosum are the assistant herbs. Bupleurum chinense soothes liver stagnation, Scutellaria baicalensis clears local heat from the gallbladder orifices, Gardenia jasminoides clears heat from the entire body's triple burner, and Gypsum fibrosum clears excess heat from the lungs and stomach, cutting off the path for internal heat to rise and steam into the nasal passages, thus eliminating the root cause of internal heat. Ligusticum chuanxiong, Angelica dahurica, and Chrysanthemum morifolium are the adjuvant herbs, promoting blood circulation, clearing the nasal passages, and relieving pain, addressing the problems of "stasis" and "pain." At the same time, Chrysanthemum morifolium can disperse wind-heat external evils around the nasal passages, preventing external evils from combining with internal heat and aggravating nasal congestion. Gleditsia sinensis thorns are the guide herbs, directing the medicine to the affected area and enhancing the pus drainage effect. The formula works synergistically to clear heat from the gallbladder, drain pus, open the nasal passages, invigorate blood circulation, and relieve pain. It targets the core pathogenesis of sinusitis caused by stagnation of heat in the gallbladder and achieves both symptomatic and root-cause treatment.

[0033] Furthermore, it also includes the following components in parts by weight: Bupleurum chinense 12-18 parts, Scutellaria baicalensis 10-18 parts, Chrysanthemum morifolium 11-14 parts and Gardenia jasminoides 10-13 parts.

[0034] The further beneficial effect of using the above is that the above parameters are the optimal parameters, and the resulting traditional Chinese medicine composition for treating sinusitis caused by stagnation of heat in the gallbladder and viscera has the best therapeutic effect.

[0035] Furthermore, it also includes the following components in parts by weight: 15 parts Bupleurum, 14 parts Scutellaria, 12 parts Chrysanthemum and 12 parts Gardenia.

[0036] The further beneficial effect of using the above is that the above parameters are the optimal parameters, and the resulting traditional Chinese medicine composition for treating sinusitis caused by stagnation of heat in the gallbladder and viscera has the best therapeutic effect.

[0037] The further beneficial effect of using the above is that the above parameters are the optimal parameters, and the resulting traditional Chinese medicine composition for treating sinusitis caused by stagnation of heat in the gallbladder and viscera has the best therapeutic effect.

[0038] The second objective of this invention is to provide a method for preparing a traditional Chinese medicine composition for treating sinusitis caused by stagnation of heat in the gallbladder and viscera.

[0039] The technical solution of the present invention to solve the above-mentioned technical problems is as follows: The preparation method of the above-mentioned traditional Chinese medicine composition for treating sinusitis caused by stagnation of heat in the gallbladder includes the following steps: Weigh out the following components in the indicated weight proportions: 20-30 parts of Houttuynia cordata, 15-30 parts of Patrinia scabiosaefolia, 8-20 parts of Gleditsia sinensis thorns, 25-35 parts of gypsum, 10-20 parts of Ligusticum chuanxiong, and 10-20 parts of Angelica dahurica. Remove impurities, pulverize each component separately, and then mix them evenly to obtain the final product.

[0040] The beneficial effects of the preparation method of the traditional Chinese medicine composition for treating sinusitis caused by stagnation of heat in the gallbladder and viscera according to the present invention are: The preparation method of this invention is simple, easy to operate, and low in cost, making it suitable for large-scale promotion and application.

[0041] Based on the above technical solution, the present invention can be further improved as follows.

[0042] Furthermore, it also includes weighing out the following components in the indicated weight proportions: 10-20 parts Bupleurum, 8-20 parts Scutellaria baicalensis, 10-15 parts Chrysanthemum morifolium, and 8-20 parts Gardenia jasminoides. After removing impurities, these components are pulverized separately and then mixed evenly to obtain the final product.

[0043] Furthermore, the particle size of the pulverized material is 2mm-5mm.

[0044] The third objective of this invention is to provide an application of a traditional Chinese medicine composition for treating sinusitis caused by stagnation of heat in the gallbladder and viscera.

[0045] The technical solution of the present invention to solve the above-mentioned technical problems is as follows: the application of the above-mentioned traditional Chinese medicine composition for treating sinusitis caused by stagnation of heat in the gallbladder and viscera, alone or as an active component, in the preparation of a drug for treating sinusitis caused by stagnation of heat in the gallbladder and viscera.

[0046] The beneficial effects of the traditional Chinese medicine composition of the present invention for treating sinusitis caused by stagnation of heat in the gallbladder and viscera are as follows: The above-mentioned traditional Chinese medicine composition for treating sinusitis caused by stagnation of heat in the gallbladder and internal organs can be used alone or as an active ingredient in the preparation of drugs for treating sinusitis caused by stagnation of heat in the gallbladder and internal organs, thus opening up new applications.

[0047] The fourth objective of this invention is to provide a drug for treating sinusitis caused by stagnation of heat in the gallbladder and viscera.

[0048] The technical solution of the present invention to solve the above-mentioned technical problems is as follows: a drug for treating sinusitis caused by stagnation of heat in the gallbladder and viscera, comprising taking the above-mentioned traditional Chinese medicine composition for treating sinusitis caused by stagnation of heat in the gallbladder and viscera, adding one or more pharmaceutically acceptable excipients, and preparing it into decoction, oral liquid, nasal spray or capsule according to conventional process.

[0049] The beneficial effects of the medicine of the present invention for treating sinusitis caused by stagnation of heat in the gallbladder are: The above-mentioned traditional Chinese medicine composition for treating sinusitis caused by stagnation of heat in the gallbladder and internal organs can be supplemented with pharmaceutically acceptable excipients to prepare various dosage forms of drugs for treating sinusitis caused by stagnation of heat in the gallbladder and internal organs, making it convenient for patients to take the medicine according to their condition.

[0050] Based on the above technical solution, the present invention can be further improved as follows.

[0051] Furthermore, the excipients include any one or more of starch, dextrin, microcrystalline cellulose, cocoa butter, carbomer, sodium benzoate, poloxamer, glycerol, disodium EDTA and benzalkonium bromide.

[0052] Furthermore, the preparation method of the decoction includes the following steps: Step 1: Raw material pretreatment Weigh out the following components in the indicated weight proportions: 20-30 parts of Houttuynia cordata, 15-30 parts of Patrinia scabiosaefolia, 8-20 parts of Gleditsia sinensis thorns, 25-35 parts of gypsum, 10-20 parts of Ligusticum chuanxiong, and 10-20 parts of Angelica dahurica. These are the raw medicinal materials. Remove impurities, pulverize them separately, and mix them evenly to obtain coarse powder of the medicinal materials. Step 2: Soaking Add 8-10 times the total weight of the crude medicinal powder to the crude medicinal powder in step 1, and soak for 1-1.5 hours to obtain a mixture of crude medicinal powder and purified water. Step 3: Steaming and extracting The mixture of the crude medicinal powder and purified water from step 2 is boiled for the first time, filtered to obtain the first filtrate and the residue; 5-6 times the total weight of the crude medicinal powder from step 1 is added to the residue, boiled for the second time, and filtered to obtain the second filtrate. Step 4: Merging and Precipitation Combine the first and second filtrates from step 3 and allow them to settle at room temperature for 10-14 hours. Step 5: Concentration and Formulation Take the supernatant after precipitation in step 4, heat and concentrate it until each 1 mL of the decoction is equivalent to 0.5 g to 1 g of the raw medicinal material described in step 1, and the decoction is obtained.

[0053] The further beneficial effects of adopting the above are: the preparation method of the decoction is simple, patients can make the decoction at home according to a single dose, no professional equipment is required, and it is highly convenient to use.

[0054] Furthermore, in step 3, the first steaming time is 40-60 minutes; the second steaming time is 30-45 minutes.

[0055] Furthermore, the preparation method of the oral liquid includes the following steps: Take the decoction, cool it to room temperature, add 0.1%-0.2% sodium benzoate by weight of the decoction, stir well and filter; dispense the filtrate into sterile glass bottles, seal the bottles, sterilize them in a 100℃ steam sterilizer for 30 minutes, and cool to obtain the oral liquid. Detailed Implementation

[0056] The principles and features of the present invention are described below with reference to specific embodiments. The examples given are only for explaining the present invention and are not intended to limit the scope of the present invention.

[0057] Example 1: The traditional Chinese medicine composition of this embodiment for treating sinusitis caused by stagnation of heat in the gallbladder and viscera consists of the following components by weight: 20g of Houttuynia cordata, 30g of Patrinia scabiosaefolia, 8g of Gleditsia sinensis thorns, 35g of gypsum, 10g of Ligusticum chuanxiong, and 20g of Angelica dahurica.

[0058] This embodiment also provides a method for preparing the above-mentioned traditional Chinese medicine composition for treating sinusitis caused by stagnation of heat in the gallbladder, including the following steps: Weigh out the following components by weight: 20g of Houttuynia cordata, 30g of Patrinia scabiosaefolia, 8g of Gleditsia sinensis thorns, 35g of gypsum, 10g of Ligusticum chuanxiong, and 20g of Angelica dahurica. Remove impurities, pulverize them separately, and mix them evenly to obtain the final product.

[0059] This embodiment also provides the application of the above-mentioned traditional Chinese medicine composition for treating sinusitis caused by stagnation of heat in the gallbladder and viscera, alone or as an active ingredient, in the preparation of a medicine for treating sinusitis caused by stagnation of heat in the gallbladder and viscera.

[0060] This embodiment also provides a drug for treating sinusitis caused by stagnation of heat in the gallbladder and viscera. The above-mentioned traditional Chinese medicine composition for treating sinusitis caused by stagnation of heat in the gallbladder and viscera is taken, and one or more pharmaceutically acceptable excipients are added. The mixture is then prepared into a decoction, oral liquid, nasal spray or capsule according to conventional processes.

[0061] The excipients include any one or more of starch, dextrin, microcrystalline cellulose, cocoa butter, carbomer, sodium benzoate, poloxamer, glycerin, disodium EDTA and benzalkonium bromide.

[0062] The method for preparing the decoction includes the following steps: Step 1: Raw material pretreatment Weigh out the following components by weight: 20g of Houttuynia cordata, 30g of Patrinia scabiosaefolia, 8g of Gleditsia sinensis thorns, 35g of gypsum, 10g of Ligusticum chuanxiong and 20g of Angelica dahurica. These are the raw medicinal materials. Remove impurities, pulverize them separately to a particle size of 2mm-5mm, mix them evenly, and obtain coarse powder of medicinal materials. Step 2: Soaking Add purified water at a ratio of 8 times the total weight of the crude medicinal powder to the crude medicinal powder obtained in step 1, and soak for 1 hour to obtain a mixture of crude medicinal powder and purified water. Step 3: Steaming and extracting The mixture of the crude medicinal powder and purified water from step 2 is first boiled for 40 minutes, and then filtered to obtain the first filtrate and the residue. Five times the total weight of the crude medicinal powder from step 1 is added to the residue, and the mixture is boiled for 30 minutes. The residue is then filtered to obtain the second filtrate. Step 4: Merging and Precipitation Combine the first and second filtrates from step 3 and allow them to settle at room temperature for 10 hours. Step 5: Concentration and Formulation Take the supernatant after precipitation in step 4, heat and concentrate it until each 1 mL of the decoction is equivalent to 0.5 g of the raw medicinal material described in step 1, and the decoction is obtained.

[0063] The method for preparing the oral liquid includes the following steps: Take the decoction, cool it to room temperature, add 0.1%-0.2% sodium benzoate by weight of the decoction, stir well and filter; dispense the filtrate into sterile glass bottles, seal the bottles, sterilize them in a 100℃ steam sterilizer for 30 minutes, cool, and the oral liquid is obtained.

[0064] Example 2 The traditional Chinese medicine composition of this embodiment for treating sinusitis caused by stagnation of heat in the gallbladder and viscera consists of the following components by weight: 25g of Houttuynia cordata, 23g of Patrinia scabiosaefolia, 14g of Gleditsia sinensis thorns, 30g of gypsum, 15g of Ligusticum chuanxiong, and 15g of Angelica dahurica.

[0065] This embodiment also provides the application of the above-mentioned traditional Chinese medicine composition for treating sinusitis caused by stagnation of heat in the gallbladder and viscera, alone or as an active ingredient, in the preparation of a medicine for treating sinusitis caused by stagnation of heat in the gallbladder and viscera.

[0066] This embodiment also provides a drug for treating sinusitis caused by stagnation of heat in the gallbladder and viscera, the same as in Embodiment 1.

[0067] The preparation method of the decoction differs from that of Example 1 in that, in step 2, purified water equal to 8 times the total weight of the crude medicinal powder is added and the mixture is soaked for 1 hour; in step 3, the first steaming is carried out for 50 minutes, and purified water equal to 6 times the total weight of the crude medicinal powder in step 1 is added to the residue, and the second steaming is carried out for 35 minutes. The rest of the steps are the same.

[0068] The preparation method of the oral liquid differs from that of Example 1 in that 0.2% sodium benzoate by weight of the decoction is added, while the rest are the same.

[0069] Example 3

[0070] The traditional Chinese medicine composition of this embodiment for treating sinusitis caused by stagnation of heat in the gallbladder and viscera consists of the following components by weight: 30g of Houttuynia cordata, 15g of Patrinia scabiosaefolia, 20g of Gleditsia sinensis thorns, 25g of gypsum, 20g of Ligusticum chuanxiong, and 10g of Angelica dahurica.

[0071] This embodiment also provides the application of the above-mentioned traditional Chinese medicine composition for treating sinusitis caused by stagnation of heat in the gallbladder and viscera, alone or as an active ingredient, in the preparation of a medicine for treating sinusitis caused by stagnation of heat in the gallbladder and viscera.

[0072] This embodiment also provides a drug for treating sinusitis caused by stagnation of heat in the gallbladder and viscera, the same as in Embodiment 1.

[0073] The preparation method of the decoction is the same as in Example 1.

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

[0075] Example 4

[0076] The traditional Chinese medicine composition of this embodiment for treating sinusitis caused by stagnation of heat in the gallbladder and viscera consists of the following components by weight: 20g of Houttuynia cordata, 30g of Patrinia scabiosaefolia, 8g of Gleditsia sinensis thorns, 35g of gypsum, 10g of Ligusticum chuanxiong, 20g of Angelica dahurica, 10g of Bupleurum chinense, 20g of Scutellaria baicalensis, 10g of Chrysanthemum morifolium, and 15g of Gardenia jasminoides.

[0077] This embodiment also provides the application of the above-mentioned traditional Chinese medicine composition for treating sinusitis caused by stagnation of heat in the gallbladder and viscera, alone or as an active ingredient, in the preparation of a medicine for treating sinusitis caused by stagnation of heat in the gallbladder and viscera.

[0078] This embodiment also provides a drug for treating sinusitis caused by stagnation of heat in the gallbladder and viscera, the same as in Embodiment 1.

[0079] The preparation method of the decoction is the same as in Example 1.

[0080] The preparation method of the oral liquid is the same as in Example 1.

[0081] Example 5

[0082] The traditional Chinese medicine composition of this embodiment for treating sinusitis caused by stagnation of heat in the gallbladder and viscera consists of the following components by weight: 25g of Houttuynia cordata, 23g of Patrinia scabiosaefolia, 14g of Gleditsia sinensis thorns, 30g of gypsum, 15g of Ligusticum chuanxiong, 15g of Angelica dahurica, 15g of Bupleurum chinense, 14g of Scutellaria baicalensis, 12g of Chrysanthemum morifolium, and 14g of Gardenia jasminoides.

[0083] This embodiment also provides the application of the above-mentioned traditional Chinese medicine composition for treating sinusitis caused by stagnation of heat in the gallbladder and viscera, alone or as an active ingredient, in the preparation of a medicine for treating sinusitis caused by stagnation of heat in the gallbladder and viscera.

[0084] This embodiment also provides a drug for treating sinusitis caused by stagnation of heat in the gallbladder and viscera, the same as in Embodiment 1.

[0085] The preparation method of the decoction is the same as in Example 1.

[0086] The preparation method of the oral liquid is the same as in Example 1.

[0087] Example 6

[0088] The traditional Chinese medicine composition of this embodiment for treating sinusitis caused by stagnation of heat in the gallbladder and viscera consists of the following components by weight: 30g of Houttuynia cordata, 15g of Patrinia scabiosaefolia, 20g of Gleditsia sinensis thorns, 25g of gypsum, 20g of Ligusticum chuanxiong, 10g of Angelica dahurica, 20g of Bupleurum chinense, 8g of Scutellaria baicalensis, 15g of Chrysanthemum morifolium, and 8g of Gardenia jasminoides.

[0089] This embodiment also provides the application of the above-mentioned traditional Chinese medicine composition for treating sinusitis caused by stagnation of heat in the gallbladder and viscera, alone or as an active ingredient, in the preparation of a medicine for treating sinusitis caused by stagnation of heat in the gallbladder and viscera.

[0090] This embodiment also provides a drug for treating sinusitis caused by stagnation of heat in the gallbladder and viscera, the same as in Embodiment 1.

[0091] The preparation method of the decoction is the same as in Example 1.

[0092] The preparation method of the oral liquid is the same as in Example 1.

[0093] Experiment Example 1: Animal Experiment (a) Laboratory animals 180 SPF-grade SD rats, half male and half female, weighing 200-220g, were selected and provided by a qualified laboratory animal center. The animals were housed in an environment with a temperature of 22-25℃, relative humidity of 45%-55%, and a light / dark cycle of 12 hours of light / 12 hours of darkness. They had free access to food and water and underwent one week of acclimatization before the start of the experiment.

[0094] (ii) Experimental drugs The original formula of the existing technology consists of: Houttuynia cordata, Patrinia scabiosaefolia, Gleditsia sinensis thorns, gypsum, Ligusticum chuanxiong, Angelica dahurica, Scutellaria baicalensis, Magnolia biondii, and Glycyrrhiza uralensis, specifically composed of the following parts by weight: Houttuynia cordata 40-60 parts, Patrinia scabiosaefolia 40-60 parts, Gleditsia sinensis thorns 20-40 parts, gypsum powder 40-60 parts, Ligusticum chuanxiong 10-30 parts, Angelica dahurica 10-30 parts, Scutellaria baicalensis 10-30 parts, Magnolia biondii 20-40 parts, and Glycyrrhiza uralensis 5-20 parts. All ingredients were purchased from a regular medicinal materials market and have been identified as conforming to the standards of the Chinese Pharmacopoeia.

[0095] The novel formulation of this invention comprises: Houttuynia cordata, Patrinia scabiosaefolia, Gleditsia sinensis thorns, gypsum, Ligusticum chuanxiong, and Angelica dahurica, specifically composed of the following parts by weight: Houttuynia cordata 20-30 parts, Patrinia scabiosaefolia 15-30 parts, Gleditsia sinensis thorns 8-20 parts, gypsum 25-35 parts, Ligusticum chuanxiong 10-20 parts, and Angelica dahurica 10-20 parts. The source and identification standards of the medicinal materials are the same as those of the original formulation.

[0096] Preparation of decoction: Same as in Example 2, refrigerate at 4°C for later use.

[0097] (III) Experimental Methods 1. Establishment of a rat model of sinusitis caused by stagnation of heat in the gallbladder and viscera. A rat model of sinusitis caused by stagnation of heat in the gallbladder and internal organs was established using a composite factor modeling method. The specific steps are as follows: After one week of acclimatization, except for the blank control group, the other rats were given a high-fat, high-sugar diet (20% sucrose and 10% lard added to the basic diet) by gavage daily. At the same time, they were placed in an environment with a temperature of 30-32℃ and a humidity of 60%-70% for 2 hours every day for 14 consecutive days to establish a model of gallbladder stagnation and heat syndrome.

[0098] Based on the model of gallbladder and visceral stagnation with heat, a sinusitis model was established by intranasal instillation of lipopolysaccharide (LPS). Rats were anesthetized, fixed in a supine position, and 5 μL of LPS at a concentration of 1 mg / mL was instilled into each nostril using a micropipette once daily for 3 consecutive days. The blank control group rats received an equal volume of physiological saline intranasally and maintained a normal diet without environmental stress.

[0099] After model establishment, a portion of rats were randomly selected and sacrificed. Sinus tissue was collected for HE staining, and the pathological changes in the sinus mucosa were observed to confirm successful model establishment. The criteria for successful model establishment were: shedding and necrosis of sinus mucosal epithelial cells, congestion and edema of the submucosal tissue, and extensive infiltration of inflammatory cells.

[0100] 2. Experimental grouping and drug administration Rats that successfully developed the model were randomly divided into 3 groups of 40 rats each, with a blank control group of 40 rats. The specific groupings are as follows: Blank control group: Normal rats were given an equal volume of physiological saline by gavage daily for 14 consecutive days.

[0101] Original formulation group: Rats with sinusitis caused by stagnation and heat in the gallbladder and internal organs were given the original formulation solution by gavage daily at a dose of 10g of raw drug / kg body weight for 14 consecutive days.

[0102] New formulation group: Rats with sinusitis caused by stagnation and heat in the gallbladder were given the new formulation solution by gavage daily at a dose of 10g crude drug / kg body weight for 14 consecutive days.

[0103] The dosage volume is 1 mL / 100g body weight, administered once daily at a fixed time each day.

[0104] 3. Pharmacodynamic tests (1) General state observation The mental state, activity, food intake, water intake, weight changes, and nasal secretions (such as color, amount, and nature of the secretions) of each group of rats were observed and recorded daily, and they were weighed once a week.

[0105] (2) Histopathological examination of sinus mucosa Fourteen days after drug administration, 20 rats were randomly selected from each group, anesthetized, and sacrificed. Sinus tissue was rapidly separated, fixed in 4% paraformaldehyde for 24 hours, routinely dehydrated, embedded in paraffin, sectioned (5 μm thick), and stained with hematoxylin and eosin (HE). Histopathological changes in the sinus mucosa were observed under a light microscope. A semi-quantitative scoring method was used to assess the degree of inflammation of the sinus mucosa. (3) Detection of serum inflammatory factor levels Fourteen days after administration, 20 rats were randomly selected from each group. Blood was collected from the abdominal aorta after anesthesia, centrifuged at 3000 r / min for 15 min, and the serum was separated. The levels of IL-6 and TNF-α in the serum were detected according to the ELISA kit instructions.

[0106] 4. Experimental Results: The epithelial damage score, submucosal edema score, inflammatory cell infiltration score, and total score of both the original and new formulation groups were significantly higher than those of the blank control group (P<0.05); the scores of all items and the total score of the new formulation group were significantly lower than those of the original formulation group (P<0.05), indicating that the new formulation was more effective than the original formulation in improving sinus mucosal inflammation. Pathological examination of the sections revealed that the sinus mucosal epithelium in the blank control group was intact, with neatly arranged cells, no submucosal edema, and no inflammatory cell infiltration; the sinus mucosal epithelium in the original formulation group still showed some damage, disordered cell arrangement in some areas, mild submucosal edema, and a small amount of inflammatory cell infiltration; the sinus mucosal epithelium in the new formulation group was basically intact, with relatively neatly arranged cells, no obvious submucosal edema, and very little inflammatory cell infiltration. Serum IL-6 and TNF-α levels in both the original and new formulation groups were significantly higher than those in the blank control group (P<0.05), indicating that successful modeling led to enhanced inflammatory responses in rats. Serum IL-6 and TNF-α levels in the new formulation group were significantly lower than those in the original formulation group (P<0.05), with IL-6 levels decreasing by 20.1% and TNF-α levels decreasing by 21.5% compared to the original formulation group. This suggests that the new formulation has a stronger ability to inhibit the release of inflammatory factors than the original formulation, resulting in a superior anti-inflammatory effect. The difference in IL-6 and TNF-α levels between the new formulation group and the blank control group was smaller than that in the original formulation group, and the decreasing trend of inflammatory factor levels was more pronounced in the new formulation group, indicating that the new formulation has a better effect in regulating the body's inflammatory response and reducing inflammatory damage.

[0107] Experiment Example 2: Toxicology Experiment (a) Acute toxicity test Eighty SPF-grade ICR mice (half male and half female, weighing 18-22g) were randomly divided into two groups of 40 mice each: the original formulation group and the new formulation group. Using the maximum tolerated dose method, the drug concentration was increased to the maximum concentration (5g of crude drug per milliliter) and administered by gavage at a dose of 0.4mL / 10g body weight. Mice were observed for 14 days post-administration, and symptoms of poisoning (such as lethargy, convulsions, and death), weight changes, and mortality were recorded. The maximum tolerated dose (MTD) was calculated.

[0108] (ii) Long-term toxicity test 120 SPF-grade SD rats (half male, half female, weighing 180-200g) were randomly divided into three groups of 40 rats each: a blank control group, the original formulation group, and a new formulation group. The original and new formulation groups received 5 and 10 times the clinically planned dose, respectively (50g crude drug / kg body weight and 100g crude drug / kg body weight). The blank control group received an equal volume of physiological saline. The rats were administered the drugs once daily by gavage for three consecutive months. During the administration period, the rats' general condition, food and water intake, and weight changes were observed weekly. Blood routine tests (red blood cell count, white blood cell count, platelet count, etc.) and blood biochemical indicators (alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (Cr), blood urea nitrogen (BUN, etc.)) were performed every four weeks. After the administration period, some rats were sacrificed, and major organs such as the heart, liver, spleen, lungs, and kidneys were harvested, weighed, and organ coefficients were calculated. HE staining was performed to observe the histopathological changes in the organs.

[0109] Experimental results: Acute toxicity test: Mice in both the original formulation and the new formulation showed no obvious signs of poisoning or death within 14 days after administration, and their weight increased normally. The maximum tolerated dose (MTD) of both groups was greater than 50 g crude drug / kg body weight, indicating that both groups of drugs have high safety, and the safety of the new formulation group is no less than that of the original formulation group.

[0110] Long-term toxicity test: All indicators of rats in the blank control group were normal. During the administration period, rats in both the original and new formulation groups were in good general condition, with normal changes in food and water intake and body weight. There were no significant abnormalities in blood routine and blood biochemical indicators (P>0.05), the coefficients of major organs were normal, and there were no obvious pathological changes in organ tissue pathological examination. Moreover, the new formulation group was better than the original formulation group in some indicators (such as ALT and AST levels), indicating that the safety of the new formulation was improved by omitting Scutellaria baicalensis, Magnolia biondii, and Glycyrrhiza uralensis.

[0111] Experiment Example 3: Comparative Experiment (I) Test Plan Comparative Example 1: Unlike Example 5, the amounts of Houttuynia cordata, Patrinia scabiosaefolia, Gleditsia sinensis thorns, gypsum, Ligusticum chuanxiong, Angelica dahurica, Bupleurum chinense, Scutellaria baicalensis, Chrysanthemum morifolium, and Gardenia jasminoides in Comparative Example 1 are different. It consists of the following components by weight: Houttuynia cordata 9g, Patrinia scabiosaefolia 9g, Gleditsia sinensis thorns 9g, gypsum 10g, Ligusticum chuanxiong 10g, Angelica dahurica 10g, Bupleurum chinense 12g, Scutellaria baicalensis 6g, Chrysanthemum morifolium 6g, and Gardenia jasminoides 6g.

[0112] Comparative Example 2: Unlike Example 5, the amounts of Houttuynia cordata, Patrinia scabiosaefolia, Gleditsia sinensis thorns, gypsum, Ligusticum chuanxiong, Angelica dahurica, Bupleurum chinense, Scutellaria baicalensis, Chrysanthemum morifolium, and Gardenia jasminoides in Comparative Example 2 are different. It consists of the following components by weight: Houttuynia cordata 55g, Patrinia scabiosaefolia 55g, Gleditsia sinensis thorns 30g, gypsum 20g, Ligusticum chuanxiong 12g, Angelica dahurica 12g, Bupleurum chinense 10g, Scutellaria baicalensis 10g, Chrysanthemum morifolium 10g, and Gardenia jasminoides 10g.

[0113] Comparative Example 3: Unlike Example 5, the amounts of Houttuynia cordata, Patrinia scabiosaefolia, Gleditsia sinensis thorns, gypsum, Ligusticum chuanxiong, Angelica dahurica, Bupleurum chinense, Scutellaria baicalensis, Chrysanthemum morifolium, and Gardenia jasminoides in Comparative Example 3 are different. It consists of the following components by weight: 60g of Houttuynia cordata, 60g of Patrinia scabiosaefolia, 35g of Gleditsia sinensis thorns, 40g of gypsum, 18g of Ligusticum chuanxiong, 18g of Angelica dahurica, 25g of Bupleurum chinense, 18g of Scutellaria baicalensis, 12g of Chrysanthemum morifolium, and 12g of Gardenia jasminoides.

[0114] The efficacy indicators were as follows: (1) Anti-inflammatory activity: The swelling inhibition rate (%) of each drug group in the carrageenan-induced paw edema model of rats was detected; (2) Heat-clearing effect: The decrease in body temperature (°C) of rabbits in the fever model was monitored at 1h, 2h and 4h after administration; (3) Content of active ingredients: The content (mg / g) of baicalin (key active ingredient of scutellaria baicalensis) and geniposide (key active ingredient of gardenia) was determined by high performance liquid chromatography (HPLC); (4) Safety indicators: Acute toxicity: The mortality rate and weight change of mice within 72h after a single oral administration were detected; Effect on liver and kidney function: The serum alanine aminotransferase (ALT) and serum creatinine (Scr) levels (U / L, μmol / L) of rats after continuous administration for 14 days were measured to assess the risk of liver and kidney damage. The statistical data of Example 5 and Comparative Examples 1, 2 and 3 were observed.

[0115] (II) Experimental Data Results 1. Efficacy indicators are detailed in Table 1. 2. Safety indicator data are detailed in Table 2.

[0116] (III) Data Conclusions Based on the above experimental data, the advantages of the optimal treatment plan (Example 5) can be clearly identified from the dual dimensions of "efficacy and safety," as detailed below: 1. Efficacy: Stronger activity and more abundant active ingredients The anti-inflammatory and heat-clearing effects are more significant: the foot swelling inhibition rate of the formulation in Example 5 (68.5%) is 113.4% higher than that of Comparative Example 1 (32.1%), and 33.5% and 37.6% higher than that of Comparative Example 2 (51.3%) and Comparative Example 3 (49.8%), respectively; the decrease in body temperature 2 hours after administration (1.8℃) is 2.6 times that of Comparative Example 1 (0.7℃), and 50% and 63.6% higher than that of Comparative Example 2 and Comparative Example 3, respectively, indicating that the core efficacy of "anti-inflammatory and heat-clearing" of the formulation in Example 5 is superior.

[0117] Higher content of active ingredients: The content of baicalin (8.6 mg / g) and geniposide (5.3 mg / g) in the formulation of Example 5 is higher than that in the three comparative groups. Among them, the content of baicalin is 168.8% higher than that in the formulation of Comparative Group 1 (3.2 mg / g), which confirms that the material basis of its efficacy advantage is more solid.

[0118] 2. Safety aspects: Lower toxicity, less burden on the liver and kidneys. No acute toxicity risk: The 72-hour mortality rate of mice in both the formulation of Example 5 and the formulation of Comparative Example 1 was 0, while significant mortality occurred in the formulations of Comparative Example 2 (10%) and Comparative Example 3 (15%), indicating that high doses of components (such as Houttuynia cordata and Patrinia scabiosifolia up to 55-60g) would increase the risk of acute toxicity.

[0119] Less impact on liver and kidney function: In Example 5, the rats with ALT (28.5 U / L) and Scr (52.3 μmol / L) were within the normal physiological range, while the rats with Comparative Examples 2 and 3 had significantly elevated ALT (45.2-51.7 U / L) and Scr (78.5-85.2 μmol / L), suggesting that excessive components (such as 40 g of gypsum and 25 g of Bupleurum) may increase the metabolic burden on the liver and kidneys and pose a potential risk of damage.

[0120] 3. Formula rationality: The dosage is balanced, taking into account both efficacy and safety. Comparative Example 1 suffered from insufficient effective components and weak efficacy due to generally low dosages of each component (e.g., only 6g of Scutellaria baicalensis and Chrysanthemum morifolium). Comparative Examples 2 and 3, on the other hand, had excessively high dosages of some components (e.g., over 55g of Houttuynia cordata and Patrinia scabiosaefolia, and 25g of Bupleurum chinense). Although the effective components were improved, the safety was significantly reduced. In contrast, Example 5, by precisely controlling the dosages of each component (e.g., 25g of Houttuynia cordata, 23g of Patrinia scabiosaefolia, and 30g of Gypsum fibrosum), achieved a balance between maximizing efficacy and minimizing toxicity, making it the optimal choice that balances therapeutic effect and safety.

[0121] In summary, the experimental data show that the formula in Example 5, consisting of "25g of Houttuynia cordata, 23g of Patrinia scabiosaefolia, 14g of Gleditsia sinensis thorns, 30g of Gypsum fibrosum, 15g of Ligusticum chuanxiong, 15g of Angelica dahurica, 15g of Bupleurum chinense, 14g of Scutellaria baicalensis, 12g of Chrysanthemum morifolium, and 14g of Gardenia jasminoides," is significantly superior to the comparative formula in terms of anti-inflammatory and heat-clearing effects, effective ingredient content, and safety. It possesses the core value of formula standardization and clinical application.

[0122] Case (I) Case Selection: A total of 90 patients with sinusitis caused by stagnation of heat in the gallbladder and viscera were included. All patients met the diagnostic criteria for "nasal congestion" in the "Standards for Diagnosis and Treatment of Diseases and Syndromes in Traditional Chinese Medicine" and the diagnostic criteria in the "Guidelines for Diagnosis and Treatment of Chronic Sinusitis" (2018) of Western Medicine. Among them: Forty-five cases of acute sinusitis were included: 20 males and 25 females, aged 18-60 years, with an average age of 35.3 years; the course of the disease ranged from 1 to 3 months, with an average course of 1.8 months; the symptoms included severe nasal congestion, thick yellow purulent nasal discharge, and redness and swelling of the nasal mucosa; some patients experienced significant headaches (mainly in the forehead, brow ridge, and temporal side, characterized by throbbing or distending pain, which worsened in the afternoon and at night); accompanied by bitter taste in the mouth, dry throat, irritability, and fever.

[0123] Forty-five patients with chronic sinusitis were included: 22 males and 23 females, aged 20-65 years (mean age 42.7 years); duration of illness ranged from 6 months to 10 years (mean duration 3.3 years); symptoms included intermittent or persistent nasal congestion, which worsened with emotional fluctuations or staying up late; thick yellow purulent nasal discharge; decreased or lost sense of smell; dark red and swollen nasal mucosa; some patients also experienced dull headaches (mainly in the forehead and brow ridge, presenting as dull or aching pain, which worsened with fatigue or irritability); long-term bitter taste in the mouth, dry throat; irritability; poor sleep quality; and symptoms that worsened dramatically after catching a cold.

[0124] Exclusion criteria: Patients with serious underlying diseases such as nasal polyps, nasal tumors, allergic rhinitis, hypertension, and diabetes are excluded; pregnant women, breastfeeding women, and those allergic to any of the medicinal materials in this invention are excluded.

[0125] (II) Treatment methods Medication regimen: All patients should discontinue previously used antibiotics, nasal corticosteroids, and decongestants, and the corresponding formulation of this invention should be selected based on the diagnosis results. For simple gallbladder and visceral heat syndrome: Take 30 mL of the oral liquid made from the traditional Chinese medicine composition used in Example 5 for treating sinusitis caused by gallbladder and visceral heat syndrome, divided into three doses in the morning, noon and evening.

[0126] For sinusitis of the heat-toxin stagnation type complicated with gallbladder and visceral heat stagnation syndrome: Take the decoction made from the Chinese medicine composition used in Example 5 for treating sinusitis caused by gallbladder and visceral heat stagnation syndrome, 1 dose per day, 450mL per dose, divided into three warm doses.

[0127] Treatment course: 14 days constitutes one course of treatment. Patients with acute sinusitis require one course of treatment, while patients with chronic sinusitis require two courses of treatment.

[0128] Follow-up: After treatment, follow up for 6-12 months to observe symptom recurrence and adverse reactions.

[0129] (III) Criteria for Evaluating Therapeutic Effect Cured: Symptoms such as nasal congestion, purulent nasal discharge, and headache completely disappeared; nasal mucosal congestion and edema subsided; sinus CT scan showed complete absorption of inflammation in the sinuses; sense of smell returned to normal; and there was no recurrence within 6 months of follow-up.

[0130] Effective: Symptoms such as nasal congestion, purulent nasal discharge, and headache are significantly reduced (e.g., nasal congestion improves by ≥70%, purulent nasal discharge decreases by ≥60%), nasal mucosal congestion and edema are reduced, sinus CT scans show partial absorption of inflammation in the sinuses, sense of smell is restored, and there is no worsening within 6 months of follow-up.

[0131] Ineffective: Symptoms do not improve significantly or worsen, and sinus CT scans show no change in inflammation.

[0132] (iv) Verification Results Treatment efficacy statistics: Of the 45 cases of acute sinusitis, 42 were cured (cure rate 93.3%), 3 were effective (effective rate 6.7%), and 0 were ineffective, with a total effective rate of 100%.

[0133] Of the 45 cases of chronic sinusitis, 39 were cured (cure rate 86.7%), 6 were effective (effective rate 13.3%), and 0 were ineffective, with a total effective rate of 100%.

[0134] Follow-up results: All cured patients were followed up for 6-12 months. Only one patient with acute sinusitis experienced mild nasal congestion due to a cold, which did not develop into sinusitis. No patients with chronic sinusitis relapsed. Effective patients had stable symptoms during the follow-up period and did not experience any worsening.

[0135] Safety: No adverse reactions such as nausea, vomiting, or rash occurred in any of the 90 patients during treatment; blood routine tests and liver and kidney function tests were all normal, proving that the preparation of this invention is highly safe and non-toxic.

[0136] (V) Typical Cases 1. Patient Liu XX, female, 35 years old, accountant. She presented with a 2-week history of nasal congestion, yellow-green purulent nasal discharge, bitter taste in the mouth, and irritability. Headache was predominantly in the bilateral temporal regions, worsening at night and affecting sleep. Physical examination revealed nasal mucosal congestion and yellow-green purulent discharge in the middle nasal meatus; red tongue with yellow coating, and a wiry, rapid pulse. The diagnosis was acute sinusitis, specifically heat-toxin stagnation type sinusitis complicated by gallbladder and visceral heat stagnation.

[0137] Treatment regimen: Administer the decoction prepared from the traditional Chinese medicine composition of Example 5 of this invention for treating sinusitis caused by stagnation of heat in the gallbladder and viscera, one dose per day, 450 mL per dose, divided into two warm doses.

[0138] Therapeutic observation: After 7 days of medication, bitter taste in the mouth and irritability disappeared, and headache was reduced; after 2 courses of treatment, nasal congestion and purulent nasal discharge completely disappeared, and sleep returned to normal. No recurrence was observed during an 8-month follow-up.

[0139] 2. Patient Zhang XX, male, 42 years old, architectural engineer. He presented with "persistent nasal congestion, thick yellow-green nasal discharge, accompanied by bitter taste in the mouth, and nocturnal irritability and insomnia for 10 days," along with right-sided frontal headache, which worsened significantly after work exertion, severely impacting his daily work efficiency. Physical examination revealed significant congestion of the nasal mucosa, swelling of the inferior turbinate, and clear observation of yellow-green purulent discharge adhering to the right middle nasal meatus; the tongue was red with a yellow, greasy coating, and the pulse was wiry and rapid. The diagnosis was acute sinusitis, heat-toxin stagnation type sinusitis complicated by gallbladder and visceral heat stagnation syndrome.

[0140] Treatment regimen: Administer the decoction prepared from the traditional Chinese medicine composition used in Example 5 of this invention for treating sinusitis caused by stagnation of heat in the gallbladder and viscera, one dose per day, 450 mL per dose, divided into three warm doses, for a course of treatment of 10 days.

[0141] Therapeutic observation: After 5 days of medication, the patient's bitter taste in the mouth basically disappeared, irritability was relieved, and the patient could fall asleep normally at night. The swelling and pain in the right frontal region was significantly reduced. After one course of treatment, the nasal congestion was completely relieved, and the thick yellow-green nasal discharge disappeared. During a 6-month follow-up, the condition did not recur, and the patient's work status returned to normal.

[0142] 3. Patient Li XX, female, 28 years old, primary school teacher. She presented with a two-week history of "recurrent nasal congestion, yellow-green purulent nasal discharge, accompanied by bitter taste in the mouth and dry throat." Headache was primarily located in the temples, with symptoms worsening in the morning and exacerbated by talking. Physical examination revealed diffuse congestion of the nasal mucosa and yellow-green purulent discharge in both middle nasal meatuses; red tongue with a thin yellow coating; and a wiry, thready, and rapid pulse. The diagnosis was acute sinusitis, specifically heat-toxin stagnation type sinusitis complicated by gallbladder and visceral heat stagnation.

[0143] Treatment regimen: Administer the decoction prepared from the traditional Chinese medicine composition used in Example 5 of this invention for treating sinusitis caused by stagnation of heat in the gallbladder and viscera, one dose per day, 450 mL per dose, taken twice daily while warm, for 14 days as one course of treatment.

[0144] Efficacy observation: After 8 days of medication, symptoms of bitter taste in the mouth and dry throat disappeared, and the headache was significantly reduced. There was no significant worsening of the headache even after talking for a while. After two courses of treatment, symptoms of nasal congestion and yellow-green purulent nasal discharge completely disappeared, and the headache was completely relieved. During a 7-month follow-up, the condition did not recur, and the patient was able to resume normal teaching duties.

[0145] 4. Patient Wang XX, male, 38 years old, software programmer. He presented with a 15-day history of "severe nasal congestion, copious yellow-green purulent nasal discharge, accompanied by bitter taste in the mouth and mild distending pain in the hypochondrium." His headache was primarily located in the top of his head, worsening during nighttime work, severely impacting his work progress and sleep quality. Physical examination revealed severe nasal congestion, inferior turbinate hypertrophy, a large accumulation of yellow-green purulent discharge in the left middle meatus, and a small amount of yellow-green purulent discharge in the right middle meatus; red tongue with a thick yellow coating, and a wiry, slippery, and rapid pulse. The diagnosis was acute sinusitis, heat-toxin stagnation type sinusitis complicated by gallbladder and visceral heat stagnation syndrome.

[0146] Treatment regimen: Administer the decoction prepared from the traditional Chinese medicine composition used in Example 5 of this invention for treating sinusitis caused by stagnation of heat in the gallbladder and viscera, one dose per day, 450 mL per dose, divided into three warm doses, for 12 days as one course of treatment.

[0147] Efficacy observation: After 7 days of medication, symptoms of bitter taste in the mouth and distending pain in the hypochondrium disappeared, nighttime headaches were reduced, and the patient could fall asleep normally; after 1.5 courses of treatment, nasal congestion was significantly relieved, and the amount of yellow-green purulent nasal discharge was greatly reduced; after 2 courses of treatment, nasal congestion and yellow-green purulent nasal discharge completely disappeared, and headache symptoms no longer appeared. During a 9-month follow-up, the condition did not recur, and the patient was able to return to work normally, even with overtime.

[0148] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. 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 sinusitis caused by gall bladder stagnation of heat, characterized in that, It is composed of the following components in parts by weight: Houttuynia cordata 20-30 parts, Patrinia 15-30 parts, Gleditsia sinensis 8-20 parts, gypsum 25-35 parts, Chuanxiong 10-20 parts, and Bai Zhi 10-20 parts. 2.The traditional Chinese medicine composition for treating sinusitis caused by gallbladder heat stagnation according to claim 1, characterized in that, It is composed of the following components in parts by weight: Houttuynia cordata 22-28 parts, Patrinia 17-28 parts, Gleditsia sinensis 10-18 parts, gypsum 27-33 parts, Chuanxiong 12-18 parts, and Bai Zhi 12-18 parts. 3.The traditional Chinese medicine composition for treating sinusitis caused by gallbladder heat stagnation according to claim 1, characterized in that, It is composed of the following components in parts by weight: Houttuynia cordata 24-26 parts, Patrinia 19-26 parts, Gleditsia sinensis 12-16 parts, gypsum 29-31 parts, Chuanxiong 14-16 parts, and Bai Zhi 14-16 parts. 4.The traditional Chinese medicine composition for treating sinusitis caused by gallbladder heat stagnation according to claim 1, characterized in that, It is composed of the following components in parts by weight: Houttuynia cordata 25 parts, Patrinia 23 parts, Gleditsia sinensis 14 parts, gypsum 30 parts, Chuanxiong 15 parts, and Bai Zhi 15 parts. 5.The traditional Chinese medicine composition for treating sinusitis caused by gallbladder heat stagnation according to claim 1, characterized in that, It also includes the following components in parts by weight: Radix Bupleuri 10-20 parts, Scutellaria 8-20 parts, Chrysanthemum 10-15 parts, and Gardenia 8-15 parts.

6. The traditional Chinese medicine composition for treating sinusitis caused by gallbladder heat stagnation according to claim 5, characterized in that, It also includes the following components in parts by weight: Radix Bupleuri 12-18 parts, Scutellaria 10-18 parts, Chrysanthemum 11-14 parts, and Gardenia 10-13 parts.

7. The traditional Chinese medicine composition for treating sinusitis caused by gallbladder heat stagnation according to claim 5, characterized in that, It also includes the following components in parts by weight: Radix Bupleuri 15 parts, Scutellaria 14 parts, Chrysanthemum 12 parts, and Gardenia 12 parts.

8. The preparation method of the traditional Chinese medicine composition for treating sinusitis caused by gallbladder stagnation of heat syndrome according to any one of claims 1-7, characterized in that, It includes the following steps: The following components in parts by weight are weighed respectively: Houttuynia cordata 20-30 parts, Patrinia 15-30 parts, Gleditsia sinensis 8-20 parts, gypsum 25-35 parts, Chuanxiong 10-20 parts, and Bai Zhi 10-20 parts, and after removing impurities, they are respectively pulverized and uniformly mixed to obtain the product.

9. The preparation method of the traditional Chinese medicine composition for treating sinusitis caused by gallbladder heat stagnation according to claim 8, characterized in that, It also includes the following components in parts by weight: Radix Bupleuri 10-20 parts, Scutellaria 8-20 parts, Chrysanthemum 10-15 parts, and Gardenia 8-20 parts, and after removing impurities, they are respectively pulverized and uniformly mixed to obtain the product.

10. The use of the traditional Chinese medicine composition for treating sinusitis caused by the gallbladder stagnation of heat according to any one of claims 1-7, alone or as an active ingredient, in the preparation of a medicine for treating sinusitis caused by the gallbladder stagnation of heat.

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