Traditional Chinese medicine preparation for treating or improving chronic rhinitis

Abstract

The application provides a traditional Chinese medicine preparation for treating or improving chronic rhinitis, and relates to the field of traditional Chinese medicine pharmacy, and the traditional Chinese medicine preparation is composed of Herba Patriniae, Herba Siegesbeckiae, Pericarpium Zanthoxyli, Radix Oxytropidis, Radix Adenophorae, Radix Ophiopogonis, Polygonatum, Rhizoma Sparganii, Fructus Kochiae, Herba Schizonepetae, Cortex Dictamni, Pericarpium Lycii, Herba Gnaphalii. The traditional Chinese medicine preparation can effectively inhibit the excessive inflammatory response of HNEpC induced by LPS, can also significantly reduce the VAS score, SNOT-20 score and endoscopic Lund-Kennedy score of chronic rhinitis patients, effectively relieves the core symptoms such as nasal congestion, rhinorrhea and hyposmia, reduces the negative influence of the disease on the sleep, emotion and daily activities of the patients, reduces the nasal mucosal edema and abnormal secretion, promotes the repair of damaged mucosa, and effectively improves the organic lesion of the nasal cavity. The traditional Chinese medicine preparation has a high total clinical treatment rate, provides a more optimal and safer new scheme for the clinical treatment of chronic rhinitis, and has important clinical application value.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine manufacturing, specifically to a traditional Chinese medicine preparation for treating or improving chronic rhinitis. Background Technology

[0002] Chronic rhinitis is a chronic inflammation of the nasal mucosa and submucosa, characterized by inflammation lasting more than 3 months or recurring episodes, making it difficult to cure. Clinical manifestations include nasal congestion, runny nose, decreased sense of smell, and facial swelling and pain. The course of the disease is prolonged and recurrent, severely impacting quality of life. Chronic rhinitis is a chronic upper respiratory tract disease with a global prevalence of approximately 10%-20%. The self-reported prevalence of allergic rhinitis in the Chinese population is 17.6%, and the incidence is on the rise. The pathogenesis of chronic rhinitis is complex. Modern medicine believes it is related to multiple factors, including nasal mucosal inflammation and immune imbalance, epithelial cell damage, neurological dysfunction, and environmental stimuli. Current clinical treatment focuses on symptom relief, commonly using corticosteroids, antihistamines, and surgical intervention. While these methods can alleviate symptoms, they also present problems such as drug resistance, high recurrence rates, and significant side effects.

[0003] Traditional Chinese medicine (TCM) categorizes chronic rhinitis as "nasal obstruction," believing its pathogenesis is closely related to dysfunction of the lungs, spleen, liver, and kidneys. The core pathogenesis is often attributed to lung and spleen qi deficiency, damp-heat accumulation in the nose, blood stasis in the nasal passages, and yin deficiency causing nasal dryness. Treatment adheres to the core principle of "differentiating syndromes and treating accordingly, addressing both the root cause and the symptoms." While existing TCM prescriptions and preparations have achieved some clinical efficacy, several shortcomings remain: First, the formulations lack specificity, failing to accurately target the core pathogenesis of chronic rhinitis—"inflammatory and immune imbalance, lung yin deficiency combined with damp-heat obstruction"—often focusing on single-minded elimination of pathogens or tonification of the body, leading to unstable efficacy. Second, some preparations suffer from redundant formulations or missing key components, failing to achieve synergistic effects and resulting in a low overall clinical efficacy rate. Third, safety evaluations are insufficient; long-term use of some preparations containing bitter-cold or warm-drying ingredients can damage spleen and stomach function or cause adverse reactions such as nasal dryness, affecting patient compliance.

[0004] In summary, existing treatments for chronic rhinitis suffer from drawbacks such as incomplete symptom relief, high risk of adverse reactions, and poor pathological repair. There is an urgent need to develop a scientifically formulated, effective, and safe traditional Chinese medicine preparation to compensate for the shortcomings of existing technologies and meet clinical treatment needs. Summary of the Invention

[0005] (a) Technical problems to be solved

[0006] In view of the shortcomings of the prior art, the present invention provides a traditional Chinese medicine preparation for treating or improving chronic rhinitis.

[0007] (II) Technical Solution

[0008] To achieve the above objectives, the present invention provides the following technical solution:

[0009] This invention provides a traditional Chinese medicine preparation for treating or improving chronic rhinitis. The preparation is composed of the following raw materials in parts by weight: 15-35 parts of Patrinia scabiosaefolia, 15-35 parts of Siegesbeckia orientalis, 3-21 parts of Gynostemma pentaphyllum, 5-25 parts of Oroxylum indicum, 10-30 parts of Adenophora stricta, 10-30 parts of Ophiopogon japonicus, 8-27 parts of Polygonatum odoratum, 5-25 parts of Sparganium stoloniferum, 3-21 parts of Kochia scoparia, 5-25 parts of Schizonepeta tenuifolia, 3-20 parts of Dictamnus dasycarpus, 5-25 parts of Lycium chinense, and 3-21 parts of Lysimachia christinae.

[0010] Specifically, the traditional Chinese medicine preparation is composed of the following raw materials in parts by weight: 20-30 parts of Patrinia scabiosaefolia, 20-30 parts of Siegesbeckia orientalis, 8-18 parts of Gynostemma pentaphyllum, 10-20 parts of Oroxylum indicum, 15-25 parts of Adenophora stricta, 15-25 parts of Ophiopogon japonicus, 13-22 parts of Polygonatum odoratum, 10-20 parts of Sparganium stoloniferum, 7-16 parts of Kochia scoparia, 10-20 parts of Schizonepeta tenuifolia, 5-15 parts of Dictamnus dasycarpus, 10-20 parts of Lycium chinense, and 7-16 parts of Lysimachia christinae.

[0011] Specifically, the traditional Chinese medicine preparation is composed of the following raw materials in parts by weight: 25 parts of Patrinia scabiosaefolia, 25 parts of Siegesbeckia orientalis, 13 parts of Gynostemma pentaphyllum, 15 parts of Oroxylum indicum, 20 parts of Adenophora stricta, 20 parts of Ophiopogon japonicus, 18 parts of Polygonatum odoratum, 15 parts of Sparganium stoloniferum, 12 parts of Kochia scoparia, 15 parts of Schizonepeta tenuifolia, 10 parts of Dictamnus dasycarpus, 15 parts of Lycium chinense, and 12 parts of Lysimachia christinae.

[0012] This invention provides a method for preparing a traditional Chinese medicine preparation for treating or improving chronic rhinitis. The traditional Chinese medicine preparation is prepared into an oral dosage form, including pills, powders, granules, oral liquids, decoctions, and tablets, using conventional pharmaceutical methods and with medically acceptable excipients.

[0013] Specifically, a method for preparing a traditional Chinese medicine decoction for treating or improving chronic rhinitis includes the following steps:

[0014] (1) Weigh each Chinese herbal raw material according to the above weight proportions, add 10 times the volume of distilled water and soak for 30 min; first boil over high heat, then simmer over low heat for 30 min, filter and collect the first decoction.

[0015] (2) Add 8 times the volume of distilled water to the dregs and boil for 20 minutes. Filter and collect the second decoction. Combine the two decoctions to obtain the final product.

[0016] This invention provides the application of the aforementioned traditional Chinese medicine preparation in the preparation of drugs for the prevention and / or treatment of chronic rhinitis.

[0017] The pharmacological effects of each Chinese herbal raw material in the Chinese herbal preparation described in this invention are as follows:

[0018] *Patrinia scabiosifolia*: The whole herb, including roots, of *Patrinia scabiosifolia* or *Patrinia scabiosifolia*, belonging to the genus *Patrinia* of the family Valerianaceae. It has a bitter taste and neutral properties, and enters the liver, stomach, and large intestine meridians. It possesses the effects of clearing heat and detoxifying, draining pus and breaking up blood stasis. It is used for intestinal abscesses, diarrhea, leukorrhea, postpartum abdominal pain due to blood stasis, red and swollen eyes, carbuncles, and scabies.

[0019] Siegesbeckia orientalis: The dried aerial parts of Siegesbeckia orientalis, belonging to the Asteraceae family. It has a pungent and bitter taste, is cold in nature, and enters the liver and kidney meridians; it has the effects of dispelling wind and dampness, benefiting joints, and detoxifying. It is used for rheumatic pain, weakness of muscles and bones, soreness of the lower back and knees, numbness of the limbs, hemiplegia, and rashes and eczema.

[0020] Tianjiangke: The fruit shell of the plant *Cynanchum paniculatum*, belonging to the Asclepiadaceae family. It has a salty taste and neutral properties, and enters the lung and kidney meridians; it has the effects of clearing the lungs and resolving phlegm, dispersing blood stasis and stopping bleeding. It is used for cough with excessive phlegm, asthma, whooping cough, epilepsy, incomplete measles eruption, traumatic injuries, and external bleeding.

[0021] Oroxylum indicum: The dried, mature seeds of the Oroxylum indicum plant, belonging to the Bignoniaceae family. It tastes bitter and sweet, is cool in nature, and enters the lung, liver, and stomach meridians; it has the effects of clearing the lungs and relieving sore throat, soothing the liver and harmonizing the stomach. It is used for cough due to lung heat, sore throat, hoarseness, and liver and stomach pain.

[0022] Adenophora stricta: The dried root of Adenophora stricta or Adenophora spp., both belonging to the Campanulaceae family. It has a sweet taste and slightly cold nature, and enters the lung and stomach meridians; it nourishes yin and clears the lungs, benefits the stomach and promotes fluid production, resolves phlegm, and invigorates qi. It is used for dry cough due to lung heat, consumptive cough due to yin deficiency, dry cough with sticky phlegm, stomach yin deficiency, poor appetite and vomiting, qi and yin deficiency, and irritability and dry mouth.

[0023] Ophiopogon japonicus: The dried tuberous root of Ophiopogon japonicus, a plant in the Liliaceae family. It has a sweet and slightly bitter taste, is slightly cold in nature, and enters the heart, lung, and stomach meridians. It nourishes yin and generates fluids, moistens the lungs and clears the heart. It is used for dry cough due to lung dryness, consumptive cough due to yin deficiency, sore throat, thirst due to fluid depletion, internal heat and thirst, irritability and insomnia, and constipation due to intestinal dryness.

[0024] Polygonatum odoratum: The dried rhizome of Polygonatum odoratum, a plant in the Liliaceae family. It has a sweet taste and slightly cold nature, and enters the lung and stomach meridians; it nourishes yin and moistens dryness, promotes body fluid production and quenches thirst. It is used for lung and stomach yin deficiency, dry cough due to heat, dry throat and thirst, and internal heat with thirst.

[0025] Sparganium rhizome: The dried tuber of Sparganium rhizome (family Trigonaceae). It has a pungent and bitter taste, is neutral in nature, and enters the liver and spleen meridians; it has the effects of breaking up blood stasis, promoting qi circulation, eliminating stagnation, and relieving pain. It is used for abdominal masses, dysmenorrhea, amenorrhea due to blood stasis, chest pain, and abdominal distension due to food stagnation.

[0026] Kochia scoparia fruit: The dried, ripe fruit of the Kochia scoparia plant (family Chenopodiaceae). It has a pungent and bitter taste, is cold in nature, and enters the kidney and bladder meridians; it has the effects of clearing heat and dampness, dispelling wind and relieving itching. It is used for painful urination, vaginal itching and leukorrhea, urticaria, eczema, and itchy skin.

[0027] Catnip: The dried aerial parts of the catnip plant (Nepeta cataria), belonging to the Lamiaceae family. It has a pungent taste and slightly warm nature, and enters the lung and liver meridians; it has the effects of relieving exterior syndromes, dispersing wind, promoting rash eruption, and eliminating sores. It is used for colds, headaches, measles, rubella, and early-stage sores.

[0028] Dictamnus dasycarpus root bark: The dried root bark of Dictamnus dasycarpus, a plant in the Rutaceae family. It is bitter and cold in nature, and enters the spleen, stomach, and bladder meridians; it has the effects of clearing heat and drying dampness, dispelling wind and detoxifying. It is used for damp-heat sores, weeping eczema, urticaria, scabies, rheumatic arthralgia, jaundice, and dark urine.

[0029] Lycium bark: The dried root bark of Lycium barbarum or Lycium chinense, both belonging to the Solanaceae family. It is sweet in taste and cold in nature, and enters the lung, liver, and kidney meridians; it has the effects of cooling the blood and relieving steaming heat, clearing the lungs and reducing fire. It is used for yin deficiency with tidal fever, night sweats due to bone steaming, cough due to lung heat, hemoptysis, epistaxis, and thirst due to internal heat.

[0030] *Salvia splendens*: The dried aerial parts of *Salvia splendens*, a plant in the Lamiaceae family. It has a bitter and pungent taste, is neutral in nature, and enters the liver and spleen meridians; it has the effects of clearing heat and detoxifying, promoting blood circulation and regulating qi, and relieving pain. It is used for acute and chronic hepatitis, abdominal distension and pain, damp-heat leukorrhea, mastitis, boils, esophageal obstruction, phlegm and asthma, and scrofula.

[0031] (III) Beneficial Effects

[0032] This invention provides a traditional Chinese medicine preparation for treating or improving chronic rhinitis. The preparation comprises *Patrinia scabiosaefolia*, *Siegesbeckia orientalis*, *Citrus aurantium*, *Oroxylum indicum*, *Adenophora stricta*, *Ophiopogon japonicus*, *Polygonatum odoratum*, *Sparganium stoloniferum*, *Kochia scoparia*, *Schizonepeta tenuifolia*, *Dictamnus dasycarpus*, *Lycium chinense*, and *Helianthus angustifolia*. The core treatment principle of this formula is to dispel wind and dampness, clear heat and relieve itching, directly addressing the key pathogenesis of chronic rhinitis. This formula uses *Kochia scoparia*, *Dictamnus dasycarpus*, and *Siegesbeckia orientalis* as the principal herbs. These three herbs work synergistically, being bitter and cold without being drying or pungent, dispelling wind without harming yin, directly targeting the symptoms of damp-heat and wind-evil in chronic rhinitis. Kochia scoparia fruit excels at clearing heat and dampness, dispelling wind and relieving itching; its medicinal power can directly reach the nasal passages, clearing away local damp-heat. Dictamnus dasycarpus root bark clears heat and dries dampness, dispels wind and detoxifies; it can clear damp-heat in the nasal passages, reduce mucosal swelling, and improve symptoms such as nasal congestion caused by damp-heat. Siegesbeckia orientalis dispels wind and dampness, clears heat and unblocks the meridians; it can disperse wind evil on the skin surface and in the nasal passages, and clear away latent damp-heat in the meridians. Patrinia scabiosaefolia, Hedyotis diffusa, Gynostemma pentaphyllum, and Lycium chinense root bark are used as assistant herbs; the four herbs work synergistically to enhance the clearing and detoxifying power of the principal herb and penetrate deep into the blood and phlegm channels. Patrinia scabiosaefolia clears heat and detoxifies, eliminates carbuncles and drains pus, invigorates blood and relieves pain. It not only assists the principal herb in clearing damp-heat and toxic pathogens from the nasal passages, but also invigorates blood and removes blood stasis, improving mucosal stasis caused by pathogenic toxins. Hedyotis diffusa clears heat and detoxifies, invigorates blood and disperses nodules, and is particularly good at resolving nasal mucosal thickening caused by the mutual binding of blood stasis and heat. Gynostemma pentaphyllum clears the lungs and resolves phlegm, benefits the throat and unblocks the meridians, and can restrain the bitter and cold nature of the principal herb, preventing damage to the spleen and stomach. Lycium chinense root bark clears deficiency heat, cools the blood and eliminates steaming heat, targeting the yin deficiency and internal heat caused by the long-term depletion of lung yin due to chronic rhinitis. Adenophora stricta, Ophiopogon japonicus, Polygonatum odoratum, and Sparganium stoloniferum are used as adjuvant herbs. The four herbs work together to supplement the deficiencies of the principal and adjuvant herbs and restrain the bias of the medicinal properties, achieving the goal of eliminating pathogens without harming the body's vital energy and supporting the body's vital energy without retaining pathogens. The three herbs, Adenophora stricta, Ophiopogon japonicus, and Polygonatum odoratum, are sweet, cool, and moistening, effectively nourishing Yin and moistening the lungs and nasal passages. They are particularly beneficial for repairing the nasal mucosal barrier, addressing the depletion of lung Yin caused by chronic rhinitis. Sparganium rhizome promotes blood circulation, regulates Qi, eliminates stagnation, and relieves pain, enhancing the blood-activating and stagnation-dispersing effects of the other herbs, particularly for stubborn thickening of the nasal mucosa and nasal congestion. Schizonepeta tenuifolia and Oroxylum indicum are used as guiding herbs. Schizonepeta tenuifolia dispels wind, releases the exterior, promotes rash eruption, and clears the nasal passages; Oroxylum indicum is light and ascending, effectively clearing the lungs and soothing the throat. The combination of these two herbs not only balances the bitter and cold nature of the principal and guiding herbs but also guides the other herbs into the nasal passages, enhancing their wind-dispelling and nasal-clearing effects. Simultaneously, it harmonizes the overall cold and hot properties of the formula, ensuring a synergistic effect across all the herbs.

[0033] Based on the combined data from in vitro experiments and clinical studies, the traditional Chinese medicine preparation of this invention has the following significant beneficial effects:

[0034] 1. The traditional Chinese medicine preparation of this invention can effectively inhibit the excessive inflammatory response of lipopolysaccharide-induced nasal mucosal epithelial cells (HNEpC). Its molecular mechanism is that it can simultaneously downregulate the expression of pro-inflammatory factors (such as TNF-α and IL-4) and upregulate the expression of anti-inflammatory factors (such as IL-10), thereby regulating the inflammatory immune balance and blocking the core pathological links of the disease at the cellular level.

[0035] 2. Clinical trials have confirmed that the traditional Chinese medicine preparation of this invention can significantly reduce the Visual Analogue Scale (VAS) score of nasal symptoms in patients with chronic rhinitis, effectively relieving core symptoms such as nasal congestion, runny nose, and decreased sense of smell. Simultaneously, the traditional Chinese medicine preparation of this invention can significantly reduce the score of the Nasal and Sinus Outcome Test (SNOT-20), mitigating the negative impact of the disease on patients' sleep, mood, and daily activities, thus comprehensively improving their quality of life. Furthermore, the traditional Chinese medicine preparation of this invention can significantly reduce the Lund-Kennedy score on nasal endoscopy, reduce nasal mucosal edema, decrease abnormal secretions, and promote the repair of damaged mucosa, effectively improving organic lesions of the nasal cavity.

[0036] In summary, the traditional Chinese medicine preparation of this invention has comprehensive efficacy in anti-inflammatory regulation at the cellular level, improvement of clinical symptoms, and repair of pathological damage. It is also highly safe and rationally formulated, providing a better and safer new solution for the clinical treatment of chronic rhinitis and has important clinical application value. Attached Figure Description

[0037] Figure 1 Comparison of Visual Analogue Scale (VAS) scores for nasal symptoms between the two groups of patients before and after treatment. Note: * indicates P<0.05, ** indicates P<0.01.

[0038] Figure 2 Comparison of nasal and sinus outcome test (SNOT-20) scores between the two groups of patients before and after treatment. Note: * indicates P<0.05, ** indicates P<0.01.

[0039] Figure 3 Comparison of Lund-Kennedy scores in nasal endoscopy between the two groups of patients before and after treatment. Note: * indicates P<0.05, ** indicates P<0.01. Detailed Implementation

[0040] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below in conjunction with the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0041] Example 1

[0042] A traditional Chinese medicine preparation for treating or improving chronic rhinitis, the preparation being made from the following raw materials in parts by weight: 25 parts of Patrinia scabiosaefolia, 25 parts of Siegesbeckia orientalis, 13 parts of Gynostemma pentaphyllum, 15 parts of Oroxylum indicum, 20 parts of Adenophora stricta, 20 parts of Ophiopogon japonicus, 18 parts of Polygonatum odoratum, 15 parts of Sparganium stoloniferum, 12 parts of Kochia scoparia, 15 parts of Schizonepeta tenuifolia, 10 parts of Dictamnus dasycarpus, 15 parts of Lycium chinense, and 12 parts of Lysimachia christinae.

[0043] Example 2

[0044] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine preparation is made from the following raw materials in parts by weight: 15 parts of Patrinia scabiosaefolia, 15 parts of Siegesbeckia orientalis, 3 parts of Gynostemma pentaphyllum, 5 parts of Oroxylum indicum, 10 parts of Adenophora stricta, 10 parts of Ophiopogon japonicus, 8 parts of Polygonatum odoratum, 5 parts of Sparganium stoloniferum, 3 parts of Kochia scoparia, 5 parts of Schizonepeta tenuifolia, 3 parts of Dictamnus dasycarpus, 5 parts of Lycium chinense, and 3 parts of Lysimachia christinae.

[0045] Example 3

[0046] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine preparation is made from the following raw materials in parts by weight: 35 parts of Patrinia scabiosaefolia, 35 parts of Siegesbeckia orientalis, 21 parts of Gynostemma pentaphyllum, 25 parts of Oroxylum indicum, 30 parts of Adenophora stricta, 30 parts of Ophiopogon japonicus, 27 parts of Polygonatum odoratum, 25 parts of Sparganium stoloniferum, 21 parts of Kochia scoparia, 25 parts of Schizonepeta tenuifolia, 20 parts of Dictamnus dasycarpus, 25 parts of Lycium chinense, and 21 parts of Lysimachia christinae.

[0047] Example 4

[0048] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine preparation is made from the following raw materials in parts by weight: 18 parts of Patrinia scabiosaefolia, 18 parts of Siegesbeckia orientalis, 5 parts of Gynostemma pentaphyllum, 7 parts of Oroxylum indicum, 12 parts of Adenophora stricta, 12 parts of Ophiopogon japonicus, 10 parts of Polygonatum odoratum, 7 parts of Sparganium stoloniferum, 5 parts of Kochia scoparia, 7 parts of Schizonepeta tenuifolia, 5 parts of Dictamnus dasycarpus, 7 parts of Lycium chinense, and 5 parts of Lysimachia christinae.

[0049] Example 5

[0050] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine preparation is made from the following raw materials in parts by weight: 20 parts of Patrinia scabiosaefolia, 20 parts of Siegesbeckia orientalis, 8 parts of Gynostemma pentaphyllum, 10 parts of Oroxylum indicum, 15 parts of Adenophora stricta, 15 parts of Ophiopogon japonicus, 12 parts of Polygonatum odoratum, 10 parts of Sparganium stoloniferum, 8 parts of Kochia scoparia, 10 parts of Schizonepeta tenuifolia, 8 parts of Dictamnus dasycarpus, 10 parts of Lycium chinense, and 9 parts of Lysimachia christinae.

[0051] Example 6

[0052] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine preparation is made from the following raw materials in parts by weight: 32 parts of Patrinia scabiosaefolia, 32 parts of Siegesbeckia orientalis, 18 parts of Gynostemma pentaphyllum, 22 parts of Oroxylum indicum, 28 parts of Adenophora stricta, 28 parts of Ophiopogon japonicus, 25 parts of Polygonatum odoratum, 22 parts of Sparganium stoloniferum, 19 parts of Kochia scoparia, 23 parts of Schizonepeta tenuifolia, 17 parts of Dictamnus dasycarpus, 22 parts of Lycium chinense, and 19 parts of Lysimachia christinae.

[0053] Example 7

[0054] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine preparation is made from the following raw materials in parts by weight: 30 parts of Patrinia scabiosaefolia, 30 parts of Siegesbeckia orientalis, 15 parts of Gynostemma pentaphyllum, 20 parts of Oroxylum indicum, 25 parts of Adenophora stricta, 25 parts of Ophiopogon japonicus, 23 parts of Polygonatum odoratum, 20 parts of Sparganium stoloniferum, 17 parts of Kochia scoparia, 20 parts of Schizonepeta tenuifolia, 15 parts of Dictamnus dasycarpus, 20 parts of Lycium chinense, and 16 parts of Lysimachia christinae.

[0055] Example 8

[0056] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine preparation is made from the following raw materials in parts by weight: 28 parts of Patrinia scabiosaefolia, 27 parts of Siegesbeckia orientalis, 17 parts of Gynostemma pentaphyllum, 18 parts of Oroxylum indicum, 23 parts of Adenophora stricta, 23 parts of Ophiopogon japonicus, 20 parts of Polygonatum odoratum, 18 parts of Sparganium stoloniferum, 15 parts of Kochia scoparia, 17 parts of Schizonepeta tenuifolia, 13 parts of Dictamnus dasycarpus, 18 parts of Lycium chinense, and 15 parts of Lysimachia christinae.

[0057] Experimental Example 1

[0058] 1. Materials and Methods

[0059] 1.1 Cells

[0060] Human nasopharyngeal epithelial cells (HNEpC) were routinely cultured in DMEM complete medium containing 10% fetal bovine serum (FBS) and 1% penicillin-streptomycin antibiotics, and incubated at 37°C in a 5% CO2 incubator.

[0061] 1.2 Experimental Drugs

[0062] Experimental Group 1: Patrinia scabiosifolia 25 g, Siegesbeckia orientalis 25 g, Gynostemma pentaphyllum 13 g, Oroxylum indicum 15 g, Adenophora stricta 20 g, Ophiopogon japonicus 20 g, Polygonatum odoratum 18 g, Sparganium stoloniferum 15 g, Kochia scoparia 12 g, Schizonepeta tenuifolia 15 g, Dictamnus dasycarpus 10 g, Lycium chinense 15 g, Lysimachia christinae 12 g.

[0063] Experimental Group 2: 25 g of Siegesbeckia orientalis, 13 g of Tianjiangke, 15 g of Muhuli, 20 g of Shashen, 20 g of Maidong, 18 g of Yuzhu, 15 g of Jingjie, 10 g of Baixianpi, 15 g of Digupi, and 12 g of Shijianchuan.

[0064] Experimental Group 3: Patrinia scabiosifolia 25 g, Tianjianghu 13 g, Oroxylum indicum 15 g, Adenophora stricta 20 g, Ophiopogon japonicus 20 g, Sparganium stoloniferum 15 g, Kochia scoparia 12 g, Dictamnus dasycarpus 10 g, Lycium chinense 15 g, and Lysimachia christinae 12 g.

[0065] Experimental Group 4: Patrinia scabiosifolia 25 g, Siegesbeckia orientalis 25 g, Adenophora stricta 20 g, Ophiopogon japonicus 20 g, Polygonatum odoratum 18 g, Sparganium stoloniferum 15 g, Kochia scoparia 12 g, Schizonepeta tenuifolia 15 g, Lycium chinense root bark 15 g.

[0066] Experimental Group 5: Patrinia scabiosifolia 25 g, Siegesbeckia orientalis 25 g, Gynostemma pentaphyllum 13 g, Oroxylum indicum 15 g, Polygonatum odoratum 18 g, Sparganium stoloniferum 15 g, Kochia scoparia 12 g, Schizonepeta tenuifolia 15 g, Dictamnus dasycarpus 10 g, Lysimachia christinae 12 g.

[0067] Preparation process: Weigh each Chinese herbal raw material according to the above weight ratio, add 10 times the volume of distilled water and soak for 30 min; first bring to a boil over high heat, then simmer over low heat for 30 min, filter and collect the first decoction; add 8 times the volume of distilled water to the residue, repeat for 20 min, and combine the two decoctions; place the combined decoction in a rotary evaporator and concentrate under reduced pressure at 60℃ to a raw herbal extract stock solution with a raw herbal content of 1 g / mL, filter through a 0.22 μm filter membrane for sterilization, and store at -20℃ for later use. Before the experiment, dilute each Chinese herbal stock solution to the required concentration with DMEM medium.

[0068] 1.3 Cell culture, modeling, and drug administration

[0069] HNEpC cells in logarithmic growth phase were digested with trypsin and then the cell density was adjusted to 5 × 10⁶ cells / year using DMEM complete medium. 5 Cells were seeded at a rate of 100 μL per well in a 96-well plate and incubated at 37°C with 5% CO2 for 24 h. Subsequent experiments were conducted after the cells reached 80% confluence.

[0070] The experiment was divided into a blank control group, a model control group, and experimental groups 1-5, with four replicates in each group. Except for the blank control group, 100 μL of 1 μg / mL LPS was added to each well of the other groups, and the cells were incubated in an incubator for 24 h to construct an HNEpC cell inflammation model.

[0071] After successful modeling, the original Chinese medicine solutions of experimental groups 1-5 were diluted to a final concentration of 500 μg / mL using DMEM medium. 100 μL was added to each well of the corresponding group. The blank control group and the model control group were added with the same volume of DMEM medium and incubated in a constant temperature incubator at 37℃ and 5% CO2 for 24 h.

[0072] 1.4 CCK-8 assay for cell viability

[0073] After drug administration, 10 μL of CCK-8 solution was added to each well, and the culture plate was wrapped in aluminum foil and incubated in the dark for 1 h. A control group was also set up, which received only DMEM medium. Cell viability was calculated by measuring the absorbance (A) at 450 nm using a microplate reader.

[0074] Cell viability (%) = (A 给药组 -A 对照组 ) / (A 空白对照组 -A对照组 ) × 100%

[0075] 1.5 Levels of inflammation-related factors

[0076] After drug administration, the upper layer of cell culture medium of each group was collected, placed in centrifuge tubes, and centrifuged at 4℃ and 3000 rpm for 5 min. The supernatant was collected, and the levels of TNF-α, IL-4, and IL-10 in each group were detected by enzyme-linked immunosorbent assay (ELISA).

[0077] 1.6 Statistical Methods

[0078] Statistical analysis was performed using GraphPad Prism 8.0. Quantitative data were expressed as mean ± standard deviation. The t-test was used for comparisons between two groups, and one-way ANOVA was used for comparisons among multiple groups. A p-value < 0.05 was considered statistically significant.

[0079] 2 Results

[0080] 2.1 Effects of various drugs on cell viability

[0081] As shown in Table 1, there was no significant difference in the viability of HNEpC cells in experimental groups 1-5 compared with the blank control group (P>0.05), indicating that the traditional Chinese medicine preparation of the present invention has no obvious toxic effects within the experimental concentration range and has good biological safety.

[0082] 2.2 Effects of various drugs on the levels of inflammation-related factors

[0083] As shown in Table 1, after LPS stimulation, the levels of TNF-α and IL-4 in the cell culture supernatant of the model control group were significantly higher than those of the blank control group (P<0.01), while the level of IL-10 was significantly lower (P<0.01), indicating that the inflammatory cell model was successfully constructed. Compared with the model control group, the levels of TNF-α and IL-4 in the cell culture supernatant of experimental groups 1-5 showed a decreasing trend, while the level of IL-10 showed an increasing trend, indicating that the traditional Chinese medicine preparation of the present invention can regulate the inflammatory balance and thus effectively inhibit the inflammatory response of nasal mucosal epithelial cells.

[0084] Table 1 Comparison of cell viability and inflammatory factor levels in each group

[0085]

[0086] Note: Compared with the blank control group # P<0.05, ## P<0.01; compared with the model control group, * P<0.05, ** P<0.01.

[0087] 3. Conclusion

[0088] The above experimental data show that the traditional Chinese medicine preparation of this invention can effectively inhibit the excessive inflammatory response of lipopolysaccharide-induced nasal mucosal epithelial cells (HNEpC). Its mechanism is related to the downregulation of pro-inflammatory factors and the upregulation of anti-inflammatory factors, thereby regulating the inflammatory balance. Furthermore, no obvious toxic reactions were observed within the experimental concentration range, demonstrating good biosafety. Further analysis revealed that group 1 showed the most significant regulatory effect on inflammatory factor levels. Groups 2-5, due to the lack of certain raw materials, exhibited varying degrees of inhibition in their effects, indicating that the formulation of the traditional Chinese medicine preparation of this invention is scientifically sound and that there is a clear synergistic effect among the various medicinal components.

[0089] Experimental Example 2

[0090] 1. Materials

[0091] 1.1 General Information

[0092] Eighty-four patients with chronic rhinitis were selected and randomly divided into a control group and an observation group, with 42 patients in each group. The control group consisted of 23 males and 19 females, with a mean age of (36.58±7.14) years and a mean disease duration of (23.46±17.88) months. The observation group consisted of 20 males and 22 females, with a mean age of (34.11±8.26) years and a mean disease duration of (25.12±15.59) months. There were no statistically significant differences in general characteristics between the two groups (P>0.05), indicating comparability.

[0093] 1.2 Diagnostic Criteria

[0094] 1.2.1 Western Medicine Diagnostic Criteria

[0095] According to the Western medical diagnostic criteria for chronic rhinitis in "Otorhinolaryngology Head and Neck Surgery": (1) Symptoms: The onset of the disease is more than three months, and the main symptoms are nasal congestion and increased nasal discharge. It may be accompanied by decreased sense of smell, postnasal drip, obstructive nasal voice, headache and discomfort at the root of the nose. (2) Signs: Bilateral inferior turbinate swelling can be seen under nasal endoscopy, and other structures in the nose cannot be clearly seen. The nasal mucosa is pale red and obvious congestion can be seen. The inferior turbinate is moist and smooth. The inferior turbinate mucosa is elastic and soft. It is indented when pressed with a probe and recovers immediately after the probe is removed. Mucous nasal discharge or mucous strands can be seen in the middle nasal meatus, common nasal meatus or nasopharynx.

[0096] 1.2.2 Traditional Chinese Medicine Diagnostic Criteria

[0097] According to the TCM diagnostic criteria for nasal obstruction in "Traditional Chinese Medicine Otorhinolaryngology": Main symptoms: alternating nasal congestion, with varying degrees of severity, scanty yellow nasal discharge, hot nasal breathing, yellow sputum, frequent dry mouth, red tongue tip, thin yellow tongue coating, and rapid pulse. Examination reveals swelling of the inferior turbinate, congestion of the nasal mucosa, and a soft, smooth, and elastic surface.

[0098] 1.2.3 Inclusion Criteria

[0099] Those who meet the diagnostic criteria for chronic rhinitis in both traditional Chinese and Western medicine; are aged 18-65 years; have a disease course of more than 3 months; agree to the treatment plan and follow the doctor's advice; and have signed an informed consent form.

[0100] 1.2.4 Exclusion Criteria

[0101] Individuals with nasal polyps, deviated nasal septum, or acute sinusitis, or other nasal diseases; those who have not fully recovered from nasal surgery; those who have recently used other treatment methods; those who cannot tolerate or are allergic to the drug components; those with mental illness who cannot cooperate with treatment or follow-up; those with serious heart, liver, or kidney diseases; and pregnant or breastfeeding women.

[0102] 2. Treatment methods

[0103] The control group patients took 6-8 tablets of Nasal Sinusitis Tablets three times a day for 4 consecutive weeks.

[0104] Patients in the observation group took the herbal preparation of this invention, one dose daily, divided into morning and evening warm doses, for four consecutive weeks. The prescription consists of: Patrinia scabiosaefolia 25 g, Siegesbeckia orientalis 25 g, Gynostemma pentaphyllum 13 g, Oroxylum indicum 15 g, Adenophora stricta 20 g, Ophiopogon japonicus 20 g, Polygonatum odoratum 18 g, Sparganium stoloniferum 15 g, Kochia scoparia 12 g, Schizonepeta tenuifolia 15 g, Dictamnus dasycarpus 10 g, Lycium chinense 15 g, and Hedyotis diffusa 12 g. Preparation process: Weigh each ingredient according to the above weight ratios, add 500 mL of water and soak for 30 min; first bring to a boil over high heat, then simmer over low heat for 30 min; finally filter the decoction through gauze to collect the herbal preparation of this invention.

[0105] 3. Observation Indicators

[0106] 3.1 Nasal Symptom Scoring

[0107] The Visual Analogue Scale (VAS) was used to score the core nasal symptoms such as nasal congestion, runny nose, and decreased sense of smell in both groups of patients before and after treatment. The total score ranged from 0 to 10, with lower scores indicating milder symptoms and higher scores indicating more severe symptoms.

[0108] 3.2 Improvement in nasal cavity

[0109] The Sinus Nasal Outcomes Scale-20 (SNOT-20) was used to evaluate the improvement in nasal function and the impact on quality of life before and after treatment in both groups of patients. The scale covers dimensions such as nasal symptoms, related accompanying symptoms, sleep disorders, and emotional outcomes, and consists of 20 items. Each item is scored from 0 to 3 points. The lower the total score, the more significant the improvement in nasal function and the less the impact on quality of life.

[0110] 3.3 Lund-Kennedy scoring in nasal endoscopy

[0111] The Lund-Kennedy scoring system was used to score the nasal polyps, nasal mucosal edema, rhinorrhea, scarring, and crusting in both groups of patients before and after treatment. Scoring criteria: Each indicator in each nasal cavity was scored from 0 to 2 points (0 points = normal, 1 point = mild abnormality, 2 points = severe abnormality), with a total score of 0 to 20 points. The lower the total score, the milder the organic lesions in the nasal cavity.

[0112] 3.4 Efficacy Evaluation Criteria

[0113] Based on the "Standards for Diagnosis and Treatment of Diseases and Syndromes in Traditional Chinese Medicine" and related treatment guidelines, and combined with clinical symptoms and nasal endoscopy results, the following four-level standards were established:

[0114] Clinical cure: The main symptoms such as nasal congestion, runny nose, nasal itching, and sneezing have completely disappeared. Nasal endoscopy shows that the color and shape of the nasal mucosa have returned to normal, with no edema and no abnormal secretions.

[0115] Significant effect: The main symptoms were significantly improved. Nasal endoscopy showed that the degree of nasal mucosal congestion and edema was significantly reduced, and the secretions were significantly reduced.

[0116] Effective: The main symptoms have improved, and nasal endoscopy shows improvement in nasal mucosal lesions and reduced secretions.

[0117] Ineffective: The main symptoms and endoscopic signs under the nose do not improve or even worsen.

[0118] 4. Statistical Methods

[0119] Data were processed using SPSS 23.0 statistical software. Count data were expressed as percentages (%), and the chi-square test was used to compare two groups. 2 Tests: Quantitative data are expressed as mean ± standard deviation. Independent samples t-tests are used for comparisons between groups, and paired t-tests are used for comparisons within groups. For non-normal distributions, the Mann-Whitney test is used. A p-value < 0.05 is considered statistically significant.

[0120] 5 Results

[0121] 5.1 Effects of various drugs on VAS scores

[0122] Depend on Figure 1 It can be seen that there was no significant difference in VAS scores between the two groups before treatment (P>0.05), indicating that the differences were comparable. After treatment, the VAS scores of both groups decreased significantly (P<0.05), indicating that both drugs could significantly improve the symptoms of patients with chronic rhinitis. However, the VAS score of the observation group was significantly lower than that of the control group (P<0.05), indicating that the traditional Chinese medicine preparation of the present invention has a better therapeutic advantage in improving the symptoms of chronic rhinitis.

[0123] 5.2 Effects of each drug on SNOT-20 score

[0124] Depend on Figure 2 It can be seen that there was no significant difference in SNOT-20 scores between the two groups before treatment (P>0.05), indicating that the baseline data were comparable. After treatment, the SNOT-20 scores of both groups decreased significantly (P<0.05), and the SNOT-20 scores of the observation group were significantly lower than those of the control group (P<0.05), indicating that the traditional Chinese medicine preparation of the present invention can effectively improve the overall quality of life, including sleep, mood, and daily activities, of patients with nasal and accompanying symptoms.

[0125] 5.3 Effects of various drugs on the Lund-Kennedy score in nasal endoscopy

[0126] Depend on Figure 3 It can be seen that there was no significant difference in the Lund-Kennedy scores of the two groups of patients before treatment (P>0.05), indicating that they were comparable; after treatment, the Lund-Kennedy scores of the two groups of patients decreased significantly (P<0.05), and the Lund-Kennedy scores of the observation group were significantly lower than those of the control group (P<0.05), indicating that the traditional Chinese medicine preparation of the present invention can reduce nasal mucosal edema, reduce abnormal secretions and promote mucosal repair.

[0127] 5.4 Clinical efficacy

[0128] As shown in Table 2, the total effective rate of clinical treatment in the control group was 76.19%, while the total effective rate of clinical treatment in the observation group was 88.10%, which was significantly higher than that in the control group (P<0.05).

[0129] Table 2 Comparison of clinical efficacy between the two groups of patients

[0130]

[0131] 3. Conclusion

[0132] The traditional Chinese medicine preparation of this invention can significantly reduce the visual VAS and SNOT-20 scores of patients with chronic rhinitis, effectively relieving core nasal symptoms such as nasal congestion, runny nose, and decreased sense of smell. It also significantly reduces the adverse effects of symptoms on patients' sleep quality, emotional state, and daily activities. Furthermore, this traditional Chinese medicine preparation can significantly reduce patients' Lund-Kennedy scores on nasal endoscopy by reducing nasal mucosal edema, decreasing abnormal secretions, promoting the repair of nasal mucosal damage, and improving organic nasal lesions. In addition, this traditional Chinese medicine preparation has a higher overall clinical efficacy rate and has not shown any adverse reactions during clinical application, providing a new treatment option for chronic rhinitis.

[0133] The above embodiments are only used to illustrate the technical solutions of the present invention, and are not intended to limit it. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A traditional Chinese medicine preparation for treating chronic rhinitis, characterized in that, The traditional Chinese medicine preparation is composed of the following raw materials in parts by weight: 25 parts of Patrinia scabiosaefolia, 25 parts of Siegesbeckia orientalis, 13 parts of Gynostemma pentaphyllum, 15 parts of Oroxylum indicum, 20 parts of Adenophora stricta, 20 parts of Ophiopogon japonicus, 18 parts of Polygonatum odoratum, 15 parts of Sparganium stoloniferum, 12 parts of Kochia scoparia, 15 parts of Schizonepeta tenuifolia, 10 parts of Dictamnus dasycarpus, 15 parts of Lycium chinense, and 12 parts of Lysimachia christinae.

2. The method for preparing a traditional Chinese medicine preparation for treating chronic rhinitis as described in claim 1, characterized in that, The traditional Chinese medicine preparations are prepared into oral dosage forms, including pills, powders, granules, oral liquids, decoctions, and tablets, using conventional pharmaceutical methods and with medically acceptable excipients.

3. The use of the traditional Chinese medicine preparation as described in claim 1 in the preparation of a drug for the prevention and / or treatment of chronic rhinitis.

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