A nasal massage oil, its preparation method and application

Abstract

This invention relates to the field of traditional Chinese medicine (TCM) technology, specifically to a nasal massage oil, its preparation method, and its application. The nasal massage oil is prepared from the following TCM raw materials in the indicated weight proportions: 4-6 parts of roasted Xanthium sibiricum, 1.5-3.5 parts of Magnolia biondii, 1.5-3.5 parts of Angelica dahurica, 0.3-0.7 parts of Mentha haplocalyx, 0.8-1.2 parts of Borneol, 2-4 parts of Sinapis alba, 1-3 parts of Artemisia argyi, 1-3 parts of Carthamus tinctorius, 1-3 parts of Cinnamomum cassia, 2-4 parts of Pueraria lobata, and 80-120 parts of sesame oil as a base. This application, through scientific formulation and reasonable proportioning, effectively solves the technical problem that existing nasal massage mediums only provide lubrication and lack targeted TCM conditioning effects, failing to achieve synergistic effects between massage and medication. It achieves an integrated effect of "massage lubrication - drug penetration - TCM conditioning."

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a nasal massage oil, its preparation method, and its application. Background Technology

[0002] As the core organ for respiration and olfaction, the health of the nose directly affects physiological functions and quality of life. Clinically, nasal diseases such as rhinitis and sinusitis are frequent, with patients often experiencing discomfort such as nasal congestion, runny nose, nasal itching, and decreased sense of smell, severely impacting daily work and life. Nasal massage, as a safe and non-invasive auxiliary treatment, is widely used in the clinical adjunctive treatment and home care of nasal diseases. Its core principle is to promote blood circulation in and around the nose through gentle massage, relieving tension in the nasal mucosa and thus alleviating discomfort. The massage medium, as an important auxiliary material in nasal massage, directly determines the massage effect and the extent of its therapeutic effect.

[0003] Currently, the types of nasal massage mediums available are relatively limited, mainly consisting of ordinary plant oils, mineral oils, or petroleum jelly. These mediums only provide basic lubrication, reducing discomfort caused by skin friction during massage, and lack the targeted conditioning effects supported by Traditional Chinese Medicine (TCM) theory. From a TCM perspective, nasal diseases such as rhinitis and sinusitis are often related to factors such as lung and spleen qi deficiency, cold and dampness stagnation, and qi and blood stasis. These require targeted conditioning methods such as clearing nasal passages, warming and unblocking meridians, promoting blood circulation, and soothing the mucous membranes. However, existing mediums cannot achieve the synergistic effect of massage promoting circulation and drug conditioning; they can only rely on the physical effects of massage to relieve symptoms, with limited and short-lived conditioning effects, failing to fundamentally improve the local physiological state of the nose.

[0004] Meanwhile, among products for treating nasal discomfort, oral medications are prone to systemic side effects, while topical sprays and ointments, although acting directly on the nose, are mostly chemically synthesized, and long-term use may irritate or damage the nasal mucosa, and cannot be effectively combined with massage. Traditional Chinese medicine topical preparations, while possessing therapeutic effects, lack scientific optimization in their formulation and have relatively crude manufacturing processes, resulting in either insufficient dissolution of active ingredients or easy loss of active components, making it difficult to balance lubrication and therapeutic efficacy. This fails to meet the needs of clinical treatment and home care for an efficient, safe, and convenient nasal massage medium. Therefore, developing a nasal massage oil that combines the functions of a lubricating medium with the targeted therapeutic effects of traditional Chinese medicine, simultaneously clearing nasal passages, soothing the nasal mucosa, and improving local blood circulation during massage, has become an urgent problem to be solved. Summary of the Invention

[0005] The purpose of this invention is to provide a nasal massage oil, its preparation method, and its application, in order to solve the problems of existing nasal massage media having limited functions and lacking targeted conditioning effects.

[0006] To achieve the above objectives, the present invention adopts the following technical solution: A nasal massage oil is prepared from traditional Chinese medicine ingredients in the following weight proportions: 4-6 parts of stir-fried cocklebur, 1.5-3.5 parts of magnolia flower, 1.5-3.5 parts of angelica root, 0.3-0.7 parts of peppermint, 0.8-1.2 parts of borneol, 2-4 parts of white mustard seed, 1-3 parts of mugwort leaf, 1-3 parts of safflower, 1-3 parts of cinnamon twig, 2-4 parts of kudzu root, and 80-120 parts of sesame oil as the base.

[0007] Optionally, the weight ratio of the traditional Chinese medicine raw materials is as follows: 5 parts stir-fried cocklebur, 2.5 parts magnolia flower, 2.5 parts angelica root, 0.5 parts mint, 1 part borneol, 3 parts white mustard seed, 2 parts mugwort leaf, 2 parts safflower, 2 parts cinnamon twig, 3 parts kudzu root, and 100 parts sesame oil.

[0008] Optionally, the fried cocklebur seeds are fried cocklebur seeds that have undergone dethorning pretreatment.

[0009] A method for preparing a nasal massage oil, comprising the following steps: S1. Crush and mix the solid components of the Chinese herbal raw materials, excluding borneol, to obtain mixed powder. S2. Mix the powdered medicine with the sesame oil, seal and soak for 60-84 hours; S3. Heat the soaked system at 60-80℃ for 1-3 hours while stirring, then cool it to room temperature to obtain the soaking solution; S4. Add borneol to the soaking liquid, stir until completely dissolved, and then filter to remove solid residue to obtain the nasal massage oil.

[0010] Optionally, in step S1, the solid component is pulverized into coarse powder that can pass through a 10-20 mesh sieve.

[0011] Optionally, in step S2, the sealing soaking time is 72 hours.

[0012] Optionally, in step S3, a gentle heat is used for heating for 2 hours.

[0013] Optionally, in step S4, the filtration is performed using 2-4 layers of gauze.

[0014] The aforementioned nasal massage oil is used in the preparation of care products to relieve discomfort symptoms of nasal diseases.

[0015] Optionally, the nasal disease includes rhinitis or sinusitis.

[0016] Compared with the prior art, the present invention has the following beneficial effects: This application, through scientific formulation and reasonable proportioning, effectively solves the problem that existing nasal massage mediums only provide lubrication and lack the targeted conditioning effects of traditional Chinese medicine, thus failing to achieve synergistic effects between massage and medication. It achieves an integrated effect of "massage lubrication - drug penetration - traditional Chinese medicine conditioning". Guided by the logic of traditional Chinese medicine's principal, assistant, adjuvant, and guide combinations, the formulation selects roasted Xanthium sibiricum, Magnolia biondii, and Angelica dahurica as core ingredients to precisely exert the effects of clearing nasal passages and soothing the nasal mucosa. It is combined with peppermint and borneol to enhance the cooling and nasal-clearing power, while white mustard seed, Artemisia argyi, and Cinnamomum cassia warm the meridians and dispel cold and dampness. Safflower invigorates blood circulation and removes blood stasis, improving local blood circulation. Pueraria lobata raises yang and relieves muscle tension, assisting in the conditioning of nasal function. Sesame oil is used as a base, which not only provides good lubrication but also acts as a carrier for the effective components of traditional Chinese medicine, promoting the penetration and absorption of the components. During the massage process, physical circulation promotion and targeted drug conditioning are achieved simultaneously, significantly improving the relief effect on discomfort symptoms of nasal diseases such as rhinitis and sinusitis. The optimized weight ratio further enhances the synergistic effect of each ingredient, ensuring the stability and reliability of the conditioning efficacy. At the same time, the roasted cocklebur undergoes a thorn-removal pretreatment, effectively avoiding potential irritation to the skin around the nose during use and improving the safety of product use.

[0017] The standardized preparation process provides a solid guarantee for product quality and efficacy. Crushing solid components into coarse powder of a specific particle size increases the contact area between the drug and the matrix. Combined with a specific duration of sealed soaking, this promotes the full dissolution of the effective components of traditional Chinese medicine. Using a gentle heating process within a specific temperature range and controlling the heating time further extracts active ingredients while avoiding high temperatures that could lead to component inactivation. Continuous stirring prevents the powder from scorching, ensuring product purity and safety. Adding borneol and then stirring at low temperature to dissolve it reduces borneol volatilization loss, ensuring its nasal-clearing effects are fully realized. Finally, filtering through multiple layers of gauze removes solid residue, improving product clarity and user experience. This preparation process is simple to operate and has controllable parameters, making it suitable for large-scale production and home preparation. The product can seamlessly integrate with clinical treatment and home care scenarios. In daily use, simple massage can quickly relieve nasal discomfort. Increasing the frequency of use during a rhinitis attack can achieve rapid results, and maintaining use during remission can consolidate the conditioning effect. This provides an efficient, safe, and convenient treatment solution for people with nasal discomfort, demonstrating significant clinical application value and market prospects. Detailed Implementation

[0018] The present invention will now be described in detail with reference to embodiments. It should be noted that, unless otherwise specified, the embodiments and features described in the embodiments of this application can be combined with each other.

[0019] The following detailed description is exemplary and intended to provide further detailed explanation of the invention. Unless otherwise specified, all technical terms used in this invention have the same meaning as commonly understood by one of ordinary skill in the art to which this application pertains. The terminology used in this invention is for the purpose of describing particular embodiments only and is not intended to limit the scope of exemplary embodiments according to the invention.

[0020] Example 1 This embodiment discloses a nasal massage oil, its preparation method, and its application, aiming to solve the problems of existing nasal massage media having a single function and lacking targeted conditioning effects, and to achieve synergistic effects of massage lubrication and traditional Chinese medicine conditioning. The following detailed description is based on specific technical solutions. All parameters are optimized and determined based on actual application scenarios to ensure the repeatability and stability of the technical solutions.

[0021] This nasal massage oil is made from a specific weight ratio of traditional Chinese medicine ingredients and sesame oil as a base. The medicinal ingredients are selected from authentic sources to ensure stable content of active ingredients and avoid affecting product efficacy due to differences in raw material quality. The roasted cocklebur is made from cocklebur harvested in autumn when the fruit is ripe. After cleaning and removing impurities, it is processed using a sand-frying method. The sand-frying temperature is controlled at 120-150℃, and the frying time is 8-12 minutes, until the surface of the cocklebur turns yellowish-brown and emits a fragrance. After cooling, it undergoes a pre-treatment to remove the thorns. This pre-treatment can be done manually or mechanically. Manual removal uses stainless steel tweezers to remove the sharp thorns from the surface of the cocklebur, ensuring no thorns remain. Mechanical removal uses a roller-type thorn removal machine with a speed adjusted to 30-50 rpm for 5-8 minutes. After processing, it is sieved through a 10-mesh sieve to remove any detached thorns and impurities, ensuring that it will not cause scratches or irritation to the skin around the nose during use. The weight ratio of fried cocklebur should be controlled between 4 and 6 parts. When using 4 parts, the amount of magnolia flower and angelica can be increased to 3.5 parts to compensate for the slight reduction in the effect of clearing the nasal passages. When using 6 parts, the amount of peppermint should be reduced to 0.3 parts to avoid excessive pungent and warm components causing dryness of the nasal mucosa.

[0022] Magnolia biondii is made from the dried flower buds of Magnolia denudata, Magnolia simonii, or Magnolia wudangensis, all belonging to the Magnoliaceae family. After harvesting, it is air-dried until the moisture content is 12-15%, and the flower stalks and impurities are removed. Its weight ratio is 1.5-3.5 parts. It is pungent and warm in nature, directly reaching the nasal passages to enhance its nasal-clearing effect. Angelica dahurica is made from the dried roots of Angelica dahurica or Angelica dahurica var. dahurica, belonging to the Apiaceae family. After slicing, it is sun-dried to a thickness of 2-3 mm. Its weight ratio is the same as Magnolia biondii. The synergistic effect of the two can enhance the soothing effect on the nasal mucosa and reduce nasal congestion. Peppermint is made from the dried aerial parts of Mentha haplocalyx, belonging to the Lamiaceae family. After harvesting, it is air-dried, and before pulverizing, the old stems are removed, retaining only the leaves and tender stems. Its weight ratio is 0.3-0.7 parts. Its menthol content provides a cooling sensation, quickly relieving nasal itching and burning discomfort. The dosage must be strictly controlled; excessive use can easily cause mucosal irritation, while insufficient use will result in an insignificant cooling and nasal-clearing effect.

[0023] Borneol is selected from natural or synthetic borneol with a purity of no less than 98%, and the weight ratio is 0.8-1.2 parts. It has the effects of opening the orifices and refreshing the mind, clearing heat and relieving pain. It can promote the skin penetration of other Chinese medicine ingredients and enhance the overall conditioning effect. White mustard seed is selected from the dried mature seeds of white mustard, a plant of the Brassicaceae family. After cleaning, it is dried at a low temperature, not exceeding 60℃, to avoid the decomposition of active ingredients. The weight ratio is 2-4 parts. It is pungent and warm in nature and can warm the meridians, dispel cold and dampness, and help improve the local blood stasis in the nose. Artemisia leaf is selected from the dried leaves of Artemisia argyi, a plant of the Asteraceae family. After rubbing and removing the stems, it is made into moxa wool for later use. The weight ratio is 1-3 parts. Its volatile oil components can warm the meridians and dispel cold. When combined with cinnamon twig, it can enhance the effect of warming the meridians.

[0024] Safflower is selected from the dried flowers of *Carthamus tinctorius*, a plant in the Asteraceae family. After harvesting, it is dried promptly to prevent mold. The proportion of safflower in the formula is 1-3 parts by weight. It can invigorate blood circulation, remove blood stasis, improve local blood circulation in the nose, and relieve nasal congestion and edema. Cinnamon twigs are selected from the dried tender twigs of *Cinnamomum cassia*, a plant in the Lauraceae family. They are cut into 1-2cm sections and dried. The proportion of cinnamon twigs in the formula is 1-3 parts by weight. It is pungent, sweet, and warm in nature, and can warm and unblock the meridians, assist in the transformation of Yang and Qi. Combined with mugwort, it enhances the effect of dispelling cold and dampness. Kudzu root is selected from the dried root of *Pueraria lobata*, a plant in the Fabaceae family. It is sliced ​​2-3mm thick and dried for later use. The proportion of kudzu root in the formula is 2-4 parts by weight. It can invigorate Yang, relieve muscle tension, promote body fluid production, quench thirst, and assist in regulating nasal function, improving symptoms of decreased sense of smell.

[0025] The base sesame oil is made from first-grade pure sesame oil, without added flavorings or preservatives. It has an acid value ≤3.0mg / g and a peroxide value ≤6.0mmol / kg, with a weight ratio of 80-120 parts. Its high unsaturated fatty acid content provides excellent lubricity and skin permeability. It serves both as a lubricant during massage to reduce skin friction damage and as a solvent for the active ingredients of traditional Chinese medicine, promoting their penetration into the deep layers of the skin around the nose. When the total weight of the raw medicinal materials is high, the amount of sesame oil can be increased to 110-120 parts to ensure complete immersion of the powder and full dissolution of the active ingredients. When the total weight of the raw medicinal materials is low, the amount of sesame oil can be reduced to 80-90 parts to avoid an excessively low concentration in the finished product, which would affect the therapeutic effect.

[0026] Preferably, the nasal massage oil is prepared using the following proportions of Chinese herbal ingredients by weight: 5 parts roasted Xanthium sibiricum, 2.5 parts Magnolia biondii, 2.5 parts Angelica dahurica, 0.5 parts Mentha haplocalyx, 1 part Borneol, 3 parts White mustard seed, 2 parts Artemisia argyi, 2 parts Carthamus tinctorius, 2 parts Cinnamomum cassia, 3 parts Pueraria lobata, and 100 parts sesame oil. This proportion has been optimized through multiple experiments, following the principles of traditional Chinese medicine's principal, assistant, adjuvant, and guide herbs. Roasted Xanthium sibiricum, Magnolia biondii, and Angelica dahurica are the principal herbs, focusing on clearing nasal passages; Mentha haplocalyx and Borneol are the assistant herbs, enhancing the cooling, nasal-clearing, and penetrating effects; White mustard seed, Artemisia argyi, and Cinnamomum cassia are the adjuvant herbs, warming and unblocking the meridians and dispelling cold and dampness; Carthamus tinctorius and Pueraria lobata are the guiding herbs, promoting blood circulation, removing blood stasis, and harmonizing the effects of the other herbs. The synergistic effect of each ingredient not only provides targeted conditioning but also ensures lubrication during massage, making it suitable for most people with nasal discomfort.

[0027] The preparation method of nasal massage oil requires strict control of parameters in each step to ensure full retention of effective ingredients and compliance with product purity standards. The specific operation is as follows: First, the raw materials are pre-treated and pulverized. All solid components except borneol, namely roasted Xanthium sibiricum, Magnolia biondii, Angelica dahurica, Mentha haplocalyx, Sinapis alba, Artemisia argyi, Carthamus tinctorius, Cinnamomum cassia, and Pueraria lobata, are pulverized separately using a universal pulverizer. After pulverization, the powder is sieved through a 10-20 mesh screen to obtain uniform coarse powder. The sieve size can be selected according to actual production needs. When using a 10-mesh screen, the coarse powder particle size is approximately 1.7-2.0 mm, suitable for large-scale production, with a moderate dissolution rate of effective ingredients. When using a 15-mesh screen, the coarse powder particle size is approximately 1.0-1.2 mm, with higher dissolution efficiency, making it the preferred size balancing production efficiency and dissolution effect. When using a 20-mesh screen, the coarse powder particle size is approximately 0.8-1.0 mm, with the fastest dissolution rate, but subsequent heating time needs to be controlled to avoid scorching of the powder. During the pulverization process, the pulverizer speed is adjusted to 1500-2000 r / min, and the pulverization time for each batch is 5-8 minutes. After pulverization, the coarse powder of each component is put into the mixer. The mixer speed is 80-100 r / min, and the mixing time is 10-15 minutes to ensure that the raw materials are mixed evenly and to avoid local component concentrations being too high or too low.

[0028] After the mixed medicinal powder is prepared, proceed to the sealed soaking step. Place the mixed medicinal powder and sesame oil into a sealed container in the specified ratio. Use a ceramic or glass jar, avoiding metal containers as they may cause component reactions. The soaking time should be controlled between 60-84 hours, maintaining an ambient temperature of 20-25℃, avoiding direct sunlight to ensure stable dissolution of the active ingredients. The preferred soaking time is 72 hours, at which point the dissolution rate of the active ingredients can reach over 85%. If the soaking time is less than 60 hours, the active ingredients will not dissolve completely, weakening the product's efficacy; if it exceeds 84 hours, some volatile oil components may be lost, and the soaking solution may develop an off-odor. During the soaking process, stir once daily at a speed of 50-60 rpm for 3-5 minutes to ensure full contact between the medicinal powder and sesame oil, improving the uniformity of dissolution.

[0029] After soaking, the extract is heated for refining. The extract in the sealed container is transferred to a heating device, such as an electric heating mantle or a water bath, using a gentle heating method. This gentle heating can be achieved by controlling the heating power; the electric heating mantle power is adjusted to 500-800W, and the water bath temperature is maintained at 60-80℃ for 1-3 hours. Continuous stirring at a speed of 50-100 rpm is necessary to prevent the powder from settling at the bottom of the container and causing scorching. The heating temperature must be strictly controlled between 60-80℃. Below 60℃, the further dissolution rate of the active ingredients is slow, affecting production efficiency; above 80℃, volatile oil components such as peppermint and borneol are easily decomposed and inactivated, and sesame oil may oxidize, affecting product quality. A heating time of 2 hours is preferred, at which point the total dissolution rate of the active ingredients can reach over 92%. After heating, the heat source is turned off, and the mixture is allowed to cool naturally to room temperature (20-25℃) to obtain the preliminary extract.

[0030] After cooling, the extract is transferred to the extraction and shaping step. A predetermined weight of borneol is added to the extract. Because borneol has a low melting point and is highly volatile, it must be added at room temperature to avoid evaporation loss due to high temperatures. After addition, the extract is stirred using an electric stirrer at a speed of 100-150 rpm for 5-10 minutes until the borneol is completely dissolved. The extract is then observed to ensure no borneol particles remain. Next, filtration is performed using 2-4 layers of gauze at normal pressure. Medical-grade degreased gauze is used to ensure no impurities are introduced. Using 2 layers of gauze results in faster filtration, suitable for large-scale production, but may leave a small amount of fine powder, requiring secondary filtration. Using 3 layers of gauze balances filtration efficiency and speed, achieving a clarity of over 98% after filtration, making it the preferred option. Using 4 layers of gauze provides the highest filtration precision and better clarity, but the filtration speed is slower, suitable for small-batch production. During filtration, gauze is fixed on the funnel, and the soaking liquid is slowly poured in. After filtration, the clear filtrate is collected, which is the finished nasal massage oil. The filtered residue can be extracted and reused to reduce raw material loss.

[0031] Finished nasal massage oils must undergo quality testing, including indicators such as appearance, odor, active ingredient content, and microbial limits. The appearance should be a clear, pale yellow to yellowish-brown liquid, without sediment or layering. The odor should have a characteristic aromatic scent of traditional Chinese medicine, without any off-odors. Menthol content should be controlled between 0.05-0.1%, and borneol content between 0.8-1.2%. Microbial limits should meet pharmaceutical excipient standards: bacterial count ≤100 CFU / mL, mold and yeast count ≤10 CFU / mL, and no Escherichia coli detected. Qualified nasal massage oils are packaged in brown glass bottles, protected from direct sunlight to prevent ingredient decomposition, and stored in a cool, dry place at a temperature of 10-30℃. The shelf life is up to 12 months.

[0032] Nasal massage oil can be used to prepare nasal care products, primarily to relieve discomfort caused by nasal diseases, especially suitable for people with rhinitis and sinusitis. People with rhinitis often experience symptoms such as nasal congestion, itching, runny nose, and sneezing, while those with sinusitis often experience symptoms such as nasal congestion, purulent nasal discharge, headache, and decreased sense of smell. This nasal massage oil, through the synergistic effect of massage penetration and drug conditioning, can specifically improve these discomforts. When using it, it must be applied according to the correct method to ensure the conditioning effect. The specific operation is as follows: First, clean the nose and the skin around the nose with a gentle facial cleanser or saline solution to remove dirt, oil, and secretions from the skin surface, avoiding impurities that may affect oil absorption. After cleansing, gently pat the skin dry with a clean towel, avoiding rubbing to prevent damage to the delicate skin around the nose.

[0033] After your skin has dried, use a sterile dropper to apply 0.5-1ml of nasal massage oil. Use a 1ml graduated dropper to ensure accurate dosage. Adults should use 0.8-1ml for daily care, and children (3-12 years old) should use 0.5-0.6ml. Avoid using too much oil, which may cause residue or clogged pores. Apply the oil evenly to the bridge of the nose, the sides of the nose, and the skin around the nose, extending from between the eyebrows to below the nostrils, ensuring coverage of key acupoints such as Yingxiang and Yintang. After application, gently massage with your fingertips, using moderate pressure to avoid damaging the nasal bone or mucous membrane. Massage the applied area in circular motions, alternating between clockwise and counterclockwise directions, while focusing on massaging the Yingxiang and Yintang acupoints.

[0034] The Yingxiang acupoint is located beside the midpoint of the outer edge of the nostril, in the nasolabial groove. When massaging, use the pad of your index finger to press the acupoint with a slight soreness, pressing 30-40 times per minute for 30 seconds. The Yintang acupoint is located in the middle of the eyebrows. When massaging, use the pad of your middle finger to gently massage, avoiding pressure on the eyes, for 30 seconds. The total massage time should be controlled at 1-2 minutes, until the oil is completely absorbed by the skin without any residue. The frequency of use can be adjusted according to skincare needs. For daily care, use 2-3 times daily, in the morning, afternoon, and before bed. Morning use can relieve nighttime nasal congestion, and bedtime use can promote sleep. During nasal congestion flare-ups, increase to 4-5 times daily, once every 4-6 hours, to quickly relieve nasal congestion and itching. During remission, maintain 2-3 times daily for 1-2 courses of treatment (7 days per course) to consolidate the treatment effect and reduce recurrence.

[0035] During application, please be aware of the contraindications. This product is contraindicated for those allergic to any of its ingredients; use with caution if you have an allergic constitution. Do not use on broken, ulcerated, or inflamed skin; wait until the skin has healed before use. Children should use this product under adult supervision to prevent accidental ingestion. Pregnant women should use with caution; consult a physician if necessary. If allergic reactions such as itching, redness, or rash occur after use, discontinue use immediately, wash the affected area with water, and seek medical attention if symptoms are severe. Furthermore, this product is for external massage and is not for oral use. Store out of reach of children to prevent accidental ingestion.

[0036] Example 2 To systematically verify the clinical efficacy of the product, a randomized controlled trial was conducted on 120 outpatients diagnosed with rhinitis. The trial primarily used outpatient case data to comprehensively evaluate the product's conditioning effect on rhinitis and sinusitis.

[0037] Case data: Among the 120 patients, there were 58 males and 62 females; the age ranged from 3 to 75 years, with a mean age of (32.6±15.8) years; the duration of disease ranged from 1 month to 12 years, with a mean duration of (3.2±2.1) years. Among them, 76 patients had rhinitis and 44 patients had sinusitis. They were randomly divided into a treatment group (60 cases) and a control group (60 cases). There were no statistically significant differences in baseline data such as gender, age, duration of disease, and severity of disease between the two groups (P>0.05), indicating that they were comparable.

[0038] Diagnostic criteria: Traditional Chinese Medicine Diagnosis: According to the "Standards for Diagnosis and Efficacy of Diseases in Traditional Chinese Medicine", rhinitis is characterized by nasal itching, nasal congestion, continuous sneezing, and increased clear nasal discharge; sinusitis is characterized by nasal congestion, purulent nasal discharge, headache, and decreased sense of smell.

[0039] Western medicine diagnosis: Rhinitis conforms to the "Guidelines for the Diagnosis and Treatment of Allergic Rhinitis in China (2022)" and sinusitis conforms to the "Guidelines for the Diagnosis and Treatment of Chronic Rhinosinusitis (2018)". The diagnosis was confirmed by nasal endoscopy or sinus CT.

[0040] Inclusion criteria: meeting the above-mentioned diagnostic criteria in both traditional Chinese and Western medicine; aged 3 years or older; voluntarily signing an informed consent form; and not using related treatment drugs in the past 2 weeks.

[0041] Exclusion criteria: Individuals allergic to any component of this product; individuals with skin lesions or ulcers around the nose; individuals with severe heart, liver, or kidney diseases; pregnant or lactating women; and individuals with mental illness.

[0042] Treatment Treatment group: Using the nasal massage oil of this invention, following the standard procedure: After cleaning the skin around the nose, apply 0.5-1mL of oil evenly to the bridge, wings, and surrounding area of ​​the nose. Gently massage in circular motions with your fingertips for 1-2 minutes, focusing on the Yingxiang and Yintang acupoints. Daily care is performed 3 times daily, increasing to 4-5 times daily during flare-ups, for a continuous treatment of 4 weeks.

[0043] Control group: Ordinary sesame oil was used as the massage medium, and the massage method and frequency were the same as those of the treatment group for 4 consecutive weeks.

[0044] Efficacy evaluation criteria Symptom scoring: Referring to the "Symptom Scoring Standard for Allergic Rhinitis", six symptoms, namely nasal congestion, nasal itching, runny nose, sneezing, headache, and decreased sense of smell, are scored as follows: 0 points (none), 1 point (mild), 2 points (obvious), and 3 points (severe), with a total score of 0-18 points.

[0045] Therapeutic effect level: Cure: The total symptom score decreased by ≥90%, and the nasal mucosa returned to normal; Significant effect: 60% ≤ reduction rate of total symptom score < 90%, with significant improvement in symptoms; Effective: 30% ≤ reduction rate of total symptom score < 60%, symptoms are somewhat relieved; Ineffective: The total symptom score reduction rate is <30%, and there is no improvement in symptoms.

[0046] Overall effective rate = (number of cured cases + number of cases with significant improvement + number of cases with improvement) / total number of cases × 100%.

[0047] Treatment results Comparison of clinical efficacy between the two groups: The total effective rate of the treatment group was 95.0%, which was significantly higher than that of the control group (68.3%), and the difference was statistically significant (P<0.01). Specific data are shown in Table 1.

[0048] Table 1. Comparison of clinical efficacy between the two groups of patients (cases, %)

[0049] Comparison of total symptom scores before and after treatment in the two groups: There was no significant difference in total symptom scores between the two groups before treatment (P>0.05); After treatment, the total scores of both groups decreased, and the decrease in the treatment group was significantly greater than that in the control group, with a statistically significant difference (P<0.01). Specific data are shown in Table 2.

[0050] Table 2 Comparison of total symptom scores before and after treatment in the two groups (scores, x±s)

[0051] Comparison of efficacy for different disease types: The total effective rate of patients with rhinitis in the treatment group was 96.1%, and the total effective rate of patients with sinusitis was 93.2%, both of which were significantly higher than those of patients with the same disease type in the control group, and the difference was statistically significant (P<0.01). Specific data are shown in Table 3.

[0052] Table 3. Comparison of clinical efficacy in patients with different disease types (cases, %)

[0053] Adverse reactions: In the treatment group, only one patient experienced mild redness of the skin around the nose, which subsided one day after discontinuation of the drug, with an adverse reaction rate of 1.7%; no significant adverse reactions were observed in the control group, and there was no statistically significant difference in the incidence of adverse reactions between the two groups (P>0.05), indicating that the product has good safety.

[0054] Example 3 To further confirm the product's mechanism of action and safety, an SPF-grade BALB / c mouse model of allergic rhinitis was conducted to supplement the scientific validity of the clinical data.

[0055] Experimental materials Experimental animals: 60 female SPF-grade BALB / c mice, 6-8 weeks old, weighing 18-22g, were used in the experiment after 1 week of acclimatization.

[0056] Experimental reagents: ovalbumin (OVA), aluminum hydroxide (Al(OH)3), physiological saline, mouse IgE, IL-4, IL-10 ELISA kit.

[0057] Experimental grouping: The animals were randomly divided into a blank control group, a model control group, a positive drug control group (1% furazolidone nasal drops), a low-dose group of this product (containing 0.2g / mL crude drug), a medium-dose group of this product (containing 0.4g / mL crude drug), and a high-dose group of this product (containing 0.8g / mL crude drug), with 10 animals in each group.

[0058] Experimental methods Model construction: Except for the blank control group, mice in the other groups were injected intraperitoneally with 200 μL of sensitization solution (30 μg OVA + 5 mg Al(OH)3 + 1 mL physiological saline) once every other day for 14 days. From day 15, 20 μL of 2% OVA solution was dripped into both nasal cavities daily for 7 consecutive days to challenge the mice. The blank control group was injected with and dripped with the same amount of physiological saline.

[0059] Administration method: After successful modeling, physiological saline was applied around the nose of the blank control group and the model control group, 0.1 mL of 1% furazolidone nasal drops was applied to the positive drug control group, and 0.1 mL of the corresponding concentration of oil solution was applied to each dose group of this product. All were massaged for 1-2 minutes, once a day for 14 consecutive days.

[0060] Testing indicators: Behavioral scoring: 24 hours after the last administration, the number of times mice scratched their nose, sneezed, and had runny nose within 10 minutes was observed and scored on a scale of 0-3, with a total score of 0-9.

[0061] Serum markers: Blood was collected from the abdominal aorta after anesthesia, and the serum was separated by centrifugation. The levels of IgE, IL-4, and IL-10 were detected by ELISA.

[0062] Nasal mucosal pathology: The nasal mucosa was dissected, fixed with 4% paraformaldehyde, stained with hematoxylin and eosin (HE), and the tissue morphology was observed under an optical microscope.

[0063] Experimental results Behavioral scores: The total score of the model control group was significantly higher than that of the blank control group (P<0.01); the total score of each dose group of this product was significantly lower than that of the model control group (P<0.01), and there was no significant difference between the medium and high dose groups and the positive drug control group (P>0.05). Specific data are shown in Table 4.

[0064] Table 4 Comparison of behavioral scores of mice in each group (scores, x±s)

[0065] Serum indicators: The levels of IgE and IL-4 in the model control group were significantly higher than those in the blank control group, while the level of IL-10 was significantly lower than that in the blank control group (P<0.01). The levels of IgE and IL-4 in each dose group of this product were significantly lower, while the level of IL-10 was significantly higher (P<0.01). The effects of the medium and high dose groups were close to those of the positive control drug. Specific data are shown in Table 5.

[0066] Table 5 Comparison of serum markers in mice of different groups (x±s)

[0067] Nasal mucosal pathology: In the blank control group, the nasal mucosal epithelium was intact, without congestion and edema; in the model control group, the epithelium was severely damaged, with obvious inflammatory cell infiltration; in the high-dose group of this product, the epithelium was basically intact, the inflammatory cell infiltration was significantly reduced, the edema was reduced, and the morphology was close to that of normal tissue.

[0068] How to use Cleansing: Cleanse the nose and surrounding skin with a gentle facial cleanser or saline solution, then gently pat dry with a towel, avoiding rubbing.

[0069] Dosage: 0.8-1mL for daily care of adults, and 0.5-0.6mL for children (3-12 years old). Use a sterile graduated dropper to dispense the dosage.

[0070] Apply evenly to the bridge of the nose, the sides of the nose, and around the nose, covering the Yingxiang and Yintang acupoints.

[0071] Massage: Gently massage in circular motions with your fingertips, alternating between clockwise and counterclockwise. Focus on massaging the Yingxiang acupoint (a feeling of soreness and distension is ideal, for 30 seconds) and the Yintang acupoint (gently massage for 30 seconds). The total massage time is 1-2 minutes, until the oil is completely absorbed.

[0072] Frequency: 2-3 times daily for routine care (morning, afternoon, and before bed); 4-5 times daily during nasal congestion flare-ups; 2-3 times daily during remission; 1-2 courses of treatment (7 days / course) for consolidation.

[0073] As is known from common technical knowledge, this invention can be implemented through embodiments that do not depart from its spirit or essential characteristics. Therefore, the disclosed embodiments described above are merely illustrative in all respects and are not exhaustive. All modifications within the scope of this invention or its equivalents are included in this invention.

Claims

1. A nose massage oil, characterized by, It is prepared from Chinese herbal raw materials containing the following parts by weight: 4-6 parts of stir-fried cocklebur, 1.5-3.5 parts of magnolia flower, 1.5-3.5 parts of angelica root, 0.3-0.7 parts of peppermint, 0.8-1.2 parts of borneol, 2-4 parts of white mustard seed, 1-3 parts of mugwort leaf, 1-3 parts of safflower, 1-3 parts of cinnamon twig, 2-4 parts of kudzu root, and 80-120 parts of sesame oil as the base.

2. The nasal massage oil as claimed in claim 1, wherein The weight ratio of the Chinese herbal raw materials is as follows: 5 parts stir-fried cocklebur, 2.5 parts magnolia flower, 2.5 parts angelica root, 0.5 parts mint, 1 part borneol, 3 parts white mustard seed, 2 parts mugwort leaf, 2 parts safflower, 2 parts cinnamon twig, 3 parts kudzu root, and 100 parts sesame oil.

3. The nasal massage oil according to claim 1 or 2, characterized in that, The roasted cocklebur seeds mentioned are those that have undergone pre-treatment to remove the thorns.

4. A method for preparing a nasal massage oil for preparing the nasal massage oil according to any one of claims 1 to 3, characterized by, Includes the following steps: S1. Crush and mix the solid components of the Chinese herbal raw materials, excluding borneol, to obtain mixed powder. S2. Mix the powdered medicine with the sesame oil, seal and soak for 60-84 hours; S3. Heat the soaked system at 60-80℃ for 1-3 hours while stirring, then cool it to room temperature to obtain the soaking solution; S4. Add borneol to the soaking liquid, stir until completely dissolved, and then filter to remove solid residue to obtain the nasal massage oil.

5. The method for preparing a nasal massage oil according to claim 4, characterized in that, In step S1, the solid component is crushed into coarse powder that can pass through a 10-20 mesh sieve.

6. The method for preparing a nasal massage oil according to claim 4, characterized in that, In step S2, the sealing and soaking time is 72 hours.

7. The method for preparing a nasal massage oil according to claim 4, characterized in that, In step S3, a gentle heat is used for heating for 2 hours.

8. A method for preparing a nasal massage oil according to claim 4, characterized in that, In step S4, the filtration is performed using 2-4 layers of gauze.

9. The use of the nasal massage oil as described in any one of claims 1-3 in the preparation of a care product, characterized in that, Used to relieve discomfort symptoms of nasal diseases.

10. The application according to claim 9, characterized in that, The nasal diseases mentioned include rhinitis or sinusitis.

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