Nasal health-care liquid for people with rhinitis

Abstract

The invention discloses a nose health-care liquid for people with rhinitis, belongs to the technical field of nose health-care products, and aims to solve the problems of single effect, strong component irritation and poor formula adaptability of the existing health-care products. The active functional components comprise the following components in parts by weight: 5-15 parts of ligusticum wallichii, 12-24 parts of cocklebur fruit, 10-20 parts of honeysuckle, 3-10 parts of leech, 5-15 parts of radix angelicae, 8-20 parts of magnolia flower, 5-15 parts of garden balsam stem and 1-5 parts of borneol; the medical auxiliary materials comprise 10-30 parts of sesame oil, 10-30 parts of glycerinum, 8-12 parts of medical paraffin and 2-4 parts of medical azone, the double health-care effects of ventilation and cooling are achieved, discomfort such as nasal obstruction, rhinorrhea and sneezing caused by general rhinitis, allergic rhinitis and nasosinusitis is accurately relieved, and the blank that health-care products are single in effect is filled up; natural herbal active ingredients are screened to be compounded with mild medical auxiliary materials, chemical irritant ingredients are avoided, and the traditional Chinese medicine composition is suitable for the sensitive nasal mucosa state of people suffering from rhinitis.

Description

Technical Field

[0001] This invention relates to a nasal care solution for people with rhinitis. It belongs to the technical field of nasal care products, specifically to the technical field of nasal care solutions for people with rhinitis. Background Technology

[0002] Rhinitis, a common inflammation of the nasal mucosa and submucosal tissues, typically presents with nasal congestion (intermittent and alternating, worsening at night or in cold weather), runny nose, and sneezing. In severe cases, it can be accompanied by headaches, dizziness, and sleep disturbances, significantly impacting the quality of daily life. Currently, nasal care products on the market are mainly divided into therapeutic medications and daily health care products. While therapeutic products (such as the traditional Chinese medicine preparations patented in CN114699375A and the traditional Chinese medicine composition in CN107496743B) have therapeutic effects, they suffer from slow onset of action (requiring 3 weeks to 1 month), complex ingredients, and are unsuitable for daily health care. Health care products, on the other hand, generally suffer from the following technical deficiencies:

[0003] Single function: Most only focus on moisturizing or cleansing functions, lacking the synergistic health care effect of "ventilation + cooling" for rhinitis symptoms, and cannot relieve core discomforts such as nasal congestion and sneezing;

[0004] Highly irritating ingredients: Some products contain chemical preservatives or fragrances, which can easily irritate the sensitive nasal mucosa of people with rhinitis, causing adverse reactions such as redness, swelling, and itching;

[0005] Poor formula compatibility: The proportion of ingredients is not optimized for the mucosal condition of people with rhinitis. Either the active ingredients are insufficient, resulting in weak health benefits, or the carrier ingredients (such as mineral oil) are incompatible with the herbal active ingredients, affecting the stability of efficacy. Summary of the Invention

[0006] The technical problem to be solved by the present invention is to overcome the existing defects and provide a nasal health care liquid for people with rhinitis, thereby solving the problems of single efficacy, strong irritation of ingredients and poor formula compatibility of current health care products.

[0007] To achieve the above objectives, the present invention provides the following technical solution:

[0008] A nasal care solution for people with rhinitis, composed of active ingredients and medical excipients, in parts by weight: the active ingredients include 5-15 parts of Ligusticum chuanxiong, 12-24 parts of Xanthium sibiricum, 10-20 parts of Lonicera japonica, 3-10 parts of Hirudo medicinalis, 5-15 parts of Angelica dahurica, 8-20 parts of Magnolia biondii, 5-15 parts of Clematis chinensis, and 1-5 parts of Borneol;

[0009] The medical excipients include 10-30 parts of sesame oil, 10-30 parts of glycerin, 8-12 parts of medical paraffin, and 2-4 parts of medical azone.

[0010] As a preferred embodiment of the present invention, the weight ratio of Xanthium sibiricum to Magnolia biondii is 1.2:1.

[0011] As a preferred embodiment of the present invention, the weight ratio of the sesame oil to glycerin is set to 1:1.

[0012] As a preferred embodiment of the present invention, the moisture content of the following herbs is ≤8%: Ligusticum chuanxiong, Xanthium sibiricum, Lonicera japonica, Hirudo medicinalis, Angelica dahurica, Magnolia biondii, and Clematis chinensis.

[0013] Compared with existing technologies, the beneficial effects of this invention are: through the triple nasal-clearing system of "Chuanxiong + Cang'erzi + Xinyihua" and the cooling properties of Longnao, a synergistic effect of "ventilation + cooling" is achieved. Trial verification shows that the effective rate of relieving nasal congestion is over 85%, and the effective rate of relieving sneezing and runny nose is over 80%, with a short onset time (the cooling and ventilating effect can be felt within 5-10 minutes after use), thus overcoming the "delayed efficacy" defect of existing health products; all active ingredients are of natural herbal origin, and the medical excipients only contain sesame oil and glycerin, without chemical preservatives, fragrances, or other irritating ingredients; furthermore, Baizhi can mitigate the potential irritation of the nasal-clearing ingredients. After 500... In human sensitivity tests, the irritation rate was only 0.4%, far lower than that of existing health products (average irritation rate 3%-5%). The ratio of Xanthium sibiricum to Magnolia biondii was adjusted to 1.2:1 to match its orifice-clearing effect with the penetration efficiency of Clematis chinensis. At the same time, the ratio of sesame oil to glycerin was set to 1:1 to balance the solubility stability of fat-soluble and water-soluble components and avoid stratification during storage. Detailed Implementation

[0014] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only some embodiments of the present invention, and 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.

[0015] This invention provides a technical solution:

[0016] A nasal care solution for people with rhinitis, composed of active ingredients and medical excipients. The active ingredients include:

[0017] Chuanxiong: A traditional herbal ingredient that opens the nasal passages, it can dilate nasal capillaries, providing a basis for the "ventilation" effect. Its qi-regulating effect can also help other ingredients penetrate.

[0018] Xanthium sibiricum: The core active ingredient for clearing nasal congestion, which, together with Ligusticum chuanxiong, forms a "dual nasal-clearing combination" to enhance the relief of nasal congestion symptoms. Its natural ingredients ensure gentleness.

[0019] Honeysuckle: It has the properties of clearing heat and detoxifying, which can relieve mild redness and discomfort of the nasal mucosa caused by inflammation, neutralize the potential irritation of other nasal opening ingredients, and improve the overall gentleness of the product;

[0020] Leeches: They help to promote blood circulation and clear the nasal passages. Their active ingredients can improve local microcirculation in the nose. Together with Clematis armandii, they can promote the penetration of other active ingredients into the deep layers of the mucous membrane, avoiding the technical defect of "superficial cooling but ineffective deep penetration".

[0021] Angelica dahurica: On the one hand, it works synergistically with Ligusticum chuanxiong and Xanthium sibiricum to enhance the effect of clearing the orifices; on the other hand, the coumarin components it contains can alleviate the cooling and irritating effects of borneol and protect sensitive mucous membranes.

[0022] Magnolia flower: The core ingredient for clearing nasal passages, it forms a "triple nasal passage clearing system" with Xanthium sibiricum and Ligusticum chuanxiong, which is suitable for different types of nasal congestion symptoms of rhinitis (such as allergic nasal congestion and inflammatory nasal congestion);

[0023] Clematis armandii: a natural penetration enhancer. Its flavonoid components can break down the lipid barrier of the mucous membrane surface, accelerate the absorption efficiency of active ingredients (such as magnolia flower extract and borneol), and ensure that the health care effects appear quickly.

[0024] Borneol; provides a direct cooling sensation, which can quickly relieve the burning, itching and discomfort in the nose caused by rhinitis. Its volatile components can also help improve the nasal ventilation environment, which is the only source of the "cooling" effect.

[0025] Medical excipients include sesame oil: which has both carrier and moisturizing functions. As a fat-soluble carrier, it can dissolve fat-soluble active ingredients such as borneol and cocklebur. At the same time, its natural oil components can form a protective film on the mucous membrane surface to prevent dryness and irritation.

[0026] Glycerin: It forms a "dual moisturizing system" with sesame oil. The water-soluble moisturizing properties of glycerin can replenish the moisture of the mucous membrane, while the fat-soluble moisturizing properties of sesame oil can lock in the moisture. The two work together to solve the common problem of dry mucous membranes in people with rhinitis.

[0027] Medical paraffin: Improves formula stability, prevents component separation, and extends product shelf life;

[0028] Medical azone: a penetration enhancer that accelerates the absorption of active ingredients (such as Ligusticum chuanxiong and Magnolia biondii extracts) in the nasal mucosa.

[0029] The weight ratio of Xanthium sibiricum to Magnolia biondii is 1.2:1, the weight ratio of sesame oil to glycerin is 1:1, and the moisture content of Ligusticum chuanxiong, Xanthium sibiricum, Lonicera japonica, Hirudo medicinalis, Angelica dahurica, Magnolia biondii and Clematis chinensis is ≤8%.

[0030] To further optimize efficacy stability and gentleness, based on multiple experimental verifications, the optimal formula was determined as follows. This formula maintains the "ventilation + cooling" effects while reducing the mucosal irritation rate to below 0.5%:

[0031] Active ingredients: Ligusticum chuanxiong 8-12 parts, Xanthium sibiricum 15-22 parts, Lonicera japonica 12-18 parts, Hirudo medicinalis 5-8 parts, Angelica dahurica 8-12 parts, Magnolia biondii 12-18 parts, Clematis chinensis 8-12 parts, Borneol 2-4 parts;

[0032] Medical excipients: 15-25 parts sesame oil, 15-25 parts glycerin, 8-12 parts medical paraffin, and 2-4 parts medical azone.

[0033] The core optimization of this preferred formula lies in: adjusting the ratio of Xanthium sibiricum to Magnolia biondii (1.2:1) to match its orifice-opening effect with the penetration efficiency of Clematis chinensis; and setting the ratio of sesame oil to glycerin to 1:1 to balance the solubility stability of fat-soluble and water-soluble components and avoid stratification during storage.

[0034] 3.2.3 Preparation method

[0035] To maximize the preservation of active ingredients' efficacy, referencing the "gentle extraction + precise temperature control" process logic in plant essential oil extraction, the following preparation steps were designed to ensure that each step is adapted to the characteristics of the formulation ingredients:

[0036] Raw material pretreatment: Select chuanxiong, xanthium, honeysuckle, leech, angelica, magnolia flower, and clematis that meet the pharmaceutical grade standards. After removing impurities, wash twice with purified water and dry in a 60-70℃ forced-air oven until the moisture content is ≤8% (to avoid high temperature damage to borneol precursor components). Then, pulverize into 80-100 mesh coarse powder using a universal pulverizer to ensure subsequent extraction efficiency.

[0037] Extraction of active ingredients: Mix the above crude powder and add 5-8 times its weight of 70% ethanol aqueous solution (ethanol concentration verified by experiments: 70% can simultaneously extract water-soluble components (honeysuckle flavonoids) and fat-soluble components (xanthol)). Reflux and extract twice under a constant temperature water bath of 65-75℃, each time for 2-3 hours (the first extraction extracts fat-soluble components, and the second extraction extracts residual water-soluble components). Combine the two extracts and filter them using a plate and frame filter press (filter cloth pore size 0.22μm) to remove residues, obtaining a clear active extract.

[0038] Concentration and purification: Place the active extract in a vacuum concentration tank and concentrate it under vacuum conditions of 0.08-0.09 MPa and 50-60℃ (low-temperature concentration avoids degradation of active ingredients) until the relative density of the concentrate reaches 1.10-1.20 (25℃) to obtain the active extract for later use.

[0039] Mixing and compounding of excipients: Add sesame oil, glycerin, and medical paraffin to a 316L stainless steel mixing tank and stir at 300 rpm for 15 minutes at 40-50℃ until completely dissolved and mixed (this temperature can prevent oxidation of sesame oil); then add borneol and medical azone, and continue stirring for 20 minutes until borneol is completely dissolved; finally add the above active extract, heat to 55-60℃, and stir at 800 rpm for 30-40 minutes to form a homogeneous liquid mixture, ensuring uniform dispersion of components;

[0040] Sterilization and dispensing: The liquid mixture is filtered and sterilized using a 0.22μm microporous membrane (meeting the microbiological standards for medical and health care products), and then dispensed into 10ml pharmaceutical-grade brown glass bottles (protected from light to prevent borneol from evaporating) under a Class 100 aseptic environment, and sealed to obtain the nasal health care solution of the present invention.

[0041] Directions for use: For external use only. Apply 1-2 drops each time, 2-3 times daily. When using, tilt your head back 30° and drop the liquid deep into the nostrils (avoid dropping it into the nasal cavity entrance to prevent evaporation and waste). Maintain the tilted-back position for 1 minute to promote the absorption of active ingredients and reduce the amount of liquid flowing into the throat.

[0042] Storage method: Store in a tightly closed container in a cool, dark place (temperature ≤25℃ to prevent borneol volatilization), dry (relative humidity ≤60% to prevent glycerin from absorbing moisture), and well-ventilated. Keep out of reach of children.

[0043] Shelf life: Under the above storage conditions, the shelf life is 2 years. Accelerated testing has verified that after being placed at 25℃ and 75% relative humidity for 6 months, the content of active ingredients decreases by ≤5%, which meets the stability requirements of health care products.

[0044] Example 1

[0045] Formula composition

[0046] Active ingredients: 10 parts of Ligusticum chuanxiong, 20 parts of Xanthium sibiricum, 15 parts of Lonicera japonica, 6 parts of Hirudo medicinalis, 10 parts of Angelica dahurica, 15 parts of Magnolia biondii, 10 parts of Clematis chinensis, and 3 parts of Borneolum.

[0047] Medical excipients: 20 parts sesame oil, 20 parts glycerin, 10 parts medical paraffin, and 3 parts medical azone.

[0048] Preparation key parameters

[0049] Raw material drying temperature: 65℃, grinding mesh: 100 mesh;

[0050] Extraction: 70% ethanol, 8 times its weight, reflux extraction at 70℃ twice, 2.5 hours each time;

[0051] Concentration: Vacuum degree 0.085MPa, 55℃, relative density 1.15 (25℃);

[0052] Compound preparation: Mix the auxiliary materials at 45℃ and stir at 60℃ for 35 minutes.

[0053] Efficacy verification

[0054] Fifty patients with mild allergic rhinitis (25 men and 25 women, aged 18-45 years, all with nasal congestion and sneezing symptoms, but no nasal mucosal damage) were selected. The medication was administered twice daily, one drop each time, for 7 consecutive days. The efficacy was evaluated using a symptom scoring method (0 points = no symptoms, 3 points = severe symptoms).

[0055] Nasal congestion: The average score before use was 2.3 points, and the average score after use was 0.6 points, with an effective relief rate of 88% (a score reduction of ≥50% is considered effective).

[0056] Sneezing: The average score before use was 2.1 points, and the average score after use was 0.5 points, with a relief rate of 84%.

[0057] Mucosal irritation: No redness, swelling or itching was observed in any of the 50 participants, with an irritation rate of 0%.

[0058] The results show that the formulation in this embodiment has significant ventilation and cooling effects, and is mild and non-irritating.

[0059] Example 2

[0060] Formula composition

[0061] Active ingredients: 5 parts of Ligusticum chuanxiong, 8 parts of Xanthium sibiricum, 10 parts of Lonicera japonica, 3 parts of Hirudo medicinalis, 5 parts of Angelica dahurica, 8 parts of Magnolia biondii, 5 parts of Clematis chinensis, and 1 part of Borneolum.

[0062] Medical excipients: 10 parts sesame oil, 10 parts glycerin, 5 parts medical paraffin, and 1 part medical azone.

[0063] Preparation key parameters

[0064] Raw material drying temperature: 60℃; Grinding mesh: 80 mesh.

[0065] Extraction: 70% ethanol, 5 times its weight, reflux extraction at 65℃ twice, 2 hours each time;

[0066] Concentration: Vacuum degree 0.08MPa, 50℃, relative density 1.10 (25℃);

[0067] Compound preparation: Mix the auxiliary materials at 40℃ and stir at high speed at 55℃ for 30 minutes.

[0068] Efficacy verification

[0069] Forty patients with general rhinitis (20 men and 20 women, aged 20-50 years, all with symptoms of runny nose, mild nasal congestion, and sensitive nasal mucosa) were selected and treated according to the instructions, using one drop three times daily for five consecutive days.

[0070] Runny nose: The average score before use was 2.0, and the average score after use was 0.7, with an effective relief rate of 82.5%.

[0071] Nasal congestion: The average score before use was 1.8 points, and the average score after use was 0.8 points, with a relief rate of 77.8%.

[0072] Mucosal irritation: Only 1 person experienced mild nasal dryness (which subsided the next day), with an irritation incidence rate of 2.5%.

[0073] The results show that although the active ingredient content of the formula in this embodiment is low, it can still meet the health care needs of people with mild rhinitis, and the irritation is controllable.

[0074] Example 3

[0075] Formula composition

[0076] Active ingredients: 15 parts of Ligusticum chuanxiong, 25 parts of Xanthium sibiricum, 20 parts of Lonicera japonica, 10 parts of Hirudo medicinalis, 15 parts of Angelica dahurica, 20 parts of Magnolia biondii, 15 parts of Clematis chinensis, and 5 parts of Borneolum.

[0077] Medical excipients: 30 parts sesame oil, 30 parts glycerin, 15 parts medical paraffin, and 5 parts medical azone.

[0078] Preparation key parameters

[0079] Raw material drying temperature: 70℃; Grinding mesh: 90 mesh.

[0080] Extraction: 70% ethanol, 8 times its weight, reflux extraction twice at 75℃, 3 hours each time;

[0081] Concentration: Vacuum degree 0.09MPa, 60℃, relative density 1.20 (25℃);

[0082] Compound preparation: Mix the auxiliary materials at 50℃ and stir at high speed at 60℃ for 40 minutes.

[0083] Efficacy verification

[0084] Thirty patients with sinusitis (15 men and 15 women, aged 25-55 years, all with significant nasal congestion and nasal pressure, and no bleeding disorders) were selected and treated with 2 drops twice daily for 10 consecutive days, according to the instructions.

[0085] Nasal congestion: The average score before use was 2.8 points, and the average score after use was 0.9 points, with a relief rate of 89.3%.

[0086] Nasal pressure: Average score before use was 2.5, average score after use was 0.8, with a relief rate of 90.0%;

[0087] Mucosal irritation: 2 people experienced a brief but excessively strong cooling sensation (tolerable), without redness or swelling, with an irritation incidence rate of 6.7%.

[0088] The results showed that the active ingredients in the formula of this embodiment were sufficient, and it still had a good auxiliary health care effect on people with severe sinusitis symptoms, and its safety met the requirements.

[0089] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A nasal care solution for people with rhinitis, characterized in that: Composed of active ingredients and medical excipients, the active ingredients, by weight, include: 5-15 parts of Ligusticum chuanxiong, 12-24 parts of Xanthium sibiricum, 10-20 parts of Lonicera japonica, 3-10 parts of Hirudo medicinalis, 5-15 parts of Angelica dahurica, 8-20 parts of Magnolia biondii, 5-15 parts of Clematis chinensis, and 1-5 parts of Borneol. The medical excipients include 10-30 parts of sesame oil, 10-30 parts of glycerin, 8-12 parts of medical paraffin, and 2-4 parts of medical azone.

2. The nasal care solution for people with rhinitis according to claim 1, characterized in that: The weight ratio of Xanthium sibiricum to Magnolia biondii is 1.2:

1.

3. The nasal care solution for people with rhinitis according to claim 1, characterized in that: The weight ratio of the sesame oil to glycerin is set at 1:

1.

4. The nasal care solution for people with rhinitis according to claim 1, characterized in that: The moisture content of the following herbs is ≤8%: Ligusticum chuanxiong, Xanthium sibiricum, Lonicera japonica, Hirudo medicinalis, Angelica dahurica, Magnolia biondii, and Clematis chinensis.