External rhinitis treatment composition based on Chinese herbal medicines and preparation method thereof

Abstract

The invention relates to the technical field of traditional Chinese medicines, and particularly discloses an external rhinitis treatment composition based on Chinese herbal medicines and a preparation method thereof, the external rhinitis treatment composition comprises propolis flavone essence, an aloe polysaccharide compound, green tea polyphenol-hyaluronic acid conjugated nanoparticles, probiotic metabolite concentrated powder, centipeda minima, asarum, ligusticum wallichii, magnolia flower, indigo naturalis, peppermint essential oil and eucalyptus essential oil; through superfine grinding, extraction, electrostatic spinning and layer-by-layer self-assembly technologies, effective extraction and stable release of medicine components are ensured, comprehensive treatment can be carried out on various symptoms of rhinitis, such as nasal obstruction and running nose relieving, nasal cavity micro-ecology adjusting, nasal cavity resistance enhancing and rhinitis repeated attack preventing can be carried out.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and in particular relates to a Chinese herbal medicine-based external rhinitis therapeutic composition and a preparation method thereof. Background Art

[0002] Rhinitis, also known as nasal inflammatory disease, is an inflammation of the nasal mucosa and submucosal tissues, usually caused by viruses, bacteria, allergens, various physical and chemical factors, and certain systemic diseases. The clinical manifestations of rhinitis include nasal congestion, runny nose, sneezing, nasal itching, etc., which seriously affect the patient's quality of life. According to the course of the disease and the cause, rhinitis can be divided into various types such as acute rhinitis, chronic rhinitis, allergic rhinitis, atrophic rhinitis, etc.

[0003] At present, there are various treatments for rhinitis, including drug therapy, surgical treatment and physical therapy. Among them, the existing drug treatment methods mostly rely on antibiotics, antihistamines and hormone drugs. Long-term use is prone to drug resistance, has large side effects, and is difficult to cure. Therefore, a rhinitis topical treatment composition based on Chinese herbal medicine and a preparation method thereof are proposed. Summary of the invention

[0004] The object of the present invention is to provide a Chinese herbal medicine-based external rhinitis therapeutic composition and a preparation method thereof, so as to solve the problems raised in the above background technology.

[0005] To achieve the above object, the present invention provides the following technical solutions:

[0006] A Chinese herbal medicine-based external rhinitis therapeutic composition comprises the following raw materials in parts by weight:

[0007] 1.5-2.5 parts of propolis flavonoids extract, 8-12 parts of aloe polysaccharide complex, 0.8-1.2 parts of green tea polyphenol-hyaluronic acid conjugated nanoparticles, 0.3-0.7 parts of probiotic metabolite concentrated powder, 12-18 parts of goose not eating grass, 2.5-3.5 parts of asarum, 13-17 parts of chuanxiong, 5-7 parts of magnolia, 2.5-3.5 parts of indigo, 0.1-0.2 parts of peppermint essential oil, and 0.1-0.2 parts of eucalyptus essential oil.

[0008] Preferably, the probiotic metabolite concentrated powder is one of lactobacillus metabolite concentrated powder or bifidobacterium metabolite extract.

[0009] A method for preparing a Chinese herbal medicine-based external rhinitis therapeutic composition comprises the following steps:

[0010] S1, mixing and ultrafine grinding of Herba Eupatorii, Asarum, Rhizoma Chuanxiong, Radix Magnoliae, and Indigo Naturalis, sieving to obtain fine powder, and obtaining a Chinese medicine extract by extraction and distillation;

[0011] S2, adding propolis flavonoid essence, aloe polysaccharide complex, green tea polyphenol-hyaluronic acid conjugated nanoparticles, and probiotic metabolite concentrated powder to the traditional Chinese medicine extract and mixing them according to a ratio, adding a stabilizer and a suspending agent, and obtaining a nanofiber membrane through electrospinning and layer-by-layer self-assembly;

[0012] S3, drying the nanofiber membrane, and then crushing it to obtain a composition for external use for treating rhinitis.

[0013] Preferably, in S1, supercritical CO is used 2 Extraction, set the temperature to 50°C, the pressure to 25MPa, and the extraction time to 3-5 hours.

[0014] Preferably, in S2, the stabilizer is polyvinyl pyrrolidone and the suspending agent is sodium carboxymethyl cellulose.

[0015] Preferably, in S2, the spinning conditions of electrospinning include voltage 20 kV, distance 20 cm, and flow rate 0.5 mL / h.

[0016] Preferably, in S2, a layer-by-layer self-assembly process is performed by alternately depositing polyelectrolyte layers with opposite charges, and the number of layers is 5-10.

[0017] Preferably, the polyelectrolyte layer is sodium polystyrene sulfonate and polyallylamine hydrochloride.

[0018] Compared with the prior art, the present invention has the following beneficial effects:

[0019] (1) Through ultrafine grinding, extraction, electrospinning and layer-by-layer self-assembly technology, the effective extraction and stable release of drug ingredients are ensured, which can provide comprehensive treatment for various symptoms of rhinitis, such as relieving nasal congestion and runny nose, while regulating the nasal microecology, enhancing nasal resistance, and preventing recurrent rhinitis.

[0020] (2) The addition of probiotic metabolites can regulate the nasal microecology, enhance the resistance of the nasal cavity, and help prevent the recurrence of rhinitis. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 It is a flow chart of the present invention. DETAILED DESCRIPTION

[0022] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0023] Embodiment 1:

[0024] See also Figure 1 As shown, a Chinese herbal medicine-based external therapeutic composition for rhinitis comprises the following raw materials in parts by weight:

[0025] 1.5 parts of propolis flavonoids extract, 8 parts of aloe polysaccharide complex, 0.8 parts of green tea polyphenol-hyaluronic acid conjugated nanoparticles, 0.3 parts of probiotic metabolite concentrated powder, 12 parts of Herba Capillaris, 2.5 parts of Asarum, 13 parts of Rhizoma Chuanxiong, 5 parts of Magnolia officinalis, 2.5 parts of Indigo Naturalis, 0.1 parts of peppermint essential oil and 0.1 parts of eucalyptus essential oil.

[0026] In one embodiment of the present invention, the probiotic metabolite concentrated powder is one of a lactobacillus metabolite concentrated powder or a bifidobacterium metabolite extract.

[0027] A method for preparing a Chinese herbal medicine-based external rhinitis therapeutic composition comprises the following steps:

[0028] S1, mixing and ultrafine grinding of Herba Eupatorii, Asarum, Rhizoma Chuanxiong, Radix Magnoliae, and Indigo Naturalis, sieving to obtain fine powder, and obtaining a Chinese medicine extract by extraction and distillation;

[0029] S2, adding propolis flavonoid essence, aloe polysaccharide complex, green tea polyphenol-hyaluronic acid conjugated nanoparticles, and probiotic metabolite concentrated powder to the traditional Chinese medicine extract and mixing them according to a ratio, adding a stabilizer and a suspending agent, and obtaining a nanofiber membrane through electrospinning and layer-by-layer self-assembly;

[0030] S3, drying the nanofiber membrane, and then crushing it to obtain a composition for external use for treating rhinitis.

[0031] In one embodiment of the present invention, in S1, supercritical CO is used. 2 For extraction, the set temperature was 50°C, the pressure was 25 MPa, and the extraction time was 5 hours.

[0032] In one embodiment of the present invention, in S2, the stabilizer is polyvinyl pyrrolidone and the suspending agent is sodium carboxymethyl cellulose.

[0033] In one embodiment of the present invention, in S2, the spinning conditions of the electrospinning include a voltage of 20 kV, a distance of 20 cm, and a flow rate of 0.5 mL / h.

[0034] In one embodiment of the present invention, in S2, a layer-by-layer self-assembly process is performed by alternately depositing polyelectrolyte layers with opposite charges, and the number of layers is 8.

[0035] In one embodiment of the present invention, the polyelectrolyte layer is sodium polystyrene sulfonate and polyallylamine hydrochloride.

[0036] In one embodiment of the present invention, the preparation method of propolis flavonoid essence is as follows: placing the propolis raw material in an extraction kettle, setting the temperature to 50°C and the pressure to 20 MPa, and introducing supercritical CO 2 The extraction time is 3 hours. After the extraction is completed, CO containing propolis flavonoids is collected. 2 Extraction liquid, CO 2 The extract was introduced into a molecular distillation device, the distillation temperature was set at 100°C and the pressure was set at 1Pa to obtain propolis flavonoid essence.

[0037] In one embodiment of the present invention, the preparation of aloe polysaccharide complex: after the aloe leaves are chopped, they are enzymatically hydrolyzed with cellulase or pectinase at 4°C for 24 hours. After the extraction is completed, the aloe polysaccharide extract is separated by filtration or centrifugation, the aloe polysaccharide extract is placed in a dialysis bag, dialyzed with deionized water to remove small molecule impurities, the dialyzed extract is purified by an ion exchange column to remove ionic impurities, and the purified aloe polysaccharide solution is freeze-dried to obtain an aloe polysaccharide complex.

[0038] In one embodiment of the present invention, green tea polyphenol-hyaluronic acid conjugated nanoparticles are prepared by dissolving green tea polyphenol and hyaluronic acid in an ethanol-water system with an ethanol volume fraction of 60%, placing the mixed solution in an ultrasonic field, and performing nanoprecipitation for 1 hour, setting the ultrasonic frequency to 30 kHz and the power to 300 W. After the precipitation is completed, the nanoparticle precipitate is separated by centrifugation, and then washed and dialyzed with deionized water to remove unbound substances and impurities to obtain green tea polyphenol-hyaluronic acid conjugated nanoparticles.

[0039] In one embodiment of the present invention, the preparation of probiotic metabolite concentrated powder: one or more combinations of Lactobacillus or Bifidobacterium are selected as probiotic strains, and cultured on a culture medium until the logarithmic growth phase is reached, the probiotic strains are inoculated into a fermentation medium, and fermented under anaerobic conditions, the temperature is controlled at 35°C, the pH value is controlled at 5.5, and the fermentation time is not less than 48 hours. After the fermentation is completed, the bacteria and large particle impurities are removed by filtration, and the filtered fermentation liquid is concentrated to reduce the volume and increase the concentration. The concentrated fermentation liquid is spray-dried or freeze-dried to obtain a probiotic metabolite concentrated powder.

[0040] Embodiment 2:

[0041] The difference from Example 1 is that a Chinese herbal medicine-based external therapeutic composition for rhinitis comprises 2.0 parts of propolis flavonoid extract, 10 parts of aloe polysaccharide complex, 1.0 parts of green tea polyphenol-hyaluronic acid conjugated nanoparticles, 0.5 parts of probiotic metabolite concentrated powder, 15 parts of scutellaria baicalensis, 3.0 parts of asarum, 15 parts of chuanxiong, 6 parts of magnolia, 3.0 parts of indigo, 0.15 parts of peppermint essential oil, and 0.15 parts of eucalyptus essential oil;

[0042] The remaining steps are the same as those in the first embodiment and will not be described in detail here.

[0043] Embodiment three:

[0044] The difference from Example 1 is that a Chinese herbal medicine-based external therapeutic composition for rhinitis comprises 2.5 parts of propolis flavonoid extract, 12 parts of aloe polysaccharide complex, 1.2 parts of green tea polyphenol-hyaluronic acid conjugated nanoparticles, 0.7 parts of probiotic metabolite concentrated powder, 18 parts of scutellaria baicalensis, 3.5 parts of asarum, 17 parts of chuanxiong, 7 parts of magnolia, 3.5 parts of indigo, 0.2 parts of peppermint essential oil, and 0.2 parts of eucalyptus essential oil;

[0045] The remaining steps are the same as those in the first embodiment and will not be described in detail here.

[0046] Application experiment example:

[0047] Compare the external therapeutic compositions for rhinitis of the three embodiments (Embodiment 1, Embodiment 2, and Embodiment 3) provided by the present invention with the existing external therapeutic drugs for rhinitis (control group);

[0048] 40 volunteers with allergic rhinitis, aged between 18 and 60 years old, were randomly divided into four groups, 10 people in each group, and were given the compositions of Example 1, Example 2, and Example 3 and the control group drug for external treatment, respectively. The treatment cycle was four weeks, 1-2 times a day, each time a small cotton ball or gauze strip was inserted into each nostril, dipped in an appropriate amount of medicine, and the retention time each time did not exceed 1 hour;

[0049] A standardized rhinitis symptom scoring table was used, including nasal congestion, runny nose, sneezing, nasal itching, eye symptoms (such as itchy eyes, tearing), etc. Symptom scores were performed before treatment, 2 weeks after treatment, and 4 weeks after treatment. The higher the score, the more severe the symptom. SPSS statistical software was used for data analysis, and t-test or variance analysis was used for statistical testing. The specific data are as follows:

[0050]

[0051] The formula for calculating the symptom improvement rate was: (symptom score before treatment - symptom score at week 4 after treatment) / symptom score before treatment × 100%;

[0052] As can be seen from the above, the three example groups all showed significant improvement in rhinitis symptoms, and the symptom improvement rates were higher than those of the control group. Among them, Example 2 group showed the best therapeutic effect and the highest symptom improvement rate.

[0053] Among them, propolis flavonoids extract, propolis is a kind of colloid solid with aromatic smell, which is made by mixing the resin collected by bees from plant spores or tree trunks with the secretions of their palatine glands and wax glands. Flavonoids are important active ingredients in propolis, with multiple biological activities such as antibacterial, anti-inflammatory and antioxidant. Propolis flavonoids extract is used to enhance the antibacterial and anti-inflammatory effects of the composition and promote the repair of nasal mucosa.

[0054] Aloe polysaccharide complex, its leaf juice contains a variety of active ingredients, including polysaccharides, amino acids, vitamins, etc. Aloe polysaccharides have moisturizing, repairing, anti-inflammatory and other effects. Aloe polysaccharide complex is used to moisturize the nasal mucosa, reduce inflammation, and promote the healing of the mucosa.

[0055] Green tea polyphenols-hyaluronic acid conjugated nanoparticles have multiple functions such as antioxidant, anti-inflammatory, and antibacterial. Hyaluronic acid is a natural moisturizing factor with good moisturizing and lubricating effects. Combining green tea polyphenols with hyaluronic acid to form conjugated nanoparticles aims to improve the stability and bioavailability of active ingredients while enhancing moisturizing and anti-inflammatory effects.

[0056] Probiotic metabolite concentrated powder. Probiotic metabolites are metabolites produced by probiotics during the fermentation process, including lactic acid, acetic acid, vitamins, etc., which have the functions of regulating intestinal flora, enhancing immunity, and anti-inflammatory. Probiotic metabolite concentrated powder may be used to regulate nasal microecology and enhance the immunity of nasal mucosa;

[0057] Goose does not eat grass, which has the effect of dispelling wind and cold and clearing the nasal passages. It is often used to treat colds, nasal congestion and runny nose, and to relieve symptoms such as nasal congestion and runny nose caused by rhinitis.

[0058] Asarum is a traditional Chinese herbal medicine with the effects of relieving exterior symptoms, dispelling cold and relieving pain. It can treat symptoms such as colds, headaches and toothaches, and is used to relieve symptoms such as nasal pain and headaches.

[0059] Chuanxiong is used to treat symptoms such as headaches, rheumatic pain, etc., and is used to improve nasal blood circulation and relieve symptoms such as nasal congestion and headaches.

[0060] Magnolia has the effect of dispersing wind and cold and clearing the nasal passages. It is used to treat symptoms such as colds and nasal congestion. It is used to enhance the effect of clearing the nasal passages and relieve nasal congestion symptoms caused by rhinitis.

[0061] Indigo is used to treat symptoms such as heat toxins in febrile diseases, blood heat spots, and to relieve symptoms such as congestion and edema of the nasal mucosa.

[0062] Peppermint essential oil has the effects of cooling and refreshing, anti-inflammatory and analgesic, and is used to provide a cooling sensation and relieve nasal discomfort and pain.

[0063] Eucalyptus essential oil has antibacterial, anti-inflammatory, antitussive and antiasthmatic effects. It is used to enhance the antibacterial effect and relieve symptoms such as cough and asthma caused by rhinitis.

[0064] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A Chinese herbal medicine-based external therapeutic composition for rhinitis, characterized in that: The invention comprises the following raw materials in parts by weight: 1.5-2.5 parts of propolis flavonoids extract, 8-12 parts of aloe polysaccharide complex, 0.8-1.2 parts of green tea polyphenol-hyaluronic acid conjugated nanoparticles, 0.3-0.7 parts of probiotic metabolite concentrated powder, 12-18 parts of goose not eating grass, 2.5-3.5 parts of asarum, 13-17 parts of chuanxiong, 5-7 parts of magnolia, 2.5-3.5 parts of indigo, 0.1-0.2 parts of peppermint essential oil, and 0.1-0.2 parts of eucalyptus essential oil.

2. A Chinese herbal medicine-based external rhinitis therapeutic composition according to claim 1, characterized in that: The probiotic metabolite concentrated powder is one of lactobacillus metabolite concentrated powder and bifidobacterium metabolite extract.

3. A method for preparing a composition for external use for treating rhinitis based on Chinese herbal medicine, characterized in that: The following steps are involved: S1, mixing and ultrafine grinding of Herba Eupatorii, Asarum, Rhizoma Chuanxiong, Radix Magnoliae, and Indigo Naturalis, sieving to obtain fine powder, and obtaining a Chinese medicine extract by extraction and distillation; S2, adding propolis flavonoid essence, aloe polysaccharide complex, green tea polyphenol-hyaluronic acid conjugated nanoparticles, and probiotic metabolite concentrated powder to the traditional Chinese medicine extract and mixing them according to a ratio, adding a stabilizer and a suspending agent, and obtaining a nanofiber membrane through electrospinning and layer-by-layer self-assembly; S3, drying the nanofiber membrane, and then crushing it to obtain a composition for external use for treating rhinitis.

4. The method for preparing a Chinese herbal medicine-based external rhinitis therapeutic composition according to claim 3, characterized in that: In S1, supercritical CO2 extraction is used, the temperature is set to 50°C, the pressure is set to 25 MPa, and the extraction time is 3-5 hours.

5. The method for preparing a Chinese herbal medicine-based external rhinitis therapeutic composition according to claim 3, characterized in that: In S2, the stabilizer is polyvinyl pyrrolidone and the suspending agent is sodium carboxymethyl cellulose.

6. The method for preparing a Chinese herbal medicine-based external rhinitis therapeutic composition according to claim 3, characterized in that: In S2, the spinning conditions of the electrospinning include a voltage of 20 kV, a distance of 20 cm, and a flow rate of 0.5 mL / h.

7. The method for preparing a Chinese herbal medicine-based external rhinitis therapeutic composition according to claim 3, characterized in that: In S2, a layer-by-layer self-assembly process is performed by alternately depositing polyelectrolyte layers with opposite charges, wherein the number of layers is 5-10.

8. The method for preparing a Chinese herbal medicine-based external rhinitis therapeutic composition according to claim 7, characterized in that: The polyelectrolyte layer is sodium polystyrene sulfonate and polyallylamine hydrochloride.

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