Traditional Chinese medicine liquid for treating rhinitis and preparation method thereof

Abstract

The application discloses a traditional Chinese medicine liquid for treating rhinitis and a preparation method thereof, and relates to the technical field of traditional Chinese medicine preparations, which is prepared from medicinal active components, an oil phase matrix and an oil-soluble antioxidant, wherein the medicinal active components comprise 15-20 parts of Centipeda minima, 15-20 parts of Lonicera japonica, 10-15 parts of Radix et Rhizoma Cynanchi Paniculati, 8-12 parts of Radix Saposhnikoviae, 3-5 parts of Radix Baphlai, 1-2 parts of Asarum, 0.5-1.0 parts of menthol and 0.1-0.3 parts of borneol according to the weight of crude drugs; the feeding ratio of the total mass of crude drugs to the oil phase matrix is 1:6-1:10 g / mL; and the oil-soluble antioxidant is added in an amount of 0.05%-0.2% of the total mass of medicinal oil. The traditional Chinese medicine liquid for treating rhinitis and the preparation method thereof have no adverse reactions such as nasal cavity dryness and mucosal atrophy caused by hormone drugs, contain no decongestant components, can exert the effects of anti-inflammation, anti-allergy and nasal orifice dredging through the active components of traditional Chinese medicines, and are high in safety.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine preparation technology, specifically to a traditional Chinese medicine drop for treating rhinitis and its preparation method. Background Technology

[0002] Rhinitis is a common inflammatory disease of the nasal mucosa, mainly including allergic rhinitis and chronic simple rhinitis. Allergic rhinitis is characterized by episodic nasal itching, nasal congestion, sneezing, and clear watery nasal discharge; chronic simple rhinitis is characterized by intermittent or alternating nasal congestion and increased nasal discharge. Both types of rhinitis are characterized by a long course and a tendency to recur, seriously affecting the patient's quality of life.

[0003] Currently, the main clinical treatments for rhinitis include medication, physical therapy, and surgery. Medication is the most widely used approach, primarily including nasal corticosteroids, antihistamines, decongestants, and other Western medicine preparations, as well as oral and topical Chinese medicine preparations. Nasal corticosteroids are the first-line treatment for allergic rhinitis, possessing clear anti-inflammatory and anti-allergic effects; however, long-term use can lead to adverse reactions such as nasal dryness and mucosal irritation, causing some patients to have concerns about hormone therapy. While decongestants can quickly relieve nasal congestion, continuous use can easily induce drug-induced rhinitis, limiting their clinical use.

[0004] Therefore, it is necessary to propose a traditional Chinese medicine drop for treating rhinitis and its preparation method to solve the above problems. Summary of the Invention

[0005] Technical problems to be solved

[0006] The purpose of this invention is to provide a traditional Chinese medicine drop for treating rhinitis that effectively replaces or reduces hormone dependence and avoids the adverse reactions of decongestants, as well as its preparation method, in order to solve the problems mentioned in the background art.

[0007] Technical solution To achieve the above objectives, the present invention is implemented through the following technical solution: a traditional Chinese medicine drop for treating rhinitis and its preparation method, which is made from active components of medicinal materials, an oil phase matrix and an oil-soluble antioxidant; the active components of medicinal materials include, by weight of raw herbs: 15-20 parts of Centipeda minima, 15-20 parts of Magnolia biondii, 10-15 parts of Cynanchum paniculatum, 8-12 parts of Saposhnikovia divaricata, 3-5 parts of Lithospermum erythrorhizon, 1-2 parts of Asarum heterotropoides, 0.5-1.0 parts of menthol, and 0.1-0.3 parts of borneol.

[0008] Preferably, the ratio of the total mass of the crude drug to the oil phase matrix is ​​1:6 to 1:10 g / mL; the amount of the oil-soluble antioxidant added is 0.05% to 0.2% of the total mass of the medicinal oil.

[0009] Preferably, the oil phase matrix is ​​selected from one or more of sesame oil, olive oil, tea seed oil, caprylic / capric triglyceride, and isopropyl myristate; the oil-soluble antioxidant is selected from one or more of vitamin E, butylated hydroxytoluene, and butylated hydroxyanisole.

[0010] Preferably, the active components of the medicinal materials are as follows, by weight of the raw herbs: 18 parts of Centipeda minima, 18 parts of Magnolia biondii, 12 parts of Cynanchum paniculatum, 10 parts of Saposhnikovia divaricata, 4 parts of Lithospermum erythrorhizon, 1.5 parts of Asarum heterotropoides, 0.8 parts of menthol, and 0.2 parts of borneol.

[0011] A method for preparing the above-mentioned traditional Chinese medicine drops for treating rhinitis, characterized by comprising the following steps: (1) Pretreatment: The herbs, including Centipeda minima, Magnolia biondii, Cynanchum paniculatum, Angelica dahurica, Saposhnikovia divaricata, and Asarum heterotropoides, were cleaned, dried, and then pulverized into 20-mesh coarse powder and stored separately. (2) Detoxification and oil production of Asarum: Add water to the crude powder of Asarum and steam distill it. Discard the initial distillate, which accounts for 10% of the total volume of the distillate. Collect the middle and later distillate and obtain Asarum volatile oil by oil-water separation. Store it in cold for later use. (3) Low-temperature oil extraction: The mixed coarse powder of Centipeda minima, Magnolia biondii, Cynanchum paniculatum, Angelica dahurica and Saposhnikovia divaricata was added to the oil phase matrix. After the medicinal materials were completely submerged, the mixture was sealed and soaked at 40-45℃ in the dark for 72 hours to obtain crude extract of medicinal oil. (4) Filtration: After coarse filtration through gauze and centrifugation, the supernatant oil is collected and finely filtered to obtain the clarified intermediate oil. (5) Solution preparation: Control the temperature of the intermediate drug oil at 40-50℃, add oil-soluble antioxidant and stir to dissolve; grind menthol and borneol together at room temperature, dilute with a small amount of intermediate drug oil, and add to the main drug oil cooled to room temperature; then add asarum volatile oil, stir evenly and make up to volume.

[0012] Preferably, the drying temperature in step (1) is not higher than 40℃, and the moisture content of the medicinal material after drying is ≤9%.

[0013] Preferably, during the soaking period in step (3), the mixture is stirred twice a day for 5 minutes each time, and the stirring speed is 80 rpm.

[0014] The theoretical basis of this invention is: Rhinitis falls under the categories of "nasal congestion" and "nasal obstruction" in Traditional Chinese Medicine. Its core pathogenesis is lung qi deficiency and cold, external wind invasion, and nasal congestion, coupled with prolonged illness affecting the collaterals and malnourishment of the nasal mucosa. Treatment should focus on clearing the nasal passages, dispelling wind and desensitizing, while also promoting blood circulation, protecting the nasal mucosa, and balancing cold and heat.

[0015] The herb *Centipeda minima* is pungent and warm, dispersing in nature, and specifically enters the lung meridian. It is effective in clearing nasal passages, dispelling wind-cold, and relieving nasal itching. The herb *Magnolia biondii* is pungent, warm, and aromatic, ascending to the head and face, directly reaching the nasal passages. It can warm and invigorate lung qi and open and close the nasal passages. When used together, these two herbs disperse cold pathogens and clear nasal passages.

[0016] Xu Changqing (Radix Cynanchi Aristolochiae) dispels wind and dampness, relieves itching and detoxifies, and is effective in treating urticaria, itching, and sneezing. It can dispel wind and desensitize to stop nasal itching and sneezing. Fangfeng (Radix Saposhnikoviae) dispels wind and releases the exterior, eliminates dampness and relieves itching, and can enhance the overall detoxifying and desensitizing effects of the formula. Zicao (Radix Lithospermi) is sweet, salty, and cold in nature, cools the blood, invigorates blood circulation, detoxifies and promotes tissue regeneration, and can restrain the pungent, warm, and drying properties of the formula. At the same time, it invigorates blood circulation, unblocks collaterals, repairs mucous membranes, and improves local blood stasis in the nasal passages. The three herbs complement each other, not only helping the principal herb dispel wind and relieve itching, but also taking into account mucous membrane repair and counteracting the warm and drying properties.

[0017] Menthol, with its pungent and cooling properties, clears the head and eyes, quickly relieving nasal itching and burning, and improving the user experience. Borneol, also pungent and cooling, penetrates and opens the nasal passages, helping the medicine penetrate deep into the nasal mucosa and guiding it upwards to the affected area. Together, these two herbs act as guiding agents, promoting penetration and harmonizing the user experience.

[0018] Beneficial effects This herbal nasal drop treatment for rhinitis inhibits the release of inflammatory factors, reduces nasal mucosal capillary permeability, alleviates mucosal edema, and relieves nasal congestion. It inhibits mast cell degranulation, reduces the release of allergy mediators, lowers nasal mucosal hyperreactivity, and improves symptoms such as nasal itching and paroxysmal sneezing. It has anti-inflammatory effects, promotes granulation tissue proliferation, repairs damaged nasal mucosal epithelium, and enhances mucosal barrier function. It does not cause adverse reactions such as nasal dryness and mucosal atrophy as with hormonal drugs, and contains no decongestants. Its anti-inflammatory, anti-allergic, and nasal decongestant effects are achieved through the active ingredients of traditional Chinese medicine, making it highly safe. Detailed Implementation

[0019] 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.

[0020] Example 1 A nasal herbal oil drop for treating rhinitis, comprising the following active ingredients by weight of raw herbs: 15g of *Centipeda minima*, 15g of *Magnolia biondii*, 10g of *Cynanchum paniculatum*, 8g of *Saposhnikovia divaricata*, 3g of *Lithospermum erythrorhizon*, 1g of *Asarum heterotropoides*, 0.5g of menthol, and 0.1g of borneol. The oil phase matrix is ​​sesame oil, with a total raw herb to sesame oil volume ratio of 1:6 g / mL. The oil-soluble antioxidant is vitamin E acetate, added at 0.05% of the total oil mass.

[0021] The preparation method is as follows: (1) Pretreatment: The above weight of Centipeda minima, Magnolia biondii, Cynanchum paniculatum, Saposhnikovia divaricata, Lithospermum erythrorhizon and Asarum heterotropoides are cleaned and impurities and mold are removed. After rapid rinsing, they are placed in a 40℃ forced-air drying oven and dried until the moisture content is ≤9%. They are then crushed into 20-mesh coarse powder and sealed for later use. (2) Detoxification and oil production of Asarum heterotropoides: The coarse powder of Asarum heterotropoides is placed in a distillation flask, and 8 times the amount of purified water is added and soaked for 30 minutes. Steam distillation is carried out. The first 10% volume of the initial distillate is discarded, and the middle and later distillate is collected. The Asarum heterotropoides volatile oil is obtained by separating it through an oil-water separator and refrigerated for later use. (3) Low-temperature oil extraction: The coarse powders of Centipeda minima, Magnolia biondii, Cynanchum paniculatum, Saposhnikovia divaricata and Lithospermum erythrorhizon are mixed evenly and put into a reaction tank. The prescribed amount of sesame oil is added and stirred to completely submerge the medicinal materials. The tank is then sealed. Place in a water bath at 40-45℃, keep away from light, and soak for 72 hours; stir once in the morning and once in the evening, for 5 minutes each time, at a speed of 80 rpm. (4) Filtration and purification: After soaking, filter coarsely with medical gauze; centrifuge the initial filtrate at 3000 rpm at room temperature for 15 minutes, and take the clear oil from the upper layer; then filter finely through a 0.45 μm microporous membrane to obtain the clear intermediate drug oil. (5) Solution preparation: Control the temperature of the intermediate drug oil in a water bath to 40-50℃, add the prescribed amount of vitamin E acetate, and stir at 80 rpm for 10 minutes until completely dissolved; grind menthol and borneol in a mortar at room temperature until completely fused, take a small amount of intermediate drug oil, dilute and mix well, and slowly add it to the main drug oil that has been cooled to room temperature, and continue stirring for 10 minutes; then add the asarum volatile oil prepared in step (2), stir evenly, and add sesame oil to a total volume of 315.6 mL. (6) Sterilization and dispensing: The prepared medicine oil is filtered through a 0.22μm organic sterilization filter membrane, and the filtration pressure is controlled to be ≤0.15MPa. It is then dispensed into 10mL brown glass nasal drop bottles, capped and sealed to obtain the finished product.

[0022] Example 2 Unlike Example 1, the active components of the medicinal materials, by weight of the raw herbs, are: 18g of Centipeda minima, 18g of Magnolia biondii, 12g of Cynanchum paniculatum, 10g of Saposhnikovia divaricata, 4g of Lithospermum erythrorhizon, 1.5g of Asarum heterotropoides, 0.8g of menthol, and 0.2g of borneol. The oil phase matrix is ​​sesame oil, with a ratio of total raw herb mass to sesame oil volume of 1:8g / mL; the oil-soluble antioxidant is vitamin E acetate, added at 0.1% of the total mass of the medicinal oil.

[0023] Example 3 Unlike Example 1, the active components of the medicinal materials, by weight of the raw herbs, are: 20g of Centipeda minima, 20g of Magnolia biondii, 15g of Cynanchum paniculatum, 12g of Saposhnikovia divaricata, 5g of Lithospermum erythrorhizon, 2g of Asarum heterotropoides, 1.0g of menthol, and 0.3g of borneol. The oil phase matrix is ​​sesame oil, with a ratio of total raw herb mass to sesame oil volume of 1:10 g / mL; the oil-soluble antioxidant is vitamin E acetate, added at 0.2% of the total mass of the medicinal oil.

[0024] Experimental Example 2: Clinical Efficacy Observation A total of 120 patients with chronic simple rhinitis and allergic rhinitis admitted to the outpatient clinic were selected, including 63 cases of allergic rhinitis and 57 cases of chronic simple rhinitis; their ages ranged from 18 to 62 years, with a mean age of 36.4 years; and the duration of illness ranged from 3 months to 2 years. Patients were randomly divided into a treatment group and a control group, with 60 patients in each group. There were no statistically significant differences between the two groups in terms of age, duration of illness, type of disease, and symptom score (P>0.05), making them comparable. Inclusion criteria: Patients met the diagnostic criteria for nasal congestion and rhinitis in the "Standards for Diagnosis and Efficacy of Traditional Chinese Medicine Diseases and Syndromes," with main symptoms including nasal congestion, nasal itching, sneezing, and runny nose, and a symptom score ≥4. Exclusion criteria: Atrophic rhinitis, nasal space-occupying lesions, severe sinusitis, pregnant or lactating women, and patients allergic to any component of this medication.

[0025] Treatment methods: Treatment group: Nasal drops containing traditional Chinese medicine oil prepared in Example 2 of this invention were used as nasal drops. Two drops were applied to the nasal cavity and acupoints around the nose and massaged in, twice daily, for two weeks as one course of treatment. Control group: Commercially available external nasal sprays were used, with dosage and administration according to the instructions, for two weeks as one course of treatment.

[0026] Therapeutic criteria: Cure: Symptoms such as nasal congestion, nasal itching, sneezing, and runny nose completely disappeared, nasal mucosal edema subsided, and there was no recurrence during a one-month follow-up. Significant effect: Symptoms are significantly reduced, symptom scores decrease by ≥70%, and mild nasal mucosal edema is observed. Improvement: Symptoms have been relieved, and symptom scores have decreased by 30% to 69%; Ineffective: Symptoms show no significant improvement, and the score decreases by <30%; Treatment results were obtained by analyzing the immediate efficacy after 2 weeks (1 course of treatment). The results are shown in Table 1.

[0027] Table 1 Comparison of clinical efficacy between the two groups

[0028] The results showed that among the 60 cases in the treatment group, the cure rate was 81.7%, 56 cases showed significant improvement (significant improvement rate 93.4%), and 1 case was ineffective. The herbal oil drops of this invention can effectively improve core symptoms such as nasal congestion, nasal itching, sneezing, and runny nose.

[0029] 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 traditional Chinese medicine drop for treating rhinitis, characterized in that: It is made from active medicinal components, an oil phase matrix, and an oil-soluble antioxidant; the active medicinal components include, by weight of raw herbs: 15-20 parts of Centipeda minima, 15-20 parts of Magnolia biondii, 10-15 parts of Cynanchum paniculatum, 8-12 parts of Saposhnikovia divaricata, 3-5 parts of Lithospermum erythrorhizon, 1-2 parts of Asarum heterotropoides, 0.5-1.0 parts of menthol, and 0.1-0.3 parts of borneol.

2. The traditional Chinese medicine drops for treating rhinitis according to claim 1, characterized in that: The ratio of the total mass of the crude drug to the oil phase matrix is ​​1:6 to 1:10 g / mL; the amount of the oil-soluble antioxidant added is 0.05% to 0.2% of the total mass of the medicinal oil.

3. The traditional Chinese medicine drops for treating rhinitis according to claim 1, characterized in that: The oil phase matrix is ​​selected from one or more of sesame oil, olive oil, tea seed oil, caprylic / capric triglyceride, and isopropyl myristate; the oil-soluble antioxidant is selected from one or more of vitamin E, butylated hydroxytoluene, and butylated hydroxyanisole.

4. The traditional Chinese medicine drops for treating rhinitis according to claim 1, characterized in that: The active components of the medicinal materials, calculated by weight of the raw herbs, are as follows: 18 parts of Centipeda minima, 18 parts of Magnolia biondii, 12 parts of Cynanchum paniculatum, 10 parts of Saposhnikovia divaricata, 4 parts of Lithospermum erythrorhizon, 1.5 parts of Asarum heterotropoides, 0.8 parts of menthol, and 0.2 parts of borneol.

5. A method for preparing a traditional Chinese medicine drop for treating rhinitis as described in any one of claims 1 to 4, characterized in that, Includes the following steps: (1) Pretreatment: The herbs, including Centipeda minima, Magnolia biondii, Cynanchum paniculatum, Angelica dahurica, Saposhnikovia divaricata, and Asarum heterotropoides, were cleaned, dried, and then pulverized into 20-mesh coarse powder and stored separately. (2) Detoxification and oil production of Asarum: Add water to the crude powder of Asarum and steam distill it. Discard the initial distillate, which accounts for 10% of the total volume of the distillate. Collect the middle and later distillate and obtain Asarum volatile oil by oil-water separation. Store it in cold for later use. (3) Low-temperature oil extraction: The mixed coarse powder of Centipeda minima, Magnolia biondii, Cynanchum paniculatum, Angelica dahurica and Saposhnikovia divaricata was added to the oil phase matrix. After the medicinal materials were completely submerged, the mixture was sealed and soaked at 40-45℃ in the dark for 72 hours to obtain crude extract of medicinal oil. (4) Filtration: After coarse filtration through gauze and centrifugation, the supernatant oil is collected and finely filtered to obtain the clarified intermediate oil. (5) Solution preparation: Control the temperature of the intermediate drug oil at 40-50℃, add oil-soluble antioxidant and stir to dissolve; grind menthol and borneol together at room temperature, dilute with a small amount of intermediate drug oil, and add to the main drug oil cooled to room temperature; then add asarum volatile oil, stir evenly and make up to volume.

6. The method for preparing a traditional Chinese medicine drop for treating rhinitis according to claim 5, characterized in that: In step (1), the drying temperature shall not exceed 40℃, and the moisture content of the medicinal material after drying shall be ≤9%.

7. The method for preparing a traditional Chinese medicine drop for treating rhinitis according to claim 5, characterized in that: In step (3), the mixture is stirred twice a day for 5 minutes each time during the soaking period, and the stirring speed is 80 rpm.

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