External ointment for rhinitis as well as preparation method and application of external ointment

Abstract

The invention discloses an external ointment for rhinitis, a preparation method and application, which can effectively treat chronic rhinitis with nasal obstruction, sneezing and dry nose as main symptoms, and the ointment is non-invasive, convenient and non-irritant to skin. The external ointment for rhinitis comprises the following raw materials in percentage by mass: 5% of ephedra, 5% of almond, 5% of cocklebur fruit, 5% of wine-processed scutellaria baicalensis, 5% of radix angelicae, 5% of moutan bark, 5% of lithospermum, 5% of magnolia flower, 5% of selaginella tamariscina, 2.5% of borneol, 45% of sesame oil and 7.5% of beewax.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine, in particular to a medicated ointment for external use for rhinitis, a preparation method of the medicated ointment for external use for rhinitis, and an application of the medicated ointment for external use for rhinitis. BACKGROUND

[0002] Chronic rhinitis is a chronic inflammation of the nasal mucosa and submucosa, with a course of more than 12 weeks, and symptoms of repeated attacks or prolonged recovery. It includes chronic simple rhinitis, chronic hypertrophic rhinitis, allergic rhinitis, and other chronic diseases with main symptoms of nasal congestion, runny nose, sneezing, and nasal dryness. Its essence is chronic inflammation and functional disorder of the nasal mucosa. Its onset may be related to industrial pollution, air pollution, and lifestyle. Studies show that about 10-30% of adults worldwide are affected by chronic rhinitis, of which allergic rhinitis (AR) accounts for the highest proportion (about 10-40%), and non-allergic rhinitis (NAR) accounts for about 20-30% (WAO Journal, 2022). In China, the direct medical costs caused by allergic rhinitis each year are about 5-10 billion yuan, and the indirect costs (such as lost work and reduced learning efficiency) are even higher.

[0003] Modern medicine believes that the main pathogenesis of chronic rhinitis is chronic inflammation of the nasal mucosa and submucosa caused by various factors, common causes include local irritation (infection, structural abnormalities, drug abuse), environmental factors (pollution, occupational exposure, climate), systemic diseases (allergy, endocrine disorders, immune abnormalities), lifestyle (smoking, diet, nose habits). The commonly used drugs in clinic mainly include nasal glucocorticoids, antihistamines, mucous promoting agents, antibiotics and anti-lgE therapy.

[0004] From the perspective of traditional Chinese medicine, the pathogenesis of chronic rhinitis is the invasion of external pathogens leading to imbalance of viscera and lung qi disorder. "Lingshuo Pulse Degree": "Lung qi is connected with the nose, and the lung is harmonious, so the nose can know the smell." Traditional Chinese medicine believes that the occurrence of chronic rhinitis is inseparable from deficiency of the healthy and excess of the evil, internal and external diseases, the internal cause is deficiency, and the external cause is wind. "Suwen Taiyin Yangming Theory" mentions "injured by wind, the upper part is first affected." The lung is the top of the five zang organs, and its canopy is opened to the nose, so the wind evil is most likely to injure the nose, leading to symptoms such as nasal congestion and runny nose. Traditional Chinese medicine clinics often use decoction, acupuncture, and drug external treatment to treat chronic rhinitis.

[0005] Ointment is a complex intervention method of local external treatment of traditional Chinese medicine. This method is based on the theory of traditional Chinese medicine and has local treatment effect. Through the percutaneous absorption of drugs, the local skin mucosa is stimulated to achieve the treatment purpose. Modern pharmacy, also known as transdermal administration, can avoid the 'first-pass elimination' and 'gastrointestinal inactivation' effect of oral administration, improve the bioavailability, stimulate the local skin mucosa by drugs, and stimulate the whole effect. Experiments have proved that the nasal mucosa has a unique physiological function, and can achieve the treatment effect. At present, the clinical application of drug external treatment is not the same, and it is combined with the relevant clinical experience of doctors. There are differences in the composition of medicine, processing method, action time, and selection of dosage form. In recent years, some new dosage forms such as traditional Chinese medicine extract nasal drops and traditional Chinese medicine extract ointment have improved the treatment effect. Through observation of the clinical effect, it is found that the ointment for external use has a short action time for improving the symptoms of patients, is convenient to carry and easy to operate. Now the ointment for external use in the treatment of chronic rhinitis has been widely accepted by people, and more and more people use the ointment for external use in the treatment of chronic rhinitis during the annual rhinitis peak period. SUMMARY

[0006] In order to overcome the defects of the prior art, the technical problem to be solved by the present application is to provide an ointment for external use in the treatment of rhinitis, which can effectively treat chronic rhinitis with nasal congestion, sneezing and nasal dryness as the main symptoms. The ointment is non-invasive, convenient and non-irritating to the skin.

[0007] The technical scheme of the present application is that the ointment for external use in the treatment of rhinitis comprises the following raw materials in percentage by mass: ephedra 5%, apricot kernel 5%, xanthium 5%, wine yellow 5%, white peony root 5%, purple grass 5%, lily 5%, sweet osmanthus 5%, clubmoss 5%, borneol 2.5%, sesame oil 45%, and beeswax 7.5%.

[0008] The ointment for external use in the treatment of rhinitis can effectively treat chronic rhinitis with nasal congestion, sneezing and nasal dryness as the main symptoms. The ointment is non-invasive, convenient and non-irritating to the skin.

[0009] The preparation method of the ointment for external use in the treatment of rhinitis comprises the following steps:

[0010] (1) crushing the percentages of ephedra, apricot kernel, xanthium, wine yellow, white peony root, purple grass, lily, sweet osmanthus and clubmoss;

[0011] (2) adding the percentage of sesame oil and mixing uniformly, then loading into a sealed container and soaking for 7-10 days;

[0012] (3) heating the mixture of the soaked medicine and sesame oil to boiling and fully stirring;

[0013] (4) filtering the mixture after heating, including: the dregs of ephedra, almond, xanthium, scutellaria baicalensis, radix angelicae dahuricae, cortex moutan, radix lithospermi, lonicera, selaginella, borneol, and sesame oil;

[0014] (5) placing the beeswax in a container and heating until melted, quickly pouring the medicine liquid containing ephedra, almond, xanthium, scutellaria baicalensis, radix angelicae dahuricae, cortex moutan, radix lithospermi, lonicera, selaginella, and sesame oil into the container, heating and stirring until uniform, and placing the percentage of borneol into the medicine liquid stirred uniformly,

[0015] cooling and solidifying into a paste after being fully dissolved.

[0016] The application also provides the use of the external use ointment for rhinitis, which is applied in chronic rhinitis. DETAILED DESCRIPTION

[0017] The external use ointment for rhinitis contains the following raw materials in percentage of mass: ephedra 5%, almond 5%, xanthium 5%, scutellaria baicalensis 5%, radix angelicae dahuricae 5%, cortex moutan 5%, radix lithospermi 5%, lonicera 5%, selaginella 5%, borneol 2.5%, sesame oil 45%, and beeswax 7.5%.

[0018] The external use ointment for rhinitis can effectively treat chronic rhinitis with the main symptoms of nasal congestion, sneezing, and dry nose, and is non-invasive, convenient, and non-irritating to the skin.

[0019] Preferably, the external use ointment for rhinitis contains the following raw materials: ephedra 140g, almond 140g, xanthium 140g, scutellaria baicalensis 140g, radix angelicae dahuricae 140g, cortex moutan 140g, radix lithospermi 140g, lonicera 140g, selaginella 140g, borneol 70g, sesame oil 1260g, and beeswax 210g.

[0020] The preparation method of the external use ointment for rhinitis includes the following steps:

[0021] (1) crushing the percentage of ephedra, almond, xanthium, scutellaria baicalensis, radix angelicae dahuricae, cortex moutan, radix lithospermi, lonicera, and selaginella;

[0022] (2) adding the percentage of sesame oil and mixing uniformly, and placing into a sealed container and soaking for 7-10 days;

[0023] (3) heating the mixture of the soaked medicine and sesame oil to boiling and fully stirring;

[0024] (4) filtering the mixture after heating, including: the dregs of ephedra, almond, xanthium, scutellaria baicalensis, radix angelicae dahuricae, cortex moutan, radix lithospermi, lonicera, selaginella, borneol, and sesame oil;

[0025] (5) Heat the beeswax in a container until it melts, then quickly pour the medicinal liquid containing ephedra, almond, cocklebur, scutellaria baicalensis, angelica dahurica, peony bark, gromwell root, magnolia flower, selaginella, and sesame oil into the container. Heat and stir until well mixed. Add the specified percentage of borneol to the well-stirred medicinal liquid.

[0026] After it has fully dissolved, cool and solidify into a paste.

[0027] It also provides the application of topical ointments for rhinitis, which are used in chronic rhinitis.

[0028] Preferably, 1-2g of ointment is applied to the nasal mucosa using a cotton swab.

[0029] The embodiments of the present invention will be described in detail below.

[0030] 140g of ephedra, 140g of apricot kernel, 140g of cocklebur, 140g of scutellaria baicalensis (processed with wine), 140g of angelica dahurica, 140g of peony bark, 140g of gromwell root, 140g of magnolia flower, and 140g of selaginella are crushed, soaked in 1260g of sesame oil, and then mixed with 210g of beeswax and 70g of borneol. The mixture is heated, cooled, and solidified into a paste to obtain the ointment of this invention.

[0031] Applying 1-2g of the above-mentioned ointment to the nasal mucosa of patients with chronic rhinitis diagnosed as having "lung qi stagnation syndrome" according to Traditional Chinese Medicine can effectively improve their clinical symptoms without side effects. Related clinical trials have been completed, and detailed information is attached below.

[0032] 1. Methods: Fifty patients meeting the Western medicine diagnosis of chronic rhinitis and the traditional Chinese medicine diagnosis of lung qi stagnation were randomly divided into two groups: an experimental group (n=25) and a control group (n=25). At each outpatient visit, patients' gender, age, duration of illness, past medical history, medication history, and TCM diagnostic methods and current symptoms were recorded. The control group received routine treatment without external medication, including symptomatic supportive treatment with TCM decoctions. The experimental group received routine treatment plus rhinitis ointment.

[0033] 2. Topical ointment: Apply 1-2g of ointment to the nasal mucosa twice daily for 7 days. Symptom relief and adverse reactions were recorded on days 1, 7, and 14 after enrollment as safety indicators. Data were compiled and analyzed using SPSS 22.0 after the trial. A p-value < 0.05 was considered statistically significant.

[0034] 3. Results:

[0035] 3.1 Comparison of baseline data between the experimental group and the control group:

[0036] (1) There were no statistically significant differences in demographic data such as gender and age between the two groups of patients (P > 0.05).

[0037] (2) Two groups of patients with chronic rhinitis, the duration of this acute exacerbation time was not statistically different (P>0.05). (3) The TCM syndrome score was not statistically different (P>0.05). The baseline data showed that the two groups were comparable.

[0038] 3.2 Effective rate evaluation:

[0039] (1) The TCM syndrome score of the test group and the control group was not statistically different (P>0.05). The scores of both groups decreased after treatment, and the difference was statistically significant (P<0.001). After treatment, the TCM syndrome score of the test group was lower than that of the control group, but there was no statistical difference (P>0.05).

[0040] (2) The effective rate was evaluated according to the improvement rate of TCM syndrome score at 1 day, 7 days, and 14 days after treatment. The effective rate of the test group (46.7%-73.3%-83.3%) was higher than that of the control group (46.7%-63.3%-70%), but there was no statistical difference (P>0.05).

[0041] (3) There was no significant difference in nasal congestion score between the two groups before treatment (P>0.05). After treatment, the nasal congestion score decreased significantly, and the difference was statistically significant (P<0.05) at 1 day after treatment in the test group and at 7 days after treatment in the control group. The nasal congestion score of the test group was lower than that of the control group, and the difference between the two groups was statistically significant (P<0.05) at 7 days and 14 days after treatment.

[0042] (4) Before treatment, there was no significant difference in sneezing score between the two groups. After treatment, the sneezing score decreased, and the difference was statistically significant (P<0.05). The sneezing score of the test group was lower than that of the control group at 14 days after treatment, and the difference was statistically significant (P<0.05).

[0043] (5) After treatment, the patients' runny nose score improved compared with before treatment (P<0.05). There was no significant difference in score between the two groups (P>0.05).

[0044] 4. Test conclusion:

[0045] (1) Tongqiao Biyan Gao can assist in improving the symptoms of patients with chronic rhinitis of lung qi dysfunction. It is superior to the control group in improving nasal congestion, runny nose, and sneezing symptoms, and it works faster.

[0046] (2) Tongqiao Biyan Gao has good safety evaluation, and no serious adverse events occurred during the trial.

[0047] The external medicine ointment of the application is applied to the nasal mucosa, and the local stimulation of drug skin absorption and the comprehensive effect of the drug achieve the purpose of preventing and treating diseases. Clinical tests show that the application has outstanding curative effect on chronic rhinitis of "lung qi dysfunction", and is a breakthrough in the treatment of chronic rhinitis by combining local mucosa and drugs. The external medicine ointment treats chronic rhinitis according to the principle of "internal disease treated externally" proposed in Huangdi Neijing, and emphasizes "the principle of external treatment is the principle of internal treatment" in Liyue Pianwen of Qing Dynasty. External application of traditional Chinese medicine absorbs drug properties through the skin and mucosa, dredges the meridians, regulates the blood, and improves local circulation. Therefore, the external medicine ointment directly acts on the nasal cavity by local drug application, and promotes the nasal meridians, expels evil and dissolves turbidity. Therefore, it can effectively achieve the effect of treating chronic rhinitis, and the drug and the local skin cooperate to treat chronic rhinitis, which has great clinical significance and outstanding economic and social benefits.

[0048] The above is only the preferred embodiment of the application, and does not limit the application in any form. Any simple modification, equivalent change and modification made according to the technical essence of the application to the above embodiment are still within the protection scope of the technical scheme of the application.

Claims

1. A topical ointment for rhinitis, characterized in that: By weight percentage, it contains the following ingredients: Ephedra 5%, Almond 5%, Xanthium sibiricum 5%, Scutellaria baicalensis (processed with wine) 5%, Angelica dahurica 5%, Paeonia suffruticosa 5%, Lithospermum erythrorhizon 5%, Magnolia biondii 5%, Selaginella tamariscina 5%, Borneol 2.5%, Sesame oil 45%, Beeswax 7.5%.

2. The topical ointment for rhinitis according to claim 1, characterized in that: It contains the following ingredients: 140g ephedra, 140g almond, 140g cocklebur, 140g scutellaria baicalensis (processed with wine), 140g angelica dahurica, 140g peony bark, 140g gromwell root, 140g magnolia flower, 140g selaginella, 70g borneol, 1260g sesame oil, and 210g beeswax.

3. The method for preparing the topical ointment for rhinitis according to claim 1 or 2, characterized in that: It includes the following steps: (1) Crush the ephedra, apricot kernel, cocklebur, scutellaria baicalensis, angelica dahurica, peony bark, gromwell root, magnolia flower, and selaginella tamariscina according to the stated percentages; (2) Add the sesame oil of the stated percentage, mix well, put into a sealed container, and soak for 7-10 days; (3) Heat the mixture of soaked herbs and sesame oil to boiling and stir thoroughly; (4) Filter the heated mixture, including the dregs of ephedra, apricot kernel, cocklebur, wine-processed scutellaria, angelica, peony bark, gromwell root, magnolia flower, and selaginella, and retain the liquid. (5) Place beeswax in a container and heat until melted. Quickly pour the medicinal liquid containing ephedra, almond, cocklebur, scutellaria baicalensis, angelica dahurica, peony bark, purple gromwell, magnolia flower, selaginella, and sesame oil into the container, heat and stir evenly. Add the percentage of borneol into the stirred medicinal liquid. After it is fully dissolved, cool and solidify into a paste.

4. The application of the topical ointment for rhinitis according to claim 1 or 2, characterized in that: It is used in chronic rhinitis.

5. The application of the topical ointment for rhinitis according to claim 4, characterized in that: Apply 1-2g of ointment to the nasal mucosa using a cotton swab.