Pharmaceutical composition for treating rhinitis as well as preparation method and application thereof

Abstract

The invention provides a pharmaceutical composition for treating rhinitis. The pharmaceutical composition is prepared from the following raw materials in parts by weight: 105 to 245 parts of herba houttuyniae, 60 to 140 parts of flos chrysanthemi indici, 60 to 140 parts of flos lonicerae, 15 to 35 parts of herba centipedae, 60 to 140 parts of herba senecionis scandentis, 1.2 to 2.8 parts of fructus xanthii oil, 1.2 to 2.8 parts of flos magnoliae oil, 0.9 to 2.1 parts of peppermint oil, 0.9 to 2.1 parts of borneol, 0.6 to 1.4 parts of radix angelicae dahuricae oil, 0.15 to 0.35 part of rhizoma chuanxiong oil and 0.15 to 0.35 part of notopterygium root oil. The invention also provides a preparation method and application of the composition. The gel is prepared by directly adding other auxiliary materials on the basis of the traditional Chinese medicine extract, the prepared gel has good affinity with the nasal cavity, allergens can be effectively isolated, nasal cavity symptoms can be improved, the process is simple, the formula is scientific, and the curative effect is remarkable.

Description

Technical Field

[0001] The invention relates to a pharmaceutical composition for treating rhinitis and a preparation method and application thereof, belonging to the field of traditional Chinese medicine. Background Art

[0002] Rhinitis is a common disease. Rhinitis is an inflammatory disease of the nasal cavity. It is an inflammation of the nasal mucosa caused by viruses, bacteria, allergens, various physical and chemical factors, and certain systemic diseases. According to the different causes, rhinitis can be divided into four categories: infectious rhinitis, allergic rhinitis, vasomotor rhinitis, and drug-induced rhinitis. The prevalence of allergic rhinitis has reached 10% to 25%, and it has become an important global health problem that is widely valued. There are more and more patients with rhinitis, and they tend to be younger. The WHO believes that 10% to 30% of adults and 40% of children worldwide are affected by allergic rhinitis. Rhinitis not only troubles personal life, study, and mental psychology, but also may affect other parts of the upper respiratory tract and the lower respiratory tract in severe cases, causing complications such as pharyngitis, otitis media, tracheitis, bronchitis, and pneumonia, increasing the family's economic burden and the consumption of social medical resources.

[0003] There is no cure for rhinitis, and its treatment mainly relies on drug therapy, immunotherapy, environmental control, health education, etc. to control the disease and relieve symptoms. Regarding the treatment of rhinitis, drug therapy occupies an important position. Traditional glucocorticoids, antihistamines, etc. are first-line treatment drugs, but the adverse reactions of these drugs have not yet been resolved. With the deepening of research on the disease, more and more efficient and safe new drugs are gradually entering the clinic and benefiting patients. Immunotherapy can treat the cause of the disease. In recent years, a large number of new immunotherapy methods have emerged, enriching the immunotherapy of rhinitis patients. However, the technology in the immunotherapy of the disease is not mature, the accurate target of treatment cannot be determined, and the treatment effect is unstable. Therefore, it is imperative to find a safe and effective method to treat rhinitis.

[0004] According to TCM theory, the nose is the gateway for the entry and exit of gases, controls the sense of smell, helps pronunciation, and belongs to the lung system. The nose is the external orifice of the lung. "Suwen·Yin Yang Ying Xiang Da Lun" says: "The lung governs the nose... The orifice is the nose", pointing out the relationship between the lung and the nose. Therefore, rhinitis is first caused by lung qi deficiency and weak defense surface, wind and cold take advantage of the weakness to enter the nasal orifice, evil and good fight each other, lung qi cannot be regulated, body fluids stagnate, and sneezing and runny nose; the fullness of lung qi depends on the distribution of spleen qi. If spleen qi is deficient, lung qi is deficient, and the root of qi is in the kidney. If kidney is deficient, it will not be able to absorb, qi will not return to the source, yang qi will be easily dissipated, and wind evil can invade the body and cause disease. Yang Jiguo said that the pathogenesis of rhinitis is deficiency of the root and excess of the symptoms, then the deficiency of lung, spleen and kidney is the root, and wind, phlegm, qi and blood stasis are the symptoms. TCM treatment of rhinitis emphasizes both the root and the symptoms. It can clear the nasal orifice and has no side effects for long-term use, eliminate allergens, and enhance the body's immune function. Summary of the invention

[0005] The invention provides a pharmaceutical composition for treating rhinitis, a preparation method and use thereof.

[0006] The present invention provides a pharmaceutical composition for treating rhinitis, which is prepared from the following raw materials in weight ratio:

[0007] 105-245 parts of Houttuynia cordata, 60-140 parts of Chrysanthemum indici, 60-140 parts of Honeysuckle, 15-35 parts of Herba Schisandrae Chinensis, 60-140 parts of Senecio grandiflora, 1.2-2.8 parts of Xanthium sibiricum oil, 1.2-2.8 parts of Magnolia officinalis oil, 0.9-2.1 parts of Peppermint oil, 0.9-2.1 parts of Borneolum, 0.6-1.4 parts of Angelica dahurica oil, 0.15-0.35 parts of Chuanxiong oil, and 0.15-0.35 parts of Notopterygium wilfordii oil.

[0008] More preferably, it is prepared from the following raw materials in weight ratio:

[0009] 175 parts of herba houttuyniae, 100 parts of chrysanthemums indica, 100 parts of honeysuckle, 25 parts of herba schizonepetae, 100 parts of senecio, 2 parts of fructus xanthii oil, 2 parts of flos magnoliae oil, 1.5 parts of peppermint oil, 1.5 parts of borneol, 1 part of angelica dahurica oil, 0.25 parts of rhizoma ligustici oil and 0.25 parts of notopterygium wilfordii oil.

[0010] The pharmaceutical composition of the present invention is prepared from water or ethanol extracts of raw materials such as houttuynia cordata, wild chrysanthemum, honeysuckle, radix aconitifolia and senecio radix as active ingredients, and is added with xanthium sibiricum oil, magnolia oil, peppermint oil, borneol, angelica dahurica oil, chuanxiong oil, notopterygium wilfordii oil, and pharmaceutically acceptable excipients or auxiliary ingredients to form a commonly used pharmaceutical nasal preparation.

[0011] Among them, the nasal preparations are nasal drops, nasal washes, sprays, nasal ointments, nasal creams, nasal gels, nasal powders, nasal powder sprays, and nasal sticks.

[0012] The present invention provides a method for preparing the pharmaceutical composition for treating rhinitis, which comprises the following steps:

[0013] a. Weigh the raw materials of each weight ratio;

[0014] b. Take Houttuynia cordata, Wild Chrysanthemum, Honeysuckle, Herba Eupatorii, and Eupatorium, add 8 to 12 times of water, soak for 10 to 60 minutes, decoct or reflux for 0.5 to 2 hours, and collect the distillate, redistill the distillate, and collect the redistillate; filter the liquid and concentrate it to an appropriate amount; or add 8 to 12 times of 50% to 95% ethanol, soak for 10 to 60 minutes, reflux for 0.5 to 2 hours, filter the liquid and concentrate it to an appropriate amount.

[0015] c. Take PEG-40 hydrogenated castor oil, anhydrous ethanol, isopropyl myristate, Xanthium sibiricum oil, magnolia oil, peppermint oil, borneol, angelica dahurica oil, chuanxiong oil, and notopterygium wilfordii oil, stir them thoroughly to emulsify and dissolve them, add them to the concentrated solution of step b, and then add pharmaceutically acceptable excipients or auxiliary ingredients to prepare a nasal preparation commonly used in medicine.

[0016] Further preferably, it comprises the following steps:

[0017] a. Weigh the raw materials of each weight ratio;

[0018] b. Take Houttuynia cordata, wild chrysanthemum, honeysuckle, radix ophiopogonis, and Senecio grandiflora, add 10 times of water, soak for 30 minutes, decoct for 1.5 hours, collect the distillate, redistillate the distillate, and collect the redistillate; filter the liquid and concentrate it to an appropriate amount;

[0019] c. Take PEG-40 hydrogenated castor oil, anhydrous ethanol, isopropyl myristate, Xanthium sibiricum oil, magnolia oil, peppermint oil, borneol, angelica dahurica oil, chuanxiong oil, and notopterygium wilfordii oil, stir them thoroughly to emulsify and dissolve them, add them to the concentrated solution of step b, and then add pharmaceutically acceptable excipients or auxiliary ingredients to prepare a nasal preparation commonly used in medicine.

[0020] The present invention provides use of the pharmaceutical composition in preparing a nasal medicine for treating rhinitis.

[0021] Wherein, the medicine is a medicine for treating allergic rhinitis. Wherein, the medicine is a medicine with the effects of clearing away heat and detoxifying, and clearing the nasal passages.

[0022] In the pharmaceutical composition of the present invention, houttuynia cordata clears away heat and detoxifies, clears the lungs and resolves phlegm, eliminates carbuncle and discharges pus, and is the main drug. Honeysuckle clears away heat and detoxifies, and dispels wind-heat; wild chrysanthemum tastes bitter and cold in nature, has the effects of dispelling wind and clearing heat, reducing swelling and detoxifying; Senecio grandiflora tastes bitter and cold in nature, clears away heat and detoxifies, and is a ministerial drug, assisting houttuynia cordata in clearing heat and detoxifying. Xanthium sibiricum dispels rheumatism and clears the nasal passages; Magnolia officinalis dispels wind and cold and clears the nasal passages; Herba Capillaris dispels the nasal passages; Angelica dahurica dispels the cold, dispels wind and relieves pain, and clears the nasal passages, and is a total adjuvant, which is used to clear the passages and disperse, so that the lung qi can rise and fall smoothly. Borneol assists in clearing the passages and dispersing; peppermint clears the head; Chuanxiong moves but does not stay, ascends to the top of the head, dispels wind and dispels cold; Notopterygium incisum rises and disperses to resolve the wind evil on the skin surface, and is a total messenger drug. All the drugs are used together to play the role of clearing heat and detoxifying, and clearing the nasal passages. The gel prepared by the present invention is simple, convenient, cheap and effective, and is made of houttuynia cordata, wild chrysanthemum, honeysuckle, radix spatholobi, radix spatholobi, xanthium sibiricum oil, magnolia oil, peppermint oil, borneol, angelica dahurica, rhizoma chuanxiong, and radix notopterygii, etc., and is combined into a formula to make a gel preparation. The gel has the beneficial effects of strong heat-clearing and detoxification, anti-inflammatory and antibacterial, swelling-reducing and analgesic, decomposing and promoting tissue regeneration, promoting blood circulation and dispelling wind, etc. in the treatment of rhinitis, and has the characteristics of wide drug source, short recovery period, and small side effects.

[0023] The present invention adopts different extraction methods according to the characteristics of the medicine, retains the characteristics of the medicine, removes unnecessary impurities, and achieves the purpose of increasing efficacy and reducing toxicity. Studies have shown that the main active ingredient of Houttuynia cordata is Houttuynia cordata volatile oil, which has multiple biological activities such as anti-oxidation, antibacterial, anti-inflammatory, anti-tumor, myocardial protection, growth promotion and antiviral. The volatile oil components in Chrysanthemum indici, Flos Lonicerae, Herba Glechomae and Herba Senecio are all functional components. Therefore. When extracting Houttuynia cordata, Chrysanthemum indici, Flos Lonicerae, Herba Glechomae and Herba Senecio, the heavy distillate thereof is collected, and the volatile effective ingredients in the medicinal materials are retained, so that the medicinal materials are fully utilized. The main toxic components of Fructus Xanthii are carboxy atractyloside, atractyloside and its derivatives. The use of Fructus Xanthii oil can greatly reduce the toxicity of Fructus Xanthii. In terms of formula, the volatile oil has strong penetrating power and rapid action, which can quickly relieve symptoms. The Chinese medicine extract can directly and rapidly act on inflammation with its penetrating power, and continuously play a role, which can be used for the relief and treatment of acute and chronic rhinitis.

[0024] The present invention directly adds other auxiliary materials to the traditional Chinese medicine extract to prepare the gel. The prepared gel has good affinity with the nasal cavity, can effectively isolate allergens, and improve nasal symptoms. The process is simple, the formula is scientific, and the therapeutic effect is significant. DETAILED DESCRIPTION

[0025] Example 1 Preparation of the drug of the present invention

[0026] 245g of houttuynia cordata; 140g of wild chrysanthemum; 140g of honeysuckle; 35g of scutellaria baicalensis; 140g of radix schizonepetae; 2.8g of xanthium sibiricum oil; 2.8g of magnolia oil; 2.1g of peppermint oil; 2.1g of borneol; 1.4g of angelica dahurica oil; 0.35g of chuanxiong oil; 0.35g of angelica dahurica oil. According to the dosage of the prescription, weigh houttuynia cordata, wild chrysanthemum, honeysuckle, scutellaria baicalensis, and radix schizonepetae slices, add 10 times of water, soak for 30min, decoct for 1.5h at a time, collect the distillate, redistill the distillate, collect 600-700ml of the redistillate; filter the liquid and concentrate it to 320-340g. Take 32.5g of PEG-40 hydrogenated castor oil, 65g of anhydrous ethanol, 4g of isopropyl myristate, and essential oils (3g of Xanthium sibiricum oil; 3g of magnolia oil; 2g of peppermint oil; 2g of borneol; 0.5g of angelica dahurica oil; 0.3g of Chuanxiong oil; 0.3g of Notopterygium incisum oil) and stir well to emulsify and dissolve, add concentrated solution, add redistilled liquid to make up to 504g, and stir evenly; take carbomer 940, add heavy distilled liquid to prepare a solution containing 3% of carbomer 940, mix the liquid and 461g of redistilled liquid containing 3% carbomer 940 (liquid: 3% carbomer 940 redistilled liquid ≈1:1), stir evenly, add 35g of triethanolamine (2.5 times the amount of carbomer 940), stir evenly, and obtain.

[0027] Example 2 Preparation of the drug of the present invention

[0028] 105g of Houttuynia cordata; 60g of Wild Chrysanthemum; 60g of Honeysuckle; 15g of Herba Eupatorii; 60g of Senecio; 1.2g of Xanthium sibiricum oil; 1.2g of Magnolia officinalis oil; 0.9g of Mentha oil; 0.9g of Borneolum; 0.6g of Angelica dahurica oil; 0.15g of Chuanxiong oil; 0.15g of Notopterygium incisum oil. Weigh Houttuynia cordata, Wild Chrysanthemum, Honeysuckle, Herba Eupatorii, and Senecio according to the dosage of the prescription, add 10 times of water, soak for 30min, decoct for 1.5h at a time, collect the distillate, redistill the distillate, collect 600-700ml of the redistillate, filter the liquid, and concentrate to 320-340g. Take 32.5g of PEG-40 hydrogenated castor oil, 65g of anhydrous ethanol, and 4g of isopropyl myristate, stir them with the essential oil to emulsify and dissolve, add the concentrate, add the redistilled liquid to make up to 504g, and stir evenly; take Carbomer 940, add the heavy distilled liquid to prepare a solution containing 3% of Carbomer 940, mix the liquid medicine with 461g of redistilled liquid containing 3% Carbomer 940 (liquid medicine: 3% Carbomer 940 redistilled liquid ≈ 1:1), stir evenly, add 35g of triethanolamine (2.5 times the amount of Carbomer 940), stir evenly, and obtain.

[0029] Example 3 Preparation of the drug of the present invention

[0030] 175 grams of Houttuynia cordata; 100 grams of wild chrysanthemum; 100 grams of honeysuckle; 25 grams of Gefei; 100 grams of Senecio; 2 grams of Xanthium sibiricum oil; 2 grams of magnolia oil; 1.5 grams of peppermint oil; 1.5 grams of borneol; 1 gram of Angelica dahurica oil; 0.25 grams of Chuanxiong oil; 0.25 grams of Notopterygium wilfordii oil.

[0031] ① Extraction: Weigh the pieces of Houttuynia cordata, Chrysanthemum indica, Honeysuckle, Herba Eupatorii, and Senecio grandiflora, add 10 times of water, soak for 30 minutes, decoct for 1.5 hours, collect the distillate, redistill the distillate, and collect 600-700 ml of the redistillate; filter the liquid and concentrate it to 320-340 g;

[0032] ② Preparation: Take 32.5g of PEG-40 hydrogenated castor oil, 65g of anhydrous ethanol, 4g of isopropyl myristate, and essential oils (2g of Xanthium sibiricum oil; 2g of magnolia oil; 1.5g of peppermint oil; 1.5g of borneol; 1g of angelica oil; 0.25g of Chuanxiong oil; 0.25g of Notopterygium wilfordii oil), stir well to emulsify and dissolve, add concentrate, add redistilled liquid to make up to 504g, and stir evenly; take carbomer 940, add heavy distilled liquid to prepare a solution containing 3% of carbomer 940, mix the liquid and 461g of redistilled liquid containing 3% carbomer 940 (liquid: 3% carbomer 940 redistilled liquid ≈1:1), stir evenly, add 35g of triethanolamine (2.5 times the amount of carbomer 940), stir evenly, and obtain.

[0033] ③How to use: Apply the gel evenly inside the nasal cavity.

[0034] The beneficial effects of the present invention are demonstrated by pharmacodynamic tests as follows.

[0035] Experimental Example 1 Effect of the drug of the present invention on mice with allergic rhinitis

[0036] The mouse allergic rhinitis (AR) model was established by ovalbumin (OVA). The severity of AR symptoms was recorded by the scoring method, and the expression levels of IL-4, IL-6, and IL-17 in the serum of each group of mice were detected by ELISA.

[0037] 1. Test substance

[0038] Chinese medicine composition 1 (prepared in Example 1), Chinese medicine composition 2 (prepared in Example 2) and Chinese medicine composition 3 (prepared in Example 3).

[0039] Houttuynia cordata control drug: Weigh 500g of Houttuynia cordata, add 10 times of water, soak for 30min, decoct for 1.5h, collect the distillate, redistill the distillate, collect 600-700ml of redistilled liquid; filter the liquid and concentrate to 320-340g. Take 32.5g of PEG-40 hydrogenated castor oil, 65g of anhydrous ethanol, 4g of isopropyl myristate, stir and emulsify with essential oil, add concentrate, add redistilled liquid to make up to 504g, stir evenly; take carbomer 940, add weighted distilled liquid to prepare a solution containing 3% carbomer 940, mix the liquid with 461g of redistilled liquid containing 3% carbomer 940 (liquid: 3% carbomer 940 redistilled liquid ≈ 1:1), stir evenly, add 35g of triethanolamine (2.5 times the amount of carbomer), stir and mix evenly, and obtain.

[0040] Essential oil control drug: Take 2g of Xanthium sibiricum oil; 2g of Magnolia officinalis oil; 1.5g of peppermint oil; 1.5g of borneol; 1g of Angelica dahurica oil; 0.25g of Chuanxiong oil; 0.25g of Notopterygium incisum oil. Take 32.5g of PEG-40 hydrogenated castor oil, 65g of anhydrous ethanol, 4g of isopropyl myristate, stir and emulsify with the essential oils, add pure water to make up to 504g, stir evenly; take Carbomer 940, add pure water to prepare a solution containing 3% Carbomer 940, add 461g of 3% Carbomer 940, stir evenly, add 35g of triethanolamine, stir and mix well, and obtain.

[0041] 2. Experimental Grouping

[0042] A total of 96 C57BL / 6 male mice were selected and randomly divided into 8 groups using the random number method: blank control group (A), model control group (B), Rhinocort positive control group (C), Chinese medicine composition 1 (D), Chinese medicine composition 2 (E), Chinese medicine composition 3 (F), Houttuynia cordata control drug group (G), and essential oil control drug group (H), with 12 mice in each group.

[0043] 3. Establishment of mouse AR model and drug administration

[0044] Except for the blank control group, the mice in other groups were intraperitoneally injected with 0.5 ml of a suspension containing 25 μg ovalbumin (OVA), 1 mg aluminum hydroxide gel, and 0.5 ml normal saline on days 1, 5, 14, and 21 for basic sensitization. After basic sensitization, 500 μg OVA plus 20 μL normal saline were administered to the mice bilaterally through nasal instillations starting on day 28, and local stimulation was continued for 10 consecutive days.

[0045] Within 30 minutes after the last stimulation, the scratching, sneezing and runny nose behaviors of the mice were observed and scored. The model was considered successful if the total score exceeded 5 points. The scoring criteria are as follows.

[0046] Table 1 Scoring criteria for mouse AR model

[0047]

[0048] After successful modeling, 50 μL of the drug solution was dripped into the nostrils of the mice using a micropipette, both sides were dripped, once in the morning and evening, for 11 consecutive days. Groups A and B were given normal saline, group C was given Renocort nasal spray, group D was given Chinese medicine composition 1, group E was given Chinese medicine composition 2, group F was given Chinese medicine composition 3, group G was given Houttuynia cordata control drug, and group H was given essential oil control drug. At the same time, OVA was dripped into the nose every other day to maintain the allergic state.

[0049] 4. Symptom score

[0050] OVA nasal drops were used to stimulate the mice 30 minutes after the last administration. The scratching of the nose, sneezing and runny nose were observed within 30 minutes. The severity of the above symptoms was recorded by the integration method and compared with the symptom scores before administration.

[0051] 5. ELISA was used to detect the expression levels of IL-4, IL-6, and IL-17 in the serum of each group of mice

[0052] 24 hours after the last stimulation of each group of mice, the mice were anesthetized, blood was collected from the abdominal aorta, and serum was separated. The ELISA method was used to detect the expression of immune cytokines IL-4, IL-6, and IL-17 in the serum of each group of mice. The operation was carried out according to the instructions of the kit.

[0053] 6. Allergic rhinitis mouse experimental results and conclusions

[0054] The behavioral scores of mice in the allergic rhinitis experiment are shown in Table 2. The results show that compared with the control group, the model group had a significantly increased behavioral score and obvious AR symptoms, indicating that the model was successfully established; compared with the model group, the behavioral index scores of the treatment group and the houttuynia control group were significantly reduced after intervention treatment, and there was no significant difference compared with the positive drug Renocort spray. It shows that the behavioral symptoms of allergic rhinitis such as sneezing, scratching nose, and runny nose in mice in the Chinese medicine composition groups 1 to 3 and the houttuynia control drug group were significantly inhibited. Compared with the model group, the behavioral index scores of mice in the essential oil control group showed a downward trend, but there was no significant difference. The amount of medicinal materials used in Chinese medicine composition 1 was significantly greater than that in Chinese medicine composition 3, but its mouse behavioral score was not significantly different from that of Chinese medicine combination 3, indicating that the efficacy of the medicine was not significantly reduced by appropriately reducing the amount of medicinal materials, and the problem of high irritation of Chinese medicine composition 1 was solved. Compared with the houttuynia control drug group, the behavioral index score of Chinese medicine composition 3 was significantly lower than that of the houttuynia control drug group, and the behavioral index score of Chinese medicine composition 2 was not significantly different from that of the houttuynia control drug group, indicating that at the same dosage of medicinal materials, the inhibitory effect of the Chinese medicine formula on the behavioral symptoms of allergic rhinitis such as sneezing, scratching the nose, and runny nose in mice was significantly higher than that of houttuynia alone, and at the same mouse behavioral index score, the dosage of the formula Chinese medicine was significantly less than that of houttuynia alone. In summary, the combination of houttuynia with wild chrysanthemum, honeysuckle, scutellaria baicalensis, semen lycopersicum, Xanthium sibiricum oil, magnolia oil, peppermint oil, borneol, angelica dahurica, ligusticum chuanxiong, and notopterygium wilfordii enhanced its inhibitory effect on the behavioral symptoms of allergic rhinitis such as sneezing, scratching the nose, and runny nose in mice.

[0055] Table 2 Behavioral scores of mice

[0056]

[0057] Note: blank control group (A), model control group (B), Rhinocort positive control group (C), Chinese medicine composition 1 (D), Chinese medicine composition 2 (E), Chinese medicine composition 3 (F), Houttuynia cordata control drug group (G), essential oil control drug group (H); compared with the blank group, * P<0.05, ** P<0.01; compared with the model group, # P<0.05, ## P<0.01; compared with the positive drug Renocort spray group, ▲P<0.05, ▲▲P<0.01.

[0058] As can be seen from Table 3, the levels of IL-4, IL-6, and IL-17 in the serum of the model group mice were higher than those in the blank group, and the differences were statistically significant (P < 0.01). The levels of IL-4, IL-6, and IL-17 in the serum of the mice in the Chinese medicine composition (1-3) group, the positive control group, and the houttuynia control drug group were lower than those in the model control group, and the differences were statistically significant (all P < 0.05), indicating that the Chinese medicine composition and the houttuynia control drug group can significantly inhibit the formation of factors related to allergies and inflammation. There was no significant difference in the levels of IL-4, IL-6, and IL-17 in the serum of the mice in the essential oil negative control group and the model control group. The amount of Chinese medicine composition 1 was significantly greater than that of Chinese medicine composition 3, but the levels of IL-4, IL-6, and IL-17 in the serum of the mice were not significantly different from those in Chinese medicine combination 3, indicating that appropriately reducing the amount of medicinal materials can achieve better therapeutic effects. Compared with the houttuynia control drug group, the levels of IL-4, IL-6, and IL-17 in the serum of mice in the Chinese medicine composition 3 were significantly lower than those in the houttuynia control drug group, and there was no significant difference in the levels of IL-4, IL-6, and IL-17 in the serum of mice in the Chinese medicine composition 2 and the houttuynia control drug group, indicating that at the same dosage of medicinal materials, the inhibitory effect of the Chinese medicine formula on the formation of factors related to allergies and inflammation was significantly higher than that of the single houttuynia drug, and at similar levels of IL-4, IL-6, and IL-17 in mouse serum, the dosage of the formula Chinese medicine was significantly less than that of the single houttuynia drug. Therefore, the combination of houttuynia with wild chrysanthemum, honeysuckle, scutellaria baicalensis, schizonepeta tenuifolia, Xanthium sibiricum oil, magnolia oil, peppermint oil, borneol, angelica dahurica, chuanxiong, and notopterygium wilfordii enhanced the inhibitory effect on the formation of factors related to allergies and inflammation.

[0059] Table 3 Expression of IL-4, IL-6 and IL-17 in mouse serum

[0060]

[0061] Note: blank control group (A), model control group (B), Rhinocort positive control group (C), Chinese medicine composition 1 (D), Chinese medicine composition 2 (E), Chinese medicine composition 3 (F), Houttuynia cordata control drug group (G), essential oil control drug group (H); compared with the blank group, * P<0.05, ** P<0.01; compared with the model group, # P<0.05, ## P<0.01; compared with the positive drug Renocort spray group, ▲ P<0.05, ▲▲ P<0.01.

[0062] The above experiments prove that Chinese medicine composition 3 has the best efficacy and its dosage is lower than that of composition 1.

[0063] Test Example 2 Clinical Trial of the Drug of the Present Invention

[0064] 1. Treatment or improvement of rhinitis

[0065] 1.1 Thirty patients with rhinitis who visited the Otolaryngology Department of a hospital in Chengdu from March 2023 to June 2024 were selected.

[0066] 1.2 Diagnostic criteria

[0067] The following standards are formulated with reference to the diagnostic criteria and symptom efficacy scoring criteria formulated by the Chinese Society of Otolaryngology and Head and Neck Surgery, the Chinese Guidelines for the Diagnosis and Treatment of Allergic Rhinitis (2022, revised edition), and the Guidelines for the Diagnosis and Treatment of Common Diseases in TCM Otolaryngology (China Traditional Chinese Medicine Press, published in 2012), the Diagnosis and Efficacy Criteria for TCM Diseases and Syndromes (China Medical Science and Technology Press, published in 2012), and the Guiding Principles for Clinical Research of New Chinese Medicines for the Treatment of Allergic Rhinitis compiled by the Chinese Association of Traditional Chinese Medicine:

[0068] (1) Symptoms: 2 or more episodes of sneezing, clear watery discharge, nasal itching, and nasal congestion; symptoms lasting or accumulating for more than 1 hour per day, and may be accompanied by respiratory symptoms (pharyngitis, cough, wheezing, etc.) and eye symptoms (including itchy eyes, tearing, red eyes, and burning sensation, etc.); fever, irritability; dry throat and dry mouth; abnormal sense of smell, such as decreased, absent, or phantom smell; nosebleeds and other symptoms of concomitant diseases.

[0069] (2) Physical signs: Pale and edematous nasal mucosa and watery nasal discharge are common.

[0070] 1.3 Inclusion criteria:

[0071] (1) Meet the above diagnostic criteria;

[0072] (2) Aged between 18 and 60 (inclusive), regardless of gender;

[0073] (3) Those who are willing to participate in this research project, can accept relevant examinations and treatments, and sign the informed consent form.

[0074] 1.4 Exclusion criteria

[0075] (1) Allergic to study drugs;

[0076] (2) Patients with other nasal diseases such as chronic rhinosinusitis and nasal polyps or those who have undergone nasal surgery;

[0077] (3) Patients with other serious cardiovascular, liver and hematopoietic diseases or malignant tumors, mental illnesses and Alzheimer's disease;

[0078] (4) Women who are breastfeeding, pregnant or planning to become pregnant;

[0079] (5) Those who have received relevant drug treatment or are currently receiving desensitization treatment within 1 week of the onset of rhinitis.

[0080] 1.5 Administration

[0081] Apply rhinitis gel evenly on the inside of the nasal cavity, once in the morning and once in the evening. The treatment course is 4 weeks.

[0082] 1.6 Rhinitis symptom score

[0083] Before and after treatment, the patients were scored for the four symptoms of nasal congestion, runny nose, nasal itching, and sneezing, and the scores were based on a scale of 0 to 3 according to the severity of the symptoms, with 0 for no symptoms; 1 for mild symptoms (mild symptoms, easy to tolerate); 2 for moderate symptoms (obvious symptoms, annoying, but tolerable); and 3 for severe symptoms (intolerable symptoms, affecting daily life and / or sleep). Efficacy index = [(pre-treatment score ~ ​​post-treatment score) / pre-treatment score] × 100%. Significant effect: efficacy index ≥ 60%; effective: 20% ≤ efficacy index < 60%; ineffective: efficacy index < 20%. Total effective rate = (number of significant effective cases + number of effective cases) / total number of cases × 100%

[0084] 1.7 Quality of life assessment

[0085] The Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) was used to evaluate the patients before and after treatment. The RQLQ contains 28 questions and is divided into 7 areas, namely daily activities, sleep, non-nasal and eye symptoms, practical problems, nasal symptoms, eye symptoms, activities and emotions. Each item is scored from 0 to 6 points, with 0 being no trouble, 1 being almost no trouble, 2 being some trouble, 3 being moderately troubled, 4 being very troubled, 5 being very troubled, and 6 being extremely troubled. The higher the score, the lower the quality of life.

[0086] 1.8 Safety evaluation

[0087] The adverse reactions during the treatment in the two groups were recorded.

[0088] 2. Clinical efficacy analysis

[0089] 2.1 Improvement or treatment of rhinitis

[0090] 2.1.1 Clinical efficacy of rhinitis gel

[0091] After 30 patients with rhinitis used the rhinitis gel for 4 weeks, 11 achieved significant results, 16 achieved effective results, and only 3 were ineffective. The total effective rate reached 90%. The results showed that the rhinitis gel has the effect of treating or improving rhinitis.

[0092] Table 4 The therapeutic effect of rhinitis gel on rhinitis

[0093]

[0094] 2.1.2 Four-point scoring and RQLQ scoring

[0095] After rhinitis gel treatment, the four-point score, RQLQ total score, and sleep score were all lower than those before treatment (P < 0.05). Rhinitis gel improved patients' rhinitis symptoms, living standards, and sleep quality.

[0096] Table 5 Comparison of four-point score and RQLQ score before and after treatment

[0097]

[0098] Note: * indicates that there is a significant difference between the treatment and pre-treatment at the P<0.05 level.

[0099] 2.1.3 Safety evaluation

[0100] During the treatment, no adverse reactions were reported in any patient.

Claims

1. A pharmaceutical composition for treating rhinitis, Features: It is prepared from the following raw materials in weight ratio: 105-245 parts of Houttuynia cordata, 60-140 parts of Chrysanthemum indici, 60-140 parts of Honeysuckle, 15-35 parts of Herba Schisandrae Chinensis, 60-140 parts of Senecio grandiflora, 1.2-2.8 parts of Xanthium sibiricum oil, 1.2-2.8 parts of Magnolia officinalis oil, 0.9-2.1 parts of Peppermint oil, 0.9-2.1 parts of Borneolum, 0.6-1.4 parts of Angelica dahurica oil, 0.15-0.35 parts of Chuanxiong oil, and 0.15-0.35 parts of Notopterygium wilfordii oil.

2. The pharmaceutical composition for treating rhinitis according to claim 1, Features: It is prepared from the following raw materials in weight ratio: 175 parts of herba houttuyniae, 100 parts of chrysanthemums indica, 100 parts of honeysuckle, 25 parts of herba schizonepetae, 100 parts of senecio, 2 parts of fructus xanthii oil, 2 parts of flos magnoliae oil, 1.5 parts of peppermint oil, 1.5 parts of borneol, 1 part of angelica dahurica oil, 0.25 parts of rhizoma ligustici oil and 0.25 parts of notopterygium wilfordii oil.

3. The pharmaceutical composition for treating rhinitis according to claim 1 or 2, Features: The invention is prepared from water or ethanol extracts of houttuynia cordata, wild chrysanthemum, honeysuckle, radix ophiopogonis and radix senecioides as active ingredients, and is added with xanthium sibiricum oil, magnolia oil, peppermint oil, borneol, angelica dahurica oil, chuanxiong oil, notopterygium wilfordii oil and pharmaceutically acceptable excipients or auxiliary ingredients to prepare a commonly used pharmaceutical nasal preparation.

4. The pharmaceutical composition for treating rhinitis according to claim 3, Features: The nasal preparations are nasal drops, nasal washes, sprays, nasal ointments, nasal creams, nasal gels, nasal powder sprays, and nasal sticks.

5. A method for preparing the pharmaceutical composition for treating rhinitis according to any one of claims 1 to 4, Features: It includes the following steps: a. Weigh the raw materials of each weight ratio; b. Take Houttuynia cordata, wild chrysanthemum, honeysuckle, radix ophiopogonis, and Senecio grandiflora, add 8 to 12 times of water, soak for 10 to 60 minutes, decoct or reflux for 0.5 to 2 hours, collect the distillate, redistillate the distillate, collect the redistillate; filter the liquid and concentrate it to an appropriate amount; or add 8 to 12 times of 50% to 95% ethanol, soak for 10 to 60 minutes, reflux for 0.5 to 2 hours, filter the liquid and concentrate it to an appropriate amount; c. Take PEG-40 hydrogenated castor oil, anhydrous ethanol, isopropyl myristate, Xanthium sibiricum oil, magnolia oil, peppermint oil, borneol, angelica dahurica oil, chuanxiong oil, and notopterygium wilfordii oil, stir them thoroughly to emulsify and dissolve them, add them to the concentrated solution of step b, and then add pharmaceutically acceptable excipients or auxiliary ingredients to prepare a nasal preparation commonly used in medicine.

6. The method for preparing the pharmaceutical composition for treating rhinitis according to claim 5, Features: It includes the following steps: a. Weigh the raw materials of each weight ratio; b. Take Houttuynia cordata, wild chrysanthemum, honeysuckle, radix ophiopogonis, and Senecio grandiflora, add 10 times of water, soak for 30 minutes, decoct for 1.5 hours, collect the distillate, redistillate the distillate, and collect the redistillate; filter the liquid and concentrate it to an appropriate amount; c. Take PEG-40 hydrogenated castor oil, anhydrous ethanol, isopropyl myristate, Xanthium sibiricum oil, magnolia oil, peppermint oil, borneol, angelica dahurica oil, chuanxiong oil, and notopterygium wilfordii oil, stir them thoroughly to emulsify and dissolve them, add them to the concentrated solution of step b, and then add pharmaceutically acceptable excipients or auxiliary ingredients to prepare a nasal preparation commonly used in medicine.

7. Use of the pharmaceutical composition according to any one of claims 1 to 4 in the preparation of a nasal medicine for treating rhinitis.

8. The use according to claim 7, Features: The medicine is a medicine for treating allergic rhinitis.

9. The use according to claim 7, Features: The medicine has the effects of clearing away heat, detoxifying and clearing the nasal passages.

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