A traditional Chinese medicine composition for external use in treating rhinitis and its preparation method

Abstract

The present invention provides a traditional Chinese medicine composition for external use in treating rhinitis and a preparation method thereof, relating to the field of pharmaceutical technology. The traditional Chinese medicine composition for external use in treating rhinitis comprises, by weight, 5-15g of Flos Magnoliae, 12-24g of Herba Schizonepetae, 12-24g of Radix Saposhnikoviae, 20-30g of Rhizoma Atractylodis Macrocephalae, 4-12g of Radix Angelicae Dahuricae, 3-9g of Periostracum Cicadae, 20-30g of Radix Puerariae, and 12-24g of Radix Sophorae Flavescentis. The traditional Chinese medicine composition for external use in treating rhinitis of the present invention has the effects of dispelling wind, opening the orifices, relieving itching and eliminating nasal discharge, and is primarily used to treat allergic rhinitis, acute and chronic rhinitis, and sinusitis. Its preparation method allows the traditional Chinese medicine composition to both treat rhinitis and improve comfort during use.

Description

Technical Field

[0001] The present invention relates to the field of pharmaceutical technology, in particular to a traditional Chinese medicine composition for external use in treating rhinitis and a preparation method thereof. Background Art

[0002] Rhinitis is a common clinical disease, an inflammation of the nasal mucosa caused by viruses, bacteria, allergens, various physical and chemical factors, and certain systemic diseases. Allergic rhinitis, also known as allergic rhinitis, refers to a non-infectious inflammatory disease of the nasal mucosa caused by exposure to allergens in atopic individuals, primarily through the release of IgE-mediated mediators (primarily histamine), with the involvement of multiple immune-active cells and cytokines. Typical symptoms of allergic rhinitis include paroxysmal sneezing, watery nasal discharge, nasal congestion, and itching, sometimes accompanied by decreased sense of smell.

[0003] At present, the main treatments for allergic rhinitis are as follows: (1) avoiding contact with allergens; (2) drug treatment; (3) immunotherapy; (4) surgical treatment. Among them, drug treatment is currently an important treatment method, and its commonly used drugs are mostly Western medicines, such as antihistamines, glucocorticoids, anti-leukotriene drugs, etc. However, these drugs have certain toxic side effects on the human body and still cannot completely cure the disease. Traditional Chinese medicine therapy has the advantages of safety, reliability, few side effects, sustained efficacy, and reduced recurrence. Therefore, it is very necessary to further explore drugs for the treatment of allergic rhinitis in the field of traditional Chinese medicine. Summary of the Invention

[0004] The present invention aims to provide a Chinese medicine composition for external use in treating rhinitis, which has the effects of dispelling wind, opening the orifices, relieving itching and removing nasal discharge, and is mainly used to treat allergic rhinitis, acute and chronic rhinitis, and sinusitis.

[0005] Another object of the present invention is to provide a method for preparing a traditional Chinese medicine composition for external use in treating rhinitis, which is used to prepare the above-mentioned traditional Chinese medicine composition so that it can not only treat rhinitis but also improve the comfort during use.

[0006] The present invention solves the technical problem by adopting the following technical solutions.

[0007] The invention provides a traditional Chinese medicine composition for external use in treating rhinitis. The composition comprises the following raw materials in parts by weight: 5-15g of magnolia flower, 12-24g of schizonepeta tenuifolia, 12-24g of siler, 20-30g of atractylodes, 4-12g of angelica dahurica, 3-9g of cicada slough, 20-30g of kudzu root and 12-24g of sophora flavescens.

[0008] The present invention provides a method for preparing a traditional Chinese medicine composition for external use in treating rhinitis, comprising the following steps:

[0009] Weigh the raw materials in proportion, add 10-15 times the amount of water to the raw materials, heat and distill to extract, collect 500 mL of aromatic water, filter the decoction, and collect the filtrate and the medicinal residue;

[0010] Add 6-10 times the amount of water to the medicinal residue, heat under reflux and decoct, filter, and collect the filtrate;

[0011] Combine the two filtrates, concentrate, and filter through a 200-mesh filter. Add ethanol to the filtrate until the alcohol concentration reaches 70%. Let it stand for 22-25 hours. Take the supernatant, concentrate it under reduced pressure, and then mix it with aromatic water. Add purified water to 1000 mL, centrifuge, boil, and add sodium chloride to obtain a mixed solution.

[0012] The antibacterial agent and the solubilizer are dissolved in propylene glycol, and then added to the mixed solution, the pH is adjusted to 6-7, and the solution is filtered to obtain the finished product.

[0013] The present invention has at least the following beneficial effects:

[0014] In the present invention, magnolia flower and siler are used as the main drugs, which play the effect of dispelling wind and relieving itching, and promoting lung function and clearing the orifices; cicada shell and schizonepeta are used as the auxiliary drugs, which play the effect of dispelling wind and relieving itching; sophora flavescens, atractylodes, kudzu root, and angelica dahurica are used as the auxiliary drugs, which play the effect of drying dampness and relieving itching, raising yang energy, and clearing the nasal orifices. The combination of these drugs can achieve the effects of dispelling wind and clearing the orifices, relieving itching and eliminating nasal discharge, can relieve mucosal swelling, help alleviate nasal congestion symptoms, can stimulate nasal nerve endings, and promote mucosal repair and regeneration, thereby effectively treating allergic rhinitis, acute and chronic rhinitis, and sinusitis.

[0015] In the present invention, the volatile components in raw material can be collected by first heating distillation extraction, and volatile components have certain antibacterial effect, can suppress the growth and reproduction of bacteria in nasal cavity, reduce the nasal infection caused by bacteria, and simultaneously can be extracted the active ingredient in raw material, be dispersed in filtrate.By medicinal residues through secondary heating reflux decocting, the active ingredient remaining in medicinal residues can be further extracted, to improve the extraction rate of active ingredient, can soften and dissolve mucus and secretions in nasal cavity by active ingredient, promote the discharge of secretions, alleviate the symptoms such as nasal congestion, sneezing, improve nasal ventilation situation.Two filtrates are merged, ethanol is added after concentrating and filtering and is left standstill, so ethanol can be utilized to allow active ingredient to be separated out, to improve the purity of active ingredient, enhance the therapeutic effect of medicine. The aromatic water is mixed with the supernatant after vacuum concentration, purified water is added, and the mixture is centrifuged and boiled to remove ethanol, thereby reducing the drug's irritation. Sodium chloride, an antibacterial agent, and a solubilizer dissolved in propylene glycol are then added to improve the drug's dispersibility in the solution. The sodium chloride is used to clean the nasal cavity, allowing the drug components to act on nasal nerve endings and enhance the therapeutic effect. Furthermore, pH adjustment can further reduce the drug's irritation and improve comfort during use. DETAILED DESCRIPTION

[0016] To make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention are described clearly and completely below. Where specific conditions are not specified in the embodiments, conventional conditions or conditions recommended by the manufacturer are used. Where the manufacturer of the reagents or instruments is not specified, all are conventional products that can be purchased commercially.

[0017] It should be noted that, in the absence of conflict, the embodiments and features of the embodiments of the present invention can be combined with each other. The present invention will be described in detail below with reference to specific embodiments.

[0018] A traditional Chinese medicine composition for external use in treating rhinitis comprises the following raw materials, measured by weight: 5-15g of magnolia flower, 12-24g of schizonepeta tenuifolia, 12-24g of siler, 20-30g of atractylodes, 4-12g of angelica dahurica, 3-9g of cicada slough, 20-30g of kudzu root and 12-24g of sophora flavescens.

[0019] Magnolia: pungent, warm, enters the lung and stomach meridians, dispels wind and cold, and clears the nasal passages. It is used for wind-cold headache, nasal congestion, rhinitis, and turbid nasal discharge.

[0020] Saposhnikovia divaricata: pungent, sweet, slightly warm, enters the bladder, liver, and spleen meridians, dispels wind and relieves exterior symptoms, overcomes dampness and relieves pain, and stops spasms. It is used for colds and headaches, rheumatic pain, rubella itching, and tetanus.

[0021] Cicada slough: sweet, cold, enters the lung and liver meridians, dispels wind-heat, relieves sore throat, clears rashes, brightens eyes and removes cataracts, relieves spasms, used for wind-heat colds, sore throats and hoarseness, measles that does not break out, itchy rubella, red eyes and cataracts, convulsions, and tetanus.

[0022] Schizonepeta: pungent, slightly warm, enters the lung and liver meridians, relieves exterior symptoms, dispels wind, promotes the production of rashes, and eliminates sores. It is used for colds, headaches, measles, rubella, and the initial stage of sores.

[0023] Sophora flavescens: bitter, cold. Entries the Heart, Liver, Stomach, Large Intestine, and Bladder meridians. Clears heat and dampness, kills parasites, and is a diuretic. It is used for heat dysentery, blood in the stool, jaundice, urinary retention, leucorrhea, vaginal swelling and itching, eczema, wet sores, itchy skin, scabies, and leprosy.

[0024] Atractylodes: pungent, bitter, warm, enters the spleen, stomach, and liver meridians, dries dampness and strengthens the spleen, dispels wind and cold, and improves eyesight. It is used for dampness blocking the middle burner, abdominal distension, diarrhea, edema, beriberi and paralysis, rheumatic pain, colds, night blindness, and blurred vision.

[0025] Pueraria root: sweet, pungent, and cool, it enters the spleen, stomach, and lung meridians, relieves muscles and reduces fever, promotes the production of body fluids and quenches thirst, clears rashes, raises yang and stops diarrhea, promotes blood circulation and activates collaterals, and detoxifies alcohol. It is used for exogenous fever and headache, stiff neck and back pain, thirst, diabetes, measles that does not break out, heat dysentery, diarrhea, dizziness and headache, hemiplegia caused by stroke, chest pain and heart pain, and alcohol poisoning.

[0026] Angelica dahurica: pungent, warm, enters the stomach, large intestine, and lung meridians, relieves exterior symptoms and dispels cold, dispels wind and relieves pain, dredges the nasal passages, dries up dampness and stops leukorrhea, reduces swelling and discharges pus, used for colds and headaches, pain in the supraorbital ridge, nasal congestion and runny nose, allergic rhinitis, sinusitis, toothache, leukorrhea, and swollen and painful sores.

[0027] The formula uses magnolia buds and siler leaves as the main ingredients, which have the effects of dispelling wind and relieving itching, promoting lung function and opening the orifices. Cicadae sloughs and schizonepeta tenuifolia are used as the secondary ingredients, which have the effects of dispelling wind and relieving itching. Sophora flavescens, atractylodes lancea, kudzu root, and angelica dahurica are used as the adjuvant ingredients, which have the effects of drying dampness and relieving itching, raising yang energy, and opening the nasal orifices. The combination of these ingredients can achieve the effects of dispelling wind and opening the orifices, relieving itching and eliminating nasal discharge, relieving mucosal swelling, helping to alleviate nasal congestion, stimulating nasal nerve endings, and promoting mucosal repair and regeneration, thereby effectively treating allergic rhinitis, acute and chronic rhinitis, and sinusitis. Furthermore, the ingredients are reasonably proportioned, with complementary effects, which is conducive to exerting the efficacy of the drugs, thereby better treating rhinitis.

[0028] In detail, the external Chinese medicine composition for treating rhinitis includes 10g of magnolia, 18g of schizonepeta, 18g of siler, 25g of atractylodes, 8g of angelica, 6g of cicada shell, 25g of kudzu root and 18g of sophora flavescens, in parts by weight.

[0029] A method for preparing a traditional Chinese medicine composition for external use in treating rhinitis comprises the following steps:

[0030] Weigh the raw materials in proportion, add 10-15 times the amount of water to the raw materials, heat and distill to extract, collect 500 mL of aromatic water, filter the decoction, and collect the filtrate and the medicinal residue;

[0031] Add 6-10 times the amount of water to the medicinal residue, heat under reflux and decoct, filter, and collect the filtrate;

[0032] Combine the two filtrates, concentrate, and filter through a 200-mesh filter. Add ethanol to the filtrate until the alcohol concentration reaches 70%. Let it stand for 22-25 hours. Take the supernatant, concentrate it under reduced pressure, and then mix it with aromatic water. Add purified water to 1000 mL, centrifuge, boil, and add sodium chloride to obtain a mixed solution.

[0033] The antibacterial agent and the solubilizer are dissolved in propylene glycol, and then added to the mixed solution, the pH is adjusted to 6-7, and the solution is filtered to obtain the finished product.

[0034] The volatile components in the raw materials can be collected through heating and distillation extraction. These volatile components have a certain antibacterial effect, which can inhibit the growth and reproduction of bacteria in the nasal cavity, reducing nasal infections caused by bacteria. At the same time, the active ingredients in the raw materials can be extracted and dispersed in the filtrate. The residue is then subjected to a second heating and reflux decoction to further extract the active ingredients remaining in the residue, thereby increasing the extraction rate of the active ingredients. The active ingredients can soften and dissolve mucus and secretions in the nasal cavity, promote the discharge of secretions, relieve symptoms such as nasal congestion and sneezing, and improve nasal ventilation. The two filtrates are combined, concentrated and filtered, and then ethanol is added and allowed to stand. This allows the ethanol to precipitate the active ingredients, thereby increasing the purity of the active ingredients and enhancing the therapeutic effect of the drug. The aromatic water is mixed with the supernatant after vacuum concentration, purified water is added, and the mixture is centrifuged and boiled to remove ethanol, thereby reducing the drug's irritation. Sodium chloride, an antibacterial agent, and a solubilizer dissolved in propylene glycol are then added to improve the drug's dispersibility in the solution. The sodium chloride is used to clean the nasal cavity, allowing the drug components to act on nasal nerve endings and enhance the therapeutic effect. Furthermore, pH adjustment can further reduce the drug's irritation and improve comfort during use.

[0035] Specifically, during the heating distillation extraction, the distillation rate is 3-5 drops / second; the two filtrates are combined and concentrated to a relative density of 1.15-1.25 at 60°C; the supernatant is concentrated under reduced pressure to a relative density of 1.08-1.12 at 60°C; the pH is adjusted to 6-7, and filtration is performed using a 0.45 μm filter membrane.

[0036] Specifically, the antibacterial agent is chlorhexidine acetate and / or a Chinese herbal extract, wherein the raw materials of the Chinese herbal extract include one or more of wormwood leaf, scutellaria root, houttuynia cordata and coptis root.

[0037] Specifically, the solubilizing agent is RH40 or Tween-80.

[0038] In detail, the mass concentration of sodium chloride is 0.9%, the mass concentration of propylene glycol is 2%, the mass concentration of chlorhexidine acetate is 0.05%, the mass concentration of the traditional Chinese medicine extract is 1%, and the mass concentrations of RH40 and Tween-80 are both 1%.

[0039] The features and performance of the present invention are further described in detail below with reference to the embodiments.

[0040] Example 1

[0041] A method for preparing a traditional Chinese medicine composition for external use in treating rhinitis comprises the following steps:

[0042] Ingredients: Magnolia 10g, Schizonepeta 18g, Saposhnikovia 18g, Atractylodes 25g, Angelica dahurica 8g, Periostracum Cicadae 6g, Pueraria 25g, and Sophora flavescens 18g;

[0043] Weigh the raw materials in proportion, add 12 times the amount of water to the raw materials, heat and distill to extract, the distillation rate is 4 drops / second, collect 500 mL of aromatic water (distillate), filter the decoction, and collect the filtrate and the medicinal residue;

[0044] Add 8 times the amount of water to the medicinal residue, heat under reflux and decoct, filter, and collect the filtrate;

[0045] Combine the two filtrates, concentrate to a relative density of 1.20 at 60°C, filter through a 200-mesh filter, add ethanol to the filtrate until the alcohol concentration reaches 70%, let it stand for 24 hours, take the supernatant, and concentrate the supernatant under reduced pressure to a relative density of 1.10 at 60°C, then mix it with aromatic water, add purified water to 1000 mL, centrifuge, boil, and add sodium chloride to obtain a mixed solution;

[0046] The antibacterial agent and the solubilizer are dissolved in propylene glycol, and then added to the mixed solution, the pH is adjusted to 6.5, and the solution is filtered through a 0.45 μm filter membrane to obtain a finished product.

[0047] In this embodiment, the antibacterial agent is chlorhexidine acetate, the solubilizer is RH40, the mass concentration of sodium chloride is 0.9%, the mass concentration of propylene glycol is 2%, the mass concentration of chlorhexidine acetate is 0.05%, and the mass concentration of RH40 is 1%.

[0048] Example 2

[0049] A method for preparing a traditional Chinese medicine composition for external use in treating rhinitis comprises the following steps:

[0050] Ingredients: 5g magnolia, 12g schizonepeta, 12g siler, 20g atractylodes, 4g angelica, 3g cicada shell, 20g kudzu root and 12g sophora flavescens.

[0051] Weigh the raw materials in proportion, add 10 times the amount of water to the raw materials, heat and distill to extract, the distillation rate is 3 drops / second, collect 500 mL of aromatic water (distillate), filter the decoction, and collect the filtrate and the medicinal residue;

[0052] Add 6 times the amount of water to the medicinal residue, heat under reflux and decoct, filter, and collect the filtrate;

[0053] Combine the two filtrates, concentrate to a relative density of 1.15 at 60°C, filter through a 200-mesh filter, add ethanol to the filtrate until the alcohol concentration reaches 70%, let it stand for 22 hours, take the supernatant, and concentrate the supernatant under reduced pressure to a relative density of 1.08 at 60°C, then mix it with aromatic water, add purified water to 1000 mL, centrifuge, boil, and add sodium chloride to obtain a mixed solution;

[0054] The antibacterial agent and the solubilizer are dissolved in propylene glycol, and then added to the mixed solution, the pH is adjusted to 6, and the solution is filtered through a 0.45 μm filter membrane to obtain a finished product.

[0055] In this embodiment, the antibacterial agent is a traditional Chinese medicine extract, the raw materials of the traditional Chinese medicine extract include mugwort, scutellaria, houttuynia cordata and coptis chinensis, the solubilizer is Tween-80, the mass concentration of sodium chloride is 0.9%, the mass concentration of propylene glycol is 2%, the mass concentration of the traditional Chinese medicine extract is 1%, and the mass concentration of Tween-80 is 1%.

[0056] Example 3

[0057] A method for preparing a traditional Chinese medicine composition for external use in treating rhinitis comprises the following steps:

[0058] Ingredients: Magnolia 15g, Schizonepeta 24g, Saposhnikovia 24g, Atractylodes 30g, Angelica 12g, Cicada Periostracum 9g, Pueraria 30g, and Sophora flavescens 24g;

[0059] Weigh the raw materials in proportion, add 15 times the amount of water to the raw materials, heat and distill to extract, the distillation rate is 5 drops / second, collect 500 mL of aromatic water (distillate), filter the decoction, and collect the filtrate and the medicinal residue;

[0060] Add 10 times the amount of water to the medicinal residue, heat under reflux and decoct, filter, and collect the filtrate;

[0061] Combine the two filtrates, concentrate to a relative density of 1.25 at 60°C, filter through a 200-mesh filter, add ethanol to the filtrate until the alcohol concentration reaches 70%, let it stand for 25 hours, take the supernatant, and concentrate the supernatant under reduced pressure to a relative density of 1.12 at 60°C, then mix it with aromatic water, add purified water to 1000 mL, centrifuge, boil, and add sodium chloride to obtain a mixed solution;

[0062] The antibacterial agent and the solubilizer are dissolved in propylene glycol, and then added to the mixed solution, the pH is adjusted to 7, and the solution is filtered through a 0.45 μm filter membrane to obtain a finished product.

[0063] In this embodiment, the antibacterial agents are chlorhexidine acetate and Chinese herbal medicine extracts. The raw materials of the Chinese herbal medicine extracts include wormwood, scutellaria, houttuynia cordata and coptis chinensis. The solubilizer is RH40. The mass concentration of sodium chloride is 0.9%, the mass concentration of propylene glycol is 2%, the mass concentration of chlorhexidine acetate is 0.05%, the mass concentration of the Chinese herbal medicine extract is 1%, and the mass concentration of RH40 is 1%.

[0064] Example 4

[0065] A method for preparing a traditional Chinese medicine composition for external use in treating rhinitis comprises the following steps:

[0066] Ingredients: 8g magnolia, 20g schizonepeta, 15g siler, 27g atractylodes, 6g angelica, 5g cicada shell, 28g kudzu root and 20g sophora flavescens.

[0067] Weigh the raw materials in proportion, add 14 times the amount of water to the raw materials, heat and distill to extract, the distillation rate is 3 drops / second, collect 500 mL of aromatic water (distillate), filter the decoction, and collect the filtrate and the medicinal residue;

[0068] Add 7 times the amount of water to the medicinal residue, heat under reflux and decoct, filter, and collect the filtrate;

[0069] Combine the two filtrates, concentrate to a relative density of 1.18 at 60°C, filter through a 200-mesh filter, add ethanol to the filtrate to an alcohol concentration of 70%, let it stand for 23 hours, take the supernatant, and concentrate the supernatant under reduced pressure to a relative density of 1.11 at 60°C, then mix it with aromatic water, add purified water to 1000 mL, centrifuge, boil, and add sodium chloride to obtain a mixed solution;

[0070] The antibacterial agent and the solubilizer are dissolved in propylene glycol, and then added to the mixed solution, the pH is adjusted to 6.2, and the solution is filtered through a 0.45 μm filter membrane to obtain a finished product.

[0071] In this embodiment, the antibacterial agent is a traditional Chinese medicine extract, the raw materials of the traditional Chinese medicine extract include mugwort leaves, the solubilizer is Tween-80, the mass concentration of sodium chloride is 0.9%, the mass concentration of propylene glycol is 2%, the mass concentration of the traditional Chinese medicine extract is 1%, and the mass concentration of Tween-80 is 1%.

[0072] Comparative Example 1

[0073] The difference between this comparative example and Example 1 is that the raw materials are: 2g magnolia flower, 10g schizonepeta tenuifolia, 10g siler, 15g atractylodes, 3g angelica dahurica, 2g cicada slough, 15g kudzu root and 10g sophora flavescens. The preparation method is the same as that of Example 1.

[0074] Comparative Example 2

[0075] The difference between this comparative example and Example 1 is that the raw materials are: 10g magnolia flower, 18g schizonepeta tenuifolia, 25g atractylodes, 8g angelica dahurica, 25g kudzu root, and 18g sophora flavescens. The preparation method is the same as that of Example 1.

[0076] Comparative Example 3

[0077] This comparative example differs from Example 1 in that the raw materials are: 10g of Magnolia Flos, 18g of Schizonepeta Tenuifolia, 18g of Saposhnikovia Divaricata, 25g of Atractylodes Rhizome, 8g of Angelica Dahurica, 6g of Periostracum Cicadae, 25g of Puerariae Root, 18g of Sophora Flavescentis, 10g of Cinnamomum Cassiae, 10g of Chrysanthemum Flos, 10g of Coptis chinensis, and 10g of Herba Echinopteris. The preparation method is the same as that of Example 1.

[0078] Comparative Example 4

[0079] This comparative example differs from Example 1 in that the raw materials are: 10g of Flos Magnoliae, 18g of Herba Schizonepetae, 18g of Radix Saposhnikoviae, 25g of Rhizoma Atractylodis Macrocephalae, 8g of Radix Angelicae Dahuricae, 6g of Periostracum Cicadae, 25g of Radix Puerariae, 18g of Sophora flavescens, 10g of Fructus Xanthii, 10g of Radix Bupleuri, 10g of Rhizoma Cimicifugae, 10g of Twig of Cinnamomum Cassiae, 10g of Flos Chrysanthemi, 10g of Cortex Phellodendri, and 10g of Herba Eupatorii. The preparation method is the same as that of Example 1.

[0080] Comparative Example 5

[0081] This comparative example is different from Example 1 in that the raw materials are: 10g of Xanthium sibiricum, 18g of Capsicum annuum, 18g of Saposhnikovia divaricata, 25g of Atractylodes macrocephala, 8g of Angelica dahurica, 6g of Periostracum cicadae, 25g of Bupleurum chinense, and 18g of Sophora flavescens.

[0082] Comparative Example 6

[0083] This comparative example differs from Example 1 in that heating and distillation extraction are not performed in the preparation method. The rest of the steps are the same as in Example 1.

[0084] Comparative Example 7

[0085] This comparative example differs from Example 1 in that heating, refluxing and decocting are not performed in the preparation method. The rest of the steps are the same as in Example 1.

[0086] Comparative Example 8

[0087] This comparative example differs from Example 1 in that ethanol is not added for standing during the preparation process. The rest of the steps are the same as in Example 1.

[0088] Comparative Example 9

[0089] This comparative example differs from Example 1 in that sodium chloride is not added during the preparation process. The rest is the same as Example 1.

[0090] Comparative Example 10

[0091] This comparative example differs from Example 1 in that the pH is not adjusted during the preparation process. The rest is the same as Example 1.

[0092] Test results

[0093] All 51 cases were outpatients, including 19 males and 32 females. The youngest was 16 years old and the oldest was 49 years old, with an average age of 26 years. The disease course was the shortest half a year and the longest 8 years, with an average of 2 years.

[0094] Diagnostic basis, symptoms: nasal itching, sneezing, runny nose, nasal congestion, headache, decreased sense of smell. Take the Chinese medicine composition prepared in Example 1 for treatment, usage: nasal drops, 1-2 drops each time, 1-2 times a day.

[0095] Efficacy criteria:

[0096] Recovery: Subjective symptoms disappear, objective examination is close to normal, or there is a small amount of secretion in the middle nasal cavity and nasal floor, and the nasal mucosa is rosy;

[0097] Markedly effective: Subjective symptoms disappear, and examination reveals a small amount of secretions and thin crusts in the middle nasal passages and nasal floor, with the mucosa slightly dry.

[0098] Improvement: All symptoms are alleviated, but not completely eliminated;

[0099] Ineffective: There was no significant improvement in symptoms after one week of medication.

[0100] Treatment effects:

[0101] Among the 51 cases, 19 were cured, accounting for 37.3%; 24 were significantly effective, accounting for 47.1%; 5 were improved, accounting for 9.8%; 3 were ineffective, accounting for 5.9%; and the overall effective rate was 94.1%.

[0102] In addition, 280 patients with rhinitis were selected, aged between 20 and 40 years old, with an average age of 28 years old. The symptoms of the patients included nasal congestion, nasal itching, excessive nasal discharge, clear nasal discharge, decreased sense of smell, headache, and dizziness. The patients were randomly divided into 14 groups, 20 people in each group, and were sequentially divided into groups 1-14. Groups 1-4 were treated with the Chinese medicine compositions of Examples 1-4, and groups 5-14 were treated with the Chinese medicine compositions of Comparative Examples 1-10. The treatment lasted for 1 week, with 1 to 2 drops in the nose each time, 1 to 2 times a day, and the patient's condition was recorded after 1 week (the efficacy standard is the same as above).

[0103] Table 1 Treatment results

[0104]

[0105]

[0106] As shown in Table 1, the Chinese medicine compositions of Examples 1-4 have better therapeutic effects on rhinitis. The composition of Comparative Example 1 exceeds the ratio range of the compositions of Examples 1-4, and its therapeutic effect on rhinitis is reduced, indicating that the ratio of the compositions of Examples 1-4 is the best.

[0107] The composition of Comparative Example 2 has less medicinal taste than the compositions of Examples 1-4, but its therapeutic effect on rhinitis is reduced, indicating that the composition ratio of Examples 1-4 is optimal.

[0108] Although the composition of Comparative Example 3-4 has similar effects to that of Example 1-4, due to the different compositions, Comparative Example 3-4 adds several medicinal materials on the basis of Example 1-4, indicating that adding several medicinal materials on the basis of Example 1-4 does not increase the therapeutic effect.

[0109] The composition of Comparative Example 5 replaces several medicinal materials with the same or similar efficacy on the basis of the compositions of Examples 1-4, and its therapeutic effect on rhinitis is reduced, indicating that replacing medicinal materials with the same or similar efficacy on the basis of Examples 1-4 cannot achieve the therapeutic effect of the examples.

[0110] The compositions of Comparative Examples 6-8 omitted the extraction process based on Examples 1-4, and the overall therapeutic effects of the compositions were all reduced, indicating that the therapeutic effects of the compositions were better based on Examples 1-4, indicating that the extraction processes of Examples 1-4 had a synergistic effect.

[0111] The compositions of Comparative Examples 9-10 have similar effects to the compositions of Examples 1-4, indicating that sodium chloride and pH have almost no effect on the therapeutic effect of the compositions.

[0112] The patient experience of using the Chinese medicine composition of Example 1, Comparative Example 9, and Comparative Example 10 was recorded, and the results are as follows:

[0113] Table 2 User experience

[0114] Group Feeling the situation Example 1 No obvious feeling Comparative Example 9 There is a slight burning sensation, rapid discharge of mucus and tears, and continuous sneezing Comparative Example 10 There is a slight burning sensation, rapid discharge of mucus and tears, and continuous sneezing

[0115] As shown in Table 2, the composition of Example 1 has a better effect, indicating that the addition of sodium chloride and the adjustment of pH can reduce the irritation of the Chinese medicine composition and improve the comfort of drug use.

[0116] In summary, the Chinese medicine composition for external use in the treatment of rhinitis according to the embodiment of the present invention has magnolia bud and siler as the main ingredients, which have the effects of dispelling wind and relieving itching, promoting lung function and clearing the orifices; cicada slough and schizonepeta tenuifolia as the auxiliary ingredients, which have the effects of dispelling wind and relieving itching; and sophora flavescens, atractylodes, kudzu root, and angelica dahurica as the adjuvant ingredients, which have the effects of drying dampness and relieving itching, raising yang energy, and clearing the nasal orifices. The combination of these ingredients can achieve the effects of dispelling wind and clearing the orifices, relieving itching and eliminating nasal discharge, relieving mucosal swelling, helping to relieve nasal congestion, stimulating nasal nerve endings, and promoting mucosal repair and regeneration, thereby effectively treating allergic rhinitis, acute and chronic rhinitis, and sinusitis.

[0117] The embodiments described above are some, but not all, of the embodiments of the present invention. The detailed description of the embodiments of the present invention is not intended to limit the scope of the invention as claimed, but rather merely represents selected embodiments of the present invention. All other embodiments derived by persons of ordinary skill in the art based on the embodiments of the present invention without inventive effort are also within the scope of protection of the present invention.

Claims

1. A Chinese medicine composition for external use in treating rhinitis, characterized in that: The invention is prepared from 5-15g of magnolia bud, 12-24g of schizonepeta tenuifolia, 12-24g of siler, 20-30g of atractylodes lancea, 4-12g of angelica dahurica, 3-9g of cicada slough, 20-30g of kudzu root, 12-24g of sophora flavescens and an antibacterial agent by weight; the antibacterial agent is chlorhexidine acetate and / or a traditional Chinese medicine extract, the mass concentration of the chlorhexidine acetate is 0.05%, and the mass concentration of the traditional Chinese medicine extract is 1%; the raw material of the traditional Chinese medicine extract is mugwort leaf; The preparation method of the Chinese medicine composition comprises the following steps: Weigh the raw materials in proportion, add 10-15 times the amount of water to the raw materials, heat and distill to extract, collect 500 mL of aromatic water, filter the decoction, and collect the filtrate and the medicinal residue; Add 6-10 times the amount of water to the medicinal residue, heat under reflux and decoct, filter, and collect the filtrate; Combine the two filtrates, concentrate, and filter through a 200-mesh filter. Add ethanol to the filtrate until the alcohol concentration reaches 70%. Let it stand for 22-25 hours. Take the supernatant, concentrate it under reduced pressure, and then mix it with aromatic water. Add purified water to 1000 mL, centrifuge, boil, and add sodium chloride to obtain a mixed solution. The antibacterial agent and the solubilizer are dissolved in propylene glycol, and then added to the mixed solution, the pH is adjusted to 6-7, and the solution is filtered to obtain the finished product.

2. The Chinese medicine composition for external use in treating rhinitis according to claim 1, characterized in that: 10g of Magnolia bud, 18g of Schizonepeta tenuifolia, 18g of Saposhnikovia divaricata, 25g of Atractylodes macrocephala, 8g of Angelica dahurica, 6g of Periostracum cicada, 25g of Pueraria root and 18g of Sophora flavescens.

3. The Chinese medicine composition for external use for treating rhinitis according to claim 1, characterized in that: During the heating distillation extraction, the distillation speed is 3-5 drops / second; the two filtrates are combined and concentrated to a relative density of 1.15-1.25 at 60°C; the supernatant is concentrated under reduced pressure to a relative density of 1.08-1.12 at 60°C; the pH is adjusted to 6-7, and filtration is performed using a 0.45 μm filter membrane.

4. The Chinese medicine composition for external use for treating rhinitis according to claim 1, characterized in that The solubilizing agent is RH40 or Tween-80.

5. The Chinese medicine composition for external use for treating rhinitis according to claim 4, characterized in that The mass concentration of sodium chloride is 0.9%, the mass concentration of propylene glycol is 2%, and the mass concentrations of RH40 and Tween-80 are both 1%.

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