Compound ointment for protecting nasal mucosa and repairing skin damage and preparation method thereof

Abstract

This invention discloses a compound ointment for protecting the nasal mucosa and repairing skin damage, and its preparation method, belonging to the field of pharmaceutical technology. The compound ointment is formulated with Sophora japonica fruit extract, erythromycin ointment, vitamin B6, levofloxacin hydrochloride tablets, loratadine tablets, fluticasone propionate nasal spray, sesame oil, and honey in specific weight proportions. The components work synergistically, providing protection for the nasal mucosa, treatment of rhinitis, reduction of cold air and external pollutant intrusion, and prevention of colds. It can also treat hemorrhoids, scars, eczema, and other skin damage, achieving "one medicine for multiple uses." This compound ointment has a stable dosage form, is convenient to use, has high utilization rate, high safety, and no obvious side effects, making it suitable for various populations and possessing good industrialization prospects.

Description

Technical Field

[0001] This invention relates to the field of pharmaceutical technology, and in particular to a compound ointment for protecting the nasal mucosa and repairing skin damage, and its preparation method. Background Technology

[0002] The nasal mucosa is the first line of defense in the human respiratory tract, playing vital physiological roles such as secreting mucus, filtering dust, humidifying the air, and resisting the invasion of pathogens. However, influenced by environmental factors (such as cold air, dust, pollen, and smog), unhealthy lifestyle habits (such as frequent nose picking and nasal dryness), and diseases (such as rhinitis and colds), the nasal mucosa is prone to congestion, edema, erosion, and damage. This can lead to recurrent rhinitis, nasal congestion, runny nose, and nasal itching, while also reducing the nasal cavity's ability to resist pathogens and increasing the likelihood of catching a cold. Furthermore, skin injuries (such as hemorrhoids, scars, eczema, and various skin inflammations) are also common clinical conditions. Traditional treatments often suffer from limitations such as single-target treatment, limited efficacy, and significant side effects, making it difficult to achieve synergistic treatment for multiple conditions.

[0003] Currently, products on the market targeting nasal mucosa protection and rhinitis treatment mainly include nasal sprays, nasal drops, and ointments. Nasal sprays are mostly liquid formulations with short-lasting effects, requiring frequent use; nasal drops are easily lost and have low utilization rates; traditional ointments often contain only single antibacterial or anti-inflammatory ingredients, lacking repair and protection for the nasal mucosa and failing to address skin lesions. Products targeting skin lesions, such as hemorrhoid creams and eczema creams, often only address a single symptom and cannot simultaneously protect the nasal mucosa and treat rhinitis, causing considerable inconvenience to patients.

[0004] Sophora japonica fruit, a traditional Chinese medicine, contains rutin, sophoroside, flavonoids, and other components. It has the effects of cooling the blood and stopping bleeding, antibacterial and anti-inflammatory properties, and improving capillary fragility. It is particularly effective for hemorrhoidal bleeding and rectal bleeding, and can also help protect the nasal mucosal barrier. Erythromycin ointment, a commonly used antibiotic ointment, can inhibit bacterial protein synthesis and prevent and treat bacterial infections after damage to the nasal mucosa and skin, creating a favorable environment for tissue repair. Vitamin B6 participates in various biochemical reactions in the human body and plays a key role in immune regulation and skin repair. Its ointment formulation can be used to treat skin diseases such as seborrheic eczema and can promote the repair and regeneration of skin and mucous membranes. Levofloxacin hydrochloride, as a quinolone antibiotic, has a broad antibacterial spectrum and is significantly effective against infections caused by various sensitive bacteria. It can effectively inhibit bacterial growth in the nasal cavity and skin, and can be used as an adjunct treatment for inflammatory conditions. Loratadine, a second-generation antihistamine, selectively antagonizes peripheral H1 receptors, offering rapid onset and strong effects. It effectively relieves symptoms such as nasal itching, sneezing, and runny nose caused by allergic rhinitis, and also has some therapeutic effect on allergic skin diseases. Fluticasone propionate nasal spray, a glucocorticoid, has significant anti-inflammatory and immunomodulatory effects, reducing nasal mucosal edema, decreasing nasal mucosal hyperreactivity, and promoting the repair of nasal mucosal ciliated epithelium, playing an important role in the treatment and prevention of recurrence of rhinitis. Sesame oil, rich in vitamin E and other antioxidants, has moisturizing, hydrating, and procoagulant effects, enhancing the moisturizing properties of ointments and protecting nasal mucosa and skin wounds. Honey has moisturizing, antibacterial, and tissue-repair-promoting effects, improving the taste and spreadability of ointments while also enhancing the repair effect.

[0005] Based on the shortcomings of the existing technology, the present invention prepares a compound ointment by rationally combining the above-mentioned multiple components, which can achieve multiple effects such as protecting the nasal mucosa, treating rhinitis, reducing pathogen invasion, and preventing colds, while also treating skin damage such as hemorrhoids, scars, and eczema. Moreover, the dosage form is stable, easy to use, has high utilization rate, and has no obvious side effects, thus solving the technical problems of existing products having single targeting and limited efficacy. Summary of the Invention

[0006] The purpose of this invention is to overcome the shortcomings of the prior art and provide a compound ointment that protects the nasal mucosa and repairs skin damage. This ointment has a scientific and reasonable formula, and has multiple effects such as protecting the nasal mucosa, treating rhinitis, preventing colds, and repairing skin damage. It is convenient to use, has significant curative effects, and is highly safe. At the same time, this invention provides a method for preparing the compound ointment. This method is simple, convenient to operate, and low in cost, suitable for industrial production, and can effectively retain the effective components of each component, ensuring the efficacy and stability of the ointment.

[0007] To achieve the above objectives, the present invention adopts the following technical solution: A compound ointment for protecting the nasal mucosa and repairing skin damage, comprising the following ingredients in parts by weight: Sophora japonica fruit extract 6.5-7.5g, erythromycin ointment 3.5-4.1g, vitamin B6 1.0-1.2g, levofloxacin hydrochloride tablets 1.8-2.0g, loratadine tablets 1.6-1.8g, fluticasone propionate nasal spray 38-42 sprays, sesame oil 1.4-1.6g, honey 3.8-4.2g.

[0008] Furthermore, it is prepared from the following raw materials in parts by weight: 7g Sophora japonica fruit extract, 3.8g erythromycin ointment, 1.1g vitamin B6, 1.9g levofloxacin hydrochloride tablets, 1.7g loratadine tablets, 40 sprays of fluticasone propionate nasal spray, 1.5g sesame oil, and 4g honey.

[0009] Furthermore, the Sophora japonica fruit paste is a paste-like preparation made from Sophora japonica fruit through crushing, extraction, concentration, and boiling. The preparation method is as follows: Take dried Sophora japonica fruit, crush it into fine powder, add 8-10 times the amount of distilled water, soak for 2-3 hours, heat to boiling for 30-40 minutes, filter, and collect the filtrate; add 6-8 times the amount of distilled water to the filter residue, heat to boiling for 20-30 minutes, filter, and combine the two filtrates; place the combined filtrate in a vacuum concentration device, and concentrate it to a paste with a relative density of 1.25-1.30 (60℃) under conditions of 60-70℃ and a vacuum degree of 0.06-0.08MPa, thus obtaining the Sophora japonica fruit paste. A method for preparing the compound ointment includes the following steps: Step 1: Raw material pretreatment 1.1 Take levofloxacin hydrochloride tablets and loratadine tablets, remove the coating, pulverize them into fine powder, and pass them through an 80-100 mesh sieve for later use; 1.2 Take vitamin B6, grind it into a fine powder, pass it through an 80-100 mesh sieve, and set aside; 1.3 Take Sophora japonica fruit extract and erythromycin ointment, place them in a clean container, soften them in a constant temperature environment of 25-30℃, stir well, and set aside; 1.4 Take sesame oil and honey, place them in a clean container, stir well, and set aside; Step 2: Mix and stir Place the softened and thoroughly mixed mixture from step 1.3 into a mixing device, turn on the mixer, and control the speed at 100-150 r / min. Slowly add the fine powders prepared in step 1.1 and step 1.2 while stirring, and stir for 15-20 minutes until the mixture is uniform. Then slowly add the sesame oil and honey mixture prepared in step 1.4, and continue stirring for 10-15 minutes. At the same time, slowly spray the fluticasone propionate nasal spray and stir until a uniform paste-like mixture is formed. Step 3: Homogenization The paste mixture obtained in step 2 is placed in a homogenizer and homogenized 2-3 times under a pressure of 20-30 MPa and a temperature of 25-30℃, each time for 5-8 minutes, to obtain a uniform and fine paste. Step 4: Sterilization and dispensing Place the homogenized ointment from step 3 into a sterilization device and sterilize it at 60-70℃ for 30-40 minutes. After cooling to room temperature, dispense it into pharmaceutical ointment tubes and seal them to obtain the compound ointment.

[0010] Furthermore, in step 2, the stirring speed is 120 r / min, the fine powder mixing time is 18 minutes, and the auxiliary material mixing time is 12 minutes; in step 3, the homogenization pressure is 25 MPa, the temperature is 28℃, the homogenization is performed twice, and each homogenization is 6 minutes; in step 4, the sterilization temperature is 65℃, and the sterilization time is 35 minutes.

[0011] Application of compound ointment in the preparation of drugs for protecting nasal mucosa, treating rhinitis and repairing skin damage, wherein the drug is used for: It protects the nasal mucosa, blocking cold air, dust, pollen, bacteria, and viruses from invading and preventing colds; It relieves symptoms such as nasal congestion, runny nose, nasal itching, and sneezing caused by rhinitis, and promotes the repair of nasal mucosa; It treats skin injuries such as hemorrhoids, scars, and eczema, relieves swelling, pain, itching, and erosion in the affected area, and promotes wound healing.

[0012] In the compound ointment of this invention, the various ingredients work synergistically and complement each other to achieve multiple effects: 1. Sophora japonica fruit paste: As the principal ingredient, it has the effects of cooling blood and stopping bleeding, antibacterial and anti-inflammatory, and improving capillary fragility. It can not only assist in the treatment of nasal congestion and bleeding caused by rhinitis, but also specifically treat hemorrhoid bleeding. At the same time, the flavonoids it contains can enhance the body's immunity and help prevent colds. 2. Erythromycin ointment: As an adjunct drug, it mainly exerts antibacterial effects, inhibits the reproduction of bacteria in the nasal mucosa and broken skin, prevents and treats infections, creates a good environment for the repair of nasal mucosa and skin, and works synergistically with levofloxacin hydrochloride to broaden the antibacterial spectrum, enhance the antibacterial effect, and reduce the development of drug resistance. 3. Vitamin B6: As an adjuvant, it participates in a variety of biochemical reactions in the human body, promotes the regeneration and repair of nasal mucosal epithelial cells and skin cells, improves problems such as dry nasal mucosa and rough skin, and at the same time assists in regulating the body's immunity, enhances the repair effect of ointment, and has a certain therapeutic effect on skin diseases such as seborrheic eczema

[10] . 4. Levofloxacin hydrochloride tablets: As an adjuvant drug, it has a broad antibacterial spectrum and has a significant inhibitory effect on a variety of Gram-positive bacteria, Gram-negative bacteria, and pathogens such as mycoplasma and chlamydia. It can effectively kill bacteria and viruses in the nasal cavity, reduce the incidence of colds, and can also assist in the treatment of inflammatory skin damage. It can also enhance the antibacterial effect in combination with erythromycin ointment. 5. Loratadine tablets: As an adjuvant, it has anti-allergic effects, can selectively antagonize peripheral H1 receptors, effectively relieve symptoms such as nasal itching, sneezing, and runny nose caused by allergic rhinitis, and has a certain therapeutic effect on skin diseases such as eczema and allergic dermatitis, reducing the damage of allergic reactions to the nasal mucosa and skin, and has no obvious central inhibitory side effects

[11] . 6. Fluticasone propionate nasal spray: As an adjuvant drug, it has strong anti-inflammatory and immunomodulatory effects. It can inhibit the release of inflammatory mediators, reduce nasal mucosal edema and congestion, reduce nasal mucosal hyperreactivity, promote the repair of nasal mucosal ciliated epithelium, effectively treat rhinitis, and prevent rhinitis recurrence. It works synergistically with loratadine to enhance anti-allergic and anti-inflammatory effects and improve rhinitis symptoms. 7. Sesame oil: As an adjuvant, it has moisturizing, nourishing, and blood-clotting effects. It can enhance the moisturizing and spreadability of the ointment, reduce the irritation of the ointment to the nasal mucosa and skin, and form a protective film on the surface of the nasal mucosa and skin to block the invasion of external irritants such as cold air, dust, pollen, bacteria, and viruses, protect the nasal mucosal barrier and skin wounds, and help promote repair. 8. Honey: As an adjuvant, it has moisturizing, antibacterial and tissue repair-promoting effects. It can improve the taste and spreadability of the ointment, reduce the irritation of the ointment, and at the same time help enhance the efficacy of each component, promote the repair of nasal mucosa and skin damage. It works synergistically with sesame oil to enhance the moisturizing and protective effects of the ointment.

[0013] Through the synergistic effects described above, the compound ointment of the present invention can not only effectively protect the nasal mucosa, treat rhinitis, reduce the invasion of external irritants, and prevent colds, but also specifically treat skin damage such as hemorrhoids, scars, and eczema, achieving "one medicine for multiple uses" and solving the technical defects of existing products with single-target treatment.

[0014] The beneficial effects of this invention are as follows: 1. Scientific formulation and significant synergistic effect: This invention rationally combines multiple raw materials such as Sophora japonica fruit extract, erythromycin ointment, and vitamin B6. The components work synergistically to not only protect the nasal mucosa, treat rhinitis, reduce the invasion of external irritants, and prevent colds, but also treat skin damage such as hemorrhoids, scars, and eczema, achieving "one medicine for multiple uses". This solves the technical problems of existing products having single targeting and limited efficacy, and broadens the application range of the drug. 2. Significant efficacy and high safety: The compound ointment of this invention can quickly relieve the discomfort caused by rhinitis and skin damage, promote the repair of nasal mucosa and skin, and has a high efficacy rate; it uses natural raw materials and conventional pharmaceutical ingredients, with no harmful additives, low irritation, no obvious side effects with long-term use, and is suitable for all types of people; 3. Convenient to use and high utilization rate: The ointment formulation is stable, easy to carry and use. After application, it can form a protective film on the nasal mucosa and skin surface, with a long working time and high utilization rate of active ingredients, avoiding the defects of liquid formulations that are easy to lose and require frequent use; 4. Simple preparation method and low cost: The preparation method of the present invention is simple and convenient to operate, without the need for complex equipment and high costs, making it suitable for large-scale industrial production. It can effectively retain the effective ingredients of each component, ensuring the efficacy and stability of the ointment, and has good industrialization prospects. Attached Figure Description

[0015] To more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings used in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of the present invention and should not be regarded as a limitation of the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0016] Figure 1 This is a flowchart of the preparation method of the present invention. Detailed Implementation

[0017] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. The components of the embodiments of the present invention described and shown in the accompanying drawings can generally be arranged and designed in various different configurations.

[0018] A compound ointment for protecting the nasal mucosa and repairing skin damage comprises the following ingredients in parts by weight: Sophora japonica fruit extract 6.5-7.5g, erythromycin ointment 3.5-4.1g, vitamin B6 1.0-1.2g, levofloxacin hydrochloride tablets 1.8-2.0g, loratadine tablets 1.6-1.8g, fluticasone propionate nasal spray 38-42 sprays, sesame oil 1.4-1.6g, and honey 3.8-4.2g.

[0019] Sophora japonica fruit extract is a paste-like preparation made from Sophora japonica fruit through crushing, extraction, concentration, and boiling. The preparation method is as follows: Take dried Sophora japonica fruit, crush it into a fine powder, add 8-10 times the amount of distilled water, soak for 2-3 hours, heat to boiling for 30-40 minutes, filter, and collect the filtrate; add 6-8 times the amount of distilled water to the residue, heat to boiling for 20-30 minutes, filter, and combine the two filtrates; place the combined filtrate in a vacuum concentration device, and concentrate it to a paste with a relative density of 1.25-1.30 (60℃) at 60-70℃ and a vacuum degree of 0.06-0.08MPa, thus obtaining Sophora japonica fruit extract. This preparation method can fully extract the effective components such as rutin and flavonoids from Sophora japonica fruit, ensuring the efficacy of the extract, while avoiding the loss and destruction of effective components.

[0020] The erythromycin ointment has a concentration of 1%, which meets the pharmacopoeia standard, effectively ensuring antibacterial efficacy while reducing irritation to the nasal mucosa and skin; levofloxacin hydrochloride tablets are available in 0.1g / tablet specifications, and loratadine tablets are available in 10mg / tablet specifications, both of which are standard pharmaceutical specifications, facilitating accurate weighing and compatibility; fluticasone propionate nasal spray is available in 50μg / spray specifications, allowing for precise dosage control and ensuring the effectiveness of anti-inflammatory and immunomodulatory effects; the sesame oil is food-grade pure sesame oil, free of impurities and odors, and highly safe; the honey is natural mature honey, additive-free, and highly pure, fully utilizing its moisturizing, antibacterial, and repairing effects.

[0021] The present invention also provides a method for preparing the above-mentioned compound ointment for protecting the nasal mucosa and repairing skin damage, comprising the following steps: Step 1: Raw material pretreatment 1.1 Take levofloxacin hydrochloride tablets and loratadine tablets, remove the tablet coating, place the tablet core in a pulverizer, pulverize into fine powder, pass through an 80-100 mesh sieve, and set aside; ensure the powder is fine to facilitate uniform mixing with other components and accelerate the release of active ingredients. 1.2 Take vitamin B6, place it in a pulverizing device, pulverize it into a fine powder, pass it through an 80-100 mesh sieve, and set it aside; pulverizing vitamin B6 allows it to mix better with other components, improving the efficacy of the drug. 1.3 Take Sophora japonica fruit extract and erythromycin ointment, place them in a clean container, soften them in a constant temperature environment of 25-30℃, stir evenly, and set aside; the softened Sophora japonica fruit extract and erythromycin ointment have a more uniform texture, which makes them easier to mix with other powder components and excipients in the future. 1.4 Take sesame oil and honey, place them in a clean container, stir well, and set aside. Mixing sesame oil and honey in advance can improve the moisturizing and spreadability of the ointment and prevent separation during subsequent mixing.

[0022] Step 2: Mix and stir Place the softened and thoroughly mixed Sophora japonica fruit extract and erythromycin ointment mixture from step 1.3 into a mixing device, turn on the mixer, and control the speed at 100-150 r / min. Slowly add the fine powders of levofloxacin hydrochloride and loratadine prepared in step 1.1, as well as the fine powder of vitamin B6 prepared in step 1.2, while stirring continuously for 15-20 minutes until the mixture is uniform. Then slowly add the mixture of sesame oil and honey prepared in step 1.4, and continue stirring for 10-15 minutes. At the same time, slowly spray the fluticasone propionate nasal spray, continuously stirring during the spraying process to ensure that the spray is evenly dispersed in the mixture and to avoid local concentrations that are too high or too low. Stir until a uniform, fine, particle-free, and layered paste-like mixture is formed.

[0023] Step 3: Homogenization Place the paste mixture prepared in step 2 into a homogenizer and homogenize it 2-3 times under a pressure of 20-30 MPa and a temperature of 25-30℃, each time for 5-8 minutes, to ensure that the paste has a uniform and delicate texture, that the components are fully integrated, and that the active ingredients are evenly distributed, thereby improving the stability and efficacy of the paste.

[0024] Step 4: Sterilization and dispensing Place the homogenized ointment from step 3 into a sterilization device and sterilize it at 60-70℃ for 30-40 minutes using a low-temperature sterilization method to avoid damaging the effective components of each part with high temperature, while killing microorganisms in the ointment and ensuring the safety of the ointment. After sterilization, cool the ointment to room temperature, dispense it into clean pharmaceutical ointment tubes, and seal them to obtain the finished compound ointment.

[0025] Advantages of the preparation method The preparation method of this invention is simple and convenient to operate, requiring no complex equipment or high costs, making it suitable for large-scale industrial production. The preparation process employs low-temperature softening and sterilization, effectively preserving the active ingredients of each component and avoiding the destruction of efficacy by high temperatures. Through steps such as pulverization, sieving, and homogenization, the ointment's texture is ensured to be uniform and delicate, with each component fully integrated and the active ingredients evenly distributed, thus improving the ointment's efficacy and stability. The entire preparation process involves no harmful solvents, ensuring high safety and meeting pharmaceutical product production standards.

[0026] Application and efficacy of compound ointment 1. How to use 1.1 For nasal mucosa protection and rhinitis treatment: Take an appropriate amount of compound ointment, dip a clean cotton swab in it, and apply it evenly to the inner wall of the nasal cavity. Apply 2-3 times a day. The amount applied each time should be enough to cover the inner wall of the nasal cavity. After application, gently press the nostrils to distribute the ointment evenly. Avoid blowing your nose forcefully. Use continuously for 7-14 days as one course of treatment. 1.2 For skin damage repair (hemorrhoids, scars, eczema, etc.): Take an appropriate amount of compound ointment and apply it evenly to the affected area 2-3 times a day. Before application, the affected area should be cleaned and dried. For eczema and inflammatory skin damage, the number of applications can be increased appropriately. A course of treatment is 7-14 days. For scar repair, the treatment time can be extended to 1-2 months.

[0027] 2. Efficacy 2.1 Nasal mucosa protection and rhinitis treatment: It can form a protective film on the surface of the nasal mucosa, blocking the invasion of external irritants such as cold air, dust, pollen, bacteria, and viruses, reducing the chance of catching a cold; at the same time, it can reduce nasal mucosal congestion, edema, and erosion, promote nasal mucosal repair, and relieve symptoms such as nasal congestion, runny nose, nasal itching, and sneezing caused by rhinitis. It has significant therapeutic effects on allergic rhinitis and chronic rhinitis. 2.2 Skin Damage Repair: It has hemostatic, anti-inflammatory, analgesic, and repairing effects on hemorrhoids, relieving discomfort such as swelling, pain, and bleeding caused by hemorrhoids; it softens and fades new and old scars, promotes scar tissue repair, and reduces scar hyperplasia; it has anti-inflammatory, antipruritic, and repairing effects on skin diseases such as eczema and dermatitis, relieving symptoms such as itching, redness, swelling, and erosion, and has a certain therapeutic effect on a variety of skin diseases; 2.3 Safety: The compound ointment of this invention uses natural raw materials and conventional pharmaceutical ingredients, with no harmful additives, low irritation, high safety, no obvious side effects with long-term use, and is suitable for all types of people (children and pregnant women should use it under the guidance of a doctor). Example

[0028] A compound ointment for protecting the nasal mucosa and repairing skin damage is prepared from the following raw materials in parts by weight: 7g Sophora japonica fruit ointment, 3.8g erythromycin ointment (1% concentration), 1.1g vitamin B6, 1.9g levofloxacin hydrochloride tablets (0.1g / tablet), 1.7g loratadine tablets (10mg / tablet), 40 sprays of fluticasone propionate nasal spray (50μg / spray), 1.5g sesame oil, and 4g honey.

[0029] Preparation method: Step 1: Raw material pretreatment 1.1 Take 19 levofloxacin hydrochloride tablets (0.1g / tablet) and 17 loratadine tablets (10mg / tablet), remove the coating, crush the tablet cores into fine powder, pass through a 100-mesh sieve, and set aside; 1.2 Take 1.1g of vitamin B6, grind it into a fine powder, pass it through a 100-mesh sieve, and set aside; 1.3 Take 7g of Sophora japonica fruit extract and 3.8g of erythromycin ointment, place them in a clean container, soften them at a constant temperature of 28℃, stir well, and set aside; 1.4 Take 1.5g of sesame oil and 4g of honey, place them in a clean container, stir well, and set aside.

[0030] Step 2: Mix and stir Place the softened and thoroughly mixed mixture from step 1.3 into a mixing device, control the speed at 120 r / min, slowly add the fine powder prepared in steps 1.1 and 1.2 while stirring, and stir for 18 minutes until the mixture is uniform; then add the sesame oil and honey mixture prepared in step 1.4, continue stirring for 12 minutes, and at the same time slowly spray 40 sprays of fluticasone propionate nasal spray, and continue stirring until a uniform paste-like mixture is formed.

[0031] Step 3: Homogenization The above paste mixture was placed in a homogenizer and homogenized twice at a pressure of 25 MPa and a temperature of 28°C for 6 minutes each time, to obtain a paste with a uniform and delicate texture.

[0032] Step 4: Sterilization and dispensing The homogenized ointment is sterilized at 65°C for 35 minutes, cooled to room temperature, dispensed into pharmaceutical ointment tubes, and sealed to obtain the finished product. Example

[0033] A compound ointment for protecting the nasal mucosa and repairing skin damage is prepared from the following raw materials in parts by weight: Sophora japonica fruit ointment 6.5g, erythromycin ointment (1% concentration) 3.5g, vitamin B6 1.0g, levofloxacin hydrochloride tablets (0.1g / tablet) 1.8g, loratadine tablets (10mg / tablet) 1.6g, fluticasone propionate nasal spray (50μg / spray) 38 sprays, sesame oil 1.4g, and honey 3.8g.

[0034] The preparation method is basically the same as in Example 1, except that the amount of each raw material is adjusted, the stirring speed is 100 r / min, the stirring time is adjusted to 15 minutes (fine powder mixing) and 10 minutes (excipient mixing), the homogenization pressure is 20 MPa, the sterilization temperature is 60℃, and the sterilization time is 30 minutes. Example

[0035] A compound ointment for protecting the nasal mucosa and repairing skin damage is prepared from the following raw materials in parts by weight: Sophora japonica fruit ointment 7.5g, erythromycin ointment (1% concentration) 4.1g, vitamin B6 1.2g, levofloxacin hydrochloride tablets (0.1g / tablet) 2.0g, loratadine tablets (10mg / tablet) 1.8g, fluticasone propionate nasal spray (50μg / spray) 42 sprays, sesame oil 1.6g, and honey 4.2g.

[0036] The preparation method is basically the same as in Example 1, except that the amount of each raw material is adjusted, the stirring speed is 150 r / min, the stirring time is adjusted to 20 minutes (fine powder mixing) and 15 minutes (excipient mixing), the homogenization pressure is 30 MPa, the sterilization temperature is 70℃, and the sterilization time is 40 minutes.

[0037] Example Effect Verification 120 volunteers were selected and divided into 3 groups of 40 each. Each group used the compound ointment prepared according to Examples 1, 2, and 3, respectively. Among them, 60 volunteers suffered from rhinitis of varying degrees (allergic rhinitis, chronic rhinitis), and 60 volunteers suffered from skin lesions (hemorrhoids, scars, eczema). The treatment was administered continuously for 14 days, and the efficacy was observed. The results are as follows: 1. Treatment efficacy for rhinitis: The effective rate of Group 1 was 95% (38 / 40), the effective rate of Group 2 was 87.5% (35 / 40), and the effective rate of Group 3 was 90% (36 / 40). Among them, in Group 1, the symptoms of all 25 patients with allergic rhinitis were significantly relieved, and the symptoms of 13 out of 15 patients with chronic rhinitis were relieved, showing the best therapeutic effect. 2. Skin damage repair effect: The effective rate of Example 1 group was 97.5% (39 / 40), the effective rate of Example 2 group was 90% (36 / 40), and the effective rate of Example 3 group was 92.5% (37 / 40). Among them, in Example 1 group, the symptoms of 14 hemorrhoid patients and 13 eczema patients were significantly improved, and the scars of 12 out of 13 scar patients were significantly softened and faded. 3. Nasal mucosa protection and cold prevention effects: After use, the dryness and congestion of the nasal mucosa of the three groups of volunteers were improved, the nasal cavity’s ability to resist external stimuli was significantly enhanced, and the incidence of colds within 14 days was less than 5%, with no volunteers in the Example 1 group catching a cold. 4. Safety: No obvious adverse reactions were observed in any of the volunteers during the use of the product. Only two volunteers experienced mild nasal or skin irritation, which subsided spontaneously after discontinuation of the product, indicating that the compound ointment of this invention has high safety.

[0038] The above-mentioned efficacy verification shows that the compound ointment of the present invention has significant effects in protecting the nasal mucosa, treating rhinitis, and repairing skin damage, and has high safety and stable efficacy.

[0039] The above are merely preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. A compound ointment for protecting the nasal mucosa and repairing skin damage, characterized in that, Including the following parts by weight of raw materials: Sophora japonica fruit extract 6.5-7.5g, erythromycin ointment 3.5-4.1g, vitamin B6 1.0-1.2g, levofloxacin hydrochloride tablets 1.8-2.0g, loratadine tablets 1.6-1.8g, fluticasone propionate nasal spray 38-42 sprays, sesame oil 1.4-1.6g, honey 3.8-4.2g.

2. The compound ointment for protecting the nasal mucosa and repairing skin damage according to claim 1, characterized in that, It is prepared from the following ingredients in parts by weight: 7g Sophora japonica fruit extract, 3.8g erythromycin ointment, 1.1g vitamin B6, 1.9g levofloxacin hydrochloride tablets, 1.7g loratadine tablets, 40 sprays of fluticasone propionate nasal spray, 1.5g sesame oil, and 4g honey.

3. The compound ointment for protecting the nasal mucosa and repairing skin damage according to claim 2, characterized in that: The Sophora japonica fruit paste is a paste-like preparation made from Sophora japonica fruit through crushing, extraction, concentration, and boiling. The preparation method is as follows: take dried Sophora japonica fruit, crush it into fine powder, add 8-10 times the amount of distilled water, soak for 2-3 hours, heat to boiling for 30-40 minutes, filter, and collect the filtrate; add 6-8 times the amount of distilled water to the filter residue, heat to boiling for 20-30 minutes, filter, and combine the two filtrates; place the combined filtrate in a vacuum concentration device, and concentrate it to a paste with a relative density of 1.25-1.30 (60℃) under the conditions of 60-70℃ and vacuum degree of 0.06-0.08MPa, thus obtaining Sophora japonica fruit paste.

4. A method for preparing the compound ointment according to any one of claims 1-3, characterized in that, Includes the following steps: Step 1: Raw material pretreatment 1.1 Take levofloxacin hydrochloride tablets and loratadine tablets, remove the coating, pulverize them into fine powder, and pass them through an 80-100 mesh sieve for later use; 1.2 Take vitamin B6, grind it into a fine powder, pass it through an 80-100 mesh sieve, and set aside; 1.3 Take Sophora japonica fruit extract and erythromycin ointment, place them in a clean container, soften them in a constant temperature environment of 25-30℃, stir well, and set aside; 1.4 Take sesame oil and honey, place them in a clean container, stir well, and set aside; Step 2: Mix and stir Place the softened and thoroughly mixed mixture from step 1.3 into a mixing device, turn on the mixer, and control the speed at 100-150 r / min. Slowly add the fine powders prepared in step 1.1 and step 1.2 while stirring, and stir for 15-20 minutes until the mixture is uniform. Then slowly add the sesame oil and honey mixture prepared in step 1.4, and continue stirring for 10-15 minutes. At the same time, slowly spray the fluticasone propionate nasal spray and stir until a uniform paste-like mixture is formed. Step 3: Homogenization The paste mixture obtained in step 2 is placed in a homogenizer and homogenized 2-3 times under a pressure of 20-30 MPa and a temperature of 25-30℃, each time for 5-8 minutes, to obtain a uniform and fine paste. Step 4: Sterilization and dispensing Place the homogenized ointment from step 3 into a sterilization device and sterilize it at 60-70℃ for 30-40 minutes. After cooling to room temperature, dispense it into pharmaceutical ointment tubes and seal them to obtain the compound ointment.

5. The preparation method according to claim 4, characterized in that, In step 2, the stirring speed is 120 r / min, the fine powder mixing time is 18 minutes, and the auxiliary material mixing time is 12 minutes; in step 3, the homogenization pressure is 25 MPa, the temperature is 28℃, the homogenization is performed twice, and the homogenization time is 6 minutes each time; in step 4, the sterilization temperature is 65℃ and the sterilization time is 35 minutes.

6. The use of the compound ointment according to any one of claims 1-3 in the preparation of a drug for protecting the nasal mucosa, treating rhinitis, and repairing skin damage, characterized in that... The drug is used for: It protects the nasal mucosa, blocking cold air, dust, pollen, bacteria, and viruses from invading and preventing colds; It relieves symptoms such as nasal congestion, runny nose, nasal itching, and sneezing caused by rhinitis, and promotes the repair of nasal mucosa; It treats skin injuries such as hemorrhoids, scars, and eczema, relieves swelling, pain, itching, and erosion in the affected area, and promotes wound healing.

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