Externally applied medicine for otitis media based on traditional Chinese medicine compound and use method of externally applied medicine

Abstract

The invention relates to the technical field of traditional Chinese medicine agentia, and discloses an otitis media external medicine based on a traditional Chinese medicine compound and a using method, the otitis media external medicine is prepared by mixing oil liquid and powder, the oil liquid comprises sesame oil, radix sophorae flavescentis, fructus xanthii, snakeskin and radix rehmanniae; the powder is prepared from the following raw materials: borneol, artificial tiger bone, plant soot, herba equiseti hiemalis and herba violae; the mixing ratio of the oil liquid to the powder is that every 100 parts by weight of the oil liquid corresponds to 5-30 parts by weight of the powder; the application method comprises the following steps: adding the powder into the oil liquid, uniformly mixing, dipping the mixed liquid with a sterile cotton swab, then coating the mixed liquid into the ear canal, continuously using for 1-3 times every day until the symptoms are relieved, and through the synergistic effect of the oil liquid (containing radix sophorae flavescentis, cocklebur fruit and the like) and the powder (containing borneol, artificial tiger bone and the like), combining the dosage forms such as ear drops, spray and the like with infrared physiotherapy for combined application. According to the scheme, the preparation process is simple, the curative effect is remarkable, and the traditional Chinese medicine composition is suitable for various otitis media patients.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine preparations, in particular to an external-use medicine for otitis media based on a traditional Chinese medicine compound and a method of use. Background Art

[0002] Otitis media is an inflammation of the middle part of the ear, behind the eardrum, caused by a viral or bacterial infection. Otitis media primarily originates from bacteria and viruses and is often triggered by illnesses such as colds, flu, or sinusitis. This condition is quite common, especially among children under 10 years old; 80% of children experience otitis media at least once, with the highest incidence rates in children aged 2 and 5 years old. The main types of otitis media include acute otitis media, acute suppurative otitis media, chronic suppurative otitis media, and secretory otitis media.

[0003] Otitis media is an inflammatory lesion affecting the structure of the middle ear and is divided into two categories: non-suppurative and suppurative. Western medicine treatment mainly relies on antibiotics and surgery, but long-term use can easily lead to drug resistance and has limited efficacy for chronic otitis media. Although traditional Chinese medicine internal preparations can relieve symptoms by dispelling wind, resolving phlegm, and promoting blood circulation, they have problems such as slow onset of action, poor taste, and low patient compliance. Existing topical medications mostly use a single ingredient or simple compound, making it difficult to achieve multi-target synergistic treatment, and the dosage form is single (such as traditional ear drops), which cannot meet the differentiated needs of patients with different disease courses. In addition, existing technologies do not combine physical therapy (such as infrared therapy) to enhance drug penetration and efficacy, resulting in room for improvement in treatment effect. Therefore, there is an urgent need for topical medications for otitis media based on traditional Chinese medicine compound and methods of use. Summary of the Invention

[0004] The purpose of the present invention is to provide an external-use medicine for otitis media based on a traditional Chinese medicine compound and a method of use, so as to solve the problems raised in the above-mentioned background technology.

[0005] In order to solve the above technical problems, the present invention provides the following technical solutions: an external-use medicine for otitis media based on a traditional Chinese medicine compound and a method of use, which is prepared by mixing an oil and a powder, wherein:

[0006] The raw materials of the oil include sesame oil, sophora flavescens, Xanthium sibiricum, snake skin and rehmannia root;

[0007] The raw materials of the powder include borneol, artificial tiger bone, Baicao Shuang, Dizetia scabra and Viola yedoensis;

[0008] The mixing ratio of the oil and the powder is 5 to 30 parts by weight of the powder for every 100 parts by weight of the oil;

[0009] The method of use is to add the powder to the oil and mix evenly. Dip a sterile cotton swab in the mixture and apply it to the ear canal. Use it 1 to 3 times a day until the symptoms are relieved.

[0010] Preferably, the method for preparing the oil comprises the following steps:

[0011] Heat the sesame oil to 40-60℃, then add Sophora flavescens, Xanthium sibiricum, snake skin and Radix Rehmanniae;

[0012] Slowly raise the temperature to 80-90℃ over low heat and fry for 25-30 minutes, making sure the ingredients are not burnt.

[0013] Filter to remove solid residue, cool to room temperature and store in sealed container.

[0014] Preferably, the preparation method of the powder comprises the following steps:

[0015] Grind borneol, artificial tiger bone, Baicao Shuang, Dizemphaea chinensis and Viola yedoensis into particle sizes less than 100 mesh respectively;

[0016] Mix according to the proportion and grind twice until uniform, then sieve and store in a dark place.

[0017] Preferably, the preparation method of the powder comprises the following steps:

[0018] Grind borneol, artificial tiger bone, Baicao Shuang, Dizemphaea chinensis and Viola yedoensis into particle sizes less than 100 mesh respectively;

[0019] Mix according to the proportion and grind twice until uniform, then sieve and store in a dark place.

[0020] Preferably, the preparation method of the powder comprises the following steps:

[0021] Grind borneol, artificial tiger bone, Baicao Shuang, Dizemphaea chinensis and Viola yedoensis into particle sizes less than 100 mesh respectively;

[0022] Mix according to the proportion and grind twice until uniform, then sieve and store in a dark place.

[0023] Preferably, the preparation method of the powder comprises the following steps:

[0024] Grind borneol, artificial tiger bone, Baicao Shuang, Dizemphaea chinensis and Viola yedoensis into particle sizes less than 100 mesh respectively;

[0025] Mix according to the proportion and grind twice until uniform, then sieve and store in a dark place.

[0026] Preferably, the preparation method of the powder comprises the following steps:

[0027] Grind borneol, artificial tiger bone, Baicao Shuang, Dizemphaea chinensis and Viola yedoensis into particle sizes less than 100 mesh respectively;

[0028] Mix according to the proportion and grind twice until uniform, then sieve and store in a dark place.

[0029] Preferably, the preparation method of the powder comprises the following steps:

[0030] Grind borneol, artificial tiger bone, Baicao Shuang, Dizemphaea chinensis and Viola yedoensis into particle sizes less than 100 mesh respectively;

[0031] Mix according to the proportion and grind twice until uniform, then sieve and store in a dark place.

[0032] Preferably, the topical medication can be used in combination with infrared therapy, specifically by:

[0033] After applying the medicine, irradiate the ear with infrared light with a wavelength of 800-1000nm once a day for 10-15 minutes each time.

[0034] Compared with the prior art, the beneficial effects achieved by the present invention are:

[0035] The present invention achieves rapid antibacterial and anti-inflammatory effects and treats both the symptoms and the root cause through the synergistic effect of oil (containing Sophora flavescens, Xanthium sibiricum, etc.) and powder (containing borneol, artificial tiger bone, etc.), combined with dosage forms such as ear drops and sprays and infrared physiotherapy. The preparation process of this solution is simple, the therapeutic effect is significant, and it is suitable for patients with various types of otitis media. DETAILED DESCRIPTION

[0036] The following will be combined with the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the embodiments described are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0037] The present invention provides the following technical solutions:

[0038] Example 1: Basic external medicine based on preferred ratio

[0039] Raw material composition: oil raw materials (weight parts): sesame oil 150 parts, sophora flavescens 10 parts, Xanthium sibiricum 20 parts, snake skin 5 parts, raw rehmannia glutinosa 20 parts;

[0040] Powder raw materials (weight parts): 8 parts of borneol, 20 parts of artificial tiger bone, 15 parts of Baicao Shuang, 20 parts of Dizempic, and 20 parts of Viola yedoensis;

[0041] Preparation method of oil: Heat 150 parts of sesame oil to 50℃, add Sophora flavescens, Xanthium sibiricum, snake skin and Rehmannia root;

[0042] Slowly raise the heat to 85°C and deep-fry for 28 minutes, stirring constantly to ensure the ingredients are not burnt.

[0043] The product was filtered through a 200-mesh filter to remove solid residues and obtain a clear oil. After cooling to room temperature, the product was sealed and stored in a brown glass bottle.

[0044] Preparation method of powder: Grind borneol, artificial tiger bone, Baicao Shuang, Dizemphaea chinensis and Viola yedoensis into particles with a traditional Chinese medicine grinder to a size of less than 100 mesh;

[0045] After mixing according to the above weight ratio, place in a three-dimensional motion mixer and grind for a second time for 30 minutes until uniform;

[0046] Pass through a 120-mesh sieve, collect the powder under the sieve, and store in a dry container away from light.

[0047] Mixing and use:

[0048] Mixing ratio: Take 100 parts by weight of oil, add 15 parts by weight of powder (this ratio is the intermediate preferred value of 5-30 parts by weight in claim 1), and stir with a glass rod for 5 minutes until the mixture is uniform;

[0049] Instructions for use: Dip a sterile cotton swab in the mixture and gently apply it to the ear canal twice a day (an intermediate frequency of 1-3 times a day in claim 1). Use continuously until the symptoms are relieved. Generally, patients with mild otitis media will see significant relief of symptoms after 3-5 days of use, and will be basically relieved after 7-10 days.

[0050] Storage conditions:

[0051] Protect from light, store in a sealed and cool dry place at a temperature of 20-25°C. The shelf life is 6 months. According to the stability test, the change of the active ingredient content during storage is less than 5%, and the microbial limit complies with the requirements of the Chinese Pharmacopoeia.

[0052] Example 2: Optimized external medicine with added honeysuckle extract

[0053] Raw material composition:

[0054] Oil raw materials (parts by weight): Based on the oil raw materials of Example 1, 3% of honeysuckle extract (satisfying the addition amount range of 1%-5% in claim 6) of the total weight of the oil was added, i.e., 150 parts of sesame oil, 10 parts of sophora flavescens, 20 parts of Xanthium sibiricum fruit, 5 parts of snake skin, 20 parts of raw rehmannia, and [(150+10+20+5+20)×3%]=6.15 parts of honeysuckle extract;

[0055] Powder raw materials: same as in Example 1;

[0056] Preparation method of oil: prepare the oil according to the steps of Example 1, cool to room temperature, add honeysuckle extract, and stir for 10 minutes until completely dissolved.

[0057] The remaining steps are the same as in Example 1.

[0058] Powder preparation, mixing, use, and storage: same as in Example 1.

[0059] Effect advantage: Honeysuckle extract has a strong broad-spectrum antibacterial effect, especially significant inhibitory effect on common pathogens of otitis media such as Staphylococcus aureus and Streptococcus. According to in vitro antibacterial tests, the diameter of the inhibition zone of the external medicine of this embodiment against the above bacteria is 2-3 mm larger than that of Example 1. Clinical verification shows that after patients with moderate to severe otitis media use this medicine, the symptom relief time is shortened by 2-3 days compared with Example 1.

[0060] Example 3: External use medicine in the form of ear drops

[0061] Raw material composition and proportion:

[0062] Oil and powder materials: Same as in Example 1, except that the oil formulation is adjusted by adding an appropriate amount of thickener (e.g., hydroxypropyl methylcellulose, 0.5% by weight of the total oil) to control the viscosity of the ear drops to 30 mPa·s (consistent with the range of 10-50 mPa·s in claim 8);

[0063] Mixing ratio: 20 parts by weight of powder for every 100 parts by weight of oil.

[0064] Oil preparation method: prepare base oil according to the steps of Example 1, add hydroxypropyl methylcellulose after cooling, stir until completely dissolved, measure the viscosity and adjust it to the target range.

[0065] Powder preparation method: same as Example 1.

[0066] Mixing: Add the powder to the oil and use a homogenizer at 1000 rpm for 5 minutes to fully disperse the powder to obtain uniform ear drops.

[0067] Instructions for use: When using, adjust the temperature of the ear drops to close to body temperature (36-37°C), the patient lies on his side with the affected ear facing upwards, drip 3-5 drops, maintain the posture for 5 minutes, 3 times a day (the upper limit of the number of daily uses in claim 1).

[0068] Dosage form advantages: The ear drop form facilitates precise control of medication dosage, avoiding the risk of ear canal damage caused by cotton swab application. It is especially suitable for children and patients with stenotic ear canals. Clinical feedback shows that the drug retention time in the ear canal with this dosage form is 15-20 minutes longer than that of traditional mixed solutions, thereby improving drug utilization.

[0069] Example 4: External use medicine in the form of spray

[0070] Raw material composition and proportion:

[0071] Oil and powder raw materials: As in Example 1, adjust the powder particle size to 50-100 mesh (the particle size in Claim 3 is less than 100 mesh, which is a range more suitable for spraying here), and add 0.1% Tween-80 as a dispersant to the oil to ensure uniform dispersion of the powder during spraying;

[0072] Mixing ratio: 10 parts by weight of powder for every 100 parts by weight of oil (the powder ratio is reduced to meet the spray fluidity requirements), and the atomized particle size of the spray is controlled at 30 μm (in line with the range of 10-50 μm in claim 8).

[0073] Preparation method of oil: Same as Example 1, add Tween-80 after cooling and stir evenly.

[0074] Powder preparation method: Grind each raw material to 50-100 mesh, mix and sieve to ensure that the particle size meets the requirements.

[0075] Mixing and filling: Add the powder to the oil, stir for 15 minutes, then dispense into spray bottles, use high-pressure gas (such as nitrogen) as the power source, and adjust the spray device to make the atomized particle size meet the standard.

[0076] Directions for use: Shake well before use, spray 2-3 cm away from the ear canal, spray 2-3 times each time, twice a day, for continuous use. This dosage form is easy to operate and can evenly cover the ear canal mucosa. It is especially suitable for patients with deep ear canal infections.

[0077] Example 5: External medication used in combination with infrared therapy

[0078] Raw materials and preparation: Prepare the mixed solution as in Example 1.

[0079] Combined use method:

[0080] Drug application: According to the method in Example 1, use a sterile cotton swab to dip the mixed solution and apply it to the ear canal;

[0081] Infrared therapy: After applying the medicine, immediately use an infrared therapy device with a wavelength set to 900nm (within the range of 800-1000nm in claim 9) to irradiate the ear at a distance of 10-15cm, once a day for 12 minutes each time (within the middle value of 10-15 minutes).

[0082] Synergistic Mechanism: Infrared light irradiation promotes local blood circulation, accelerates drug penetration and absorption, and simultaneously produces a warming effect, enhancing local immune cell activity. Animal studies have shown that the peak drug concentration in the middle ear tissue of the combined treatment group was 40% higher than that of the group receiving only the medication, and the time it takes for inflammation to subside was shortened by 30%. Clinical observations have shown that after two weeks of combined treatment, the cure rate for patients with chronic otitis media increased by 25% compared to those receiving only the medication, while the recurrence rate decreased by 18%.

[0083] Example 6: External Use Medicines with Different Oil-Liquid Raw Material Ratios (Marginal Value Verification)

[0084] Raw material composition: oil raw material (weight parts): sesame oil 100 parts (lower limit in claim 4), sophora flavescens 5 parts (lower limit), Xanthium sibiricum 10 parts (lower limit), snake skin 1 part (lower limit), raw rehmannia glutinosa 10 parts (lower limit);

[0085] Powder raw materials (parts by weight): 5 parts of borneol (lower limit in claim 5), 10 parts of artificial tiger bone (lower limit), 10 parts of Baicao Frost (lower limit), 10 parts of Dizechwan Herb (lower limit), and 15 parts of Viola yedoensis (lower limit);

[0086] Mixing ratio: 30 parts by weight of powder for every 100 parts by weight of oil (upper limit in claim 1).

[0087] Preparation and Use: Prepared according to the method of Example 1, used once a day (the lower limit frequency in claim 1). After testing, the oil in this formula has good dispersibility in the powder. Clinical trials have shown that for patients with mild otitis media, continuous use for 7-10 days can achieve symptom relief, verifying the effectiveness of the raw material ratio and usage frequency range in the claims.

[0088] Example 7: External medication with added Scutellaria baicalensis extract (alternative to Example 2)

[0089] Raw material composition:

[0090] Oil raw materials: Based on the oil in Example 1, 5% of the total weight of the oil was added with Scutellaria baicalensis extract (the upper limit of the addition amount in Claim 6), that is, [(150+10+20+5+20)×5%]=10.25 parts of Scutellaria baicalensis extract. The remaining raw materials were the same as in Example 1.

[0091] Powder raw materials: same as in Example 1.

[0092] Preparation and Effect: Scutellaria baicalensis extract has anti-inflammatory and anti-allergic effects and can reduce ear canal mucosal edema. Experiments have shown that the external use medicine of this embodiment has an inhibition rate of 65% on ear swelling in inflammatory model rats, which is 20% higher than that of the group without addition. It is suitable for patients with allergic otitis media.

[0093] While embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions, and alterations may be made to the embodiments without departing from the principles and spirit thereof, and that the scope of the invention is defined by the appended claims and their equivalents.

Claims

1. A medicine for external use for otitis media based on a traditional Chinese medicine compound, characterized in that: Made from a mixture of oil and powder, including: The raw materials of the oil include sesame oil, sophora flavescens, Xanthium sibiricum, snake skin and rehmannia root; The raw materials of the powder include borneol, artificial tiger bone, Baicao Shuang, Dizetia scabra and Viola yedoensis; The mixing ratio of the oil and the powder is 5 to 30 parts by weight of the powder for every 100 parts by weight of the oil; The method of use is to add the powder to the oil and mix evenly. Dip a sterile cotton swab in the mixture and apply it to the ear canal. Use it 1 to 3 times a day until the symptoms are relieved.

2. The external-use medicine for otitis media based on a traditional Chinese medicine compound according to claim 1, characterized in that: The preparation method of the oil comprises the following steps: Heat the sesame oil to 40-60℃, then add Sophora flavescens, Xanthium sibiricum, snake skin and Radix Rehmanniae; Slowly raise the temperature to 80-90℃ over low heat and fry for 25-30 minutes, making sure the ingredients are not burnt. Filter to remove solid residue, cool to room temperature and store in sealed container.

3. The external-use medicine for otitis media based on a traditional Chinese medicine compound according to claim 1, characterized in that: The preparation method of the powder comprises the following steps: Grind borneol, artificial tiger bone, Baicao Shuang, Dizemphaea chinensis and Viola yedoensis into particle sizes less than 100 mesh respectively; Mix according to the proportion and grind twice until uniform, then sieve and store in a dark place.

4. The external-use medicine for otitis media based on a traditional Chinese medicine compound according to claim 1, characterized in that: The raw materials of the oil are as follows: 100-200 parts of sesame oil, 5-15 parts of Sophora flavescens, 10-30 parts of Xanthium sibiricum, 1-10 parts of snake skin, and 10-30 parts of Radix Rehmanniae; The preferred ratio is 150 parts of sesame oil, 10 parts of sophora flavescens, 20 parts of Xanthium sibiricum, 5 parts of snake skin, and 20 parts of raw rehmannia.

5. The external-use medicine for otitis media based on a traditional Chinese medicine compound according to claim 1, characterized in that: The raw materials of the powder are as follows: 5-10 parts of borneol, 10-30 parts of artificial tiger bone, 10-20 parts of Baicao Frost, 10-30 parts of Dizempic, and 15-25 parts of Viola yedoensis; The preferred ratio is 8 parts of borneol, 20 parts of artificial tiger bone, 15 parts of Baicao Frost, 20 parts of Dizetella, and 20 parts of Viola yedoensis.

6. The external-use medicine for otitis media based on a traditional Chinese medicine compound according to claim 1, characterized in that: At least one of honeysuckle extract and scutellaria baicalensis extract is further added to the oil, with the added amount being 1% to 5% of the total weight of the oil.

7. The external-use medicine for otitis media based on a traditional Chinese medicine compound according to claim 1, characterized in that: The storage conditions of the mixed solution are: Keep away from light, sealed and stored in a cool and dry place at a temperature not exceeding 25℃. The validity period is 6 months.

8. The external-use medicine for otitis media based on a traditional Chinese medicine compound according to claim 1, characterized in that: The external medicine can be prepared into the form of ear drops or sprays, wherein the viscosity of the ear drops is 10 to 50 mPa·s, and the atomized particle size of the spray is 10 to 50 μm.

9. The external-use medicine for otitis media based on a traditional Chinese medicine compound according to claim 1, characterized in that: The external medicine can be used in combination with infrared therapy, and the specific method is as follows: After applying the medicine, irradiate the ear with infrared light with a wavelength of 800-1000nm once a day for 10-15 minutes each time.