Plant-based pet ear drops with effects of diminishing inflammation and relieving itching and preparation method of plant-based pet ear drops

Abstract

The invention relates to plant-based pet ear drops with effects of diminishing inflammation and relieving itching and a preparation method of the plant-based pet ear drops, and belongs to the technical field of veterinary drugs. The invention discloses plant-based pet ear drops. The plant-based pet ear drops are prepared from, by mass, comprising 6%-8% of a tea tree extract, 6%-8% of a witch hazel extract, 6%-8% of a chamomile extract, 6%-8% of a soybean extract, 2%-6% of a lithospermum extract, 2%-6% of a centella asiatica extract, 2%-6% of a mint extract, 2%-6% of a licorice extract, 4%-6% of a humectant, 0.1%-0.5% of a preservative, 0.1%-0.5% of a conditioning agent and the balance of water. Through reasonable matching of various plant extracts, the ear drops have broad-spectrum antibacterial, anti-inflammatory, soothing and repairing effects, and can effectively deal with various common problems of pet ears, such as bacterial infection, fungal infection, allergic dermatitis, ear mite expelling and the like. The pet ear canal cleaner can also be used for cleaning and nursing pet ear canals, is mild in performance, and can effectively remove dirt, dust and wax in the ear canals.

Description

Technical Field

[0001] The present invention belongs to the technical field of veterinary drugs, and particularly relates to a plant-based pet ear drops with anti-inflammatory and antipruritic effects and a preparation method thereof. Background Art

[0002] In the field of pet health, ear diseases are one of the common problems of pets such as dogs and cats, with a relatively high incidence rate and being prone to recurrence. Pet ear diseases mainly include otitis externa, otitis media, and otitis interna, among which otitis externa is the most common, mainly manifested as symptoms such as ear itching, swelling, and increased secretions. These symptoms not only affect the quality of life of pets but may also lead to further complications, such as otitis media and otitis interna. The causes of pet ear diseases are complex and diverse, including bacteria, fungi, parasites (such as ear mites), allergic reactions, and mechanical injuries. In addition, the special anatomical structure of the pet ear canal (such as the ear canals of dogs and cats being "L"-shaped) makes the humidity in the ear canal relatively high and the temperature suitable, providing a good environment for the growth of pathogenic microorganisms, further exacerbating the incidence rate and recurrence rate of ear diseases.

[0003] Currently, the drugs clinically used to treat pet ear diseases mainly include external medicaments such as antibiotics, antifungal agents, insecticides, and adrenal corticosteroids. However, there are many problems in the actual application of these traditional drugs. First, the long-term use of antibiotics and antifungal drugs is likely to lead to the generation of pathogen drug resistance, resulting in a gradual decline in the treatment effect and increasing the treatment difficulty. Second, some drugs such as aminoglycoside antibiotics have ototoxicity and may damage the hearing of pets, while some antifungal drugs may cause gastrointestinal reactions or other adverse reactions. In addition, the dosage forms of many drugs are not ideal. For example, ear ointments have poor fluidity, are difficult to evenly cover the deep and surface of the ear canal, and the dosage is difficult to control, easily soiling the pet's hair and bringing inconvenience to the pet owner for cleaning. While some imported liquid ear drops have better fluidity, they have problems such as insufficient stability and incomplete drug efficacy. The existence of these problems makes the existing drugs for treating pet ear diseases difficult to meet the needs of pet owners for safe, effective, and convenient drugs.

[0004] In recent years, with the continuous in-depth research on natural plant extracts, many plant components have been found to have good pharmacological activities, such as antibacterial, anti-inflammatory, and antipruritic effects. Compared with chemically synthesized drugs, plant extracts usually have higher safety, lower toxic and side effects, and are not easily resistant. For example, monoterpenoid compounds in some plant extracts have a cooling sensation and certain analgesic, anti-inflammatory, and antibacterial effects, and can be used as topical antipruritic agents. In addition, some plant extracts also have immunomodulatory effects, which help to enhance the pet's own immunity and thus better resist diseases. Therefore, the development of pet ear drops based on plant extracts can not only meet the needs of pet owners for safe, effective, and natural drugs, but also is expected to provide a new option for the treatment of pet ear diseases.

[0005] Although there are already some pet ear drop products on the market, the research and development of plant-based ear drops with anti-inflammatory and antipruritic effects are still relatively few. At present, there is no relevant report on effectively combining a variety of plant extracts with synergistic effects and preparing them into a stable, highly effective, and easy-to-use ear drop product. Therefore, the development of a pet ear drop with plant extracts as the main component, which has significant effects in anti-inflammatory, antipruritic, antibacterial, and antifungal aspects through reasonable compatibility and optimized preparation processes, and at the same time has good stability and safety, has important practical significance for meeting the clinical treatment needs of pets and improving the health level of pets. Summary of the Invention

[0006] To solve the above technical problems, the present invention provides a plant-based pet ear drop with anti-inflammatory and antipruritic effects and its preparation method. The plant-based pet ear drop uses natural plant extracts, can quickly relieve pet ear inflammation, has a significant antipruritic effect, and has no irritation to the pet ear skin.

[0007] The first object of the present invention is to provide a plant-based pet ear drop with anti-inflammatory and antipruritic effects. The plant-based pet ear drop with anti-inflammatory and antipruritic effects, calculated by mass fraction, includes: 6%-8% of tea tree extract, 6%-8% of witch hazel extract, 6%-8% of chamomile extract, 6%-8% of soybean extract, 2%-6% of lithospermum extract, 2%-6% of centella asiatica extract, 2%-6% of mint extract, 2%-6% of licorice extract, 4%-6% of humectant, 0.1%-0.5% of preservative, 0.1%-0.5% of regulator, and the balance is water.

[0008] In one embodiment of the present invention, the tea tree extract contains components such as α-eudesmol, γ-eudesmol, linalool, etc., and has antibacterial, anti-inflammatory, antioxidant and other effects. It can effectively inhibit the growth of bacteria and fungi causing ear infections and reduce the inflammatory response. The witch hazel extract contains components such as tannins, hyperin, quercetin, etc., and has astringent, anti-inflammatory, antibacterial and other effects. It can reduce the secretions of the ear skin, relieve inflammation and itching, and keep the ear skin clean and dry. The chamomile extract contains components such as chamazulene, matricin, quercetin, isorhamnetin, etc., and has anti-inflammatory, soothing, sedative and other effects. It can effectively relieve the allergic reaction and itching of the ear skin, and promote the repair and regeneration of damaged skin. The soybean extract contains components such as vitamin E, soy isoflavones, soy saponins, etc., and has antioxidant, moisturizing, anti-inflammatory and other effects. It can enhance the immunity of the ear skin, keep the skin hydrated, prevent skin dryness and cracking, and provide a good nutritional environment for the ear skin. The lithospermum extract contains components such as allantoin, shikonin, hydroxyshikonin, acetylshikonin, etc., and has the effects of clearing heat and cooling blood, activating blood circulation and detoxifying, and promoting eruption. It can effectively improve the blood circulation of the ear skin, promote the subsidence of inflammation, and also has a certain therapeutic effect on ear eczema, scalds and burns, etc. The centella asiatica extract contains various terpene compounds, umbelliferone, p-hydroxyacetophenone, etc., and has the effects of clearing heat and promoting diuresis, activating blood circulation and detumescence. It can effectively remove the moisture of the ear skin, reduce inflammation and swelling, and promote the repair and regeneration of the ear skin. The mint extract contains components such as menthone, menthol, etc., and has a cool feeling, and also has certain anti-itching, anti-inflammatory and antibacterial effects. It can relieve the itching and burning sensation of the ear skin, bring a cool and comfortable feeling to the ear, and at the same time help to inhibit the growth of bacteria and fungi. The licorice extract contains components such as glycyrrhizin, liquiritin, isoliquiritin, etc., and has the effects of clearing heat and detoxifying, relieving spasm and pain, and coordinating various medicines. It can effectively relieve the inflammation and pain of the ear skin and reduce discomfort symptoms such as itching.

[0009] In one embodiment of the present invention, the humectant includes glycerol and hyaluronic acid; glycerol has good hygroscopicity and can form a moisturizing film in the ear canal to prevent the ear canal from being overly dry, providing continuous moisture replenishment for the ear skin; in addition, glycerol has a mild nature and has a soothing effect on the ear skin, capable of relieving ear itching and swelling caused by reasons such as inflammation and allergy. Hyaluronic acid is an efficient moisturizing ingredient that can lock in a large amount of moisture, enhance the moisture content of the ear canal, keep the ear skin soft and elastic, and reduce itching and discomfort caused by dryness; in addition, hyaluronic acid has certain biological activity, can promote the repair and regeneration of ear skin cells, accelerate the healing process of damaged skin, help reduce ear inflammation, and improve the health condition of the ear skin; furthermore, hyaluronic acid can increase the viscosity of the ear drops, reduce their fluidity, extend the residence time of the drug components in the ear canal, thereby improving the utilization rate and efficacy of the drug; in addition, hyaluronic acid can also soften earwax, reduce the blockage of earwax to the drug, and make the drug more easily penetrate into the deep layer of the ear skin to play a better therapeutic role.

[0010] In one embodiment of the present invention, the mass ratio of glycerol to hyaluronic acid is (7 - 5):1. When used in combination, they can not only adjust the moisturizing performance of hyaluronic acid through glycerol to make the moisturizing effect more lasting and stable, but also improve the usage feeling of glycerol through hyaluronic acid, make the ear drops more evenly distributed in the ear canal, reduce the greasiness brought by glycerol, and improve the tolerance and acceptance of pets to the ear drops.

[0011] In one embodiment of the present invention, the hyaluronic acid is obtained by mixing high-molecular-weight hyaluronic acid, medium-molecular-weight hyaluronic acid, and low-molecular-weight hyaluronic acid; the molecular weight of the high-molecular-weight hyaluronic acid is 280 kDa - 300 kDa, and the network structure formed by it can lock in a large amount of moisture, like forming a moisturizing film on the skin surface, reducing water evaporation, playing a long-term moisturizing role, and at the same time can form a protective layer in the ear canal to prevent damage to the ear canal caused by external stimuli; the molecular weight of the medium-molecular-weight hyaluronic acid is 80 kDa - 100 kDa, which has good moisturizing and permeability properties, can be quickly absorbed by the ear canal skin to replenish moisture for the skin, and at the same time can also play a certain repair role to enhance the barrier function of the skin; the molecular weight of the low-molecular-weight hyaluronic acid is 10 kDa - 20 kDa, with good permeability, can quickly penetrate into the deep layer of the skin, provide deep moisturizing and nutrition for skin cells, promote the metabolism of skin cells, and enhance the repair ability of the skin.

[0012] In one embodiment of the present invention, the mass ratio of the high-molecular-weight hyaluronic acid, medium-molecular-weight hyaluronic acid, and low-molecular-weight hyaluronic acid is (5 - 7):(2 - 4):(1 - 3); the high-molecular-weight hyaluronic acid can provide long-lasting moisturizing and protective effects, while the medium-molecular-weight and low-molecular-weight hyaluronic acids can quickly replenish moisture and penetrate deep into the skin. The three work synergistically to achieve better moisturizing and repair effects.

[0013] In one embodiment of the present invention, the preservative is selected from phenoxyethanol and / or potassium sorbate.

[0014] In one embodiment of the present invention, the regulator is selected from citric acid and / or sodium hydroxide.

[0015] In one embodiment of the present invention, the pH of the plant-based pet ear drops with anti-inflammatory and antipruritic effects is 6.5 - 7.5.

[0016] The second object of the present invention is to provide a preparation method of the plant-based pet ear drops with anti-inflammatory and antipruritic effects, comprising the following steps:

[0017] S1. Dissolve the humectant in water to obtain a humectant solution.

[0018] S2. Add tea tree extract, witch hazel extract, chamomile extract, soybean extract, lithospermum extract, centella asiatica extract, mint extract, and licorice extract to the humectant solution obtained in S1 and stir evenly to obtain a mixture.

[0019] S3. Add the preservative and the regulator to the mixture obtained in S2 and stir evenly to obtain the plant-based pet ear drops with anti-inflammatory and antipruritic effects.

[0020] In one embodiment of the present invention, during the preparation process, the temperature is maintained at 40°C - 60°C.

[0021] The technical solution of the present invention has the following advantages compared with the prior art:

[0022] (1) The main components of the tea tree extract in the plant-based pet ear drops of the present invention are monoterpenes and sesquiterpenoids such as terpenes and alcohols, which have antibacterial activity, can destroy the bacterial cell membrane structure, increase its permeability, interfere with the normal metabolism of bacteria, and thus inhibit or kill bacteria. The witch hazel extract is rich in tannin compounds such as gallic acid and witch hazelin, and also has antibacterial effects. It can act together with the tea tree extract to enhance the inhibitory effect on bacteria. The combination of the two can also expand the antibacterial spectrum and produce a better inhibitory effect on a variety of bacteria. In addition, the antibacterial effect of the tea tree extract can reduce inflammation caused by bacterial infection, and cooperate with the anti-inflammatory components such as chamomile extract to better relieve the inflammatory symptoms.

[0023] (2) Components such as matricin in the chamomile extract in the plant-based pet ear drops of the present invention can inhibit the generation of inflammatory mediators and play an anti-inflammatory role. Components such as asiaticoside in the centella asiatica extract have an inhibitory effect on inflammatory cells, can reduce the infiltration and aggregation of inflammatory cells. The two work synergistically to more effectively reduce the inflammatory response. At the same time, the chamomile extract has a soothing and sedative effect, can relieve itching and discomfort caused by inflammation, and the centella asiatica extract also has a similar effect, which can further enhance the antipruritic effect.

[0024] (3) Components such as shikonin in the lithospermum erythrorhizon extract in the plant-based pet ear drops of the present invention have anti-inflammatory, antibacterial and other effects, can inhibit the production of inflammatory factors, and relieve symptoms such as swelling, redness, heat and pain at the inflammatory site. Components such as glycyrrhizic acid in the licorice extract also have anti-inflammatory, anti-allergic and other effects, can inhibit the activation of immune cells and the release of inflammatory mediators in the inflammatory response. The two are combined to enhance the anti-inflammatory effect and relieve itching and discomfort caused by ear inflammation.

[0025] (4) While the tea tree extract in the plant-based pet ear drops of the present invention plays an antibacterial and anti-inflammatory role, its oil components can form a protective film with glycerin on the surface of the ear canal skin, lock in moisture, enhance the moisturizing effect, maintain the moist state of the ear canal skin, and help promote the repair and regeneration of the ear canal skin. The nutritional components in the chamomile extract can be absorbed by the ear canal skin, provide nutrition for skin cells, promote skin metabolism, and enhance skin immunity and repair ability. Hyaluronic acid is a highly efficient moisturizing component, can form a transparent gel layer on the surface of the ear canal skin, lock in a large amount of moisture, and keep the skin moist and soft. The synergistic effect of the chamomile extract and hyaluronic acid can not only provide nutrition for the ear canal skin, but also maintain the moist environment of the skin, which is beneficial to the health and recovery of the ear canal skin.

[0026] (5) The reasonable combination of various plant extracts in the plant-based pet ear drops of the present invention enables the ear drops to have broad-spectrum antibacterial, anti-inflammatory, soothing and repair effects, can effectively deal with various common problems of pet ears, such as bacterial infection, fungal infection, allergic dermatitis, expelling ear mites, etc. It can also be used to clean and care for the pet ear canal, with mild performance, and can effectively remove dirt, dust and wax in the ear canal. Detailed Embodiments

[0027] The present invention will be further described below in conjunction with specific embodiments, so that those skilled in the art can better understand the present invention and be able to implement it. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. It should be understood that the specific embodiments are only used to explain the present invention, but the exemplified embodiments do not limit the present invention.

[0028] In the present invention, unless otherwise specified, the molecular weight of the high molecular weight hyaluronic acid used in the embodiments of the present invention is about 290 kDa, the molecular weight of the medium molecular weight hyaluronic acid is about 90 kDa, and the molecular weight of the low molecular weight hyaluronic acid is about 15 kDa.

[0029] Example 1

[0030] The plant-based pet ear drops with anti-inflammatory and antipruritic effects in this example, by mass fraction, include: 7% tea tree extract, 7% witch hazel extract, 7% chamomile extract, 7% soybean extract, 4% lithospermum extract, 4% asiatic pennywort extract, 4% mint extract, 4% licorice extract, 6% humectant, 0.3% preservative, 0.3% regulator, and the balance is water;

[0031] The humectant is obtained by mixing glycerol and hyaluronic acid in a mass ratio of 5:1; the hyaluronic acid is obtained by mixing high molecular weight hyaluronic acid, medium molecular weight hyaluronic acid, and low molecular weight hyaluronic acid in a mass ratio of 6:3:2;

[0032] The preservative is obtained by mixing phenoxyethanol and potassium sorbate in a mass ratio of 1:1;

[0033] The regulator is citric acid and sodium hydroxide, and the specific dosage is adjusted to a pH of about 7.

[0034] The preparation of the plant-based pet ear drops with anti-inflammatory and antipruritic effects specifically includes the following steps:

[0035] S1. Heat deionized water to 50 °C, add the humectant, and stir until completely dissolved to obtain a humectant solution;

[0036] S2. Add the tea tree extract, witch hazel extract, chamomile extract, soybean extract, lithospermum extract, asiatic pennywort extract, mint extract, and licorice extract to the humectant solution, stir evenly to ensure that the extracts are completely dissolved, and obtain a mixed solution;

[0037] S3. During stirring, slowly add the preservative and the regulator to the mixed solution, adjust the pH to about 7, continue stirring until completely dissolved, then cool to room temperature, filter to remove impurities, and fill into an ear drop bottle to obtain the plant-based pet ear drops with anti-inflammatory and antipruritic effects.

[0038] Example 2

[0039] Basically the same as Example 1, the difference lies in the composition of the plant-based pet ear drops with anti-inflammatory and antipruritic effects by mass fraction:

[0040] 6% tea tree extract, 8% witch hazel extract, 6% chamomile extract, 8% soybean extract, 2% lithospermum extract, 6% asiatic pennywort extract, 2% mint extract, 6% licorice extract, 6% humectant, 0.1% preservative, 0.5% regulator, the balance being water;

[0041] The humectant is obtained by mixing glycerol and hyaluronic acid in a mass ratio of 5:1; the hyaluronic acid is obtained by mixing high-molecular-weight hyaluronic acid, medium-molecular-weight hyaluronic acid and low-molecular-weight hyaluronic acid in a mass ratio of 6:3:2;

[0042] The preservative is phenoxyethanol;

[0043] The regulator is citric acid and sodium hydroxide.

[0044] Example 3

[0045] Basically the same as Example 1, the difference lies in the composition of the plant-based pet ear drops with anti-inflammatory and antipruritic effects:

[0046] 8% tea tree extract, 6% witch hazel extract, 8% chamomile extract, 6% soybean extract, 6% lithospermum extract, 2% asiatic pennywort extract, 6% mint extract, 2% licorice extract, 6% humectant, 0.5% preservative, 0.1% regulator, the balance being water;

[0047] The humectant is obtained by mixing glycerol and hyaluronic acid in a mass ratio of 5:1; the hyaluronic acid is obtained by mixing high-molecular-weight hyaluronic acid, medium-molecular-weight hyaluronic acid and low-molecular-weight hyaluronic acid in a mass ratio of 6:3:2;

[0048] The preservative is potassium sorbate;

[0049] The regulator is citric acid and sodium hydroxide.

[0050] Comparative Example 1

[0051] Basically the same as Example 1, the difference lies in the composition of the plant-based pet ear drops with anti-inflammatory and antipruritic effects: no tea tree extract is added.

[0052] Comparative Example 2

[0053] Basically the same as Example 1, the difference lies in the composition of the plant-based pet ear drops with anti-inflammatory and antipruritic effects: no chamomile extract is added.

[0054] Comparative Example 3

[0055] Basically the same as Example 1, the difference lies in the composition of the plant-based pet ear drops with anti-inflammatory and antipruritic effects: no lithospermum extract is added.

[0056] Comparative Example 4

[0057] Basically the same as Example 1, the difference lies in the composition of the plant-based pet ear drops with anti-inflammatory and antipruritic effects: both high-molecular-weight hyaluronic acid and low-molecular-weight hyaluronic acid are replaced with medium-molecular-weight hyaluronic acid.

[0058] Comparative Example 5

[0059] Basically the same as Example 1, the difference lies in the composition of the plant-based pet ear drops with anti-inflammatory and antipruritic effects: no hyaluronic acid is added.

[0060] Test Example 1 Skin Irritation Test

[0061] Take 30 BALB / c mice and divide them into 3 groups. Depilate the areas on both sides of the spine on the back, and the depilated area is about 10 cm 2 . After washing the depilated area 24 hours later, apply 0.8 mL of the plant-based pet ear drops with anti-inflammatory and antipruritic effects of Examples 1-3 to the depilated area twice a day for one week. After the experiment, sacrifice the BALB / c mice, and perform pathological examinations on the heart, liver, kidneys and depilated skin. The results show that in the depilated area of the BALB / c mouse trunk, there is no local skin edema, congestion, erythema, bleeding points or ulcers; and there is no abnormality in the hair color, food intake, limb movement, etc. of the BALB / c mice; pathological histological examination shows that there is no abnormality in the heart, liver, kidneys and depilated skin of the BALB / c mice. It shows that the plant-based pet ear drops with anti-inflammatory and antipruritic effects of the present invention have no local irritation effect and no systemic toxicity manifestation.

[0062] Test Example 2 Bacteriostatic Experiment

[0063] Select Staphylococcus aureus ATCC 6538, Escherichia coli ATCC 8739, and Candida albicans ATCC 10231 commonly found in pet ears as strains. The specific method is as follows:

[0064] (1) Prepare the experimental bacterial suspension with a concentration of 1×10 8 cfu / mL - 5×10 8 cfu / mL;

[0065] (2) Take a sterile large test tube for disinfection test, first add 0.5 mL of the experimental bacterial suspension, then add 0.5 mL of the organic interfering substance, mix well, place it in a water bath at 20°C ± 1°C for 5 minutes, and then use a sterile pipette to suck 4.0 mL of the above-mentioned concentration of disinfectant and inject it into it, mix well and record the time;

[0066] (3) Wait until the test bacteria and the plant-based pet ear drops interact for each predetermined time, and respectively suck 0.5 mL of the mixture of the test bacteria and the plant-based pet ear drops and add it to 4.5 mL of the sterilized neutralizer, and mix well;

[0067] (4) After each tube of the test bacteria and the plant-based pet ear drops mixture is treated with a neutralizer for 10 minutes, 1.0 mL of the sample solution is respectively taken, and the number of surviving bacteria is determined by the viable bacteria culture counting method. It is sufficient to inoculate 2 petri dishes with each tube of the sample solution; if there are a large number of colonies growing on the petri dish, serial 10-fold dilutions can be carried out and then viable bacteria culture counting can be performed;

[0068] (5) At the same time, use the dilution solution to replace the disinfectant and conduct a parallel test as a positive control;

[0069] (6) All test samples are cultured in an incubator at 37°C. Observe the final results after culturing the vegetative bacteria for 48 hours; observe the final results after culturing the bacterial spores for 72 hours;

[0070] (7) The test is repeated 3 times, calculate the number of viable bacteria in each group, and then calculate the bacteriostatic rate according to the following formula: Bacteriostatic rate = (number of viable bacteria in the control group - number of viable bacteria in the test group) / number of viable bacteria in the control group × 100%;

[0071] Table 1 shows the relevant data finally measured:

[0072] Table 1

[0073]

[0074]

[0075] As can be seen from Table 1, the bacteriostatic rates of the plant-based pet ear drops in the examples against Staphylococcus aureus, Escherichia coli, and Candida albicans all reached 99.99%, indicating that the ear drops have extremely strong antibacterial ability and can effectively inhibit the growth of common pathogenic bacteria.

[0076] By comparing Example 1 and Comparative Example 1, it can be seen that after the tea tree extract is not added, the bacteriostatic rate decreases significantly. In particular, the bacteriostatic rates against Staphylococcus aureus and Escherichia coli decreased by 4.76% and 5.44% respectively. This indicates that the tea tree extract plays an important role in antibacterial, and its components such as α-eudesmol and γ-eudesmol have significant inhibitory effects on bacteria and fungi.

[0077] By comparing Example 1 and Comparative Example 2, it can be seen that after the chamomile extract is not added, the bacteriostatic rate also decreases, but the decrease amplitude is relatively small. Although the chamomile extract also has a certain effect on antibacterial, its main efficacy is anti-inflammatory and soothing, so its impact on the bacteriostatic rate is not as significant as that of the tea tree extract.

[0078] By comparing Example 1 and Comparative Example 3, it can be seen that after the lithospermum extract is not added, the bacteriostatic rate decreases slightly, but still remains at a relatively high level overall. The lithospermum extract plays a relatively small role in antibacterial, but its efficacy of clearing heat and cooling blood, promoting blood circulation and detoxicating still makes a certain contribution to the synergistic effect of the overall formula.

[0079] Comparing Example 1 and Comparative Example 4, it can be seen that after replacing high-molecular-weight hyaluronic acid and low-molecular-weight hyaluronic acid with medium-molecular-weight hyaluronic acid, the antibacterial rate decreased, but still remained at a relatively high level. This indicates that the molecular weight distribution of hyaluronic acid has a certain impact on the antibacterial effect, and high-molecular-weight hyaluronic acid may enhance the stability of antibacterial components through the protective film formed by it.

[0080] Comparing Example 1 and Comparative Example 5, it can be seen that after not adding hyaluronic acid, the antibacterial rate decreased significantly. This may be because hyaluronic acid not only has a moisturizing effect, but also can enhance the synergistic effect of other components, improve the viscosity and stability of the ear drops, thereby enhancing the antibacterial effect.

[0081] Test Example 3 Animal Experiment

[0082] Test pets: 90 dogs (half male and half female) were all diagnosed with otitis media.

[0083] Diagnostic criteria: Effusion in the tympanic cavity can be seen by X-ray examination, tympanic membrane perforation and middle ear pus can be seen by otoscope examination.

[0084] Clinical symptoms: The external ear canals of the pets were flushing, edematous and itchy, and light yellow serous secretions flowed out from the ear canals, soiling the hair on the lower part of the ears. They showed restlessness, shook their heads and scratched their ears.

[0085] Test grouping and treatment method: The drug group (8 groups) was given 2 drops of the ear drops of the present invention, once in the morning and once in the evening every day for one week continuously; the control group (1 group) was given 2 drops of medical glycerol, once in the morning and once in the evening every day for one week continuously.

[0086] Observe the symptom recovery situation and adverse reactions during the process of each group of cases. Each pet was separately raised in a pet cage, fed and watered freely, and the recovery situation was recorded every day. The test results are shown in Table 2:

[0087] Table 2

[0088] Group 1d 2d 3d 4d 5d 6d 7d Adverse reaction Example 1 Relieve Alleviate Alleviate Recover / / / None Example 2 Relieve Alleviate Alleviate Recover / / / None Example 3 Relieve Alleviate Alleviate Recover / / / None Comparative Example 1 Relieve Alleviate Alleviate Alleviate Alleviate Alleviate Recover None Comparative Example 2 Relieve Alleviate Alleviate Alleviate Alleviate Alleviate Recover None Comparative Example 3 Relieve Alleviate Alleviate Alleviate Alleviate Alleviate Recover None Comparative Example 4 Relieve Alleviate Alleviate Alleviate Alleviate Alleviate Recover None Comparative Example 5 Relieve Alleviate Alleviate Alleviate Alleviate Alleviate Recover None

[0089] As can be seen from Table 2, the plant-based pet ear drops of the examples showed excellent performance in treating pet otitis media, all achieved recovery on the 4th day, and no adverse reactions occurred. This indicates that the ear drops have a rapid treatment effect and good safety.

[0090] Comparing Example 1 and Comparative Examples 1-3, it can be seen that after not adding tea tree extract, chamomile extract or lithospermum extract, the treatment cycle was prolonged and the recovery time was postponed to the 7th day. This shows that these plant extracts have a synergistic effect in the formula and can accelerate the remission of inflammation and the repair of ear skin.

[0091] Comparing Example 1 and Comparative Example 4, it can be seen that after replacing with medium molecular weight hyaluronic acid, the treatment period is also extended, and the healing time is postponed to the 7th day. This further confirms the influence of the molecular weight distribution of hyaluronic acid on the treatment effect. The synergistic effect of high molecular weight and low molecular weight hyaluronic acid is crucial for maintaining the stability of the ear drops and the effectiveness of the drug components.

[0092] Comparing Example 1 and Comparative Example 5, it can be seen that after not adding hyaluronic acid, the treatment period is also extended, and the healing time is postponed to the 7th day. Hyaluronic acid not only has a moisturizing effect, but also can enhance the synergistic effect of other components, improve the viscosity and stability of the ear drops, thereby improving the treatment effect.

[0093] Obviously, the above examples are only for illustration and are not intended to limit the implementation methods. For those of ordinary skill in the art, other different forms of changes or variations can be made based on the above description. It is not necessary and impossible to list all implementation methods here. And the obvious changes or variations derived therefrom are still within the protection scope of the present invention.

Claims

1. A plant-based pet ear drops with anti-inflammatory and antipruritic effects, characterized in that, The plant-based pet ear drops with anti-inflammatory and antipruritic effects, by mass fraction, include: 6%-8% of tea tree extract, 6%-8% of witch hazel extract, 6%-8% of chamomile extract, 6%-8% of soybean extract, 2%-6% of lithospermum extract, 2%-6% of centella asiatica extract, 2%-6% of mint extract, 2%-6% of licorice extract, 4%-6% of humectant, 0.1%-0.5% of preservative, 0.1%-0.5% of regulator, and the balance is water.

2. The plant-based pet ear drops with anti-inflammatory and antipruritic effects according to claim 1, characterized in that, The humectant includes glycerol and hyaluronic acid.

3. The plant-based pet ear drops with anti-inflammatory and antipruritic effects according to claim 2, characterized in that, The mass ratio of the glycerol to the hyaluronic acid is (7-5):

1.

4. The plant-based pet ear drops with anti-inflammatory and antipruritic effects according to claim 2, characterized in that, The hyaluronic acid is obtained by mixing high-molecular-weight hyaluronic acid, medium-molecular-weight hyaluronic acid, and low-molecular-weight hyaluronic acid; the molecular weight of the high-molecular-weight hyaluronic acid is 280 kDa - 300 kDa, the molecular weight of the medium-molecular-weight hyaluronic acid is 80 kDa - 100 kDa, and the molecular weight of the low-molecular-weight hyaluronic acid is 10 kDa - 20 kDa.

5. The plant-based pet ear drops with anti-inflammatory and antipruritic effects according to claim 4, characterized in that, The mass ratio of the high-molecular-weight hyaluronic acid, medium-molecular-weight hyaluronic acid, and low-molecular-weight hyaluronic acid is (5-7):(2-4):(1-3).

6. The plant-based pet ear drops with anti-inflammatory and antipruritic effects according to claim 1, characterized in that, The preservative is selected from phenoxyethanol and / or potassium sorbate.

7. The plant-based pet ear drops with anti-inflammatory and antipruritic effects according to claim 1, characterized in that, The regulator is selected from citric acid and / or sodium hydroxide.

8. The plant-based pet ear drops with anti-inflammatory and antipruritic effects according to claim 1, characterized in that, The pH of the plant-based pet ear drops with anti-inflammatory and antipruritic effects is 6.5 - 7.

5.

9. The preparation method of the plant-based pet ear drops with anti-inflammatory and antipruritic effects according to any one of claims 1-8, characterized in that, It includes the following steps: S1. Dissolve the humectant in water to obtain a humectant solution. S2. Add tea tree extract, witch hazel extract, chamomile extract, soybean extract, lithospermum extract, centella asiatica extract, mint extract, and licorice extract to the humectant solution obtained in S1 and stir evenly to obtain a mixture. S3. Add the preservative and the regulator to the mixture obtained in S2 and stir evenly to obtain the plant-based pet ear drops with anti-inflammatory and antipruritic effects.

10. The plant-based pet ear drops with anti-inflammatory and antipruritic effects according to claim 9, characterized in that, During the preparation process, keep the temperature at 40°C - 60°C.

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