Antiallergic soft chewable tablet for dogs and preparation method thereof

Abstract

The present invention provides an anti-allergic soft chewable tablet for dogs and a preparation method thereof, wherein the components thereof are composed of active ingredients, adhesives, wetting agents, flavoring agents, preservatives, lubricants and fillers, wherein the active ingredients include psoralea corylifolia extract, linseed oil microcapsule powder, vitamin E acetate, dimethyl sulfone, bromelain and sodium hyaluronate. The anti-allergic soft chewable tablet for dogs provided by the present invention uses a plurality of ingredients to synergistically act, and takes a multi-pronged approach from the aspects of anti-inflammation, anti-oxidation, skin hydration and improving immunity to improve and prevent the allergic symptoms of dogs. The tablets prepared by the present invention have a unique dosage form, are convenient for feeding, and have good palatability. The product adopts a soft chewable tablet, which has a lower hardness and a higher water content than conventional tablets or hard chewable tablets, and is therefore more likely to be liked by pet dogs and more convenient for feeding. The process of the present invention is simple and easy to operate.

Description

Technical Field

[0001] The invention relates to the field of animal health products, and in particular to an anti-allergic soft chewable tablet for dogs and a preparation method thereof. Background Art

[0002] With the increasing number of pets, changes in their living environment and the increasing variety of food, the incidence of pet allergies is also increasing. According to veterinary clinical statistics, about 70% of pet dogs are allergic. Pet allergies can be divided into two main types, namely food-borne allergies and environmental allergies, of which environmental pet allergies account for about 80% and food-borne allergies account for about 20%. Pet food-borne allergies are a special immune response caused by the consumption of certain foods or food additives. The most common foods that cause pet food allergies are: beef, milk, chicken products and wheat, followed by soybeans, lamb, pork, fish and corn. Environmental elements such as pollen, mold spores, dust mites, flea bites, etc. can cause environmental allergies. Almost all pet allergies may show skin problems, such as itching, excessive scratching and licking of the skin; frequent rolling and rubbing of the body; excessive hair loss and changes in body odor, etc. In addition, pet food-borne allergies may also be accompanied by gastrointestinal symptoms (such as diarrhea).

[0003] At present, the measures used to treat symptoms of canine skin allergies mainly include glucocorticoids, antihistamines, supplementation of unsaturated fatty acids such as omega-3 and other nutritional supplements, and the use of shampoos. However, long-term use of glucocorticoids or antihistamines may lead to adverse reactions. It is difficult to achieve therapeutic effects using essential fatty acids alone, and they often need to be used in conjunction with glucocorticoids or antihistamines. It is relatively safe to use shampoo to treat pets' skin allergies, but shampoo alone rarely effectively relieves itching and needs to be used in combination with other drugs. Most shampoos need to be in contact with the pet's skin for 10-15 minutes and rinsed thoroughly for 10 minutes. If it is a restrained, active animal, it may take longer, which brings inconvenience to the use of shampoo on pets. Therefore, in order to meet the skin health care needs of pets with allergic constitutions, it is necessary to further develop anti-allergic pet health products with high safety and good palatability.

[0004] For example, CN108347969A discloses a food composition for controlling non-food allergies in companion animals. The pet food composition comprises a combination of nutrients including ω-6, ω-3, ω-9, alpha lipoic acid, a quercetin source (including selected herbs, fruits and vegetables), egg products and microorganisms E and C, which can effectively reduce skin redness, repair skin, improve hair texture and reduce hair oiliness. Summary of the invention

[0005] In view of the problems existing in the prior art, the present invention provides an antiallergic soft chewable tablet for dogs, which comprises the following components by weight percentage: 27-37% of active ingredients, 18-20% of wetting agents, 4-10% of adhesives, 12-18% of flavoring agents, 24-29% of fillers, 0.2-0.3% of preservatives and 0.8-1.2% of lubricants, wherein the active ingredients include psoralea corylifolia extract, linseed oil microcapsule powder, vitamin E acetate, dimethyl sulfone, bromelain and sodium hyaluronate.

[0006] In some embodiments, the wetting agent is selected from one or more of water, glycerol, soybean oil or polyethylene glycol.

[0007] In some embodiments, the binder is selected from one or more of starch, hydroxypropyl methylcellulose, sodium carboxymethyl cellulose or polyvinyl pyrrolidone.

[0008] In some embodiments, the wetting agent is selected from one or more of water, glycerol, soybean oil or polyethylene glycol.

[0009] In some embodiments, the flavoring agent is selected from one or more of enzymatically hydrolyzed chicken meat powder, enzymatically hydrolyzed duck meat powder, or enzymatically hydrolyzed chicken liver powder.

[0010] In some embodiments, the preservative is selected from one or more of potassium sorbate, sodium benzoate, calcium propionate or sodium diacetate, preferably potassium sorbate, sodium benzoate or sodium diacetate.

[0011] In some embodiments, the filler is selected from one or more of microcrystalline cellulose, pregelatinized starch, sucrose or mannitol.

[0012] In some embodiments, the lubricant is selected from one or more of magnesium stearate, talc, or colloidal silicon dioxide.

[0013] In some embodiments, the antiallergic soft chewable tablet for dogs provided by the present invention consists of 37% active ingredient, 4% binder, 18% wetting agent, 12.5% ​​flavoring agent, 0.2% preservative, 0.8% lubricant and 27.5% filler.

[0014] In some typical embodiments, the antiallergic soft chewable tablet for dogs provided by the present invention consists of the following ingredients:

[0015]

[0016] In some embodiments, the antiallergic soft chewable tablets for dogs provided by the present invention are composed of 30.1% active ingredients, 5% binders, 20% wetting agents, 15% flavoring agents, 0.25% preservatives, 1.2% lubricants and 28.45% fillers.

[0017] In some typical embodiments, the antiallergic soft chewable tablet for dogs provided by the present invention consists of the following ingredients:

[0018]

[0019]

[0020] In some embodiments, the antiallergic soft chewable tablet for dogs provided by the present invention consists of 27% active ingredient, 10% binder, 19% wetting agent, 18% flavoring agent, 0.3% preservative, 0.8% lubricant and 24.9% filler.

[0021] In some typical embodiments, the antiallergic soft chewable tablet for dogs provided by the present invention consists of the following ingredients:

[0022]

[0023] On the other hand, the present invention also provides a method for preparing the antiallergic soft chewable tablet for dogs, comprising the following steps:

[0024] 1) The active ingredient, binder, flavoring agent, preservative and filler are respectively passed through a 40-mesh sieve and mixed using a wet granulator at room temperature for about 20 minutes to obtain a solid powder mixture;

[0025] 2) Mix the prescribed amount of wetting agent at room temperature, mix for 15 minutes to make it uniform, then slowly add it to the uniformly mixed solid powder mixture and continue stirring and shearing for 10 minutes to obtain wet granules;

[0026] 3) Put the wet granules into a drying oven with non-circulating air and set the temperature at 30°C, and slowly dry the wet granules to a moisture content of 5-10%;

[0027] 4) granulating the wet granules dried in step 3) through a 20-mesh sieve;

[0028] 5) Add lubricant to the granules obtained in step 4) and mix well, then press the granules on a rotary tablet press using a 18.3 mm*18.3 mm square punch, with the tablet weight controlled at 3.0±0.15 g and the hardness not exceeding 2 kg.

[0029] Beneficial effects of the present invention:

[0030] 1. The soft chewable tablets of the present invention are designed for dogs with allergies. Whether it is food allergies or environmental allergies, the present invention helps to reduce the immune response of animals to these allergens. Psoralea corylifolia is a commonly used medicinal material in traditional Chinese medicine. It has anti-inflammatory, antibacterial, anti-tumor, anti-rheumatic activities, and is often used clinically to treat skin diseases such as vitiligo and psoriasis. Psoralea corylifolia mainly contains active ingredients such as coumarins, monoterpene phenols, flavonoids, and benzofurans. Among them, psoralen belongs to the furanocoumarin compounds, which can regulate the balance of Th1 / Th2 lymphocytes, promote the release of TNF-α, IL-6, and IL-1β, and play a significant anti-inflammatory and immunomodulatory effect. Psoralea corylifolia, as a commonly used feed plant additive, can improve the symptoms of dermatitis in dogs and reduce skin sensitivity. Flaxseed oil derived from flax plants is a safe natural source of high-content omega fatty acids. It is rich in α-linolenic acid and linoleic acid, which can strengthen the skin barrier and support the skin health of sensitive dogs. The use of linseed oil microcapsule powder is not only easier to take, but also can solve the problem of linseed oil being easily oxidized and corrupted during storage, thereby improving its bioavailability and effectiveness in the body. Bromelain is a plant protease extracted from pineapple plants and a plant extract that can be used for clinical treatment. Studies have shown that it has anti-edema, anti-inflammatory, and immunomodulatory functions. At present, bromelain has been developed and produced as a drug for treating allergies abroad, and its anti-allergic effect is closely related to the therapeutic effect on inflammation. In addition, bromelain is also used as a nutritional supplement to promote the health of the animal digestive system and can reduce gastrointestinal problems caused by food allergies. Vitamin E acetate helps to limit the oxidation of fatty acids, stimulate hair growth, soften dry skin, smooth skin irritation, reduce skin scar damage and promote scar healing. Sodium hyaluronate, also known as a thousand-fold water-locking factor, can play a role in skin hydration, soothing, anti-inflammatory and promoting skin healing and repair. Dimethyl sulfone is the main sulfur donor in animal bodies. Once the exogenous supply is insufficient, the development of hair, skin and other tissues will be affected. Dimethyl sulfone can not only provide sufficient sulfur to the animal body, but also its anti-inflammatory, anti-oxidation and immunity-enhancing effects have been confirmed in experiments. The effective ingredient combination of the present invention works synergistically from multiple aspects such as anti-inflammatory, anti-oxidation, skin hydration and immunity enhancement to combat canine allergies.

[0031] 2. Unique dosage form, convenient feeding, good palatability. This product uses soft chewable tablets, which have lower hardness and higher water content than conventional tablets or hard chewable tablets, so it is more popular with pet dogs and more convenient to feed. Moreover, compared with other dosage forms such as pastes, powders or liquid preparations, the feeding dosage is easier to control and more convenient to store. In addition, this product is specially designed to minimize the possibility of allergic reactions while ensuring good palatability by using enzymatic protein attractants.

[0032] 3. The process of the present invention is simple, the operation is convenient, and the properties and performance of the product are stable. Compared with other soft chewable tablet extruders or molding machines, the final implementation form of the present invention can be obtained by using a conventional tablet press in pharmaceutical production, with a simple process and convenient operation. DETAILED DESCRIPTION

[0033] The following embodiments can enable those skilled in the art to more fully understand the present invention, but the present invention is not limited to the scope of the embodiments.

[0034] Example 1

[0035] An antiallergic soft chewable tablet for dogs and a preparation method thereof, wherein the contents of the components are as follows, calculated by weight percentage:

[0036] Linseed oil microcapsule powder 14％ Psoralea corylifolia extract 17％ Dimethyl sulfone 4.2％ Bromelain 0.8％ Vitamin E Acetate 0.4％ Sodium Hyaluronate 0.6％ Soybean Oil 6％ glycerin 12％ Povidone K30 4％ Enzymatic Chicken Liver Powder 12.5％ Pregelatinized starch 27.5％ Sodium Benzoate 0.2％ Magnesium Stearate 0.8％

[0037] The preparation method thereof comprises the following steps:

[0038] 1) linseed oil microcapsule powder, psoralea corylifolia extract, dimethyl sulfone, bromelain, vitamin E acetate, sodium hyaluronate, povidone K30, enzymatic chicken liver powder, pregelatinized starch, sodium benzoate and other solid raw and auxiliary materials are respectively passed through a 40-mesh sieve, and mixed using a wet granulator at room temperature for about 20 minutes to obtain a solid powder mixture;

[0039] 2) Mix the prescribed amount of glycerin and soybean oil at room temperature for about 15 minutes to make them uniform, then slowly add them to the uniformly mixed solid powder mixture and continue stirring and shearing for 10 minutes to obtain wet granules;

[0040] 3) Put the wet granules into a drying oven (non-circulating air, set temperature 30°C) and slowly dry the wet granules to between 5-10%;

[0041] 4) granulating the wet granules dried in step 3) through a 20-mesh sieve;

[0042] 5) adding magnesium stearate to the granules obtained in step 4) and mixing them evenly, and then compressing the granules on a rotary tablet press using a 18.3 mm*18.3 mm square punch, wherein the tablet weight is controlled at 3.0±0.15 g and the hardness is not more than 2 kg.

[0043] Example 2

[0044] An antiallergic soft chewable tablet for dogs and a preparation method thereof, wherein the contents of the components are as follows, calculated by weight percentage:

[0045]

[0046]

[0047] The preparation method thereof comprises the following steps:

[0048] 1) linseed oil microcapsule powder, psoralea corylifolia extract, dimethyl sulfone, bromelain, vitamin E acetate, sodium hyaluronate, sodium carboxymethyl cellulose, enzymatic chicken powder, microcrystalline cellulose, pregelatinized starch, potassium sorbate and other solid raw and auxiliary materials are respectively passed through a 40-mesh sieve and mixed using a wet granulator at room temperature for about 20 minutes to obtain a solid powder mixture;

[0049] 2) Mix the prescribed amount of glycerin and water at room temperature for about 15 minutes to make them uniform, then slowly add them to the uniformly mixed solid powder mixture and continue stirring and shearing for 10 minutes to obtain wet granules;

[0050] 3) Put the wet granules into a drying oven (non-circulating air, set temperature 25°C) and slowly dry the wet granules to between 5-10%;

[0051] 4) granulating the wet granules dried in step 3) through an 18-mesh sieve;

[0052] 5) Add colloidal silicon dioxide to the granules obtained in step 4) and mix well, then press the granules on a rotary tablet press using a 18.3 mm*18.3 mm square punch, with the tablet weight controlled at 3.0±0.15 g and the hardness not exceeding 2 kg.

[0053] Example 3

[0054] An antiallergic soft chewable tablet for dogs and a preparation method thereof, wherein the contents of the components are as follows, calculated by weight percentage:

[0055] Linseed oil microcapsule powder 10％ Psoralea corylifolia extract 10％ Dimethyl sulfone 4％ Bromelain 0.5％ Vitamin E Acetate 1％ Sodium Hyaluronate 1.5％ Soybean Oil 7％ Polyethylene glycol 12％ starch 10％ Enzymatic Duck Meat Powder 18％ Mannitol 16.5％ sucrose 8.4％ Sodium diacetate 0.3％ Colloidal Silica 0.8％

[0056] The preparation method thereof comprises the following steps:

[0057] 1) linseed oil microcapsule powder, psoralea corylifolia extract, dimethyl sulfone, bromelain, vitamin E acetate, sodium hyaluronate, starch, enzymatic duck powder, mannitol, sucrose, sodium diacetate and other solid raw and auxiliary materials are respectively passed through a 40-mesh sieve, and mixed in a wet granulator at room temperature for about 20 minutes to obtain a solid powder mixture;

[0058] 2) Mix the prescribed amount of soybean oil and polyethylene glycol at room temperature for about 15 minutes to make them uniform, then slowly add them to the uniformly mixed solid powder mixture and continue stirring and shearing for 10 minutes to obtain wet granules;

[0059] 3) Put the wet granules into a drying oven (non-circulating air, set temperature 35°C) and slowly dry the wet granules to between 5-10%;

[0060] 4) granulating the wet granules dried in step 3) through a 20-mesh sieve;

[0061] 5) Add colloidal silicon dioxide to the granules obtained in step 4) and mix well, then press the granules on a rotary tablet press using a 18.3 mm*18.3 mm square punch, with the tablet weight controlled at 3.0±0.15 g and the hardness not exceeding 2 kg.

[0062] Test Example 1: Palatability Test

[0063] Ten pet dogs were selected and fed with the soft chewable products of the three embodiments above. The results of the palatability test are shown in Table 1:

[0064] Table 1 Palatability test results

[0065] name dog 1 dog 2 dog 3 dog 4 dog 5 Dog 6 dog 7 dog 8 Dog 9 Dog 10 Example 1 eat eat eat Like to eat eat eat eat eat eat eat Example 2 eat eat eat eat eat eat Like to eat eat eat eat Example 3 eat Do not eat eat eat eat eat eat eat eat eat

[0066] From the palatability test results, the soft chewable tablets of the three formulations of Example 1 to Example 3 are all well accepted by dogs and have good palatability.

[0067] Test Example 2: Anti-allergic effectiveness test

[0068] The pet soft chewable tablets obtained in Examples 1 and 2 were tested for anti-allergic effectiveness on dogs to evaluate their preventive and therapeutic effects on canine dermatitis. The specific test process is as follows:

[0069] 1. Test Materials

[0070] The basic dog food is a Pedigree brand universal complete food for all dog breeds; the product used in the test group is the soft chewable tablets of Examples 1 and 2 of the present invention, and the product used in the control group is a commercially available soft chewable tablet for beautifying hair and protecting skin.

[0071] 2. Experimental Animals and Grouping

[0072] Fifteen healthy adult beagles of similar size and weight that met the animal experiment standard requirements were used as experimental dogs. The 15 beagles were randomly divided into three groups: experimental group 1 (n=5), experimental group 2 (n=5), and control group (n=5).

[0073] 3. Test Management

[0074] All dogs were intradermally inoculated with 0.1 mL of 0.1% DNCB in the skin of the scapular area every 1 day. DNCB was dissolved in propylene glycol and injected 14 times in total. Two weeks after the last injection, the test dogs underwent a patch test on the skin of the abdominal area. After the dog's abdomen was shaved, the dog was subjected to a 5% DNCB ethanol patch to induce a dermatitis model. Each dog was given 8 patches, and the patches were fixed to the shaved area of ​​the dog for a continuous effect of 24 hours. After the patch, the dogs in the control group were fed with basic dog food + 2 pieces of commercially available hair and skin care soft chews daily, and the test group 1 was fed with basic dog food + 2 pieces of soft chews obtained in Example 1 daily; the test group 2 was fed with basic dog food + 2 pieces of soft chews obtained in Example 2 daily; and the feeding continued for 4 weeks.

[0075] 4. Testing indicators

[0076] The dogs were evaluated for body weight before the test, before patching, and at the end of the test. The experimental dogs were clinically examined on the 1st, 7th, 14th, and 28th days after the patch test, and the degree of skin inflammatory lesions and the degree of pruritus in the dogs were mainly evaluated by sensory evaluation. The skin at the patch site was scored for macroscopic lesions on a four-point scale: 0, 1, 2, and 3 points. The scoring criteria are as follows: 0, no obvious reaction; 1 point, erythema; 2 points, erythema, nodules, or edema (papules); 3 points, erythema with blistering or more severe reaction. The dogs' behavioral performance of itching was observed and the degree of itching was scored as follows: 0, no itching; 1-2 points, mild itching; 3-4 points, moderate itching; 5 points, continuous and severe itching.

[0077] V. Test Results

[0078] (1) The body weights of the dogs before the test, before patching and at the final time point are shown in Table 2. The results are expressed as "mean ± standard deviation"

[0079] Table 2 Experimental animals weight kg

[0080]

[0081] The results showed that the body weights of the experimental group 1, the experimental group 2 and the control group were uniform, and the body weights of the animals were stable at different time points, with no significant differences among the groups, which also illustrates the safety of the tablets of the present invention.

[0082] (2) The scoring results of inflammation and itching degree are shown in Table 3-8:

[0083] Table 3 Inflammation degree score of experimental group 1

[0084] Feeding days / experimental dogs No. 6 No. 7 No. 8 No. 9 No. 10 Mean 1 day 1.6 1.7 1.8 1.5 1.6 1.6 7 days 1.5 1.2 1.4 1.3 1.4 1.4 14 days 0.8 0.9 1.2 1.0 1.0 1.0 28 days 0.7 0.4 0.6 0.7 0.6 0.6

[0085] Table 4 Inflammation degree score of experimental group 2

[0086] Feeding days / experimental dogs No. 1 No. 2 No. 3 No. 4 No. 5 Mean 1 day 1.6 1.8 1.5 1.7 1.9 1.7 7 days 1.6 1.7 1.8 2.1 2.3 1.9 14 days 1.3 1.5 1.6 1.5 1.4 1.4 28 days 0.5 0.8 1.0 0.7 0.5 0.7

[0087] Table 5 Inflammation degree scores of the control group

[0088] Feeding days / experimental dogs No. 11 No. 12 No. 13 No. 14 No. 15 Mean 1 day 1.8 1.6 1.7 1.6 1.6 1.7 7 days 1.8 2.2 2.1 2.2 1.7 2.0 14 days 1.6 1.8 1.9 1.9 1.4 1.7 28 days 1.4 1.2 1.63 1.6 1.3 1.3

[0089] Table 6 Itch score of test group 1

[0090] Feeding days / experimental dogs No. 1 No. 2 No. 3 No. 4 No. 5 Mean 1 day 0.4 0.6 0.3 0.5 0.4 0.4 7 days 2.4 2.3 2.2 2.1 2.2 2.2 14 days 1.2 1.1 1.0 1.2 1.3 1.2 28 days 0.6 0.8 0.8 0.3 0.8 0.7

[0091] Table 7 Itch score of test group 2

[0092] Feeding days / experimental dogs No. 6 No. 7 No. 8 No. 9 No. 10 Mean 1 day 0.6 0.2 0.5 0.4 0.5 0.4 7 days 2.6 2.9 2.5 3.1 2.8 2.8 14 days 1.5 1.6 1.6 1.2 1.2 1.4 28 days 0.5 0.3 0.7 0.6 0.4 0.5

[0093] Table 8 Itch score of the control group

[0094] Feeding days / experimental dogs No. 11 No. 12 No. 13 No. 14 No. 15 Mean 1 day 0.6 0.5 0.4 0.5 0.6 0.5 7 days 2.7 3.3 3.1 2.8 2.9 3.0 14 days 2.1 2.0 2.6 2.8 2.3 2.4 28 days 1.5 1.7 1.8 2.3 1.9 1.8

[0095] The results showed that the test dogs began to experience skin redness, swelling, itching and other symptoms one day after the patch was applied, and some dogs developed dermatitis symptoms such as scabs on the red and swollen skin 7 days after the patch was applied. The dermatitis symptoms of the dogs in the test group and the control group were alleviated after continuous feeding of soft chews for 14 to 28 days, but compared with the control group, the conditioning effect of soft chews on dermatitis in the test group was more significant.

[0096] Test case 3: Clinical case treatment

[0097] The soft chewable tablets prepared in Examples 1-3 were used for clinical trials, and the results were as follows:

[0098]

[0099]

Claims

1. An antiallergic soft chewable tablet for dogs, characterized in that: The antiallergic soft chewable tablet for dogs is composed of the following ingredients by weight percentage:

2. An antiallergic soft chewable tablet for dogs, characterized in that: The antiallergic soft chewable tablet for dogs is composed of the following ingredients by weight percentage:

3. An antiallergic soft chewable tablet for dogs, characterized in that: The antiallergic soft chewable tablet for dogs is composed of the following ingredients by weight percentage:

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