Oral dissolving film preparation for improving animal halitosis and preparation method of oral dissolving film preparation

Abstract

The invention relates to the field of animal health-care products, in particular to an oral soluble film preparation for improving animal halitosis and a preparation method of the oral soluble film preparation. The oral soluble film preparation for improving animal halitosis comprises the following preparation raw materials in parts by weight: 0.8-2 parts of tea theanine, 3-8 parts of lysozyme, 0.1-1 part of glutamine, 1-4 parts of traditional Chinese medicine components, 1-2 parts of isomaltooligosacharide, 1-4 parts of probiotics, 0.1-1.6 parts of vitamins, 0.05-1 part of citric acid, 0-0.8 part of a flavoring agent, 7-10 parts of a film-forming agent, 2-10 parts of a plasticizer, 50-80 parts of purified water and the balance of glucose, and the sum of the preparation raw materials is 100 parts. The oral soluble film preparation for improving animal halitosis has the advantages of being easy to coat and peel, uniform in color, light-transmitting, high in toughness, good in uniformity and short in disintegration time.

Description

Technical Field

[0001] The invention relates to the field of animal health products, and in particular to an orodispersible film preparation for improving animal halitosis and a preparation method thereof. Background Art

[0002] With the development of society, pets play an increasingly important role in people's lives, but pet health issues are also receiving more and more attention. Pet bad breath not only has a negative impact on the owner's daily life, but also affects the oral health of the pet. Bad breath is a preventable and treatable problem. By taking the right preventive and treatment methods, you can help pets avoid bad breath problems while improving their quality of life and lifespan.

[0003] Orodispersible film dosage forms are a new type of preparation in recent years. They have the advantages of rapid release of active substances and release of drugs without chewing or drinking water, which perfectly avoids the problem of difficult feeding of tablets and capsules. Currently, the products on the market for animal oral problems are mainly tooth cleaning water, breath freshening spray, and breath freshening tablets, and there are very few orodispersible films for animal breath freshening. Summary of the invention

[0004] In view of the above-mentioned deficiencies in the prior art, the purpose of the present invention is to provide an orodispersible film preparation for improving animal halitosis and a preparation method thereof, aiming to fill the existing market gap and help animals solve the problem of halitosis.

[0005] In order to achieve the above object, the present invention adopts the following technical solutions:

[0006] The first aspect of the present invention provides an orodispersible film preparation for improving animal halitosis, wherein, by weight, the raw materials for its preparation include: 0.8-2 parts of tea theanine, 3-8 parts of lysozyme, 0.1-1 parts of glutamine, 1-4 parts of traditional Chinese medicine components, 1-2 parts of isomaltooligosaccharides, 1-4 parts of probiotics, 0.1-1.6 parts of vitamins, 0.05-1 parts of citric acid, 0-0.8 parts of flavor enhancers, 7-10 parts of film formers, 2-10 parts of plasticizers, 50-80 parts of purified water, and the rest is glucose, and the total of the raw materials for the preparation is 100 parts.

[0007] The orodispersible film preparation for improving animal halitosis, wherein the plasticizer comprises at least one of triethyl citrate, glycerol, glycerol, polyethylene glycol, polypropylene glycol, ethyl citrate and propylene glycol.

[0008] The orodispersible film preparation for improving animal halitosis, wherein the film-forming agent comprises at least one of polyvinyl alcohol, polyoxyethylene, hydroxypropyl methylcellulose, povidone, and hydroxypropyl cellulose sodium.

[0009] The orodispersible film preparation for improving animal halitosis, wherein the plasticizer is glycerol, the film-forming agent is hydroxypropyl methylcellulose E15 (abbreviated as HPMC E15), and the mass ratio of glycerol to hydroxypropyl methylcellulose E15 is 0.75:1.

[0010] The orodispersible film preparation for improving animal halitosis, wherein the probiotics include at least one of thermophilic Streptococcus salivarius subspecies and Lactobacillus acidophilus.

[0011] The orodispersible film preparation for improving animal bad breath, wherein the vitamins include at least one of vitamin C and vitamin B2.

[0012] The orodispersible film preparation for improving animal bad breath, wherein the traditional Chinese medicine component includes at least one of Patchouli and Cyperus rotundus.

[0013] The second aspect of the present invention provides a method for preparing an orodispersible film preparation, which is used to prepare the orodispersible film preparation for improving animal halitosis as described above, comprising the following steps:

[0014] S001. Preheat the purified water, add the Chinese medicinal components, isomaltooligosaccharide, tea theanine, lysozyme, glutamine, citric acid, flavor enhancer, glucose according to the formula, stir to dissolve completely, and keep warm for use;

[0015] S002. Add a film-forming agent and stir until dissolved to obtain a mixed solution;

[0016] S003. After the mixture is cooled to room temperature, probiotics, vitamins, and plasticizers are added and stirred evenly;

[0017] S004. The mixed solution is allowed to stand until all bubbles are completely removed, and then the mixed solution is evenly applied on a glass plate and dried in an oven to obtain the orodispersible film preparation.

[0018] The method for preparing the orosoluble film preparation, wherein in S004, the drying temperature is 50°C.

[0019] Beneficial effects: The first aspect of the present invention provides an orodispersible film preparation for improving animal halitosis. The orodispersible film preparation for improving animal halitosis is prepared by reasonably matching various preparation raw materials. The film has a flat and uniform appearance, is smooth, has no obvious bubbles, has good mechanical properties and disintegration time, and meets production and usage requirements.

[0020] The second aspect of the present invention provides a method for preparing an orodissolving film preparation, which is used to prepare the orodissolving film preparation for improving animal halitosis as described above. The method for preparing the orodissolving film preparation has simple process steps, is easy to implement, has good controllability, and is suitable for large-scale production of orodissolving film preparations. DETAILED DESCRIPTION

[0021] The present invention provides an orodispersible film preparation for improving animal halitosis and a preparation method thereof. To make the purpose, technical scheme and effect of the present invention clearer and more specific, the present invention is further described in detail with reference to the following examples. It should be understood that the specific examples described herein are only used to explain the present invention and are not intended to limit the present invention.

[0022] The first aspect of the present invention provides an orodispersible film preparation for improving animal halitosis. The raw materials for its preparation include, by weight: 0.8-2 parts of tea theanine, 3-8 parts of lysozyme, 0.1-1 parts of glutamine, 1-4 parts of traditional Chinese medicine components, 1-2 parts of isomaltooligosaccharides, 1-4 parts of probiotics, 0.1-1.6 parts of vitamins, 0.05-1 parts of citric acid, 0-0.8 parts of flavor enhancers, 7-10 parts of film formers, 2-10 parts of plasticizers, 50-80 parts of purified water, and the rest is glucose, and the total of the raw materials for the preparation is 100 parts.

[0023] Among the above components, tea theanine has antioxidant, anti-inflammatory, neuroprotective and mental regulating effects. Lysozyme has antibacterial, antiviral, hemostatic, detumescent and analgesic effects and accelerates tissue recovery function, which can help maintain the oral health of animals. Glutamine can promote wound healing and improve inflammation. Isomaltooligosaccharide can prevent tooth decay. Probiotics are mainly used to inhibit the growth of oral bacteria in dogs and cats, regulate the balance of intestinal flora, and control bad breath. Chinese medicine components have the effects of aromatic dehumidification, invigorating the spleen and appetite, and stopping vomiting. Citric acid is used to remove dental plaque in dogs and cats and reduce the content of pathogenic microorganisms that cause bad breath. HPMC E15 is used as a film-forming agent. Glucose is used as a filler and does not affect film formation. It is used to control a single variable in a single-factor screening test.

[0024] Preferably, the plasticizer includes at least one of triethyl citrate, glycerol, glycerol, polyethylene glycol, polypropylene glycol, ethyl citrate and propylene glycol.

[0025] Preferably, the film-forming agent includes at least one of polyvinyl alcohol, polyoxyethylene, hydroxypropyl methylcellulose, povidone, and hydroxypropyl cellulose sodium.

[0026] Preferably, the plasticizer is glycerol, the film-forming agent is hydroxypropyl methylcellulose E15, and the mass ratio of glycerol to hydroxypropyl methylcellulose E15 is 0.75:1. Different from the oral dissolving film for humans with only one or two main drug components, the oral dissolving film for animals has more main drug components and the precipitation problem is more serious. Under the above ratio of glycerol to hydroxypropyl methylcellulose E15, the oral dissolving film preparation for improving animal halitosis of the present invention has the best comprehensive performance. This prescription process improves the uniformity of this product, so that its film appearance is smooth and uniform without precipitation and obvious bubbles.

[0027] Preferably, the probiotics include at least one of Streptococcus salivarius subspecies thermophilus and Lactobacillus acidophilus.

[0028] Preferably, the probiotics include: 0.5-2 parts of Streptococcus salivarius thermophilus subspecies and 0.5-2 parts of Lactobacillus acidophilus.

[0029] Preferably, the vitamins include at least one of vitamin C and vitamin B2.

[0030] Preferably, the vitamins include: 0.05-0.8 parts of vitamin C and 0.05-0.8 parts of vitamin B2.

[0031] Preferably, the Chinese medicinal components include at least one of Patchouli and Cymbopogon citratus.

[0032] Preferably, the Chinese medicinal components include: 0.5-2 parts of Patchouli and 0.5-2 parts of Cymbidium.

[0033] The second aspect of the present invention provides a method for preparing an orodispersible film preparation, which is used to prepare the orodispersible film preparation for improving animal halitosis as described above, comprising the following steps:

[0034] S001. Preheat the purified water, add the Chinese medicinal components, isomaltooligosaccharide, tea theanine, lysozyme, glutamine, citric acid, flavor enhancer, and glucose according to the formula, and stir to dissolve completely;

[0035] S002. Add HPMC E15 and stir until dissolved to obtain a mixed solution;

[0036] S003. After the mixture is cooled to room temperature, probiotics, vitamins, and glycerol are added and stirred evenly;

[0037] S004. The mixed solution is allowed to stand until all bubbles are completely removed, and then the mixed solution is evenly applied on a glass plate and dried in an oven to obtain the orodispersible film preparation.

[0038] Preferably, in S001, pure water is preheated to 55° C., and each prepared raw material is stirred and dissolved completely in a water bath.

[0039] Preferably, in S004, the drying temperature is 50° C. At this drying temperature, the obtained orally dissolving film preparation has the best comprehensive performance. Specifically, the drying time is 30 minutes.

[0040] The present invention is further described below with reference to specific experiments.

[0041] The test methods for the following parameters are as follows:

[0042] 1. Appearance and thickness

[0043] The best orally dissolving film is one that is uniform and smooth, has consistent thickness, high transparency and no precipitation.

[0044] 2. Elongation

[0045] Take a group of sheet films, 3 pieces per group. Let it cool to room temperature, fix one end with a clip, and stretch the other end evenly in the opposite direction with a clip until the film breaks, and measure it with a ruler. Calculate the elongation according to the formula, elongation at break = stretch length ÷ effective test length × 100%, measure 3 times for each group, and calculate the average value. The best orodispersible film is one with high flexibility and is not easy to break.

[0046] 3. Folding resistance

[0047] Take a group of sheet films, 3 sheets in each group. Fold them repeatedly at an angle of 180° to the same side until they break to determine the folding resistance. The best orally dissolving film is the one that can be folded more than 100 times until it breaks or has visible cracks.

[0048] 4. Disintegration time

[0049] Take a group of 3 films after each film formation, add them into a beaker filled with 30mL 37℃ pure water, immerse the beaker in a 37℃ water bath to maintain constant temperature, shake, record the time for each film to completely dissolve, and take the average. The orodispersible film with the shortest average dissolution time is the best.

[0050] Experiment 1: HPMC E15 single factor screening

[0051] The basic formula of the orodispersible film preparation of this test is as follows:

[0052] The raw materials for preparation include, by weight: 1 part of tea theanine, 6 parts of lysozyme, 0.8 parts of glutamine, 1 part of traditional Chinese medicine component, 1 part of isomaltooligosaccharide, 2 parts of probiotics, 1.6 parts of vitamins, 0.5 parts of citric acid, 0.1 parts of flavor enhancer, 5 parts of glycerol, 65 parts of purified water, 5-10 parts of HPMC E15, and the rest is glucose, and the total of the raw materials for preparation is 100 parts;

[0053] Among them, the Chinese medicine components include 0.5 parts of Patchouli and 0.5 parts of Cymbopogon citratus; the probiotics include 1 part of Streptococcus salivarius thermophilus subspecies and 1 part of Lactobacillus acidophilus; and the vitamins include 0.8 parts of vitamin C and 0.8 parts of vitamin B2.

[0054] The dosage of HPMC E15 and glucose was adjusted, and a plurality of samples were prepared according to the preparation method of the orodispersible film preparation described above. The dosage of HPMC E15 and glucose in each sample formulation and the test results of the samples are shown in Table 1.

[0055] Table 1

[0056]

[0057] From the results in Table 1, it can be seen that when the dosage of HPMC E15 is 7-9 parts, the comprehensive performance of the prepared orodispersible film preparation is the best.

[0058] Experiment 2: Glycerol single factor screening

[0059] The basic formula of the orodispersible film preparation of this test is as follows:

[0060] The raw materials for preparation include, by weight: 1 part of tea theanine, 6 parts of lysozyme, 0.8 parts of glutamine, 1 part of traditional Chinese medicine component, 1 part of oligosaccharide, 2 parts of probiotics, 1.6 parts of vitamins, 0.5 parts of citric acid, 0.1 parts of flavor enhancer, 5 parts of HPMC E15, 65 parts of purified water, the mass ratio of glycerol to HPMC E15 is 0-2, and the rest is glucose, and the total of the raw materials for preparation is 100 parts;

[0061] Among them, the Chinese medicine components include 0.5 parts of Patchouli and 0.5 parts of Cymbopogon citratus; the probiotics include 1 part of Streptococcus salivarius thermophilus subspecies and 1 part of Lactobacillus acidophilus; and the vitamins include 0.8 parts of vitamin C and 0.8 parts of vitamin B2.

[0062] According to the ratio of glycerol to HPMC E15 in Table 2 below, the amount of glycerol and glucose in each sample was adjusted, and a plurality of samples were prepared according to the preparation method of the orodispersible film preparation described above. The ratio of glycerol to HPMC E15 in each sample formula and the test results of the samples are shown in Table 2.

[0063] Table 2

[0064]

[0065] From the results in Table 2, it can be seen that when the mass ratio of glycerol to HPMC E15 is 0.75-1.25, the comprehensive performance of the orodispersible film preparation is the best.

[0066] Experiment 3: Drying temperature single factor screening

[0067] The basic formula of the orodispersible film preparation of this test is as follows:

[0068] The raw materials for its preparation include, by weight: 1 part of tea theanine, 6 parts of lysozyme, 0.8 parts of glutamine, 1 part of traditional Chinese medicine component, 1 part of oligosaccharide, 2 parts of probiotics, 1.6 parts of vitamins, 0.5 parts of citric acid, 0.1 parts of flavor enhancer, 5 parts of HPMCE15, 5 parts of glycerol, 65 parts of purified water, 11 parts of glucose, the total of which is 100 parts;

[0069] Among them, the Chinese medicine components include 0.5 parts of Patchouli and 0.5 parts of Cymbopogon citratus; the probiotics include 1 part of Streptococcus salivarius thermophilus subspecies and 1 part of Lactobacillus acidophilus; and the vitamins include 0.8 parts of vitamin C and 0.8 parts of vitamin B2.

[0070] In this test, the preparation method of the orodispersible film preparation comprises the following steps:

[0071] S001. Preheat the purified water, add the Chinese medicinal components, isomaltooligosaccharide, tea theanine, lysozyme, glutamine, citric acid, flavor enhancer, and glucose according to the formula, and stir to dissolve completely;

[0072] S002. Add HPMC E15 and stir until dissolved to obtain a mixed solution;

[0073] S003. After the mixture is cooled to room temperature, probiotics, vitamins, and glycerol are added and stirred evenly;

[0074] S004. The mixed solution is allowed to stand until all bubbles are completely removed, and then evenly applied to the plate and dried to obtain the orosoluble film preparation;

[0075] In the preparation method of this test, a plurality of different drying temperatures are set to prepare the orodispersible film preparations respectively. The relevant drying temperature settings are shown in Table 3, and the test data of each sample prepared are shown in Table 3.

[0076] Table 3

[0077]

[0078] From the results in Table 3, it can be seen that when the drying temperature is 40-50°C, the comprehensive performance of the orodispersible film preparation is the best.

[0079] Experiment 4: Orthogonal experiment

[0080] The L9(34) orthogonal table was selected to design the experiment based on the principle of 3 factors and 3 levels. The dosage of HPMC E15, glycerol dosage and drying temperature were used as independent variables, and the appearance, elongation, folding endurance, disintegration time and were used as the evaluation indicators.

[0081] The specific scheme is shown in Table 4 and the scoring criteria are shown in Table 5;

[0082] Table 4

[0083] A: HPMCE15 / (%) B: Glycerol: HPMCE15 C: Temperature / (℃) 1 7 0.75 40 2 8 1 45 3 9 1.25 50

[0084] Table 5

[0085]

[0086] The basic formula of the orodispersible film preparation of this test is as follows:

[0087] The raw materials for the preparation include, by weight: 1 part of tea theanine, 6 parts of lysozyme, 0.8 parts of glutamine, 1 part of traditional Chinese medicine component, 1 part of isomaltooligosaccharide, 2 parts of probiotics, 1.6 parts of vitamins, 0.5 parts of citric acid, 0.1 parts of flavor enhancer, 65 parts of purified water, and the rest are HPMC E15, glycerol and glucose, and the total amount of the raw materials for the preparation is 100 parts;

[0088] The specific amounts of HPMC E15 and glycerol in each sample were calculated based on the amount of HPMC E15 and the mass ratio of glycerol to HPMC E15 in Table 6, and the drying temperature of each sample was also implemented according to the design in Table 6.

[0089] Table 6

[0090]

[0091] From the test data in Table 6, it can be seen that the dosage of HPMC E15 has the greatest influence on the film-forming properties of the animal orally soluble film preparation, followed by the dosage of glycerol, and the drying temperature has the least influence on the film-forming properties. The optimal film-forming combination is A2B1C3, i.e., 8 parts of HPMC E15, glycerol / HPMC E15=0.75, and drying temperature 50°C.

[0092] The performance of the orodispersible film preparation with the optimal combination was further measured, and the results are shown in Table 7.

[0093] Table 7

[0094]

[0095] From the results in Table 7, it can be seen that the orodispersible film preparation prepared under this condition is easy to apply and peel, has uniform color, is translucent and has no precipitation, has strong toughness and short disintegration time.

[0096] It is understandable that those skilled in the art can make equivalent substitutions or changes based on the technical solution and inventive concept of the present invention, and all these changes or substitutions should fall within the protection scope of the claims attached to the present invention.

Claims

1. An orodispersible film preparation for improving animal bad breath, characterized in that: The raw materials for the preparation include, by weight: 0.8-2 parts of tea theanine, 3-8 parts of lysozyme, 0.1-1 parts of glutamine, 1-4 parts of Chinese medicine components, 1-2 parts of isomaltooligosaccharides, 1-4 parts of probiotics, 0.1-1.6 parts of vitamins, 0.05-1 parts of citric acid, 0-0.8 parts of flavor enhancers, 7-10 parts of film formers, 2-10 parts of plasticizers, 50-80 parts of purified water, and the rest is glucose. The total of the raw materials for the preparation is 100 parts.

2. The orodispersible film preparation for improving animal bad breath according to claim 1, characterized in that: The plasticizer includes at least one of triethyl citrate, glycerol, glycerol, polyethylene glycol, polypropylene glycol, ethyl citrate and propylene glycol.

3. The orodispersible film preparation for improving animal bad breath according to claim 1, characterized in that: The film-forming agent comprises at least one of polyvinyl alcohol, polyoxyethylene, hydroxypropyl methylcellulose, povidone and hydroxypropyl cellulose sodium.

4. The orodispersible film preparation for improving animal bad breath according to claim 1, characterized in that: The plasticizer is glycerin, and the film-forming agent is hydroxypropyl methylcellulose E15.

5. The orodispersible film preparation for improving animal bad breath according to claim 4, characterized in that: The mass ratio of the glycerol to the hydroxypropyl methylcellulose E15 is 0.75:

1.

6. The orodispersible film preparation for improving animal bad breath according to claim 1, characterized in that: The probiotics include at least one of Streptococcus salivarius thermophilus subspecies and Lactobacillus acidophilus.

7. The orodispersible film preparation for improving animal bad breath according to claim 1, characterized in that: The vitamins include at least one of vitamin C and vitamin B2.

8. The orodispersible film preparation for improving animal bad breath according to claim 1, characterized in that: The Chinese medicinal components include at least one of Patchouli and Cymbidium orientale.

9. A method for preparing an orally dissolving film preparation, characterized in that: The method for preparing the orodispersible film preparation for improving animal halitosis according to any one of claims 1 to 8 comprises the following steps: S001. Preheat the purified water, add the Chinese medicinal components, isomaltooligosaccharide, tea theanine, lysozyme, glutamine, citric acid, flavor enhancer, glucose according to the formula, stir to dissolve completely, and keep warm for use; S002. Add a film-forming agent and stir until dissolved to obtain a mixed solution; S003. After the mixture is cooled to room temperature, probiotics, vitamins, and plasticizers are added and stirred evenly; S004. The mixed solution is allowed to stand until all bubbles are completely removed, and then the mixed solution is evenly applied on a glass plate and dried in an oven to obtain the orodispersible film preparation.

10. The method for preparing the orodissolving film preparation according to claim 9, characterized in that: In the step S004, the drying temperature is 50°C.

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