Oral care composition and application thereof

Abstract

The invention discloses an oral care composition and application thereof. The oral care composition disclosed by the invention is prepared from guaiazulene, allantoin and dipotassium glycyrrhizinate. According to the oral care composition disclosed by the invention, guaiazulene, allantoin and dipotassium glycyrrhizinate are organically combined, so that gingival bleeding can be effectively relieved, gingival inflammation can be relieved, and uncomfortable symptoms such as red and swollen gingiva and pain can be eliminated; the three components can synergistically promote oral mucosa repair, enhance anti-inflammatory and anti-allergic effects, comprehensively nurse oral health, and can be prepared into various oral care products.

Description

Technical Field

[0001] This application relates to the field of oral care technology, and in particular to an oral care composition and its application. Background Technology

[0002] Bleeding gums are a common problem, and gingivitis is also prevalent. Gingivitis, for example, causes red, swollen, and painful gums, affecting normal eating and daily life. Currently available oral care products often have limited effectiveness in addressing these issues. Most products only provide basic oral cleaning and are unlikely to quickly stop bleeding. Many oral care products only work on the surface of the oral mucosa and cannot effectively address deeper problems such as bleeding gums, inflammation, and tooth sensitivity, as they cannot penetrate deep into the gum cells.

[0003] Currently, some oral care products on the market claim to have hemostatic and gum-protecting effects. Some products achieve this by adding hemostatic agents, but these agents may pose potential safety risks, and long-term use may affect the body's normal blood clotting mechanism. Other products add anti-inflammatory ingredients, such as certain plant extracts or medicinal components, but the effect of a single ingredient is often limited, and it may not be fully effective due to poor compatibility with other ingredients. For example, some toothpastes containing only a single anti-inflammatory ingredient are not very effective in relieving gum inflammation and cannot fundamentally solve the problem of bleeding and inflammation of the gums.

[0004] Therefore, how to more effectively solve the problems of gingival bleeding and inflammation remains a key research focus in the field of oral care technology. Summary of the Invention

[0005] The purpose of this application is to provide a new oral care composition and its application.

[0006] To achieve the above objectives, this application adopts the following technical solution:

[0007] The first aspect of this application discloses an oral care composition comprising guaiac, allantoin, and dipotassium glycyrrhizate.

[0008] It should be noted that this application creatively combines guaiacine (guaiac blue hydrocarbon), allantoin, and dipotassium glycyrrhizate in an oral care product, which can effectively alleviate gingival bleeding. Through the synergistic effect of multiple ingredients, it reduces the frequency and amount of gingival bleeding, resolving the concerns caused by gingival bleeding, such as worries about the impact of bleeding on social image. In terms of gum care, the oral care composition of this application can reduce gingival inflammation, eliminate discomfort such as gingival redness, swelling, and pain, improve oral comfort, and allow users to eat normally without having their quality of life affected by gingival problems. It can also provide some relief for users with sensitive teeth, reducing tooth sensitivity caused by eating hot, cold, sweet, or sour foods.

[0009] It should also be noted that the oral care composition of this application, with the synergistic effect of guaiac, allantoin, and dipotassium glycyrrhizate, exhibits better efficacy in promoting oral mucosal repair, enhancing anti-inflammatory and anti-allergic effects, and providing comprehensive oral health care. Specifically, in terms of synergistically promoting oral mucosal repair, guaiac promotes tissue regeneration, accelerating the repair and renewal of oral mucosal tissue; allantoin promotes cell growth, accelerates wound healing, and enhances the barrier function of the oral mucosa; dipotassium glycyrrhizate, through hormone-like effects, effectively promotes the self-repair of human tissues and promotes the healing of oral ulcers. The combination of these three components, working together from different angles, can more significantly promote the healing of oral mucosal damage, and has a better repair effect on mucosal damage caused by oral ulcers, oral inflammation, etc. In terms of enhancing anti-inflammatory and anti-allergic effects, guaiacine has anti-allergic and anti-inflammatory properties, inhibiting the growth of oral microorganisms and helping to prevent and treat oral inflammation. Dipotassium glycyrrhizate also has anti-inflammatory and anti-allergic effects, inhibiting mast cell degranulation, reducing the release of inflammatory factors such as histamine, and alleviating inflammatory reactions and allergic symptoms of the oral mucosa. When combined, their anti-inflammatory and anti-allergic effects synergistically relieve discomfort symptoms such as redness, swelling, pain, and itching of the oral mucosa more effectively, and have better preventive and therapeutic effects on diseases such as allergic stomatitis and gingivitis. In terms of comprehensive oral health care, guaiacine can inhibit the growth of oral microorganisms and help maintain the balance of oral microorganisms; dipotassium glycyrrhizate has antibacterial effects, which can inhibit the growth of bacteria in the mouth and reduce problems such as bad breath and tooth decay; allantoin helps prevent tooth decay and promotes gum health. The combination of the three can play a role in multiple aspects such as antibacterial, anti-caries, and gum protection, providing more comprehensive oral care and helping to maintain the overall health of the oral cavity.

[0010] It is understood that the key to this application lies in the organic combination of guaiacine, allantoin, and dipotassium glycyrrhizate. Through their synergistic effect, they promote oral mucosal repair, enhance anti-inflammatory and anti-allergic properties, and provide comprehensive oral care. Other components in the oral care composition can be determined according to needs; for example, when the oral care composition is used to prepare mouthwash or toothpaste, it may also include at least one of solvents, humectants, preservatives, flavorings, sweeteners, and foaming agents, depending on requirements. The specific selection of these components can refer to existing technologies. However, to ensure that the three active ingredients—guaiacine, allantoin, and dipotassium glycyrrhizate—can function better, the improved technical solution of this application further selects solvents, humectants, preservatives, flavorings, sweeteners, and foaming agents.

[0011] Furthermore, the active ingredients in this application mainly include guaiacine, allantoin, and dipotassium glycyrrhizate. It can consist solely of these three active ingredients, or other existing active ingredients can be added as needed or according to product requirements. In principle, any added active ingredients are acceptable as long as they do not have incompatibilities with the guaiacine, allantoin, and dipotassium glycyrrhizate of this application; that is, the added active ingredients should not affect the function of the guaiacine, allantoin, and dipotassium glycyrrhizate of this application, nor should they affect the stability of the three.

[0012] In one implementation of this application, the weight ratio of guaiac, allantoin, and dipotassium glycyrrhizate is (0.01-0.1):(0.05-0.5):(0.05-2).

[0013] In one implementation of this application, the oral care composition further includes a solvent for dispersing or dissolving the components.

[0014] In one implementation of this application, the solvent is water.

[0015] In one implementation of this application, the oral care composition further includes a moisturizer.

[0016] In one implementation of this application, the moisturizer includes at least one of polyethylene glycol 400, glycerin, sorbitol, and propylene glycol.

[0017] In one implementation of this application, the moisturizer is composed of polyethylene glycol 400, glycerin and sorbitol, or the moisturizer is composed of polyethylene glycol 400, sorbitol and propylene glycol.

[0018] In one implementation of this application, the oral care composition further includes a preservative.

[0019] In one implementation of this application, the preservative includes sodium benzoate.

[0020] In one implementation of this application, the oral care composition further includes a fragrance.

[0021] In one implementation of this application, the fragrance agent includes a flavoring.

[0022] In one implementation of this application, the oral care composition further includes a sweetener.

[0023] In one implementation of this application, the sweetener includes at least one of sucralose and sodium saccharin.

[0024] In one implementation of this application, the oral care composition further includes a foaming agent.

[0025] In one implementation of this application, the foaming agent includes at least one of sodium lauryl sulfate and disodium cocoyl glutamate.

[0026] The second aspect of this application discloses the use of the oral care composition of this application in the preparation of mouthwash, oral spray, toothpaste or oral repair gel.

[0027] A third aspect of this application discloses a mouthwash prepared using the oral care composition of this application.

[0028] The mouthwash of this application, by employing the oral care composition of this application, can also promote oral mucosal repair, enhance anti-inflammatory and anti-allergic effects, and provide comprehensive oral health care; furthermore, the mouthwash of this application can achieve rapid hemostasis and has a gingival repair effect with long-term use.

[0029] In one implementation of this application, the mouthwash includes the oral care composition of this application and a solubilizer.

[0030] In one implementation of this application, the solubilizer is at least one of poloxamer 407 and PEG-40 hydrogenated castor oil.

[0031] In one implementation of this application, the mouthwash also includes an appearance improver.

[0032] In one implementation of this application, the appearance modifier is at least one of CI 19140 and CI 42053.

[0033] In one implementation of this application, the mouthwash is a blue or dark blue liquid.

[0034] The fourth aspect of this application discloses a toothpaste prepared using the oral care composition of this application.

[0035] It should be noted that the toothpaste of this application also has the advantages of the oral care composition of this application, such as promoting oral mucosal repair, enhancing anti-inflammatory and anti-allergic effects, and providing comprehensive oral health care; similarly, the toothpaste of this application can also achieve rapid hemostasis and has a gingival repair effect with long-term use.

[0036] In one implementation of this application, the toothpaste includes the oral care composition and an abrasive.

[0037] In one implementation of this application, the friction agent includes at least one of friction-type silica, thickened silica, calcium pyrophosphate, and calcium hydrogen phosphate.

[0038] In one implementation of this application, the toothpaste further includes a thickener.

[0039] In one implementation of this application, the thickener includes at least one of carrageenan, cellulose gum, and hydroxyethyl cellulose.

[0040] In one implementation of this application, the toothpaste also includes a whitening enhancer.

[0041] In one implementation of this application, the whitening enhancer includes tetrasodium pyrophosphate.

[0042] In one implementation of this application, the toothpaste also includes an anti-caries agent.

[0043] In one implementation of this application, the caries-preventing agent includes sodium monofluorophosphate.

[0044] In one implementation of this application, the toothpaste also includes an appearance improver.

[0045] In one implementation of this application, the appearance modifier includes at least one of CI 17200.

[0046] In one implementation of this application, the toothpaste is blue or dark blue.

[0047] In one implementation of this application, the toothpaste is packaged in a toothpaste tube. The tube body is an aluminum-plastic composite tube, and the shoulder of the toothpaste tube contains a barrier material or a barrier layer formed by the barrier material. The barrier material includes at least one of PET and Bopp.

[0048] In one implementation of this application, the tube shoulder is made of a mixture of PE and Bopp, or the tube shoulder is first made of PE and then PET is injection molded onto the PE tube shoulder to form a barrier layer.

[0049] Due to the adoption of the above technical solutions, the beneficial effects of this application are as follows:

[0050] The oral care composition of this application, which organically combines guaiac, allantoin and dipotassium glycyrrhizate, can effectively relieve gingival bleeding, reduce gingival inflammation, and eliminate discomfort symptoms such as gingival redness, swelling and pain. The three components can synergistically promote oral mucosal repair, enhance anti-inflammatory and anti-allergic effects, and provide comprehensive oral health care, and can be formulated into various oral care products. Attached Figure Description

[0051] Figures 1 to 4 These are the test results for different toothpaste tube packaging materials in the embodiments of this application. Detailed Implementation

[0052] Existing oral care products either use hemostatic agents, which pose potential safety risks, or use single plant extracts or drug ingredients, which are not very effective in relieving gingivitis and cannot fundamentally solve the problems of gingival bleeding and inflammation.

[0053] This application creatively combines guaiacine (guaiac blue hydrocarbon), allantoin, and dipotassium glycyrrhizate in an oral care product, bringing significant value to users. It effectively alleviates gum bleeding by reducing the frequency and amount of bleeding through the synergistic effect of multiple ingredients, addressing user concerns about gum bleeding, such as its impact on social image. Regarding gum care, it reduces gum inflammation, eliminates redness, swelling, and pain, improving oral comfort and allowing users to eat normally without gum problems affecting their quality of life. It also provides relief for users with sensitive teeth, reducing tooth sensitivity caused by eating hot, cold, sweet, or sour foods.

[0054] The oral care composition of this application has the advantage of "highly effective hemostasis and gum protection", and has a significant effect on solving gum bleeding and inflammation problems. Guaifenesin, allantoin, and dipotassium glycyrrhizate are all relatively natural ingredients, making users more confident in using it. In addition, the oral care composition of this application has the advantage of "comprehensive oral care", which can not only stop bleeding and protect gums, but also improve other oral problems such as tooth sensitivity to a certain extent.

[0055] Technically, this application achieves an innovative combination of multiple active ingredients. Previously, there was no precedent for specifically combining guaiac, allantoin, and dipotassium glycyrrhizate for oral care. Research has shown that they can synergistically interact in oral care settings, delivering better results than any single ingredient. In terms of product formulation design, the compatibility issues between different ingredients have been resolved, ensuring that each ingredient remains stable and functions effectively in oral care products.

[0056] The oral care composition of this application, or the mouthwash or toothpaste prepared therefrom, possesses a unique natural color. Since guaiac itself is dark blue, this natural blue color can give oral care products a unique appearance, making them stand out among many similar products. Whether in toothpaste, the blue paste will bring consumers a novel and unique visual experience; or in mouthwash, the blue liquid may create a fresh and professional feeling. Currently, most oral care products on the market are relatively monochromatic, mostly white, transparent, or other conventional colors. This blue-looking oral care product can attract consumers' attention and stimulate their purchasing interest.

[0057] The present application will be further described in detail below through specific embodiments. The following embodiments are only for further illustration of the present application and should not be construed as limiting the present application.

[0058] Unless otherwise specified, the technical means used in the embodiments are conventional means well known to those skilled in the art.

[0059] Example 1

[0060] This example uses a whole blood dynamic coagulation assay to verify the coagulation effects of guaiac, allantoin, and dipotassium glycyrrhizate as a single component, in any pairwise combinations, and in combinations of all three, as detailed below:

[0061] 1. Vacuum-drawn peripheral blood from a healthy volunteer (who had not taken any anticoagulants within the past two weeks) (female, 34 years old), anticoagulated with 3.2% sodium citrate, and set aside for use.

[0062] 2. Mix 50 μL of the test sample thoroughly and add it to 450 μL of anticoagulated whole blood. Add 50 μL of physiological saline to 450 μL of anticoagulated whole blood as a control.

[0063] 3. Add 50 μL of 0.2 M CaCl2 to the anticoagulated whole blood containing the sample, invert the plate three times to mix, and use a pipette to add 10 μL of the recalcified anticoagulated whole blood to the center of the 24-well plate. Incubate at 37°C. Perform the detection after 3 min, 5 min and 10 min of incubation. After the incubation time is up, add 1 mL of deionized water along the edge of the 24-well plate and incubate in a constant temperature incubator for 5 min to coagulate the uncoagulated red blood cells.

[0064] 4. Add 10 μL of calcium-reconstituted anticoagulated whole blood directly to 1 mL of deionized water and incubate at 37°C with shaking for 5 min as an experimental control.

[0065] 5. Use a pipette to take 1 mL of the supernatant from the plate and add it to a 1.5 mL centrifuge tube. Centrifuge at 3000 rpm for 10 min. Take 200 μL of the supernatant from the centrifuge tube and add it to a 96-well plate. Measure the absorbance of the solution at 540 nm using a microplate reader. Repeat the test 3 times for each sample supernatant and take the average value.

[0066] A higher absorbance value indicates a higher concentration of hemoglobin in the solution, a greater number of dissolved red blood cells, and a lower degree of blood clotting, meaning the sample has lower procoagulant properties. Conversely, a lower absorbance value indicates a lower concentration of hemoglobin in the solution, a greater number of dissolved red blood cells, and a lower degree of blood clotting.

[0067] The blood anticoagulation index (BCI) of a sample is calculated using the following formula:

[0068] BCI = Ia / Iw × 100%

[0069] Wherein, Ia represents the absorbance of the solution after the compound calcium anticoagulated whole blood has been in contact with the sample for a set time; Iw represents the absorbance of the solution after the anticoagulated whole blood is mixed with deionized water. The smaller the BCI value, the higher the degree of blood coagulation, indicating that the material has a lower degree of anticoagulation. Conversely, the larger the value, the lower the degree of blood coagulation.

[0070] Experiment 1, Guaiacone test sample: Guaiacone was pre-dissolved with polyethylene glycol 400 and then water was added to prepare a 0.05wt% guaiaac aqueous solution.

[0071] Experiment 2, allantoin test sample: Allantoin was pre-dissolved with polyethylene glycol 400 and then water was added to prepare an allantoin aqueous solution with a concentration of 0.2 wt%.

[0072] Experiment 3, Dipotassium glycyrrhizate sample: Dipotassium glycyrrhizate was pre-dissolved with polyethylene glycol 400 and then water was added to prepare a 0.6 wt% dipotassium glycyrrhizate aqueous solution.

[0073] Experiment 4, Guaifenesin + Allantoin test sample: Guaifenesin and allantoin were pre-dissolved with polyethylene glycol 400 and then water was added to prepare a test sample solution with a guaiac concentration of 0.05wt% and an allantoin concentration of 0.2wt%.

[0074] Experiment 5, Guaifenesin + Dipotassium Glycyrrhizate Test Sample: Guaifenesin and dipotassium glycyrrhizate were pre-dissolved in polyethylene glycol 400 and then water was added to prepare a test sample solution with a guaiac concentration of 0.05wt% and a dipotassium glycyrrhizate concentration of 0.6wt%.

[0075] Experiment 6, Allantoin + Dipotassium Glycyrrhizate: Allantoin and dipotassium glycyrrhizate were pre-dissolved in polyethylene glycol 400 and then water was added to prepare a sample solution with an allantoin concentration of 0.2 wt% and a dipotassium glycyrrhizate concentration of 0.6 wt%.

[0076] Experiment 7, Guaifenesin + Allantoin + Dipotassium Glycyrrhizate Test Sample: Guaifenesin, allantoin and dipotassium glycyrrhizate were pre-dissolved in polyethylene glycol 400 and then water was added to prepare a test sample solution with a guaiac concentration of 0.05wt%, an allantoin concentration of 0.2wt%, and a dipotassium glycyrrhizate concentration of 0.6wt%.

[0077] The test results of the seven samples are shown in Table 1.

[0078] Table 1. Coagulation test results of different test samples

[0079] Serial Number 3min BCI 5min BCI 10min BCI Experiment 1 94.48％ 90.92％ 24.79％ Experiment 2 96.36％ 92.60％ 24.07％ Experiment 3 95.58％ 91.02％ 24.56％ Experiment 4 90.87％ 86.53％ 22.14％ Experiment 5 90.73 86.71 22.61 Experiment 6 90.36 86.60 22.07 Experiment 7 83.57 80.32 20.06

[0080] The results in Table 1 show that, based on the comparison of single components and efficacy combinations, the coagulation effect of combinations of two efficacy components at 3 min, 5 min, and 10 min is better than that of single components, and the coagulation effect of combinations of three efficacy components is better than that of combinations of two efficacy components.

[0081] Example 2

[0082] This example demonstrates the formulation of a toothpaste based on an oral care composition of guaiac, allantoin, and dipotassium glycyrrhizate, and its performance was tested.

[0083] Toothpaste formulation process:

[0084] Weigh out a portion of polyethylene glycol 400 and carrageenan to pre-dissolve; pre-dissolve the remaining portion of polyethylene glycol 400 and guaiac in a water bath at 50-60℃, add the remaining components, including humectant, whitening synergist, preservative, sweetener, and anti-caries agent, and stir at 3000 rpm for 20 minutes until evenly dispersed; after fully mixing the remaining powder components, proceed to the paste preparation, and stir at 2000 rpm for 15 minutes at room temperature using a propeller mixer until the paste is fine and uniform, then degas under vacuum to obtain the toothpaste paste.

[0085] In this example, control example 1 was prepared with guaiac + allantoin, control example 2 was prepared with guaiac + dipotassium glycyrrhizate, control example 3 was prepared with allantoin + dipotassium glycyrrhizate, and experiment 1 and experiment 2 were prepared with different combinations of guaiac + allantoin + dipotassium glycyrrhizate dosages. The toothpaste formulations of each control example and experiment are shown in Table 2.

[0086] Table 2 Toothpaste Formula (Unit: wt%)

[0087]

[0088]

[0089] Three control toothpastes and two test toothpastes were prepared according to the formula in Table 2 to test their hemostatic efficacy. The test method was the same as in Example 1, and the test results are shown in Table 3.

[0090] Table 3. Results of hemostatic efficacy tests for different toothpastes

[0091] Serial Number 3min BCI 5min BCI 10min BCI Compare with Example 1 95.58％ 90.52％ 26.79％ Compare with Example 2 96.36％ 91.34％ 26.07％ Compare with Example 3 95.88％ 90.77％ 26.56％ Experiment 1 85.57％ 83.32％ 20.06％ Experiment 2 89.06％ 85.66％ 22.61％

[0092] The results in Table 3 show that, compared with the control group, the experimental group had better coagulation effects at 3 min, 5 min, and 10 min, and Experiment 1 had better coagulation effects than Experiment 2.

[0093] In this study, 15 patients with significant gingival bleeding were randomly selected for testing. The specific testing method was as follows: the toothpaste described in this study was used 2-3 times daily, and patients were advised not to drink water or eat for half an hour after application. The scoring mechanism was a 10-point scale: 0 points (very poor) → 10 points (very good). The test results are shown in Table 4.

[0094] Table 4. Test results of toothpaste on gingival bleeding (all results are total from 15 participants, 2-3 times daily).

[0095]

[0096] The results in Table 4 show that the technical effects of the three-efficacy combination (such as Experiment 1 and Experiment 2) are significantly better than those of the two-efficacy combination (such as Control Examples 1 to 3). This indicates that the three-efficacy combination can produce a synergistic effect, promote the relief of gingival bleeding and inflammation, and has a pain-relieving effect.

[0097] Example 3

[0098] In this example, an oral care composition of guaiac, allantoin, and dipotassium glycyrrhizate was formulated into a mouthwash and its performance was tested.

[0099] Mouthwash formulation process:

[0100] Weigh out polyethylene glycol 400, guaiac and poloxamer 407 and pre-dissolve them in a water bath at 50-60℃. Add the remaining components in sequence and stir at 1000r / min for 30min to obtain mouthwash.

[0101] In this example, control example 1 was prepared with guaiac + allantoin, control example 2 was prepared with guaiac + dipotassium glycyrrhizate, control example 3 was prepared with allantoin + dipotassium glycyrrhizate, and experiment 1 and experiment 2 were prepared with different combinations of guaiac + allantoin + dipotassium glycyrrhizate dosages. The mouthwash formulations of each control example and experiment are shown in Table 5.

[0102] Table 5 Mouthwash Formula (Unit: wt%)

[0103]

[0104]

[0105] Three control mouthwashes and two test mouthwashes were prepared according to the formula in Table 5 to test their hemostatic efficacy. The test method was the same as in Example 1, and the test results are shown in Table 6.

[0106] Table 6. Results of hemostatic efficacy tests for different mouthwashes

[0107] Serial Number 3min BCI 5min BCI 10min BCI Compare with Example 1 93.78％ 88.02％ 24.59％ Compare with Example 2 93.56％ 87.64％ 24.27％ Compare with Example 3 93.28％ 88.52％ 24.46％ Example 1 83.67％ 80.12％ 18.16％ Example 2 85.26％ 82.36％ 20.21％

[0108] The results in Table 6 show that, compared with the control group, the coagulation effect of the case group was better than that of the control group at 3 min, 5 min and 10 min, and the coagulation effect of Experiment 1 was better than that of Experiment 2.

[0109] In this study, 15 patients with significant gingival bleeding were randomly selected for testing. The specific testing method was as follows: 15 mL of the mouthwash used in this study was applied 2-3 times daily, and patients were advised not to drink water or eat for half an hour after application. Scoring mechanism: 10-point scale: 0 points (very poor) → 10 points (very good). The test results are shown in Table 7.

[0110] Table 7 Test results of mouthwash on gum bleeding (total test results of 15 people each, used 2 - 3 times a day,)

[0111]

[0112] The results in Table 7 show that the technical effects of the three - efficacy combinations (such as Test 1 and Test 2) are significantly better than those of the two - efficacy combinations, such as Control Examples 1 to 3; thus, it can be seen that the three - efficacy combinations can produce a synergistic effect, promote the relief of gum bleeding and inflammation, and have an effect of pain relief.

[0113] Example 4

[0114] In this example, the Test 1 toothpaste of Example 2 and the Test 1 mouthwash of Example 3 were used to conduct an anti - inflammatory experiment on mouse ear swelling.

[0115] I. Materials and Methods

[0116] 1. Test substances: Toothpaste (labeled as Test Group 1), mouthwash (labeled as Test Group 2).

[0117] 2. Experimental animals and rearing environment

[0118] 36 SPF - grade KM mice, male, 18 g - 22 g, provided by Zhuhai Beston Biotechnology Co., Ltd., production license number for experimental animals: SCXK(Yue)2020 - 0051, quality certificate number: No.44822700060876. The feed was provided by Jiangsu Medison Biomedical Co., Ltd. After the animals were purchased, they were reared in a barrier - environment animal laboratory and used after passing quarantine. Experimental animal use license number: SYXK(Yue)2023 - 0137. Temperature 20°C - 26°C, relative humidity 30% - 70%.

[0119] 3. Instruments and reagents

[0120] Main instruments: Electronic balance, 8 - mm hole puncher.

[0121] Reagents: Xylene.

[0122] 4. Test method

[0123] 4.1 After passing quarantine, the 36 SPF - grade KM mice were randomly divided into 3 groups, with 12 mice in each group, namely Test Group 1, Test Group 2, and model control group.

[0124] 4.2 After mouse quarantine and grouping, the left ear was left untreated as a baseline value. 30 μL of xylene solution was applied to both the inner and outer surfaces of the right ear. After 30 minutes, the model control group received no treatment, while the test substance group had 100 μL of the test substance applied to both sides of the right ear. One hour after application, the mice were euthanized by cervical dislocation. The test substance was cleaned, and both ears were cut off. Ear pieces (from the same location on both ears) with a diameter of 8 mm were weighed and recorded. The weight difference between the left and right ears of the same animal represents the degree of swelling.

[0125] Swelling degree = Weight of right earpiece - Weight of left earpiece

[0126] Swelling inhibition rate = (average swelling degree of model control group - average swelling length of test substance group) / average swelling degree of model control group × 100%.

[0127] 4.3 Statistical Analysis

[0128] Experimental data are expressed as mean ± standard deviation (X ± S), and independent samples t-tests were performed using SPSS software.

[0129] II. Test Results

[0130] Compared with the model control group, the ear swelling of mice in the test group was reduced, and the difference was statistically significant (P<0.05). The inhibitory effect on mouse ear swelling is shown in Table 8.

[0131] Table 8. Inhibitory effect on mouse ear swelling (X±S, n=12)

[0132] Group Degree of ear swelling (mg) Ear swelling suppression rate (%) Model control group 23.7±3.7 - Subject group 1 18.6±4.8* 21.52 Subject group 2 18.1±4.9* 23.62

[0133] Note: *P<0.05 compared with the model control group.

[0134] III. Conclusion

[0135] Under the conditions of this experiment, compared with the model control group, the ear swelling length of mice in test group 1 and test group 2 was reduced, and the difference was statistically significant (P<0.05), suggesting that the test substance has a certain anti-inflammatory effect in vivo.

[0136] Example 5

[0137] In this example, the toothpaste from Example 2 (labeled as test sample group 1) and the mouthwash from Example 3 (labeled as test sample group 2) were used to evaluate the oral mucosal repair efficacy in mice.

[0138] I. Materials and Methods

[0139] SPF-grade SD rats, 30 males, 6 to 8 weeks old, were provided by Zhuhai Beston Biotechnology Co., Ltd. The production license number is SCXK(Guangdong)2020-0051, and the quality certificate number of experimental animals is No.44822700040609. The feed was provided by Jiangsu Medison Biomedical Co., Ltd., with the production license number of Su Feed License(2023)10030 and the quality certificate number of NO.12024051303. The rats were housed in the barrier laboratory of our unit, and the experimental animal use license number is SYXK(Guangdong)2023-0137. The laboratory temperature was 20°C to 26°C, and the relative humidity was 40% to 70%. Feeding conditions: Grouped in cages with 5 rats per cage. A 10h:14h day-night intermittent lighting was adopted.

[0140] Dose selection and experimental grouping: A model control group, Test Sample Group 1, and Test Sample Group 2 were set up, with 10 SD rats in each group.

[0141] Main instruments and reagents: Shuangjie brand JJ3000 electronic balance; FA301181 type digital display electronic caliper; glacial acetic acid.

[0142] Test methods:

[0143] (1) Preparation of oral ulcer model: Refer to GQT / ZY-YB-97 to establish an oral ulcer model.

[0144] (2) Ulcer intervention test: The rats with successful model establishment were randomly divided into a model control group, Test Sample Group 1, and Test Sample Group 2 according to the ulcer area, with 10 rats in each group. The test sample groups were given the corresponding test substances. Use a pipette to take 100 μL of the mouthwash test sample or use a cotton swab to evenly apply an equal amount of the toothpaste test sample on the oral ulcer surface, 3 times a day for 5 consecutive days.

[0145] (3) Index detection

[0146] Before dosing (before the first day of dosing) and on the 1st, 2nd, 3rd, 4th, and 5th days after dosing, measure the maximum longitudinal diameter (d1) and maximum transverse diameter (d2) of the oral ulcer. Use a compass to intercept the maximum longitudinal and transverse diameters of the ulcer and mark them on the measurement paper, and then measure the diameters with a digital micrometer.

[0147] (4) Detection indexes and calculation methods

[0148] ① Ulcer area S = d1 × d2 × π / 4 (π is taken as 3.14);

[0149] ② Decrease value of ulcer area Dn = ulcer area S0 - ulcer area Sn

[0150] Where S0 = 0, the ulcer area before sampling; n = 1, 2, 3, 4, 5, the ulcer areas on days 1, 2, 3, 4, and 5 after sampling;

[0151] ③Final ulcer reduction rate (%) = (ulcer area S0 - ulcer area S5) / ulcer area S0 × 100%;

[0152] ④ Ulcer healing and healing rate;

[0153] ⑤Weight.

[0154] Statistical analysis of experimental data

[0155] Experimental data are expressed as mean ± standard deviation (X±S). Statistical analysis was performed using SPSS software. The comparison between the test sample group and the model control group was performed using the t-test, and P < 0.05 was considered statistically significant.

[0156] Results evaluation: Meeting any of the following conditions indicates that the test substance has a certain oral mucosal repair effect:

[0157] ① Compared with the model control group, the final ulcer area reduction rate of the test sample group increased, and the difference was statistically significant (P<0.05);

[0158] ②The healing rate of the test sample group was higher than that of the model control group.

[0159] II. Test Results

[0160] (1) Effect of the test sample on rat body weight

[0161] The results of the test on the effect of the test samples on the weight of rats are shown in Table 9.

[0162] Table 9. Changes in rat body weight (X±S, n=10)

[0163] Group Initial body weight (g) Final body weight (g) Weight gain (g) Model control group 191.6±9.1 227.5±9.7 35.9±4.4 Test sample group 1 196.6±5.2 229.3±7.1 32.7±4.9 Test sample group 2 195.4±4.8 228.4±7.3 33±4.3

[0164] The results in Table 9 show that no significant abnormalities were observed in rats in the model control group and the test sample group during the experiment. Compared with the model control group, there were no statistically significant differences in initial body weight, final body weight, and weight gain in the test sample group (P > 0.05), indicating that the test sample did not affect the body weight of the rats.

[0165] (2) Effect of the test sample on the area of ​​oral ulcers in rats

[0166] The results of the test on the effect of the test sample on the area of ​​oral ulcers in rats are shown in Table 10.

[0167] Table 10. Oral ulcer area in rats (X±S, n=10)

[0168] Group Model control group Test sample group 1 Test sample group 2 <![CDATA[Ulcer area on the 0th day (mm 2 )]]> 22.27±2.29 22.32±3.03 22.22±3.12 <![CDATA[Ulcer area on the 1st day (mm 2 )]]> 24.81±2.21 22.41±2.32* 22.43±2.29* <![CDATA[Ulcer area on the second day (mm 2 )]]> 24.24±3.27 19.36±2.83* 19.31±2.34* <![CDATA[Ulcer area on the 3rd day (mm 2 )]]> 19.49±1.78 15.67±2.61* 16.71±2.56* <![CDATA[Ulcer area on the 4th day (mm 2 )]]> 17.17±1.20 14.36±2.87* 14.76±2.78* <![CDATA[Ulcer area on the 5th day (mm 2 )]]> 14.64±1.30 10.31±5.68* 10.51±5.23*

[0169] In Table 10, "*" indicates a comparison with the model control group, where P < 0.05.

[0170] The results in Table 10 show that before sampling, there was no statistically significant difference in ulcer area between the model control group and the test sample group (P > 0.05). After sampling, compared with the model control group, the ulcer area in the test sample group decreased on days 1, 2, 3, 4, and 5, and the differences were statistically significant (P < 0.05).

[0171] (3) Effects of the test sample on the healing of oral ulcers in rats

[0172] The results of the test on the effect of the test samples on the healing of oral ulcers in rats are shown in Table 11.

[0173] Table 11. Decrease in oral ulcer area and healing status in rats (X±S, n=10)

[0174] Group Model control group Test sample group 1 Test sample group 2 <![CDATA[The ulcer area decrease value on the first day (mm 2 )]]> -2.54±3.10 -0.07±1.63* -0.21±1.33* <![CDATA[Ulcer area reduction value on the second day (mm 2 )]]> -1.98±4.34 2.96±2.90* 2.91±2.88* <![CDATA[Area reduction value of ulcer on the 3rd day (mm 2 )]]> 2.77±2.12 6.63±2.83* 5.51±2.73* <![CDATA[The ulcer area decrease value on the 4th day (mm 2 )]]> 5.10±2.53 7.94±2.54* 7.46±2.34* <![CDATA[The ulcer area reduction value on the 5th day (mm 2 )]]> 7.62±1.81 12.00±6.08* 11.71±6.18* Ulcer area reduction rate on day 3 (%) 11.93±8.86 29.41±10.26* 24.79±10.16* Final ulcer area reduction rate (%) 33.96±5.23 53.1±5.16* 52.7±5.06* Final healing rate (%) 0 20 20

[0175] In Table 11, "*" indicates a comparison with the model control group, P < 0.05; "-" indicates an increase in ulcer area. For example, "Model Control Group" "Decrease in Ulcer Area on Day 1" "-2.54" means that the ulcer area in this group increased by 2.54 mm. 2 .

[0176] The results in Table 11 show that, compared with the model control group, the decrease in ulcer area on days 1, 2, 3, 4, and 5 in the tested sample groups were statistically significant (P < 0.05). During the experimental period, the final healing rate of the model control group was 0%, while the final healing rate of tested sample groups 1 and 2 was 20%. Compared with the model control group, the decrease in final ulcer area in tested sample groups 1 and 2 was significantly increased (P < 0.05).

[0177] III. Conclusion

[0178] Under the conditions of this experiment, the final ulcer area reduction rate of rats in test sample group 1 and test sample group 2 was increased compared with that of the model control group, and the difference was statistically significant (P<0.05). The final healing rate of the test sample group was increased compared with that of the model control group, suggesting that the test sample has a repair effect on the oral mucosa.

[0179] Based on the above embodiments, this application further tested different dosages of guaiac, allantoin, and dipotassium glycyrrhizate. The results showed that a weight ratio of (0.01-0.1):(0.05-0.5):(0.05-2) of guaiac, allantoin, and dipotassium glycyrrhizate, when used in toothpaste or mouthwash, resulted in rapid hemostasis. In toothpaste or mouthwash, the dosage ranges as follows: guaiac 0.01-0.1 wt%, allantoin 0.05-0.5 wt%, and dipotassium glycyrrhizate 0.05-2 wt%; rapid hemostasis was achieved within these dosage ranges.

[0180] Example 6

[0181] When guaiac is used in toothpaste systems, its oxidative fading is mainly driven by two core factors: oxygen penetration and photocatalysis. By introducing a barrier layer into the toothpaste tube packaging—that is, using an aluminum-plastic composite tube for the tube body and introducing PET or Bopp barrier material in the tube shoulder—oxygen intrusion and light penetration can be specifically blocked, reducing the risk of oxidation from the source. Alternatively, microencapsulation technology can be used to encapsulate guaiac, forming an isolation layer to prevent oxidation and penetration.

[0182] This example uses the addition of a barrier layer to an aluminum-plastic composite pipe for detailed analysis and discussion. The material selection, working mechanism, and implementation method of the barrier layer are as follows:

[0183] Two key issues need to be addressed simultaneously:

[0184] 1. Oxygen barrier: Oxygen is the core reactant in oxidation reactions. Therefore, reducing the penetration of oxygen from the air into the toothpaste system through the packaging material can prevent guaiac from being oxidized.

[0185] 2. Under high temperature conditions, ordinary aluminum-plastic packaging materials will accelerate the volatilization of guaiac itself, resulting in a faster rate of contamination of the packaging materials.

[0186] 3. Light blocking: Light is a key factor that accelerates oxidation. Therefore, blocking ultraviolet (UV) and visible light penetration can prevent the photocatalytic generation of singlet oxygen or free radicals.

[0187] I. Fundamentals of Material Properties and High-Temperature Stability

[0188] At high temperatures, the thermal motion of guaiazoline molecules intensifies, significantly increasing their volatility. They also readily diffuse through the intermolecular gaps in the packaging material, accelerating contamination. The core function of the barrier layer is to reduce the volatilization channels of guaiazoline molecules (lowering the diffusion rate) and enhance the packaging material's resistance to high temperatures (preventing the material's own structure from being damaged by high temperatures, thus reducing its barrier properties).

[0189] Both BOPP and PET, as barrier layers, possess the fundamental characteristics to adapt to high-temperature environments:

[0190] • Temperature resistance: After biaxial stretching, BOPP (biaxially oriented polypropylene) has a dense molecular arrangement and better high temperature resistance than ordinary polypropylene. It does not soften easily at 60-80℃ (the extreme high temperature range for toothpaste storage; the normal high temperature test temperature for toothpaste is 45℃-50℃), and has good structural stability. PET has even better temperature resistance, and can withstand 120℃ for a short period of time. Its molecular chains do not easily loosen at high temperatures, and its structure remains stable.

[0191] • Chemical inertness: Both are non-polar or weakly polar polymer materials, which have poor compatibility with guaiac (a fat-soluble component) and are not easily swollen or dissolved by guaiac, thus reducing the "wetting-penetration" effect of guaiac on the packaging material.

[0192] II. Barrier Mechanism: How to Slow Down Volatilization and Infection

[0193] 1. PET: The core barrier layer, relying on "dense structure + low diffusion coefficient"

[0194] PET has a high degree of molecular chain regularity, with a crystallinity of 30-50%, and the molecules are closely arranged with small intermolecular gaps (low free volume).

[0195] • Barrier to guaiac volatilization: Although guaiac molecules are active at high temperatures, the dense structure of PET significantly reduces their diffusion rate. This is because guaiac molecules need to overcome the intermolecular forces of PET molecules to pass through the material, and the high crystallinity of PET greatly increases this resistance, reducing the amount of guaiac volatilized from the toothpaste matrix towards the packaging material.

[0196] • Inhibition of contamination: PET has low surface energy and poor compatibility with guaiac, making it difficult for guaiac molecules to adsorb onto the PET surface or penetrate into its interior (low diffusion coefficient), thus slowing down the rate of contamination of the packaging material. Even at high temperatures, the crystalline structure of PET is not easily destroyed, the intermolecular gaps are stable, and the long-term barrier effect is reliable.

[0197] • High oxygen barrier properties: PET has regular molecular chains, high crystallinity (30-50%), and small intermolecular gaps, resulting in significantly better oxygen barrier properties than BOPP (oxygen permeability approximately 10-50 cm³ / (m²·24h·0.1MPa) at 23°C). This high barrier property effectively prevents external oxygen from penetrating into the toothpaste, significantly reducing the oxygen content within the system and directly decreasing the supply of reactants for the oxidation reaction, thereby significantly slowing down the oxidation rate of guaiac.

[0198] • Partial blocking of light: PET has a certain ability to absorb ultraviolet rays (especially thick-layer PET), which can weaken the stimulating effect of ultraviolet rays on guaiazoline and indirectly reduce the possibility of "light-induced oxidation".

[0199] 2. BOPP: Auxiliary barrier layer, relying on "tensile strengthening + composite synergy"

[0200] After biaxial stretching, the molecular chains of BOPP are aligned along the stretching direction, increasing the crystallinity (by about 50-60%). The structure is more compact than that of ordinary polypropylene. Although its barrier properties are slightly inferior to PET, it has good mechanical strength and processability and is often used in combination with PET.

[0201] • Slowing down volatilization: The oriented structure of BOPP reduces the "gaps" between molecules, and at high temperatures, it is not easy for the structure to become loose due to the relaxation of molecular chains, which can block the penetration of guaiac molecules to a certain extent. When compounded with PET, it can form a double-layer structure of "PET as the main barrier + BOPP as the auxiliary support", which prolongs the diffusion path of guaiac molecules and further reduces the volatilization rate.

[0202] • Auxiliary inhibition of contamination: BOPP has a smooth surface, good chemical resistance, and is not easily infiltrated by guaiac. Its high mechanical strength can enhance the overall puncture resistance of the packaging material, avoiding guaiac leakage and contamination caused by packaging damage.

[0203] • Oxygen barrier properties: After biaxial stretching, BOPP has a more compact molecular arrangement, resulting in better oxygen barrier properties than ordinary unstretched polypropylene (PP). However, it is still considered a medium-to-low barrier material (oxygen permeability approximately 100-300 cm³ / (m²·24h·0.1MPa) at 23°C). This means it can reduce the penetration of external oxygen into the toothpaste system through the packaging material to a certain extent, lowering the oxygen concentration within the system and thus slightly slowing down oxidation.

[0204] III. High-Temperature Adaptability: Why it's Suitable for Solving the "High-Temperature Acceleration Problem"

[0205] The advantages of PET and BOPP are:

[0206] • Structural stability at high temperatures: Neither of them will experience significant structural damage (no softening, no large-scale relaxation of molecular chains) within the high temperature range of toothpaste storage (≤80℃). The molecular gaps remain stable, ensuring that the barrier performance does not decrease significantly.

[0207] Synergy with aluminum-plastic substrate: After adding a PET or BOPP barrier layer to the aluminum-plastic packaging, the aluminum foil in the tube body can block light and gas, and the PET or BOPP on the tube shoulder can solve the problem of guaiazoline's fat-soluble volatility. The synergistic effect can effectively resist the "volatile-penetration-infection" chain of guaiazoline.

[0208] IV. Summary

[0209] Both BOPP and PET can indirectly slow down the oxidation of guaiac by blocking oxygen penetration (core) and maintaining barrier stability at high temperatures, but the effects differ significantly.

[0210] • PET: With its high oxygen barrier properties and excellent high-temperature stability, it can significantly reduce the entry of oxygen into the system, making it a core material for slowing down oxidation.

[0211] BOPP: It has weak oxygen barrier properties and limited effect on slowing down oxidation, but it can be used as an auxiliary layer to be laminated with PET. By enhancing the overall structural stability of the packaging material, it indirectly supports the barrier effect of PET.

[0212] Based on the above analysis, conventional toothpaste tubes and toothpaste tubes with different barrier materials on the tube shoulders were used to package the toothpaste for Experiment 1 of Example 2. The tubes were then placed at 25℃, 5℃, -18℃, 45℃, and 50℃ for two weeks respectively, and the color change of the toothpaste was observed to characterize its protective effect against guaiac. The specific experimental toothpaste tubes are shown in Table 12, and the experimental results are as follows: Figures 1 to 4 As shown. Among them, the accelerated stability test at 50℃ simulates the situation where one month at high temperature is equivalent to three years at room temperature under harsh conditions.

[0213] Table 12 Test toothpaste tubes

[0214] serial number tube body shoulder 1 Aluminum-plastic composite (PE + aluminum foil + PE) PE pipe shoulder 2 Aluminum-plastic composite (PE + aluminum foil + PE) PE pipe shoulder re-injection molding PET layer 3 All plastic (PE+all plastic+PE) PE pipe shoulder re-injection molding PET layer 4 Aluminum-plastic composite (PE + aluminum foil + PE) PE and equal amounts of Bopp are mixed and blow-molded into pipe shoulders.

[0215] In this example, the toothpaste tube has an aluminum-plastic body and a PE shoulder, both of which are standard toothpaste tube sizes. The thickness of the PET layer is half the thickness of the PE shoulder.

[0216] Figures 1 to 4 The test results for toothpaste tubes numbered 1 to 4 in Table 12 are shown in order. Figure 1 , 2 The test results in section 4, from top to bottom, show the results after two weeks of storage at 25℃, 5℃, -18℃, 45℃, and 50℃. Figure 3 The results, from top to bottom, are the test results after being placed at 25℃, 45℃, and 50℃ for two weeks.

[0217] Figures 1 to 4 The results showed that adding a barrier layer was better than not adding one, providing better protection against guaiac, and that aluminum-plastic composite pipes were more effective than all-plastic flexible pipes. Furthermore, as analyzed earlier, after mixing PE and Bopp and blow molding it into a pipe shoulder, a PET layer can be injection molded to form a PET+Bopp combined protective barrier.

[0218] The above description, in conjunction with specific embodiments, provides a further detailed explanation of this application and should not be construed as limiting the specific implementation of this application to these descriptions. Those skilled in the art to which this application pertains can make several simple deductions or substitutions without departing from the concept of this application.

Claims

1. An oral care composition, characterized in that: Including guaiac, allantoin, and dipotassium glycyrrhizate.

2. The oral care composition according to claim 1, characterized in that: The weight ratio of guaiac, allantoin and dipotassium glycyrrhizate is (0.01-0.1):(0.05-0.5):(0.05-2).

3. The oral care composition according to claim 1 or 2, characterized in that: It also includes solvents, used to disperse or dissolve the components; Preferably, the solvent is water.

4. The oral care composition according to claim 3, characterized in that: It also includes at least one of the following: humectants, preservatives, fragrances, sweeteners, and foaming agents.

5. The oral care composition according to claim 4, characterized in that: The moisturizer includes at least one of polyethylene glycol 400, glycerin, sorbitol, and propylene glycol; Optionally, the moisturizer is composed of polyethylene glycol 400, glycerin and sorbitol, or the moisturizer is composed of polyethylene glycol 400, sorbitol and propylene glycol.

6. The oral care composition according to claim 4, characterized in that: The preservative includes sodium benzoate.

7. The oral care composition according to claim 4, characterized in that: The fragrance agent includes flavorings.

8. The oral care composition according to claim 4, characterized in that: The sweetener includes at least one of sucralose and sodium saccharin.

9. The oral care composition according to claim 4, characterized in that: The foaming agent includes at least one of sodium lauryl sulfate and disodium cocoyl glutamate.

10. Use of the oral care composition according to any one of claims 1-9 in the preparation of mouthwash, oral spray, toothpaste or oral repair gel.

11. A mouthwash prepared using the oral care composition according to any one of claims 1-9.

12. The mouthwash according to claim 11, characterized in that: Includes the oral care composition according to any one of claims 1-9 and a solubilizer; Optionally, the solubilizer is at least one of poloxamer 407 and PEG-40 hydrogenated castor oil.

13. The mouthwash according to claim 11 or 12, characterized in that: It also includes appearance improvers; Optionally, the appearance improver is at least one of CI 19140 and CI 42053.

14. The mouthwash according to any one of claims 11-13, characterized in that: The mouthwash is a blue or dark blue liquid.

15. Toothpaste prepared using the oral care composition according to any one of claims 1-9.

16. The toothpaste according to claim 15, characterized in that: Includes the oral care composition and abrasive as described in any one of claims 1-9; Optionally, the friction agent includes at least one of friction-type silica, thickened silica, dicalcium phosphate, and calcium pyrophosphate.

17. The toothpaste according to claim 16, characterized in that: It also includes at least one of thickeners, whitening enhancers, anti-caries agents, and appearance improvers.

18. The toothpaste according to claim 17, characterized in that: The thickener includes at least one of carrageenan, cellulose gum, and hydroxyethyl cellulose; Optionally, the whitening enhancer includes tetrasodium pyrophosphate; Optionally, the caries-preventing agent includes sodium monofluorophosphate; Optionally, the appearance modifier includes at least one of CI 17200.

19. The toothpaste according to any one of claims 15-18, characterized in that: The toothpaste is blue or dark blue.

20. The toothpaste according to any one of claims 15-18, characterized in that: The toothpaste is packaged in a toothpaste tube. The tube body is an aluminum-plastic composite tube, and the shoulder of the toothpaste tube contains a barrier material or a barrier layer formed by the barrier material. The barrier material includes at least one of PET and Bopp. Optionally, the shoulder is made of a mixture of PE and Bopp, and / or the shoulder is first made of PE and then PET is injection molded onto the PE shoulder to form a barrier layer.

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