Oral care composition and preparation method thereof

Abstract

The invention discloses an oral care composition and a preparation method thereof, the oral care composition comprises a friction agent, a periodontal repair agent, a thickening agent, a humectant and a foaming agent, the friction agent comprises a dental plaque release agent, and the dental plaque release agent is configured to destroy a bacterial extracellular polysaccharide matrix in dental plaque; the periodontal repair agent comprises at least one of the following components: an inflammation inhibitor, a tissue repair promoter, a mucous membrane stimulation alleviator and a bacteriostatic agent. The oral care composition contains the dental plaque release agent and the periodontal repair agent, and can synergistically improve periodontal health.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of oral care, in particular to an oral care composition and a preparation method thereof. BACKGROUND

[0002] Toothpaste is a commonly used oral care product in daily life, which usually exists in the form of paste. By cooperating with toothbrush, toothpaste achieves the purpose of cleaning teeth and preventing oral diseases through physical friction and chemical action. Dental plaque is a soft biofilm of colorless or light yellow, which is mainly composed of bacteria, bacterial metabolites, saliva components, food residues and the like. These components adhere to the surface of teeth and form a layer of viscous film, especially at the gum edge, tooth gap and around the denture. When the dental plaque accumulates more, it is easy to stimulate the periodontal and cause inflammation, leading to periodontal disease. Periodontal disease is a chronic inflammatory disease of gingiva and periodontal tissue. Mild periodontal disease, i.e. gingivitis, can cause symptoms such as gingival swelling and bleeding. Severe periodontal disease, i.e. periodontitis, can cause oral odor, gingival atrophy, tooth loosening, periodontal pocket formation, tooth loosening, and even tooth loss. It is necessary to reasonably use oral care products to improve oral health status, which is very necessary to reduce the incidence of periodontal disease. Therefore, it is necessary to provide an oral care composition which is helpful to improve periodontal health. SUMMARY

[0003] The present application provides an oral care composition and a preparation method thereof, which are used to solve the problem of poor effect of improving periodontal health in the existing oral care products.

[0004] This application discloses an oral care composition comprising: an abrasive, a periodontal repair agent, a thickener, a humectant, and a foaming agent. The abrasive includes a plaque-removing agent configured to disrupt the bacterial extracellular polysaccharide matrix in dental plaque. The periodontal repair agent includes at least one of the following: an inflammation inhibitor, a tissue repair promoter, a mucosal irritation reliever, or an antibacterial agent. It should be noted that the oral care composition of this application contains both a periodontal repair agent and a plaque-removing agent that disrupts the bacterial extracellular polysaccharide matrix in dental plaque. By first disintegrating dental plaque and then repairing periodontal tissue, the two work synergistically to help improve periodontal health more effectively. Specifically, dental plaque biofilms have strong resistance; bacteria in the biofilm are protected within a dense matrix formed by extracellular polysaccharides. This matrix acts as a barrier, tolerating dryness and resisting the penetration of host defense components or drugs, which are generally difficult for abrasives to penetrate. The plaque-removing agent of this application can destroy the extracellular polysaccharide matrix of bacteria in plaque, thereby facilitating plaque loosening and aiding in its removal under mechanical cleaning force. When combined with the periodontal repair agent of this application, it repairs the periodontal tissues, synergistically improving periodontal health in conjunction with the plaque-removing agent. Furthermore, the periodontal repair agent can synergistically repair periodontal tissues, such as the gingiva, through one or more mechanisms, including improving inflammation, tissue repair, cell proliferation and remodeling processes, and inhibiting bacterial growth, to further improve periodontal health.

[0005] In one implementation of this application, the plaque-removing agent comprises sodium bicarbonate. It should be noted that dental plaque biofilms possess strong resistance; the high-viscosity plaque matrix acts as a barrier, tolerating dryness and resisting the penetration of host defense components or drugs, thus reducing plaque sensitivity to drugs. Bacteria within the biofilm are protected within the dense structure of extracellular polysaccharides, shielding them from host defense mechanisms and therapeutic drugs. Dental plaque forms a matrix structure that is typically difficult for ordinary abrasives to penetrate. Sodium bicarbonate microcrystals can penetrate this matrix structure, disrupting the extracellular polysaccharide matrix of dental plaque, breaking the bridge chains in the biofilm, loosening the plaque, and enhancing the mechanical cleaning ability during brushing, thereby facilitating plaque removal.

[0006] In one implementation of this application, the periodontal repair agent comprises all of the following: an inflammation inhibitor, a tissue repair promoter, a mucosal irritation reliever, and an antibacterial agent. It should be noted that the periodontium is easily irritated by factors such as bacterial infection and improper brushing, leading to inflammation. Periodontal disease (such as gingivitis and periodontitis) is essentially a chronic inflammatory disease, its development driven by the excessive release of inflammatory factors during the immune response. These inflammatory factors can cause vasodilation and damage to periodontal supporting structures. By inhibiting inflammatory factors, the excessive response of the immune system can be regulated, resulting in long-term improvement of periodontal health. Periodontal disease (such as gingivitis and periodontitis) can lead to gingival bleeding, alveolar bone resorption, and periodontal ligament damage. By promoting tissue repair, it can accelerate tissue repair, close wounds, strengthen gingival tissue, and thus improve periodontal health. For individuals with sensitive oral mucosa, certain ingredients in toothpaste (such as abrasives) may cause irritation. Periodontal inflammation is often accompanied by swollen and red gums, burning sensation, and pain when brushing. Relieving oral mucosal irritation can soothe and calm the affected area, reducing local discomfort and preventing further inflammation. The oral cavity contains various bacteria, some of which are closely related to oral diseases such as tooth decay and periodontitis. Inhibiting the growth of oral bacteria (such as plaque-causing bacteria) can inhibit plaque accumulation at its source and improve periodontal health. In this application, multiple mechanisms, including inhibiting inflammation, promoting tissue repair, relieving oral mucosal irritation, and inhibiting oral bacterial growth, synergistically promote periodontal (e.g., gingival) repair, which is beneficial for further protecting periodontal health. Furthermore, sodium bicarbonate has a poor taste (it is salty), and the oral care composition is an anhydrous system, which can irritate the oral mucosa. A mucosal irritation reliever can help alleviate oral irritation.

[0007] In one implementation of this application, the inflammation inhibitor includes at least one of the following: dipotassium glycyrrhizate and arginine; the tissue repair promoter includes at least one of the following: allantoin and guaiac; the mucosal irritation reliever includes at least one of the following: sodium hyaluronate and bisabolol; and the antibacterial agent includes at least one of the following: clove oil, eucalyptus oil, tea tree oil, and fluoride. It should be noted that the periodontal repair agents of this application are all of natural origin or highly biocompatible components, with low toxicity and high safety. Their mechanisms of action are milder, and they can synergistically promote periodontal (e.g., gingival) repair through multiple mechanisms (e.g., inhibiting inflammation, promoting tissue repair, relieving oral mucosal irritation, and inhibiting oral bacterial growth), thus contributing to the protection of periodontal health. In addition, the periodontal repair agent of this application does not include tranexamic acid (a chemically synthesized drug) commonly used in the industry. Although tranexamic acid can stop bleeding quickly, it only treats the symptoms and not the root cause. It cannot improve the periodontal inflammation and is not suitable for long-term use. It may cause drug resistance in consumers and may even delay the best time for periodontitis treatment because the toothpaste masks the symptoms of bleeding gums. Among them: dipotassium glycyrrhizate can block the release of arachidonic acid, thereby reducing the synthesis of downstream inflammatory mediators; arginine can inhibit the NF-κB inflammatory pathway; allantoin can promote cell proliferation and migration, soften the keratin layer, and remove necrotic tissue; guaiac can improve local blood circulation, which is beneficial to tissue regeneration, and has anti-inflammatory and soothing effects; the combined use of allantoin and guaiac can achieve a synergistic effect of "anti-inflammatory → repair"; sodium hyaluronate can form a hydrating protective film on the damaged oral mucosa surface, isolate external stimuli, and can also penetrate into the gingival tissue, increase the water content of the gingival tissue, improve the flexibility and elasticity of the gingiva, and help activate the proliferation of fibroblasts and epithelial cells, accelerate wound healing, help prevent gingival recession, and also have a certain auxiliary effect in reducing gingival inflammation; bisabolol can reduce capillary permeability and reduce redness. It relieves swelling, heat, and pain, accelerates epidermal repair, and shortens the recovery time of mucosal damage. When sodium hyaluronate and bisabolol are used together, they achieve multiple soothing effects of "physical protection + biological repair + anti-inflammatory and sedative effects." Clove oil contains the active ingredient eugenol, which can inhibit bacterial growth by disrupting cell membrane structure, inhibiting the activity of key enzymes (such as dehydrogenases, ATPases, and proteases), and inhibiting the formation of dental plaque biofilm. Eucalyptus oil contains the active ingredient 1,8-cineole, which can inhibit bacterial growth through mechanisms such as disrupting cell membrane integrity, inhibiting the bacterial respiratory chain, and anti-biofilm activity. Tea tree oil can inhibit bacterial growth by increasing cell membrane permeability, inducing oxidative stress, and inhibiting bacterial sensitization. Fluoride can inhibit bacterial glycolytic enzymes, reduce bacterial acid production, and enhance the acid resistance of tooth enamel (stannous fluoride also has a direct bactericidal effect). Through the synergistic effect of multiple antibacterial agents, a broad-spectrum antibacterial effect can be enhanced, more effectively inhibiting the growth of oral bacteria, thereby inhibiting the accumulation of dental plaque from the source and improving periodontal health.

[0008] In one implementation of this application, the abrasive does not release ions in the humectant that can combine with fluoride to form fluoride precipitates, or the solubility product of the abrasive in the humectant is less than the solubility product of the fluoride formed by the combination of its released ions and fluoride. It should be noted that when periodontal repair agents contain fluoride (e.g., sodium fluoride), some abrasives may release ions that can react with fluoride to form fluoride precipitates (e.g., calcium fluoride). This not only causes the fluoride in the periodontal repair agent to become ineffective, but also causes instability and hardening of the oral care composition. Therefore, it is necessary to ensure that the abrasive does not release ions in the humectant that can combine with fluoride to form fluoride precipitates, or that the solubility product of the abrasive in the humectant is less than the solubility product of the fluoride formed by the combination of its released ions and fluoride, in order to reduce the formation of fluoride precipitates.

[0009] In one implementation of this application, the oral care composition does not contain water. It should be noted that making the oral care composition an anhydrous system has the following advantages: an anhydrous system helps reduce the formation of fluoride precipitates; in an anhydrous system, sodium bicarbonate is less likely to decompose and produce carbon dioxide, thus preventing the formula from bloating.

[0010] In one implementation of this application, the abrasive further includes at least one of the following: silica, calcium pyrophosphate, dicalcium phosphate, and calcium carbonate. It should be noted that sodium bicarbonate is a white crystalline powder with a certain hardness, which can generate a certain mechanical friction effect and help loosen dental plaque; the addition of silica and / or dicalcium phosphate with medium to high cleaning power can enhance the mechanical cleaning power of the oral care composition and reduce the salty feeling caused by sodium bicarbonate abrasive, making brushing more comfortable; dicalcium phosphate and calcium carbonate are commonly used abrasives, but in anhydrous systems, they may still partially react with fluoride to produce calcium fluoride precipitate. Therefore, silica and / or dicalcium phosphate are preferred; in addition, hydrated compounds such as dicalcium phosphate dihydrate will introduce water into the oral care composition system, so this application does not consider using them.

[0011] In one implementation of this application, the oral care composition, by weight, comprises: 5-50 parts of the abrasive, 1-5.5 parts of the periodontal repair agent, 0.5-2 parts of the thickener, 38-65 parts of the humectant, and 1.5-3 parts of the foaming agent. It should be noted that, through appropriate proportions, the oral care composition can achieve good cleaning effect, palatability, and periodontal repair effect.

[0012] In one implementation of this application, the periodontal repair agent, by weight, comprises: 0.2-0.5 parts of dipotassium glycyrrhizate, 0.2-0.5 parts of arginine, 0.01-0.5 parts of allantoin, 0.001-0.5 parts of guaiac, 0.01-0.5 parts of sodium hyaluronate, 0.01-0.5 parts of bisabolol, 0.01-0.5 parts of clove oil, 0.01-0.5 parts of eucalyptus oil, 0.01-0.5 parts of tea tree oil, and 0.76-1.1 parts of fluoride. It should be noted that this enables the oral care composition to have a good periodontal repair effect.

[0013] This application also discloses a method for preparing the above-mentioned oral care composition, comprising the following steps: adhesive preparation step: weigh each component according to the ratio, add the thickener to part of the humectant, heat, and stir evenly to obtain adhesive; paste preparation step: if polyvinylpyrrolidone is available, add polyvinylpyrrolidone under heating conditions, stir evenly until swollen, add the remaining humectant, and then add the remaining components; subsequently, stir at room temperature, degas under vacuum, and obtain paste, which is the oral care composition.

[0014] The beneficial effects of this application are as follows:

[0015] The oral care composition of this application contains a periodontal repair agent and a plaque-removing agent that can destroy the bacterial extracellular polysaccharide matrix in dental plaque. By first breaking down dental plaque and then repairing periodontal tissues, the two work synergistically to help improve periodontal health more effectively. It should be noted that dental plaque biofilms have strong resistance; the bacteria in the biofilm are protected within a dense matrix formed by extracellular polysaccharides. This matrix acts as a barrier, tolerating dryness and resisting the penetration of host defense components or drugs, making it difficult for general abrasives to penetrate. The plaque-removing agent of this application can destroy the bacterial extracellular polysaccharide matrix in dental plaque, thereby facilitating plaque loosening and aiding in its removal under mechanical cleaning forces. Furthermore, the periodontal repair agent of this application, combined with improvements in inflammation, tissue repair, cell proliferation and remodeling processes, and bacterial growth, repairs periodontal tissues such as the gingiva. Detailed Implementation

[0016] The present invention will be further described in detail below through specific embodiments. In the following embodiments, many details are described to facilitate a better understanding of this application. However, those skilled in the art will readily recognize that some features may be omitted in different situations, or may be replaced by other materials or methods. In some cases, certain operations related to this application are not shown or described in the specification. This is to avoid obscuring the core parts of this application with excessive description. For those skilled in the art, detailed description of these related operations is not necessary; they can fully understand the related operations based on the description in the specification and general technical knowledge in the art.

[0017] Furthermore, the features, operations, or characteristics described in the specification can be combined in any suitable manner to form various embodiments. At the same time, the steps or actions in the method description can be rearranged or adjusted in a manner obvious to those skilled in the art. Therefore, the various orders in the specification are only for clearly describing a particular embodiment and do not imply a necessary order, unless otherwise stated that a particular order must be followed.

[0018] The serial numbers assigned to components in this article, such as "first" and "second", are used only to distinguish the objects being described and have no sequential or technical meaning.

[0019] Periodontal disease is a chronic inflammatory disease of the gums and periodontal tissues. Mild periodontal disease, also known as gingivitis, can cause symptoms such as red, swollen, and bleeding gums. Severe periodontal disease, also known as periodontitis, can lead to gum recession, bone loosening, periodontal pocket formation, tooth loosening, periodontal pus discharge, bad breath, and even tooth loss. Periodontal disease is a leading cause of tooth loss in adults. Therefore, it is essential to use oral care products appropriately to improve oral health and reduce the incidence of periodontal disease. Currently, many commercially available gum-protecting toothpastes claim their gum-protecting effects by adding tranexamic acid and other gum-protecting ingredients. However, tranexamic acid is a prescription drug; while it can mask bleeding gums, it may delay the optimal treatment for periodontitis. In view of this, this application provides an oral care composition for improving periodontal health. This application uses a plaque loosening agent to promote plaque shedding, and combines it with active ingredients to protect periodontal tissues by inhibiting inflammatory factors, promoting tissue repair, relieving oral mucosal irritation, and inhibiting the growth of oral bacteria. This can achieve the effect of quickly inhibiting plaque and reducing gum problems. At the same time, the oral care composition of this application has a stable formula and is easy to manufacture.

[0020] This application provides an oral care composition.

[0021] In one specific embodiment, the oral care composition includes an abrasive.

[0022] In one specific embodiment, the abrasive may include sodium bicarbonate. Sodium bicarbonate is a white crystalline powder with particles of a certain hardness, which can generate a certain mechanical abrasive effect. Furthermore, dental plaque biofilms have strong resistance; the high-viscosity plaque matrix acts as a barrier, can withstand drying, and resists the penetration of host defense components or drugs, reducing the plaque's sensitivity to drugs. Bacteria in the biofilm are protected within the dense structure of extracellular polysaccharides, shielding them from host defense mechanisms and therapeutic drugs. Dental plaque forms a matrix structure that is generally difficult for ordinary abrasives to penetrate. Sodium bicarbonate microcrystals can penetrate the matrix structure, disrupting the extracellular polysaccharide matrix of dental plaque, breaking the bridge chains in the biofilm, loosening the plaque, and enhancing the mechanical cleaning ability during brushing, thereby facilitating plaque removal.

[0023] In one specific embodiment, the average particle size of sodium bicarbonate is 5 μm to 30 μm.

[0024] In one specific embodiment, the oral care composition does not contain water. That is, the oral care composition of this application is an anhydrous system. It should be noted that in an anhydrous system, sodium bicarbonate is not easily decomposed to produce carbon dioxide, which would cause the formula to bloat.

[0025] In one specific embodiment, the abrasive in the oral care composition does not release ions that can combine with fluoride to form fluoride precipitates, or the solubility product of the abrasive in the oral care composition is less than the solubility product of the fluoride formed by the combination of its released ions and fluoride. This helps to avoid the reaction between the abrasive and fluoride-containing active ingredients (such as periodontal repair agents described later) to form fluoride precipitates, which could lead to the inactivation of the active ingredients and changes in the texture of the oral care composition product.

[0026] In one specific embodiment, the abrasive may further include other abrasives. Other abrasives include at least one of silica and calcium pyrophosphate. It should be noted that sodium bicarbonate helps loosen dental plaque, and when combined with silica and / or calcium pyrophosphate, which have medium to high cleaning power (typically with an RDA value between 80 and 120 for silica and between 90 and 120 for calcium pyrophosphate), it can further enhance physical friction during brushing. Simultaneously, it can reduce the salty sensation caused by sodium bicarbonate abrasive, resulting in a better brushing experience. The average particle size of silica can be 5 μm to 20 μm. The average particle size of calcium pyrophosphate can be 5 μm to 25 μm. Other abrasives may also be selected from dicalcium phosphate and calcium carbonate. However, dicalcium phosphate and calcium carbonate may still partially react with fluoride in an anhydrous system to produce calcium fluoride precipitate; therefore, other abrasives are preferably selected from silica and pyrophosphate. Furthermore, hydrated compounds such as dicalcium phosphate dihydrate are not considered for use in this application because they introduce water into the oral care composition system.

[0027] In one specific embodiment, the oral care composition comprises, by weight, 5 to 50 parts of an abrasive. For example, it may include 5, 10, 15, 20, 25, 30, 35, 40, 45, or 50 parts of an abrasive.

[0028] In one specific embodiment, the oral care composition may include 5 to 50 parts by weight of sodium bicarbonate. For example, it may include 5, 10, 15, 20, 25, 30, 35, 40, 45, or 50 parts of sodium bicarbonate.

[0029] In one specific embodiment, the oral care composition may include 5 to 30 parts by weight of other abrasives.

[0030] In one specific embodiment, the oral care composition may include 0 to 20 parts by weight of silica. For example, it may include 0, 5, 10, 15, or 20 parts of silica.

[0031] In one specific embodiment, the oral care composition may include 0 to 20 parts by weight of calcium pyrophosphate. For example, it may include 0, 5, 10, 15, or 20 parts of calcium pyrophosphate.

[0032] In one specific embodiment, the oral care composition further includes a moisturizer.

[0033] In one specific embodiment, the humectant may be selected from at least one of the following: glycerin, polyethylene glycol, and propylene glycol. This allows for adjustment of the viscosity of the oral care composition, contributing to a good texture for easy extrusion and good firmness. Furthermore, the humectant of this application is preferably a low-heat-generating component, thereby reducing the likelihood of the oral care composition generating heat upon contact with water during use, which helps to minimize the decomposition and deactivation of sodium bicarbonate.

[0034] In one specific embodiment, the abrasive does not release ions in the humectant that can combine with fluorine to form fluoride precipitates, or the solubility product of the abrasive in the humectant is less than the solubility product of the fluoride formed by the combination of its released ions and fluorine.

[0035] In one specific embodiment, the oral care composition comprises, by weight, 38 to 65 parts of a moisturizer. For example, it may include 38, 40, 45, 50, 55, 60, or 65 parts of a moisturizer.

[0036] In one specific embodiment, the oral care composition may include 35 to 60 parts by weight of glycerin. For example, it may include 35, 40, 45, 50, 55, or 60 parts of glycerin.

[0037] In one specific embodiment, the oral care composition may include 3 to 5 parts by weight of polyethylene glycol. For example, it may include 3, 3.5, 4, 4.5, or 5 parts of polyethylene glycol.

[0038] In one specific embodiment, the oral care composition may include 1 to 5 parts by weight of propylene glycol. For example, it may include 1, 2, 3, 4, or 5 parts of propylene glycol.

[0039] In one specific embodiment, the oral care composition further includes a periodontal repair agent. It should be noted that the periodontal repair agent can improve or protect periodontal tissues and can synergistically improve periodontal health in conjunction with plaque removers.

[0040] In one specific embodiment, the periodontal repair agent includes at least one of the following: an inflammation inhibitor, a tissue repair promoter, a mucosal irritation reliever, and an antibacterial agent. It should be noted that it can improve periodontal health through multiple mechanisms.

[0041] In one specific embodiment, the periodontal repair agent comprises all of the following: an inflammation inhibitor, a tissue repair promoter, a mucosal irritation reliever, and an antibacterial agent. It should be noted that periodontal disease (such as gingivitis and periodontitis) is essentially a chronic inflammatory disease. Its development is driven by the excessive release of inflammatory factors during the immune response. These inflammatory factors can lead to vasodilation and damage to periodontal supporting structures. By inhibiting inflammatory factors, the excessive response of the immune system can be regulated, thus improving periodontal health in the long term. Periodontal disease (such as gingivitis and periodontitis) can cause gingival bleeding, alveolar bone resorption, and periodontal ligament damage. By promoting tissue repair, it can accelerate tissue repair, close wounds, and strengthen gingival tissue, thereby improving periodontal health. Periodontal inflammation is often accompanied by gingival redness and swelling, burning sensation, and pain when brushing teeth. By relieving oral mucosal irritation, it can have a soothing and calming effect, reducing local discomfort and preventing irritation from aggravating inflammation. Clove oil, eucalyptus oil, tea tree oil, and fluoride can inhibit the growth of oral bacteria. By inhibiting the growth of oral bacteria (such as plaque-causing bacteria), plaque accumulation can be suppressed at its source, improving periodontal health. In this application, periodontal (e.g., gingival) repair is promoted through multiple mechanisms, including inhibiting inflammation, promoting tissue repair, relieving oral mucosal irritation, and inhibiting oral bacterial growth, which is beneficial for further protecting periodontal health. In addition, sodium bicarbonate has a poor taste (sodium bicarbonate has a salty taste), and the oral care composition is an anhydrous system, which has a certain irritating effect on the oral mucosa. The mucosal irritation reliever can help alleviate oral irritation.

[0042] In one specific embodiment, the inflammation inhibitor includes at least one of the following: dipotassium glycyrrhizate and arginine. It should be noted that dipotassium glycyrrhizate can block the release of arachidonic acid, thereby reducing the synthesis of downstream inflammatory mediators; arginine can inhibit the NF-κB inflammatory pathway.

[0043] In one specific embodiment, the tissue repair promoter includes at least one of the following: allantoin and guaiac. It should be noted that allantoin can promote cell proliferation and migration, soften the stratum corneum, and remove necrotic tissue; guaiac can improve local blood circulation, which is beneficial to tissue regeneration, and has anti-inflammatory and soothing effects; the combined use of allantoin and guaiac can achieve a synergistic effect of "anti-inflammatory → repair".

[0044] In one specific embodiment, the mucosal irritation reliever includes at least one of the following: sodium hyaluronate and bisabolol. It should be noted that sodium hyaluronate can form a hydrating protective film on the surface of damaged oral mucosa, isolating it from external stimuli, and can also help activate the proliferation of fibroblasts and epithelial cells, accelerating wound healing; bisabolol can reduce capillary permeability, alleviate redness, swelling, heat, and pain, accelerate epidermal repair, and shorten the recovery time of mucosal damage; when sodium hyaluronate and bisabolol are used in combination, they can achieve multiple soothing effects of "physical protection + biological repair + anti-inflammatory and sedative effects".

[0045] In one specific embodiment, the antibacterial agent includes at least one of the following: clove oil, eucalyptus oil, tea tree oil, and fluoride. Fluoride may include at least one of sodium monofluorophosphate, sodium fluoride, stannous fluoride, and olaflumethrin. It should be noted that clove oil contains the active ingredient eugenol, which can inhibit bacterial growth by disrupting cell membrane structure, inhibiting the activity of key enzymes (such as dehydrogenases, ATPases, proteases, etc.), and inhibiting the formation of dental plaque biofilm; eucalyptus oil contains the active ingredient 1,8-cineole, which can inhibit bacterial growth by disrupting cell membrane integrity, inhibiting the bacterial respiratory chain, and acting as an anti-biofilm agent; tea tree oil can inhibit bacterial growth by increasing cell membrane permeability, inducing oxidative stress, and inhibiting bacterial sensitization; fluoride can interfere with bacterial growth by inhibiting bacterial glycolytic enzymes, reducing bacterial acid production, and enhancing the acid resistance of tooth enamel (stannous fluoride also has a direct bactericidal effect). By using multiple antibacterial agents in synergy, the broad-spectrum antibacterial effect can be enhanced, which can more effectively inhibit the growth of oral bacteria, thereby inhibiting the accumulation of dental plaque from the source and improving periodontal health.

[0046] It should also be noted that the periodontal repair agents in this application are all of natural origin or highly biocompatible ingredients, with low toxicity and high safety. Their mechanisms of action are gentler, and they can synergistically promote periodontal (e.g., gingival) repair through multiple mechanisms (e.g., inhibiting inflammation, promoting tissue repair, relieving oral mucosal irritation, and inhibiting oral bacterial growth), thus contributing to periodontal health. Furthermore, the periodontal repair agents in this application do not include tranexamic acid (a chemically synthesized drug) commonly used in the industry. While tranexamic acid can quickly stop bleeding, it only treats the symptoms and not the root cause, failing to improve periodontal inflammation and being unsuitable for long-term use. This may lead to drug resistance in consumers, and even delay optimal periodontitis treatment due to toothpaste masking gingival bleeding symptoms.

[0047] In one specific embodiment, the oral care composition includes, by weight, 1 to 5.5 parts of periodontal repair agent. For example, it may include 1 part, 1.5 parts, 2 parts, 2.5 parts, 3 parts, 3.5 parts, 4 parts, 4.5 parts, 5 parts, or 5.5 parts of periodontal repair agent.

[0048] In one specific embodiment, the oral care composition may include 0.2 to 1 part by weight of an inflammation inhibitor. For example, it may include 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, or 1 part of an inflammation inhibitor.

[0049] In one specific embodiment, the oral care composition may include 0.2 to 0.5 parts by weight of dipotassium glycyrrhizate. For example, it may include 0.2, 0.3, 0.4, or 0.5 parts of dipotassium glycyrrhizate.

[0050] In one specific embodiment, the oral care composition may include 0.2 to 0.5 parts by weight of arginine. For example, it may include 0.2, 0.3, 0.4, or 0.5 parts of arginine.

[0051] In one specific embodiment, the oral care composition may include 0.01 to 1 part by weight of a tissue repair promoter. For example, it may include 0.01, 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, or 1 part of a tissue repair promoter.

[0052] In one specific embodiment, the oral care composition may include 0.01 to 0.5 parts by weight of allantoin. For example, it may include 0.01, 0.1, 0.2, 0.3, 0.4, or 0.5 parts of allantoin.

[0053] In one specific embodiment, the oral care composition may include 0.001 to 0.5% of guaiac by weight. For example, it may include 0.001, 0.01, 0.1, 0.2, 0.3, 0.4, or 0.5 parts of guaiac.

[0054] In one specific embodiment, the oral care composition may include 0.01 to 1 part by weight of a mucosal irritation reliever. For example, it may include 0.01, 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, or 1 part of a mucosal irritation reliever.

[0055] In one specific embodiment, the oral care composition may include 0.01 to 0.5 parts of sodium hyaluronate by weight. For example, it may include 0.01, 0.1, 0.2, 0.3, 0.4, or 0.5 parts of sodium hyaluronate.

[0056] In one specific embodiment, the oral care composition may include 0.01 to 0.5 parts by weight of bisabolol. For example, it may include 0.01, 0.1, 0.2, 0.3, 0.4, or 0.5 parts of bisabolol.

[0057] In one specific embodiment, the oral care composition may include 0.8 to 2.6 parts by weight of an antibacterial agent. For example, it may include 0.8, 1, 1.5, 2, or 2.6 parts of an antibacterial agent.

[0058] In one specific embodiment, the oral care composition may include 0.01 to 0.5 parts of clove oil by weight. For example, it may include 0.01, 0.1, 0.2, 0.3, 0.4, or 0.5 parts of clove oil.

[0059] In one specific embodiment, the oral care composition may include 0.01 to 0.5 parts by weight of eucalyptus oil. For example, it may include 0.01, 0.1, 0.2, 0.3, 0.4, or 0.5 parts of eucalyptus oil.

[0060] In one specific embodiment, the oral care composition may include 0.01 to 0.5 parts by weight of tea tree oil. For example, it may include 0.01, 0.1, 0.2, 0.3, 0.4, or 0.5 parts of tea tree oil.

[0061] In one specific embodiment, the oral care composition may include 0.76 to 1.1 parts by weight of fluoride. For example, it may include 0.76 parts, 0.8 parts, 0.85 parts, 0.9 parts, 0.95 parts, 1 part, 1.05 parts, or 1.1 parts of fluoride.

[0062] In one embodiment, the oral care composition further includes a thickener.

[0063] In one specific embodiment, the thickener includes at least one of the following: microcrystalline cellulose, sodium carboxymethyl cellulose, polyvinylpyrrolidone, hydroxypropyl cassia gum, and hydroxyethyl cellulose. It should be noted that microcrystalline cellulose has good flowability and compressibility, providing a stable matrix structure for toothpaste, helping to maintain the uniformity of the paste, and facilitating smoother extrusion of toothpaste from the tube, reducing the likelihood of clogging or separation. Sodium carboxymethyl cellulose has water solubility and high viscosity, effectively increasing the viscosity of the toothpaste, preventing component separation, and maintaining the stability and extrusion performance of the paste. The combination of microcrystalline cellulose and sodium carboxymethyl cellulose also helps the toothpaste maintain a more stable state under different ambient temperatures, reducing the impact of temperature changes on the paste structure. Furthermore, the anionic form of sodium carboxymethyl cellulose can prevent the aggregation of microcrystalline cellulose, thereby improving the stability of the thickening composition and the toothpaste. Polyvinylpyrrolidone forms a film, prevents staining, and stabilizes foam. Hydroxypropyl cassia gum exhibits good thixotropy, remaining viscous when still and thinning upon extrusion (shear thinning), making it easy to extrude and less prone to separation. It can synergistically improve overall stability when used with cellulose-based thickeners. Hydroxyethyl cellulose can increase formulation viscosity and exhibits significant shear thinning (pseudoplasticity).

[0064] In one specific embodiment, the oral care composition may include 0.5 to 2 parts by weight of a thickener. For example, it may include 0.5, 1, 1.5, or 2 parts by weight of a thickener.

[0065] In one specific embodiment, the oral care composition may include 0.5 to 2 parts by weight of microcrystalline cellulose. For example, it may include 0.5 parts, 1 part, 1.5 parts, or 2 parts of microcrystalline cellulose.

[0066] In one specific embodiment, the oral care composition may include 0.01 to 1 part of sodium carboxymethyl cellulose by weight. For example, it may include 0.01, 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, or 1 part of sodium carboxymethyl cellulose.

[0067] In one specific embodiment, the oral care composition may include 0.1 to 2 parts by weight of polyvinylpyrrolidone. For example, it may include 0.1, 0.5, 1, 1.5, or 2 parts of polyvinylpyrrolidone.

[0068] In one specific embodiment, the oral care composition may include 0 to 1 parts by weight of hydroxypropyl cassia gelatin. For example, it may include 0 parts, 0.1 parts, 0.2 parts, 0.3 parts, 0.4 parts, 0.5 parts, 0.6 parts, 0.7 parts, 0.8 parts, 0.9 parts, or 1 part of hydroxypropyl cassia gelatin.

[0069] In one specific embodiment, the oral care composition may include 0 to 1 part by weight of hydroxyethyl cellulose. For example, it may include 0, 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, or 1 part of hydroxyethyl cellulose.

[0070] In one embodiment, the oral care composition further includes a foaming agent. The foaming agent may include at least one of sodium lauryl sulfate, cocamidopropyl betaine, sodium lauroyl sarcosinate, disodium lauroyl glutamate, disodium cocoyl glutamate, sodium methyl lauroyl taurate, sodium methyl cocoyl taurate, and sodium cocoyl methyl taurate.

[0071] In one specific embodiment, the oral care composition may include 1.5 to 3 parts by weight of a foaming agent. For example, it may include 1.5, 2, 2.5, or 3 parts of hydroxyethyl cellulose.

[0072] In one specific embodiment, the oral care composition further includes a fragrance. The fragrance may include at least one of the following: marine flavoring, peach flavoring, tea flavoring, bergamot flavoring, eucalyptus flavoring, citrus flavoring, lemon flavoring, coffee flavoring, peppermint flavoring, menthol, licorice flavoring, wintergreen flavoring, coffee flavoring, vanilla flavoring, lime flavoring, apple flavoring, peach flavoring, mango flavoring, cherry flavoring, blueberry flavoring, strawberry flavoring, cola flavoring, cinnamon flavoring, vanilla flavoring, and watermelon flavoring. The fragrance may also be other types of flavorings suitable for oral use, which will not be detailed herein.

[0073] In one specific embodiment, the oral care composition may include 0.8 to 1.2 parts by weight of a fragrance. For example, it may include 0.8, 0.9, 1, 1.1, or 1.2 parts of a fragrance.

[0074] In one specific embodiment, the oral care composition further includes a sweetener. The sweetener may include at least one selected from xylitol, sorbitol, mannitol, iodine, lactitol, maltitol, isomaltitol, hydrogenated starch hydrolysate, erythritol, maltodextrin, aspartame, acesulfame potassium, sodium saccharin, sucralose, neotame, cyclamate, alitane, steviol glycosides, arabinitol, and monk fruit sweetener. The sweetener may also be selected from other edible-grade substances, which will not be elaborated upon herein.

[0075] In one specific embodiment, the oral care composition may include 0.05 to 8 parts by weight of a fragrance. For example, it may include 0.05 parts, 0.1 parts, 1 part, 2 parts, 3 parts, 4 parts, 5 parts, 6 parts, 7 parts, or 8 parts of a fragrance.

[0076] In one embodiment, the oral care composition may further include a cooling agent. The cooling agent may include at least one of menthol, menthol derivatives, WS-3, and WS-23.

[0077] In one embodiment, the oral care composition may further include a pigment. The pigment may be an edible pigment.

[0078] In one embodiment, the oral care composition may further include a whitening agent. The whitening agent includes titanium dioxide.

[0079] This application provides a method for preparing an oral care composition.

[0080] In one specific embodiment, the preparation method includes the following steps: Adhesive preparation step: Weigh each component according to the ratio, add the thickener to part of the humectant, heat, and stir evenly to obtain adhesive; Paste preparation step: If polyvinylpyrrolidone is available, add polyvinylpyrrolidone under heating conditions, stir evenly until swollen, add the remaining humectant, and then add the remaining components; Subsequently, stir at room temperature, degas under vacuum, and obtain a paste, i.e., oral care composition.

[0081] In one specific embodiment, in the adhesive preparation step, heating refers to heating to 60℃~90℃. Stirring refers to a stirring rate of 2000~12000 rpm and a stirring time of 10~60 min.

[0082] In one specific embodiment, in the ointment preparation step, heating refers to heating to 50℃~65℃. Stirring until swelling refers to a stirring speed of 2000rpm~8000rpm and a stirring time of 2~10min. Room temperature stirring refers to stirring at room temperature (around 25℃) at 800~1200rpm for 20~40min.

[0083] The present application will be further described in detail below through specific embodiments and comparative examples. The following embodiments or comparative examples are only for further illustration of the present application and should not be construed as limiting the present application. In the embodiments or comparative examples, unless otherwise specified, the reagents and instruments used are all commercially available, and the experimental operations are all carried out in accordance with the product instructions and conventional experimental procedures.

[0084] The following toothpastes (oral care compositions) were prepared according to the formulations shown in the table below. All are anhydrous toothpastes. The preparation methods are as follows: Step 1, preparation of the glue: Weigh microcrystalline cellulose, sodium carboxymethyl cellulose, sucralose and a portion of glycerin, disperse them evenly, heat to 60℃~90℃, homogenize for 10~60 min using a homogenizer at 2000~12000r / min, cool to room temperature, and obtain the glue for later use. Step 2, paste preparation: Weigh a certain amount of glue into a beaker, add polyvinylpyrrolidone, heat to 50℃~65℃, homogenize for 5 min using a homogenizer at 5000r / min, and after full swelling and uniformity, add polyethylene glycol and the remaining glycerin and stir evenly. Then add the powders in the formulation (in no particular order) and fragrance, and stir at 1000r / min for 30 min at room temperature using a propeller mixer until the paste is fine and uniform. Degas under vacuum to obtain the toothpaste paste.

[0085]

[0086]

[0087] Performance testing:

[0088] (1) Stability of various toothpastes:

[0089] Appearance stability: The stability of each toothpaste was observed at room temperature (25℃) and 45℃, referring to the standard GB 8372-2017 "Toothpaste". The experimental results are shown in the table below. The results show that the toothpaste has good stability. (The left side of " / " represents the test results at room temperature, and the right side represents the test results at 45℃; "not forming strips" means that after the toothpaste is squeezed out, it cannot maintain a strip shape and collapses; "slightly thinner paste" means that the paste viscosity is low and it is difficult to form, and it is closer to a fluid (thinner) than the paste in the "not forming strips" case; "slightly harder" and "harder" both refer to the increase in paste viscosity. "Slightly harder" means that the paste viscosity increases slightly, and "harder" means that the paste viscosity is >600kPa·s).

[0090]

[0091] Fluorine content stability: The soluble fluoride content of each toothpaste was determined according to GB / T 8372-2017 "Toothpaste" 5.8, and the total fluoride content was determined according to GB / T 8372-2017 "Toothpaste" 5.9. The experimental results are shown in the table below. The results indicate that the soluble fluoride content of each toothpaste did not decrease over time, suggesting that the fluoride stability in each toothpaste is normal.

[0092]

[0093] (2) Clinical efficacy of various toothpastes:

[0094] A clinical study was conducted using Shige toothpaste as the experimental group to investigate its ability to inhibit dental plaque and reduce gingival inflammation, and to evaluate its clinical efficacy in inhibiting dental plaque and reducing gingivitis.

[0095] Experimental methods:

[0096] 1. The participants were healthy adult men and women who met the inclusion and exclusion criteria. A total of 78 eligible participants underwent baseline screening (pre-treatment screening), and 75 participants completed the entire 12-week study.

[0097] 2. Inclusion criteria: Age between 18 and 65 years; good general health; able to participate in examinations at any time during the 12-week trial period; good general health, no significant systemic diseases, and more than 20 intact teeth; Quigley-Hein plaque index (PI) ≥ 1.5, Loe-Silness gingival index (GI) ≥ 1.0, and bleeding index (BI) ≥ 1.0; no allergic reaction to toothpaste or its ingredients; not participating in other similar trials concurrently; and not using any medications in the month prior to participation in the study.

[0098] 3. Evaluation method: In accordance with "WS / T 326.3-2010 Inhibiting dental plaque and / or reducing gingival inflammation", the scores of plaque index (PI), gingival index (GI) and bleeding index (BI) of subjects in each group before and after the test were evaluated.

[0099] The plaque index (PI) counts of each group of subjects at baseline and one week after use are shown in the table below. Subjects using toothpaste 1 showed a plaque index increase of only 7.09% after one week of use, significantly lower than the plaque index of subjects in other toothpaste groups. After one week of product use, there was a significant difference in plaque index between the experimental group (toothpaste 1) and the control group (toothpaste 2–5) (P<0.05), with the increase rate in the experimental group being significantly lower than that in the control group.

[0100] This indicates that toothpaste 1 has a significant effect in inhibiting dental plaque.

[0101]

[0102] The gingival index (GI) counts of each group of subjects at baseline and one and two weeks after use are shown in the table below. A significant difference in GI was observed between the experimental group (toothpaste 1) and the control group (toothpaste 2–5) after two weeks of toothpaste use (P < 0.01). Compared with baseline, the GI of the experimental group after one and two weeks of using the test toothpaste was significantly lower than the baseline GI, and this difference was statistically significant (P < 0.01).

[0103]

[0104]

[0105] The bleeding index (BI) counts of each group of subjects at baseline and one and two weeks after use are shown in the table below. A significant difference in bleeding index was observed between the experimental group (toothpaste 1) and the control group (toothpastes 2–5) after two weeks of toothpaste use (P < 0.01). Compared with baseline, the bleeding index of the experimental group after one and two weeks of using the test toothpaste was significantly lower than the baseline bleeding index, and this was statistically significant (P < 0.01).

[0106]

[0107] 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, include: The product comprises an abrasive, a periodontal repair agent, a thickener, a humectant, and a foaming agent, wherein the abrasive includes a plaque-removing agent configured to destroy the bacterial extracellular polysaccharide matrix in dental plaque; and the periodontal repair agent comprises at least one of the following: an inflammation inhibitor, a tissue repair promoter, a mucosal irritation reliever, and an antibacterial agent.

2. The oral care composition according to claim 1, characterized in that, The plaque-removing agent includes sodium bicarbonate.

3. The oral care composition according to claim 1, characterized in that, The periodontal repair agent includes all of the following: inflammation inhibitors, tissue repair promoters, mucosal irritation relievers, and antibacterial agents.

4. The oral care composition according to any one of claims 1 to 3, characterized in that, The inflammation inhibitor includes at least one of the following: dipotassium glycyrrhizate and arginine; the tissue repair promoter includes at least one of the following: allantoin and guaiac; the mucosal irritation reliever includes at least one of the following: sodium hyaluronate and bisabolol; the antibacterial agent includes at least one of the following: clove oil, eucalyptus oil, tea tree oil, and fluoride.

5. The oral care composition according to claim 4, characterized in that, The fluoride includes at least one of the following: sodium monofluorophosphate, sodium fluoride, stannous fluoride, and oraflu.

6. The oral care composition according to claim 4, characterized in that, The abrasive does not release ions in the humectant that can combine with fluorine to form fluoride precipitates, or the solubility product of the abrasive in the humectant is less than the solubility product of the fluoride formed by the combination of its released ions and fluorine.

7. The oral care composition according to claim 4, characterized in that, The oral care composition contains no water.

8. The oral care composition according to claim 4, characterized in that, The friction agent also includes at least one of the following: silica, calcium pyrophosphate, calcium hydrogen phosphate, and calcium carbonate.

9. The oral care composition according to claim 8, characterized in that, The oral care composition comprises, by weight parts: 5 to 50 parts of the abrasive, 1 to 5.5 parts of the periodontal repair agent, 0.5 to 2 parts of the thickener, 38 to 65 parts of the humectant, and 1.5 to 3 parts of the foaming agent.

10. The oral care composition according to claim 9, characterized in that, The friction agent comprises, by weight, 5 to 30 parts sodium bicarbonate, 0 to 20 parts silicon dioxide, and 0 to 20 parts calcium silicate.

11. The oral care composition according to claim 9, characterized in that, The periodontal repair agent comprises, by weight, 0.2 to 1 part of the inflammation inhibitor, 0.01 to 1 part of the tissue repair promoter, 0.01 to 1 part of the mucosal irritation reliever, and 0.8 to 2.6 parts of the antibacterial agent.

12. The oral care composition according to claim 9, characterized in that, The periodontal repair agent, by weight, comprises: 0.2-0.5 parts of dipotassium glycyrrhizate, 0.2-0.5 parts of arginine, 0.01-0.5 parts of allantoin, 0.001-0.5 parts of guaiac, 0.01-0.5 parts of sodium hyaluronate, 0.01-0.5 parts of bisabolol, 0.01-0.5 parts of clove oil, 0.01-0.5 parts of eucalyptus oil, 0.01-0.5 parts of tea tree oil, and 0.76-1.1 parts of fluoride.

13. A method for preparing an oral care composition according to any one of claims 1 to 12, characterized in that, Includes the following steps: glue Preparation steps: Weigh each component according to the ratio, add the thickener to part of the humectant, heat, stir evenly, and obtain the glue; Preparation steps: If polyvinylpyrrolidone is available, add it under heating conditions and stir until it swells. Add the remaining humectant and then the remaining components. Subsequently, stir at room temperature and degas under vacuum to obtain the paste, which is the oral care composition.

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