A sensitive mouth care composition comprising a sulfur-containing aluminosilicate and uses thereof

Abstract

The application belongs to the technical field of oral care, and relates to a sensitive-resistant oral care composition containing sucralfate and application thereof, the oral care composition comprising sucralfate and an auxiliary desensitizing component, the mass ratio of the sucralfate and the auxiliary desensitizing component being 1-9:1; the auxiliary desensitizing component is selected from one or more of fluoride, strontium chloride, potassium nitrate, hydroxyapatite nanoparticles and arginine. The application applies sucralfate as a desensitizer to the field of oral care, breaks through the traditional cognition that sucralfate is only used for gastrointestinal ulcers, and fills the technical gap; the sucralfate is highly and long-acting, physically blocks dentin tubules, takes effect quickly, and is obviously relieved after 1-3 uses, and has a single holding effect of 8-14 hours, which is much better than the 4-6 hours of existing products.

Description

Technical Field

[0001] This invention belongs to the field of oral care technology and relates to an anti-sensitivity oral care composition containing sulforaphane and its application. Background Technology

[0002] Dentin hypersensitivity is a common oral disease. The core cause is enamel wear and gingival recession, leading to exposure of dentinal tubules. External stimuli such as hot, cold, sweet, sour, and mechanical stimuli are transmitted through these tubules to the dental pulp nerve, causing stinging pain. Currently, most desensitizing oral care products on the market use two main types of desensitizing ingredients: potassium channel blockers and deposition-type ingredients. Potassium channel blockers, such as potassium nitrate and potassium chloride, reduce nerve conduction and relieve sensitivity and stinging pain by blocking the flow of potassium ions within the dentinal tubules. Deposition-type ingredients, such as strontium chloride and hydroxyapatite, deposit within the dentinal tubules to form a protective barrier, blocking external stimuli. In addition, some products add fluoride for cavity prevention and remineralization, but fluoride is not a primary desensitizing ingredient, and its combination with other desensitizing ingredients is often a simple addition, lacking scientific synergistic design. Current desensitizing oral care products have the following drawbacks: (1) Desensitization is slow to take effect and has a short duration of effect: Most products require long-term use to see slight effects, and relapse is easy after discontinuation. The effect of a single use is usually only 4 to 6 hours.

[0003] (2) The effect of a single component is limited: it is difficult to achieve the dual needs of "long-term desensitization + tooth repair". Potassium nitrate can only temporarily block nerve signals and cannot block dentinal tubules; the deposition effect of strontium chloride is unstable and easily brushed off.

[0004] (3) Insufficient safety: Long-term use of potassium nitrate may interfere with dental pulp microcirculation; high concentration or high frequency use of fluoride products may lead to dental fluorosis and is not suitable for special populations such as pregnant women and children.

[0005] (4) Poor synergy of components: Existing compound formulations lack scientific design for synergistic effect and cannot give full play to the complementary effect between components.

[0006] Sucralfate is a basic aluminum salt of sucrose sulfate. As a gastric mucosal protectant, it dissociates into negatively charged octasulfate sucrose under acidic conditions and polymerizes into an insoluble colloid, which binds to proteins on the ulcer surface to form a protective film. However, there are currently no reports of sucralfate being used as a desensitizing agent in oral care products to relieve dentin hypersensitivity. Summary of the Invention

[0007] The main objective of this invention is to overcome the deficiencies in the prior art and provide a sulforaphane-containing anti-sensitivity oral care composition and its application.

[0008] To achieve the above objectives, the specific technical solution is as follows: This invention provides a sucralfate-containing anti-sensitivity oral care composition, comprising sucralfate and an auxiliary desensitizing ingredient, wherein the mass ratio of sucralfate to the auxiliary desensitizing ingredient is 1 to 9:1; The auxiliary desensitizing ingredients are selected from one or more of fluorides, strontium chloride, hydroxyapatite nanoparticles, and arginine.

[0009] The sucralfate contained in the oral care composition of this invention dissociates into negatively charged octasulfate sucrose in the acidic environment of the oral cavity (such as after eating sweet or sour foods or when bacteria produce acid through metabolism), and rapidly polymerizes into an insoluble colloid. This colloid can bind to the positively charged proteins exposed on the surface of dentinal tubules, forming a dense and stable physical protective layer on the surface of the dentinal tubules, blocking the tubules, and fundamentally preventing the transmission of external stimuli such as cold, heat, sweetness, acidity, and mechanical stimulation to the dental pulp nerve, thus quickly relieving the stinging sensation. This protective layer has strong adhesion and can last for 8–12 hours.

[0010] The oral care composition of this invention includes an auxiliary desensitizing component that forms a synergistic system with sucralfate, which synergistically enhances the desensitizing effect and achieves multiple physical / chemical occlusions.

[0011] Furthermore, the auxiliary desensitizing component is a fluoride, which is selected from one or more of sodium fluoride, sodium monofluorophosphate, stannous fluoride, and ammonium fluoride.

[0012] This invention assists in the synergistic system of desensitizing ingredients fluoride and sucralfate. Fluoride combines with hydroxyapatite in tooth enamel to form more acid-resistant fluorapatite, enhancing acid resistance, promoting remineralization of demineralized enamel, and reducing dentinal tubule exposure. The protective layer formed by sucralfate prolongs the residence time of fluoride in the oral cavity, improving its utilization rate; fluoride, in turn, indirectly assists sucralfate in enhancing desensitizing persistence by repairing enamel and reducing tubule exposure. The synergistic effect of the two enhances both desensitization efficacy and caries prevention and remineralization capabilities, achieving the dual functions of desensitization and repair.

[0013] The present invention utilizes the above-mentioned fluoride, which can stably coexist with sucralfate, and is beneficial to exert a synergistic desensitizing effect with sucralfate.

[0014] The present invention further provides the application of the above-mentioned oral care composition in the preparation of oral care products or food, wherein the oral care products are toothpaste, oral suspensions, oral sprays, dental gels or dental strips; and the food is chewing gum.

[0015] This invention allows for the adjustment of excipient ratios and molding processes to obtain corresponding products based on product form. For example, sucralfate in oral gels or teeth whitening strips can be increased to 5.0% to enhance adhesion, while in oral suspensions it can be as low as 0.5% to maintain fluidity, making it suitable for large-scale production.

[0016] The present invention also provides a toothpaste comprising the above-described oral care composition, comprising the following components by weight percentage: The oral care composition contains 1.0%–5.7% abrasive, 25%–35% humectant, 10%–25% surfactant, 1.5%–2.5% thickener, 1.0%–2.0% flavoring agent, and 0.2%–0.5% preservative.

[0017] Preferably, the toothpaste comprises the following components by weight percentage: The oral care composition contains 1.0%–3.0% abrasive, 25%–32% humectant, 15%–22% surfactant, 1.5%–2.2% thickener, 1.2%–1.8% flavoring agent, and 0.2%–0.5% preservative.

[0018] The composition of this invention employs a humectant to retain product moisture (e.g., to prevent toothpaste from drying and hardening) and enhance smoothness; a surfactant to reduce surface tension and emulsify and decompose dental plaque and food residue; a thickener to adjust consistency and stabilize the system; a flavoring agent to mask the bitterness of other ingredients or to provide a cooling sensation and aroma, thereby improving palatability; and an abrasive to remove plaque, soft deposits, and extrinsic stains from the tooth surface through physical friction.

[0019] Furthermore, the sucralfate in the toothpaste is 0.5% to 5.0% by mass, preferably 1.0% to 3.0%, and more preferably 2.0%; And / or, the fluoride in the toothpaste is 0.05% to 0.15% by mass.

[0020] The sucralfate in the composition of this invention achieves an optimal balance of pharmacological activity, formulation stability, and sensory properties using the aforementioned mass percentages. This ensures effective oral care without insufficient efficacy due to low dosage, or decreased system stability, increased particle texture, or reduced user comfort due to excessive dosage. This results in an oral care composition that combines repair and protection, long-term stability, and a pleasant user experience. The fluoride, using the aforementioned mass percentages, meets the fluoride concentration standard of 1100–1500 ppm. This invention combines sucralfate and fluoride. Sucralfate primarily acts on the gums and oral mucosa, forming a protective layer and promoting the repair of damaged tissues; fluoride primarily acts on the hard tissues of the teeth, promoting enamel remineralization, improving tooth acid resistance, and exerting an anti-caries effect. Although their targets are different, their functions are complementary. Within the aforementioned mass percentage range, they can simultaneously address gum care, oral mucosal repair, and tooth decay protection, while ensuring the stability of the toothpaste system, sensory properties, and long-term safety, resulting in a good synergistic oral care effect.

[0021] Furthermore, the pH of the toothpaste is 6.0 to 8.0, preferably 6.5 to 7.5.

[0022] The present invention uses the above-mentioned pH range to maintain the film-forming properties of sucralfate, avoid irritation, and is suitable for sensitive people.

[0023] Furthermore, the moisturizer is selected from one or more of sorbitol, glycerin, polyethylene glycol, propylene glycol, xylitol, mannitol, erythritol, and maltitol.

[0024] Furthermore, the surfactant is selected from one or more of sodium lauryl sulfate (SLS), sodium lauroyl sarcosinate, sodium cocoyl glycinate, sodium cocoyl sarcosinate, cocamidopropyl betaine, and cocamidopropyl hydroxysulfonate betaine.

[0025] Furthermore, the thickener is selected from one or more of xanthan gum, sodium carboxymethyl cellulose, carrageenan, sodium alginate, hydroxyethyl cellulose, hydroxypropyl methyl cellulose, and guar gum.

[0026] Furthermore, the flavoring agent is selected from one or more of steviol glycosides, menthol, fruit flavorings, sodium saccharin, and spearmint oil.

[0027] Furthermore, the preservative is one or more of sodium benzoate, potassium sorbate, methylparaben, ethylparaben, and propylparaben.

[0028] Furthermore, the friction agent is selected from one or more of ultrafine silica, silicohydroxyapatite, calcium hydrogen phosphate dihydrate (DCPD), calcium carbonate, and calcium pyrophosphate.

[0029] Furthermore, the median particle size D50 of the friction agent is 1 μm to 13 μm.

[0030] The ultrafine silica is a precipitated hydrophilic amorphous hydrated silica (hydrated silica), with rounded particles and no sharp edges; its median particle size D50 is 7μm~13μm, and its BET specific surface area is 30m². 2 / g~60m 2The 5% aqueous suspension (g / g) has a pH of 6.5–7.5; it possesses moderate abrasive cleaning ability and also has a certain thickening and stabilizing effect, exhibiting good compatibility with oral active ingredients such as fluoride. The silicon molar doping content of the silanolapatite is 1–8 mol%, with a median particle size D50 of 1 μm–8 μm; the median particle size D50 of the calcium phosphate dihydrate is 4 μm–12 μm; the calcium carbonate is heavy calcium carbonate or light calcium carbonate, with a median particle size D50 of 2 μm–10 μm; and the median particle size D50 of the calcium pyrophosphate is 3 μm–12 μm.

[0031] Preferably, the RDA of the friction agent is <70.

[0032] The present invention further provides that the toothpaste is made by the following preparation method: (1) Mix the humectant, thickener and deionized water evenly and stir until completely dissolved to obtain the base material; (2) Add sucralfate, auxiliary desensitizing ingredients, abrasive, surfactant, flavoring agent and preservative to the base material, stir and mix, then grind and degas.

[0033] The present invention also provides an oral suspension comprising the above-mentioned oral care composition, comprising the following components by weight percentage: The oral care composition contains 0.55%–5.0% humectant, 12%–25% humectant, 0.2%–0.5% flavoring agent, 0.03%–0.10% preservative, 0%–0.5% solubilizer, and the balance being deionized water.

[0034] Preferably, the oral suspension comprises, by mass percentage, the following components: The oral care composition contains 2.0%–4.5% humectant, 12%–22% humectant, 0.2%–0.5% flavoring agent, 0.05%–0.10% preservative, and 0.1%–0.30% solubilizer.

[0035] Furthermore, the sucralfate in the oral suspension is 0.5% to 3.0% by mass, preferably 1.0% to 2.5%, and more preferably 2.0%; And / or, the fluoride provides a fluoride ion concentration of 225 to 900 ppm.

[0036] Furthermore, the co-solvent is one or more of ethanol, polysorbate 80, and polyethylene glycol 400.

[0037] This invention uses ethanol as a co-solvent to promote the dissolution of fragrances and some hydrophobic active ingredients, while also improving the clarity of the system. By adjusting the solvent environment of the system, it forms a synergistic effect with the preservative, thereby improving the microbial stability of the composition and enhancing the preservative effect. Polysorbate 80 and polyethylene glycol 400 improve the dispersion stability of hydrophobic ingredients such as peppermint fragrance in the aqueous system. At the same time, polysorbate 80 also acts as an emulsifier, and polyethylene glycol 400 also acts as a wetting agent and a system stabilizer.

[0038] Furthermore, the moisturizer is selected from one or more of sorbitol, glycerin, polyethylene glycol, propylene glycol, xylitol, mannitol, erythritol, and maltitol; the flavoring agent is selected from one or more of steviol glycosides, menthol, fruit flavoring, sodium saccharin, and spearmint oil; and the preservative is one or more of sodium benzoate, potassium sorbate, methylparaben, ethylparaben, and propylparaben.

[0039] The present invention further provides that the oral suspension is prepared by the following method: (1) Add the humectant, solubilizer, flavoring agent, and preservative to deionized water and stir to dissolve; (2) Add sucralfate and desensitizing agents to the above solution, stir to dissolve and filter.

[0040] Compared with the prior art, the present invention has the following significant advantages: This invention is the first to apply sucralfate as a desensitizing agent in the field of oral care, breaking through the traditional understanding that it is only used for gastrointestinal ulcers and filling a technological gap. Sucralfate is highly effective and long-lasting in desensitizing, physically blocking dentinal tubules, with rapid onset of action. Significant relief is achieved after 1-3 uses, and the effect lasts for 8-14 hours after a single application, far superior to the 4-6 hours of existing products.

[0041] The sucralfate and fluoride in the composition of this invention can work synergistically to improve the desensitization effect and enhance the caries prevention and remineralization capabilities, achieving the dual functions of desensitization and repair, with a relief rate of 90% to 98.3% in 4 weeks.

[0042] The pH range and dosage of the composition of this invention meet safety standards, there is no risk of nerve interference from potassium nitrate, no high fluoride hazard, pregnant women and children can use it under supervision, the incidence of adverse reactions is 0, and the safety is high.

[0043] The raw materials used in this invention are all commonly used oral care excipients. No special equipment is required, the process is simple and the cost is controllable, making it suitable for large-scale production and with broad market prospects. Detailed Implementation

[0044] To make the objectives, technical solutions, and advantages of this invention clearer, the technical solutions of this invention will be clearly and completely described below in conjunction with the embodiments of this invention. Obviously, the described embodiments are only some embodiments of this invention, not all embodiments. Based on the embodiments of this invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this invention.

[0045] The terms "preferred," "further preferred," and "more preferred" used in this invention, followed by technical features, constitute preferred embodiments of the invention in a specific aspect, but should not be construed as limiting the scope of protection. When the preferred definitions at each level are combined in a progressive relationship, the degree of preference increases progressively.

[0046] In this invention, the technical features described in an open-ended manner include both closed-ended technical solutions composed of the listed features and open-ended technical solutions that include the listed features.

[0047] In this invention, numerical ranges are involved. Unless otherwise specified, the numerical ranges are considered continuous and include the minimum and maximum values ​​of the range, as well as every value between the minimum and maximum values. Furthermore, when the range refers to integers, it includes every integer between the minimum and maximum values ​​of the range. In other words, unless otherwise specified, all ranges disclosed herein should be understood to include any and all subranges to which they are included.

[0048] The technical solution of the present invention will be described in detail below through embodiments and comparative examples. It should be noted that the following embodiments are only used to help understand the technical solution of the present invention and do not constitute any limitation on the scope of protection of the present invention.

[0049] Unless otherwise specified, specific techniques or conditions in the embodiments of this invention shall be performed in accordance with the techniques or conditions described in the literature in this field, or in accordance with the product instructions. Devices, instruments, reagents, etc., whose manufacturers are not specified are all conventional products that can be purchased through legitimate channels. All raw materials used in this invention are readily available in the domestic market.

[0050] The following describes some of the raw materials used in the embodiments and comparative examples of this invention: Sucralfate is sourced from Shandong Xinhua Pharmaceutical Co., Ltd. The ultrafine silica is sourced from Evonik in Germany, with the preferred model being SIDENT. ® 9; Hydroxyapatite is sourced from Shanghai Aladdin Biochemical Technology Co., Ltd. Sodium fluoride is sourced from Hunan Nonferrous Fluorochemical Co., Ltd. Strontium chloride is sourced from Sinopharm Chemical Reagent Co., Ltd. Sorbitol is sourced from Shandong Tianli Pharmaceutical Co., Ltd. The glycerin is sourced from Jiangsu Haixing Chemical Co., Ltd.

[0051] Example 1 This embodiment provides an anti-sensitivity toothpaste and its preparation method. The toothpaste is prepared from the following composition by weight percentage: Sucralfate 2.0%, sodium fluoride 0.145%, glycerol 20%, ultrafine silica 30%, sodium carboxymethyl cellulose 1.5%, sodium lauroyl sarcosinate 2.0%, menthol 0.3%, sodium benzoate 0.1%, with the balance being deionized water.

[0052] The toothpaste in this embodiment is prepared by the following method: (1) Mix glycerol, sodium carboxymethyl cellulose and deionized water evenly and stir until completely dissolved to obtain the base material; (2) Add sucralfate, sodium fluoride, ultrafine silica, sodium lauroyl sarcosinate, menthol and sodium benzoate to the base material, stir and mix thoroughly for 30 minutes, then send it to a grinder to grind so that the particle size is ≤5μm. After grinding, degassing treatment is performed (degassing pressure is -0.08MPa, degassing time is 15 minutes), and finally fill it to obtain anti-sensitivity toothpaste.

[0053] Example 2 This embodiment provides an anti-sensitivity toothpaste and its preparation method. The toothpaste is prepared from the following composition by weight percentage: Sucralfate 1.0%, sodium monofluorophosphate 0.12%, propylene glycol 15%, hydroxyapatite 25%, xanthan gum 1.2%, sodium lauryl sulfate 1.5%, steviol glycosides 0.2%, ethylparaben 0.08%, with the balance being deionized water.

[0054] The toothpaste in this embodiment is prepared by the following method: (1) Mix propylene glycol, xanthan gum and deionized water evenly and stir until completely dissolved to obtain the base material; (2) Add sucralfate, sodium monofluorophosphate, hydroxyapatite, sodium lauryl sulfate, steviol glycosides and ethylparaben to the base material, stir and mix thoroughly for 30 minutes, then send it to a grinder to grind so that the particle size is ≤5μm. After grinding, degassing treatment is performed (degassing pressure is -0.08MPa, degassing time is 15 minutes), and finally fill it to obtain anti-sensitivity toothpaste.

[0055] Example 3 This embodiment provides an anti-sensitivity toothpaste and its preparation method. The toothpaste is prepared from the following composition by weight percentage: Sucralfate 2.0%, sodium fluoride 0.145%, strontium chloride 0.5%, glycerol 22%, ultrafine silica 32%, sodium carboxymethyl cellulose 1.8%, sodium lauroyl sarcosinate 2.2%, menthol 0.4%, sodium benzoate 0.12%, with the balance being deionized water.

[0056] The toothpaste in this embodiment is prepared by the following method: (1) Mix glycerol, sodium carboxymethyl cellulose and deionized water evenly and stir until completely dissolved to obtain the base material; (2) Add sucralfate, sodium fluoride, strontium chloride, ultrafine silica, sodium lauroyl sarcosinate, menthol and sodium benzoate to the base material, stir and mix thoroughly for 30 minutes, then send it to a grinder to grind so that the particle size is ≤5μm. After grinding, degassing treatment is performed (degassing pressure is -0.08MPa, degassing time is 15 minutes), and finally fill it to obtain anti-sensitivity toothpaste.

[0057] Example 4 This embodiment provides an anti-sensitivity oral suspension and its preparation method. The oral suspension is prepared from the following composition by weight percentage: Sucralfate 3.0%, potassium fluoride 0.10%, sorbitol 12%, ethanol 0.1%, polyethylene glycol 400 0.1%, fruit flavoring 0.5%, sodium benzoate 0.05%, with the balance being deionized water.

[0058] The oral suspension in this embodiment is prepared by the following method: (1) Add sorbitol, ethanol, polyethylene glycol, fruit flavoring, and sodium benzoate to deionized water and stir until completely dissolved; (2) Add sucralfate and potassium fluoride to the above solution and continue stirring for 60 minutes to ensure that the components are fully dissolved and homogeneous. Then filter with a 0.22μm filter membrane to remove insoluble impurities and finally fill into the solution to obtain an anti-sensitivity oral suspension.

[0059] Example 5 This embodiment provides an anti-sensitivity oral suspension and its preparation method. The oral suspension is prepared from the following composition by weight percentage: Sucralfate 2.0%, sodium fluoride 0.05%, xylitol 8%, glycerin 5%, polysorbate 80 0.20%, peppermint flavor 0.30%, sodium benzoate 0.08%, balance deionized water.

[0060] The oral suspension in this embodiment is prepared by the following method: (1) Add xylitol, glycerin, polysorbate 80, peppermint flavoring, and sodium benzoate to deionized water and stir at room temperature until completely mixed; (2) Add sucralfate and sodium fluoride, and continue stirring for 60 minutes to ensure that the components are fully dispersed and uniform; then filter with a 0.22 μm filter membrane, and finally fill into the container to obtain the anti-sensitivity oral suspension.

[0061] Example 6 This embodiment provides an anti-sensitivity oral suspension and its preparation method. The oral suspension is prepared from the following composition by weight percentage: Sucralfate 4.0%, sodium monofluorophosphate 0.12%, sorbitol 15%, glycerin 6%, polyethylene glycol 400 0.30%, spearmint flavor 0.40%, potassium sorbate 0.10%, with the balance being deionized water.

[0062] The oral suspension in this embodiment is prepared by the following method: (1) Add sorbitol, glycerin, polyethylene glycol 400, spearmint flavoring and potassium sorbate to deionized water and stir until a homogeneous solution is formed; (2) Add sucralfate and sodium monofluorophosphate, stir continuously for 60 minutes to ensure that the system is fully dispersed and uniform; filter through a 0.22 μm filter membrane and fill into the container to obtain the anti-sensitivity oral suspension.

[0063] Example 7 This embodiment provides an anti-sensitivity oral suspension and its preparation method. The oral suspension is prepared from the following composition by weight percentage: Sucralfate 1.5%, potassium fluoride 0.15%, xylitol 10%, glycerin 4%, polyethylene glycol 400 0.20%, peppermint flavor 0.25%, methylparaben 0.06%, balance deionized water.

[0064] The oral suspension in this embodiment is prepared by the following method: (1) Add xylitol, glycerin, polyethylene glycol 400, peppermint flavoring and methylparaben to deionized water and stir well; (2) Add sucralfate and potassium fluoride, and continue stirring for 60 minutes to ensure that the components are fully dispersed and uniform; filter with a 0.22 μm filter membrane and fill into the container to obtain the anti-sensitivity oral suspension.

[0065] Comparative Example 1 The difference between Comparative Example 1 and Example 1 is that sucralfate and sodium fluoride were not added, and an equal amount of deionized water was used instead.

[0066] Comparative Example 2 The difference between Comparative Example 2 and Example 1 is that sucralfate was not added, sodium fluoride was 0.8%, and the remainder was deionized water.

[0067] Comparative Example 3 The difference between Comparative Example 3 and Example 1 is that sodium fluoride was not added, and an equal amount of deionized water was used to replace sodium fluoride. The remaining components and preparation methods are the same as in Example 1.

[0068] Comparative Example 4 The difference between Comparative Example 7 and Example 1 is that the amount of sucralfate added is 0.20%, and an equal amount of deionized water is used to make up for the reduced amount of sucralfate. The remaining components and preparation methods are the same as in Example 1.

[0069] Comparative Example 5 The difference between Comparative Example 8 and Example 1 is that the amount of sucralfate added is 5.50%, while the remaining components and preparation methods are the same as in Example 1.

[0070] Comparative Example 6 The difference between Comparative Example 9 and Example 1 is that the amount of sodium fluoride added is 0.02%, while the remaining components and preparation methods are the same as in Example 1.

[0071] Comparative Example 7 The difference between Comparative Example 10 and Example 1 is that the amount of sodium fluoride added is 0.30%, while the remaining components and preparation methods are the same as in Example 1.

[0072] Comparative Example 8 The difference between Comparative Example 4 and Example 4 is that sucralfate and potassium fluoride were not added, and an equal amount of deionized water was used to replace sucralfate and potassium fluoride. The remaining components and preparation methods are the same as in Example 4.

[0073] Comparative Example 9 The difference between Comparative Example 5 and Example 4 is that sucralfate was not added, only 0.10% potassium fluoride was retained, and an equal amount of deionized water was used to replace sucralfate. The remaining components and preparation methods are the same as in Example 4.

[0074] Comparative Example 10 The difference between Comparative Example 6 and Example 4 is that potassium fluoride was not added, only 3.0% sucralfate was retained, and an equal amount of deionized water was used to replace potassium fluoride. The remaining components and preparation methods are the same as in Example 4.

[0075] Effect test Three hundred and twenty participants (aged 20–70 years) diagnosed with dentin hypersensitivity by a dentist were randomly divided into a toothpaste test group and an oral suspension test group. The toothpaste test group included Examples 1–3 and Comparative Examples 1–3, 7, and 9, with 25 participants in each group. The oral suspension test group included Example 4 and Comparative Examples 4–6, with 30 participants in each group. All participants discontinued using any anti-sensitivity oral care products one week prior to the trial. The toothpaste group used the Bass brushing method, brushing twice daily (morning and evening) with approximately 1 g of toothpaste each time, for 2 minutes each time. The oral suspension group rinsed their mouths twice daily (morning and evening) with 15 mL of toothpaste each time, rinsing for 30 seconds before spitting it out, for four consecutive weeks. Dentin sensitivity was evaluated before use, at 1 week, and at 4 weeks using an air stimulation method (a dental three-way gun held approximately 1 cm from the tooth surface, continuously blowing air for 1 second) combined with the Visual Analogue Scale (VAS) and the Schiff cold air sensitivity index. The sensitivity relief rate was calculated as follows: [Sensitivity relief rate (%) = (VAS score before treatment - VAS score after treatment) / VAS score before treatment × 100%]. The duration of pain relief after each treatment and the occurrence of adverse reactions such as gingival irritation, oral mucosal redness and swelling, and burning sensation were also recorded. The test results are shown in Tables 1 and 2.

[0076] Table 1

[0077] Table 2

[0078] The results showed that Examples 1-4 all exhibited good anti-dentin hypersensitivity effects. Example 3 (a combination of sucralfate and fluoride) showed superior results compared to Examples 1, 2, and the comparative examples in terms of 1-week relief rate, 4-week relief rate, duration of pain relief, and improvement in the Schiff sensitivity index (P<0.05). Furthermore, while formulations containing only sucralfate (Comparative Examples 3 and 10) or only fluoride (Comparative Examples 2 and 9) had some anti-sensitivity effects, their relief rates and durations were significantly lower than those of the examples in this invention, indicating a significant synergistic effect between sucralfate and fluoride. On the other hand, when the amount of sucralfate or fluoride added was low (Comparative Examples 7 and 9), the anti-sensitivity effect of the product decreased significantly.

[0079] The above description is merely a specific embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the scope of the technology disclosed in the present invention should be included within the scope of protection of the present invention.

Claims

1. A sulforaphane-containing anti-sensitivity oral care composition, characterized in that, It includes sucralfate and an auxiliary desensitizing ingredient, wherein the mass ratio of sucralfate to the auxiliary desensitizing ingredient is 1 to 9:1; The auxiliary desensitizing ingredients are selected from one or more of fluorides, strontium chloride, hydroxyapatite nanoparticles, and arginine.

2. The oral care composition according to claim 1, characterized in that, The auxiliary desensitizing component is a fluoride, which is selected from one or more of sodium fluoride, sodium monofluorophosphate, stannous fluoride, and ammonium fluoride.

3. The use of the oral care composition as described in claim 1 or 2 in the preparation of oral care products or food products; preferably, the oral care product is toothpaste, oral suspension, oral spray, dental gel or dental strip, and the food product is chewing gum.

4. A toothpaste, characterized in that, The oral care composition as described in claim 1 or 2, by weight percentage, comprises the following components: The oral care composition contains 1.0%–5.7% abrasive, 25%–35% humectant, 10%–25% surfactant, 1.5%–2.5% thickener, 1.0%–2.0% flavoring agent, 0.2%–0.5% preservative, and the balance is deionized water.

5. The toothpaste according to claim 4, characterized in that, The sucralfate in the toothpaste is 0.5% to 5.0% by mass. And / or, the fluoride in the toothpaste is 0.05% to 0.15% by mass.

6. The toothpaste according to claim 4 or 5, characterized in that, The toothpaste has a pH of 6.0 to 8.0, preferably 6.5 to 7.

5.

7. The toothpaste according to claim 6, characterized in that, The humectant is selected from one or more of sorbitol, glycerin, polyethylene glycol, propylene glycol, xylitol, mannitol, erythritol, and maltitol; the surfactant is selected from one or more of sodium lauryl sulfate, sodium lauroyl sarcosinate, sodium cocoyl glycinate, sodium cocoyl sarcosinate, cocamidopropyl betaine, and cocamidopropyl hydroxysulfonate; the thickener is selected from one or more of xanthan gum, sodium carboxymethyl cellulose, carrageenan, sodium alginate, hydroxyethyl cellulose, hydroxypropyl methyl cellulose, and guar gum; the flavoring agent is selected from one or more of steviol glycosides, menthol, fruit flavorings, sodium saccharin, and spearmint oil; the preservative is selected from one or more of sodium benzoate, potassium sorbate, methylparaben, ethylparaben, and propylparaben; and the abrasive is selected from one or more of ultrafine silica, silicohydroxyapatite, calcium hydrogen phosphate dihydrate, calcium carbonate, and calcium pyrophosphate.

8. An oral suspension, characterized in that, The oral care composition as described in claim 1 or 2, by weight percentage, comprises the following components: The oral care composition contains 0.55%–5.0% humectant, 12%–25% humectant, 0.2%–0.5% flavoring agent, 0.03%–0.10% preservative, 0%–0.5% solubilizer, and the balance being deionized water.

9. The oral suspension according to claim 8, characterized in that, The sucralfate in the oral suspension is 0.5% to 3.0% by mass. And / or, the fluoride provides a fluoride ion concentration of 225 to 900 ppm.

10. The oral suspension according to claim 8, characterized in that, The cosolvent is one or more of ethanol, polysorbate 80, and polyethylene glycol 400; the humectant is one or more of sorbitol, glycerin, polyethylene glycol, propylene glycol, xylitol, mannitol, erythritol, and maltitol; the flavoring agent is one or more of steviol glycosides, menthol, fruit flavoring, sodium saccharin, and spearmint oil; and the preservative is one or more of sodium benzoate, potassium sorbate, methylparaben, ethylparaben, and propylparaben.

Images