An oral care toothpaste and its preparation method

Abstract

This invention belongs to the technical field of oral care products, specifically relating to an oral care toothpaste and its preparation method. The oral care toothpaste provided by this invention includes active ingredients and excipients. The active ingredients include five components: human recombinant enamel matrix protein, casein phosphopeptide, calcium lactate, amla extract, and sour cherry extract. The human recombinant enamel matrix protein, amla extract, and sour cherry extract, when used in combination, can synergistically promote oral anti-inflammatory effects; the casein phosphopeptide, calcium lactate, amla extract, and sour cherry extract, when used in combination, can synergistically promote the remineralization of tooth enamel and dentin. Furthermore, the oral care toothpaste of this invention also has anti-inflammatory and repairing effects, can be used to maintain oral health, and has broad market application value.

Description

Technical Field

[0001] This invention belongs to the field of oral care products technology, specifically relating to an oral care toothpaste and its preparation method. Background Technology

[0002] With the increasing prevalence of oral health problems such as tooth sensitivity, gingivitis, bad breath, and cavities, more and more people are realizing the importance of oral hygiene. Cavities, a common chronic oral disease, are a bacterial infection that can lead to pulpitis and periapical periodontitis, and even inflammation of the alveolar bone and jawbone.

[0003] Invasive treatments, a traditional approach to caries management, involve the preparation of oral tissues and cavities, as well as restorations using artificial materials such as amalgam and composite resins. However, due to the differences in properties between artificial materials and tooth tissue, long-term clinical outcomes are often unsatisfactory. For caries prevention, commercially available oral care products (such as functional toothpastes and mouthwashes) typically contain antibiotics, chlorhexidine, or fluoride, which work by inhibiting the colonization of cariogenic bacteria and the formation of biofilms. However, antibiotic resistance and side effects, along with high concentrations of fluoride that can irritate the gums and oral mucosa and trigger inflammation, limit the long-term value of existing preventative measures.

[0004] Therefore, there is an urgent need to develop an oral care toothpaste that can systematically prevent and treat tooth decay by reducing inflammation in the oral cavity and promoting the remineralization of enamel and dentin, thereby filling the current market gap. Summary of the Invention

[0005] In view of the above-mentioned defects or improvement needs of the existing technology, the present invention provides an oral care toothpaste and its preparation method, which solves the problem that the existing oral care products have poor effects in preventing and treating tooth decay.

[0006] To achieve the above objectives, the present invention adopts the following technical solution: In a first aspect, the present invention provides an oral care toothpaste, the toothpaste comprising active ingredients and excipients; the active ingredients, by mass percentage, comprise: 0.08%-0.15% human recombinant enamel matrix protein, 0.15%-0.3% casein phosphopeptide, 0.03%-0.1% calcium lactate, 0.05%-0.1% amla extract, and 0.08%-0.15% sour cherry extract.

[0007] In this invention, the human recombinant enamel matrix protein contains a variety of biologically active growth factors. Amelogenin, as the main component of the human recombinant enamel matrix protein, is the active part that promotes periodontal regeneration. The human recombinant enamel matrix protein also has anti-inflammatory effects on periodontal immune cells and tissue cells, and can prevent or treat dental caries.

[0008] Casein phosphopeptide is a polypeptide extracted from natural proteins that can bind calcium ions from food to the site of tooth decay, reducing enamel demineralization and thus preventing tooth decay. It also has high absorption properties and can enhance the body's immunity.

[0009] Phyllanthus emblica extract contains a large amount of polyphenols, which have significant antioxidant, anti-inflammatory, antibacterial, antiviral, anti-aging and cariogenic bacteria-inhibiting effects. It is a natural plant ingredient with multiple oral health benefits and has broad application prospects in oral care products with anti-caries effects.

[0010] Tart cherry extract is rich in anthocyanins, flavonoids, vitamin C, and polyphenolic compounds. It has strong antioxidant, anti-inflammatory, antibacterial, and plaque-inhibiting properties, which help protect the health of gum tissue and oral mucosa. It shows promise for use in anti-caries oral care products.

[0011] Preferably, by weight percentage, the excipients include: 40%-60% humectant, 0.5%-2% thickener, 10%-25% abrasive, 0.02%-5% sweetener, 0.5%-2% surfactant, 0.001%-0.5% enzyme, 0%-1% preservative, 0.3%-1.5% fragrance, and the balance being deionized water.

[0012] More preferably, the active ingredients, by mass percentage, include: 0.1% human recombinant enamel matrix protein, 0.25% casein phosphopeptide, 0.05% calcium lactate, 0.08% amla extract, and 0.1% sour cherry extract.

[0013] More preferably, the moisturizer is selected from at least one of sorbitol, glycerin, polyethylene glycol, and propylene glycol.

[0014] More preferably, the thickener is selected from at least one of carbomer, cellulose gum, xanthan gum, and gum arabic.

[0015] More preferably, the friction agent is selected from at least one of silica, dicalcium phosphate, and calcium pyrophosphate.

[0016] More preferably, the sweetener is selected from at least one of sodium saccharin, sucralose, xylitol, erythritol, steviol glycosides, mogrosides, and licorice extract.

[0017] More preferably, the surfactant is selected from at least one of anionic surfactants, nonionic surfactants, amphoteric surfactants, and biosurfactants.

[0018] More preferably, the anionic surfactant includes at least one of sodium lauryl sulfate and sodium laureth sulfate.

[0019] More preferably, the nonionic surfactant comprises an alkyl glycoside.

[0020] More preferably, the amphoteric surfactant includes at least one of cocamidopropyl betaine, sodium lauroyl sarcosinate, sodium lauroyl glutamate, and sodium cocoyl glutamate.

[0021] More preferably, the biosurfactant includes at least one of rhamnolipid and sophorolipid.

[0022] More preferably, the bioenzyme is selected from at least one of glucanase, lysozyme, protease, glucosyl oxidase, amylase, papain, bromelain, cellulase, superoxide dismutase, and catalase.

[0023] More preferably, the preservative is selected from at least one of plant antibacterial agents, sodium benzoate, benzyl alcohol, ethylhexylglycerin, octyl glycol, pentylene glycol, and p-hydroxyacetophenone.

[0024] More preferably, the fragrance is selected from at least one of peppermint flavoring, fruit flavoring, spearmint flavoring, wintergreen flavoring, and tea flavoring.

[0025] In a second aspect, the present invention provides a method for preparing the oral care toothpaste described in the first aspect, comprising the following steps: S1. Add the humectant, sweetener, and preservative to the deionized water, stir well, then add the biological enzyme and thickener, stir well to obtain a mixture; S2. Add abrasive, surfactant, fragrance and active ingredients to the mixture, stir evenly and degas to obtain the oral care toothpaste.

[0026] The beneficial effects of this invention are: The oral care toothpaste provided by this invention comprises five active ingredients: recombinant human enamel matrix protein, casein phosphopeptide, calcium lactate, amla extract, and sour cherry extract. The recombinant human enamel matrix protein promotes periodontal tissue regeneration and repair, and has anti-inflammatory effects. The combination of casein phosphopeptide and calcium lactate promotes the remineralization of enamel and dentin. The amla extract and sour cherry extract have antibacterial, anti-inflammatory, and antioxidant effects. The combination of recombinant human enamel matrix protein, amla extract, and sour cherry extract synergistically promotes oral inflammation. Furthermore, the combination of casein phosphopeptide, calcium lactate, amla extract, and sour cherry extract synergistically promotes the remineralization of enamel and dentin. In addition, the oral care toothpaste provided by this invention has anti-inflammatory and repairing effects, can be used to maintain oral health, and has broad market application value. Detailed Implementation

[0027] To further illustrate the technical means and effects of the present invention in achieving the intended purpose, the following detailed description of the specific embodiments, structure, features and effects of the present invention, in conjunction with the composition, is provided below.

[0028] For the following compositions, unless otherwise specified, experimental methods are generally performed under standard conditions or as recommended by the manufacturer. Unless otherwise specified, all materials and reagents used are commercially available.

[0029] Some of the raw materials and their sources are as follows: Human recombinant enamel matrix protein was purchased from Bestway Biotechnology Co., Ltd. Casein phosphopeptide was purchased from Guangzhou Green Extract Biotechnology Co., Ltd. Calcium lactate was purchased from Purac Biochem bv (PU) in the Netherlands; Phyllanthus emblica extract was purchased from Shaanxi Jiahe Biotechnology Co., Ltd.; The sour cherry extract was purchased from Shaanxi Jiahe Biotechnology Co., Ltd.

[0030] Example 1 The oral care toothpaste of this embodiment includes active ingredients and excipients. By mass percentage, the active ingredients include: 0.08% human recombinant enamel matrix protein, 0.15% casein phosphopeptide, 0.03% calcium lactate, 0.05% amla extract, and 0.08% sour cherry extract. The excipients include: 40% humectant, 0.5% thickener, 12% abrasive, 0.02% sweetener, 0.5% surfactant, 0.001% enzyme, 0.1% preservative, 0.3% fragrance, and the balance being deionized water. The humectant is a 1:1 mass ratio of glycerin and propylene glycol; the thickener is cellulose gum; the abrasive is silica; the sweetener is xylitol; the surfactant is cocamidopropyl betaine; the enzyme is protease; the preservative is sodium benzoate; and the fragrance is peppermint flavoring.

[0031] The method for preparing oral care toothpaste in this embodiment includes the following steps: S1. Add the humectant, sweetener, and preservative to the deionized water, stir well, then add the biological enzyme and thickener, stir well to obtain a mixture; S2. Add abrasive, surfactant, fragrance and active ingredients to the mixture, stir evenly and degas to obtain the oral care toothpaste.

[0032] Example 2 The oral care toothpaste of this embodiment includes active ingredients and excipients. By mass percentage, the active ingredients include: 0.1% human recombinant enamel matrix protein, 0.25% casein phosphopeptide, 0.05% calcium lactate, 0.08% amla extract, and 0.1% sour cherry extract. The excipients include: 50% humectant, 1% thickener, 20% abrasive, 3% sweetener, 1% surfactant, 0.2% enzyme, 0.5% preservative, 0.9% fragrance, and the balance being deionized water. The humectant is sorbitol and glycerin in a mass ratio of 2:3; the thickener is carbomer; the abrasive is calcium hydrogen phosphate; the sweetener is sucralose; the surfactant is sodium cocoyl glutamate; the enzyme is lysozyme; the preservative is sodium benzoate; and the fragrance is fruit flavoring.

[0033] The preparation method of the oral care toothpaste in this embodiment is the same as that in Embodiment 1.

[0034] Example 3 The oral care toothpaste of this embodiment includes active ingredients and excipients. By mass percentage, the active ingredients include: 0.15% human recombinant enamel matrix protein, 0.3% casein phosphopeptide, 0.1% calcium lactate, 0.1% amla extract, and 0.15% sour cherry extract. The excipients include: 60% humectant, 2% thickener, 25% abrasive, 5% sweetener, 2% surfactant, 0.5% enzyme, 1% preservative, 1.5% fragrance, and the balance being deionized water. The humectant is sorbitol and propylene glycol in a 1:1 mass ratio; the thickener is gum arabic; the abrasive is silica; the sweetener is erythritol; the surfactant is cocamidopropyl betaine; the enzyme is glucanase; the preservative is sodium benzoate; and the fragrance is spearmint flavoring.

[0035] The preparation method of the oral care toothpaste in this embodiment is the same as that in Embodiment 1.

[0036] Comparative Example 1 Compared with Example 2, the difference is that the active ingredient in Comparative Example 1 does not contain human recombinant enamel matrix protein, and the missing amount is made up by amla extract and sour cherry extract in a mass ratio of 4:5. All other conditions and preparation methods are the same as in Example 2.

[0037] Comparative Example 2 Compared with Example 2, the difference is that the active ingredient in Comparative Example 2 does not contain Phyllanthus emblica extract, and the missing amount is made up by human recombinant enamel matrix protein and sour cherry extract in a mass ratio of 1:1. All other conditions and preparation methods are the same as in Example 2.

[0038] Comparative Example 3 Compared with Example 2, the difference is that the active ingredient in Comparative Example 3 does not contain sour cherry extract, and the missing amount is made up with human recombinant enamel matrix protein and amla extract in a mass ratio of 5:4. All other conditions and preparation methods are the same as in Example 2.

[0039] Comparative Example 4 Compared with Example 2, the difference is that the mass percentages of human recombinant enamel matrix protein, amla extract and sour cherry extract in the active ingredients of Comparative Example 4 are 0.05%, 0.13% and 0.1%, respectively. All other conditions and preparation methods are the same as in Example 2.

[0040] Comparative Example 5 Compared with Example 2, the difference is that the mass percentages of human recombinant enamel matrix protein, amla extract and sour cherry extract in Comparative Example 5 are 0.16%, 0.02% and 0.1%, respectively, while other conditions and preparation methods are the same as in Example 2.

[0041] Comparative Example 6 Compared with Example 2, the difference is that the active ingredients of Comparative Example 6 do not contain casein phosphopeptide and calcium lactate, and the missing amounts are made up by amla extract and sour cherry extract in a mass ratio of 4:5. All other conditions and preparation methods are the same as those of Example 2.

[0042] Comparative Example 7 Compared with Example 2, the difference is that the active ingredient in Comparative Example 7 does not contain Phyllanthus emblica extract, and the missing amount is made up by casein phosphopeptide, calcium lactate and sour cherry extract in a mass ratio of 5:1:2. All other conditions and preparation methods are the same as in Example 2.

[0043] Comparative Example 8 Compared with Example 2, the difference is that the active ingredient in Comparative Example 8 does not contain sour cherry extract, and the missing amount is made up by casein phosphopeptide, calcium lactate and amla extract in a mass ratio of 25:5:8. All other conditions and preparation methods are the same as in Example 2.

[0044] Comparative Example 9 Compared with Example 2, the difference is that the mass percentages of casein phosphopeptide, calcium lactate, amla extract and sour cherry extract in the active ingredients of Comparative Example 9 are 0.28%, 0.04%, 0.12% and 0.04%, respectively. All other conditions and preparation methods are the same as in Example 2.

[0045] Comparative Example 10 Compared with Example 2, the difference is that the mass percentages of casein phosphopeptide, calcium lactate, amla extract and sour cherry extract in Comparative Example 10 are 0.2%, 0.04%, 0.04% and 0.2%, respectively. All other conditions and preparation methods are the same as in Example 2.

[0046] Example 1: Anti-inflammatory efficacy test This efficacy test case evaluates the anti-inflammatory effect of toothpastes prepared in Examples 1-3 and Comparative Examples 1-5 on the expression of inflammatory factors in periodontal ligament cells by detecting their influence on periodontal cells.

[0047] Sample preparation: DMEM medium was added to the toothpaste prepared in Examples 1-3 and Comparative Examples 1-5, respectively. After mixing and homogenization, the samples were prepared into test solutions with a concentration of 0.1 g / mL for later use. The experimental procedure is as follows: Human periodontal ligament cells in the logarithmic growth phase were taken at a concentration of 2 × 10⁻⁶. 7 Cells were seeded at a density of 1 mL of DMEM medium containing 10% fetal bovine serum in each well of a 24-well plate and incubated at 37°C and 5% CO2 for 24 h. The medium was then discarded, and the cells were added to the plates according to the following groups and the treatment lasted for 48 h, with 5 replicates per group. The specific groupings are as follows: Blank control group: Add 1 mL of DMEM culture medium; Model group: Add 1 mL of DMEM medium containing 10 μg / mL LPS; Sample group: Add 1 mL of DMEM medium containing 10 μg / mL LPS and 0.1 g / mL test solution; After the intervention, cell mRNA was extracted, and the concentrations of IL-6 and TNF-α were detected by qPCR. The inhibition rates of IL-6 and TNF-α were calculated according to the following formula. The experimental data are presented as average values. The specific results are shown in Table 1. ; In the formula: IL-6 空白对照组 The IL-6 concentration was used as the blank control group. IL-6 模型组 The IL-6 concentration in the model group; IL-6 样品组 The IL-6 concentration of the sample group; ; In the formula: TNF-α 空白对照组 The TNF-α concentration was in the blank control group. TNF-α 模型组 The TNF-α concentration in the model group; TNF-α 样品组 The value represents the TNF-α concentration in the sample group.

[0048] Table 1 Anti-inflammatory efficacy test data Group IL-6 inhibition rate (%) TNF-α inhibition rate (%) Example 1 69.75 77.13 Example 2 70.51 78.67 Example 3 72.48 80.02 Comparative Example 1 61.23 67.18 Comparative Example 2 56.92 62.36 Comparative Example 3 59.34 65.45 Comparative Example 4 67.57 75.29 Comparative Example 5 66.40 73.84 Compared with Example 2, Comparative Examples 1-3 did not contain any of the following: recombinant human amelena matrix protein, amla extract, and sour cherry extract. Comparative Examples 4-5 adjusted the ratio of human recombinant amelena matrix protein, casein phosphopeptide, calcium lactate, amla extract, and sour cherry extract.

[0049] As can be seen from the data on IL-6 inhibition rate and TNF-α inhibition rate of Examples 1-3 in Table 1, the toothpaste of the present invention has anti-inflammatory effect on periodontal cells.

[0050] As shown in Table 1, the IL-6 inhibition rate and TNF-α inhibition rate of Example 2 and Comparative Examples 1-3 are as follows: the toothpaste prepared by selecting three components, namely human recombinant enamel matrix protein, amla extract and sour cherry extract, can significantly improve the IL-6 inhibition rate and TNF-α inhibition rate. This indicates that human recombinant enamel matrix protein, amla extract and sour cherry extract have a synergistic effect, which makes the anti-inflammatory ability of Example 2 significantly improved compared with Comparative Examples 1-3.

[0051] As can be seen from the data on IL-6 inhibition rate and TNF-α inhibition rate of Example 2 and Comparative Examples 4-5 in Table 1, the ratio of human recombinant enamel matrix protein, amla extract and sour cherry extract affects the anti-inflammatory effect of toothpaste on periodontal cells. When the ratio of human recombinant enamel matrix protein, amla extract and sour cherry extract falls within the range defined by this invention, the anti-inflammatory effect of toothpaste is better.

[0052] Example 2 of the effect test: Remineralization test Tooth enamel is the hardest tissue in the human body, and its hardness primarily stems from its high degree of mineralization. When tooth enamel undergoes demineralization (such as acid etching or caries), mineral loss occurs, leading to a significant decrease in surface microhardness (SMH). Active ingredients with remineralizing properties can promote the redeposition of calcium and phosphorus, restoring the integrity of the enamel structure and thus improving surface hardness. Vickers Hardness (HV) is the most commonly used measurement method and numerical expression for SMH; therefore, HV is widely used as one of the gold standard indicators for quantitatively assessing the degree of enamel demineralization and the effectiveness of remineralization repair.

[0053] In this effect test example, in order to evaluate the effect of the test sample on the surface hardness of teeth, the Vickers hardness value of the extracted bovine teeth was measured using a Vickers hardness tester, thereby evaluating the remineralization and repair capabilities of the toothpastes prepared in Examples 1-3 and Comparative Examples 6-10.

[0054] The specific experimental steps are as follows: 1) Preparation of tooth enamel specimens: Select freshly extracted bovine teeth, cut them into pieces approximately 5mm × 5mm in size, and embed them in polymethyl methacrylate resin. Under water cooling conditions, use a P180 grinding wheel on a polishing machine to grind the enamel surface of the tooth grinding block until it is completely exposed and the surface of the tooth grinding block is level. Then, use P600 and 2500 silicon carbide sandpaper to grind it smooth in sequence. Finally, use a soft cloth with 1µm diamond polishing paste to polish it to a mirror finish. The prepared tooth grinding blocks are stored in deionized water for later use. 2) Preparation of artificial saliva: Weigh 0.246g calcium nitrate, 0.1225g potassium dihydrogen phosphate, 9.685g potassium chloride, and 4.184g bis(2-hydroxyethyl)aminotris(hydroxymethyl)methane into a 1L beaker, add 800mL deionized water, stir thoroughly to dissolve, and adjust the pH to 7.0±0.05 with 1mol / L HCl; transfer this solution to a 1L volumetric flask and dilute to the mark with deionized water. 3) Preparation of demineralization solution: Weigh 5g of citric acid into a 500mL volumetric flask, add deionized water to make up to 500mL, and adjust the pH to 3.80 using 1mol / L NaOH solution; 4) Screening of enamel specimens: The hardness of enamel specimens was measured using a Vickers hardness tester (100g pressure, 5s loading time). Four points were measured on each specimen, with each point at least 0.5mm from the edge of the tooth block. The four points were evenly distributed, with a minimum distance of 1mm between each point. The hardness of the enamel specimen was the average of the four measurements, recorded as HV0 (the baseline value for enamel hardness). A hardness value of (300-350) kg / mm² was selected. 2 Specimens from between were included in this study; 5) Preparation of toothpaste paste for test samples: Weigh a certain amount of the toothpaste to be tested and deionized water according to the ratio of 1g:1.3mL (toothpaste:water), stir and mix well, and avoid foaming; add 5mL of toothpaste paste to each tooth enamel specimen; the preparation method of toothpaste paste for each group is the same; 6) Demineralization treatment: Immerse the enamel specimen in 1% citric acid for 30 minutes at a temperature controlled at 37℃±2℃, stirring with a propeller at low speed (60 r / min), keeping the propeller 5 cm above the enamel specimen. Then, thoroughly rinse the specimen with deionized water and dry it. Use a Vickers hardness tester (100g pressure, 5s loading time) to measure the hardness of the demineralized enamel specimen. Measure four points on each specimen, ensuring the measurement points are at least 0.5 mm from the edge of the tooth block, and distribute the measurements evenly across the four points. There are four measurement points, and the distance between each measurement point should not be less than 1 mm. The hardness of the enamel specimen is the average of the four measurements, denoted as HV1 (hardness value of enamel after demineralization). Demineralized enamel samples are screened, and then the enamel specimens are randomly divided into 9 experimental groups, namely Examples 1-3, Comparative Examples 6-10, and 1 blank control group, with 8 samples in each group. After grouping, the Vickers surface hardness values ​​of the two groups are tested using an independent samples t-test, requiring no significant difference between the two groups (P>0.05). 7) Experimental Cycle: In the experimental group, the toothpaste slurry was used to soak the specimen for 15 minutes under constant temperature and shaking conditions (37℃±2℃, 100 rpm / min). The specimen was then thoroughly rinsed with deionized water, and then soaked in artificial saliva under constant temperature and shaking conditions for 6 hours (temperature and shaking as above). The toothpaste slurry was then used to soak the specimen for 15 minutes under constant temperature and humidity conditions (temperature and shaking as above), and the specimen was thoroughly rinsed with deionized water. Finally, the specimen was soaked in artificial saliva under constant temperature and shaking conditions overnight (37℃±2℃, 100 rpm / min). The above operation was repeated for a total of 7 days. The blank control group was soaked in an equal amount of deionized water instead of toothpaste slurry, and other treatments were the same as those in the experimental group. 8) Hardness test: After the cycle ends on day 7, the hardness of the enamel specimen is measured using a Vickers hardness tester (pressure 100g, loading time 5s). Four points are measured for each specimen. The distance between the measurement point and the edge of the tooth block should not be less than 0.5mm. The four measurement points should be evenly distributed, and the distance between each measurement point should not be less than 1mm. The hardness of the enamel specimen is the average of the four measurements, which is recorded as HV2 (hardness value of enamel after remineralization). 9) Experimental data are expressed as mean ± standard deviation (Mean ± SD); the results are shown in Table 2.

[0055] Table 2. Data from the remineralization test of demineralized enamel. Group <![CDATA[HV0]]> <![CDATA[HV1]]> <![CDATA[HV2]]> Blank control group 347.15±8.61 135.23±4.45 139.01±5.89 Example 1 342.01±10.06 131.76±5.92 <![CDATA[172.15±6.83 * ]]> Example 2 349.24±8.49 128.91±5.14 <![CDATA[174.36±5.27 * ]]> Example 3 345.19±9.52 133.35±6.03 <![CDATA[180.24±6.80 * ]]> Comparative Example 6 346.27±7.90 134.79±5.36 <![CDATA[156.12±7.65 * ]]> Comparative Example 7 343.10±7.63 130.90±6.91 <![CDATA[155.93±8.12 * ]]> Comparative Example 8 341.23±7.82 134.32±5.28 <![CDATA[162.47±6.78 * ]]> Comparative Example 9 344.18±8.04 136.67±4.07 <![CDATA[168.61±5.86 * ]]> Comparative Example 10 345.71±10.28 134.88±6.15 <![CDATA[164.35±5.41 * ]]> Note:" * "P < 0.05" indicates that the remineralization values ​​of Examples 1-3 and Comparative Examples 6-10 are compared with the remineralization values ​​of the blank control group.

[0056] Compared with Example 2, Comparative Examples 6-8 were without casein phosphopeptide and calcium lactate, amla extract and tart cherry extract, respectively, while Comparative Examples 9-10 were with adjusted ratios of casein phosphopeptide, calcium lactate, amla extract and tart cherry extract, respectively.

[0057] As can be seen from the remineralization test data of Example 2 and Comparative Examples 6-8 in Table 2, casein phosphopeptide, calcium lactate, amla extract, and sour cherry extract can synergistically improve the Vickers hardness value of Example 2, thereby improving the remineralization and repair ability of tooth enamel in the toothpaste of Example 2.

[0058] As can be seen from the data of Examples 1-3 and Comparative Examples 9-10 in Table 2, the ratio of casein phosphopeptide, calcium lactate, amla extract, and sour cherry extract affects the toothpaste's promoting effect on remineralization. When the ratio of casein phosphopeptide, calcium lactate, amla extract, and sour cherry extract falls within the range defined by this invention, the toothpaste has a better promoting effect on tooth enamel remineralization.

[0059] Comparative Example 11 (Blank Comparative Example) Compared with Example 2, the difference is that Comparative Example 11 did not add human recombinant enamel matrix protein, casein phosphopeptide, calcium lactate, amla extract and sour cherry extract, and the missing amounts were made up with an equal amount of deionized water. All other conditions and preparation methods were the same as in Example 2.

[0060] Example 3 of efficacy test: Human efficacy trial This efficacy test example examines the anti-inflammatory and repairing effects of the toothpastes prepared in Examples 1-3 and Comparative Example 11 of this invention.

[0061] The specific experimental steps are as follows: Eighty patients with periodontitis were selected as volunteers, half male and half female, aged 22-40 years, with a disease duration of 1-2 years; they were randomly divided into 4 groups of 20 patients each; all patients in each group brushed their teeth twice a day, morning and evening, using 2 grams of the drug each time for 5 minutes each time, and were prohibited from eating or drinking for 30 minutes after brushing, and the treatment was continued for 3 months; the sulcus bleeding index (SBI) and gingival index (GI) were observed. The Sulcus Bleeding Index (SBI) was proposed by Muheman and Sou in 1971. The scoring system ranges from 0 to 5: 0 indicates healthy gums with no inflammation and no bleeding on probing; 1 indicates normal gum color but pinpoint bleeding on probing (blood spots only appear at the tip of the probe); 2 indicates mild redness and swelling of the gums, with linear bleeding on probing (blood seeps along the sulcus); 3 indicates significant redness and swelling of the gums, with spontaneous bleeding on probing (bleeding is visible even without probing) or noticeable bleeding; 4 indicates severe gingival inflammation with ulcers or necrosis, and heavy bleeding on probing; 5 indicates severe gingival inflammation, spontaneous bleeding, and purulent discharge. Gingival Index (GI): Proposed by Loe and Silness in 1963, the scoring system ranges from 0 to 3. 0 indicates healthy gums, no inflammation, pink color, firm texture, and no bleeding on probing; 1 indicates mild gingival inflammation: slight color change (slightly red), mild edema, and no bleeding on probing; 2 indicates moderate gingival inflammation: obvious redness, edema, and shine, with bleeding on probing; 3 indicates severe gingival inflammation: significant redness and swelling, ulceration, spontaneous bleeding, and even pseudo-periodontal pockets. Experimental data are expressed as mean ± standard deviation (Mean ± SD); results are shown in Tables 3-4.

[0062] Table 3 Data on the Sulcus Bleeding Index (SBI) Group Before using toothpaste After using toothpaste Example 1 2.02±0.15 <![CDATA[0.78±0.06 * ]]> Example 2 2.13±0.19 <![CDATA[0.69±0.07 * ]]> Example 3 2.07±0.16 <![CDATA[0.72±0.05 * ]]> Comparative Example 11 2.18±0.11 2.06±0.14 Note:" * "P < 0.05" indicates that compared with Examples 1-3 and Comparative Example 11, P < 0.05.

[0063] Table 4. Data on the Gingival Index (GI) Group Before using toothpaste After using toothpaste Example 1 1.68±0.14 <![CDATA[0.65±0.05 * ]]> Example 2 1.71±0.13 <![CDATA[0.58±0.04 * ]]> Example 3 1.63±0.10 <![CDATA[0.62±0.03 * ]]> Comparative Example 11 1.52±0.17 1.55±0.11 Note:" * "P < 0.05" indicates that compared with Examples 1-3 and Comparative Example 11, P < 0.05.

[0064] As shown in Tables 3-4, the sulcus bleeding index (SBI) and gingival index (GI) of Examples 1-3 and Comparative Example 11 can be obtained by the toothpaste prepared in Examples 1-3. This indicates that the toothpaste prepared from five active ingredients and excipients, namely human recombinant enamel matrix protein, casein phosphopeptide, calcium lactate, amla extract, and sour cherry extract, has anti-inflammatory and repairing effects and can be used to maintain oral health.

[0065] The above description is merely a preferred composition of the present invention and is not intended to limit the present invention in any way. Although the present invention has been disclosed above with preferred compositions, it is not intended to limit the present invention. Any person skilled in the art can make some modifications or alterations to the above-disclosed technical content to create equivalent compositions without departing from the scope of the present invention. Any simple modifications, equivalent changes and alterations made to the above compositions based on the technical essence of the present invention without departing from the scope of the present invention shall still fall within the scope of the present invention.

Claims

1. An oral care toothpaste, characterized in that, The toothpaste includes active ingredients and excipients; The active ingredients, by weight percentage, include: 0.08%-0.15% human recombinant enamel matrix protein, 0.15%-0.3% casein phosphopeptide, 0.03%-0.1% calcium lactate, 0.05%-0.1% amla extract, and 0.08%-0.15% sour cherry extract. The excipients include: 40%-60% humectant, 0.5%-2% thickener, 12%-25% abrasive, 0.02%-5% sweetener, 0.5%-2% surfactant, 0.001%-0.5% enzyme, 0%-1% preservative, 0.3%-1.5% fragrance, and the balance being deionized water.

2. The oral care toothpaste as described in claim 1, characterized in that, The active ingredients, by weight percentage, include: 0.1% human recombinant enamel matrix protein, 0.25% casein phosphopeptide, 0.05% calcium lactate, 0.08% amla extract, and 0.1% sour cherry extract.

3. The oral care toothpaste as described in claim 1, characterized in that, The moisturizer is selected from at least one of sorbitol, glycerin, polyethylene glycol, and propylene glycol.

4. The oral care toothpaste as described in claim 1, characterized in that, The thickener is selected from at least one of carbomer, cellulose gum, xanthan gum, and gum arabic.

5. The oral care toothpaste as described in claim 1, characterized in that, The friction agent is selected from at least one of silicon dioxide, dicalcium phosphate, and calcium pyrophosphate.

6. The oral care toothpaste as described in claim 1, characterized in that, The sweetener is selected from at least one of sodium saccharin, sucralose, xylitol, erythritol, steviol glycosides, mogrosides, and licorice extract.

7. The oral care toothpaste as described in claim 1, characterized in that, The surfactant is selected from at least one of anionic surfactants, nonionic surfactants, amphoteric surfactants, and biosurfactants.

8. The oral care toothpaste as described in claim 1, characterized in that, The bioenzyme is selected from at least one of glucanase, lysozyme, protease, glucosyl oxidase, amylase, papain, bromelain, cellulase, superoxide dismutase, and catalase.

9. The oral care toothpaste as described in claim 1, characterized in that, The preservative is selected from at least one of the following: plant antibacterial agents, sodium benzoate, benzyl alcohol, ethylhexylglycerin, octyl glycol, pentylene glycol, and p-hydroxyacetophenone.

10. The method for preparing the oral care toothpaste as described in claim 1, characterized in that, Includes the following steps: S1. Add the humectant, sweetener, and preservative to the deionized water, stir well, then add the biological enzyme and thickener, stir well to obtain a mixture; S2. Add abrasive, surfactant, fragrance and active ingredients to the mixture, stir evenly and degas to obtain the oral care toothpaste.