Composition for repairing oral soft tissue injury

Abstract

The invention provides a composition for repairing oral soft tissue injury. The composition for repairing the oral soft tissue injury comprises amelogenin, a plant extract and a zinc ion compound, and the plant extract comprises at least one of a liquorice extract, a scindapsus aureus flower extract and a fructus piperis longi extract. The composition for repairing oral soft tissue injury can effectively repair oral soft tissue cells, inhibit release of inflammatory factors and improve halitosis, so that oral soft tissue injury symptoms are improved, injury healing is promoted, and fresh breath is kept.

Description

Technical Field

[0001] The present invention relates to the technical field of oral care, and in particular to a composition for repairing oral soft tissue damage. Background Art

[0002] The oral cavity is a vital gateway between the human body and the outside world. The health of its soft tissues is crucial for maintaining normal chewing, swallowing, and speech functions, as well as defending against microbial invasion. Oral soft tissue injuries, primarily encompassing damage, infection, and inflammation occurring in the oral mucosa (e.g., oral ulcers, oral mucositis) and periodontal tissues (e.g., gingivitis, periodontitis), are extremely common oral problems that plague patients. These injuries can be induced by a variety of factors, including mechanical trauma (e.g., improper brushing, friction from braces), chemical irritation (e.g., spicy foods, certain medications), microbial infections (bacteria, fungi, viruses), decreased immunity, nutritional deficiencies, and systemic diseases.

[0003] Such injuries not only cause significant local pain, swelling, bleeding, burning and other discomfort symptoms, seriously affecting the patient's quality of life (such as difficulty eating and social disorders), but are also likely to become a channel for pathogens to enter deep tissues and even systemic circulation, leading to more serious infectious complications.

[0004] Currently, the treatments for oral soft tissue injuries mainly include: Topical medications: These include mouthwashes, gels, films, or sprays containing antibacterial agents (such as chlorhexidine), anti-inflammatory drugs (corticosteroids like triamcinolone acetonide), or local anesthetics (such as lidocaine). These methods aim to relieve symptoms (pain relief, anti-inflammation) or control infection.

[0005] Physical therapy: such as laser therapy, can promote the healing of ulcer surface.

[0006] Systemic treatment: For severe or recurrent cases, antibiotics, immunomodulators, or nutritional supplements (eg, B vitamins, zinc) may be used.

[0007] However, existing technologies still have obvious limitations: Mainly relieving symptoms, but with limited repair-promoting capabilities: Existing products mostly focus on short-term anti-inflammatory and analgesic effects, or inhibiting specific pathogens, but are insufficient in effectively promoting the repair and regeneration of oral soft tissue cells. This can result in a prolonged healing period, especially for deep or recurring injuries.

[0008] Single ingredient functions and insufficient synergy: Single ingredients (e.g., only antibacterial or only anti-inflammatory) often fail to fully address the soft tissue repair needs of the complex oral environment (where multiple bacterial species coexist and the environment is constantly stimulated). There is a lack of synergistic formulas that can simultaneously and effectively inhibit multiple oral pathogens, regulate the release of inflammatory factors, and directly promote cell repair.

[0009] Long-term use safety and tolerance issues: long-term use of some antibacterial agents (such as chlorhexidine) can cause changes in taste, tooth staining, oral flora imbalance; long-term local application of strong anti-inflammatory drugs (such as high-concentration glucocorticoids) has the risk of potential mucosal atrophy and other side effects.

[0010] Therefore, there is an urgent need in the art to develop a new oral care composition which not only effectively relieves the symptoms of oral soft tissue damage (such as inflammation and pain), but also has the core ability to promote the repair and regeneration of oral soft tissue cells, can efficiently inhibit a variety of common oral pathogenic bacteria, regulate excessive inflammatory response, and has good safety and use compliance, so as to accelerate the healing of broken damage, prevent recurrence, and more comprehensively and fundamentally maintain the health of oral soft tissue. SUMMARY

[0011] The first technical problem to be solved by the present application is to provide a composition for repairing oral soft tissue damage, which can effectively repair oral soft tissue cells, inhibit the release of inflammatory factors, improve halitosis, thereby improving the symptoms of oral soft tissue damage, promoting the healing of broken damage, and keeping the breath fresh.

[0012] The second technical problem to be solved by the present application is to provide an application of the above-mentioned composition for repairing oral soft tissue damage in the preparation of products with the efficacy of repairing oral soft tissue damage.

[0013] The third technical problem to be solved by the present application is to provide a product containing the above-mentioned composition for repairing oral soft tissue damage.

[0014] To solve the first technical problem, the present application adopts the following technical scheme: A composition for repairing oral soft tissue damage, comprising the following components in mass parts: amelogensin 0.01-1 parts, plant extract 0.2-5 parts, zinc ion compound 0.2-2 parts, wherein the plant extract comprises at least one of licorice extract, green ivy flower extract, and piper longum extract.

[0015] Preferably, the plant extract comprises licorice extract, green ivy flower extract, and piper longum extract in a mass ratio of 1:0.1-0.3:0.2-0.4.

[0016] Preferably, the zinc ion compound is zinc lactate and / or zinc chloride. More preferably, the zinc ion compound is zinc lactate.

[0017] Preferably, in the composition for repairing oral soft tissue damage, the mass part of amelogensin is 0.1-0.8 parts; more preferably, 0.4 parts.

[0018] Preferably, the mass fraction of the plant extract in the composition for repairing oral soft tissue damage is 1-2 parts; more preferably 1.5 parts.

[0019] Preferably, the mass fraction of the zinc ion compound in the composition for repairing oral soft tissue damage is 0.5-1.5 parts; more preferably 1 part.

[0020] To solve the second technical problem, the application provides an application of the composition for repairing oral soft tissue damage in preparing a product with the efficacy of repairing oral soft tissue damage.

[0021] Preferably, the product is any one of toothpaste, mouthwash, mouth spray, tooth powder, tooth paste, and oral gel.

[0022] To solve the third technical problem, the application provides a product with the efficacy of repairing oral soft tissue damage.

[0023] Preferably, the product is specifically a mouthwash.

[0024] More preferably, the mouthwash comprises 0.1-7wt% of the composition for repairing oral soft tissue damage.

[0025] Preferably, the product is specifically a toothpaste.

[0026] More preferably, the toothpaste comprises 0.1-9wt% of the composition for repairing oral soft tissue damage.

[0027] Compared with the prior art, the application has the following beneficial effects: The composition for repairing oral soft tissue damage provided by the application can effectively repair oral soft tissue cells, inhibit the release of inflammatory factors, improve halitosis, thereby improving the symptoms of oral soft tissue damage, promoting the healing of damage, and keeping breath fresh. DETAILED DESCRIPTION

[0028] In order to more clearly illustrate the application, the application will be further described below in conjunction with preferred embodiments. Those skilled in the art should understand that the specific description below is illustrative rather than limiting, and should not limit the protection scope of the application.

[0029] Unless otherwise specified, all percentages and ratios used herein are based on weight of the total composition. Unless otherwise specified, all percentages, ratios, and contents of ingredients referred to herein are based on the actual amount of the ingredient, and do not include solvents, fillers, or other materials with which the ingredient can be combined as a commercially available product, unless otherwise indicated.

[0030] The term "comprising" used herein means that other steps and ingredients can be added without affecting the final result.

[0031] The term "preferably" and its variants herein refer to embodiments of the present invention that can provide specific beneficial effects under specific circumstances. However, other embodiments may also be preferred under the same or other circumstances. In addition, the detailed description of one or more preferred embodiments does not mean that other embodiments are useless and is not intended to exclude other embodiments from the scope of the present invention.

[0032] If no specific conditions are specified in the examples of the present invention, the experiments were carried out according to conventional conditions or the conditions recommended by the manufacturer. If no manufacturer is specified for the reagents or instruments used, they are all conventional products that can be purchased commercially.

[0033] Licorice extract: purchased from Guangdong Hongyou Biotechnology Co., Ltd., the extraction method is water extraction to obtain water-soluble licorice extract.

[0034] Piper longum extract: purchased from Shanyang Lianfeng Biotechnology Co., Ltd., the extraction method is alcohol extraction to obtain water-soluble Piper longum extract.

[0035] Scindapsus flower extract: purchased from Gansu Yishengxiang Biotechnology Co., Ltd., the extraction method is alcohol extraction to obtain water-soluble Scindapsus flower extract.

[0036] Amelogenin: purchased from Zefang (Guangzhou) Biological Co., Ltd., and its production method is microbial fermentation.

[0037] Zinc lactate: purchased from Ruipu Biotechnology.

[0038] Zinc chloride: purchased from Shandong Jinshengtai Chemical Co., Ltd., CAS: 7646-85-7.

[0039] Composition 1: A composition for repairing oral soft tissue damage, its components, mass fractions and preparation method are as follows: Amelogenin: 0.4 parts; Plant extract: 1.5 parts; Zinc lactate: 1 part; The plant extracts are liquorice extract, scindapsus flower extract, and longipes longifolia extract in a mass ratio of 1:0.2:0.3; The preparation method of composition 1 comprises the following steps: Evenly mix amelogenin, licorice extract, scindapsus flower extract, longissimus lanceolata extract and zinc lactate, and store in a sealed container away from light.

[0040] Composition 2: A composition for repairing oral soft tissue damage, its components, mass fractions and preparation method are as follows: Amelogenin: 0.1 part; Plant extract: 1 part; Zinc chloride: 1.5 parts; The plant extract is glycyrrhiza extract, green anthurium extract, and piper longum extract at a mass ratio of 1:0.1:0.4; The preparation method of the composition 2 comprises the following steps: Mix the amelogens, glycyrrhiza extract, green anthurium extract, piper longum extract, and zinc chloride uniformly, and store in a sealed container away from light.

[0041] Composition 3: A composition for repairing oral soft tissue injury, the components, mass fractions, and preparation method are as follows: Aamelogens: 0.8 parts; Plant extract: 2 parts; Zinc lactate: 0.5 parts; The plant extract is glycyrrhiza extract, green anthurium extract, and piper longum extract at a mass ratio of 1:0.1:0.4; The preparation method is the same as that of the composition 1.

[0042] Composition A: Different from the composition 1, it lacks green anthurium extract and piper longum extract, and lacks mass fractions of glycyrrhiza extract, and the rest of the raw materials and preparation method are the same as those of the composition 1.

[0043] Composition B: Different from the composition 1, it lacks glycyrrhiza extract and piper longum extract, and lacks mass fractions of green anthurium extract, and the rest of the raw materials and preparation method are the same as those of the composition 1.

[0044] Composition C: Different from the composition 1, it lacks green anthurium extract and glycyrrhiza extract, and lacks mass fractions of piper longum extract, and the rest of the raw materials and preparation method are the same as those of the composition 1.

[0045] Composition D: Different from the composition 1, the mass ratio of glycyrrhiza extract, green anthurium extract, and piper longum extract is 1:1:1, and the rest of the raw materials and preparation method are the same as those of the composition 1.

[0046] Composition F: Different from the composition 1, it lacks amelogens and zinc lactate, and lacks mass fractions of plant extract, and the rest of the raw materials and preparation method are the same as those of the composition 1.

[0047] Test Example 1: Inhibition of inflammatory factor test Test cells: HGF-1 human gingival cells Test samples: The compositions 1-3, A-F are respectively prepared into a mixture of 1 mg / mL using DMEM culture medium containing 10% fetal bovine serum, and sealed for use.

[0048] Test method: The cells were cultured in a 37℃ incubator with 5% carbon dioxide concentration using DMEM medium containing 10% fetal bovine serum. Cells in the logarithmic growth phase were inoculated in a 24-well plate, with a cell count of 1×10 5 After 24 hours of incubation, the supernatant was removed, and the cells were divided into a model group, a blank group, and a test group, with 3 replicates in each group. 0.5 mL of the test sample was added to the test group, and the blank group and the model group were added with an equal amount of DMEM medium containing 10% fetal bovine serum. Then, the model group and the test group were simultaneously added with LPS, so that the final concentration of LPS was 1 μg / mL. The blank group was added with an equal amount of DMEM medium containing 10% fetal bovine serum instead of LPS. After 24 hours of induction, the cell supernatant was collected, and the content of the inflammatory factor IL-6 in the cell supernatant after LPS induction was determined using an ELISA kit. The inhibition rate of the inflammatory factor IL-6 was calculated, and the average value ± standard deviation (with two decimal places) was used to represent the inhibition rate of the inflammatory factor IL-6. Table 1 shows the specific values.

[0049] Inflammatory factor IL-6 inhibition rate = (lm-ls) / (lm-ln) × 100% In the formula, lm is the inflammatory factor secretion amount of the model group, pg / mL; ls is the inflammatory factor secretion amount of the sample group, pg / mL; and ln is the inflammatory factor secretion amount of the blank group, pg / mL.

[0050] Table 1 Effect of the composition on the secretion of inflammatory factors by HGF-1 (n=3, ±SD) experimental group IL-6 inhibition rate (%) Composition 1 79.40±0.64 Composition 2 77.92±1.04 Composition 3 75.89±0.97 Composition A 58.84±0.98* Composition B 54.01±1.26* Composition C 48.14±0.44* Composition D 64.61±1.31* Composition E 34.37±0.74* Composition F 61.39±0.42* Note: “*” indicates that p<0.05 compared with the composition 1.

[0051] According to the test results of the compositions 1-3 in Table 1, when the enamelogenin, the plant extract, and the zinc lactate are mixed in a mass ratio of 0.1-0.8:1-2:0.5-1.5, and the plant extract includes licorice extract, green ivy flower extract, and piper longum extract in a mass ratio of 1:0.1-0.3:0.2-0.4, the composition can significantly inhibit the secretion of the IL-6 inflammatory factor by HGF-1 human gingival cells.

[0052] According to the comparison between the composition 1 and the compositions A-C, the licorice extract, the green ivy flower extract, and the piper longum extract have a significant synergistic effect on the inhibition of the secretion of the IL-6 inflammatory factor by HGF-1 cells. According to the comparison between the composition 1 and the composition D, the plant extract obtained in the limited mass ratio has a better effect on the inhibition of the secretion of the IL-6 inflammatory factor by HGF-1 cells. According to the comparison between the composition 1 and the compositions E and F, the combination of the plant extract, the enamelogenin, and the zinc lactate can significantly inhibit the secretion of the IL-6 inflammatory factor by HGF-1 human gingival cells.

[0053] Test Example 2: Animal Test Test Animals: Several 8-week-old SPF male SD rats weighing 200 ± 20 g were used. The rats were raised in a room temperature of 20-25°C, relative humidity of 45-65%, and 12 h light-dark cycle environment, and were allowed to freely eat and drink.

[0054] Test Samples: Compositions 1, Compositions A-F.

[0055] Test Method: Modeling: 70 rats were taken, each of which was anesthetized by intraperitoneal injection of 10% chloral hydrate (3 mL / kg), fixed on a workbench, and the labial mucosa of the SD rats was dried using a sterile cotton ball. A 3 mm x 3 mm square filter paper was placed in 50% concentrated glacial acetic acid, taken out after 5 s, and immediately placed on the dried labial mucosa. After 30 s, the filter paper was removed, and the treated part was wiped with a sterile cotton ball soaked with normal saline to remove residual acetic acid. The rats were raised for 48 h, and obvious ulcers were observed in the modeling area, which was characterized by central depression, pseudomembrane coverage, ulcer edge redness, strong irritation and pain response, and regular circular ulcers with a diameter of ≥5 mm.

[0056] Test: The above modeling successful rats were divided into 7 groups, 10 rats in each group, and another 10 normal rats were taken, i.e. seven test groups and one blank group. The test groups were smeared with test samples on the affected area, 2 times / day, with an interval of 6 h; the blank group was smeared with an equal amount of deionized water on the affected area. Smearing method: the test sample was applied to the oral ulcer site using a sterile cotton swab, so that the test sample completely covered the wound.

[0057] Index Detection: The rats in each group were continuously treated until the ulcer healed, the treatment days of the rats were recorded, and the ulcer healing time was calculated (in days (d) as the measurement unit), and the healing standard was that the mucosal epithelium completely covered the ulcer depression.

[0058] The experimental results are expressed as mean ± standard deviation (retaining 1 digit after the decimal point), as shown in Table 2.

[0059] Table 2 Effect of Compositions on the Average Healing Time of Oral Ulcers in Rats (n=10, ±SD) Group Healing time (d) Blank group 11.2±0.6 Composition 1 4.1±0.3* Composition A 6.2±0.4*# Composition B 6.6±0.7*# Composition C 7.2±0.4*# Composition D 5.5±0.5*# Composition E 8.2±0.8*# Composition F 5.9±0.6*# Note: “*” indicates p<0.05 compared with the blank group; “#” indicates p<0.05 compared with Composition 1.

[0060] According to the results in Table 2, the composition in the application can accelerate the healing of oral ulcer. According to the results of comparing composition 1 with compositions A-C, it can be seen that there is a significant synergistic effect among licorice extract, green vine flower extract and piper longum extract, and the use of the same with enamel protein and zinc lactate can significantly accelerate the healing speed of oral ulcer. According to the results of comparing composition 1 with composition D, it can be seen that the use of plant extracts in the quality ratio defined in the application together with enamel protein and zinc lactate can significantly promote the healing time of oral ulcer in rats. According to the results of comparing composition 1 with compositions E and F, it can be seen that there is a synergistic effect between plant extracts and enamel protein and zinc lactate, and the use of the same together can accelerate the healing time of oral ulcer in rats.

[0061] Application Example 1: A mouthwash, which comprises the following raw materials in mass percentage: Composition 1: 7wt%; Sweetener: 0.3wt%; Anhydrous ethanol: 2wt%; The balance is drinking water.

[0062] The sweetener is aspartame.

[0063] The preparation method of the mouthwash is: Anhydrous ethanol, sweetener and composition 1 are added to drinking water and mixed uniformly, and then sealed and stored in dark place.

[0064] Application Example 2: The difference from application example 1 is that composition A is used to replace composition 1, and the rest of the raw materials and steps are the same as application example 1.

[0065] Application Example 3: The difference from application example 1 is that composition B is used to replace composition 1, and the rest of the raw materials and steps are the same as application example 1.

[0066] Application Example 4: The difference from application example 1 is that composition C is used to replace composition 1, and the rest of the raw materials and steps are the same as application example 1.

[0067] Application Example 5: The difference from application example 1 is that composition D is used to replace composition 1, and the rest of the raw materials and steps are the same as application example 1.

[0068] Application Example 6: The difference from application example 1 is that composition E is used to replace composition 1, and the rest of the raw materials and steps are the same as application example 1.

[0069] Application Example 7: The difference from application example 1 is that composition F is used to replace composition 1, and the rest of the raw materials and steps are the same as application example 1.

[0070] Application Example 8: Different from Application Example 1, drinking water was used to replace Composition 1, and the remaining raw materials and steps were the same as those in Application Example 1.

[0071] Test Example 3: Anti-oral malodor effect test Test samples: Application Examples 1-8.

[0072] Sample usage method: The volunteers used the test samples once in the morning and evening, and took 15 mL of the test samples at a time, and then spat out after gargling for 60 s.

[0073] Test period: 7 days.

[0074] Test subjects: 80 people with oral malodor were selected, aged 25-50 years old, and both men and women were included.

[0075] Before the test, the volatile sulfide content in the oral cavity was measured using an oral malodor detector (Halimeter). The test method was as follows: the test subjects first gargled with water for 60 s and then spat out, closed their mouths and breathed through their nostrils for 2 min, then inserted the probe of the oral malodor detector into the test subjects' mouths and recorded the data T0.

[0076] The test subjects were randomly divided into 8 groups, and each group used the corresponding test sample every day. During the test period, the test subjects had basically the same diet and living habits. The volatile sulfide content in the oral cavity of the test subjects was measured 5 min after the test subjects used the test samples on the 7th day. The test method was as follows: the test subjects first gargled with water for 60 s and then spat out, closed their mouths and breathed through their nostrils for 2 min, then inserted the probe of the oral malodor detector into the test subjects' mouths and recorded the data T7, and then calculated the volatile sulfide concentration reduction rate according to the following formula. The test results are shown in Table 3.

[0077] Volatile sulfide concentration reduction rate / % = (T0-T7) / T0 x 100% Table 3 Anti-oral malodor effect test of compositions (n=10, ±SD) Group Volatile sulfur compound concentration reduction rate / % Application Example 1 75.24±1.92 Application Example 2 52.15±1.19* Application Example 3 46.61±2.57* Application Example 4 51.39±1.46* Application Example 5 65.42±1.27* Application Example 6 29.36±0.91* Application Example 7 61.71±1.39* Application Example 8 2.24±0.07* Note: “*” indicates that p<0.05 compared with Application Example 1.

[0078] According to the results in Table 3, Application Examples 1-7 all have certain anti-halitosis effects; by comparing the results of Application Example 1 with those of Application Examples 2-4, it can be seen that the combined use of licorice extract, scindapsus flower extract, and longissimus lanceolata extract in the plant extracts can effectively promote the decrease in the concentration of volatile sulfides and effectively inhibit bad breath; by comparing the results of Application Example 1 with those of Application Example 5, it can be seen that the use of licorice extract, scindapsus flower extract, and longissimus lanceolata extract in the mass ratio of 1:0.2:0.3 as defined in the present invention has a better effect on inhibiting bad breath, and by comparing the results of Application Examples 1, 6-7, it can be seen that compared with amelogenin and zinc lactate or plant extracts, the combined use of amelogenin and zinc lactate in the mass ratio defined in the present invention and plant extracts has a better effect on inhibiting bad breath.

[0079] The embodiments of the present invention are described in detail above, but the present invention is not limited to the described embodiments. It is apparent to those skilled in the art that various changes, modifications, substitutions, and variations to these embodiments may be made without departing from the principles and spirit of the present invention, and the changes still fall within the scope of protection of the present invention.

Claims

1. A composition for repairing oral soft tissue damage, characterized in that: The composition comprises the following components in parts by weight: Amelogenin: 0.01-1 part; Plant extract: 0.2-5 parts; Zinc ion compound: 0.2-2 parts; The plant extract comprises at least one of licorice extract, scindapsus flower extract and longipes extract.

2. The composition according to claim 1, wherein The plant extracts include liquorice extract, scindapsus flower extract and longipes longifolia extract in a mass ratio of 1:0.1-0.3:0.2-0.

4.

3. The composition according to claim 1, wherein The composition includes the following components in parts by weight: Amelogenin: 0.1-0.8 parts; Plant extract: 1-2 parts; Zinc ion compound: 0.5-1.5 parts.

4. The composition according to claim 1, wherein The composition includes the following components in parts by weight: Amelogenin: 0.4 parts; Plant extract: 1.5 parts; Zinc ion compound: 1 part.

5. The composition according to any one of claims 1 to 4, wherein The zinc ion compound is zinc lactate and / or zinc chloride.

6. Use of the composition according to any one of claims 1 to 5 in preparing a product having the efficacy of repairing oral soft tissue damage.

7. The use according to claim 6, characterized in that The product is any one of toothpaste, mouthwash, mouth spray, tooth powder, tooth strips, and oral gel.

8. A mouthwash, characterized in that The mouthwash comprises 0.1-7 wt % of the composition according to any one of claims 1-5.

9. A toothpaste, characterized in that The toothpaste comprises 0.1-9 wt % of the composition according to any one of claims 1-5.