Composition for improving gingivitis and preparation method thereof, and gargling lotion

Abstract

The invention relates to a composition for improving gingivitis, a preparation method of the composition and gargling and relates to the technical field of gingivitis, and the composition for improving gingivitis comprises the following components in parts by weight: 20-40 parts of shiny-leaved yellowhorn leaves, 5-15 parts of peach gum and 10-25 parts of humulus lupulus. The shiny-leaved yellowhorn leaves, the peach gum and the humulus lupulus which can be used as both medicines and foods are matched to be used as functional raw materials, and meanwhile, effective components are extracted by combining a modern supercritical carbon dioxide extraction process under proper parameters, so that the treatment effect of the obtained composition on gingivitis diseases is remarkably improved, and the use safety of patients is greatly improved. On the basis, the invention further provides the suhuang capable of improving oral diseases such as gingivitis, and the suhuang has the advantages of being safe, effective and the like and is wide in application prospect.

Description

Technical Field

[0001] This invention relates to the field of gingivitis technology, and more particularly to a composition for improving gingivitis and its preparation method, as well as a mouthwash. Background Technology

[0002] Gingivitis is a common oral disease with a high incidence rate in the population. Epidemiological surveys show that gingivitis occurs to varying degrees in people of all ages, but is particularly prevalent among adolescents and adults. The main clinical manifestations of gingivitis include red, swollen, bleeding, and painful gums. It not only causes physical discomfort, affecting basic daily functions such as eating and speaking, and reducing quality of life, but can also negatively impact mental health, leading to feelings of inferiority and anxiety due to bad breath and changes in gum appearance.

[0003] If gingivitis is not treated promptly and effectively, the condition may progress, leading to more serious oral diseases such as periodontitis. Periodontitis can cause alveolar bone resorption, tooth loosening, and even tooth loss, not only impairing oral chewing function but also affecting facial aesthetics, increasing the patient's financial burden and the difficulty of treatment. Furthermore, numerous studies have shown that oral health is closely related to overall health; oral diseases such as gingivitis may be associated with the development of systemic diseases such as cardiovascular disease, diabetes, and respiratory diseases, seriously threatening the patient's overall health.

[0004] Currently, commonly used chemical drugs for treating gingivitis in clinical practice mainly include antibiotics and anti-inflammatory drugs. Antibiotics such as metronidazole and amoxicillin, while effectively inhibiting or killing pathogenic bacteria in the oral cavity and relieving inflammatory symptoms, can easily lead to bacterial resistance with long-term use, resulting in decreased drug efficacy and potentially disrupting the normal oral flora balance, causing adverse reactions such as superinfection. Anti-inflammatory drugs such as ibuprofen and aspirin primarily reduce inflammatory responses by inhibiting the synthesis and release of inflammatory mediators; however, these drugs may have certain side effects on the gastrointestinal tract, liver, and kidneys, especially for patients with underlying medical conditions, who face greater risks.

[0005] To address the side effects of existing chemical medications on gingivitis patients, natural plant extracts have gained increasing attention in recent years for treating gingivitis. Some plant extracts with anti-inflammatory, antibacterial, and hemostatic properties, such as honeysuckle extract and peppermint extract, are used in oral care products. However, most natural plant extract products on the market currently suffer from limited efficacy and single-ingredient composition, resulting in suboptimal treatment outcomes. Furthermore, the extraction processes for the active ingredients of different plant extracts vary; improper extraction processes may lead to the loss of active ingredients or the introduction of impurities, affecting product quality and safety. Summary of the Invention

[0006] To address the above problems, the present invention provides a composition for improving gingivitis, a method for preparing the same, and a mouthwash.

[0007] In a first aspect, the present invention provides a composition for improving gingivitis, wherein the composition for improving gingivitis comprises, by weight, the following components:

[0008] 20-40 parts of *Sapindus mukorossi* leaves, 5-15 parts of peach gum, and 10-25 parts of hops.

[0009] Furthermore, the ratio M1 / M2 of the weight parts of the *Sapindus mukorossi* leaves and the total weight parts of the peach gum and the hops is 1.

[0010] Furthermore, the composition for improving gingivitis comprises, by weight, the following components:

[0011] 30 parts of *Sapindus mukorossi* leaves, 10 parts of peach gum, and 20 parts of hops.

[0012] In a second aspect, the present invention provides a method for preparing the composition for improving gingivitis described in the first aspect, comprising the following steps:

[0013] The leaves of the Chinese tallow tree, peach gum, and hops are crushed and mixed to obtain a mixture;

[0014] The mixture was subjected to supercritical carbon dioxide extraction to obtain the composition for improving gingivitis.

[0015] Furthermore, the operating conditions for the supercritical carbon dioxide extraction include: a temperature of 40-50°C, a pressure of 20-30 MPa, a carbon dioxide fluid as the medium, and an entrainer composed of heptane and ethanol in a volume ratio of (1-3):(4-7).

[0016] Furthermore, the temperature for supercritical carbon dioxide extraction is 46°C.

[0017] Furthermore, the pressure of the supercritical carbon dioxide extraction is 23 MPa.

[0018] Furthermore, the entrainer is composed of heptane and ethanol in a volume ratio of 3:7.

[0019] Thirdly, the present invention provides a mouthwash comprising the composition for improving gingivitis as described in any one of the first aspects or the composition for improving gingivitis prepared by the preparation method described in any one of the second aspects.

[0020] Furthermore, the mouthwash comprises the following components by weight percentage:

[0021] The traditional Chinese medicine composition for improving gingivitis: 5%~25%;

[0022] Sorbitol: 5%~10%

[0023] Tween-60: 0.1%~0.5%;

[0024] PEG-40 hydrogenated castor oil: 0.3%~0.7%;

[0025] Sodium benzoate: 0.1%~0.5%;

[0026] Sodium citrate: 0.2%~0.5%;

[0027] Stevioside: 0.1%~0.3%;

[0028] The remainder is water.

[0029] The technical solutions provided in the embodiments of the present invention have at least the following advantages compared with the prior art:

[0030] This invention provides a composition for improving gingivitis, its preparation method, and a mouthwash. The invention uses *Xanthoceras sorbifolium* leaves (a medicinal and edible plant), peach gum, and hops as active ingredients, and employs a modern supercritical carbon dioxide extraction process under suitable parameters to extract the effective components. This significantly enhances the therapeutic effect of the resulting composition on gingivitis and greatly improves patient safety. Based on this, the invention also provides a mouthwash that can improve oral diseases such as gingivitis, possessing safety and effectiveness, and has broad application prospects. Specifically:

[0031] On the one hand, this invention uses *Xanthoceras sorbifolium* leaves as the main active ingredient, which is rich in flavonoids (such as quercetin and kaempferol), saponins, polysaccharides, and polyphenols. These substances can reduce gingival inflammation and protect gingival cells from oxidative damage. Simultaneously, it is supplemented with appropriate amounts of peach gum and hops as active ingredients. Peach gum contains plant polysaccharides and collagen, which form a viscous protective film covering the oral mucosa, reducing physical damage to the gums from external irritants. Hops contain active acids, flavonoids, and volatile oils, which can relieve gingivitis pain and reduce the impact of stress on oral health. Based on this, this invention uses *Xanthoceras sorbifolium* leaves (both medicinal and edible), peach gum, and hops in combination, achieving a synergistic effect and improving the treatment efficacy for gingivitis.

[0032] On the other hand, this invention employs modern supercritical carbon dioxide extraction technology, utilizing the combined properties of carbon dioxide—liquid density (strong solubility) and gas diffusivity (high mass transfer efficiency)—to avoid the problem of heat-sensitive components being destroyed by high temperatures in conventional decoction processes. Furthermore, a suitable ratio of heptane-ethanol mixture is used as an entrainer; ethanol enhances the solubility of polar components (such as polysaccharides and flavonoids), while heptane promotes the extraction of non-polar components (such as volatile oils), achieving highly efficient co-extraction of multipolar components. This ensures the efficient co-extraction of the multipolar active ingredients in the composition, guaranteeing its therapeutic effect. Detailed Implementation

[0033] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the present invention will be clearly and completely described below in conjunction with the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0034] It should be noted that, unless otherwise specified, the raw materials involved in the composition for improving gingivitis provided by this invention can be prepared in-house or directly from commercially available products according to the preparation process disclosed in the prior art. At the same time, unless otherwise specified, the preparation process operation steps and parameters involved can be carried out according to the preparation process disclosed in the prior art or using existing equipment. This invention document will not elaborate further.

[0035] The present invention will be further illustrated below with reference to specific embodiments. It should be understood that these embodiments are for illustrative purposes only and are not intended to limit the scope of the invention. Experimental methods in the following embodiments, unless otherwise specified, are generally performed according to national standards. If no corresponding national standard exists, then generally accepted international standards, conventional conditions, or conditions recommended by the manufacturer are followed.

[0036] Example 1

[0037] This example provides a composition for improving gingivitis, which, by weight, comprises the following components:

[0038] 30 parts of *Sapindus mukorossi* leaves, 10 parts of peach gum, and 20 parts of hops.

[0039] The method for preparing the above-mentioned composition for improving gingivitis includes the following steps:

[0040] The leaves of the Chinese tallow tree, peach gum, and hops are crushed and mixed to obtain a mixture;

[0041] The mixture was placed in a supercritical carbon dioxide extraction device, and an entrainer consisting of heptane and ethanol in a volume ratio of 3:7 was added. The volume (L) of the entrainer accounted for approximately 1% of the total weight (kg) of the mixture (i.e., 1% by volume / weight). The pressure was set to 23 MPa and the temperature to 46 °C. Supercritical carbon dioxide was introduced for extraction for 1 hour. The extract was collected, the entrainer was removed, and the mixture was concentrated and dried under reduced pressure to obtain the composition for improving gingivitis.

[0042] Example 2

[0043] This example provides a composition for improving gingivitis, which, by weight, comprises the following components:

[0044] 20 parts of *Sapindus mukorossi* leaves, 5 parts of peach gum, and 10 parts of hops.

[0045] The method for preparing the above-mentioned composition for improving gingivitis includes the following steps:

[0046] The leaves of the Chinese tallow tree, peach gum, and hops are crushed and mixed to obtain a mixture;

[0047] The mixture was placed in a supercritical carbon dioxide extraction device, and an entrainer consisting of heptane and ethanol in a volume ratio of 1:4 was added. The volume (L) of the entrainer accounted for approximately 1% of the total weight (kg) of the mixture (i.e., 1% by volume / weight). The pressure was set to 20 MPa and the temperature to 40 °C. Supercritical carbon dioxide fluid was introduced for supercritical carbon dioxide extraction for 1 hour. The extract was collected, the entrainer was removed, and the mixture was concentrated and dried under reduced pressure to obtain the composition for improving gingivitis.

[0048] Example 3

[0049] This example provides a composition for improving gingivitis, which, by weight, comprises the following components:

[0050] 40 parts of *Sapindus mukorossi* leaves, 15 parts of peach gum, and 25 parts of hops.

[0051] The method for preparing the above-mentioned composition for improving gingivitis includes the following steps:

[0052] The leaves of the Chinese tallow tree, peach gum, and hops are crushed and mixed to obtain a mixture;

[0053] The mixture was placed in a supercritical carbon dioxide extraction device, and an entrainer consisting of heptane and ethanol in a volume ratio of 2:5 was added. The volume (L) of the entrainer accounted for approximately 1% of the total weight (kg) of the mixture (i.e., 1% by volume / weight). The pressure was set to 30 MPa and the temperature to 50 °C. Supercritical carbon dioxide fluid was introduced for supercritical carbon dioxide extraction for 1 hour. The extract was collected, the entrainer was removed, and the mixture was concentrated and dried under reduced pressure to obtain the composition for improving gingivitis.

[0054] Example 4

[0055] This example provides a composition for improving gingivitis and its preparation method, which differs from Example 2 only in that:

[0056] (1) The composition for improving gingivitis comprises the following components in parts by weight: 30 parts of *Sapindus mukorossi* leaves, 10 parts of peach gum and 20 parts of hops.

[0057] Example 5

[0058] This example provides a mouthwash that, by mass percentage, comprises the following components:

[0059] Example 1: A traditional Chinese medicine composition for improving gingivitis: 15%;

[0060] Sorbitol: 8%

[0061] Tween-60: 0.4%;

[0062] PEG-40 hydrogenated castor oil: 0.5%;

[0063] Sodium benzoate: 0.2%;

[0064] Sodium citrate: 0.4%;

[0065] Stevioside: 0.2%;

[0066] The remainder is water.

[0067] Comparative Example 1

[0068] This example provides an extract for improving gingivitis and its preparation method, which differs from Example 1 only in that:

[0069] (1) 60 parts of *Sapindus mukorossi* leaves, 0 parts of peach gum and 0 parts of hops (i.e., only *Sapindus mukorossi* leaves were added).

[0070] Comparative Example 2

[0071] This example provides an extract for improving gingivitis and its preparation method, which differs from Example 1 only in that:

[0072] (1) 0 parts of Sapindus mukorossi leaves, 60 parts of peach gum and 0 parts of hops (i.e., only peach gum was added).

[0073] Comparative Example 3

[0074] This example provides an extract for improving gingivitis and its preparation method, which differs from Example 1 only in that:

[0075] (1) 0 parts of Sapindus mukorossi leaves, 0 parts of peach gum and 60 parts of hops (i.e., only hops were added).

[0076] Test Example 1

[0077] This test case uses a rat model of gingivitis disclosed in the prior art to conduct animal experiments to examine the effects of the extracts provided in Examples 1-4 and Comparative Examples 1-3 on the improvement of gingivitis symptoms.

[0078] 1. Experimental animals: 40 male SD rats, weighing 200±20g, were acclimatized for one week before the experiment. During the experiment, they were allowed free access to food and water and followed a 12h diurnal rhythm.

[0079] 2. Method for establishing a rat model of gingivitis: Rats were anesthetized by intraperitoneal injection of 10% chloral hydrate. The bilateral maxillary second molars were ligated with 4-0 silk sutures, with the suture wrapped three times and knotted, and the suture was pressed as far under the gum line as possible. Postoperatively, rats were fed moist food and given 10% sucrose water. One week later, after sevoflurane inhalation anesthesia, the condition of the gums, tooth mobility, and suture detachment were observed. If any sutures detached, they were re-ligated.

[0080] 3. Grouping and administration: Rats were randomly divided into a blank group (no modeling, no administration, and given an equal volume of physiological saline), a model control group (modeling, no administration, and given an equal volume of physiological saline), and an administration treatment group (modeling, administration, and each group was given an equal amount of the extracts provided in Examples 1-4 and Comparative Examples 1-3, with an administration dose of 1.5g crude drug / kg / time, once in the morning and once in the evening). Each group consisted of 10 rats, and the treatment lasted for one week.

[0081] 4. Index Measurement and Data Statistics: After one week of treatment, the content of aspartate aminotransferase (AST) in the saliva of rats was measured, and the content of superoxide dismutase (SOD) in the gingival tissue around the second molars from both sides of the maxilla of sacrificed rats was detected. Experimental data were statistically analyzed using SPSS 22.0 software. Data are expressed as mean ± standard deviation. The test results are shown in Table 1.

[0082] Table 1

[0083] Group AST content (U / L) SOD content (U / g) Blank control group 15.49±4.80 51.15±7.98 Model control group 35.01±6.09 17.93±5.67 Example 1: Drug Treatment Group 15.98±3.95 49.57±6.42 Example 2: Drug Treatment Group 20.32±5.92 41.08±7.10 Example 3: Drug Treatment Group 16.25±4.13 47.10±7.35 Example 4: Drug Treatment Group 17.46±5.58 45.82±6.49 Comparative Example 1 Treatment Group 25.10±6.04 30.99±6.30 Comparative Example 2 Treatment Group 31.57±6.77 21.47±5.51 Comparative treatment group 3 27.43±5.81 24.68±5.26

[0084] The test results in Table 1 above show that, compared with the blank control group, the AST content of rats in the model control group was significantly increased and the SOD content was significantly decreased, indicating that the rat model of gingivitis was successfully established. Furthermore, compared with comparative examples 1-3, the treatment group given the composition of this invention showed better improvement in the symptoms of gingivitis rats, and the leaves of *Sapindus mukorossi*, peach gum, and hops exhibited a positive synergistic effect, significantly enhancing the therapeutic effect of the obtained composition on gingivitis.

[0085] Test Example 2

[0086] This example uses the mouthwash provided in Example 5 to test its inhibitory effect on oral bacteria in patients with gingivitis, with water as a control. Subjects were randomly divided into two groups of 10 each. In one group, oral samples were taken before using the mouthwash provided in Example 5, followed by rinsing for 60 seconds, and then another sample was taken. The reduction rate of oral bacteria in patients with gingivitis before and after rinsing was calculated. In the other group, water was used instead of the composition for rinsing and the same test was performed.

[0087] The test results are shown in Table 2.

[0088] Table 2

[0089] Group Low bacterial count (%) Shimizu Group 4.09 Example 5: Mouthwash Set 99.81

[0090] As can be seen from the test results in Table 2 above, the mouthwash provided in this embodiment of the invention has a good inhibitory effect on oral bacteria in patients with gingivitis, with an antibacterial rate of over 99%.

[0091] In summary, the embodiments of the present invention provide a composition for improving gingivitis, a method for preparing the same, and a mouthwash. The present invention uses *Xanthoceras sorbifolium* leaves (a medicinal and edible plant), peach gum, and hops as active ingredients, and employs a modern supercritical carbon dioxide extraction process under suitable parameters to extract the effective components. This not only significantly enhances the therapeutic effect of the resulting composition on gingivitis but also greatly improves the safety for patients. Based on this, the present invention also provides a mouthwash that can improve oral diseases such as gingivitis, possessing characteristics of safety and effectiveness, and has broad application prospects.

[0092] Various embodiments of the present invention may exist in the form of a range; it should be understood that the description in the form of a range is merely for convenience and brevity and should not be construed as a hard limitation on the scope of the invention; therefore, it should be considered that the range description has specifically disclosed all possible subranges and single numerical values ​​within that range. For example, it should be considered that the range description from 1 to 6 has specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6, etc., and single numbers within the range, such as 1, 2, 3, 4, 5, and 6, regardless of the range. Furthermore, whenever a numerical range is referred to herein, it means including any referenced number (fraction or integer) within the range referred to.

[0093] The above description is merely a specific embodiment of the present invention, enabling those skilled in the art to understand or implement the invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the invention. Therefore, the present invention is not to be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the principles and novel features claimed herein.

Claims

1. A composition for improving gingivitis, characterized in that, The composition for improving gingivitis comprises the following components in parts by weight: 20-40 parts of *Sapindus mukorossi* leaves, 5-15 parts of peach gum, and 10-25 parts of hops.

2. The composition for improving gingivitis according to claim 1, characterized in that, The ratio M1 / M2 of the weight fraction of the *Sapindus mukorossi* leaves and the total weight fraction of the peach gum and hops is 1.

3. The composition for improving gingivitis according to claim 1, characterized in that, The composition for improving gingivitis comprises the following components in parts by weight: 30 parts of *Sapindus mukorossi* leaves, 10 parts of peach gum, and 20 parts of hops.

4. A method for preparing a composition for improving gingivitis according to any one of claims 1 to 3, characterized in that, Includes the following steps: The leaves of the Chinese tallow tree, peach gum, and hops are crushed and mixed to obtain a mixture; The mixture was subjected to supercritical carbon dioxide extraction to obtain the composition for improving gingivitis.

5. The method for preparing the composition for improving gingivitis according to claim 4, characterized in that, The working conditions for supercritical carbon dioxide extraction include: a temperature of 40-50°C, a pressure of 20-30 MPa, a carbon dioxide fluid as the medium, and an entrainer composed of heptane and ethanol in a volume ratio of (1-3):(4-7).

6. The method for preparing the composition for improving gingivitis according to claim 4, characterized in that, The temperature for supercritical carbon dioxide extraction is 46°C.

7. The method for preparing the composition for improving gingivitis according to claim 4, characterized in that, The pressure for supercritical carbon dioxide extraction is 23 MPa.

8. The method for preparing the composition for improving gingivitis according to claim 4, characterized in that, The entrainer is composed of heptane and ethanol in a volume ratio of 3:

7.

9. A mouthwash, characterized in that, The composition for improving gingivitis according to any one of claims 1 to 3, or the composition for improving gingivitis prepared by any one of claims 4 to 8.

10. The mouthwash according to claim 9, characterized in that, The mouthwash comprises the following components by weight percentage: The traditional Chinese medicine composition for improving gingivitis: 5%~25%; Sorbitol: 5%~10% Tween-60: 0.1%~0.5%; PEG-40 hydrogenated castor oil: 0.3%~0.7%; Sodium benzoate: 0.1%~0.5%; Sodium citrate: 0.2%~0.5%; Stevioside: 0.1%~0.3%; The remainder is water.