Oral care composition comprising hyaluronic acid and ginseng root extract

Abstract

The invention discloses an oral care composition which comprises hyaluronic acid and / or a derivative thereof and a ginseng root extract, and the weight ratio of the hyaluronic acid and / or the derivative thereof to the ginseng root extract is 50: 1 to 10000: 1; and wherein the hyaluronic acid derivative is a hyaluronate salt in the form of a salt having a cation selected from the group consisting of a sodium ion, a potassium ion, a zinc ion, an ammonium ion, mono-, di-, tri-alkanolamine, and combinations thereof.

Description

Technical Field

[0001] The present invention relates to oral care compositions, such as toothpaste, chewing gum, mouthwash, etc., comprising ginseng root extract and hyaluronic acid and / or its derivatives. The present invention also relates to the use of such compositions for providing oral care benefits (particularly oral mucosal care benefits) in the oral cavity of an individual. Background Art

[0002] Oral mucosa is a term used to describe the soft tissue lining (lining) of the oral cavity, including buccal mucosa and gums (gingiva). It has many different functions, and is composed of different layered structures similar to the structure and function of the skin. Oral mucosa mainly serves as a barrier against external harmful environments. The loss of its barrier function due to disease or injury can cause significant dysfunction in the oral cavity. Oral mucosa is usually affected by various patient conditions, such as periodontitis, gingivitis, mucositis, recurrent aphthous ulcers, stomatitis, herpes and candidiasis. These diseases can cause serious damage to the oral mucosa.

[0003] Hyaluronic acid (also known as hyaluronan) is a linear, glycosaminoglycan polymer of the extracellular matrix composed of repeating units of the disaccharide [-D-glucuronic acid-β1,3-N-acetyl-D-glucosamine-β1,4-]n, and is identified via CAS No. 9004-61-9, and it can be found in all tissues and body fluids of vertebrates and in some bacteria. It is a linear polymer of exceptional molecular weight, particularly abundant in loose connective tissue. Recent studies have shown that hyaluronic acid is an important component of the extracellular matrix of periodontal tissue in the oral cavity.

[0004] US2020 / 0390677A1 (The Procter & Gamble Company) discloses providing a rinse-free oral care composition having good spreadability and improved retention properties for promoting gum health of the user. The rinse-free oral care composition comprises hyaluronic acid or its salt, polyacrylic acid as a mucoadhesive polymer, and an additional polymer.

[0005] US2020 / 0390801A1 (The Procter & Gamble Company) discloses providing a leave-in oral care composition comprising hyaluronic acid and a gum-strengthening polyol for promoting the gum health of the user.

[0006] CN107536725A (Guangzhou Weimeizi Industrial Co., Ltd.) discloses a multi-effect oral composition containing a hyaluronic acid mixture. The multi-effect oral composition contains 0.1 to 5.0 parts of a hyaluronic acid mixture and 0.5 to 2.0 parts of zinc citrate, wherein the hyaluronic acid mixture contains low molecular weight hyaluronic acid and high molecular weight hyaluronic acid, and the weight ratio of the low molecular weight hyaluronic acid to the high molecular weight hyaluronic acid is 1:(0.5-2.0).

[0007] CN115154501A (Yunnan Baiyao Group Co., Ltd.) discloses a composition for oral care, a prepared gel preparation and an application. The composition comprises a Panax notoginseng extract, an American cockroach extract and a Magnolia officinalis extract. The prepared gel preparation comprises the pharmaceutical composition, a gel adhesive and an additive. The gel adhesive is prepared from the following components in parts by mass: 0.02 to 1 part of low molecular weight sodium hyaluronate, 0.02 to 1 part of high molecular weight sodium hyaluronate and 0.06 to 1 part of Tremella fuciformis extract.

[0008] KR20170141034A (LG HOUSEHOLD & HEALTH CARE LTD) discloses a composition for preventing, treating or alleviating dental diseases including a ginseng extract.

[0009] There remains a need to develop oral care compositions that provide oral mucosal care benefits in the oral cavity of an individual. Summary of the invention

[0010] In a first aspect, the present invention relates to an oral care composition comprising:

[0011] (a) hyaluronic acid and / or its derivatives; and

[0012] (b) ginseng root extract;

[0013] wherein the weight ratio of the hyaluronic acid and / or its derivative to the ginseng root extract is in the range of 50:1 to 10000:1; and wherein the hyaluronic acid derivative is a hyaluronate in the form of a salt having a cation selected from sodium ions, potassium ions, zinc ions, ammonium ions, mono-, di-, tri-alkanolamines and combinations thereof.

[0014] In a second aspect, the present invention relates to a packaged oral care product comprising an oral care composition according to the first aspect of the invention.

[0015] In a third aspect, the present invention relates to the use of an oral care composition of any embodiment of the first aspect for providing oral mucosal care benefits in the oral cavity of an individual. Preferably, the present invention relates to the use of an oral care composition of any embodiment of the first aspect for providing oral mucosal repair benefits in the oral cavity of an individual. The use is preferably for non-therapeutic benefits.

[0016]

[0013] All further aspects of the invention will become more readily apparent upon consideration of the following detailed description and examples. DETAILED DESCRIPTION

[0017] Except in the examples, or where otherwise expressly indicated, all numerical values ​​in this description indicating amounts of material or conditions of reactions, physical properties of materials and / or use may optionally be understood as modified by "about".

[0018] Unless otherwise indicated, all amounts are by weight of the final composition.It should be noted that in specifying any range of values, any particular upper value can be associated with any particular lower value.

[0019] For the avoidance of doubt, the word "comprising" is intended to mean "including" but not necessarily "consisting of" or "composed of." In other words, the listed steps or options need not be exhaustive.

[0020] The disclosure of the invention found herein should be considered to cover all embodiments as found in mutually multiply dependent claims, regardless of the fact that the claims may be found without multiple dependence or redundancy.

[0021] Where features are disclosed in relation to a particular aspect of the invention (eg, the composition of the invention), such disclosure should also be considered applicable, mutatis mutandis, to any other aspect of the invention (eg, the method of the invention).

[0022] Hyaluronic acid and / or its derivatives

[0023] The oral care composition of the present invention comprises hyaluronic acid and / or its derivatives. Hyaluronic acid (HA) is a linear polysaccharide composed of repeating disaccharides of (1-3) and (1-4)-linked β-d-glucuronic acid and N-acetyl-β-d-glucosamine units. It can be found in all tissues and body fluids of vertebrates and in some bacteria. It is a linear polymer of extra large molecular weight, which is particularly abundant in loose connective tissue. Recent studies have shown that hyaluronic acid is an important component of the extracellular matrix of periodontal tissue in the oral cavity.

[0024] The hyaluronic acid derivative is a hyaluronate in the form of a salt having a cation selected from sodium ions, potassium ions, zinc ions, ammonium ions, mono-, di-, tri-alkanolamines and combinations thereof. Mixtures of these ions may also be used. Preferably, the cation is selected from sodium ions, potassium ions, zinc ions and combinations thereof. Sodium hyaluronate is particularly preferred.

[0025] In another embodiment of the present invention, the hyaluronic acid derivative is a modified hyaluronic acid having a substituent of a bisphosphonate, an amine, a cystamine, a hydrazide, a dopamine, a thiol or a mixture thereof. Examples of suitable modified hyaluronic acids include HA-bisphosphonates, HA-amines, HA-cystamines, HA-hydrazides, HA-dopamines, HA-thiol or a mixture thereof.

[0026] Preferably, hyaluronic acid and / or its derivatives have a molecular weight of 50,000 to 2,000,000 daltons, more preferably 100,000 to 1,000,000 daltons, even more preferably 150,000 to 800,000 daltons, most preferably 200,000 to 600,000 daltons. The term "molecular weight" used in the context of the present invention refers to the viscosity-average molecular weight of hyaluronic acid and / or its derivatives herein, which is measured using an Ubbelohde viscometer to obtain the intrinsic viscosity [η], and the molecular weight is calculated by the following formula:

[0027]

[0028] Preferably, the hyaluronic acid and / or its derivatives suitable for use in the present invention include (i) low molecular weight hyaluronic acid and / or its derivatives; and (ii) a combination of high molecular weight hyaluronic acid and / or its derivatives. The term "low molecular weight hyaluronic acid and / or its derivatives" used in the context of the present invention refers to hyaluronic acid and / or its derivatives having a molecular weight of less than 1,000,000 Daltons, preferably less than 800,000 Daltons, more preferably less than 600,000 Daltons, and even more preferably less than 400,000 Daltons. The term "high molecular weight hyaluronic acid and / or its derivatives" used in the context of the present invention refers to hyaluronic acid and / or its derivatives having a molecular weight greater than 1,000,000 Daltons, preferably 1,000,000 to 2,000,000 Daltons, more preferably 1,000,000 to 1,800,000 Daltons, and even more preferably 1,200,000 to 1,500,000 Daltons.

[0029] Preferably, the hyaluronic acid and / or its derivative suitable for use in the present application is sodium hyaluronate. An example is available from Bloomage Biotechnology Corp Ltd. under the trade name Commercially available.

[0030] The oral care composition of the present invention preferably comprises 0.0001 to 10 wt% hyaluronic acid and / or its derivatives, more preferably 0.001 to 5 wt%, even more preferably 0.001 to 1 wt%, most preferably 0.005 to 0.5 wt%, based on the total weight of the oral composition and including all ranges subsumed therein.

[0031] Ginseng Root Extract

[0032] Panax Ginseng (also known as Asian Ginseng, Korean Ginseng, Chinese Ginseng and true Ginseng), belongs to the "Ginseng" plant family. Ginseng root extract is an extract obtained from the root of Ginseng.

[0033] The ginseng root extract may be provided in any suitable form, such as a solid or a liquid. The ginseng root extract may be solid, preferably in the form of a powder. When the ginseng root extract is solid, it preferably contains less than 10 wt% water, more preferably less than 7 wt%, even more preferably less than 5 wt%, most preferably less than 1 wt% water. In other words, the ginseng root extract preferably contains 0 to 10 wt% water, more preferably 0 to 7 wt%, even more preferably 0 to 5 wt%, most preferably 0 to 1 wt% water.

[0034] Preferably, the ginseng root extract is a liquid. A ginseng root extract suitable for use in the present invention can be prepared by a method comprising the following steps:

[0035] i) washing, drying and crushing ginseng roots;

[0036] ii) extracting the ginseng root with ethanol by refluxing, and concentrating the extract;

[0037] iii) fermenting the concentrate of step (ii) with microorganisms (enzymes and strains);

[0038] iv) filtering the fermentation broth of step (iii);

[0039] v) Optionally, dispersing the filtrate obtained in step (iv) in water or other solvents to obtain a ginseng root extract.

[0040] Preferably, the ethanol in step (ii) has a concentration of 70 to 95 wt%, more preferably 75 to 85 wt%. Preferably, the extract of step (ii) is filtered before concentration. A suitable solvent for step (v) is butanediol.

[0041] A suitable method for preparing ginseng root extract is disclosed in CN112852621B.

[0042] The weight of ginseng root extract used in the context of the present invention refers to the dry weight of the ginseng root extract. As used herein, "dry weight" refers to the weight of the material remaining after removing water and / or solvent from the ginseng root extract. The remaining material contains less than 1.5wt% water and / or solvent, preferably less than 1.0wt%, more preferably less than 0.75wt%, still more preferably less than 0.5wt%, even more preferably less than 0.1wt%, most preferably 0.0 to 0.01wt% water and / or solvent.

[0043] Preferably, the ginseng root extract includes ginsenosides. The ginsenosides are a group of glycosylated triterpenes, also known as saponins, which represent active compounds found in ginseng roots. Ginsenosides preferably include prototype ginsenosides, rare ginsenosides or mixtures thereof. Prototype ginsenosides refer to ginsenosides directly extracted from the "Ginseng" plant system. Examples of prototype ginsenosides include, but are not limited to, Ra, Rb1, Rb2, Rb3, Rc, Rd, Re, Rf, Rg, Ro or mixtures thereof. Rare ginsenosides are derived from prototype ginsenosides by bioenzymatic conversion or metabolism. Examples of rare ginsenosides include, but are not limited to, Rk1, Rk2, Rk3, Rg3, Rg5, Rh1, Rh2, Rh3, Rh4, aPPT, aPPD, or mixtures thereof.

[0044] Preferably, the ginseng root extract comprises a rare ginsenoside selected from the group consisting of Rk1, Rk2, Rk3, Rg3, Rg5, Rh1, Rh2, Rh3, Rh4, aPPT, aPPD and a combination thereof. Preferably, the ginseng root extract comprises ginsenoside Rg3, ginsenoside Rh2 or a mixture thereof, preferably a combination of ginsenoside Rg3 and ginsenoside Rh2. The ginsenoside Rg3 is preferably present in the ginseng root extract in an amount of 0.001 to 10%, more preferably 0.01 to 5%, even more preferably 0.05 to 1%, and most preferably 0.1 to 0.2%. Ginsenoside Rh2 is preferably present in the ginseng root extract in an amount of 0.001 to 10%, more preferably 0.005 to 5%, even more preferably 0.01 to 1%, and most preferably 0.02 to 0.1%.

[0045] Suitable ginseng root extracts are commercially available, for example from Guangzhou COFINE Biotechnology Co. under the trade name Cotuline Mix GSG.

[0046] The ginseng root extract is preferably present in an amount of 0.00001 to 1 wt %, more preferably 0.0001 to 0.5 wt %, most preferably 0.0005 to 0.1 wt % by weight of the composition, based on the total weight of the composition and including all ranges subsumed therein.

[0047] The weight ratio of hyaluronic acid and / or its derivatives to ginseng root extract in the composition is 50:1 to 10000:1, preferably 80:1 to 8000:1, more preferably 100:1 to 6000:1, most preferably 150:1 to 5000:1.

[0048] Carrier

[0049] The composition of the present invention may include a physiologically acceptable carrier. The carrier preferably includes at least a surfactant, a thickener, a wetting agent or a combination thereof.

[0050] Preferably, the composition comprises a surfactant. Preferably, the composition comprises at least 0.01 wt% surfactant, more preferably at least 0.1 wt%, most preferably 0.5 to 7 wt% surfactant, based on the weight of the composition. Suitable surfactants include anionic surfactants, such as the sodium, magnesium, ammonium or ethanolamine salts of: C8 to C 18 Alkyl sulfates (e.g. sodium lauryl sulfate), C8 to C 18 Alkyl sulfosuccinates (e.g. sodium dioctyl sulfosuccinate), C8 to C 18 Alkyl sulfoacetates (e.g. sodium lauryl sulfoacetate), C8 to C 18 Alkyl sarcosinates (e.g. sodium lauryl sarcosinate), C8 to C 18Alkyl phosphates (which may optionally include up to 10 ethylene oxide and / or propylene oxide units) and sulfated monoglycerides. Preferred anionic surfactants are sodium lauryl sulfate and / or sodium dodecylbenzene sulfonate. Other suitable surfactants include nonionic surfactants. Other suitable surfactants include nonionic surfactants, such as optionally polyethoxylated fatty acid sorbitan esters, ethoxylated fatty alcohols (e.g. C8 to C18 alkyl alcohol ethoxylates, with an average of 3 to 20 moles of ethylene oxide per mole of alcohol), ethoxylated fatty acids, esters of polyethylene glycol, ethoxylates of fatty acid monoglycerides and diglycerides (e.g. coconut oil fatty acid esters, palm oil fatty acid esters and palm kernel oil fatty acid esters), and ethylene oxide / propylene oxide block polymers, fatty acid amides, alkyl polyglycosides (e.g. decyl glucoside). Other suitable surfactants include amphoteric surfactants, such as betaines or sulfobetaines. Mixtures of any of the above materials may also be used.

[0051] Preferably, the surfactant comprises sodium lauryl sulfate, decyl glucoside, cocoamidopropyl betaine, or a mixture thereof. More preferably, the surfactant comprises decyl glucoside, cocoamidopropyl betaine, or a mixture thereof.

[0052] Thickeners may also be used in the present invention. Illustrative examples of types of thickeners that may be used in the present invention include sodium carboxymethylcellulose (SCMC), hydroxyethylcellulose, methylcellulose, ethylcellulose, tragacanth, gum arabic, gum karaya, sodium alginate, carrageenan, guar gum, xanthan gum, Irish moss, starch, modified starch, silica-based thickeners including silica aerogels, magnesium aluminum silicate (e.g., Veegum), carbomers (cross-linked acrylates), and mixtures thereof.

[0053] Typically, xanthan gum and / or sodium carboxymethylcellulose and / or carbomer are preferred. When using carbomer, those with a weight average molecular weight of at least 700,000 are required, preferably those with a molecular weight of at least 1,200,000, and most preferably those with a molecular weight of at least about 2,500,000. Mixtures of carbomers may also be used herein.

[0054] In a particularly preferred embodiment, the carbomer is Synthalen PNC, Synthalen KP or a mixture thereof. It has been described as a high molecular weight and cross-linked polyacrylic acid and is identified by CAS No. 9063-87-0. These types of materials are commercially available from suppliers such as Sigma.

[0055] In another particularly preferred embodiment, the sodium carboxymethylcellulose (SCMC) used is SCMC 9H. It has been described as the sodium salt of a cellulose derivative having carboxymethyl groups bound to the hydroxyl groups of the pyranose glucose backbone monomers and is identified by CAS number 9004-32-4. This is also available from suppliers such as Alfa Chem.

[0056] In another particularly preferred embodiment, the thickener is xanthan gum.

[0057] Thickeners typically comprise from 0.01 to about 15 wt %, more preferably from 0.1 to 10 wt %, most preferably from 0.1 to 9 wt % of the composition, based on the total weight of the composition and including all ranges subsumed therein.

[0058] Suitable humectants are preferably used in the compositions of the present invention, and they include, for example, glycerol; sorbitol; propylene glycol; dipropylene glycol; diglycerol; triacetin; mineral oil; polyethylene glycol (preferably PEG-400); alkanediols, such as butylene glycol and hexylene glycol, ethanol, pentylene glycol; or mixtures thereof. Glycerol, polyethylene glycol, sorbitol or mixtures thereof are preferred humectants.

[0059] The wetting agent may be present in the range of 10 to 90 wt% by weight of the composition. More preferably, the carrier wetting agent comprises 25 to 80 wt%, most preferably 30 to 60 wt% of the composition, based on the total weight of the composition and including all ranges subsumed therein.

[0060] Fluoride source

[0061] The composition may include a fluoride source. Preferred fluoride sources include sodium fluoride, stannous fluoride, potassium fluoride, sodium monofluorophosphate, sodium fluorosilicate, ammonium fluorosilicate, amine fluoride, ammonium fluoride or a mixture thereof. Preferably, the fluoride source is stannous fluoride, sodium fluoride, sodium monofluorophosphate or a mixture thereof. Sodium fluoride is particularly preferred. Based on the gross weight of the composition and including all ranges contained therein, the fluoride source may be present in an amount of 0.01 to 10 wt %, more preferably 0.03 to 5 wt %, most preferably 0.05 to 2 wt % by weight of the composition.

[0062] Antimicrobial Agents

[0063] The composition may include an antimicrobial agent. The antimicrobial agent may be selected from: one or more metal salts, wherein the metal is selected from zinc, copper, silver or mixtures thereof; chlorhexidine; sanguinarine extract; metronidazole; quaternary ammonium compounds, such as cetylpyridinium chloride; cetylpyridium chloride clay complex; biguanides, such as chlorhexidine digluconate, hexetidine, octenidine, alexidine; and halogenated bisphenol compounds, such as 2,2'methylenebis-(4-chloro-6-bromophenol).

[0064] Preferably, the antimicrobial is a zinc salt. Examples of suitable zinc salts include, but are not limited to, zinc oxide, zinc chloride, zinc acetate, zinc ascorbate, zinc sulfate, zinc nitrate, zinc citrate, zinc lactate, zinc peroxide, zinc fluoride, zinc ammonium sulfate, zinc bromide, zinc iodide, zinc gluconate, zinc tartrate, zinc succinate, zinc formate, zinc phenolsulfonate, zinc salicylate, zinc glycerophosphate, zinc monoglycerolate, zinc pyrophosphate, zinc maleate or a mixture thereof. Preferably, the antimicrobial is zinc citrate, zinc sulfate or a mixture thereof. Zinc citrate is particularly preferred.

[0065] The antimicrobial agent is preferably present in an amount of 0.01 to 5 wt %, more preferably 0.05 to 4 wt %, most preferably 0.1 to 3 wt % by weight of the composition, based on the total weight of the composition and including all ranges subsumed therein.

[0066] The compositions of the present invention may include various other ingredients commonly used in the art to enhance physical properties and performance. These ingredients include sunscreens, colorants, anti-inflammatory agents (e.g., ibuprofen, flurbiprofen, aspirin, indomethacin), anti-caries agents (sodium trimetaphosphate and casein), plaque buffers (e.g., urea, calcium lactate, calcium glycerophosphate, and strontium polyacrylates), vitamins (e.g., vitamins A, C, and E), plant extracts, plant-derived antioxidants (e.g., flavonoids, catechins, polyphenols, and tannin compounds and mixtures thereof), desensitizers (e.g., potassium citrate, potassium chloride, potassium tartrate, potassium bicarbonate, potassium oxalate, potassium nitrate, and strontium salts), anticalculus agents (e.g., alkali metal pyrophosphates, hypophosphite-containing polymers, organic phosphonates, and iodine-containing compounds). phosphonates and phosphocitrates), biomolecules (e.g., bacteriocins, antibodies, enzymes), flavorants (e.g., peppermint oil and spearmint oil), proteinaceous materials (e.g., collagen), preservatives, amino acids (e.g., arginine), pH adjusters, sweeteners, polymeric compounds, buffers and salts to buffer the pH and ionic strength of the composition, and mixtures thereof.

[0067] Such ingredients typically and collectively comprise less than 20 wt %, preferably 0.0 to 15 wt %, and most preferably 0.01 to 12 wt % of the composition, including all ranges subsumed therein.

[0068] Form of composition

[0069] Oral care composition can be in any form common in the art. Preferred forms are dentifrice, toothpaste, gel, mouthwash, medicine, oral film, slurry, chewing gum and lozenge, more preferably toothpaste, gel or mouthwash. When the oral care composition is toothpaste or gel, it usually has a viscosity of about 30,000 to 300,000 mPa.s (centipoise), preferably 60,000 to 280,000 mPa.s (centipoise), most preferably 65,000 to 250,000 mPa.s (centipoise), the viscosity being obtained at room temperature (25°C) using a Brookfield viscometer, a 93 / 94 rotor and at a speed of 5rpm for 1 minute. Typically, the composition will be packaged. In toothpaste or gel form, the composition can be packaged in conventional plastic laminates, metal tubes or single-chamber dispensers. It can be applied to the tooth surface by any physical means, such as a toothbrush, a fingertip or directly applied to a sensitive area by an applicator. In liquid mouthwash form, the composition may be packaged in a bottle, sachet or other convenient container.

[0070] Preferably, the oral care composition is a toothpaste composition, which may additionally contain an abrasive. Preferred abrasives include silicas, aluminas, calcium carbonates, dicalcium phosphates, calcium pyrophosphates, hydroxyapatites, trimetaphosphates, insoluble hexametaphosphates or mixtures thereof, including agglomerated particulate abrasives. Calcium carbonate and silicon dioxide are particularly preferred, especially silicon dioxide. The abrasive may be present in a range of 0.01 to 60 wt %, more preferably 0.1 to 30 wt %, most preferably 1 to 15 wt %, based on the total weight of the composition and including all ranges contained therein. Preferably, the toothpaste composition contains at least 5 wt % of water, more preferably at least 10 %, even more preferably at least 15 % of water. Preferably, the water content is from 1.5 to 95 wt % by weight of the toothpaste composition, more preferably from 10 to 80 wt %, even more preferably from 15 to 60 wt %, most preferably from 20 to 50 wt % by weight of the toothpaste composition, based on the total weight of the composition and including all ranges subsumed therein.

[0071] It is also preferred that the oral care composition is a mouthwash composition, which may additionally comprise at least 20 wt% of a liquid medium selected from water, alcohol and combinations thereof. Preferably, the mouthwash composition comprises at least 20 wt% of water, more preferably at least 30 wt%, even more preferably at least 40 wt% of water. Preferably, based on the total weight of the composition and including all ranges contained therein, the water content is 20 to 99 wt%, more preferably 30 to 95 wt%, even more preferably 40 to 95 wt%, most preferably 50 to 90 wt% by weight of the mouthwash composition. Preferably, the mouthwash composition comprises less than 0.5 wt% of alcohol, more preferably less than 0.1 wt% of alcohol. Based on the total weight of the composition and including all ranges contained therein, the mouthwash composition preferably comprises 0.1 to 20 wt% of a sweetener, more preferably 1 to 15 wt%, most preferably 3 to 10 wt% of a sweetener. The sweetener in the mouthwash composition is preferably a sugar substitute. Examples of suitable sweeteners include, but are not limited to, stevia, aspartame, sucralose, neotame, acesulfame potassium, saccharin, advantame, sorbitol, lactitol, xylitol, or mixtures thereof. Preferably, the sweetener in the mouthwash composition is selected from sucralose, saccharin, sorbitol, xylitol, and combinations thereof. The mouthwash composition of the present invention preferably comprises one or more preservatives selected from benzyl alcohol, phenoxyethanol, sodium benzoate, methyl paraben, zinc, and combinations thereof. Preferably, the preservative comprises benzyl alcohol, phenoxyethanol, or mixtures thereof.

[0072] use

[0073] The oral care composition of the present invention can be used in a method for providing oral mucosal care benefits in the oral cavity of an individual. The term "oral mucosa" used in the context of the present invention refers to the soft tissue lining of the oral cavity, including the buccal mucosa and the gums (gingiva). The term "oral mucosal care benefits" used in the context of the present invention refers to the benefits provided to the oral mucosa (particularly the gum tissue), which include reducing red, swollen, bleeding or tender oral mucosa, repairing the oral mucosa (e.g., improving oral mucosal healing). Preferably, the oral care composition of the present invention is used in a method for providing oral mucosal repair benefits in the oral cavity of an individual. Preferably, the method is non-therapeutic.

[0074] Additionally or alternatively, the present invention relates to an oral care composition for providing oral mucosal care benefits, preferably for providing oral mucosal repair benefits, in the oral cavity of an individual.

[0075] Additionally or alternatively, the present invention relates to the use of an oral care composition for providing oral mucosal care benefits in the oral cavity of an individual. Preferably, the present invention relates to the use of an oral care composition for providing oral mucosal repair benefits in the oral cavity of an individual. The use is preferably non-therapeutic.

[0076] Additionally or alternatively, the present invention relates to the use of an oral care composition in the preparation of a medicament for providing oral mucosal care benefits in the oral cavity of an individual. Preferably, the present invention relates to the use of an oral care composition in the preparation of a medicament for providing oral mucosal repair benefits in the oral cavity of an individual.

[0077] Even when used in an individual's daily oral hygiene routine, the composition will be effective. The oral care composition of the present invention is preferably applied in the oral cavity at least once a day. More preferably, the oral care composition is applied in the oral cavity 1 to 4 times a day, and most preferably, the oral care composition is applied in the oral cavity 2 to 3 times a day. The oral care composition of the present invention is preferably applied on tooth surfaces, oral mucosa (particularly gingival tissue) and combinations thereof.

[0078] When the oral care composition is a toothpaste, the composition is preferably brushed onto the teeth. For example, the composition may be in contact with the teeth for a period of 1 second to 20 hours. More preferably, 1 second to 10 hours, still more preferably 10 seconds to 1 hour, and most preferably 30 seconds to 5 minutes. The composition may be used daily, for example, once, twice, or three times a day by an individual.

[0079] When the oral care composition is a mouthwash, the oral care composition can be applied in the oral cavity by ingesting the composition and keeping the composition in the oral cavity for at least 10 seconds. More preferably, the composition is kept in the mouth for 15 to 120 seconds, and most preferably, the composition is kept in the mouth for 20 to 60 seconds. At least 30 seconds after applying the composition in the oral cavity, the composition is preferably removed from the oral cavity, wherein at least 80 wt % of the composition is removed from the oral cavity. More preferably, at least 90 wt % of the composition is removed from the oral cavity. Most preferably, at least 95 wt % of the composition is removed from the oral cavity. Removing the composition from the oral cavity involves spitting out, optionally after washing the oral cavity with rinse water.

[0080] When the oral care composition is a wash-free composition such as a gel, the composition is preferably applied in the oral cavity after brushing teeth or as the last step of a daily oral hygiene routine. The term "wash-free" used in the context of the present invention refers to a time period of more than 1 minute, preferably more than 2 minutes, on the surface of the composition. Preferably, a "wash-free" composition refers to a composition intended not to be rinsed off or spit out. Preferably, the composition is applied to the oral mucosa (particularly gum tissue) of the oral cavity of an individual, and is left in place for more than 2 minutes, preferably more than 10 minutes, more preferably more than 30 minutes, even more preferably more than 60 minutes or longer. The wash-free composition is preferably applied in the oral cavity using a delivery carrier, wherein the delivery carrier may include a strip, a material film, a dental tray, an orthodontic appliance, a sponge material applicator, or a mixture thereof.

[0081] Example

[0082] Example 1

[0083] This example demonstrates the effect of the composition of the present invention on the repair of oral mucosa.

[0084] The samples were prepared as shown in Table 1. All ingredients are expressed as weight percent based on the total formulation.

[0085] Table 1

[0086] sample <![CDATA[Sodium Hyaluronate 1 > <![CDATA[Ginseng extract 2 > <![CDATA[Low-nutrient medium 3 > A 0.01 - Up to 100 B 0.02 - Up to 100 C 0.05 - Up to 100 D - 0.01 Up to 100 E - 0.10 Up to 100 F 0.01 0.10 Up to 100 1 0.05 0.10 Up to 100 2 0.02 0.01 Up to 100 3 0.05 0.01 Up to 100

[0087] 1. Commercially available under the trade name Biomoist from Bloomage Biotechnology Co. Ltd.

[0088] 2. Commercially available from Shanghai Saifu Chemical Development Co. Ltd. under the trade name Cotuline Mix GSG (active content 0.5%).

[0089] 3. DMEM (Dulbecco's Modified Eagle Medium, Gibco) and 2% (v / v) fetal bovine serum (FBS, Gibco).

[0090] method

[0091] The cell scratch assay is used to evaluate oral mucosal repair in vitro. It is a method to determine the migration and repair capacity of cells.

[0092] Cell culture and scratch procedure

[0093] Human gingival fibroblast (HGF) cells were cultured in complete medium consisting of DMEM (Dulbecco's Modified Eagle Medium, Gibco) and 10% (v / v) fetal bovine serum (FBS, Gibco) at 37°C and 5% CO2.

[0094] Dilute the cell suspension to 5 × 10 5 The cells were cultured at a concentration of 10 cells / mL and spread to a 6-well culture plate for cell culture. After 48 h of cell culture, the cells were scratched using a sterile pipette tip to simulate wound formation and rinsed twice with phosphate buffered saline (PBS) to remove scraped cell debris. Then, at 0 h after the scratch, the cells were immediately treated with the sample and cultured at 37 ° C for 24 h. For the negative control (NC), at 0 h, the cells were treated with a low nutrient medium under the same conditions. At 0 h and 24 h after the scratch, the culture plate was photographed to record the recovery of the scratch.

[0095] Wound closure rate test

[0096] The oral mucosal repair capacity of the test samples can be evaluated by their ability to enhance the growth and migration of cells used for wound healing. Using the image analysis software ImageJ, the photos covering the blank area were quantitatively analyzed at 0h and 24h after scratching. NC (wound closure rate) was calculated according to the following formula NC ) and each sample (wound closure rate X ) of the wound closure rate.

[0097]

[0098] By comparing the wound closure rate of each sample (wound closure rate X ) and NC wound closure rate (wound closure rate NC ), the relative wound closure rate (RWCR) of each sample was calculated X ).

[0099]

[0100] result

[0101] The relative wound closure rates (RWCR) of the samples are listed in Table 2.

[0102] Table 2

[0103] sample Calculated RWCR Experimental RWCR A - 122.1％ B - 117.3％ C - 123.3％ D - 115.0％ E - 115.7％ F 137.8％ 130.6％ 1 139.0％ 148.8％ 2 132.3％ 161.1％ 3 138.3％ 151.9％

[0104] From the results, it can be seen that the experimental relative wound closure rates of the cells treated with Samples 1, 2 and 3 according to the present invention were higher compared to their calculated relative wound closure rates, indicating improved oral mucosal repair ability.

Claims

1. An oral care composition comprising: (a) hyaluronic acid and / or its derivatives; and (b) ginseng root extract; wherein the weight ratio of the hyaluronic acid and / or its derivatives to the ginseng root extract is in the range of 50:1 to 10000:1; and The hyaluronic acid derivative is a hyaluronate in the form of a salt having a cation selected from the group consisting of sodium ions, potassium ions, zinc ions, ammonium ions, mono-, di-, tri-alkanolamines and combinations thereof.

2. The oral care composition according to claim 1, wherein the hyaluronic acid derivative is sodium hyaluronate.

3. The oral care composition according to claim 1, wherein the hyaluronic acid derivative is a modified hyaluronic acid having a substituent of bisphosphonate, amine, cystamine, hydrazide, dopamine, thiol or a mixture thereof.

4. An oral care composition according to any one of the preceding claims, wherein the molecular weight of the hyaluronic acid and / or its derivatives is in the range of 50,000 to 2,000,000 Daltons, preferably 100,000 to 1,000,000 Daltons.

5. An oral care composition according to any one of the preceding claims, wherein the ginseng root extract comprises ginsenosides, including prototype ginsenosides, rare ginsenosides or mixtures thereof, preferably rare ginsenosides.

6. The oral care composition according to claim 5, wherein the rare ginsenoside comprises Rk1, Rk2, Rk3, Rg3, Rg5, Rh1, Rh2, Rh3, Rh4, aPPT, aPPD or a mixture thereof, preferably Rg3, Rh2 or a mixture thereof.

7. An oral care composition according to any one of the preceding claims, wherein the ginseng root extract comprises a combination of ginsenoside Rg3 and ginsenoside Rh2.

8. An oral care composition according to any one of the preceding claims, wherein the hyaluronic acid and / or its derivatives are present in an amount of 0.0001 to 10 wt%, preferably 0.001 to 5 wt% by weight of the composition.

9. An oral care composition according to any one of the preceding claims, wherein the ginseng root extract is present in an amount of from 0.00001 to 1 wt%, preferably from 0.0001 to 0.5 wt% by weight of the composition.

10. An oral care composition according to any one of the preceding claims, wherein the weight ratio of the hyaluronic acid and / or its derivatives to the ginseng root extract is in the range of 80:1 to 8000:1, preferably 100:1 to 6000:

1.

11. An oral care composition according to any one of the preceding claims, wherein the oral care composition is a toothpaste, a gel or a mouthwash, preferably a toothpaste composition or a mouthwash composition.

12. An oral care composition according to any one of the preceding claims, wherein the oral care composition is a mouthwash and additionally comprises at least 20 wt% of a liquid medium selected from the group consisting of water, alcohol and combinations thereof.

13. Use of an oral care composition according to any preceding claim for providing an oral mucosal care benefit, preferably an oral mucosal repair benefit, in the oral cavity of an individual.

14. The use according to claim 13, wherein the composition is applied in the oral cavity at least once a day.

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