An oral care composition and a method of making the same

Abstract

This invention provides an oral care composition comprising a bioactive mineral material and a mixture of traditional Chinese medicines. The bioactive mineral material includes SiO2, CaO, and P2O5. The traditional Chinese medicine mixture includes raw herbs such as Ophiopogon japonicus, Poria cocos, Piper longum, Angelica dahurica, Lophatherum gracile, Pueraria lobata, Cimicifuga foetida, Imperata cylindrica, Panax ginseng, and Lonicera japonica. The composition of this invention can be formulated into an anhydrous oral care system, such as gingival gel, spray, patches, and oral dressings. During use, it can quickly repair tooth enamel, prevent tooth decay, and repair gingivitis and gingival recession caused by Helicobacter pylori. It also provides some protection against gingival bleeding and tooth sensitivity.

Description

Technical Field

[0001] This invention belongs to the field of oral care, specifically relating to an oral care composition containing bioactive mineral materials and a mixture of traditional Chinese medicine and its preparation method. Background Technology

[0002] Oral health is crucial to overall health, not only keeping your mouth clean and allowing you to enjoy delicious food, but also preventing and reducing the occurrence of viral infections and conditions such as coronary heart disease, diabetes, stomach problems, and low birth weight in newborns. There are many types of oral diseases, mainly including tooth decay, cementum loss, oral ulcers, gingivitis, receding gums, bleeding gums, and periodontitis. These are caused by excessive consumption of sweets and acidic foods, improper brushing, and the growth of bacteria from food debris trapped between teeth. Many causes remain unclear, and many oral diseases cannot be completely cured. Therefore, with increasing emphasis on oral health, developing preventative and restorative oral care products is essential.

[0003] Discovered by Hench in 1969, bioactive glass is a mineral material with sodium calcium phosphosilicate as its active ingredient. This material exhibits good biocompatibility and functions such as inhibiting oral and periodontal bacteria, reducing dentin hypersensitivity, and promoting enamel remineralization. However, bioactive mineral materials in aqueous systems suffer from thermodynamic imbalances and are prone to chemical reactions, leading to system instability. Anhydrous compositions effectively avoid this problem. Furthermore, my country is rich in traditional Chinese medicine resources, and traditional Chinese medicine is increasingly favored by consumers due to its high safety and low toxicity in the oral care field. Therefore, developing an oral care product containing bioactive mineral materials and traditional Chinese medicine compositions has broad market prospects. Summary of the Invention

[0004] This invention explores the role of bioactive mineral materials in rapidly repairing tooth enamel in the oral field and the improvement and repair effects of traditional Chinese medicine compositions on the oral environment, thereby inventing an oral care product containing bioactive mineral materials and traditional Chinese medicine compositions and its preparation method.

[0005] To overcome the shortcomings of the prior art, the first aspect of the present invention provides an oral care composition, preferably an anhydrous composition, comprising, by weight percentage, the following raw materials: 0-30 wt% (e.g., 5 wt%, 10 wt%, 15 wt%, 20 wt%, 25 wt%) of bioactive mineral materials, 0-15 wt% (e.g., 5 wt%, 10 wt%) of a traditional Chinese medicine mixture, and 55-90 wt% (e.g., 60 wt%, 65 wt%, 70 wt%, 75 wt%, 80 wt%, 85 wt%) of pharmaceutical excipients; the sum of the weights of all raw materials and unavoidable impurities is 100 wt%, and the amounts of the bioactive mineral materials and the traditional Chinese medicine mixture are not both 0 wt%;

[0006] The bioactive mineral materials include SiO2, CaO and P2O5;

[0007] The raw materials of the Chinese herbal medicine mixture include any one or more of the following: Ophiopogon japonicus, Poria cocos, Piper longum, Angelica dahurica, Lophatherum gracile, Pueraria lobata, Cimicifuga foetida, Imperata cylindrica, Panax ginseng, and Lonicera japonica.

[0008] In some embodiments, the oral care composition comprises the following ingredients: 0.1-30 wt% bioactive mineral materials, 1-15 wt% traditional Chinese medicine mixture, and 5-90 wt% pharmaceutical excipients.

[0009] In some embodiments, the oral care composition comprises the following ingredients: 5-30 wt% bioactive mineral materials, 5-10 wt% traditional Chinese medicine mixture, and 5-90 wt% pharmaceutical excipients.

[0010] In some embodiments, the dosage form of the oral care composition is selected from: gingival gel, spray, patch, and oral dressing.

[0011] In some embodiments, the bioactive mineral material further includes metal oxides, preferably including at least one of sodium oxide, strontium oxide, copper oxide, and zinc oxide.

[0012] In some embodiments, the bioactive mineral material comprises 40-70 wt% (e.g., 45 wt%, 50 wt%, 55 wt%, 60 wt%, 65 wt%) of silica and 30-60 wt% (e.g., 35 wt%, 40 wt%, 45 wt%, 50 wt%, 55 wt%) of oxides selected from phosphorus, calcium, and sodium.

[0013] In some embodiments, in the bioactive mineral material, the silica forms a three-dimensional network structure, with calcium and phosphorus ions orderly distributed among the silicon atoms in the three-dimensional network; wherein pentavalent and / or hexavalent silicon atoms account for 1 mol% to 10 mol% of all silicon atoms (e.g., 2 mol%, 1 mol%, 3 mol%, 4 mol%, 5 mol%, 6 mol%, 7 mol%, 8 mol%, 9 mol%); and the content of phosphorus oxides is 2-5 wt%. Preferably, the content of calcium oxides in the bioactive mineral material is 10-20 wt%.

[0014] Preferably, the content of sodium oxide in the bioactive mineral material is 10-20 wt%.

[0015] The bioactive mineral material of this invention can be prepared according to the methods described in patent applications CN106362214A (application number 201610955130.X) or CN110101904A (application number 201910538684.3). It exhibits a three-dimensional network structure and can rapidly repair tooth enamel, prevent cavities, and repair gingivitis and gingival recession caused by Helicobacter pylori. Alternatively, it can use Regesi regenerated silica, commercially available from Beijing Xingfu Yisheng High-Tech Co., Ltd. Any type of Regesi regenerated silica can be used in this invention. This material is Regesi regenerated silica composed of SiO2, CaO, and P2O5, and is a solid powder with a large specific surface area and a stable pH after contact with body fluids. The bioactive mineral material of the present invention can also be a regenerated silicon material-POSS-based regenerative medical material prepared according to the method described in Chinese Patent Publication No. CN109771692A (Application No. 201810030488.0). This material is a product obtained by calcining polyhedral cage-type oligomeric silsesquioxane to remove its organic components, forming a polyhedral cage-type structure with Si-O-Si bonds in silicon oxide as the framework, and calcium and phosphorus elements embedded therein, which is a novel bioactive material.

[0016] Bioactive mineral materials play a role in preventing tooth decay, repairing gum recession and bleeding gums, and repairing tooth enamel.

[0017] In some embodiments, the raw medicinal materials in the herbal mixture include: 0-20 parts by weight of Ophiopogon japonicus (e.g., 2, 4, 6, 8, 10, 12, 14, 16, or 18 parts), Poria cocos (e.g., 2, 4, 6, 8, 10, 12, 14, 16, or 18 parts), Piper longum (e.g., 2, 4, 6, 8, 10, 12, 14, 16, or 18 parts), Angelica dahurica (e.g., 2, 4, 6, 8, 10, 12, 14, 16, or 18 parts), Lophatherum gracile (e.g., 2, 4, 6, or 8 parts), and Pueraria lobata (e.g., 0-20 parts by weight). For example, 2 parts, 4 parts, 6 parts, 8 parts, 10 parts, 12 parts, 14 parts, 16 parts, 18 parts), Cimicifuga rhizome 0-25 parts (for example, 2 parts, 4 parts, 6 parts, 8 parts, 10 parts, 12 parts, 14 parts, 16 parts, 18 parts, 20 parts, 22 parts, 24 parts), Imperata rhizome 0-20 parts (for example, 2 parts, 4 parts, 6 parts, 8 parts, 10 parts, 12 parts, 14 parts, 16 parts, 18 parts), Ginseng 0-10 parts (for example, 2 parts, 4 parts, 6 parts, 8 parts), Honeysuckle 0-25 parts (for example, 2 parts, 4 parts, 6 parts, 8 parts, 10 parts, 12 parts, 14 parts, 16 parts, 18 parts, 20 parts, 22 parts, 24 parts), wherein the weight of each of the raw medicinal materials is not 0 at the same time.

[0018] In some embodiments, the raw materials in the herbal mixture include, by weight: 8-15 parts of Ophiopogon japonicus, 10-18 parts of Poria cocos, 8-15 parts of Piper longum, 3-12 parts of Angelica dahurica, 3-7 parts of Lophatherum gracile, 7-15 parts of Pueraria lobata, 8-19 parts of Cimicifuga foetida, 8-14 parts of Imperata cylindrica, 3-7 parts of Panax ginseng, and 2-20 parts of Lonicera japonica.

[0019] The conventional effects of the Chinese medicinal materials selected in this invention are as follows:

[0020] Ophiopogon japonicus (Ophiopogon japonicus): Sweet, slightly bitter, slightly cold. It enters the heart, lung, and stomach meridians. It nourishes yin and generates fluids, moistens the lungs and clears the heart. It is used for dry cough due to lung dryness, consumptive cough due to yin deficiency, sore throat, thirst due to fluid depletion, internal heat and thirst, irritability and insomnia, and constipation due to intestinal dryness.

[0021] Poria cocos: Sweet, bland, and neutral in nature. It enters the heart, lung, spleen, and kidney meridians. It promotes diuresis and eliminates dampness, strengthens the spleen, and calms the mind. It is used for edema with scanty urine, phlegm retention with dizziness and palpitations, spleen deficiency with poor appetite, loose stools and diarrhea, restlessness, palpitations, and insomnia.

[0022] Piperis longi fruit (also known as Piperis longi fruit): pungent and hot. It enters the stomach and large intestine meridians. It warms the middle jiao (spleen and stomach), dispels cold, lowers qi, and relieves pain. It is used for cold pain in the epigastrium and abdomen, vomiting, diarrhea, qi stagnation due to cold, chest pain, headache, and toothache.

[0023] Angelica dahurica (Radix Angelicae Radix): Pungent, warm. Enters the stomach, large intestine, and lung meridians. Relieves exterior syndromes and dispels cold, dispels wind and relieves pain, clears nasal passages, dries dampness and stops leukorrhea, reduces swelling and drains pus. Used for colds with headache, supraorbital neuralgia, nasal congestion and runny nose, rhinitis, sinusitis, toothache, leukorrhea, and sores and swelling.

[0024] Lophatheri Herba: Sweet, bland, and cold in nature. It enters the heart, stomach, and small intestine meridians. It clears heat and drains fire, relieves irritability and quenches thirst, and promotes urination. It is used for feverish thirst, scanty, dark, painful urination, and mouth and tongue sores.

[0025] Kudzu root (PUERARIAE LOBATAE RADIX): Sweet, pungent, and cool in nature. It enters the spleen, stomach, and lung meridians. It relieves muscle tension and reduces fever, promotes fluid production and quenches thirst, promotes rash eruption, raises yang and stops diarrhea, unblocks meridians and collaterals, and detoxifies alcohol. It is used for exogenous fever and headache, stiff neck and back pain, thirst, diabetes, incomplete measles eruption, dysentery, diarrhea, dizziness and headache, hemiplegia due to stroke, chest pain, and alcohol poisoning.

[0026] Cimicifuga rhizoma: pungent, slightly sweet, slightly cold. It enters the lung, spleen, stomach, and large intestine meridians. It releases exterior pathogens and promotes rash eruption, clears heat and detoxifies, and raises yang qi. It is used for wind-heat headache, toothache, canker sores, sore throat, incomplete measles eruption, rashes caused by yang toxins, rectal prolapse, and uterine prolapse.

[0027] Imperata cylindrica, also known as white imperata root (IMPERATAE RHIZOMA): sweet and cold in nature. It enters the lung, stomach, and bladder meridians. It cools the blood and stops bleeding, clears heat and promotes diuresis. It is used for hematemesis due to blood heat, epistaxis, hematuria, thirst due to febrile diseases, jaundice due to damp-heat, edema with scanty urine, and painful urination due to heat.

[0028] Ginseng (GINSENG RADIX ET RHIZOMA): Sweet, slightly bitter, slightly warm. It enters the spleen, lung, heart, and kidney meridians. It greatly replenishes vital energy, restores the pulse and consolidates the body, tonifies the spleen and lungs, generates fluids and nourishes blood, calms the mind and improves intelligence. It is used for weakness and impending collapse, cold limbs and weak pulse, spleen deficiency with poor appetite, lung deficiency with cough and asthma, thirst due to fluid depletion, internal heat and thirst, deficiency of qi and blood, chronic illness and emaciation, palpitations and insomnia, impotence and cold uterus.

[0029] Honeysuckle (LONICERAE JAPONICAE FLOS): Sweet, cold. Enters the lung, heart, and stomach meridians. Clears heat and detoxifies, disperses wind-heat. Used for carbuncles, boils, sore throat, erysipelas, dysentery due to heat toxins, wind-heat colds, and febrile diseases.

[0030] In some embodiments, the preparation steps of the traditional Chinese medicine mixture are as follows:

[0031] The raw materials of the traditional Chinese medicine mixture are mixed, pulverized, sieved, and the sieved powder is collected to obtain the traditional Chinese medicine mixture; or

[0032] The raw materials of the Chinese herbal medicine mixture are crushed and sieved separately. The powders that pass through the sieve are then mixed to obtain the Chinese herbal medicine mixture.

[0033] In some implementations, the material is passed through a 50-200 mesh sieve.

[0034] In some embodiments, the raw materials of the Chinese herbal medicine mixture are cleaned and dried before use.

[0035] In some embodiments, the drying is performed at 50-100°C for 0.5-48 hours.

[0036] In some embodiments, based on 100 wt% of the oral care composition, the pharmaceutical excipients include 10-80 wt% of a humectant (e.g., 15 wt%, 20 wt%, 25 wt%, 30 wt%, 35 wt%, 40 wt%, 45 wt%, 50 wt%, 55 wt%, 60 wt%, 65 wt%, 70 wt%, 75 wt%) and 0.1-10 wt% of a binder (e.g., 1 wt%, 2 wt%, 3 wt%, 4 wt%, 5 wt%, 6 wt%). 7wt%, 8wt%, 9wt%), thickeners 5-20wt% (e.g., 6wt%, 7wt%, 10wt%, 12wt%, 14wt%, 16wt%, 18wt%), surfactants 0-5wt% (e.g., 1wt%, 2wt%, 3wt%, 4wt%), sweeteners 0-5wt% (e.g., 1wt%, 2wt%, 3wt%, 4wt%), flavorings 0-5wt% (e.g., 1wt%, 2wt%, 3wt%, 4wt%).

[0037] In some embodiments, the humectant is polyethylene glycol and / or a polyol.

[0038] In some embodiments, the polyol is selected from any one or a combination of several of glycerol, sorbitol, and propylene glycol.

[0039] In some embodiments, the adhesive is selected from carbomer series, carrageenan, xanthan gum, sodium carboxymethyl cellulose, sodium alginate, or a combination of several of these.

[0040] In some embodiments, the thickener is selected from any one or a combination of several of hydrated silica, calcium phosphate, dicalcium phosphate, calcium carbonate, and aluminum hydroxide.

[0041] In some embodiments, the surfactant is selected from one or a combination of several of sodium dodecyl sulfate, sodium methyl cocoyl taurate, sodium lauroyl sarcosinate, sodium lauryl sulfate, and betaine.

[0042] In some embodiments, the sweetener is any one or a combination of several of sodium saccharin, sucralose, and xylitol.

[0043] In some embodiments, the fragrance is any one or a combination of several of the following: mint, sweet orange, jasmine tea, strawberry, bamboo leaf, spearmint, fruit, tea, and floral.

[0044] A second aspect of the present invention provides a method for preparing the oral care composition described in the first aspect of the present invention, the method comprising the following steps:

[0045] A) The humectant and the binder are mixed to obtain a first mixture;

[0046] B) The bioactive mineral material, the thickener, and the traditional Chinese medicine mixture are added to the first mixture to obtain the second mixture.

[0047] In some embodiments, the preparation method further includes the following steps:

[0048] C) The surfactant and / or the sweetener are added to the second mixture to obtain a third mixture.

[0049] In some embodiments, the preparation method further includes the following steps:

[0050] D) The flavoring is added to the third mixture to obtain the fourth mixture.

[0051] The second mixture, the third mixture, and the fourth mixture can all be used as pharmaceutical compositions.

[0052] In some embodiments, in step A), the adhesive and the humectant are heated at 20-90°C (e.g., 20°C, 40°C, 50°C, 60°C, 70°C, 80°C) and at 10-2000 r / min (e.g., 50 r / min, 100 r / min, 200 r / min, 300 r / min, 400 r / min, 500 r / min, 600 r / min, 700 r / min, 800 r / min, 900 r / min). The mixture is homogenized at stirring speeds of 1000 r / min, 1100 r / min, 1200 r / min, 1300 r / min, 1400 r / min, 1500 r / min, 1600 r / min, 1700 r / min, 1800 r / min, and 1900 r / min for 1-20 hours (e.g., 3 hours, 5 hours, 10 hours, 15 hours, and 18 hours), and then degassed under vacuum to obtain the first mixture.

[0053] In some embodiments, in step B), the bioactive mineral material and the thickener are mixed and stirred and dispersed for 1-300 minutes (e.g., 30 minutes, 50 minutes, 200 minutes, 300 minutes, 400 minutes, 500 minutes, 600 minutes, 700 minutes, 800 minutes, 900 minutes, 1000 minutes, 1100 minutes, 1200 minutes, 1300 minutes, 1400 minutes, 1500 minutes, 1600 minutes, 1700 minutes, 1800 minutes) at a stirring speed of 10-2000 r / min (e.g., 50 minutes, 100 minutes, 150 minutes, 180 minutes, 250 minutes, 280 minutes), and then the traditional Chinese medicine mixture is added to obtain a second mixture.

[0054] In some embodiments, in step C), the surfactant and / or the sweetener are added to the second mixture to obtain the third mixture.

[0055] In some embodiments, in step D), the flavoring is added to the third mixture to obtain the fourth mixture.

[0056] The third aspect of the present invention provides the use of the composition described in the first aspect of the present invention or the preparation method described in the second aspect of the present invention in the preparation of a medicament for treating, preventing or alleviating oral diseases; preferably, the oral disease is at least one of gingivitis, gingival bleeding, toothache and tooth sensitivity.

[0057] The present invention also includes reasonable combinations of any of the foregoing technical features or sub-solutions that can be expected to produce similar technical effects with the knowledge and skills of those skilled in the art.

[0058] The present invention also includes replacing any active medicinal material with one or a combination of medicinal materials with the same or similar medicinal properties.

[0059] The present invention also includes replacing excipients other than medicinal materials from which the active pharmaceutical ingredient is derived with one or a combination of materials with similar properties, and also includes removing excipients from which the therapeutic efficacy of the disclosed oral care composition is not expected to be lost after the removal of the corresponding excipients.

[0060] The present invention also includes adding, to the medicinal materials from which the active pharmaceutical ingredient is derived, conventionally used in the art for the prevention or treatment of oral diseases (e.g., gingivitis, bleeding gums, toothache, or tooth sensitivity) and / or conventionally effective ingredients and / or generally ineffective ingredients and / or ingredients that do not antagonize or produce toxic side effects with those in the disclosed formulation.

[0061] The weight portions described in this invention mainly include the disclosed numerical range, any value (including integers and decimals) within the disclosed range, or an interval between any two values, or multiple discontinuous intervals. It also includes values ​​or numerical ranges whose effects are expected to be similar to the endpoints of the numerical range, such as 5-10 parts. This does not only include 5, 6, 7, 8, 9, 10 parts, or any interval between any two parts. Other numerical ranges, not listed individually, are all included in this invention. Therefore, this invention also includes sub-ranges of any directly disclosed numerical range or any specific value within that range.

[0062] The present invention also includes combination therapy that can be anticipated by those skilled in the art, such as using the oral disease treatment composition of the present invention while taking other drugs orally, or mixing other drugs with the oral disease treatment composition of the present invention and applying them together to the affected area.

[0063] The present invention also includes adding other conventional Western medicines to the drug, for example, adding them in accordance with the theory of integrating traditional Chinese and Western medicine.

[0064] The beneficial effects of the oral care composition containing bioactive mineral materials and traditional Chinese medicine mixture provided by this invention are as follows: during use, it can quickly repair tooth enamel, prevent tooth decay, repair gingivitis and gingival recession caused by Helicobacter pylori, and at the same time, it has a certain protective effect against gingival bleeding and tooth sensitivity. It is fully functional and suitable for people of different ages, and can achieve the effect of repairing and preventing oral diseases. Detailed Implementation

[0065] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments 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.

[0066] The bioactive mineral material used in the oral care composition of the present invention can be a bioactive repair material including SiO2, CaO and P2O5. The bioactive mineral material (i.e. bioactive silicon) used in the following examples of this application is Regesi regenerated silicon V type produced by Beijing Xingfu Yisheng High-tech Co., Ltd.

[0067] The medicinal parts, properties, identification, inspection, content determination, processing, and storage of the medicinal materials used in this invention are all based on the 2015 edition of the Pharmacopoeia of the People's Republic of China. All other reagents are conventional reagents used in the pharmaceutical industry.

[0068] Example 1

[0069] This embodiment provides an oral care composition containing bioactive mineral materials and a mixture of traditional Chinese medicine, specifically in the form of a tooth-strengthening and gum-protecting repair gel. The mass ratios of each component are shown in Tables 1 and 2.

[0070] The preparation method of the traditional Chinese medicine mixture 1 used in this embodiment is as follows:

[0071] The raw materials are weighed according to the weight ratio of mixture 1 shown in Table 2. After cleaning, they are dried in an oven at 50-100℃ for 0.5-48 hours. The dried raw materials are ground into powder, passed through a 50-200 mesh sieve, and the powder passing through the sieve is collected to obtain traditional Chinese medicine mixture 1.

[0072] Mixtures 2-3 were prepared using the same method.

[0073] The composition is prepared as follows:

[0074] 1) Add the binder and humectant to a shear disperser, and disperse them at high temperature by swelling. The temperature is controlled at 50°C, the dispersion speed is 100 r / min, and the dispersion time is controlled at 10 h. Vacuum the mixture until there are no bubbles, and degas it to obtain mixture A.

[0075] 2) Weigh the ingredients, add the bioactive mineral materials and thickener in sequence, stir and disperse evenly at a stirring speed of 60 r / min for 20 min; then add the Chinese herbal mixture 1 and disperse evenly; then add the surfactant and sweetener and disperse evenly; finally add the fragrance. Once the paste is evenly dispersed, it can be discharged to obtain tooth-strengthening and gum-protecting repair gel B.

[0076] Example 2

[0077] This embodiment provides an oral care composition containing bioactive mineral materials and a mixture of traditional Chinese medicine, specifically in the form of a tooth-strengthening and gum-protecting repair gel. The mass ratios of each component are shown in Tables 1 and 2.

[0078] The preparation method is the same as in Example 1.

[0079] Example 3

[0080] This embodiment provides an oral care composition containing bioactive mineral materials and a mixture of traditional Chinese medicine, specifically in the form of a tooth-strengthening and gum-protecting repair gel. The mass ratios of each component are shown in Tables 1 and 2.

[0081] The preparation method is the same as in Example 1.

[0082] Example 4

[0083] This embodiment provides an oral care composition containing bioactive mineral materials and a mixture of traditional Chinese medicine, specifically a tooth-strengthening and gum-protecting repair gel. The mass ratios of each component are shown in Tables 1 and 2.

[0084] The preparation method is the same as in Example 1.

[0085] Example 5

[0086] This embodiment provides an oral care composition containing bioactive mineral materials and a mixture of traditional Chinese medicine, specifically a tooth-strengthening and gum-protecting repair gel. The mass ratios of each component are shown in Tables 1 and 2.

[0087] The preparation method is the same as in Example 1.

[0088] Example 6

[0089] This embodiment provides an oral care composition containing bioactive mineral materials and a mixture of traditional Chinese medicine, specifically a tooth-strengthening and gum-protecting repair gel. The mass ratios of each component are shown in Tables 1 and 2.

[0090] The preparation method is the same as in Example 1.

[0091] Comparative Example 1

[0092] This embodiment provides an oral care composition containing bioactive mineral materials and a mixture of traditional Chinese medicine, specifically a tooth-strengthening and gum-protecting repair gel. The mass ratios of each component are shown in Tables 1 and 2.

[0093] The preparation method is the same as in Example 1.

[0094] Comparative Example 2

[0095] This embodiment provides an oral care composition containing bioactive mineral materials and a mixture of traditional Chinese medicine, specifically a tooth-strengthening and gum-protecting repair gel. The mass ratios of each component are shown in Tables 1 and 2.

[0096] The preparation method is the same as in Example 1.

[0097] Comparative Example 3

[0098] This embodiment provides an oral care composition containing bioactive mineral materials and a mixture of traditional Chinese medicine, specifically a tooth-strengthening and gum-protecting repair gel. The mass ratios of each component are shown in Tables 1 and 2.

[0099] The preparation method is the same as in Example 1.

[0100] Table 1. Formulations (by weight percentage) of the tooth-strengthening and gum-protecting repair gel products of Examples 1-6 and Comparative Examples 1-3.

[0101]

[0102]

[0103]

[0104] Table 2. Formula (parts by weight) of the herbal mixture in the tooth-strengthening and gum-protecting repair gel product.

[0105]

[0106] Test Example 1. Evaluation of Physicochemical Properties

[0107] (I) pH value measurement

[0108] Experimental methods:

[0109] The composition of the present invention is mixed with distilled water at a weight ratio of 1:9, the insoluble matter is removed by filtration, the diluted solution is retained, and the pH value of the filtrate is measured with a precision pH meter.

[0110] The test results are shown in Table 3.

[0111] Table 3 pH test results of the samples

[0112]

[0113]

[0114] (II) Stability tests at room temperature, heat resistance and cold resistance

[0115] Experimental methods and results:

[0116] The compositions were encapsulated in toothpaste tubes. The compositions of Examples 1-6 were observed at room temperature for 30 days without any change in taste or stratification. The compositions of Examples 1-6 were observed in a constant temperature chamber at 46°C for 30 days, and after being allowed to thaw completely at room temperature, none of them showed any stratification or change in taste. The compositions of Examples 1-6 were observed in a refrigerator at -4°C for 30 days, and after being allowed to thaw completely at room temperature, none of them showed any stratification or change in taste. The compositions of Comparative Examples 1-3 showed no abnormalities in room temperature and cold resistance tests, but all showed change in taste, hardening of the paste consistency, and poor stability in heat resistance tests.

[0117] Test Example 2. Clinical Test

[0118] (I) Trial Experience

[0119] Test method:

[0120] Using a public opinion survey evaluation method, the tooth-strengthening and gum-protecting repair compositions prepared using Examples 1-6 and Comparative Examples 1-3 were tested twice daily, morning and evening, for a period of 4 weeks. After the trial, 10 indicators were evaluated, including paste color, skeleton state, fragrance, viscosity, sweetness, taste, foaming performance, cleaning performance, gingival bleeding, and oral repair effect. The total score for each effect was 10 points: 10 points is the maximum score, very satisfied; 8 points is excellent, fairly satisfied; and below 6 points (excluding 6 points) is unacceptable.

[0121] Each item (such as paste color, structure, fragrance, viscosity, sweetness, taste, foaming properties, cleaning performance, gum bleeding, and oral repair effect) is scored out of 10, for a total of 100 points. Users can rate each item individually, and the scores for each item are averaged to obtain the final score for that item.

[0122] Target audience:

[0123] Nine hundred volunteers were selected as trial subjects, aged between 15 and 50, with an equal number of men and women, and who had symptoms such as bleeding gums, toothache, tooth sensitivity, and gingivitis.

[0124] Experimental results:

[0125] Statistical results show that the subjects generally had a good experience with the tooth-strengthening and gum-protecting restorative composition, with 92.38% of the subjects scoring an average of 8 points or higher on the aforementioned 10 indicators.

[0126] (ii) Anti-inflammatory test of the product

[0127] Test subjects:

[0128] Ninety mice (Kunming mice) of uniform weight were selected. The mice were divided into nine groups of ten mice each, with half males and half females, and the compositions of each embodiment were tested in each group.

[0129] Test method:

[0130] 30 μL of xylene was evenly applied to the back of the left ear of each group of mice. The right ear was left untreated as a blank control. After 1 hour of inflammation, the composition of each group was applied to the left ear of each group of mice. The amount of drug applied was 0.1g.

[0131] Evaluation criteria:

[0132] One hour after applying the medication, use a 2mm punch to remove round pieces from the same area of ​​the left and right ears of the mouse, weigh them, and calculate the ear weight difference. Swelling degree = weight of left ear round piece - weight of right ear round piece.

[0133] The experimental results are shown in Table 4.

[0134] Table 4. Effects of the composition on ear swelling in mice (average values)

[0135] Group Swelling degree (mg) Example 1 1.72 Example 2 1.28 Example 3 1.41 Example 4 1.56 Example 5 1.42 Example 6 1.27 Comparative Example 1 2.29 Comparative Example 2 1.54 Comparative Example 3 1.98

[0136] As shown in Table 4, compared with Comparative Examples 1-3, Examples 1-6 had lower swelling, with Examples 2 and 6 having the lowest swelling and the best effect. Among Comparative Examples 1-3, Comparative Example 2 had lower swelling and better effect, which indicates that the combination of bioactive mineral materials and traditional Chinese medicine composition in this invention has a better effect.

[0137] (III) Hemostatic effect test

[0138] Subjects:

[0139] Forty-five domestic rabbits were divided into nine groups of five each. Their ears were shaved and disinfected.

[0140] Test method:

[0141] A 1cm long incision was made at the same location on different rabbit ears using a scalpel, and the time T0 was recorded. After 3 seconds, the compositions prepared in Examples 1-6 and Comparative Examples 1-3 were evenly applied to the wound surface, and the weight of the compositions used was recorded as W0. The wound surface was observed for any blood seepage, and hemostasis was achieved when there was no seepage for 10 consecutive seconds, and the time was recorded as T1. The total weight W1 of the hemostatic composition and the blood adsorbed on the composition was weighed, and the amount of bleeding W and the hemostasis time T were calculated.

[0142] Blood loss W = W1 - W0;

[0143] The hemostasis time T = T1 - T0, and the experimental results are shown in Table 5.

[0144] Table 5. Test results (average values) of the composition's hemostatic effect.

[0145] Group Blood loss (w / mg) Hemostasis time T(s) Example 1 31.15 456.23 Example 2 28.36 356.15 Example 3 29.84 426.58 Example 4 29.63 408.15 Example 5 29.21 398.18 Example 6 28.45 345.26 Comparative Example 1 33.26 502.17 Comparative Example 2 29.45 415.23 Comparative Example 3 31.48 468.49

[0146] As can be seen from the data in Table 5, the amount and duration of bleeding in rabbit ears treated with the compositions of Examples 1-6 were significantly lower than those treated with the composition of Comparative Example 1, indicating that the products of Examples 1-6 had better hemostatic effects. Compared with Comparative Examples 2 and 3, Examples 1-6 demonstrate that the combination of bioactive mineral materials and traditional Chinese medicine compositions can achieve a synergistic effect.

[0147] (iv) Oral ulcer test

[0148] Subjects:

[0149] Nine hundred patients with oral ulcers, aged 15-50 years, were selected and divided into nine groups of 100 patients each, with an equal number of men and women. Patients had no serious systemic diseases, had experienced oral ulcers for more than three days, and had not taken or used any other medications for oral ulcers within the past three days. These patients had not received any other treatment for this episode.

[0150] Administration method:

[0151] Patients should use the product after each of the three daily meals, applying the mixture to the oral ulcers and holding it in their mouth for 3 minutes. Continue use for 5 consecutive days, observe the therapeutic effect, and record the results.

[0152] Efficacy evaluation criteria:

[0153] Healing: Pain disappears within 5 days;

[0154] Significant effect: Pain relief of grade 2 or higher;

[0155] Effective: Pain relief of grade 1 or higher;

[0156] Ineffective: The pain level is basically not relieved.

[0157] The experimental results are shown in Table 6.

[0158] Table 6. Results of the product's therapeutic effect on oral ulcers.

[0159]

[0160] As can be seen from Table 6, the healing rate of the compositions in Examples 1-6 was significantly higher than that in Comparative Examples 1-3, indicating better efficacy. The efficacy rates of the compositions in Examples 1-6 and Comparative Examples 2 and 3 were significantly higher than those in Comparative Example 1, suggesting that bioactive mineral materials and mixtures of traditional Chinese medicine, or combinations thereof, are effective for oral ulcers.

[0161] The foregoing has described and evaluated some embodiments of the present invention. It should be understood that the present invention is not limited to the specific embodiments described above. Any person skilled in the art can make many possible variations and modifications to the technical solutions of the present invention, or modify them into equivalent embodiments, without departing from the scope of the present invention. This does not affect the essential content of the present invention. Therefore, any simple modifications, equivalent changes, and modifications made to the above embodiments based on the technical essence of the present invention, without departing from the content of the present invention, still fall within the protection scope of the present invention.

Claims

1. An oral care composition, comprising, by weight percentage: 5 wt% bioactive mineral material, 5 wt% traditional Chinese medicine mixture, and 90 wt% pharmaceutical excipients; the sum of the weights of all raw materials and unavoidable impurities is 100 wt%. wherein The bioactive mineral material includes SiO2, CaO and P2O5, and is Regesi recycled silicon produced by Beijing Xingfu Yisheng High-tech Co., Ltd. The raw materials of the Chinese herbal mixture are composed of Ophiopogon japonicus, Poria cocos, Piper longum, Angelica dahurica, Lophatherum gracile, Pueraria lobata, Cimicifuga foetida, Imperata cylindrica, Panax ginseng, and Lonicera japonica; The raw materials in the mixture of Chinese herbs include: 12 parts of Ophiopogon japonicus, 15 parts of Poria cocos, 10 parts of Piper longum, 7 parts of Angelica dahurica, 3 parts of Lophatherum gracile, 12 parts of Pueraria lobata, 8 parts of Cimicifuga foetida, 10 parts of Imperata cylindrica, 3 parts of Panax ginseng, and 20 parts of Lonicera japonica. Based on 100 wt% of the oral care composition, the pharmaceutical excipients include 70 wt% humectant, 1 wt% binder, 17 wt% thickener, 1 wt% sweetener, and 1 wt% flavoring. The dosage form of the oral care composition is selected from one of the following: gingival gel, spray, patch, and oral dressing.

2. The oral care composition as claimed in claim 1, characterized in that: The preparation steps of the traditional Chinese medicine mixture are as follows: The raw materials of the traditional Chinese medicine mixture are mixed, pulverized, sieved, and the sieved powder is collected to obtain the traditional Chinese medicine mixture; or The raw materials of the Chinese herbal medicine mixture are crushed and sieved separately. The powders that pass through the sieve are then mixed to obtain the Chinese herbal medicine mixture. Pass through a 50-200 mesh sieve; The raw materials of the Chinese herbal medicine mixture should be cleaned and dried before use; The drying process involves drying at 50-100℃ for 0.5-48 hours.

3. The oral care composition as claimed in claim 1, characterized in that: The humectant is polyethylene glycol and / or polyol; The polyol is selected from any one or a combination of several of glycerol, sorbitol, and propylene glycol; The adhesive is selected from any one or a combination of several of the following: carbomer series, carrageenan, xanthan gum, sodium carboxymethyl cellulose, and sodium alginate; The thickener is selected from any one or a combination of several of hydrated silica, calcium phosphate, dicalcium phosphate, calcium carbonate, and aluminum hydroxide. The sweetener is any one or a combination of several of sodium saccharin, sucralose, and xylitol; The fragrance is any one or a combination of several of the following: mint, sweet orange, jasmine tea, strawberry, bamboo leaf, spearmint, fruit, tea, and floral.

4. Use of the oral care composition according to any one of claims 1-3 in the preparation of a medicament for treating, preventing or alleviating oral diseases.

5. The use as described in claim 4, characterized in that, The oral disease is at least one of gingivitis, bleeding gums, toothache, and tooth sensitivity.

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