A toothpaste composition and its preparation method, use method and application

Abstract

The present invention provides a toothpaste composition and a preparation method, a use method and an application thereof, comprising toothpaste and a catalyst; the components of the toothpaste include a hemostatic active ingredient, a peroxide, an auxiliary material and water; the peroxide is hydrogen peroxide or sodium peroxide; the catalyst is a triethanolamine solution, a sodium bicarbonate solution or a catalase. When the present invention is used, after the peroxide contacts the catalyst, oxygen can be quickly released, the blood oxygen saturation is increased, the hypoxic state of the periodontal tissue is alleviated, and the metabolism is promoted. The toothpaste composition of the present invention is easy to use, and only needs to apply the toothpaste and the catalyst on the toothbrush head at the same time to react and release oxygen, and no complex equipment such as high pressure is required, which is convenient for promotion and use. It can help people in plateaus to effectively improve the symptoms of gingival bleeding caused by high-altitude polycythemia and reduce the probability of the occurrence of the symptom.

Description

Technical Field

[0001] The invention belongs to the technical field of oral hygiene products, and specifically relates to a toothpaste composition and a preparation method, a use method and an application thereof. Background Art

[0002] Gingival bleeding is one of the common symptoms of high-altitude polycythemia. Due to the unique hypoxic environment in the plateau and other factors, gingival bleeding is more common. First, the damage caused by plateau hypoxia can lead to an increase in red blood cells in the blood of periodontal tissues, increased hemoglobin, increased blood flow viscosity, increased blood flow resistance, vasodilation and red blood cell aggregation causing microthrombosis, thereby reducing oxygen perfusion of periodontal tissues, causing microcirculation disorders, malnutrition of periodontal tissues, and cell catabolism greater than anabolism. Secondly, due to the long-term treatment of periodontal tissues in a state of hypoxia, aerobic metabolism is reduced, anaerobic metabolism is enhanced, harmful and acidic substances are increased, the chance of oral infection is increased, bacteria are easily invaded by periodontal tissues, and periodontal tissues are in an inflammatory state for a long time, and resistance is reduced. In addition, periodontitis is a mixed infection dominated by anaerobic bacteria. Plateau hypoxia accelerates the growth and reproduction of anaerobic bacteria and seriously damages periodontal tissues.

[0003] The disease is not well responded to conventional anti-inflammatory, hemostatic and adequate vitamin supplementation, and the treatment process often relapses. Studies have shown that hyperbaric oxygen is a good measure to treat high-altitude polycythemia and has a significant effect on relieving gingival bleeding, but this method can only be used in a medical environment or with oxygen, which is less convenient. Summary of the invention

[0004] In view of the shortcomings of the prior art, the present invention provides a toothpaste composition and a preparation method, a use method and an application thereof. The toothpaste composition is easy to use, can quickly release oxygen, and has the effects of hemostasis and anti-inflammatory. It can help people in plateaus to effectively improve the symptoms of gingival bleeding caused by high-altitude polycythemia and reduce the probability of occurrence of the symptoms.

[0005] The present invention is achieved through the following technical solutions:

[0006] The present invention provides a toothpaste composition, comprising toothpaste and a catalyst;

[0007] The components of the toothpaste include hemostatic active ingredients, peroxide, auxiliary materials and water;

[0008] The peroxide is hydrogen peroxide or sodium peroxide;

[0009] The catalyst is triethanolamine solution, sodium bicarbonate solution or catalase.

[0010] Preferably, the hemostatic active ingredient is one or more of Saussurea bracteata extract, Meconopsis pilosa extract, Psoralea corylifolia extract, Psoralea corylifolia extract, Oxytropis microphylla extract and Elsholtzia scoparia extract.

[0011] Preferably, the hemostatic active ingredients include Saussurea ensifolia extract, Meconopsis koreana extract, Psoralea corylifolia extract, Psoralea corylifolia extract, Oxytropis microphylla extract and Elsholtzia ciliata extract; the excipients include xanthan gum, carrageenan, glycerin, polyethylene glycol, sorbitol, xylitol, sodium lauryl sulfate, titanium dioxide, silicon dioxide, citric acid and EDTA-2Na; the components of the toothpaste include, by mass percentage, 0.1% to 10.0% Saussurea ensifolia extract, 0.1% to 10.0% Meconopsis koreana extract, 0.01% to 1.0% Psoralea corylifolia extract and 0.01% to 1.0% Psoralea corylifolia extract. %~1.0%, Oxytropis microphylla extract 0.1%~3.0%, hydrogen peroxide 1.0%~15.0%, Elsholtzia ciliata extract 0.1%~10.0%, xanthan gum 0.1%~1.5%, carrageenan 0.1%~1.5%, glycerin 1.0%~25.0%, polyethylene glycol 1.0%~15.0%, sorbitol 3.0%~50.0%, xylitol 1.0%~10.0%, silicon dioxide 1.0%~20.0%, sodium lauryl sulfate 0.5%~5.0%, titanium dioxide 0.1%~1.0%, citric acid 0.1%~5.0%, EDTA-2Na 0.1%~2.0% and water 10%~45.0%.

[0012] Preferably, the hemostatic active ingredients include Saussurea ensifolia extract, Meconopsis koreana extract, Psoralea corylifolia extract, Psoralea corylifolia extract, Oxytropis microphylla extract and Elsholtzia esculenta extract; the excipients include carbomer, glycerin, polyethylene glycol, xylitol, sodium lauryl sulfate, titanium dioxide, silicon dioxide, sodium hydroxide and EDTA-2Na; the components of the toothpaste include, by mass percentage: 0.1% to 10.0% Saussurea ensifolia extract, 0.1% to 10.0% Meconopsis koreana extract, 0.01% to 1.0% Psoralea corylifolia ... Pleurotus ostreatus extract 0.01%~1.0%, Oxytropis microphylla extract 0.1%~3.0%, Sodium peroxide 1.0%~15.0%, Elsholtzia ciliata extract 0.1%~10.0%, Carbomer 0.01%~2.0%, Glycerin 1.0%~25.0%, Polyethylene glycol 1.0%~15.0%, Xylitol 1.0%~10.0%, Silicon dioxide 1.0%~20.0%, Sodium lauryl sulfate 0.5%~5.0%, Titanium dioxide 0.1%~1.0%, Sodium hydroxide 0.1%~5.0%, EDTA-2Na 0.1%~2.0%.

[0013] In the toothpaste composition, the preparation method of the toothpaste comprises the following steps:

[0014] Step 1, dispersing xanthan gum and carrageenan in glycerin, stirring to make the dispersion uniform, to obtain colloid A;

[0015] Step 2, dissolving polyethylene glycol, sorbitol, xylitol, citric acid, hydrogen peroxide, and EDTA-2Na in water, and stirring until the solution is completely clear to obtain solution B;

[0016] Step 3, adding solution B to colloid A, stirring and mixing, and fully swelling at 45-50° C. to obtain gel C;

[0017] Step 4, silicon dioxide, sodium dodecyl sulfate, titanium dioxide, Saussurea membranacea extract, Meconopsis pilosula extract, Psoralea corylifolia extract, Psoralea corylifolia extract, Oxytropis microphylla extract, and Elsholtzia scoparia extract are mixed and added into gel C, and stirred.

[0018] Alternatively, include the following steps:

[0019] Step 1, dispersing carbomer in glycerol and polyethylene glycol, stirring to make the dispersion uniform, to obtain colloid A;

[0020] Step 2, adding sodium hydroxide to colloid A, stirring and swelling the mixture to obtain colloid B;

[0021] Step 3, mix the Saussurea membranacea extract, Meconopsis koelreuteriae extract, Psoralea corylifolia extract, Psoralea corylifolia extract, Oxytropis microphylla extract, Elsholtzia scoparia extract, sodium peroxide, xylitol, silicon dioxide, sodium dodecyl sulfate, titanium dioxide, and EDTA-2Na, add to gel B, and stir.

[0022] A storage box for storing the toothpaste composition, the storage box comprising an outer box, an inner box and a toothbrush slot are arranged on the inner wall of the outer box, the inner box is used to contain catalase, and the toothbrush slot is used to place a toothbrush;

[0023] Alternatively, the storage box includes an outer box, and a spray bottle slot and a toothbrush slot are provided on the inner wall of the outer box. The spray bottle slot is used to place a spray bottle containing triethanolamine solution or sodium bicarbonate solution, and the toothbrush slot is used to place a toothbrush.

[0024] Alternatively, the storage box includes an outer box, and an inner box, a spray bottle slot, and a toothbrush slot are provided on the inner wall of the outer box. The inner box is used to hold catalase, the spray bottle slot is used to place a spray bottle containing triethanolamine solution or sodium bicarbonate solution, and the toothbrush slot is used to place a toothbrush.

[0025] The method for using the toothpaste composition comprises coating the catalyst and the toothpaste on a toothbrush head, and then brushing teeth with the toothbrush head.

[0026] Preferably, the triethanolamine solution or the sodium bicarbonate solution is sprayed onto the toothbrush head using the spray bottle, toothpaste is squeezed onto the toothbrush head, and the toothbrush head is used for brushing teeth;

[0027] Alternatively, after wetting the toothbrush head with water, dip the catalase in the inner box with the toothbrush head, squeeze toothpaste on the toothbrush head, and use the toothbrush head to brush teeth.

[0028] The present invention provides the use of the toothpaste composition in an oxygen-deficient environment. The oxygen-deficient environment in the present invention refers to an environment with an oxygen concentration lower than 100-310 mg / L.

[0029] Compared with the prior art, the present invention has the following beneficial effects:

[0030] The toothpaste composition of the present invention, when in use, after the peroxide contacts the catalyst, can quickly release oxygen, increase blood oxygen saturation, alleviate the hypoxic state of periodontal tissue, and promote metabolism. In addition, in an oxygen-rich environment, the sulfur-containing enzymes in anaerobic bacteria are oxidized and inactivated, which can effectively inhibit the growth and reproduction of anaerobic bacteria and other harmful bacteria, so that inflammation can be controlled, and can help people in hypoxic environments such as plateaus to effectively improve the symptoms of gingival bleeding caused by high-altitude polycythemia, and reduce the probability of occurrence of the symptom. The toothpaste composition of the present invention is easy to use, and only needs to apply the toothpaste and the catalyst on the toothbrush head at the same time, and oxygen can be released by reaction, without the need for complex equipment such as high pressure, which is convenient for promotion and use.

[0031] Furthermore, in the toothpaste of the present invention, Saussurea membranacea, Meconopsis thunbergii, Psoralea corylifolia, Psoralea corylifolia and Oxytropis microphylla are all plateau plants, and the above extracts are used in combination, which has good hemostatic, anti-inflammatory, analgesic and other effects. In the toothpaste of the present invention, Elsholtzia plateauensis is distributed on roadsides, grass slopes and under forests at an altitude of 2800 to 3200 meters, and its essential oil has a cool taste and a special aroma, and is used in toothpaste for the first time.

[0032] The invention designs a storage box for storing toothpaste composition, which is convenient for storing and using the catalyst. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] Figure 1 For storage box (empty)

[0034] Figure 2 For storage box (loading) DETAILED DESCRIPTION

[0035] In order to further understand the present invention, the present invention is described below in conjunction with embodiments. These descriptions are only to further explain the features and advantages of the present invention and are not intended to limit the claims of the present invention.

[0036] The toothpaste composition for treating plateau gingival bleeding of the present invention comprises toothpaste and a catalyst; the components of the toothpaste comprise a hemostatic active ingredient, a peroxide, an auxiliary material and water; the peroxide is hydrogen peroxide or sodium peroxide; the hemostatic active ingredient is one or more of Saussurea membranacea extract, Meconopsis koreana extract, Psoralea corylifolia extract, Psoralea corylifolia extract, Oxytropis microphylla extract and Elsholtzia plateau extract; the catalyst is a triethanolamine solution, a sodium bicarbonate solution or catalase.

[0037] The auxiliary materials are one or more of xanthan gum, carrageenan, carbomer, glycerin, polyethylene glycol, sorbitol, xylitol, sodium lauryl sulfate, titanium dioxide, citric acid and sodium hydroxide.

[0038] The polyethylene glycol is selected from one or more of PEG-400, PEG-600, PEG-1500 and PEG-4000. The silicon dioxide is selected from one or two of friction-type silicon dioxide (such as 103, 113, 115, 124, etc.) and thickening silicon dioxide (such as 165, H, etc.). The carbomer is selected from one or more of carbomer 940, carbomer 971 and carbomer 980. The citric acid is a pH regulator, which is used together with the chelating agent EDTA-2Na to improve the preservation and stability of peroxide.

[0039] The present invention also provides a storage box for storing catalysts, such as Figure 1 and 2 As shown, the storage box includes an outer box 1, and an inner box 2, a toothbrush slot 3 and a spray bottle slot 4 are provided on the inner wall of the outer box 1. The toothbrush slot 3 is used to place a toothbrush 5, and the spray bottle slot 4 is used to place a spray bottle 6. Generally, an appropriate amount of catalase is directly placed in the inner box 2, and an appropriate amount of triethanolamine solution and sodium bicarbonate solution are placed in a spray bottle. When in use, a spray bottle is used to spray an appropriate amount of solution on the toothbrush, and an appropriate amount of toothpaste is squeezed out on the toothbrush head after wetting the toothbrush head, and brushing teeth according to the conventional method can be used. Alternatively, after wetting the toothbrush head with water, open the inner box cover, dip the toothbrush head in an appropriate amount of catalase, squeeze out an appropriate amount of toothpaste on the toothbrush head, and brush teeth according to the conventional method.

[0040] In a specific embodiment of the present invention, the components of the toothpaste include, by mass percentage: 0.1% to 10.0% of Saussurea calyx extract, 0.1% to 10.0% of Meconopsis pilosa extract, 0.01% to 1.0% of Pleurotus eryngii extract, 0.01% to 1.0% of Pleurotus eryngii extract, 0.1% to 3.0% of Oxytropis microphylla extract, 1.0% to 15.0% of hydrogen peroxide, and 0.1% to 10.0% of Elsholtzia scoparia extract. , xanthan gum 0.1% ~ 1.5%, carrageenan 0.1% ~ 1.5%, glycerin 1.0% ~ 25.0%, polyethylene glycol 1.0% ~ 15.0%, sorbitol 3.0% ~ 50.0%, xylitol 1.0% ~ 10.0%, silicon dioxide 1.0% ~ 20.0%, sodium lauryl sulfate 0.5% ~ 5.0%, titanium dioxide 0.1% ~ 1.0%, citric acid 0.1% ~ 5.0%, EDTA-2Na 0.1% ~ 2.0% and water 10% ~ 45.0%.

[0041] In the above specific embodiment of the present invention, the preparation process of toothpaste using hydrogen peroxide as the oxygen-releasing component comprises the following steps:

[0042] Step 1, dispersing xanthan gum and carrageenan in glycerin, stirring to make the dispersion uniform, to obtain colloid A;

[0043] Step 2, dissolving polyethylene glycol, sorbitol, xylitol, citric acid, hydrogen peroxide, and EDTA-2Na in purified water, and stirring until the solution is completely clear to obtain solution B;

[0044] Step 3, adding solution B to colloid A, stirring and mixing, and fully swelling at 45-50° C. to obtain gel C;

[0045] Step 4, silicon dioxide, sodium dodecyl sulfate, titanium dioxide, Saussurea membranacea extract, Meconopsis pilosa extract, Psoralea corylifolia extract, Psoralea corylifolia extract, Oxytropis microphylla extract, and Elsholtzia oleifera extract are mixed and added to gel C and stirred until no dry powder is visible on the surface of the colloid;

[0046] Step 5, turn on vacuum, dispersion and stirring, set the vacuum degree to -0.9MPa, the dispersion frequency to 10Hz, the stirring speed to 300rpm, stir until the paste is fine and uniform, add flavor and mix well.

[0047] In a specific embodiment of the present invention, the components of the toothpaste include, by mass percentage, 0.1% to 10.0% of Saussurea membranacea extract, 0.1% to 10.0% of Meconopsis pilosa extract, 0.01% to 1.0% of Pleurotus eryngii extract, 0.01% to 1.0% of Pleurotus eryngii extract, 0.1% to 3.0% of Oxytropis microphylla extract, 1.0% to 15.0% of Sodium peroxide, 0.1% to 10.0% of Elsholtzia ciliata extract, 0.01% to 2.0% of Carbomer, 1.0% to 25.0% of Glycerin, 1.0% to 15.0% of Polyethylene Glycol, 1.0% to 10.0% of Xylitol, 1.0% to 20.0% of Silicon Dioxide, 0.5% to 5.0% of Sodium Lauryl Sulfate, 0.1% to 1.0% of Titanium Dioxide, 0.1% to 5.0% of Sodium Hydroxide, and 0.1% to 2.0% of EDTA-2Na.

[0048] In the above specific embodiment of the present invention, the preparation process of toothpaste using sodium peroxide as the oxygen-releasing component comprises the following steps:

[0049] Step 1, dispersing carbomer in glycerol and polyethylene glycol, stirring to make the dispersion uniform, to obtain colloid A;

[0050] Step 2, adding sodium hydroxide to colloid A, stirring and swelling the mixture to obtain colloid B;

[0051] Step 3, mix the Saussurea membranacea extract, Meconopsis koelreuteriae extract, Psoralea corylifolia extract, Psoralea corylifolia extract, Oxytropis microphylla extract, Elsholtzia oleifera extract, sodium peroxide, xylitol, silicon dioxide, sodium dodecyl sulfate, titanium dioxide, and EDTA-2Na, and then add the mixture into gel B and stir until there is no dry powder visible on the surface of the gel;

[0052] Step 4, turn on vacuum, dispersion and stirring, set the vacuum degree to -0.9MPa, the dispersion frequency to 10Hz, the stirring speed to 300rpm, stir until the paste is fine and uniform, add flavor and mix well.

[0053] Example 1

[0054] This embodiment provides a toothpaste for treating plateau gingival bleeding, which comprises, by mass percentage:

[0055] 1.0% Saussurea ensifolia extract, 1.0% Meconopsis koelreuteria extract, 0.3% Psoralea corylifolia extract, 0.2% Psoralea corylifolia extract, 0.6% Oxytropis microphylla extract, 3.0% hydrogen peroxide (35%), 0.6% Elsholtzia esculenta extract, 0.9% xanthan gum, 0.3% carrageenan, 14.0% glycerin, 1.5% polyethylene glycol 1500, 27.0% sorbitol, 5.0% xylitol, 15.4% silicon dioxide 113, 1.5% sodium lauryl sulfate, 0.2% titanium dioxide, 0.3% citric acid, 0.2% EDTA-2Na, and 27.0% purified water.

[0056] The preparation process of the toothpaste for treating plateau gingival bleeding in this embodiment comprises the following steps:

[0057] Step 1, dispersing xanthan gum and carrageenan in glycerin, stirring to make the dispersion uniform, to obtain colloid A;

[0058] Step 2, dissolving polyethylene glycol 1500, sorbitol, xylitol, citric acid, hydrogen peroxide (35%), and EDTA-2Na in purified water, and stirring until the solution is completely clear to obtain solution B;

[0059] Step 3, adding solution B to colloid A, stirring and mixing, and fully swelling at 45-50° C. to obtain gel C;

[0060] Step 4, silicon dioxide 113, sodium dodecyl sulfate, titanium dioxide, Saussurea membranacea extract, Meconopsis pilosula extract, Psoralea corylifolia extract, Psoralea corylifolia extract, Oxytropis microphylla extract, and Elsholtzia scoparia extract are mixed and added into gel C and stirred until no dry powder is visible on the surface of the colloid;

[0061] Step 5, turn on vacuum, dispersion and stirring, set the vacuum degree to -0.9MPa, the dispersion frequency to 10Hz, the stirring speed to 300rpm, stir until the paste is fine and uniform, add flavor and mix well.

[0062] Example 2

[0063] This embodiment provides a toothpaste for treating plateau gingival bleeding, which comprises, by mass percentage:

[0064] 1.0% Saussurea bracteata extract, 1.0% Meconopsis koelreuteria extract, 0.3% Psoralea corylifolia extract, 0.2% Psoralea corylifolia extract, 0.6% Oxytropis microphylla extract, 4.5% hydrogen peroxide (35%), 0.6% Elsholtzia scoparia extract, 0.9% xanthan gum, 0.3% carrageenan, 14.0% glycerin, 1.5% polyethylene glycol 1500, 25.4% sorbitol, 5.0% xylitol, 15.4% silicon dioxide 113, 1.5% sodium lauryl sulfate, 0.2% titanium dioxide, 0.5% citric acid, 0.2% EDTA-2Na, 27.0% purified water.

[0065] The preparation process of the toothpaste for treating plateau gingival bleeding in this embodiment comprises the following steps:

[0066] Step 1, dispersing xanthan gum and carrageenan in glycerin, stirring to make the dispersion uniform, to obtain colloid A;

[0067] Step 2, dissolving polyethylene glycol 1500, sorbitol, xylitol, citric acid, hydrogen peroxide (35%), and EDTA-2Na in purified water, and stirring until the solution is completely clear to obtain solution B;

[0068] Step 3, adding solution B to colloid A, stirring and mixing, and fully swelling at 45-50° C. to obtain gel C;

[0069] Step 4, silicon dioxide 113, sodium dodecyl sulfate, titanium dioxide, Saussurea membranacea extract, Meconopsis pilosula extract, Psoralea corylifolia extract, Psoralea corylifolia extract, Oxytropis microphylla extract, and Elsholtzia scoparia extract are mixed and added into gel C and stirred until no dry powder is visible on the surface of the colloid;

[0070] Step 5, turn on vacuum, dispersion and stirring, set the vacuum degree to -0.9MPa, the dispersion frequency to 10Hz, the stirring speed to 300rpm, stir until the paste is fine and uniform, add flavor and mix well.

[0071] Example 3

[0072] This embodiment provides a toothpaste for treating plateau gingival bleeding, which comprises, by mass percentage:

[0073] 1.0% Saussurea ensifolia extract, 1.0% Meconopsis koelreuteria extract, 0.3% Psoralea corylifolia extract, 0.2% Psoralea corylifolia extract, 0.6% Oxytropis microphylla extract, 2.4% Sodium peroxide, 0.6% Elsholtzia ciliata extract, 1.0% Carbomer 980, 40.0% Glycerin, 25.0% Polyethylene glycol 400, 5.0% Xylitol, 20.7% Silicon dioxide 113, 1.5% Sodium lauryl sulfate, 0.2% Titanium dioxide, 0.3% Sodium hydroxide, 0.2% EDTA-2Na.

[0074] The preparation process of the toothpaste for treating plateau gingival bleeding in this embodiment comprises the following steps:

[0075] Step 1, dispersing Carbomer 980 in glycerol and polyethylene glycol, stirring to make the dispersion uniform, to obtain colloid A;

[0076] Step 2, adding sodium hydroxide to colloid A, stirring and swelling the mixture to obtain colloid B;

[0077] Step 3, mix the extract of Saussurea membranacea, the extract of Meconopsis koelreuteriae, the extract of Psoralea corylifolia, the extract of Psoralea corylifolia, the extract of Oxytropis microphylla, the extract of Elsholtzia esculenta, sodium peroxide, xylitol, silicon dioxide 113, sodium dodecyl sulfate, titanium dioxide, and EDTA-2Na, and then add the mixture to gel B and stir until there is no dry powder visible on the surface of the gel;

[0078] Step 4, turn on vacuum, dispersion and stirring, set the vacuum degree to -0.9MPa, the dispersion frequency to 10Hz, the stirring speed to 300rpm, stir until the paste is fine and uniform, add flavor and mix well.

[0079] Comparative Example 1

[0080] In order to further illustrate the beneficial effects of the present invention, a toothpaste containing only plateau plant extracts as effective ingredients is provided, which comprises, by mass percentage:

[0081] 1.0% Saussurea ensifolia extract, 1.0% Meconopsis koelreuteria extract, 0.3% Psoralea corylifolia extract, 0.2% Psoralea corylifolia extract, 0.6% Oxytropis microphylla extract, 0.6% Elsholtzia ciliata extract, 0.9% Xanthan gum, 0.3% Carrageenan, 15.5% Glycerin, 1.5% Polyethylene glycol 1500, 28.0% Sorbitol, 5.0% Xylitol, 15.0% Silicon dioxide 113, 1.5% Sodium lauryl sulfate, 0.2% Titanium dioxide, 28.4% Purified water.

[0082] The preparation steps of Comparative Example 1 are as follows:

[0083] Step 1, dispersing xanthan gum and carrageenan in glycerin, stirring to make the dispersion uniform, to obtain colloid A;

[0084] Step 2, dissolving polyethylene glycol 1500, sorbitol and xylitol in purified water, and stirring until the solution is completely clear to obtain solution B;

[0085] Step 3, adding solution B to colloid A, stirring and mixing, and fully swelling at 45-50° C. to obtain gel C;

[0086] Step 4, silicon dioxide 113, sodium dodecyl sulfate, titanium dioxide, Saussurea membranacea extract, Meconopsis pilosula extract, Psoralea corylifolia extract, Psoralea corylifolia extract, Oxytropis microphylla extract, and Elsholtzia scoparia extract are mixed and added into gel C and stirred until no dry powder is visible on the surface of the colloid;

[0087] Step 5, turn on vacuum, dispersion and stirring, set the vacuum degree to -0.9MPa, the dispersion frequency to 10Hz, the stirring speed to 300rpm, stir until the paste is fine and uniform, add flavor and mix well.

[0088] Comparative Example 2

[0089] In order to further illustrate the beneficial effects of the present invention, a toothpaste containing only the effective ingredient hydrogen peroxide (35%) is provided, which comprises, by mass percentage:

[0090] Hydrogen peroxide (35%) 3.0%, Patchouli extract 0.6%, xanthan gum 0.9%, carrageenan 0.3%, glycerin 15.5%, polyethylene glycol 1500 1.5%, sorbitol 28.0%, xylitol 5.0%, silicon dioxide 113 15.0%, sodium lauryl sulfate 1.5%, titanium dioxide 0.2%, citric acid 0.3%, EDTA-2Na 0.2%, purified water 28.5%.

[0091] The preparation steps of Comparative Example 2 are as follows:

[0092] Step 1, dispersing xanthan gum and carrageenan in glycerin, stirring to make the dispersion uniform, to obtain colloid A;

[0093] Step 2, dissolving polyethylene glycol 1500, sorbitol, xylitol, hydrogen peroxide (35%), citric acid, and EDTA-2Na in purified water, and stirring until the solution is completely clear to obtain solution B;

[0094] Step 3, adding solution B to colloid A, stirring and mixing, and fully swelling at 45-50° C. to obtain gel C;

[0095] Step 4, mixing silicon dioxide 113, sodium dodecyl sulfate, titanium dioxide, and Elsholtzia ciliata extract, adding the mixture to gel C and stirring until no dry powder is visible on the surface of the gel;

[0096] Step 5, turn on vacuum, dispersion and stirring, set the vacuum degree to -0.9MPa, the dispersion frequency to 10Hz, the stirring speed to 300rpm, stir until the paste is fine and uniform, add flavor and mix well.

[0097] Comparative Example 3

[0098] In order to further illustrate the beneficial effects of the present invention, a commercially available toothpaste with hemostatic effect and containing tranexamic acid as a main effective ingredient is provided as Comparative Example 3.

[0099] Comparative Example 4

[0100] In order to further illustrate the beneficial effects of the present invention, a commercially available toothpaste with clove oil and borax as main effective ingredients and the efficacy of relieving gingivitis and periodontitis is provided as Comparative Example 4.

[0101] The safety and effectiveness of the plateau hemostatic toothpaste composition prepared by the present invention and commercially available toothpaste are compared and analyzed through product stability evaluation, oral mucosal irritation experiment, animal effectiveness evaluation experiment and human effectiveness evaluation.

[0102] The combination of different toothpastes and catalysts of the present invention is shown in Table 1:

[0103]

[0104] Experiment 1: Stability evaluation of hemostatic toothpaste

[0105] 1) Test samples: Examples 1 to 3 of the present invention.

[0106] 2) Experimental method: Fifteen samples were randomly selected from each example and placed in a 55°C oven. Five samples were taken after 1 week, 2 weeks, and 4 weeks, and another five freshly prepared samples were taken to detect the amount of hydrogen peroxide reduced and calculate the residual ratio (%) of hydrogen peroxide in the paste.

[0107] Accurately weigh 2.0 g of sample and dissolve it in 50 ml of 0.25 mol / L sulfuric acid solution. Add 10 ml of isopropanol, shake well, and then use 0.1 mol / L Ce(SO 4 )·2(NH 4 ) 2 SO 4 The solution is titrated until it turns light yellow, and the amount of hydrogen peroxide reduced is calculated. 4 )·2(NH 4 ) 2 SO 4 The solution is equal to 1.701 mg of hydrogen peroxide.

[0108] 3) Experimental results: as shown in Table 2.

[0109]

[0110] As can be seen from Table 2, the hemostatic toothpastes prepared in Examples 1 to 3 all have good stability.

[0111] Experiment 2: Evaluation of oxygen release capacity of different combinations

[0112] 1) Test samples: Combinations 1 to 7 of the present invention.

[0113] 2) Experimental methods

[0114] a. Through preliminary experiments, the optimal amount of catalyst added in the sample of 2.0g of the embodiment was found;

[0115] b. Prepare 7 clean test tubes, numbered 1 to 7. Accurately weigh 2.0 g of the sample of the example in each test tube and dissolve it in 50 ml of purified water, and then plug it with a special stopper;

[0116] c. Use an oxygen detector to detect the initial oxygen content in the tube;

[0117] d. According to the preliminary experimental results, add appropriate amounts of triethanolamine solution, sodium bicarbonate solution and catalase to test tubes 1 to 7 respectively, and quickly plug the stoppers;

[0118] e. After 30 seconds and 1 minute of reaction, use the oxygen detector to detect the oxygen content in the tube again, and evaluate the oxygen release capacity of different combinations by comparing the difference between the two tests and the initial test.

[0119] 3) Experimental results

[0120]

[0121] It can be seen from Table 3 that under the same conditions, the oxygen-releasing capacity of hydrogen peroxide is greater than that of sodium peroxide; among the three different catalysts, catalase has the best catalytic effect, and sodium bicarbonate has the worst catalytic effect.

[0122] Experiment 3: Oral mucosal irritation test

[0123] 1) Test samples: combinations 1 to 7 of the present invention and comparative combinations 1 to 4.

[0124] 2) Experimental animals: golden hamsters.

[0125] 3) Experimental method: Refer to the method specified in GB / T 16886.10 Biological evaluation of medical devices Part 10: Irritation and skin sensitization test for testing. Three golden hamsters were selected for each group. The sample was soaked in a sterile cotton ball and acutely contacted with one cheek pouch of the golden hamster. The other cheek pouch was contacted with a sterile cotton ball soaked in 0.9% sodium chloride injection. The contact time was 10 minutes. After contact, the sample and control were removed. The above steps were repeated once every hour for a total of 4 hours. The hamsters were painlessly killed 24 hours after the last contact. The golden hamsters were observed with the naked eye for abnormal changes in both cheek pouches, and the scores were recorded.

[0126] The cheek pouch mucosal tissue of the test contact site was fixed in 10% formalin, embedded in paraffin, sliced, stained with HE, and examined under a microscope. The tissue reaction score of each animal was calculated according to the tissue reaction scoring system, and then the irritation index grade was obtained.

[0127] 4) Test results

[0128] The oral mucosal irritation index and of the test samples are shown in Table 4.

[0129]

[0130] As can be seen from Table 4, the oral mucosal irritation of the above combinations is good, among which the oral mucosal irritation index of combination 1, combination 5 and comparison combination 2 is extremely light, and the oral mucosal irritation index of other combinations is none.

[0131] Experiment 4: Animal effectiveness evaluation

[0132] 1) Test samples: combinations 1 to 7 of the present invention and comparative combinations 1 to 4.

[0133] 2) Experimental animals: Sprague-Dawley rats.

[0134] 3) Experimental methods

[0135] a. Take 144 clean-grade Sprague-Dawley rats weighing (200±10) g, half male and half female, and place them in separate cages for 3 days of adaptive feeding.

[0136] b. The rats were randomly divided into 24 groups, with 6 rats in each group. They were normoxic control group (H), hypoxic control group (N), normoxic periodontitis groups 1-11 (H1-H11), and hypoxic periodontitis groups 1-11 (N1-N11). The periodontitis model of the rats was established according to the method of Fischer et al., that is, the rats were anesthetized by intraperitoneal injection of 30g / L sodium pentobarbital, and the cervical part of the right maxillary first molar was ligated with an orthodontic 0.20 ligature. Every other day, 1.25mg / kg prednisolone acetate solution was injected into the quadriceps of the rats, once a day, for 3 consecutive days. On the 5th day of the experiment, a mixed bacterial solution of Porphyromonas gingivalis, Prevotella intermedia and Fusobacterium nucleatum (2:1:1) was inoculated orally, 0.1ml per rat, and the inoculation was continued for 3 consecutive days. After anesthesia on the 15th day, the rats were re-examined to ensure that the ligature entered the periodontal pocket as much as possible. During the 8-week modeling period, the rats in the normoxic group were housed in a conventional laboratory (400 m above sea level), and the rats in the hypoxia group were kept in a hypobaric chamber (simulating an altitude of 5000 m) for 23 h per day.

[0137] c. After 8 weeks of modeling, the ligature of the tooth neck was removed, and the rats in the control group used cotton swabs dipped in appropriate amount of physiological saline to wipe the periodontal pockets or gingival sulci of the experimental teeth, and the rats in the experimental group used cotton swabs dipped in appropriate amount of experimental samples to wipe the periodontal pockets or gingival sulci of the experimental teeth; 3 times / day. The feeding method was the same as that of modeling.

[0138] d. After 1, 3, and 7 days of administration, the periodontal pockets or gingival sulci of the experimental teeth were gently probed for 10 seconds with a periodontal probe, and the scores were calculated according to the 4-degree scoring standard of Loe and Sillness. The depth of the periodontal pockets or gingival sulci at the mesio-buccal, buccal, and distal buccal sites of the experimental teeth was measured with a fine-scale periodontal probe, and the average value was taken.

[0139] 4) Experimental results

[0140] a. The probing bleeding index is shown in Table 5. H1 to H7 correspond to combinations 1 to 7, H8 to H11 correspond to comparison combinations 1 to 4, N1 to N7 correspond to combinations 1 to 7, and N8 to N11 correspond to comparison combinations 1 to 4.

[0141]

[0142] As can be seen from Table 5, after 1d, 3d and 7d of administration, the probing bleeding index of rats in each administration group was reduced. Under normoxic conditions, the probing bleeding index of rats in groups H1, H2, H3, H4 and H10 was relatively good; under hypoxic conditions, the probing bleeding index of rats in groups N1 to N7 was relatively good, among which the probing bleeding index of group N3 was the best controlled. This indicates that the hemostatic toothpaste provided by the present invention has a significant therapeutic effect on gingival bleeding in plateau or hypoxic environments, that is, under hypoxic conditions, the gingival bleeding symptoms of rats in the combination group of the present invention were significantly alleviated, and the relief effect was significantly better than that of the control combination group; under normoxic conditions, there was no significant difference in the therapeutic effect of the combination group of the present invention on gingival bleeding compared with the control combination 3.

[0143] b. The results of the probe depth test are shown in Table 6.

[0144]

[0145] As can be seen from Table 6, after 1d, 3d and 7d of administration, the probe depth of rats in each administration group decreased. Under normoxic conditions, the probe depth of rats in groups H1 to H8 and H11 decreased relatively significantly, indicating that the degree of gingival inflammation and swelling in rats was significantly reduced, and there was no significant difference in the anti-inflammatory effect between the combination of the present invention and the comparative combination 1 and the comparative combination 4; under hypoxic conditions, the probe depth of rats in groups N1 to N7 decreased significantly, among which the probe depth of group N4 decreased most significantly, while the probe depth of rats in the comparative combination decreased significantly less than that of the combination group of the present invention. That is to say, the hemostatic toothpaste provided by the present invention has a significantly better anti-inflammatory effect on plateau or hypoxic environments than the comparative combination group. The reason may be that the present invention can quickly release oxygen at the site of gingival bleeding or inflammation on the basis of adding hemostatic and anti-inflammatory ingredients, so that its hemostatic or anti-inflammatory effect under hypoxic conditions is significantly different from that of the comparative combination.

[0146] Experiment 5: Human effectiveness evaluation

[0147] 1) Experimental methods

[0148] 240 patients with high-altitude polycythemia were selected and randomly divided into 12 groups, namely the control group (N) and N1-N11 groups. Among them, the patients in the control group brushed their teeth with ordinary toothpaste, and the patients in the N1-N11 groups brushed their teeth with combinations 1-7 and control combinations 1-4, respectively. Twice a day, after continuous use for 1 month, the effect of use was determined by observing the patient's gums. The judgment criteria are: Cured: The gums appear normal or slightly red, and there is no bleeding when the gingival sulcus is probed with a blunt round probe. Effective: The gums appear purple-red, and there is no obvious bleeding when the gingival sulcus is probed with a blunt round probe. Invalid: The gums appear purple-red, and there is obvious bleeding when the gingival sulcus is probed with a blunt round probe.

[0149] The recurrence rate of gingival bleeding in patients was followed up by telephone 3 to 6 months after discontinuation of use.

[0150] 2) Experimental results

[0151]

[0152] As shown in Tables 7 and 8, the hemostatic toothpaste of the present invention, which uses plateau plant extracts in combination with oxygen supply substances, has a high therapeutic effect on gingival bleeding caused by plateau polycythemia, and the recurrence rate is relatively low. Although the toothpaste containing tranexamic acid sold on the market also has a high therapeutic effect, the recurrence rate is relatively high.

[0153] In summary, it can be seen that the hemostatic toothpaste with hydrogen peroxide as the oxygen-releasing component has a better oxygen-releasing capacity than sodium peroxide; compared with the three catalysts, the catalytic efficiency and safety of catalase are significantly better than triethanolamine solution and sodium bicarbonate solution, but catalase is easily inactivated and has relatively high requirements for temperature and humidity. Considering the convenience of use, cost, safety and effectiveness of each combination method, the present invention preferably uses hydrogen peroxide in combination with triethanolamine solution.

[0154] The above content is only for explaining the technical idea of ​​the present invention, and cannot be used to limit the protection scope of the present invention. Any changes made on the basis of the technical solution in accordance with the technical idea proposed by the present invention shall fall within the protection scope of the claims of the present invention.

Claims

1. A toothpaste composition, characterized in that It is composed of toothpaste and catalyst; The components of the toothpaste include hemostatic active ingredients, peroxide, auxiliary materials and water; the hemostatic active ingredients include Saussurea calyx extract, Meconopsis koelreuteria extract, Psoralea corylifolia extract, Psoralea corylifolia extract, Oxytropis microphylla extract and Elsholtzia oleifera extract; the auxiliary materials include xanthan gum, carrageenan, glycerin, polyethylene glycol, sorbitol, xylitol, sodium lauryl sulfate, titanium dioxide, silicon dioxide, citric acid and EDTA-2Na; the peroxide is hydrogen peroxide; The catalyst is triethanolamine solution, sodium bicarbonate solution or catalase; When the toothpaste composition is used, the triethanolamine solution or the sodium bicarbonate solution is sprayed on the toothbrush head, the toothpaste is squeezed on the toothbrush head, and the toothbrush head is used for brushing teeth; Alternatively, dip the toothbrush head in catalase, squeeze toothpaste onto the toothbrush head, and use the toothbrush head to brush your teeth.

2. The toothpaste composition according to claim 1, characterized in that The components of the toothpaste include, by mass percentage, 0.1% to 10.0% of Saussurea calyx extract, 0.1% to 10.0% of Meconopsis pilosa extract, 0.01% to 1.0% of Pleurotus eryngii extract, 0.01% to 1.0% of Pleurotus eryngii extract, 0.1% to 3.0% of Oxytropis microphylla extract, 1.0% to 15.0% of hydrogen peroxide, 0.1% to 10.0% of Elsholtzia ciliata extract, 0.1% to 1.5% of xanthan gum, and 0.1% to 1.0% of Carrageenan gum. Gum 0.1% ~ 1.5%, glycerin 1.0% ~ 25.0%, polyethylene glycol 1.0% ~ 15.0%, sorbitol 3.0% ~ 50.0%, xylitol 1.0% ~ 10.0%, silicon dioxide 1.0% ~ 20.0%, sodium lauryl sulfate 0.5% ~ 5.0%, titanium dioxide 0.1% ~ 1.0%, citric acid 0.1% ~ 5.0%, EDTA-2Na 0.1% ~ 2.0% and water 10% ~ 45.0%.

3. The method for preparing the toothpaste composition according to claim 2, characterized in that: The preparation method of toothpaste comprises the following steps: Step 1, dispersing xanthan gum and carrageenan in glycerin, stirring to make the dispersion uniform, to obtain colloid A; Step 2, dissolving polyethylene glycol, sorbitol, xylitol, citric acid, hydrogen peroxide, and EDTA-2Na in water, and stirring until the solution is completely clear to obtain solution B; Step 3, adding solution B to colloid A, stirring and mixing, and fully swelling at 45-50° C. to obtain gel C; Step 4, silicon dioxide, sodium dodecyl sulfate, titanium dioxide, Saussurea membranacea extract, Meconopsis pilosula extract, Psoralea corylifolia extract, Psoralea corylifolia extract, Oxytropis microphylla extract, and Elsholtzia scoparia extract are mixed and added into gel C, and stirred.

4. A toothpaste composition, characterized in that It is composed of toothpaste and catalyst; The components of the toothpaste include hemostatic active ingredients, peroxide, excipients and water; the hemostatic active ingredients include Saussurea calyx extract, Meconopsis pilosa extract, Psoralea corylifolia extract, Psoralea corylifolia extract, Oxytropis microphylla extract and Elsholtzia oleifera extract; the excipients include carbomer, glycerin, polyethylene glycol, xylitol, sodium lauryl sulfate, titanium dioxide, silicon dioxide, sodium hydroxide and EDTA-2Na; The peroxide is sodium peroxide; The catalyst is triethanolamine solution, sodium bicarbonate solution or catalase; When the toothpaste composition is used, the triethanolamine solution or the sodium bicarbonate solution is sprayed on the toothbrush head, the toothpaste is squeezed on the toothbrush head, and the toothbrush head is used for brushing teeth; Alternatively, dip the toothbrush head in catalase, squeeze toothpaste onto the toothbrush head, and use the toothbrush head to brush your teeth.

5. The toothpaste composition according to claim 4, characterized in that The components of the toothpaste include, by mass percentage, 0.1% to 10.0% of Saussurea ensiformis extract, 0.1% to 10.0% of Meconopsis pilosa extract, 0.01% to 1.0% of Pleurotus eryngii extract, 0.01% to 1.0% of Pleurotus eryngii extract, 0.1% to 3.0% of Oxytropis microphylla extract, 1.0% to 15.0% of Sodium peroxide, 0.1% to 10.0% of Elsholtzia ciliata extract, 0.01% to 2.0% of Carbomer, 1.0% to 25.0% of Glycerin, 1.0% to 15.0% of Polyethylene Glycol, 1.0% to 10.0% of Xylitol, 1.0% to 20.0% of Silicon Dioxide, 0.5% to 5.0% of Sodium Lauryl Sulfate, 0.1% to 1.0% of Titanium Dioxide, 0.1% to 5.0% of Sodium Hydroxide, and 0.1% to 2.0% of EDTA-2Na.

6. The method for preparing the toothpaste composition according to claim 5, characterized in that: The preparation method of toothpaste comprises the following steps: Step 1, dispersing carbomer in glycerol and polyethylene glycol, stirring to make the dispersion uniform, to obtain colloid A; Step 2, adding sodium hydroxide to colloid A, stirring and swelling the mixture to obtain colloid B; Step 3, mix the Saussurea membranacea extract, Meconopsis koelreuteriae extract, Psoralea corylifolia extract, Psoralea corylifolia extract, Oxytropis microphylla extract, Elsholtzia scoparia extract, sodium peroxide, xylitol, silicon dioxide, sodium dodecyl sulfate, titanium dioxide, and EDTA-2Na, add to gel B, and stir.

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