Whitening and anti-allergy tooth paste with good stability

Abstract

The invention relates to a whitening anti-allergy tooth paste with good stability, the whitening anti-allergy tooth paste is composed of a film viscous adhesion layer, a high-viscosity gel layer and a hard film backing layer, and the high-viscosity gel layer is prepared by the following preparation method: dissolving glycerol, polyvinylpyrrolidone, hydrogen peroxide, ethyl cellulose and sodium polyacrylate in ethanol; a first gel agent with the viscosity of CP1 is prepared through heating or vacuum emulsification, and the content of hydrogen peroxide is 2%-10%; glycerin, polyvinylpyrrolidone, sylvite, ethyl cellulose and sodium polyacrylate are dissolved in pure water, a second gel with the viscosity of CP2 is prepared through heating or vacuum emulsification, and the content of the sylvite is 0.5%-5%; cooling the first gel and the second gel to normal temperature, putting the first gel and the second gel into a constant-temperature stirring device according to a ratio of 2: 1, and stirring and mixing at a low speed at a constant temperature to obtain mixed gel with the viscosity of CP3; and uniformly coating the mixed gel on the film viscous adhesion layer, and drying to obtain the high-viscosity gel layer.

Description

Technical Field

[0001] The invention relates to the field of oral products, and in particular to a whitening and anti-sensitivity tooth paste with good stability. Background Art

[0002] White and beautiful teeth have always been a fashion that people pursue. Discolored teeth are very common in clinical practice, which has many adverse effects on the patient's face, psychology and life. The use of peroxides (hydrogen peroxide, carbamide peroxide, etc.) for teeth whitening has high safety and has been widely recognized. The whitening teeth patch made by applying gel containing peroxide on the patch is easy to carry, simple and practical, and is loved by consumers.

[0003] However, according to the teeth whitening report released by the American Dental Association (ADA), hydrogen peroxide and carbamide peroxide may cause a certain degree of irritation to the dental pulp and gums, which makes it difficult for people with tooth sensitivity to use tooth strips for a long time. At the same time, since tooth sensitivity symptoms are also relatively common, the use of tooth strips for whitening can also prevent and reduce tooth sensitivity, which has become a market demand and expectation.

[0004] In this regard, since potassium salt and strontium salt can be used as desensitizing agents in toothpaste (publication number CN1528260A), some people assume that in theory, potassium salt and / or strontium salt can be added to the formula of tooth paste products to directly produce tooth pastes with both whitening and anti-allergic effects. But in fact, there are many problems with this direct addition. Among them, the more prominent problem is that the stability of tooth paste products is poor, and the produced tooth pastes often have the problem of potassium salt and / or strontium salt precipitation, and cannot be stored for a long time at room temperature, which does not meet the requirements of mass production and product shelf life. Summary of the invention

[0005] The present invention aims to provide a whitening and anti-sensitivity tooth paste with good stability. By selecting the whitening components and anti-sensitivity components and the quantitative selection, selecting the thickener, and adopting a specific production method, a whitening and anti-sensitivity tooth paste with good stability is obtained. The whitening and anti-sensitivity effects can be stably exerted, and the high-viscosity gel layer can maintain stable teeth whitening and anti-sensitivity active substances without precipitation for more than six months at room temperature not higher than 40°C.

[0006] The technical solution adopted by the present invention is: to provide a whitening and anti-sensitivity tooth paste with good stability, which is composed of a thin film adhesive attachment layer, a high viscosity gel layer, and a hard film backing layer, and the high viscosity gel layer is obtained by the following preparation method:

[0007] (a) preparing a first gelling agent: dissolving glycerol, polyvinyl pyrrolidone, hydrogen peroxide, ethyl cellulose and sodium polyacrylate in ethanol, and preparing a first gelling agent with a viscosity of CP1 by heating or vacuum emulsification, wherein the content of hydrogen peroxide in the first gelling agent is 2% to 10%;

[0008] (b) preparing a second gelling agent: dissolving glycerol, polyvinyl pyrrolidone, potassium salt, ethyl cellulose and sodium polyacrylate in pure water, and preparing a second gelling agent with a viscosity of CP2 by heating or vacuum emulsification, wherein the content of potassium salt in the second gelling agent is 0.5% to 5%;

[0009] (c) after cooling the first gelling agent and the second gelling agent to room temperature, placing them in a constant temperature stirring device in a ratio of 2:1, stirring and mixing at a constant temperature and low speed to obtain a mixed gel with a viscosity of CP3;

[0010] (d) uniformly coating the mixed gel on the thin film adhesive layer and drying it to obtain the high viscosity gel layer.

[0011] Furthermore, the CP3>CP1>CP2.

[0012] Furthermore, the temperature of the constant temperature and low speed stirring is set to a constant value between 45°C and 65°C.

[0013] Preferably, when preparing the first gel, fluoride, such as sodium fluoride, sodium monofluorophosphate, olaflurane, etc., is added.

[0014] Furthermore, the potassium salt is one or more of potassium nitrate, dipotassium glycyrrhizinate, potassium citrate and the like.

[0015] Optionally, when preparing the first gel or the second gel, one or more sweeteners selected from the group consisting of xylitol, stevioside and menthol are added.

[0016] Optionally, flavor is added when preparing the first gel and / or the second gel.

[0017] Preferably, papain and / or polyglucosidase are added during the step of constant temperature and low stirring.

[0018] Furthermore, in the finally formed high-viscosity gel layer, the total content of hydrogen peroxide is not less than 2%, and the total content of potassium salt is not less than 0.5%.

[0019] Furthermore, the high-viscosity gel layer finally formed can keep the teeth whitening and anti-allergic active substances stable without precipitation for more than six months under the condition of not more than 40°C.

[0020] The above technical solution adopted by the present invention fully considers solving the following problems:

[0021] 1. Through experimental verification, under the condition of a specific ratio (the ratio of the two contents is about 2:1), the stability of the mixture of hydrogen peroxide and potassium salt is better than that of other ratios, and the precipitation is less. However, the best solution is to prepare a first gel with whitening effect and a second gel with anti-allergic effect separately. After each of them forms a stable gel state, the two gels are placed in a constant temperature stirring device, stirred and mixed at a constant temperature and low speed (maintaining a constant temperature and low speed can further prevent precipitation) to obtain a water-free and super-viscous mixed gel.

[0022] 2. Sodium polyacrylate is selected as a stabilizer and thickener, not only because it usually increases the adhesion of the coating, maintains the moisture of the gel, and prevents the whitening agent from drying, but also effectively increases the stability of the desensitizing agent potassium nitrate. The experimental results show that when the mass fraction of sodium polyacrylate added is not less than 0.5%, it can improve the phase stability of potassium nitrate and at the same time produce a coating effect on the polymer, further improving the stability.

[0023] 3. The content of hydrogen peroxide in the first gel is 2% to 10%, the content of potassium salt in the second gel is 0.5% to 5%, and the two are added in a ratio of 2:1 and stirred at a constant temperature to obtain a tooth paste product with good whitening and anti-sensitivity effects.

[0024] 4. The viscosity value of each gel was monitored, and it was found that when CP3>CP1>CP2, the production efficiency and product quality and stability were better.

[0025] 5. Add papain to the formula, and the protein in the food residues will be hydrolyzed and broken by the protease, so that the tiny food residues attached to the tooth surface become soft and easy to remove. Papain can also relieve redness, swelling and bleeding of gums. And dextranase can catalyze the degradation of the substrate dextran, which plays a role in resisting plaque accumulation and preventing tooth decay. Therefore, people have explored adding these two substances to tooth pastes, but the effective temperature of these two substances cannot exceed 65°C. If the temperature exceeds this, they are likely to lose their activity. Therefore, this patent adds them in the constant temperature and low-speed stirring link to ensure their effectiveness.

[0026] In summary, compared with the prior art, the technical solution of the present invention provides a whitening and anti-sensitivity tooth paste with good stability, in which the effects of both whitening and anti-sensitivity substances are effectively exerted, and the stability and safety are stronger, and it is suitable for wide application in this field. DETAILED DESCRIPTION

[0027] The present invention is further described below with reference to the embodiments.

[0028] Embodiment 1:

[0029] The whitening and anti-sensitivity tooth paste with good stability described in the present invention is composed of a thin film adhesive attachment layer (cut into a property suitable for being attached to teeth, using a food-grade PE film), a high-viscosity gel layer, and a hard film backing layer (using polyester plastic), wherein the high-viscosity gel layer is obtained by the following preparation method:

[0030] (a) preparing a first gel: dissolving glycerol, polyvinyl pyrrolidone, hydrogen peroxide, ethyl cellulose and sodium polyacrylate in ethanol, adding a small amount of xylitol, stevioside, menthol and essence, and heating to 100° C. to 130° C. to obtain a first gel with a viscosity of CP1, wherein the content of hydrogen peroxide in the first gel is 2%;

[0031] (b) preparing a second gelling agent: dissolving glycerol, polyvinyl pyrrolidone, potassium nitrate, ethyl cellulose and sodium polyacrylate (the content of the components is not less than 0.5%) in pure water, and preparing a second gelling agent with a viscosity of CP2 by vacuum emulsification, wherein the content of potassium nitrate in the second gelling agent is 0.5%;

[0032] (c) cooling the first gel and the second gel to room temperature, placing them in a constant temperature stirring device in a ratio of 2:1, adding papain and polyglucosidase, and stirring and mixing at a constant temperature of 45° C. at a low speed to obtain a mixed gel with a viscosity of CP3;

[0033] (d) uniformly coating the mixed gel on the thin film adhesive layer and drying it to obtain the high viscosity gel layer.

[0034] Embodiment 2:

[0035] The whitening and anti-sensitivity tooth paste with good stability described in the present invention is composed of a thin film adhesive attachment layer (cut into a property suitable for being attached to teeth, and a food-grade PE film is selected), a high-viscosity gel layer, and a hard film backing layer (polyester plastic is selected, and a release agent can be pre-coated on the contact surface), and the high-viscosity gel layer is obtained by the following preparation method:

[0036] (a) preparing a first gel: dissolving glycerol, polyvinyl pyrrolidone, hydrogen peroxide, ethyl cellulose and sodium polyacrylate in ethanol, adding a small amount of xylitol, stevioside, menthol and essence, and emulsifying by heating or vacuum to obtain a first gel with a viscosity of CP1, wherein the content of hydrogen peroxide in the first gel is 10%;

[0037] (b) preparing a second gelling agent: dissolving glycerol, polyvinyl pyrrolidone, potassium salt (one or more of potassium salts such as potassium nitrate, dipotassium glycyrrhizinate, potassium citrate, etc.), ethyl cellulose, sodium polyacrylate (the content of the component is not less than 1%) in pure water, and preparing a second gelling agent with a viscosity of CP2 by heating or vacuum emulsification, wherein the content of potassium salt in the second gelling agent (calculated as potassium) is 5%;

[0038] (c) cooling the first gel and the second gel to room temperature, placing them in a constant temperature stirring device in a ratio of 2:1, adding papain, and stirring and mixing at a constant temperature of 65° C. at a low speed to obtain a mixed gel with a viscosity of CP3;

[0039] (d) uniformly coating the mixed gel on the thin film adhesive layer and drying it to obtain the high viscosity gel layer.

[0040] In the above embodiment, CP3>CP1>CP2, the total content of hydrogen peroxide in the finally formed high-viscosity gel layer is not less than 2%, and the total content of potassium salt (calculated as potassium) is not less than 0.5%, and the tooth whitening and anti-allergic active substances can remain stable without precipitation for more than six months under conditions not higher than 40°C.

[0041] Embodiment three:

[0042] The whitening and anti-sensitivity tooth paste with good stability described in the present invention is composed of a thin film adhesive attachment layer (cut into a property suitable for being attached to teeth, using a food-grade PE film), a high-viscosity gel layer, and a hard film backing layer (using polyester plastic), wherein the high-viscosity gel layer is obtained by the following preparation method:

[0043] (a) preparing a first gel: dissolving glycerol, polyvinyl pyrrolidone, hydrogen peroxide, ethyl cellulose and sodium polyacrylate in ethanol, adding a small amount of xylitol, stevioside, menthol and essence, and heating to 100° C. to 130° C. to obtain a first gel with a viscosity of CP1, wherein the content of hydrogen peroxide in the first gel is 3%;

[0044] (b) preparing a second gelling agent: dissolving glycerol, polyvinyl pyrrolidone, potassium nitrate, ethyl cellulose and sodium polyacrylate in pure water, and preparing a second gelling agent with a viscosity of CP2 by vacuum emulsification, wherein the content of potassium nitrate in the second gelling agent is 1.5%;

[0045] (c) cooling the first gel and the second gel to room temperature, placing them in a constant temperature stirring device in a ratio of 2:1, adding papain and polyglucosidase, and stirring and mixing at a constant temperature of 45° C. at a low speed to obtain a mixed gel with a viscosity of CP3;

[0046] (d) uniformly coating the mixed gel on the thin film adhesive layer and drying it to obtain the high viscosity gel layer.

[0047] Clinical trial example:

[0048] The whitening and anti-sensitivity tooth paste prepared in Example 3 above was applied to clinical trials according to the following test method:

[0049] The test randomly selected 96 eligible subjects, including 25 males and 71 females. A randomized, double-blind controlled study was conducted, and the subjects were divided into two groups, namely the experimental group and the control group, using a random number table method. The experimental group used the whitening and anti-sensitivity tooth paste prepared in Example 3, and the control group used a commercially available whitening tooth paste without potassium nitrate. The test time points of the subjects were 1 week and 3 weeks after use, and the gradual effect of the changes in the color and sensitivity of teeth 13-23 was observed. The whitening efficacy evaluation was carried out by visual evaluation of colorimetric cards and quantitative evaluation by spectrophotometer, and the anti-sensitivity efficacy evaluation was carried out by cold air blowing sensitivity evaluation. The inclusion and exclusion criteria of the subjects in this test, as well as the cold air blowing sensitivity evaluation, colorimetric card visual evaluation, and spectrophotometer quantitative evaluation were respectively referred to WS / T 326.4 "Toothpaste Efficacy Evaluation Part 4: Anti-Dentin Sensitivity" and T / COCIA13-2021 "Clinical Evaluation Methods for Efficacy Evaluation of Toothpaste for Oral Cleaning and Care Products Bleaching and Optical Whitening Effects".

[0050] The clinical trial results and conclusions are as follows:

[0051] (1) After the subjects used the test sample tooth paste for 1 week and 3 weeks, the dental whiteness index (ΔWID value) and 29 color scale values ​​of the test teeth 13-23 of the test group were statistically significant compared with the baseline data. Compared with the baseline, the ΔWID value of the test group tooth paste increased by 3 and 6 after 1 week and 3 weeks, and the 29 color scale value decreased by 1 and 2, respectively, indicating that the tooth paste has a certain degree of teeth whitening effect;

[0052] (2) After the subjects used the test sample tooth paste for 1 week and 3 weeks, the comparison between the test group and the control group showed that the differences in the ΔWID values ​​and 29 color scale values ​​of the test teeth 13-23 between the two groups were not statistically significant at each time point, indicating that the effect of the test group tooth paste on teeth whitening was not significantly different from that of the control group tooth paste;

[0053] (3) After the subjects used the test sample tooth paste for 1 week and 3 weeks, the Schiff cold air sensitivity index of the test teeth 13-23 in the test group did not change significantly compared with the baseline, and the difference was not statistically significant, indicating that the tooth paste did not cause obvious symptoms of dentin sensitivity during the continuous use of 3 weeks and was not likely to cause dentin sensitivity;

[0054] (4) After the subjects used the test sample tooth stickers for 1 week and 3 weeks, the Schiff cold air sensitivity index of the test teeth 13-23 between the test group and the control group showed significant differences, indicating that the test group tooth stickers can reduce the risk of dentin hypersensitivity to a certain extent and are less likely to cause dentin hypersensitivity;

[0055] (5) In this clinical trial, no adverse reactions were observed after using the whitening and anti-sensitivity tooth patch of the present invention.

[0056] The above contents are further detailed descriptions of the present invention in combination with specific embodiments, and it cannot be determined that the specific implementation of the present invention is limited to these descriptions. For ordinary technicians in the technical field to which the present invention belongs, several simple deductions or substitutions can be made without departing from the concept of the present invention, which should be regarded as falling within the protection scope of the present invention.

Claims

1. A whitening and anti-sensitivity tooth paste with good stability, consisting of a thin film adhesive attachment layer, a high viscosity gel layer, and a hard film backing layer, characterized in that: The high viscosity gel layer is obtained by the following preparation method: (a) preparing a first gelling agent: dissolving glycerol, polyvinyl pyrrolidone, hydrogen peroxide, ethyl cellulose and sodium polyacrylate in ethanol, and preparing a first gelling agent with a viscosity of CP1 by heating or vacuum emulsification, wherein the content of hydrogen peroxide in the first gelling agent is 2% to 10%; (b) preparing a second gelling agent: dissolving glycerol, polyvinyl pyrrolidone, potassium salt, ethyl cellulose and sodium polyacrylate in pure water, and preparing a second gelling agent with a viscosity of CP2 by heating or vacuum emulsification, wherein the content of potassium salt in the second gelling agent is 0.5% to 5%; (c) after cooling the first gelling agent and the second gelling agent to room temperature, placing them in a constant temperature stirring device in a ratio of 2:1, stirring and mixing at a constant temperature and low speed to obtain a mixed gel with a viscosity of CP3; (d) uniformly coating the mixed gel on the thin film adhesive layer and drying it to obtain the high viscosity gel layer.

2. The whitening and anti-sensitivity tooth paste according to claim 1, characterized in that: The CP3>CP1>CP2.

3. The whitening and anti-sensitivity tooth paste according to claim 1, characterized in that: The temperature of the constant temperature and low speed stirring is set to a constant value between 45°C and 65°C.

4. The whitening and anti-sensitivity tooth paste according to claim 1, characterized in that: When preparing the first gel, fluoride is added.

5. The whitening and anti-sensitivity tooth paste according to claim 1, characterized in that: The potassium salt is one or more of potassium nitrate, dipotassium glycyrrhizinate and potassium citrate.

6. The whitening and anti-sensitivity tooth paste according to claim 1, characterized in that: When preparing the first gel or the second gel, one or more sweeteners selected from the group consisting of xylitol, stevioside and menthol are added.

7. The whitening and anti-sensitivity tooth paste according to claim 1, characterized in that: When preparing the first gel and / or the second gel, flavor is added.

8. The whitening and anti-sensitivity tooth paste according to claim 3, characterized in that: During the step of constant temperature and low speed stirring, papain and / or polyglucosidase are added.

9. The whitening and anti-sensitivity tooth paste according to claim 1, characterized in that: In the finally formed high-viscosity gel layer, the total content of hydrogen peroxide is not less than 2%, and the total content of potassium salt is not less than 0.5%.

10. The whitening and anti-sensitivity tooth paste according to claim 8, characterized in that: The high-viscosity gel layer finally formed can keep the teeth whitening and anti-sensitivity active substances stable and without precipitation for more than six months under the condition of no more than 40°C.