Oral cavity debridement gel as well as preparation method and application thereof

Abstract

The invention provides oral cavity debridement gel as well as a preparation method and application thereof. The preparation method of the oral cavity debridement gel comprises the following steps: (1) mixing edetate disodium, a pH regulator and water to prepare an edetate disodium solution; (2) mixing the edetate disodium solution with a dispersing agent to prepare a mixed solution; (3) mixing the mixed solution with a gel excipient to prepare a gel material; and (4) swelling the gel material to prepare the oral cavity debridement gel. According to the oral cavity debridement gel and the preparation method thereof, the preparation process is improved, and the gel excipient is added into the mixed solution containing edetate disodium, so that edetate disodium is relatively uniformly distributed in the process that the gel excipient forms a gel matrix, the distribution uniformity of edetate disodium in the prepared oral cavity debridement gel is improved, and the oral cavity debridement gel can be used for preparing oral cavity debridement gel. Furthermore, the removal effect of the oral cavity debridement gel on a contamination layer is improved, and the risk of damaging dentin is reduced.

Description

Technical Field

[0001] The present application relates to the technical field of oral medical materials, and in particular to an oral debridement gel, a preparation method and application thereof, and a medical device comprising the oral debridement gel. Background Art

[0002] Subgingival scaling, root planing and root canal therapy are the most common and effective methods for treating diseases on the tooth surface and inside the root canal. Subgingival scaling and root planing mainly include flushing and scaling; root canal therapy is mainly achieved through mechanical preparation, chemical disinfection and drug filling. The key to the success of the above treatment methods is to effectively remove plaque and other impurities.

[0003] The main purpose of subgingival scaling and root planing is to remove periodontal plaque and tartar and create a plane that is conducive to the attachment and growth of periodontal tissues. During the scaling process, debris is usually generated to form a smear layer, which is conducive to the hiding of microorganisms, has an adverse effect on the subsequent attachment of cells and the recovery of periodontal tissues, and may even lead to treatment failure. Similarly, a smear layer will be generated during the root canal preparation process and cover the dentinal tubules, which will not only affect the penetration of disinfectants into the dentinal tubules and weaken its bactericidal effect; it will also affect the combination of root canal filling materials and the root canal wall, leading to the failure of root canal treatment. Therefore, the removal of the smear layer is of great significance in root canal treatment.

[0004] At present, debridement gel is usually used to remove the smear layer in clinical practice. However, the removal effect of the smear layer of the root surface and the root canal by the traditional debridement gel is not ideal and still needs to be further improved. Summary of the invention

[0005] Based on this, one or more embodiments of the present application provide an oral debridement gel having a good effect on removing the smear layer, a preparation method and application thereof, and a medical device comprising the oral debridement gel.

[0006] According to the first aspect of the present application, a method for preparing an oral debridement gel is provided, comprising the following steps:

[0007] (1) mixing edetate disodium, a pH adjuster and water to prepare an edetate disodium solution;

[0008] (2) adding a dispersant to the edetate disodium solution to prepare a mixed solution;

[0009] (3) adding a gel excipient to the mixed solution to prepare a gel material;

[0010] (4) Swelling the gel material to obtain the oral debridement gel.

[0011] The preparation method of the oral debridement gel of the present application improves the preparation process by adding a gel excipient to a mixed solution containing disodium edetate, so that the disodium edetate is more evenly distributed during the process of the gel excipient forming a gel matrix, thereby improving the distribution uniformity of the disodium edetate in the prepared oral debridement gel, thereby improving the cleaning effect of the prepared oral debridement gel on the smear layer and reducing the risk of damaging the dentin.

[0012] In some embodiments, step (1) comprises the following steps:

[0013] Mixing the pH adjuster and water to obtain a pH adjusting solution;

[0014] The edetate disodium and the pH adjustment solution are mixed to obtain the edetate disodium solution.

[0015] In some embodiments, the edetate disodium and the pH adjustment solution are mixed under heating conditions;

[0016] Optionally, the heating temperature is above 60°C;

[0017] Further optionally, the heating temperature is 60°C~100°C.

[0018] In some embodiments, the mass content of disodium edetate in the disodium edetate solution is 15% to 30%; and / or,

[0019] The mass content of disodium edetate in the oral debridement gel is 15% to 27%.

[0020] In some embodiments, the dispersant includes one or more of propylene glycol, glycerol, polyethylene glycol, hexadecyl alcohol and water; optionally, the dispersant includes polyethylene glycol; more optionally, the polyethylene glycol is selected from one or more of polyethylene glycol 400, polyethylene glycol 600 and polyethylene glycol 800; and / or,

[0021] The gel excipient includes one or more of sodium carboxymethylcellulose, carbomer, carboxymethylcellulose, hydroxyethylcellulose, hydroxypropylmethylcellulose and silicon dioxide; optionally, the gel excipient includes sodium carboxymethylcellulose; optionally, the molecular weight of the sodium carboxymethylcellulose is 400kDa~1000kDa; and / or,

[0022] The pH adjuster includes one or more of sodium hydroxide, potassium hydroxide and sodium bicarbonate.

[0023] In some embodiments, the amount of edetate disodium is 15 to 30 parts, the amount of the dispersant is 3 to 20 parts, and the amount of the gel excipient is 0.5 to 8 parts by weight;

[0024] Optionally, by weight, the edetate disodium is 17 to 24 parts, the dispersant is 5 to 15 parts, and the gel excipient is 1 to 5 parts;

[0025] Optionally, the dispersant comprises polyethylene glycol and the gel excipient comprises sodium carboxymethylcellulose.

[0026] In some embodiments, the swelling is static swelling, and the swelling time is 18h~24h; and / or,

[0027] The swelling step further includes a vacuum centrifugal treatment step; optionally, the vacuum degree of the vacuum centrifugal treatment is 90KPa~110KPa, the revolution speed is 900rpm~1100rpm, the rotation speed is 750rpm~850rpm, and the time is 5min~15min.

[0028] According to another aspect of the present application, an oral debridement gel is provided, wherein the oral debridement gel is prepared by the above-mentioned preparation method; or,

[0029] The oral debridement gel comprises the following components: disodium edetate, polyethylene glycol and sodium carboxymethyl cellulose; optionally, in the oral debridement gel, the disodium edetate is 15 to 30 parts, the polyethylene glycol is 3 to 20 parts, and the sodium carboxymethyl cellulose is 0.5 to 8 parts by weight; optionally, the molecular weight of the sodium carboxymethyl cellulose is 400 kDa to 1000 kDa; optionally, the polyethylene glycol is selected from one or more of polyethylene glycol 400, polyethylene glycol 600 and polyethylene glycol 800.

[0030] Disodium edetate is compounded with polyethylene glycol and sodium carboxymethyl cellulose in specific mass proportions to prepare an oral debridement gel. Since both polyethylene glycol and sodium carboxymethyl cellulose are polymer materials, they can cooperate and act synergistically with each other to further improve the distribution uniformity of the oral debridement gel in the gel matrix, thereby effectively removing the smear layer on the surface of dentin and softening and demineralizing the dentin.

[0031] According to another aspect of the present application, provided is an oral debridement gel prepared by the above preparation method or use of the above oral debridement gel in preparing a medicine or medical device for treating oral diseases.

[0032] According to another aspect of the present application, a medical device is provided, comprising the oral debridement gel prepared by the above preparation method or the above oral debridement gel. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] In order to more clearly illustrate the specific implementation methods of the present application or the technical solutions in the prior art, the drawings required for use in the specific implementation methods or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some implementation methods of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0034] Figure 1 This is a comparison of the SEM effects of applying the oral debridement gel prepared in Example 1 of the present application and the control group to the cementum root surface. DETAILED DESCRIPTION

[0035] In order to make the above-mentioned purposes, features and advantages of the present application more obvious and easy to understand, the specific implementation methods of the present application are described in detail. In the following description, many specific details are set forth to facilitate a full understanding of the present application. However, the present application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without violating the connotation of the present application, so the present application is not limited by the specific embodiments disclosed below.

[0036] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those generally understood by those skilled in the art of the present application. The terms used herein in the specification of the present application are only for the purpose of describing specific embodiments and are not intended to limit the present application. Unless otherwise specifically stated, various raw materials, reagents, instruments and equipment used in the present application, etc. can be purchased from the market or can be prepared by existing methods.

[0037] In the present application, the technical features described in an open manner include closed technical solutions composed of the listed features, and also include open technical solutions containing the listed features.

[0038] In the present application, when it comes to numerical intervals (i.e., numerical ranges), unless otherwise specified, the optional numerical distribution is considered continuous within the above numerical interval, and includes the two numerical endpoints (i.e., the minimum and maximum values) of the numerical range, and each numerical value between the two numerical endpoints. Unless otherwise specified, when the numerical interval only refers to the integers within the numerical interval, it includes the two endpoint integers of the numerical range, and each integer between the two endpoints. In this article, it is equivalent to directly listing each integer, such as t is an integer selected from 1-10, indicating that t is any integer selected from the integer group consisting of 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10. In addition, when multiple ranges are provided to describe features or characteristics, these ranges can be combined. In other words, unless otherwise specified, the ranges disclosed herein should be understood to include any and all sub-ranges included therein.

[0039] In this application, "optionally", "optional", and "optional" mean optional or dispensable, that is, any one of the two parallel schemes of "yes" or "no". If multiple "options" appear in a technical solution, unless otherwise specified and there is no contradiction or mutual restriction, each "optional" is independent.

[0040] In the present application, "preferred", "better", "more preferred" and "suitable" are only used to describe implementation methods or examples with better effects. It should be understood that they do not constitute limitations on the scope of protection of the present application.

[0041] In the present application, "further", "further", "particularly" and the like are used for descriptive purposes to indicate differences in content, but should not be construed as limiting the scope of protection of the present application.

[0042] The temperature parameters in this application, unless otherwise specified, are allowed to be either constant temperature treatment or to vary within a certain temperature range. It should be understood that the constant temperature treatment allows the temperature to fluctuate within the accuracy range controlled by the instrument. Fluctuations within the range of ±5°C, ±4°C, ±3°C, ±2°C, and ±1°C are allowed.

[0043] As described in the background technology, the traditional debridement gel is not ideal for removing the smear layer of the root surface and the root canal. Therefore, the present application has found through a large number of studies that one of the main reasons for the poor removal effect of the debridement gel on the smear layer of the root surface and the root canal is the poor uniformity of disodium edetate in the gel matrix. Practical applications have found that the traditional preparation process often leads to local high concentration and local low concentration of disodium edetate in the gel matrix. The high concentration part will cause greater damage to the dentin, while the low concentration part cannot achieve the ideal cleaning effect, thus resulting in poor cleaning effect.

[0044] Since there is a certain saturation concentration of disodium edetate in the solution, the conventional preparation process of oral debridement gel generally adds disodium edetate in the form of solid powder to achieve a higher content of disodium edetate. Therefore, in the conventional preparation process of oral debridement gel, disodium edetate powder is usually added at the end; however, the disodium edetate in the debridement gel prepared by this method is difficult to be evenly distributed, has high requirements on equipment, and has poor effect on removing the smear layer of the root surface and the root canal.

[0045] Based on a large amount of practice and research, the present application creatively proposes a new method for preparing an oral debridement gel, and accordingly also provides the oral debridement gel prepared thereby.

[0046] In one aspect, the present application provides a method for preparing an oral debridement gel, comprising steps (1) to (4).

[0047] Step (1): Mixing disodium edetate, a pH regulator and water to prepare a disodium edetate solution.

[0048] Step (2): Mixing the disodium edetate solution with a dispersant to prepare a mixed solution.

[0049] Step (3): Mixing the mixed solution with a gel excipient to prepare a gel material.

[0050] Step (4): allowing the gel material to swell to obtain an oral debridement gel.

[0051] Disodium edetate, also known as disodium ethylenediaminetetraacetic acid, is a calcium ion chelating agent that can react with calcium ions in hydroxyapatite to form a water-soluble complex. Therefore, adding disodium edetate to oral debridement gel can achieve the purpose of decalcifying the root surface. In the process of treating the root surface, disodium edetate can remove the smear layer on the root surface and soften the dentin.

[0052] The preparation method of the oral debridement gel of the present application improves the preparation process by adding a gel excipient to a mixed solution containing disodium edetate, so that the disodium edetate is more evenly distributed during the process of the gel excipient forming a gel matrix, thereby improving the distribution uniformity of the disodium edetate in the prepared oral debridement gel, thereby improving the cleaning effect of the prepared oral debridement gel on the smear layer and reducing the risk of damaging the dentin.

[0053] In addition, the oral debridement gel is a gel product with good fluidity, which can make it easier for the oral debridement gel to penetrate into the lines on the root surface and fit well with the teeth, thereby improving the removal effect of the smear layer. After using the oral debridement gel to remove the smear layer on the root surface, using instruments such as files for subsequent treatment can reduce the resistance to the files, thereby increasing the service life of the instruments.

[0054] In some embodiments, disodium edetate, a pH adjuster and water are mixed under heating conditions; optionally, the heating temperature is above 60°C; further optionally, the heating temperature is 60°C to 100°C.

[0055] In some embodiments, step (1) includes step (1.1) to step (1.2):

[0056] Step (1.1): Mix a pH adjuster and water to obtain a pH adjusting solution.

[0057] Step (1.2): Mixing disodium edetate and the pH adjustment solution to obtain a mixed solution.

[0058] In some specific embodiments, the pH adjuster and water are mixed by stirring. Further, the stirring speed is 45 rpm to 55 rpm, and the time is 5 min to 10 min; further, the stirring speed is 50 rpm.

[0059] In this application, "rpm" refers to the number of rotations per minute, ie, revolutions per minute, and similarly hereinafter.

[0060] In some specific embodiments, the pH regulator includes one or more of sodium hydroxide, potassium hydroxide and sodium bicarbonate. It should be noted that the types of pH regulators are not limited to the above, and can also be other types commonly used in the art, as long as the purpose of this application can be achieved.

[0061] In some specific embodiments, the mixing method of edetate disodium and the pH adjustment solution is stirring.

[0062] Further, the stirring speed is 45 rpm to 55 rpm, and the stirring time is 10 min to 30 min. Further, the stirring speed is 50 rpm.

[0063] In some specific embodiments, edetate disodium and the pH adjusting solution are mixed under heating conditions.

[0064] Specifically, before adding the gel excipient, disodium edetate is dissolved under heating conditions to form a supersaturated solution, and the solution is cooled to room temperature and allowed to stand for a period of time before precipitation, so that the system contains uniformly precipitated disodium edetate.

[0065] Furthermore, the heating temperature is above 60°C; furthermore, the heating temperature is between 60°C and 100°C.

[0066] As an example, the heating temperature can be 60℃, 61℃, 62℃, 63℃, 64℃, 65℃, 66℃, 67℃, 68℃, 69℃, 70℃, 71℃, 72℃, 73℃, 74℃, 75℃, 76℃, 77℃, 78℃, 79℃, 80℃, 81℃, 82℃, 83℃, 84℃, 85℃, 86℃, 87℃, 88℃, 89℃, 90℃, 91℃, 92℃, 93℃, 94℃, 95℃, 96℃, 97℃, 98℃, 99℃, 100℃, or any value within the range formed by any two of the above point values.

[0067] In some specific embodiments, the step of mixing the pH adjuster and water may be performed by stirring while heating. Further, the temperature is raised to a temperature above 60°C.

[0068] In some embodiments, the mass content of disodium edetate in the disodium edetate solution is 15% to 30%.

[0069] As an example, the mass content of disodium edetate in the disodium edetate solution can be 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, 25%, 26%, 27%, 28%, 29%, 30%, or any value within the range formed by any two of the above point values.

[0070] The solubility of edetate disodium varies under different temperature conditions. Adding edetate disodium under heating conditions can effectively increase its solubility and make its concentration reach 15%~30%.

[0071] Optionally, the mass content of disodium edetate in the disodium edetate solution is 17% to 24%.

[0072] In some embodiments, the mass content of edetate disodium in the oral debridement gel is 15% to 27%.

[0073] As an example, the mass content of edetate disodium in the oral debridement gel can be 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, 25%, 26%, 27%, or any value within the range formed by any two of the above point values.

[0074] Furthermore, the mass content of edetate disodium in the oral debridement gel is 15% to 24%.

[0075] In some specific embodiments, the disodium edetate solution and the dispersant are mixed by stirring. Further, the stirring speed is 45 rpm to 55 rpm, and the time is 5 min to 10 min. Further, the stirring speed is 50 rpm.

[0076] In some specific embodiments, the edetate disodium solution and the dispersant are mixed at room temperature; in the present application, room temperature can be understood as any temperature between 10° C. and 30° C., and similarly hereinafter.

[0077] In some specific embodiments, the dispersant includes one or more of propylene glycol, glycerol, polyethylene glycol, cetyl alcohol and water.

[0078] Optionally, the dispersant includes polyethylene glycol; further optionally, the polyethylene glycol includes one or more of polyethylene glycol 400, polyethylene glycol 600 and polyethylene glycol 800; further, the polyethylene glycol is selected from polyethylene glycol 400.

[0079] Furthermore, polyethylene glycol includes polyethylene glycol 400 and polyethylene glycol 800.

[0080] Furthermore, polyethylene glycol includes polyethylene glycol 400, polyethylene glycol 600 and polyethylene glycol 800. Experiments have shown that the use of the above three combinations as dispersants can further improve the uniformity of edetate disodium in the oral debridement gel. This may be because polyethylene glycols of different molecular weights have different properties, and mixing them in a specific ratio can make edetate disodium more uniform during saturated precipitation.

[0081] Polyethylene glycol can adjust the overall consistency of the gel system, making the oral debridement gel stable and not prone to deterioration, thereby extending the storage life of the gel.

[0082] In some specific embodiments, the mixed solution and the gel excipient are mixed at room temperature.

[0083] The preparation method of the oral debridement gel of the present application comprises the following steps: firstly dissolving disodium edetate under heating conditions to form a disodium edetate solution with a high concentration; then adding a gel excipient and mixing the mixture at room temperature; during the process of lowering the temperature, the disodium edetate will gradually precipitate, thereby improving the uniformity of the disodium edetate in the gel matrix.

[0084] In some specific embodiments, the gel excipient includes one or more of sodium carboxymethylcellulose, carbomer, carboxymethylcellulose, hydroxyethylcellulose, hydroxypropylmethylcellulose and silicon dioxide.

[0085] Optionally, the gel excipient includes sodium carboxymethylcellulose. Further optionally, the molecular weight of sodium carboxymethylcellulose is 400kDa~1000kDa.

[0086] Selecting sodium carboxymethyl cellulose as the excipient can make the oral debridement gel finally gel-like; and sodium carboxymethyl cellulose can avoid excessive demineralization of disodium edetate, and play a role in lubrication and adhesion of residues during the treatment process.

[0087] Optionally, the mixed solution obtained in step (2) is mixed with the gel excipient by stirring. Further, the stirring speed is 45 rpm to 55 rpm, and the time is 45 min to 60 min. Further, the stirring speed is 50 rpm.

[0088] In some of the embodiments, in the raw materials for preparing the oral debridement gel, by weight, edetate disodium is 15 to 30 parts, the dispersant is 3 to 20 parts, and the gel excipient is 0.5 to 8 parts.

[0089] As an example, the mass fraction of edetate disodium can be 15 parts, 16 parts, 17 parts, 18 parts, 19 parts, 20 parts, 21 parts, 22 parts, 23 parts, 24 parts, 25 parts, 26 parts, 27 parts, 28 parts, 29 parts, 30 parts, or any value within the range formed by any two of the above point values.

[0090] As an example, the mass fraction of the dispersant can be 3 parts, 4 parts, 5 parts, 6 parts, 7 parts, 8 parts, 9 parts, 10 parts, 11 parts, 12 parts, 13 parts, 14 parts, 15 parts, 16 parts, 17 parts, 18 parts, 19 parts, 20 parts, or any value within the range formed by any two of the above point values.

[0091] As an example, the mass fraction of the gel excipient can be 0.5 parts, 0.6 parts, 0.7 parts, 0.8 parts, 0.9 parts, 1 parts, 2 parts, 3 parts, 4 parts, 5 parts, 6 parts, 7 parts, 8 parts, or any value within the range formed by any two of the above point values.

[0092] In some embodiments, in the raw materials for preparing the oral debridement gel, by weight, 15 to 30 parts of disodium edetate, 3 to 20 parts of dispersant, 0.5 to 8 parts of gel excipient, and 1.5 to 3 parts of pH adjuster are used. An appropriate amount of pH adjuster is added to adjust the pH value of the oral debridement gel so that its pH value is between 6 and 8; in this way, the irritation of the oral debridement gel to the oral mucosa can be reduced, and the health of the oral tissue can be maintained.

[0093] As an example, the mass fraction of the pH adjuster can be 1.5 parts, 1.6 parts, 1.7 parts, 1.8 parts, 1.9 parts, 2 parts, 2.1 parts, 2.2 parts, 2.3 parts, 2.4 parts, 2.5 parts, 2.6 parts, 2.7 parts, 2.8 parts, 2.9 parts, 3 parts, or any value within the range formed by any two of the above point values.

[0094] The present application reasonably regulates the mass fractions of the above raw materials so that the prepared oral debridement gel has better uniformity and a suitable mass content of disodium edetate, thereby improving the cleaning effect of the stain layer.

[0095] In some embodiments, in the raw materials for preparing the above-mentioned oral debridement gel, by weight, edetate disodium is 17 to 24 parts, dispersant is 5 to 15 parts, and gel excipient is 1 to 5 parts.

[0096] In some embodiments, the dispersant is selected from polyethylene glycol, and the gel excipient is selected from sodium carboxymethylcellulose. In other words, the raw materials or components for preparing the oral debridement gel include disodium edetate, polyethylene glycol and sodium carboxymethylcellulose.

[0097] The inventor unexpectedly discovered that oral debridement gel can be prepared by compounding disodium edetate with polyethylene glycol and sodium carboxymethyl cellulose, wherein polyethylene glycol and sodium carboxymethyl cellulose are both polymer materials, and based on their specific molecular segments and molecular configurations, the two can cooperate and act synergistically with each other, so that during the saturated precipitation process of disodium edetate, the distribution uniformity of disodium edetate in the gel matrix can be further improved, thereby effectively removing the smear layer on the surface of dentin and softening and demineralizing the dentin.

[0098] Further, by weight, edetate disodium is 15 to 30 parts, polyethylene glycol is 3 to 20 parts, and carboxymethyl cellulose sodium is 0.5 to 8 parts. Further, by weight, edetate disodium is 17 to 24 parts, polyethylene glycol is 5 to 15 parts, and carboxymethyl cellulose sodium is 1 to 5 parts.

[0099] The oral debridement gel is prepared by compounding disodium edetate with polyethylene glycol and sodium carboxymethyl cellulose in specific mass proportions, which can further improve the distribution uniformity of the oral debridement gel in the gel matrix, thereby effectively removing the smear layer on the surface of dentin and softening and demineralizing the dentin.

[0100] In some specific embodiments, in the oral debridement gel, the content of disodium edetate is 15 to 30 parts, the content of polyethylene glycol is 3 to 20 parts, and the content of sodium carboxymethyl cellulose is 0.5 to 8 parts by weight.

[0101] As an example, the mass fraction of edetate disodium can be 15 parts, 16 parts, 17 parts, 18 parts, 19 parts, 20 parts, 21 parts, 22 parts, 23 parts, 24 parts, 25 parts, 26 parts, 27 parts, 28 parts, 29 parts, 30 parts, or any value within the range formed by any two of the above point values.

[0102] As an example, the mass fraction of polyethylene glycol can be 3 parts, 4 parts, 5 parts, 6 parts, 7 parts, 8 parts, 9 parts, 10 parts, 11 parts, 12 parts, 13 parts, 14 parts, 15 parts, 16 parts, 17 parts, 18 parts, 19 parts, 20 parts, or any value within the range formed by any two of the above point values.

[0103] As an example, the mass fraction of sodium carboxymethyl cellulose can be 0.5 parts, 0.6 parts, 0.7 parts, 0.8 parts, 0.9 parts, 1 parts, 2 parts, 3 parts, 4 parts, 5 parts, 6 parts, 7 parts, 8 parts, or any value within the range formed by any two of the above point values.

[0104] Optionally, by weight, the amount of disodium edetate is 17 to 24 parts, the amount of polyethylene glycol is 5 to 15 parts, and the amount of sodium carboxymethyl cellulose is 1 to 5 parts.

[0105] In some specific embodiments, the molecular weight of sodium carboxymethyl cellulose is 400 kDa-1000 kDa.

[0106] In some specific embodiments, the polyethylene glycol is selected from one or more of polyethylene glycol 400, polyethylene glycol 600 and polyethylene glycol 800. Optionally, the polyethylene glycol is selected from polyethylene glycol 400.

[0107] Further, the polyethylene glycol includes polyethylene glycol 400 and polyethylene glycol 800. Optionally, the mass ratio of polyethylene glycol 400 to polyethylene glycol 800 is (2.8-3.2):2; further optionally, the mass ratio of polyethylene glycol 400 to polyethylene glycol 800 is 3:2.

[0108] Furthermore, the polyethylene glycol includes polyethylene glycol 400, polyethylene glycol 600 and polyethylene glycol 800. Optionally, the mass ratio of polyethylene glycol 400, polyethylene glycol 600 and polyethylene glycol 800 is (1.8-2.2):1:(1.8-2.2); further optionally, the mass ratio of polyethylene glycol 400, polyethylene glycol 600 and polyethylene glycol 800 is 2:1:2.

[0109] In some specific embodiments, the oral debridement gel further comprises a pH regulator. Optionally, the pH regulator is selected from one or more of sodium hydroxide, potassium hydroxide and sodium bicarbonate. Optionally, the pH regulator is 1.5 to 3 parts by weight.

[0110] As an example, the mass fraction of the pH adjuster can be 1.5 parts, 1.6 parts, 1.7 parts, 1.8 parts, 1.9 parts, 2 parts, 2.1 parts, 2.2 parts, 2.3 parts, 2.4 parts, 2.5 parts, 2.6 parts, 2.7 parts, 2.8 parts, 2.9 parts, 3 parts, or any value within the range formed by any two of the above point values.

[0111] Further optionally, the pH adjuster is 2 to 3 parts.

[0112] When the above-mentioned oral debridement gel is used for root canal preparation and expansion, it can lubricate the root canal wall, thereby reducing the resistance to the instrument, shortening the root canal preparation time and increasing the service life of the instrument; when used for subgingival scaling and root planing, it can remove periodontal plaque and tartar, expose dentinal tubules, and create a plane that is conducive to the attachment and growth of periodontal tissue.

[0113] In some embodiments, after the mixed solution is mixed with the gel excipient, a homogenization step is further included.

[0114] Furthermore, the speed of the homogenization process is 900 rpm to 1100 rpm, and the time is 10 min to 20 min. Furthermore, the speed of the homogenization process is 1000 rpm.

[0115] In some specific embodiments, the swelling is static swelling, and the swelling time is 18 hours to 24 hours. It can be understood that when the gel material is static, the gel material can swell spontaneously.

[0116] As an example, the swelling time can be 18 h, 19 h, 20 h, 21 h, 22 h, 23 h, 24 h, or any value within the range formed by any two of the above point values.

[0117] In some specific embodiments, the swelling is performed at room temperature.

[0118] In the preparation process of oral debridement gel, swelling can make the gel have a larger specific surface area, thereby improving the gel's adsorption capacity for the stain layer.

[0119] In some embodiments, after swelling, the following step is further included: vacuum centrifuging the swollen gel material to obtain an oral debridement gel.

[0120] In some specific embodiments, the vacuum degree of the vacuum centrifugation treatment is 90 KPa to 110 KPa, the revolution speed is 900 rpm to 1100 rpm, the rotation speed is 750 rpm to 850 rpm, and the time is 5 min to 15 min.

[0121] Through vacuum centrifugation, bubbles inside the gel system can be effectively removed, making the structure and component distribution inside the gel more uniform.

[0122] As an example, the vacuum degree of vacuum centrifugation treatment can be 90KPa, 91KPa, 92KPa, 93KPa, 94KPa, 95KPa, 96KPa, 97KPa, 98KPa, 99KPa, 100KPa, 101KPa, 102KPa, 103KPa, 104KPa, 105KPa, 106KPa, 107KPa, 108KPa, 109KPa, 110KPa, or any value within the range formed by any two of the above point values.

[0123] As an example, the revolution speed of the vacuum centrifugation treatment can be 950rpm, 960rpm, 970rpm, 980rpm, 990rpm, 1000rpm, 1010rpm, 1020rpm, 1030rpm, 1040rpm, 1050rpm, or any value within the range formed by any two of the above point values.

[0124] As an example, the rotation speed of the vacuum centrifugation treatment can be 750rpm, 760rpm, 770rpm, 780rpm, 790rpm, 800rpm, 810rpm, 820rpm, 830rpm, 840rpm, 850rpm, or any value within the range formed by any two of the above point values.

[0125] As an example, the time for vacuum centrifugation treatment can be 5 min, 6 min, 7 min, 8 min, 9 min, 10 min, 11 min, 12 min, 13 min, 14 min, 15 min, or any value within the range formed by any two of the above point values.

[0126] Furthermore, the vacuum degree of the vacuum centrifugal treatment is 100 KPa, the revolution speed is 1000 rpm, the rotation speed is 800 rpm, and the time is 10 min.

[0127] In some embodiments, after swelling and before vacuum centrifugation, the following step is further included: stirring the swollen gel material.

[0128] Further, the stirring speed is 45 rpm to 55 rpm, and the time is 45 min to 60 min. Further, the stirring speed is 50 rpm.

[0129] It can be understood that each step in the preparation method of the oral debridement gel is performed in a sterile environment.

[0130] In some embodiments, the method further comprises packaging the oral debridement gel after the vacuum centrifugation treatment.

[0131] The preparation method of the present application improves the uniformity of the oral debridement gel, and the prepared oral debridement gel has good fluidity, thereby being able to effectively remove the smear layer on the root surface, soften and demineralize the dentin, and causing less damage to the dentin.

[0132] Furthermore, when the above-mentioned oral debridement gel is used for root canal preparation and expansion, it can lubricate the root canal wall, reduce resistance, shorten the preparation time and increase the service life of the instrument; when the above-mentioned oral debridement gel is used for subgingival scaling and root planing, it can effectively remove periodontal plaque and tartar, expose dentinal tubules, and thus create a plane that is conducive to the attachment and growth of periodontal tissue.

[0133] On the other hand, the present application provides an oral debridement gel, which can be prepared by the above preparation method.

[0134] The oral debridement gel prepared by the above preparation method includes a gel matrix formed by a gel excipient and edetate disodium is distributed in the gel matrix; due to the process improvement of the above preparation method, the distribution uniformity of edetate disodium in the oral debridement gel is improved, thereby improving the cleaning effect of the prepared oral debridement gel on the smear layer and reducing the risk of damaging the dentin.

[0135] In some embodiments, the mass content of edetate disodium in the oral debridement gel is 15% to 27%.

[0136] Furthermore, the mass content of edetate disodium in the oral debridement gel is 15% to 24%.

[0137] In some embodiments, the pH of the oral debridement gel is 6-8.

[0138] In some of the embodiments, the raw materials for preparing the oral debridement gel include the above-mentioned mass fractions of disodium edetate, dispersant, gel excipient, pH regulator and water, which will not be repeated here.

[0139] In some embodiments, the oral debridement gel comprises the following components: disodium edetate, polyethylene glycol, and sodium carboxymethylcellulose.

[0140] The inventor unexpectedly discovered that disodium edetate can be compounded with polyethylene glycol and sodium carboxymethyl cellulose to prepare oral debridement gel, wherein polyethylene glycol and sodium carboxymethyl cellulose are both polymer materials, and based on their specific molecular segments and molecular configurations, the two can cooperate and synergize with each other, so that during the saturated precipitation of disodium edetate, the distribution uniformity of disodium edetate in the gel matrix can be further improved, thereby effectively removing the smear layer on the surface of dentin and softening and demineralizing the dentin. Replacing polyethylene glycol or sodium carboxymethyl cellulose with other similar substances cannot achieve this excellent effect.

[0141] Furthermore, the weight percentages of disodium edetate, polyethylene glycol and sodium carboxymethyl cellulose are as described above and will not be repeated here.

[0142] On the other hand, the present application provides an oral debridement gel prepared by the above preparation method or use of the above oral debridement gel in preparing medicines or medical devices for treating oral diseases.

[0143] For example, the oral debridement gel can be pre-equipped in a periodontal scaler, a periodontal irrigator or other oral cleaning device, and when used, it can be delivered to the dentin surface through the internal passage of the device.

[0144] On the other hand, the present application provides a medicine for treating oral diseases, including the oral debridement gel prepared by the above preparation method or the above oral debridement gel.

[0145] In some embodiments, the medicament for treating oral diseases further comprises a moisturizer.

[0146] It should be noted that the above-mentioned drugs for treating oral diseases may also contain other functional preparations commonly used in the art, and this application does not specifically limit this.

[0147] In another aspect, the present application provides a medical device, comprising the oral debridement gel prepared by the above-mentioned preparation method or the above-mentioned oral debridement gel.

[0148] As an example, the medical device may be a root canal file, etc., which may be loaded with the oral debridement gel.

[0149] The present application will be further described below in conjunction with specific examples and comparative examples, but they should not be construed as limiting the scope of protection of the present application. The raw materials involved in the following specific examples, unless otherwise specified, can all be sourced from commercial sources, the instruments used, unless otherwise specified, can all be sourced from commercial sources, and the processes involved, unless otherwise specified, are all conventionally selected by those skilled in the art.

[0150] The normal temperature condition in the embodiments of the present application refers to a condition where the temperature is 10°C to 30°C.

[0151] Example 1

[0152] (1) Weigh the following raw materials by mass: 24 parts of edetate disodium, 5 parts of polyethylene glycol 400, 5 parts of sodium carboxymethyl cellulose (molecular weight 650 kDa), 2.4 parts of sodium hydroxide and 63.6 parts of water; the total mass is 100 parts.

[0153] (2) Add sodium hydroxide and water into a vacuum homogenizer and stir at 50 rpm for 10 min at 85°C to form a uniform and transparent sodium hydroxide solution.

[0154] (3) Add disodium edetate into a vacuum homogenizing emulsifier and mix with the sodium hydroxide solution. Stir at 85°C and 50 rpm for 30 min to form a transparent disodium edetate solution.

[0155] (4) Add polyethylene glycol 400 into a vacuum homogenizer and mix with the disodium edetate solution. Stir at room temperature and 50 rpm for 5 minutes to form a clear and transparent mixed solution.

[0156] (5) adding sodium carboxymethyl cellulose to a vacuum homogenizing emulsifier and mixing with the solution obtained in step (4), stirring at 50 rpm for 60 min at room temperature, and then homogenizing at 1000 rpm for 20 min to form a white or light yellow gel;

[0157] (6) The gel was allowed to swell for 24 h, and then stirred at 50 rpm for 60 min at room temperature to form a uniform white gel material.

[0158] (7) Add the gel material obtained in step (6) into a vacuum centrifugal defoaming machine, under normal temperature conditions, a vacuum degree of 100 KPa, a centrifugal speed of 1000 rpm, a rotation speed of 800 rpm, and a centrifugal time of 10 min; then fill the obtained gel into a syringe to obtain an oral debridement gel, and the pH value of the oral debridement gel is 7.

[0159] (8) Preparation of cementum root slices: Select teeth extracted for orthodontic treatment, select teeth without obvious cracks and with larger root planes, remove soft tissues, and store in saline. Use a diamond grinding needle to prepare a 4mm×4mm×1mm cementum root slice under water cooling.

[0160] The prepared cementum root slice was scraped, and an appropriate amount of the oral debridement gel prepared in this example was applied to cover the cementum root slice, and then rinsed with normal saline after 2 minutes.

[0161] Control group: No oral debridement gel was used for coating and covering, and only normal saline was used to rinse the cementum root slices.

[0162] The samples of Example 1 and the control group were dehydrated with alcohol gradient and then observed by scanning electron microscope. Figure 1 As shown: the surface of the root slice of the control group has more debris, while the surface of the cementum root slice coated with the oral debridement gel of Example 1 of the present application is relatively smooth, with exposed dentinal tubules. The above results show that the oral debridement gel of the present application has a good debridement effect.

[0163] Example 2

[0164] (1) Weigh the following raw materials by mass: 20 parts of edetate disodium, 10 parts of polyethylene glycol 400, 2.5 parts of sodium carboxymethyl cellulose (molecular weight 600 kDa), 2 parts of sodium hydroxide and 65.5 parts of water; the total mass is 100 parts.

[0165] (2) Add sodium hydroxide and water into a vacuum homogenizer and stir at 50 rpm for 8 minutes at room temperature to form a uniform and transparent sodium hydroxide solution.

[0166] (3) Add disodium edetate into a vacuum homogenizing emulsifier and mix with the sodium hydroxide solution. Stir at 85°C and 50 rpm for 25 minutes to form a transparent disodium edetate solution.

[0167] (4) Add polyethylene glycol 400 into a vacuum homogenizer and mix with the disodium edetate solution. Stir at room temperature and 50 rpm for 8 minutes to form a clear and transparent mixed solution.

[0168] (5) adding sodium carboxymethyl cellulose to a vacuum homogenizing emulsifier and mixing with the solution obtained in step (4), stirring at 50 rpm for 50 min at room temperature, and then homogenizing at 1000 rpm for 15 min to form a white or light yellow gel;

[0169] (6) The gel was allowed to swell for 20 h, and then stirred at 50 rpm for 50 min at room temperature to form a uniform white gel material.

[0170] (7) Add the gel material obtained in step (6) into a vacuum centrifugal defoaming machine under room temperature conditions, a vacuum degree of 100 KPa, a centrifugal speed of 1000 rpm, a rotation speed of 800 rpm, and a centrifugal time of 10 min; then fill the obtained gel into a syringe to obtain an oral debridement gel, and the pH value of the oral debridement gel is 6.

[0171] Example 3

[0172] (1) Weigh the following raw materials by weight: 24 parts of edetate disodium, 15 parts of polyethylene glycol 400, 2 parts of sodium carboxymethyl cellulose (molecular weight 700 kDa), 3 parts of sodium hydroxide and 56 parts of water; the total weight is 100 parts.

[0173] (2) Add sodium hydroxide and water into a vacuum homogenizer and stir at 50 rpm for 10 min at room temperature to form a uniform and transparent sodium hydroxide solution.

[0174] (3) Add disodium edetate into a vacuum homogenizing emulsifier and mix with the sodium hydroxide solution. Stir at 85°C and 50 rpm for 30 min to form a transparent disodium edetate solution.

[0175] (4) Add polyethylene glycol 400 into a vacuum homogenizer and mix with the disodium edetate solution. Stir at room temperature and 50 rpm for 10 min to form a clear and transparent mixed solution.

[0176] (5) adding sodium carboxymethyl cellulose to a vacuum homogenizing emulsifier and mixing with the solution obtained in step (4), stirring at 50 rpm for 45 min at room temperature, and then homogenizing at 1000 rpm for 10 min to form a white or light yellow gel;

[0177] (6) The gel was allowed to swell for 18 h, and then stirred at 50 rpm for 45 min at room temperature to form a uniform white gel material.

[0178] (7) Add the gel material obtained in step (6) into a vacuum centrifugal defoaming machine under room temperature conditions, a vacuum degree of 100 KPa, a centrifugal speed of 1000 rpm, a rotation speed of 800 rpm, and a centrifugal time of 10 min; then fill the obtained gel into a syringe to obtain an oral debridement gel, and the pH value of the oral debridement gel is 8.

[0179] Example 4

[0180] The method is basically the same as Example 1, except that the weight fractions of the raw materials are different. Specifically, the raw materials for preparing the oral debridement gel in Example 4 include: 17 parts of disodium edetate, 10 parts of polyethylene glycol 400, 1 part of sodium carboxymethyl cellulose, 2.4 parts of sodium hydroxide and 69.6 parts of water, with a total weight fraction of 100 parts.

[0181] Example 5

[0182] The method is basically the same as Example 1, except that the weight fractions of the raw materials are different. Specifically, the raw materials for preparing the oral debridement gel in Example 5 include: 15 parts of disodium edetate, 3 parts of polyethylene glycol 400, 0.5 parts of sodium carboxymethyl cellulose, 1.5 parts of sodium hydroxide and 80 parts of water, with a total weight fraction of 100 parts.

[0183] Example 6

[0184] The method is basically the same as Example 1, except that the weight fractions of the raw materials are different. Specifically, the raw materials for preparing the oral debridement gel in Example 6 include: 27 parts of disodium edetate, 20 parts of polyethylene glycol 400, 8 parts of sodium carboxymethyl cellulose, 3 parts of sodium hydroxide and 42 parts of water, with a total weight fraction of 100 parts.

[0185] Example 7

[0186] It is basically the same as Example 1, except that the type of dispersant is different, and an equal amount of glycerol is used. Specifically, by mass fraction, the raw materials of the oral debridement gel in Example 7 include: 24 parts of disodium edetate, 5 parts of glycerol, 5 parts of sodium carboxymethyl cellulose, 2.4 parts of sodium hydroxide and 63.6 parts of water; the total mass fraction is 100 parts.

[0187] Example 8

[0188] It is basically the same as Example 1, except that the type of gel excipient is different, and the same mass of hydroxypropyl cellulose is used. Specifically, by mass, the raw materials of the oral debridement gel in Example 8 include: 24 parts of disodium edetate, 5 parts of polyethylene glycol 400, 5 parts of hydroxypropyl cellulose, 2.4 parts of sodium hydroxide and 63.6 parts of water; the total mass is 100 parts.

[0189] Example 9

[0190] It is basically the same as Example 1, except that the dispersant is different, and a mixture of polyethylene glycol 400 and polyethylene glycol 600 is used. Specifically, the raw materials of the oral debridement gel in Example 9 include, by weight, 24 parts of disodium edetate, 3 parts of polyethylene glycol 400 and 2 parts of polyethylene glycol 800, 5 parts of sodium carboxymethyl cellulose, 2.4 parts of sodium hydroxide and 63.6 parts of water; the total weight is 100 parts.

[0191] Example 10

[0192] It is basically the same as Example 1, except that the dispersant is different, and a mixture of polyethylene glycol 400, polyethylene glycol 600 and polyethylene glycol 800 is used. Specifically, by weight, the raw materials of the oral debridement gel in Example 10 include: 24 parts of disodium edetate, 2 parts of polyethylene glycol 400, 1 part of polyethylene glycol 600, 2 parts of polyethylene glycol 800, 5 parts of sodium carboxymethyl cellulose, 2.4 parts of sodium hydroxide and 63.6 parts of water; the total weight is 100 parts.

[0193] Comparative Example 1

[0194] The method is basically the same as Example 1, except that the preparation process is different, in which the step of adding edetate disodium is adjusted to step (5); the specific preparation method is as follows:

[0195] (1) Weigh the following raw materials by mass: 24 parts of edetate disodium, 5 parts of polyethylene glycol 400, 5 parts of sodium carboxymethyl cellulose (molecular weight 650 kDa), 2.4 parts of sodium hydroxide and 63.6 parts of water.

[0196] (2) Add sodium hydroxide and water into a vacuum homogenizer and stir at 50 rpm for 10 min at room temperature to form a uniform and transparent sodium hydroxide solution.

[0197] (3) Add polyethylene glycol 400 into a vacuum homogenizer and mix with the sodium hydroxide solution. Stir at room temperature and 50 rpm for 5 minutes to form a clear polyethylene glycol solution.

[0198] (4) Add sodium carboxymethyl cellulose to a vacuum homogenizer and mix with the polyethylene glycol solution. Stir at 50 rpm for 60 min at room temperature, and then homogenize at 1000 rpm for 20 min to form a gel material.

[0199] (5) Add disodium edetate into a vacuum homogenizer and mix with the gel material. Stir at 85°C and 50 rpm for 30 min to form a transparent mixture.

[0200] (6) The mixture obtained in step (5) was allowed to swell for 24 h, and then stirred at 50 rpm for 60 min at room temperature to form a uniform white paste-like gel.

[0201] (7) Add the gel obtained in step (6) into a vacuum centrifugal defoaming machine under room temperature conditions, a vacuum degree of 100 KPa, a centrifugal speed of 1000 rpm, a rotation speed of 800 rpm, and a centrifugal time of 10 min; then fill the obtained gel into a syringe to obtain an oral debridement gel, and the pH value of the oral debridement gel is 7.

[0202] Comparative Example 2

[0203] Comparative Example 2 is substantially the same as Example 1, except that no dispersant polyethylene glycol is added, and the mass fraction of sodium carboxymethyl cellulose is increased to 10 parts, while other components and amounts remain unchanged; the specific preparation method is as follows:

[0204] (1) Weigh the following raw materials by mass: 24 parts of disodium edetate, 10 parts of sodium carboxymethyl cellulose (molecular weight 650 kDa), 2.4 parts of sodium hydroxide and 63.6 parts of water.

[0205] (2) Add sodium hydroxide and water into a vacuum homogenizer and stir at 50 rpm for 10 min at room temperature to form a uniform and transparent sodium hydroxide solution.

[0206] (3) Add disodium edetate into a vacuum homogenizing emulsifier and mix with the sodium hydroxide solution. Stir at 85°C and 50 rpm for 30 min to form a transparent disodium edetate solution.

[0207] (4) adding sodium carboxymethyl cellulose to a vacuum homogenizing emulsifier and mixing with the disodium edetate solution, stirring at 50 rpm for 60 min at room temperature, and then homogenizing at 1000 rpm for 20 min to form a gel-like intermediate gel;

[0208] (5) The intermediate gel was allowed to swell for 24 h, and then stirred at 50 rpm for 60 min at room temperature to form a uniform white paste gel.

[0209] (6) Add the gel obtained in step (5) into a vacuum centrifugal defoaming machine under room temperature conditions, a vacuum degree of 100 KPa, a centrifugal speed of 1000 rpm, a rotation speed of 800 rpm, and a centrifugal time of 10 min; then fill the obtained gel into a syringe to obtain an oral debridement gel, and the pH value of the oral debridement gel is 7.

[0210] Some parameters of the embodiments and comparative examples are shown in Tables 1 and 2 below.

[0211] Table 1

[0212]

[0213] Table 2

[0214]

[0215] Performance Testing

[0216] (a) Homogeneity test: Take 10 mL of the oral debridement gel product prepared in Examples 1 to 6 and Comparative Examples 1 to 2, take 1 mL of sample at each of three random sites (site A, site B and site C), detect the content of disodium edetate in the sample at each site and calculate the variance of the content of disodium edetate at the three sites; the results are shown in the following table.

[0217] The content of disodium edetate refers to the mass content of disodium edetate in a unit mass sample.

[0218] The average content refers to the average value of the content of edetate disodium in site A, site B and site C.

[0219] The smaller the variance, the higher the distribution uniformity of edetate disodium in the prepared oral debridement gel product; conversely, the lower the distribution uniformity of edetate disodium.

[0220] Table 3

[0221]

[0222] As can be seen from Tables 1 to 3, in Comparative Example 1, edetate disodium was added after the gel material was formed, and the distribution uniformity of the oral debridement gel product finally obtained was low; in Comparative Example 2, polyethylene glycol was not added, and the uniformity of the oral debridement gel product finally obtained was low. The distribution uniformity of edetate disodium in the oral debridement gel prepared in each embodiment of the present application is good, which is significantly better than Comparative Examples 1-2.

[0223] Compared with Examples 1 to 6, glycerol was selected as a dispersant in Example 7, and hydroxypropyl cellulose was selected as a gel excipient in Example 8, and the uniformity of the oral debridement gel products prepared in Examples 7 to 8 was slightly poor; while in Examples 1 to 6, edetate disodium, polyethylene glycol and sodium carboxymethyl cellulose were selected as raw materials, and oral debridement gels with better uniformity than Examples 7 to 8 were prepared. It is speculated that this is because edetate disodium, polyethylene glycol and sodium carboxymethyl cellulose are used as preparation raw materials, and there is a synergistic effect between the three, wherein polyethylene glycol and sodium carboxymethyl cellulose are both polymer materials, and based on their specific molecular segments and molecular configurations, the two can cooperate and synergize with each other, so that the distribution uniformity of the material body in the oral debridement gel can be further improved during the saturated precipitation of edetate disodium.

[0224] Compared with Examples 5 to 6, the main difference in Examples 1 to 4 is the mass fractions of edetate disodium, dispersant and gel excipient, and the oral debridement gel prepared in Examples 1 to 4 has better uniformity. This shows that the present application uses 17 to 24 parts of edetate disodium, 5 to 15 parts of dispersant 5, and 1 to 5 parts of gel excipient as preparation raw materials, which can further improve the uniformity of the oral debridement gel.

[0225] Compared with Examples 1 to 8, in Example 9, polyethylene glycol 400 and polyethylene glycol 800 are used as dispersants, and the uniformity of edetate disodium in the prepared oral debridement gel is better than that in Examples 1 to 8. This indicates that the combination of two polyethylene glycols with different molecular weights can further improve the uniformity of the oral debridement gel.

[0226] Compared with Example 9, in Example 10, polyethylene glycol 400, polyethylene glycol 600 and polyethylene glycol 800 are used as dispersants, and the uniformity of edetate disodium in the prepared oral debridement gel is better than that in Example 9. This indicates that the combination of three polyethylene glycols with different molecular weights can further improve the uniformity of the oral debridement gel.

[0227] The technical features of the above-described embodiments may be arbitrarily combined. To make the description concise, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0228] The above-mentioned embodiments only express several implementation methods of the present application, and the descriptions thereof are relatively specific and detailed, but they cannot be understood as limiting the scope of the invention patent. It should be pointed out that, for a person of ordinary skill in the art, several variations and improvements can be made without departing from the concept of the present application, and these all belong to the protection scope of the present application. Therefore, the protection scope of the present application shall be subject to the attached claims.

Claims

1. A method for preparing an oral debridement gel, characterized in that: The steps include: (1) mixing edetate disodium, a pH adjuster and water to prepare an edetate disodium solution; (2) mixing the disodium edetate solution with a dispersant to prepare a mixed solution; (3) mixing the mixed solution with a gel excipient to prepare a gel material; (4) Swelling the gel material to obtain the oral debridement gel.

2. The method for preparing the oral debridement gel according to claim 1, characterized in that: Step (1) includes the following steps: Mixing the pH adjuster and water to obtain a pH adjusting solution; The edetate disodium and the pH adjustment solution are mixed to obtain the edetate disodium solution.

3. The method for preparing the oral debridement gel according to claim 2, characterized in that: The edetate disodium and the pH adjustment solution are mixed under heating conditions; Optionally, the heating temperature is above 60°C; Further optionally, the heating temperature is 60°C~100°C.

4. The method for preparing the oral debridement gel according to any one of claims 1 to 3, characterized in that: The mass content of disodium edetate in the disodium edetate solution is 15% to 30%; and / or, The mass content of disodium edetate in the oral debridement gel is 15% to 27%.

5. The method for preparing the oral debridement gel according to any one of claims 1 to 3, characterized in that: The dispersant includes one or more of propylene glycol, glycerol, polyethylene glycol, hexadecyl alcohol and water; optionally, the dispersant includes polyethylene glycol; more optionally, the polyethylene glycol is selected from one or more of polyethylene glycol 400, polyethylene glycol 600 and polyethylene glycol 800; and / or, The gel excipient includes one or more of sodium carboxymethylcellulose, carbomer, carboxymethylcellulose, hydroxyethylcellulose, hydroxypropylmethylcellulose and silicon dioxide; optionally, the gel excipient includes sodium carboxymethylcellulose; optionally, the molecular weight of the sodium carboxymethylcellulose is 400kDa~1000kDa; and / or, The pH adjuster includes one or more of sodium hydroxide, potassium hydroxide and sodium bicarbonate.

6. The method for preparing the oral debridement gel according to any one of claims 1 to 3, characterized in that: By weight, the edetate disodium is 15 to 30 parts, the dispersant is 3 to 20 parts, and the gel excipient is 0.5 to 8 parts; Optionally, by weight, the edetate disodium is 17 to 24 parts, the dispersant is 5 to 15 parts, and the gel excipient is 1 to 5 parts; Optionally, the dispersant comprises polyethylene glycol and the gel excipient comprises sodium carboxymethylcellulose.

7. The method for preparing the oral debridement gel according to any one of claims 1 to 3, characterized in that: The swelling is static swelling, and the swelling time is 18h to 24h; and / or, The swelling step further includes a vacuum centrifugal treatment step; optionally, the vacuum degree of the vacuum centrifugal treatment is 90KPa~110KPa, the revolution speed is 900rpm~1100rpm, the rotation speed is 750rpm~850rpm, and the time is 5min~15min.

8. An oral debridement gel, characterized in that: The oral debridement gel is prepared by the preparation method according to any one of claims 1 to 7; or The oral debridement gel comprises the following components: disodium edetate, polyethylene glycol and sodium carboxymethyl cellulose; optionally, in the oral debridement gel, the disodium edetate is 15 to 30 parts, the polyethylene glycol is 3 to 20 parts, and the sodium carboxymethyl cellulose is 0.5 to 8 parts by mass; optionally, the molecular weight of the sodium carboxymethyl cellulose is 400 kDa to 1000 kDa; optionally, the polyethylene glycol is selected from one or more of polyethylene glycol 400, polyethylene glycol 600 and polyethylene glycol 800.

9. Use of the oral debridement gel prepared by the preparation method according to any one of claims 1 to 7 or the oral debridement gel according to claim 8 in the preparation of drugs or medical devices for treating oral diseases.

10. A medical device, characterized in that: The invention comprises the oral debridement gel prepared by the preparation method according to any one of claims 1 to 7 or the oral debridement gel according to claim 8.

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