Periodontal occlusion treatment agent as well as preparation method and application thereof

Abstract

The invention relates to a periodontal plug treatment agent, and relates to the field of oral implants. The periodontal occlusion treatment agent comprises a diluent, a hydrophilic agent, a water repellent agent, egg yolk lecithin and a plasticizer, the mass ratio of the hydrophilic agent to the water repellent agent to the egg yolk lecithin to the plasticizer is (4-10): (2-6): (1-4): 1, the hydrophilic agent comprises dopamine, sodium alginate and polyvinylpyrrolidone, and the water repellent agent comprises sodium alginate and polyvinylpyrrolidone. The prepared periodontal occlusion treatment agent has high adhesiveness and plasticity in an oral wet environment, can be tightly attached to a wound surface, greatly improves the adhesiveness and degradation time, and is beneficial to efficient promotion of wound surface healing.

Description

Technical Field

[0001] The present invention belongs to the field of oral implants, and more particularly relates to a periodontal plugging agent and a preparation method and application thereof. Background Art

[0002] Periodontal disease is a common oral disease that may not only cause teeth to loosen and fall out, but in severe cases may also affect chewing function, increase the burden on the gastrointestinal tract, and even induce certain systemic diseases. Surgical treatment is an indispensable part of the treatment of oral diseases. However, oral surgery can cause damage to periodontal soft tissues, which can easily cause local or even systemic problems, and in severe cases, even endanger life.

[0003] In order to reduce or avoid complications, close the wound surface as soon as possible, and provide a suitable repair environment for the wound, periodontal plugs have become an indispensable part of periodontal treatment. During oral surgery, periodontal plugs are covered on the wound surface of periodontal tissue to provide a closed repair environment for the periodontium. Periodontal plugs have multiple functions such as analgesia, hemostasis, antibacterial, wound protection, accelerated wound healing, and fixation of loose teeth and gingival flaps.

[0004] At present, the research on degradable periodontal plugs is mainly focused on trying to strike a balance between hydrophilic materials and hydrophobic materials, because the addition of hydrophobic materials will lead to poor adhesion of periodontal plugs to oral soft tissues, so it is necessary to add hydrophilic materials with mucosal adhesion. However, hydrophilic materials will continue to swell and dissolve with saliva, which will cause the periodontal plugs to gradually disintegrate in the mouth. Therefore, the periodontal plugs currently developed still have a short time to protect the wound surface, generally they will be completely degraded within 24 hours, and the wound surface in the mouth generally takes about 5 days to heal. Therefore, at this stage, the wound surface needs to be continuously protected multiple times during the wound healing process to avoid irritation of the wound surface, and the patient's experience is poor.

[0005] In view of the problems existing in the prior art, there is an urgent need to develop a periodontal plugging agent with high adhesion ability and long dissolution time, which can provide longer-lasting protection for different types of periodontal soft tissue wounds. Summary of the invention

[0006] In view of the above-mentioned defects and problems of the prior art, the present invention develops a periodontal plugging agent and a preparation method and use thereof.

[0007] The first aspect of the present invention provides a periodontal plugging agent, comprising a diluent, a hydrophilic agent, a hydrophobic agent, egg yolk lecithin and a plasticizer, wherein the mass ratio of the hydrophilic agent, the hydrophobic agent, the egg yolk lecithin and the plasticizer is (4-10):(2-6):(1-4):1, wherein the hydrophilic agent comprises dopamine, sodium alginate and polyvinyl pyrrolidone.

[0008] Optionally, the mass ratio of the dopamine, the sodium alginate and the polyvinyl pyrrolidone is 1:(0.5-0.8):(1.2-1.5).

[0009] Optionally, functional components are also included, and the functional components include one or more of a hemostatic material, a flavoring agent and a lubricant; preferably, the mass ratio of the hydrophilic agent, the hemostatic material, the flavoring agent and the lubricant is (6-17):1:(0.1-0.5):(0.5-2).

[0010] Optionally, the hemostatic material includes one or more of carboxymethyl chitosan and hyaluronic acid; the flavoring agent includes one or more of xylitol, sucralose and menthol; and the lubricant includes one or more of glycerol, polyethylene glycol and stearic acid.

[0011] Optionally, the mass ratio of the hydrophilic agent to the diluent is (1-2.6):1. Preferably, the diluent includes one or more of purified water, ethanol, polyethylene glycol and propylene glycol.

[0012] Optionally, the plasticizer includes one or more of microcrystalline wax, paraffin wax, vaseline, lanolin, beeswax, triacetin, citrate and dibutyl adipate; the hydrophobic agent includes one or more of polyvinyl acetate, methyl methacrylate, ethyl cellulose, rosin glycerol ester and natural rubber.

[0013] Another aspect of the present invention provides a method for preparing a periodontal plugging agent, comprising the following steps:

[0014] (1) mixing a hydrophobic agent and a portion of a diluent, heating, and stirring to obtain a mixture A;

[0015] (2) mixing a hydrophilic agent and another portion of a diluent, stirring, adding the mixture A, heating, and stirring again to obtain a mixture B;

[0016] (3) mixing the mixture B and the plasticizer, stirring, to obtain a mixture C;

[0017] (4) mixing the mixture C and egg yolk lecithin, stirring, and preparing the periodontal plug agent;

[0018] Wherein, the hydrophilic agent includes dopamine, sodium alginate and polyvinyl pyrrolidone.

[0019] Preferably, a functional component is also added in step (2) and / or step (4), and the functional component includes one or more of a hemostatic material, a flavoring agent and a lubricant; preferably, the mass ratio of the hydrophilic agent, the hemostatic material, the flavoring agent and the lubricant is (6-17):1:(0.1-0.5):(0.5-2).

[0020] Optionally, in step (1), at a temperature of 90°C-120°C, the mixture is stirred at a stirring speed of 100-300 rpm for 2-4 hours to obtain the mixture A; in step (2), at a temperature of 60°C-80°C, the mixture is stirred at a stirring speed of 100-300 rpm for 1.5 hours to 3 hours to obtain the mixture B; in step (3), at a stirring speed of 100-300 rpm, the mixture is stirred for 0.5 hours to 2 hours to obtain the mixture C; in step (4), at a stirring speed of 100-300 rpm, the mixture is stirred for 0.8 hours to 2.6 hours.

[0021] Another aspect of the present invention further provides the use of the above-mentioned periodontal plugging agent in the preparation of medicines or medical devices for treating oral wounds; preferably, the oral wound is a periodontal tissue wound.

[0022] In summary, the present application has at least one of the following beneficial effects:

[0023] By selecting hydrophilic agents including dopamine, sodium alginate and polyvinyl pyrrolidone, and making them work synergistically with diluents, hydrophobic agents, egg yolk lecithin and plasticizers in a suitable ratio, the prepared periodontal plug can show strong wet adhesion ability when entering the moist environment of the oral cavity, form close contact with the wound surface, eliminate the gap with the tissue interface, quickly seal the wound surface, and avoid plaque formation. In addition, the adhesion and degradation time of the periodontal plug in the oral cavity are greatly improved, which is conducive to promoting wound healing efficiently. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art are briefly introduced below.

[0025] Figure 1 This is a schematic diagram of the working state when the testing machine fixes the test sample and applies tension in opposite directions to the test sample. The "1cm" marked in the figure means that the width of the test sample is 1cm. DETAILED DESCRIPTION

[0026] The present application is further described in detail with reference to the following examples. It should be noted that if no specific conditions are specified in the following examples, the conventional conditions or the conditions recommended by the manufacturer are followed, and the raw materials used in the following examples can be obtained from common commercial sources unless otherwise specified.

[0027] 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 below. 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.

[0028] In this application, "first aspect", "second aspect", "third aspect", etc. are used only for descriptive purposes and cannot be understood as indicating or implying relative importance or quantity, nor can they be understood as implicitly indicating the importance or quantity of the indicated technical features. Moreover, "first", "second", "third", etc. only serve the purpose of non-exhaustive enumeration and description, and it should be understood that they do not constitute a closed limitation on quantity.

[0029] In this application, "preferably", "preferred", "optionally", and "optional" mean optional, 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.

[0030] In this application, when it comes to numerical ranges, unless otherwise specified, the above numerical ranges are deemed to be continuous and include the minimum and maximum values ​​of the range, as well as each value between such minimum and maximum values. Further. In addition, when multiple ranges are provided to describe features or characteristics, the ranges can be combined. In other words, unless otherwise specified, all ranges disclosed herein should be understood to include any and all subranges included therein.

[0031] 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.

[0032] Unless otherwise defined, all technical and scientific terms used in this application have the same meaning as those generally understood by those skilled in the art to which this application belongs. The terms used in this application and in the specification of this application are only for the purpose of describing specific embodiments and are not intended to limit this application. The term "and / or" used in this application includes any and all combinations of one or more related listed items. The term "multiple" in this application means at least two, such as two, three, etc., unless otherwise clearly and specifically limited.

[0033] In order to facilitate the description of the technical solution of this application, the following materials and steps are described before starting the experiment of this application:

[0034] (1) The sources of the main raw materials in this application are as follows:

[0035] Egg yolk lecithin: purchased from Shenyang Tianfeng Biopharmaceutical Co., Ltd.;

[0036] Dopamine: purchased from Henan Puhui Tiancheng Biotechnology Co., Ltd.;

[0037] Sodium alginate: purchased from Xi'an Tianzheng Pharmaceutical Excipients Co., Ltd., with a molecular weight of 30,000 Da to 100,000 Da;

[0038] Polyvinylpyrrolidone: purchased from Boai Xinkaiyuan Pharmaceutical Co., Ltd., with a molecular weight of 20,000 Da-50,000 Da;

[0039] Sodium carboxymethyl cellulose: purchased from Jiangsu Bosite Chemical Technology Co., Ltd., with a molecular weight of 30,000 Da-40,000 Da;

[0040] Methyl glycerate: purchased from Shaoyuan Technology (Shanghai) Co., Ltd.

[0041] Tween 80: purchased from Shanghai Aladdin Biochemical Technology Co., Ltd.;

[0042] Mussel mucin: purchased from Jiangsu Jinpu Noan Biotechnology Co., Ltd., with a molecular weight of 100 kDa-300 kDa.

[0043] (2) The diluent in the present application can be one or more of purified water, ethanol, polyethylene glycol and propylene glycol. It is understood that when the diluent is mixed with other materials, the diluent can be selected according to the principle of like dissolves like.

[0044] (3) Plasticizers can improve the plasticity of periodontal plugs, adapt them to the complex oral environment, and effectively seal the wound site. The plasticizer in the present application is selected from one or more of microcrystalline wax, solid paraffin, vaseline, lanolin, beeswax, triacetin, citrate, and dibutyl adipate.

[0045] (4) The hydrophobic agent in the present application is selected from one or more of polyvinyl acetate, methyl methacrylate, ethyl cellulose, rosin glycerol ester and natural rubber.

[0046] (5) The hemostatic material in the present application includes but is not limited to one or more of carboxymethyl chitosan and hyaluronic acid; the flavoring agent includes but is not limited to one or more of xylitol, sucralose and menthol; the lubricant includes but is not limited to one or more of glycerol, polyethylene glycol and stearic acid. As an example, in the following specific embodiments, the hemostatic material is carboxymethyl chitosan, the flavoring agent is xylitol, and the lubricant is glycerol.

[0047] The preparation method of the periodontal plugging agent in the present application comprises the following steps:

[0048] (1) mixing a hydrophobic agent and a portion of a diluent, heating, and stirring to obtain a mixture A;

[0049] (2) mixing a hydrophilic agent and another portion of a diluent, stirring, and then adding mixture A, heating, and stirring to obtain mixture B;

[0050] (3) mixing mixture B and a plasticizer, and stirring to obtain a mixture C;

[0051] (4) Mixing mixture C and egg yolk lecithin, stirring, and preparing a periodontal plugging agent;

[0052] Among them, the hydrophilic agent includes dopamine, sodium alginate and polyvinyl pyrrolidone.

[0053] In the preparation method of the above-mentioned periodontal plug agent, in step (1), at a temperature of 90°C-120°C, stirring at a stirring speed of 100-300 rpm for 2-4 hours to obtain mixture A; in step (2), at a temperature of 60°C-80°C, stirring at a stirring speed of 100-300 rpm for 1.5 hours to 3 hours to obtain mixture B; in step (3), stirring at a stirring speed of 100-300 rpm for 0.5 hours to 2 hours to obtain mixture C; in step (4), stirring at a stirring speed of 100-300 rpm for 0.8 hours to 2.6 hours to obtain the periodontal plug agent.

[0054] Furthermore, in step (2) and / or step (4), a functional component is added, and the functional component includes one or more of a hemostatic material, a flavoring agent, and a lubricant; preferably, the mass ratio of the hydrophilic agent, the hemostatic material, the flavoring agent, and the lubricant is (6-17):1:(0.1-0.5):(0.5-2). The periodontal plug therapeutic agent prepared by the above preparation method is a paste formed by a hydrophobic substance encapsulating a hydrophilic substance. When entering the moist environment of the oral cavity, the surface is smooth and the texture is soft. It is not easy to cause damage to the buccal side or the wound surface due to friction caused by oral movement. Moreover, under the dissolution effect of saliva, the hydrophilic substance in the periodontal plug therapeutic agent slowly dissolves without the need for removal.

[0055] The molecular chain of egg yolk lecithin is relatively long, and it is not easy to break itself. It can be mutually entangled and coated with other substances, especially with hydrophilic agents. The hydrophilic agents (dopamine, sodium alginate and polyvinyl pyrrolidone) themselves have phenolic hydroxyl groups and / or aniline structures, especially dopamine, which can be fully adsorbed inside and outside the structure of each material, so that the entire periodontal plug therapeutic agent has strong adhesion from the inside to the outside. The above-mentioned hydrophilic agent and diluent, hydrophobic agent, egg yolk lecithin and plasticizer work together under appropriate ratios. The prepared periodontal plug therapeutic agent can show strong wet adhesion ability when entering the moist environment of the oral cavity, forming close contact with the wound surface, eliminating the gap with the tissue interface, quickly closing the wound surface, and avoiding plaque formation. And the adhesion and degradation time of the periodontal plug therapeutic agent in the oral cavity are greatly improved, which is conducive to efficiently promoting wound healing.

[0056] It is understandable that the periodontal plug agent prepared by the above method can be used in the preparation of medicines or medical devices for treating oral wounds; preferably, the oral wound is a periodontal tissue wound.

[0057] Example

[0058] The following are specific embodiments, among which Embodiment 1 is a preferred embodiment, which is preferably an example with the best conditions of adhesion strength, adhesion time and in vitro degradation time. The prepared periodontal plug has good plasticity and can play a role in wound repair for a long time, making it easy for clinicians to shape it to adapt to more complex wound environments.

[0059] Examples 1-6

[0060] The preparation method of the periodontal plugging agent is as follows:

[0061] (1) A hydrophobic agent, 10 g of anhydrous ethanol and 2 g of propylene glycol were stirred at 100° C. and 150 rpm for 2 h to obtain a mixture A.

[0062] (2) Dopamine, sodium alginate (molecular weight of 50,000 Da), polyvinyl pyrrolidone (molecular weight of 38,000 Da) and 6 g of carboxymethyl chitosan (molecular weight of 9,000 Da) were placed in a stirring device, 10 g of purified water and 2 g of propylene glycol were added, and the mixture was stirred at a stirring speed of 150 rpm for 3 min. Mixture A was added, and the mixture was heated to 70°C while stirring, and stirring was continued for 2 h to obtain mixture B.

[0063] (3) Add a plasticizer to mixture B, and stir the mixture at a stirring speed of 200 rpm for 30 min to obtain mixture C.

[0064] (4) Add egg yolk lecithin to mixture C, and stir at 150 rpm for 1 h to obtain mixture D.

[0065] (5) 5 g of glycerol and 2 g of xylitol were added to the mixture D, and the mixture was stirred at 150 rpm for 30 min to prepare a periodontal plug preparation.

[0066] The addition amount of each substance in Examples 1-6 is shown in Table 1. It should be noted that the periodontal plug preparations prepared in Examples 1-7 are all pastes with uniform texture.

[0067] Table 1. Addition amount of each substance in Examples 1-6

[0068]

[0069] Example 7

[0070] The preparation method of the periodontal plugging agent is as follows:

[0071] The difference from Example 1 is that step (5) is not performed, and carboxymethyl chitosan (molecular weight 9 kiloDa) is not added in step (2), and the remaining steps are the same as Example 1.

[0072] Comparative Example

[0073] Comparative Examples 1-8

[0074] The preparation method is as follows:

[0075] The difference from Example 1 is that the amount of material added is different. The amount of material added in Comparative Examples 1-8 is shown in Table 2.

[0076] Table 2. Addition amount of materials in comparative examples 1-8

[0077]

[0078] Comparative Example 9

[0079] The preparation method is as follows:

[0080] The difference from Example 1 is that in step (2), dopamine is replaced by an equal amount of mussel mucin (molecular weight 130 kiloDa), and the remaining steps are the same as Example 1.

[0081] Comparative Example 10

[0082] The preparation method is as follows:

[0083] The difference from Example 1 is that in step (2), polyvinyl pyrrolidone is replaced by an equal amount of sodium carboxymethyl cellulose (molecular weight 30,000 Da), and the remaining steps are the same as Example 1.

[0084] Comparative Example 11

[0085] The preparation method is as follows:

[0086] The difference from Example 1 is that in step (4), egg yolk phosphatidylcholine is replaced by an equal amount of methyl glyceride.

[0087] It should be noted that egg yolk lecithin can also be replaced by an equal amount of Tween 80. Since the data are close, this application only lists the corresponding data when egg yolk lecithin is replaced by an equal amount of methyl glyceride.

[0088] Comparative Example 12

[0089] The periodontal plugging agent was prepared according to the preparation method of Example 4 in the patent application publication number CN113679848A, and 6 g of carboxymethyl chitosan (molecular weight 9 kiloDa) was added in step 3.

[0090] Performance testing

[0091] It should be noted that the present application prepares artificial saliva according to the following method, so as to simulate the state of the periodontal plugging agent in the oral saliva environment in the performance test. Artificial saliva is prepared according to the ISO / TR10271 method, and the ingredients are as follows: 0.4g NaCl, 0.4g KCl, 0.78g NaH2PO4·2H2O, 0.005g Na2S·2H2O, 1.0g urea, 0.795g CaCl2·2H2O, 1000mL purified water. The pH value of the artificial saliva is adjusted to 6.0 with NaOH and HCl solution, and stored in a refrigerator at 4°C for use.

[0092] Experiment 1: Adhesion Strength Test

[0093] The adhesion strength test can quantitatively evaluate the adhesion of periodontal plug therapeutic agents on oral wounds. The specific experimental operation is as follows: trim fresh pig skin into 1cm×6cm strips, overlap the ends of two pig skins, and the overlapping area is 1cm×1cm. Use artificial saliva to moisten the overlapping surface, and take 1g of the periodontal plug therapeutic agent prepared in Example 1-7 and Comparative Example 1-12 respectively and apply it evenly on the overlapping surface, gently press the overlapping part for 1 minute, and obtain the test sample. Place the test sample in the fixture of the testing machine (the testing machine is purchased from Xiamen Easy Instrument Co., Ltd., model STD500), and the force direction is the long axis direction of the test sample, such as Figure 1 As shown, the fixture of the testing machine fixes the two ends of the long axis direction of the sample to be tested, and applies a pulling force in the opposite direction to the sample to be tested at a speed of 5mm / min along the long axis direction of the sample to be tested until the sample to be tested is destroyed, and the maximum force at the time of destruction is recorded. The adhesion strength is determined by dividing the maximum force by the adhesion area. Repeat three times and calculate the average value. The test data of the embodiment is shown in Table 3; the test data of the comparative example is shown in Table 4.

[0094] Experiment 2: Adhesion time test

[0095] The adhesion time test can quantitatively evaluate the adhesion time of periodontal plugs on oral wounds. The specific experimental operation is as follows: Cut the pig gums into appropriate sizes (1cm×1cm, 2mm thick), moisten them with a small amount of physiological saline, and fix the moistened pig gums on a microscope slide with a cyanoacrylate adhesive. Take 0.1g of the periodontal plugs prepared in Examples 1-7 and Comparative Examples 1-12 respectively, apply them evenly on the pig gums, and press lightly for 2 minutes. Afterwards, place the slide in a beaker containing 40mL of artificial saliva and stir slowly with a magnetic force. The time it takes for the sample to completely detach from the pig gums is the adhesion time. Repeat three times and take the average value. The test data of the embodiment is shown in Table 3; the test data of the comparative example is shown in Table 4.

[0096] Experiment 3: In vitro degradation time test

[0097] The in vitro degradation time can roughly infer the degradation time of the periodontal plug therapeutic agent in the oral cavity. The specific experimental operation is as follows: Take 1g of the periodontal plug therapeutic agent prepared in Examples 1-7 and Comparative Examples 1-12 respectively, make it into a sphere, press it on the inner wall of a beaker with a specification of 250mL and shape it into a round sample with a diameter of about 1.6cm, add 100mL of artificial saliva, stir at 37°C and 200rpm until it is completely dissolved, and observe the dissolution of the sample. The time corresponding to the complete dissolution of the sample is counted as the degradation time. The test data of the embodiment is shown in Table 3; the test data of the comparative example is shown in Table 4.

[0098] Table 3. Adhesion strength, adhesion time and in vitro degradation time data of samples prepared in the examples

[0099]

[0100] Table 4. Adhesion strength, adhesion time and in vitro degradation time data of samples prepared in comparative examples

[0101]

[0102]

[0103] It can be seen from the data in Table 3 and Table 4 (it should be noted that the data of Comparative Examples 5 and 6 are close to the data of Comparative Example 4, and the data of Comparative Examples 5 and 6 are not listed here; the data of Comparative Example 8 is close to the data of Comparative Example 7, and the data of Comparative Example 8 is not listed here), dopamine, sodium alginate and polyvinyl pyrrolidone need to be used in combination, and none of them can be missing. In particular, when the mass ratio of dopamine, sodium alginate and polyvinyl pyrrolidone is appropriate, the prepared periodontal plug has a higher adhesion strength and a longer adhesion time, and the degradation time is also longer (up to 120 hours or more), which is much longer than the periodontal plug prepared in the comparative example, indicating that the periodontal plug prepared in the present application can provide sufficient healing time for wound healing. When hydrophilic agents including dopamine, sodium alginate and polyvinyl pyrrolidone work synergistically with diluents, hydrophobic agents, egg yolk lecithin and plasticizers in a suitable ratio, it helps the periodontal suppository to enter the moist environment of the oral cavity and exhibit strong wet adhesion ability, which helps to provide long-term protection for the wound, form close contact with the wound surface, eliminate gaps with the tissue interface, quickly seal the wound surface, and last longer in the mouth.

[0104] Experiment 4: Swelling performance test

[0105] The swelling test was used to evaluate the size change of the periodontal plug in the oral cavity. The specific operation was as follows: 1 g of the periodontal plug prepared in Example 1 and Comparative Example 12 was respectively put into a centrifuge tube, 20 mL of artificial saliva was added, and the tube was placed in a 37° C. shaker at a speed of 100 rpm. The artificial saliva was replaced daily. The mass W1 of the sample was tested when the swelling volume was the largest, and the swelling rate A was calculated according to the following formula:

[0106] A(%)=(W1-W0) / W0×100, where W0 is the initial mass of the sample. The swelling performance test data is shown in Table 5.

[0107] Experiment 5: Consistency Test

[0108] The consistency test can be used to evaluate the shaping ability of the periodontal plug agent, that is, the shaping effect of the sample during the actual operation of the clinician. The specific operation is as follows: Take 1g of the periodontal plug agent prepared in Example 1 and Comparative Example 12, respectively, make it into a sphere and place it on a glass plate, cover it with a 5cm×5cm weighing paper, and then place a 500g standard weight vertically above the center of the sample. After staying for 30s, remove the weight, and use a measuring tool with an accuracy of 1mm to measure the diameter of the sample after deformation (if it is an ellipse, take the average value of its major and minor axes), record the diameter, and the results are shown in Table 5.

[0109] Table 5. Swelling rate and consistency of the periodontal plug prepared in Example 1 and Comparative Example 12

[0110]

[0111]

[0112] The swelling rate of the periodontal tampon prepared in Example 1 is less than 500%, indicating that the periodontal tampon has good dimensional stability and good comfort in the patient's mouth during use, while the swelling rate of the periodontal tampon prepared in Comparative Example 12 is higher, indicating that the periodontal tampon has a large size change due to water absorption when used in the oral cavity, affecting the use experience and oral activities, and causing inconvenience to the patient. The consistency of the periodontal tampon prepared in Example 1 is higher than that of Comparative Example 12, indicating that the periodontal tampon prepared in Example 1 has good shaping ability and can adapt to different wound shapes.

[0113] Experiment 6: Drug release rate

[0114] The release of the hemostatic material was evaluated by the drug release rate. The specific operation was as follows: 1 g of the periodontal plug prepared in Example 1 and Comparative Example 12 was respectively taken, made into a sphere and adhered to the inner wall of a beaker, and then 200 mL of artificial saliva was added to the beaker, and the mixture was shaken at 37° C. and 100 rpm to simulate the release.

[0115] At time periods of 4h, 8h, 12h, 16h, 20h, and 24h, 2.0mL of the solution in the beaker was taken into a 15mL stoppered test tube, and 1mL of DNS test solution was added. The mixture was heated in a boiling water bath for 5min to develop color. The mixture was then cooled with running water, diluted to 10mL with water, vortexed and mixed, and the absorbance was measured at a wavelength of 525nm. The carboxymethyl chitosan content was calculated using the standard curve, and the drug release rate of the periodontal plug was obtained based on the above. The results are shown in Table 6.

[0116] Table 6. Drug release rate of periodontal plug preparations prepared in Example 1 and Comparative Example 12

[0117]

[0118] It can be seen from Table 6 that the periodontal tampon prepared in Example 1 can achieve the slow release of the hemostatic material and has a good drug sustained release effect, and the total release rate of the periodontal tampon prepared in Example 1 is greater than that of Comparative Example 12. During the entire release process, the release curve of the hemostatic material in the periodontal tampon prepared in Example 1 is relatively slow, which may be due to the synergistic effect of the hydrophilic agent and the diluent, the hydrophobic agent, the egg yolk lecithin and the plasticizer in a suitable ratio, and the formed coating structure is uniform and stable, and has a better drug release control effect.

[0119] It should be understood that the disclosed invention is not limited only to the specific method, scheme and material of description, because these all can change.It should also be understood that the terminology used herein is only for the purpose of describing specific embodiment scheme, rather than being intended to limit the scope of the present invention, and the scope of the present invention is only limited to the appended claims.

[0120] Those skilled in the art will also recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments of the invention described herein. Such equivalents are also intended to be encompassed by the appended claims.

Claims

1. A periodontal plugging agent, characterized in that: The invention comprises a diluent, a hydrophilic agent, a hydrophobic agent, egg yolk lecithin and a plasticizer, wherein the mass ratio of the hydrophilic agent, the hydrophobic agent, the egg yolk lecithin and the plasticizer is (4-10):(2-6):(1-4):1, wherein the hydrophilic agent comprises dopamine, sodium alginate and polyvinyl pyrrolidone.

2. The periodontal plugging agent according to claim 1, characterized in that: The mass ratio of the dopamine, the sodium alginate and the polyvinyl pyrrolidone is 1:(0.5-0.8):(1.2-1.5).

3. The periodontal plugging agent according to claim 1, characterized in that: It also includes functional components, which include one or more of a hemostatic material, a flavoring agent and a lubricant; preferably, the mass ratio of the hydrophilic agent, the hemostatic material, the flavoring agent and the lubricant is (6-17):1:(0.1-0.5):(0.5-2).

4. The periodontal plugging agent according to claim 3, characterized in that: The hemostatic material includes one or more of carboxymethyl chitosan and hyaluronic acid; the flavoring agent includes one or more of xylitol, sucralose and menthol; and the lubricant includes one or more of glycerol, polyethylene glycol and stearic acid.

5. The periodontal plugging agent according to claim 1, characterized in that: The mass ratio of the hydrophilic agent to the diluent is (1-2.6):

1. Preferably, the diluent includes one or more of purified water, ethanol, polyethylene glycol and propylene glycol.

6. The periodontal plugging agent according to claim 1, characterized in that: The plasticizer includes one or more of microcrystalline wax, paraffin wax, vaseline, lanolin, beeswax, triacetin, citrate and dibutyl adipate; the hydrophobic agent includes one or more of polyvinyl acetate, methyl methacrylate, ethyl cellulose, rosin glycerol ester and natural rubber.

7. The method for preparing the periodontal plugging agent according to any one of claims 1 to 6, characterized in that: The steps include: (1) mixing a hydrophobic agent and a portion of a diluent, heating, and stirring to obtain a mixture A; (2) mixing a hydrophilic agent and another portion of a diluent, stirring, adding the mixture A, heating, and stirring again to obtain a mixture B; (3) mixing the mixture B and the plasticizer, stirring, to obtain a mixture C; (4) mixing the mixture C and egg yolk lecithin, stirring, and preparing the periodontal plug agent; Wherein, the hydrophilic agent includes dopamine, sodium alginate and polyvinyl pyrrolidone.

8. The method for preparing the periodontal plugging agent according to claim 7, characterized in that: Functional components are also added in step (2) and / or step (4), and the functional components include one or more of a hemostatic material, a flavoring agent and a lubricant; preferably, the mass ratio of the hydrophilic agent, the hemostatic material, the flavoring agent and the lubricant is (6-17):1:(0.1-0.5):(0.5-2).

9. The method for preparing the periodontal plugging agent according to claim 7, characterized in that: In step (1), at a temperature of 90°C-120°C, the mixture is stirred at a stirring speed of 100-300 rpm for 2-4 hours to obtain the mixture A; in step (2), at a temperature of 60°C-80°C, the mixture is stirred at a stirring speed of 100-300 rpm for 1.5 hours to 3 hours to obtain the mixture B; in step (3), the mixture is stirred at a stirring speed of 100-300 rpm for 0.5 hours to 2 hours to obtain the mixture C; in step (4), the mixture is stirred at a stirring speed of 100-300 rpm for 0.8 hours to 2.6 hours.

10. Use of the periodontal plug agent according to any one of claims 1 to 6 in the preparation of a medicine or medical device for treating an oral wound; preferably, the oral wound is a periodontal tissue wound.

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