JP4746549B2 - Denture stabilizing composition - Google Patents

Description

  The present invention relates to a composition for stabilizing a denture that is simple to use in denture attachment and has excellent properties such as adhesiveness, cushioning properties, durability, feeling of use, and safety to the human body. The present invention relates to a composition for stabilizing dentures, which eliminates or alleviates instability and pain due to poor maintenance of wearing and realizes comfortable wearing of dentures.

  Regardless of how accurately the denture is fitted and occluded, the unevenness of the denture material (gum etc.) and palate will cause incompatibility due to uneven rigidity and deformation of the denture material. May occur. In addition, with the passage of time, the jaw crest is often absorbed, resulting in decreased stability, inability to eat satisfactorily, and difficulty in conversation. In this case, it is essentially necessary to readjust the denture by a dentist, but it is often difficult to readjust immediately for economic or time reasons. For this reason, denture stabilizers are often used as a provisional treatment until readjustment.

  In recent years, in Japan, aging has progressed rapidly, and elderly people who need dentures have risen, and the need for denture stabilizers has rapidly increased. There is a strong need for denture stabilizers that are safe and harmless, especially for elderly people requiring nursing care, even if they are swallowed unexpectedly or are insufficiently wiped.

Denture stabilizers currently available on the market are classified into a denture type and a cushion type depending on the method of denture stabilization. The adhesive type is composed mainly of a water-soluble polymer and absorbs saliva and / or water between the denture base and the oral mucosal surface to form sticky high-viscosity materials (including gel-like materials). The denture is fixed using the sex. Examples of the substance used include CMC, Karaya gum, Arabia gum, tragacanth gum, sodium polyacrylate, polyethylene oxide, PVA, and methoxymethylene maleic anhydride copolymer. (See Patent Documents 1 and 2)
The cushion mold is a substance having a rubber-like cushioning property and is used to fix a denture by filling between the denture base and the oral mucosa surface. Examples of the substance used include vinyl acetate copolymer, partially hydrolyzed vinyl acetate copolymer, polyethylene oxide, PVA, and low saponification degree PVA (see Patent Documents 3 and 4). These are classified into powder type, cream type, tape type, and the like when classified by form.

  These denture stabilizers are added with a plasticizer to improve viscoelastic properties and tackiness. Further, a colorant, a bactericidal agent, an antibacterial agent, a bacteriostatic agent, a flavoring agent, a pH adjusting agent and the like are added as necessary.

  These existing denture stabilizers are difficult to wipe from the dentures and the oral mucosa surface regardless of the adhesive type or the cushion type. For this reason, there are problems such that the oral mucosa is inflamed by the denture stabilizer remaining on the surface of the oral mucosa, and the oral mucosa is damaged by excessive wiping. In addition, there are troubles such as remaining on the denture, causing dirt and germs to propagate, and deteriorating the hygienic condition of the denture.

  In addition, the cushion type is a rubber-like material with poor fluidity, so it is difficult to cover the denture and the oral mucosal surface thinly and evenly. Continuing use deteriorates the compatibility with the denture and the oral surface and causes occlusion. May change. And this causes problems such as causing alveolar bone and jawbone resorption.

In addition to these problems, depending on the types of existing denture stabilizers and added plasticizers, these substances may dissolve in the mouth and cause abnormal taste, or may be absorbed into the human body and adversely affect the whole body. There are problems such as concern over In addition, it is also known that when the plasticizer is eluted, the denture stabilizer hardens and the cushioning property is remarkably lowered.
Japanese Patent No. 3179102 Japanese Patent No. 3460349 Japanese Patent No. 2547276 Japanese Patent No. 2568397

  The present invention seeks to solve the above-mentioned problems of existing denture stabilizers. In particular, in Japan, the aging of society is rapidly progressing, and elderly people who need dentures are increasing, and the need for denture stabilizers is rapidly increasing. In particular, it is intended to respond to the strong demand for safe and harmless denture stabilizers for unexpected elderly swallowing or inadequate wiping.

  That is, the composition for stabilizing dentures according to the present invention is easy to use in attaching dentures, and has excellent properties such as adhesiveness, cushioning properties, durability, feeling of use, safety to the human body, etc. It eliminates or relieves instability and pain due to poor maintenance of dentures and realizes comfortable dentures.

  Specifically, (1) Difficulty of wiping from dentures and oral mucosal surfaces in existing adhesive-type and cushion-type denture stabilizers (2) Inflammation and damage of oral mucosa caused by difficulty of wiping and insufficient wiping Oral mucosal troubles such as (3) Denture fouling caused by difficult and insufficient wiping, dengue hygiene problems such as bacterial growth (4) Dentures in denture stabilizers composed of synthetic polymers Abnormal taste caused by elution of stabilizer components, unreacted monomers, oligomers, plasticizers, etc. and adverse effects on the whole body caused by absorption in the human body (5) Environmental hormones found in some oligomers and plasticizers (6) Poor flow and difficulty in thin and uniform lining due to it, (7) Due to problems such as danger, in addition to this, cushion type rubbery denture stabilizer Stiff change particular absorption of alveolar bone and jaw bone occlusion (8) is intended to solve the problems such as a reduction in cushioning property due to curing denture stabilizer plasticizer elution causes.

The present inventors solved the problems of the existing denture stabilizers as described above by using poly-γ-glutamic acid (hereinafter referred to as “γ-PGA”) as a denture stabilizing composition. That is, it has been found that the problem can be solved by using γ-PGA as a highly viscous material (including a gel-like material) dissolved in saliva and / or water.

  Next, the contents will be described in detail. For example, an appropriate amount of powdery γ-PGA is thinly and uniformly placed on the surface of a denture that contacts the oral mucosal surface. Subsequently, when an appropriate amount of water is dropped onto the γ-PGA, the γ-PGA absorbs the water, rapidly swells and dissolves, and becomes a highly viscous material exhibiting appropriate fluidity and elasticity. In this state, when the denture is brought into contact with the oral mucosal surface and gently pressed, the denture is adhesively fixed to the oral mucosal surface. In this state, the denture was extremely stable for a long time without loosening, and an appropriate cushioning effect was obtained, and there was no trouble in eating, talking, chewing and the like.

  In addition, an appropriate amount of powdery γ-PGA is thinly and uniformly placed on the surface of the denture contacting the oral mucosal surface. Subsequently, when the denture ridge and the mucous membrane of the oral cavity that are in contact with the surface of the denture are sufficiently moistened with saliva and water, and the denture and the mucosa of the oral cavity and the oral mucosa are brought into contact and gently pressed, γ-PGA absorbs moisture It rapidly swells and dissolves and becomes a highly viscous material exhibiting moderate fluidity and elasticity. The denture is adhesively fixed to the oral mucosal surface. In this state, the denture was extremely stable for a long time without loosening, and an appropriate cushioning effect was obtained, and there was no trouble in eating, talking, chewing and the like.

  In addition, γ-PGA prepared as a highly viscous material with appropriate fluidity and elasticity by adding water is made into a film, tape, or gel and placed thinly and evenly on the surface of the denture contacting the oral mucosal surface. In this state, when the denture is brought into contact with the oral mucosal surface and gently pressed, the denture is adhesively fixed to the oral mucosal surface. In this state, the denture was extremely stable for a long time without loosening, and an appropriate cushioning effect was obtained, and there was no trouble in eating, talking, chewing and the like.

  Such excellent action of γ-PGA is due to the following action. That is, γ-PGA molecules form strong hydrogen bonds within and between molecules in an aqueous solution. At the same time, a strong hydrogen bond is formed with water as a solvent. The γ-PGA molecule takes a helical conformation in an aqueous solution. In other words, γ-PGA high-viscosity material that swells and dissolves with water and / or saliva has a strong intramolecular γ-PGA molecule, intermolecular hydrogen bonding and helical conformation, and is necessary as a composition for stabilizing dentures. It has been found that appropriate moderate tackiness, cushioning properties and viscoelasticity are exhibited.

  In the denture stabilizing composition of the present invention, γ-PGA is a component necessary for developing the adhesiveness, cushioning properties, and viscoelasticity necessary for the denture stabilizing composition, and γ-PGA alone or γ- The composition which added arbitrary components, such as an antibacterial plant extract, a coloring agent, a disinfectant, an antibacterial agent, a fragrance | flavor, a pH adjuster etc. which are mentioned later to PGA, in the range which does not impair the property which (gamma) -PGA has may be sufficient.

  Here, the safety of γ-PGA and saliva and / or water will be described. Saliva is a physiological fluid. Needless to say, water is a safe substance. γ-PAG is a viscous component of natto and exhibits biodegradability, biocompatibility and physiological activity, and is not only extremely safe for the human body but also exhibits excellent physiological functions. In addition, since no synthetic polymer or plasticizer is used, there is no concern about taste abnormalities caused by unreacted monomers, oligomers, added plasticizers, etc., and adverse effects on the whole body caused by absorption of these into the human body. In addition, there is no danger as an environmental hormone concerned about some unreacted monomers, oligomers and plasticizers. That is, it is clear that the denture stabilizing composition shown in the present invention is extremely safe. Here, the inclusion of other substances such as glycerin, lactose, soluble starch and the like within a range not impairing the action of saliva and / or water does not impair the significance of the present invention.

The molecular weight of γ-PGA used here is preferably 500,000 or more in order to exhibit appropriate tackiness and viscoelasticity as a denture stabilizing composition. In particular, it is desirable to be 1 million or more. If the molecular weight is appropriate, γ-PGA dissolves smoothly in saliva and / or water, and a high-viscosity product having excellent adhesiveness and suitable viscoelasticity is obtained. Here, a polysaccharide such as a fructan may be included as long as γ-PGA exhibits water solubility and strong adhesiveness. The presence of an appropriate amount of fructan has the effect of increasing the spinnability and fluidity of the γ-PGA high-viscosity product, and the γ-PGA high-viscosity product is spread thinly and evenly on the contact surface between the denture and the oral mucosa surface. It is valid.

  If necessary, chitosan may be mixed. Chitosan can be uniformly mixed with γ-PGA at an arbitrary ratio, and the molecular chain is rigid, so the addition of an appropriate amount of chitosan is effective in increasing the elasticity of the highly viscous material. In addition, since chitosan exhibits antibacterial and biocompatibility, it is as effective and safe as a substance used in the oral cavity, like γ-PGA.

  If necessary, γ-PGA may be cross-linked within a range that does not impair its original properties. Crosslinking is effective for controlling swelling, elasticity and strength. As the crosslinking method, a reagent, heat, radiation, or the like can be used. Further, γ-PGA and crosslinked γ-PGA may be mixed.

  Γ-PGA may have all side chain carboxyl groups in acid form, all side chain carboxyl groups in salt form, or one group of carboxyl groups in both acid and salt forms. Alternatively, some or all of these may be mixed and mixed. Here, the salt form may be a cation that forms an ion with a carboxyl group, and the type thereof is not limited. That is, metal ions such as ions of lithium, potassium, sodium, calcium, magnesium, tin, aluminum, iron, nickel, cobalt, ammonium ions, and organic amine cations can be used. In particular, it was found that when the carboxyl group of the side chain is in a salt form of 10 mol% or more, the affinity for saliva and water is improved and the swelling and dissolution becomes smooth. Γ-PGA described in the present invention is a general term for γ-PGA described herein. Further, these γ-PGA alone or a mixture thereof may be a mixture with fractane or chitosan.

  The production method of γ-PGA used here will be described. As long as the γ-PGA used is obtained by the bacteria that produce it, the type, culture method and conditions of the bacteria are not questioned, but those produced by culturing natto bacteria from the viewpoint of safety to the human body Is preferred.

  It is well known that γ-PGA is not only a edible substance as a viscous component of natto but also has biodegradability, biocompatibility, and physiological activity. Is not conceivable, but rather has a bioactive effect. That is, even if it is swallowed with saliva or water or eluted from between the denture and the oral mucosa, there is no concern about the adverse effects on the whole body due to absorption into the human body. Further, as described above, since no plasticizer is added, there is no adverse effect of the plasticizer on the human body, and high safety can be obtained.

  Furthermore, refine | purified (gamma) -PGA does not impair the taste, aroma, etc. of food and drink.

  It should be noted that the addition of an appropriate amount of optional components such as a colorant, bactericidal agent, antibacterial agent, flavoring agent, pH adjuster and the like as required does not change the contents of the present invention. In addition, natural products such as Karaya gum, Arabia gum, tragacanth gum, and xanthan gum, or similar CMC and glycerin can be added as long as the characteristics of the present invention are not impaired, and the contents of the present invention are not changed. In particular, an antibacterial plant extract is suitable as the antibacterial agent. Addition of antibacterial plant extract is effective in suppressing the degradation of γ-PGA by oral microorganisms, normalizing the structure of oral microorganisms, increasing the regenerative power of oral mucosal surfaces, improving immunity, etc. It was found to show an effect. Antibacterial plant extracts include, for example, Arnica, Owaku, Auren, Calendula, Clara (Cushin), Mulberry (Mulberry Leaf), Gentian Shoko, Shikon, Daffodil, Honeysuckle, Apricot, Thyme, Cha, Choji, Tokasenka, Garlic, Heath ( Erica), hinokitiol, buttons, hops, etc., but the effect is particularly remarkable when polyphenol is added. Here, the polyphenol is at least one selected from epigallocatechin (EGC), epigallocatechin gallate (ECGg), epicatechin (EC), and epicatechin gallate (ECg).

  The composition for stabilizing dentures of the present invention is easy to use in denture attachment and has excellent properties such as adhesiveness, cushioning properties, durability, feeling of use, safety to the human body, etc. It eliminates or relieves instability and pain due to poor maintenance of wearing and realizes comfortable wearing of dentures. (1) Difficulty of wiping from dentures and oral mucosal surfaces in existing adhesive-type and cushion-type denture stabilizers (2) Inflammation and damage of oral mucosa caused by wiping difficulties and insufficient wiping Oral mucosal troubles (3) Denture hygiene problems such as denture fouling and bacterial growth caused by difficulty and insufficient wiping (4) Denture stabilizers in denture stabilizers composed of synthetic polymers Taste abnormalities caused by elution of components, unreacted monomers, oligomers, plasticizers, etc. and adverse effects on the whole body caused by absorption in the human body (5) Danger as an environmental hormone found in some oligomers and plasticizers In addition to this, (6) poor flow and difficulty in thin and uniform lining caused by it in the cushion-type rubber-like denture stabilizer, (7) caused by this If the change in particular the absorption of alveolar bone and jaw (8) of the relationship is to solve the problems such as a reduction in cushioning property due to curing denture stabilizer plasticizer elution causes.

    The contents and effects of the present invention will be specifically described below, but it goes without saying that the present invention is not limited to the examples shown here.

(1) Preparation of test piece An alginic acid impression material was used to obtain an impression of the toothed jaw palate without pressure, and an upper jaw model was prepared from the impression using an anhydrite. A test plate was prepared from the anhydrite model using an instant polymerization resin. The test plate was sized to cover the palate with the trailing edge of the line connecting the second molar distal portion from a position 3 mm away from the tooth neck line, and the weight was 2.4 g. A loop-like silk suture (standard GA03SB) was attached to the center of the test plate on the palate floor with an immediate polymerization resin.

(2) Measurement of adhesive strength The test plate described above is set on the intraoral palate, and the lips and upper and lower jaws are closed and lightly crimped for 1 minute with the back of the tongue. Next, the silk suture thread (standard GA03SB) fixed in a loop shape is pulled in parallel with the occlusal plane by the measuring needle of a tensiometer (manufactured by HAAG-STREIT (SWITZERLAND)), and the tension required to pull the test plate away from the palate. The tension was measured and used as an index of adhesive strength. During the measurement, the mouth was cleaned as much as possible to suppress the influence of contamination.

(3) Measurement results Measurements were made in Comparative Example 1: Saliva only, Comparative Example 2: Commercially available fine powder type denture stabilizer, Example 1: Denture stabilizing composition of the present invention (fine powder type γ- with a molecular weight of 3 million) Three types of (PGA ammonium) were used.

  The denture stabilizing composition of the present invention and a commercially available denture stabilizer are each thinly spread by 0.1 g on the surface of the denture that comes into contact with the oral mucosal surface, and 0.9 g of water is uniformly applied in a mist form by spraying. The denture stabilizing composition and the commercial denture stabilizer of the present invention that have absorbed moisture rapidly swell and dissolve to become a highly viscous product exhibiting appropriate fluidity and elasticity. In this state, when the denture was brought into contact with the oral mucosal surface and pressed gently, the denture was adhered and fixed to the oral mucosal surface.

Table 1 shows the change in adhesive strength when pressure bonding and peeling were repeated with saliva, a denture stabilizing composition of the present invention, and a denture coated with a commercially available denture stabilizer. In the case of only the saliva of Comparative Example 1, there is no change in the adhesive strength even when the pressure bonding and peeling are repeated, but the adhesive strength is low. In the case of the commercially available fine powder type denture stabilizer of Comparative Example 1, the initial adhesive strength is high to some extent, but a tendency to decrease is shown when pressure bonding and peeling are repeated. On the other hand, in the case of the composition for stabilizing dentures of Example 1 of the present invention, the initial adhesive strength is the highest, and the decrease is small even after repeated pressing and peeling. It can be seen that the denture stabilizing composition of the present invention has high adhesive force and excellent stability.

Table 2 shows the reproducibility of the adhesive strength of the denture stabilizing composition of the present invention and the commercially available denture stabilizer. Both were newly applied to the denture every time and the adhesive strength was measured. Although both show adhesive force and reproducibility is recognized, it can be seen that the denture stabilizing composition of the present invention has high adhesive force and excellent stability.

  An appropriate amount of fine powdery sodium γ-PGA (molecular weight 3 million) is spread thinly on the surface of the denture that comes into contact with the oral mucosal surface, and then a small amount of water is dropped. Finely powdered sodium γ-PGA that has absorbed moisture rapidly swells and dissolves to become a highly viscous product exhibiting moderate fluidity and elasticity. The viscosity of the solution was 5000 centipoise. In this state, when the denture was brought into contact with the oral mucosal surface and pressed gently, the denture was adhered and fixed to the oral mucosal surface. In this state, the denture was extremely stable and free of slack for a long period of time, and an appropriate cushioning effect was obtained, and there was no trouble in eating, speaking, chewing and the like.

  Table 3 shows the measurement results of denture maintenance force (adhesive strength) of the composition for stabilizing dentures of the present invention measured by the same method as in Example 1. After the denture was fixed to the oral mucosal surface, the adhesive strength at the time of peeling was measured after a predetermined time. It can be seen that the adhesive strength is maintained for a long time.

  After use, γ-PGA could be easily wiped away by washing the denture with running water such as tap water or by using light brushing together with running water washing. Further, γ-PGA adhering to the oral mucosal surface could be easily wiped off with clean water such as tap water or by a combination of light brushing and scooping. There was no inflammation or damage to the oral mucosa.

The refined sodium γ-PGA did not impair the taste and aroma of food and drink. In addition, the γ-PGA sodium that was eluted had no adverse effect on the human body.

  Appropriate amount of γ-PGA (molecular weight 3 million) prepared to a highly viscous product (viscosity 5500 centipoise) with a concentration of 5% using water as a solvent is thinly spread on the surface of the denture that contacts the oral mucosa. In this state, when the denture was brought into contact with the oral mucosal surface and pressed gently, the denture was adhered and fixed to the oral mucosal surface. In this state, the denture was extremely stable for a long time without loosening, and an appropriate cushioning effect was obtained, and there was no problem in eating, speaking, chewing and the like.

  Table 4 shows the relationship between the elapsed time of use and the maintenance force of the composition for stabilizing dentures of the present invention measured by the same method as in Example 1. It is clear that a stable denture maintenance force is maintained.

  After use, the γ-PGA could be easily wiped away by washing the denture with running water such as tap water or using both running water washing and light brushing. Further, γ-PGA adhering to the oral mucosal surface could be easily wiped and removed by scrubbing with clean water such as tap water or by combining light brushing and scooping. There was no inflammation or damage to the oral mucosa.

The refine | purified (gamma) -PGA did not impair the taste, fragrance, etc. of food and drink. Moreover, there was no adverse effect on the human body of the eluted γ-PGA.

  Gamma-PGA ammonium having a molecular weight of 500,000, 1,000,000, 1.5 million, 2 million, 2.5 million, and 3 million was prepared, and each was mixed and dissolved in water to prepare a highly viscous product having a concentration of 6.5% by mass. When an appropriate amount of this high-viscosity material was spread thinly on the side of the denture that contacts the oral mucosal surface, and the denture was brought into contact with the oral mucosal surface and gently pressed in this state, the denture was adhered and fixed to the oral mucosal surface. The denture was extremely stable and free of slack for a long time in this state, an appropriate cushioning effect was obtained, and there was no trouble in eating, speaking, chewing, etc., and it was extremely stable for a long time in this state. Although γ-PGA ammonium can be used even with a molecular weight of 500,000, it was particularly suitable at a molecular weight of 1 million or more.

  Table 5 shows the relationship between the molecular weight of γ-PGA ammonium and the adhesive strength measured by the same method as in Example 1. It is clear that a stable denture maintenance force (adhesive strength) is maintained.

After use, the γ-PGA ammonium could be easily wiped away by washing the denture with running water such as tap water or using a light brushing together. In addition, γ-PGA ammonium adhering to the oral mucosal surface could be easily wiped away by rinsing with clean water such as tap water or by using both light brushing and rinsing. There was no inflammation or damage to the oral mucosa. The refined γ-PGA ammonium did not impair the taste and aroma of food and drink. In addition, the γ-PGA ammonium that was eluted had no adverse effect on the human body.

  An appropriate amount of γ-PGA having a carboxyl group in acid form (molecular weight of 3.2 million) is dissolved in water at 80 ° C., and sodium bicarbonate dissolved in a small amount of water is dissolved in a small amount of 1/10 mole per structural unit of γ-PGA. In addition, it was mixed uniformly. Further, a small amount of polyphenol as an antibacterial agent was added at 500 μg / ml. The concentration of the highly viscous material was 5% by mass.

  An appropriate amount of this high-viscosity material was spread in a thin tape on the surface of the denture that contacts the oral mucosal surface, and in this state the denture was brought into contact with the oral mucosal surface and gently pressed to fix the denture to the oral mucosal surface. In this state, the denture was extremely stable for a long time without loosening, and an appropriate cushioning effect was obtained, and there was no trouble in eating, talking, chewing and the like.

  Table 6 shows the relationship between the elapsed time of use and the adhesive strength of the denture stabilizing composition of the present invention measured by the same method as in Example 1. It is clear that a stable denture maintenance force (adhesive strength) is maintained.

  In addition, the composition for stabilizing dentures of the present invention containing polyphenols shown in this example has a remarkable effect of suppressing Porphyromonas gingivalis, which is one of oral bacteria, and is a main component of a bad breath causing substance. The effect of significantly suppressing certain methyl mercaptans and hydrogen sulfide was also remarkable. In addition, the formation of amorphous calcium phosphate, which is the causative agent of plaque and calculus, and the transition of amorphous calcium phosphate to crystalline calcium phosphate were suppressed, and the formation of plaque and calculus was less likely to occur.

After use, γ-PGA could be easily wiped away by washing the denture with running water such as tap water or using a light brushing together. Further, γ-PGA adhering to the oral mucosal surface could be easily wiped and removed by scrubbing with clean water such as tap water or by combining light brushing and scooping. There was no inflammation or damage to the oral mucosa. The refine | purified (gamma) -PGA did not impair the taste, fragrance, etc. of food and drink. Moreover, there was no adverse effect on the human body of the eluted γ-PGA.

  γ-PGA (molecular weight 2.5 million) is dispersed and dissolved in tetrahydrofuran at a concentration of 5 g / 100 ml. To this was added 1/50 equivalent of carbodiimide per structural unit of γ-PGA, and γ-PGA molecules were cross-linked by reaction of both. After the reaction, tetrahydrofuran was removed, and further washed with an acidic aqueous solution and pure water to completely remove unreacted reagents from γ-PGA. Next, γ-PGA was converted to a sodium salt and dissolved in water to prepare a highly viscous product. When an appropriate amount of this high-viscosity material was spread thinly on the surface of the denture that contacts the oral mucosa surface, and in this state the denture was brought into contact with the oral mucosa surface and gently pressed, the denture was adhered and fixed to the oral mucosa surface. In this state, the denture was extremely stable for a long time and did not loosen, and an appropriate cushioning effect was obtained, and there was no problem in eating, speaking, chewing and the like. In particular, the improvement in cushioning effect due to crosslinking was significant.

  Table 7 shows the results of measuring the change in denture maintenance force (adhesive strength) with the elapsed use time of the denture stabilizing composition of the present invention.

After use, the γ-PGA sodium could be easily wiped away by washing the denture with running water such as tap water or using a light brushing together. Further, sodium γ-PGAA adhering to the oral mucosal surface could be easily wiped and removed by rinsing with clean water such as tap water or by combining light brushing and rinsing. There was no inflammation or damage to the oral mucosa. The refined sodium γ-PGA did not impair the taste and aroma of food and drink. In addition, the γ-PGA sodium that was eluted had no adverse effect on the human body.

  Γ-PGA sodium (molecular weight 2.5 million) is added to and mixed with a chitosan solution dissolved in a 60% formic acid aqueous solution. Both are uniformly mixed to obtain a transparent uniform solution. γ-PGA sodium and chitosan were prepared at a mass ratio of 80:20. This solution was dried and solidified, and further pulverized into a fine powder. Next, this powdery sodium γ-PGA and chitosan mixture was dissolved in water to prepare a highly viscous product having a concentration of 5%. When an appropriate amount of this high-viscosity material was spread in a thin film on the side of the denture that contacts the oral mucosa surface, and the denture was brought into contact with the oral mucosal surface and gently pressed in this state, the denture was adhesively fixed to the oral mucosal surface. In this state, the denture was extremely stable for a long time without loosening, and an appropriate cushioning effect was obtained. In particular, the improvement of the cushioning effect by chitosan was remarkable.

  Table 8 shows the results of measuring the denture maintenance force (adhesive strength) of the denture stabilizing composition of this example according to the method of Example 1.

  After use, when the denture was washed with running water such as tap water or light brushing was used in combination, γ-PGA sodium and chitosan could be easily removed and wiped. In addition, γ-PGA sodium and chitosan adhering to the oral mucosal surface could be easily removed by rinsing with clean water such as tap water, or by combining light brushing and rinsing. There was no inflammation or damage to the oral mucosa.

Purified sodium γ-PGA and chitosan are tasteless and odorless, and the taste and aroma of food and drink were not impaired during use. In addition, the γ-PGA sodium and chitosan eluted did not have any adverse effects on the human body.

  Sample of γ-PGA sodium (molecular weight 3 million) with high viscosity of 5% (viscosity 5500 centipoise) using water as a solvent (sample 1), sample containing 0.5% by mass of fructan (sample 2) (viscosity 5200 centipoise) and 4% by mass of the sample << Sample 3 >> (viscosity 6500 centipoise) were prepared. Appropriate amounts of these samples are spread thinly on the surface of the denture that contacts the oral mucosal surface. << Sample 1 >> << Sample 2 >> << Sample 3 >> all have sufficient spreadability, but << Sample 2 >> << Sample 3 >> are particularly excellent in spreadability. In this state, when the denture was brought into contact with the oral mucosal surface and pressed gently, the denture was adhered and fixed to the oral mucosal surface. In this state, the denture was extremely stable for a long time without loosening, and an appropriate cushioning effect was obtained, and there was no problem in eating, speaking, chewing and the like.

  Table 9 shows the relationship between the elapsed time of use and the maintenance force of the composition for stabilizing dentures of the present invention measured by the same method as in Example 1. It is clear that a stable denture maintenance force is maintained. Fractans not only improve the spreadability of high-viscosity substances, but also have the effect of improving denture retention.

  After use, the γ-PGA high-viscosity samples 1, 2 and 3 could be easily wiped away by washing the denture with running water such as tap water or using both running water washing and light brushing. In addition, the γ-PGA high viscosity samples 1, 2 and 3 adhering to the oral mucosal surface were easily wiped and removed by scrubbing with clean water such as tap water or by combining light brushing and scooping. There was no inflammation or damage to the oral mucosa.

The refined γ-PGA high-viscosity samples 1, 2, and 3 did not impair the taste and aroma of food and drink. Moreover, there was no adverse effect on the human body of the eluted γ-PGA and fructan.

  γ-PGA ammonium (molecular weight 2.5 million) 4.6% by mass, gum arabic 0.7% by mass, glycerin 20% by mass, tea catechin 0.5% by mass mixed and dissolved in water, highly viscous uniform solution (viscosity 6000 centipoise) Was prepared. An appropriate amount of this solution is spread thinly on the surface of the denture that contacts the oral mucosal surface. In this state, when the denture was brought into contact with the oral mucosal surface and pressed gently, the denture was adhered and fixed to the oral mucosal surface. In this state, the denture was extremely stable for a long time without loosening, and an appropriate cushioning effect was obtained, and there was no problem in eating, speaking, chewing and the like.

  Table 10 shows the relationship between the elapsed time of use and the maintenance force of the composition for stabilizing dentures of the present invention, measured by the same method as in Example 1. It is clear that a stable denture maintenance force is maintained.

  After use, the γ-PGA could be easily wiped away by washing the denture with running water such as tap water or using both running water washing and light brushing. Moreover, the highly viscous solution of γ-PGA adhering to the oral mucosal surface could be easily wiped off by rinsing with clean water such as tap water, or by using light brushing and glazing together. There was no inflammation or damage to the oral mucosa.

The refined γ-PGA high-viscosity solution did not impair the taste and aroma of food and drink. Further, the γ-PGA high viscosity solution to be eluted had no adverse effect on the human body.

Claims (6)

A composition for stabilizing dentures, comprising poly-γ-glutamic acid having a molecular weight of 500,000 or more .   The poly-γ-glutamic acid is an acid form, a salt form, a mixed form of acid and salt, and / or a cross-linked product, and these are composed of poly-γ-glutamic acid which is a single substance or a mixture thereof. The composition for stabilizing dentures according to 1. The composition for stabilizing dentures according to claim 1, comprising fructan . An antibacterial plant extract is contained, The composition for denture stabilization of any one of Claims 1-3 characterized by the above-mentioned.   The composition for stabilizing dentures according to any one of claims 1 to 4, comprising polyphenol as an antibacterial plant extract.   Chitosan is contained, The composition for denture stabilization of any one of Claims 1-5 characterized by the above-mentioned.