JP5069030B2 - Denture stabilizer - Google Patents

Description

  The present invention relates to a denture stabilizer used for filling a gap between a denture base and a ridge, to eliminate the backlash of the denture and to improve the reduction of masticatory power, and more particularly, it is easy to formulate and The present invention relates to a denture stabilizer that can reliably exert its function as a stabilizer.

Denture stabilizers include water-insoluble paste-like denture stabilizers mainly composed of vinyl acetate resin, water-soluble paste-like denture stabilizers in which water-soluble polymers are dispersed in mineral oil, There are molecular powder denture stabilizers.

  A water-insoluble paste denture stabilizer fills the gap between the denture and the oral mucosa and is excellent in pain relief and detachability, but does not show adhesiveness. It has the disadvantage of choosing. On the other hand, water-soluble paste-like denture stabilizers are sticky when dissolved in saliva, so they have excellent short-term denture fixing power, but use mineral oil (mainly petrolatums, paraffins) as the main ingredient. Therefore, it presents an uncomfortable feeling peculiar to oil-based preparations in the oral cavity. When a powder denture stabilizer is applied to a denture, the powder scatters and the operability during application is not good.

  In order to make up for these drawbacks, some mixed type denture stabilizers containing both a water-soluble polymer and a vinyl acetate resin have been proposed.

For example, Patent Document 1 discloses that a base material that can be applied includes alginic acid, polyvinyl acetate, carboxymethyl cellulose, and an emulsifier. An anionic cellulose ester that dissolves in alcohol, a gel composed of neutral oil, an emulsifier and an organically modified montmorillonite as a stabilizer, and a blend of an alcohol solvent, and an adhesive for dentures, etc. have been proposed and patented. Reference 2 includes polyvinyl acetate as a base material, hydroxyethylcellulose, hydroxymethylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, methylcellulose, polyvinylpyrrolidone, polyvinylmethylether, A water-soluble polymer of at least one kind of xylvinyl polymer, methoxyethylene maleic anhydride copolymer and derivatives thereof, polyethylene oxide, sodium carboxymethylcellulose, sodium polyacrylate, propylene glycol alginate, polyethylene glycol having a molecular weight of 1000 or more, and pectin Formulated denture stabilizers have been proposed. However, these were insufficient as denture stabilizers.
Japanese Patent Laid-Open No. 1-229086 JP-A-5-65210

  The present invention differs from the above-described prior art in that dentures and oral mucosa are adhesive and have the advantage of a non-water-soluble paste denture stabilizer without blending with mineral oils that are uncomfortable in the mouth. It is an object of the present invention to provide a denture stabilizer excellent in detachability that can reliably fill the gap.

  As a result of repeated studies to solve the above problems, the present inventors have formulated a specific vinyl acetate resin, a water-soluble polymer compound, water, and ethanol, and vinyl acetate resin / water-soluble polymer compound. When the weight ratio of water and the weight ratio of water / ethanol are set within specific ranges, a denture stabilizer that combines the advantages of a water-insoluble paste-like denture stabilizer and a water-soluble paste-like denture stabilizer is obtained. The present invention has been completed.

  That is, the denture stabilizer according to the present invention includes a vinyl acetate resin having an average polymerization degree of 500 to 700, a water-soluble polymer compound, water, and ethanol, and the weight ratio of vinyl acetate resin / water-soluble polymer compound is It is 1.6 to 3.0, and the weight ratio of water / ethanol is 1.0 to 4.0.

  In the denture stabilizer according to the present invention, when the average degree of polymerization of the vinyl acetate resin is less than 500, the denture stabilizer adheres strongly to the denture and is difficult to peel off, and when it exceeds 700, the resin becomes a lump and difficult to formulate. is there. The average degree of polymerization of the vinyl acetate resin is 500 to 700, preferably 600 to 700, and more preferably 630.

  In the denture stabilizer according to the present invention, when the weight ratio of vinyl acetate resin / water-soluble polymer compound is less than 1.6, the composition comprising the above components exhibits a gel-like shape, and is dispersed and dissolved by saliva in the mouth. End up. If it exceeds 3.0, the denture stabilizer causes insufficient adhesion due to vinyl acetate. The weight ratio of vinyl acetate resin / water-soluble polymer compound is 1.6 to 3.0, preferably 2.2 to 2.8, and more preferably 2.4 to 2.5.

  In the present invention, the vinyl acetate resin is contained in the denture stabilizer in an amount of 25 to 45% by weight, preferably 28 to 42% by weight, and more preferably 30 to 38% by weight.

  In the present invention, the water-soluble polymer compound is contained in the denture stabilizer in an amount of 10 to 18% by weight, preferably 12 to 16% by weight, and more preferably 13 to 15% by weight.

  In the denture stabilizer according to the present invention, when the water / ethanol weight ratio is less than 1.0, the denture stabilizer becomes adhesive-like and difficult to remove from the denture, and when it exceeds 4.0, the vinyl acetate resin becomes a lump. In this case, formulation is difficult. The weight ratio of water / ethanol is 1.0 to 4.0, preferably 1.5 to 2.8, more preferably 1.7 to 2.8, and particularly preferably 2.4 to 2.8. .

  In the present invention, water is contained in the denture stabilizer in an amount of 15 to 45% by weight, preferably 28 to 42% by weight, and more preferably 30 to 40% by weight.

  Moreover, in this invention, ethanol contains 5-30 weight% in a denture stabilizer, It is preferable to contain 10-25 weight%, It is more preferable to contain 14-20 weight%.

  In the denture stabilizer according to the present invention, the 2% viscosity at 25 ° C. of the water-soluble polymer compound is preferably 30 to 45 mPa · s, more preferably 32 to 40 mPa · s. When the 2% viscosity at 25 ° C. of the water-soluble polymer compound is less than 30 mPa · s, the denture stabilizer cannot exhibit sufficient adhesiveness, and the denture cannot be stably maintained in the oral cavity. When the 2% viscosity at 25 ° C. of the water-soluble polymer compound exceeds 45 mPa · s, the denture stabilizer becomes hard, and it is difficult to extrude from the tube container, resulting in poor usability.

  The viscosity is measured using a B-type viscometer (LVDV-II +, manufactured by Brookfield) using a UL / Y adapter.

  In the denture stabilizer according to the present invention, the water-soluble polymer compound is preferably a cellulose derivative.

  The cellulose derivative used in the present invention is preferably a cellulose derivative that dissolves or gels in water and produces tackiness. For example, water-soluble cellulose ether such as methyl cellulose, ethyl cellulose, hydroxylated alkyl cellulose (hydroxypropyl methyl cellulose, hydroxyethyl cellulose, etc. ), Carboxymethylcellulose, alkali metal carboxymethylcellulose (sodium carboxymethylcellulose, potassium carboxymethylcellulose, etc.), and alkali metal cellulose sulfate. Of these, hydroxylated alkyl cellulose, carboxymethyl cellulose, and alkali metal carboxymethyl cellulose are preferable, and sodium carboxymethyl cellulose is more preferable.

   In the denture stabilizer according to the present invention, the weight ratio of the total amount of vinyl acetate resin and water-soluble polymer compound / total amount of water and ethanol is preferably 0.8 to 1.3, more preferably 0.8 to 1.1. It is. When the weight ratio of the total amount of vinyl acetate resin and water-soluble polymer compound / total amount of water and ethanol is less than 0.8, the composition comprising the above components becomes almost liquid, and when it exceeds 1.3, the denture stabilizer is It becomes a lump and is difficult to formulate in any case.

  Particularly preferred embodiments in the present invention include a vinyl acetate resin / water-soluble polymer compound having a weight ratio of 2.4 to 2.5, a water / ethanol weight ratio of 2.4 to 2.8, and a solute / solvent ratio. The weight ratio is 1.0 to 1.3. By setting it as such a mixture ratio, it is excellent especially in the point of formulation property, adhesiveness, peelability, and ease of application.

  The denture stabilizer according to the present invention may further comprise an aminoalkyl methacrylate copolymer. Denture stabilizers containing aminoalkyl methacrylate copolymers have moderate hardness, and denture stabilizers contained in tube containers can be extruded from the container without hindrance. A preferred addition ratio of the aminoalkyl methacrylate copolymer is 0.6 to 3.5% by weight based on the total weight of the denture stabilizer.

  In addition to vinyl acetate resin, water-soluble polymer compound, water and ethanol, the denture stabilizer according to the present invention includes a plasticizer, an emulsifier, a viscosity modifier, a water-insoluble powder to give the denture stabilizer the desired properties. Well-known additives such as wetting agents, preservatives, metal soaps, solvents, solubilizers, stabilizers, deodorants, functional ingredients, refreshing agents, fragrances, coloring agents, enzymes, etc. As long as it is, you may mix | blend suitably.

  Examples of the plasticizer include beeswax, wood wax, carnauba wax, and candelilla wax.

  Examples of emulsifiers include glycerin fatty acid esters such as glycerin monostearate, sorbitan fatty acid esters such as sorbitan monostearate, and sucrose fatty acid esters such as sucrose stearate and sucrose laurate.

  Examples of the water-insoluble powder include calcium carbonate, calcium phosphate, plastic powder, talc, silica, bentonite, and zeolite.

  Examples of the wetting agent include glycerin, polyethylene glycol, polypropylene glycol, and hyaluronic acid.

  Examples of the preservative include benzoic acid, sodium benzoate, paraoxybenzoic acid ester, methyl paraben, ethyl paraben, and propyl paraben.

  An example of the metal soap is calcium stearate.

  An example of the solvent is phenoxyethanol.

  Solubilizers include polyoxyethylene hydrogenated castor oil, polyoxyethylene fatty acid esters such as polyethylene glycol monooleate, N-acyl amino acid salts such as sodium N-lauroylsarcosine, and alkyls such as lauryldimethylaminoacetic acid betaine. Examples include (amide) betaines, polyoxyalkylene lauryl ethers such as polyoxyethylene lauryl ether, polyoxyethylene alkyl ethers, alkyl alkanol amides such as coconut oil fatty acid monoethanolamide, and the like.

  Examples of the stabilizer include titanium oxide, sodium chloride, potassium chloride, magnesium chloride, aluminum lactate and the like.

  Examples of the deodorant include polyphenols extracted from copper chlorophyllin sodium, coffee, green tea, grapes and the like.

  As functional components, anti-inflammatory agents such as glycyrrhetinic acid, glycyrrhetinic acid salt, glycyrrhizic acid, glycyrrhizinate, isopropylmethylphenol, triclosan, cetylpyridinium chloride, decalinium chloride, benzethonium chloride, benzalkonium chloride, chlorhexidines, Examples include bactericides such as hinokitiol, antibiotics, ascorbic acid, ascorbic acid derivatives, vitamins such as tocopherol acetate, and the like.

  Examples of the enzyme include dextranase, amylase, protease, mutanase, lytic enzyme, lysozyme and the like.

  Examples of the refreshing agent include l-menthol, dl-menthol, menthol derivatives, carvone and the like.

  It is also preferable to add a sodium / calcium methoxyethylene maleic anhydride copolymer salt in order to reduce the solubility of the denture stabilizer in the mouth in the saliva and gradually dissolve the agent.

  The denture stabilizer according to the present invention is not particularly limited. For example, a vinyl acetate resin and ethanol, if necessary, additives are added, and the mixture is sufficiently stirred, and then a water-soluble polymer compound and water are added. Stir thoroughly and homogenize the whole.

The denture stabilizer according to the present invention usually takes a form housed in a tube container capable of preventing volatilization of components in the preparation and contamination of the preparation, preferably aluminum tubes, aluminum / epoxyphenol resin multilayer tubes, aluminum It takes the form accommodated in aluminum laminate tubes such as polyethylene multilayer tubes and multilayer tubes made of aluminum / polyethylene / epoxyphenol resin.

  According to the present invention, the gap between the denture and the oral mucosa, which is an advantage of the non-water-soluble paste denture stabilizer, is reliably filled even without adding a mineral oil that exhibits discomfort in the mouth. It is possible to provide a denture stabilizer with excellent detachability.

  Next, in order to explain the present invention specifically, some examples of the present invention and comparative examples for showing comparison with the examples are given, and the performance test results of the obtained denture stabilizer are shown. However, the present invention is not limited to these examples.

Examples 1-18, Comparative Examples 1-18
The components shown in Tables 1 to 4 are weighed in the weight percentages shown in these tables, and vinyl acetate resin and ethanol, and if necessary, additives are added, and sufficiently stirred using a planetary mixer (manufactured by Inoue Seisakusho). Then, a water-soluble polymer compound and water were added and the whole was sufficiently stirred and homogenized to obtain a denture stabilizer.

  The components shown in Tables 1 to 4 will be described.

Vinyl acetate resin (1): Vinyl acetate resin (average polymerization degree 630) manufactured by Denki Kagaku Kogyo Co., Ltd., trade name “SN04-T”
Vinyl acetate resin (2): Vinyl acetate resin (average polymerization degree 1060) manufactured by Denki Kagaku Kogyo Co., Ltd., trade name “SN09-T”
Vinyl acetate resin (3): Vinyl acetate resin (average polymerization degree 1390) manufactured by Denki Kagaku Kogyo Co., Ltd., trade name “SN14-H”
CMCNa: carboxymethylcellulose sodium manufactured by Daiichi Kogyo Seiyaku Co., Ltd., trade name “Serogen F803A”, 2% viscosity at 25 ° C. 33 mPa · s
Water: Purified water Ethanol: JP ethanol (95 degrees)
Copolymer: Degussa Japan Co., Ltd. aminoalkyl methacrylate copolymer, trade name “Eudragid RS100”
Colorant: Red pigment manufactured by Kiriya Chemical Co., Ltd., trade name "Red No. 102 Aluminum Lake"
Preservative: Propylparaben Vinyl acetate resin / CMCNa: Vinyl acetate resin / CMCNa weight ratio Water / ethanol: Purified water / Japan ethanol (95 degrees) weight ratio Solute / solvent: (vinyl acetate resin + CMCNa) / (water + Ethanol) weight ratio

Evaluation test The denture stabilizers obtained in Examples and Comparative Examples were subjected to performance tests on the following items, and the results are shown in Tables 1 to 4.

a) Formulation
Add vinyl acetate resin and ethanol, if necessary, and additives, and stir well using a planetary mixer (manufactured by Inoue Seisakusho), then add water-soluble polymer compound and water and stir the whole well Then, the state of the obtained denture stabilizer was visually observed, and the formulation properties were evaluated according to the following criteria.

○: The preparation is pasty. Δ: The preparation is pasty but is liquid. ×: The preparation is not pasty (in the form of a lump) or is not homogeneously kneaded.

b) Adhesive strength
When 1 g of the denture stabilizer obtained in a) was put on water, the presence or absence of glue-like adhesiveness to fingers was confirmed. The number of N of the monitor was 10 people, and 8 or more judged that “shows adhesive strength” as “◯”, and 7 or less as “x”.

○: Shows adhesive strength ×: Shows little or no adhesive strength

c) Peelability
1 g of the denture stabilizer obtained in a) is spread evenly on an acrylic resin plate, immersed in water at 37 ° C. overnight, and then the denture stabilizer is peeled off from the acrylic resin plate with just the fingertips. Was evaluated according to the following criteria.

The number of monitors N was 10 people, and “8” was evaluated for 8 or more, “Δ” for 6-7, and “x” for 5 or less.

○: Easy to peel Δ: Slightly easy to peel ×: Hard to peel

d) Ease of spreading The ease of spreading when 1 g of denture stabilizer was uniformly spread with a finger on an acrylic resin plate was evaluated according to the following evaluation criteria. The number of N monitors is 10 people. Eight or more people judge that “easy to spread” is evaluated as “◎”. In case of 6-7 people, “○”, in case of 4-5 people Was evaluated as “C” and “x” in the case of 3 people or less.

◎: Easy to spread ○: Slightly easy to spread △: Slightly difficult to spread ×: Difficult to spread

 As can be seen from the evaluation test results, when the weight ratio of vinyl acetate resin / water-soluble polymer is 1.6 to 3.0 and the weight ratio of water / ethanol is 1.0 to 4.0, The preparations of the examples showed better results in all the items of preparation, stickiness and peelability than those of the comparative examples. Furthermore, as a result of testing for ease of spreading of the preparations of the examples, the weight ratio of vinyl acetate resin / water-soluble polymer compound is 2.4 to 2.5, and the weight ratio of water / ethanol is 1. It was particularly excellent when it was 7 to 2.8, and it was excellent overall as a denture stabilizer.

Formulation example

 The preparations of the above-mentioned formulation examples showed good results in any of the items of formulation, adhesiveness and peelability as in the preparations of the examples.

Claims (5)

A vinyl acetate resin having an average degree of polymerization of 500 to 700, a cellulose derivative selected from the group consisting of methyl cellulose, ethyl cellulose, hydroxylated alkyl cellulose, carboxymethyl cellulose, alkali metal carboxymethyl cellulose, alkali metal cellulose sulfate , water, A denture stabilizer comprising ethanol and having a vinyl acetate resin / cellulose derivative weight ratio of 1.6 to 3.0 and a water / ethanol weight ratio of 1.0 to 4.0. The denture stabilizer according to claim 1, wherein the cellulose derivative has a 2% viscosity at 25 ° C. of 30 to 45 mPa · s. The denture stabilizer according to claim 1 or 2 , wherein the cellulose derivative is sodium carboxymethylcellulose. The denture stabilizer according to any one of claims 1 to 3, wherein a weight ratio of the total amount of the vinyl acetate resin and the cellulose derivative / the total amount of water and ethanol is 0.8 to 1.3.   The denture stabilizer according to any one of claims 1 to 4, further comprising an aminoalkyl methacrylate copolymer.