WO1997031614A1

WO1997031614A1 - Denture stabilizer composition

Info

Publication number: WO1997031614A1
Application number: PCT/JP1997/000542
Authority: WO
Inventors: Toshiko Sato; Kazushi Ebisudani; Chikako Yonezato
Original assignee: Sunstar Kabushiki Kaisha
Priority date: 1996-03-01
Filing date: 1997-02-26
Publication date: 1997-09-04

Abstract

A denture stabilizer composition which comprises as the main tacky ingredient a polyvinyl alcohol having a specific tack strength and optionally contains a specific tackifier such as alginic acid. The composition is excellent in tackiness and tack stability, remains in place within the mouth, and is advantageously usable.

Description

TECHNICAL FIELD The present invention relates to a denture stabilizer composition which has excellent adhesiveness and adhesive stability in the oral cavity and can stably stabilize a denture. Conventional technology Changes in the oral environment due to factors such as aging and inflammation, which lowers the compatibility of dentures with the ridge, so that many denture wearers cannot eat hard food or have difficulty talking. I am worried about the stability of dentures. In such cases, denture wearers have temporarily used denture stabilizer compositions to improve the stability of the denture.

Commercially available denture stabilizer compositions disperse a water-soluble polymer such as sodium carboxymethylcellulose or polyethylene glycol in an oil-based base such as liquid paraffin / vaseline, and use the adhesive force of the water-soluble polymer due to moisture in the oral cavity to form a denture. There are roughly two types: a descendant type that improves the stability of dental prostheses, and a cushion type that improves the stability of dentures by plasticizing polyvinyl acetate with a solvent such as ethanol and filling the gap between the denture and the mucous membrane of the ridge. In addition, powder type, sheet type and the like can be mentioned.

However, in the conventional soft-type denture stabilizer composition, the water-soluble polymer in the denture stabilizer composition flows out into the oral cavity due to moisture from saliva and food during wearing, Not only does not provide a sufficient stabilizing effect, but also gives discomfort. On the other hand, the cushion-type denture stabilizer composition irritates the oral mucosa with a solvent such as ethanol as a plasticizer and elutes the plasticizer, thereby hardening the denture stabilizer composition and fixing it to the denture material to remove it. The adverse effects of irritating and irritating the oral mucosa have been a problem.

On the other hand, when the sheet-type denture stabilizer composition is used, the adjusted occlusal height of the denture changes and uneven stress is applied to the ridge, so that bone resorption may occur.

Among them, an important technical problem in the descendant type denture stabilizer composition is to improve the adhesive stability to the mucous membrane and the denture material to a satisfactory level for the denture wearer.

In particular, Japanese Unexamined Patent Publication No. 56-164107 discloses a technique which has been studied to improve the adhesive stability of the stabilizer composition. Japanese Patent Application Laid-Open No. 56-164107 discloses sodium carboxymethylcellulose and poly (ethylene oxide) homo. Denture stabilizer compositions comprising polymers have been proposed. In JP-A-5-32δ15, a denture stabilizer composition comprising a spinnable polyacrylic acid salt and sodium carboxymethylcellulose is disclosed. A denture stabilizer composition comprising a specific mixture salt of an alkyl vinyl ether-maleic acid copolymer has been proposed.

Such techniques have been developed to improve the adhesive strength of denture stabilizer compositions, but each has not yet sufficiently improved the maintenance and stability of dentures.

Also, U.S. Pat. No. 5,302,628 discloses a denture stabilizer composition using polyvinyl alcohol. In this technique, polyacrylate is the main component of the adhesive. Polyvinyl alcohol is one of the auxiliary adhesive components. In this case, a suitable polyvinyl alcohol (Nippon Synthetic Chemical Co., Ltd.) KP-08) of KOGYO CO., LTD. Cannot be a sufficient tackifier because of its low adhesive strength, and it is clear that polyvinyl alcohol is not blended as the main tackifier in the denture stabilizer composition. It is.

Japanese Patent Application Laid-Open No. 63-169395 discloses a sheet-shaped denture stabilizer using a compound selected from sticky compounds including polyvinyl alcohol, wherein the outer layer and the inner layer have different properties. A composition is disclosed. Here, too, polyvinyl alcohol is not disclosed as a component that contributes to the main adhesive force of a denture stabilizer composition having adhesiveness and retention, and therefore, the adhesive physicality that polyvinyl alcohol should have is not disclosed. .

Further, Japanese Patent Application Laid-Open No. Hei 4-310558 discloses that polyorganosiloxane is used as a main component of a tackifier to improve tackiness, and polyvinyl alcohol is used as an auxiliary agent.

As described above, the technique of using polyvinyl alcohol for denture stabilizer compositions has been used as a conventional technique, but the purpose of blending polyvinyl alcohol is to aid in adhesion, and to impart initial adhesive strength. The use of polyvinyl alcohol itself as the main material that imparts the adhesiveness of the denture stabilizer composition, which promotes swelling, makes it possible to improve the adhesive strength in the oral cavity, which is a technical problem of the denture stabilizer composition. There is no attempt to resolve maintenance. Furthermore, it does not disclose any component that enhances the adhesion of a specific polyvinyl alcohol. Object of the Invention It is an object of the present invention to have excellent adhesiveness to materials such as oral mucosa and allyl resin, and in particular, its adhesiveness is remarkably improved as compared with the preparation according to the prior art. An object of the present invention is to provide a denture stabilizing composition which maintains a denture firmly against sway such as mastication. SUMMARY OF THE INVENTION The present inventors have studied polyvinyl alcohol as an adhesive main component in order to improve the adhesive strength of a denture stabilizer composition. As a result, by using polyvinyl alcohol having specific adhesive physical properties, One or more of a specific water-soluble polymer compound such as sodium alginate and an alkaline earth metal salt can be used as an adhesive strength-enhancing component in combination with the polyvinyl alcohol to improve the adhesive stability of the stabilizer composition. It has been found that a compound having a high adhesive strength can be obtained by adding the compound of formula (1) to the denture stabilizer, and the present invention has been completed.

That is, the present invention relates to a denture stabilizer composition containing one or more adhesive components, wherein the adhesive strength of a 50% water mixture is 2δ0 g / cm ² or more and / or a 25% water mixture. The present invention relates to a denture stabilizer composition comprising polyvinyl alcohol having an adhesive strength of not less than 200 g Z cm ² as an adhesive main component. In the composition of the present invention, alginic acid and salts thereof, sodium carboxymethylcellulose, polyethylene glycol having a molecular weight of 200,000 or more, polyvinyl pyridone, polyvinyl ether-maleic acid copolymer, It is preferable that one or more compounds selected from the group consisting of lithium earth metal compound salts be combined with the denture stabilizer.

ADVANTAGE OF THE INVENTION According to this invention, the denture stability which can solve the above-mentioned problem and is excellent in the adhesiveness in an oral cavity and an adhesive stability, and can stabilize a denture suitably. Agent composition can be provided. DETAILED DISCLOSURE OF THE INVENTION The cohesive strength of a denture stabilizer composition is related to its ability to absorb liquids such as saliva while it remains in the oral cavity and still have cohesive strength. Therefore, when considering the adhesive stability, the adhesive strength at the stage of high water content, that is, at the water content of 50% and 75% is important.

Therefore, the polyvinyl alcohol used as an adhesive main component in the present invention has an adhesive strength of 250 g / cm ² or more in a 50% water mixture (water content 50%) or an adhesive strength in a 25% water mixture (water content 75%). May be in the form of a chain or a cross-link, as long as it satisfies one or both of the conditions of 200 g Z cm ² or more. Examples of the polyvinyl alcohol satisfying the former condition include commercially available Gohsenol KH-20 (manufactured by Nippon Synthetic Chemical Co., Ltd.) and Poval PA-05 (manufactured by Shin-Etsu Chemical Co., Ltd.). For example, Gohsenol KH-17 (manufactured by Nippon Kasei Kagaku Co., Ltd.) can be exemplified.

Here, the adhesive strength (g / cm ² ) means that the measurement sample is compressed between two acrylic plates, the acrylic plate is attached to an autograph, and one acrylic plate is vertically moved downward at a constant speed. This is the value obtained by dividing the maximum stress value (total adhesive force) when the material was moved to by the area of the acrylic plate.

In addition, the main component of the adhesive refers to a component having the largest value when comparing the total adhesive strength of each adhesive component measured in an amount proportional to the amount of the component. In other words, a 50% water mixture of the adhesive components was used, and the maximum amount of 1 g of the adhesive components in the preparation was used as the sample amount. The total adhesive strength is measured and determined in the same manner as the adhesive strength using the amount of pull (g). In the denture stabilizer composition of the present invention, it is necessary that polybutyl alcohol has the largest total adhesive force among one or more kinds of adhesive components to be blended. In the denture stabilizer composition of the present invention, the above polyvinyl alcohol may be used alone, or may be used in combination with a specific adhesion-enhancing component.

Alcohol and its salts, sodium carboquine methylcellulose, polyethylene glycol with a molecular weight of 200,000 or more, polyvinylpyrrolidone, polyvinyl ether-maleic acid copolymer, Examples include compounds selected from the group consisting of lithium earth metal compound salts, and these may be used alone or in combination of two or more.

The alginic acid and its salts are selected from alginic acid, sodium alginate, potassium alginate, calcium alginate, and magnesium alginate. Particularly, the viscosity of a 1% aqueous solution at 20 ° C. is 40 cps to 100 cps. It is preferred to distribute the sodium in combination with the polyvinyl alcohol to the denture stabilizer.

The alkaline earth metal compound salt is selected from magnesium chloride, calcium chloride, calcium lactate, calcium nitrate, calcium formate, strontium chloride, barium chloride, etc., and in particular, magnesium chloride or chloride chloride Is preferred.

As other components, those commonly used in denture stabilizer compositions can be used. For example, low molecular weight polyhydric alcohols such as glycerin-propylene glycol, polyethylene glycol 400, sodium carboxymethyl cellulose, Drokinethyl cellulose, hydroquinopropylmethyl Water-soluble polymers such as cellulose-based polymer compounds such as cellulose, natural polysaccharides, and polymer compounds composed of amino acids such as gelatin can be exemplified.

The denture stabilizer composition of the present invention can be produced by a conventional method and can be provided in the form of a solid powder, an oily or aqueous paste, a gum, a film, a sheet, and the like. Powder, paste and gum forms are preferred. When the denture stabilizer composition is in the form of a paste or gum, the formulation of the adhesion-enhancing component such as polyvinyl alcohol or alginic acid in the formulation can be any of dissolution, emulsification, suspension, and simple dispersion as solid particles. When mixed and dispersed as a solid powder in the denture stabilizer composition base, the particles are preferably fine powder, and the particle size is 60 mesh or less, more preferably 100 mesh or less. Is desirable.

The blending amount of polyvinyl alcohol is 5% to 60% by weight, preferably 25% to 50% by weight of the total weight of the denture stabilizer composition, and has the strongest adhesive strength. By adding 2.5% to 40% by weight, preferably 2.5% to 20% by weight of the total weight, the adhesive strength is enhanced. The denture stabilizer composition of the present invention may contain other components, such as an oily base, an aqueous base, a powder base, a gum base, an excipient, an emulsifier, a wetting agent, Adjusters, viscosity adjusters, preservatives, pigments, sweeteners, fragrances, water, etc. can be added as appropriate.

Next, the present invention will be described in more detail with reference to Examples, but the present invention is not limited thereto. “%” Means “% by weight” unless otherwise specified.

The adhesive strength of the paste-like denture stabilizer composition according to the present invention described in the examples and the comparative examples were measured for the adhesive strength, and the sensory evaluation of the adhesive strength and the adhesive stability was carried out. Was.

Measurement and evaluation method

Measurement of adhesive strength

Water was added to each of the polyvinyl alcohol preparations described in the examples (and comparative examples) shown in Table 1 below, and the mixture was stirred to give a 50% or 75% water content (50% water mixture or 25% water, respectively). Mixture), apply an excessive amount of this preparation to the lower movable acrylic plate (050 mm) of an autograph (manufactured by Shimadzu Corporation), and make the gap with the upper fixed acrylic plate (050 mm) lmm. Compress and wipe off the overflow. Next, the lower movable acrylic plate was moved vertically downward at a speed of 200 mm / min, the maximum stress indicated at this time was measured, and this value was divided by the area of the acrylic plate to obtain the adhesive strength (gZc m ² ).

Evaluation of adhesive strength

1. Adhesive strength

Based on the examples (and 'comparative examples) shown in Table 1 below, each polyvinyl alcohol was stirred to a 50% concentration in liquid paraffin Z-Serine base, and filled in a tube container. Test denture stabilizer compositions were produced and their adhesive strength was evaluated.

The above composition was allocated to 5 subjects recruited for this test, one item per day, and each subject used and evaluated all 15 items. Subjects wear the assigned denture stabilizer composition early in the morning, and after three meals in the morning, noon, and evening, evaluate the adhesive stability at the beginning of wearing, after breakfast, after lunch, and after dinner. It was evaluated by sensory evaluation.

The evaluation was performed at each time,

Good (does not shift, does not fluctuate): Rating 3 Normal (Slight deviation): Rating 2 Poor (Wobble and not stable): Rating 13 Evaluation was made in 3 stages, and judgment was made using the average of the scores.

Evaluation criteria

〇: Average score is 2.34 or more

Δ: Average score is 1.68 to 2.33

X: Average score is 1.67 or less

. Comprehensive evaluation

At the same time as the evaluation of 1., a comprehensive evaluation was made according to the following criteria.

〇: Good until evaluation after dinner. Δ: Good until evaluation after lunch.

X: Those which were not evaluated as good up to the evaluation after lunch. The results are shown in Table 1.

As shown in Table 1, the denture stabilizer composition of the present invention was found to have improved adhesive stability due to its excellent adhesive strength, and was a superior denture stabilizer composition as compared with Comparative Examples.

Evaluation of adhesive strength by combination of polyvinyl alcohol and specific components

1. Preparation of test preparation

Polyvinyl alcohol (adhesive strength of 50% water mixture: 390 g_cm2) was added at 35% to the total weight, and a predetermined amount of the adhesion-enhancing component was added to the total weight. The formulation base was added and mixed.

2. Measurement of adhesive strength

Attach the bovine palate mucosa to a 40 mm diameter methacrylic resin disc, apply 0.5 g of the test preparation to another 40 mm diameter methacrylic resin disc, and immerse it in artificial saliva shown below. The two disks were combined and a 2 kg load was applied for 15 seconds. Using an autograph (DSS2000, manufactured by Shimadzu Corporation), the tensile strength (g / cm2) of the test preparation was measured as the adhesive strength of the test preparation at a pulling speed of 20 Omm / min. The two disks were immersed in artificial saliva as they were, and after 2 minutes, a 2 kg load was applied again for 15 seconds, and then the tensile strength was measured. The same operation was performed in addition to the measurements at the initial and 2 minutes, and the adhesive force was measured at 5, 9, 14, and 20 minutes, and the total of the 6 measurements was taken as the adhesive force.

Artificial saliva, 1.5 mM CaCl ₃ in purified _{water, 8.2mM NaH CO 3, 4.8mM NaCK} 137. OmM KC1, 4. was used a solution prepared by dissolving OmM KH ₂ P0 _4.

As the index of each test drug, the ratio of the adhesive force of each test preparation was determined, with the adhesive force of Example 9 without the addition of the adhesion-enhancing component as 100. In the evaluation of the effect of the adhesion-enhancing component, those having an index of more than 100 were evaluated as having an effect, and those having an index of more than 20 were evaluated as having a particular effect.

Table 2 shows the results.

As shown in Table 2, sodium alginate, polyethylene glycol with a molecular weight of 200,000 or more, sodium carboquine methylcellulose, methyl vinyl ether; maleic acid copolymer, polyvinylpyrrolidone, magnesium chloride, and calcium chloride have the effect of enhancing adhesion. Was done.

Furthermore, it was confirmed that the denture stabilizer compositions of Examples 26 to 30, and Examples 31 and 32 produced by a conventional method also have excellent denture stability due to good adhesive strength.

Example 26: Paste denture stabilizer composition

Component Amount (%) Polyvinyl alcohol 30.0

(Adhesive strength of 50% water mixture: 370 gZcm ² )

Hydroquinethyl cellulose 5.0 Magnesium chloride 5.0 Preservative trace amount

Pigment

Glycerin qs

Total 100.0 Example 27: Paste denture stabilizer composition

Component Amount (%) Polyvinyl alcohol 25.0

(50% water mixture adhesive strength: 289 gZcm ² )

Sodium carboxymethylcellulose 10.0 Polyethylene glycol (average molecular weight 4 million) 10.0 Preservative trace

Sorbit solution Total 100.0 Example 28: Paste denture stabilizer composition

Component Amount (%) Polyvinyl alcohol 30.0

(50% water mixture adhesive strength: 327 gZcm ² )

Carboxymethylcellulose sodium 5.0 Methyl vinyl ether / maleic acid copolymer 5.0 Preservative trace amount petrolatum qs liquid paraffin 10.0 total 100.0 Example 29: Gum-like denture stabilizer composition

Component Amount (.%) Polyvinyl alcohol 25.0

(25% water mixture adhesive strength: 32 ^ £ ^ πι ² )

Polyvinyl acetate 25.0 Polypropylene glycol 5.0 Ethanol Appropriate amount Total 100.0 Example 30: Paste denture stabilizer composition

Component Amount () Polyvinyl alcohol 35.0 Sodium alginate 5.0 Sodium carboxymethylcellulose 5.0 Preservative Trace amount Vaseline appropriate amount

Liquid paraffin 10.0

Total 100.0

Example 31: Film denture stabilizer composition

Mix polyvinyl alcohol (adhesive strength of 50% water mixture: 288 × 111 ² ; adhesive strength of 25% mixture: 315 g / cm ² ), sodium carboxymethyl cellulose, polyethylene glycol (average molecular weight: 4,000,000) and polybutene Then, it is extruded and molded by an extruder to obtain a film-shaped denture stabilizer composition. The mixing ratio at the time of mixing is 40% of polyvinyl alcohol, 10% of sodium carboxymethylcellulose, 40% of polyethylene glycol, and 10% of polybutene, based on the total amount of the mixture.

Example 32: Sheet denture stabilizer composition

Polyvinyl alcohol (Adhesive strength of 50% water mixture: SSSgZcm ² , Adhesive strength of 25% water mixture: 294 gZcm ² ) 1% and 5% of sodium carboxymethylcellulose are dispersed ♦ Dissolved water / ethanol: 1 tank of solution The denture is then washed and dried five times to obtain a sheet-shaped denture stabilizer composition.

As described above, by using a polyvinyl alcohol having a specific adhesive property and, if desired, the above-mentioned specific adhesiveness-enhancing component, the denture gradually flows out as in the case of the conventional denture stabilizer composition. An excellent denture stabilizer composition can be provided that can stably wear a denture for a long time without losing stability.

Claims

The scope of the claims

1. In denture fixative composition containing one or more adhesive components, the polyvinyl alcohol is adhesion strength of 50% water mixture 250 adhesive strength of GZcm ² or more and Z or 25% water mixture 200 gZ cm ² or more A denture stabilizer composition characterized by being used as an adhesive main component.

2. Alginic acid and its salts, sodium carboxymethylcellulose, polyethylene glycol with a molecular weight of 200,000 or more, polyvinylpyrrolidone, polyvinylether, maleic acid copolymer, and alkaline earth metal 2. The denture stabilizer composition according to claim 1, comprising one or more compounds selected from the group consisting of compound salts.

3. The denture stabilizer composition according to claim 1, wherein a sodium alginate having a viscosity of a 1% aqueous solution at 20 ° C of 40 cPs to 100 cps is blended as an adhesion-enhancing component.

4. The denture stabilizer composition according to claim 1, which is in the form of a solid powder, a paste, or a gum.