Method for evaluating water permeability of oral dry matter removal agent, and oral dry matter removal agent
The superimposed filter paper method and pectin-based composition with divalent metal ions enhance moisture permeability and adhesion in oral dry matter removers, addressing the limitations of existing technologies by ensuring rapid and sustained moisture penetration and effective removal of oral dry matter.
Patent Information
- Application Number
- JP2024095569
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2023-06-13
- Filing Date
- 2024-06-13
- Publication Date
- 2024-12-25
- Estimated Expiration
- 2044-06-13
AI Technical Summary
Existing methods for evaluating moisture permeability in oral dry matter removers are inadequate, particularly in addressing the challenge of penetration against gravity and the influence of gravity on dry oral epithelial membranes, and conventional compositions fail to provide sustained moisture penetration and adhesion to oral surfaces.
A method using the superimposed filter paper technique to measure moisture permeability, combined with a jelly-like composition containing pectin with a specific DE value and divalent metal ions, ensuring suitable spreadability, adhesion, and moisture permeability, with a hardness range that allows effective application and removal of dry oral matter.
The method and composition enable rapid and sustained moisture penetration into oral dry matter, facilitating easy removal of dry oral materials like exfoliated epithelial membranes and tongue coating, improving the effectiveness of oral care products for individuals with dry mouth.
Smart Images

Figure 2024178942000001_ABST
Abstract
Description
[Technical field]
[0001] The present invention relates to a method for evaluating the water permeability of an oral dry matter remover and to an oral dry matter remover. [Background technology]
[0002] The number of patients receiving tube feeding is increasing due to the aging of society. In addition, the number of patients with swallowing disorders caused by chemotherapy in cancer treatment, cerebral infarction, and cerebral hemorrhage is also on the rise. These patients suffer from severe dry mouth, and symptoms include oral epithelial membrane drying and sticking to the mouth, and spreading tongue coating. These symptoms not only reduce saliva secretion and swallowing function itself, but also cause aspiration pneumonia.
[0003] Dentists and dental hygienists perform professional oral care by removing dry oral epithelial membrane and tongue coating, but with the recent increase in the number of patients, further product development is required.
[0004] Patent Document 1 describes an oral cavity moisturizing composition that contains agar, at least one thickener selected from the group consisting of sodium carboxymethylcellulose, sodium alginate, and xanthan gum, and a moisturizing agent, and has a viscosity of 10,000 to 50,000 mPa s at 25°C, as a composition that quickly absorbs moisture into dry matter in the oral cavity, making it easier to clean the oral cavity and increasing the retention of the composition in the oral cavity.
[0005] Patent Document 2 describes a composition containing cysteine protease and at least one thickening polysaccharide selected from the group consisting of xanthan gum, guar gum, hyaluronic acid, and hydroxyethyl cellulose as a tongue coating remover that can remove firmly adhered tongue coating while minimizing the burden on the subject.
[0006] Patent Document 3 describes a composition that can soften dry phlegm adhering to the oral mucosa in a short period of time and easily remove the dry phlegm without damaging the oral mucosa. The composition contains a lubricant (maltitol) as the main ingredient, a viscosity imparting agent (hydroxyethyl cellulose, tamarind gum) and a foaming agent (dipotassium glycyrrhizinate), and is composed of 50% or more purified water.
[0007] Patent Document 4 describes an oral composition containing 0.01 to 20 mass% glyceryl glucoside, which is a composition that quickly supplies moisture to a dry oral cavity, thereby relieving dryness in the oral cavity, and quickly penetrates moisture into phlegm and dirt that has dried and stuck in the oral cavity, making it easier to clean.
[0008] Pectin jelly is described in Patent Documents 5 to 7. These patent documents relate to jelly drinks or jelly foods for people with dysphagia. In recent years, the number of people with dysphagia has increased rapidly with the aging of the population, and aspiration has become a social problem. Aspiration occurs when water or food is not properly guided into the esophagus and enters the lungs. If a person aspires, a strong cough reflex occurs, making it impossible to eat through the mouth, leading to malnutrition and putting the person's life at risk. Hydration is very important, especially for the elderly, to prevent dehydration. However, water is the most likely to be aspirated because it passes through the pharynx quickly when swallowed. In recent years, jelly drinks for hydration have been developed to slow down the speed of passage through the pharynx when swallowed and make aspiration less likely. However, food jelly drinks (jelly made from carrageenan or agar) that have been sold in the past have been accompanied by syneresis (a phenomenon in which water separates from the jelly itself in the product container). This syneresis has been welcomed because it leads to a fruity taste and improves palatability, but it has been disliked by patients with swallowing disorders because it increases the risk of aspiration. In light of this background, Patent Documents 5 to 7 relate to "jelly foods that do not syneresis for a long period of time," "jelly beverages that do not cause syneresis leading to aspiration," and "hydration jelly beverages for people with difficulty chewing and swallowing, characterized by the absence of syneresis," all of which are aimed at safe hydration for people with dysphagia. The "filter paper method" shown as a test method in these patent documents is also intended to show that "there is no syneresis leading to aspiration," and there is no description or suggestion whatsoever about the permeability of moisture to the target of application by the oral dry matter remover of the present invention. Patent Documents 5 to 7 are aimed at completely different targets and purposes from the oral dry matter remover of the present invention. [Prior art documents] [Patent documents]
[0009] [Patent Document 1] JP 2010-138080 A [Patent Document 2] JP 2016-204330 A [Patent Document 3] JP 2010-285374 A [Patent Document 4] JP 2012-153619 A [Patent Document 5] Patent No. 6453547 [Patent Document 6] Patent No. 6546788 [Patent Document 7] JP 2020-62060 A Summary of the Invention [Problem to be solved by the invention]
[0010] An object of the present invention is to provide a method for appropriately evaluating the water permeability in an oral dry matter remover, and further to provide an oral dry matter remover having extensibility, adhesiveness and water permeability. [Means for solving the problem]
[0011] In order to solve the above problems, the present inventors first studied a method for correctly evaluating the permeability of moisture in an oral dry matter remover to an application target. As a conventional evaluation method, Patent Document 1 describes a method for evaluating the permeability of moisture in a remover to a filter paper assuming oral dry matter as an "experimental method for measuring the amount of moisture provided". A metal plate (diameter 22 mm, thickness 1.5 mm) with a hole of diameter 5 mm is placed in the center of an ADAVATEC 5B (diameter 110 mm), 25 μl of a sample is placed in the hole, and the filter paper is left to stand for 10 minutes at room temperature, after which the diameter of the part discolored by water absorption is measured. The configuration is shown in Figure 1 (left figure). However, the present inventors thought that there were two problems with this method. One is that it is influenced by gravity in a direction that promotes permeation. The dry oral exfoliated epithelial membrane formed in the oral cavity is often formed on the upper palate, and when applying to the dry oral exfoliated epithelial membrane formed on the upper palate, it is necessary to be able to measure the force of permeation against gravity. The second problem is the problem of gaps. If the viscosity of the applied composition is low, it will be pushed by gravity and enter the gaps, from which it will penetrate into the filter paper. Therefore, the inventors of the present invention independently devised the "top filter paper method." The structure of this method is shown in Figure 1 (right).
[0012] Furthermore, for ease of swallowing for people with dysphagia, it is important that the jelly does not adhere to the oral cavity or throat. For this reason, the slipperiness of the jelly is important. Patent documents 5 to 7 state that pectin jelly has a slight water release that does not lead to aspiration, and moistens the surface of the jelly, so that it can pass through the pharynx without adhering to the oral cavity or throat. Conversely, for the subjects of the present invention, "slipperiness" is a negative characteristic that reduces adhesion to dry matter in the oral cavity. As a result of further research, the present inventors have found that an oral dry matter remover consisting of a jelly-like composition containing pectin with a specified DE value has suitable extensibility and adhesion, and can penetrate moisture into the target more quickly and continuously than oral moisturizers using conventional thickeners, thereby completing the present invention.
[0013] That is, the present invention is as follows. 1. A method for evaluating the water permeability of oral dry matter removers using the diameter of the water permeation circle measured by the following filter paper method: Top-up filter paper method; A container with a water-impermeable bottom and cylindrical part is filled with the sample without leaving any gaps, and water-permeable paper is placed on top so that it is in contact with the sample. After a specified time has passed, the longest and shortest diameters of the part of the paper where water has penetrated (the water penetration circle) are measured, and the average value is taken as the diameter of the water penetration circle. 2. An oral dry matter remover comprising a jelly-like composition containing pectin, a divalent metal ion and water, Pectin has a DE value of 20 to 50. A dry mouth remover having a water penetration circle diameter of 28 mm or more after 3 minutes, 32 mm or more after 10 minutes, and / or 36 mm or more after 30 minutes, as measured by the filter paper method described in the preceding paragraph 1 under at least the following conditions: Top-up filter paper method; The sample is packed tightly into an acrylic cylinder with an inner diameter of 23 mm, outer diameter of 25 mm, and height of 15 mm, the bottom of which is covered with paraffin film, and a cellulose filter paper (quantitative filter paper No. 5B (diameter 90 mm), manufactured by Advantec) is placed on top. The container is then left to stand in an incubator at 25°C. After a specified time (3 minutes, 10 minutes, 30 minutes) has elapsed, the longest and shortest diameters of the area where water has penetrated into the filter paper (water penetration circle) are measured, and the average value is taken as the diameter of the water penetration circle. 3. The hardness of the jelly-like composition measured in accordance with the approval standards for foods for people with dysphagia (filling height 15 mm, measurement temperature 25°C) is 1640 to 7479 N / m 2 3. The oral dry matter remover according to item 2 above, 4. The oral dry matter remover according to the preceding item 2 or 3, wherein the pectin content of the jelly composition is 0.5 to 3.0% by weight. 5. The divalent metal ion is a calcium ion; 5. The oral dry matter remover according to any one of items 2 to 4 above, wherein the calcium ion content in the jelly composition is 0.05 to 1.5% by weight calculated as calcium lactate. 6. The DE value is 30-45. The hardness of the jelly-like composition measured in accordance with the approval standards for foods for people with dysphagia (filling height 15 mm, measurement temperature 25°C) is 2000 to 6158 N / m 2 6. The oral dry matter remover according to any one of items 2 to 5 above, 7. The DE value is 39-45. 7. The oral dry matter remover according to any one of the preceding items 2 to 6, wherein the diameter of the water penetration circle after 3 minutes, after 10 minutes, and after 30 minutes, measured by the filter paper overlay method described in the preceding item 1, is 30 to 78 mm, 40 to 80 mm, and 46 to 80 mm, respectively. 8. The DE value is 30-34. The divalent metal ion is a calcium ion, 7. The oral dry matter remover according to any one of items 2 to 6 above, wherein the calcium ion content in the jelly composition is 0.2 to 0.4% by weight calculated as calcium lactate. 9. The oral dry matter remover according to any one of items 2 to 5 above, wherein the pectin is at least one selected from the group consisting of citrus fruit-derived pectin having a DE value of 33 to 50, apple-derived pectin having a DE value of 23 to 34, and combinations thereof. 10. The oral dry matter remover according to any one of the preceding items 2 to 9, which is applied to oral dry matter, oral mucosa and / or teeth. 11. The oral dry matter remover described in any one of items 2 to 10 above, wherein the jelly composition further contains at least one selected from the group consisting of pH adjusters, dispersants, fragrances, taste agents, colorants and functional ingredients. 12. The oral dry matter remover according to any one of items 2 to 11 above, wherein the jelly composition is substantially free of any thickener other than pectin. 13. An oral dry matter remover as described in the preceding paragraph 12, in which the thickener other than pectin is selected from the group consisting of gums, alginic acid and its salts, vegetable proteins, synthetic polymers, cellulose derivatives and their salts, soybean polysaccharides, carrageenan, fucoidan, casein, gelatin, and glucomannan. Effect of the Invention
[0014] According to the present invention, it is possible to provide a method for evaluating the permeability of moisture in an oral dry matter remover in a direction against gravity, and to provide an oral dry matter remover that has suitable extensibility and adhesiveness and is capable of quickly and sustainably allowing the moisture in the oral dry matter remover to permeate into an application target. [Brief description of the drawings]
[0015] [Figure 1] A conceptual diagram of a method for correctly evaluating the permeability of moisture in an oral dry matter remover to an application target. The left diagram shows the configuration of an experimental method for measuring the amount of moisture provided. The right diagram shows the top filter paper method of the present invention. [Diagram 2] Schematic diagram showing the relationship between DE value and calcium lactate concentration in jelly formation. [Diagram 3] FIG. 1 is a conceptual diagram of a method for evaluating sensory evaluation of extensibility and adhesiveness. [Figure 4]Results of evaluation of moisture permeability of commercially available oral moisturizers using the top-up filter paper method (Reference Example 1) [Diagram 5] Results of evaluation of water permeability of aqueous solutions of thickeners using the top filter paper method (Reference Example 2) [Figure 6] Relationship between water permeability, adhesion, and hardness of a jelly-like composition (Test Example 3) DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0016] The present invention will be described in detail below.
[0017] The present invention encompasses a method for evaluating the water permeability of an oral dry matter remover using as an index the diameter of a water permeation circle measured by the following overlay filter paper method: Top-up filter paper method; A container with a water-impermeable bottom and cylindrical part is filled with the sample without leaving any gaps, and water-permeable paper is placed on top so that it is in contact with the sample. After a specified time has passed, the longest and shortest diameters of the part of the paper where water has penetrated (the water penetration circle) are measured, and the average value is taken as the diameter of the water penetration circle.
[0018] The material of the container having a water-impermeable bottom and cylindrical portion in the present invention is not particularly limited as long as water does not permeate (transmit), and may be, for example, acrylic, paraffin, etc. The water-permeable paper in the present invention is not particularly limited as long as water can permeate, but filter paper is preferred, and cellulose filter paper is more preferred. In the present invention, the container having a water-impermeable bottom and cylindrical portion is placed so that the top (open end) of the container faces vertically upward, and the water-permeable paper is placed on the top in contact with the sample, thereby evaluating the water permeability. A preferred example of the overlay filter paper method is, for example, the overlay filter paper method under the following conditions. Top-up filter paper method; The sample is packed tightly into an acrylic cylinder with an inner diameter of 23 mm, outer diameter of 25 mm, and height of 15 mm, the bottom of which is covered with paraffin film, and a cellulose filter paper (quantitative filter paper No. 5B (diameter 90 mm), manufactured by Advantec) is placed on top. The container is then left to stand in an incubator at 25°C. After a specified time (3 minutes, 10 minutes, 30 minutes) has elapsed, the longest and shortest diameters of the area where water has penetrated into the filter paper (water penetration circle) are measured, and the average value is taken as the diameter of the water penetration circle.
[0019] The dry mouth remover of the present invention comprises a jelly-like composition containing pectin having a specific DE value, divalent metal ions, and water.
[0020] Pectin has a structure in which galacturonic acid and methyl-esterified galacturonic acid are linked together in long chains. The degree of esterification of galacturonic acid in a pectin molecule (the proportion of methyl-esterified galacturonic acid) is called the DE value. Pectins with a DE value of 50 or more are called high methoxyl (HM) pectins, and those with a DE value of less than 50 are called low methoxyl (LM) pectins. There are two types of pectin gels: gels made from HM pectin and gels made from LM pectin. The gel is formed when the galacturonic acid in pectin is cross-linked by divalent metal ions such as calcium ions. Therefore, the DE value and the concentration of divalent metal ions are factors that have a significant effect on the physical properties of pectin gel.
[0021] Figure 2 shows a conceptual diagram of the region in which jelly is formed. In the study of this patent, the physical properties were compared under the conditions of the gelling region for each DE value. Furthermore, depending on the fruit from which pectin is derived, the physical properties when gelled can differ even at the same DE value. Generally, pectin derived from citrus fruits such as limes and lemons forms a firm gel, while pectin derived from apples forms a soft gel.
[0022] The DE value of the pectin in the present invention may be 20 to 50, and may be, for example, 20 to 45, 23 to 45, 30 to 45, 39 to 45, or 30 to 34. The pectin in the present invention may be either citrus fruit-derived or apple-derived, and two or more types of pectin may be used in combination. The DE value of the citrus fruit-derived pectin in the present invention is preferably 27 to 50 from the viewpoint of having both excellent water permeability and extensibility, more preferably 33 to 50, and more preferably 33 to 45, from the viewpoint of having particularly excellent water permeability and extensibility. The DE value of the apple-derived pectin in the present invention is preferably 23 to 34 from the viewpoint of having particularly excellent water permeability and extensibility. The pectin in the present invention may be at least one selected from the group consisting of citrus fruit-derived pectin having a DE value of 33 to 50, apple-derived pectin having a DE value of 23 to 34, and a combination thereof.
[0023] The content of pectin in the jelly-like composition of the present invention is not particularly limited as long as it does not impair the effects of the present invention, and may be, for example, 0.1 to 0.8% by weight, 0.5 to 2.0% by weight, 1.3 to 5.0% by weight, 0.6 to 3.0% by weight, 0.7 to 3.0% by weight, 0.8 to 3.0% by weight, 0.9 to 3.0% by weight, 1.0 to 3.0% by weight, 1.1 to 3.0% by weight, 1.2 to 3.0% by weight, 1.3 to 3.0% by weight, 1.4 to 3. From the viewpoint of adhesion and penetration, the content is preferably 0.1 to 5.0% by weight, more preferably 0.2 to 4.0% by weight, more preferably 0.3 to 3.0% by weight, more preferably 0.4 to 3.0% by weight, more preferably 0.5 to 3.0% by weight, more preferably 0.6 to 2.5% by weight, more preferably 0.7 to 2.0% by weight, and more preferably 0.8 to 1.8% by weight. The pectin content means the total amount when two or more types of pectin are used in combination.
[0024] The divalent metal ion in the present invention is not particularly limited, but includes, for example, calcium ion, magnesium ion, etc., with calcium ion being preferred. The divalent metal ion can be incorporated, for example, by blending a divalent metal salt. The divalent metal salt is not particularly limited as long as it is acceptable from the viewpoint of food hygiene or pharmacology, but includes calcium salt, magnesium salt, etc., with calcium salt being preferred. The calcium salt is, for example, calcium lactate, calcium chloride, calcium citrate, calcium gluconate, calcium carbonate, calcium acetate, calcium oxide, calcium sulfate, etc., with calcium lactate being preferred. The content of calcium ions in the jelly composition of the present invention is not particularly limited as long as it does not impede the effects of the present invention, but is preferably 0.05 to 1.5 wt% (free calcium ion concentration 65 to 1950 ppm) in terms of calcium lactate weight, more preferably 0.1 to 1.5 wt%, more preferably 0.1 to 1.0 wt%, more preferably 0.1 to 0.9 wt%, more preferably 0.1 to 0.8 wt%, more preferably 0.1 to 0.7 wt%, more preferably 0.1 to 0.6 wt%, more preferably 0.1 to 0.5 wt%, and more preferably 0.1 to 0.4 wt%. When the DE value of pectin in the jelly composition of the present invention is 30 to 34, the content of calcium ions in terms of calcium lactate weight is more preferably 0.2 to 0.4 wt%, more preferably 0.2 to 0.3 wt%. In the case where the jelly composition of the present invention contains divalent metal ions other than calcium ions, the content of the divalent metal ions may be such that the concentration of free divalent metal ions is equivalent to the concentration of free calcium ions in the case where the jelly composition of the present invention contains calcium ions in terms of the weight of calcium lactate. In the case where two or more kinds of divalent metal ions are used in combination, the content of the divalent metal ions means the total amount. In the present invention, the "jelly composition" is not particularly limited as long as it is a composition containing pectin, divalent metal ions, and water, but is preferably a composition in a gel state.
[0025] The hardness of the jelly-like composition of the present invention, measured according to the method conforming to the approval standards for foods for people with dysphagia (however, the filling height is 15 mm, and the measurement temperature is 25° C.), is 1640 to 7479 N / m from the viewpoint of having both excellent water permeability and appropriate extensibility and adhesiveness. 2 is preferable, and the hardness is 1700 to 7400 N / m 2 More preferably, 1700 to 7300 N / m 2 More preferably, 2000 to 6158 N / m 2 More preferably, 2000 to 4000 N / m 2 The hardness of the jelly composition of the present invention is, for example, 2000 to 6900 N / m 2 , 2000~6700N / m 2 , 2300~6500N / m 2 , 2500~6400N / m 2 , 2500~6200N / m 2 , 2611~6158N / m 2 , 2700~6100N / m 2 , 2800~6000N / m 2 , 2900~6000N / m 2 , 3000~6000N / m 2 , 3100~6000N / m 2 , 3200~6000N / m 2 , 3300~6000N / m 2 , 3400~6000N / m 2 , 3500~6000N / m 2 , 3600~6000N / m 2 , 3700~6000N / m 2 , 1900~7000N / m 2 , 2000~7200N / m 2 , 2300~7200N / m 2 , 2500~7100N / m 2 , 2611~7018N / m 2 , 2700~6400N / m 2 , 2800~6400N / m 2 , 3000~6400N / m 2 , 3200~6400N / m 2 , 3263~6400N / m 2 , 3400~6400N / m2 , 3600~6400N / m 2 , 3800~6400N / m 2 , 4000~6400N / m 2 , 4100~6400N / m 2 In this specification, the term "hardness of a jelly-like composition measured according to a method conforming to the approval standards for foods for people with dysphagia" refers to the hardness (N / m2) measured according to the "Testing methods for foods for people with dysphagia" (filling height 15 mm, measuring temperature 25°C) described in Appendix 2 of "Complete revision of 'Approval for labeling of foods for special dietary uses' (Dietary Table No. 296, Notice from the Deputy Director-General of the Consumer Affairs Agency, September 9, 2019)". 2 )
[0026] The jelly composition of the present invention is substantially free of any thickener other than pectin. In this specification, "substantially free of any thickener other than pectin" means that it does not contain any thickener other than pectin, or that it may contain a thickener other than pectin in an amount that does not produce its effect or side effects, or that it may contain it as an impurity that is inevitably mixed in during its production. For example, the content of the thickener other than pectin in the jelly composition may be 0.1% by weight or less, preferably 0.05% by weight or less, and more preferably 0.01% by weight or less.
[0027] Examples of thickeners other than pectin include gums (xanthan gum, guar gum, tamarind gum, locust bean gum, tamarind seed gum, Caesalpinia spinosa gum, tara gum, gellan gum, gum arabic, etc.), alginic acid and its salts (sodium alginate, potassium alginate, calcium alginate, etc.), vegetable proteins (wheat protein, rice protein, soy protein, etc.), synthetic polymers (polyacrylic acid, polymethacrylic acid, acrylic acid / methacrylic acid alkyl copolymer, polyethylene glycol, polyvinylpyrrolidone, etc.), cellulose derivatives (carboxymethylcellulose, hydroxyethylcellulose, hydroxypropylmethylcellulose, hydroxypropylcellulose, methylcellulose, etc.) and their salts, soy polysaccharides, carrageenan, fucoidan, casein, gelatin, glucomannan, etc.
[0028] The oral dry matter remover of the present invention has water permeability. The water permeability is a performance of releasing water in the oral dry matter remover and allowing the water to permeate the target against gravity, and can be evaluated by the amount of water released against gravity from the oral dry matter remover, specifically, by the diameter of the water permeation circle of the jelly-like composition measured by the above-mentioned filter paper method.
[0029] The oral dry matter remover of the present invention has extensibility. The extensibility can be evaluated by the evaluation method and evaluation criteria described in the Examples below. Extensibility can be rephrased as ease of application, and the higher the extensibility, the easier it is to apply evenly, while the lower the extensibility, the more likely it is that the application will be uneven, and the more likely it is that some areas will be applied and some areas will not be applied.
[0030] The oral dry matter remover of the present invention has adhesiveness. The adhesiveness can be evaluated by the evaluation method and evaluation criteria described in the Examples below. The higher the adhesiveness, the longer the oral dry matter remover applied to the target such as oral dry matter, oral mucosa, or tooth surface will adhere without peeling off. The oral dry matter remover of the present invention has both extensibility and adhesiveness, and thus has the effect of being easy to apply when placed on a finger or an oral sponge brush and applied to dry matter formed in the oral cavity or dry oral mucosa, and is less likely to drip when applied to the upper palate, tooth surface, etc.
[0031] The target of the dry mouth remover of the present invention is a person having dry mouth or a person suspected of having dry mouth, preferably a person having dry mouth who cannot take orally.
[0032] In the present invention, "dry matter in the oral cavity" refers to dry matter present in the oral cavity, such as exfoliated epithelial membrane, tongue coating, dry sputum, crusts, etc. Exfoliated epithelial membrane is caused by dry mouth and is mainly waste matter, saliva, and / or food debris in the oral cavity that has dried. Dry matter in the oral cavity is mainly removed by rubbing with oral hygiene tools such as toothbrushes and oral sponge brushes, and is softened and easily removed by permeating moisture into the dry matter in the oral cavity. The oral dry matter remover of the present invention can soften and remove the dry matter in the oral cavity by permeating moisture into the dry matter in the oral cavity, and / or can facilitate removal (assist removal).
[0033] In removing intraoral dry matter using the oral dry matter remover of the present invention, the time required for moisture penetration (softening) varies depending on the size and dryness of intraoral dry matter such as oral exfoliated epithelium, and where it is formed in the oral cavity. In addition, moisture must penetrate against gravity into intraoral dry matter formed in the upper palate of the oral cavity. For this reason, in the present invention, the performance of the oral dry matter remover in facilitating removal of intraoral dry matter, specifically, the moisture penetration (softening) effect against gravity for each required time, was evaluated by measuring the diameter of the moisture penetration circle after 3 minutes, 10 minutes, and / or 30 minutes using the overlay filter paper method.
[0034] In a series of procedures in professional oral care, it is desirable that the moisture penetration (softening) of the dry matter in the oral cavity and the removal of the dry matter in the oral cavity can be completed in a short time. From the viewpoint of moisture penetration in a short time, the diameter of the moisture penetration circle after 3 minutes measured by the above-mentioned filter paper method is 28 mm or more, preferably 28 to 78 mm, more preferably 29 to 78 mm, more preferably 30 to 78 mm, more preferably 30 to 70 mm, more preferably 30 to 60 mm, more preferably 30 to 55 mm, and more preferably 30 to 50 mm. If the diameter of the penetration circle after 3 minutes is less than 28 mm, the effect of removing the peeled epithelial membrane, etc. in a short time tends to be insufficient.
[0035] Depending on the size, position, dryness, etc. of the intraoral dry matter, it may take time for moisture to penetrate (soften) and be removed. From the viewpoint of moisture penetration over a relatively long time, the diameter of the moisture penetration circle after 10 minutes measured by the above-mentioned filter paper method is 32 mm or more, preferably 32 to 90 mm, more preferably 35 to 85 mm, more preferably 36 to 85 mm, more preferably 38 to 85 mm, more preferably 39 to 85 mm, more preferably 40 to 80 mm, more preferably 40 to 70 mm, and more preferably 40 to 65 mm. If the average diameter of the penetration circle after 10 minutes is less than 32 mm, the effect of removing the peeled epithelial membrane, etc., tends to be insufficient over a relatively long time.
[0036] Further, from the viewpoint of moisture permeability over a long period of time, the diameter of the moisture permeation circle after 30 minutes measured by the above-mentioned filter paper method may be 36 mm or more, preferably 36 to 90 mm, more preferably 38 to 90 mm, more preferably 39 to 90 mm, more preferably 40 to 90 mm, more preferably 41 to 90 mm, more preferably 43 to 90 mm, more preferably 45 to 90 mm, more preferably 46 to 90 mm, more preferably 46 to 85 mm, more preferably 46 to 80 mm, more preferably 47 to 80 mm, more preferably 48 to 80 mm, more preferably 49 to 80 mm, and more preferably 50 to 75 mm. If the average diameter of the permeation circle after 30 minutes is less than 36 mm, the effect of removing the peeled epithelial membrane and the like over a long period of time tends to be insufficient. If the diameter of the water penetration circle after 3 minutes is 28 mm or more, the diameter of the water penetration circle after 10 minutes is 32 mm or more, and the diameter of the water penetration circle after 30 minutes is 36 mm or more, then not only is the material excellent in rapid water penetration in a short period of time, but the excellent water penetration is sustained for at least 30 minutes, and therefore the material also has excellent sustained water penetration.
[0037] The present invention encompasses a method for removing dry oral matter, comprising the step of applying the oral dry matter remover of the present invention to the oral cavity of a subject. The step of applying to the oral cavity of the subject preferably comprises the step of coating the oral cavity of the subject. The method preferably further comprises the step of allowing a certain time (e.g., 30 seconds to 2 hours, 1 minute to 2 hours, 1 minute to 1 hour, 1 minute to 40 minutes, 1 minute to 30 minutes, 3 minutes to 30 minutes, 5 minutes to 30 minutes, 3 minutes to 5 minutes, etc.) to pass from the step of applying to the oral cavity of the subject, and / or the step of removing the oral dry matter. The step of applying to the oral cavity of the subject, the step of allowing the certain time to pass, and the step of removing the oral dry matter may be repeated in any order depending on the size, position, dryness, etc. of the oral dry matter. For example, a series of steps of applying the composition to the oral cavity of the subject, allowing the composition to stand for a certain period of time, and then removing the dried oral matter may be repeated 2 to 5 times, or the step of applying the composition to the oral cavity of the subject, allowing the composition to stand for a certain period of time may be repeated 2 to 5 times, and then removing the dried oral matter may be performed. The method for removing the dried oral matter in the step of removing the dried oral matter is not particularly limited, but is preferably performed using an oral hygiene tool such as an oral sponge brush or a medical material such as gauze.
[0038] The method of applying the oral dry matter remover of the present invention to the oral cavity of a subject is not particularly limited as long as the moisture in the oral dry matter remover of the present invention can be permeated into the oral dry matter of the subject to facilitate removal, but the oral dry matter remover of the present invention is preferably brought into contact with the oral cavity of the subject, more preferably applied to the oral dry matter, oral mucosa and / or teeth surface of the subject. The amount of the oral dry matter remover of the present invention to be applied can be appropriately adjusted depending on the size, position, dryness, etc. of the oral dry matter, and is not particularly limited, and may be, for example, 0.5 to 10 g per application.
[0039] The jelly composition of the present invention may contain other components in addition to the above components. Examples of other components include pH adjusters, dispersants, surfactants, flavors, sweeteners, colorants, preservatives, antibacterial agents, antifoaming agents, and functional components, and are not particularly limited as long as they can be used in pharmaceuticals, foods, or cosmetics. Examples of pH adjusters include inorganic acids such as phosphoric acid, inorganic acid salts such as sodium monohydrogen phosphate, sodium dihydrogen phosphate, potassium monohydrogen phosphate, and potassium dihydrogen phosphate, organic acids such as citric acid, malic acid, pyrophosphoric acid, tartaric acid, succinic acid, fumaric acid, gluconic acid, lactic acid, and acetic acid, or organic acid salts thereof (e.g., trisodium citrate, etc.), and bases such as sodium hydroxide and sodium bicarbonate, and can be used alone or in combination of two or more kinds. The content of the pH adjuster in the jelly composition of the present invention is not particularly limited, but may be 0.01 to 5% by weight, preferably 0.1 to 2% by weight, and more preferably 0.2 to 1.6% by weight. When two or more pH adjusters are used, the total amount is meant. Examples of dispersants include sugar alcohols such as dextrin, maltitol, sorbitol, lactitol, and xylitol, and can be used alone or in combination of two or more. The content of the dispersant in the jelly-like composition of the present invention is not particularly limited, but may be 0.01 to 15% by weight, preferably 0.5 to 10% by weight, and more preferably 3 to 10% by weight. When two or more dispersants are used, the total amount is meant. Examples of surfactants include anionic surfactants, nonionic surfactants, cationic surfactants, and amphoteric surfactants. Examples of anionic surfactants include alkyl sulfates such as sodium lauryl sulfate, N-acyl sarcosinates such as sodium N-lauroyl sarcosinate, and N-acyl glutamate.Examples of nonionic surfactants include sugar fatty acid esters such as sucrose fatty acid esters and maltose fatty acid esters, sugar alcohol fatty acid esters such as maltitol fatty acid esters, sorbitan fatty acid esters, glycerin fatty acid esters, polyglycerin fatty acid esters, polyoxyethylene sorbitan fatty acid esters, polyoxyethylene fatty acid esters, polyoxyethylene higher alcohol ethers, fatty acid alkanolamides, polyoxyethylene polyoxypropylene copolymers, polyoxyethylene polyoxypropylene fatty acid esters, etc. Examples of amphoteric surfactants include betaine-based and imidazoline-based surfactants. These surfactants can be used alone or in combination of two or more. By incorporating a surfactant into the oral cavity dry matter remover of the present invention, the penetration of water into the oral cavity dry matter can be further promoted. Examples of flavors include menthol, peppermint oil, spearmint oil, or fruit-derived essential oils, various masking flavors, etc., and can be used alone or in combination of two or more. Examples of sweeteners include saccharin, saccharin sodium, sodium glycyrrhizinate, aspartame, stevia, sucralose, erythritol, acesulfame K, etc., and these can be used alone or in combination of two or more. Colorants can be used as natural or synthetic dyes, either alone or in combination of two or more. Examples of preservatives include parabens (paraoxybenzoic acid esters) such as methylparaben, ethylparaben, isopropylparaben, propylparaben, butylparaben, isobutylparaben, and benzylparaben, as well as sorbic acid, benzoic acid, dehydroacetic acid, propionic acid, or salts thereof (e.g., sodium benzoate, etc.), and these can be used alone or in combination of two or more. Examples of antibacterial agents include cetylpyridinium chloride, benzalkonium chloride, benzethonium chloride, dequalinium chloride, chlorhexidine salts, triclosan, isopropylmethylphenol, bisabolol chlorhexidine, hinokitiol, peptides, catechins, lactoferrin, etc., and these can be used alone or in combination of two or more.Examples of the defoaming agent include silicone-based defoaming agents, oil-based defoaming agents, fatty acid ester-based defoaming agents, alcohol-based defoaming agents, and sulfate ester-based defoaming agents. These may be used alone or in combination of two or more.
[0040] The method for producing the oral dry matter remover of the present invention is not particularly limited, and may include, for example, a step of heating a mixture of pectin, water, and other components to 80 to 100°C, adding a mixture of a divalent metal salt and water heated to the same temperature as the mixture, heating, and cooling to prepare a jelly-like composition. The method for producing the oral dry matter remover of the present invention may further include a step of filling the jelly-like composition into a stick package or a tube container. The volume filled into the stick package is not particularly limited, and may be, for example, 3 g to 20 g, or 3 to 15 g. The volume filled into the tube container is not particularly limited, and may be, for example, 20 g to 150 g, or 50 g to 150 g.
[0041] The jelly composition of the present invention can also be used as an oral mucosa moistening agent comprising the jelly composition. The oral mucosa moistening agent of the present invention can penetrate moisture into the oral mucosa of the application target, thereby moistening the oral mucosa. EXAMPLES
[0042] EXAMPLES In the following, the present invention will be specifically described with reference to examples and comparative examples in order to deepen understanding of the present invention. However, it goes without saying that these do not limit the scope of the present invention.
[0043] The moisture permeability of each sample was measured using the following filter paper topping method, and the moisture permeability (the ability to release moisture and allow the moisture to permeate into an object) was evaluated based on the diameter of the moisture permeation circle. [Additional filter paper method] A sample stored at 25°C is tightly packed into an open-top container made of an acrylic cylinder with an inner diameter of 23 mm, outer diameter of 25 mm, and height of 15 mm, the bottom of which is covered with paraffin film, using a 50 ml Terumo syringe (outlet inner diameter: 4 mm). A cellulose filter paper (quantitative filter paper No. 5B (diameter 90 mm), manufactured by Advantec) is placed on top and allowed to stand in an incubator at 25°C. After a specified time (3 minutes, 10 minutes, 30 minutes) has passed, the longest and shortest diameters of the part of the filter paper where water has penetrated (water penetration circle) are measured, and the average value is taken as the diameter of the water penetration circle. When the moisture in the composition penetrates against gravity, the diameter of the penetration circle becomes larger than the outer diameter of the container (25 mm). And when this diameter increases over time, it indicates that the composition has a sustained penetration ability.
[0044] [Sensory evaluation] Two expert panelists performed a sensory evaluation of the spreadability during application and the adhesion after application. The evaluation method and criteria are as follows:
[0045] <Method for evaluating extensibility> The prepared jelly-like composition was filled in a 50 ml Terumo syringe (outlet inner diameter: 4 mm) and extruded into a 25 x 25 mm, 1 mm deep recessed area on an acrylic plate. A thin acrylic plate was pressed from above to spread the jelly over the entire area, creating a 25 x 25 mm, 1 mm deep coated state (coated body), which was evaluated according to the following extensibility evaluation criteria. A conceptual diagram of the evaluation method is shown in Figure 3.
[0046] <Evaluation criteria for extensibility> 4: No nodules and extensible. 3: Contains soft nodules but is extensible. 2: Contains hard nodules but is extensible. 1: Breaks into hard lumps and has no extensibility. In this evaluation standard, when a gel was pressed and spread over a 1 mm concave area with a thin acrylic plate, if the gel spread over the entire area without cracking, it was evaluated as "extensible", and if the gel did not spread over the entire area and cracked, it was evaluated as "not extensible". A lump refers to a lump of jelly with a maximum diameter of about 2 mm to 4 mm. Regarding the hardness of the lump, if the lump could be crushed by pressing it with a finger, it was evaluated as "soft", and if it could not be crushed by pressing it with a finger, it was evaluated as "hard".
[0047] <Method for evaluating adhesion> The applied body prepared by the spreadability evaluation method was stood vertically, and after 1 minute, the changes in the entire applied body and the surface of the applied body were evaluated according to the following adhesion evaluation criteria.
[0048] <Adhesion evaluation criteria> ●: The entire coated body remained in the same position on the acrylic plate without slipping at all, and there was absolutely no shifting of the coated body surface. ◯: The entire applied body was not slippery, but some part of the surface of the applied body was displaced. Δ: The entire applied body slipped, but the slippage was less than 5 mm and stopped immediately. ×: The entire applied body slid by 5 mm or more.
[0049] Reference example 1 The moisture permeability of commercially available oral moisturizers that promote the removal of oral exfoliated epithelial membrane and tongue coating in combination with a moisturizing effect was evaluated using the top-up filter paper method. The commercially available oral moisturizers used were "Oral Plus Mouth Gel Moisture Keep" (manufactured by Asahi Group Foods Co., Ltd.), "Mouth Wash Gel" (manufactured by Nippon Dental Pharmaceuticals Co., Ltd.), "N.act Oral Removal Gel" (manufactured by Earth Pharmaceuticals Co., Ltd.), "Wet Aid (gel type)" (manufactured by Dent Care Co., Ltd.), "Wet Aid (foam type)" (manufactured by Dent Care Co., Ltd.), and Viva Gelette (manufactured by Tokyo Giken Co., Ltd.). "Oral Plus" is an oral moisturizer commercialized based on Patent Document 1. "Wet Aid" is a remover commercialized based on Patent Document 2.
[0050] The results are shown in Table 1 and Figure 4. The dotted line in Figure 4 indicates the outer diameter of the acrylic cylinder, 25 mm. For none of the oral moisturizers, the water penetration circle continued to grow after 3 minutes, 10 minutes, or 30 minutes, and did not expand significantly from the outer diameter of the acrylic cylinder. Therefore, it was confirmed that conventional oral moisturizers do not release moisture sufficiently and are unable to sufficiently moisturize dry matter in the oral cavity or the oral mucosa.
[0051] [Table 1]
[0052] Reference example 2 In Reference Example 1, the reason why the moisture penetration circle using the top filter paper method did not increase sustainably with commercially available oral moisturizers was thought to be due to the thickeners that are added to the oral moisturizers to give them shape retention (maintain their shape as a drug) and adhesiveness. Therefore, the moisture penetration was also evaluated using the top filter paper method for aqueous solutions of thickeners that are used in the prior art documents mentioned above and that are widely used in oral moisturizers.
[0053] [Preparation of Comparative Example 1] 2 g of carboxymethylcellulose (CMC Daicel 1390, Daicel Miraize) was mixed with 4 g of dextrin (Oil Q No. 50, Nippon Starch Chemical Co., Ltd.) in advance, and added to 194 g of purified water (adjusted to a total of 200 g) while stirring to dissolve and disperse the mixture. The mixture was left to stand overnight at 25°C as Comparative Example 1, and the water permeability was evaluated by the overlay filter paper method. The evaluation results are shown in Table 2.
[0054] [Preparation of Comparative Examples 2 to 8] According to the composition shown in Table 2, Comparative Examples 2 to 8 were prepared in the same manner as Comparative Example 1, and the moisture permeability was evaluated by the top-up filter paper method. The evaluation results are shown in Table 2. The thickeners used were carboxymethylcellulose (CMC Daicel 1390, Daicel Miraize), hydroxyethylcellulose (SE900, Daicel Miraize), hydroxypropylmethylcellulose (NE-4000, Shin-Etsu Chemical), xanthan gum (SAN-ACE NXG-S, San-Ei Gen F.F.I), guar gum (purified guar gum PF-20, DSP Gokyo Food & Chemical), tamarind gum (Glyloid 6C, DSP Gokyo Food & Chemical), sodium alginate (Chimica Algin I-3, Chimica), and sodium hyaluronate (Nippon Shinyaku), and the dispersant used was dextrin (Nippon Starch Chemical).
[0055] [Table 2]
[0056] The results are shown in Table 2 and Figure 5. The dotted line in Figure 5 indicates the outer diameter of the acrylic cylinder, 25 mm. For all of the thickener solutions, the water penetration circle did not continue to grow after 3 minutes, 10 minutes, or 30 minutes, and did not significantly expand from the outer diameter of the acrylic cylinder. This result suggests that the thickener inhibits water penetration into the coated object due to its water retention, and that it is better not to add a thickener in order to ensure sufficient water penetration.
[0057] Test Example 1 Considering that the DE value has a large effect on the physical properties of jelly, we prepared jelly-like compositions using pectins derived from citrus fruits with various DE values and evaluated their water permeability and extensibility.
[0058] [Preparation of Preparation Example 1-1] (1) 2.4 g of pectin (LM-104AS-J, Sansho Co., Ltd.), 8 g of dextrin (Oil Q No. 50, Nippon Starch Chemical Co., Ltd.), 0.8 g of citric acid crystal N1560 (Maruzen Pharmaceutical Co., Ltd.), 0.38 g of trisodium citrate crystal S (Showa Kako Co., Ltd.), and 168.12 g of purified water (adjusted so that the total of Solutions A and B was 200 g) were mixed and stirred at room temperature to prepare Solution A. (2) 0.3 g of calcium lactate (pentahydrate) (manufactured by Fuso Chemical Co., Ltd.) and 20 g of purified water were mixed and stirred at room temperature to prepare liquid B. (3) Solution A was covered with Saran Wrap and heated in a microwave (600 W, 1 minute 40 seconds), the Saran Wrap was removed, the solution was stirred well, and the solution was covered with Saran Wrap again and heated in a microwave (600 W, 20 seconds). (4) Remove the Saran Wrap and add solution B dropwise to solution A while stirring, and mix thoroughly. (5) Cover with Saran Wrap and heat again in the microwave (600W, 20 seconds). Remove any bubbles on the surface and then cool in a water bath (tap water). (6) The sample was stored in a 25°C thermostatic chamber (product name Cool Incubator CN-25B, manufactured by Mitsubishi Electric Engineering Co., Ltd.) for one day and designated as Preparation Example 1-1. The moisture permeability and extensibility were evaluated by the top filter paper method. The evaluation results are shown in Table 3.
[0059] [Preparation of Preparation Examples 1-2 to 1-5] Preparation Examples 1-2 to 1-5 were prepared in the same manner as Preparation Example 1-1 according to the compositions shown in Table 3, and the same tests were carried out. The evaluation results are shown in Table 3.
[0060] [Table 3] UNIPECTINE OF645C (manufactured by Unitech Foods), UNIPECTINE OF845C (manufactured by Unitech Foods), LM-105AS-J (manufactured by Sansho), UNIPECTINE OF959C SB (manufactured by Unitech Foods).
[0061] As shown in Table 3, in all jelly compositions, the diameter of the water penetration circle after 3 minutes was 28 mm or more, the diameter of the water penetration circle after 10 minutes was 32 mm or more, and the diameter of the water penetration circle after 30 minutes was 36 mm or more. In all jelly compositions, the water penetration circle continues to grow after 3 minutes, 10 minutes, and 30 minutes. Compared with the conventional oral moisturizers and thickener aqueous solutions in Tables 1 and 2, the water penetration was very good, and was particularly good at DE values of 40 or less. In addition, in jelly compositions using pectin jellies with different DE values, differences were observed in the water penetration after 3 minutes, 10 minutes, and 30 minutes. For this reason, it was revealed that the water penetration in the jelly composition using pectin derived from citrus fruits is affected by the DE value, and the quick and sustained penetration with a penetration circle diameter of 28 mm or more after 3 minutes is preferably a DE value of 50 or less, more preferably a DE value of 45 or less. In addition, Oil Q is dextrin, and is used to disperse and dissolve pectin powder in water, and does not affect the properties of the jelly composition. When the extensibility is 2 points or more, the jelly composition can be spread while being applied, when the extensibility is 3 points, the composition contains small jelly pieces that are soft enough to be crushed by pressing with a finger, so uniform application is easy, and when the extensibility is 4 points, the composition does not contain small pieces, so more uniform application is easy. From the results in Table 3, the extensibility is 2 points or more at DE values of 27 to 50, and the extensibility is 3 points or more at DE values of 33 to 50. From the above, it has been revealed that the oral dry matter remover consisting of a jelly composition containing pectin derived from citrus fruits has both excellent moisture permeability and extensibility at DE values of 27 to 50, and has particularly excellent moisture permeability and extensibility at DE values of 33 to 50.
[0062] Test Example 2 As with the citrus fruit-derived pectin in Test Example 1, jelly compositions were prepared using apple-derived pectin having various DE values, and their water permeability and extensibility were evaluated.
[0063] [Preparation of Preparation Example 2-1] (1) 2.8 g of apple-derived pectin (OF305SB, Unitec Foods Co., Ltd.), 8 g of dextrin (Oil Q No. 50, Nippon Starch Chemical Co., Ltd.), 0.8 g of citric acid crystals N1560 (Maruzen Pharmaceutical Co., Ltd.), 0.38 g of trisodium citrate crystals S (Showa Kako Co., Ltd.), and 167.72 g of purified water (adjusted so that the total amount of solutions A and B was 200 g) were mixed and stirred at room temperature to prepare solution A. (2) 0.3 g of calcium lactate (pentahydrate) (manufactured by Fuso Chemical Co., Ltd.) and 20 g of purified water were mixed and stirred at room temperature to prepare liquid B. (3) Solution A was covered with Saran Wrap (registered trademark) and heated in a microwave oven (600 W, 1 minute 40 seconds), the Saran Wrap was removed, the mixture was stirred well, and the solution was covered with Saran Wrap again and heated in a microwave oven (600 W, 20 seconds). (4) Remove the Saran Wrap and add solution B dropwise to solution A while stirring, and mix thoroughly. (5) Cover with Saran Wrap and heat again in the microwave (600W, 20 seconds). Remove any bubbles on the surface and then cool in a water bath (tap water). (6) The sample was stored in a 25°C thermostatic chamber (product name Cool Incubator CN-25B, manufactured by Mitsubishi Electric Engineering Co., Ltd.) for one day and designated as Preparation Example 2-1. The moisture permeability and extensibility were evaluated using the filter paper topping method. The evaluation results are shown in Table 4.
[0064] [Preparation of Preparation Examples 2-2 to 2-4] Preparation Examples 2-2 to 2-4 were prepared in the same manner as Preparation Example 2-1 according to the compositions shown in Table 4, and were evaluated in the same manner. The evaluation results are shown in Table 4.
[0065] [Table 4] UNIPECTINE LM-SN-325 (manufactured by Unitech Foods), UNIPECTINE OF805 (manufactured by Unitech Foods), UNIPECTINE OB700SB (manufactured by Unitech Foods).
[0066] As shown in Table 4, all of the jelly compositions had a water penetration circle diameter of 28 mm or more after 3 minutes, 32 mm or more after 10 minutes, and 36 mm or more after 30 minutes. The jelly compositions using apple-derived pectin also showed a sustained increase in water penetration circle size after 3 minutes, 10 minutes, and 30 minutes, showing very good water penetration compared to the conventional oral moisturizers and thickener aqueous solutions shown in Tables 1 and 2. In addition, the water penetration in the jelly compositions using apple-derived pectin was 28 mm or more after 3 minutes for all jelly compositions with DE values of 23 to 34, showing rapid and sustained penetration. In addition, the spreadability was rated at criterion 3 or more for all jelly compositions with DE values of 23 to 34. From the above, it was made clear that an oral dry matter remover consisting of a jelly-like composition containing apple-derived pectin has both excellent water permeability and extensibility at a DE value of 23 to 34, with a DE value of 23 to 34 being preferable.
[0067] Test Example 3 In general, the hardness of a jelly depends on the amount of gelling agent such as gelatin, carrageenan, or agar. Increasing the amount of gelling agent increases shape retention and adhesiveness, but if the amount is too high, spreadability is lost. Conversely, if the amount is too low, the shape retention of the jelly decreases and it will not maintain its adhesiveness when applied. Jelly compositions of various hardness were prepared, and the range of hardness of the jelly composition that satisfies suitable water permeability, spreadability, and adhesiveness was investigated.
[0068] [Preparation of Preparation Example 3-1] (1) 1.5 g of pectin (LM-105AS-J, Sansho Co., Ltd.), 8 g of dextrin (Oil Q No. 50, Nippon Starch Chemical Co., Ltd.), 0.8 g of citric acid crystal N1560 (Maruzen Pharmaceutical Co., Ltd.), 0.38 g of trisodium citrate crystal S (Showa Kako Co., Ltd.), and purified water adjusted to a total amount of 200 g for solutions A and B were mixed with stirring at room temperature to prepare solution A. (2) 0.8 g of calcium lactate (pentahydrate) (manufactured by Fuso Chemical Co., Ltd.) and 20 g of purified water were mixed and stirred at room temperature to prepare liquid B. (3) Solution A was covered with Saran Wrap and heated in a microwave (600W, 1 minute 40 seconds) and stirred thoroughly. It was covered with Saran Wrap again and heated in a microwave (600W, 20 seconds). (4) Remove the Saran Wrap and add B dropwise to A while stirring, and mix thoroughly. Cover with Saran Wrap again and heat in a microwave (600W, 20 seconds) to remove any bubbles on the surface. (5) The mixture was poured into three stainless steel petri dishes (outer diameter 40 mm, height 15 mm), placed in Tupperware, covered, and stored in a thermostatic chamber at 25°C for one day. The remainder was wrapped in plastic wrap, cooled in a water bath (tap water), and then stored in a thermostatic chamber at 25°C. (6) The product was stored in a thermostatic chamber at 25°C for one day and designated Preparation Example 3-1. The moisture permeability, adhesiveness, and extensibility were evaluated using the filter paper method, and the hardness was measured according to the method prescribed in the Food Approval Standards for People with Dysphagia. The evaluation results are shown in Table 5. The method conforming to the approval standards for foods for people with dysphagia was as follows: the dissolved sample was filled into a stainless steel container 40 mm in diameter and 15 mm in height, and stored overnight at 25°C. After that, using a texture analyzer (Yamaden Corporation: Creep Meter RE2-3305C), the sample was compressed twice with a silicon plunger 20 mm in diameter and 8 mm in height at a compression speed of 10 mm / s and a clearance of 5 mm, and the maximum load at that time was recorded as the hardness of the sample.
[0069] [Preparation of Preparation Examples 3-2 to 3-21] According to the compositions shown in Table 5, Preparation Examples 2 to 21 were prepared in the same manner as Preparation Example 1, and various evaluations were carried out. OF805C (manufactured by Unitech Foods Co., Ltd.) and LM-102AS-J (manufactured by Sansho Co., Ltd.) are pectins derived from citrus fruits. The evaluation results are shown in Table 5.
[0070] [Table 5]
[0071] The relationships between moisture permeability, adhesion, extensibility, and hardness based on Table 5 are shown in Figure 6. In Figure 6, the symbols "●", "◯", "△", and "X" indicate the evaluation results of adhesion for Preparation Examples 3-1 to 3-21, the numbers "2", "3", and "4" written adjacent to the symbols indicate the evaluation results of the corresponding extensibility, and "1700", "2500", "6000", and "7100" indicate the hardness (N / m 2 ) is shown. Regarding water permeability, from Table 5, the hardness of the jelly-like composition is 626 N / m 2 Below and 7480N / m 2 In the above cases, the diameter of the water penetration circle after 3 minutes was less than 28 mm, the diameter of the water penetration circle after 10 minutes was less than 32 mm, and the diameter of the water penetration circle after 30 minutes was less than 36 mm. If the hardness of the jelly composition was too high or too low, the water permeability tended to decrease. On the other hand, if the hardness of the jelly composition was 627 to 7479 N / m 2 In all preparation examples within the range, the diameter of the water penetration circle after 3 minutes was 28 mm or more, the diameter of the water penetration circle after 10 minutes was 32 mm or more, and the diameter of the water penetration circle after 30 minutes was 36 mm or more, and not only was the water penetration circle excellent in a short time, but the excellent water penetration was sustained for at least 30 minutes. Furthermore, when the DE value was 40, the hardness was 1639 to 7019 N / m 2 In all preparation examples within the range, the water penetration circle diameter after 3 minutes was 30 mm or more, the water penetration circle diameter after 10 minutes was 40 mm or more, and the water penetration circle diameter after 30 minutes was 46 mm or more, and the superior water penetration was sustained for at least 30 minutes. Regarding the extensibility, as shown in Table 5, except for the jelly composition with an extremely low hardness, the lower the hardness of the jelly composition, the more improved the extensibility. 2 In all of the above preparation examples, the extensibility is 2 or more, which is excellent from the viewpoint of ease of uniform application, and the hardness is 2335 to 5760 N / m 2 In all preparation examples within the range, the extensibility was 3 or more, which was particularly excellent in terms of ease of uniform application. Furthermore, when the DE value was 30 to 40, the hardness was 2335 to 6158 N / m 2In all preparation examples within the range, the extensibility was 3 or more, which was particularly excellent in terms of ease of uniform application. Note that preparation examples 3-8, 3-13, and 3-15 were not included in the evaluation of extensibility because the gel broke with a small external force and behaved like a liquid. Regarding adhesion, as shown in Table 5, the higher the hardness of the jelly composition, the better the adhesion. 2 In all of the above preparation examples, the adhesion was △, ◯, or ●, which means that the coating continues to adhere after application without peeling off. The hardness was 2659 N / m 2 In all of the above preparation examples, the adhesion was ◯ or ●, and the entire jelly composition (applied body) after application was particularly excellent in terms of continuing to adhere without slipping. Furthermore, when the DE value was 30 to 40, the hardness was 2611 N / m 2 In all of the above preparation examples, the adhesion was rated as ◯ or ●, and was particularly excellent in terms of the fact that the entire jelly-like composition (applied body) after application continued to adhere without slipping. From the above, the hardness of the jelly-like composition is 1640 to 7479 N / m 2 If the diameter of the water penetration circle after 3 minutes is 28 mm or more, the diameter of the water penetration circle after 10 minutes is 32 mm or more, and the diameter of the water penetration circle after 30 minutes is 36 mm or more, not only is it excellent in rapid water penetration in a short time, but the excellent water penetration is sustained for at least 30 minutes, the extensibility is 2 or more, it is excellent in terms of ease of uniform application, and the adhesion is △, ◯, or ●, it is excellent in terms of continuing to adhere without peeling after application. 2 Within this range, the diameter of the water penetration circle after 3 minutes was 28 mm or more, the diameter of the water penetration circle after 10 minutes was 32 mm or more, and the diameter of the water penetration circle after 30 minutes was 36 mm or more, meaning that not only was it excellent in rapid water penetration in a short period of time, but the excellent water penetration was sustained for at least 30 minutes, the extensibility was 3 or more, which was particularly excellent in terms of ease of uniform application, and the adhesion was ◯ or ●, meaning that the entire jelly composition (applied body) after application continued to adhere without slipping. Also, when the DE value is 30 to 40, the hardness is 2611 to 6158 N / m 2 Within this range, the diameter of the water penetration circle after 3 minutes was 28 mm or more, the diameter of the water penetration circle after 10 minutes was 32 mm or more, and the diameter of the water penetration circle after 30 minutes was 36 mm or more, meaning that not only was it excellent in rapid water penetration in a short period of time, but the excellent water penetration was sustained for at least 30 minutes, the extensibility was 3 or more, which was particularly excellent in terms of ease of uniform application, and the adhesion was ◯ or ●, meaning that the entire jelly composition (applied body) after application continued to adhere without slipping. Also, if the DE value is 40, the hardness is 1640 to 7479 N / m 2 In all preparation examples within the range, the diameter of the water penetration circle after 3 minutes is 30 mm or more, the diameter of the water penetration circle after 10 minutes is 40 mm or more, and the diameter of the water penetration circle after 30 minutes is 46 mm or more, and particularly excellent water penetration is maintained for at least 30 minutes, and the extensibility is 2 or more, which is excellent in terms of ease of uniform application, and the adhesion is △, ◯, or ●, which is excellent in terms of continuing to adhere without peeling after application, and the hardness is 2611 to 7018 N / m 2 In all preparation examples within the range, the diameter of the water penetration circle after 3 minutes was 30 mm or more, the diameter of the water penetration circle after 10 minutes was 40 mm or more, and the diameter of the water penetration circle after 30 minutes was 46 mm or more, meaning that particularly excellent water penetration was sustained for at least 30 minutes, the extensibility was 3 or more, which was particularly excellent in terms of ease of uniform application, and the adhesion was ◯ or ●, which was particularly excellent in terms of the entire jelly composition (applied body) continuing to adhere without slipping after application.
[0072] Test Example 4 Dental hygienists administered the oral dry matter remover of the present invention to elderly people living in a special nursing home who actually had oral exfoliated epithelial membrane and tongue coating as professional oral care, and evaluated the effectiveness of removing oral exfoliated epithelial membrane and tongue coating.
[0073] [Clinical evaluation] <Method for evaluating removal of oral desquamated epithelium and / or tongue coating> Nine elderly subjects requiring nursing care and who had oral exfoliated epithelial membrane and / or tongue coating were used as subjects. Five dental hygienists performed regular professional oral care to remove the oral exfoliated epithelial membrane and / or tongue coating, and the five dental hygienists evaluated the removal of oral exfoliated epithelial membrane and / or tongue coating using the following evaluation criteria. The outline of the professional oral care is as follows: The oral dry matter remover of the present invention was applied to the fingertips, a toothbrush, an oral sponge brush, etc., and applied so as to cover the entire oral exfoliated epithelial membrane and / or tongue coating in the oral cavity of the subject, and after waiting 3 to 30 minutes until the oral exfoliated epithelial membrane and / or tongue coating became soft, the oral dry matter remover was removed using a toothbrush, an oral sponge brush, etc.
[0074] <Criteria for evaluation of removal of oral desquamated epithelium and / or tongue coating> A: Compared to the oral moisturizer (Viva Jelette; Tokyo Giken Co., Ltd.) that had been used as a remover until now, it was able to remove oral exfoliated epithelial membrane and / or tongue coating very effectively. B: Compared to the oral moisturizer that had been used as a remover until now, oral epithelial membrane and / or tongue coating were effectively removed. C: Compared to the oral moisturizer that had been used previously as a remover, there was no change in the effect of removing oral desquamated epithelial membrane and / or tongue coating.
[0075] [Preparation of Preparation Example 4] Pectin, maltitol, gluconic acid, and sodium citrate were dispersed and dissolved in 70 g of water while heating to 80°C to prepare liquid A. Next, calcium lactate was dissolved in 20 g of water and heated to 60°C to prepare liquid B. Liquid A was mixed with liquid B in small amounts while stirring, and finally flavoring and sweetener were mixed in, the total amount was adjusted with water, and 20 g portions were packed into aluminum sachets and sterilized by immersion in a bathtub at 80°C for 30 minutes to obtain an oral dry matter remover consisting of a jelly-like composition having the composition shown in Table 6. The hardness was measured using the same method as in Test Example 3 in accordance with the approval standards for foods for people with swallowing difficulties, and was found to be 2,122 N / m 2 Using the obtained oral dry matter remover, the effect of removing oral exfoliated epithelial membrane and tongue coating was evaluated according to the above-mentioned evaluation method and criteria. The evaluation results are shown in Table 7.
[0076] [Table 6]
[0077] [Table 7]
[0078] The hardness of a conventional oral moisturizer (Viva Jelette; manufactured by Tokyo Giken Co., Ltd.) was measured in the same manner as in Test Example 3, in accordance with the approval standards for foods for people with swallowing difficulties. The hardness was 1538 N / m 2 As shown in Reference Example 1, the diameter of the water penetration circle of Viva Jelette after 3 minutes was less than 28 mm, the diameter of the water penetration circle after 10 minutes was less than 32 mm, and the diameter of the water penetration circle after 30 minutes was less than 36 mm by the overlay filter paper method, and the water penetration was lower than the jelly-like compositions of Test Examples 1 to 3. From the results of Table 7, the removal of oral exfoliated epithelial membrane and / or tongue coating using Preparation Example 4 was able to remove oral exfoliated epithelial membrane and / or tongue coating very well in all subjects compared to the conventional oral moisturizer. In addition, since subject 6 did not have oral exfoliated epithelial membrane, only the removal of tongue coating was evaluated. Therefore, the effect of removing oral dry matter by the oral dry matter remover of the present invention was confirmed. From the above results, it was confirmed that the oral dry matter remover of the present invention is superior in the effect of removing oral dry matter compared to the conventional oral moisturizer, and the effect of removing oral dry matter can be evaluated by using the diameter of the water penetration circle measured by the overlay filter paper method as an index.
[0079] Test Example 5 Dental hygienists administered the oral dry matter remover of the present invention or a conventional product (Oralpiece; manufactured by Foodcare Co., Ltd.) to dental patients who actually had oral exfoliated epithelial membrane and tongue coating as part of professional oral care, and the effectiveness of removing oral exfoliated epithelial membrane and tongue coating was evaluated.
[0080] [Clinical evaluation] <Method for evaluating removal of oral desquamated epithelium and / or tongue coating> Four dental patients with oral desquamated epithelium and / or tongue coating were used as subjects, and dental hygienists performed professional oral care similar to that in Test Example 4 to remove the oral desquamated epithelium and / or tongue coating, and the soaking time and removal time were measured.
[0081] [Preparation of Preparation Example 5] A dry oral material remover consisting of a jelly-like composition having the composition shown in Table 8 was obtained in the same manner as in Preparation Example 4, except that the filling amount was 10 g. The hardness was measured in the same manner as in Test Example 3, in accordance with the approval standards for foods for people with swallowing difficulties, and was found to be 2,400 N / m 2 The obtained oral dry matter remover was subjected to the above-mentioned clinical evaluation and evaluation of water permeability by the overlay filter paper method. The results of the clinical evaluation and the evaluation of water permeability are shown in Tables 9 and 10, respectively.
[0082] [Table 8]
[0083] [Table 9] Dryness in the mouth: Dryness in the mouth was evaluated according to the following criteria, with reference to the "buccal mucosa" item of the OHAT (Oral Health Assessment). 1: Healthy 2: Slightly changed 3: Changed 4: Slightly morbid 5: morbid Dryness: The degree of dryness in the oral cavity was evaluated according to the following criteria, with reference to the "saliva" item in the OHAT. 1: Healthy 2: Slightly changed 3: Changed 4: Slightly morbid 5: morbid Plaque volume: The amount of plaque in the oral cavity was evaluated according to the following criteria, with reference to the OHAT item "oral hygiene status." 1: Healthy 2: Slightly changed 3: Changed 4: Slightly morbid 5: morbid
[0084] [Table 10]
[0085] As a result, as shown in Table 9, the time to soften the oral exfoliated epithelial membrane and / or tongue coating after application and the removal time were each shortened to half to one-quarter of those of the conventional product in all patients with different severity of oral dry matter, dryness, and plaque amount. The shortened softening time indicates that high water permeability to the oral dry matter was maintained compared to the conventional product, and the shortened removal time indicates that a greater amount of water penetrated into the oral dry matter compared to the conventional product. Furthermore, it was confirmed that the oral dry matter remover has both sufficient extensibility to be applied evenly and adhesiveness that allows it to adhere to the applied area during oral care without peeling off. In addition, the results of evaluating the moisture permeability by the overlay filter paper method show that, as shown in Table 10, the conventional product did not show sufficient moisture permeation after 3 minutes, 10 minutes, and 30 minutes, whereas the composition of Preparation Example 5 showed a moisture permeation circle diameter of 28 mm or more after 3 minutes, a moisture permeation circle diameter of 32 mm or more after 10 minutes, and a moisture permeation circle diameter of 36 mm or more after 30 minutes, and the excellent moisture permeability was confirmed to last at least 30 minutes by the overlay filter paper method. From this, it was confirmed that the oral dry matter remover of the present invention has a superior effect of permeating moisture into the target and removing oral dry matter compared to conventional oral care products. [Industrial Applicability]
[0086] The method for evaluating the water permeability of an oral application agent of the present invention can appropriately evaluate the water permeability in the oral dry matter remover, and the oral dry matter remover of the present invention is useful because it can effectively perform water penetration (softening) of intraoral dry matter such as oral exfoliated epithelial membrane and remove intraoral dry matter without bleeding, etc.
Claims
1. A method for evaluating the water permeability of oral dry matter removers using the diameter of the water permeation circle measured by the following filter paper method as an index: Top-up filter paper method; A container with a water-impermeable bottom and cylindrical portion is filled with the sample without leaving any gaps, and water-permeable paper is placed on top in contact with the sample. After a specified time has passed, the longest and shortest diameters of the area where water has penetrated into the paper (the water penetration circle) are measured, and the average value is taken as the diameter of the water penetration circle.
2. A mouth dry matter remover comprising a jelly-like composition containing pectin, a divalent metal ion and water, Pectin has a DE value of 20 to 50. An oral dry matter remover, in which the diameter of the water penetration circle after 3 minutes is 28 mm or more, the diameter of the water penetration circle after 10 minutes is 32 mm or more, and / or the diameter of the water penetration circle after 30 minutes is 36 mm or more, as measured by the overlay filter paper method according to claim 1 under at least the following conditions: Top-up filter paper method; The sample is packed tightly into an acrylic cylinder with an inner diameter of 23 mm, outer diameter of 25 mm, and height of 15 mm, the bottom of which is covered with paraffin film, and a cellulose filter paper (quantitative filter paper No. 5B (diameter 90 mm), manufactured by Advantec) is placed on top. The container is then left to stand in an incubator at 25°C. After a specified period of time (3 minutes, 10 minutes, and 30 minutes), the longest and shortest diameters of the area where water has penetrated into the filter paper (water penetration circle) are measured, and the average value is taken as the diameter of the water penetration circle.
3. The hardness of the jelly-like composition measured in accordance with the approval standards for foods for people with dysphagia (filling height 15 mm, measurement temperature 25°C) is 1640-7479 N / m 2 The oral dry matter remover according to claim 2,
4. 3. The oral dry matter remover according to claim 2, wherein the pectin content of the jelly composition is 0.5 to 3.0% by weight.
5. The divalent metal ion is a calcium ion, 3. The oral dry matter remover according to claim 2, wherein the calcium ion content of the jelly-like composition is 0.05 to 1.5% by weight calculated as calcium lactate.
6. DE value is 30-45, The hardness of the jelly-like composition, measured according to the food approval standards for people with dysphagia (filling height 15 mm, measurement temperature 25°C), is 2000 to 6158 N / m 2 The oral dry matter remover according to claim 2,
7. DE value is 39-45, The agent for removing dry matter from an oral cavity according to claim 2, wherein the diameter of the water penetration circle after 3 minutes is 30 to 78 mm, the diameter of the water penetration circle after 10 minutes is 40 to 80 mm, and the diameter of the water penetration circle after 30 minutes is 46 to 80 mm, as measured by the overlay filter paper method described in claim 1.
8. DE value is 30-34, The divalent metal ion is a calcium ion, 3. The oral dry matter remover according to claim 2, wherein the calcium ion content of the jelly-like composition is 0.2 to 0.4% by weight calculated as calcium lactate.
9. 3. The agent for removing dry matter in the oral cavity according to claim 2, wherein the pectin is at least one selected from the group consisting of citrus fruit-derived pectin having a DE value of 33 to 50, apple-derived pectin having a DE value of 23 to 34, and combinations thereof.
10. The oral dry matter remover according to claim 2, which is applied to oral dry matter, oral mucosa and / or teeth.
11. The oral dry matter remover according to claim 2 , wherein the jelly-like composition further contains at least one selected from the group consisting of a pH adjuster, a dispersant, a flavoring, a taste-imparting agent, a colorant, and a functional ingredient.
12. The agent for removing dry matter from the mouth according to claim 2 , wherein the jelly-like composition is substantially free of any thickener other than pectin.
13. The agent for removing dry matter from the mouth according to claim 12, wherein the thickener other than pectin is selected from the group consisting of gums, alginic acid and its salts, vegetable proteins, synthetic polymers, cellulose derivatives and their salts, soybean polysaccharides, carrageenan, fucoidan, casein, gelatin, and glucomannan.
Citation Information
Patent Citations
Composition for oral cavity
JP2012153677A
Cosmetic product
JP2018199662A
Plasma etching
JP1989053547A
Oral composition
JP2010138080A
Dried phlegm softener
JP2010285374A
