TW202045146A - Adhesive sheet for teeth - Google Patents
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- TW202045146A TW202045146A TW109107965A TW109107965A TW202045146A TW 202045146 A TW202045146 A TW 202045146A TW 109107965 A TW109107965 A TW 109107965A TW 109107965 A TW109107965 A TW 109107965A TW 202045146 A TW202045146 A TW 202045146A
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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/66—Phosphorus compounds
- A61K31/661—Phosphorus acids or esters thereof not having P—C bonds, e.g. fosfosal, dichlorvos, malathion or mevinphos
- A61K31/6615—Compounds having two or more esterified phosphorus acid groups, e.g. inositol triphosphate, phytic acid
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
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- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
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- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/02—Cosmetics or similar toiletry preparations characterised by special physical form
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
- A61K8/33—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
- A61K8/34—Alcohols
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
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- A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
- A61K8/33—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
- A61K8/37—Esters of carboxylic acids
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
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- A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
- A61K8/64—Proteins; Peptides; Derivatives or degradation products thereof
- A61K8/65—Collagen; Gelatin; Keratin; Derivatives or degradation products thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/72—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
- A61K8/73—Polysaccharides
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
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- A61K8/72—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
- A61K8/81—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds obtained by reactions involving only carbon-to-carbon unsaturated bonds
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- A61K8/96—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
- A61K8/98—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution of animal origin
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
- A61Q11/00—Preparations for care of the teeth, of the oral cavity or of dentures; Dentifrices, e.g. toothpastes; Mouth rinses
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Abstract
Description
本發明係關於一種牙齒用貼片。The present invention relates to a dental patch.
無論是為了維持健康,亦或是就美容上之觀點而言,每天對於牙齒或牙齦等牙齒周邊部之適當護理不可或缺。若不進行足夠之護理,則牙石或污垢會附著、堆積於牙齒表面而產生不需要之著色或者牙齦退化,而成為牙周病或牙齦炎等之原因,亦可能成為牙齒鬆動或疼痛之發生要素,而且亦有可能損害美感。 為了此種與牙齒或牙齒周邊部相關之各種症狀之預防或治療、賦予美觀,而開發出一種含有所需成分之牙齒用貼片,並嘗試藉由將其貼附於牙齒或牙齒周邊部,而使所需成分發揮作用一定時間。Whether it is to maintain health or from a cosmetic point of view, proper care of the teeth and gums and other peripheral parts of the teeth is indispensable every day. If adequate care is not taken, tartar or dirt will adhere to and accumulate on the surface of the teeth, resulting in unwanted staining or degeneration of the gums, which can cause periodontal disease or gingivitis. It may also be a factor in tooth looseness or pain. , And it may damage the beauty. In order to prevent or treat various symptoms related to teeth or tooth peripherals, and to impart aesthetics, a dental patch containing the required ingredients was developed and tried to attach it to teeth or teeth peripherals. And make the required ingredients work for a certain time.
例如於專利文獻1中揭示有一種牙齒用貼片,其具有溶解至水中時之pH值顯示相互不同之值之層(A)與層(B),且於後者之層中含有植酸等,藉由將該牙齒用貼片貼附於牙齒,而對牙齒表面之pH環境賦予經時變化,並且使植酸等有效地發揮作用,而發揮對牙齒之美白效果。 又,於專利文獻2中揭示有一種牙周病用膜狀外用劑,其包含直接貼附於牙齒及/或牙齦之側之最下接著層與最上保護層,且使各層對牙齒及/或牙齦之接著性及對唾液之溶解速度有差異;且做出了以下嘗試:以該外用劑整體計設為自睡眠開始至睡眠中之至少3小時內對唾液不會完全溶解之溶解速度,藉此欲使之長時間滯留於口腔內,而於睡眠時充分地發揮藥效成分之效果。For example, Patent Document 1 discloses a dental patch, which has layers (A) and (B) whose pH values when dissolved in water show mutually different values, and the latter layer contains phytic acid, etc., By attaching the dental patch to the teeth, the pH environment on the surface of the teeth is changed over time, and the phytic acid etc. can work effectively, thereby exerting a whitening effect on the teeth. In addition, Patent Document 2 discloses a film-like external preparation for periodontal disease, which includes the lowermost adhesive layer and the uppermost protective layer directly attached to the side of the teeth and/or gums, and each layer is opposed to the teeth and/or There are differences in gum adhesion and saliva dissolution rate; and the following attempts have been made: the external agent as a whole is set to a dissolution rate that does not completely dissolve saliva within at least 3 hours from the start of sleep to sleep. This wants to make it stay in the oral cavity for a long time, and fully exert the effect of the medicinal ingredient during sleep.
(專利文獻1)國際公開第2014/069595號 (專利文獻2)日本專利特開2016-84287號公報(Patent Document 1) International Publication No. 2014/069595 (Patent Document 2) Japanese Patent Laid-Open No. 2016-84287
本發明提供一種牙齒用貼片,其係將最內貼附層(X)、以及最外保護層(Y)積層而成, 該最內貼附層(X)具有對牙齒之附著性及對水之溶解性,且含有藥用成分(xa); 該最外保護層(Y)為對牙齒之附著性及對水之溶解性低於最內貼附層(X)之層,含有水不溶性高分子(ya),且含有選自丙二醇(yb)及甘油(yc)中之1種或2種, 較佳為本發明提供一種牙齒用貼片,其係將最內貼附層(X)、以及最外保護層(Y)積層而成, 該最內貼附層(X)具有對牙齒之附著性及對水之溶解性,且含有藥用成分(xa); 該最外保護層(Y)為對牙齒之附著性及對水之溶解性低於最內貼附層(X)之層,含有水不溶性高分子(ya),且含有選自丙二醇(yb)及甘油(yc)中之1種或2種,且成分(yb)之含量、與成分(yb)及成分(yc)之合計含量之質量比((yb)/((yb)+(yc)))大於0.5。The present invention provides a patch for teeth, which is formed by laminating the innermost adhesive layer (X) and the outermost protective layer (Y), The innermost adhesive layer (X) has adhesion to teeth and solubility in water, and contains medicinal ingredients (xa); The outermost protective layer (Y) is a layer whose adhesion to teeth and water solubility are lower than that of the innermost adhesive layer (X), and contains a water-insoluble polymer (ya), and contains selected from propylene glycol (yb) And one or two of glycerin (yc), Preferably, the present invention provides a dental patch, which is formed by laminating the innermost adhesive layer (X) and the outermost protective layer (Y), The innermost adhesive layer (X) has adhesion to teeth and solubility in water, and contains medicinal ingredients (xa); The outermost protective layer (Y) is a layer whose adhesion to teeth and water solubility are lower than that of the innermost adhesive layer (X), and contains a water-insoluble polymer (ya), and contains selected from propylene glycol (yb) And glycerin (yc) one or two, and the content of component (yb), and the mass ratio of the total content of component (yb) and component (yc) ((yb)/((yb) + (yc)) )) is greater than 0.5.
上述專利文獻中所記載之片材儘管可給牙齒或其周邊部帶來所需之作用,但所有片材均未充分地確保貼附時之最外層之透明性,從而無法視認片材之溶解狀況或所需成分之擴散情況,又,亦難以藉由視認來判斷適當之貼附時間。Although the sheets described in the above patent documents can bring the required effects to the teeth or their peripheral parts, all the sheets do not sufficiently ensure the transparency of the outermost layer at the time of attachment, so that the dissolution of the sheet cannot be visually recognized The condition or the diffusion of the required ingredients, and it is difficult to judge the appropriate time of attachment by visual recognition.
因此,本發明者進行了各種研究,結果發現,藉由設為具備至少兩層,即對牙齒之附著性及對水之溶解性顯示出差異之最內貼附層及最外保護層之構造,且為了給牙齒或牙齒周邊部帶來所需效果,而使最內貼附層含有藥用成分,並且使最外保護層含有水不溶性高分子以及丙二醇或甘油之至少一者,可獲得具備確保良好之成形性並且顯示優異之透明性之最外保護層的牙齒貼片。Therefore, the inventors conducted various studies and found that by having at least two layers, the innermost adhesive layer and the outermost protective layer showing differences in the adhesion to teeth and water solubility , And in order to bring the desired effect to the teeth or the periphery of the teeth, the innermost adhesive layer contains medicinal ingredients, and the outermost protective layer contains at least one of water-insoluble polymers and propylene glycol or glycerin. A tooth patch with the outermost protective layer that ensures good moldability and shows excellent transparency.
即,本發明係關於一種牙齒貼片,其具備提高貼附至牙齒或牙齒周邊部時之最外層之透明性而能夠視認構成貼附面之最內層之經時變化之兩層。That is, the present invention relates to a dental patch provided with two layers that increase the transparency of the outermost layer when it is attached to a tooth or the periphery of a tooth, so that the innermost layer constituting the attachment surface can be visually changed with time.
根據本發明之牙齒用貼片,由於在貼附至牙齒或牙齒周邊部時由透明性較高之最外保護層所被覆、保護,故而能夠透過最外保護層視認較最外保護層更內側之層中之藥用成分向牙齒或牙齒周邊部之傳遞、擴散等經時變化,而能夠適當地明確需要之貼附時間。又,亦能夠使本發明之牙齒用貼片與牙齒或牙齒周邊部在視覺上同化,而減少異物感。According to the dental patch of the present invention, since it is covered and protected by the outermost protective layer with higher transparency when it is attached to the tooth or the peripheral part of the tooth, it can be seen through the outermost protective layer to be more inside than the outermost protective layer The transmission and diffusion of the medicinal ingredients in the layer to the tooth or the periphery of the tooth changes over time, and the required time of application can be appropriately determined. In addition, the dental patch of the present invention can be visually assimilated with the teeth or the peripheral part of the teeth, thereby reducing the sensation of foreign bodies.
以下,對本發明進行詳細地進行說明。 本發明之牙齒用貼片包含具備最內貼附層(X)與透明性較高之最外保護層(Y)之至少兩層之構造,且將最內貼附層(X)貼附於牙齒或牙齒周邊部來使用。如此,本發明之牙齒用貼片於貼附至牙齒或牙齒周邊部時,最內貼附層(X)能夠良好地溶解於唾液中,並且能夠適當地發揮各自之特定作用。 具體而言,最內貼附層(X)良好地附著於牙齒或牙齒周邊部,先於最外保護層(Y)溶解於唾液中,並且使所含有之藥用成分(xa)自一面對牙齒或牙齒周邊部發揮作用。其間,與最內貼附層(X)相比,最外保護層(Y)不會過度地附著於牙齒或牙齒周邊部等口腔內,又,相較於最內貼附層(X),最外保護層(Y)對唾液之溶解延遲,因此最內貼附層(X)對唾液之溶解不會因唾液或舌頭而受到不必要之阻礙,可促進藥用成分(xa)良好地向牙齒或牙齒周邊部傳遞、擴散,並且透過最外保護層(Y)視認此種經時變化。Hereinafter, the present invention will be described in detail. The dental patch of the present invention includes a structure with at least two layers of the innermost adhesive layer (X) and the outermost protective layer (Y) with higher transparency, and the innermost adhesive layer (X) is attached to Use it on the teeth or around the teeth. In this way, when the dental patch of the present invention is attached to a tooth or a peripheral portion of a tooth, the innermost adhesive layer (X) can be dissolved in saliva well, and can appropriately perform their specific functions. Specifically, the innermost adhesive layer (X) adheres well to the tooth or the periphery of the tooth, dissolves in the saliva before the outermost protective layer (Y), and makes the contained medicinal ingredients (xa) from one side It acts on the teeth or the periphery of the teeth. Meanwhile, compared with the innermost adhesive layer (X), the outermost protective layer (Y) does not excessively adhere to the teeth or the teeth around the oral cavity, and compared to the innermost adhesive layer (X), The outermost protective layer (Y) delays the dissolution of saliva. Therefore, the dissolution of saliva by the innermost adhesive layer (X) will not be unnecessarily hindered by saliva or the tongue. It can promote the good distribution of medicinal ingredients (xa) The tooth or the periphery of the tooth is transmitted and spread, and this change with time is recognized through the outermost protective layer (Y).
此處,所謂牙齒周邊部,意指包含牙齦、所謂牙床之位於牙齒周邊之口腔內器官,本發明之牙齒用貼片係僅貼附於牙齒、僅貼附於牙齒周邊部、或遍及牙齒及牙齒周邊部兩者貼附來使用之片材。以下,將「牙齒或牙齒周邊部」總稱為「牙齒等」。 又,除用於製造本發明之牙齒用貼片之原液以外,關於各質量,設為乾燥狀態下之質量(乾燥質量)。Here, the term “tooth periphery” refers to the oral organs located around the teeth including gums and so-called gums. The dental patch of the present invention is attached only to the teeth, only to the periphery of the teeth, or all over the teeth. A sheet used by attaching both to the periphery of the tooth. Hereinafter, the "teeth or the peripheral parts of the teeth" are collectively referred to as "teeth, etc." In addition, with the exception of the stock solution used to manufacture the dental patch of the present invention, each mass is the mass in a dry state (dry mass).
本發明之牙齒用貼片所具備之最內貼附層(X)係具有對牙齒之附著性及對水之溶解性,且含有藥用成分(xa)之層,係具有於使用本發明之牙齒用貼片時供直接貼附於牙齒等之面之層。藉此,於將本發明之牙齒用貼片貼附至牙齒等時,最內貼附層(X)可良好地附著於牙齒等並逐漸地溶解於唾液中,從而使藥用成分(xa)自最內貼附層(X)內向牙齒等傳遞、擴散,可給所需部位帶來所需之作用。The innermost adhesive layer (X) of the dental patch of the present invention has adhesion to teeth and water solubility, and a layer containing medicinal ingredients (xa), which is useful for using the present invention When using a tooth patch, it is a layer that is directly attached to the surface of the tooth. Thereby, when the dental patch of the present invention is attached to teeth, etc., the innermost adhesive layer (X) can be well attached to the teeth, etc. and gradually dissolved in saliva, thereby making the medicinal ingredient (xa) Transfer and spread from the innermost attachment layer (X) to the teeth, etc., which can bring the required effects to the required parts.
作為最內貼附層(X)所含有之藥用成分(xa),可列舉:對預防或治療牙周病或牙齦炎等有效之成分、對防蛀牙有效之成分、或帶來美白作用之成分等。具體而言,可列舉:選自植酸、焦磷酸、三聚磷酸、甘草酸、甘草次酸及該等之鹽、以及硝酸鉀及氟中之1種或2種以上。其中,就期望使藥用成分集中地作用於牙齒表面之技術之觀點而言,更佳為使用植酸或其鹽、硝酸鉀、及氟化物。作為較佳之氟化物,可列舉氟化鈉、氟化鉀、氟化銨等氟離子供給化合物、及單氟磷酸鈉等。尤其是就期望簡便地美化牙齒之技術之觀點而言,更佳為使用植酸或其鹽。The medicinal ingredients (xa) contained in the innermost adhesive layer (X) include: ingredients effective for preventing or treating periodontal disease or gingivitis, ingredients effective for preventing tooth decay, or whitening Ingredients etc. Specifically, one or more selected from the group consisting of phytic acid, pyrophosphoric acid, tripolyphosphoric acid, glycyrrhizic acid, glycyrrhetinic acid, and salts thereof, potassium nitrate and fluorine, can be cited. Among them, from the viewpoint of a technology in which medicinal ingredients are expected to act concentratedly on the tooth surface, it is more preferable to use phytic acid or its salt, potassium nitrate, and fluoride. Examples of preferable fluorides include fluoride ion-donating compounds such as sodium fluoride, potassium fluoride, and ammonium fluoride, sodium monofluorophosphate, and the like. In particular, from the viewpoint of a simple and convenient technology for beautifying teeth, it is more preferable to use phytic acid or its salt.
就有效地給牙齒等帶來作用之觀點而言,藥用成分(xa)之含量於最內貼附層(X)100質量%中較佳為0.05質量%以上,更佳為0.07質量%以上,進而較佳為0.1質量%以上。又,就確保對牙齒等之良好之浸透性之觀點而言,藥用成分(xa)之含量於最內貼附層(X)100質量%中較佳為30質量%以下,更佳為20質量%以下,進而較佳為15質量%以下。From the viewpoint of effectively exerting effects on teeth, etc., the content of the medicinal ingredient (xa) in 100% by mass of the innermost adhesive layer (X) is preferably 0.05% by mass or more, more preferably 0.07% by mass or more , And more preferably 0.1% by mass or more. In addition, from the viewpoint of ensuring good permeability to teeth, the content of the medicinal component (xa) in 100% by mass of the innermost adhesive layer (X) is preferably 30% by mass or less, more preferably 20 Mass% or less, more preferably 15 mass% or less.
更具體而言,就作用於牙齒等而引導至良好之狀態之觀點而言,藥用成分(xa)之含量較佳為下述範圍。於藥用成分(xa)為植酸或其鹽之情形時,成分(xa)之含量於最內貼附層(X)100質量%中以酸換算量計較佳為1~30質量%,更佳為5~20質量%,進而較佳為10~15質量%。More specifically, the content of the medicinal component (xa) is preferably in the following range from the viewpoint of acting on teeth and the like and leading to a good state. When the medicinal component (xa) is phytic acid or its salt, the content of the component (xa) in 100% by mass of the innermost adhesive layer (X) is preferably 1-30% by mass in terms of acid conversion amount, and more It is preferably from 5 to 20% by mass, and more preferably from 10 to 15% by mass.
就確保對唾液之良好之溶解性,不僅提高最外保護層(Y)之透明性亦提高最內貼附層(X)之透明性,而賦予牙齒用貼片整體較高之透明性,進一步提昇成分(xa)向牙齒等之溶解、擴散之可視化之觀點而言,最內貼附層(X)較佳為進而含有非離子界面活性劑(xb)。作為該非離子界面活性劑(xb),較佳為含有聚氧乙烯氫化蓖麻油(xb-1)及聚甘油脂肪酸酯(xb-2)之任1種,更佳為含有聚氧乙烯氫化蓖麻油(xb-1)及聚甘油脂肪酸酯(xb-2)兩者。 作為聚氧乙烯氫化蓖麻油(xb-1),就確保對牙齒之附著性,並且進一步提高最內貼附層(X)之透明性之觀點而言,較佳為伸乙氧基之平均加成莫耳數為20~60,更佳為40~60。 作為聚甘油脂肪酸酯(xb-2),就確保對唾液之良好之溶解性,並且進一步提高最內貼附層(X)之透明性之觀點而言,作為構成其之脂肪酸部分,較佳為源自碳數10~16之脂肪酸者,更佳為源自碳數12~14之脂肪酸者。又,就與上述相同之觀點而言,甘油之平均縮合度較佳為5~12。In order to ensure good solubility in saliva, it not only improves the transparency of the outermost protective layer (Y) but also increases the transparency of the innermost attachment layer (X), and imparts higher transparency to the dental patch as a whole, further From the viewpoint of enhancing the visualization of the dissolution and diffusion of the component (xa) to teeth, etc., the innermost adhesion layer (X) preferably further contains a nonionic surfactant (xb). The nonionic surfactant (xb) preferably contains either polyoxyethylene hydrogenated castor oil (xb-1) and polyglycerol fatty acid ester (xb-2), and more preferably contains polyoxyethylene hydrogenated castor. Both sesame oil (xb-1) and polyglycerol fatty acid ester (xb-2). As polyoxyethylene hydrogenated castor oil (xb-1), from the viewpoint of ensuring the adhesion to teeth and further improving the transparency of the innermost adhesion layer (X), the average addition of ethoxylate is preferred The number of moles is 20-60, more preferably 40-60. As polyglycerol fatty acid ester (xb-2), from the viewpoint of ensuring good solubility in saliva and further improving the transparency of the innermost adhesion layer (X), the fatty acid part constituting it is preferred It is derived from a fatty acid having 10 to 16 carbon atoms, and more preferably derived from a fatty acid having 12 to 14 carbon atoms. In addition, from the same viewpoint as the above, the average condensation degree of glycerin is preferably 5-12.
就確保對牙齒之附著性及對唾液之溶解性,並且進一步提高最內貼附層(X)之透明性之觀點而言,最內貼附層(X)中之聚氧乙烯氫化蓖麻油(xb-1)之含量與聚甘油脂肪酸酯(xb-2)之含量之質量比((xb-1)/(xb-2))較佳為0.1以上,更佳為0.5以上,進而較佳為1以上,且較佳為10以下,更佳為9以下,進而較佳為7以下。In terms of ensuring the adhesion to teeth and the solubility to saliva, and further improving the transparency of the innermost adhesion layer (X), the polyoxyethylene hydrogenated castor oil in the innermost adhesion layer (X) ( The mass ratio of the content of xb-1) to the content of polyglycerin fatty acid ester (xb-2) ((xb-1)/(xb-2)) is preferably 0.1 or more, more preferably 0.5 or more, and more preferably It is 1 or more, and is preferably 10 or less, more preferably 9 or less, and still more preferably 7 or less.
最內貼附層(X)亦可含有除聚氧乙烯氫化蓖麻油(xb-1)及聚甘油脂肪酸酯(xb-2)以外之非離子界面活性劑作為非離子界面活性劑(xb)。作為該非離子界面活性劑,可列舉選自聚氧乙烯烷基醚、聚氧乙烯聚氧丙烯共聚物、蔗糖脂肪酸酯、山梨醇酐脂肪酸酯、甘油脂肪酸酯、聚氧乙烯山梨醇酐脂肪酸酯、聚氧乙烯山梨糖醇脂肪酸酯、聚氧乙烯甘油脂肪酸酯、聚氧乙二醇脂肪酸酯、聚氧乙烯植固醇及植物固烷醇、聚氧乙烯羊毛脂及羊毛醇、聚氧乙烯烷基胺及脂肪醯胺、聚氧乙烯烷基苯基甲醛縮合物、聚氧乙烯聚氧丙烯烷基醚、聚氧乙烯烷基苯醚、聚氧乙烯烷基苯醚及脂肪酸乙醇醯胺等中之1種或2種以上。其中,較佳為選自蔗糖脂肪酸酯及聚氧乙烯山梨醇酐脂肪酸酯中之1種或2種。The innermost adhesive layer (X) can also contain nonionic surfactants other than polyoxyethylene hydrogenated castor oil (xb-1) and polyglycerol fatty acid esters (xb-2) as nonionic surfactants (xb) . Examples of the nonionic surfactant include those selected from polyoxyethylene alkyl ethers, polyoxyethylene polyoxypropylene copolymers, sucrose fatty acid esters, sorbitan fatty acid esters, glycerin fatty acid esters, and polyoxyethylene sorbitan Fatty acid esters, polyoxyethylene sorbitol fatty acid esters, polyoxyethylene glycerol fatty acid esters, polyoxyethylene glycol fatty acid esters, polyoxyethylene phytosterol and plant sterols, polyoxyethylene lanolin and wool Alcohol, polyoxyethylene alkyl amine and fatty amide, polyoxyethylene alkyl phenyl formaldehyde condensate, polyoxyethylene polyoxypropylene alkyl ether, polyoxyethylene alkyl phenyl ether, polyoxyethylene alkyl phenyl ether and One type or two or more types of fatty acid ethanolamide. Among them, preferably one or two selected from sucrose fatty acid esters and polyoxyethylene sorbitan fatty acid esters.
就良好地保持最內貼附層(X)對牙齒之附著性及對唾液之溶解性,並且進一步提高最內貼附層(X)之透明性之觀點而言,包含聚氧乙烯氫化蓖麻油(xb-1)及聚甘油脂肪酸酯(xb-2)之非離子界面活性劑(xb)之總含量於最內貼附層(X)100質量%中較佳為0.8質量%以上,較佳為2質量%以上,更佳為3質量%以上,進而較佳為4質量%以上,且較佳為6質量%以下,更佳為5質量%以下,進而較佳為4.7質量%以下。From the viewpoint of maintaining the adhesion of the innermost attachment layer (X) to teeth and the solubility to saliva, and further improving the transparency of the innermost attachment layer (X), polyoxyethylene hydrogenated castor oil is included The total content of the nonionic surfactant (xb) of (xb-1) and polyglycerol fatty acid ester (xb-2) in 100% by mass of the innermost adhesive layer (X) is preferably 0.8% by mass or more, which is more It is preferably 2% by mass or more, more preferably 3% by mass or more, still more preferably 4% by mass or more, and more preferably 6% by mass or less, more preferably 5% by mass or less, and still more preferably 4.7% by mass or less.
又,就與上述相同之觀點而言,聚氧乙烯氫化蓖麻油(xb-1)之含量於最內貼附層(X)100質量%中較佳為0.2~5.5質量%,更佳為0.6~4.5質量%,進而較佳為1.5~3.5質量%。 進而,就與上述相同之觀點而言,聚甘油脂肪酸酯(xb-2)之含量於最內貼附層(X)100質量%中較佳為0.1~3質量%,更佳為0.2~2.2質量%,進而較佳為0.5~2質量%。In addition, from the same viewpoint as the above, the content of polyoxyethylene hydrogenated castor oil (xb-1) in 100% by mass of the innermost adhesion layer (X) is preferably 0.2 to 5.5% by mass, more preferably 0.6 -4.5% by mass, more preferably 1.5 to 3.5% by mass. Furthermore, from the same viewpoint as the above, the content of the polyglycerin fatty acid ester (xb-2) in 100% by mass of the innermost adhesion layer (X) is preferably 0.1-3% by mass, more preferably 0.2- 2.2% by mass, more preferably 0.5 to 2% by mass.
最內貼附層(X)可進而含有香料(xc)。作為該香料(xc),例如可列舉:薄荷腦、蒲勒醇(pulegol)、香旱芹酮、大茴香腦、桉樹腦、水楊酸甲酯、桂皮醛、丁香酚、3-1-薄荷氧基丙烷-1,2-二醇、瑞香草酚、乙酸香茅酯、沉香醇、乙酸沉香酯、香葉草醇、乙酸香葉酯、香茅醇、檸檬烯、薄荷酮、乙酸薄荷酯、N-取代-對薄荷烷-3-甲醯胺、蒎烯、辛醛、檸檬醛、蒲勒酮(pulegone)、乙酸香芹酯、乙酸二氫香芹酯、茴香醛、苯甲醛、樟腦、內酯、乙酸乙酯、丁酸乙酯、環己基丙酸烯丙酯、鄰胺苯甲酸甲酯、甲基苯基縮水甘油酸乙酯、香草醛、十一酸內酯、己醛、乙酸丁酯、乙酸異戊酯、己烯醇、二甲基硫醚、甲基環戊烯醇酮(cyclotene)、糠醛、三甲基吡𠯤、乳酸乙酯、乳酸甲酯、硫代乙酸乙酯等單品香料成分;草莓香料、蘋果香料、香蕉香料、菠蘿香料、葡萄香料、芒果香料、黃油香料、牛奶香料、水果混合香料、熱帶水果香料等調合香料成分;胡椒薄荷油、綠薄荷油、錫蘭肉桂油、大茴香油、桉葉油、鹿蹄草油、肉桂油、丁香油、百里香油、鼠尾草油、香紫蘇油、肉豆蔻油、茴香油、檸檬油、甜油、薄荷油、小豆蔻油、芫荽籽油、羅勒油、紅橘油、萊姆油、熏衣草油、迷迭香油、薑油、葡萄柚油、月桂油、黃金菊油、葛縷子油、馬郁蘭油、香葉油、檸檬草油、香蜂草油、多香果油、玫瑰草油、乳香油、松針油、卑檸油、橙花油、玫瑰油、茉莉油等天然香料成分、及將該等天然香料成分進行加工處理所得之香料成分。 就帶來良好之風味,並且掩蓋成分(xa)之異味而減少貼附時之不舒適感之觀點而言,該成分(xc)之含量於最內貼附層(X)100質量%中較佳為0.1~3質量%,更佳為0.2~2質量%,進而較佳為0.3~1質量%。The innermost adhesive layer (X) may further contain fragrance (xc). As the fragrance (xc), for example, menthol, pulegol, valvone, anethole, cineole, methyl salicylate, cinnamaldehyde, eugenol, 3-menthol Oxypropane-1,2-diol, revanol, citronellyl acetate, linalol, linalyl acetate, geraniol, geranyl acetate, citronellol, limonene, menthone, menthyl acetate, N-substituted-p-menthane-3-carboxamide, pinene, caprylic aldehyde, citral, pulegone, carvyl acetate, dihydrocarvyl acetate, anisaldehyde, benzaldehyde, camphor, Lactone, ethyl acetate, ethyl butyrate, allyl cyclohexyl propionate, methyl anthranilate, ethyl methyl phenyl glycidate, vanillin, undecanoic acid lactone, hexanal, acetic acid Butyl ester, isoamyl acetate, hexenol, dimethyl sulfide, cyclotene, furfural, trimethylpyridine, ethyl lactate, methyl lactate, ethyl thioacetate Other single-product flavor ingredients; strawberry flavor, apple flavor, banana flavor, pineapple flavor, grape flavor, mango flavor, butter flavor, milk flavor, fruit mixed flavor, tropical fruit flavor and other blended flavor ingredients; peppermint oil, spearmint oil, Ceylon cinnamon oil, star anise oil, eucalyptus oil, wintergrass oil, cinnamon oil, clove oil, thyme oil, sage oil, scented perilla oil, nutmeg oil, anise oil, lemon oil, sweet oil, peppermint Oil, cardamom oil, coriander oil, basil oil, tangerine oil, lime oil, lavender oil, rosemary oil, ginger oil, grapefruit oil, bay oil, rudbeckia oil, caraway oil, marjoram Oil, geraniol oil, lemongrass oil, lemon balm oil, allspice oil, palmarosa oil, frankincense oil, pine needle oil, base lime oil, neroli oil, rose oil, jasmine oil and other natural fragrance ingredients, and will These natural flavor ingredients are processed to obtain flavor ingredients. From the viewpoint of bringing a good flavor and masking the peculiar smell of the component (xa) to reduce the uncomfortable feeling during application, the content of the component (xc) is more than 100% by mass in the innermost adhesive layer (X) It is preferably 0.1 to 3% by mass, more preferably 0.2 to 2% by mass, and still more preferably 0.3 to 1% by mass.
就確保最內貼附層(X)本身之良好之成形性之觀點、及促進成分(xa)向牙齒等之傳遞、擴散之觀點而言,較佳為最內貼附層(X)含有水溶性高分子(xd)。此處,水溶性係指於25℃下於100 g水中溶解0.1 g以上之成分。 作為該水溶性高分子(xd),具體而言,可列舉:選自支鏈澱粉、羥乙基纖維素、瓜爾膠、羥丙基纖維素、羥丙基甲基纖維素、明膠及瓊脂中之1種或2種以上。其中,就提高最內貼附層(X)之透明性,使成分(xa)向牙齒等之傳遞、擴散可視化之觀點而言,較佳為選自支鏈澱粉、瓊脂及羥丙基甲基纖維素中之1種或2種。From the viewpoint of ensuring the good formability of the innermost adhesive layer (X) itself and the viewpoint of promoting the transmission and diffusion of the component (xa) to teeth, etc., it is preferable that the innermost adhesive layer (X) contains water-soluble性polymer (xd). Here, water solubility means that 0.1 g or more of ingredients are dissolved in 100 g of water at 25°C. As the water-soluble polymer (xd), specific examples include: selected from pullulan, hydroxyethyl cellulose, guar gum, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, gelatin, and agar One or more of them. Among them, from the viewpoint of improving the transparency of the innermost adhesive layer (X) and visualizing the transmission and diffusion of the component (xa) to teeth, etc., it is preferably selected from pullulan, agar, and hydroxypropylmethyl One or two of cellulose.
關於水溶性高分子(xd)之含量,就確保最內貼附層(X)本身之良好之成形性之觀點、及促進成分(xa)向牙齒等之傳遞、擴散之觀點而言,水溶性高分子(xd)之含量於最內貼附層(X)100質量%中較佳為30~70質量%,更佳為40~65質量%,進而較佳為45~60質量%。Regarding the content of the water-soluble polymer (xd), from the viewpoint of ensuring good formability of the innermost adhesive layer (X) itself, and the viewpoint of promoting the transfer and diffusion of the component (xa) to teeth, etc., water-soluble The content of the polymer (xd) in 100% by mass of the innermost adhesive layer (X) is preferably 30 to 70% by mass, more preferably 40 to 65% by mass, and still more preferably 45 to 60% by mass.
最內貼附層(X)除上述成分以外,亦可於不損害本發明之效果之範圍內含有例如氫氧化鈉或氫氧化鉀等pH值調節劑、丙二醇、甘油等濕潤劑、糖精鈉或蔗糖素等甜味料、防腐劑、色素等作為上述以外之成分。其中,若使用氫氧化鉀作為pH值調節劑,則亦可有助於提高所含有之成分於牙齒用貼片內之溶解性或分散性。 再者,於使用本發明之牙齒用貼片時,就保持良好之附著性或柔軟性之觀點、及確保所含有之成分於牙齒用貼片內之溶解性或分散性之觀點而言,較理想為於經過製造時之乾燥步驟後之最內貼附層(X)中亦保持適度之含水量。該含水量於最內貼附層(X)100質量%中較佳為5~16質量%,更佳為6~15質量%,進而較佳為7~14質量%。In addition to the above-mentioned components, the innermost adhesive layer (X) may also contain pH regulators such as sodium hydroxide or potassium hydroxide, humectants such as propylene glycol and glycerin, sodium saccharin or within a range that does not impair the effects of the present invention. Sweeteners such as sucralose, preservatives, pigments, etc. are used as ingredients other than the above. Among them, if potassium hydroxide is used as a pH adjuster, it can also help improve the solubility or dispersibility of the contained components in the dental patch. Furthermore, when using the dental patch of the present invention, it is more important from the viewpoint of maintaining good adhesion or flexibility and ensuring the solubility or dispersibility of the ingredients contained in the dental patch. It is ideal to maintain a moderate moisture content in the innermost adhesive layer (X) after the drying step during manufacturing. The water content in 100% by mass of the innermost adhesive layer (X) is preferably 5-16% by mass, more preferably 6-15% by mass, and still more preferably 7-14% by mass.
本發明之牙齒用貼片所具備之最外保護層(Y)為對牙齒之附著性及對水之溶解性低於最內貼附層(X)之層,含有水不溶性高分子(ya),且含有選自丙二醇(yb)及甘油(yc)中之1種或2種。藉此,可使對牙齒之附著性及對唾液之溶解性低於最內貼附層(X),並且提高最外保護層(Y)之成形性並賦予優異之透明性。因此,於將本發明之牙齒用貼片貼附至牙齒等時,對唾液之溶解性低於最內貼附層(X)之最外保護層(Y)能夠被覆、保護會先溶解於唾液之最內貼附層(X),並且透過該最外保護層(Y)視認最內貼附層(X)中之藥用成分(xa)向牙齒等之傳遞、擴散等經時變化。又,最外保護層(Y)於藥用成分(xa)發揮作用後可利用牙刷之刷洗而容易地去除。The outermost protective layer (Y) of the dental patch of the present invention is a layer that has lower adhesion to teeth and water solubility than the innermost adhesive layer (X), and contains a water-insoluble polymer (ya) , And contains one or two selected from propylene glycol (yb) and glycerin (yc). Thereby, the adhesion to teeth and the solubility to saliva can be made lower than the innermost attachment layer (X), and the moldability of the outermost protective layer (Y) is improved and excellent transparency is imparted. Therefore, when the dental patch of the present invention is attached to teeth, etc., the solubility to saliva is lower than that of the innermost attachment layer (X). The outermost protective layer (Y) can be covered, and the protection will dissolve in saliva first The innermost adhesive layer (X), and through the outermost protective layer (Y), the transmission and diffusion of the medicinal ingredients (xa) in the innermost adhesive layer (X) to the teeth, etc. change with time. In addition, the outermost protective layer (Y) can be easily removed by brushing with a toothbrush after the medicinal ingredient (xa) has worked.
此處,水不溶性係指於25℃下於100 g水中溶解之量未達0.1 g之成分。 再者,於最外保護層(Y)中,就有效地抑制魚眼等產生、賦予優異之透明性之觀點而言,界面活性劑之含量於最外保護層(Y)100質量%中較佳為未達0.1質量%,進而較佳為未達0.01質量%,特佳為最外保護層(Y)不含有界面活性劑。Here, water insolubility refers to components that dissolve less than 0.1 g in 100 g of water at 25°C. Furthermore, in the outermost protective layer (Y), in terms of effectively suppressing the production of fish eyes and imparting excellent transparency, the content of the surfactant is more than 100% by mass in the outermost protective layer (Y). It is preferably less than 0.1% by mass, and more preferably less than 0.01% by mass, and it is particularly preferable that the outermost protective layer (Y) does not contain a surfactant.
作為該水不溶性高分子(ya),可列舉選自乙基纖維素、醋酸羥丙基甲基纖維素琥珀酸酯、鄰苯二甲酸醋酸纖維素、羥丙甲纖維素鄰苯二甲酸酯、蟲膠、聚乙酸乙烯酯、聚甲基丙烯酸甲酯、甲基丙烯醯基乙基甜菜鹼/甲基丙烯酸酯共聚物、甲基丙烯酸共聚物、甲基丙烯酸胺基烷基酯共聚物及瓊脂中之1種或2種以上。其中,就防止最外保護層(Y)中之白濁部分出現,賦予優異之透明性之觀點而言,較佳為選自乙基纖維素及蟲膠中之1種或2種,更佳為乙基纖維素。Examples of the water-insoluble polymer (ya) include those selected from ethyl cellulose, hydroxypropyl methyl cellulose acetate succinate, cellulose acetate phthalate, and hypromellose phthalate. , Shellac, polyvinyl acetate, polymethyl methacrylate, methacryloyl ethyl betaine/methacrylate copolymer, methacrylic acid copolymer, aminoalkyl methacrylate copolymer and One or more of agar. Among them, from the viewpoint of preventing the appearance of the cloudy part in the outermost protective layer (Y) and imparting excellent transparency, preferably one or two selected from ethyl cellulose and shellac, more preferably Ethyl cellulose.
就有效地抑制最外保護層(Y)中之魚眼等產生、賦予優異之透明性之觀點而言,丙二醇(yb)及甘油(yc)之含量、與水不溶性高分子(ya)之含量之質量比(((yb)+(yc))/(ya)),即,成分(yb)及成分(yc)之合計含量、與成分(ya)之含量之質量比(((yb)+(yc))/(ya))較佳為0.1以上,更佳為0.25以上,進而較佳為0.43以上,較佳為9以下,更佳為4以下,進而較佳為2.3以下。又,成分(yb)及成分(yc)之合計含量、與成分(ya)之含量之質量比(((yb)+(yc))/(ya))較佳為0.1~9,更佳為0.25~4,進而較佳為0.43~2.3。又,丙二醇(yb)之含量與水不溶性高分子(ya)之含量之質量比((yb)/(ya))較佳為0.1~9,更佳為0.25~4,進而較佳為0.43~2.3。From the viewpoint of effectively suppressing the production of fish eyes in the outermost protective layer (Y) and imparting excellent transparency, the content of propylene glycol (yb) and glycerin (yc) and the content of water-insoluble polymer (ya) The mass ratio (((yb)+(yc))/(ya)), that is, the total content of component (yb) and component (yc), and the mass ratio of the content of component (ya) (((yb)+ (yc))/(ya)) is preferably 0.1 or more, more preferably 0.25 or more, still more preferably 0.43 or more, preferably 9 or less, more preferably 4 or less, and still more preferably 2.3 or less. In addition, the total content of the component (yb) and the component (yc), and the mass ratio of the content of the component (ya) (((yb) + (yc))/(ya)) are preferably 0.1-9, more preferably 0.25 to 4, more preferably 0.43 to 2.3. In addition, the mass ratio ((yb)/(ya)) of the content of propylene glycol (yb) to the content of the water-insoluble polymer (ya) is preferably 0.1-9, more preferably 0.25-4, and still more preferably 0.43- 2.3.
丙二醇(yb)之含量、與丙二醇(yb)及甘油(yc)之合計含量之質量比((yb)/((yb)+(yc)))大於0.5,較佳為大於0.7,進而較佳為大於0.9。關於質量比(yb)/((yb)+(yc))之上限值,為1以下即可。The mass ratio of the content of propylene glycol (yb) to the total content of propylene glycol (yb) and glycerin (yc) ((yb)/((yb)+(yc))) is greater than 0.5, preferably greater than 0.7, and more preferably Is greater than 0.9. The upper limit of the mass ratio (yb)/((yb)+(yc)) may be 1 or less.
就亦確保最外保護層(Y)之良好之成形性與由刷洗引起之崩解性之觀點而言,選自成分(yb)及(yc)中之1種或2種以上之合計含量於最外保護層(Y)100質量%中較佳為7質量%以上,更佳為20質量%以上,進而較佳為40質量%以上,且較佳為90質量%以下,更佳為80質量%以下,進而較佳為70質量%以下。From the viewpoint of also ensuring good formability of the outermost protective layer (Y) and disintegration caused by brushing, the total content of one or more of ingredients (yb) and (yc) is In 100% by mass of the outermost protective layer (Y), it is preferably 7 mass% or more, more preferably 20 mass% or more, still more preferably 40 mass% or more, and preferably 90 mass% or less, more preferably 80 mass% % Or less, more preferably 70% by mass or less.
最外保護層(Y)除上述成分以外,亦可於不損害本發明之效果之範圍內含有例如防腐劑、色素等作為上述以外之成分。In addition to the above-mentioned components, the outermost protective layer (Y) may contain, for example, preservatives, pigments, etc., as components other than the above-mentioned components within a range that does not impair the effects of the present invention.
就有效地防止最內貼附層(X)對唾液之溶解因唾液或舌頭而受到不必要之阻礙、促進最內貼附層(X)對唾液之溶解以及藥用成分(xa)向牙齒等良好地傳遞、擴散之觀點而言,最外保護層(Y)之厚度較佳為0.1 μm以上,更佳為0.2 μm以上,進而較佳為0.3 μm以上。又,就確保對最外保護層(Y)賦予較高透明性之觀點、及即便於貼附中閉口亦不易產生不適感之觀點而言,最外保護層(Y)之厚度較佳為5 μm以下,更佳為3 μm以下,進而較佳為2.5 μm以下。並且,最外保護層(Y)之厚度較佳為0.1~5 μm,更佳為0.2~3 μm,進而較佳為0.3~2.5 μm。It effectively prevents the innermost adhesive layer (X) from dissolving saliva from being unnecessarily hindered by saliva or the tongue, and promotes the innermost adhesive layer (X) to dissolve saliva and the medicinal ingredients (xa) to teeth, etc. From the viewpoint of good transfer and diffusion, the thickness of the outermost protective layer (Y) is preferably 0.1 μm or more, more preferably 0.2 μm or more, and still more preferably 0.3 μm or more. In addition, from the viewpoint of ensuring higher transparency to the outermost protective layer (Y), and the viewpoint that it is less likely to cause discomfort even when the mouth is closed during application, the thickness of the outermost protective layer (Y) is preferably 5 μm Hereinafter, it is more preferably 3 μm or less, and still more preferably 2.5 μm or less. In addition, the thickness of the outermost protective layer (Y) is preferably 0.1-5 μm, more preferably 0.2-3 μm, and still more preferably 0.3-2.5 μm.
就於藥用成分(xa)向牙齒等良好地傳遞、擴散之期間被最外保護層(Y)有效地被覆、保護之觀點、及於適度之時間內完全溶解於唾液中之觀點而言,最內貼附層(X)之厚度較佳為9.9~95 μm,更佳為19.8~87 μm,進而較佳為29.7~77.5 μm以下。From the viewpoint of being effectively covered and protected by the outermost protective layer (Y) during the period when the medicinal ingredient (xa) is well transferred and spreading to teeth, etc., and from the viewpoint of being completely dissolved in saliva in a moderate time, The thickness of the innermost attachment layer (X) is preferably 9.9 to 95 μm, more preferably 19.8 to 87 μm, and still more preferably 29.7 to 77.5 μm or less.
本發明之牙齒用貼片除上述最內貼附層(X)及最外保護層(Y)以外,亦可進而具備於最內貼附層(X)與最外保護層(Y)之層間所形成之中間層(Z)。藉此,於使用時最內貼附層(X)溶解於唾液中而將藥用成分(xa)釋出至口腔內後,繼而中間層(Z)溶解於唾液中而藥用成分(xa-2)被釋出至口腔內。(xa-2)係與最內側貼附層(X)中所含之藥用成分(xa)不同之成分,可列舉選自植酸、焦磷酸、三聚磷酸、甘草酸、甘草次酸及該等鹽、以及硝酸鉀及氟中之1種或2種以上。藉由設置中間層(Z),容易賦予階段性之溶解性,即於使最內貼附層(X)溶解之後繼而使中間層(Z)溶解。 作為該中間層(Z)之材質,可列舉選自支鏈澱粉、羥乙基纖維素、瓜爾膠、羥丙基纖維素、羥丙甲纖維素、明膠及瓊脂中之1種或2種以上。In addition to the above-mentioned innermost adhesive layer (X) and outermost protective layer (Y), the dental patch of the present invention may be further provided between the innermost adhesive layer (X) and the outermost protective layer (Y). The formed middle layer (Z). Thereby, during use, the innermost adhesive layer (X) is dissolved in saliva to release the medicinal ingredient (xa) into the oral cavity, and then the middle layer (Z) is dissolved in the saliva and the medicinal ingredient (xa- 2) Is released into the oral cavity. (xa-2) is a component different from the medicinal component (xa) contained in the innermost adhesive layer (X), which can be selected from phytic acid, pyrophosphate, tripolyphosphate, glycyrrhizic acid, glycyrrhetinic acid and These salts, and one or more of potassium nitrate and fluorine. By providing the intermediate layer (Z), it is easy to give stepwise solubility, that is, the intermediate layer (Z) is dissolved after the innermost adhesive layer (X) is dissolved. As the material of the intermediate layer (Z), one or two selected from pullulan, hydroxyethyl cellulose, guar gum, hydroxypropyl cellulose, hypromellose, gelatin, and agar can be cited the above.
就確保適於貼附之柔軟性或對牙齒等之追隨性之觀點、及確保藥用成分(xa)作用於牙齒等並引導至良好狀態所需要之量之觀點而言,本發明之牙齒用貼片之總厚度較佳為100~10 μm,更佳為90~20 μm,進而較佳為80~30 μm以下。From the viewpoint of ensuring the softness suitable for attachment or the followability to teeth, etc., and the viewpoint of ensuring that the medicinal ingredient (xa) acts on the teeth and the amount required to guide it to a good state, the dental use of the present invention The total thickness of the patch is preferably 100-10 μm, more preferably 90-20 μm, and still more preferably 80-30 μm or less.
為了製造本發明之牙齒用貼片,可於分別形成包含最內貼附層(X)之單一層之片材、包含最外保護層(Y)之單一層之片材、及包含視需要之中間層(Z)之單一層之片材後,積層該等,又,亦可於基材之上依序積層。最內貼附層(X)使用原液(X),最外保護層(Y)使用原液(Y),同樣地中間層(Z)亦使用原液,繼而將該等原液分別製成層狀後,經由乾燥步驟,藉此可形成本發明之牙齒用貼片。 再者,用於形成最內貼附層(X)之原液(X)只要將藥用成分(xa)以成為上述特定量之方式含有,此外適當含有水等成分而進行製備即可,用於形成最外保護層(Y)之原液(Y)只要將水不溶性高分子(ya)及丙二醇(yb)以成為上述特定之質量比之方式含有,此外適當含有水等成分而進行製備即可。用於形成中間層(Z)之原液亦只要以相同之方式進行製備即可。In order to manufacture the dental patch of the present invention, a single-layer sheet including the innermost attachment layer (X), a single-layer sheet including the outermost protective layer (Y), and a single-layer sheet including the outermost protective layer (Y) can be formed separately. After the single-layer sheet of the intermediate layer (Z), the sheets are laminated, and the layers can also be laminated on the substrate in sequence. The innermost adhesive layer (X) uses the original solution (X), the outermost protective layer (Y) uses the original solution (Y), and the middle layer (Z) also uses the original solution. Then the original solutions are made into layers, Through the drying step, the dental patch of the present invention can be formed thereby. Furthermore, the stock solution (X) used to form the innermost adhesive layer (X) only needs to contain the medicinal component (xa) in the above-mentioned specific amount, and in addition, it may be prepared by appropriately containing components such as water. The undiluted solution (Y) forming the outermost protective layer (Y) may be prepared by containing the water-insoluble polymer (ya) and propylene glycol (yb) so as to achieve the above-mentioned specific mass ratio, and appropriately containing components such as water. The stock solution used to form the intermediate layer (Z) can also be prepared in the same manner.
具體而言,例如於形成包含最內貼附層(X)之單一層之片材之情形時,於製備含有藥用成分(xa)之原液(X)之後,一面考慮厚度,一面於實施過脫模處理等之聚對苯二甲酸乙二酯(PET)膜上塗佈原液(X),使其乾燥。然後,藉由剝離PET膜,可獲得各包含單一層之片材。其中,關於構成供貼附於牙齒等之側之面之片材,亦可不剝離PET膜而直接擔載。繼而,於最下層配置PET膜,於其上依序積層包含構成供貼附於牙齒等之側之面之單一層之最內貼附層(X)、其他中間層(Z)、及包含相當於最外保護層(Y)之單一層之片材後,例如使用加壓裝置進行壓接。再者,此處加壓裝置亦可進行加熱。其後,藉由剝離最下層之PET膜,可獲得本發明之牙齒用貼片。Specifically, for example, in the case of forming a single-layer sheet including the innermost adhesive layer (X), after preparing the stock solution (X) containing the medicinal ingredient (xa), the thickness is considered, and the implementation Coating the stock solution (X) on a polyethylene terephthalate (PET) film such as mold release treatment and drying it. Then, by peeling off the PET film, sheets each containing a single layer can be obtained. Among them, the sheet constituting the side surface to be attached to the tooth or the like may be directly carried without peeling the PET film. Then, a PET film is placed on the lowermost layer, and the innermost adhesive layer (X), other intermediate layers (Z), and other intermediate layers (Z), including the innermost adhesive layer (X), other intermediate layers (Z), and the After the single-layer sheet of the outermost protective layer (Y), for example, a pressing device is used for crimping. Furthermore, the pressurizing device here may also perform heating. Thereafter, by peeling off the PET film of the lowermost layer, the dental patch of the present invention can be obtained.
又,於在基材上依序積層之情形時,於最內貼附層(X)構成供貼附於牙齒等之側之面時,例如首先將PET膜作為基材,塗佈原液(X),使其乾燥而形成最內貼附層(X)。其次,於最內貼附層(X)上視需要形成中間層(Z)後,塗佈原液(Y),使其乾燥而形成最外保護層(Y),藉此亦可獲得本發明之牙齒用貼片。In the case of sequential layering on a substrate, when the innermost adhesive layer (X) constitutes the surface for attaching to the tooth or the like, for example, first use a PET film as the substrate and apply the original solution (X ), it is dried to form the innermost adhesive layer (X). Secondly, after forming an intermediate layer (Z) on the innermost adhesive layer (X) as needed, apply the stock solution (Y) and dry it to form the outermost protective layer (Y), thereby obtaining the present invention Patches for teeth.
本發明之牙齒用貼片藉由貼附於牙齒等,可給被貼附體之牙齒等帶來源自藥用成分(xa)之所需效果。於將牙齒用貼片貼附至牙齒等時,自剛貼附後至最內貼附層(X)全部溶解於唾液中為止之時間較佳為3分鐘以上,更佳為5分鐘以上,進而較佳為7分鐘以上,且較佳為60分鐘以下,更佳為45分鐘以下,進而較佳為30分鐘以下。The dental patch of the present invention can bring the desired effect derived from the medicinal ingredient (xa) to the teeth of the attached body by being attached to the teeth. When attaching a dental patch to teeth, etc., the time from immediately after attaching to when the innermost attaching layer (X) is completely dissolved in saliva is preferably 3 minutes or more, more preferably 5 minutes or more, and then It is preferably 7 minutes or more, and preferably 60 minutes or less, more preferably 45 minutes or less, and still more preferably 30 minutes or less.
本發明之牙齒用貼片係貼附至牙齒等時構成所貼附之面之最內貼附層(X)被透明性較高之最外保護層(Y)所被覆、保護而成。因此,於貼附有片材之部位,可透過最外保護層(Y)視認配置於較最外保護層(Y)更內側之層之溶解狀況或藥用成分(xa)向牙齒等之傳遞、擴散狀況,亦可適當地明確適當之貼附時間。又,藉由在配置於較最外保護層(Y)更內側之層施加顏色或花紋,亦可容易地透過這種最外保護層(Y)來視認經時變化。進而,若亦提高最內貼附層(X)之透明性,則亦能夠使本發明之牙齒用貼片與牙齒或牙齒周邊部於視覺上同化,而減少異物感。 [實施例]The dental patch of the present invention is formed by covering and protecting the innermost adhesive layer (X) that constitutes the attached surface when it is attached to a tooth or the like by the outermost protective layer (Y) with higher transparency. Therefore, at the part where the sheet is attached, the dissolution status of the layer arranged on the inner side of the outermost protective layer (Y) or the transfer of medicinal ingredients (xa) to the teeth can be visually recognized through the outermost protective layer (Y) , The spreading situation, and the appropriate time for attaching can also be clearly specified. Moreover, by applying a color or pattern to a layer arranged on the inner side of the outermost protective layer (Y), it is also possible to easily recognize changes over time through the outermost protective layer (Y). Furthermore, if the transparency of the innermost adhesive layer (X) is also improved, the dental patch of the present invention can also be visually assimilated to the teeth or the peripheral part of the teeth, thereby reducing the foreign body sensation. [Example]
以下,基於實施例,對本發明具體地進行說明。再者,表中只要無特別表示,則各成分之含量以質量%表示。Hereinafter, the present invention will be specifically described based on examples. In addition, unless otherwise indicated in the table, the content of each component is indicated by mass %.
[實施例1~21、比較例1~2] 為了獲得表1中所示之最內貼附層(X),使用純化水作為溶劑並且將含有植酸作為藥用成分(xa)之各成分加以混合而製備原液(X)。同樣地,為了獲得表1中所示之最外保護層(Y),使用乙醇作為溶劑並且將水不溶性高分子(ya)及丙二醇(yb)或甘油(yc)加以混合而製備原液(Y)。 繼而,一面考慮厚度,一面將所獲得之原液(X)塗佈於聚對苯二甲酸乙二酯(PET)膜上,使其乾燥而獲得最內貼附層(X)。繼而,自最內貼附層(X)上塗佈原液(Y),使其乾燥,獲得於最內貼附層(X)60~70 μm上積層最外保護層(Y)1~2 μm而成之總厚度為61~72 μm之牙齒用貼片。 再者,表1中所示之值係構成乾燥後之牙齒用貼片之最內貼附層(X)及最外保護層(Y)之值。[Examples 1 to 21, Comparative Examples 1 to 2] In order to obtain the innermost adhesive layer (X) shown in Table 1, purified water was used as a solvent and the components containing phytic acid as a medicinal component (xa) were mixed to prepare a stock solution (X). Similarly, in order to obtain the outermost protective layer (Y) shown in Table 1, ethanol was used as a solvent and a water-insoluble polymer (ya) and propylene glycol (yb) or glycerin (yc) were mixed to prepare a stock solution (Y) . Then, while considering the thickness, the obtained dope (X) is coated on a polyethylene terephthalate (PET) film and dried to obtain the innermost adhesive layer (X). Then, the stock solution (Y) is applied on the innermost adhesive layer (X) and dried to obtain the outermost protective layer (Y) 1~2 μm on the innermost adhesive layer (X) 60~70 μm The total thickness of the dental patch is 61-72 μm. Furthermore, the values shown in Table 1 constitute the values of the innermost attachment layer (X) and the outermost protective layer (Y) of the dental patch after drying.
《最外保護層(Y)之透明性及牙齒用貼片整體之透明性之評價》 關於最外保護層(Y)之透明性,將該最外保護層(Y)中有無白濁作為評價之指標。具體而言,將所獲得之牙齒用貼片配置於黑紙上,藉由目視並以下述5階段評價來判斷有無白濁。 將結果示於表1。 1:完全無白濁部,因此能夠立即識別黑色 2:無白濁部(無法識別為白濁部區域),能夠識別黑色 3:雖存在少許白濁部(大概1/4以下),但能夠識別黑色 4:存在相當之白濁部(大概1/2左右),無法識別一部分黑色 5:白濁部遍及整體存在(大概3/4以上),無法識別黑色"Evaluation of the transparency of the outermost protective layer (Y) and the overall transparency of the dental patch" Regarding the transparency of the outermost protective layer (Y), the presence or absence of turbidity in the outermost protective layer (Y) was used as an index for evaluation. Specifically, the obtained tooth patch was placed on black paper, and the presence or absence of white turbidity was judged by visual inspection and the following five-stage evaluation. The results are shown in Table 1. 1: There is no cloudy part at all, so black can be recognized immediately 2: No turbidity area (cannot be recognized as a turbidity area), black can be recognized 3: Although there is a little cloudy part (about 1/4 or less), black can be recognized 4: There is quite a cloudy part (about 1/2), and a part of black cannot be recognized 5: The turbidity part exists throughout the whole (about 3/4 or more), and black cannot be recognized
又,關於牙齒用貼片整體之透明性,以透過片材能否識別文字作為評價之指標。具體而言,於距離印有文字之紙一定距離處配置牙齒用貼片,依據下述判定基準來判定能否藉由目視透過片材識別文字。 將結果示於表2。 1:由於透明,故而能夠立即識別文字 2:雖透明度稍低,但能夠充分識別文字 3:透明度多少有些低,但勉強能夠識別文字 4:透明度相當欠缺,勉強能夠識別文字本身 5:透明度完全欠缺,難以識別文字本身In addition, regarding the overall transparency of the dental patch, whether characters can be recognized through the sheet is used as an evaluation index. Specifically, the tooth patch is placed at a certain distance from the paper on which the characters are printed, and it is determined whether the characters can be recognized through the sheet by visual observation based on the following judgment criteria. The results are shown in Table 2. 1: Because of the transparency, the text can be recognized immediately 2: Although the transparency is slightly low, but can fully recognize the text 3: Transparency is somewhat low, but it can barely recognize text 4: Transparency is quite lacking, barely able to identify the text itself 5: Transparency is completely lacking and it is difficult to identify the text itself
[表1]
[表2]
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