JP2019199467A - Denture base composition and denture base fitting method - Google Patents
Denture base composition and denture base fitting method Download PDFInfo
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- JP2019199467A JP2019199467A JP2019087630A JP2019087630A JP2019199467A JP 2019199467 A JP2019199467 A JP 2019199467A JP 2019087630 A JP2019087630 A JP 2019087630A JP 2019087630 A JP2019087630 A JP 2019087630A JP 2019199467 A JP2019199467 A JP 2019199467A
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- Prior art keywords
- denture base
- denture
- composition
- mounting
- salt
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Landscapes
- Dental Preparations (AREA)
Abstract
Description
本発明は、義歯床の装着性及び装着力の持続性が優れる義歯床用組成物及びこれを用いた義歯床の装着方法に関する。 The present invention relates to a denture base composition having excellent denture base mounting properties and durability of the mounting force, and a denture base mounting method using the same.
口腔内の乾燥は、日常生活において経験され、不快感、口臭の発生等を伴うだけでなく、義歯装着者においては義歯床装着の不具合を招き易い。
近年、残存歯の増加に伴い、部分義歯装着者が増加しており、６５歳以上の高齢者では、約３人に１人が部分義歯を装着している。義歯（入れ歯）は人工歯と義歯床を有し、義歯装着時は義歯床が粘膜に直接接するため、義歯床の装着性は重要である。義歯床装着性には、口腔内の環境が大きく影響し、口腔内が唾液で潤った状態であれば、義歯床とその装着部位の床下粘膜との間の密着性は増し、装着による痛みや違和感はある程度緩和される。しかしながら、高齢者は、ストレスや服用している薬剤の影響、口腔機能の低下に伴う咀嚼回数の減少や咀嚼力の低下などが原因となって、唾液の分泌量が減少して口腔内が乾燥している場合が多い。このため、特に高齢者においては、装着部位における義歯床の装着力が落ち、痛くて義歯床が装着できない、あるいは装着中にずっと違和感を感じてしまうといった不具合を生じることが多く、義歯装着時のケアが課題となっていた。
Drying in the oral cavity is experienced in daily life, and not only causes uncomfortable feeling and bad breath, but also tends to cause problems in denture base wearing in a denture wearer.
In recent years, with the increase in the number of remaining teeth, the number of partial denture wearers has increased, and about one in every three elderly people aged 65 or older are wearing partial dentures. Dentures (dentures) have artificial teeth and denture bases, and when the dentures are mounted, the denture base is in direct contact with the mucous membrane, so the mounting properties of the denture base are important. If the oral environment is greatly affected by the environment in the oral cavity and the oral cavity is moistened with saliva, the adhesion between the denture base and the submucosa at the site of attachment increases, and pain and Discomfort is alleviated to some extent. However, the elderly suffer from reduced saliva secretion and dry mouth due to stress, effects of drugs taken, decreased number of mastications due to decreased oral function, and decreased masticatory power. There are many cases. For this reason, especially in elderly people, the mounting force of the denture base at the mounting site is reduced, and it is often painful that the denture base cannot be mounted, or it often causes a sense of incongruity during mounting. Care was an issue.
一方、口腔内の唾液分泌促進にポリグルタミン酸又はその塩が有効であることは公知である。特許文献１（特許第４６３２０４８号公報）には、口腔組織に対して刺激性無しに唾液分泌を促進する手段としてポリグルタミン酸又はその塩の利用が提案されており、ポリグルタミン酸ナトリウム又はカリウムを配合した洗口液及び口中清涼剤、ポリグルタミン酸アンモニウム、クエン酸等を配合したうがい用錠剤、ポリグルタミン酸エタノールアミン塩、グリセリン等を配合した給水吸引機能付き口腔ケアシステム用溶液が開示されている。
また、ポリグルタミン酸又はその塩による効果の持続性改善のため、特許文献２（特許第５２３３３９９号公報）では、ポリグルタミン酸塩と有機酸とグリセリンを配合し、口腔乾燥症による口中の乾燥感を使用直後から長時間に亘り持続的に改善し、かつ口腔粘膜等への刺激やベタツキ感が抑制され、経時での保存安定性、噴霧性も良い口腔スプレー用組成物及び口腔用製剤が開示されている。
On the other hand, it is known that polyglutamic acid or a salt thereof is effective for promoting salivary secretion in the oral cavity. Patent Document 1 (Patent No. 4632048) proposes the use of polyglutamic acid or a salt thereof as a means for promoting salivation without stimulating the oral tissue, and contains sodium or potassium polyglutamate. A mouthwash tablet containing a mouthwash and a mouth freshener, polyglutamate ammonium, citric acid and the like, a solution for an oral care system with a water supply suction function containing a polyglutamate ethanolamine salt, glycerin and the like are disclosed.
In addition, in order to improve the durability of the effect of polyglutamic acid or a salt thereof, Patent Document 2 (Patent No. 5233399) uses polyglutamate, organic acid and glycerin, and uses a dry feeling in the mouth due to dry mouth. Disclosed are compositions for oral sprays and oral preparations that improve continuously over a long period of time immediately afterwards, suppress irritation and stickiness to oral mucous membranes, etc., and have good storage stability and sprayability over time Yes.
本発明は、上記事情に鑑みなされたもので、義歯床の装着性が優れると共に高い装着力が持続する義歯床用組成物及びこれを用いた義歯床の装着方法を提供することを目的とする。 This invention is made | formed in view of the said situation, and it aims at providing the mounting method of the denture base using the composition for denture bases with which the mounting property of a denture base is excellent and high mounting force lasts. .
本発明者らは、上記目的を達成するため鋭意検討を行った結果、ポリグルタミン酸及びその塩から選ばれる１種以上に、アニオン性水溶性高分子物質のイオタ−カラギーナン及びカッパ−カラギーナンから選ばれる１種以上を併用して配合すると、口腔内に義歯床を装着する際の装着性が優れると共に装着力及びその持続性が向上し、これにより、特に口腔内への義歯床装着に有効な義歯床用組成物が得られることを知見した。
即ち、本発明では、（Ａ）ポリグルタミン酸及びその塩から選ばれる１種以上と、（Ｂ）イオタ−カラギーナン及びカッパ−カラギーナンから選ばれる１種以上とを含有する義歯床用組成物によって、この義歯床用組成物を義歯床に適用した後、義歯床を口腔内の装着部位に装着すると、義歯床の装着性が優れると共に高い装着力が持続し、また、経時でもｐＨ変化が抑えられて安定化し、製剤の均一性も保持され、製剤安定性を良好に保持できることを知見し、本発明をなすに至った。
As a result of intensive studies to achieve the above object, the present inventors have selected one or more selected from polyglutamic acid and salts thereof from iota-carrageenan and kappa-carrageenan as anionic water-soluble polymer substances. When one or more types are used in combination, the wearability when the denture base is worn in the oral cavity is improved, and the wear force and its durability are improved, which makes the denture particularly effective for wearing the denture base in the oral cavity. It has been found that a flooring composition can be obtained.
That is, in the present invention, the denture base composition containing (A) one or more selected from polyglutamic acid and a salt thereof and (B) one or more selected from iota-carrageenan and kappa-carrageenan. After applying the denture base composition to the denture base, if the denture base is attached to the mounting site in the oral cavity, the denture base is excellent in wearability and maintains a high mounting force, and the change in pH is suppressed over time. It was found that the stability of the preparation was maintained, the uniformity of the preparation was maintained, and the preparation stability could be maintained well, and the present invention was achieved.
更に詳述すると、本発明者らが、ポリグルタミン酸又はその塩を応用した義歯装着時のケアについて検討したところ、唾液分泌促進作用を有するアニオン性の水溶性高分子物質であるポリグルタミン酸又はその塩を口腔用組成物等の組成物に配合すると、適度な製剤粘度が付与されることから、例えば口腔内の義歯床装着部位に義歯床を装着する場合、使用直後は義歯床と床下粘膜との間に滞留し、義歯床の密着性を向上させ、装着による痛みや違和感の緩和を期待できた。しかしながら、ポリグルタミン酸又はその塩による唾液分泌促進作用の持続性は十分ではなく、しかも、これらによって唾液分泌が促進されると、分泌された唾液によってポリグルタミン酸又はその塩配合の製剤が経時で希釈され、義歯床とその装着部位の床下粘膜との間に製剤が滞留し難くなり、ますます作用が持続しなくなり、義歯床装着に伴う違和感の緩和効果を維持することができなかった。このため、ポリグルタミン酸又はその塩だけを配合した製剤では、義歯床の装着力の持続性が十分とは言えず、改善の余地が残された。
そこで、本発明者らは、ポリグルタミン酸又はその塩の口腔内滞留性の向上を目指して更に検討を進めた。その結果、（Ａ）成分に、（Ｂ）成分を併用し、好ましくはそれぞれを特定量で配合すると、両者のアニオン性水溶性高分子物質が特異的に作用し、（Ｂ）成分が（Ａ）成分によって分泌促進された唾液中の成分と作用して粘性が増すことで、唾液で希釈されても製剤粘性が適度に維持されて製剤の滞留性が向上し、かつ（Ａ）成分による唾液分泌促進作用が長時間に亘って持続した。これらにより、本発明では、唾液分泌量が減少して口腔内が乾燥傾向にあるとしても、義歯床を口腔内の装着部位に装着する際の抵抗感や違和感が低減して優れた装着性を与え、かつ義歯床を装着して数時間経過後も装着力が低下することなく持続し、また、経時でも製剤安定性を維持することができた。
More specifically, when the present inventors examined the care at the time of denture application using polyglutamic acid or a salt thereof, polyglutamic acid or a salt thereof which is an anionic water-soluble polymer substance having a salivary secretion promoting action. When blended into a composition such as a composition for oral cavity, an appropriate formulation viscosity is imparted.For example, when a denture base is mounted on a denture base mounting site in the oral cavity, It stayed in between, improved the adhesion of the denture base, and was expected to relieve pain and discomfort due to wearing. However, the persistence of the salivary secretion promoting action by polyglutamic acid or its salt is not sufficient, and when salivary secretion is promoted by these, the preparation containing polyglutamic acid or its salt is diluted with time by the secreted saliva. The preparation is less likely to stay between the denture base and the submucosa at the site of attachment, and the action no longer continues, and the alleviation of the uncomfortable feeling associated with the denture base attachment cannot be maintained. For this reason, in the formulation which mix | blended only polyglutamic acid or its salt, it could not be said that the durability of the denture base was sufficient, and the room for improvement was left.
Therefore, the present inventors have further studied for the purpose of improving the retention in the oral cavity of polyglutamic acid or a salt thereof. As a result, when the component (B) is used in combination with the component (A), preferably each is blended in a specific amount, both anionic water-soluble polymer substances act specifically, and the component (B) is (A ) Increases viscosity by acting with the components in saliva secreted by the component, so that the viscosity of the formulation is maintained moderately even when diluted with saliva, and the retention of the formulation is improved, and the saliva by component (A) Secretion promoting action lasted for a long time. Thus, in the present invention, even if the saliva secretion amount is reduced and the oral cavity tends to dry, resistance and discomfort at the time of mounting the denture base on the mounting site in the oral cavity are reduced and excellent wearability is achieved. It was maintained without deterioration of the mounting force even after several hours had passed after the denture base was mounted, and the formulation stability could be maintained over time.
後述の実施例及び比較例からも明らかなように、本発明では、（Ａ）及び（Ｂ）成分を組み合わせることによって上記格別な作用効果を奏するものであり、（Ａ）成分に、非イオン性水溶性高分子物質のポリビニルピロリドンを併用した場合（比較例４）、あるいはアニオン性水溶性高分子物質であってもカルボキシメチルセルロースナトリウムを併用した場合（比較例５）、また、口腔内乾燥に有効な保湿剤であるヒアルロン酸ナトリウムと（Ｂ）成分とを併用した場合（比較例３）は、本作用効果が劣るものであった。 As will be apparent from the examples and comparative examples described later, in the present invention, the above-mentioned special effects are achieved by combining the components (A) and (B), and the component (A) is nonionic. When combined with polyvinylpyrrolidone, a water-soluble polymer substance (Comparative Example 4), or when an anionic water-soluble polymer substance is used with sodium carboxymethylcellulose (Comparative Example 5), it is also effective for dry mouth When sodium hyaluronate, which is a humectant, and component (B) were used in combination (Comparative Example 3), this effect was inferior.
本発明では、（Ａ）及び（Ｂ）成分に加えて、更に好ましくは（Ｃ）ｐＨ調整剤を添加し、組成物のｐＨを８以下に調整すると、義歯床装着力の持続性及び製剤安定性を十分に維持できる。 In the present invention, in addition to the components (A) and (B), more preferably (C) a pH adjuster is added, and when the pH of the composition is adjusted to 8 or less, the durability of the denture base mounting force and the formulation stability are improved. Sex can be maintained sufficiently.
なお、特許文献３（特許第３７９７４３１号公報）は、カラギーナン等のゲル化剤を水性溶媒に溶解した溶解液を、前記ゲル化剤を架橋させる架橋剤の存在下でゲル化しながら剪断することによって得られるミクロゲル粒子を含有する低粘度の口腔用組成物を開示し、唾液腺活性化成分としてポリグルタミン酸が記載されているが、具体的な配合組成は記載されていない。特許文献４（特許第４８５９１１５号公報）は、カラギーナン等の水溶性高分子と、γ−ポリグルタミン酸又はその塩を含有する口腔衛生用可食フィルムを開示するが、フィルム剤型で舌上等にのせて使用するため口腔内での分散性に均一性は認められない。特許文献３、４は、口腔用組成物に関する特許であり、義歯床用組成物及び義歯床装着への応用について何ら言及がなく装着性等に関する作用効果は不明である。 Patent Document 3 (Japanese Patent No. 3797431) discloses a method in which a solution obtained by dissolving a gelling agent such as carrageenan in an aqueous solvent is sheared while gelling in the presence of a crosslinking agent that crosslinks the gelling agent. The composition for oral cavity containing the resulting microgel particles is disclosed, and polyglutamic acid is described as a salivary gland activating component, but no specific formulation composition is described. Patent Document 4 (Patent No. 4859115) discloses an edible film for oral hygiene containing a water-soluble polymer such as carrageenan and γ-polyglutamic acid or a salt thereof. Since it is used on top of it, there is no uniformity in dispersibility in the oral cavity. Patent documents 3 and 4 are patents relating to a composition for oral cavity, and there is no mention of application to a denture base composition and denture base mounting, and the operational effects relating to mounting properties are unclear.
従って、本発明は、下記の義歯床用組成物及び義歯床の装着方法を提供する。
〔１〕
（Ａ）ポリグルタミン酸及びその塩から選ばれる１種以上、及び
（Ｂ）イオタ−カラギーナン及びカッパ−カラギーナンから選ばれる１種以上
を含有することを特徴とする義歯床用組成物。
〔２〕
（Ａ）成分を０．０５〜１質量％、（Ｂ）成分を０．１〜１質量％含有する〔１〕に記載の義歯床用組成物。
〔３〕
（Ａ）／（Ｂ）が質量比として０．１〜１０である〔１〕又は〔２〕に記載の義歯床用組成物。
〔４〕
組成物の２０℃でのｐＨが５〜８である〔１〕〜〔３〕のいずれかに記載の義歯床用組成物。
〔５〕
更に、（Ｃ）ｐＨ調整剤を含有する〔４〕に記載の義歯床用組成物。
〔６〕
（Ｃ）ｐＨ調整剤が、（Ｃ１）リン酸又はその塩、及び（Ｃ２）クエン酸又はその塩である〔５〕に記載の義歯床用組成物。
〔７〕
液体又はジェルである〔１〕〜〔６〕のいずれかに記載の義歯床用組成物。
〔８〕
固形、粒状又はフィルム状の製剤の溶液である〔７〕に記載の義歯床用組成物。
〔９〕
スプレー剤、浸漬剤又は塗布剤である〔１〕〜〔８〕のいずれかに記載の義歯床用組成物。
〔１０〕
義歯床装着用である〔１〕〜〔９〕のいずれかに記載の義歯床用組成物。
〔１１〕
〔１〕〜〔１０〕のいずれかに記載の義歯床用組成物を義歯床に適用した後、義歯床を装着部位に装着することを特徴とする義歯床の装着方法。
Accordingly, the present invention provides the following denture base composition and denture base mounting method.
[1]
A denture base composition comprising (A) one or more selected from polyglutamic acid and a salt thereof, and (B) one or more selected from iota-carrageenan and kappa-carrageenan.
[2]
The denture base composition as described in [1], containing 0.05 to 1% by mass of the component (A) and 0.1 to 1% by mass of the component (B).
[3]
The denture base composition according to [1] or [2], wherein (A) / (B) is 0.1 to 10 as a mass ratio.
[4]
The denture base composition according to any one of [1] to [3], wherein the composition has a pH of 5 to 8 at 20 ° C.
[5]
The denture base composition according to [4], further comprising (C) a pH adjuster.
[6]
(C) Denture base composition as described in [5] whose pH adjuster is (C1) phosphoric acid or its salt, and (C2) citric acid or its salt.
[7]
The denture base composition according to any one of [1] to [6], which is a liquid or a gel.
[8]
The denture base composition according to [7], which is a solid, granular or film solution.
[9]
The denture base composition according to any one of [1] to [8], which is a spray, a dipping agent, or a coating agent.
[10]
The denture base composition according to any one of [1] to [9], which is used for mounting a denture base.
[11]
A denture base mounting method comprising: mounting a denture base on a mounting site after applying the denture base composition according to any one of [1] to [10] to the denture base.
本発明によれば、義歯床の装着性が優れると共に高い装着力が持続し、また、製剤安定性も良い義歯床用組成物及びこれらを用いた義歯床の装着方法を提供できる。前記組成物は、義歯床装着用として好適であり、装着時のケアに有効である。 ADVANTAGE OF THE INVENTION According to this invention, the mounting property of a denture base using these can be provided and the composition for denture bases with which the mounting property of a denture base is excellent, high mounting force is continued, and formulation stability is also good. The composition is suitable for mounting on a denture base and is effective for care during mounting.
以下、本発明につき更に詳述する。本発明の義歯床用組成物は、（Ａ）ポリグルタミン酸及びその塩から選ばれる１種以上、及び（Ｂ）イオタ−カラギーナン及びカッパ−カラギーナンから選ばれる１種以上を含有する。 The present invention will be described in further detail below. The denture base composition of the present invention contains (A) one or more selected from polyglutamic acid and salts thereof, and (B) one or more selected from iota-carrageenan and kappa-carrageenan.
（Ａ）成分のポリグルタミン酸、その塩は、唾液分泌促進作用を有する。（Ａ）成分は、ポリグルタミン酸及びその塩を併用してもよく、塩は、ナトリウム塩、カリウム塩等のアルカリ金属塩である。 The polyglutamic acid (A) component and its salt have a salivary secretion promoting action. (A) A component may use together polyglutamic acid and its salt, and a salt is alkali metal salts, such as a sodium salt and potassium salt.
ポリグルタミン酸又はその塩の粘度は、特に限定されないが、下記方法でＢ型粘度計を用いて測定した４質量％水溶液の粘度が１０〜２００ｍＰａ・ｓであることが好ましく、より好ましくは３０〜１２０ｍＰａ・ｓである。粘度が１０ｍＰａ・ｓ以上であると、唾液分泌促進効果及び義歯床装着性の向上効果が十分に発現する。上限値は特に制限はないが、２００ｍＰａ・ｓ以下であると、製剤の粘度を適度に保ち良い使用感を維持できる。 The viscosity of polyglutamic acid or a salt thereof is not particularly limited, but the viscosity of a 4% by mass aqueous solution measured using a B-type viscometer by the following method is preferably 10 to 200 mPa · s, more preferably 30 to 120 mPa -S. When the viscosity is 10 mPa · s or more, the salivary secretion promoting effect and the effect of improving the denture base mounting property are sufficiently exhibited. The upper limit is not particularly limited, but if it is 200 mPa · s or less, the viscosity of the preparation can be kept moderately and good usability can be maintained.
粘度測定方法：
２００ｍＬビーカーに水９６ｇを取り、スターラーで攪拌しながらこれにポリグルタミン酸又はその塩を４．０ｇ加えて完全に溶解させた。次に、２５℃恒温水槽中に１時間静置後、下記のＢＬ型粘度計を用いて正確に１分後の粘度を測定した。
ＢＬ型粘度計：東京計器（株）、Ｂ型粘度計、型式ＢＬ
ローター：Ｎｏ．２
回転数：６０ｒｐｍ
測定温度：２５℃
Viscosity measurement method:
In a 200 mL beaker, 96 g of water was taken, and while stirring with a stirrer, 4.0 g of polyglutamic acid or a salt thereof was added and completely dissolved. Next, after leaving still in a 25 degreeC thermostat for 1 hour, the viscosity after 1 minute was measured correctly using the following BL type | mold viscometer.
BL type viscometer: Tokyo Keiki Co., Ltd., B type viscometer, model BL
Rotor: No. 2
Rotation speed: 60rpm
Measurement temperature: 25 ° C
上記のポリグルタミン酸又はその塩は、例えばγ−ポリグルタミン酸ナトリウム（明治フードマテリアル（株）製）等の市販品を用いることができる。 As the polyglutamic acid or a salt thereof, for example, a commercially available product such as sodium γ-polyglutamate (manufactured by Meiji Food Material Co., Ltd.) can be used.
（Ａ）成分の配合量は、組成物全体の０．０５〜１％（質量％、以下同様）が好ましく、０．１〜０．５％がより好ましい。０．０５％以上であると、義歯床の装着性向上効果、その持続性が十分に発現する。１％以下であると、製剤の粘度を適度に維持して義歯床への適用がより容易になり、また、液体製剤の場合は製剤安定性（ｐＨ変化のなさ）を十分に維持できる。 The compounding amount of the component (A) is preferably 0.05 to 1% (mass%, the same applies hereinafter) of the whole composition, and more preferably 0.1 to 0.5%. When it is 0.05% or more, the effect of improving the mounting property of the denture base and its sustainability are sufficiently expressed. When it is 1% or less, the viscosity of the preparation is moderately maintained and application to the denture base becomes easier, and in the case of a liquid preparation, preparation stability (no change in pH) can be sufficiently maintained.
（Ｂ）成分のイオタ−カラギーナン、カッパ−カラギーナンは、アニオン性水溶性高分子物質であり、イオタ−カラギーナン及びカッパ−カラギーナンを併用してもよい。
カラギーナンは、原料とする海藻の種類の違いから糖構造に違いがあり、κ（カッパ）−カラギーナン、ι（イオタ）−カラギーナン、λ（ラムダ）−カラギーナンがあるが、本発明では、κ−カラギーナン、ι−カラギーナンを使用する。κ−カラギーナンが、義歯床装着性及び義歯床装着力の持続性の点で、より好ましい。
このようなカラギーナンとしては、ＣＰケルコ社製等の市販品を用いることができる。
The component (B) iota-carrageenan and kappa-carrageenan are anionic water-soluble polymer substances, and iota-carrageenan and kappa-carrageenan may be used in combination.
Carrageenan has a difference in sugar structure due to the difference in the type of seaweed used as a raw material. , Ι-carrageenan is used. κ-carrageenan is more preferable in terms of denture base mounting ability and durability of the denture base mounting force.
As such carrageenan, commercially available products such as those manufactured by CP Kelco can be used.
（Ｂ）成分の配合量は、組成物全体の０．１〜１％であり、好ましくは０．２〜０．７％である。０．１％以上であると、唾液で希釈されると適度に増粘して口腔内での滞留性が高まり、義歯床の装着性、装着力の持続性が十分に優れる。１％以下であると、適度な製剤粘度が維持されて義歯床装着力の持続性が十分に優れる。また、特に組成物が液体の場合、配合量が０．５％以下とすると、低温保存における製剤粘度安定性が優れるため、特に好ましい。 (B) The compounding quantity of a component is 0.1 to 1% of the whole composition, Preferably it is 0.2 to 0.7%. When it is 0.1% or more, when diluted with saliva, the viscosity is increased moderately, the retention in the oral cavity is increased, and the attachment property of the denture base and the durability of the attachment force are sufficiently excellent. When it is 1% or less, an appropriate formulation viscosity is maintained, and the durability of the denture base mounting force is sufficiently excellent. In particular, when the composition is a liquid, it is particularly preferable that the blending amount is 0.5% or less because the formulation viscosity stability during low-temperature storage is excellent.
本発明において、（Ａ）成分と（Ｂ）成分との配合量比を示す（Ａ）／（Ｂ）は、質量比として好ましくは０．１〜１０、より好ましくは０．２５〜３．５、特に好ましくは０．２５〜２である。上記範囲内であると、義歯床の装着性、義歯床の装着力の持続性及び製剤安定性（ｐＨ変化のなさ）がより向上する。（Ａ）／（Ｂ）の質量比が０．１に満たないと、唾液分泌促進効果が不十分となり、口腔内での滞留性が劣り、義歯床の装着性及び装着力の持続性が悪くなる場合があり、１０を超えると、口腔内での増粘が不十分となり、口腔内での滞留性が劣り、義歯床の装着性及び装着力の持続性が低下する場合がある。 In this invention, (A) / (B) which shows the compounding quantity ratio of (A) component and (B) component is preferably 0.1-10 as a mass ratio, More preferably, it is 0.25-3.5. Especially preferably, it is 0.25-2. Within the above range, the mounting property of the denture base, the durability of the mounting force of the denture base, and the preparation stability (no change in pH) are further improved. If the mass ratio of (A) / (B) is less than 0.1, the effect of promoting salivation is insufficient, the retention in the oral cavity is inferior, and the attachment of the denture base and the durability of the attachment force are poor. If it exceeds 10, the thickening in the oral cavity will be insufficient, the retention in the oral cavity will be inferior, and the mounting property of the denture base and the durability of the mounting force may be reduced.
本発明の義歯床用組成物は、２０℃におけるｐＨが、好ましくは５〜８、より好ましくは５．５〜６．５である。ｐＨ８以下であると、義歯床装着力の持続性及び製剤安定性を十分に維持できる。なお、ｐＨ５以上であると、歯の脱灰を防止し、義歯床に隣接している残存歯の脱灰を十分に防止できる。 The denture base composition of the present invention has a pH at 20 ° C. of preferably 5 to 8, more preferably 5.5 to 6.5. When the pH is 8 or less, the durability of the denture base mounting force and the preparation stability can be sufficiently maintained. When the pH is 5 or more, demineralization of teeth can be prevented, and demineralization of the remaining teeth adjacent to the denture base can be sufficiently prevented.
本発明では、更に、（Ｃ）ｐＨ調整剤を配合することが好ましく、（Ｃ）ｐＨ調整剤を使用して上記ｐＨに調整することが好ましい。
（Ｃ）ｐＨ調整剤としては、リン酸、クエン酸及びそれらの塩が挙げられ、これらから選ばれる１種又は２種以上を使用できる。この場合、（Ｃ１）クエン酸又はその塩、（Ｃ２）リン酸又はその塩のうちのいずれか一方（（Ｃ１）又は（Ｃ２）成分）を使用してもよいが、（Ｃ１）及び（Ｃ２）成分を併用することが好ましい。（Ａ）及び（Ｂ）成分に、更に（Ｃ）成分、特に（Ｃ１）及び（Ｃ２）成分を併用して配合すると、製剤安定性がより高まり、高温保存後もｐＨ変化が抑えられて十分に安定化し、低温保存後も製剤の均一性が十分に維持される。（Ｃ１）成分又は（Ｃ２）成分を欠く場合は、特に液体製剤の場合、製剤安定性（ｐＨ変化のなさ）が低下するおそれがある。
In the present invention, it is preferable to further blend (C) a pH adjuster, and (C) it is preferable to adjust the pH to the above using a pH adjuster.
(C) As a pH adjuster, phosphoric acid, a citric acid, and those salts are mentioned, The 1 type (s) or 2 or more types chosen from these can be used. In this case, either (C1) citric acid or a salt thereof, (C2) phosphoric acid or a salt thereof ((C1) or (C2) component) may be used, but (C1) and (C2 ) Component is preferably used in combination. When the components (A) and (B) are further combined with the component (C), particularly the components (C1) and (C2), the stability of the preparation is further enhanced, and the pH change is sufficiently suppressed even after high temperature storage. And the uniformity of the preparation is sufficiently maintained even after low-temperature storage. When the component (C1) or the component (C2) is lacking, the formulation stability (no change in pH) may be reduced particularly in the case of a liquid formulation.
（Ｃ１）成分は、クエン酸、クエン酸のアルカリ金属塩を使用でき、無水和物でも、水和物でもよい。具体的にクエン酸塩は、クエン酸一水和物、クエン酸ナトリウム、クエン酸三ナトリウム一水和物、クエン酸三ナトリウム二水和物等が挙げられる。特に、ｐＨの調整や安定性の点から、クエン酸、クエン酸ナトリウム、とりわけクエン酸が好ましい。これらは、１種単独で又は２種以上を併用することができる。
（Ｃ１）成分は、市販品を使用でき、例えばクエン酸、クエン酸ナトリウムはそれぞれ小松屋（株）製を用いることができる。
As the component (C1), citric acid or an alkali metal salt of citric acid can be used, and it may be an anhydride or a hydrate. Specific examples of the citrate include citric acid monohydrate, sodium citrate, trisodium citrate monohydrate, trisodium citrate dihydrate and the like. In particular, citric acid, sodium citrate, and particularly citric acid are preferable from the viewpoint of pH adjustment and stability. These can be used alone or in combination of two or more.
As the component (C1), commercially available products can be used. For example, citric acid and sodium citrate can be manufactured by Komatsuya Co., Ltd.
（Ｃ２）成分は、リン酸、リン酸のアルカリ金属塩やアンモニウム塩を使用でき、塩は正塩でも水素塩でもよい。具体的にリン酸塩は、リン酸ナトリウム、リン酸カリウム、リン酸アンモニウム等の正塩、リン酸二水素ナトリウム、リン酸水素二ナトリウム、リン酸二水素カリウム、リン酸水素二カリウム等の水素塩が挙げられる。特に、ｐＨの調整や安定性の点から、リン酸塩、中でもリン酸水素塩であるリン酸二水素ナトリウム、リン酸水素二ナトリウム、とりわけリン酸水素二ナトリウムが好ましい。これらは、１種単独で又は２種以上を併用することができる。
（Ｃ２）成分は、市販品を使用でき、例えばリン酸二水素ナトリウム、リン酸水素二ナトリウムはそれぞれ太平化学産業（株）製を用いることができる。
As the component (C2), phosphoric acid, an alkali metal salt of phosphoric acid or an ammonium salt can be used, and the salt may be a normal salt or a hydrogen salt. Specifically, the phosphate is a normal salt such as sodium phosphate, potassium phosphate, or ammonium phosphate, hydrogen such as sodium dihydrogen phosphate, disodium hydrogen phosphate, potassium dihydrogen phosphate, or dipotassium hydrogen phosphate. Salt. In particular, from the viewpoints of pH adjustment and stability, phosphates, particularly sodium dihydrogen phosphate, disodium hydrogen phosphate, and particularly disodium hydrogen phosphate, which are hydrogen phosphates are preferable. These can be used alone or in combination of two or more.
As the component (C2), commercially available products can be used. For example, sodium dihydrogen phosphate and disodium hydrogen phosphate can be manufactured by Taihei Chemical Industry Co., Ltd., respectively.
（Ｃ）成分の配合量は、組成物のｐＨを適切に調整できれば特に制限されないが、組成物全体の０．０２〜０．７％、特に０．０６〜０．２％が好ましい。（Ｃ１）成分を配合する場合、その好ましい配合量は、組成物全体の０．０１〜０．２％、特に０．０１〜０．１％であり、（Ｃ２）成分を配合する場合、その好ましい配合量は、組成物全体の０．０１〜０．５％、特に０．０５〜０．１％である。 Although the compounding quantity of (C) component will not be restrict | limited especially if the pH of a composition can be adjusted appropriately, 0.02-0.7% of the whole composition, 0.06-0.2% are preferable. (C1) When mix | blending a component, the preferable compounding quantity is 0.01 to 0.2% of the whole composition, especially 0.01 to 0.1%, When blending (C2) component, A preferable blending amount is 0.01 to 0.5%, particularly 0.05 to 0.1% of the entire composition.
組成物の粘度は、特に組成物が液体の場合、２５℃での粘度を５〜３００ｍＰａ・ｓ、特に１０〜１００ｍＰａ・ｓに設定することが、使用実感や使用性の点から望ましい。粘度が５ｍＰａ・ｓ以上であると、特に組成物を口腔内に適用したときの使用実感が十分に良く、３００ｍＰａ・ｓ以下であると、良好な使用性を十分に維持でき、特にスプレータイプの容器に充填してスプレー剤に調製して使用した際の吐出性が良好である。
また、組成物がジェルの場合、２５℃での粘度を１，０００〜３０，０００ｍＰａ・ｓ、特に３，０００〜１５，０００ｍＰａ・ｓに設定することが、使用実感や使用性の点から望ましい。粘度が１，０００ｍＰａ・ｓ以上であると、組成物を口腔内に適用したときにジェルが垂れることなく使用でき、使用性が十分に良く、３０，０００ｍＰａ・ｓ以下であると、義歯表面に均一に広がり、使用感が良好である。
なお、組成物の粘度は、東機産業（株）（形式：ＶＩＳＣＯＭＥＴＥＲ ＴＶＢ−１０）、ローターＮｏ．Ｍ１、Ｍ２、Ｍ３又はＭ４から適切な種類を使用、回転数３０ｒｐｍ、測定時間６０秒間、２５℃における測定値である（以下同様）。
In particular, when the composition is a liquid, the viscosity of the composition is preferably set to a viscosity at 25 ° C. of 5 to 300 mPa · s, particularly 10 to 100 mPa · s from the viewpoint of actual use and usability. When the viscosity is 5 mPa · s or more, the feeling of use is particularly good when the composition is applied to the oral cavity, and when it is 300 mPa · s or less, good usability can be sufficiently maintained. Good dischargeability when filled into a container and used as a spray.
Further, when the composition is a gel, it is desirable from the viewpoint of use feeling and usability to set the viscosity at 25 ° C. to 1,000 to 30,000 mPa · s, particularly 3,000 to 15,000 mPa · s. . When the viscosity is 1,000 mPa · s or more, the gel can be used without dripping when the composition is applied to the oral cavity, and the usability is sufficiently good. When the viscosity is 30,000 mPa · s or less, the surface of the denture Spreads evenly and feels good.
In addition, the viscosity of the composition is Toki Sangyo Co., Ltd. (form: VISCOMETER TVB-10), rotor No. Using an appropriate type from M1, M2, M3, or M4, measured values at 30 ° C., measuring time 60 seconds, and 25 ° C. (the same applies hereinafter).
本発明の義歯床用組成物は、液体、ジェル、固形、粒状、フィルム状等の形態の製剤として調製することができる。特に、液体製剤又はジェル製剤とすることが好ましい。液体製剤とする場合、液体製剤をそのまま、或いは濃縮液体製剤の場合は希釈し、液体義歯床用組成物として、義歯床に適用することが好ましい。なお、上記製剤のうち、例えば固形、粒状又はフィルム状の製剤は、それぞれを使用時に水に溶解させて溶液を調製し、液体又はジェルとしてから義歯床に適用することができる。この場合、義歯床に適用するために希釈又は溶解した、使用時の（Ａ）、（Ｂ）成分量がそれぞれ上記配合量の範囲内であることが好ましく、前記使用時の成分量を満たすための製剤成分量と用法・用量に設計された、各種製剤に調製することができる。
義歯床への適用方法は、直接塗布、スプレーによる噴霧、浸漬等の手段を採用でき、例えば塗布剤、スプレー剤、浸漬剤等の形態の製剤として調製することができる。
本発明の義歯床用組成物は、前記組成物を義歯床の装着面に適用した後、義歯床を装着部位に装着する方法を採用でき、口腔内に装着する前の未装着状態の義歯床の装着面に適用し、その後に義歯床を口腔内の装着部位に装着することが好ましい。また、装着中に追加して使用する場合は、既に装着している義歯を外した後、義歯床の装着面に義歯床用組成物を再適用してから装着するのが好ましい。義歯床は部分義歯床、全部義歯床のどちらでもよい。
The denture base composition of the present invention can be prepared as a preparation in the form of liquid, gel, solid, granular, film or the like. In particular, a liquid preparation or a gel preparation is preferable. In the case of a liquid preparation, it is preferable to apply the liquid preparation as it is, or in the case of a concentrated liquid preparation, to be diluted and applied to the denture base as a liquid denture base composition. Of the above preparations, for example, solid, granular or film preparations can be dissolved in water at the time of use to prepare a solution, which can be applied to a denture base as a liquid or gel. In this case, it is preferable that the amounts of the components (A) and (B) at the time of use, diluted or dissolved for application to the denture base, are each within the range of the above blending amounts, in order to satisfy the amount of components at the time of use. Can be prepared into various preparations designed for the amount of formulation ingredients and usage / dosage.
As a method of application to the denture base, means such as direct application, spraying by spraying, and immersion can be adopted, and for example, it can be prepared as a preparation in the form of application agent, spray agent, immersion agent and the like.
The denture base composition of the present invention can employ a method in which the composition is applied to the mounting surface of the denture base, and then the denture base is mounted on the mounting site. It is preferable to apply the denture base to the mounting site in the oral cavity after that. Moreover, when using additionally during mounting | wearing, after removing the already mounted denture, it is preferable to mount | wear after reapplying the denture base composition to the mounting surface of a denture base. The denture base may be a partial denture base or a full denture base.
本発明の義歯床用組成物には、上記成分に加えて、剤型等に応じたその他の公知成分を必要に応じて、本発明の効果を妨げない範囲で配合できる。任意成分としては、例えば、液体製剤やジェル製剤では、界面活性剤、湿潤剤、増粘剤、賦形剤、香料、溶剤、着色剤、防腐剤、薬効成分等を配合できる。 In the denture base composition of the present invention, in addition to the above-described components, other known components according to the dosage form and the like can be blended, as necessary, within a range not impeding the effects of the present invention. As optional components, for example, in liquid preparations and gel preparations, surfactants, wetting agents, thickeners, excipients, fragrances, solvents, coloring agents, preservatives, medicinal ingredients and the like can be blended.
界面活性剤は、アニオン性界面活性剤、両性界面活性剤、ノニオン性界面活性剤、カチオン性界面活性剤を使用できる。界面活性剤は、１種単独で又は２種以上を組み合わせて使用できる。
アニオン性界面活性剤は、アルキル硫酸塩、α−オレフィンスルホン酸塩、アシルアミノ酸塩、アルキルリン酸塩が挙げられ、塩は、ナトリウム塩、カリウム塩等のアルカリ金属塩、特にナトリウム塩が好ましい。
両性界面活性剤は、アルキルアミンオキシド、ベタイン型両性界面活性剤が挙げられる。アルキルアミンオキシドのアルキル基の炭素数は１２〜１８が好ましい。
ノニオン性界面活性剤は、ポリエチレングリコール型、とりわけポリオキシエチレンアルキルエーテル、ポリオキシエチレン硬化ヒマシ油がよい。特に、アルキル基の炭素数が１２〜２０で、エチレンオキサイドの平均付加モル数（以下、Ｅ．Ｏ．と略記）が１０〜２０モルのポリオキシエチレンアルキルエーテル、Ｅ．Ｏ．が５〜６０モルのポリオキシエチレン硬化ヒマシ油が好ましい。
カチオン性界面活性剤は、アルキル（炭素数６〜２０）トリメチルアンモニウム塩、ジアルキル（炭素数６〜２０）ジメチルアンモニウム塩、及びアルキル（炭素数６〜２０）ジメチルベンジルアンモニウム塩等の第４級アンモニウム塩、アルキル（炭素数６〜２０）アミン塩、アルキル（炭素数６〜２０）アミンエチレンオキサイド付加物、アルキルピリジニウム塩が挙げられる。
界面活性剤の配合量は、組成物全体の０．１〜１０％、特に０．２〜６％が好ましい。
As the surfactant, an anionic surfactant, an amphoteric surfactant, a nonionic surfactant, and a cationic surfactant can be used. Surfactant can be used individually by 1 type or in combination of 2 or more types.
Examples of the anionic surfactant include alkyl sulfates, α-olefin sulfonates, acyl amino acid salts, and alkyl phosphates. The salts are preferably alkali metal salts such as sodium salts and potassium salts, particularly sodium salts.
Examples of amphoteric surfactants include alkylamine oxides and betaine-type amphoteric surfactants. As for carbon number of the alkyl group of an alkylamine oxide, 12-18 are preferable.
The nonionic surfactant is preferably a polyethylene glycol type, particularly polyoxyethylene alkyl ether, polyoxyethylene hydrogenated castor oil. In particular, a polyoxyethylene alkyl ether having 12 to 20 carbon atoms in the alkyl group and an average added mole number of ethylene oxide (hereinafter abbreviated as EO) of 10 to 20 moles; O. Is preferably 5 to 60 mol of polyoxyethylene hydrogenated castor oil.
Cationic surfactants include quaternary ammonium such as alkyl (C6-20) trimethylammonium salt, dialkyl (C6-20) dimethylammonium salt, and alkyl (C6-20) dimethylbenzylammonium salt. Examples thereof include salts, alkyl (C 6-20) amine salts, alkyl (C 6-20) amine ethylene oxide adducts, and alkyl pyridinium salts.
The blending amount of the surfactant is preferably 0.1 to 10%, particularly preferably 0.2 to 6% of the entire composition.
湿潤剤は、ソルビトール、キシリトール等の糖アルコール、プロピレングリコール、グリセリン等の多価アルコールが挙げられる。湿潤剤の配合量は、１０〜５０％がよい。 Examples of the wetting agent include sugar alcohols such as sorbitol and xylitol, and polyhydric alcohols such as propylene glycol and glycerin. The blending amount of the wetting agent is preferably 10 to 50%.
増粘剤は、（Ｂ）成分以外のもの、例えばアルギン酸ナトリウム、カルボキシメチルセルロースナトリウム、キサンタンガム等が挙げられる。これら増粘剤の配合量は、０〜１％、特に０．０１〜１％がよい。
賦形剤としては、α化デンプン、デンプン、マルチトール、マンニトール、乳糖等が挙げられる。
Examples of the thickener include those other than the component (B), such as sodium alginate, sodium carboxymethyl cellulose, xanthan gum and the like. The blending amount of these thickeners is 0 to 1%, particularly 0.01 to 1%.
Examples of excipients include pregelatinized starch, starch, maltitol, mannitol, and lactose.
香料は、スペアミント油、ペパーミント油、アニス油、ユーカリ油、ウィンターグリーン油、カシア油、クローブ油、タイム油、セージ油、レモン油、オレンジ油、ハッカ油、カルダモン油、コリアンダー油、マンダリン油、ライム油、ラベンダー油、ローズマリー油、ローレル油、カモミル油、キャラウェイ油、マジョラム油、ベイ油、レモングラス油、オリガナム油、パインニードル油、シンナモンバーク油等の天然香料、及び、メントール、メントン、カルボン、エチルブチレート、バニリン、エチルマルトール、アネトール、サリチル酸メチル、シンナミックアルデヒド、シネオール、オイゲノール、エチルバニリン、マルトール、リモネン、シトロネロール、リナロール、リナリールアセテート、メンチルアセテート、ピネン、オクチルアルデヒド、シトラール、プレゴン、カルビールアセテート、アニスアルデヒド、ジンジャーオレオレジン、クレオソール、ｄｌ−カンファー等の単品香料、更に、エチルアセテート、アリルシクロヘキサンプロピオネート、メチルアンスラニレート、エチルメチルフェニルグリシデート、ウンデカラクトン、ヘキサナール、エチルアルコール、プロピルアルコール、ブタノール、イソアミルアルコール等の単品香料や、天然香料も含む各種調合香料が挙げられ、口腔用製剤に用いられる公知の香料を通常量で使用できる。 Perfumes are spearmint oil, peppermint oil, anise oil, eucalyptus oil, winter green oil, cassia oil, clove oil, thyme oil, sage oil, lemon oil, orange oil, peppermint oil, cardamom oil, coriander oil, mandarin oil, lime Natural fragrances such as oil, lavender oil, rosemary oil, laurel oil, camomil oil, caraway oil, marjoram oil, bay oil, lemongrass oil, origanum oil, pine needle oil, cinnamon bark oil, and menthol, menton Carboxyl, ethyl butyrate, vanillin, ethyl maltol, anethole, methyl salicylate, cinnamic aldehyde, cineol, eugenol, ethyl vanillin, maltol, limonene, citronellol, linalool, linalyl acetate, menthyl acetate, pinene, o Single fragrances such as tyraldehyde, citral, pulegone, carbyl acetate, anisaldehyde, ginger oleoresin, creosole, dl-camphor, further ethyl acetate, allylcyclohexane propionate, methyl anthranilate, ethyl methyl phenyl glycidate , Undecalactone, hexanal, ethyl alcohol, propyl alcohol, butanol, isoamyl alcohol, and other single flavors, and various blended flavors including natural flavors, and known flavors used in oral preparations can be used in normal amounts.
溶剤は、通常、水（イオン交換水）が用いられるが、エタノール等の炭素数１〜３の低級アルコールを５〜３０％程度添加することもできる。 As the solvent, water (ion-exchanged water) is usually used, but about 5 to 30% of a lower alcohol having 1 to 3 carbon atoms such as ethanol can be added.
着色剤は、赤色２号、赤色３号、赤色２２５号、赤色２２６号、黄色４号、黄色５号、黄色２０５号、青色１号、青色２号、青色２０１号、青色２０４号、緑色３号等の法定色素、カラメル色素、ベニバナ色素、クチナシ色素、コチニール色素、アナトー色素、雲母チタン、酸化チタンが挙げられる。
防腐剤は、パラオキシ安息香酸エステル、安息香酸又はその塩が挙げられる。
The colorants are Red No. 2, Red No. 3, Red No. 225, Red No. 226, Yellow No. 4, Yellow No. 5, Yellow No. 205, Blue No. 1, Blue No. 2, Blue No. 201, Blue No. 204, Green No. 3 And the like, legal dyes such as No. 1, caramel dye, safflower dye, gardenia dye, cochineal dye, anato dye, mica titanium and titanium oxide.
Examples of the preservative include p-hydroxybenzoic acid ester, benzoic acid or a salt thereof.
薬効成分は、イソプロピルメチルフェノール等の殺菌剤が挙げられる。配合量は本発明の効果を妨げない範囲で有効量である。 Examples of the medicinal component include bactericides such as isopropylmethylphenol. The blending amount is an effective amount as long as the effects of the present invention are not hindered.
以下、実施例及び比較例、処方例を示し、本発明を具体的に説明するが、本発明は下記の実施例に制限されるものではない。なお、下記の例において％は特に断らない限りいずれも質量％を示す。 EXAMPLES Hereinafter, although an Example, a comparative example, a formulation example is shown and this invention is demonstrated concretely, this invention is not restrict | limited to the following Example. In the following examples, “%” means “% by mass” unless otherwise specified.
［実施例、比較例］
表１〜３に示す組成の義歯床用組成物（液体製剤）を通常の方法で調製し、これらをサンプルとして用いて下記の実験１〜３に示す方法で評価した。結果を表に併記した。
また、表４、５に示す組成の義歯床用組成物（ジェル製剤）を通常の方法で調製し、これらをサンプルとして用いて下記の実験１〜３に示す方法で評価した。結果を表に併記した。
[Examples and Comparative Examples]
Denture base compositions (liquid preparations) having the compositions shown in Tables 1 to 3 were prepared by ordinary methods, and these were used as samples and evaluated by the methods shown in Experiments 1 to 3 below. The results are shown in the table.
Moreover, the composition for denture bases (gel formulation) of the composition shown to Table 4, 5 was prepared by the normal method, and it evaluated by the method shown in the following experiments 1-3 using these as a sample. The results are shown in the table.
使用した主原料の詳細を下記に示す。
（Ａ）ポリグルタミン酸ナトリウム：
γ−ポリグルタミン酸ナトリウム、４％水溶液粘度３５．５ｍＰａ・ｓ（明治フードマテリアル（株）製）
（Ｂ）κ−カラギーナン：ＧＥＮＵＧＥＬ ＪＰＥ−１２６（ＣＰケルコ社製）
（Ｂ）ι−カラギーナン：ＧＥＮＵＶＩＳＣＯ ＣＦ０２（ＣＰケルコ社製）
（Ｃ１）クエン酸：クエン酸水和物（小松屋（株）製）
（Ｃ２）リン酸水素二ナトリウム：リン酸水素二ナトリウム（太平化学産業（株）製）
ヒアルロン酸ナトリウム（比較品）：ヒアルロン酸ＦＣＨ−Ａ（キッコーマンバイオケミファ（株）製）
ポリビニルピロリドン（Ｋ９０）（比較品）：ルビスコールＫ−９０（ＢＡＳＦ社製）
カルボキシメチルセルロースナトリウム（比較品）：サンローズＦ０４−ＨＣ（日本製紙ケミカル（株）製）
アルギン酸ナトリウム：キミカアルギン（タイプ：ＩＬ−３）（（株）キミカ製）
Details of the main raw materials used are shown below.
(A) Sodium polyglutamate:
Sodium γ-polyglutamate, 4% aqueous solution viscosity 35.5 mPa · s (Meiji Food Material Co., Ltd.)
(B) κ-carrageenan: GENUGEL JPE-126 (CP Kelco)
(B) ι-carrageenan: GENUVISCO CF02 (CP Kelco)
(C1) Citric acid: Citric acid hydrate (manufactured by Komatsuya Co., Ltd.)
(C2) Disodium hydrogen phosphate: Disodium hydrogen phosphate (manufactured by Taihei Chemical Industry Co., Ltd.)
Sodium hyaluronate (comparative product): Hyaluronic acid FCH-A (manufactured by Kikkoman Biochemifa Corporation)
Polyvinylpyrrolidone (K90) (comparative product): Rubiscol K-90 (manufactured by BASF)
Sodium carboxymethylcellulose (comparative product): Sunrose F04-HC (manufactured by Nippon Paper Chemicals Co., Ltd.)
Sodium alginate: Kimika Argin (type: IL-3) (Kimika Co., Ltd.)
なお、上記ポリグルタミン酸塩の粘度は、下記方法によって測定した。
粘度測定方法：
２００ｍＬビーカーに水９６ｇを取り、スターラーで攪拌しながらこれにポリグルタミン酸又はその塩を４．０ｇ加えて完全に溶解させた。次に、２５℃恒温水槽中に１時間静置後、下記のＢＬ型粘度計を用いて正確に１分後の粘度を測定した。
ＢＬ型粘度計：東京計器（株）、Ｂ型粘度計、型式ＢＬ
ローター：Ｎｏ．２
回転数：６０ｒｐｍ
測定温度：２５℃
The viscosity of the polyglutamate was measured by the following method.
Viscosity measurement method:
In a 200 mL beaker, 96 g of water was taken, and while stirring with a stirrer, 4.0 g of polyglutamic acid or a salt thereof was added and completely dissolved. Next, after leaving still in a 25 degreeC thermostat for 1 hour, the viscosity after 1 minute was measured correctly using the following BL type | mold viscometer.
BL type viscometer: Tokyo Keiki Co., Ltd., B type viscometer, model BL
Rotor: No. 2
Rotation speed: 60rpm
Measurement temperature: 25 ° C
また、実施例の義歯床用組成物の２５℃での粘度（東機産業（株）、形式：ＶＩＳＣＯＭＥＴＥＲ ＴＶＢ−１０、ローターＮｏ．Ｍ１、Ｍ２、Ｍ３、Ｍ４のうちの適切なものを使用。回転数３０ｒｐｍ、測定時間６０秒間）は、液体製剤は５〜３００ｍＰａ・ｓ、ジェル製剤は１，０００〜１５，０００ｍＰａ・ｓであった。 In addition, the viscosity at 25 ° C. of the denture base composition of Examples (Toki Sangyo Co., Ltd., type: VISCOMETER TVB-10, rotor No. M1, M2, M3, M4) is used. The number of rotations was 30 rpm, and the measurement time was 60 seconds. The liquid preparation was 5 to 300 mPa · s, and the gel preparation was 1,000 to 15,000 mPa · s.
＜実験１：義歯床装着性（義歯床装着時の抵抗のなさ）の評価＞
義歯床用組成物を３７℃に温めた後、約１．５ｇをとり、片側第二小臼歯から第一大臼歯を欠損部位とした下顎顎模型（Ｄ１６ＦＥ−５００Ａ−ＱＦ、（株）ニッシン製）の欠損部位（義歯床装着部位）に塗布した。塗布後、レオメータ（ＣＯＭＰＡＣ−１００ＩＩ、（株）サン科学）の試料台に顎模型を固定し、欠損部位への装着が可能な部分義歯の義歯床を欠損部位上に載せ、垂直方向から直径１０．０±０．５ｍｍの感圧軸によって圧着速度５ｍｍ／分、１ｋｇｆの荷重で圧着したときに感圧軸にかかる最大荷重を読み取った。
繰り返し３回の平均値について、無塗布時での最大力と比較し、その低減度から下記の評価基準によって、義歯床装着性（義歯床装着時の抵抗のなさ）を評価した。
評価基準
◎：最大力の低減度が２０％以上
○：最大力の低減度が１０％以上２０％未満
△：最大力の低減度が５％以上１０％未満
×：最大力の低減度が５％未満
<Experiment 1: Evaluation of Denture Base Wearability (No Resistance at Denture Base Wear)>
After warming the denture base composition to 37 ° C., about 1.5 g was taken, and the mandibular jaw model (D16FE-500A-QF, manufactured by Nissin Co., Ltd.) with the first molar from the one side second premolar to the defect site. ) Was applied to the missing part (the denture base mounting part). After application, the jaw model is fixed to a sample table of a rheometer (COMPAC-100II, Sun Kagaku Co., Ltd.), a denture base of a partial denture that can be attached to the defect site is placed on the defect site, and the diameter is 10 from the vertical direction. The maximum load applied to the pressure-sensitive shaft when the pressure-bonding speed was 5 mm / min with a pressure of 0 ± 0.5 mm and a load of 1 kgf was read.
The average value of three repetitions was compared with the maximum force at the time of no application, and the denture base mounting property (the absence of resistance at the time of denture base mounting) was evaluated according to the following evaluation criteria from the reduction degree.
Evaluation criteria ◎: Maximum force reduction degree is 20% or more ○: Maximum force reduction degree is 10% or more and less than 20% △: Maximum force reduction degree is 5% or more and less than 10% ×: Maximum force reduction degree is 5 %Less than
＜実験２：義歯床装着力の持続性の評価＞
２〜５歯の部分義歯を装着している部分義歯装着者１０名に対して、試験を実施した。義歯床用組成物を義歯床の装着面に塗布した後に義歯を装着し（義歯への塗布量の目安は、１歯につき約０．１ｇ）、装着後３０分、６０分、１２０分後の義歯の装着感を以下の評価基準に基づき評価した。１０名の平均点を算出し、下記の評価基準にて義歯装着時のあたり心地の良さを判定した。実験２は、実験１において△以上の義歯床用組成物について評価した。
評価基準
４点：１２０分後も義歯の装着感が持続している
３点：６０分後に義歯の装着感が持続しているが１２０分後には感じられなかった
２点：３０分後に義歯の装着感が持続しているが６０分後には感じられなかった
１点：３０分後に義歯の装着感が感じられなかった
評価基準
◎：３．５点以上
〇：３．０点以上３．５点未満
△：２．０点以上３．０点未満
×：２．０点未満
<Experiment 2: Evaluation of durability of denture base mounting force>
The test was performed on 10 partial denture wearers wearing 2-5 partial dentures. After the denture base composition is applied to the mounting surface of the denture base, the denture is mounted (approximate amount applied to the denture is about 0.1 g per tooth), 30 minutes, 60 minutes, and 120 minutes after mounting. Denture wearing feeling was evaluated based on the following evaluation criteria. The average score of 10 people was calculated, and the comfort level at the time of denture wearing was determined according to the following evaluation criteria. Experiment 2 evaluated the denture base composition more than (triangle | delta) in Experiment 1. FIG.
Evaluation criteria 4 points: The feeling of wearing dentures continued after 120 minutes 3 points: The feeling of wearing dentures continued after 60 minutes but was not felt after 120 minutes 2 points: Dentures after 30 minutes Wearing feeling persisted but was not felt after 60 minutes 1 point: Denture wearing feeling was not felt after 30 minutes Evaluation criteria ◎: 3.5 points or more 〇: 3.0 points or more 3.5 Less than point △: 2.0 point or more and less than 3.0 point ×: Less than 2.0 point
＜実験３：製剤安定性（ｐＨ変化のなさ）＞
義歯床用組成物を液体製剤の場合は容量３０ｍＬのスプレー容器に充填してスプレー剤として調製し、ジェル製剤の場合はチューブ容器に充填して塗布剤として調製し、それぞれ５０℃の温度条件下に１ヶ月間放置し、ｐＨメーターにてｐＨ測定を行った。保存前後のｐＨ変化の度合いを下記の評価基準によって判定し、高温保存後の製剤安定性（ｐＨ変化のなさ）を評価した。
評価基準
◎：ｐＨ変化が±０．３
〇：ｐＨ変化が±０．５
△：ｐＨ変化が±１．０
×：ｐＨ変化が±１．０超
<Experiment 3: formulation stability (no change in pH)>
In the case of a liquid formulation, the denture base composition is filled into a 30 mL capacity spray container and prepared as a spray. In the case of a gel formulation, it is filled into a tube container and prepared as a coating agent. For 1 month, and the pH was measured with a pH meter. The degree of pH change before and after storage was determined according to the following evaluation criteria, and formulation stability after storage at high temperature (no change in pH) was evaluated.
Evaluation criteria A: pH change is ± 0.3
◯: pH change is ± 0.5
Δ: pH change is ± 1.0
X: pH change exceeds ± 1.0
［処方例１］固形義歯装着剤
水で約２０倍に希釈して溶解させて得た液体義歯床用組成物をスプレー容器に充填してスプレー剤とし、義歯床に噴霧して義歯床装着剤として使用する。（ ）内は、液体義歯床用組成物中の濃度（噴霧液中の濃度）である。
（Ａ）ポリグルタミン酸ナトリウム ５．０ （０．２５％）
（Ｂ）κ−カラギーナン ３．０ （０．１５％）
α化デンプン ５．０
ｌ−メントール ０．５
スクラロース ０．５
結晶セルロース バランス
合計 １００．０％
（Ａ）／（Ｂ）＝１．６７
[Prescription Example 1] Solid Denture Wearing Agent A liquid denture base composition obtained by diluting and dissolving approximately 20 times with water is filled in a spray container to form a spray, and sprayed onto the denture base to prepare a denture base wearing agent. Use as The values in () are the concentration in the liquid denture base composition (concentration in the spray solution).
(A) Sodium polyglutamate 5.0 (0.25%)
(B) κ-carrageenan 3.0 (0.15%)
Pregelatinized starch 5.0
l-Menthol 0.5
Sucralose 0.5
Crystalline cellulose Total balance 100.0%
(A) / (B) = 1.67
［処方例２］顆粒状固形義歯ケア剤
水で約２０倍に希釈して溶解させて得た液体義歯床用組成物を義歯床に塗布し、義歯床装着剤として使用する。（ ）内は、液体義歯床用組成物中の濃度（塗布液中の濃度）である。
（Ａ）ポリグルタミン酸ナトリウム ３．０ （０．１５％）
（Ｂ）κ−カラギーナン ２．０ （０．１％）
マルチトール ２０．０
ショ糖脂肪酸エステル １．０
スクラロース ０．１
ｌ−メントール ０．５
キシリトール バランス
合計 １００．０％
（Ａ）／（Ｂ）＝１．５
[Prescription Example 2] Granular solid denture care agent A liquid denture base composition obtained by diluting with water about 20 times and dissolving is applied to the denture base and used as a denture base mounting agent. The values in parentheses are the concentration in the liquid denture base composition (concentration in the coating solution).
(A) Sodium polyglutamate 3.0 (0.15%)
(B) κ-carrageenan 2.0 (0.1%)
Maltitol 20.0
Sucrose fatty acid ester 1.0
Sucralose 0.1
l-Menthol 0.5
Total xylitol balance 100.0%
(A) / (B) = 1.5
Claims (11)
（Ｂ）イオタ−カラギーナン及びカッパ−カラギーナンから選ばれる１種以上
を含有することを特徴とする義歯床用組成物。 A denture base composition comprising (A) one or more selected from polyglutamic acid and a salt thereof, and (B) one or more selected from iota-carrageenan and kappa-carrageenan.
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|---|---|---|---|---|
| JPH10179615A (en) * | 1996-12-25 | 1998-07-07 | Lion Corp | Denture stabilizer |
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| JP2007254287A (en) * | 2005-03-25 | 2007-10-04 | Seiren Co Ltd | Composition for stabilizing denture |
| JP2008253303A (en) * | 2007-03-30 | 2008-10-23 | Kobayashi Pharmaceut Co Ltd | Denture stabilizer |
| JP2009514983A (en) * | 2005-11-09 | 2009-04-09 | ザ プロクター アンド ギャンブル カンパニー | Denture adhesive articles |
| JP2009203246A (en) * | 2006-04-26 | 2009-09-10 | Lion Corp | Water-soluble polymer compound and aqueous coating agent composition containing the same |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH10179615A (en) * | 1996-12-25 | 1998-07-07 | Lion Corp | Denture stabilizer |
| WO2006033162A1 (en) * | 2004-09-24 | 2006-03-30 | Fukuoka Soy Sauce Brewing Cooperation | Composition for denture stabilization |
| JP2007254287A (en) * | 2005-03-25 | 2007-10-04 | Seiren Co Ltd | Composition for stabilizing denture |
| JP2009514983A (en) * | 2005-11-09 | 2009-04-09 | ザ プロクター アンド ギャンブル カンパニー | Denture adhesive articles |
| JP2009203246A (en) * | 2006-04-26 | 2009-09-10 | Lion Corp | Water-soluble polymer compound and aqueous coating agent composition containing the same |
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