JP2022163808A - Improver of oral bacterial flora - Google Patents
Improver of oral bacterial flora Download PDFInfo
- Publication number
- JP2022163808A JP2022163808A JP2021068864A JP2021068864A JP2022163808A JP 2022163808 A JP2022163808 A JP 2022163808A JP 2021068864 A JP2021068864 A JP 2021068864A JP 2021068864 A JP2021068864 A JP 2021068864A JP 2022163808 A JP2022163808 A JP 2022163808A
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- JP
- Japan
- Prior art keywords
- polyoxyethylene
- bacteria
- ether
- component
- agent
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
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Abstract
Description
本発明は、口腔菌叢改善剤に関する。 The present invention relates to an oral flora improving agent.
歯周病は日本で最も蔓延している疾患の一つであり、日本の成人の約70%が歯肉に何らかの所見(歯周病)を有している。歯周病を予防することは、歯の寿命を延ばし、健康寿命を延伸するために重要である。歯周病は口腔細菌による感染症であり、近年の細菌由来DNAを用いた解析技術の発展により、歯周病患者は健常者と比較して、口腔細菌のバランスが異なることが報告されており、歯周病の予防には口腔細菌叢のバランスを好適な状態に整えることが重要であるといわれている。この口腔細菌叢には、いわゆる非病原性の常在菌と、日和見感染菌を含む病原性を示す細菌とが混在しているが、通常は口腔細菌叢のバランスが保たれ、いわゆる健康な状態であり、病原性細菌を原因とする疾患は抑制されている。また、身体の部位ごとにその細菌構成は異なるものでもあるが、内的あるいは外的要因によってその細菌構成のバランスが乱れ恒常性が破綻することで病原性細菌が優位となり病気へと進展する。 Periodontal disease is one of the most prevalent diseases in Japan, and approximately 70% of Japanese adults have some findings (periodontal disease) in the gums. Prevention of periodontal disease is important for prolonging the life span of teeth and extending the healthy life span. Periodontal disease is an infectious disease caused by oral bacteria, and with the recent development of analysis technology using DNA derived from bacteria, it has been reported that the balance of oral bacteria in patients with periodontal disease differs from that in healthy subjects. It is said that it is important to adjust the balance of the oral flora to a suitable state for the prevention of periodontal disease. This oral flora contains a mixture of so-called non-pathogenic indigenous bacteria and pathogenic bacteria including opportunistic bacteria. and diseases caused by pathogenic bacteria are suppressed. In addition, although the composition of bacteria differs depending on the part of the body, the balance of the composition of bacteria is disturbed by internal or external factors, and the homeostasis is disrupted.
歯周病は、口腔内に共生する口腔細菌叢の恒常性が破綻して病原性細菌が優勢となることで発症する。病原性細菌は殺菌剤を用いることで減らすことができるが、常在細菌も減らすため、口腔細菌叢のバランスは変わらない。その一方で、単に病原性細菌を殺菌するだけではなく、病原性細菌以外の非病原性である常在菌の存在割合を保持又は増やして常在菌をより優勢な状態にすることで、口腔細菌叢の恒常性を維持又は改善するほうが、口腔疾患の発症予防にも効果的であり、口腔疾患の発症又は進行の抑制には重要であると考えられる。 Periodontal disease develops when pathogenic bacteria become dominant due to disruption of homeostasis of the oral flora that coexists in the oral cavity. Pathogenic bacteria can be reduced by using antiseptics, but they also reduce resident bacteria, leaving the balance of the oral flora unchanged. On the other hand, it not only sterilizes pathogenic bacteria, but also maintains or increases the ratio of non-pathogenic indigenous bacteria other than pathogenic bacteria to make the indigenous bacteria more dominant. Maintaining or improving the homeostasis of the bacterial flora is also effective in preventing the onset of oral diseases, and is considered important for suppressing the onset or progression of oral diseases.
しかしながら、一般的に口腔用組成物に用いられている殺菌剤は、殺菌作用によって病原性細菌が排除されることで口腔疾患に対して一定の治療、予防効果はあるものの、その作用によって病原性細菌だけでなく、それ以外の非病原性の常在菌をも殺菌してしまうことから、菌交代症のリスクもあった。更に、口腔内の細菌は、数時間で再び増加してしまうこともあり、殺菌剤の作用効果は十分に持続するとは言えなかった。 However, bactericidal agents generally used in oral compositions have a certain therapeutic and preventive effect on oral diseases by eliminating pathogenic bacteria due to their bactericidal action, but their action causes pathogenicity. Since it kills not only bacteria but also other non-pathogenic indigenous bacteria, there is a risk of superinfection. Furthermore, the bacteria in the oral cavity may increase again in several hours, and it cannot be said that the effect of the disinfectant is sufficiently sustained.
そのため、細菌構成の恒常性を維持するだけでなく、病原性細菌だけを抑制し、非病原性の常在菌がより優勢となり、恒常性の破綻が生じにくい口腔細菌叢とするために、例えば、ヤマブシタケ等のキノコの乾燥粉末又はその抽出物を用いた口腔内の菌叢改善剤(特許文献1:国際公開第2016/043103号)、特定のリゾホスファチジン酸やその誘導体等とホスファチジン酸やその誘導体等とを組み合わせた口腔内常在菌の生育促進剤(特許文献2:特開2019-001720号公報)、口腔バイオフィルム除去剤及びこれを含有する口腔用組成物(特許文献3:特開2019-48802号公報)が提案されている。 Therefore, in order not only to maintain the homeostasis of the bacterial composition, but also to suppress only pathogenic bacteria, non-pathogenic indigenous bacteria become more dominant, and the oral flora is less likely to break homeostasis, for example, , Oral bacterial flora improving agent using dry powder or extract of mushroom such as Lion's Mane mushroom (Patent Document 1: International Publication No. 2016/043103), specific lysophosphatidic acid and its derivatives and phosphatidic acid and its A growth promoter for oral indigenous bacteria combined with a derivative or the like (Patent Document 2: JP 2019-001720 A), an oral biofilm remover and an oral composition containing the same (Patent Document 3: JP 2019-001720 A) 2019-48802) has been proposed.
本発明は、上記事情に鑑みなされたもので、口腔菌叢を改善でき、口腔内の健康に資することのできる成分を提供することを課題とする。 The present invention has been made in view of the above circumstances, and an object of the present invention is to provide a component that can improve oral flora and contribute to oral health.
本発明は、以下を提供する。
〔1〕(A)エチレンオキサイドの平均付加モル数が4~25であるポリオキシエチレンラウリルエーテルを含有する口腔菌叢改善剤。
〔2〕(B)非イオン性界面活性剤(但し、(A)成分を除く)をさらに含む、〔1〕に記載の剤。
〔3〕(B)成分が、ポリオキシエチレン硬化ヒマシ油及びポリオキシエチレンアルキルエーテルからなる群から選ばれる1種を含む、〔2〕に記載の剤。
〔4〕(B)成分が、エチレンオキサイドの平均付加モル数が5~100のポリオキシエチレン硬化ヒマシ油を少なくとも含む、〔3〕に記載の剤。
〔5〕(B)成分が、ポリオキシエチレンセチルエーテル、ポリオキシエチレンステアリルエーテル、ポリオキシエチレンベヘニルエーテル、及びポリオキシエチレンオレイルエーテルからなる群から選ばれる少なくとも1種を含む、〔3〕に記載の剤。
〔6〕(A)成分に対する(B)成分の質量比が、1~200である、〔2〕~〔5〕のいずれか1項に記載の剤。
〔7〕少なくとも1種の病原性細菌及び少なくとも1種の常在菌の総菌数に対する病原性細菌の菌数の比率を低下させる、〔1〕~〔6〕のいずれか1項に記載の剤。
〔8〕病原性細菌が、歯周病の病原性細菌を含む、〔7〕に記載の剤。
〔9〕病原性細菌が、黒色色素産生菌を含む、〔7〕又は〔8〕に記載の剤。
〔10〕常在菌が、ストレプトコッカス属細菌を含む、〔7〕~〔9〕のいずれか1項に記載の剤。
The present invention provides the following.
[1] (A) An oral flora-improving agent containing polyoxyethylene lauryl ether having an average number of added moles of ethylene oxide of 4 to 25.
[2] The agent according to [1], further comprising (B) a nonionic surfactant (excluding component (A)).
[3] The agent according to [2], wherein component (B) contains one selected from the group consisting of polyoxyethylene hydrogenated castor oil and polyoxyethylene alkyl ether.
[4] The agent according to [3], wherein component (B) contains at least polyoxyethylene hydrogenated castor oil having an average number of added moles of ethylene oxide of 5 to 100.
[5] As described in [3], wherein component (B) contains at least one selected from the group consisting of polyoxyethylene cetyl ether, polyoxyethylene stearyl ether, polyoxyethylene behenyl ether, and polyoxyethylene oleyl ether. agent.
[6] The agent according to any one of [2] to [5], wherein the mass ratio of component (B) to component (A) is 1-200.
[7] Any one of [1] to [6], which reduces the ratio of the number of pathogenic bacteria to the total number of at least one pathogenic bacteria and at least one indigenous bacteria agent.
[8] The agent of [7], wherein the pathogenic bacteria include periodontal pathogenic bacteria.
[9] The agent of [7] or [8], wherein the pathogenic bacteria include black pigment-producing bacteria.
[10] The agent according to any one of [7] to [9], wherein the indigenous bacteria include Streptococcus bacteria.
本発明によれば、菌叢を効率よく改善できる剤が提供される。本発明の口腔菌叢改善剤によれば、口腔内の病原性細菌を選択的に抗菌すること等により、口腔内を健康な状態に保つことができる。 ADVANTAGE OF THE INVENTION According to this invention, the agent which can improve a bacterial flora efficiently is provided. According to the oral flora-improving agent of the present invention, the oral cavity can be maintained in a healthy state by selectively antibacterially controlling pathogenic bacteria in the oral cavity.
以下、本発明について詳細に説明する。 The present invention will be described in detail below.
[1.有効成分]
[(A)成分:ポリオキエチレンラウリルエーテル]
本発明の剤は、ポリオキエチレンラウリルエーテル((A)成分)を含有する。これにより、菌叢改善効果を発揮し得る。
[1. Active ingredient]
[(A) component: polyoxyethylene lauryl ether]
The agent of the present invention contains polyoxyethylene lauryl ether (component (A)). Thereby, a bacterial flora improvement effect can be exhibited.
ポリオキシエチレンラウリルエーテルのエチレンオキサイドの平均付加モル数は、通常、4以上、好ましくは8以上である。上限は、通常25以下、好ましくは20以下、より好ましくは15以下、更に好ましくは10以下である。従って、平均付加モル数は、通常、4~25、好ましくは、4~20、より好ましくは、4~15、更に好ましくは、8~10である。 The average number of moles of ethylene oxide added to polyoxyethylene lauryl ether is usually 4 or more, preferably 8 or more. The upper limit is usually 25 or less, preferably 20 or less, more preferably 15 or less, still more preferably 10 or less. Therefore, the average added mole number is usually 4-25, preferably 4-20, more preferably 4-15, still more preferably 8-10.
本発明の剤は、(A)成分として、ポリオキエチレンラウリルエーテル単独を含んでもよいし、エチレンオキサイドの平均付加モル数の異なる2種以上のポリオキエチレンラウリルエーテルの組み合わせを含んでもよい。 The agent of the present invention may contain polyoxyethylene lauryl ether alone as component (A), or may contain a combination of two or more polyoxyethylene lauryl ethers having different average added mole numbers of ethylene oxide.
-(A)成分の含有量-
(A)成分の含有量は、剤全体(100質量%)に対し、好ましくは0.0001質量%以上、より好ましくは0.001質量%以上、更に好ましくは0.01質量%以上である。上限は、通常、1質量%以下、好ましくは0.1質量%以下である。従って、好ましくは0.0001~1質量%、より好ましくは0.001~0.1質量%、更に好ましくは0.01~0.1質量%である。これにより、口腔内の菌叢改善効果及び菌叢制御効果をより高めることができる。
- Content of component (A) -
The content of component (A) is preferably 0.0001% by mass or more, more preferably 0.001% by mass or more, and still more preferably 0.01% by mass or more relative to the entire agent (100% by mass). The upper limit is usually 1% by mass or less, preferably 0.1% by mass or less. Therefore, it is preferably 0.0001 to 1% by mass, more preferably 0.001 to 0.1% by mass, still more preferably 0.01 to 0.1% by mass. Thereby, the intraoral bacterial flora improving effect and the bacterial flora controlling effect can be further enhanced.
[(B)成分]
本発明の剤は、非イオン性界面活性剤((B)成分)を更に含む組成物でもよい。これにより、(A)成分による菌叢改善効果を増強でき、中でも、菌叢のバランスをより適切化(例えば、常在菌の比率を高める)ことができる。
[(B) Component]
The agent of the present invention may be a composition further containing a nonionic surfactant (component (B)). As a result, the effect of component (A) on improving the bacterial flora can be enhanced, and above all, the balance of the bacterial flora can be made more appropriate (for example, the ratio of indigenous bacteria can be increased).
-非イオン性界面活性剤の例-
非イオン性界面活性剤としては、(A)成分以外であればよく、例えば、ポリオキシエチレンアルキルエーテル(但し、ポリオキシエチレンラウリルエーテルを除く)、ポリオキシエチレン硬化ヒマシ油、ソルビタン脂肪酸エステル、ポリオキシエチレンソルビタン脂肪酸エステル(例、ポリオキシエチレンソルビタンモノステアレート)、アルキロールアミド、ポリオキシエチレン脂肪酸エステル、ポリオキシエチレンアルケニルエーテル、ポリグリセリン脂肪酸エステル、ショ糖脂肪酸エステル(例、マルトース脂肪酸エステル)、糖アルコール脂肪酸エステル(例、マルチトール脂肪酸エステル、ラクチトール脂肪酸エステル)、脂肪酸ジエタノールアミド(例、ラウリル酸モノ又はジエタノールアミド)、ポリオキシエチレンポリオキシプロピレン共重合体、ポリオキシエチレンポリオキシプロピレン脂肪酸エステル、グリセリン脂肪酸エステル、ポリオキシエチレングリセリン脂肪酸エステル、ポリオキシエチレングリコール脂肪酸エステル、ポリオキシエチレンフィトステロール及びフィトスタノール、ポリオキシエチレンラノリン及びラノリンアルコール、ポリオキシエチレンアルキルアミン及び脂肪酸アミド、ポリオキシエチレンアルキルフェニルホルムアルデヒド縮合物、ポリオキシエチレンポリオキシプロピレンアルキルエーテル、ポリオキシエチレンアルキルフェニルエーテルが挙げられる。これらのうち、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好ましく、ポリオキシエチレン硬化ヒマシ油がより好ましい。
- Examples of nonionic surfactants -
Nonionic surfactants other than component (A) may be used, for example, polyoxyethylene alkyl ether (excluding polyoxyethylene lauryl ether), polyoxyethylene hydrogenated castor oil, sorbitan fatty acid ester, poly Oxyethylene sorbitan fatty acid ester (e.g., polyoxyethylene sorbitan monostearate), alkylolamide, polyoxyethylene fatty acid ester, polyoxyethylene alkenyl ether, polyglycerin fatty acid ester, sucrose fatty acid ester (e.g., maltose fatty acid ester), sugar alcohol fatty acid esters (e.g., maltitol fatty acid esters, lactitol fatty acid esters), fatty acid diethanolamides (e.g., lauric acid mono- or diethanolamides), polyoxyethylene-polyoxypropylene copolymers, polyoxyethylene-polyoxypropylene fatty acid esters, Glycerin fatty acid esters, polyoxyethylene glycerin fatty acid esters, polyoxyethylene glycol fatty acid esters, polyoxyethylene phytosterols and phytostanols, polyoxyethylene lanolin and lanolin alcohols, polyoxyethylene alkylamines and fatty acid amides, polyoxyethylene alkylphenyl formaldehyde condensation polyoxyethylene polyoxypropylene alkyl ethers, polyoxyethylene alkylphenyl ethers. Among these, polyoxyethylene alkyl ether and polyoxyethylene hydrogenated castor oil are preferred, and polyoxyethylene hydrogenated castor oil is more preferred.
-ポリオキシエチレンアルキルエーテルの例-
ポリオキシエチレンアルキルエーテルのアルキル鎖の炭素原子数は、通常、12以上、好ましくは14以上である。上限は、通常、26以下、好ましくは24以下、より好ましくは22以下である。従って、炭素原子数は、通常12~26、好ましくは14~24、より好ましくは14~22である。エチレンオキサイド平均付加モル数は、通常、5以上、好ましくは10以上である。上限は、通常100以下、好ましくは60以下である。従って、エチレンオキサイド平均付加モル数は、5~100、好ましくは10~60である。
-Example of polyoxyethylene alkyl ether-
The number of carbon atoms in the alkyl chain of the polyoxyethylene alkyl ether is usually 12 or more, preferably 14 or more. The upper limit is usually 26 or less, preferably 24 or less, more preferably 22 or less. Therefore, the number of carbon atoms is generally 12-26, preferably 14-24, more preferably 14-22. The average number of added moles of ethylene oxide is usually 5 or more, preferably 10 or more. The upper limit is usually 100 or less, preferably 60 or less. Therefore, the average added mole number of ethylene oxide is 5-100, preferably 10-60.
ポリオキシエチレンアルキルエーテルとしては、例えば、ポリオキシエチレンセチルエーテル、ポリオキシエチレンステアリルエーテル、ポリオキシエチレンベヘニルエーテル、ポリオキシエチレンオレイルエーテルが挙げられる。 Polyoxyethylene alkyl ethers include, for example, polyoxyethylene cetyl ether, polyoxyethylene stearyl ether, polyoxyethylene behenyl ether, and polyoxyethylene oleyl ether.
-ポリオキシエチレン硬化ヒマシ油の例-
ポリオキシエチレン硬化ヒマシ油のエチレンオキサイド平均付加モル数は、通常5以上、好ましくは20以上、より好ましくは40以上である。上限は、通常150以下、好ましくは100以下である。従って、通常5~150、好ましくは5~100、より好ましくは20~100、さらにより好ましくは40~100である。
-Example of polyoxyethylene hydrogenated castor oil-
The average number of moles of ethylene oxide added to the polyoxyethylene hydrogenated castor oil is usually 5 or more, preferably 20 or more, and more preferably 40 or more. The upper limit is usually 150 or less, preferably 100 or less. Therefore, it is usually 5-150, preferably 5-100, more preferably 20-100, still more preferably 40-100.
-他の非イオン性界面活性剤の例-
ソルビタン脂肪酸エステルの脂肪酸の炭素原子数は、通常12~18である。ポリオキシエチレンソルビタン脂肪酸エステルの脂肪酸の炭素原子数は、通常16~18であり、エチレンオキサイド平均付加モル数は、通常10~40モルである。アルキロールアミドのアルキル鎖の炭素原子数は、通常12~14である。
- Examples of other nonionic surfactants -
The number of carbon atoms in the fatty acid of the sorbitan fatty acid ester is usually 12-18. The number of carbon atoms in the fatty acid of the polyoxyethylene sorbitan fatty acid ester is generally 16-18, and the average number of moles of ethylene oxide added is generally 10-40 mol. The alkyl chain of the alkylolamide usually has 12-14 carbon atoms.
(B)成分は、非イオン性界面活性剤1種でもよいし、異なる2種以上の非イオン性界面活性剤の組み合わせでもよい。 Component (B) may be one nonionic surfactant or a combination of two or more different nonionic surfactants.
-(B)成分の含有量-
(B)成分の含有量は、剤全体(100質量%)に対し、通常、0.0005質量%以上、好ましくは0.001質量%以上、より好ましくは0.01質量%以上、更に好ましくは0.1質量%以上である。上限は、好ましくは10質量%以下、より好ましくは5質量%以下、更に好ましくは3質量%以下、更により好ましくは2質量%以下である。従って、通常、0.0005~10質量%、好ましくは0.001~10質量%、より好ましくは、0.01~5質量%、更に好ましくは0.1~3質量%、更により好ましくは0.1~2質量%である。これにより、(B)成分配合による効果がより効率よく発揮される。
- Content of component (B) -
The content of component (B) is usually 0.0005% by mass or more, preferably 0.001% by mass or more, more preferably 0.01% by mass or more, and still more preferably It is 0.1% by mass or more. The upper limit is preferably 10% by mass or less, more preferably 5% by mass or less, even more preferably 3% by mass or less, and even more preferably 2% by mass or less. Therefore, usually 0.0005 to 10% by mass, preferably 0.001 to 10% by mass, more preferably 0.01 to 5% by mass, still more preferably 0.1 to 3% by mass, still more preferably 0 .1 to 2% by mass. Thereby, the effect by blending the component (B) is exhibited more efficiently.
-B/A質量比-
口腔菌叢改善剤において、(A)成分に対する(B)成分の質量比((B)/(A))は、通常、0.5以上、又は1以上、好ましくは5以上、より好ましくは10以上である。上限は、通常200以下、好ましくは100以下、より好ましくは50以下である。従って、(B)/(A)は、通常0.5~200又は1~200、好ましくは1~100、より好ましくは5~100、更に好ましくは10~50、更により好ましくは1~30である。(B)/(A)の質量比が上記範囲内にあると、菌叢改善効果を高めることができ、病原性細菌と常在菌のバランス調整が良好となる。
-B/A mass ratio-
In the oral flora improving agent, the mass ratio of component (B) to component (A) ((B)/(A)) is usually 0.5 or more, or 1 or more, preferably 5 or more, more preferably 10 That's it. The upper limit is usually 200 or less, preferably 100 or less, more preferably 50 or less. Therefore, (B)/(A) is usually 0.5 to 200 or 1 to 200, preferably 1 to 100, more preferably 5 to 100, still more preferably 10 to 50, still more preferably 1 to 30. be. When the mass ratio of (B)/(A) is within the above range, the effect of improving bacterial flora can be enhanced, and the balance between pathogenic bacteria and indigenous bacteria can be well adjusted.
[2.菌叢改善作用]
本発明の剤は、菌叢改善作用を有する。本明細書において、菌叢を改善するとは、口腔内の細菌構成比を改善又は適切な状態を維持することをいう。菌叢改善の方法としては、例えば、病原性細菌(1種以上)の存在割合を低下させること、常在菌(1種以上)の存在割合を増やすこと、およびその両方が挙げられる。中でも、病原性細菌(1種以上)の存在割合を低下させることが好ましく、少なくとも1種の病原性細菌及び少なくとも1種の常在菌の総菌数に対する前記病原性細菌の菌数の比率を低下させることがより好ましい。
[2. Bacterial flora improving effect]
The agent of the present invention has a microbial flora-improving action. As used herein, to improve the bacterial flora means to improve the composition ratio of bacteria in the oral cavity or to maintain an appropriate condition. Methods for improving bacterial flora include, for example, decreasing the abundance of pathogenic bacteria (one or more species), increasing the abundance of indigenous bacteria (one or more species), and both. Among them, it is preferable to reduce the abundance ratio of pathogenic bacteria (one or more), and the ratio of the number of pathogenic bacteria to the total number of at least one pathogenic bacteria and at least one indigenous bacteria is reduced. Lowering is more preferable.
病原性細菌としては、生体内(例えば、口腔内)に存在し病原性を有する細菌であればよく、例えば、黒色色素産生菌、フゾバクテリウム属細菌、トレポネマ属細菌、タネレラ属細菌、カンピロバクター属細菌、ユウバクテリウム属細菌等の歯周病の原因菌が挙げられる。黒色色素産生菌としては、ポルフィロモナス ジンジバリス(Porphyromonas gingivalis)等のポルフィロモナス属細菌、プレボテラ インターメディア(Prevotella intermedia)等のプレボテラ属細菌、その他、西川ら「重度歯周疾患患者の歯周ポケットから分離した黒色色素産生性Bacteroidesの同定ならびに薬剤感受性に関する研究」歯科医学、1990年53巻3号 p.299-312に記載されている菌が挙げられる。 The pathogenic bacterium may be any bacterium that exists in vivo (for example, in the oral cavity) and has pathogenicity. Causative bacteria of periodontal disease such as bacteria of the genus Eubacterium can be mentioned. Examples of black pigment-producing bacteria include Porphyromonas genus bacteria such as Porphyromonas gingivalis, Prevotella bacteria such as Prevotella intermedia, Nishikawa et al. Identification of black chromogenic Bacteroides isolated from cereals and research on drug susceptibility," Dental Medicine, 1990, Vol.53, No.3, p. 299-312.
常在菌としては、生体内(例えば、口腔内)に常在する細菌であって、上記の病原性細菌以外の菌であればよく、例えば、ストレプトコッカス属細菌、ナイセリア属細菌、ロキア属細菌、アクチノマイセス属細菌が挙げられ、ストレプトコッカス属細菌が好ましい。ストレプトコッカス属細菌としては、例えば、ストレプトコッカス ゴルドニアイ(Streptococcus gordonii)、ストレプトコッカス オラリス(Streptococcus oralis)、ストレプトコッカス ミティス(Streptococcus mitis)、ストレプトコッカス サリバリウス(Streptococcus salivarius)、ストレプトコッカス パーオリス(Streptococcus peroris)、ストレプトコッカス インファンティス(Streptococcus infantis)、ストレプトコッカス サングイニス(Streptococcus sanguinis)、アクチノマイセス ビスコーサス(Actinomyces viscosus)、アクチノマイセス ナエスランディ(Actinomyces naeslundii)、ナイセリア サブフラバ(Neisseria subflaba)、ロキア デントカリオサ(Rothia dentocariosa)等が挙げられる。 The indigenous bacteria may be bacteria that are always present in the body (e.g., the oral cavity) and are other than the pathogenic bacteria described above. Examples include Actinomyces bacteria, and Streptococcus bacteria are preferred.ストレプトコッカス属細菌としては、例えば、ストレプトコッカス ゴルドニアイ(Streptococcus gordonii)、ストレプトコッカス オラリス(Streptococcus oralis)、ストレプトコッカス ミティス(Streptococcus mitis)、ストレプトコッカス サリバリウス(Streptococcus salivarius)、ストレプトコッカス パーオリス(Streptococcus peroris)、ストレプトコッカス インファンティス(Streptococcus infantis ), Streptococcus sanguinis, Actinomyces viscosus, Actinomyces naeslundii, Neisseria subflaba, Rothia dentariasis, and the like.
本発明においては、歯周病の原因菌(例えば、黒色色素産生菌、中でもポルフィロモナス ジンジバリス)の生育の抑制、口腔内常在菌(例えば、ストレプトコッカス属細菌、中でも、ストレプトコッカス ゴルドニアイ)の生育の維持、又はこれらの両方により、口腔内の菌叢を改善することが好ましい。後述の試験1又は2で評価した場合、病原性細菌の割合の減少率が、好ましくは20%以上、30%以上であり、より好ましくは40%以上、50%以上又は60%以上であり、更に好ましくは70%以上又は80%以上である。一方、試験1におけるポルフィロモナス ジンジバリスの、口腔内常在菌と当該菌の和に対する比率は、30%以下が好ましく、25%以下がより好ましい。また、試験2における黒色色素産生菌の、総菌数に対する比率は、10%以下が好ましく、8%以下がより好ましい。 In the present invention, the growth of periodontal disease-causing bacteria (e.g., black pigment-producing bacteria, especially Porphyromonas gingivalis) is suppressed, and the growth of oral bacteria (e.g., Streptococcus bacteria, especially Streptococcus gordonii) is suppressed. It is preferable to improve the flora in the oral cavity by maintenance or both. When evaluated in Test 1 or 2 described later, the reduction rate of the percentage of pathogenic bacteria is preferably 20% or more and 30% or more, more preferably 40% or more, 50% or more or 60% or more, It is more preferably 70% or more or 80% or more. On the other hand, the ratio of Porphyromonas gingivalis to the sum of the oral cavity indigenous bacteria and the bacteria in Test 1 is preferably 30% or less, more preferably 25% or less. In Test 2, the ratio of black pigment-producing bacteria to the total number of bacteria is preferably 10% or less, more preferably 8% or less.
[3.剤形]
剤形としては、例えば、液状(液剤)、シロップ状(シロップ剤)、クリーム状、ペースト状、錠剤(錠剤、タブレット)、カプセル状(カプセル剤)、粉末状(顆粒、細粒)、ソフトカプセル状(ゼラチン基剤等のソフトカプセル剤)、ハードカプセル状(ハードカプセル剤)、が挙げられ、投与形態に応じて適宜選択すればよい。
[3. dosage form]
Dosage forms include, for example, liquid (solution), syrup (syrup), cream, paste, tablets (tablets, tablets), capsules (capsules), powder (granules, fine granules), and soft capsules. (soft capsules such as gelatin bases) and hard capsules (hard capsules), which may be appropriately selected according to the dosage form.
[4.投与方法・対象]
剤の投与方法としては、例えば、経口投与(例えば、口腔内投与、舌下投与)、非経口投与(例えば、経皮投与、静脈内投与、筋肉内投与、皮下投与、経鼻投与、経肺投与)が挙げられ、これらの中でも侵襲性の少ない投与形態が好ましく、経皮投与(外用)、経口投与(内服)、がより好ましく、粘膜投与(粘膜外用)が更に好ましい。
[4. Administration method/target]
Methods of administering the agent include, for example, oral administration (e.g., buccal administration, sublingual administration), parenteral administration (e.g., transdermal administration, intravenous administration, intramuscular administration, subcutaneous administration, nasal administration, pulmonary administration, Among these, less invasive dosage forms are preferred, transdermal administration (external use) and oral administration (internal use) are more preferred, and mucosal administration (external use to the mucosa) is even more preferred.
投与対象は、ヒトを含む動物であればよく、通常はヒトである。投与対象は健常者でもよいが、口腔内の細菌感染症(例えば、歯周病、う蝕、口臭)の感染者又は感染が疑われる者でもよい。ヒト以外の動物としては、例えば、マウス、ラット、ハムスター、イヌ、ネコ、ヒツジ、ヤギ、ウシ、ブタ、サルなどの哺乳類が挙げられる。 The subject of administration may be any animal including humans, and is usually a human. The subject of administration may be a healthy subject, but may also be a subject infected or suspected of having an intraoral bacterial infection (eg, periodontal disease, caries, halitosis). Examples of animals other than humans include mammals such as mice, rats, hamsters, dogs, cats, sheep, goats, cows, pigs, and monkeys.
[5.任意成分]
本発明の剤が、他の任意成分を含むいわゆる組成物の形態である場合、他の成分としては、例えば、殺菌剤、防腐剤、薬効成分、界面活性剤、研磨剤、湿潤剤、粘結剤、緩衝剤、溶解補助剤、等張化剤、安定化剤、キレート剤、保湿剤、矯味剤(甘味剤、香料、酸味料)、油性成分、着色剤、pH調整剤、溶媒、賦形剤、崩壊剤、結合剤、滑沢剤、発色剤、酸化防止剤、強化剤、膨張剤、増粘剤、清涼剤、収斂剤、紫外線吸収剤、水性溶媒、調味料、食品原料(食品添加物を含む)等の、上記有効成分以外の成分が挙げられる。任意成分の種類、含有量は、医薬品、医薬部外品、食品組成物、化粧料の各用途、及び/又は剤形、投与方法等に応じて選択すればよく、1種でもよいし2種以上の組み合わせでもよい。
[5. Optional component]
When the agent of the present invention is in the form of a so-called composition containing other optional ingredients, other ingredients include, for example, bactericides, preservatives, medicinal ingredients, surfactants, abrasives, wetting agents, caking agents agent, buffer, solubilizer, tonicity agent, stabilizer, chelating agent, humectant, corrigent (sweetener, flavoring agent, acidulant), oily component, coloring agent, pH adjuster, solvent, excipient agents, disintegrants, binders, lubricants, coloring agents, antioxidants, reinforcing agents, swelling agents, thickeners, cooling agents, astringents, UV absorbers, aqueous solvents, seasonings, food ingredients (food additives ingredients other than the above active ingredients, such as The type and content of optional ingredients may be selected according to the application of pharmaceuticals, quasi-drugs, food compositions, cosmetics, dosage forms, administration methods, etc., and may be one or two. A combination of the above may also be used.
-殺菌剤-
殺菌剤としては、例えば、塩化セチルピリジニウム、塩化ベンザルコニウム、塩化ベンゼトニウム、塩酸アルキルジアミノエチルグリシン、クロルヘキシジン又はその塩、トリクロサン、イソプロピルメチルフェノール、ヒノキチオール、グルコン酸クロルヘキシジン、塩化デカリニウム、ヨウ素、ヨウ化カリウム、スルファメトキサゾール、スルファメトキサゾールナトリウム、スルフイソキサゾール、スルフイソミジンナトリウムが挙げられる。
-Fungicide-
Bactericides include, for example, cetylpyridinium chloride, benzalkonium chloride, benzethonium chloride, alkyldiaminoethylglycine hydrochloride, chlorhexidine or its salts, triclosan, isopropylmethylphenol, hinokitiol, chlorhexidine gluconate, dequalinium chloride, iodine, potassium iodide. , sulfamethoxazole, sulfamethoxazole sodium, sulfisoxazole, sulfisomidine sodium.
-防腐剤-
防腐剤としては、例えばメチルパラベン、エチルパラベン、プロピルパラベン、ブチルパラベン等のパラオキシ安息香酸エステル、安息香酸又はその塩、デヒドロ酢酸又はその塩、プロピオン酸又はその塩、ソルビン酸又はその塩(ソルビン酸カリウム等)、ホウ酸、ホウ砂、フェニルエチルアルコール、ベンジルアルコール、フェノール、アクリノール等のアルコール、アルキルポリアミノエチルグリシンが挙げられる。
-Preservative-
Examples of antiseptics include paraoxybenzoic acid esters such as methylparaben, ethylparaben, propylparaben, butylparaben, benzoic acid or its salts, dehydroacetic acid or its salts, propionic acid or its salts, sorbic acid or its salts (potassium sorbate etc.), boric acid, borax, phenylethyl alcohol, benzyl alcohol, phenol, alcohols such as acrinol, and alkylpolyaminoethylglycine.
本発明においては、上記殺菌剤及び/又は防腐剤を含有させない(それぞれの含有量が0%)ほうが、口腔細菌叢改善の点で好適であるが、本発明の効果を妨げない範囲であれば殺菌剤及び/又は防腐剤を含有させてもよい。含有させる場合は、通常、殺菌剤及び/又は防腐剤は合計で、剤組成物全体の0.1質量%以下、好ましくは0.05質量%以下、より好ましくは0.03質量%以下、更に好ましくは0.01質量%以下、更により好ましくは0.005質量%以下である。これにより、病原性細菌及び常在菌に対する非選択的な殺菌を抑制し、口腔内の菌バランスの崩壊による菌交代症のリスクを低下させることができる。 In the present invention, it is preferable not to contain the above-mentioned bactericide and / or antiseptic (each content is 0%) in terms of oral flora improvement, as long as it does not interfere with the effects of the present invention. Bactericides and/or preservatives may be included. When contained, the total amount of bactericides and/or preservatives is usually 0.1% by mass or less, preferably 0.05% by mass or less, more preferably 0.03% by mass or less, and further It is preferably 0.01% by mass or less, and still more preferably 0.005% by mass or less. As a result, non-selective sterilization of pathogenic bacteria and indigenous bacteria can be suppressed, and the risk of superinfection due to disruption of the balance of bacteria in the oral cavity can be reduced.
-薬効成分-
薬効成分としては、例えば、デキストラナーゼ、ムタナーゼ、アミラーゼ、プロテアーゼ、リテックエンザイム等の酵素;フッ化ナトリウム、モノフルオロリン酸ナトリウム、フッ化スズ等のフッ化物;トラネキサム酸、イプシロンアミノカプロン酸、アラントイン、グリチルリチン酸塩(例えば、グリチルリチン2カリウム塩)、グリチルレチン酸、グリチルレチン酸誘導体(例えば、グリチルレチン酸ステアリル)、アラントインクロルヒドロキシアルミニウム、アズレン、ジヒドロコレステロール等の抗炎症剤;亜鉛塩、銅塩、スズ塩等の金属塩;縮合リン酸塩、エタンヒドロキシジホスフォネート等の歯石予防剤;ビタミンE(例えば、酢酸トコフェロール)等の血流促進剤;塩化ストロンチウム等の知覚過敏抑制剤;ヒドロキシエチルセルロースジメチルジアリルアンモニウムクロリド等のコーティング剤;ビタミンC(例えば、アスコルビン酸又はその塩)、塩化リゾチーム、塩化ナトリウム等の収斂剤;銅クロロフィル等の水溶性銅化合物;歯石予防剤;アラニン、グリシン、プロリン等のアミノ酸類;タイム、オウゴン、チョウジ、ハマメリス等の植物エキス;カロペプタイド;ポリビニルピロリドン等を挙げることができる。他の例としては、充血除去剤、消炎剤、収斂剤、抗ヒスタミン剤、ビタミン類、アミノ酸類、殺菌剤、局所麻酔剤、上記本発明における有効成分以外の菌叢改善作用を有する成分、これらから選ばれる2以上の組み合わせも挙げられる。充血除去剤としては、例えば、塩酸ナファゾリン、塩酸テトラヒドロゾリン、塩酸フェニレフリン、エピネフリン、塩酸エピネフリン、塩酸エフェドリン、dl-塩酸メチルエフェドリン、硝酸テトラヒドロゾリン、硝酸ナファゾリンが挙げられる。消炎、収斂剤としては、例えば、メチル硫酸ネオスチグミン、アラントイン、塩化ベルベリン、硫酸ベルベリン、硫酸亜鉛、乳酸亜鉛、塩化リゾチーム、ブロメライン、グリチルリチン酸二カリウム、グリチルリチン酸アンモニウム、グリチルレチン酸、サリチル酸メチル、アズレンスルホン酸ナトリウム、カミツレ、クロモグリク酸ナトリウムが挙げられる。抗ヒスタミン剤としては、例えば、塩酸イプロヘプチン、塩酸ジフェンヒドラミン、ジフェンヒドラミン、塩酸イソチペンジル、マレイン酸クロルフェニラミンが挙げられる。ビタミン類としては、例えば、フラビンアデニンジヌクレオチドナトリウム、塩酸ピリドキシン、シアノコバラミン、ビタミンA類(例えば酢酸レチノール、パルミチン酸レチノール)、ビタミンE類(酢酸トコフェロール(例えば、酢酸d-α-トコフェロール)が挙げられる。アミノ酸類としては、例えば、L-アスパラギン酸カリウム、L-アスパラギン酸マグネシウム、アミノエチルスルホン酸、コンドロイチン硫酸ナトリウムが挙げられる。局所麻酔剤としては、例えば、リドカイン、塩酸リドカイン、塩酸ジブカイン、クロロブタノールが挙げられる。それぞれの薬効成分は、1つ又は2以上を組み合わせて用いてもよい。薬効成分の含有量は、常法に従って有効量を適宜設定できる。
- Medicinal Ingredients -
Examples of medicinal ingredients include enzymes such as dextranase, mutanase, amylase, protease, and litek enzyme; fluorides such as sodium fluoride, sodium monofluorophosphate, and tin fluoride; tranexamic acid, epsilon aminocaproic acid, allantoin, Anti-inflammatory agents such as glycyrrhizinate (e.g., glycyrrhizin dipotassium salt), glycyrrhetinic acid, glycyrrhetinic acid derivatives (e.g., stearyl glycyrrhetinate), allantoin chlorohydroxyaluminum, azulene, dihydrocholesterol; zinc salts, copper salts, tin salts, etc. anticalculus agents such as condensed phosphate and ethane hydroxydiphosphonate; blood flow promoters such as vitamin E (e.g., tocopherol acetate); hypersensitivity inhibitors such as strontium chloride; hydroxyethylcellulose dimethyldiallylammonium coating agents such as chloride; astringents such as vitamin C (e.g., ascorbic acid or its salts), lysozyme chloride, sodium chloride; water-soluble copper compounds such as copper chlorophyll; anticalculus agents; amino acids such as alanine, glycine, and proline plant extracts such as thyme, scutellaria root, clove and hamamelis; calopeptides; polyvinylpyrrolidone and the like. Other examples include decongestants, antiphlogistic agents, astringents, antihistamines, vitamins, amino acids, bactericidal agents, local anesthetics, and components other than the active ingredients of the present invention that have an action to improve bacterial flora. Combinations of two or more are also included. Examples of decongestants include naphazoline hydrochloride, tetrahydrozoline hydrochloride, phenylephrine hydrochloride, epinephrine, epinephrine hydrochloride, ephedrine hydrochloride, dl-methylephedrine hydrochloride, tetrahydrozoline nitrate, and naphazoline nitrate. Examples of anti-inflammatory and astringent agents include neostigmine methyl sulfate, allantoin, berberine chloride, berberine sulfate, zinc sulfate, zinc lactate, lysozyme chloride, bromelain, dipotassium glycyrrhizinate, ammonium glycyrrhizinate, glycyrrhetinic acid, methyl salicylate, and azulene sulfonic acid. Sodium, chamomile, cromoglycate sodium. Antihistamines include, for example, iproheptine hydrochloride, diphenhydramine hydrochloride, diphenhydramine, isothipendyl hydrochloride, and chlorpheniramine maleate. Examples of vitamins include flavin adenine dinucleotide sodium, pyridoxine hydrochloride, cyanocobalamin, vitamins A (e.g. retinol acetate, retinol palmitate), vitamins E (tocopherol acetate (e.g. d-α-tocopherol acetate) Examples of amino acids include potassium L-aspartate, magnesium L-aspartate, aminoethylsulfonic acid and sodium chondroitin sulfate Local anesthetics include lidocaine, lidocaine hydrochloride, dibucaine hydrochloride and chlorobutanol. Each medicinal ingredient may be used singly or in combination of two or more.The content of the medicinal ingredient can be appropriately set to an effective amount according to a conventional method.
-界面活性剤-
界面活性剤は、(A)及び(B)以外の界面活性剤であればよく、例えば、アニオン性界面活性剤、両性界面活性剤が挙げられる。
-Surfactant-
The surfactant may be any surfactant other than (A) and (B), and examples thereof include anionic surfactants and amphoteric surfactants.
アニオン性界面活性剤としては、例えば、アルキル硫酸塩、アシルアミノ酸塩、アシルタウリン塩、α-オレフィンスルホン酸塩、水素添加ココナッツ脂肪酸モノグリセリドモノ硫酸塩、ラウリルスルホ酢酸塩が挙げられる。アルキル基、アシル基は直鎖及び分岐鎖のいずれでもよく、飽和及び不飽和のいずれでもよく、その炭素原子数は通常10~20であり、好ましくは12~18であり、より好ましくは12~14である。塩は、薬理学的に許容される塩から選択され得る。薬理学的に許容される塩としては、例えば、塩基付加塩及びアミノ酸塩が挙げられる。その具体例としては、ナトリウム塩、カリウム塩、カルシウム塩、マグネシウム塩、アンモニウム塩等の無機塩基塩;トリエチルアンモニウム塩、トリエタノールアンモニウム塩、ピリジニウム塩、ジイソプロピルアンモニウム塩等の有機塩基塩;アルギニン塩等の塩基性アミノ酸塩が挙げられる。中でも、無機塩基塩が好ましく、アルカリ金属塩(例えば、ナトリウム塩、カリウム塩)又はアンモニウム塩がより好ましく、ナトリウム塩が更に好ましい。アルキル硫酸塩としては、例えば、ミリスチル硫酸塩が挙げられる。アシルアミノ酸塩としては、例えば、ラウロイルグルタミン酸塩、ミリストイルグルタミン酸塩、パルミトイルグルタミン酸塩等のアシルグルタミン酸塩;N-ラウロイル-N-メチルグリシン塩、ココイルグリシン塩等のアシルグリシン塩;N-ラウロイル-β-アラニン塩、N-ミリスチル-β-アラニン塩、N-ココイル-β-アラニン塩、N-ラウロイル-N-メチル-β-アラニン塩、N-ミリストイル-N-メチル-β-アラニン塩、N-メチル-N-アシルアラニン塩等のアシルアラニン塩;ラウロイルアスパラギン酸塩等のアシルアスパラギン酸塩が挙げられる。アシルタウリン塩としては、例えば、N-メチル-N-アシルタウリン塩、N-ココイルメチルタウリン塩が挙げられる。アニオン性界面活性剤の他の例としては、水素添加ココナッツ脂肪酸モノグリセリドモノ硫酸ナトリウム、ラウリルスルホ酢酸ナトリウムも挙げられる。 Anionic surfactants include, for example, alkyl sulfates, acyl amino acid salts, acyl taurine salts, α-olefin sulfonates, hydrogenated coconut fatty acid monoglyceride monosulfate, and lauryl sulfoacetate. Alkyl groups and acyl groups may be linear or branched, saturated or unsaturated, and usually have 10 to 20 carbon atoms, preferably 12 to 18 carbon atoms, more preferably 12 to 14. Salts may be selected from pharmacologically acceptable salts. Pharmaceutically acceptable salts include, for example, base addition salts and amino acid salts. Specific examples thereof include inorganic base salts such as sodium salts, potassium salts, calcium salts, magnesium salts and ammonium salts; organic base salts such as triethylammonium salts, triethanolammonium salts, pyridinium salts and diisopropylammonium salts; arginine salts and the like. and basic amino acid salts of Among them, inorganic base salts are preferred, alkali metal salts (eg, sodium salts, potassium salts) or ammonium salts are more preferred, and sodium salts are even more preferred. Alkyl sulfates include, for example, myristyl sulfate. Acyl amino acid salts include acyl glutamates such as lauroyl glutamate, myristoyl glutamate and palmitoyl glutamate; acylglycinates such as N-lauroyl-N-methylglycinate and cocoylglycinate; N-lauroyl-β- Alanine salt, N-myristyl-β-alanine salt, N-cocoyl-β-alanine salt, N-lauroyl-N-methyl-β-alanine salt, N-myristoyl-N-methyl-β-alanine salt, N-methyl - acyl alanine salts such as N-acyl alanine salts; and acyl aspartates such as lauroyl aspartate. Acyl taurine salts include, for example, N-methyl-N-acyl taurine salts and N-cocoyl methyl taurine salts. Other examples of anionic surfactants also include hydrogenated coconut fatty acid monoglyceride monosulfate, sodium lauryl sulfoacetate.
両性界面活性剤としては、例えば、アルキルジメチルアミノ酢酸ベタイン(例えば、ラウリルジメチルアミノ酢酸ベタイン)、脂肪酸アミドプロピルジメチルアミノ酢酸ベタイン等のベタイン型両性界面活性剤;N-脂肪酸アシル-N-カルボキシメチル-N-ヒドロキシエチルエチレンジアミン塩、ヤシ油脂肪酸イミダゾリニウムベタイン等のイミダゾリン型両性界面活性剤;ラウリルジメチルアミノ酢酸ベタイン等のアルキルベタインが挙げられる。 Examples of amphoteric surfactants include betaine-type amphoteric surfactants such as alkyldimethylaminoacetic acid betaine (eg, lauryldimethylaminoacetic acid betaine), fatty acid amidopropyldimethylaminoacetic acid betaine; N-fatty acid acyl-N-carboxymethyl- imidazoline-type amphoteric surfactants such as N-hydroxyethylethylenediamine salts and coconut oil fatty acid imidazolinium betaine; and alkylbetaines such as lauryldimethylaminoacetate betaine.
界面活性剤を含む場合、アニオン性、ノニオン性、両性界面活性剤それぞれの含有量は、通常、剤全体の0.01~10質量%、好ましくは0.1~5質量%、より好ましくは0.2~3質量%である。 When a surfactant is included, the content of each of the anionic, nonionic, and amphoteric surfactants is usually 0.01 to 10% by mass, preferably 0.1 to 5% by mass, more preferably 0% of the total agent. .2 to 3% by mass.
-研磨剤-
研磨剤としては、例えば、無機研磨剤及び有機研磨剤のいずれでもよい。無機研磨剤としては、例えば、沈降性シリカ、アルミノシリケート、ジルコノシリケート、結晶性ジルコニウムシリケート、チタン結合性シリカ等の研磨性シリカ;第2リン酸カルシウム・2水和塩又は無水和物、第1リン酸カルシウム、第3リン酸カルシウム、ピロリン酸カルシウム等のリン酸カルシウム系化合物;炭酸カルシウム等の炭酸カルシウム系研磨剤;水酸化カルシウム、硫酸カルシウム等の、炭酸/リン酸以外のカルシウム系研磨剤;酸化アルミニウム、水酸化アルミニウム、アルミナ等のアルミニウム系材料;無水ケイ酸、ゼオライト、ケイ酸ジルコニウム等のケイ酸系材料;炭酸マグネシウム、第3リン酸マグネシウム等のマグネシウム系材料;ハイドロキシアパタイト、フルオロアパタイト、カルシウム欠損アパタイト等のアパタイト系材料;二酸化チタン、雲母チタン、酸化チタン等のチタン系材料;ベントナイト等の鉱物が挙げられる。有機研磨剤としては、例えば、ポリメチルメタアクリレート、合成樹脂系研磨剤が挙げられる。これらのうち、研磨性シリカ、リン酸カルシウム系化合物が好ましく、無水ケイ酸がより好ましい。研磨剤の量は、剤全体に対し、50質量%以下が好ましく、8~50質量%がより好ましい。
-Abrasive-
The abrasive may be, for example, either an inorganic abrasive or an organic abrasive. Examples of inorganic abrasives include abrasive silica such as precipitated silica, aluminosilicate, zirconosilicate, crystalline zirconium silicate, and titanium-bonded silica; Calcium phosphate compounds such as tribasic calcium phosphate and calcium pyrophosphate; calcium carbonate abrasives such as calcium carbonate; calcium hydroxide, calcium sulfate and other calcium-based abrasives other than carbonate/phosphate; aluminum oxide, aluminum hydroxide, Aluminum-based materials such as alumina; Silicic acid-based materials such as silicic anhydride, zeolite, and zirconium silicate; Magnesium-based materials, such as magnesium carbonate and magnesium triphosphate; Apatite-based materials, such as hydroxyapatite, fluoroapatite, and calcium-deficient apatite Materials; Titanium-based materials such as titanium dioxide, titanium mica, and titanium oxide; and minerals such as bentonite. Examples of organic abrasives include polymethyl methacrylate and synthetic resin abrasives. Among these, abrasive silica and calcium phosphate compounds are preferred, and silicic anhydride is more preferred. The amount of abrasive is preferably 50% by mass or less, more preferably 8 to 50% by mass, based on the total amount of the agent.
-湿潤剤-
湿潤剤としては、例えば、糖アルコール、糖アルコール以外の多価アルコールが挙げられる。糖アルコールとしては、例えば、ソルビトール(ソルビット)、エリスリトール、マルチトール、ラクチトール、キシリトール等が挙げられる。糖アルコール以外の多価アルコールとしては、グリセリン;エチレングリコール、プロピレングリコール、ジプロピレングリコール、ブチレングリコール、ポリエチレングリコール(PEG)等のグリコール;還元でんぷん糖化物が挙げられる。ポリエチレングリコールとしては、例えば、平均分子量150~6000のポリエチレングリコールが好ましく、平均分子量190~630のポリエチレングリコール(PEG200、PEG300、PEG400、PEG600)が好ましい。平均分子量は、医薬部外品原料規格2006記載の平均分子量である。湿潤剤の含有量は、剤全体に対し、通常、40質量%以下であり、好ましくは1~30質量%である。
-wetting agent-
Wetting agents include, for example, sugar alcohols and polyhydric alcohols other than sugar alcohols. Examples of sugar alcohols include sorbitol (sorbitol), erythritol, maltitol, lactitol, and xylitol. Examples of polyhydric alcohols other than sugar alcohols include glycerin; glycols such as ethylene glycol, propylene glycol, dipropylene glycol, butylene glycol and polyethylene glycol (PEG); and reduced starch saccharification products. As polyethylene glycol, for example, polyethylene glycol having an average molecular weight of 150 to 6000 is preferable, and polyethylene glycol having an average molecular weight of 190 to 630 (PEG200, PEG300, PEG400, PEG600) is preferable. The average molecular weight is the average molecular weight described in the Standards for Quasi-drug Ingredients 2006. The content of the wetting agent is usually 40% by mass or less, preferably 1 to 30% by mass, based on the entire agent.
-粘結剤-
粘結剤としては、従来公知の任意好適な有機粘結剤、例えば、多糖類、セルロース系粘結剤(例えば、カルボキシメチルセルロース(CMC)、ヒドロキシエチルセルロース、ヒドロキシプロピルセルロース、ヒドロキシプロピルメチルセルロース、メチルセルロース、カチオン化セルロース等)、その他の多糖系増粘剤(例、キサンタンガム、グアガム、ジェランガム、トラガントガム、カラヤガム、アラビヤガム、ローカストビーンガム、カラギーナン、アルギン酸ナトリウム)、合成水溶性高分子(例、ポリアクリル酸ナトリウム、カルボキシビニルポリマー、ポリビニルピロリドン、ポリビニルアルコール、アルギン酸プロピレングリコール)が挙げられる。さらには増粘性シリカ、ケイ酸アルミニウム等の無機粘結剤を含有させることもできる。有機粘結剤の含有量は、剤全体に対し、0~3質量%が好ましく、0.1~2質量%がより好ましい。無機粘結剤の含有量は、0~10質量%が好ましく、1~8質量%がより好ましい。
-Binder-
As the binding agent, any suitable conventionally known organic binding agent such as polysaccharides, cellulose-based binding agents (e.g., carboxymethylcellulose (CMC), hydroxyethylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, methylcellulose, cationic cellulose, etc.), other polysaccharide thickeners (e.g., xanthan gum, guar gum, gellan gum, tragacanth gum, karaya gum, gum arabic, locust bean gum, carrageenan, sodium alginate), synthetic water-soluble polymers (e.g., sodium polyacrylate, carboxyvinyl polymer, polyvinylpyrrolidone, polyvinyl alcohol, propylene glycol alginate). Furthermore, inorganic binders such as thickening silica and aluminum silicate can also be contained. The content of the organic binder is preferably 0 to 3% by mass, more preferably 0.1 to 2% by mass, relative to the total agent. The content of the inorganic binder is preferably 0 to 10% by mass, more preferably 1 to 8% by mass.
-緩衝剤-
緩衝剤としては、例えば、クエン酸又はその塩(例えば、クエン酸ナトリウム)、リン酸又はその塩(例えば、リン酸水素ナトリウム、リン酸二水素ナトリウム、リン酸二カリウム、リン酸二水素カリウム)、酒石酸又はその塩(例えば、酒石酸ナトリウム)、グルコン酸又はその塩(例えば、グルコン酸ナトリウム)、酢酸又はその塩(例えば、酢酸ナトリウム)、炭酸又はその塩(例えば、炭酸水素ナトリウム)、トロメタモール、アミノ酸類(例えば、アスパラギン酸カリウム、アミノエチルスルホン酸、グルタミン酸、グルタミン酸ナトリウム)、これらの2以上の組み合わせが挙げられる。
- Buffer -
Examples of buffering agents include citric acid or salts thereof (e.g., sodium citrate), phosphoric acid or salts thereof (e.g., sodium hydrogen phosphate, sodium dihydrogen phosphate, dipotassium phosphate, potassium dihydrogen phosphate). , tartaric acid or its salts (e.g. sodium tartrate), gluconic acid or its salts (e.g. sodium gluconate), acetic acid or its salts (e.g. sodium acetate), carbonic acid or its salts (e.g. sodium bicarbonate), trometamol, Amino acids (eg, potassium aspartate, aminoethylsulfonic acid, glutamic acid, sodium glutamate), combinations of two or more thereof.
-溶解補助剤-
溶解補助剤としては、例えば、プロピレングリコール、ポリエチレングリコール、これらの2以上の組み合わせが挙げられる。
-Solubilizer-
Solubility aids include, for example, propylene glycol, polyethylene glycol, and combinations of two or more thereof.
-等張化剤-
等張化剤としては、例えば、塩化ナトリウム、塩化カリウム、グリセリン、これらの2以上の組み合わせが挙げられる。
- Tonicity agent -
Tonicity agents include, for example, sodium chloride, potassium chloride, glycerin, combinations of two or more thereof.
-安定化剤-
安定化剤としては、例えば、エデト酸ナトリウム、シクロデキストリン、亜硫酸塩、クエン酸又はその塩、ジブチルヒドロキシトルエン、アスコルビン酸、これらの2以上の組み合わせが挙げられる。
-Stabilizer-
Stabilizers include, for example, sodium edetate, cyclodextrins, sulfites, citric acid or salts thereof, dibutylhydroxytoluene, ascorbic acid, combinations of two or more thereof.
-キレート剤-
キレート剤としては、例えば、エデト酸ナトリウム、クエン酸ナトリウム、これらの組み合わせが挙げられる。
- Chelating agent -
Chelating agents include, for example, sodium edetate, sodium citrate, and combinations thereof.
-保湿剤-
保湿剤としては、例えば、グリセリン、濃グリセリン、糖アルコール類(例えば、ソルビトール、キシリトール、マルチトール、マンニトール、還元水飴、還元パラチノース、エリスリトール、ラクチトール、イソマルト)、これらの2以上の組み合わせが挙げられる。
-moisturizer-
Humectants include, for example, glycerin, concentrated glycerin, sugar alcohols (eg, sorbitol, xylitol, maltitol, mannitol, reduced starch syrup, reduced palatinose, erythritol, lactitol, isomalt), and combinations of two or more thereof.
-矯味剤-
矯味剤としては、例えば、甘味剤(例、サッカリンナトリウム、グリチルリチン酸二カリウム、アスパルテーム、ステビア、ステビオサイド、パラメトキシシンナミックアルデヒド、ネオヘスペリジンジヒドロカルコン、ペリラルチン、アスパラチルフェニルアラニンメチルエステル、ソーマチン、アセスルファムカリウム、スクラロース、マルチトール、ソルビトール、マンニトール、還元水飴、還元パラチノース、キシリトール、エリスリトール、ラクチトールなどの人工甘味料など);香料(例、アニス油、カシア油、ウィンターグリーン油、マスチック油、ネロリ油(オレンジフラワー油)、レモングラス油、ジャスミン油、ローズ油、イリス油、クローブ油、セージ油、カルダモン油、ローズマリー油、ローレル油、カモミル油、バジル油、マジョラム油、レモン油、オレンジ油、ライム油、柚子油、ナツメグ油、ラベンダー油、パラクレス油、バニラ油、桂皮油、ピメント油、桂葉油、シソ油、冬緑油、ハッカ油、ライチ油等の天然精油);メントール、カルボン、シンナミックアルデヒド、アネトール、メチルサリシレート、オイゲノール、リナロール、リモネン、メントン、メンチルアセテート、シトラール、デカナール、カンファー、ボルネオール、ピネン、スピラントール、n-デシルアルコール、シトロネロール、α-テルピネオール、シトロネリルアセテート、エチルリナロール、ワニリン等の上記天然精油中に含まれる香料成分;エチルアセテート、エチルブチレート、イソアミルアセテート、ヘキサナール、ヘキセナール、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、ベンズアルデヒド、バニリン、エチルバニリン、フラネオール、N-エチル-p-メンタン-3-カルボキサミド、メンチルラクテート、エチレングリコール-l-メンチルカーボネート等の香料成分;及びいくつかの香料成分や天然精油を組み合わせてなるミント系、フルーツ系、ハーブ系等の各種調合フレーバー(例えば、ペパーミントミクロンX-8277-T、ドライコート抹茶#421)、酸味料(例、クエン酸、酒石酸、リンゴ酸)、緑茶末が挙げられる。
-Flavoring agent-
Flavoring agents include, for example, sweeteners (e.g., sodium saccharin, dipotassium glycyrrhizinate, aspartame, stevia, stevioside, paramethoxycinnamic aldehyde, neohesperidin dihydrochalcone, perillartine, asparatylphenylalanine methyl ester, thaumatin, acesulfame potassium, sucralose , maltitol, sorbitol, mannitol, reduced starch syrup, reduced palatinose, xylitol, erythritol, artificial sweeteners such as lactitol, etc.); fragrances (e.g., anise oil, cassia oil, wintergreen oil, mastic oil, neroli oil (orange flower oil ), lemongrass oil, jasmine oil, rose oil, iris oil, clove oil, sage oil, cardamom oil, rosemary oil, laurel oil, chamomile oil, basil oil, marjoram oil, lemon oil, orange oil, lime oil, yuzu oil, nutmeg oil, lavender oil, paracress oil, vanilla oil, cinnamon oil, pimento oil, cinnamon oil, perilla oil, wintergreen oil, peppermint oil, lychee oil, etc.); menthol, carvone, cinnamic aldehyde, anethole , methyl salicylate, eugenol, linalool, limonene, menthone, menthyl acetate, citral, decanal, camphor, borneol, pinene, spiranthol, n-decyl alcohol, citronellol, α-terpineol, citronellyl acetate, ethyl linalool, vanillin, etc. Perfume ingredients contained in essential oils: ethyl acetate, ethyl butyrate, isoamyl acetate, hexanal, hexenal, methyl anthranilate, ethyl methyl phenylglycidate, benzaldehyde, vanillin, ethyl vanillin, furaneol, N-ethyl-p-menthane Fragrance ingredients such as 3-carboxamide, menthyl lactate, ethylene glycol-l-menthyl carbonate; and various prepared flavors such as mint, fruit, herb, etc., which are obtained by combining several fragrance ingredients and natural essential oils (for example, peppermint micron X-8277-T, dry coat matcha #421), acidulants (eg, citric acid, tartaric acid, malic acid), green tea powder.
-油性成分-
油性成分としては、例えば、脂肪酸エステル(例えば、グリセリン脂肪酸エステル)、炭化水素(例、パラフィン、流動パラフィン、セレシン、スクワラン、ワセリン、マイクロクリスタリンワックス)、高級脂肪酸(例えば、ラウリン酸、ミリスチン酸、オレイン酸、イソステアリン酸等の炭素原子数8~22の脂肪酸)、高級アルコール(例えば、ラウリルアルコール、セチルアルコール、セトステアリルアルコール、オレイルアルコール、イソステアリルアルコール等の炭素原子数8~22のアルコール)、植物油脂(例えば、オリーブ油、ヒマシ油、やし油等の植物油;ミリスチン酸イソプロピル等の脂肪酸エステル)、蜜蝋、これらの2以上の組み合わせが挙げられる。
- Oily component -
Oily components include, for example, fatty acid esters (e.g. glycerin fatty acid esters), hydrocarbons (e.g. paraffin, liquid paraffin, ceresin, squalane, vaseline, microcrystalline wax), higher fatty acids (e.g. lauric acid, myristic acid, olein acids, fatty acids with 8 to 22 carbon atoms such as isostearic acid), higher alcohols (for example, alcohols with 8 to 22 carbon atoms such as lauryl alcohol, cetyl alcohol, cetostearyl alcohol, oleyl alcohol, and isostearyl alcohol), plants Oils and fats (eg, vegetable oils such as olive oil, castor oil, and coconut oil; fatty acid esters such as isopropyl myristate), beeswax, and combinations of two or more thereof.
-湿潤剤-
湿潤剤としては、例えば、糖アルコール、糖アルコール以外の多価アルコールが挙げられる。糖アルコールとしては、例えば、ソルビトール(ソルビット)、エリスリトール、マルチトール、ラクチトール、キシリトール等が挙げられる。糖アルコール以外の多価アルコールとしては、グリセリン;エチレングリコール、プロピレングリコール、ジプロピレングリコール、ブチレングリコール、ポリエチレングリコール(PEG)等のグリコール;還元でんぷん糖化物が挙げられる。ポリエチレングリコールとしては、例えば、平均分子量150~6000のポリエチレングリコールが好ましく、平均分子量190~630のポリエチレングリコール(PEG200、PEG300、PEG400、PEG600)が好ましい。平均分子量は、医薬部外品原料規格2006記載の平均分子量である。湿潤剤の量は、剤全体に対し、通常、40質量%以下であり、好ましくは1~30質量%である。
-wetting agent-
Wetting agents include, for example, sugar alcohols and polyhydric alcohols other than sugar alcohols. Examples of sugar alcohols include sorbitol (sorbitol), erythritol, maltitol, lactitol, and xylitol. Examples of polyhydric alcohols other than sugar alcohols include glycerin; glycols such as ethylene glycol, propylene glycol, dipropylene glycol, butylene glycol and polyethylene glycol (PEG); and reduced starch saccharification products. As polyethylene glycol, for example, polyethylene glycol having an average molecular weight of 150 to 6000 is preferable, and polyethylene glycol having an average molecular weight of 190 to 630 (PEG200, PEG300, PEG400, PEG600) is preferable. The average molecular weight is the average molecular weight described in the Standards for Quasi-drug Ingredients 2006. The amount of the wetting agent is generally 40% by mass or less, preferably 1 to 30% by mass, based on the total agent.
-着色剤-
着色剤としては例えば、ベニバナ赤色素、クチナシ黄色素、クチナシ青色素、シソ色素、紅麹色素、赤キャベツ色素、ニンジン色素、ハイビスカス色素、カカオ色素、スピルリナ青色素、タマリンド色素等の天然色素や、赤色2号、赤色3号、赤色104号、赤色105号、赤色106号、赤色227号、黄色4号、黄色5号、緑色3号、青色1号等の法定色素、リボフラビン、銅クロロフィリンナトリウム、二酸化チタンが挙げられる。着色剤を含む場合、その含有量は、剤全体に対し0.00001~3質量%とすることが好ましい。
-coloring agent-
Examples of coloring agents include natural pigments such as safflower red pigment, gardenia yellow pigment, gardenia blue pigment, perilla pigment, monascus pigment, red cabbage pigment, carrot pigment, hibiscus pigment, cacao pigment, spirulina blue pigment, tamarind pigment, Legal pigments such as Red No. 2, Red No. 3, Red No. 104, Red No. 105, Red No. 106, Red No. 227, Yellow No. 4, Yellow No. 5, Green No. 3, Blue No. 1, riboflavin, sodium copper chlorophyllin, Titanium dioxide may be mentioned. When a coloring agent is included, its content is preferably 0.00001 to 3% by mass with respect to the entire agent.
-pH調整剤-
pH調整剤としては、例えば、フタル酸、クエン酸、コハク酸、酢酸、フマル酸、リンゴ酸、及び乳酸等の有機酸又はそれらの塩(クエン酸ナトリウム)、リン酸(オルトリン酸)等の無機酸又はそれらの塩(例えば、カリウム塩、ナトリウム塩、及びアンモニウム塩)、水酸化ナトリウム、水酸化カリウム等の水酸化物が挙げられる。無機酸塩としては、例えば、リン酸水素二ナトリウム、リン酸二水素ナトリウムが挙げられる。pH調整剤の含有量は、通常、添加後の剤のpHが5~9、好ましくは6~8.5となる量とすることができる。本明細書において、pH値は、通常、測定開始から25℃、3分後の値をいう。pH値は、例えば、東亜電波工業社製のpHメーター(型番Hm-30S)を用いて測定することができる。
-pH adjuster-
Examples of pH adjusters include organic acids such as phthalic acid, citric acid, succinic acid, acetic acid, fumaric acid, malic acid, and lactic acid, salts thereof (sodium citrate), and inorganic acids such as phosphoric acid (orthophosphoric acid). Acids or salts thereof (eg, potassium salts, sodium salts, and ammonium salts), and hydroxides such as sodium hydroxide and potassium hydroxide. Examples of inorganic acid salts include disodium hydrogen phosphate and sodium dihydrogen phosphate. The content of the pH adjuster can be adjusted so that the pH of the agent after addition is usually 5 to 9, preferably 6 to 8.5. In this specification, the pH value usually refers to the value after 3 minutes at 25°C from the start of measurement. The pH value can be measured, for example, using a pH meter (model number Hm-30S) manufactured by Toa Denpa Kogyo Co., Ltd.
-溶媒-
溶媒としては、例えば、水(精製水)、エタノールが挙げられ、水が好ましい。溶媒は1種を単独で用いても2種以上を組み合わせて用いてもよい。
-solvent-
Examples of the solvent include water (purified water) and ethanol, with water being preferred. A solvent may be used individually by 1 type, or may be used in combination of 2 or more type.
-賦形剤-
賦形剤としては、例えば、ヒドロキシプロピルセルロース、ヒドロキシプロピルメチルセルロース、メチルセルロース、結晶セルロース、エチルセルロース、メチルエチルセルロース、低置換度ヒドロキシプロピルセルロース等のセルロース、及びその薬理学的に許容される誘導体;ポリビニルピロリドン、部分けん化ポリビニルアルコール等の合成高分子;ゼラチン、アラビアゴム末、プルラン、寒天、アルギン酸、アルギン酸ナトリウム、キタンサンガム等の多糖類;トウモロコシデンプン、バレイショデンプン、α化デンプン、ヒドロキシプロピルスターチ等のスターチ、及びその薬理学的に許容される誘導体;乳糖、乳糖造粒物、果糖、ブドウ糖、白糖、グラニュウ糖、含水ブドウ糖、トレハロース、パラチノース、マンニトール、ソルビトール、エリスリトール、キシリトール、マルトテトラオース、ラクチトール、イソマルト、還元パラチノース、還元水飴、粉末還元麦芽糖水飴、マルチトール;炭酸マグネシウム、炭酸カルシウム、軽質無水ケイ酸、二酸化ケイ素(別名:無水ケイ酸、微粒二酸化ケイ素)、酸化チタン、水酸化アルミニウムゲル等の無機賦形剤;これらの2以上の組み合わせが挙げられる。
-Excipient-
Excipients include, for example, celluloses such as hydroxypropylcellulose, hydroxypropylmethylcellulose, methylcellulose, crystalline cellulose, ethylcellulose, methylethylcellulose, low-substituted hydroxypropylcellulose, and pharmacologically acceptable derivatives thereof; polyvinylpyrrolidone, Synthetic polymers such as partially saponified polyvinyl alcohol; Polysaccharides such as gelatin, gum arabic powder, pullulan, agar, alginic acid, sodium alginate, and xanthan gum; Starches such as corn starch, potato starch, pregelatinized starch, and hydroxypropyl starch, and their Pharmacologically acceptable derivatives; lactose, lactose granules, fructose, glucose, sucrose, granulated sugar, hydrous glucose, trehalose, palatinose, mannitol, sorbitol, erythritol, xylitol, maltotetraose, lactitol, isomalt, reduced palatinose , reduced starch syrup, powdered reduced maltose starch syrup, maltitol; inorganic excipients such as magnesium carbonate, calcium carbonate, light anhydrous silicic acid, silicon dioxide (another name: anhydrous silicic acid, fine silicon dioxide), titanium oxide, aluminum hydroxide gel, etc. and combinations of two or more of these.
-崩壊剤-
崩壊剤としては、例えば、クロスポビドン、カルメロースカルシウム、クロスカルメロースナトリウム、低置換度ヒドロキシプロピルセルロース、カルボキシメチルセルロース、カルボキシメチルスターチナトリウム、クロスカルメロースナトリウム、クロスリンクドインソルブルポリビニルピロリドン、ヒドロキシプロピルスターチ、部分α化デンプン、トウモロコシデンプン、これらの2以上の組み合わせが挙げられる。
-Disintegrant-
Examples of disintegrants include crospovidone, carmellose calcium, croscarmellose sodium, low-substituted hydroxypropyl cellulose, carboxymethyl cellulose, carboxymethyl starch sodium, croscarmellose sodium, cross-linked insoluble polyvinylpyrrolidone, and hydroxypropyl starch. , partially pregelatinized starch, corn starch, combinations of two or more thereof.
-結合剤-
結合剤としては、例えば、ヒドロキシプロピルセルロース、ヒドロキシプロピルメチルセルロース、メチルセルロース、エチルセルロース、ポリビニルアルコール、ポリビニルピロリドン、ゼラチン、デキストリン、デンプン、アルファー化デンプン、これらの2以上の組み合わせが挙げられる。
-Binder-
Binders include, for example, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, methyl cellulose, ethyl cellulose, polyvinyl alcohol, polyvinyl pyrrolidone, gelatin, dextrin, starch, pregelatinized starch, combinations of two or more thereof.
-滑沢剤-
滑沢剤としては、例えば、ステアリン酸カルシウム、ステアリン酸マグネシウム、ショ糖脂肪酸エステル、軽質無水ケイ酸、フマル酸ステアリルナトリウム、ポリエチレングリコール、タルク、ステアリン酸、これらの2以上の組み合わせが挙げられる。
-lubricant-
Lubricants include, for example, calcium stearate, magnesium stearate, sucrose fatty acid esters, light anhydrous silicic acid, sodium stearyl fumarate, polyethylene glycol, talc, stearic acid, and combinations of two or more of these.
-他の任意成分-
上記以外の任意成分の例としては、ポリイソブチレン、ポリブタジエン、ウレタン、シリコン、天然ゴムが挙げられる。これら他の任意成分の含有量は、本発明の効果を妨げない範囲で適宜設定できる。
-Other optional ingredients-
Examples of optional components other than the above include polyisobutylene, polybutadiene, urethane, silicon, and natural rubber. The content of these other optional components can be appropriately set within a range that does not impair the effects of the present invention.
[6.剤型、適用部位]
本発明の剤は、医薬、医薬部外品、化粧料、食品として利用できる。剤型は、例えば、液剤、スプレー剤、固形剤、半固形剤、液剤、粉剤、顆粒剤が挙げられ、特に限定されない。医薬、医薬部外品の場合の適用部位は、例えば、口腔、鼻腔、眼が挙げられる。口腔用としては、例えば、歯磨剤(例えば、練歯磨、ゲル状歯磨、潤製歯磨、液体歯磨)、洗口剤、舌磨剤、口腔内スプレー、口腔内タブレット、ガム、口中清涼剤、うがい用錠剤、口腔用パスタ、ゲル剤、軟膏剤が挙げられる。鼻腔用としては、例えば、点鼻剤、鼻腔洗浄剤が挙げられる。眼用としては、例えば、点眼剤(例えば、一般用点眼剤、コンタクトレンズ使用者用点眼剤)、洗眼剤(一般用洗眼剤、コンタクトレンズ使用者用洗眼剤)、コンタクトレンズ用剤(例えば、コンタクトレンズ保存剤、コンタクトレンズ洗浄剤、コンタクトレンズ洗浄剤)が挙げられる。
[6. dosage form, application site]
The agent of the present invention can be used as pharmaceuticals, quasi-drugs, cosmetics, and foods. The dosage form is not particularly limited and includes, for example, liquids, sprays, solids, semi-solids, liquids, powders, and granules. Examples of application sites for pharmaceuticals and quasi-drugs include the oral cavity, nasal cavity, and eyes. For the oral cavity, for example, dentifrice (e.g., toothpaste, gel toothpaste, wet toothpaste, liquid toothpaste), mouthwash, tongue polish, oral spray, oral tablet, gum, mouth freshener, gargle tablets, buccal pastes, gels, and ointments. For the nasal cavity, for example, nasal drops and nasal washes can be mentioned. For the eyes, for example, eye drops (e.g., general eye drops, eye drops for contact lens users), eye washes (general eye wash, eye wash for contact lens users), contact lens agents (e.g., contact lens preservatives, contact lens cleaning agents, contact lens cleaning agents).
化粧料としては、例えば、クリーム剤、乳液、パック剤、ジェル剤、エアゾール、シート剤等の剤形で利用できる。具体的には例えば、化粧水、美容液、美白剤、保湿剤、フェイスマスク、乳液、ファンデーション、アイシャドウ、マスカラ、眉墨、アイライン、チークパウダー、口紅、リップクリーム等の皮膚用化粧料;ヘアリンス、ヘアコンディショナー、ヘアトリートメント、ヘアローション、ヘアトニック、ヘアパック、ヘアクリーム、コンディショニングムース、ヘアムース、ヘアスプレー、シャンプー、リーブオントリートメント、染毛料、整髪料等の毛髪用化粧料が挙げられる。 As cosmetics, for example, it can be used in dosage forms such as creams, milky lotions, packs, gels, aerosols, and sheets. Specifically, for example, skin cosmetics such as lotion, serum, whitening agent, moisturizer, face mask, milky lotion, foundation, eye shadow, mascara, eyebrow, eyeliner, cheek powder, lipstick, lip balm; hair rinse , hair conditioners, hair treatments, hair lotions, hair tonics, hair packs, hair creams, conditioning mousses, hair mousses, hair sprays, shampoos, leave-on treatments, hair dyes, and hair cosmetics.
食品(食品組成物)としては例えば、健康食品、機能性食品、健康食品、健康補助食品(サプリメント)、栄養補助食品、特定保健用食品、栄養機能食品、医療用食品、病者用食品、乳児用食品、介護用食品、高齢者用食品等の用途を付した食品組成物が挙げられる。 Foods (food compositions) include, for example, health foods, functional foods, health foods, health supplements (supplements), dietary supplements, foods for specified health uses, functional nutritive foods, medical foods, foods for the sick, and infants. Food compositions with uses such as food for nursing care, food for nursing care, and food for the elderly.
[7.製造方法]
本発明の剤の製造方法は、剤型、用途、適用部位に応じて定めればよい。例えば、練歯磨剤として利用する場合、溶媒に溶解する成分を調製した後、それ以外の不溶性成分を混合し、必要に応じて脱泡(例えば、減圧等)を行う方法が挙げられる。また他の例としては、有効成分及び必要に応じて用いる他の成分を水性溶媒(例えば、精製水、滅菌水等の水)に分散し、溶解することにより組成物を調製し、適切な容器(例えば、ガラス製、樹脂製)に充てんする方法が挙げられる。容器は、口腔用剤の容器としては、例えば、ラミネートチューブが挙げられ、材質は例えば、ポリエチレン、ポリプロピレン、ポリエチレンテレフタレート、ナイロン等の樹脂が用いられ得る。スプレー剤の場合には、噴霧手段を備える容器(例えば、トリガー式、ポンプ式、エアゾール式容器)を選択すればよい。得られる練歯磨剤は、容器に収容して製品とすることができる。容器は、形状、材質は特に制限されず、通常の口腔用組成物に使用される容器を使用できる。
[7. Production method]
The method for producing the agent of the present invention may be determined according to the dosage form, application, and application site. For example, when it is used as a toothpaste, a method of preparing a component that dissolves in a solvent, mixing other insoluble components, and defoaming (for example, reducing pressure, etc.) as necessary. Another example is dispersing and dissolving the active ingredient and optionally other ingredients in an aqueous solvent (for example, water such as purified water and sterilized water) to prepare a composition, (For example, glass, resin, etc.). As for the container, for example, a container for an oral agent includes a laminated tube, and resin such as polyethylene, polypropylene, polyethylene terephthalate, and nylon can be used as the material. In the case of a spray, a container equipped with an atomizing means (for example, a trigger-type, pump-type, or aerosol-type container) may be selected. The obtained toothpaste can be put into a container to be used as a product. The shape and material of the container are not particularly limited, and containers commonly used for oral compositions can be used.
[8.使用方法]
本発明の剤の使用方法は、例えば、適用部位に剤を投与すればよい。1日あたり投与回数は特に限定されないが、例えば1~6回、それ以上でもよい。口腔用剤の場合例えば、適量の剤を歯ブラシに載せ歯の表面をブラッシングし、使用後水ですすぐ方法(歯磨剤)、適量の剤を口に含みうがいをした後吐き出す方法(洗口剤)、適量の剤を噛み砕いて飲み込む方法(口腔内タブレット)、適量の剤を口腔内に吹きかける方法(口腔内スプレー)によればよい。
[8. how to use]
The method of using the agent of the present invention may be, for example, administering the agent to the application site. The number of administrations per day is not particularly limited, but may be, for example, 1 to 6 times or more. In the case of oral preparations, for example, put an appropriate amount of the agent on a toothbrush, brush the surface of the teeth, and then rinse with water after use (dentifrice), or spit out after gargling with an appropriate amount of the agent in the mouth (mouthwash). , a method of chewing and swallowing an appropriate amount of the agent (intraoral tablet), and a method of spraying an appropriate amount of the agent into the oral cavity (intraoral spray).
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 The present invention will be specifically described below by showing Examples, Comparative Examples, and Formulation Examples, but the present invention is not limited to the following Examples. In the following examples, % indicates % by mass unless otherwise specified.
表に示す物質を評価サンプルとして調製し、各評価サンプルについて、下記に示す試験方法で評価を行った。評価結果は表に併記した。 The substances shown in the table were prepared as evaluation samples, and each evaluation sample was evaluated by the test methods shown below. The evaluation results are also shown in the table.
<試験1>2種混合菌に対する選択的抗菌効果の評価(実施例1~24、比較例1~3)
[細菌のプレカルチャー]
後述の各種細菌(口腔内常在菌、歯周病原菌)の凍結菌液を、それぞれ血液平板培地*1に白金耳で植菌し、37℃で72時間嫌気培養(80体積%窒素、10体積%二酸化炭素、10体積%水素)を行い起菌した。続いて増殖したコロニーを5mg/Lのヘミン(Sigma社製)及び1mg/LのビタミンK(富士フイルム和光純薬工業社製)を含むトッドへヴィットブロス(Todd Hewitt Broth、Becton and Dickinson社製)〔THBHM〕4mLに懸濁し、37℃24時間嫌気培養した。さらに、この培養液を20mLのTHBHMに1%接種し、37℃24時間嫌気培養した。
<Test 1> Evaluation of selective antibacterial effect on two types of mixed bacteria (Examples 1 to 24, Comparative Examples 1 to 3)
[Pre-culture of bacteria]
Frozen bacterial solutions of various bacteria (indigenous bacteria in the oral cavity, periodontal pathogens) described later were inoculated on a blood plate medium * 1 with a platinum loop, and anaerobic culture was performed at 37 ° C for 72 hours (80 vol% nitrogen, 10 vol. % carbon dioxide, 10% by volume hydrogen) was performed to initiate bacteria. Subsequently, the grown colony was added to Todd Hewitt Broth (manufactured by Becton and Dickinson) containing 5 mg/L hemin (manufactured by Sigma) and 1 mg/L vitamin K (manufactured by Fujifilm Wako Pure Chemical Industries, Ltd.). The cells were suspended in 4 mL of [THBHM] and cultured anaerobically at 37° C. for 24 hours. Further, 1% of this culture solution was inoculated into 20 mL of THBHM, and anaerobically cultured at 37° C. for 24 hours.
評価には、American Type Culture Collection(以下、ATCCと略記。)より購入した、下記の菌種を用いた。
口腔内常在菌:
ストレプトコッカス ゴルドニアイ(S.gordonii) ATCC10558(以下、S.g菌と略記)
歯周病原菌:
ポルフィロモナス ジンジバリス(P.gingivalis) ATCC33277(以下、P.g菌と略記)
For the evaluation, the following bacterial strains purchased from the American Type Culture Collection (hereinafter abbreviated as ATCC) were used.
Indigenous bacteria in the oral cavity:
Streptococcus gordonii (S.gordonii) ATCC10558 (hereinafter abbreviated as S.g fungus)
Periodontal pathogens:
Porphyromonas gingivalis ATCC33277 (hereinafter abbreviated as P.g bacteria)
*1:血液平板培地の組成
トッドへーウィットブロース
(Becton and Dickinson社製): 30g/L
寒天(Becton and Dickinson社製):15g/L
ヘミン(シグマ アルドリッチ社製): 5mg/L
ビタミンK(富士フイルム和光純薬(株)製): 1mg/L
蒸留水: 残部
(全量が1Lになるようにメスアップし、121℃で20分間オートクレーブした。)
綿羊脱繊血(日本バイオテスト研究所製): 100mL
*1: Composition of blood plate medium Todd Hewitt broth (manufactured by Becton and Dickinson): 30 g/L
Agar (manufactured by Becton and Dickinson): 15 g / L
Hemin (manufactured by Sigma-Aldrich): 5 mg/L
Vitamin K (manufactured by Fujifilm Wako Pure Chemical Industries, Ltd.): 1 mg / L
Distilled water: Remainder (filled up to 1 L and autoclaved at 121°C for 20 minutes)
Defibrinated sheep blood (manufactured by Nihon Biotest Laboratories): 100 mL
[2種混合菌に対する選択的抗菌効果]
上記培養後の菌液を11,000rpm 5minで遠心分離し、沈殿物をトッドへヴィットブロス培地を用いて、上記各種細菌が各々濁度(O.D.550nm)1.0になるように再懸濁し、菌液を調製した。その後、5mg/Lのヘミン(Sigma社製)及び1mg/LのビタミンK(富士フイルム和光純薬工業社製)を含むトッドへヴィットブロス(Todd Hewitt Broth、Becton and Dickinson社製)〔THBHM〕4mLに対して、濁度1.0に調製した各種菌をP.g菌は終濃度5%、S.g菌は終濃度0.5%になるようにそれぞれ200μL、20μL添加し、その後、表に示すように調製した評価サンプル溶液又は蒸留水(コントロール)を40μL添加し、37℃8時間嫌気培養した。培養後、トリプチックソイブロス(Tryptic Soy Broth、Becton and Dickinson社製)を用いて10倍希釈系列を作製した。10-3、10-4、10-5、10-6希釈液を50μL、下記に示す選択培地に塗抹して培養した。培養後、生えてくる細菌コロニー数を計測することにより、生菌数を算出した。すなわちトリプチックソイアガー寒天培地(Tryptic Soy Agar、Becton and Dickinson社製)で、37℃、2日間嫌気培養することで生えてくるS.gordonii ATCC10558、200μg/mLのカナマイシンを添加した血液平板培地*1で37℃、7日間嫌気培養することで生えてくるP.gingivalis ATCC33277のそれぞれの生菌数を測定した。
[Selective antibacterial effect against two kinds of mixed bacteria]
The cultured bacterial solution was centrifuged at 11,000 rpm for 5 minutes, and the precipitate was reconstituted using Todd Hewitt Broth medium so that each of the above bacteria had a turbidity (OD 550 nm) of 1.0. Suspended to prepare a bacterial solution. Then, 4 mL of Todd Hewitt Broth (manufactured by Becton and Dickinson) containing 5 mg/L of hemin (manufactured by Sigma) and 1 mg/L of vitamin K (manufactured by Fujifilm Wako Pure Chemical Industries, Ltd.) [THBHM]. , various bacteria prepared to have a turbidity of 1.0 were added to P. The final concentration of S.g bacteria was 5%. 200 μL and 20 μL of g bacteria were added to a final concentration of 0.5%, respectively, and then 40 μL of an evaluation sample solution or distilled water (control) prepared as shown in the table was added and anaerobically cultured at 37° C. for 8 hours. . After culturing, a 10-fold dilution series was prepared using Tryptic Soy Broth (manufactured by Becton and Dickinson). 50 μL of the 10 −3 , 10 −4 , 10 −5 and 10 −6 dilutions were smeared on the selective medium shown below and cultured. After culturing, the number of viable bacteria was calculated by counting the number of bacterial colonies that grew. That is, S. cerevisiae grown by anaerobic culture at 37° C. for 2 days on a tryptic soy agar agar medium (Tryptic Soy Agar, manufactured by Becton and Dickinson). P. gordonii ATCC10558, grown by anaerobically culturing on a blood plate medium * 1 supplemented with 200 μg/mL of kanamycin at 37° C. for 7 days. gingivalis ATCC33277 was measured.
各評価サンプルにおける、総菌中の歯周病菌の割合(S.gの菌数+P.gの菌数=総菌数に対するP.gの菌数の割合;表中のP.g菌比率)をa(%)、評価サンプルを処置していないコントロール(比較例1)の培養液における歯周病菌の割合(総菌数に対するP.g菌の数の割合)をb(%)とし、下記に示す計算式にて歯周病原菌の割合の減少率(P.g菌比率減少率:%)を算出した。この減少率から、下記に示す評価基準に基づき歯周病原菌に対する選択的抗菌効果を評価した。
歯周病原菌の割合の減少率(%)={1-(a/b)}×100
なお、コントロール(比較例1)の培養液におけるにおける歯周病原菌の割合(式中のb)は、47.5%であった。
Percentage of periodontal disease bacteria in total bacteria in each evaluation sample (S.g bacteria count + P.g bacteria count = ratio of P.g bacteria count to total bacteria count; P.g bacteria ratio in the table) is a (%), and the ratio of periodontal disease bacteria in the culture solution of the control (Comparative Example 1) that is not treated with the evaluation sample (the ratio of the number of P.g bacteria to the total number of bacteria) is b (%), and the following The reduction rate of the ratio of periodontal pathogens (P.g bacteria ratio reduction rate: %) was calculated using the formula shown in . From this reduction rate, the selective antibacterial effect against periodontal pathogens was evaluated based on the evaluation criteria shown below.
Reduction rate of periodontal pathogens (%) = {1-(a/b)} x 100
The percentage of periodontopathogenic bacteria (b in the formula) in the culture solution of the control (Comparative Example 1) was 47.5%.
サンプル溶液に含まれる(A)成分及び(B)成分の詳細は下記のとおりである。なお、ポリオキシエチレンの後の( )内の数字はエチレンオキサイドの重合度である。
ポリオキシエチレン(8)ラウリルエーテル:エマルミンNL-80(三洋化成工業(株)製)
ポリオキシエチレン(9)ラウリルエーテル:EMALEX 709(日本エマルジョン(株)製)
ポリオキシエチレン(10)ラウリルエーテル:EMALEX 710(日本エマルジョン(株)製)
ポリオキシエチレン(5)硬化ヒマシ油:NIKKOL HCO-5(NIKKO CHEMICALS(株)製)
ポリオキシエチレン(100)硬化ヒマシ油 :NIKKOL HCO-100(NIKKO CHEMICALS(株)製)
ポリオキシエチレン(40)セチルエーテル:NIKKOL BC-40(NIKKO CHEMICALS(株)製)
ポリオキシエチレン(20)ステアリルエーテル:NIKKOL BS-20(NIKKO CHEMICALS(株)製)
ポリオキシエチレン(30)ベヘニルエーテル:NIKKOL BB-30(NIKKO CHEMICALS(株)製)
ポリオキシエチレン(50)オレイルエーテル:NIKKOL BO-50V(NIKKO CHEMICALS(株)製)
ポリオキシエチレン(60)硬化ヒマシ油 :NIKKOL HCO-60 NIKKO CHEMICALS(株)製)
Details of the components (A) and (B) contained in the sample solution are as follows. The number in parentheses after polyoxyethylene is the degree of polymerization of ethylene oxide.
Polyoxyethylene (8) lauryl ether: Emalmin NL-80 (manufactured by Sanyo Chemical Industries, Ltd.)
Polyoxyethylene (9) lauryl ether: EMALEX 709 (manufactured by Nippon Emulsion Co., Ltd.)
Polyoxyethylene (10) lauryl ether: EMALEX 710 (manufactured by Nippon Emulsion Co., Ltd.)
Polyoxyethylene (5) hydrogenated castor oil: NIKKOL HCO-5 (manufactured by NIKKO CHEMICALS Co., Ltd.)
Polyoxyethylene (100) hydrogenated castor oil: NIKKOL HCO-100 (manufactured by NIKKO CHEMICALS Co., Ltd.)
Polyoxyethylene (40) cetyl ether: NIKKOL BC-40 (manufactured by NIKKO CHEMICALS Co., Ltd.)
Polyoxyethylene (20) stearyl ether: NIKKOL BS-20 (manufactured by NIKKO CHEMICALS Co., Ltd.)
Polyoxyethylene (30) behenyl ether: NIKKOL BB-30 (manufactured by NIKKO CHEMICALS Co., Ltd.)
Polyoxyethylene (50) oleyl ether: NIKKOL BO-50V (manufactured by NIKKO CHEMICALS Co., Ltd.)
Polyoxyethylene (60) hydrogenated castor oil: NIKKOL HCO-60 (manufactured by NIKKO CHEMICALS Co., Ltd.)
(A)成分を含有する実施例1~24は、(A)及び(B)成分のいずれも含有していない比較例1、及び(A)成分を含有していない比較例2及び3と比較して、高いP.g菌比率減少率を示した。中でも、(A)及び(B)成分を含有する実施例5~12、16~24は、(A)成分の含有量が同量である各実施例と比較して、(B)成分が(A)成分のS.g菌、P.g菌への抗菌効果を調整し、よりP.g菌への選択的抑制効果を高めることで、結果としてより高いP.g菌比率減少率を示した(表1~4)。 Examples 1 to 24 containing component (A) are compared with Comparative Example 1 containing neither component (A) nor component (B), and Comparative Examples 2 and 3 containing no component (A). and high P.I. g bacteria ratio reduction rate. Among them, Examples 5 to 12 and 16 to 24 containing components (A) and (B) are compared with each example in which the content of component (A) is the same, and component (B) is ( A) Component S.I. g bacteria, P. By adjusting the antibacterial effect on P.g bacteria, more P.g. By enhancing the selective inhibitory effect on P.g bacteria, higher P.g. g bacteria ratio reduction rate is shown (Tables 1 to 4).
<試験2>ヒト唾液を用いたin vitroでの菌叢制御効果の評価(実施例25~36、比較例4~6)
4mLの液体培地*2の入った試験管(Kimble Chase Life Science and Research Products LLC社製)に、80μLの安静時唾液および40μLの各添加濃度となるように調製した評価サンプル溶液又は蒸留水(コントロール)を添加し、37℃で8時間嫌気培養を行った。その後、回収した培養液を、トリプチックソイブロス(Tryptic Soy Broth、Becton and Dickinson社製)を用いて10倍希釈系列を作製した。10-3、10-4、10-5、10-6希釈液を50μLずつ、下記に示す選択培地に塗抹して培養した。培養後、生えてくる細菌コロニー数を計測することにより、生菌数及び菌構成比を算出した。すなわち、血液平板培地*1で、37℃、7日間嫌気培養することで生えてくる総菌数と、200μg/mLのカナマイシンを添加した血液平板培地で、37℃、7日間嫌気培養することで生えてくる歯周病原菌(黒色色素産生菌)数を、それぞれ計測した。
<Test 2> Evaluation of bacterial flora control effect in vitro using human saliva (Examples 25-36, Comparative Examples 4-6)
Test tube containing 4 mL of liquid medium * 2 (manufactured by Kimble Chase Life Science and Research Products LLC), evaluation sample solution or distilled water (control ) was added, and anaerobic culture was performed at 37° C. for 8 hours. Thereafter, the recovered culture medium was serially diluted 10-fold using Tryptic Soy Broth (manufactured by Becton and Dickinson). 50 μL of each of the 10 −3 , 10 −4 , 10 −5 and 10 −6 diluted solutions was smeared on the selective medium shown below and cultured. After culturing, the number of viable bacterial colonies and bacterial composition ratio were calculated by counting the number of bacterial colonies that grew. That is, the total number of bacteria grown by anaerobic culture at 37 ° C for 7 days on a blood plate medium * 1 , and the total number of bacteria grown on a blood plate medium supplemented with 200 μg / mL kanamycin, anaerobic culture at 37 ° C for 7 days The number of growing periodontal pathogens (black pigment-producing bacteria) was counted.
*2:液体培地組成
プロテオースペプトン : 10.0g/L
(Becton and Dickinson社製)
トリプトン(Becton and Dickinson社製): 5.0g/L
イーストエキス(Becton and Dickinson社製):5.0g/L
ヘミン(シグマ社製): 1.0mg/L
ビタミンK(富士フイルム和光純薬(株)製): 0.2mg/L
KCl(富士フイルム和光純薬(株)製): 2.5g/L
システイン(富士フイルム和光純薬(株)製): 0.5g/L
グルコース: 1.0g/L
蒸留水: 残部
(全量が1Lになるようにメスアップし、121℃で20分間オートクレーブした。)
*2: Liquid medium composition Proteose peptone: 10.0 g/L
(manufactured by Becton and Dickinson)
Tryptone (manufactured by Becton and Dickinson): 5.0 g/L
Yeast extract (manufactured by Becton and Dickinson): 5.0 g / L
Hemin (manufactured by Sigma): 1.0 mg/L
Vitamin K (manufactured by Fujifilm Wako Pure Chemical Industries, Ltd.): 0.2 mg/L
KCl (manufactured by FUJIFILM Wako Pure Chemical Industries, Ltd.): 2.5 g / L
Cysteine (manufactured by FUJIFILM Wako Pure Chemical Industries, Ltd.): 0.5 g/L
Glucose: 1.0g/L
Distilled water: Remainder (filled up to 1 L and autoclaved at 121°C for 20 minutes)
各評価サンプルにおける、総菌中の黒色色素産生菌の割合(総菌数に対する黒色色素産生菌の数の割合;表中の黒色色素産生菌比率)をa(%)、評価サンプルを処置していないコントロール(比較例4)の培養液における総菌中の黒色色素産生菌の割合(総菌数に対する黒色色素産生菌の数の割合)をb(%)とし、下記に示す計算式にて黒色色素産生菌の割合の減少率(黒色色素産生菌比率減少率:%)を算出した。この減少率から、下記に示す評価基準に基づき黒色色素産生菌に対する口腔菌叢の評価をした。
黒色色素産生菌の割合の減少率(%)={1-(a/b)}×100
なお、コントロール(比較例4)における黒色色素産生菌の割合(b)は14.1%であった。
In each evaluation sample, the ratio of black pigment-producing bacteria in the total number of bacteria (the ratio of the number of black pigment-producing bacteria to the total number of bacteria; black pigment-producing bacteria ratio in the table) is a (%), and the evaluation sample is treated. The ratio of black pigment-producing bacteria in the total bacteria in the culture solution of the control (Comparative Example 4) without black pigment-producing bacteria (the ratio of the number of black pigment-producing bacteria to the total number of bacteria) is defined as b (%), and the black color is expressed by the formula shown below. The rate of decrease in the percentage of pigment-producing bacteria (ratio of decrease in ratio of black pigment-producing bacteria: %) was calculated. Based on this reduction rate, the oral flora against black pigment-producing bacteria was evaluated based on the evaluation criteria shown below.
Decrease rate of black pigment-producing bacteria (%) = {1-(a/b)} × 100
The ratio (b) of black pigment-producing bacteria in the control (Comparative Example 4) was 14.1%.
サンプル溶液に含まれる(A)成分及び(B)成分の詳細は下記のとおりである。なお、グリセリルの後の( )内の数字はグリセリンの重合度である。
ポリオキシエチレン(9)ラウリルエーテル:EMALEX 709(日本エマルジョン(株)製)
ポリオキシエチレン(60)ヒマシ油 :NIKKOL HCO-60 NIKKO CHEMICALS(株)製)
Details of the components (A) and (B) contained in the sample solution are as follows. The number in parentheses after glyceryl is the degree of polymerization of glycerin.
Polyoxyethylene (9) lauryl ether: EMALEX 709 (manufactured by Nippon Emulsion Co., Ltd.)
Polyoxyethylene (60) castor oil: NIKKOL HCO-60 (manufactured by NIKKO CHEMICALS Co., Ltd.)
(A)成分を含有する実施例25~36は、(A)及び(B)成分のいずれも含有していない比較例4、及び(A)成分を含有していない比較例5及び6と比較して、黒色色素産生菌比率減少率が高く40%以上であった。中でも、(A)及び(B)成分を含有する実施例29~36は、(A)成分の含有量が同量である各実施例と比較して、黒色色素産生菌の比率の大幅な減少がみられ、より高い減少率(60%以上)を示した(表5~6)。
これらの実施例の結果は、本発明の剤が、口腔内の菌叢を良好に改善できることを示している。
Examples 25 to 36 containing component (A) are compared with Comparative Example 4 containing neither component (A) nor component (B), and Comparative Examples 5 and 6 containing no component (A). As a result, the rate of decrease in the proportion of black pigment-producing bacteria was high at 40% or more. Among them, Examples 29 to 36 containing components (A) and (B) significantly reduced the ratio of black pigment-producing bacteria compared to each example in which the content of component (A) was the same. was observed, showing a higher reduction rate (60% or more) (Tables 5-6).
The results of these Examples demonstrate that the agent of the present invention can favorably improve the bacterial flora in the oral cavity.
以下に口腔菌叢改善剤の処方例を示す。 The formulation examples of the oral flora-improving agent are shown below.
[処方例1-1]ゲル状歯磨剤
(A)ポリオキシエチレン(9)ラウリルエーテル 0.1
無水ケイ酸 15.0
カルボキシメチルセルロースナトリウム 1.5
サッカリンナトリウム 0.1
ポリエチレングリコール 3.0
グリセリン 15.0
香料 1.0
水 残部
合計 100.0%
[Prescription Example 1-1] Gel toothpaste (A) Polyoxyethylene (9) Lauryl ether 0.1
Silicic anhydride 15.0
Carboxymethylcellulose sodium 1.5
Saccharin sodium 0.1
Polyethylene glycol 3.0
Glycerin 15.0
Perfume 1.0
water
Total 100.0%
[処方例1-2]ゲル状歯磨剤
(A)ポリオキシエチレン(9)ラウリルエーテル 0.1
(B)ポリオキシエチレン(60)硬化ヒマシ油 5.0
無水ケイ酸 15.0
カルボキシメチルセルロースナトリウム 1.5
サッカリンナトリウム 0.1
ポリエチレングリコール 3.0
グリセリン 15.0
香料 1.0
水 残部
合計 100.0%
[Prescription Example 1-2] Gel toothpaste (A) Polyoxyethylene (9) Lauryl ether 0.1
(B) Polyoxyethylene (60) hydrogenated castor oil 5.0
Silicic anhydride 15.0
Carboxymethylcellulose sodium 1.5
Saccharin sodium 0.1
Polyethylene glycol 3.0
Glycerin 15.0
Perfume 1.0
water
Total 100.0%
[処方例2-1]洗口剤
(A)ポリオキシエチレン(9)ラウリルエーテル 0.1
プロピレングリコール 3.0
サッカリンナトリウム 0.2
クエン酸ナトリウム 0.3
クエン酸 0.1
香料 0.5
水 残部
合計 100.0%
[Formulation Example 2-1] Mouthwash (A) Polyoxyethylene (9) Lauryl ether 0.1
Propylene glycol 3.0
Saccharin sodium 0.2
Sodium citrate 0.3
Citric acid 0.1
Perfume 0.5
water
Total 100.0%
[処方例2-2]洗口剤
(A)ポリオキシエチレン(9)ラウリルエーテル 0.1
(B)ポリオキシエチレン(60)硬化ヒマシ油 5.0
プロピレングリコール 3.0
サッカリンナトリウム 0.2
クエン酸ナトリウム 0.3
クエン酸 0.1
香料 0.5
水 残部
合計 100.0%
[Formulation Example 2-2] Mouthwash (A) Polyoxyethylene (9) Lauryl ether 0.1
(B) Polyoxyethylene (60) hydrogenated castor oil 5.0
Propylene glycol 3.0
Saccharin sodium 0.2
Sodium citrate 0.3
Citric acid 0.1
Perfume 0.5
water
Total 100.0%
[処方例3-1]口中清涼剤
(A)ポリオキシエチレン(9)ラウリルエーテル 0.1
エタノール 10.0
グリセリン 5.0
香料 1.0
水 残部
合計 100.0%
[Prescription Example 3-1] Mouth freshener (A) Polyoxyethylene (9) Lauryl ether 0.1
Ethanol 10.0
Glycerin 5.0
Perfume 1.0
water
Total 100.0%
[処方例3-2]口中清涼剤
(A)ポリオキシエチレン(9)ラウリルエーテル 0.1
(B)ポリオキシエチレン(60)硬化ヒマシ油 5.0
エタノール 10.0
グリセリン 5.0
香料 1.0
水 残部
合計 100.0%
[Prescription Example 3-2] Mouth freshener (A) Polyoxyethylene (9) Lauryl ether 0.1
(B) Polyoxyethylene (60) hydrogenated castor oil 5.0
Ethanol 10.0
Glycerin 5.0
Perfume 1.0
water
Total 100.0%
Claims (10)
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