JP2018111663A - Two phase liquid oral composition - Google Patents
Two phase liquid oral composition Download PDFInfo
- Publication number
- JP2018111663A JP2018111663A JP2017003503A JP2017003503A JP2018111663A JP 2018111663 A JP2018111663 A JP 2018111663A JP 2017003503 A JP2017003503 A JP 2017003503A JP 2017003503 A JP2017003503 A JP 2017003503A JP 2018111663 A JP2018111663 A JP 2018111663A
- Authority
- JP
- Japan
- Prior art keywords
- oil
- phase liquid
- liquid oral
- oral composition
- composition
- 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.)
- Granted
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- 239000007788 liquid Substances 0.000 title claims abstract description 96
- 239000000203 mixture Substances 0.000 title claims abstract description 91
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- 239000003795 chemical substances by application Substances 0.000 claims description 31
- 238000002156 mixing Methods 0.000 claims description 22
- -1 alcohol compound Chemical class 0.000 claims description 19
- 210000000214 mouth Anatomy 0.000 claims description 19
- 150000003242 quaternary ammonium salts Chemical class 0.000 claims description 17
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Landscapes
- Cosmetics (AREA)
Abstract
Description
本発明は、使用時の均一な分散性と使用後の分離性と清澄性を同時に実現でき、洗口液として好適な２相液体口腔用組成物に関する。 The present invention relates to a two-phase liquid composition for oral cavity that can simultaneously achieve uniform dispersibility during use, separability after use, and clarity, and is suitable as a mouthwash.
従来、油液層と水層の２相に分離した製剤で、静置時には２相に分離しており、振とうすることにより一時的な水中油滴型のエマルションを形成させて使用する液体組成物は公知であり、特許文献１には口内洗剤が、特許文献２には口腔用液体組成物が記載されている。
油液層と水層の２相に分離した口腔用組成物を洗口液として使用する場合には、振とう後、均一なエマルション状態が一定時間保持される必要がある。一方で、均一なエマルション状態を保持しようとすると、洗口に使用後もなかなか２相に分離せず、美観上好ましくないという問題があった。
Conventionally, it is a preparation that is separated into two phases, an oil liquid layer and an aqueous layer, and is separated into two phases when left standing, and a liquid composition that is used by forming a temporary oil-in-water emulsion by shaking. The product is well known, Patent Document 1 describes an oral detergent, and Patent Document 2 describes an oral liquid composition.
When the composition for oral cavity separated into two phases of an oil liquid layer and an aqueous layer is used as a mouthwash, it is necessary to maintain a uniform emulsion state for a certain period of time after shaking. On the other hand, when trying to maintain a uniform emulsion state, there is a problem in that it is difficult to separate into two phases even after use in the mouthwash, which is undesirable from the aesthetic point of view.
本発明は、上記のような状況を鑑みてなされたものであり、使用時の均一な分散性と使用後の分離性と清澄性を同時に実現できる、２相液体口腔用組成物を提供することを課題としている。 The present invention has been made in view of the situation as described above, and provides a two-phase liquid oral composition capable of simultaneously realizing uniform dispersibility during use and separation and clarity after use. Is an issue.
本発明者は、上記課題を解決するために鋭意研究を重ねた結果、特定の油剤（Ａ）および（Ｂ）を併用し、これを（Ｃ）水と混合することにより、振とう後は均一なエマルション状態が一定時間保持されるものの、使用後は速やかに２相に分離し清澄性が得られること、すなわち、使用時の均一な分散性と使用後の分離性と清澄性を同時に実現できることを見出し、本発明を完成するに至った。
従来の２相に分離した口腔用組成物において、２種類の油剤を組み合わせることは公知の手法であったが、本発明は、特定の２種の油剤を組み合わせることにより、新たな効果が得られることを見出し、上記課題を解決するに至ったものである。
As a result of intensive research in order to solve the above-mentioned problems, the present inventor uses a specific oil agent (A) and (B) in combination, and mixes it with (C) water, so that it is uniform after shaking. The emulsion state is maintained for a certain period of time, but after use it can be quickly separated into two phases to obtain clarity, that is, uniform dispersibility during use, separation after use and clarity can be realized simultaneously. As a result, the present invention has been completed.
In the conventional composition for oral cavity separated into two phases, combining two types of oil was a known technique, but the present invention provides a new effect by combining two specific types of oil. It has been found that the above problems have been solved.
本発明は、具体的には次の事項を要旨とする。
１．油剤（Ａ）、油剤（Ｂ）および（Ｃ）水を含有し、
前記油剤（Ａ）は、流動パラフィンであり、
前記油剤（Ｂ）は、ミリスチン酸オクチルドデシルおよび／またはトリ（カプリル／カプリン酸）グリセリルであることを特徴とする、
２相液体口腔用組成物。
２．油剤（Ａ）は、１−オクタノール／水計算分配係数（ＣＬｏｇＰｏｗ値）が１０．５以上１１．５以下である流動パラフィンから選択される１種以上であることを特徴とする、１．に記載の２相液体口腔用組成物。
３．油剤（Ａ）の油剤（Ｂ）に対する配合比率が、重量比で１．０以上であることを特徴とする、１．または２．に記載の２相液体口腔用組成物。
４．さらに、（Ｄ）四級アンモニウム塩を含有することを特徴とする、１．〜３．いずれかに記載の２相液体口腔用組成物。
５．さらに、（Ｅ）アルコール化合物を含有することを特徴とする、１．〜４．いずれかに記載の２相液体口腔用組成物。
The gist of the present invention is specifically as follows.
1. Oil agent (A), oil agent (B) and (C) containing water,
The oil agent (A) is liquid paraffin,
The oil (B) is octyldodecyl myristate and / or glyceryl tri (capryl / caprate),
Two-phase liquid oral composition.
2. The oil agent (A) is one or more selected from liquid paraffin having a 1-octanol / water calculated distribution coefficient (CLogPow value) of 10.5 or more and 11.5 or less. The two-phase liquid oral composition described in 1.
3. The blending ratio of the oil agent (A) to the oil agent (B) is 1.0 or more by weight, Or 2. The two-phase liquid oral composition described in 1.
4). And (D) a quaternary ammonium salt, ~ 3. The two-phase liquid oral composition according to any one of the above.
5. And (E) an alcohol compound. ~ 4. The two-phase liquid oral composition according to any one of the above.
本発明の２相液体口腔用組成物は、振とうにより均一なエマルション状態が一定時間保持され、その後速やかに２相に分離するので、洗口液として使用した場合には、使用後速やかに分離するため、清澄性や美観に優れ好適である。
さらに、本発明の２相液体口腔用組成物は、均一なエマルション状態から速やかに２相に分離するため、油液層に含有される油剤、特に、油剤（Ｂ）が水により分解する恐れが少なく、油剤（Ａ）および（Ｂ）において油溶性薬用成分を高濃度配合した処方においても、製剤安定性に優れた処方を得ることが可能である。
また、本発明の２相液体口腔用組成物を洗口液とした場合には、高濃度に配合した油剤（Ａ）および（Ｂ）により、歯の汚れ、特に油汚れに対する高い洗浄効果が得られるほか、油剤による歯牙のコーティングや殺菌効果、口腔内の保湿効果を得ることができる。さらに、成分（Ｄ）の四級アンモニウム塩を配合することにより、四級アンモニウム塩が有する抗菌効果も併せ得ることもでき、さらに、成分（Ｅ）のアルコール化合物を配合することにより、さっぱりとした使用感を高めることもできる。
The two-phase liquid oral composition of the present invention maintains a uniform emulsion state by shaking for a certain period of time, and then quickly separates into two phases. Therefore, when used as a mouthwash, it separates quickly after use. Therefore, it is excellent in clarity and aesthetics.
Furthermore, since the two-phase liquid oral composition of the present invention quickly separates into two phases from a uniform emulsion state, the oil agent contained in the oil liquid layer, in particular, the oil agent (B) may be decomposed by water. Even in a formulation in which oil-soluble medicinal components are blended in high concentrations in the oil agents (A) and (B), it is possible to obtain a formulation with excellent formulation stability.
Further, when the two-phase liquid oral composition of the present invention is used as a mouthwash, the oils (A) and (B) blended at a high concentration provide a high cleaning effect on tooth stains, particularly oil stains. In addition, it is possible to obtain tooth coating and bactericidal effects and moisturizing effects in the oral cavity. Furthermore, by blending the quaternary ammonium salt of component (D), the antibacterial effect of the quaternary ammonium salt can also be obtained, and by blending the alcohol compound of component (E), it is refreshed. The feeling of use can also be enhanced.
以下、本発明の２相液体口腔用組成物について詳細に説明する。
本発明の２相液体口腔用組成物は、２つの油剤（Ａ）および（Ｂ）を含有してなる油液層と、（Ｃ）水を含有してなる水層との２相に分離した製剤型のものである。
ここで、２相に分離した製剤型とは、静置時には油液層と水層の２相に分離しており、使用時に振とうすることにより均一なエマルション状態となり、使用後静置すると速やかに２相に分離する形態の製剤を意味する。すなわち、２相に分離した製剤は、静置しておくと油液層と水層の２相に分離した外観であり、使用時は振とうにより２相が混ざり合い均一なエマルション状態となり、静置すると再度速やかに２相に分離した外観に戻る。さらに、この製剤は、振とうして使用した後に静置しておくと、油液層と水層との２相が分離した状態が維持されるが、２相に分離した後に再度振とうすれば、再び均一なエマルション状態となり、静置および振とうを繰り返して何度も使用することができる。
本発明の２相液体口腔用組成物において、「速やかに２相に分離する」とは、均一なエマルション状態となった後、静置し概ね１５〜３０秒以内に２相に分離した状態に戻ることを意味する。
また、「２相に分離する」とは、１００ｍＬ容量のサンプル瓶に組成物１００ｇを入れ、１秒間に２回の速さで上下に２０回振とうした後、静置した場合に、組成物が概ね２つの相に分離することが外観上視認できることを意味する。ここで、２相の境界に油液層、水層とは外観上異なる乳白色の水や油の微小な粒子の分散層を有していても良いが、この分散層は、油液層と水層とを合わせた全体の体積として５％以下とする。
Hereinafter, the two-phase liquid oral composition of the present invention will be described in detail.
The two-phase liquid oral composition of the present invention was separated into two phases of an oil liquid layer containing two oil agents (A) and (B) and an aqueous layer containing (C) water. It is of the formulation type.
Here, the formulation type separated into two phases is separated into two phases of an oil liquid layer and an aqueous layer at the time of standing, and becomes a uniform emulsion state by shaking at the time of use. It means a preparation that is separated into two phases. That is, the preparation separated into two phases has an appearance that is separated into two phases of an oil liquid layer and an aqueous layer when left standing, and when used, the two phases are mixed by shaking to form a uniform emulsion state. When placed, it quickly returns to the appearance separated into two phases. Furthermore, when the preparation is left to stand after being shaken, the two phases of the oil liquid layer and the aqueous layer are maintained in a separated state, but are shaken again after separating into two phases. Then, it becomes a uniform emulsion state again and can be used many times by repeatedly standing and shaking.
In the two-phase liquid oral cavity composition of the present invention, “separate rapidly into two phases” means that after a uniform emulsion state, the mixture is allowed to stand and separated into two phases within approximately 15 to 30 seconds. Means going back.
In addition, “separate into two phases” means that when 100 g of the composition is put into a 100 mL capacity sample bottle, shaken up and down 20 times at a rate of 2 times per second, and then left to stand, Means that the separation into two phases is visually visible. Here, the oil liquid layer and the water layer may have a milky white water or a fine particle dispersion layer of oil, which differs in appearance from the two phase boundaries. The total volume of the layers together is 5% or less.
本発明の２相液体口腔用組成物は、油剤（Ａ）として流動パラフィンを含有するものである。
＜油剤（Ａ）について＞
本発明における、油剤（Ａ）の流動パラフィンは、２相に分離する製剤として外観を特徴づけるものである。
本発明の「流動パラフィン」は、無色無臭の液状の炭素数２０以上のアルカンの混合物であって、市販されている公知のものが使用可能であり、特に限定されるものではないが、本発明においては、日本薬局方等に規定する規格に適合するもの等を好ましく用いることができる。
本発明における、油剤（Ａ）の流動パラフィンは、１−オクタノール／水計算分配係数（ＣＬｏｇＰｏｗ値）が１０．５以上１１．５以下である流動パラフィンから選択される１種以上のもの（例えば、（株）モレスコ社製のモレスコホワイトＰ−２００、ＣＬｏｇＰｏｗ：１０．９５〜１１．０１等）を、好適に使用することができる。
ここで、１−オクタノール／水計算分配係数（calculated octanol-water partition coefficient：ＣＬｏｇＰｏｗ：以下、「ＬｏｇＰ」ということがある。）は、一般に常用対数表記で示される値である。ＬｏｇＰ値は、化学物質の性質を表す数値の一つであり、添加量に依存しない一定の値である。対象とする物質が、１−オクタノールと水の混合液において、１−オクタノール相と水相が接した系中で平衡状態にある場合を対象として、各相の濃度をその常用対数で示したものである。ＬｏｇＰ値が大きくなると、比較的に疎水性が増大する傾向があり、ＬｏｇＰ値が小さくなると、比較的に親水性が増大する傾向がある。
本発明におけるＬｏｇＰ値は、既知の計算方法により算出したものである。また、ＬｏｇＰ値は、定量的構造活性相関アルゴリズムを用いた市販ソフト等による計算によって求めた値を用いたものであってもよいし、フラグメント法を採用してもよい。フラグメント法では、ある分子の分配係数を、その分子の部分構造ごとの分配係数の総和によって計算する。
ＬｏｇＰ値を計算により算出可能な市販ソフトとしては、Ｃｈｅｍｄｒａｗ Ｐｒｏ１２．０等を挙げることができ、また、ｈｔｔｐ：／／ｗｗｗ．ｖｃｃｌａｂ．ｏｒｇ／ｌａｂ／ａｌｏｇｐｓ／ｓｔａｒｔ．ｈｔｍｌを利用して得た値としてもよい。
The two-phase liquid oral composition of the present invention contains liquid paraffin as the oil agent (A).
<About oil agent (A)>
The liquid paraffin of the oil agent (A) in the present invention characterizes the appearance as a preparation that separates into two phases.
The “liquid paraffin” of the present invention is a colorless and odorless liquid mixture of alkanes having 20 or more carbon atoms, and commercially available known ones can be used and are not particularly limited. In the method, those conforming to the standards prescribed in the Japanese Pharmacopoeia and the like can be preferably used.
In the present invention, the liquid paraffin of the oil agent (A) is one or more selected from liquid paraffin having a 1-octanol / water calculated distribution coefficient (CLogPow value) of 10.5 or more and 11.5 or less (for example, Moresco White P-200 manufactured by Moresco Co., Ltd., CLogPow: 10.95-11.01, etc.) can be suitably used.
Here, 1-octanol-water partition coefficient (calculated octanol-water partition coefficient: CLogPow: hereinafter, sometimes referred to as “LogP”) is a value generally expressed in common logarithmic notation. The LogP value is one of the numerical values representing the properties of the chemical substance, and is a constant value that does not depend on the addition amount. In the case where the target substance is in an equilibrium state in a system in which the 1-octanol phase and the aqueous phase are in contact with each other in a mixed solution of 1-octanol and water, the concentration of each phase is indicated by its common logarithm. It is. When the LogP value increases, the hydrophobicity tends to increase relatively, and when the LogP value decreases, the hydrophilicity tends to increase relatively.
The LogP value in the present invention is calculated by a known calculation method. Further, the LogP value may be a value obtained by calculation using commercially available software using a quantitative structure-activity relationship algorithm, or a fragment method may be employed. In the fragment method, the distribution coefficient of a molecule is calculated by the sum of the distribution coefficients for each partial structure of the molecule.
Examples of commercially available software that can calculate the LogP value by calculation include Chemdraw Pro 12.0, and the like, and http: // www. vcclab. org / lab / logps / start. It is good also as a value obtained using html.
さらに、本発明における、油剤（Ａ）の流動パラフィンは、４０℃における動粘度が４．０ｍｍ２／ｓ以上６０．０ｍｍ２／ｓ以下、より好ましくは、９．０ｍｍ２／ｓ以上４０．０ｍｍ２／ｓ以下である流動パラフィンから選択される１種以上のものを好適に使用することができる。これらの流動パラフィンとしては、三光化学工業（株）社製の１５０−Ｓ（動粘度：約２５．４ｍｍ２／ｓ）、２６０−Ｓ（動粘度：約４９．０ｍｍ２／ｓ）や、（株）モレスコ社製のモレスコホワイトＰ−１２０（動粘度：約２３．５ｍｍ２／ｓ）、Ｐ−１５０（動粘度：約３０．１ｍｍ２／ｓ）、Ｐ−２００（動粘度：約３９．３ｍｍ２／ｓ）等が挙げられる。
ここで、動粘度はＪＩＳ Ｋ２２８３に基づいて測定することができ、具体的には、一定容量（２５ｍＬ）の試料が、４０℃の条件下でウベローデ型粘度計の毛細管を自然流下するのに要した時間（秒）を測定し、この値を動粘度の値とすることができる。
Furthermore, the liquid paraffin of the oil agent (A) in the present invention has a kinematic viscosity at 40 ° C. of 4.0 mm 2 / s to 60.0 mm 2 / s, more preferably 9.0 mm 2 / s to 40.0 mm. One or more selected from liquid paraffin that is 2 / s or less can be suitably used. Examples of these liquid paraffins include 150-S (kinematic viscosity: about 25.4 mm 2 / s), 260-S (kinematic viscosity: about 49.0 mm 2 / s) manufactured by Sanko Chemical Co., Ltd. Moresco White P-120 (kinematic viscosity: about 23.5 mm 2 / s), P-150 (kinematic viscosity: about 30.1 mm 2 / s), P-200 (kinematic viscosity: about 39) manufactured by Moresco .3 mm 2 / s) and the like.
Here, the kinematic viscosity can be measured based on JIS K2283. Specifically, it is necessary for a sample of a constant volume (25 mL) to flow down naturally through the capillary of the Ubbelohde viscometer under the condition of 40 ° C. The measured time (seconds) is measured, and this value can be used as the value of kinematic viscosity.
本発明の２相液体口腔用組成物は、油剤（Ｂ）としてミリスチン酸オクチルドデシルおよび／またはトリ（カプリル／カプリン酸）グリセリルを、含有するものである。
＜油剤（Ｂ）について＞
本発明における油剤（Ｂ）は、油剤（Ａ）の流動パラフィン同様に、２相に分離する製剤として外観を特徴づけるものである。
本発明の油剤（Ｂ）として、ミリスチン酸オクチルドデシルを単独で使用すると、均一なエマルション状態から油液層と水層の２相に速やかに分離する点において、より好適である。
The two-phase liquid oral composition of the present invention contains octyldodecyl myristate and / or glyceryl tri (capryl / caprate) as the oil agent (B).
<About oil agent (B)>
The oil agent (B) in the present invention characterizes the appearance as a preparation that separates into two phases, like the liquid paraffin of the oil agent (A).
When octyldodecyl myristate is used alone as the oil agent (B) of the present invention, it is more preferable in that it can be rapidly separated from a uniform emulsion state into two phases of an oil liquid layer and an aqueous layer.
本発明の２相液体口腔用組成物における、油剤（Ａ）および（Ｂ）の配合量は、使用時の均一な分散性と使用後の分離性と清澄性を同時に実現する観点から、組成物全体の５重量％以上５０重量％以下が好ましく、７重量％以上３０重量％以下がより好ましく、１０重量％以上２０重量％以下が最も好ましい。
さらに、油剤（Ａ）の油剤（Ｂ）に対する配合比率は、重量比で１．０以上２０．０以下にすると、均一なエマルション状態から油液層と水層の２相に速やかに分離する観点において好ましく、２．０以上にするとより好ましく、３．０以上にすることが均一な分散後の分離性と清澄性が速やかに得られるために最も好ましい。
The blending amounts of the oil agents (A) and (B) in the two-phase liquid oral cavity composition of the present invention are compositions from the viewpoint of simultaneously realizing uniform dispersibility during use, separability and clarity after use. 5 wt% or more and 50 wt% or less of the whole is preferable, 7 wt% or more and 30 wt% or less is more preferable, and 10 wt% or more and 20 wt% or less is most preferable.
Furthermore, when the blending ratio of the oil agent (A) to the oil agent (B) is 1.0 to 20.0 in terms of weight ratio, the viewpoint of quickly separating from a uniform emulsion state into two phases of an oil liquid layer and an aqueous layer. In this case, it is more preferably 2.0 or more, and most preferably 3.0 or more, since uniform separability and clarity after dispersion can be obtained quickly.
本発明の２相液体口腔用組成物における油液層成分には、油溶性の任意の成分、例えば、香料、油溶性着色剤、油溶性薬用成分等を配合できる。
香料としては、例えば、メントール、アネトール、オイゲノール、カンファー、シトロネロール、１，８−シネオール、シンナミックアルデヒド、チモール、バニリルブチルエーテル、バニリン、フェネチルアルコール、ヘリオトロピン、ボルネオール、サリチル酸メチル、ｐ−メンタン−３，８−ジオール、ラクトン酸メンチル、リナロール、リモネン、オシメン、ｎ−デシルアルコール、α−テルピネオール、メチルアセテート、シトロネリルアセテート、メチルオイゲノール、リナロール、エチルリナロール、ワニリン、スペアミント油、ペパーミント油、レモン油、オレンジ油、グレープフルーツ油、ベルガモット油、ライム油、セージ油、タイム油、ローズマリー油、ローレル油、桂皮油、ピメント油、シソ油、ユーカリ油などが挙げられる。また、アップルフレーバー、アプリコットフレーバー、ストロベリーフレーバー、チェリーフレーバー、パイナップルフレーバー、ピーチフレーバー、バナナフレーバー、メロンフレーバーなどのフレーバー香料を配合することができる。さらに、エタノール、プロピレングリコールなどの香料溶剤を配合することも可能である。なお、これらの香料は単独で用いても２種以上を併用してもよいが、発明の効果を損なわない範囲の配合量は、通常、油液層成分に対して０．０１重量％以上２０重量％以下、好ましくは０．１重量％以上１５重量％以下である。
油溶性着色剤としては、例えば、赤色２１５号、赤色２２５号、黄色２０１号、黄色２０４号、緑色２０２号、紫色２０１号などの中から１種あるいは２種以上を適宜選択できるが、発明の効果を損なわない範囲の配合量は、通常、２相液体口腔用組成物に対して０．００１重量％以下が好ましい。
油溶性薬用成分としては、例えば、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、トコフェロール、トコトリエノール、酢酸トコフェロール、ニコチン酸トコフェロール、イブプロフェンなどが挙げられる。なお、これらの薬用成分は単独で用いても２種以上を併用してもよいが、発明の効果を損なわない範囲の配合量は、通常、２相液体口腔用組成物に対して０．００１重量％以上１０重量％以下、好ましくは０．０１重量％以上１．０重量％以下である。
The oil-liquid layer component in the two-phase liquid oral composition of the present invention can contain any oil-soluble component such as a fragrance, an oil-soluble colorant, an oil-soluble medicinal component and the like.
Examples of the fragrance include menthol, anethole, eugenol, camphor, citronellol, 1,8-cineole, cinnamaldehyde, thymol, vanillyl butyl ether, vanillin, phenethyl alcohol, heliotropin, borneol, methyl salicylate, p-menthane-3 , 8-diol, menthyl lactone, linalool, limonene, osimene, n-decyl alcohol, α-terpineol, methyl acetate, citronellyl acetate, methyl eugenol, linalool, ethyl linalool, crocodile, spearmint oil, peppermint oil, lemon oil, Orange oil, grapefruit oil, bergamot oil, lime oil, sage oil, thyme oil, rosemary oil, laurel oil, cinnamon oil, pimento oil, perilla oil, eucalyptus oil, etc. It is below. In addition, flavor flavors such as apple flavor, apricot flavor, strawberry flavor, cherry flavor, pineapple flavor, peach flavor, banana flavor and melon flavor can be blended. Furthermore, it is also possible to mix | blend fragrance | flavor solvents, such as ethanol and propylene glycol. In addition, although these fragrance | flavors may be used independently or may use 2 or more types together, the compounding quantity of the range which does not impair the effect of invention is 0.01 to 20 weight% normally with respect to an oil-liquid layer component. % By weight or less, preferably 0.1% by weight or more and 15% by weight or less.
As the oil-soluble colorant, for example, one or more of red 215, red 225, yellow 201, yellow 204, green 202, purple 201 and the like can be appropriately selected. The blending amount in a range not impairing the effect is usually preferably 0.001% by weight or less based on the two-phase liquid oral composition.
Examples of the oil-soluble medicinal component include triclosan, isopropylmethylphenol, hinokitiol, tocopherol, tocotrienol, tocopherol acetate, tocopherol nicotinate, ibuprofen and the like. In addition, although these medicinal components may be used alone or in combination of two or more, the blending amount within a range not impairing the effects of the invention is usually 0.001 with respect to the two-phase liquid oral composition. % By weight or more and 10% by weight or less, preferably 0.01% by weight or more and 1.0% by weight or less.
本発明の２相液体口腔用組成物は、さらに、成分（Ｄ）として四級アンモニウム塩を配合することが好ましい。四級アンモニウム塩を配合することにより、当該化合物が有する抗菌性により、本発明の２相液体口腔用組成物の保存安定性を向上させることができる。
成分（Ｄ）の四級アンモニウム塩としては、例えば、塩化ベンザルコニウム、塩化セチルピリジニウム、塩化ベンゼトニウムなどが挙げられ、これらの１種または２種以上を併用することができる。この中でも、塩化セチルピリジニウムの配合が好ましい。
これら成分（Ｄ）の四級アンモニウム塩は、カチオン性界面活性剤として公知の化合物群であるため、油液層と水層の２相の分離性においては、成分（Ｄ）の配合は好ましくないものの、四級アンモニウム塩が有する抗菌性を本発明の２相液体口腔用組成物に付与するためには、成分（Ｄ）を配合することが好ましい。一般的に、成分（Ｄ）の四級アンモニウム塩の配合は、均一な分散性を促進し２相への分離性を阻害すると考えられるが、本発明の２相液体口腔用組成物においては、成分（Ｄ）の四級アンモニウム塩を配合しても分離性に影響がないことが、後述する試験データより明らかとなった。本発明の２相液体口腔用組成物に成分（Ｄ）の四級アンモニウム塩を配合する場合には、油液層と水層の２相の分離性と抗菌性の両方の効果を得るために、２相液体口腔用組成物全体の０．００１重量％以上０．１重量％以下の範囲で配合することが好ましく、０．００５重量％以上０．０５重量％以下の範囲で配合することがより好ましい。
The two-phase liquid oral composition of the present invention preferably further contains a quaternary ammonium salt as the component (D). By mix | blending a quaternary ammonium salt, the storage stability of the two-phase liquid oral cavity composition of this invention can be improved with the antibacterial property which the said compound has.
Examples of the quaternary ammonium salt of component (D) include benzalkonium chloride, cetylpyridinium chloride, benzethonium chloride, and the like, and one or more of these can be used in combination. Among these, the combination of cetylpyridinium chloride is preferable.
Since the quaternary ammonium salts of these components (D) are a group of compounds known as cationic surfactants, the mixing of the components (D) is not preferable in the separability of the two phases of the oil liquid layer and the aqueous layer. However, in order to impart the antibacterial property of the quaternary ammonium salt to the two-phase liquid oral composition of the present invention, it is preferable to add the component (D). In general, the combination of the quaternary ammonium salt of component (D) is considered to promote uniform dispersibility and inhibit separation into two phases, but in the two-phase liquid oral composition of the present invention, It became clear from the test data mentioned later that even if the quaternary ammonium salt of component (D) was added, the separability was not affected. In the case where the quaternary ammonium salt of the component (D) is blended in the two-phase liquid oral composition of the present invention, in order to obtain both the separability and antibacterial effects of the two phases of the oil liquid layer and the water layer. It is preferable to mix in the range of 0.001% by weight or more and 0.1% by weight or less of the entire two-phase liquid oral composition, and in the range of 0.005% by weight or more and 0.05% by weight or less. More preferred.
本発明の２相液体口腔用組成物は、さらに、成分（Ｅ）としてアルコール化合物を配合することが好ましい。
成分（Ｅ）のアルコール化合物としては、ソルビット、キシリット、マルチトール、エリスリトール、スクラロースなどの糖アルコールや、グリセリン、プロピレングリコール、ポリエチレングリコール、ヘキシレングリコール、ブチレングリコールなどの多価アルコールを配合することが可能であり、さらに、エタノールなどの炭素数が１〜４の低級アルコールを、成分（Ｃ）の水とともに溶剤として配合することも可能である。成分（Ｅ）のアルコール化合物の配合は、一般的には、均一な分散性を促進し２相への分離性を阻害すると考えられるが、本発明の２相液体口腔用組成物においては、成分（Ｅ）のアルコール化合物を配合しても分離性に影響がなく、分離後の清澄性や美観に優れることも特徴の１つである。特に、エタノールは、本発明の２相液体口腔用組成物を洗口液として使用する場合において、さっぱりとした使用感を付与するために好適である。
成分（Ｅ）のアルコール化合物は単独で用いても２種以上を併用してもよく、その配合量は、２相液体口腔用組成物に対して５重量％以上３０重量％以下が好ましく、１０重量％以上２５重量％以下がより好ましい。
The two-phase liquid oral composition of the present invention preferably further contains an alcohol compound as the component (E).
As the alcohol compound of component (E), a sugar alcohol such as sorbit, xylit, maltitol, erythritol, sucralose, or a polyhydric alcohol such as glycerin, propylene glycol, polyethylene glycol, hexylene glycol, or butylene glycol may be blended. Furthermore, it is also possible to mix | blend a C1-C4 lower alcohol, such as ethanol, with a component (C) water as a solvent. The compounding of the alcohol compound of component (E) is generally considered to promote uniform dispersibility and inhibit separation into two phases, but in the two-phase liquid oral composition of the present invention, the component Even if the alcohol compound (E) is blended, there is no influence on the separability, and it is also one of the features that it is excellent in clarity and aesthetics after separation. In particular, ethanol is suitable for providing a refreshing feeling when the two-phase liquid oral composition of the present invention is used as a mouthwash.
The alcohol compound of component (E) may be used alone or in combination of two or more, and the blending amount is preferably 5% by weight or more and 30% by weight or less with respect to the two-phase liquid oral composition. More preferably, it is more than 25% by weight.
本発明の２相液体口腔用組成物の水層には、成分（Ｃ）の水、さらに成分（Ｄ）の四級アンモニウム塩、成分（Ｅ）のアルコール化合物に加え、その他の公知の水溶性成分を必要に応じて配合することができ、例えば、粘度調整剤、矯味剤、着色剤、ｐＨ調整剤などが挙げられる。
粘度調整剤としては、カルボキシメチルセルロースナトリウム、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などのセルロース誘導体や、アルギン酸ナトリウムなどのアルカリ金属アルギネート、アルギン酸プロピレングリコールエステル、キサンタンガム、トラガントガム、カラヤガム、アラビヤガム、カラギーナンなどのガム類、ポリビニルアルコール、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などの合成粘結剤などが挙げられ、これらの１種または２種以上を配合することができる。これらの配合量は、２相液体口腔用組成物全体に対して０．００１重量％以上１．０重量％以下が好ましく、０．０５重量％以上０．５重量％以下がより好ましい。
In the aqueous layer of the two-phase liquid oral composition of the present invention, water of component (C), quaternary ammonium salt of component (D), alcohol compound of component (E), and other known water-soluble substances A component can be mix | blended as needed, for example, a viscosity modifier, a corrigent, a coloring agent, a pH adjuster etc. are mentioned.
Viscosity modifiers include cellulose derivatives such as sodium carboxymethylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, alkali metal alginates such as sodium alginate, propylene glycol alginate, xanthan gum, tragacanth gum, karaya gum, arabiya gum, carrageenan, etc. Examples thereof include synthetic binders such as gums, polyvinyl alcohol, sodium polyacrylate, carboxyvinyl polymer, and polyvinylpyrrolidone, and one or more of these can be blended. These blending amounts are preferably 0.001% by weight or more and 1.0% by weight or less, and more preferably 0.05% by weight or more and 0.5% by weight or less with respect to the whole two-phase liquid oral composition.
矯味剤としては、サッカリンナトリウム、アスパルテーム、ステビアエキスなどの甘味料のほか、上記成分（Ｅ）のアルコール化合物の例示化合物として挙げたソルビット、キシリット、マルチトール、エリスリトール、スクラロースなどの糖アルコールも使用することができるが、発明の効果を損なわない範囲の配合量は、通常、２相液体口腔用組成物に対して０．００１重量％以上１．０重量％以下が好ましく、０．０５重量％以上０．５重量％以下がより好ましい。
着色剤としては、赤色２号、赤色３号、赤色１０２号、赤色１０６号、黄色４号、黄色５号、橙色２０５号、青色１号、緑色３号、緑色２０１号などの水溶液色素が挙げられるが、発明の効果を損なわない範囲の配合量は、通常、２相液体口腔用組成物に対して０．００１重量％以下が好ましい。
本発明の２相液体口腔用組成物は、２５℃におけるｐＨが６．０〜８．５の範囲に調整されることが好ましく、そのために、リン酸、リンゴ酸、酒石酸、クエン酸やこれらの水溶性塩をｐＨ調整剤として使用することが好ましく、中でも、リン酸三ナトリウム、リン酸二水素ナトリウムとリン酸一水素ナトリウムを組み合わせたものを配合することが好適である。
なお、本発明の２相液体口腔用組成物は、均一なエマルション状態から油液層と水層の２相への速やかな分離性を得るためには、成分（Ｄ）以外の界面活性剤を含有しないことが好ましい。
As a corrigent, in addition to sweeteners such as saccharin sodium, aspartame, stevia extract, etc., sugar alcohols such as sorbitol, xylit, maltitol, erythritol, sucralose, etc. mentioned as examples of alcohol compounds of the above component (E) should be used. However, the blending amount within the range not impairing the effects of the invention is usually preferably 0.001% by weight or more and 1.0% by weight or less, and 0.05% by weight or more and 0% by weight based on the two-phase liquid oral composition. More preferable is 5% by weight or less.
Examples of the colorant include aqueous dyes such as Red No. 2, Red No. 3, Red No. 102, Red No. 106, Yellow No. 4, Yellow No. 5, Orange No. 205, Blue No. 1, Green No. 3, and Green No. 201. However, the blending amount in a range not impairing the effects of the invention is usually preferably 0.001% by weight or less with respect to the two-phase liquid oral composition.
The two-phase liquid oral composition of the present invention preferably has a pH adjusted to a range of 6.0 to 8.5 at 25 ° C. For that purpose, phosphoric acid, malic acid, tartaric acid, citric acid and these It is preferable to use a water-soluble salt as a pH adjuster, and among them, it is preferable to mix trisodium phosphate, a combination of sodium dihydrogen phosphate and sodium monohydrogen phosphate.
In addition, the two-phase liquid oral composition of the present invention contains a surfactant other than the component (D) in order to obtain rapid separation from a uniform emulsion state into two phases of an oil liquid layer and an aqueous layer. It is preferable not to contain.
本発明の２相液体口腔用組成物における、油液層の水層に対する配合比率は、重量比で０．０１以上１０．０以下であることが好ましい。本発明の２相液体口腔用組成物を洗口液として使用する場合には、使用時の均一な分散性と使用後の分離性と清澄性を得て、かつ、歯の汚れ、特に油汚れに対する洗浄効果を得るために、油液層の水層に対する配合比率の上限を５．０以下とすることがより好ましく、１．０以下とすることがさらに好ましい。
本発明の２相液体口腔用組成物からなる洗口液は、静置時には油液層と水層との２相に分離しているが、使用するときに軽く振とうすることで、均一なエマルション状態が得られる。この均一なエマルション状態は一定時間保持されるので、この間に口に含み洗口することができる。使用後は静置することにより、速やかに２相に分離し清澄性が得られ、美観に優れた洗口液となる。また、２相に分離した洗口液は、再度振とうすることにより均一なエマルション状態となるため、これを何度も繰り返して使用することができる。
The blending ratio of the oil liquid layer to the water layer in the two-phase liquid oral composition of the present invention is preferably 0.01 or more and 10.0 or less by weight. When the two-phase liquid oral composition of the present invention is used as a mouthwash, uniform dispersibility at the time of use, separability and clarity after use are obtained, and tooth dirt, especially oil dirt In order to obtain a cleaning effect on the water layer, the upper limit of the blending ratio of the oil liquid layer to the water layer is more preferably 5.0 or less, and further preferably 1.0 or less.
The mouthwash composed of the two-phase liquid oral cavity composition of the present invention is separated into two phases of an oil liquid layer and an aqueous layer at the time of standing, but it is uniform by shaking lightly when used. An emulsion state is obtained. Since this uniform emulsion state is maintained for a certain period of time, it can be included in the mouth and rinsed during this time. After use, it is allowed to stand still to quickly separate into two phases to obtain clarity, resulting in a mouthwash with excellent aesthetics. Moreover, since the mouthwash liquid separated into two phases becomes a uniform emulsion state by shaking again, it can be used repeatedly.
以下、製剤例及び試験例等により、本発明をさらに詳しく説明するが、本発明は、これらの例に限定されるものではない。
まず、本発明の油剤（Ａ）、油剤（Ｂ）および（Ｃ）水を含有する組成物の試験検体例を示す。なお、実施例において、特に明記しない限り、部は重量部を意味する。
Hereinafter, the present invention will be described in more detail with reference to formulation examples and test examples, but the present invention is not limited to these examples.
First, an example of a test specimen of a composition containing the oil (A), the oil (B) and (C) water of the present invention is shown. In the examples, unless otherwise specified, parts means parts by weight.
＜分離性と清澄性の評価試験＞
（１）試験検体
実施例１
モレスコホワイトＰ−２００を１４．０重量部、ミリスチン酸オクチルドデシルを１．０重量部、エタノールを５．０重量部、グリセリン１０重量部および精製水を使用して、全体量を１００重量部として２相液体口腔用組成物を調製した。
実施例２〜９は下記表１に、比較例１〜５は下記表２に示した配合で、実施例１と同様にして２相液体口腔用組成物を調製し、それぞれの試験検体を得た。
なお、以下の実施例および比較例の２相液体口腔用組成物の調製に際し、以下に示すものを使用した。
流動パラフィン１：（株）モレスコ社製モレスコホワイトＰ−２００
ＬｏｇＰ：１０．９５〜１１．０１
４０℃における動粘度：約３９．３ｍｍ２／ｓ
流動パラフィン２：（株）モレスコ社製モレスコホワイトＰ−４０
ＬｏｇＰ：８．６３〜９．０１
４０℃における動粘度：約４．３ｍｍ２／ｓ
ミリスチン酸オクチルドデシル：高級アルコール工業（株）社製
トリ（カプリル／カプリン酸）グリセリル：太陽化学（株）社製
ミリスチン酸イソプロピル：日光ケミカルズ（株）社製
アジピン酸ジイソプロピル：日光ケミカルズ（株）社製
塩化セチルピリジニウム・一水和物：メルク（株）社製
<Evaluation test for separability and clarity>
(1) Test sample example 1
Using 14.0 parts by weight of Moresco White P-200, 1.0 part by weight of octyldodecyl myristate, 5.0 parts by weight of ethanol, 10 parts by weight of glycerin and purified water, the total amount is 100 parts by weight. A two-phase liquid oral composition was prepared.
Examples 2 to 9 are the compositions shown in Table 1 below, and Comparative Examples 1 to 5 are the compositions shown in Table 2 below. A two-phase liquid oral composition is prepared in the same manner as in Example 1, and each test specimen is obtained. It was.
In addition, what was shown below was used in the case of preparation of the two-phase liquid oral cavity composition of a following example and a comparative example.
Liquid paraffin 1: Moresco White P-200 manufactured by Moresco
LogP: 10.95-11.01
Kinematic viscosity at 40 ° C .: about 39.3 mm 2 / s
Liquid paraffin 2: Moresco White P-40 manufactured by Moresco
LogP: 8.63-9.01
Kinematic viscosity at 40 ° C .: about 4.3 mm 2 / s
Octyldodecyl myristate: High Alcohol Industry Co., Ltd. Tri (Capryl / Capric Acid) Glyceryl: Taiyo Kagaku Co., Ltd. Isopropyl myristate: Nikko Chemicals Co., Ltd. Diisopropyl Adipate: Nikko Chemicals Co., Ltd. Cetylpyridinium chloride monohydrate manufactured by Merck Ltd.
（２）分離性の評価試験方法
１００ｍＬ容量のサンプル瓶にそれぞれの試験検体１００ｇを入れ、１秒間に２回の速さで上下に２０回振とうした後の均一な分散性を確認し、２相の分離が視認できるまでの時間（秒）を測定した。
本発明の２相液体口腔用組成物においては、１５〜３０秒以内に２相分離が視認できたものを分離性が良好であると評価した。
(2) Separation evaluation test method 100 g of each test specimen is put in a 100 mL capacity sample bottle, and after confirming uniform dispersibility after shaking 20 times up and down at a speed of 2 times per second, 2 The time (seconds) until phase separation was visible was measured.
In the two-phase liquid oral cavity composition of the present invention, those in which two-phase separation could be visually recognized within 15 to 30 seconds were evaluated as having good separability.
（３）清澄性の評価試験方法
上記（２）分離性の評価試験で２相分離を視認確認したものを、３時間静置し、油液層および水層の清澄性を下記の評価基準により５段階で評価した。
［評価基準］
「◎」：油液層および水層ともに完全に透明である。
「〇」：油液層および水層ともに完全な透明ではないが清澄である。
「●」：油液層および水層ともに「〇」に準じて清澄である。
「△」：油液層および水層ともに少し濁っている。
「×」：油液層および水層ともに完全に濁っている。
(3) Clarity evaluation test method The two-phase separation visually confirmed in the above (2) separation evaluation test is allowed to stand for 3 hours, and the clarification of the oil liquid layer and the water layer is determined according to the following evaluation criteria. Evaluation was made in 5 stages.
[Evaluation criteria]
“◎”: The oil liquid layer and the water layer are completely transparent.
“◯”: The oil liquid layer and the water layer are not completely transparent but clear.
“●”: Both the oil liquid layer and the water layer are clear according to “◯”.
“Δ”: The oil liquid layer and the water layer are slightly cloudy.
“X”: The oil liquid layer and the aqueous layer are completely turbid.
（４）油残り感と油臭さの評価試験方法
１００ｍＬ容量のサンプル瓶にそれぞれの試験検体１００ｇを入れ、１秒間に２回の速さで上下に２０回振とうした後の均一な分散性を確認し、２０ｍＬを口に含み２５秒間すすいでから吐き出した。
「口腔内の油残り感」評価は、パネラー８名が「油残り感が全くない(４点)」、「油残り感がほとんどない(３点)」、「やや油残り感がある(２点)」、「油残り感がある(１点)」、「油残り感が強い(０点)」の５段階で点数評価した。
「口に含んだ際に感じる油臭さ」評価は、パネラー８名が「油臭さが全くない(４点)」、「油臭さがほとんどない(３点)」、「やや油臭さがある(２点)」、「油臭さがある(１点)」、「油臭さが強い(０点)」の５段階で点数評価した。
それぞれの評価点数から平均値を求め、以下の判定基準で判定した結果を表３に示す。
［評価基準］
「◎」：平均点３．５点以上。
「〇」：平均点２．５点以上、３．５点未満。
「●」：平均点１．５点以上、２．５点未満。
「△」：平均点０．５点以上、１．５点未満。
「×」：平均点０．５点未満。
(4) Evaluation test method for feeling of oil residue and oil odor Uniform dispersibility after putting 100 g of each test specimen into a 100 mL capacity sample bottle and shaking 20 times up and down at a speed of 2 times per second Then, 20 mL was contained in the mouth, rinsed for 25 seconds, and then exhaled.
In the evaluation of “feeling of oil residue in the oral cavity”, the panelists evaluated “no oil residue feeling (4 points)”, “no oil residue feeling (3 points)”, “slight oil residue feeling (2 The score was evaluated in five stages: “point)”, “feeling oil residue (1 point)”, and “strong oil feeling (0 points)”.
“Oil odor felt when put in the mouth” was evaluated by eight panelists, “No oil odor (4 points)”, “Little oil odor (3 points)”, “Slight oil odor” The score was evaluated in five levels: “There is (2 points)”, “There is an oily odor (1 point)”, and “The oily odor is strong (0 points)”.
Table 3 shows the results obtained by obtaining the average value from the respective evaluation scores and judging according to the following judgment criteria.
[Evaluation criteria]
“◎”: Average score of 3.5 or more.
“◯”: An average score of 2.5 or more and less than 3.5.
“●”: An average score of 1.5 points or more and less than 2.5 points.
“Δ”: An average score of 0.5 or more and less than 1.5.
“×”: Average score of less than 0.5.
上記（２）〜（４）の評価試験結果を、まとめ表３に示した。
表３の評価試験の結果より、本発明の２相液体口腔用組成物の具体例である実施例１〜９は、１５〜３０秒以内に油液層と水層の２相に分離する分離性と、３時間後の清澄性ともに優れた組成物であることが明らかとなった。さらに、実施例１〜９の２相液体口腔用組成物は、洗口液として使用した場合においても、油残り感や油臭さの評価が良好であり、使用感に優れることが明らかとなった。
さらに詳しく説明すると、実施例１〜３と実施例４〜６との比較により、流動パラフィンとミリスチン酸オクチルドデシルとの組み合わせは、流動パラフィンとトリ（カプリル／カプリン酸）グリセリルとの組み合わせに比べ、分離性と清澄性において、より優れた組み合わせであることが明らかとなった。また、実施例２と実施例７、８との比較により、１−オクタノール／水計算分配係数が特定範囲である流動パラフィンを採用することや、成分（Ｅ）としてアルコール化合物を配合しても、分離性や清澄性を損なうことなく、洗口液として高い性能が得られることも確認できた。さらに、実施例９の結果より、成分（Ｄ）四級アンモニウム塩を配合しても、分離性や清澄性を損なうことなく、洗口液に抗菌性を付与できることが明らかとなった。
一方、比較例１〜５は、油残り感や油臭さの評価の何れかまたは両方が、最低評価「×」であり、洗口液として利用することはできない組成であることが確認された。
これらの結果より、特定の油剤（Ａ）および（Ｂ）を組み合わせ、（Ｃ）水を配合することによる本発明の２相液体口腔用組成物は、分離性と清澄性に優れた組成であり、洗口液として使用する場合には、油剤（Ａ）および（Ｂ）による油残り感や油臭さもないため、好適な組成であることが明らかとなった。さらに、成分（Ｄ）の四級アンモニウム塩を配合しても分離性と清澄性を維持したまま、洗口液に抗菌性を付与できることが確認され、成分（Ｅ）としてアルコール化合物を配合しても、分離性と清澄性を損なうことなく使用感を高めることが明らかとなった。
本発明の２相液体口腔用組成物が奏するこれらの効果は、本発明者が多くの実験を行い初めて確認した格別顕著な効果である。
From the results of the evaluation test of Table 3, Examples 1 to 9, which are specific examples of the two-phase liquid oral composition of the present invention, are separated into two phases of an oil liquid layer and an aqueous layer within 15 to 30 seconds. It was revealed that the composition was excellent in both properties and clarity after 3 hours. Furthermore, even when the two-phase liquid oral compositions of Examples 1 to 9 are used as mouthwashes, it is clear that the feeling of oil residue and the oily odor are good and the feeling of use is excellent. It was.
More specifically, by comparing Examples 1 to 3 and Examples 4 to 6, the combination of liquid paraffin and octyldodecyl myristate is compared to the combination of liquid paraffin and tri (capryl / capric) glyceryl, It became clear that it was a better combination in terms of separation and clarity. In addition, by comparing Example 2 with Examples 7 and 8, adopting liquid paraffin having a specific range of 1-octanol / water calculated distribution coefficient, or blending an alcohol compound as component (E), It was also confirmed that high performance was obtained as a mouthwash without impairing separability and clarity. Furthermore, from the results of Example 9, it was revealed that even when the component (D) quaternary ammonium salt was added, antibacterial properties could be imparted to the mouthwash without impairing separability and clarity.
On the other hand, in Comparative Examples 1 to 5, it was confirmed that either or both of the evaluation of the feeling of oil residue and the oil odor were the lowest evaluation “x”, and the composition cannot be used as a mouthwash. .
From these results, the two-phase liquid oral composition of the present invention by combining specific oils (A) and (B) and blending (C) water is a composition excellent in separability and clarity. When used as a mouthwash, the oil composition (A) and (B) have no feeling of oil residue and no oily odor. Furthermore, it was confirmed that antibacterial properties can be imparted to the mouthwash while maintaining the separability and clarity even when the quaternary ammonium salt of component (D) is blended, and an alcohol compound is blended as component (E). However, it was revealed that the feeling of use was enhanced without impairing the separability and clarity.
These effects exhibited by the two-phase liquid oral cavity composition of the present invention are exceptionally remarkable effects that the present inventors have confirmed for the first time through many experiments.
＜処方例＞
以下に示す油液層と水層からなる、本発明の２相液体口腔用組成物を調製した。
油液層：モレスコホワイトＰ−２００、ミリスチン酸オクチルドデシル、薬用成分、香料および着色剤
上記油液層における、モレスコホワイトＰ−２００のミリスチン酸オクチルドデシルに対する配合比率は、重量比で約４．０である。
水層：エタノール、グリセリン、塩化セチルピリジニウム、粘度調整剤、ｐＨ調整剤、矯味剤、着色剤および精製水
この処方例における、油液層の水層に対する配合比率は、重量比で約０．１８である。
<Prescription example>
A two-phase liquid oral composition of the present invention comprising an oil liquid layer and an aqueous layer shown below was prepared.
Oil liquid layer: Moresco white P-200, octyldodecyl myristate, medicinal ingredients, fragrance and colorant The blending ratio of Moresco white P-200 to octyldodecyl myristate in the oil liquid layer is about 4 by weight. .0.
Aqueous layer: ethanol, glycerin, cetylpyridinium chloride, viscosity modifier, pH adjuster, corrigent, colorant and purified water In this formulation example, the blending ratio of the oil-liquid layer to the aqueous layer is about 0.18 by weight. It is.
上記処方例による本発明の２相液体口腔用組成物を、上述の（２）分離性や（３）３時間後の清澄性の評価を行ったところ、３０秒以内に２相分離が視認でき分離性に優れることが、また、３時間静置したものは油液層および水層ともに完全に透明であり、清澄性にも優れることが明らかとなった。
さらに、上述の（４）油残り感や油臭さの評価を行ったところ、処方例による本発明の２相液体口腔用組成物を洗口液とすると、歯の汚れ、特に油汚れに対する高い洗浄効果を期待できることや、油液層による油残り感や油臭さもないことから、好適な処方であることが確認された。
When the two-phase liquid oral composition of the present invention according to the above formulation example was evaluated for the above-mentioned (2) separability and (3) clarity after 3 hours, two-phase separation could be visually recognized within 30 seconds. It was revealed that it was excellent in separability, and the oil liquid layer and the aqueous layer that were allowed to stand for 3 hours were completely transparent and excellent in clarity.
Furthermore, when (4) the above-mentioned feeling of oil residue and oil odor were evaluated, when the two-phase liquid oral composition of the present invention according to the formulation example was used as a mouthwash, it was highly resistant to tooth stains, particularly oil stains. From the fact that a cleaning effect can be expected and there is no feeling of oil residue or oil odor due to the oil liquid layer, it was confirmed that this was a suitable formulation.
本発明の２相液体口腔用組成物は、特定の油剤（Ａ）および（Ｂ）を組み合わせ、（Ｃ）水と配合することにより、振とうにより均一なエマルション状態が一定時間保持され、その後速やかに２相に分離し清澄性が得られる。この速やかな分離性により、油液層に含有される油剤、特に、油剤（Ｂ）が水により分解する恐れが少なく、油剤（Ａ）および（Ｂ）において油溶性薬用成分を高濃度配合した処方においても、製剤安定性に優れた処方を得ることが可能である。
特に、本発明の２相液体口腔用組成物を洗口液として使用すると、高濃度に配合した油剤（Ａ）および（Ｂ）により、歯の汚れ、特に油汚れに対する高い洗浄効果が得られるほか、油剤による歯牙のコーティングや殺菌効果、口腔内の保湿効果を得ることができる。さらに、成分（Ｄ）の四級アンモニウム塩を配合することにより、四級アンモニウム塩が有する抗菌効果も併せ得ることができ、さらに、成分（Ｅ）のアルコール化合物を配合することにより、さっぱりとした使用感を高めることができるため好適である。
The two-phase liquid oral cavity composition of the present invention combines a specific oil agent (A) and (B) and is blended with (C) water, whereby a uniform emulsion state is maintained for a certain period of time by shaking, and then promptly. To be separated into two phases to obtain clarity. Due to this rapid separability, the oil contained in the oil liquid layer, in particular, the oil (B) is less likely to be decomposed by water, and is formulated with a high concentration of oil-soluble medicinal ingredients in the oils (A) and (B). In this case, it is possible to obtain a formulation with excellent drug product stability.
In particular, when the two-phase liquid oral composition of the present invention is used as a mouthwash, the oils (A) and (B) blended at a high concentration can provide a high cleaning effect on tooth stains, particularly oil stains. It is possible to obtain tooth coating, bactericidal effect, and moisturizing effect in the oral cavity. Furthermore, the antibacterial effect which a quaternary ammonium salt has can be acquired by mix | blending the quaternary ammonium salt of a component (D), and also it was refreshing by mix | blending the alcohol compound of a component (E). This is preferable because the feeling of use can be enhanced.
Claims (5)
前記油剤（Ａ）は、流動パラフィンであり、
前記油剤（Ｂ）は、ミリスチン酸オクチルドデシルおよび／またはトリ（カプリル／カプリン酸）グリセリルであることを特徴とする、
２相液体口腔用組成物。 Oil agent (A), oil agent (B) and (C) containing water,
The oil agent (A) is liquid paraffin,
The oil (B) is octyldodecyl myristate and / or glyceryl tri (capryl / caprate),
Two-phase liquid oral composition.
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| WO2012124533A1 (en) * | 2011-03-11 | 2012-09-20 | ライオン株式会社 | Liquid oral composition with two separate layers |
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| WO2012124533A1 (en) * | 2011-03-11 | 2012-09-20 | ライオン株式会社 | Liquid oral composition with two separate layers |
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