JP6968523B2 - 口腔用又は外用組成物 - Google Patents
口腔用又は外用組成物 Download PDFInfo
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- JP6968523B2 JP6968523B2 JP2016186251A JP2016186251A JP6968523B2 JP 6968523 B2 JP6968523 B2 JP 6968523B2 JP 2016186251 A JP2016186251 A JP 2016186251A JP 2016186251 A JP2016186251 A JP 2016186251A JP 6968523 B2 JP6968523 B2 JP 6968523B2
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- oral
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- chloride
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Description
項1. (A)ハッカ油と、(B)ホスホコリン基含有重合体と、(C)第四級アンモニウム塩と、(D)水とを含有する、口腔用又は外用組成物。
項2. 前記(B)成分が、2−メタクリロイルオキシエチルホスホリルコリン・メタクリル酸ブチル共重合体である、項1に記載の口腔用又は外用組成物。
項3. 前記(C)成分が、塩化セチルピリジニウム、塩化ベンゼトニウム、及び塩化ベンザルコニウムよりなる群から選択される少なくとも1種である、項1又は2に記載の口腔用又は外用組成物。
項4. (A)ハッカ油、(B)ホスホコリン基含有重合体、及び(D)水を含む口腔用又は外用組成物における当該(A)成分の析出を抑制するために使用される析出抑制剤であって、
第四級アンモニウム塩を有効成分とする、析出抑制剤。
項5. (A)ハッカ油、(B)ホスホコリン基含有重合体、及び(D)水を含む口腔用又は外用組成物において、当該(A)成分の析出を抑制する析出抑制方法であって、
口腔用又は外用組成物に、前記(A)成分と前記(B)成分と前記(D)成分共に、(C)第四級アンモニウム塩を配合する、析出抑制方法。
本発明の口腔用又は外用組成物は、ハッカ油(以下、(A)成分と表記することがある)と、ホスホコリン基含有重合体(以下、(B)成分と表記することがある)と、第四級アンモニウム塩(以下、(C)成分と表記することがある)と、水(以下、(D)成分と表記することがある)とを含有することを特徴とする。以下、本発明の口腔用又は外用組成物について詳述する。
本発明の口腔用又は外用組成物は、(A)成分としてハッカ油を含有する。ハッカ油は、ハッカの地上部を水蒸気蒸留して得られる油を冷却し、固形分を除去した精油であり、CAS No.8006−90−4としても知られている公知の成分である。
本発明の口腔用又は外用組成物は、(B)成分として、ホスホコリン基含有重合体を含有する。
本発明の口腔用又は外用組成物は、(C)成分として、第四級アンモニウム塩を含有する。このように第四級アンモニウム塩を含有させることによって、ハッカ油とホスホコリン基含有重合体を共存させて保存した際に生じるハッカ油の析出物の生成を抑制することが可能になる。
本発明の口腔用又は外用組成物は、基剤として水を含有する。前記(A)成分は、(B)成分と水存在下で共存する状態で保存すると、析出を生じる傾向を示すが、本発明の口腔用又は外用組成物によれば、このような(A)成分の析出を効果的に抑制することができる。
本発明の口腔用又は外用組成物は、前述する成分以外に、本発明の効果を損なわない範囲で、口腔用又は外用組成物の製剤形態に応じて、当該技術分野で通常使用される成分を含有していてもよい。このような成分としては、例えば、防腐剤、殺菌剤、抗菌剤、消炎剤、研磨剤、グルコシルトランスフェラーゼ(GTase)阻害剤、プラーク抑制剤、知覚過敏抑制剤、歯石予防剤、歯質強化/再石灰化剤、抗ヒスタミン剤、局所麻酔剤、血行促進剤、増粘剤、湿潤剤、賦形剤、香料、甘味剤、色素、消臭剤、界面活性剤、溶剤、pH調整剤等が挙げられる。
また、本発明の口腔用又は外用組成物のpHについては、口腔内への適用又は経皮適用が許容される範囲で適宜設定すればよいが、例えば、4〜8、好ましくは5〜7.5、更に好ましくは6〜7が挙げられる。ここで、pHとは、25℃の温度条件下で測定される値である。
前述するように、第四級アンモニウム塩は、ハッカ油、ホスホコリン基含有重合体及び水を含む口腔用又は外用組成物において、ハッカ油の析出を抑制することができる。従って、本発明は、更に、ハッカ油、ホスホコリン基含有重合体、及び水を含む口腔用又は外用組成物におけるハッカ油の析出を抑制するために使用される析出抑制剤であって、第四級アンモニウム塩を有効成分とする析出抑制剤を提供する。また、本発明は、ハッカ油、ホスホコリン基含有重合体、及び水を含む口腔用又は外用組成物において、口腔用又は外用組成物に、ハッカ油とホスホコリン基含有重合体と水と共に、第四級アンモニウム塩を配合する、析出抑制方法を提供する。
表1に示す組成の液剤を50℃の温度条件下で調製し、得られた液剤5mLをガラス製スクリュー管瓶(容量6mL)に充填し、遮光条件下で、4℃で3日間静置した。3日間静置後の各液剤の外観を観察し、以下に示す判定基準に従って、析出物の生成の程度を評価した。なお、調製直後の液剤は、いずれも析出物が認められず、澄明な外観であった。
<析出物の生成の程度の判定基準>
◎:析出物は全く認められず、澄明な状態が維持できている。
○:僅かにだけ析出物が生成していたが、全体的に澄明な状態が維持できている。
×:析出物が多く生成しており、澄明な状態が失われている。
××:析出物が著しく多く生成しており、澄明な状態が失われている。
表2に示す組成の練歯磨剤、表3に示す組成の洗口液又は液体歯磨剤、表4に示す組成のマウススプレー、表5に示す組成の口腔用軟膏剤、表6に示す組成の口腔用液剤、表7に示す組成の外用ローション剤、表8に示す組成の外用ジェル剤、表9に示す組成の外用クリーム剤、及び表10に示す組成の外用乳液剤を製造した。なお、表2〜10において、各成分の含有量の単位は、重量%である。得られた各口腔用組成物及び外用組成物については、いずれも保存後に析出物の生成を抑制できていた。
Claims (4)
- (A)ハッカ油と、(B)ホスホコリン基含有重合体と、(C)塩化セチルピリジニウム、塩化ベンゼトニウム、及び塩化ベンザルコニウムよりなる群から選択される少なくとも1種と、(D)水とを含有する、外用組成物。
- 前記(B)成分が、2−メタクリロイルオキシエチルホスホリルコリン・メタクリル酸ブチル共重合体である、請求項1に記載の外用組成物。
- (A)ハッカ油、(B)ホスホコリン基含有重合体、及び(D)水を含む外用組成物における当該(A)成分の析出を抑制するために使用される析出抑制剤であって、
塩化セチルピリジニウム、塩化ベンゼトニウム、及び塩化ベンザルコニウムよりなる群から選択される少なくとも1種を有効成分とする、析出抑制剤。 - (A)ハッカ油、(B)ホスホコリン基含有重合体、及び(D)水を含む外用組成物において、当該(A)成分の析出を抑制する析出抑制方法であって、
外用組成物に、前記(A)成分と前記(B)成分と前記(D)成分と共に、(C)塩化セチルピリジニウム、塩化ベンゼトニウム、及び塩化ベンザルコニウムよりなる群から選択される少なくとも1種を配合する、析出抑制方法。
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