JP2020100603A - 外用組成物 - Google Patents
外用組成物 Download PDFInfo
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- JP2020100603A JP2020100603A JP2018241393A JP2018241393A JP2020100603A JP 2020100603 A JP2020100603 A JP 2020100603A JP 2018241393 A JP2018241393 A JP 2018241393A JP 2018241393 A JP2018241393 A JP 2018241393A JP 2020100603 A JP2020100603 A JP 2020100603A
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Abstract
Description
項1. (A)尿素、(B)増粘剤、及び(C)固形炭化水素油を含有する、外用組成物。
項2. 前記(C)成分がワセリンである、項1に記載の外用組成物。
項3. 前記(B)成分が(メタ)アクリル酸系高分子である、項1に記載の外用組成物。
項4. 前記(A)成分の含有量が5〜40重量%である、項1〜3のいずれかに記載の外用組成物。
項5. 前記(C)成分の含有量が0.01〜20重量%である、項1〜4のいずれかに記載の外用組成物。
項6. 前記(A)成分1重量当たりの前記(C)成分の含有量が0.01〜1重量部である、項1〜5のいずれかに記載の外用組成物。
項7. 乳化組成物である、項1に記載の外用組成物。
項8. (A)尿素及び(B)増粘剤を含有する外用組成物の粘度低下を抑制する方法であって、
外用組成物に、前記(A)成分及び(B)成分と共に、(C)固形炭化水素油を配合する、粘度低下抑制方法。
本発明の外用組成物は、(A)尿素(以下、「(A)成分」とも記載する。)、(B)増粘剤(以下、「(B)成分」とも記載する。)、(C)固形炭化水素油(以下、「(C)成分」とも記載する。)を含有することを特徴とする。以下、本発明の外用組成物について詳述する。
本発明の外用組成物は、(A)成分として尿素を含有する。尿素は、水素結合による皮膚角質の水分保持作用、及びタンパク質変性により不要な角質を除去する角質溶解作用を有する成分として公知の成分である。
本発明の外用組成物は、(B)成分として増粘剤を含有する。増粘剤としては、化粧料や外用医薬品等に通常用いられるものであればよい。本発明において使用される増粘剤の好適な例としては、水溶性増粘剤が挙げられる。水溶性増粘剤としては、例えば、(メタ)アクリル酸系高分子、セルロースエーテル系高分子、ビニル系高分子、多糖類等が挙げられる。
本発明の外用組成物は、(C)成分として固形炭化水素油を含有する。固形炭化水素油は尿素及び増粘剤を含有する外用組成物に配合されることで、優れた粘度低下抑制効果を発揮する。
本発明の外用組成物は、水(以下、「(D)成分」とも記載する)を含有することができる。尿素及び増粘剤を含有する外用組成物は、水存在下において粘度低下が顕著であるが、本発明の外用組成物によると、水を含んでいても、効果的に粘度低下を抑制することができる。
本発明の外用組成物は、さらに、上記(C)成分以外の油分(以下、「(E)成分」とも記載する)を含有することができる。(E)成分は、製剤形態等に応じて適宜使用することができ、例えば、本発明の外用組成物が乳化組成物である場合の油相として使用される。
液状油とは、25℃において液状の形態を保つ油である。本発明で使用される液状油としては、化粧料や外用医薬品等に通常用いられるものであればよく、例えば、アボガド油、ツバキ油、マカデミアナッツ油、オリーブ油、ホホバ油等の植物油;オレイン酸、イソステアリン酸等の脂肪酸;エチルヘキサン酸セチル、パルミチン酸エチルヘキシル、ミリスチン酸オクチルドデシル、ジエチルヘキサン酸ネオペンチルグリコール、トリ2−エチルへキサン酸グリセリル、オレイン酸オクチルドデシル、ミリスチン酸イソプロピル、トリイソステアリン酸グリセリル、ジバラメトキシケイヒ酸−モノエチルへキサン酸グリセリル等のエステル油;ジメチルポリシロキサン、メチルハイドロジエンポリシロキサン、メチルフェニルポリシロキサン、オクタメチルシクロテトラシロキサン等のシリコン油;流動パラフィン、スクワレン、スクワラン等の液状炭化水素油;ラウリルアルコール等の高級アルコール等が挙げられる。
炭化水素以外の固形油とは、25℃において固形の形態を保つ炭化水素以外の油である。本発明で使用される炭化水素以外の固形油としては、通常化粧料や外用医薬品等に用いられるものであればよく、例えば、キャンデリラロウ、コメヌカロウ、ミツロウ、綿ロウ、カルナウバロウ、ラノリン、セラックロウ等のロウ類;ラウリン酸、ミリスチン酸、パルミチン酸、ステアリン酸、ベヘニン酸、12−ヒドロキシステアリン酸、ウンデシレン酸等の高級脂肪酸;ミリスチン酸ミリスチル、ミリスチン酸セチル、ステアリン酸ステアリル、ステアリン酸セチル、パルミチン酸セチル、ステアリン酸コレステリル、オレイン酸コレステリル、パルミチン酸デキストリン、ステアリン酸イヌリン、水素添加ホホバ油等のエステル油;セタノール、ステアリルアルコール、ベヘニルアルコール、ミリスチルアルコール、セトステアリルアルコール、オレイルアルコール、モノステアリルグリセリンエーテル(バチルアルコール)等の直鎖又は分岐高級アルコール;シリコーンワックス等が挙げられる。
本発明の外用組成物は、さらに、界面活性剤(以下、「(F)成分」とも記載する)を含む。(F)成分は製剤形態等に応じて適宜使用することができ、例えば、本発明の外用組成物が乳化組成物である場合は、乳化状態とするために使用される。界面活性剤としては、薬学的又は香粧学的に許容されることを限度として特に制限されないが、例えば、ノニオン性界面活性剤、アニオン性界面活性剤、カチオン性界面活性剤、両性界面活性剤等が挙げられ、好ましくはノニオン性界面活性剤が挙げられる。
本発明の外用組成物は、前述する成分の他に、必要に応じて、通常使用される他の添加剤が含まれていてもよい。このような添加剤としては、例えば、pH調節剤、多価アルコール、緩衝剤、可溶化剤、キレート剤、防腐剤、保存剤、酸化防止剤、安定化剤、香料、着色料等が挙げられる。
本発明の外用組成物の製剤形態については、ある程度の粘性があれば特に制限されず、例えば、油性ゲル状組成物、乳化組成物等が挙げられる。尿素及び増粘剤を含有する外用組成物は、水存在下において粘度低下抑制が顕著であるが、本発明の外用組成物によると、水を含んでいても、効果的に粘度低下を抑制することができる。このような本発明の効果を鑑みれば、本発明の外用組成物の好ましい製剤形態としては、乳化組成物が挙げられる。本発明の外用組成物が乳化組成物である場合の乳化タイプについては、水中油型又は油中水型のいずれであってもよいが、上記本発明の効果を鑑みれば、好ましい乳化タイプとしては、水の含有量が比較的多い水中油型が挙げられる。
本発明の外用組成物は、製剤形態に応じて、公知の製剤化手法に従って製造することができる。例えば、本発明の外用組成物の製造方法としては、上記(A)〜(C)成分、及び必要に応じて配合される(D)〜(F)成分、上記他の薬効成分、添加剤等を所望量混合することにより調製される。本発明の外用組成物が乳化組成物である場合は、乳化タイプに応じて、公知の乳化製剤の製剤化手法に従って製造することができる。例えば、乳化組成物である場合の本発明の外用組成物の製造方法としては、含有させる成分を水溶性成分と油性成分に分けて、水溶性成分を含む水相と、油性成分を含む油相とを調製し、これらを公知の手法に従って乳化させる方法が挙げられる。
上述するように、固形炭化水素油は尿素及び増粘剤を含有する外用組成物に配合されることで、優れた粘度低下抑制効果を発揮する。従って、本発明は、更に、(A)尿素及び(B)増粘剤を含有する外用組成物の粘度低下を抑制する方法であって、外用組成物に、前記(A)成分及び(B)成分と共に、(C)固形炭化水素油を配合する、粘度低下抑制方法を提供する。本発明の粘度低下抑制方法において、粘度低下を抑制するとは、尿素及び増粘剤を含有する外用組成物において、固形炭化水素油を含まない場合に比べ、高温保存後における粘度低下率が小さいことをいう。粘度低下抑制は、例えば、外用組成物を50℃で2週間保存した後に、保存前の粘度を100%とした場合の粘度低下率が15%未満、好ましくは5%未満に抑えられていることによって測定することができる。
表1に示す組成の外用組成物を調製した。具体的には、表1中の(I)成分を混合し均一になるまで80℃条件下で撹拌することで油性予製物を得て、別途、(II)成分を混合した後にカルボキシビルポリマーを徐々に添加し均一になるまで撹拌することで水性予製物を得て、油性予製物に水性予製物を添加し均一になるまで混合し、さらに、トリエタノールアミンを添加し均一になるまで撹拌することで、クリーム状の乳化状態の外用組成物を得た。
調製した外用組成物の初期粘度を測定した。具体的には、ブルックフィールドE型粘度計(R/S−CPS PLUS RHEOMETER)でスピンドルNo.RC3−50−1を使用して外用組成物の粘度(初期粘度)を測定した。なお、測定条件は、温度25℃、回転速度1rpmとし、計測開始から1分後の粘度を測定した。例えば実施例3の場合で初期粘度は10150mPa・sであった。外用組成物を50℃条件下で2週間保存し、保存後の外用組成物の粘度を同様に測定した。初期粘度を100%とした場合の保存後における粘度低下率を導出した。粘度低下率を以下の基準に基づいて分類し、粘度低下抑制性を評価した。結果を表1に示す。
◎: 5%未満
○: 5%以上15%未満
△: 15%以上25%未満
×: 25%以上
Claims (8)
- (A)尿素、(B)増粘剤、及び(C)固形炭化水素油を含有する、外用組成物。
- 前記(C)成分がワセリンである、請求項1に記載の外用組成物。
- 前記(B)成分が(メタ)アクリル酸系高分子である、請求項1に記載の外用組成物。
- 前記(A)成分の含有量が5〜40重量%である、請求項1〜3のいずれかに記載の外用組成物。
- 前記(C)成分の含有量が0.01〜20重量%である、請求項1〜4のいずれかに記載の外用組成物。
- 前記(A)成分1重量当たりの前記(C)成分の含有量が0.01〜1重量部である、請求項1〜5のいずれかに記載の外用組成物。
- 乳化組成物である、請求項1に記載の外用組成物。
- (A)尿素及び(B)増粘剤を含有する外用組成物の粘度低下を抑制する方法であって、
外用組成物に、前記(A)成分及び(B)成分と共に、(C)固形炭化水素油を配合する、粘度低下抑制方法。
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