JP2018197203A - 乳化組成物 - Google Patents
乳化組成物 Download PDFInfo
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- JP2018197203A JP2018197203A JP2017101827A JP2017101827A JP2018197203A JP 2018197203 A JP2018197203 A JP 2018197203A JP 2017101827 A JP2017101827 A JP 2017101827A JP 2017101827 A JP2017101827 A JP 2017101827A JP 2018197203 A JP2018197203 A JP 2018197203A
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- Prior art keywords
- oil
- acid
- precipitates
- phase
- component
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- 239000000839 emulsion Substances 0.000 title claims abstract description 38
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- 150000003839 salts Chemical class 0.000 claims abstract description 40
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims abstract description 35
- 238000005191 phase separation Methods 0.000 claims abstract description 34
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- JDLSRXWHEBFHNC-UHFFFAOYSA-N Ufenamate Chemical compound CCCCOC(=O)C1=CC=CC=C1NC1=CC=CC(C(F)(F)F)=C1 JDLSRXWHEBFHNC-UHFFFAOYSA-N 0.000 claims abstract description 28
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Abstract
Description
項1. (A)グリチルレチン酸、グリチルリチン酸、これらの誘導体、及びこれらの塩よりなる群から選択される少なくとも1種と、(B)ウフェナマートと、(C)ジフェンヒドラミン及び/又はその塩と、(D)ウールワックスアルコールを含有する、乳化組成物。
項2. (E)無極性油を含有する、項1に記載の乳化組成物。
項3. 水中油型乳化組成物である、項1又は2に記載の乳化組成物。
項4. 皮膚外用剤である、項1〜3のいずれかに記載の乳化組成物。
項5. (A)グリチルレチン酸、グリチルリチン酸、これらの誘導体、及びこれらの塩よりなる群から選択される少なくとも1種、並びに(B)ウフェナマートを含む乳化組成物において、析出物及び沈殿の生成、並びに油相と水相の相分離を抑制する方法であって、
(A)グリチルレチン酸、グリチルリチン酸、これらの誘導体、及びこれらの塩よりなる群から選択される少なくとも1種、並びに(B)ウフェナマートと共に、(C)ジフェンヒドラミン及び/又はその塩、並びに(D)ウールワックスアルコールを配合する、方法。
本発明の乳化組成物は、グリチルレチン酸、グリチルリチン酸、これらの誘導体、及びこれらの塩よりなる群から選択される少なくとも1種(以下、(A)成分と表記することがある)と、ウフェナマート(以下、(B)成分と表記することがある)と、ジフェンヒドラミン及び/又はその塩(以下、(C)成分と表記することがある)と、ウールワックスアルコール(以下、(D)成分と表記することがある)を含有することを特徴とする。以下、本発明の乳化組成物について詳述する。
本発明の乳化組成物は、グリチルレチン酸、グリチルリチン酸、それらの誘導体、及び/又はそれらの塩を含有する。
本発明の乳化組成物は、ウフェナマートを含有する。ウフェナマートは、脂溶性の非ステロイド性抗炎症薬として公知の薬剤である。
本発明の乳化組成物は、ジフェンヒドラミン及び/又はその塩を含有する。前記(A)成分及び(B)成分を含有する乳化組成物は、析出物や沈殿を生成して不安定化する傾向があるが、本発明の乳化組成物では、ジフェンヒドラミン及び/又はその塩を含有することによって、析出物や沈殿の生成を抑制することが可能になっている。
本発明の乳化組成物は、ウールワックスアルコールを含有する。前記(A)成分及び(B)成分を含有する乳化組成物は、油相と水相が相分離して製剤が不安定化する傾向があるが、本発明の乳化組成物では、ウールワックスアルコールを含有することによって、油相と水相が相分離を抑制することが可能になっている。
本発明の乳化組成物は、25℃で固体の高級アルコールを含有してもよい。25℃で固体の高級アルコールを含有させることによって、油相と水相の相分離の抑制効果を更に向上させることが可能になる。
本発明の乳化組成物は、ポリオキシエチレン硬化ヒマシ油を含有してもよい。ポリオキシエチレン硬化ヒマシ油を含有させることによって、析出物や沈殿の生成を抑制する効果を更に向上させることが可能になる。
本発明の乳化組成物は、油相を形成する成分として、無極性油(以下、(E)成分と表記することもある)が含まれていてもよい。従来技術では、(A)成分及び(B)成分を含む乳化組成物において無極性油を含有させると、析出物や沈殿の生成が顕著になる傾向が現れるが、本発明の乳化組成物では、無極性油を含んでいても、析出物や沈殿の生成を効果的に抑制することができる。
本発明の乳化組成物は、油相を形成する成分として、極性油を含んでいてもよい。本発明の乳化組成物において、前記無極性油を含む場合には、極性油は含まれていなくてもよく、また前記無極性油と極性油を併用してもよい
本発明の乳化組成物は、水相を形成する基材として水を含有する。
本発明の乳化組成物は、乳化状態を安定に形成させるために、前記ポリオキシエチレン硬化ヒマシ油以外の界面活性剤が含まれていてもよい。界面活性剤(ポリオキシエチレン硬化ヒマシ油以外)としては、薬学的に許容されることを限度として特に制限されず、ノニオン性界面活性剤(ポリオキシエチレン硬化ヒマシ油以外)、アニオン性界面活性剤、カチオン性界面活性剤、両性界面活性剤のいずれを使用してもよい。
本発明の乳化組成物は、前述する成分の他に、保湿性等を備えさえるために、必要に応じて、多価アルコールが含まれていてもよい。
本発明の乳化組成物は、前述する成分の他に、所望の粘性等を備えさえるために、必要に応じて、増粘剤が含まれていてもよい。
本発明の乳化組成物は、前述する成分の他に、必要に応じて、皮膚外用剤等に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、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、キレート剤、香料、着色料等が挙げられる。
本発明の乳化組成物の乳化状態については、水中油型又は油中水型のいずれであってもよいが、好ましくは水中油型が挙げられる。
本発明の乳化組成物は、公知の乳化組成物の製造方法に従って製造することができる。本発明の乳化組成物の製造方法として、例えば、以下に示す方法が挙げられる。先ず、(A)成分、(B)成分、(C)成分、(D)成分、無極性油及び/又は極性油、並びに必要に応じて添加される他の親油性成分を混合して油相用組成物を調製する。別途、水、及び必要に応じて添加される他の水溶性成分を混合して水相用組成物を調製する。なお、ポリオキシエチレン硬化ヒマシ油及び/又は界面活性剤(ポリオキシエチレン硬化ヒマシ油以外)を含有させる場合には、これらは、油相用組成物又は水相用組成物のいずれか一方又は双方に添加して混合すればよいが、油相用組成物に添加することが好ましい。次いで、得られた油相用組成物と水相用組成物を混合し、ホモジナイザー等の乳化手法によって乳化させることにより、本発明の乳化組成物が製造される。
本発明は、更に、(A)グリチルレチン酸、グリチルリチン酸、これらの誘導体、及びこれらの塩よりなる群から選択される少なくとも1種、並びに(B)ウフェナマートを含む乳化組成物において、析出物及び沈殿の生成、並びに油相と水相の相分離を抑制する方法であって、(A)グリチルレチン酸、グリチルリチン酸、これらの誘導体、及びこれらの塩よりなる群から選択される少なくとも1種、並びに(B)ウフェナマートと共に、(C)ジフェンヒドラミン及び/又はその塩、並びに(D)ウールワックスアルコールを配合することを特徴とする、析出物及び沈殿の生成、並びに油相と水相の相分離の抑制方法を提供する。
表1に示す組成のクリーム状の水中油型乳化組成物を製造し、沈殿生成の程度、析出物の生成の程度、及び相分離の程度について、評価した。クリーム状の水中油型乳化組成物の製造方法、及び試験方法は、以下の通りである。
まず、表1中の(I)に示す成分の内、(A)成分(グリチルレチン酸又はグリチルリチン酸ジカリウム)以外の成分を所定量計り取り、80℃に加温して混合した。その後、(A)成分を所定量添加して混合し、油相用組成物を調製した。別途、表1中の(II)に示す成分を所定量計り取り、混合して水相用組成物を調製した。水相用組成物を80℃に加温した後に、80℃の油相用組成物を少量ずつ添加し、混合しながら乳化を行った。その後、30℃まで冷却し、クリーム状の水中油型乳化組成物を得た。
(沈殿生成の程度)
各乳化組成物の製造工程において調製した油相用組成物について、調製直後の外観を目視にて観察し、以下の判定基準に従って、沈殿生成の程度を評価した。
<沈殿生成の程度の判定基準>
○ :液が澄明であり、沈殿が一切認められない。
× :液が澄明であるが、沈殿が僅かに生じている。
×× :液が懸濁しており、沈殿が一部認められる。
×××:液が懸濁しており、沈殿が著しく認められる。
各乳化組成物を1日間室温で保存した後に、偏光顕微鏡にて観察し、以下の判定基準に従って、析出物の生成の程度を評価した。
<析出物の生成の程度の判定基準>
○ :析出物が一切認められない。
× :微細な析出物が認められる。
×× :大きな析出物はあまりないが、析出物が多数認められる。
×××:大きな析出物が多数認められる。
各乳化組成物を40℃で3カ月間、50℃で1カ月間、及び60℃で2週間保存した後に、外観を観察し、以下の判定基準に従って、相分離の程度を評価した。なお、比較例1〜5の乳化組成物では、沈殿及び析出物の生成が認められたため、相分離の程度の評価は行わなかった。
<相分離の程度の判定基準>
○ :40℃で3カ月間及び50℃で1カ月の条件で油相と水相の相分離は全く認められず、60℃で2週間の条件でも、油相と水相の相分離がほとんど認められない。
× :40℃で3カ月間及び50℃で1カ月の条件で油相と水相の相分離は殆ど認められない。但し、60℃で2週間の条件で油相と水相の相分離が明らかに認められる。
×× :40℃で3カ月の条件で油相と水相の相分離は認められないが、50℃で1カ月間及び60℃で2週間の条件で油相と水相の相分離が明らかに認められる。
×××:40℃で3カ月間、50℃で1カ月間及び60℃で2週間の条件で油相と水相の相分離が明らかに認められる。
得られた結果を表1に示す。グリチルレチン酸及びウフェナマートを含み、ジフェンヒドラミンを含まない乳化組成物では、沈殿及び析出物の生成が著しく認められた(比較例1〜4)。また、グリチルレチン酸、ウフェナマート、及びジフェンヒドラミンを含み、ウールワックスアルコールを含まない乳化組成物では、沈殿及び析出物の生成を抑制できていたが、油相と水相の相分離を十分に抑制できていなかった(比較例5〜9)。
表2に示す組成の水中油型乳化組成物を調製した。これらの製剤は、いずれも、前記試験例の場合と同様に、沈殿及び析出物の生成が抑制された乳化組成物である。
Claims (5)
- (A)グリチルレチン酸、グリチルリチン酸、これらの誘導体、及びこれらの塩よりなる群から選択される少なくとも1種と、(B)ウフェナマートと、(C)ジフェンヒドラミン及び/又はその塩と、(D)ウールワックスアルコールを含有する、乳化組成物。
- (E)無極性油を含有する、請求項1に記載の乳化組成物。
- 水中油型乳化組成物である、請求項1又は2に記載の乳化組成物。
- 皮膚外用剤である、請求項1〜3のいずれかに記載の乳化組成物。
- (A)グリチルレチン酸、グリチルリチン酸、これらの誘導体、及びこれらの塩よりなる群から選択される少なくとも1種、並びに(B)ウフェナマートを含む乳化組成物において、析出物及び沈殿の生成、並びに油相と水相の相分離を抑制する方法であって、
(A)グリチルレチン酸、グリチルリチン酸、これらの誘導体、及びこれらの塩よりなる群から選択される少なくとも1種、並びに(B)ウフェナマートと共に、(C)ジフェンヒドラミン及び/又はその塩、並びに(D)ウールワックスアルコールを配合する、方法。
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