JP2020045316A - 経皮吸収用組成物及び経皮吸収性向上方法 - Google Patents
経皮吸収用組成物及び経皮吸収性向上方法 Download PDFInfo
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- 229960003656 ricinoleic acid Drugs 0.000 description 1
- FEUQNCSVHBHROZ-UHFFFAOYSA-N ricinoleic acid Natural products CCCCCCC(O[Si](C)(C)C)CC=CCCCCCCCC(=O)OC FEUQNCSVHBHROZ-UHFFFAOYSA-N 0.000 description 1
- 239000010667 rosehip oil Substances 0.000 description 1
- 150000004671 saturated fatty acids Chemical class 0.000 description 1
- RMAQACBXLXPBSY-UHFFFAOYSA-N silicic acid Chemical compound O[Si](O)(O)O RMAQACBXLXPBSY-UHFFFAOYSA-N 0.000 description 1
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Landscapes
- Medicinal Preparation (AREA)
- Cosmetics (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Description
成分(A)として乳化剤を、
成分(B)として液状油を、
成分(C)として油ゲル化剤を、
成分(D)として水を含有し、水相からなる分散相の占める割合が70質量%以上である。この場合、後述の実施例に示されるように、成分(C)として油ゲル化剤を配合することにより、高内相W/O型乳化組成物の乳化状態を安定化させることができる。
表1に示す配合で、下記に示す各種の乳化組成物を調製した。
・調製例1−2:油相からなる分散相と水相からなる連続相との比が85:15であるO/W型乳化組成物(酢酸DL−α−トコフェロール1質量%含有)
・調製例1−3:水相からなる分散相と油相からなる連続相との比が50:50であるW/O型乳化組成物(酢酸DL−α−トコフェロール1質量%含有)
・調製例1−4:油相からなる分散相と水相からなる連続相との比が50:50であるO/W型乳化組成物(酢酸DL−α−トコフェロール1質量%含有)
・調製例1−5:水相からなる分散相と油相からなる連続相との比が15:85であるW/O型乳化組成物(酢酸DL−α−トコフェロール1質量%含有)
・調製例1−6:油相からなる分散相と水相からなる連続相との比が15:85であるO/W型乳化組成物(酢酸DL−α−トコフェロール1質量%含有)
静置型フランツセル:垂直型ガラス製拡散セル、開口部直径11.28mm、レシーバー容量 8.0mL(パーメギア社)
皮膚代替膜:「Strat-M(登録商標)メンブレン、経皮拡散試験モデル、直径25mm」、厚さおよそ300μm(メルク社)
レシーバー側の溶液:ウシ血清アルブミン5%含有PBS溶液8.0mL
ドナー側への試料適用量:1.0mL(酢酸DL−α−トコフェロール10mg含有)
試験温度:32℃
試験時間:24時間
酢酸DL−α−トコフェロールの定量:HPLC
HPLC:Thermo Fisher Scientific社 UltiMate3000
カラム:phenomenex社 Kinetex C18(50x3.0mm)
移動相:85%エタノール水溶液
流速:0.5mL/min
検出:UV254nm
表3に示す配合で、水相からなる分散相の占める割合が90質量%である高内相W/O型乳化組成物の調製を試みた。具体的には、油相及び水相の各原料を秤量後、それぞれ80℃にて溶解・混合させ、80℃にて油相に水相を少量ずつ添加しながらディスパーミキサー(商品名「スリーワンモーター Blh600」(撹拌翼φ40mm)、新東科学株式会社製)により、撹拌翼回転速度600rpmで分散させた後、35℃まで冷却した。
○:遠心分離処理後に油相と水相に分離していない。
△:遠心分離処理後に油相と水相に一部分離している。
×:遠心分離処理後に油相と水相に完全に分離している。
表4に示す配合で、試験例2と同様の調製方法で、水相からなる分散相の占める割合が90質量%である高内相W/O型乳化組成物の調製を試み、試験例2と同様にして、乳化状態が安定な高内相W/O型乳化組成物が得られるかどうかを試験した。
○:遠心分離処理後に油相と水相に分離していない。
△:遠心分離処理後に油相と水相に一部分離している。
×:遠心分離処理後に油相と水相に完全に分離している。
表5に示す配合で、試験例2と同様の調製方法で、水相からなる分散相の占める割合が90質量%である高内相W/O型乳化組成物の調製を試み、試験例2、3と同様にして、乳化状態が安定な高内相W/O型乳化組成物が得られるかどうかを試験した。
○:遠心分離処理後に油相と水相に分離していない。
△:遠心分離処理後に油相と水相に一部分離している。
×:遠心分離処理後に油相と水相に完全に分離している。
表6に示す配合で化粧料を調製した。具体的には、油相及び水相の各原料を秤量後、それぞれ80℃にて溶解・混合させ、80℃にて油相に水相を少量ずつ添加しながら更にディスパーミキサー(商品名「TK ROBOMICS」(撹拌翼φ35mm)、フィルミックス株式会社製)により、撹拌翼回転速度2500rpmで分散させた後、35℃まで冷却した。
表7に示す配合で、調製例6−1と調製例6−2の乳化組成物を調製し、皮膚代替膜を用いた皮膚透過試験を実施した。乳化組成物の調製及び皮膚透過試験は、試験例1と同様にして行った。
・調製例6−2:油相からなる分散相と水相からなる連続相との比が13.1:86.9であるO/W型乳化組成物(酢酸DL−α−トコフェロール1質量%含有)
表9に示す配合で、調製例7−1と調製例7−2の乳化組成物を調製し、皮膚代替膜を用いた皮膚透過試験を実施した。乳化組成物の調製及び皮膚透過試験は、グリチルレチン酸ステアリルの定量のためのHPLCを下記条件とした以外、試験例1と同様にして行った。
・調製例7−2:油相からなる分散相と水相からなる連続相との比が13.9:86.1であるO/W型乳化組成物(グリチルレチン酸ステアリル0.3質量%含有)
HPLC:Thermo Fisher Scientific社 UltiMate3000
カラム:phenomenex社 Kinetex C18(50x3.0mm)
移動相:90%エタノール水溶液
流速:0.5mL/min
検出:UV254nm
表11に示す配合で、調製例8−1と調製例8−2の乳化組成物を調製し、皮膚代替膜を用いた皮膚透過試験を実施した。乳化組成物の調製及び皮膚透過試験は、パルミチン酸レチノールの定量のためのHPLCを下記条件とした以外、試験例1と同様にして行った。
・調製例8−2:油相からなる分散相と水相からなる連続相との比が13.9:86.1であるO/W型乳化組成物(パルミチン酸レチノール0.25質量%含有)
HPLC:Thermo Fisher Scientific社 UltiMate3000
カラム:phenomenex社 Kinetex C18(50x3.0mm)
移動相:90%エタノール水溶液
流速:0.5mL/min
検出:UV325nm
表13に示す配合で、調製例9−1と調製例9−2と調製例9−3の乳化組成物を調製し、皮膚代替膜を用いた皮膚透過試験を実施した。乳化組成物の調製及び皮膚透過試験は、試験例1と同様にして行った。
・調製例9−2:水相からなる分散相と油相からなる連続相との比が70:30であるW/O型乳化組成物(酢酸DL−α−トコフェロール1質量%含有)
・調製例9−3:水相からなる分散相と油相からなる連続相との比が85:15であるW/O型乳化組成物(酢酸DL−α−トコフェロール1質量%含有)
Claims (10)
- 所定の成分を含有せしめたうえ、それを皮膚に塗布することにより該成分を経皮吸収させるための組成物であって、前記組成物は、W/O型乳化組成物であることを特徴とする経皮吸収用組成物。
- 前記組成物は、水相の占める割合が70質量%以上であり、油ゲル化剤の配合により安定化されたW/O型乳化組成物である、請求項1記載の経皮吸収用組成物。
- 前記油ゲル化剤は、デキストリン脂肪酸エステル及びグリセリン脂肪酸エステルからなる群から選ばれた1種又は2種以上を含むものである、請求項1又は2記載の経皮吸収用組成物。
- 前記油ゲル化剤は、パルミチン酸デキストリン、ミリスチン酸デキストリン、ベヘン酸グリセリル、及び(ベヘン酸/エイコサン二酸)グリセリルからなる群から選ばれた1種又は2種以上を含むものである、請求項1〜3のいずれか1項に記載の経皮吸収用組成物。
- 前記成分として、油溶性成分を経皮吸収させるためのものである、請求項1〜4のいずれか1項に記載の経皮吸収用組成物。
- 経皮吸収させるべき成分を、W/O型乳化組成物に含有せしめる、前記成分の経皮吸収性向上方法。
- 前記組成物は、水相の占める割合が70質量%以上であり、油ゲル化剤の配合により安定化されたW/O型乳化組成物である、請求項6記載の方法。
- 前記油ゲル化剤は、デキストリン脂肪酸エステル及びグリセリン脂肪酸エステルからなる群から選ばれた1種又は2種以上を含むものである、請求項6又は7記載の方法。
- 前記油ゲル化剤は、パルミチン酸デキストリン、ミリスチン酸デキストリン、ベヘン酸グリセリル、及び(ベヘン酸/エイコサン二酸)グリセリルからなる群から選ばれた1種又は2種以上を含むものである、請求項6〜8のいずれか1項に記載の方法。
- 前記成分として、油溶性成分を経皮吸収させるためのものである、請求項6〜9のいずれか1項に記載の方法。
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