JP7406057B2 - 外用微粒子カプセル製剤及び皮膚外用剤 - Google Patents
外用微粒子カプセル製剤及び皮膚外用剤 Download PDFInfo
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- JP7406057B2 JP7406057B2 JP2021033431A JP2021033431A JP7406057B2 JP 7406057 B2 JP7406057 B2 JP 7406057B2 JP 2021033431 A JP2021033431 A JP 2021033431A JP 2021033431 A JP2021033431 A JP 2021033431A JP 7406057 B2 JP7406057 B2 JP 7406057B2
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- capsule
- skin
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- microparticle
- active ingredient
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Classifications
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- A61P17/00—Drugs for dermatological disorders
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K8/02—Cosmetics or similar toiletry preparations characterised by special physical form
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- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
- A61K8/55—Phosphorus compounds
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- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
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- A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
- A61K2800/40—Chemical, physico-chemical or functional or structural properties of particular ingredients
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Landscapes
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- Cosmetics (AREA)
Description
また、親水性から親油性まで幅広く対応できる合成できるポリグリセリン脂肪酸エステルは、耐酸性、耐塩基性、耐熱性も備えることができるので、両親媒性カプセル膜の構成成分として適用できるものである。
また、上記効果を奏する外用微粒子カプセル製剤を含有する皮膚外用剤においては、有効成分により皮膚生理活性を充分に高めることができる利点がある。
また、特にナノメーターサイズの微粒子カプセル製剤の剤型を採用することによって、その効果がより優れていることが、後述する試験結果からも明らかである。
これらのスフィンゴシンはD(-)体ならびにL(+)体の光学活性体を用いても、さらに天然型と非天然型の混合物を用いてもよい。
この発明のカプセル製剤には、上記したセラミド類縁体を1種のみを用いてもよく、また2種以上を併用してもよい。
この発明の外用微粒子カプセル製剤を調製するときのセラミド類縁体の濃度は0.1~10質量%が好ましく、安定なカプセル製剤を調製するためには1~3質量%が特に好ましい。
また、この発明の外用微粒子カプセル製剤は、マイクロカプセル製剤である場合の他、ナノカプセル製剤であってもよい。
すなわち、上記のようにして得られたマイクロカプセル製剤を、さらに薄膜旋回型高速ミキサーや高圧乳化機(高圧ホモジナイザー)などの周知の乳化機を用いて、機械的なせん断力、衝撃力、乱流などによって微粒化し、粒子径1μm未満のナノサイズの微粒子カプセル製剤を製造できる。
この発明に係るカプセル製剤を所要の割合に配合して化粧料、医薬品等の皮膚外用剤とする場合、微粒子カプセル製剤の1種又は2種以上を配合してもよい。
得られた実施例、参考例及び比較例については、レーザ回折/散乱式粒子径分布測定装置(HORIBA製:LA-950)を用いて粒子径を測定し、その結果を表1及び表2中に併記した。
イソステアリルアスコルビルリン酸2ナトリウム塩(前記化2の式で示されるもの、以下同じ)0.5質量%、市販の水素添加レシチン2.0質量%、グリセリン50.0質量%、水を混合し、そこに内包成分としてレチノール0.1質量%、イソステアリン酸10.0質量%、エチルヘキサン酸セチル5.0質量%、オレフィンオリゴマー10.0質量%、ベヘニルアルコール0.2質量%を加えてホモジナイザーによる分散・乳化することによって、表1に示される粒子径の実施例1を得た。
イソステアリルアスコルビルリン酸2ナトリウム塩0.5質量%、セラミド類縁体として市販のスフィンゴモナスエキス2.5質量%、グリセリン45.0質量%、水を混合し、そこに内包成分としてトコフェロール0.1質量%、イソステアリン酸20.0質量%、エチルヘキサン酸セチル5.0質量%を加えてホモジナイザーによる分散・乳化によって実施例4のカプセル製剤を得た。
イソステアリルアスコルビルリン酸2ナトリウム塩0.5質量%、市販のジイソステアリン酸ポリグリセリル5.0質量%、モノミリスチン酸デカグリセリル5.0質量%、グリセリン40.0質量%、水を混合し、そこに内包成分としてトコフェロール0.1質量%、エチルヘキサン酸セチル5.0質量%、スクワラン5.0質量%、オレフィンオリゴマー10.0質量%、ベヘニルアルコール0.3質量%を加えてホモジナイザーによる分散・乳化することによって実施例7のカプセル製剤を得た。
以下の表2に示す配合割合で、実施例10、13、14、16、17、参考例4~6ならびに比較例4~6のカプセル製剤を薄膜旋回型高速ミキサーによって微粒子化することにより、表中に示す粒子径の実施例10、11、13、14、16、17、参考例4~6ならびに比較例4~6の外用微粒子カプセル製剤を得た。
ヒト正常表皮角化細胞から構成された三次元培養皮膚モデルである倉敷紡績社製のEPI-200Xを用いて経皮吸収性試験を行なった。
すなわち、上記三次元培養皮膚モデルを専用培地を用いて6穴マイクロプレートにて全培養をし、その後、皮膚モデルの上部に実施例1、2、4、5、7、8、10、11、13、14、16、17、参考例1~6ならびに比較例1~6の50%水溶液を50μL添加し、24時間後にモデル下部の培養液ならびに皮膚モデルを採取した。採取した皮膚モデルは1mLの50%エタノール水溶液にてホモジナイザーにより破砕抽出して皮膚モデル抽出液を得た。これらの採取した培養液と皮膚モデル抽出液を高速液体クロマトグラフィー(HPLC)にて内包成分を定量した。
経皮浸透総量は、培養液及び皮膚モデル抽出液中の内包成分総量とし、その結果は図1~6に示した。
皮膚内での内包成分のデリバリー率(%)=(皮膚モデル抽出液中の内包成分総量)/(培養液及び皮膚モデル抽出液中の内包成分総量)
図1~3、7~9に示される結果からも明らかなように、実施例1、2、4、5、7、8、参考例1~3に示す水素添加レシチン、スフィンゴモナスエキス、ポリグリセリン脂肪酸エステルをカプセル殻構成成分とするマイクロカプセル製剤は、イソステアリルアスコルビルリン酸2ナトリウム塩を導入することにより、イソステアリルアスコルビルリン酸2ナトリウム塩を配合しない比較例1~3よりも、経皮浸透総量は増加し、さらに皮膚内での内包成分のデリバリー率も向上した。
カプセル製剤A(実施例1) 2.0
グリセリン 10.0
エタノール 5.0
POE(60)硬化ひまし油 0.3
香料 適量
防腐剤 適量
精製水 残余
微粒子カプセル製剤A(実施例14) 10.0
グリセリン 5.0
エタノール 5.0
水酸化ナトリウム 0.5
カルボキシビニルポリマー 0.8
香料 適量
防腐剤 適量
精製水 残余
カプセル化製剤B(実施例6) 5.0
1,3-ブチレングリコール 10.0
カルボキシビニルポリマー 0.3
スクワラン 5.0
セタノール 0.6
L-アルギニン 0.3
香料 適量
防腐剤 適量
精製水 残余
微粒子カプセル化製剤B(実施例16) 20.0
1,3-ブチレングリコール 10.0
カルボキシビニルポリマー 0.4
スクワラン 5.0
セタノール 3.0
ミツロウ 3.0
L-アルギニン 0.3
香料 適量
防腐剤 適量
精製水 残余
Claims (5)
- 前記乳化粒子が、粒径100~300nmの乳化粒子である請求項1~3のいずれかに記載の外用微粒子カプセル製剤。
- 前記有効成分が、皮膚生理活性の有効成分である請求項1~4のいずれかに記載の外用微粒子カプセル製剤を含有する皮膚外用剤。
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