JP5485522B2 - 乳化組成物 - Google Patents
乳化組成物 Download PDFInfo
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- JP5485522B2 JP5485522B2 JP2008187495A JP2008187495A JP5485522B2 JP 5485522 B2 JP5485522 B2 JP 5485522B2 JP 2008187495 A JP2008187495 A JP 2008187495A JP 2008187495 A JP2008187495 A JP 2008187495A JP 5485522 B2 JP5485522 B2 JP 5485522B2
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Description
[1](A)ワセリン、
(B)レシチン、
(C)グリセリン、及び
(D)吉草酸酢酸プレドニゾロン
を含有する乳化組成物。
[2](A)ワセリンの含有量が、乳化組成物全量に対して10〜30重量%である、上記[1]に記載の乳化組成物。
[3](C)グリセリンの含有量が、乳化組成物全量に対して10〜20重量%である、上記[1]又は[2]に記載の乳化組成物。
[4]さらに、水溶性高分子を含有する、上記[1]〜[3]のいずれかに記載の乳化組成物。
[5]水溶性高分子が、セルロース系高分子、ビニル系高分子、アクリル酸系高分子、植物系高分子、微生物系高分子、リン脂質極性基を有する高分子、及びムコ多糖類からなる群より選択される一種以上である、上記[4]に記載の乳化組成物。
[6]さらに、非ステロイド性抗炎症剤、ビタミン類、美白剤、抗シワ剤、消炎鎮痛剤、抗真菌剤、ステロイド剤、育毛剤、痩身剤、局所麻酔剤、鎮痒剤、抗菌剤、抗ウイルス剤、角質軟化剤、保湿剤、収斂剤、抗酸化剤、発毛抑制剤、紫外線吸収剤、及び紫外線散乱剤からなる群より選択される1種以上を含有する、上記[1]〜[5]のいずれかに記載の乳化組成物。
[7]さらに、非ステロイド性抗炎症剤、局所麻酔剤、鎮痒剤及び保湿剤からなる群より選択される少なくとも1種の有効成分を含有することを特徴とする、上記[1]〜[5]のいずれかに記載の乳化組成物。
[8]黄色ブドウ球菌の皮膚への付着抑制に使用されることを特徴とする、上記[1]〜[7]のいずれかに記載の乳化組成物。
[9]皮膚の乾燥に起因する症状、及び/又は皮膚の乾燥に起因する症状を示す疾患の治療、予防又は改善に使用されることを特徴とする、上記[1]〜[7]のいずれかに記載の乳化組成物。
[10]アトピー性皮膚炎の治療、予防又は改善に使用されることを特徴とする、上記[1]〜[6]のいずれかに記載の乳化組成物。
本発明の組成物は、保湿性に優れるので、皮膚の乾燥に起因する症状、及び/又は皮膚の乾燥に起因する症状を示す疾患(特に、アトピー性皮膚炎等)の治療、予防又は改善のための組成物等として有用である。また、本発明の組成物は優れた痒み低減効果も有するので、痒み低減のための組成物等としても有用である。
本発明においては、黄色ワセリン、白色ワセリンのいずれを用いてもよいが、低刺激性等の観点から、不純物含量が低い白色ワセリンが好ましい。
これらのレシチンは、1種単独で又は2種以上を組み合わせて使用できる。
さらに本発明におけるレシチンの配合量は、本発明の乳化組成物の乳化安定性及び使用感の観点から、ワセリン100重量%に対して5〜30重量%であることが好ましく、10〜20重量%であることがより好ましい。
さらに本発明におけるグリセリンの配合量は、本発明の乳化組成物の保湿効果の観点から、ワセリン100重量%に対して20〜200重量%であることが好ましく、30〜150重量%であることがより好ましい。
吉草酸酢酸プレドニゾロンは、公知の方法により合成してもよく、或いは市販品として入手することもできる。
本発明に用いる水溶性高分子は、医薬品、医薬部外品、化粧品で通常用いられているものであれば特に制限されず用いることができる。
また、水溶性高分子は塩の形態であってもよい。水溶性高分子の塩としては、ナトリウム、カリウム等のアルカリ金属塩;マグネシウム、カルシウム等のアルカリ土類金属塩;等が挙げられる。
メチルセルロース、エチルセルロース、カルボキシメチルセルロース、ヒドロキシエチルセルロース、ヒドロキシエチルメチルセルロース、ヒドロキシプロピルセルロース、ヒドロキシプロピルメチルセルロース、カルメロースナトリウム、ステアロキシヒドロキシプロピルメチルセルロース等のセルロース系高分子;
ポリビニルアルコール(部分けん化物)、ポリビニルピロリドン、ポリエチレングリコール、カルボキシビニルポリマー、ポリビニルメチルエーテル、N−アクリロイルジメチルタウリンアンモニウム・ビニルピロリドン共重合体等のビニル系高分子;
ポリアクリル酸ナトリウム、ポリアクリル酸部分中和物、アクリル酸・メタクリル酸アルキルエステル共重合体(例えば、Pemulen(登録商標)等)等のアクリル酸系高分子;
アラビアガム、トラガントガム、ガラクタン、グアーガム、ペクチン、カラギーナン、アルギン酸、アルギン酸ナトリウム、アルギン酸プロピレングリコールエステル等の植物系高分子;
キサンタンガム、デキストラン、プルラン等の微生物系高分子;
コンドロイチン硫酸、コンドロイチン硫酸ナトリウム、ヒアルロン酸、ヒアルロン酸ナトリウム等のムコ多糖類;
MPCポリマー(例えば、LIPIDURE(登録商標)等)等のリン脂質極性基を有する高分子;
等が挙げられる。これらの水溶性高分子は、1種単独で又は2種以上を組み合わせて使用できる。
ポリビニルアルコール(部分けん化物)、ポリビニルピロリドン、ポリエチレングリコール、カルボキシビニルポリマー、ポリビニルメチルエーテル、N−アクリロイルジメチルタウリンアンモニウム・ビニルピロリドン共重合体;
ポリアクリル酸ナトリウム、ポリアクリル酸部分中和物、アクリル酸・メタクリル酸アルキルエステル共重合体(例えば、Pemulen(登録商標)等);
アラビアガム、トラガントガム、ガラクタン、グアーガム、ペクチン、カラギーナン、アルギン酸、アルギン酸ナトリウム;
キサンタンガム、デキストラン、プルラン;
コンドロイチン硫酸、コンドロイチン硫酸ナトリウム、ヒアルロン酸、ヒアルロン酸ナトリウム;
等が好ましく、カルボキシビニルポリマー、アクリル酸・メタクリル酸アルキルエステル共重合体(例えば、Pemulen(登録商標)等)、アルギン酸プロピレングリコールエステル、キサンタンガム、ヒアルロン酸、ヒアルロン酸ナトリウム等が特に好ましい。
さらに本発明における水溶性高分子の配合量は、本発明の乳化組成物の乳化安定性及び使用感の観点から、ワセリン100重量%に対して0.1〜10重量%であることが好ましく、1〜7重量%であることがより好ましく、2〜4重量%であることが特に好ましい。
さらに本発明における水の配合量は、本発明の乳化組成物の乳化安定性及び使用感の観点から、ワセリン100重量%に対して250〜550重量%であることが好ましく、400〜500重量%であることがより好ましい。
非ステロイド性抗炎症剤:カンゾウ抽出物、グリチルリチン酸、グリチルリチン酸二カリウム、グリチルリチン酸モノアンモニウム等のグリチルリチン酸誘導体;グリチルレチン酸又はその誘導体;アラントイン又はその誘導体;インドメタシン;イブプロフェン;イブプロフェンピコノール;ブフェキサマク;フルフェナム酸ブチル;ベンダザック;ピロキシカム;ケトプロフェン;フェルビナク;サリチル酸メチル又はサリチル酸グリコール等のサリチル酸誘導体;メントール;カンフルなど。
β−カロチン、α−カロチン、γ−カロチン、δ−カロチン、リコピン、ゼアキサンチン、クリプトキサンチン、エキネノン等のプロビタミンA類;
α−トコフェロール、β−トコフェロール、δ−トコフェロール、酢酸トコフェロール、コハク酸dl−α−トコフェロール、コハク酸dl−α−トコフェロールカルシウム等のビタミンE類;
リボフラビン、フラビンモノヌクレオチド、フラビンアデニンジヌクレオチド、リボフラビン酪酸エステル、リボフラビンテトラ酪酸エステル、リボフラビン5’−リン酸エステルナトリウム、リボフラビンテトラニコチン酸エステル等のビタミンB2類;
ニコチン酸メチル、ニコチン酸、ニコチン酸アミドなどのニコチン酸類;
アスコルビン酸ステアリン酸エステル、ジパルミチン酸L−アスコルビル、テトライソパルミチン酸アスコルビル、アスコルビン酸、アスコルビン酸ナトリウム、デヒドロアスコルビン酸、アスコルビン酸リン酸エステルナトリウム、アスコルビン酸リン酸エステルマグネシウム、アスコルビン酸リン酸マグネシウム塩、アスコルビン酸リン酸ナトリウム塩、アスコルビン酸グルコシドなどのビタミンC類;
メチルヘスペリジン、エルゴカルシフェロール、コレカルシフェロールなどのビタミンD類;
フィロキノン、ファルノキノン等のビタミンK類;
γ−オリザノール、ジベンゾイルチアミン、ジベンゾイルチアミン塩酸塩、チアミン塩酸塩、チアミンセチル塩酸塩、チアミンチオシアン酸塩、チアミンラウリル塩酸塩、チアミン硝酸塩、チアミンモノリン酸塩、チアミンリジン塩、チアミントリリン酸塩、チアミンモノリン酸エステルリン酸塩、チアミンモノリン酸エステル、チアミンジリン酸エステル、チアミンジリン酸エステル塩酸塩、チアミントリリン酸エステル、チアミントリリン酸エステルモノリン酸塩等のビタミンB1類;
塩酸ピリドキシン、酢酸ピリドキシン、塩酸ピリドキサール、5’−リン酸ピリドキサール、塩酸ピリドキサミン等のビタミンB6類;
シアノコバラミン、ヒドロキソコバラミン、デオキシアデノシルコバラミン等のビタミンB12類;
葉酸、プテロイルグルタミン酸等の葉酸類;
パントテン酸、パントテン酸カルシウム、パントテニルアルコール(パンテノール)、D−パンテサイン、D−パンテチン、補酵素A、パントテニルエチルエーテル等のパントテン酸類;
ビオチン、ビオチシン等のビオチン類;
カルニチン、フェルラ酸、α−リポ酸、オロット酸等のビタミン様作用因子など。
皮膚からの水分蒸散を低減させることが肝要な乾皮症へ適用するという観点からは、保湿剤としてその治療に使用されるヘパリン類似物質や尿素を本発明の乳化組成物に配合することが好ましい。
これらの中でもヘパリン類似物質は、皮膚からの水分蒸散を低減させることが肝要なアトピー性皮膚炎の治療にも頻繁に用いられることから特に好ましい。
また、乾燥による炎症の予防という観点から、汎用されている非ステロイド性抗炎症剤の配合が好ましい。
これらの中でも、安全性の面から一般に広く使われているメントール、カンフル、グリチルリチン酸二カリウム、アラントインの配合が特に好ましい。
また、乾燥による痒みの治療薬を考えた場合、痒みを抑えるために鎮痒剤として使われるクロタミトンやジフェンヒドラミンやその塩の配合が好ましい。
これらの中でも、一般的によく使われているクロタミトンの配合が特に好ましい。
パラフィン、オゾケライト、セレシン、ハードファット、マイクロクリスタリンワックス、スクワラン(合成・植物性)、αーオレフィンオリゴマー、流動パラフィン、軽質イソパラフィン、流動イソパラフィン、ポリエチレン末等の炭化水素;
ラウリン酸、ミリスチン酸、パルミチン酸、ステアリン酸、ベヘン酸、イソステアリン酸、オレイン酸、リノール酸等の脂肪酸;
トリ2−エチルヘキサン酸グリセリル(トリオクタノイン)等のトリ脂肪酸グリセリド;
高重合メチルポリシロキサン、ジメチルポリシロキサン、ジメチルシロキサン・メチル(ポリオキシエチレン)シロキサン・メチル(ポリオキシプロピレン)シロキサン共重合体、ジメチルシロキサン・メチル(ポリオキシエチレン)シロキサン共重合体、ジメチルシロキサン・メチル(ポリオキシプロピレン)シロキサン共重合体、ポリオキシエチレン・メチルポリシロキサン共重合体、ポリ(オキシエチレン・オキシプロピレン)・メチルポリシロキサン共重合体、ジメチルシロキサン・メチルセチルオキシシロキサン共重合体、ジメチルシロキサン・メチルステアロキシシロキサン共重合体、アクリル酸アルキル共重合体メチルポリシロキサンエステル、架橋型メチルポリシロキサン、架橋型メチルフェニルポリシロキサン、架橋型ポリエーテル変性シリコーン、架橋型アルキルポリエーテル変性シリコーン、架橋型アルキル変性シリコーン等の重合型シリコーン;
エチレングリコールモノアセタート、エチレングリコールジアセタート、トリエチレングリコールジアセタート、ヘキシレングリコールジアセタート、及び2−メチル−2−プロペン−1,1−ジオールジアセタート等のグリコールアセタート;
トリエチレングリコールジバレラート、2,2,4−トリメチル−1,3−ペンタンジオールモノイソブチラート、2,2,4−トリメチル−1,3−ペンタンジオールジイソブチラート等のグリコールエステル;
エチレングリコールジアクリラート、ジエチレングリコールジアクリラート、プロピレングリコールモノアクリラート、2,2−ジメチル−トリメチレングリコールジアクリラート、及び1,3−ブチレングリコールジアクリラート等のグリコールアクリラート;
エチレングリコールジニトラート、ジエチレングリコールジニトラート、トリエチレングリコールジニトラート、及びプロピレングリコールジニトラート等のグリコールジニトラート;
2,2′−[1,4−フェニレンジオキシ]ジエタノール、ジオキサン、ブチレングリコールアジピン酸ポリエステル等のエーテル化合物;
エタノール、イソプロパノール等の低級アルコール;
セタノール、ステアリルアルコール、ベヘニルアルコール、セトステアリルアルコール、ヘキシルデカノール、イソステアリルアルコール、オクチルドデカノール、オレイルアルコール、デシルテトラデカノール、ミリスチルアルコール等の高級アルコール;
エチレングリコール、プロピレングリコール、1,3−ブチレングリコール、1,2−ペンタンジオール、1,2−ヘキサンジオール等の多価アルコール(グリセリンを除く);
ジエチレングリコールモノエチルエーテル等のジエチレングリコールアルキルエーテル;
マクロゴール;
ミリスチン酸イソプロピル、ミリスチン酸オクチルドデシル、パルミチン酸イソプロピル、パルミチン酸セチル、トリ2−エチルヘキシル酸グリセリル、モノステアリン酸グリセリル、中鎖脂肪酸トリグリセリド等のエステル類;
ポリオキシエチレンベヘニルエーテルなどのポリオキシエチレンアルキルエーテル;
オリーブ油等の植物油などが挙げられる。
平均粒径50nm未満の乳化組成物を得るには、より多くのエネルギーが必要となり、また乳化するために乳化力は高いが刺激性が高い界面活性剤を使用する必要が生じることがあり、経済性及び刺激性低減の観点から好ましくない場合がある。また、平均粒径が5000nmより大きい場合は、安定性、使用感及び保湿性の観点から好ましくない場合がある。
乳化組成物はエマルションであり、本明細書においてエマルションとは、相互に混合しない2つの液体の一方が小滴となって、他方の液体中に分散したものである。また乳化組成物の内相とは、前記小滴を指す。
この動的光散乱法により動的光散乱理論に基づいて測定した本発明の乳化組成物の内相の平均粒径は特に制限されないが、通常800nm以下であり、好ましくは700nm以下、特に好ましくは500nm以下である。平均粒径が800nmを超えると、乳化組成物の使用感と安定性が低下してくる。また平均粒径の下限は特に制限されないが、通常10nm、好ましくは50nm、より好ましくは100nm、特に好ましくは150nmである。
この場合の乳化組成物の内相の平均粒径は、レーザー回折・散乱式粒度分布測定器(例えば大塚電子 FPAR−1000)を用いてバッチ式測定法により測定された散乱光データから動的光散乱理論により粒度分布を自動計算させることによって得たメジアン径を意味する。メジアン径は頻度分布が累積50%に相当する粒子径である。
ここで、乳化処理の方法としては、本発明の乳化組成物を構成する(A)〜(D)成分、並びに所望により(E)成分、水、有効成分や基剤等の各種成分の混合物を、ホモミキサーよりも強力なエネルギーをかけられる乳化機(例えば、マイクロフルイダイザー、超音波乳化機、高圧乳化機(高圧ホモジナイザー)など)などを用い、強力なエネルギーで乳化処理する方法等が挙げられる。当該乳化処理により、平均粒径が、所望の範囲、例えば上記の範囲を満たす本発明の乳化組成物が得られる。
なお、本発明の乳化組成物を構成する(A)〜(D)成分と、(E)成分、水、有効成分や基剤等の各種成分との全量を乳化処理してもよいし、場合によっては、その一部のみを乳化処理した後に、残りの成分をさらに配合することも可能である。全量を乳化処理するか、一部のみを乳化処理した後に残りの成分を配合するかは、配合する原料により適宜選択すればよい。
粘度が30000mPa・sより大きい場合は、使用感、例えば皮膚上での塗り延ばしやすさ(塗布しやすさ)やべたつき感の点で劣る場合がある。また、粘度が500mPa・s未満の場合は、保存安定性が劣る場合がある。
測定方法をより詳細に説明すると、乳化組成物の粘度が500mPa・s以上4500mPa・s未満である場合、M2ローターで25℃、回転速度6rpm、1分経過後に測定した場合の値をいう。乳化組成物の粘度が4500mPa・s以上18000mPa・s未満である場合、M3ローターで25℃、回転速度6rpm、1分経過後に測定した場合の値をいう。乳化組成物の粘度が18000mPa・s〜30000mPa・sである場合、M4ローターで25℃、回転速度12rpm、1分経過後に測定した場合の値をいう。
皮膚の乾燥に起因する症状の具体例としては、皮膚表面の落屑、粉ふき、けばだち、かさつき、ひび、あかぎれ、ひじ・ひざ・かかと・くるぶし等の角化、顔の小じわ、皮膚柔軟性の低下、手指のあれ、痒み、乾燥肌(ドライスキン)、敏感肌、皮膚のかぶれ、紅斑、アトピー肌、肌荒れ等がある。
これらの症状を示す具体的な疾患としては、乾皮症、老人性乾皮症、尋常性鱗癬(鮫肌)、小児乾燥性皮膚、アトピー性皮膚炎、アレルギー性皮膚炎、皮脂減少性湿疹、敏感肌、季節性乾皮症、水性掻痒症、主婦湿疹が挙げられる。
ワセリン、レシチン、セラミド及び吉草酸酢酸プレドニゾロンを混合し、加熱溶解し、75〜80℃とした。一方、水の一部、グリセリン及び保存剤を混合し、75〜80℃に加熱した後、前記ワセリン及びレシチンの混合物に加え、ホモミキサーにて予備混合した。得られた混合物を、温度を75〜80℃に保ったまま、500barの圧力で高圧ホモジナイザー処理を行って乳化し、冷却した。これに、水の残部に溶解させたキサンタンガム、pH調整剤を混合することにより、表1に示す組成の乳化組成物を得た。
テープストリッピング法により各試料の黄色ブドウ球菌付着抑制を評価した。試験はn=4〜5で実施した。
菌の付着抑制率(%)=(1−試料の付着菌数/コントロール群の付着菌数)×100
健常人(5名)の上腕内側皮膚(2cm×2cm)を被験部位とし、被験製剤塗布後の角質水分量を測定することにより保湿性を評価した。
具体的には、恒温恒湿測定室内(室温21±1℃、相対湿度50±3%)内で、被験部位を露出して15分間馴化した後、被験部位に被験製剤(8mg)を均等に塗布し、塗布前、5分後、1時間後、3時間後、6時間後の被験部位と無塗布のコントロール部位の高周波伝導度(μS)をSKICON−200EX(IBM社製)で測定した。測定は各被験部位において5回行い、3回の平均値を算出した。高周波伝導度(μS)の平均値を表4に示す。なお高周波伝導度の値が大きいほど保湿効果が高いことを示す。
被験製剤として実施例1の製剤、並びに、比較例としてPVA及びワセリンを含有する興和(株)製の、クリーム、ローション及び軟膏を使用した。ただし、比較例として使用したいずれの製剤もレシチン及びグリセリンは含有していない。
アトピー性皮膚炎の定義・診断基準によりアトピー性皮膚炎と診断され、その程度が中等症〜軽症の20歳以上60歳未満の成人男女59名を対象に試験を実施し、実施例1の製剤のアトピー性皮膚炎に対する有効性を評価した。
被験部位に1日2〜3回、実施例1の製剤を2週間連続して塗布した。
〔観察評価項目及び観察日〕
塗布前、1週間後、及び2週間後に、皮膚所見(紅斑、丘疹/浮腫、湿潤/痂皮、糜爛(びらん)、苔癬化/痒疹、落屑/乾燥)のそれぞれの程度を4段階(3:中程度、2:軽度、1:軽微、0:なし)で判定した。
また塗布前及び2週間後に、痒みの自覚症状をVAS法より評価した。ここでVAS法とは、100mmのスケールに痒みの最小を0mm、最大を100mmとして、患者自身がその時の痒みの程度に応じてプロットすることにより、痒みの自覚症状を測定する方法である。
痒みの自覚症状に関しては、塗布前の平均値が4.5であったのに対し、塗布2週後の平均値が1.3**(**:P<0.01(t−検定))となり、本発明の組成物は痒みの軽減効果も有することが認められた。
以上の通り、本発明の乳化組成物がアトピー性皮膚炎の治療、予防又は改善用として有用であること、並びに痒み低減効果を有することが認められた。
Claims (2)
- (A)ワセリン、
(B)レシチン、
(C)グリセリン、及び
(D)吉草酸酢酸プレドニゾロン
を含有する、皮膚の乾燥に起因する症状、及び/又は皮膚の乾燥に起因する症状を示す疾患の治療、予防又は改善に使用される、乳化組成物。 - (A)ワセリンを10〜30重量%、
(B)レシチンを0.1〜5重量%、
(C)グリセリンを1〜30重量%、及び
(D)吉草酸酢酸プレドニゾロンを0.03〜0.3重量%
含有する、請求項1に記載の乳化組成物。
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