TW202408460A - 非水膨潤性之皮膜形成型外用劑基劑 - Google Patents
非水膨潤性之皮膜形成型外用劑基劑 Download PDFInfo
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Abstract
本發明之課題為提供用於皮膚刺激性低、有速乾性,且耐水性等優良的非水膨潤之皮膜形成型外用劑的基劑。
本發明例如可列舉含有如下成分A~成分C的非水膨潤性之皮膜形成型外用劑基劑:
A)由(甲基)丙烯酸系聚合物等之聚合物粒子分散於水介質中之水系聚合物乳化液所構成的皮膜形成劑,其中前述聚合物之玻璃轉移溫度及前述乳化液之最低成膜溫度均為30℃以下,且將所形成的皮膜浸漬於水中24小時使其膨潤時之由下述式所算出的膨潤率未達30%,
膨潤率(%)=(W2-W1)/W1×100
(式中,W1為浸漬前重量(g)、W2為浸漬後重量(g));
B)酯系非離子性界面活性劑等之可塑劑;及
C)作為乘載體溶劑之水或水及基劑總量中未達20質量%之有機溶劑。
Description
本發明屬於外用劑之技術領域。本發明係關於用於在使用前為液狀或凝膠狀,但若塗佈於皮膚時,乘載體成分之溶劑揮發,於皮膚上形成皮膜的皮膜形成型外用劑(例如液狀絆創膏)之基劑。本發明之皮膜形成型外用劑基劑,具有即使將形成於皮膚上之皮膜暴露於水亦不易膨潤的特性,故為非水膨潤性。
作為施用於皮膚的外用劑之一,已知有於使用前為液狀或凝膠狀,但若塗佈於皮膚時,乘載體成分之溶劑蒸發,於皮膚上形成皮膜的皮膜形成型外用劑(例如液體絆創膏)。該皮膜形成型外用劑,剝離時之物理刺激少,可依損傷部位之大小或形狀形成皮膜,故為便利。又,亦可以容器直接塗佈。
作為皮膜形成型外用劑之皮膜形成劑,自以往起,例如已知有羥基丙基纖維素、纖維素系樹脂、聚乙烯醇及聚乙烯基吡咯啶酮等之水溶性高分子(專利文獻1~3)、(甲基)丙烯酸系聚合物(專利文獻4)、火棉膠(專利文獻5)。
水系聚合物乳化液,為於水等之水系溶劑中分散有聚合物粒子者,若該水系溶劑揮發時,藉由聚合物粒子彼此成為一起而融著及變形,而形成皮膜。該水系聚合物乳化液,例如於化妝品領域中使用,專利文獻6中,揭示關於使用了水系聚合物乳化液的人工爪被覆用組成物之發明。
[先前技術文獻]
[專利文獻]
[專利文獻1]日本特開昭59-139325號公報
[專利文獻2]日本特開平03-275619號公報
[專利文獻3]日本特開平06-157327號公報
[專利文獻4]日本特開平09-2943號公報
[專利文獻5]日本特開平05-58914號公報
[專利文獻6]日本特開2015-199702號公報
[發明所欲解決之課題]
以往之皮膜形成型外用劑中,為了謀求迅速形成皮膜,係使用醇或有機溶劑作為乘載體成分,但該醇或有機溶劑所致之皮膚刺激,或經形成皮膜之膜無耐水性係作為問題而存在。就(甲基)丙烯酸系聚合物或火棉膠而言,係形成具有耐水性之皮膜,但摻合醇或有機溶劑所致之皮膚刺激仍強。對皮膚之刺激性,可藉由以凝膠或乳劑、軟膏等之形態施用,而某種程度地避免,但如此一來係有新誘發如塗佈部之黏附或對衣服之附著的問題之虞。又,為了洗去凝膠等,塗佈後必需洗淨手指。又,至今為止的皮膜形成型外用劑中,尚未發現充分滿足如皮膚刺激性低、有速乾性、密合於皮膚而吸收性或耐水性優良,進而有柔軟性、伸縮性及強度的條件者。
另一方面,就以水為乘載體溶劑之水系外用劑而言,雖可避免對皮膚之刺激性,但由於為水系故乾燥慢,皮膜之形成需要時間。又,於醫藥用時,藥效成分中為多的疏水性藥物由於難溶於水故難以摻合於水系之外用劑中,於水系外用劑中摻合藥物時,有限於親水性藥物之虞。
本發明之主要課題為提供用於皮膚刺激性低、有速乾性,又,滿足如耐水性、柔軟性、伸縮性及強度的條件之新穎的非水膨潤性之皮膜形成型外用劑之基劑。
[用以解決課題之手段]
為了解決上述課題,本發明者深入探討的結果,發現藉由於由一定的水系聚合物乳化液所構成的皮膜形成劑中添加數種添加物,可解決上述課題,而完成本發明。
本發明例如可列舉下述態樣。
[1]一種非水膨潤性之皮膜形成型外用劑基劑,其含有如下成分A~成分C:
A)由選自(甲基)丙烯酸系聚合物及分子內包含(甲基)丙烯酸系單體之共聚物的聚合物粒子分散於水介質中之水系聚合物乳化液所構成的皮膜形成劑,其中前述聚合物之玻璃轉移溫度及前述乳化液之最低成膜溫度均為30℃以下,且將所形成的皮膜浸漬於水中24小時使其膨潤時之由下述式所算出的膨潤率未達30%,
膨潤率(%)=(W2-W1)/W1×100
(式中,W1表示浸漬前重量(g)、W2表示浸漬後重量(g));
B)選自酯系非離子性界面活性劑及纖維素類的1種以上之可塑劑;及
C)作為乘載體溶劑之水或水及基劑總量中未達20質量%之有機溶劑。
[2]如上述[1]之皮膜形成型外用劑基劑,其進一步含有水不溶性之油分。
[3]如上述[1]之皮膜形成型外用劑基劑,其中上述聚合物,為(甲基)丙烯酸烷酯聚合物,或包含(甲基)丙烯酸烷酯單體之共聚物。
[4]如上述[1]之皮膜形成型外用劑基劑,其中以動態光散射法測定時的上述聚合物粒子之平均粒子徑,為10~300nm之範圍內。
[5]如上述[1]之皮膜形成型外用劑基劑,其中上述水系乳化液中之聚合物固體成分量,為20~70質量%之範圍內。
[6]如上述[1]之皮膜形成型外用劑基劑,其中上述酯系非離子性界面活性劑,為單脂肪酸聚乙二醇,上述纖維素類,為羥基丙基纖維素。
[7]如上述[2]之非水膨潤性之皮膜形成型外用劑基劑,其中上述水不溶性之油分,為選自由酯類、烴類、脂肪酸、動植物油,及聚矽氧所成之群的1種以上。
[8]如上述[7]之皮膜形成型外用劑基劑,其中酯類為肉豆蔻酸異丙酯、肉豆蔻酸辛基十二烷酯、乙酸生育酚、三(辛酸/癸酸)甘油酯,或癸二酸二乙酯;烴類為流動石蠟、鯊烷,或凡士林;脂肪酸為月桂酸、肉豆蔻酸、硬脂酸、異硬脂酸,或油酸;動植物油為蓖麻油、荷荷芭油,或夏威夷豆油;或聚矽氧為聚二甲基矽氧烷。
[9]一種非醫藥用外用劑,其含有如上述[1]~[8]中任一項之皮膜形成型外用劑基劑。
[10]一種醫藥用外用劑,其含有如上述[1]~[8]中任一項之皮膜形成型外用劑基劑與藥效成分。
[11]如上述[10]之醫藥用外用劑,其為液體絆創膏。
[12]如上述[10]之醫藥用外用劑,其中上述藥效成分,為殺菌消毒劑、足癬藥、止癢劑、保濕劑,或鎮痛消炎劑。
[13]如上述[9]之非醫藥用外用劑,其中外用劑被封入於推針型容器、迷你滾珠容器或迷你滾珠容器、噴霧容器,或附刷毛容器。
[14]如上述[10]之醫藥用外用劑,其中外用劑被封入於推針型容器、滾珠容器或迷你滾珠容器、噴霧容器,或附刷毛容器。
[發明之效果]
本發明之非水膨潤性之皮膜形成型外用劑基劑(以下稱「本發明基劑」),由於乘載體溶劑基本上為水,故不僅即使對皮膚塗佈刺激性亦少,且可無遲滯地乾燥,而於皮膚上形成皮膜。又,例如柔軟性、伸縮性、耐水性優良。而一旦成膜時,即使暴露於水亦不易膨潤,因此可比較長時間停留於皮膚上。此外,使用本發明基劑作為醫藥用外用劑之基劑時,可廣泛地摻合從親水性藥物到疏水性藥物。
1 本發明基劑
本發明基劑,其特徵為含有如下成分A~成分C。
A)由選自(甲基)丙烯酸系聚合物及分子內包含(甲基)丙烯酸系單體之共聚物的聚合物粒子分散於水介質中之水系聚合物乳化液所構成的皮膜形成劑,其中前述聚合物之玻璃轉移溫度及前述乳化液之最低成膜溫度均為30℃以下,且將所形成的皮膜浸漬於水中24小時使其膨潤時之由下述式所算出的膨潤率未達30%。
膨潤率(%)=(W2-W1)/W1×100
(式中,W1及W2與前述同義)。
B)選自酯系非離子性界面活性劑及纖維素類的1種以上之可塑劑。
C)作為乘載體溶劑之水或水及基劑總量中未達20質量%之有機溶劑。
1.1 關於成分A
本發明基劑含有成分A。成分A為由選自(甲基)丙烯酸系聚合物及分子內包含(甲基)丙烯酸系單體之共聚物的聚合物粒子分散於水介質中之水系聚合物乳化液所構成的皮膜形成劑,該皮膜形成劑中,前述聚合物之玻璃轉移溫度(Tg),及前述乳化液之最低成膜溫度(MFT:Minimum Film-forming Temperature)均為30℃以下,且將所形成的皮膜浸漬於水中24小時使其膨潤時之由下述式所算出的膨潤率未達30%。該皮膜形成劑之成分A為水溶液。
膨潤率(%)=(W2-W1)/W1×100
(式中,W1及W2與前述同義)。
水系聚合物乳化液,如前所述,為於水等之水系溶劑中分散有聚合物粒子者,若該水系溶劑揮發時,聚合物粒子彼此成為一起而融著及變形,藉以形成皮膜。因而,基本上藉由成分A,於皮膚上形成由聚合物等所構成的皮膜。又,分散有聚合物粒子之水基本上作為本發明基劑之乘載體溶劑。因此,本發明基劑含有水。
成分A中之水系聚合物乳化液或其中所含有的聚合物,Tg及MFT均為30℃以下,較佳為Tg及MFT均為28℃至26℃~-15℃之範圍內。如由後述試驗結果明顯可知的,由Tg及MFT之任一者高於30℃之聚合物所構成的水系乳化液,難以於皮膚上形成皮膜。
玻璃轉移溫度(Tg)為所屬技術領域中具有通常知識者眾所週知的物性,可藉由常規方法求得。具體而言,例如可列舉一邊使聚合物試樣之溫度慢慢上昇或下降一邊測定力學物性之變化或吸熱/放熱之方法(例如示差掃描熱量測定(DSC)、示差熱分析(DTA))、機械式分光術(動態黏彈性測定)法。又,可藉由所謂的Fox公式計算Tg。
最低成膜溫度(MFT),為以均質且透明之皮膜的形態凝集的最低溫度,可藉由常規方法,以最低成膜溫度測定裝置來求得。
又,本發明之水系聚合物乳化液所形成之皮膜,由上述式所算出的膨潤率未達30%,若該膨潤率為30%以上時,將形成於皮膚上之皮膜暴露於水時有混濁而耐水性不良之虞。
成分A中之水系聚合物乳化液的聚合物,係由(甲基)丙烯酸系聚合物及分子內包含(甲基)丙烯酸系單體之共聚物中選擇。此處,「(甲基)丙烯酸」,意指一併稱呼丙烯酸與甲基丙烯酸的用語。
本發明中,較佳為以(甲基)丙烯酸烷酯為主要構成單體的聚合物或共聚物((甲基)丙烯酸烷酯聚合物)。於其中例如亦能夠以(甲基)丙烯酸,或疏水性單體、親水性單體的1種以上作為構成單體而含於分子內。
作為上述聚合性單體之(甲基)丙烯酸烷酯,例如可列舉(甲基)丙烯酸甲酯、(甲基)丙烯酸乙酯、(甲基)丙烯酸異丙酯、(甲基)丙烯酸n-丁酯、(甲基)丙烯酸異丁酯、(甲基)丙烯酸n-戊酯、(甲基)丙烯酸異戊酯、(甲基)丙烯酸n-己酯、(甲基)丙烯酸2-乙基己酯、(甲基)丙烯酸辛酯、(甲基)丙烯酸癸酯、(甲基)丙烯酸十二烷酯、(甲基)丙烯酸十八烷酯、(甲基)丙烯酸環己酯、(甲基)丙烯酸苯酯、(甲基)丙烯酸苄酯、(甲基)丙烯酸異戊酯。其中較佳為(甲基)丙烯酸甲酯、(甲基)丙烯酸乙酯、(甲基)丙烯酸n-丁酯、(甲基)丙烯酸異丁酯、(甲基)丙烯酸n-丁酯、(甲基)丙烯酸異丁酯、(甲基)丙烯酸異戊酯。此等可為1種、亦可為任意的2種以上。
上述疏水性單體例如可列舉苯乙烯、2-甲基苯乙烯、t-丁基苯乙烯、氯苯乙烯等之苯乙烯系單體;丙烯酸烯丙酯等之烯丙基系單體;氯乙烯等之氯乙烯系單體;丁基縮水甘油醚、(甲基)丙烯酸縮水甘油酯、(甲基)丙烯酸二縮水甘油酯、烯丙基縮水甘油醚等之環氧系單體;二甲基矽氧烷等之聚矽氧系單體;胺基甲酸酯等之胺基甲酸酯系單體。
上述親水性單體例如可列舉(甲基)丙烯酸2-羥基乙酯、(甲基)丙烯酸羥基丙酯等之側鏈具有羥基之(甲基)丙烯酸烷酯;丙烯醯胺、馬來酸醯胺、N-羥甲基(甲基)丙烯醯胺等之醯胺系單體;馬來酸酐等之馬來酸系單體、乙酸乙烯酯等之乙烯基系單體。
成分A中之水系聚合物乳化液之製造方法不特別限制,例如可藉由將丙烯酸系單體、乳化劑等之原料於水中均勻分散,將該單體以乳化劑進行微胞化,並對其添加聚合起始劑(例如過氧化氫、過氧乙酸、t-丁基氫過氧化物、過氧苯甲酸)加熱並乳化聚合,來製造該水系聚合物乳化液。又,亦可藉由使用了反應性乳化劑的無皂聚合法,或不含乳化劑之水介質不均勻聚合法等之手法來製造。
上述乳化劑例如可列舉聚氧乙烯壬基苯基醚等之聚氧乙烯烷基苯基醚、聚氧乙烯十二烷基醚等之聚氧化烯烷基醚等之非離子系乳化劑;聚氧化烯烷基醚硫酸酯銨、聚氧乙烯月桂基醚硫酸酯鈉、2-乙基己基硫酸酯鈉、二辛基磺琥珀酸鈉等之陰離子系乳化劑。
成分A中之水系聚合物乳化液中之聚合物粒子的平均粒子徑不特別限制,以動態光散射法(DLS)進行測定時,以重量平均粒子徑計,例如以10~300nm之範圍內為適當,較佳為30~200nm之範圍內、更佳為40~200nm之範圍內。該平均粒子徑例如可使用奈米粒子徑測定裝置Nanotrac WaveII(MICROTRAC公司製)、Zetasizer PRO (Spectris公司製)來測定。
成分A中之水系聚合物乳化液中之聚合物固體成分量不特別限制,係以20~70質量%之範圍內為適當,較佳為35~55質量%之範圍內。
成分A中之水系聚合物乳化液的1%水溶液之黏度,於室溫下為1~10,000mPa・s,較佳為3~5,000mPa・s、更佳為5~3,000mPa。
成分A中之水系聚合物乳化液係有市售,本發明中可使用市售品。其具體例子,可列舉丙烯酸烷酯乳化液(COVACRTL MS11 WP(Sensient Technologies公司製)、YODOSOL GH810F(Nouryon Japan公司製)、Vinysol 1086WP(大同化成工業公司製)等)、丙烯酸烷酯/苯乙烯共聚合乳化液(TODOSOL GH41H(Nouryon Japan公司製)、Vinysol 1012JC(大同化成工業公司製)等)。
本發明基劑中之成分A之含量,可依期望適當設定,不特別限制。
1.2 關於成分B
成分B為選自酯系非離子性界面活性劑及纖維素類的1種以上之可塑劑,本發明基劑含有該成分B。成分B為對形成於皮膚上之皮膜(成膜)賦予柔軟性與伸縮性,維持成膜之耐水性者。
此處「酯系非離子性界面活性劑」係指溶解於中性水時,具有不離子化之親水基的界面活性劑,其係具備甘油、二醇、乙二醇、山梨醇、蔗糖等之多元醇與脂肪酸進行酯鍵結而得的結構者。
成分B中之酯系非離子性界面活性劑,例如可列舉聚氧化烯脂肪酸酯、高級醇脂肪酸酯、乙二醇脂肪酸酯、丙二醇脂肪酸酯、丁二醇脂肪酸酯、山梨醇酐脂肪酸酯、甘油脂肪酸酯、蔗糖脂肪酸酯。聚氧化烯脂肪酸酯,例如可列舉(單、二、三)脂肪酸聚乙二醇。該脂肪酸,例如可列舉硬脂酸、油酸、異硬脂酸、月桂酸、鯨蠟基醚硬脂酸、硬脂基醚硬脂酸。成分B中之酯系非離子性界面活性劑之具體例子,可列舉單硬脂酸聚乙二醇(例如MYS-10V、MYS-25V、MYS-45MV、MYS-55MV(Nikko Chemicals公司製))、單油酸聚乙二醇(例如MYO-10V(Nikko Chemicals公司製))、單異硬脂酸聚乙二醇、單月桂酸聚乙二醇(例如MYL-10V(Nikko Chemicals公司製))、二月桂酸聚乙二醇、二硬脂酸聚乙二醇、二油酸聚乙二醇。此等之中,較佳為單脂肪酸聚乙二醇,其中尤更佳為單油酸聚乙二醇、單月桂酸聚乙二醇。
成分B中之纖維素類,例如可列舉羥基丙基纖維素、羥丙甲纖維素(hypromellose)、疏水化羥基丙基甲基纖維素。其中較佳為羥基丙基纖維素。
成分B可為上述任1種,亦可合併使用任意2種以上。
本發明基劑中之成分B之含量係依所期望而適當設定,不特別限制,係以0.01~50質量%之範圍內為適當,較佳為0.1~30質量%之範圍內、更佳為0.5~20質量%之範圍內。少於0.01質量%時,有得不到充分的柔軟性或伸縮性之虞,多於50質量%時,有對形成於皮膚上之皮膜的柔軟性、伸縮性,或耐水性造成不良影響之虞。
1.3 關於成分C
本發明基劑,含有水或水及本發明基劑總量中未達20質量%之有機溶劑,作為乘載體溶劑。此處「乘載體溶劑」,係指至將使用本發明基劑的製劑施用於皮膚為止,用以將皮膜形成劑之成分A或可塑劑之成分B等保持於基劑中的介質,其係於皮膚施用後,最終會蒸發而消失者。該乘載體溶劑以下稱「成分C」。
成分C基本上僅有水,本發明基劑中較佳不含有機溶劑(0質量%)。成分C含有有機溶劑時,在本發明基劑總量中為未達20質量%,較佳為未達15質量%、更佳為未達10質量%、又更佳為未達5質量%或未達1質量%,應儘可能為少量。由於成分C基本上為水或含有水與僅少許的有機溶劑者,故本發明基劑為低刺激性。又,耐水性亦為良好。
由於成分C最終會蒸發而消失,故本發明基劑中所含有的有機溶劑,通常為揮發性有機溶劑或低沸點有機溶劑,具體而言,例如可列舉低級(碳數1~4左右)一元醇(例如甲醇、乙醇、丙醇、異丙醇、異丁醇)、丙酮、乙酸乙酯、甲基醚、乙基醚。一般而言,為低級一元醇,為乙醇。
成分C係如上述,基本上為水,故包含乙醇等之低級一元醇的有機溶劑,在本發明基劑中亦可不含有,就刺激性之觀點,較佳為不含有。
1.4 關於成分D
本發明基劑,可含有水不溶性之油分。該油分以下亦稱「成分D」。成分D可協助疏水性藥物溶解於本發明基劑,可使於本發明基劑中摻合該藥物成為容易。因此,成分D亦可稱為用於藥物(藥效成分)之可溶化劑、溶解促進劑等。因而,本發明基劑除了可用於非醫藥用外用劑之調製以外,藉由於本發明基劑中含有成分D,可更擴展對醫藥用外用劑之用途。
此處「水不溶性之油分」係指對於20℃的中性水之溶解度為100μg/mL以下之油性的化合物。成分D中之水不溶性之油分,只要為符合上述目的者則不特別限制,係適當選擇,例如可列舉酯類、烴類、脂肪酸、動植物油、聚矽氧。
酯類具體而言,例如可列舉異辛酸鯨蠟酯、肉豆蔻酸異丙酯、棕櫚酸異丙酯、肉豆蔻酸辛基十二烷酯、三辛酸甘油酯、二異硬脂酸聚甘油酯、三異硬脂酸二甘油酯、三-二十二酸甘油酯、三(辛酸/癸酸)甘油酯、蘋果酸二異硬脂酯、二辛酸新戊二醇、癸二酸二乙酯、膽固醇脂肪酸酯、N-月桂醯基-L-麩胺酸二(膽固醇酯/二十二烷酯/辛基十二烷酯)、乙酸生育酚。
烴類具體而言,例如可列舉流動石蠟、輕質流動石蠟、鯊烷、凡士林。
脂肪酸具體而言,例如可列舉二十二酸、月桂酸、肉豆蔻酸、硬脂酸、異硬脂酸、油酸。
動植物油具體而言,例如可列舉酪梨油、亞麻仁油、杏仁油、橄欖油、可可油、牛油、桐油、小麥胚芽油、芝麻油、米胚芽油、米糠油、紅花籽油、大豆油、月見草油、山茶油、玉米油、菜籽油、馬油、杏子油、棕櫚油、棕櫚仁油、蓖麻油、葵花油、豬油、葡萄籽油、荷荷芭油、夏威夷豆油、貂油、綿籽油、木蠟、蜂蠟、白蜂蠟、椰子油、硬化椰子油、花生油、羊毛脂、蛋黃油、玫瑰果油。
聚矽氧具體而言,例如可列舉二甲基聚矽氧烷(聚二甲基矽氧烷)、高聚合甲基聚矽氧烷、甲基苯基聚矽氧烷、甲基氫聚矽氧烷、八甲基環四矽氧烷、八甲基環五矽氧烷、十甲基環六矽氧烷、硬脂氧基聚矽氧等之高級烷氧基改質聚矽氧、烷基改質聚矽氧、高級脂肪酸酯改質聚矽氧。
上述水不溶性之油分可為上述任1種,亦可合併使用任意2種以上。
本發明基劑中之成分D之含量係依所期望而適當設定,不特別限制,係以0.01~50質量%之範圍內為適當,較佳為0.5~25質量%之範圍內、更佳為1~10質量%之範圍內。少於0.01質量%時,係有疏水性藥物對基劑之溶解不充分的情況,多於50質量%時,係有對形成於皮膚上之皮膜的柔軟性、伸縮性,或耐水性造成不良影響之虞。
1.5 其他
本發明基劑基本上不含乙醇等之低級醇。因此,可稱為非醇性水系基劑。
本發明基劑中,在不損及本發明之效果的範圍,可依期望摻合其他添加劑。該添加劑例如可列舉安定(化)劑、可溶化劑、抗氧化劑、濕潤劑、清涼化劑、著色劑、香味劑(香料)、乳化劑、黏著劑、黏著增強劑、黏稠(化)劑、pH調整劑、防腐劑、溶劑、收斂劑、鉗合劑、增黏劑、刺激減低劑。
上述安定(化)劑例如可列舉抗壞血酸、乙二胺四乙酸鈉水合物、氯化鈉、氯化鎂。
上述可溶化劑例如可列舉三乙酸甘油酯、D-甘露醇、D-山梨醇、苯甲酸苄酯、三胺基甲烷、膽固醇、三乙醇胺、碳酸鈉、檸檬酸鈉。
上述抗氧化劑例如可列舉丁基羥基苯甲醚、亞硫酸鈉、抗壞血酸及其鹽、亞硫酸氫鈉、亞硫酸鈉、焦亞硫酸鈉、苯并三唑、鹽酸半胱胺酸、檸檬酸。
濕潤劑例如可列舉1,3-丁二醇、甲基纖維素、月桂基硫酸鈉。
清涼化劑例如可列舉薄荷腦(l-薄荷腦、dl-薄荷腦等)、樟腦(d-樟腦、dl-樟腦等)、氯丁醇、香葉醇、桉葉素、茴香腦、檸檬烯、龍腦等之萜類、含有萜類之精油(薄荷油)。
上述著色劑例如可列舉溚色素(褐色201號、藍色201號、黃色4號、黃色403號等)、焦糖、銅葉綠素鈉、亞甲藍、梔子色素、萬壽菊色素、胡蘿蔔素色素、花青素色素、果汁色素、蔬菜色素、三氧化二鐵等之合成或天然來源的色素。
上述香味劑(香料)例如可列舉丁香油、向日花香醛、d-龍腦。
上述乳化劑例如可列舉蔗糖脂肪酸酯、氫化大豆磷脂質。
上述黏著劑例如可列舉羧基乙烯基聚合物、羧甲基纖維素鈉。
上述黏著增強劑例如可列舉三仙膠、聚乙二醇(Macrogol)6000。
上述黏稠(化)劑例如可列舉矽酸鎂鋁、聚乙烯醇。
上述pH調整劑例如可列舉檸檬酸、檸檬酸鈉、檸檬酸酐、蘋果酸、馬來酸、琥珀酸、富馬酸、酒石酸、酒石酸鈉、乳酸、乳酸鈣、乳酸鈉、乙酸、乙酸鈉、冰醋酸等之有機酸或其鹽;鹽酸、硫酸、磷酸、硼酸、磷酸氫鈉、磷酸二氫鉀、磷酸二氫鈉、碳酸鈉、碳酸氫鈉等之無機酸或其鹽;氫氧化鈉、氫氧化鉀、氫氧化鈣、氫氧化鎂、硼砂等之氫氧化鹼;單乙醇胺、三乙醇胺、二乙醇胺、二異丙醇胺、三異丙醇胺等之胺類。
上述防腐劑例如可列舉對羥苯甲酸甲酯、對羥苯甲酸乙酯、對羥苯甲酸丙酯、對羥苯甲酸異丙酯、對羥苯甲酸丁酯、對羥苯甲酸異丁酯、對羥苯甲酸苄酯、苯甲酸、苯甲酸鈉、苯甲酸、苯甲酸苄酯、去氫乙酸鈉、氯化苯二甲烴銨(benzalkonium chloride)、氯化鯨蠟基吡啶鎓、氯化苯索寧(benzethonium chloride)、胺基乙基磺酸、苯氧基乙醇、氯丁醇、苄醇、苯乙醇、百里酚、山梨酸及其鹽。
上述溶劑例如可列舉濃甘油、丙二醇、苄醇。
上述收斂劑例如可列舉源自明礬、硫酸鋅、硫酸鋁鉀、鹼性乳酸鋁鋅等之金屬鹽;單寧酸、檸檬酸、乳酸、琥珀酸等之有機酸;植物(例如海藻、百里香、紅茶、烏龍茶、綠茶、小連翹、金縷梅、枇杷、牡丹皮、虎耳草、博士茶、紫雲英、朝鮮薊、洋甘菊、桉樹、檸檬、迷迭香、地榆、鼠尾草等)之成分。
上述鉗合劑例如可列舉乙二胺四乙酸(四乙酸乙二胺)、乙二胺四乙酸鹽(鈉鹽(乙二胺四乙酸鈉:日本藥典、EDTA-2Na等)、鉀鹽等)、植酸、葡萄糖酸、多磷酸、偏磷酸。
上述增黏劑例如可列舉瓜爾膠、果膠、普魯南糖、明膠、刺槐豆膠、鹿角菜膠、寒天、聚葡甘露糖、卡德蘭膠、結蘭膠、三仙膠、聚乙二醇、皂土、海藻酸、海藻酸丙二醇、聚乙二醇(Macrogol)、軟骨素硫酸鈉、玻尿酸、玻尿酸鈉。
上述刺激減低劑例如可列舉明膠、阿拉伯膠、普魯南糖、α化澱粉、洋菜、西黃蓍膠、海藻酸鈉、海藻酸丙二醇酯、甘草萃取物、2-甲基丙烯醯氧基乙基磷酸膽鹼。
上述添加劑依期望可為任1種,亦可合併使用任意2種以上。
本發明基劑通常具有pH2~9之液性,就對皮膚之刺激性及皮膚使用感的觀點,較佳為pH3~8、更佳為pH4~8、特佳為pH5~8。再者,該pH可藉由上述pH調整劑的使用而適當調整。
本發明基劑只要具備1~10,000mPa・s之範圍內的黏度即可,就手指取用性或塗佈容易性等之觀點,較佳為3~5,000mPa・s之範圍內、更佳為5~3,000mPa・s之範圍內。
本發明基劑所形成之皮膜,較佳由上述式算出的膨潤率未達30%、更佳為20%以下、特佳為10%以下。該膨潤率若為30%以上時,形成於皮膚上之皮膜暴露於水時有混濁而耐水性不良之虞。該膨脹率之下限,例如可列舉完全不膨脹之0%。
本發明基劑之製造方法不特別限制,可藉由適當選擇並摻合本發明基劑之調製所必要的各種成分,並使用適當的攪拌機以常規方法進行攪拌等,來製造本發明基劑。
2 本發明基劑之用途等
本發明基劑,可作為用於作為非醫藥品之皮膜形成型外用劑,或摻合有醫藥品相關藥效成分的皮膜形成型外用劑之基劑使用。本發明中,可包含如含有本發明基劑且不含藥效成分之雜貨、化妝品等的非醫藥用外用劑,及含有本發明基劑與藥效成分之醫藥用外用劑。
本發明之非醫藥用外用劑之其一態樣,可列舉液體手套等之雜貨、睫毛膏等之化妝品。
本發明之醫藥用外用劑之其一態樣,可列舉液體絆創膏、雞眼/老繭用劑。以下將本發明之非醫藥用外用劑與本發明之醫藥用外用劑一併稱為「本發明外用劑」。
醫藥用之本發明外用劑中,可摻合從親水性藥物到疏水性藥物的廣範圍之藥效成分。親水性藥物,可直接摻合於本發明基劑中,疏水性藥物可直接或溶解於水不溶性之油分來進行摻合。該藥物(藥效成分)例如可列舉殺菌消毒劑、足癬藥、止癢劑、保濕劑、鎮痛消炎劑、抗組織胺劑、抗發炎劑、局部麻醉劑、角質軟化劑、組織修復劑、皮膚保護劑、維生素劑。
醫藥用之本發明外用劑之製造方法不特別限制,例如可藉由將本發明基劑及所期望之藥效成分,以及依需要的添加物以常規方法用攪拌機等實施攪拌混合等之操作來製造。更詳細言之,例如可藉由包含下述步驟之方法,來製造醫藥用之本發明外用劑。非醫藥用之本發明外用劑的情況時,除了下述步驟1外,能夠同樣地進行製造。
步驟1:將藥物(藥效成分)溶解(藥物相)。
步驟2:於本發明之水系乳化液中摻合各種添加物,以攪拌機攪拌而調製本發明基劑(基劑相)。
步驟3:對基劑相添加藥物相,以攪拌機攪拌(原料製劑(bulk drug))。
步驟4:將原料製劑使用填充機填充於任意容器。
本發明外用劑,可封入於密封狀之任意容器,例如發泡橡膠內栓塗佈容器、(迷你)滾珠容器、噴霧(噴射)容器、滴下容器、乳液容器、鋁管、推針型容器中。可由該容器直接塗佈於皮膚。就抑制塗佈部之乾燥的觀點等,較佳為封入於推針型容器、滾珠容器、迷你滾珠容器、噴霧容器、附刷毛容器中。
該容器之材質例如可列舉聚乙烯、聚丙烯、聚對苯二甲酸乙二酯等塑膠全部。
醫藥用之本發明外用劑之施用方法,係依疾病、藥效成分、患部、性別、年齡等而異,不特別限制,通常,可每1日1次~數次塗佈適量於皮膚等之外皮上的包含患部之區域來使用。塗佈後,本發明外用劑會迅速乾燥,於經塗佈本發明外用劑的皮膚上形成皮膜。該皮膜即使暴露於水亦不易膨潤,若不施加任何力,則可比較長期間停留於皮膚上。
[實施例]
以下示出實施例或試驗例以更具體說明本發明。惟,本發明不受以下實施例等的任何限定。
[試驗例1]水系聚合物乳化液之探討
針對市售之下述水系聚合物乳化液(WPE),評價膜的形成狀態。
該膜係將WPE液0.5g置入5.0cm
2之圓形之聚丙烯製容器,於室溫乾燥一晚而調製(塗佈量:0.1g/cm
2、n=3)。其結果示於表1及表2。
再者,膨潤率(%)係由如下方法算出(以下之試驗例亦同)。
測定所得到的膜之重量(W1)後,將該膜置入加入有純水的玻璃容器,於室溫下浸漬24小時。浸漬後從玻璃容器取出該膜,測定擦拭表面之水分後的該膜重量(W2),由下述式算出膨潤率(%)。
膨潤率(%)=(W2-W1)/W1×100
(式中,W1及W2與前述同義)。
又,聚合物粒子之重量平均粒子徑,係使用Nanotrac WaveII(MICROTRAC公司製),藉由動態光散射法(DLS)測定。
<使用於探討的市售之水系聚合物乳化液(WPE)的例子>
1:丙烯酸烷酯共聚物乳化液(DERMACRYL、Matsumoto Trading公司製)
2:丙烯酸烷酯共聚物乳化液(COVACRYL E14 WP、Sensient Technologies Japan公司製)
3:丙烯酸烷酯共聚物乳化液(COVACRYL MS11 WP、Sensient Technologies Japan公司製)
4:丙烯酸烷酯共聚物乳化液(YODOSOL GH800F、Matsumoto Trading公司製)
5:丙烯酸烷酯共聚物乳化液(YODOSOL GH810F、Matsumoto Trading公司製)
6:丙烯酸烷酯共聚物乳化液(Vinysol 1086WP、大同化成工業公司製)
7:丙烯酸烷酯共聚物乳化液(Vinysol 1089HT、大同化成工業公司製)
8:丙烯酸烷酯/苯乙烯共聚物乳化液(YODOSOL GH41H、Matsumoto Trading公司製)
9:丙烯酸烷酯/苯乙烯共聚物乳化液(Vinysol 1012JC、大同化成工業公司製)
10:丙烯酸烷酯/苯乙烯共聚物乳化液(Vinysol 1013JH、大同化成工業公司製)
11:丙烯酸烷酯/苯乙烯共聚物乳化液(Vinysol 1019CT、大同化成工業公司製)
12:丙烯酸烷酯/乙酸乙烯酯共聚物乳化液(Vinysol 2140L、大同化成工業公司製)
13:丙烯酸烷酯/乙酸乙烯酯共聚物乳化液(Vinysol 2140LH、大同化成工業公司製)
如表1及表2所示,玻璃轉移溫度(Tg)與最低成膜溫度(MFT)均高於30℃之水系聚合物乳化液7與10中未形成膜。就水系聚合物乳化液12及13而言,若浸漬於純水時則混濁,膨潤率全部超過30%,耐水性不良。另一方面,就水系聚合物乳化液3、5、6、8、9而言,即使浸漬於純水亦維持透明至半透明,膨潤率未達30%,耐水性良好。
[試驗例2]添加物:可塑劑之探討1
秤量一定之添加物10質量%後,於其中添加上述水系聚合物乳化液6,成為100質量%。將該液體以攪拌機(IKA T18basic(ULTRA-TURRAX公司製))攪拌1分鐘。使用所得到的液體0.5g,與試驗例1同樣地進行膜調製,評價所得到的膜之氣泡狀態、透明性、柔軟性、伸縮性、強度,及耐水性(色調與柔軟性)(n=3)。又,各算出所得到的膜之膨潤率。
各試驗中,氣泡與透明性之評價係對所得到的膜以目視進行。柔軟性之評價係將所得到的膜以手指折彎來進行,伸縮性之評價係所得到的膜以手指拉伸來進行,強度之評價係將所得到的膜以手指複數次折彎來進行。耐水性之評價係將所得到的膜於加入有純水的玻璃容器中室溫下浸漬24小時,浸漬後從玻璃容器將膜取出,擦拭表面之水分後,顏色係以目視、柔軟性係就折彎時的硬度之觀點來進行。各自藉由評分方式進行評價(以下之試驗亦同)。其結果示於表3及表4。
如表3及表4所示,僅以水系聚合物乳化液6形成皮膜時,該皮膜強度佳,若浸漬於純水時維持透明,膨潤率為9.3%而耐水性優良,但稍欠缺柔軟性,幾乎無伸縮性。於水系聚合物乳化液6中添加多元醇或多糖類時,雖提高所得到的膜之柔軟性及伸縮性,但將該膜浸漬於純水時會混濁,耐水性惡化。又,若摻合界面活性劑時,亦有基劑凝集的情況,但添加作為酯系之非離子性界面活性劑的單油酸聚乙二醇時,所得到的膜之柔軟性及伸縮性改善,將該膜浸漬於純水時之膨潤率為20%以下,維持半透明。就纖維素類而言,特別是羥基丙基纖維素會改善所得到的膜之柔軟性及伸縮性,將該膜浸漬於純水時之膨潤率為20%以下,維持半透明。
[試驗例3]添加物:可塑劑之濃度之探討
試驗例2中,由於作為酯系非離子性界面活性劑的單油酸聚乙二醇之結果良好,故針對單油酸聚乙二醇之添加量進行探討。試驗係使用水系聚合物乳化液6與9作為皮膜形成劑,與試驗例2同樣地進行膜調製,針對所調製的膜進行與試驗例2相同的評價(n=3)。其結果示於表5與表6。
如表5及表6所示,皮膜形成劑之水系聚合物乳化液6及9,均隨著單油酸聚乙二醇(可塑劑)之濃度增加,膨潤率增加,耐水性(顏色)亦為半透明~混濁而顯示降低傾向。
就外觀(氣泡、透明性)、柔軟性、伸縮性、強度及耐水性優良而言,使用水系聚合物乳化液6時,單油酸聚乙二醇之添加量為0.5~2.5質量%之範圍內,使用水系聚合物乳化液9時,單油酸聚乙二醇之添加量為1.0~2.5質量%之範圍,該範圍的膨潤率為30%以下。
[試驗例4]添加物:可塑劑之探討2
試驗例2中,由於作為酯系非離子性界面活性劑的單油酸聚乙二醇之結果良好,故針對數種單脂肪酸聚乙二醇系界面活性劑亦與試驗例2同樣地進行膜調製,針對所調製的膜進行與試驗例2相同之評價(n=3)。其結果示於表7與表8。
如表7及表8所示,所探討的全部的單脂肪酸聚乙二醇中,所得到的膜之柔軟性及伸縮性改善,將該膜浸漬於純水時之膨潤率為30%以下,耐水性亦優良。
[試驗例5]添加物:油分之探討1
於上述水系聚合物乳化液6中添加單月桂酸聚乙二醇(MYL-10V)與一定的水不溶性油分(添加量:1.25質量%及2.50質量%),與試驗例2同樣地進行膜調製,針對所調製的膜進行與試驗例2相同之評價(n=3)。又,其結果示於表9及表10。
如表9及表10所示,可知於單月桂酸聚乙二醇1.25質量%及2.50質量%摻合下,摻合了如肉豆蔻酸異丙酯、肉豆蔻酸辛基十二烷酯、乙酸生育酚、三(辛酸/癸酸)甘油酯、癸二酸二乙酯之酯類;如油酸之脂肪酸;如聚二甲基矽氧烷之聚矽氧;如荷荷芭油之植物油;如流動石蠟、鯊烷之烴類的情況,亦形成柔軟性、伸縮性、強度及耐水性優良的皮膜。
[試驗例6]添加物:油分之探討2
於上述水系聚合物乳化液9中,添加單油酸聚乙二醇(MYO-10V)與一定的水不溶性油分(添加量:1.00質量%、塗佈量:0.5g),與試驗例2同樣地進行膜調製,針對所調製的膜進行與試驗例2相同之評價(n=3)。又,其結果示於表11及表12。
如表11及表12所示,可知於單油酸聚乙二醇1.00質量%摻合下,摻合了如肉豆蔻酸異丙酯、肉豆蔻酸辛基十二烷酯、乙酸生育酚、三(辛酸/癸酸)甘油酯、癸二酸二乙酯之酯類;如油酸之脂肪酸;如聚二甲基矽氧烷之聚矽氧;如荷荷芭油之植物油;如流動石蠟、鯊烷之烴類的情況,亦形成柔軟性、伸縮性、強度及耐水性優良的皮膜。
由以上結果明顯可知,本發明基劑由於摻合有水不溶性之油分,故即使摻合疏水性藥物,亦可抑制其凝集或沈澱。特別是作為該油分之酯類,一般而言亦發揮皮膚吸收促進效果,因此藥物之吸收促進效果受到期待。
[產業上之可利用性]
本發明基劑,例如有用於作為雜貨等之非醫藥用外用劑及液體絆創膏等之醫藥用外用劑的基劑。該非醫藥用外用劑有用於日常生活領域,醫藥用外用劑有用於醫藥品領域。
Claims (13)
- 一種非水膨潤性之皮膜形成型外用劑基劑,其含有如下成分A~成分C: A)由選自丙烯酸烷酯共聚物及丙烯酸烷酯/苯乙烯共聚物的聚合物粒子分散於水介質中之水系聚合物乳化液所構成的皮膜形成劑,其中前述聚合物之玻璃轉移溫度及前述乳化液之最低成膜溫度均為30℃以下,且將所形成的皮膜浸漬於水中24小時使其膨潤時之由下述式所算出的膨潤率未達30%, 膨潤率(%)=(W2-W1)/W1×100 (式中,W1表示浸漬前重量(g)、W2表示浸漬後重量(g)); B)單脂肪酸聚乙二醇系界面活性劑;及 C)作為乘載體溶劑之水及基劑總量中0~10質量%之範圍內的有機溶劑。
- 如請求項1之皮膜形成型外用劑基劑,其進一步含有水不溶性之油分。
- 如請求項1之皮膜形成型外用劑基劑,其中上述聚合物粒子之平均粒子徑,為10~300nm之範圍內。
- 如請求項1之皮膜形成型外用劑基劑,其中上述水系聚合物乳化液中之聚合物固體成分量,為20~70質量%之範圍內。
- 如請求項1之皮膜形成型外用劑基劑,其進一步含有羥基丙基纖維素。
- 如請求項2之非水膨潤性之皮膜形成型外用劑基劑,其中上述水不溶性之油分,為選自由酯類、烴類、脂肪酸、動植物油,及聚矽氧所成之群的1種以上。
- 如請求項6之皮膜形成型外用劑基劑,其中酯類為肉豆蔻酸異丙酯、肉豆蔻酸辛基十二烷酯、乙酸生育酚、三(辛酸/癸酸)甘油酯,或癸二酸二乙酯;烴類為流動石蠟、鯊烷或凡士林;脂肪酸為月桂酸、肉豆蔻酸、硬脂酸、異硬脂酸,或油酸;動植物油為蓖麻油、荷荷芭油,或夏威夷豆油;或聚矽氧為聚二甲基矽氧烷。
- 一種非醫藥用外用劑,其含有如請求項1~7中任一項之皮膜形成型外用劑基劑。
- 一種醫藥用外用劑,其含有如請求項1~7中任一項之皮膜形成型外用劑基劑與藥效成分。
- 如請求項9之醫藥用外用劑,其為液體絆創膏。
- 如請求項9之醫藥用外用劑,其中上述藥效成分,為殺菌消毒劑、足癬藥、止癢劑、保濕劑,或鎮痛消炎劑。
- 如請求項8之非醫藥用外用劑,其中外用劑被封入於推針型容器、滾珠容器或迷你滾珠容器、噴霧容器,或附刷毛容器。
- 如請求項9之醫藥用外用劑,其中外用劑被封入於推針型容器、滾珠容器或迷你滾珠容器、噴霧容器,或附刷毛容器。
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