CN117597148A - 非水膨润性的皮膜形成型外用剂基剂 - Google Patents
非水膨润性的皮膜形成型外用剂基剂 Download PDFInfo
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- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L26/00—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
- A61L26/0009—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form containing macromolecular materials
- A61L26/0014—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form containing macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
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- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
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Abstract
本发明的技术问题为提供用于皮肤刺激性低、有速干性,且耐水性等优良的非水膨润性的皮膜形成型外用剂的基剂。本发明例如可举出包含如下成分A~成分C的非水膨润性的皮膜形成型外用剂基剂:A)由(甲基)丙烯酸类聚合物等的聚合物粒子分散于水介质中而成的水性聚合物乳剂所构成的皮膜形成剂,其中所述聚合物的玻璃化转变温度及所述乳剂的最低成膜温度均为30℃以下,且将所形成的皮膜浸渍于水中24小时使其膨润时的由下述式所算出的膨润率小于30%,膨润率(%)=(W1‑W2)/W1×100(式中,W1为浸渍前重量(g)、W2为浸渍后重量(g));B)酯类非离子性表面活性剂等增塑剂;及C)载体溶剂,其为水、或水及基剂总量中小于20质量%的有机溶剂。
Description
技术领域
本发明属于外用剂的技术领域。本发明涉及用于在使用前为液态或凝胶状,但若涂布于皮肤时,载体成分的溶剂挥发,于皮肤上形成皮膜的皮膜形成型外用剂(例如液态绊创膏)的基剂。本发明的皮膜形成型外用剂基剂,具有即使将形成于皮肤上的皮膜暴露于水也不易膨润的特性,故为非水膨润性。
技术背景
作为施用于皮肤的外用剂之一,已知有于使用前为液态或凝胶状,但若涂布于皮肤时,载体成分的溶剂蒸发,于皮肤上形成皮膜的皮膜形成型外用剂(例如液体绊创膏)。该皮膜形成型外用剂,剥离时的物理刺激少,可依损伤部位的大小、形状形成皮膜,故为便利的。此外,也可以容器直接涂布。
作为皮膜形成型外用剂的皮膜形成剂,自以往起,例如已知有羟丙基纤维素、纤维素类树脂、聚乙烯醇及聚乙烯吡咯烷酮等水溶性高分子(专利文献1~3)、(甲基)丙烯酸类聚合物(专利文献4)、焦木素(专利文献5)。
水性聚合物乳剂为于水等水性溶剂中分散有聚合物粒子的乳剂,若该水性溶剂挥发时,通过聚合物粒子彼此成为一起而熔接及变形,从而形成皮膜。该水性聚合物乳剂,例如于化妆品领域中使用,专利文献6中,公开了涉及使用了水性聚合物乳剂的人工爪被覆用组合物的发明。
现有技术文献
专利文献
[专利文献1]日本特开昭59-139325号公报
[专利文献2]日本特开平03-275619号公报
[专利文献3]日本特开平06-157327号公报
[专利文献4]日本特开平09-2943号公报
[专利文献5]日本特开平05-58914号公报
[专利文献6]日本特开2015-199702号公报
发明内容
所要解决的技术问题
以往的皮膜形成型外用剂中为了谋求迅速形成皮膜,而使用醇、有机溶剂作为载体成分,但存在该醇、有机溶剂所致的皮肤刺激、或皮膜形成而成的膜无耐水性的问题。就(甲基)丙烯酸类聚合物、焦木素而言,形成具有耐水性的皮膜,但配合醇、有机溶剂所致的皮肤刺激仍强。对皮肤的刺激性,可通过以凝胶或乳膏、软膏等的形态施用,而某种程度地避免,但如此一来存在新诱发如涂布部的黏附或对衣服的附着的问题的风险。此外,为了洗去凝胶等,涂布后必需清洗手指。此外,至今为止的皮膜形成型外用剂中,尚未发现充分满足如皮肤刺激性低、有速干性、密合于皮肤而吸收性、耐水性优良,进而有柔软性、伸缩性及强度这样的条件的。
另一方面,就以水为载体溶剂的水性外用剂而言,虽可避免对皮肤的刺激性,但由于为水性故干燥慢,皮膜的形成需要时间。此外,当用于医药时,药效成分中为多的疏水性药物由于难溶于水故难以配合于水性的外用剂中,在水性外用剂中配合药物时,有限于亲水性药物的风险。
本发明的主要技术问题为提供用于皮肤刺激性低、有速干性,此外,满足如耐水性、柔软性、伸缩性及强度这样的条件的新颖的非水膨润性的皮膜形成型外用剂的基剂。
解决技术问题的手段
为了解决所述技术问题,本发明者深入探讨的结果,发现通过在由一定的水性聚合物乳剂所构成的皮膜形成剂中添加数种添加物,可解决所述技术问题,而完成本发明。
本发明例如可举出下述方式。
[1]一种非水膨润性的皮膜形成型外用剂基剂,其包含如下成分A~成分C:
A)皮膜形成剂,其由选自(甲基)丙烯酸类聚合物及分子内包含(甲基)丙烯酸类单体的共聚物的聚合物粒子分散于水介质中而成的水性聚合物乳剂所构成,其中所述聚合物的玻璃化转变温度及所述乳剂的最低成膜温度均为30℃以下,且将所形成的皮膜浸渍于水中24小时使其膨润时的由下述式所算出的膨润率小于30%,
膨润率(%)=(W1-W2)/W1×100
(式中,W1表示浸渍前重量(g)、W2表示浸渍后重量(g));
B)增塑剂,其为选自酯类非离子性表面活性剂及纤维素类中的1种以上;及
C)载体溶剂,其为水、或水及基剂总量中小于20质量%的有机溶剂。
[2]根据所述[1]所述的皮膜形成型外用剂基剂,其进一步包含水不溶性的油分。
[3]根据所述[1]所述的皮膜形成型外用剂基剂,其中,所述聚合物为(甲基)丙烯酸烷基酯聚合物、或包含(甲基)丙烯酸烷基酯单体的共聚物。
[4]根据所述[1]所述的皮膜形成型外用剂基剂,其中,以动态光散射法测定时的所述聚合物粒子的平均粒径为10~300nm的范围内。
[5]根据所述[1]所述的皮膜形成型外用剂基剂,其中,所述水性乳剂中的聚合物固体成分量为20~70质量%的范围内。
[6]根据所述[1]所述的皮膜形成型外用剂基剂,其中,所述酯类非离子性表面活性剂为聚乙二醇单脂肪酸酯,所述纤维素类为羟丙基纤维素。
[7]根据所述[1]所述的非水膨润性的皮膜形成型外用剂基剂,其中,所述水不溶性的油分为选自酯类、烃类、脂肪酸、动植物油及聚硅氧烷中的1种以上。
[8]根据所述[7]所述的皮膜形成型外用剂基剂,其中,酯类为肉豆蔻酸异丙酯、肉豆蔻酸辛基十二烷酯、生育酚乙酸酯、三(辛酸/癸酸)甘油酯、或癸二酸二乙酯;烃类为液体石蜡、角鲨烷、或凡士林;脂肪酸为月桂酸、肉豆蔻酸、硬脂酸、异硬脂酸、或油酸;动植物油为蓖麻油、荷荷巴油、或澳洲坚果油;或聚硅氧烷为聚二甲基硅氧烷。
[9]一种非医药用外用剂,其包含根据所述[1]~[8]中任一项所述的皮膜形成型外用剂基剂。
[10]一种医药用外用剂,其包含根据所述[1]~[8]中任一项所述的皮膜形成型外用剂基剂与药效成分。
[11]根据所述[10]所述的医药用外用剂,其为液体绊创膏。
[12]根据所述[10]所述的医药用外用剂,其中,所述药效成分为杀菌消毒剂、足癣药、止痒剂、保湿剂、或镇痛消炎剂。
[13]根据所述[9]所述的非医药用外用剂,其中,外用剂被封入于推针型容器、迷你滚珠容器或迷你滚珠容器、喷雾容器、或附刷毛容器。
[14]根据所述[10]所述的医药用外用剂,其中,外用剂被封入于推针型容器、滚珠容器或迷你滚珠容器、喷雾容器、或附刷毛容器。
发明效果
本发明的非水膨润性的皮膜形成型外用剂基剂(以下称“本发明基剂”),由于载体溶剂基本上为水,故不仅即使对皮肤涂布刺激性也少,且可无迟滞地干燥,而于皮肤上形成皮膜。此外,例如柔软性、伸缩性、耐水性优良。而一旦成膜时,即使暴露于水也不易膨润,因此可比较长时间停留于皮肤上。此外,使用本发明基剂作为医药用外用剂的基剂时,可广泛地配合从亲水性药物到疏水性药物。
具体实施方式
1本发明基剂
本发明基剂,其特征为包含如下成分A~成分C。
A)皮膜形成剂,其由选自(甲基)丙烯酸类聚合物及分子内包含(甲基)丙烯酸类单体的共聚物的聚合物粒子分散于水介质中而成的水性聚合物乳剂所构成,其中所述聚合物的玻璃化转变温度及所述乳剂的最低成膜温度均为30℃以下,且将所形成的皮膜浸渍于水中24小时使其膨润时的由下述式所算出的膨润率小于30%。
膨润率(%)=(W1-W2)/W1×100
(式中,W1及W2与所述同义)。
B)增塑剂,其为选自酯类非离子性表面活性剂及纤维素类中的1种以上。
C)载体溶剂,其为水、或水及基剂总量中小于20质量%的有机溶剂。
1.1关于成分A
本发明基剂包含成分A。成分A为皮膜形成剂,其由选自(甲基)丙烯酸类聚合物及分子内包含(甲基)丙烯酸类单体的共聚物的聚合物粒子分散于水介质中而成的水性聚合物乳剂所构成,该皮膜形成剂中,所述聚合物的玻璃化转变温度(Tg)、及所述乳剂的最低成膜温度(MFT:Minimum Film-forming Temperature)均为30℃以下,且将所形成的皮膜浸渍于水中24小时使其膨润时的由下述式所算出的膨润率小于30%。该皮膜形成剂的成分A为水溶液。
膨润率(%)=(W1-W2)/W1×100
(式中,W1及W2与所述同义)。
水性聚合物乳剂,如前所述为于水等水性溶剂中分散有聚合物粒子者,若该水性溶剂挥发时,聚合物粒子彼此成为一起而熔接及变形,从而形成皮膜。因而,基本上通过成分A,于皮肤上形成由聚合物等所构成的皮膜。此外,分散有聚合物粒子的水基本上作为本发明基剂的载体溶剂。因此,本发明基剂包含水。
成分A中的水性聚合物乳剂或其中所包含的聚合物,Tg及MFT均为30℃以下,优选Tg及MFT均为28℃至26℃~-15℃的范围内。如由后述试验结果明显可知,由Tg及MFT的任一者高于30℃的聚合物所构成的水性乳剂,难以于皮肤上形成皮膜。
玻璃化转变温度(Tg)为本领域技术人员众所周知的物性,可通过常规方法求得。具体而言,例如可举出一边使聚合物试样的温度慢慢上升或下降一边测定力学物性的变化或吸热/放热的方法(例如差示扫描热量测定(DSC)、差热分析(DTA))、机械式分光术(动态黏弹性测定)法。此外,可通过所谓的Fox公式计算Tg。
最低成膜温度(MFT)为以均质且透明的皮膜的形态凝集的最低温度,可通过常规方法,以最低成膜温度测定装置来求得。
此外,就本发明的水性聚合物乳剂所形成的皮膜而言,由所述式所算出的膨润率小于30%,若该膨润率为30%以上,则存在将形成于皮肤上的皮膜暴露于水时有白浊而耐水性不良的风险。
成分A中的水性聚合物乳剂的聚合物由(甲基)丙烯酸类聚合物及分子内包含(甲基)丙烯酸类单体的共聚物中选择。此处,“(甲基)丙烯酸,”意指一并称呼丙烯酸与甲基丙烯酸的用语。
本发明中,优选为以(甲基)丙烯酸烷基酯为主要构成单体的聚合物或共聚物((甲基)丙烯酸烷基酯聚合物)。其中,例如也可以以(甲基)丙烯酸、或疏水性单体、亲水性单体的1种以上作为构成单体而含于分子内。
作为所述聚合性单体的(甲基)丙烯酸烷基酯,例如可举出(甲基)丙烯酸甲酯、(甲基)丙烯酸乙酯、(甲基)丙烯酸异丙酯、(甲基)丙烯酸正丁酯、(甲基)丙烯酸异丁酯、(甲基)丙烯酸正戊酯、(甲基)丙烯酸异戊酯、(甲基)丙烯酸正己酯、(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)丙烯酸环己酯、(甲基)丙烯酸苯酯、(甲基)丙烯酸苄酯、(甲基)丙烯酸异戊酯。其中优选为(甲基)丙烯酸甲酯、(甲基)丙烯酸乙酯、(甲基)丙烯酸正丁酯、(甲基)丙烯酸异丁酯、(甲基)丙烯酸正丁酯、(甲基)丙烯酸异丁酯、(甲基)丙烯酸异戊酯。此等可为1种、也可为任意的2种以上。
所述疏水性单体例如可举出苯乙烯、2-甲基苯乙烯、叔丁基苯乙烯、氯苯乙烯等苯乙烯类单体;丙烯酸烯丙酯等烯丙基类单体;氯乙烯等氯乙烯类单体;丁基缩水甘油醚、(甲基)丙烯酸缩水甘油酯、(甲基)丙烯酸二缩水甘油酯、烯丙基缩水甘油醚等环氧类单体;二甲基硅氧烷等聚硅氧烷类单体;胺基甲酸酯等胺基甲酸酯类单体。
所述亲水性单体例如可举出(甲基)丙烯酸2-羟基乙酯、(甲基)丙烯酸羟基丙酯等在侧链具有羟基的(甲基)丙烯酸烷基酯;丙烯酰胺、马来酸酰胺、N-羟甲基(甲基)丙烯酰胺等酰胺类单体;马来酸酐等马来酸类单体、乙酸乙烯酯等乙烯基类单体。
成分A中的水性聚合物乳剂的制造方法不特别限制,例如可通过将丙烯酸类单体、乳化剂等原料于水中均匀分散,将该单体以乳化剂进行胶束化,并对其添加聚合引发剂(例如过氧化氢、过氧乙酸、叔丁基氢过氧化物、过氧苯甲酸)加热并乳液聚合,来制造该水性聚合物乳剂。此外,也可通过使用了反应性乳化剂的无皂聚合法、或不含乳化剂的水介质不均匀聚合法等手法来制造。
所述乳化剂例如可举出聚氧乙烯壬基苯基醚等聚氧乙烯烷基苯基醚、聚氧乙烯十二烷基醚等聚氧化烯烷基醚等非离子类乳化剂;聚氧化烯烷基醚硫酸酯铵、聚氧乙烯月桂基醚硫酸酯钠、2-乙基己基硫酸酯钠、二辛基磺琥珀酸钠等的阴离子类乳化剂。
成分A中的水性聚合物乳剂中的聚合物粒子的平均粒径不特别限制,以动态光散射法(DLS)进行测定时,以重均粒径计,例如以10~300nm的范围内为适当,优选为30~200nm的范围内、更优选为40~200nm的范围内。该平均粒径例如可使用纳米粒径测定装置Nanotrac WaveII(MICROTRAC公司制)、Z etasizer PRO(Spectris公司制)来测定。
成分A中的水性聚合物乳剂中的聚合物固体成分量不特别限制,以20~70质量%的范围内为适当,优选为35~55质量%的范围内。
成分A中的水性聚合物乳剂的1%水溶液的黏度,于室温下为1~10000m Pa·s,优选为3~5000mPa·s、更优选为5~3000mPa。
成分A中的水性聚合物乳剂有市售,本发明中可使用市售品。其具体例子,可举出丙烯酸烷基酯乳剂(COVACRTL MS11 WP(Sensient Technologies公司制)、YODOSOL GH810F(Nouryon Japan公司制)、Vinysol 1086WP(大同化成工业公司制)等)、丙烯酸烷基酯/苯乙烯共聚乳剂(TODOSOL GH41H(No uryon Japan公司制)、Vinysol 1012JC(大同化成工业公司制)等)。
本发明基剂中的成分A的含量,可依期望适当设定,不特别限制。
1.2关于成分B
成分B为增塑剂,其为选自酯类非离子性表面活性剂及纤维素类中的1种以上,本发明基剂包含该成分B。成分B对形成于皮肤上的皮膜(成膜)赋予柔软性与伸缩性,维持成膜的耐水性。
此处“酯类非离子性表面活性剂”是指溶解于中性水时,具有不离子化的亲水基团的表面活性剂,其具备甘油、二醇、乙二醇、山梨醇、蔗糖等多元醇与脂肪酸进行酯键合而得的结构。
成分B中的酯类非离子性表面活性剂,例如可举出聚氧化烯脂肪酸酯、高级醇脂肪酸酯、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,例如可举出聚乙二醇(单、二、三)脂肪酸酯。该脂肪酸,例如可举出硬脂酸、油酸、异硬脂酸、月桂酸、鲸蜡基醚硬脂酸、硬脂基醚硬脂酸。作为成分B中的酯类非离子性表面活性剂的具体例子,可举出聚乙二醇单硬脂酸酯(例如MYS-10V、MYS-25V、MYS-45MV、MYS-55MV(Nikko Chemicals公司制))、聚乙二醇单油酸酯(例如MYO-10V(Nikko Chemicals公司制))、聚乙二醇单异硬脂酸酯、聚乙二醇单月桂酸酯(例如MYL-10V(Nikko Chemicals公司制))、聚乙二醇二月桂酸酯、聚乙二醇二硬脂酸酯、聚乙二醇二油酸酯。其中,优选聚乙二醇单脂肪酸酯,其中更优选聚乙二醇单油酸酯、聚乙二醇单月桂酸酯。
作为成分B中的纤维素类,例如可举出羟丙基纤维素、羟丙甲纤维素(hypromellose)、疏水化羟丙基甲基纤维素。其中优选羟丙基纤维素。
成分B可为所述任1种,也可组合使用任意2种以上。
本发明基剂中的成分B的含量根据期望而适当设定,不特别限制,以0.01~50质量%的范围内为适当,优选为0.1~30质量%的范围内、更优选为0.5~20质量%的范围内。少于0.01质量%时,有得不到充分的柔软性、伸缩性的风险,多于50质量%时,有对形成于皮肤上的皮膜的柔软性、伸缩性或耐水性造成不良影响的风险。
1.3关于成分C
本发明基剂,包含水或水及本发明基剂总量中小于20质量%的有机溶剂,作为载体溶剂。此处“载体溶剂,”是指至将使用本发明基剂的制剂施用于皮肤为止,用以将皮膜形成剂的成分A、增塑剂的成分B等保持于基剂中的介质,其于皮肤施用后,最终会蒸发而消失。该载体溶剂以下称为“成分C。”
成分C基本上仅有水,本发明基剂中优选不包含机溶剂(0质量%)。成分C包含有机溶剂时,在本发明基剂总量中为小于20质量%,优选为小于15质量%、更优选为小于10质量%、进一步优选为小于5质量%或小于1质量%,应尽可能少。由于成分C基本上为水或包含水与仅少许的有机溶剂,故本发明基剂为低刺激性的。此外,耐水性也良好。
由于成分C最终会蒸发而消失,故本发明基剂中所包含的有机溶剂,通常为挥发性有机溶剂或低沸点有机溶剂,具体而言,例如可举出低级(碳数1~4左右)一元醇(例如甲醇、乙醇、丙醇、异丙醇、异丁醇)、丙酮、乙酸乙酯、甲醚、***。一般而言为作为低级一元醇的乙醇。
成分C,如上所述,基本上为水,故包含乙醇等低级一元醇的有机溶剂,在本发明基剂中也可不包含,就刺激性的观点,优选为不包含。
1.4关于成分D
本发明基剂,可包含水不溶性的油分。该油分以下也称为“成分D。”成分D可协助疏水性药物溶解于本发明基剂,可使于本发明基剂中配合该药物为容易的。因此,成分D也可称为用于药物(药效成分)的增溶剂、溶解促进剂等。因而,本发明基剂除了可用于非医药用外用剂的制备以外,通过于本发明基剂中包含成分D,可更扩展对医药用外用剂的用途。
此处“水不溶性的油分”是指对于20℃的中性水的溶解度为100μg/mL以下的油性的化合物。作为成分D中的水不溶性的油分,只要符合所述目的则不特别限制,可适当选择,例如可举出酯类、烃类、脂肪酸、动植物油、聚硅氧烷。
酯类具体而言,例如可举出异辛酸鲸蜡酯、肉豆蔻酸异丙酯、棕榈酸异丙酯、肉豆蔻酸辛基十二烷酯、三辛酸甘油酯、二异硬脂酸聚甘油酯、三异硬脂酸二甘油酯、三-二十二酸甘油酯、三(辛酸/癸酸)甘油酯、苹果酸二异硬脂酯、二辛酸新戊二醇、癸二酸二乙酯、胆固醇脂肪酸酯、N-月桂酰基-L-谷氨酸二(胆固醇酯/二十二烷酯/辛基十二烷酯)、生育酚乙酸酯。
烃类具体而言,例如可举出液体石蜡、轻质液体石蜡、角鲨烷、凡士林。
脂肪酸具体而言,例如可举出二十二酸、月桂酸、肉豆蔻酸、硬脂酸、异硬脂酸、油酸。
动植物油具体而言,例如可举出鳄梨油、亚麻仁油、杏仁油、橄榄油、可可油、牛油、桐油、小麦胚芽油、芝麻油、米胚芽油、米糠油、红花籽油、大豆油、月见草油、山茶油、玉米油、菜籽油、马油、杏子油、棕榈油、棕榈仁油、蓖麻油、葵花油、猪油、葡萄籽油、荷荷巴油、澳洲坚果油、貂油、绵籽油、木蜡、蜂蜡、白蜂蜡、椰子油、硬化椰子油、花生油、羊毛脂、蛋黄油、玫瑰果油。
聚硅氧烷具体而言,例如可举出二甲基聚硅氧烷(聚二甲基硅氧烷)、高聚合甲基聚硅氧烷烷、甲基苯基聚硅氧烷烷、甲基氢聚硅氧烷烷、八甲基环四硅氧烷、八甲基环五硅氧烷、十甲基环六硅氧烷、硬脂氧基聚硅氧烷等高级烷氧基改性聚硅氧烷、烷基改性聚硅氧烷、高级脂肪酸酯改性聚硅氧烷。
所述水不溶性的油分可为所述任1种,也可组合使用任意2种以上。
本发明基剂中的成分D的含量根据期望而适当设定,不特别限制,以0.01~50质量%的范围内为适当,优选为0.5~25质量%的范围内、更优选为1~10质量%的范围内。少于0.01质量%时,有疏水性药物在基剂中的溶解不充分的情况,多于50质量%时,有对形成于皮肤上的皮膜的柔软性、伸缩性或耐水性造成不良影响的风险。
1.5其他
本发明基剂基本上不含乙醇等低级醇。因此,可称为非醇性水性基剂。
本发明基剂中,在不损害本发明的效果的范围,可依期望配合其他添加剂。该添加剂例如可举出稳定(化)剂、增溶剂、抗氧化剂、湿润剂、清凉化剂、着色剂、香味剂(香料)、乳化剂、黏着剂、黏着增强剂、黏稠(化)剂、pH调整剂、防腐剂、溶剂、收敛剂、螯合剂、增黏剂、刺激减低剂。
所述稳定(化)剂例如可举出抗坏血酸、乙二胺四乙酸钠水合物、氯化钠、氯化镁。
所述增溶剂例如可举出三乙酸甘油酯、D-甘露醇、D-山梨醇、苯甲酸苄酯、三氨基甲烷、胆固醇、三乙醇胺、碳酸钠、柠檬酸钠。
所述抗氧化剂例如可举出丁基羟基苯甲醚、亚硫酸钠、抗坏血酸及其盐、亚硫酸氢钠、亚硫酸钠、焦亚硫酸钠、苯并***、盐酸半胱氨酸、柠檬酸。
湿润剂例如可举出1,3-丁二醇、甲基纤维素、月桂基硫酸钠。
清凉化剂例如可举出薄荷醇(l-薄荷醇、dl-薄荷醇等)、樟脑(d-樟脑、dl-樟脑等)、氯丁醇、香叶醇、桉叶素、茴香脑、柠檬烯、龙脑等萜类、包含萜类的精油(薄荷油)。
所述着色剂例如可举出焦油色素(褐色201号、蓝色201号、黄色4号、黄色403号等)、焦糖、铜叶绿素钠、亚甲蓝、栀子色素、万寿菊色素、胡萝卜素色素、花青素色素、果汁色素、蔬菜色素、三氧化二铁等合成或天然来源的色素。
所述香味剂(香料)例如可举出丁香油、向日花香醛、d-龙脑。
所述乳化剂例如可举出蔗糖脂肪酸酯、氢化大豆磷脂质。
所述黏着剂例如可举出羧基乙烯基聚合物、羧甲基纤维素钠。
所述黏着增强剂例如可举出黄原胶、聚乙二醇(Macrogol)6000。
所述黏稠(化)剂例如可举出硅酸镁铝、聚乙烯醇。
所述pH调整剂例如可举出柠檬酸、柠檬酸钠、柠檬酸酐、苹果酸、马来酸、琥珀酸、富马酸、酒石酸、酒石酸钠、乳酸、乳酸钙、乳酸钠、乙酸、乙酸钠、冰醋酸等有机酸或其盐;盐酸、硫酸、磷酸、硼酸、磷酸氢钠、磷酸二氢钾、磷酸二氢钠、碳酸钠、碳酸氢钠等无机酸或其盐;氢氧化钠、氢氧化钾、氢氧化钙、氢氧化镁、硼砂等氢氧化碱;单乙醇胺、三乙醇胺、二乙醇胺、二异丙醇胺、三异丙醇胺等胺类。
所述防腐剂例如可举出对羟基苯甲酸甲酯、对羟基苯甲酸乙酯、对羟基苯甲酸丙酯、对羟基苯甲酸异丙酯、对羟基苯甲酸丁酯、对羟基苯甲酸异丁酯、对羟基苯甲酸苄酯、苯甲酸、苯甲酸钠、苯甲酸、苯甲酸苄酯、去氢乙酸钠、苯扎氯铵(benzalkonium chloride)、氯化鲸蜡基吡啶鎓、苄索氯铵(benz ethonium chloride)、氨基乙基磺酸、苯氧基乙醇、氯丁醇、苄醇、苯乙醇、百里酚、山梨酸及其盐。
所述溶剂例如可举出浓甘油、丙二醇、苄醇。
所述收敛剂例如可举出明矾、硫酸锌、硫酸铝钾、碱性乳酸铝锌等金属盐;单宁酸、柠檬酸、乳酸、琥珀酸等有机酸;源自植物(例如海藻、百里香、红茶、乌龙茶、绿茶、小连翘、金缕梅、枇杷、牡丹皮、虎耳草、博士茶、紫云英、朝鲜蓟、洋甘菊、桉树、柠檬、迷迭香、地榆、鼠尾草等)的成分。
所述螯合剂例如可举出乙二胺四乙酸(依地酸)、乙二胺四乙酸盐(钠盐(乙二胺四乙酸钠:日本药典、EDTA-2Na等)、钾盐等)、植酸、葡萄糖酸、多磷酸、偏磷酸。
所述增黏剂例如可举出瓜尔胶、果胶、普鲁兰糖、明胶、刺槐豆胶、鹿角菜胶、琼脂、聚葡甘露糖、卡德兰胶、结冷胶、黄原胶、聚乙二醇、膨润土、海藻酸、海藻酸丙二醇、聚乙二醇(Macrogol)、软骨素硫酸钠、玻尿酸、玻尿酸钠。
所述刺激减低剂例如可举出明胶、***胶、普鲁兰糖、α化淀粉、洋菜、西黄蓍胶、海藻酸钠、海藻酸丙二醇酯、甘草萃取物、2-甲基丙烯酰氧基乙基磷酸胆碱。
所述添加剂依期望可为任1种,也可组合使用任意2种以上。
本发明基剂通常具有pH2~9的液性,就对皮肤的刺激性及皮肤使用感的观点,优选为pH3~8、更优选为pH4~8、特别优选为pH5~8。需要说明的是,该pH可通过所述pH调整剂的使用而适当调整。
本发明基剂只要具备1~10000mPa·s的范围内的黏度即可,就手指取用性、涂布容易性等的观点,优选为3~5000mPa·s的范围内、更优选为5~3000mPa·s的范围内。
本发明基剂所形成的皮膜,优选由所述式算出的膨润率小于30%、更优选为20%以下、特别优选为10%以下。该膨润率为30%以上时,形成于皮肤上的皮膜暴露于水时有白浊而耐水性不良的风险。该膨胀率的下限,例如可举出完全不膨胀的0%。
本发明基剂的制造方法不特别限制,可通过适当选择并配合本发明基剂的制备所必要的各种成分,并使用适当的搅拌机以常规方法进行搅拌等,来制造本发明基剂。
2本发明基剂的用途等
本发明基剂,可作为用于作为非医药品的皮膜形成型外用剂、或配合有医药品相关药效成分的皮膜形成型外用剂的基剂使用。本发明中,可包含含有本发明基剂且不含药效成分的杂货、化妆品等非医药用外用剂、及包含本发明基剂与药效成分的医药用外用剂。
作为本发明的非医药用外用剂的其一方式,可举出液体手套等杂货、睫毛膏等化妆品。
作为本发明的医药用外用剂的其一方式,可举出液体绊创膏、鸡眼/老茧用剂。以下将本发明的非医药用外用剂与本发明的医药用外用剂一并称为“本发明外用剂。”
医药用的本发明外用剂中,可配合从亲水性药物到疏水性药物的广范围的药效成分。亲水性药物,可直接配合于本发明基剂中,疏水性药物可直接或溶解于水不溶性的油分来进行配合。该药物(药效成分)例如可举出杀菌消毒剂、足癣药、止痒剂、保湿剂、镇痛消炎剂、抗组胺剂、抗炎剂、局部麻醉剂、角质软化剂、组织修复剂、皮肤保护剂、维生素剂。
医药用的本发明外用剂的制造方法不特别限制,例如可通过将本发明基剂及所期望的药效成分,以及依需要的添加物以常规方法用搅拌机等实施搅拌混合等操作来制造。更详细而言,例如可通过包含下述工序的方法,来制造医药用的本发明外用剂。非医药用的本发明外用剂的情况时,除了下述工序1外,可同样地进行制造。
工序1:将药物(药效成分)溶解(药物相)。
工序2:于本发明的水性乳剂中配合各种添加物,以搅拌机搅拌而制备本发明基剂(基剂相)。
工序3:对基剂相添加药物相,以搅拌机搅拌(原料制剂(bulk drug))。
工序4:将原料制剂使用填充机填充于任意容器。
本发明外用剂,可封入于密封状的任意容器,例如发泡橡胶内栓涂布容器、(迷你)滚珠容器、喷雾(喷射)容器、滴下容器、乳液容器、铝管、推针型容器中。可由该容器直接涂布于皮肤。就抑制涂布部的干燥的观点等,优选为封入于推针型容器、滚珠容器、迷你滚珠容器、喷雾容器、附刷毛容器中。
该容器的材质例如可举出聚乙烯、聚丙烯、聚对苯二甲酸乙二酯等塑料全部。
医药用的本发明外用剂的施用方法,是依疾病、药效成分、患部、性别、年龄等而异,不特别限制,通常,可每1日1次~数次涂布适量于皮肤等的外皮上的包含患部的区域来使用。涂布后,本发明外用剂会迅速干燥,于经涂布本发明外用剂的皮肤上形成皮膜。该皮膜即使暴露于水也不易膨润,若不施加任何力,则可比较长期间停留于皮肤上。
实施例
以下示出实施例或试验例以更具体说明本发明。但是本发明不受以下实施例等的任何限定。
[试验例1]水性聚合物乳剂的探讨
针对市售的下述水性聚合物乳剂(WPE),评价膜的形成状态。
该膜是将WPE液0.5g置入5.0cm2的圆形的聚丙烯制容器,于室温干燥一晚而制备的(涂布量:0.1g/cm2、n=3)。其结果示于表1及表2。
需要说明的是,膨润率(%)由如下方法算出(以下的试验例也同)。
测定所得到的膜的重量(W1)后,将该膜置入加入有纯水的玻璃容器,于室温下浸渍24小时。浸渍后从玻璃容器取出该膜,测定擦拭表面的水分后的该膜重量(W2),由下述式算出膨润率(%)。
膨润率(%)=(W1-W2)/W1×100
(式中,W1及W2与所述同义)。
此外,聚合物粒子的重均粒径,是使用Nanotrac WaveII(MICROTRAC公司制),通过动态光散射法(DLS)测定的。
<探讨中使用的市售的水性聚合物乳剂(WPE)的例子>
1:丙烯酸烷基酯共聚物乳剂(DERMACRYL、Matsumoto Trading公司制)
2:丙烯酸烷基酯共聚物乳剂(COVACRYL E14 WP、Sensient Technolog ies Japan公司制)
3:丙烯酸烷基酯共聚物乳剂(COVACRYL MS11 WP、Sensient Technol ogiesJapan公司制)
4:丙烯酸烷基酯共聚物乳剂(YODOSOL GH800F、Matsumoto Trading公司制)
5:丙烯酸烷基酯共聚物乳剂(YODOSOL GH810F、Matsumoto Trading公司制)
6:丙烯酸烷基酯共聚物乳剂(Vinysol 1086WP、大同化成工业公司制)
7:丙烯酸烷基酯共聚物乳剂(Vinysol 1089HT、大同化成工业公司制)
8:丙烯酸烷基酯/苯乙烯共聚物乳剂(YODOSOL GH41H、Matsumoto Tr ading公司制)
9:丙烯酸烷基酯/苯乙烯共聚物乳剂(Vinysol 1012JC、大同化成工业公司制)
10:丙烯酸烷基酯/苯乙烯共聚物乳剂(Vinysol 1013JH、大同化成工业公司制)
11:丙烯酸烷基酯/苯乙烯共聚物乳剂(Vinysol 1019CT、大同化成工业公司制)
12:丙烯酸烷基酯/乙酸乙烯酯共聚物乳剂(Vinysol 2140L、大同化成工业公司制)
13:丙烯酸烷基酯/乙酸乙烯酯共聚物乳剂(Vinysol 2140LH、大同化成工业公司制)
[表1]
[表2]
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如表1及表2所示,玻璃化转变温度(Tg)与最低成膜温度(MFT)均高于30℃的水性聚合物乳剂7与10中未形成膜。就水性聚合物乳剂12及13而言,浸渍于纯水时白浊,膨润率全部超过30%,耐水性不良。另一方面,就水性聚合物乳剂3、5、6、8、9而言,即使浸渍于纯水也维持透明至半透明,膨润率小于30%,耐水性良好。
[试验例2]添加物:增塑剂的探讨1
秤量一定的添加物10质量%后,于其中添加所述水性聚合物乳剂6,成为100质量%。将该液体以搅拌机(IKAT18basic(ULTRA-TURRAX公司制))搅拌1分钟。使用所得到的液体0.5g,与试验例1同样地进行膜制备,评价所得到的膜的气泡状态、透明性、柔软性、伸缩性、强度、及耐水性(色调与柔软性)(n=3)。此外,各算出所得到的膜的膨润率。
各试验中,气泡与透明性的评价是对所得到的膜以目视进行的。柔软性的评价是将所得到的膜以手指折弯来进行的,伸缩性的评价是所得到的膜以手指拉伸来进行的,强度的评价是将所得到的膜以手指多次折弯来进行的。耐水性的评价是将所得到的膜于加入有纯水的玻璃容器中室温下浸渍24小时,浸渍后从玻璃容器将膜取出,擦拭表面的水分后,颜色是以目视、柔软性是就折弯时的硬度的观点来进行的。各自通过评分方式进行评价(以下的试验也相同)。其结果示于表3及表4。
[表3]
[表4]
如表3及表4所示,仅以水性聚合物乳剂6形成皮膜时,该皮膜强度佳,浸渍于纯水时维持透明,膨润率为9.3%而耐水性优良,但稍欠缺柔软性,几乎无伸缩性。于水性聚合物乳剂6中添加多元醇、多糖类时,虽提高所得到的膜的柔软性及伸缩性,但将该膜浸渍于纯水时会白浊,耐水性恶化。此外,配合表面活性剂时,也有基剂凝集的情况,但添加作为酯类的非离子性表面活性剂的聚乙二醇单油酸酯时,所得到的膜的柔软性及伸缩性改善,将该膜浸渍于纯水时的膨润率为20%以下,维持半透明。就纤维素类而言,特别是羟丙基纤维素会改善所得到的膜的柔软性及伸缩性,将该膜浸渍于纯水时的膨润率为20%以下,维持半透明。
[试验例3]添加物:增塑剂的浓度的探讨
试验例2中,由于作为酯类非离子性表面活性剂的聚乙二醇单油酸酯的结果良好,故针对聚乙二醇单油酸酯的添加量进行探讨。试验使用水性聚合物乳剂6与9作为皮膜形成剂,与试验例2同样地进行膜制备,针对所制备的膜进行与试验例2相同的评价(n=3)。其结果示于表5与表6。
[表5]
[表6]
如表5及表6所示,皮膜形成剂的水性聚合物乳剂6及9,均随着聚乙二醇单油酸酯(增塑剂)的浓度增加,膨润率增加,耐水性(颜色)也为半透明~白浊而显示降低倾向。
就外观(气泡、透明性)、柔软性、伸缩性、强度及耐水性优良而言,使用水性聚合物乳剂6时,聚乙二醇单油酸酯的添加量为0.5~2.5质量%的范围内,使用水性聚合物乳剂9时,聚乙二醇单油酸酯的添加量为1.0~2.5质量%的范围,该范围的膨润率为30%以下。
[试验例4]添加物:增塑剂的探讨2
试验例2中,由于作为酯类非离子性表面活性剂的聚乙二醇单油酸酯的结果良好,故针对数种聚乙二醇单脂肪酸酯类表面活性剂也与试验例2同样地进行膜制备,针对所制备的膜进行与试验例2相同的评价(n=3)。其结果示于表7与表8。
[表7]
[表8]
如表7及表8所示,所探讨的全部的聚乙二醇单脂肪酸酯中,所得到的膜的柔软性及伸缩性改善,将该膜浸渍于纯水时的膨润率为30%以下,耐水性也优良。
[试验例5]添加物:油分的探讨1
于所述水性聚合物乳剂6中添加聚乙二醇单月桂酸酯(MYL-10V)与一定的水不溶性油分(添加量:1.25质量%及2.50质量%),与试验例2同样地进行膜制备,针对所制备的膜进行与试验例2相同的评价(n=3)。此外,其结果示于表9及表10。
[表9]
[表10]
如表9及表10所示,可知于聚乙二醇单月桂酸酯1.25质量%及2.50质量%配合下,配合了如肉豆蔻酸异丙酯、肉豆蔻酸辛基十二烷酯、生育酚乙酸酯、三(辛酸/癸酸)甘油酯、癸二酸二乙酯的酯类;如油酸的脂肪酸;如聚二甲基硅氧烷的聚硅氧烷;如荷荷巴油的植物油;如液体石蜡、角鲨烷的烃类的情况,也形成柔软性、伸缩性、强度及耐水性优良的皮膜。
[试验例6]添加物:油分的探讨2
于所述水性聚合物乳剂9中,添加聚乙二醇单油酸酯(MYO-10V)与一定的水不溶性油分(添加量:1.00质量%、涂布量:0.5g),与试验例2同样地进行膜制备,针对所制备的膜进行与试验例2相同的评价(n=3)。此外,其结果示于表11及表12。
[表11]
*:使用该油分者外观干净
[表12]
如表11及表12所示,可知于聚乙二醇单油酸酯1.00质量%配合下,配合了如肉豆蔻酸异丙酯、肉豆蔻酸辛基十二烷酯、生育酚乙酸酯、三(辛酸/癸酸)甘油酯、癸二酸二乙酯的酯类;如油酸的脂肪酸;如聚二甲基硅氧烷的聚硅氧烷;如荷荷巴油的植物油;如液体石蜡、角鲨烷的烃类的情况,也形成柔软性、伸缩性、强度及耐水性优良的皮膜。
由以上结果明显可知,本发明基剂由于配合有水不溶性的油分,故即使配合疏水性药物,也可抑制其凝集或沈淀。特别是作为该油分的酯类,一般而言也发挥皮肤吸收促进效果,因此药物的吸收促进效果受到期待。
工业实用性
本发明基剂,例如有用于作为杂货等非医药用外用剂及液体绊创膏等医药用外用剂的基剂。该非医药用外用剂有用于日常生活领域,医药用外用剂有用于医药品领域。
Claims (14)
1.一种非水膨润性的皮膜形成型外用剂基剂,其包含如下成分A~成分C:
A)皮膜形成剂,其由选自(甲基)丙烯酸类聚合物及分子内包含(甲基)丙烯酸类单体的共聚物的聚合物粒子分散于水介质中而成的水性聚合物乳剂所构成,其中所述聚合物的玻璃化转变温度及所述乳剂的最低成膜温度均为30℃以下,且将所形成的皮膜浸渍于水中24小时使其膨润时的由下述式所算出的膨润率小于30%,
膨润率(%)=(W1-W2)/W1×100
式中,W1表示浸渍前重量(g)、W2表示浸渍后重量(g);
B)增塑剂,其为选自酯类非离子性表面活性剂及纤维素类中的1种以上;及
C)载体溶剂,其为水、或水及基剂总量中小于20质量%的有机溶剂。
2.根据权利要求1所述的皮膜形成型外用剂基剂,其进一步包含水不溶性的油分。
3.根据权利要求1所述的皮膜形成型外用剂基剂,其中,
所述聚合物为(甲基)丙烯酸烷基酯聚合物、或包含(甲基)丙烯酸烷基酯单体的共聚物。
4.根据权利要求1所述的皮膜形成型外用剂基剂,其中,
所述聚合物粒子的平均粒径为10~300nm的范围内。
5.根据权利要求1所述的皮膜形成型外用剂基剂,其中,
所述水性乳剂中的聚合物固体成分量为20~70质量%的范围内。
6.根据权利要求1所述的皮膜形成型外用剂基剂,其中,
所述酯类非离子性表面活性剂为聚乙二醇单脂肪酸酯,
所述纤维素类为羟丙基纤维素。
7.根据权利要求1所述的非水膨润性的皮膜形成型外用剂基剂,其中,
所述水不溶性的油分为选自酯类、烃类、脂肪酸、动植物油及聚硅氧烷中的1种以上。
8.根据权利要求7所述的皮膜形成型外用剂基剂,其中,
酯类为肉豆蔻酸异丙酯、肉豆蔻酸辛基十二烷酯、生育酚乙酸酯、三(辛酸/癸酸)甘油酯、或癸二酸二乙酯;
烃类为液体石蜡、角鲨烷、或凡士林;
脂肪酸为月桂酸、肉豆蔻酸、硬脂酸、异硬脂酸、或油酸;
动植物油为蓖麻油、荷荷巴油、或澳洲坚果油;或
聚硅氧烷为聚二甲基硅氧烷。
9.一种非医药用外用剂,其包含权利要求1~8中任一项所述的皮膜形成型外用剂基剂。
10.一种医药用外用剂,其包含权利要求1~8中任一项所述的皮膜形成型外用剂基剂与药效成分。
11.根据权利要求10所述的医药用外用剂,其为液体绊创膏。
12.根据权利要求10所述的医药用外用剂,其中,
所述药效成分为杀菌消毒剂、足癣药、止痒剂、保湿剂、或镇痛消炎剂。
13.根据权利要求9所述的非医药用外用剂,其中,
外用剂被封入于推针型容器、滚珠容器或迷你滚珠容器、喷雾容器、或附刷毛容器。
14.根据权利要求10所述的医药用外用剂,其中,
外用剂被封入于推针型容器、滚珠容器或迷你滚珠容器、喷雾容器、或附刷毛容器。
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JPS59139325A (ja) | 1982-10-19 | 1984-08-10 | Nissan Chem Ind Ltd | 透明速乾性塗布剤組成物 |
JPH03275619A (ja) | 1990-03-23 | 1991-12-06 | Nitsusui Seiyaku Kk | 外用剤組成物 |
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