TWI813460B - 含有抗壞血酸以及/或是其鹽之油中水型外用組成物 - Google Patents
含有抗壞血酸以及/或是其鹽之油中水型外用組成物 Download PDFInfo
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- TWI813460B TWI813460B TW111137124A TW111137124A TWI813460B TW I813460 B TWI813460 B TW I813460B TW 111137124 A TW111137124 A TW 111137124A TW 111137124 A TW111137124 A TW 111137124A TW I813460 B TWI813460 B TW I813460B
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Classifications
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Abstract
本發明提供一種含有抗壞血酸或其鹽之油中水型外用組成物。本發明製備一種油中水型外用組成物,含有:(A)選自由抗壞血酸及抗壞血酸之鹽所組成之群組中的至少一種;(B)丙二醇;(C)油分;及(D)聚矽氧系界面活性劑。此種油中水型外用組成物的穩定性良好。
Description
本發明係關於一種含有抗壞血酸以及或是其鹽之油中水型外用組成物。
對於抗壞血酸,已知發揮抗炎效果、青春痘改善效果、美白效果、抗老化效果、抗氧化效果、由促進合成膠原蛋白等活體成分所帶來之細胞活化效果、抑制表皮角化細胞因紫外線所致之細胞毒殺(cytotoxic)、DNA(deoxyribonucleic acid;去氧核糖核酸)損傷之效果等各種效果,期待這些效果而被廣泛地用作皮膚外用劑。
提供一種包含抗壞血酸且穩定性及使用感優異之外用組成物(例如,專利文獻1:WO2018/003850號公報)。
[先前技術文獻]
[專利文獻]
[專利文獻1]WO2018/003850號公報。
[發明所欲解決之課題]
本發明的目的在於提供一種含有抗壞血酸以及或是其鹽之優異的油中水型外用組成物。
[用以解決課題之手段]
乳霜劑、乳液係保濕性優異而被廣泛地用作例如化妝品之形態。根據本發明者等人之研究,確定含有抗壞血酸以及或是其鹽之製劑根據皮膚狀態有時存在刺激皮膚之問題。進而,本發明者等人注意到含有抗壞血酸以及或是其鹽之製劑的穩定性有時亦會產生問題。
本發明者等人為了解決本課題而反復進行了努力研究,結果發現,藉由含有(A)選自由抗壞血酸及抗壞血酸之鹽所組成之群組中的至少一種、(B)丙二醇、及(C)油分,可獲得優異的油中水型外用組成物,從而完成本發明。
亦即,本發明提供下述揭示之油中水型外用組成物。
[1]一種油中水型外用組成物,含有:(A)選自由抗壞血酸及抗壞血酸之鹽所組成之群組中的至少一種;(B)丙二醇;(C)油分;及(D)聚矽氧系界面活性劑。
[2]如項1所記載之油中水型外用組成物,其中前述(A)選自由抗壞血酸及抗壞血酸之鹽所組成之群組中的至少一種的含量為1質量%至30質量%。
[3]如項1或2所記載之油中水型外用組成物,其中前述(B)丙二醇的含量為15質量%以上。
[4]如項1至3中任一項所記載之油中水型外用組成物,其中水的含量為10質量%以下。
[5]如項1至4中任一項所記載之油中水型外用組成物,其中前述(C)油分包含聚矽氧油。
[6]如項1至5中任一項所記載之油中水型外用組成物,進而含有低級醇。
[7]一種緩和油中水型外用組成物之皮膚刺激之方法,係藉由使(A)選自由抗壞血酸及抗壞血酸之鹽所組成之群組中的至少一種、(B)丙二醇、(C)油分、及(D)聚矽氧系界面活性劑共存,來緩和含有(A)選自由抗壞血酸及抗壞血酸之鹽所組成之群組中的至少一種之油中水型外用組成物之皮膚刺激。
[發明功效]
藉由本發明,能夠提供一種皮膚刺激少的油中水型外用組成物。
藉由本發明,亦能夠提供一種穩定的油中水型外用組成物。
本說明書中,含量的單位「質量%」與「g/100g」為同義。
[油中水型外用組成物]
本發明之油中水型外用組成物係含有(A)選自由抗壞血酸及抗壞血酸之鹽所組成之群組中的至少一種、(B)丙二醇、(C)油分、及(D)聚矽氧系界面活性劑之油中水型外用組成物。
[(A)選自由抗壞血酸及抗壞血酸之鹽所組成之群組中的至少一種]
作為本發明中所使用之抗壞血酸,可使用於醫藥品、準藥品或化妝品領域中作為皮膚外用劑之成分市售之抗壞血酸,這些通常係指L體之抗壞血酸。
於本發明中,亦可使用抗壞血酸之鹽。此處,抗壞血酸之鹽係指藥學上所容許之鹽。並無限定,例如可例舉:與有機鹼之鹽(例如,三甲胺鹽、三乙胺鹽、單乙醇胺鹽、三乙醇胺鹽、吡啶鹽等與三級胺之鹽、精胺酸等鹼性銨鹽等)、與無機鹼之鹽(例如,銨鹽、鈉鹽、鉀鹽等鹼金屬鹽、鈣鹽、鎂鹽等鹼土金屬鹽、鋁鹽等)等。尤佳的抗壞血酸之鹽為鈉鹽、鉀鹽。具體而言,可例舉:抗壞血酸鈉、抗壞血酸單磷酸酯鈉、抗壞血酸二磷酸酯鈉、抗壞血酸三磷酸酯鈉、抗壞血酸-2-硫酸酯鈉等。
於本發明中,抗壞血酸或其鹽可使用一種或組合使用兩種以上。
本發明之油中水型外用組成物中,相對於油中水型外用組成物的總量之(A)成分的總含量可根據與其他成分之平衡而適宜設定。相對於油中水型外用組成物的總量,(A)成分的總含量較佳為1質量%以上,更佳為3質量%以上,進而較佳為5質量%以上。相對於油中水型外用組成物的總量,(A)成分的總含量較佳為30質量%以下,更佳為20質量%以下,進而較佳為15質量%以下。相對於油中水型外用組成物的總量,(A)成分的總含量較佳為1質量%至30質量%,更佳為3質量%至20質量%,進而較佳為5質量%至15質量%,進而更佳為5質量%至10質量%。另外,亦可為1質量%至10質量%、2質量%至7質量%、3質量%至5質量%等。
[(B)丙二醇]
作為本發明中所使用之丙二醇,只要為於醫藥品、準藥品或化妝品領域中用作皮膚外用劑之成分之丙二醇,則並無特別限定。另外,可直接使用市售品。丙二醇係指1,3-丙二醇(CAS編號:504-63-2,英文名:1,3-Dihydroxypropane或TrimethyleneGlycol)。(B)成分可有助於本發明之油中水型外用組成物的穩定性。
本發明之油中水型外用組成物中,相對於油中水型外用組成物的總量之(B)成分的總含量並無特別限定,較佳為15質量%以上,更佳為20質量%以上,進而較佳為30質量%以上,進而更佳為40質量%以上。相對於油中水型外用組成物的總量之(B)成分的總含量較佳為80質量%以下,更佳為70質量%以下,進而較佳為60質量%以下。就提高本發明之油中水型外用組成物的穩定性之觀點而言,相對於油中水型外用組成物的總量之(B)成分的總含量並無特別限定,較佳為15質量%至80質量%,更佳為20質量%至75質量%,進而較佳為40質量%至70質量%。另外,亦可為20質量%至80質量%、20質量%至60質量%、30質量%至75質量%、30質量%至60質量%、或40質量%至60質量%等範圍。
本發明之油中水型外用組成物中,相對於(A)成分之(B)成分的調配量的比率並無特別限定,相對於(A)成分的總含量1質量份,較佳為0.5質量份至80質量份,更佳為1質量份至30質量份,進而較佳為4質量份至12質量份。另外,亦可為2質量份至80質量份、4質量份至35質量份、8質量份至20質量份等。
[(C)油分]
作為本發明中所使用之(C)油分,並無限定,例如可例舉:天然動植物油脂類、烴油、酯油、聚矽氧油、高級脂肪酸、動植物、合成之精油等。
作為天然動植物油脂類,例如可例舉:鱷梨油、亞麻籽油、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、紅花油、大豆油、月見草油、山茶油、玉米油、菜籽油、馬油、桃仁油、棕櫚油、棕櫚仁油、蓖麻油、葵花籽油、豬油、葡萄油、荷荷芭油、澳洲胡桃油、貂油、棉籽油、木蠟、蜂蠟、白蜂蠟、椰子油、氫化油(非限定性的示例為氫化荷荷芭油、氫化蓖麻油、氫化大豆油、氫化米油、氫化椰子油等)、花生油、羊毛脂、蛋黃油、玫瑰果油、薄荷油、檸檬油、桉葉油、薰衣草油、羅馬洋甘菊油、柳橙油、薏苡油、西番蓮籽油(Passiflora Edulis Seed Oil)、野薔薇油、茶樹油、葡萄柚油、雜薰衣草油、岩薔薇油、茴香油、或橙皮油(Orange Roughy Oil)等。
作為烴油,例如可使用石蠟系烴、烯烴系烴,更具體而言,例如可例舉:角鯊烷、角鯊烯、地蠟(ceresin)、石蠟、姥鮫烷、微晶蠟、液態石蠟、凡士林、烯烴寡聚物、氫化聚異丁烯、異構石蠟、聚乙烯蠟、地石蠟(ozokerite)等。
作為酯油,例如可使用合成酯類、高級醇與高級脂肪酸之酯類,例如可例舉:己二酸二異丁酯、己二酸2-己基癸酯、己二酸二-2-庚基十一烷基酯、異硬脂酸異硬脂酯、三羥甲基丙烷三異硬脂酸酯、2-乙基己酸鯨蠟酯、新戊二醇二-2-乙基己酸酯、三羥甲基丙烷三-2-乙基己酸酯、季戊四醇四-2-乙基己酸酯、辛酸鯨蠟酯、油酸油酯、油酸辛基十二烷基酯、油酸癸酯、新戊二醇二癸酸酯、琥珀酸2-乙基己酯、硬脂酸異鯨蠟酯、硬脂酸丁酯、癸二酸二異丙酯、乳酸鯨蠟酯、乳酸十四烷基酯、肉豆蔻酸異丙酯、肉豆蔻酸辛基十二烷基酯、肉豆蔻酸鯨蠟酯、肉豆蔻酸肉豆蔻酯、棕櫚酸辛酯、棕櫚酸2-乙基己酯、棕櫚酸2-己基癸酯、棕櫚酸2-庚基十一烷基酯、膽固醇12-羥基硬脂酸酯、植固醇油酸酯、蘋果酸二異硬脂酯、對甲氧基肉桂酸酯、季戊四醇四松脂酸酯、或甘油三(辛酸/癸酸)酯等。
所謂聚矽氧油,典型地指包含至少1個矽原子、尤其是包含至少1個Si-O基之油。亦可使用具有2個至7個之矽原子,且任意地包含含有1個至10個碳原子之烷基或烷氧基之油。作為聚矽氧油,例如可例舉:二甲基聚矽氧烷、甲基聚矽氧烷(包含高聚合甲基聚矽氧烷、交聯型甲基聚矽氧烷)、甲基苯基聚矽氧烷、甲基氫聚矽氧烷、環六矽氧烷、八甲基環四矽氧烷、八甲基環五矽氧烷、十甲基環六矽氧烷、辛基甲聚矽氧烷、十甲基環五矽氧烷、十二甲基環六矽氧烷、七甲基己基三矽氧烷、七甲基辛基三矽氧烷、六甲基二矽氧烷、八甲基三矽氧烷、十甲基四矽氧烷及十二甲基五矽氧烷、硬脂氧基聚矽氧等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等或這些之混合物。
作為高級脂肪酸,可使用飽和或不飽和之直鏈或支鏈之碳數12至22之脂肪酸,例如可例舉:異硬脂酸、氧硬脂酸、油酸、硬脂酸、棕櫚酸、俞樹酸、肉豆蔻酸、月桂酸、羊毛脂酸、亞麻油酸、次亞麻油酸等。
作為(C)成分,可使用這些成分中的一種或組合使用兩種以上。
並無限定,作為(C)成分,較佳為至少包含聚矽氧油。
這些油分可利用天然物或藉由合成而製備,亦可直接使用市售品。
本發明之油中水型外用組成物中,相當於油中水型外用組成物的總量之(C)成分的總含量並無特別限定,較佳為1質量%以上,更佳為3質量%以上,進而較佳為5質量%以上。相對於油中水型外用組成物的總量,(C)成分的總含量較佳為40質量%以下,更佳為30質量%以下,進而較佳為20質量%以下。相對於油中水型外用組成物的總量,(C)成分的含量較佳為1質量%至40質量%,更佳為3質量%至30質量%,進而較佳為5質量%至20質量%。
本發明之油中水型外用組成物中,相對於(A)成分之(C)成分的調配量的比率並無特別限定,相對於(A)成分的總含量1質量份,較佳為0.01質量份至40質量份,更佳為0.1質量份至10質量份,進而較佳為0.5質量份至4質量份。另外,亦可為0.1質量份至40質量份、0.4質量份至15質量份、1質量份至7質量份等。
[(D)聚矽氧系界面活性劑]
本發明中所使用之(D)聚矽氧系界面活性劑並無限定,就提高本發明之油中水型外用組成物的穩定性之觀點而言,例如可例舉:(二甲聚矽氧烷/(PEG-10/15))交聯聚合物、PEG-11甲醚二甲聚矽氧烷、PEG/PPG-20/22丁醚二甲聚矽氧烷、PEG-3二甲聚矽氧烷、PEG-10二甲聚矽氧烷、PEG-32甲醚二甲聚矽氧烷、鯨蠟基PEG/PPG-10/1二甲聚矽氧烷、PEG-9聚二甲基矽烷氧基乙基二甲聚矽氧烷、月桂基PEG-9聚二甲基矽烷氧基乙基二甲聚矽氧烷、鯨蠟基二甘油基三(三甲基矽烷氧基)矽基乙基二甲聚矽氧烷、或聚氧乙烯-甲基聚矽氧烷共聚物等。較佳的活性劑的HLB(Hydrophilic Lipophilic Balance,親水親油平衡值)較佳為1至10,更佳為2至8,更佳為3至5。
作為(D)成分,可使用這些成分中的一種或組合使用兩種以上。
本發明之油中水型外用組成物中,相對於油中水型外用組成物的總量之(D)成分的總含量並無特別限定,就提高本發明之油中水型外用組成物的穩定性之觀點而言,較佳為1質量%以上,更佳為3質量%以上,進而較佳為5質量%以上。相對於油中水型外用組成物的總量,(D)成分的總含量較佳為30質量%以下,更佳為20質量%以下,進而較佳為10質量%以下。(D)成分的總含量較佳為1質量%至30質量%,更佳為,3質量%至20質量%,進而較佳為5質量%至10質量%。
本發明之油中水型外用組成物中,相對於(A)成分之(D)成分的比率相對於(A)成分的總含量1質量份,較佳為0.01質量份至30質量份,更佳為0.1質量份至7質量份,進而較佳為0.5質量份至2質量份。另外,亦可為0.1質量份至30質量份、0.4質量份至10質量份、1質量份至4質量份等。
[水]
本發明之油中水型外用組成物可為含有水之液狀組成物,亦可為不含水之組成物。所調配之水的比例並無限定,相對於油中水型外用組成物,較佳為15質量%以下,更佳為10質量%以下,進而較佳為7質量%以下。於含有水之情形時,較佳為1質量%至15質量%,更佳為1質量%至10質量%,進而較佳為1質量%至7質量%。即便於本發明之油中水型外用組成物中不含水之情形時,藉由(B)成分或任意之水性成分,亦會形成油中水型中的水相。
本發明之油中水型外用組成物中,關於相對於(A)成分之水的比率,相對於(A)成分的總含量1質量份,較佳為0.01質量份至10質量份,更佳為0.05質量份至3質量份,進而較佳為0.1質量份至1質量份。另外,亦可為0.1質量份至10質量份、0.1質量份至3.5質量份、0.2質量份至2質量份等。
[(E)低級醇]
本發明之油中水型外用組成物中,就使用感之提升、更高的穩定性及經皮吸收之促進之觀點而言,只要不妨礙本發明的效果,則除上述(A)成分、(B)成分、(C)成分及(D)成分以外,亦可任意地包含(E)低級醇。
作為本發明中所使用之低級醇,只要為於醫藥品、準藥品或化妝品領域中用作皮膚外用劑之成分之低級醇,則並無特別限定。本說明書中,記為「低級醇」時,係指C1-C6之醇。當中,可尤佳地使用C1-C3之醇。作為此種示例,可例舉:甲醇、乙醇、正丙醇、異丙醇等。
於本發明之一態樣中,相對於油中水型外用組成物的總量之(E)成分的總含量較佳為1質量%至30質量%,更佳為3質量%至20質量%,進而較佳為5質量%至10質量%。
本發明之油中水型外用組成物中,關於相對於(A)成分之(E)成分的調配量的比率,相對於(A)成分的總含量1質量份,較佳為0.01質量份至30質量份,更佳為0.1質量份至7質量份,進而較佳為0.5質量份至2質量份。另外,亦可為0.1質量份至30質量份、0.2質量份至15質量份、0.4質量份至10質量份、1質量份至4質量份等。
[多元醇]
本發明之油中水型外用組成物中,只要不妨礙本發明的效果,則除上述(A)成分、(B)成分、(C)成分及(D)成分以外,亦可包含(B)成分以外的多元醇。
作為本發明中所使用之多元醇,只要為於醫藥品、準藥品或化妝品領域中用作皮膚外用劑之成分之多元醇,則並無特別限定。多元醇並無限定,有時亦為了保濕或作為助溶劑而添加。具體而言,可例舉:甘油、雙甘油、二丙二醇、丙二醇、1,3-丁二醇、3-甲基-1,3-丁二醇、己二醇、戊二醇、山梨醇、或麥芽糖醇等。
於本發明之一態樣中,於含有(B)成分以外的多元醇之情形時,相對於油中水型外用組成物的總量,(B)成分以外的多元醇的總含量較佳為0.1質量%至30質量%,更佳為0.5質量%至20質量%,進而較佳為1質量%至10質量%左右。
於本發明之一態樣中,(B)成分於油中水型外用組成物中的多元醇整體中所佔之較佳比例可為30%質量以上,更佳可為40質量%以上。於本發明之一態樣中,亦可為僅包含(B)成分作為油中水型外用組成物中的多元醇之態樣。
於本發明之一態樣中,關於相對於(B)成分之(B)成分以外的多元醇的比率,就提高穩定性之觀點而言,相對於(B)成分的含量1質量份,較佳為0質量份至3質量份,更佳為0.001質量份至2質量份,進而較佳為0.005質量份至1.5質量份。另外,相對於(B)成分的含量1質量份,(B)成分以外的多元醇的比率亦可為0質量份至1質量份、0質量份至0.5質量份、0質量份至0.35質量份等。
於本發明之一態樣中,就提高穩定性之觀點而言,例如相對於(B)成分的含量1質量份,1,3-丁二醇較佳可為0質量份至3質量份,更佳可為0.001質量份至2質量份,進而較佳可為0.005質量份至1質量份。
[3-O-乙基抗壞血酸]
本發明之油中水型外用組成物中,只要不妨礙本發明的效果,則除上述(A)成分、(B)成分、(C)成分及(D)成分以外,亦可包含3-O-乙基抗壞血酸或其鹽。
3-O-乙基抗壞血酸可將抗壞血酸的3位上的羥基進行乙氧基化而合成(例如,依據日本特開平8-134055中所記載之公知的方法等)。3-O-乙基抗壞血酸亦可直接使用市售品。作為市售品,並無限定,例如,除日本精化製造的「VC乙醚」以外,亦例示有純正化學股份有限公司製造的製品等。
3-O-乙基抗壞血酸有助於本發明之油中水型外用組成物的穩定性。
3-O-乙基抗壞血酸亦可以鹽的形式使用。此處,3-O-乙基抗壞血酸之鹽係指藥學上所容許之鹽。並無限定,例如可例舉:與有機鹼之鹽(例如,三甲胺鹽、三乙胺鹽、單乙醇胺鹽、三乙醇胺鹽、吡啶鹽等與三級胺之鹽、精胺酸等鹼性銨鹽等)、與無機鹼之鹽(例如,銨鹽、鈉鹽、鉀鹽等鹼金屬鹽、鈣鹽、鎂鹽等鹼土金屬鹽、鋁鹽等)等。尤佳的3-O-乙基抗壞血酸之鹽為鈉鹽、鉀鹽。
於本發明中,3-O-乙基抗壞血酸或其鹽可使用一種或組合使用兩種以上。
於本發明之一態樣中,相對於油中水型外用組成物的總量之3-O-乙基抗壞血酸或其鹽的總含量可根據與其他成分之平衡而適宜設定。相對於油中水型外用組成物的總量,3-O-乙基抗壞血酸或其鹽的總含量較佳為0.0001質量%至10質量%,更佳為0.001質量%至5質量%,進而較佳為0.005質量%至3質量%,進而更佳為0.01質量%至3質量%。
於本發明之一態樣中,關於相對於(A)成分之3-O-乙基抗壞血酸或其鹽的調配量的比率,相對於(A)成分的總含量1質量份,3-O-乙基抗壞血酸或其鹽的總含量較佳為0.000003質量份至10質量份,更佳為0.00025質量份至1質量份,進而較佳為0.001質量份至0.6質量份。
[(D)成分以外的界面活性劑]
只要不妨礙本發明的效果,則本發明之油中水型外用組成物亦可包含界面活性劑。界面活性劑可有助於成分的穩定化。作為界面活性劑,例如可使用聚氧乙烯氫化蓖麻油40、聚氧乙烯氫化蓖麻油60、聚氧乙烯氫化蓖麻油80、聚氧乙烯聚氧丙烯癸基十四烷基醚、聚氧乙烯(20)聚氧丙烯(4)鯨蠟醚、PEG-8甘油異硬脂酸酯、聚氧乙烯山梨醇酐單月桂酸酯(20E.O.)、聚氧乙烯山梨醇酐異硬脂酸酯(20E.O.)、聚氧乙烯山梨醇酐硬脂酸酯(20E.O.)、聚甘油-10椰子油脂肪酸酯、聚甘油-3椰子油脂肪酸酯、PEG-7甘油椰子油脂肪酸酯、聚甘油-10二油酸酯、聚甘油-10二異硬脂酸酯、PEG-40甘油三異硬脂酸酯、PEG-40甘油異硬脂酸酯、聚甘油-10三月桂酸酯、六甘油三辛酸酯、聚甘油月桂酸酯、聚甘油肉豆蔻酸酯、聚氧乙烯月桂醚等,尤其可例舉:聚氧乙烯聚氧丙烯癸基十四烷基醚、聚氧乙烯氫化蓖麻油40、聚氧乙烯氫化蓖麻油60、聚氧乙烯氫化蓖麻油80、聚氧乙烯山梨醇酐異硬脂酸酯(20E.O.)、聚氧乙烯山梨醇酐單月桂酸酯(20E.O.)、聚甘油月桂酸酯等。
於本發明之一態樣中,相對於油中水型外用組成物的總量之界面活性劑的總含量可根據與其他成分之平衡而適宜設定。相對於油中水型外用組成物的總量,包括(D)成分在內之界面活性劑的總含量較佳為1質量%至30質量%,更佳為3質量%至20質量%,進而較佳為5質量%至10質量%。
[其他成分]
本發明之油中水型外用組成物中,除上述(A)成分、(B)成分、(C)成分及(D)成分以外,進而以增強或補充抗壞血酸以及或是其鹽所具有之各種作用為目的,且為了附加其他有用的作用,可將以下成分使用一種或組合使用兩種以上:美白成分、抗炎成分、抗菌成分、細胞活化成分、收斂成分、抗氧化成分、青春痘改善成分、膠原蛋白等活體成分合成促進成分、血流促進成分、保濕成分、抗老化成分等各種成分。較佳為美白成分、抗炎成分、抗菌成分、細胞活化成分、收斂成分、抗氧化成分、抗老化成分或保濕成分之一種或兩種以上之成分。作為這些成分的尤佳組合,可例舉:與美白成分之組合、美白成分與抗氧化成分之組合、與抗氧化成分之各組合、與抗老化成分之組合、美白成分與抗老化成分之各組合。作為這些各成分,只要為於醫藥品、準藥品、或化妝品領域中先前用作且將來用作皮膚外用劑之成分的成分,則並無特別限制,可適宜選擇使用任意成分。
[基劑或載體]
本發明之油中水型外用組成物中,就使用感之提升、穩定性之提升等觀點而言,只要不妨礙本發明的效果,則除上述(A)成分、(B)成分、及(C)成分以外,亦可包含基劑或載體。作為基劑或載體,例如可例舉:如乙基纖維素、羥基丙基纖維素、及羥基丙基甲基纖維素之類的纖維素衍生物;聚乙烯基吡咯烷酮;角叉菜膠;聚乙烯醇縮丁醛;聚乙二醇;如乙二醇單甲醚、乙二醇單乙醚、乙二醇單丙醚、二乙二醇單甲醚、二乙二醇單乙醚、二乙二醇單丙醚、二乙二醇單丁醚、丙二醇單乙醚、丙二醇單丙醚、二丙二醇單乙醚、及二丙二醇單丙醚之類的二醇醚;或二甲基二硬脂基銨鋰膨潤石等有機改質黏土礦物。基劑或載體可使用一種或兩種以上。
[添加劑]
本發明之油中水型外用組成物中,在無損外觀穩定性及黏度等品質且無損本發明的效果之量及質的範圍內,可視需要調配於醫藥品、準藥品或化妝品領域中一般用作外用劑之成分之各種成分,例如胺基酸、刺激減輕劑、增黏劑、防腐劑、紫外線吸收劑、紫外線防禦劑、著色劑、分散劑、追加之pH值調整劑、香料等。再者,這些成分可單獨調配一種或任意調配兩種以上。
[製造方法]
本發明之油中水型外用組成物之製造方法並無特別限定,乳化時的攪拌方法、乳化溫度、油相與水相之投入順序、投入速度等可適宜設定。
具體而言,可例舉視需要分別準備加熱溶解後混合之油相及水相,於室溫下向油相中緩慢地加入水相,藉由均質機等機械攪拌力進行乳化之方法等,但並不特別限定於這些方法。
[製劑形態]
本發明之油中水型外用組成物可與醫藥品、準藥品、或化妝品中通常所使用之基劑或載體、及視需要之添加劑一起混合,製成醫藥品、準藥品、或化妝品用之油中水型外用組成物。
醫藥品用之油中水型外用組成物之形態並無特別限定,例如可例舉:液劑、懸浮劑、乳劑、乳霜劑、軟膏劑、凝膠劑、擦劑、洗劑、貼附劑及氣溶膠劑等。這些製劑可依據日本藥典第十五次修訂製劑總則所記載之方法等進行製造。當中,較佳為液劑、懸浮劑、乳劑、乳霜劑、軟膏劑、凝膠劑、洗劑、貼附劑,更佳為乳霜劑、乳劑、軟膏劑、洗劑及凝膠劑。
於製成準藥品或化妝品用之油中水型外用組成物之情形時,亦可製成與上述醫藥品同樣之形態。另外,除此以外,亦可例舉:棒劑、及不織布中含浸有藥液之片劑等。當中,較佳為液劑、懸浮劑、乳劑、乳霜劑、軟膏劑、凝膠劑、洗劑、棒劑及片劑,更佳為乳霜劑、乳劑、軟膏劑、凝膠劑或洗劑。
本發明之油中水型外用組成物包含油相及水相,會發生乳化,典型地可採取乳霜劑或乳液等形態。
作為製成準藥品或化妝品用之油中水型外用組成物之情形時的用途,具體而言,例如可例舉:如化妝水、乳液、凝膠、乳霜、美容液、防曬用化妝品、敷劑、面膜、護手霜、及身體乳之類的基礎化妝品;以及粉餅、隔離等面部彩妝用化妝品、口紅、唇膏、唇彩、唇線筆等口唇化妝品等。
本發明中的油相與水相的質量比可適宜設定,並無限定,就獲得更良好的穩定性及使用感之方面而言,較佳為油相:水相=1:9至6:4。
[容器]
本發明之油中水型外用組成物可收容於根據使用目的及用途適宜選擇之形狀、材質之容器中而使用。作為具體的容器,例如可例示:噴霧型、瓶型、管型、罐型、滴管型、分注器型、棒型、小袋(pouch)、及企鵝包(CHEER PACK)等。
另外,作為容器的材質,可例示:聚對苯二甲酸乙二酯、聚丙烯、聚乙烯(HDPE(High Density Polyethylene;高密度聚乙烯)、LDPE(Low Density Polyethylene;低密度聚乙烯)、LLDPE(Linear Low Density Polyethylene;線性低密度聚乙烯)等)、ABS(Acrylonitrile Butadiene Styrene;丙烯腈-丁二烯-苯乙烯)樹脂、乙烯乙烯醇樹脂、聚苯乙烯、玻璃、及金屬(鋁等)等。另外,對於這些材料,可考慮強度、柔軟性、耐候性、或成分的穩定性等,進行各種塗佈處理,或將這些材料例如混合等而組合,或進行積層,從而用作容器材料。
[緩和皮膚刺激之方法]
另外,本發明亦包含緩和含有(A)抗壞血酸以及或是其鹽之油中水型外用組成物之皮膚刺激之方法。根據本發明,藉由製成含有(A)選自由抗壞血酸及抗壞血酸之鹽所組成之群組中的至少一種、(B)丙二醇、(C)油分、及(D)聚矽氧系界面活性劑之油中水型外用組成物,能夠緩和油中水型外用組成物之皮膚刺激,因此能夠製成低刺激性之油中水型外用組成物。此處,皮膚刺激抑制方法中的各成分的含量、比率、其他成分等條件係依據[油中水型外用組成物]中所記載之內容。
[提升穩定性之方法]
另外,本發明亦包含提升含有(A)抗壞血酸以及或是其鹽之油中水型外用組成物的穩定性之方法。根據本發明,藉由使含有(A)選自由抗壞血酸及抗壞血酸之鹽所組成之群組中的至少一種、(C)油分、及(D)聚矽氧系界面活性劑之油中水型外用組成物與(B)丙二醇共存,能夠提升油中水型外用組成物的穩定性。此處,提升穩定性之方法中的各成分的含量、比率、其他成分等條件係依據[油中水型外用組成物]中所記載之內容。
[用途]
本發明之油中水型外用組成物尤其作為美白劑、抗炎劑、抗老化劑有效,例如具有青春痘預防或治療、抗氧化之作用。進而,可用於以美白、抗皺、抗老化為目的之製品。藉由應用於皮膚,有時會發揮出皮膚的透明感提高、保持濕潤、肌理平整、抑制粗糙之效果。進而,有時亦發揮使毛孔不顯著、調整肌膚保濕等效果,除此以外,亦可用於黃褐斑之預防或治療。
就對皮膚之作用效果而言,本發明較佳為用於作為皮膚外用劑(外皮用製劑)所應用之製品。本發明之油中水型組成物可根據用途等每天一次至分為數次,以公知或慣用之用法、用量來使用。
本發明係關於:(1)一種油中水型外用組成物,含有:(A)選自由抗壞血酸及抗壞血酸之鹽所組成之群組中的至少一種;(B)丙二醇;(C)油分;及(D)聚矽氧系界面活性劑。
此處,可例舉以下態樣。
(2)如上述(1)之油中水型外用組成物,其中前述(A)選自由抗壞血酸及抗壞血酸之鹽所組成之群組中的至少一種的含量為5質量%至15質量%。
(3)如(1)或(2)所記載之油中水型外用組成物,其中前述(B)丙二醇的含量為15質量%至80質量%。
(4)如(1)至(3)中任一項所記載之油中水型外用組成物,其中前述(C)油分的含量為1質量%至40質量%。
(5)如(1)至(4)中任一項所記載之油中水型外用組成物,其中前述(D)成分的含量為1質量%至30質量%。
(6)如(5)所記載之油中水型外用組成物,其中前述(D)成分的含量為1質量%至5質量%。
(7)如(1)至(6)中任一項所記載之油中水型外用組成物,進而含有乙醇。
(8)如(1)至(7)中任一項所記載之油中水型外用組成物,進而含有(B)成分以外的多元醇。
(9)如(8)所記載之油中水型外用組成物,其中(B)成分於前述油中水型外用組成物中的全部多元醇中所佔之比例為30質量%以上。
(10)如(1)至(9)中任一項所記載之油中水型外用組成物,其為乳霜劑或乳液。
(11)如(1)至(10)中任一項所記載之油中水型組成物,其中相對於(A)成分的總含量1質量份,水為0.05質量份至3質量份。
(12) 如(1)至(10)中任一項所記載之油中水型組成物,其中相對於(A)成分的總含量1質量份,(B)成分為4質量份至35質量份。
[實施例]
其次,藉由實施例具體地說明本發明,但本發明並不限定於以下之實施例。再者,表中的各成分量的單位為質量%。
依據常規方法製備表1至表4中所示之組成的組成物。表中,只要無特別說明,則數值表示質量%。
[細胞毒殺性試驗]
製備比較例及實施例之組成物後,利用三維培養皮膚實施細胞毒殺性試驗。
於人三維培養表皮LabCyte EPI-MODEL24(Japan Tissue Engineering公司)的透過多孔性膜(transwell)(24孔板用透過多孔性膜)的下部所附帶之專用的檢測培養基中每孔加入0.5mL,於37℃(5%至10%CO2)預培養18小時至22小時。
然後,將專用之檢測培養基置換成0.5mLPBS(phosphate buffered saline,磷酸緩衝生理鹽水),於37℃之恆溫槽上預培養30分鐘。進而,將PBS置換成等量的新鮮的PBS,於細胞的上部直接添加各組成物0.1mL,並靜置30分鐘。
其次,利用PBS將透過多孔性膜仔細地洗淨後,將透過多孔性膜的下部的PBS置換成0.5mL之(3-(4,5-二甲基噻唑-2-基)-2,5-二苯基溴化四唑溶液(MTT溶液)。然後,於37℃培養3小時,於遮光下培養。MTT溶液係藉由將0.5mg之MTT溶解於1mL之PBS中而製備。然後,將自透過多孔性膜剝離之人三維培養表皮移至微管,加入0.3mL之異丙醇後,於陰涼處培養15小時以上,進行色素萃取。針對所萃取之色素,使用電暈電氣股份有限公司的微盤讀取器來測定吸光度(測定波長:570nm、650nm)。基於實測值,使用下述式算出細胞存活率,評價組成物的細胞毒殺性。測定值=[(各組成物處置組對於570nm之吸光度)-(各組成物處置組對於650nm之吸光度)]-[(異丙醇對於570nm之吸光度)-(異丙醇對於650nm之吸光度)]細胞存活率(%)=100×(各組成物處置組的測定值)/(PBS處置組的測定值)細胞存活率改善率(%)=100×{(基於各組成物的存活率/基於基準組成物的存活率)-1}
實施例、參考例、及比較例的組成物的評價結果示於表1至表3。
[表1]
[%表示質量%]
比較例1-1 | 實施例1-1 | |
成分名 | 調配量(%) | 調配量(%) |
1,3-丙二醇 | - | 50 |
二乙二醇單乙醚 | 50 | - |
抗壞血酸 | 10 | 10 |
乙醇 | 15 | 15.5 |
十甲基環五矽氧烷與交聯型甲基聚矽氧烷之混合液 | 1.5 | 1.5 |
交聯型聚醚改質聚矽氧混合物與甲基聚矽氧烷之混合物 | 3 | 3 |
鯨蠟基PEG/PPG-10/1二甲聚矽氧烷 | 3 | 3 |
甲基聚矽氧烷 | 17 | 17 |
純化水 | 10 | 10 |
合計 | 100 | 100 |
以比較例1為基準的存活率改善率(%) | / | 55.8 |
於表1中,比較例1-1及實施例1-1為油中水型組成物。如表1所示,相對於使用二乙二醇單乙醚之比較例1-1,使用1,3-丙二醇之實施例1-1可見細胞存活率之改善。
[表2]
[%表示質量%]
比較例2-1 | 比較例2-2 | 實施例2-1 | 實施例2-2 | |
成分名 | 調配量(%) | 調配量(%) | 調配量(%) | 調配量(%) |
1,3-丙二醇 | 50 | 50 | 50 | 50 |
抗壞血酸 | 10 | 10 | 10 | 10 |
乙醇 | 5 | 5 | 5 | 5 |
甘油 | 5.5 | 5.5 | 5.5 | 5.5 |
1,3-丁二醇 | 19.5 | 29.5 | - | 10 |
十甲基環五矽氧烷與交聯型甲基聚矽氧烷之混合液 | - | - | 1.5 | 1.5 |
交聯型聚醚改質聚矽氧混合物與甲基聚矽氧烷之混合物 | - | - | 3 | 3 |
鯨蠟基PEG/PPG-10/1二甲聚矽氧烷 | - | - | 3 | 3 |
甲基聚矽氧烷 | - | - | 12 | 12 |
純化水 | 10 | - | 10 | - |
合計 | 100 | 100 | 100 | 100 |
以比較例2-1為基準之細胞存活率改善率(%) | / | -7.4 | 9.2 | 10.3 |
以比較例2-2為基準之細胞存活率改善率(%) | / | / | 17.9 | 19.1 |
於表2中,比較例2-1及比較例2-2係由水性成分所構成之美容液,實施例2-1及實施例2-2係油中水型組成物。如表2所示,若使用1,3-丙二醇,則尤其是於未調配水之美容液中,細胞存活率降低。使用1,3-丙二醇來製成油中水型組成物之乳霜劑時,細胞存活率得到改善。再者,未調配水之乳霜劑顯示出進一步得到改善之細胞存活率。
[表3]
[%表示質量%]
比較例3-1 | 實施例3-1 | |
成分名 | 調配量(%) | 調配量(%) |
3-O-乙基抗壞血酸 | 0.5 | 0.5 |
1,3-丙二醇 | - | 60 |
1,2-丙二醇 | 60 | - |
抗壞血酸 | 10 | 10 |
乙醇 | 5 | 5 |
十甲基環五矽氧烷與交聯型甲基聚矽氧烷之混合液 | 1.5 | 1.5 |
交聯型聚醚改質聚矽氧混合物與甲基聚矽氧烷之混合物 | 3 | 3 |
鯨蠟基PEG/PPG-10/1二甲聚矽氧烷 | 3 | 3 |
甲基聚矽氧烷 | 17 | 17 |
純化水 | - | - |
合計 | 100 | 100 |
以比較例3-1為基準時的存活率改善率 | / | 29.2 |
根據表3之結果,可知與調配有1,2-丙二醇之油中水型組成物之乳霜劑相比,調配有1,3-丙二醇之油中水型組成物之乳霜劑中可見細胞存活率之改善。根據以上內容,可知藉由製成調配有1,3-丙二醇之油中水型組成物之乳霜劑,實現了該組成物之皮膚刺激之緩和。
[穩定性試驗]
製備比較例及實施例之組成物後,於室溫靜置一天而確認初始性狀。然後,於60℃之恆溫槽中靜置,確認2週後、3週後的製劑的狀態。對於60℃保管後的製劑的狀態,分別自60℃之恆溫槽中取出後,於25℃恆溫化而根據製劑的外觀進行性狀觀察。
實施例、參考例、及比較例的組成物的評價結果示於表4。
[表4]
[%表示質量%]
實施例4-1 | 實施例4-2 | 實施例4-3 | 比較例4-1 | 比較例4-2 | ||
成分名 | 調配量(%) | 調配量(%) | 調配量(%) | 調配量(%) | 調配量(%) | |
1,3-丙二醇 | 50 | 20 | 50 | - | - | |
1,2-丙二醇 | - | - | - | 50 | - | |
二丙二醇 | - | - | - | - | 50 | |
1,3-丁二醇 | - | 30 | - | - | - | |
抗壞血酸 | 5 | 5 | 3 | 5 | 3 | |
乙醇 | 5 | 5 | 5 | 5 | 5 | |
十甲基環五矽氧烷與交聯型甲基聚矽氧烷之混合液 | 2 | 2 | 2 | 2 | 2 | |
(二甲聚矽氧烷/(PEG-10/15))交聯聚合物與二甲聚矽氧烷之混合物 | 2 | 2 | 2 | 2 | 2 | |
二甲基二硬脂基銨鋰膨潤石與十甲基環五矽氧烷與聚氧乙烯-甲基聚矽氧烷共聚物之混合物 | 8 | 8 | 8 | 8 | 8 | |
甲基聚矽氧烷 | 18 | 18 | 20 | 18 | 20 | |
純化水 | 10 | 10 | 10 | 10 | 10 | |
合計 | 100 | 100 | 100 | 100 | 100 | |
性狀 | 製備第二天 | 未分離 | 未分離 | 未分離 | 未分離 | 分離 |
60℃1週後 | 未分離 | 未分離 | 未分離 | 未分離 | - | |
60℃3週後 | 未分離 | 未分離 | 未分離 | 分離 | - |
如表4所示,於調配有1,3-丙二醇之情形時,獲得了穩定的油中水型外用組成物。另一方面,如比較例1所示,於未調配1,3-丙二醇而僅調配有1,2-丙二醇之組成物中,於60℃下保存3週後確認到分離。再者,於比較例1之組成物中,自於60℃保存2週後可見分離傾向。如比較例2所示,於僅調配有二丙二醇之組成物中,於製備第二天確認到分離。
[配方例]
於下述表5及表6中顯示配方例(製劑例1至製劑例10)。配方例均為乳霜劑,配方例中的含量均為質量%。再者,表6係表5之延續。
[表5]
[表6]
製劑例1 | 製劑例2 | 製劑例3 | 製劑例4 | 製劑例5 | 製劑例6 | 製劑例7 | 製劑例8 | 製劑例9 | 製劑例10 | |
乳霜 | 乳霜 | 乳霜 | 乳霜 | 乳霜 | 乳霜 | 乳霜 | 乳霜 | 防曬霜 | 防曬霜 | |
抗壞血酸 | 5 | 5 | 7 | 10 | 3 | 10 | 12 | 15 | 5 | 15 |
1,3-丙二醇 | 30 | 50 | 40 | 30 | 50 | 60 | 30 | 30 | 30 | 50 |
角鯊烷 | 5 | 8 | 3 | |||||||
甘油三(辛酸/癸酸)酯 | 1.5 | 3 | 1 | |||||||
白芒花籽油 | 3 | 5 | 2 | 2 | ||||||
氫化油 | 0.5 | 1 | ||||||||
2-乙基己酸鯨蠟酯 | 4 | 5 | ||||||||
甲基聚矽氧烷 | 5 | 8 | 4 | 10 | 5 | 3 | 15 | 20 | ||
凡士林 | 2 | 2 | 1 | |||||||
牛油樹油酯 | 3 | 1 | ||||||||
甘油三(辛酸/癸酸/肉豆蔻酸/硬脂酸)酯 | 0.5 | 1 | ||||||||
硬脂酸 | 1 | 0.3 | ||||||||
鯨蠟醇 | 0.5 | |||||||||
俞樹醇 | 0.5 | 0.5 | ||||||||
異壬酸異壬酯 | 1 | 2 | ||||||||
液態石蠟 | 2 | 5 | ||||||||
十甲基環五矽氧烷 | 1 | 3 | 2 | |||||||
交聯型甲基聚矽氧烷 | 2 | 1 | 4 | |||||||
交聯型聚醚改質聚矽氧混合物 | 3 | 2 | 0.5 | |||||||
鯨蠟基PEG/PPG-10/1二甲聚矽氧烷 | 3 | 3 | 2.5 | |||||||
高聚合甲基聚矽氧烷(1) | 5 | 2 | ||||||||
月桂基PEG-9聚二甲基矽烷氧基乙基二甲聚矽氧烷 | 2 | 1 | ||||||||
PEG/PPG-20/22丁醚二甲聚矽氧烷 | 2 | |||||||||
(二甲聚矽氧烷/(PEG-10/15))交聯聚合物 | 1 | 3 | ||||||||
甲基苯基聚矽氧烷 | 0.5 | 2 | 0.8 | |||||||
二甲基二硬脂基銨鋰膨潤石 | 2 | 3 | 1 | |||||||
聚氧乙烯-甲基聚矽氧烷共聚物 | 3 | 6 | 4 | |||||||
無水乙醇 | 5 | 7 | 10 | 10 | 12 | 5 | 3 | 5 | 10 | 7 |
3-O-乙基抗壞血酸 | 0.5 | 1 | 0.5 | 0.3 | 0.5 | 0.5 | ||||
甘油 | 17.52 | 29.7 | ||||||||
1,3-丁二醇 | 34.3 | 6.75 | 0.2 | |||||||
1,2-丙二醇 | 8.04 | 13.23 | ||||||||
戊二醇 | 3 | |||||||||
己二醇 | 2 | |||||||||
二丙二醇 | 6.35 | 1.69 | 26.7 | |||||||
對羥基苯甲酸甲酯 | 0.2 | 0.25 | ||||||||
焦亞硫酸鈉 | 0.02 | 0.03 | ||||||||
苯氧基乙醇 | 0.3 | 0.3 | 0.2 | |||||||
氯苯甘醚 | 0.1 | |||||||||
甘油單2-乙基己醚 | 0.05 | 0.1 | ||||||||
羧基乙烯基聚合物 | 0.2 | 0.15 | ||||||||
羥基丙基甲基纖維素 | 0.05 | 0.1 | ||||||||
聚氧乙烯山梨醇酐異硬脂酸酯(20E.O.) | 2 | 1.5 | ||||||||
二甘油三異硬脂酸酯 | 0.5 | 3 | 2 | |||||||
大豆蛋白水解物 | 0.01 | 0.1 | ||||||||
水解膠原蛋白 | 0.02 | 0.05 | ||||||||
神經醯胺2 | 0.005 | 0.05 | ||||||||
神經醯胺3 | 0.01 | 0.05 | ||||||||
甘油葡萄糖苷 | 1 | |||||||||
薏苡仁萃取物 | 0.02 |
朝鮮薊萃取物 | 0.05 | |||||||||
香菊萃取物 | 0.01 | |||||||||
刺蘼萃取物 | 0.04 | |||||||||
迷迭香萃取物 | 0.01 | |||||||||
檸檬萃取物 | 0.02 | |||||||||
葡萄柚萃取物 | 0.04 | 0.01 | ||||||||
酵母萃取物 | 0.01 | 0.01 | ||||||||
d-δ-生育酚 | 0.05 | 0.1 | 0.1 | |||||||
蜂王漿萃取物 | 0.06 | |||||||||
檸檬酸 | 適量 | 適量 | 適量 | |||||||
檸檬酸鈉 | 適量 | 適量 | 適量 | |||||||
乙二胺四乙酸二鈉 | 0.1 | 0.05 | 0.1 | 0.05 | 0.1 | 0.05 | 0.1 | |||
對甲氧基肉桂酸2-乙基己酯 | 2 | |||||||||
水楊酸2-乙基己酯 | 0.5 | |||||||||
4-第三丁基-4'-甲氧基二苯甲醯甲烷 | 1.5 | |||||||||
苯基苯并咪唑磺酸 | 0.2 | |||||||||
二乙胺基羥基苯甲醯苯甲酸己酯 | 2 | |||||||||
雙乙基己氧基苯基甲氧基苯基三嗪 | 2 | |||||||||
純化水 | 5 | 3 | 10 | 5 | 3 | 10 | 5 | 3 | 8 | 10 |
合計 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 |
Claims (6)
- 一種油中水型外用組成物,含有:(A)選自由抗壞血酸及抗壞血酸之鹽所組成之群組中的至少一種;(B)1,3-丙二醇15質量%以上;(C)油分;及(D)聚矽氧系界面活性劑。
- 如請求項1所記載之油中水型外用組成物,其中前述(A)選自由抗壞血酸及抗壞血酸之鹽所組成之群組中的至少一種的含量為1質量%至30質量%。
- 如請求項1所記載之油中水型外用組成物,其中水的含量為10質量%以下。
- 如請求項1所記載之油中水型外用組成物,其中前述(C)油分包含聚矽氧油。
- 如請求項1所記載之油中水型外用組成物,進而含有低級醇。
- 一種緩和油中水型外用組成物之皮膚刺激之方法,係藉由使(A)選自由抗壞血酸及抗壞血酸之鹽所組成之群組中的至少一種、(B)1,3-丙二醇15質量%以上、(C)油分、及(D)聚矽氧系界面活性劑共存,來緩和含有(A)選自由抗壞血酸及抗壞血酸之鹽所組成之群組中的至少一種之油中水型外用組成物之皮膚刺激。
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US20210093539A1 (en) * | 2019-09-30 | 2021-04-01 | Concept Matrix Solutions | Topical cosmetic |
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