TWI833741B - 外用油性固形組成物 - Google Patents
外用油性固形組成物 Download PDFInfo
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- TWI833741B TWI833741B TW108111267A TW108111267A TWI833741B TW I833741 B TWI833741 B TW I833741B TW 108111267 A TW108111267 A TW 108111267A TW 108111267 A TW108111267 A TW 108111267A TW I833741 B TWI833741 B TW I833741B
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Abstract
本發明之外用油性固形組成物係含有選自由(A)類固醇化合物及抗組織胺劑所組成之群組中之至少一種,該外用油性固形組成物可滑順地塗抹於皮膚或黏膜。該組成物可製成條狀的固形組成物。(A)類固醇化合物之含量相對於組成物全量可為0.0001至5重量%,(B)抗組織胺劑之含量相對於組成物全量可為0.01至5重量%。
Description
本發明係有關條(stick)狀等固體形狀之外用油性組成物。
以往,口紅、唇膏、粉底、化粧底粧、眼霜、止汗劑、美白劑等化粧料或準藥品(quasi drug)係常使用經成形為條狀等之油性組成物。該等固形組成物有於塗抹時不會弄髒手而可簡便地使用、且於狹窄部位亦可正確塗抹之利點。
惟,如此之固形油性組成物在塗抹於皮膚或嘴唇等之黏膜上時,在皮膚或黏膜上會因沾黏等原因而導致難以塗抹延展。由於近年來消費者重視使用感,故若欲商品化,則必需製成可滑順地塗抹於皮膚或黏膜之組成物。
本發明係以提供可滑順地塗抹於皮膚或黏膜上之外用油性固形組成物為課題。
本發明人等為了解決上述課題而進行深入研究,發現在油性固形組成物中,不僅可藉由基劑之組成,亦可藉由如有效成分或添加物等調配成分,而使塗抹時之滑順度有大幅變化。此外,尤其是發現藉由在油性固形組成物中調配(A)類固醇化合物及/或(B)抗組織胺劑,而使塗抹於皮膚或黏膜時之摩擦變小,可滑順地塗抹。
本發明係以上述見解為基礎而完成之發明,提供下述之外用油性固形組成物。
項1.一種外用油性固形組成物,係含有選自由(A)類固醇化合物及(B)抗組織胺劑所組成之群組中之至少1種。
項2.如項1所述之組成物,其中,(A)類固醇化合物為選自由去氫皮質醇(prednisolone)、地塞米松(dexamethasone)、氫化可體松(hydrocortisone)、此等之酯及此等之鹽所組成之群組中之化合物。
項3.如項2所述之組成物,其中,(A)類固醇化合物為選自由去氫皮質醇戊酸酯乙酸酯、地塞米松乙酸酯、氫化可體松及氫化可體松乙酸酯所組成之群組中之化合物。
項4.如項1至項3中任一項所述之組成物,其中,(B)抗組織胺劑為選自由苯海拉明(Diphenhydramine)及其鹽所組構成之群組中之至少1種化合物。
項5.如項1至項4中任一項所述之組成物,其中,(A)類固醇化合物之含量相對於組成物全量而為0.0001至5重量%。
項6.如項1至項5中任一項所述之組成物,其中,(B)抗組織胺劑之含量相對於組成物全量而為0.01至5重量%。
項7.如項1至項6中任一項所述之組成物,其更含有選自由(D)局部麻醉劑、(C)抗組織胺劑以外之止癢劑、(E)非類固醇性抗炎症劑、(F)殺菌劑及(G)清涼化劑所組成之群組中之至少1種。
項8.如項1至項7中任一項所述之組成物,其為皮膚外用組成物。
項9.如項1至項8中任一項所述之組成物,其為條狀。
項10.一種塗抹外用油性固形組成物時降低與皮膚或黏膜之摩擦的方法,係藉由使外用油性固形組成物中含有(A)類固醇化合物及/或(B)抗組織胺劑,而於塗抹該外用油性固形組成物時降低與皮膚或黏膜之摩擦。
通常,固形之油性組成物於塗抹於皮膚或黏膜上時之摩擦大而難以塗抹延展。關於此點,本發明之外用油性固形組成物由於含有類固醇化合物及/或抗組織胺劑,故可滑順地塗抹於皮膚或黏膜。
如此,本發明之外用油性固形組成物係由於塗抹時之使用感優越,故商品價值高。再者,塗抹時之滑順度若差,則在塗抹部位有發炎或損傷時會有造成刺激之虞,此外,皮膚或嘴唇之落屑或污垢容易附著於組成物而造成不衛生之狀況;不過,由於本發明之外用油性固形組成物係與皮膚或黏膜之摩擦少,故即使是在於發生炎症或損傷之部位亦容易塗抹,而且落屑或污垢係不容易附著於組成物。另外,由於上述調配成分具有藥理活性,故較佳係減少附著於患部以外的部位並且限定性地塗抹於患部;不過,由於本發明之外用油性固形組成物可滑順地塗抹,故可容易且正確地塗抹於目的部位。
第1圖為表示於油性固形組成物中藉由調配(A)類固醇化合物及/或(B)抗組織胺劑而降低與皮膚之摩擦係數之圖。
以下,將本發明加以詳細說明。
本發明之組成物為含有(A)類固醇化合物及/或(B)抗組織胺劑之外用油性固形組成物。
(A)類固醇化合物
類固醇化合物之具體例可列舉例如去氫皮質醇、氫化可體松、可體松(cortisone)、地塞米松、曲安西諾隆(Triamcinolone)、曲安西諾隆縮丙酮(Triamcinolone acetonide)、二氟潑尼酯(Difluprednate)、莫美他松(Mometasone)、二氟可龍(Diflucortolone)、氟蟲脲(fluoniside)、貝克美他松(Beclometasone)、地潑羅酮(Deprodone)、阿氯美他松(Alclometasone)、氟美他松(flumetasone)、安西諾德(Amcinonide)、可洛貝他松(Clobetasone)、二氟拉松(Diflorasone)及此等之衍生物。
就衍生物而言,代表性例子可列舉酯(尤其是有機酸或無機酸之酯)、鹽、以及酯之鹽。
類固醇化合物可為水合物、半水合物或無水物。
酯可列舉例如:如戊酸、乙酸、琥珀酸、酪酸(亦即丁酸)、丙酸、磺酸基苯甲酸、席貝席酸(cipecilic acid)、棕櫚酸、呋喃甲酸(furancarboxylic acid)、三甲基乙酸等有機酸之酯;如磷酸等無機酸之酯。此外,於1分子中亦可含有複數個酯。於1分子中含有複數個酯時,可含有複數個與1種酸所成之酯,或亦可含有與2種以上之酸所成之酯。
鹽可列舉如:與有機鹼所成之鹽(如甲胺鹽、三乙胺鹽、三乙醇胺鹽、嗎啉鹽、六氫吡嗪(piperazine)鹽、吡咯啶(pyrrolidine)鹽、三聯吡啶鹽、甲基吡啶鹽等有機胺鹽等)、與無機鹼所成之鹽(銨鹽;如鈉鹽、鉀鹽等鹼金屬鹽,如鈣鹽、鎂鹽等鹼土金屬鹽,如鋅鹽、鋁鹽等金屬鹽等)。其中,較佳為鈉鹽、鉀鹽等鹼金屬鹽。
類固醇化合物衍生物之具體例可列舉:去氫皮質醇戊酸酯乙酸酯(PVA)、去氫皮質醇琥珀酸酯、去氫皮質醇乙酸酯、去氫皮質醇磷酸酯等去氫皮質醇酯,地塞米松戊酸酯、地塞米松丙酸酯、地塞米松乙酸酯、地塞米松磷酸酯、地塞米松甲間磺酸基苯甲酸酯、地塞米松席貝席酸酯、地塞米松棕櫚酸酯等地塞米松酯,氫化可體松丁酸酯(尤其是氫化可體松-17-丁酸酯)、氫化可體松乙酸酯、氫化可體松琥珀酸酯、氫化可體松丁酸酯丙酸酯、氫化可體松磷酸酯等氫化可體松酯,莫美他松呋喃甲酸酯、二氟可龍戊酸酯、貝克美他松丙酸酯、貝克美他松二丙酸酯、可洛貝他松丁酸酯、地潑羅酮丙酸酯、阿氯美他松丙酸酯、氟美他松三甲基乙酸酯、可洛貝他松丙酸酯、可洛貝他松丁酸酯、二氟拉松乙酸酯等。
其中,較佳為去氫皮質醇戊酸酯乙酸酯、地塞米松乙酸酯、氫化可體松、氫化可體松乙酸酯,更佳為去氫皮質醇戊酸酯乙酸酯、氫化可體松、氫化可體松乙酸酯,再更佳為去氫皮質醇戊酸酯乙酸酯。
當不含有抗組織胺劑時,藉由使用去氫皮質醇、地塞米松、氫化可體松及/或此等之衍生物(尤其是酯)作為類固醇化合物,而特別顯著地降低與皮膚之摩擦。其中,較佳為去氫皮質醇戊酸酯乙酸酯、地塞米松乙酸酯、氫化可體松、氫化可體松乙酸酯,更佳為去氫皮質醇戊酸酯乙酸酯、氫化可體松、氫化可體松乙酸酯,特佳為去氫皮質醇戊酸酯乙酸酯。
類固醇化合物可單獨使用1種或將2種以上組合使用。
類固醇化合物之含量相對於組成物全量較佳為0.0001重量%以上,更佳為0.001重量%以上,再更佳為0.01重量%以上。此外,較佳為5重量%以下,更佳為2.5重量%以下,再更佳為1重量%以下,又再更佳為0.5重量%以下。只要於該範圍,即可於獲得適當藥理活性之同時亦成為滑順性良好之組成物。
類固醇化合物之含量相對於組成物全量而可列舉0.0001至5重量%、0.0001至2.5重量%、0.0001至1重量%、0.0001至0.5重量%、0.001至5重量%、0.001至2.5重量%、0.001至1重量%、0.001至0.5重量%、0.01至5重量%、0.01至2.5重量%、0.01至1重量%、0.01至0.5重量%。
其中,去氫皮質醇或其衍生物(尤其是酯)之含量相對於組成物全量較佳為0.01重量%以上,更佳為0.06重量%以上,再更佳為0.1重量%以上。此外,較佳為1重量%以下,更佳為0.5重量%以下,再更佳為0.2重量%以下。又以0.15重量%為特佳。
去氫皮質醇或其衍生物(尤其是酯)之含量相對於組成物全量而可列舉0.01至1重量%、0.01至0.5重量%、0.01至0.2重量%、0.01至0.15重量%、0.06至1重量%、0.06至0.5重量%、0.06至0.2重量%、0.06至0.15重量%、0.1至1重量%、0.1至0.5重量%、0.1至0.2重量%、0.1至0.15重量%。
其中,地塞米松或其衍生物(尤其是酯)之含量相對於組成物全量較佳為0.005重量%以上,更佳為0.01重量%以上,再更佳為0.0125重量%以上。此外,較佳為0.1重量%以下,更佳為0.05重量%以下,再更佳為0.025重量%以下。
地塞米松或其衍生物(尤其是酯)之含量相對於組成物全量而可列舉0.005至0.1重量%、0.005至0.05重量%、0.005至0.025重量%、0.01至0.1重量%、0.01至0.05重量%、0.01至0.025重量%、0.0125至0.1重量%、0.0125至0.05重量%、0.0125至0.025重量%。
其中,氫化可體松或其衍生物(尤其是酯)之含量相對於組成物全量較佳為0.05重量%以上,更佳為0.1重量%以上,再更佳為0.15重量%以上。此外,較佳為2重量%以下,更佳為1重量%以下,又更佳為0.5重量%以下。
氫化可體松或其衍生物(尤其是酯)之含量相對於組成物全量而可列舉0.05至2重量%、0.05至1重量%、0.05至0.5重量%、0.1至2重量%、0.1至1重量%、0.1至0.5重量%、0.15至2重量%、0.15至1重量%、0.15至0.5重量%。
(B)抗組織胺劑
抗組織胺劑可列舉:如苯海拉明、溴苯海拉明、克雷滿汀(Clemastine)、氯苯氧胺(Chlorphenoxamine)、二苯拉林(Diphenylpyraline)、多西拉敏(Doxylamine)、奧菲那特林(Orphenadrine)、苯妥沙敏(Phenyltoloxamine)等乙醇胺系抗組織胺劑,如氯菲氨明(Chlorpheniramine)、二甲茚定(Dimetindene)、他拉斯丁(Talastine)等丙胺系抗組織胺劑,如美吡拉敏(Mepyramine)、美沙吡啉(Methapyrilene)、曲吡那敏(Tripelennamine)等乙二胺系抗組織胺劑,如阿利馬嗪(Alimemazine)、羥乙基異 丙嗪(Hydroxyethylpromethazine)、異西噴地(Isothipendyl)、美喹塔嗪(Mequitazine)、奧索馬嗪(Oxomemazine)、異丙嗪(Promethazine)等吩噻嗪(Phenothiazine)系抗組織胺劑,如布克力嗪(Buclizine)、西替利嗪(Cetirizine)、高氯賽克力嗪(Homochlorcyclizine)、賽克力嗪(Cyclizine)、羥嗪(Hydroxyzine)、左旋西替利嗪(levocetirizine)、美克利嗪(Meclizine)、歐沙多胺(Oxatomide)等六氫吡嗪系抗組織胺劑,如可多替芬(Ketotifen)、奧洛他定(Olopatadine)、非索非那定(Fexofenadine)、樂雷他定(Loratadine)、特芬那定(Terfenadine)、安塔洛林(Antazoline)、阿札他定(Azatadine)、巴米呯(Bamipine)、賽庚啶(Cyproheptadine)、地普托品(Deptropine)、依巴斯汀(Ebastine)、依美達斯汀(Emedastine)、依匹斯汀(Epinastine)、美海得林(Mebhydrolin)、美索斯汀(Mizolastine)、匹美噻噸(Pimethixene)、吡咯布他明(Pyrrobutamine)、奎非那定(Quifenadine)、盧帕他定(Rupatadine)、屈普利定(Triprolidine)、阿伐斯汀(Acrivastine)、阿斯特米唑(Astemizole)、氮卓斯汀(Azelastine)、畢拉斯汀(Bilastine)、地氯雷他定(Desloratadine)及此等之鹽等。
抗組織胺劑可為水合物、半水合物或無水物。
鹽只要是藥學或生理學上所容許之鹽即可,可列舉無機酸鹽、有機酸鹽等。無機酸鹽可列舉鹽酸鹽、氫溴酸鹽、硝酸鹽、硫酸鹽、磷酸鹽等。有機酸鹽可列舉:如乙酸鹽、三氟乙酸鹽、丁酸鹽、棕櫚酸鹽、硬脂酸鹽等單羧酸鹽,如富馬酸鹽、馬來酸鹽、琥珀酸鹽、丙二酸鹽等多元羧酸鹽,如乳酸鹽、酒石酸鹽、檸檬酸鹽等羥基羧酸鹽,如甲磺酸鹽、甲苯磺酸鹽(toluenesulfonate salt)、對甲苯磺酸鹽(tosylate salt)、萘二磺酸鹽等有機磺酸鹽等。
具體而言,可列舉苯海拉明鹽酸鹽、溴苯海拉明鹽酸鹽、克雷滿汀富馬酸鹽、氯苯氧胺鹽酸鹽、二苯拉林鹽酸鹽、多西拉敏琥珀酸鹽、奧菲那特林鹽酸鹽、苯妥沙敏檸檬酸鹽、氯菲氨明馬來酸鹽、二甲茚定馬來酸鹽、美吡拉敏馬來酸鹽、美沙吡啉鹽酸鹽、曲吡那敏鹽酸鹽、阿利馬嗪酒石酸鹽、異西噴地鹽酸鹽、奧索馬嗪鹽酸鹽、異丙嗪鹽酸鹽、西替利嗪鹽酸鹽、高氯賽克力嗪鹽酸鹽、賽克力嗪鹽酸鹽、羥嗪鹽酸鹽、左旋西替利嗪鹽酸鹽、美克利嗪鹽酸鹽、可多替芬富馬酸鹽、奧洛他定鹽酸鹽、非索非那定鹽酸鹽、安塔洛林鹽酸鹽、阿札他定二馬來酸鹽、巴米呯鹽酸鹽、賽庚啶鹽酸鹽、地普托品檸檬酸鹽、依美達斯汀富馬酸鹽、依匹斯汀鹽酸鹽、美海得林萘二磺酸鹽、盧帕他定富馬酸鹽、屈普利定鹽酸鹽、氮卓斯汀鹽酸鹽。
其中,較佳為乙醇胺系抗組織胺劑,更佳為苯海拉明或其鹽(尤其是鹽酸鹽),再更佳為苯海拉明。
抗組織胺劑可單獨使用1種或將2種以上組合使用。
抗組織胺劑之含量相對於組成物全量較佳為0.01重量%以上,更佳為0.1重量%以上,再更佳為0.5重量%以上。此外,較佳為5重量%以下,更佳為3重量%以下,再更佳為2重量%以下。另外,亦可作成1重量%以下。只要於該範圍,即可於獲得適當藥理活性之同時亦成為滑順性良好之組成物。
抗組織胺劑之含量相對於組成物全量而可列舉0.01至5重量%、0.01至3重量%、0.01至2重量%、0.01至1重量%、0.1至5重量%、0.1至3重量%、0.1至2重量%、0.1至1重量%、0.5至5重量%、0.5至3重量%、0.5至2重量%、0.5至1重量%。
本發明之外用油性固形組成物中,除了含有上述(A)成分及/或(B)成分之外,即使含有(C)抗組織胺劑以外之止癢劑、(D)局部麻醉劑、(E)非類固醇性抗炎症劑、(F)殺菌劑及(G)清涼化劑中之1種或2種以上,亦具有可滑順地塗抹之效果。該「2種以上」係包括例如含有(C)成分及(D)成分之情況、或含有2種以上之(C)成分之情況。
(C)抗組織胺劑以外之止癢劑
抗組織胺劑以外之止癢劑可列舉丁烯醯苯胺(Crotamiton)、魚石脂(Ichthammol)、松焦油(pine tar)、百里酚(Thymol)等。其中,較佳為丁烯醯苯胺。
抗組織胺劑以外之止癢劑可為水合物、半水合物或無水物。
抗組織胺劑以外之止癢劑之含量相對於組成物全量較佳為0.01重量%以上,更佳為0.1重量%以上,再更佳為1重量%以上。此外,較佳為20重量%以下,更佳為15重量%以下,再更佳為10重量%以下。只要於該範圍,即可於獲得適當藥理活性之同時亦成為滑順性良好之組成物。
抗組織胺劑以外之止癢劑之含量相對於組成物全量而可列舉0.01至20重量%、0.01至15重量%、0.01至10重量%、0.1至20重量%、0.1至15重量%、0.1至10重量%、1至20重量%、1至15重量%、1至10重量%。
(D)局部麻醉劑
局部麻醉劑可列舉:如利多卡因(Lidocaine)、二丁卡因(Dibucaine)、甲哌卡因(Mepivacaine)、布比卡因(Bupivacaine)、洛比卡因(Ropivacaine)、左旋布比卡因(levobupivacaine)、奧昔卡因(Oxethazaine)及此等之鹽等具有胺構造及醯胺構造之局部麻醉劑,如古柯鹼(Cocaine)、普魯卡因(Procaine)、氯普魯卡因 (Chloroprocaine)、四卡因(Tetracaine)及此等之鹽等具有胺構造及酯構造之局部麻醉劑,具有酯構造之胺基苯甲酸乙酯、羥基聚乙氧基十二烷等。
局部麻醉劑可為水合物、半水合物或無水物。
鹽只要是藥學或生理學上所容許之鹽即可,可列舉無機酸鹽、有機酸鹽等。無機酸鹽可列舉鹽酸鹽、氫溴酸鹽、硝酸鹽、硫酸鹽、磷酸鹽等。有機酸鹽可列舉:如乙酸鹽、三氟乙酸鹽、丁酸鹽、棕櫚酸鹽、硬脂酸鹽等單羧酸鹽,如富馬酸鹽、馬來酸鹽、琥珀酸鹽、丙二酸鹽等多元羧酸鹽,如乳酸鹽、酒石酸鹽、檸檬酸鹽等羥基羧酸鹽,如甲磺酸鹽、甲苯磺酸鹽、對甲苯磺酸鹽、萘二磺酸鹽等有機磺酸鹽等。
具體而言,可列舉利多卡因鹽酸鹽、二丁卡因鹽酸鹽、甲哌卡因鹽酸鹽、布比卡因鹽酸鹽、洛比卡因鹽酸鹽、左旋布比卡因鹽酸鹽、奧昔卡因鹽酸鹽、古柯鹼鹽酸鹽、普魯卡因鹽酸鹽、氯普魯卡因鹽酸鹽、四卡因鹽酸鹽等。
其中,較佳為利多卡因、二丁卡因、胺基苯甲酸乙酯、羥基聚乙氧基十二烷、或此等之鹽(鹽酸鹽等),更佳為利多卡因或其鹽,再更佳為利多卡因、鹽酸利多卡因,特佳為利多卡因。
局部麻醉劑可單獨使用1種或將2種以上組合使用。
局部麻醉劑之含量相對於組成物全量較佳為0.01重量%以上,更佳為0.05重量%以上,又更佳為0.1重量%以上,再更佳為0.5重量%以上。此外,可作成1重量%以上。另外,較佳為5重量%以下,更佳為3重量%以下,再更佳為2重量%以下。只要於該範圍,即可於獲得適當藥理活性之同時亦成為滑順性良好之組成物。
局部麻醉劑之含量相對於組成物全量而可列舉0.01至5重量%、0.01至3重量%、0.01至2重量%、0.05至5重量%、0.05至3重量%、0.05至2重量%、0.1至5重量%、0.1至3重量%、0.1至2重量%、0.5至5重量%、0.5至3重量%、0.5至2重量%、1至5重量%、1至3重量%、1至2重量%。
(E)非類固醇性抗炎症劑
非類固醇性抗炎症劑可列舉:尿囊素(Allantoin)、甘草酸(glycyrrhizinic acid)、甘草酸甲酯、甘草酸硬脂酯、甘草次酸(glycyrrhetinic acid)、甘草次酸硬脂酯、乙醯胺酚(Acetaminophen)、ε-胺基己酸(ε-Aminocaproic acid)、小蘗鹼(Berberine)、甘菊藍(Azulene)、鳳梨蛋白酶(Bromelain)、鋅;如甘草萃取物、鼠尾草(sage)萃取物、迷迭香萃取物等植物萃取物;如溶菌酶(Lysozyme)、舍雷肽酶(Serrapeptase)、半鹼性蛋白酶(Semi-alkaline proteinase)等酵素系抗炎症劑;如甲芬那酸(mefenamic acid)、氟芬那酸(Flufenamic acid)、托芬那酸(Tolfenamic acid)等芬那酸系抗炎症劑;如阿西美辛(Acemetacin)、吲哚美辛(Indometacin)、吲哚美辛法呢酯(Indomethacin farnesyl)、依托度酸(Etodolac)、待克菲那(Diclofenac)、蘇林達克(Sulindac)、萘丁美酮(Nabumetone)、芬布芬(Fenbufen)、丙谷美辛(Proglumetacin)、莫苯唑酸(Mofezolac)等芳基乙酸系抗炎症劑;氨布洛芬(Aminoprofen)、布洛芬(Ibuprofen)、奧沙普嗪(Oxaprozin)、酮洛芬(Ketoprofen)、扎托洛芬(Zaltoprofen)、泰普菲酸(Tiaprofenic acid)、那普洛仙(Naproxen)、氟比洛芬(Flurbiprofen)、扎托洛芬、布洛芬吡啶甲醇(Ibuprofen piconol)、氟比洛芬甲替酯(Flurbiprofen axetil)、菲諾洛芬(Fenoprofen)、普拉洛芬(Pranoprofen)、洛索洛芬(Loxoprofen)等丙酸系抗炎症劑;如安匹洛昔康(Ampiroxicam)、特諾昔康 (Tenoxicam)、匹洛昔康(Piroxicam)、美洛昔康(Meloxicam)、羅諾昔康(Lomoxicam)等昔康(Oxicam)系抗炎症劑等。該等亦可為鹽。
非類固醇性抗炎症劑可為水合物、半水合物或無水物。
鹽只要是藥學或生理學上所容許之鹽即可,可列舉無機酸鹽、有機酸鹽等。無機酸鹽可列舉鹽酸鹽、氫溴酸鹽、硝酸鹽、硫酸鹽、磷酸鹽等。有機酸鹽可列舉:如乙酸鹽、三氟乙酸鹽、丁酸鹽、棕櫚酸鹽、硬脂酸鹽等單羧酸鹽,如富馬酸鹽、馬來酸鹽、琥珀酸鹽、丙二酸鹽等多元羧酸鹽,如乳酸鹽、酒石酸鹽、檸檬酸鹽等羥基羧酸鹽,如甲磺酸鹽、甲苯磺酸鹽、對甲苯磺酸鹽、萘二磺酸鹽等有機磺酸鹽等。
此外,亦可列舉:與有機鹼所成之鹽(如甲胺鹽、三乙胺鹽、三乙醇胺鹽、嗎啉鹽、六氫吡嗪鹽、吡咯啶鹽、三聯吡啶鹽、甲基吡啶鹽等有機胺鹽等)、與無機鹼所成之鹽(如銨鹽;如鈉鹽、鉀鹽等鹼金屬鹽,如鈣鹽、鎂鹽等鹼土金屬鹽,如鋅鹽、鋁鹽等金屬鹽等)。
具體而言可列舉尿囊素、甘草酸二鉀鹽、甘草酸單銨鹽、甘草次酸、甘草次酸硬脂酯、吲哚美辛鹽酸鹽、待克菲那鈉鹽、溴菲那酸鈉鹽(Bromfenac sodium)、小蘗鹼硫酸鹽、小蘗鹼鹽酸鹽、小蘗鹼丹寧酸鹽、甘菊藍磺酸鈉鹽、硫酸鋅、乳酸鋅、溶菌酶鹽酸鹽、丙谷美辛馬來酸鹽、菲諾洛芬鈣鹽、洛索洛芬鈉鹽等。
其中,較佳為尿囊素、甘草酸二鉀鹽、甘草酸單銨鹽、甘草次酸、甘草次酸硬脂酯,更佳為尿囊素、甘草酸二鉀鹽、甘草酸單銨鹽、甘草次酸,再更佳為甘草次酸。
非類固醇性抗炎症劑可單獨使用1種或將2種以上組合使用。
非類固醇性抗炎症劑之含量相對於組成物全量較佳為0.01重量%以上,更佳為0.1重量%以上,再更佳為0.5重量%以上。此外,較佳為5重量%以下,更佳為3重量%以下,再更佳為1重量%以下。只要於該範圍,即可於獲得適當藥理活性之同時亦成為滑順性良好之組成物。
非類固醇性抗炎症劑之含量相對於組成物全量而可列舉0.01至5重量%、0.01至3重量%、0.01至1重量%、0.1至5重量%、0.1至3重量%、0.1至1重量%、0.5至5重量%、0.5至3重量%、0.5至1重量%。
(F)殺菌劑
殺菌劑可列舉異丙基甲基酚、苯氧基乙醇、地喹氯銨(Dequalinium chloride)、氯化烷基二甲基苯甲基銨(Benzalkonium chloride)、氯化苯索寧(benzethonium chloride)、鹽酸氯己定(Chlorhexidine HCl)、葡萄糖酸氯己定(Chlorhexidine gluconate)、鹽酸烷基二胺基乙基甘胺酸、氯化鯨蠟基吡啶鎓鹽(cetylpyridinium chloride)、苯甲酸鈉、乙醇、氯丁醇、山梨酸、山梨酸鉀、四氫乙酸鈉、對羥基苯甲酸甲酯、對羥基苯甲酸乙酯、對羥基苯甲酸丙酯、對羥基苯甲酸丁酯、羥基喹啉硫酸鹽、苯乙醇、苯甲醇、水楊酸、甲酚、三氯沙(Triclosan)及雙胍(biguanide)化合物等。
其中,較佳為異丙基甲基酚、氯化烷基二甲基苯甲基銨、氯化苯索寧,更佳為異丙基甲基酚。
殺菌劑可單獨使用1種或將2種以上組合使用。
殺菌劑可為水合物、半水合物或無水物。
此外,本發明之外用油性固形組成物亦可製成不含有抗生物質者。
殺菌劑之含量相對於組成物全量較佳為0.001重量%以上,更佳為0.01重量%以上,再更佳為0.05重量%以上。此外,較佳為3重量%以下,更佳為1重量%以下,再更佳為0.5重量%以下。只要於該範圍,即可於獲得適當之殺菌效果之同時亦成為滑順性良好之組成物。
殺菌劑之含量相對於組成物全量而可列舉0.001至3重量%、0.001至1重量%、0.001至0.5重量%、0.01至3重量%、0.01至1重量%、0.01至0.5重量%、0.05至3重量%、0.05至1重量%、0.05至0.5重量%。
(G)清涼化劑
清涼化劑可列舉:如薄荷醇、樟腦、龍腦、香葉醇、桉油醇(cineol)、茴香腦、檸檬烯、丁香酚等萜烯類(此等可為d體、l體或dl體中之任何一種);如桉樹油(Eucalyptus oil)、佛手柑油(Bergamot oil)、胡椒薄荷油(pepper mint oil)、冷薄荷油(cool mint oil)、綠薄荷油(spear mint oil)、茴香油、薄荷油、桂皮油、玫瑰油、松節油等精油等。
其中,較佳為薄荷醇、樟腦、龍腦,更佳為薄荷醇。
清涼化劑可單獨使用1種或將2種以上組合使用
清涼化劑之含量相對於組成物全量較佳為0.001重量%以上,更佳為0.01重量%以上,再更佳為0.1重量%以上。此外,較佳為10重量%以下,更佳為5重量%以下,再更佳為3.5重量%以下。只要於該範圍,即可於獲得適當之清涼化效果之同時亦成為滑順性良好之組成物。
清涼化劑之含量相對於組成物全量而可列舉0.001至10重量%、0.001至5重量%、0.001至3.5重量%、0.01至10重量%、0.01至5重量%、0.01至3.5重量%、0.1至10重量%、0.1至5重量%、0.1至3.5重量%。
其他成分
本發明之外用油性固形組成物,係可藉由將上述有效成分與「醫藥品、準藥品或化粧品中所使用之基劑或載體、以及視需要之添加劑或其他生理活性或藥理活性成分」混合而製成醫藥品、準藥品或化粧品之外用組成物。尤其是可為醫藥組成物(醫藥外用組成物)。
添加劑可列舉例如:抗氧化劑、界面活性劑、增黏劑、防腐劑或保存劑、pH調整劑、安定化劑、螯合劑、紫外線吸收劑或紫外線散射劑、刺激減輕劑、著色劑、香料等。
添加劑可單獨使用1種或將2種以上組合使用。
此外,添加劑可於不損及本發明效果之範圍內使用。
抗氧化劑可列舉:二丁基羥基甲苯、丁基羥基茴香醚、對羥基茴香醚、山梨酸、亞硫酸鈉、抗壞血酸、抗壞血酸衍生物(抗壞血酸硬脂酸酯、抗壞血酸棕櫚酸酯、抗壞血酸二棕櫚酸酯、抗壞血酸單磷酸酯、抗壞血酸二磷酸酯、抗壞血酸三磷酸酯、抗壞血酸硫酸酯等)、生育醇、生育醇衍生物(乙酸生育醇、琥珀酸生育醇、琥珀酸生育醇鈣等)、異抗壞血酸、L-半胱胺酸鹽酸、番茄紅素、麩胱甘肽、没食子酸丙酯、丹寧酸、表沒食子兒茶素(Epigallocatechin)、花青素、羥基酪醇(hydroxytyrosol)、去甲基二氫癒創木酸(nordihydroguaiaretic acid)、咖啡酸、酵素(過氧化氫酶、超氧化物歧化酶、麩胱甘肽過氧化物酶、彈性蛋白酶(elastase)等)等。
當本發明之組成物含有水等水性基劑或水溶性成分時,亦有調配界面活性劑之情形。
界面活性劑可列舉:如山梨醇酐單異硬脂酸酯、山梨醇酐單月桂酸酯、山梨醇酐單棕櫚酸酯、山梨醇酐單硬脂酸酯、山梨醇酐五-2-乙基己酸二甘油酯及山梨醇酐四-2-乙基己酸二甘油酯等山梨醇酐脂肪酸酯類;如丙二醇單硬脂酸酯等丙二醇脂肪酸酯類;如聚氧伸乙基硬化蓖麻油40(HCO-40)、聚氧伸乙基硬化蓖麻油50(HCO-50)、聚氧伸乙基硬化蓖麻油60(HCO-60)及聚氧伸乙基硬化蓖麻油80等硬化蓖麻油衍生物;如聚氧伸乙基(20)山梨醇酐單月桂酸酯(聚山梨醇酯20)、聚氧伸乙基(20)山梨醇酐單硬脂酸酯(聚山梨醇酯60)、聚氧伸乙基(20)山梨醇酐單油酸酯(聚山梨醇酯80)及聚氧伸乙基(20)山梨醇酐異硬脂酸酯等聚氧伸乙基山梨醇酐脂肪酸酯類;聚氧伸乙基單椰子油脂肪酸甘油酯;甘油烷基醚;烷基葡萄糖苷;如聚氧伸乙基鯨蠟醚等聚氧伸烷基烷基醚;如硬脂胺及油胺等胺類;如聚氧伸乙基/甲基聚矽氧烷共聚物、月桂基PEG-9聚二甲基矽氧基乙基聚二甲基矽氧烷(lauryl PEG-9 polydimethylsiloxyethyl dimethicone)及PEG-9聚二甲基矽氧基乙基聚二甲基矽氧烷等有機聚矽氧(organic silicone)系界面活性劑;磷脂質、表面素(surfactin)及皂素等天然界面活性劑;硬脂酸二乙基胺基乙醯胺及硬脂酸二乙基胺基丙醯胺等脂肪酸醯胺;三月桂胺、二甲基硬脂胺及二-2-乙基己胺等烷基胺;硬脂酸二甲基胺基丙基醯胺及月桂基羥基磺酸基甜菜鹼等甜菜鹼系兩性界面活性劑等。
增黏劑可列舉:阿拉伯樹膠、刺槐豆膠(locust bean gum)、角叉菜膠(carrageenan)、黃原膠(xanthan gum)、聚乙烯醇、聚乙烯基吡咯啶、羧基乙烯系聚合物、丙烯酸甲基丙烯酸烷酯共聚物、聚乙二醇(polyethylene glycol)、膨潤土、海藻酸、聚乙二醇(Macrogol)、軟骨素硫酸鈉、透明質酸及纖維素系增黏劑 (甲基纖維素、乙基纖維素、羥基乙基纖維素、羥基甲基纖維素、羥基丙基纖維素、羥基丙基甲基纖維素、羧基甲基纖維素及羧基乙基纖維素等)等。
防腐劑或保存劑可列舉苯甲酸、苯甲酸鈉、去氫乙酸、去氫乙酸鈉、對羥基苯甲酸異丁酯、對羥基苯甲酸異丙酯、對羥基苯甲酸丁酯、對羥基苯甲酸乙酯、對羥基苯甲酸丙酯、對羥基苯甲酸苯甲酯、對羥基苯甲酸甲酯、苯氧基乙醇、苯甲醇、氯丁醇、山梨酸及其鹽、葡萄糖酸氯己定、烷二醇及甘油脂肪酸酯等。防腐劑或保存劑之中亦有包含於(F)殺菌劑者。
pH調整劑可列舉無機酸(鹽酸及硫酸等)、有機酸(乳酸、乳酸鈉、檸檬酸、檸檬酸鈉、琥珀酸及琥珀酸鈉等)、無機鹼(氫氧化鉀及氫氧化鈉等)及有機鹼(三乙醇胺、二異丙醇胺及三異丙醇胺等)等。
安定化劑可列舉例如聚丙烯酸鈉、二丁基羥基甲苯及丁基羥基茴香醚等。
螯合劑可列舉EDTA/2鈉鹽、EDTA/鈣/2鈉鹽等。
刺激降低劑可列舉甘草萃取物及海藻酸鈉等。
紫外線吸收劑或紫外線散射劑可列舉對甲氧基桂皮酸2-乙基己酯、2-[4-(二乙基胺基)-2-羥基苯甲醯基]苯甲酸己酯、2,4,6-三[4-(2-乙基己氧基羰基)苯胺基]-1,3,5-三嗪、第三丁基甲氧基二苯甲醯基甲烷、二亞苄基二側氧基咪唑啶丙酸乙基己酯、乙氧基己基三唑啉、對胺基苯甲酸及其衍生物、對二甲基胺基苯甲酸辛酯、水楊酸乙二醇、二羥基二苯基酮、氧化鈦及氧化鋅等。
著色料可列舉法定色素手冊(日本化粧品工業連合會編(2004))中記載之色素等。
此外,本發明之外用油性固形組成物亦可製成不含用於掩飾皮膚炎症、發紅、色素沉澱等皮膚疾病之成分。
香料可列舉:如薰衣草油、迷迭香油、快樂鼠尾草(clary sage)油、麝香草油、佛手柑油、桉樹油等香料植物(herb)系精油,如胡椒薄荷油、綠薄荷油、薄荷油等薄荷系精油,如橘子油、檸檬油、葡萄柚油等柑橘系精油之各種精油、調合香料等。香料之中亦可含有作為(G)成分者。
其他之生理活性或藥理活性成分(亦即(A)至(G)成分以外之生理活性或藥理活性成分)可列舉例如保濕成分、維生素類、肽或其衍生物、促進血液循環成分、細胞賦活化成分、抗老化成分、角質軟化成分、收斂成分、胺基酸、蛋白質、植物萃取物、海藻萃取物、抗真菌劑、美白成分等。
其他之生理活性或藥理活性成分可單獨使用1種或將2種以上組合使用。
此外,其他之生理活性或藥理活性成分可在不損及本發明效果之範圍內使用。
保濕成分可列舉:如甘油、二丙二醇、1,3-丁二醇、丙二醇、聚乙二醇、雙甘油(diglycerin)、戊二醇、己二醇、辛二醇等多元醇,如海藻糖、木糖醇、山梨醇(sorbitol)等糖類,如透明質酸鈉、類肝素物質、軟骨素硫酸鈉、角蛋白、幾丁質、殼聚糖等高分子化合物,如神經醯胺、膽固醇、磷脂質等脂質,如德國洋甘菊萃取物、金縷梅萃取物、茶萃取物、蘆薈萃取物等植物萃取萃取物等。
維生素類可列舉:如dl-α-生育醇、乙酸dl-α-生育醇、琥珀酸dl-α-生育醇、琥珀酸dl-α-生育醇鈣等維生素E類、輔酶Q衍生物及其藥學上或生理學上容許之鹽、核黃素、黃素單核苷酸、黃素腺嘌呤二核苷酸、核黃素丁酸酯、核黃素四丁酸酯、核黃素5’-磷酸酯鈉、核黃素四菸鹼酸酯、菸鹼酸dl-α-生育醇、菸鹼酸苯甲酯、菸鹼酸甲酯、菸鹼酸β-丁氧基乙酯、菸鹼酸1-(4-甲基苯基)乙酯、抗壞血酸原-A、抗壞血酸硬脂酸酯、抗壞血酸棕櫚酸酯、二棕櫚酸L-抗壞血酸酯、甲基橘皮苷、麥角鈣化醇、膽鈣化醇、葉醌、金合歡醌(Farnoquinone)、γ-榖醇(γ-oryzanol)、二苯甲醯基硫胺素(dibenzoyl thiamine)、二苯甲醯基硫胺素鹽酸鹽、硫胺素鹽酸鹽、硫胺素鯨蠟基鹽酸鹽、硫胺素硫氰酸鹽、硫胺素月桂鹽酸鹽、硫胺素硝酸鹽、硫胺素單磷酸鹽、硫胺素賴胺酸鹽、硫胺素三磷酸鹽、硫胺素單磷酸酯磷酸鹽、硫胺素單磷酸酯、硫胺素二磷酸酯、硫胺素二磷酸酯鹽酸鹽、硫胺素三磷酸酯、硫胺素三磷酸酯單磷酸鹽、鹽酸吡哆醇、乙酸吡哆醇、鹽酸吡哆醛、5’-磷酸吡哆醛、鹽酸吡哆胺、氰鈷胺、羥鈷胺、去氧腺苷鈷胺、葉酸、喋醯基麩胺酸(Pteroylglutamic acid)、菸鹼酸、菸鹼醯胺、泛酸、泛酸鈣、泛酸醇(pantothenyl alcohol,亦即泛醇(panthenol))、D-泛得辛、D-泛醯硫乙胺(D-pantethine)、補酵素A、泛醇基乙基醚(pantothenylethyl ether)等泛酸類、生物素、生物胞素(biocytin)、抗壞血酸、抗壞血酸鈉、去氫抗壞血酸、抗壞血酸磷酸酯鈉、抗壞血酸磷酸酯鎂、肉鹼(carnitine)、阿魏酸(Ferulic acid)、α-硫辛酸、乳清酸、橘皮苷、γ-榖醇、芸香苷、聖草次苷等。
肽或其衍生物可列舉角蛋白分解肽、水解角蛋白、膠原蛋白、明膠、彈性蛋白、彈性蛋白分解肽、膠原蛋白分解肽、水解膠原蛋白、水解絲(hydrolyzed silk)等。
促進血液循環成分較佳可例示如源自植物之成分。可列舉例如源自高麗人參、明日葉、山金車(Arnica)、銀杏、延命草、荷蘭橡木、胡蘿蔔、龍膽(Gentiana)、牛蒡、米、野山楂、香菇、西洋山楂、西洋杜松、川芎、當藥、麝香草、丁香、陳皮、當歸、桃仁、唐檜、人參、蒜、假葉樹(Butcher's Broom)、葡萄、牡丹、七葉樹、蜜蜂花、香橙(Citrus junos)、薏苡仁、迷迭香、玫瑰果、桃子、杏桃、核桃、玉米等之成分(該等植物之萃取物等),或葡萄糖苷基橘皮苷等。
細胞賦活成分可列舉:如γ-胺基丁酸、γ-胺基-β-羥基丁酸、ε-胺基己酸等胺基酸類,如視黃醇、硫胺素、核黃素、鹽酸吡哆醇、泛酸類、生物素等維生素類,如乙醇酸、乳酸等α-羥基酸類,丹寧、類黃酮、皂素、尿囊素、感光素301號、胎盤萃取液、扁柏醇(hinokitiol)、千金藤素(Cepharanthine)、奇異果種子萃取物等。
抗老化成分可列舉泛配子酸(Pangamic acid)、激動素(Kinetin)、熊果酸、薑黃萃取物、神經鞘胺醇(sphingosine)衍生物、矽、矽酸、N-甲基-L-絲胺酸、甲基羥基戊酸內酯(mevalonolactone)等。
角質軟化成分可列舉水楊酸、水楊酸衍生物、乙醇酸、果酸、植酸、硫黃、乙醇、異丙醇、丙醇、丁醇、1,3-丁二醇、丙二醇、聚乙二醇、甘油、苯甲醇、苯基乙醇、碳酸伸丙酯、己基十二醇、尿囊素、二甲基亞碸、二甲基乙醯胺、二甲基甲醯胺、三乙醇胺、己二酸二異丙酯、月桂酸乙酯、綿羊油、脂肪酸二烷基醇醯胺、尿素、間苯二酚、乳酸、乳酸鹽、氫氧化鈉、氫氧化鉀等。
收斂成分可列舉對酚磺酸鋅、氧化鋅、薄荷醇及乙醇等。
植物萃取物可列舉:桑白皮、虎耳草、紫蘇、米糠、酒粕、白芥子、芍藥、日本紫珠、蓮種子、薏米種子、七葉蘭(Pandanus amaryllifolius Roxb.)、古山龍(Arcangelicia flava Merrilli)、德國洋甘菊、珊瑚草、稻之葉、杏桃果實、琼枝麒麟菜(Betaphycus Gelatinum)、玫瑰之花、竹筍之皮、龍膽、人參、高麗人 參、紅參、絲瓜、桃、桃仁、奇異果、向日葵、洋棗樹(Zizyphus joazeiro)、風鈴木、萱草(Daylily)、木僅之花、羽衣草、秘魯番荔枝(Annona cherimola)、芒果、紅富貴、紫蘭、山椒果皮或種皮、紅花(Carthamus tinctorius)之花、卡沙布蘭卡(Casablanca)、番石榴葉、魚腥草、晚白柚、蘆薈、無花果之花、蘋果、白蘆筍、瑪黛茶、櫻花葉、伊蘭伊蘭葉(ylang ylang leaves)等植物萃取物。
海藻萃取物可列舉:如小球藻(Chlorella vulgaris)、蛋白核小球藻(Chlorella pyrenoidosa)、橢圓小球藻(Chlorella ellipsoidea)、青海苔、石蓴、孔石蓴等綠藻類;如昆布(籠目昆布、真昆布、利尻昆布、細目昆布、三石昆布等)、巨形海帶(Giant Kelp)、裙帶菜或青裙帶菜、水雲、葉囊裙帶菜(Undaria undarioides)、羊棲菜、褐藻、海扇(sea fan)、南方團扇藻(Padina australis Hauck)、楔形團扇藻(Padina australis var.cuneata)、包氏團扇藻(Padina boryana Thivy in Taylor)、粉海團扇藻(Padina crassa Yamada)、日本團扇藻(Padina japonica Yamada)、小團扇藻(Padina minor Yamada)、具柄圈扇藻(Padina stipitata Tanaka & Nozawa in Tanaka)等褐藻類;如葉膜藻(Phyllymenia sparsa)、優美石花菜或天草、刀形石花菜、鬼草、鷄毛菜、翼枝菜、矢部田石花菜(Yatabella hirsuta)、鷄腳菜、匐枝凝花菜、鶏冠菜、鋸齒麒麟菜、對生麒麟菜、麒麟菜、柏狀麒麟菜、角叉菜、大葉角叉菜、皺波角叉菜或皺葉角叉菜、楔基角叉菜、刺枝角叉菜、羽片角叉菜、琴柱角叉菜、異色角叉菜、日本角叉菜、線形杉藻、平杉藻(Chondracanthus chamissoi)、小杉藻、扇形頂群藻、具鉤頂群藻、細脈頂群藻、遠氏頂群藻、紅藻等紅藻類等。
抗真菌劑可列舉:特比奈芬(Terbinafine)、萘替芬(Naftifine)、布特萘芬(Butenafine)、托奈福特(Tolnaftate)、利拉奈福特(Liranaftate)、咪康唑 (Miconazole)、拉諾康唑(Lanoconazole)、盧利康唑(Luliconazole)、艾索康唑(Isoconazole)、酮康唑(Ketoconazole)、克催瑪汝(Clotrimazole)、奈替康唑(Neticonazole)、硫康唑(Sulconazole)、百弗那唑(Bifonazole)、肟那唑(Oxiconazole)、益康唑(Econazole)、弗康唑(Fluconazole)、伊曲康唑(Itraconazole)、福司氟康唑(Fosfluconazole)、伏立康唑(Voriconazole)、益菲康唑(Efinaconazole)、布妥康唑(Butoconazole)、芬替康唑(Fenticonazole)、舍他康唑(Sertaconazole)等。
美白成分可列舉生育酚、抗壞血酸、傳明酸、熊果素、4-烷基間苯二酚、4-甲氧基水楊酸、氫醌、麴酸、此等之鹽或此等之衍生物、胎盤萃取物、黃柏萃取物、虎耳草萃取物、蘆薈萃取物等。
基劑或載體
基劑或載體可列舉油性基劑、水性基劑。
油性基劑可列舉:如凡士林(白色凡士林、黃色凡士林)、膠態烴(樹脂基質(Plastibase)等)、地蠟(Ozokerite)、純地蠟(Ceresin)、微晶蠟、角鯊烯(squalene)、角鯊烷(squalane)、α-烯烴低聚物、石蠟、液體石蠟及輕質液體石蠟等烴;如鯨蠟醇、鯨蠟硬脂醇、硬脂醇及山崳醇等高級醇;如膽固醇、植物固醇及植物固醇羥基硬脂酸酯等固醇類;如乳木果脂(Shea Butter)、棕櫚蠟、可可脂及小燭樹蠟等植物脂;如酪梨油、橄欖油、山茶油、夏威夷果仁油、月見草油、荷荷巴油、菜籽油、卵黃油、芝麻油、蓖麻油、紅花籽油、棉籽油、大豆油、茶籽油、米糠油、米胚芽油、小麥胚芽油、花生油、向日葵油、扁桃油、玉米胚芽油、椰子油、橘子油、鼠尾草油、棕櫚油、貂油、白芒花油、薰衣草油、迷迭香油、玫瑰果油等植物油;如綿羊油、橙魚油、角鯊烷、馬油、鯨蠟及蜜蠟等動物油脂;硬化油;如甲基聚矽氧烷、交聯型甲基聚矽氧烷、高聚合甲基聚矽氧烷、環狀聚矽氧、烷基改性聚矽氧、交聯型烷基改性聚矽氧、胺基改性聚矽氧、聚醚改性聚矽氧、聚甘油改性聚矽氧、交聯型聚醚改性聚矽氧、交聯型烷基聚醚改性聚矽氧、聚矽氧/烷基鏈共改性聚醚改性聚矽氧、聚矽氧/烷基鏈共改性聚甘油改性聚矽氧、聚醚改性分岐聚矽氧、聚甘油改性分岐聚矽氧、丙烯酸聚矽氧、苯基改性聚矽氧及聚矽氧樹脂等聚矽氧油;如乙基纖維素、羥基丙基纖維素、羥基丙基甲基纖維素、陽離子化瓜爾膠及乙醯化透明質酸等天然高分子衍生物;如聚乙烯基吡咯啶、羧基乙烯系聚合物及丙烯酸甲基丙烯酸烷酯共聚物等合成高分子;如卡拉膠、海藻酸、纖維素、瓜爾膠、榅桲籽、右旋糖酐(dextran)、結蘭膠及透明質酸等天然高分子;肉豆蔻酸異丙酯、肉豆蔻酸辛基十二烷酯、棕櫚酸異丙酯、棕櫚酸鯨蠟酯、異壬酸異壬酯、新戊四醇四-2-乙基己酸酯及三(辛酸/癸酸)甘油酯等酯類;如糊精及麥芽糊精等多糖類;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、乙二醇單乙醚、乙二醇單丙醚、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等二醇醚等。
此外,就水性基劑而言,除了水、緩衝液之外,尚可列舉如:乙醇及異丙醇等低級醇;如聚乙二醇、丙二醇、二丙二醇、1,3-丁二醇、甘油、雙甘油、異戊二醇等多元醇等。
基劑或載體可單獨使用1種或將2種以上組合使用。
其中,較佳為烴基劑,更佳為凡士林、石蠟、液體石蠟、纯地蠟、微晶蠟、角鯊烯、角鯊烷、α-烯烴低聚物及輕質液體石蠟。含有烴基劑時,其合計含量相對於基劑或載體全量而為40重量%以上,較佳為50重量%以上,再較佳為60重量%以上。亦可作成80重量%以上或90重量%以上。亦可只使用烴基劑(相對於基劑或載體全量而為100重量%)作為基劑。
此外,亦以將水性基劑混合至烴化合物中而成之基劑為較佳。於該情況下,水性基劑之含量係相對於外用油性固形組成物全量而例如為15重量%以下,其中較佳為10重量%以下,亦可作成5重量%以下。另外,也可作成3重量%以下。水性基劑之含量相對於外用油性固形組成物全量可為0.00001重量%以上。
其中,亦以將水混合至烴化合物中而成之基劑為較佳。於該情況下,水之含量係相對於外用油性固形組成物全量而例如為30重量%以下,其中,可作成20重量%以下、10重量%以下、5重量%以下(尤其是未達5重量%)、3重量%以下、1重量%以下、0.5重量%以下。水之含量相對於外用油性固形組成物全量可為0.00001重量%以上。
此外,亦以將硬化油混合至烴化合物中而成之基劑為較佳。於該情況下,烴基劑之合計含量係相對於基劑或載體全量而為40重量%以上,其中,較佳為50重量%以上、較佳為60重量%以上。亦可作成80重量%以上或90重量%以上。另外,於該情況下,烴基劑之合計含量之上限值係相對於基劑或載體全量可作成約99重量%。
此外,當本發明之外用油性固形組成物含有水溶性多元醇(多元醇通常為水溶性)時,其含量相對於組成物全量可設為未達25重量%、未達10重量%、未達5重量%。另外,亦可不含有水溶性多元醇。
更且,本發明之外用油性固形組成物可為「一種組成物,其含有選自由腎上腺皮質激素(adrenal cortex hormone)及抗組織胺劑中之1種或2種以上之醫藥有效成分、以及水溶性多元醇、高級脂肪酸鹽、水溶性高分子及精製水」 以外者。更且,亦可為「一種組成物,其含有水溶性多元醇、高級脂肪酸鹽、水溶性高分子及精製水」以外者。
此外,本發明之外用油性固形組成物可為「一種組成物,其含有類固醇、不飽和脂肪酸醇、選自丙二醇、丁二醇、二丙二醇、二丁二醇中之烷二醇、剛性化劑(增黏劑、蠟樣物質、由碳數14至36之羧酸與碳數14至36之醇所成之單酯、或是碳數18至36之脂肪酸三甘油酯或碳數18至36之脂肪酸二醇酯)」以外者。另外,可為「一種組成物,其含有不飽和脂肪酸醇、選自丙二醇、丁二醇、二丙二醇、二丁二醇中之烷二醇、剛性化劑(增黏劑、蠟樣物質、由碳數14至36之羧酸與碳數14至36之醇所成之單酯、或是碳數18至36之脂肪酸三甘油酯或碳數18至36之脂肪酸二醇酯)」以外者。
此外,本發明之外用油性固形組成物可為「一種組成物,其含有皮質類固醇(corticosteroid)、凡士林、蠟、約5至約20重量%之丙二醇、以及乳化劑,但實質上不含水」以外者。另外,亦可為「一種組成物,其含有凡士林、蠟、約5至約20重量%之丙二醇、以及乳化劑,但實質上不含水」以外者。
油性組成物
本發明之外用油性固形組成物係基劑或載體主要為油性基劑之油性組成物。本發明之組成物中水性基劑之含量相對於組成物全量較佳為15重量%以下,更佳為10重量%以下,再更佳為5重量%以下,特佳為3重量%以下。基劑或載體亦可為實質上只由油性基劑所構成者(其中,只由油性基劑所構成)。本發明之外用油性固形組成物含有水性基劑時,水性基劑之含量相對於組成物全量可為0.00001重量%以上。
尤其是,本發明之組成物中水之含量相對於組成物全量較佳為30重量%以下,更佳為20重量%以下,再更佳為10重量%以下,特佳為5重量%以下,又更佳為未達5重量%,最佳為3重量%以下。此外,可作成1重量%以下、0.5重量%以下。亦可為實質上不含水(未含水)。本發明之外用油性固形組成物含有水時,水之含量相對於組成物全量可為0.00001重量%以上。
本發明之外用油性固形組成物含有水性基劑(尤其是水)時,通常會成為油中水型之乳劑,但有時亦會因所使用之界面活性劑而成為水中油型之乳劑。
性狀
本發明之外用油性固形組成物於25℃之溫度下為固形之組成物,其中,可為經成形之組成物。所謂「經成形」係指於25℃之溫度下不會流動而維持一定形狀。所謂「經成形之組成物」係包括:具有可藉由施加力而變性之可塑性的組成物、以及凝膠狀組成物。
其中,較佳為經成形為條狀或棒狀之組成物。所謂「條狀」及「棒狀」係包含軸方向之長度比周方向之直徑長者及短者雙方。此外,周方向之截面形狀並無特別限制,可列舉如圓形、橢圓形、角形、不定形等。另外,軸方向之端面(上端面及/或底端面)可為平面,亦可為凸面或凹面。
本發明之外用油性固形組成物之硬度可作成例如1至100(g),較佳為5至90(g),更佳為10至80(g),再更佳為15至65(g),特佳為20至50(g)。只要於該範圍,即可作成不會對於塗抹部位造成過度刺激、且可適量塗抹製劑、並可防止於使用時折斷(尤其是填充於伸縮容器中之油性組成物在伸縮時發生之折斷)且滑順性良好之組成物。
本發明中之硬度係指:,對於以約25℃、12小時以上作為填充後之冷卻而經恆溫化之製劑,使用流變儀(rheometer)(商品名「SUN RHEO METER CR-100」、SUN科學股份有限公司製造),使直徑1mm之圓柱狀轉接器(adapter)以20mm/分鐘的速度進入筒狀容器之中心位置,在從進入時開始算起之30秒間之最大值(單位:g)。
適用部位
本發明之外用油性固形組成物可適用於皮膚或黏膜,較佳為皮膚外用組成物。皮膚包含頭皮。
製造方法
本發明之外用油性固形組成物可依照常法製造之。例如可藉由將全部成分(包含固形成分及/或液體狀或是流動狀成分)一邊加熱一邊混合及攪拌而使其溶解或分散,予以填充於模具後冷卻,填充於容器中而製造之;惟不只限於此製法。
降低摩擦的方法
本發明包括下述方法:藉由在外用油性固形組成物中含有(A)類固醇化合物及/或(B)抗組織胺劑,而降低該組成物於塗抹時與皮膚或黏膜之摩擦之方法。各成分之種類及含量、組成物之性狀等係如對於本發明之外用油性固形組成物之說明。
以下,列舉實施例以更詳細說明本發明,惟本發明不只限於該等例。
將表1所示之組成之油性條狀組成物(重量約3.4g)依照常法填充於直徑1.3cm之伸縮容器中而調製之。具體而言,將以下表1所示之成分加熱溶解,填充於伸縮容器之筒體內,予以冷卻而使其固化成棒狀後,再度進行溶解、固化之操作,作成表面平滑之製劑。
使用摩擦試驗機(Trinity-Lab公司製造之「靜/動摩擦測定機(Trilab Trivomaster型號:TL201Sa)」)評估各條狀製劑塗抹時之摩擦。
具體而言,將經切成縱5cm×橫15cm的人工皮革安裝在摩擦試驗機上。繼而,將填充於容器中之各條狀組成物以伸縮約0.5cm之狀態設置於支架上,以移動速度2mm/分鐘、測定距離50mm、荷重50g之條件測定平均動摩擦係數(μk)。
依照下述式(1),算出以不含有(A)類固醇化合物及(B)抗組織胺劑之比較例1組成物之摩擦係數作為100時之各實施例組成物之摩擦係數之比率。
摩擦係數比率(%)=(各實施例之摩擦係數/比較例1之摩擦係數)×100.....(1)
於表1及第1圖表示摩擦係數比率。
如表1所示,藉由在油性基劑中調配去氫皮質醇戊酸酯乙酸酯、氫化可體松乙酸酯或苯海拉明,而使摩擦係數降低,並且,藉由調配去氫皮質醇戊酸酯乙酸酯及苯海拉明,而使摩擦係數顯著降低。
測定實施例1-1油性組成物之硬度,結果為32.63(g)。
此外,關於硬度,係對於以與實施例-1相同之方法另外作成之製劑,於約25℃、12小時以上而經恆溫化後,使用流變儀(商品名「SUN RHEO METER CR-100」、SUN科學股份有限公司製造),使直徑1mm之圓柱狀轉接器以20mm/ 分鐘的速度進入經填充油狀組成物之伸縮容器之中心位置,求出在從進入開始算起之30秒間之最大值(單位:g)。
試驗例2 評估塗抹時之摩擦(2)
除了使用表2所示者作為油性條狀組成物之外,以與試驗例1相同之方法評估塗抹時之摩擦。
依照下述式(2),算出以比較例2-1組成物之摩擦係數作為100時之實施例2-1組成物之摩擦係數之比率。
摩擦係數比率(%)=(實施例2-1之摩擦係數/比較例2-1之摩擦係數)×100.....(2)
於表2表示摩擦係數比率。
如表2所示,當含有水或水性基劑作為基劑時,摩擦係數降低,確認在塗抹條狀劑時之摩擦降低。
試驗例3 評估塗抹時之摩擦(3)
製作含有氫化可體松作為(A)類固醇化合物之油性條狀組成物,以與試驗例1相同之方法評估塗抹時之摩擦。藉由調配氫化可體松,而使摩擦係數降低,確認在塗抹條狀劑時之摩擦降低。
製劑例
以下述處方調製外用油性固形組成物(製劑處方例1至3)。
<製劑處方例1>
<製劑處方例2>
<製劑處方例3>
本發明之外用油性固形組成物可滑順地塗抹於皮膚或黏膜上,為使用感覺良好之組成物。
Claims (7)
- 一種條狀之外用油性固形組成物,係含有(A)類固醇化合物、(B)相對於組成物全量為0.1至5重量%之苯海拉明及/或基劑,其中,(A)類固醇化合物為選自由相對於組成物全量為0.06至0.2重量%之去氫皮質醇戊酸酯乙酸酯、相對於組成物全量為0.01至0.05重量%之地塞米松乙酸酯、相對於組成物全量為0.05至0.5重量%之氫化可體松、及相對於組成物全量為0.05至0.5重量%之氫化可體松乙酸酯所組成之群組中之至少1種;惟,排除基劑含有高級脂肪酸金屬鹽之情況。
- 如申請專利範圍第1項所述之外用油性固形組成物,更含有選自由(D)局部麻醉劑、(C)抗組織胺劑以外之止癢劑、(E)非類固醇性抗炎症劑、(F)殺菌劑及(G)清涼化劑所組成之群組中之至少1種。
- 如申請專利範圍第1項所述之外用油性固形組成物,更含有多元醇。
- 如申請專利範圍第1項所述之外用油性固形組成物,其為皮膚外用組成物。
- 如申請專利範圍第1項所述之外用油性固形組成物,其中,相對於組成物全量,水性基劑之含量為15重量%以下。
- 如申請專利範圍第1項所述之外用油性固形組成物,其不含丙二醇,或者丙二醇之含量未達5重量%。
- 如申請專利範圍第1項所述之外用油性固形組成物,其為藉由將全部成分一邊加熱一邊混合及攪拌,並填充於模具或伸縮容器之筒體後冷卻而製造者。
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