TWI839432B - 皮膚外用組成物和氣溶膠劑 - Google Patents
皮膚外用組成物和氣溶膠劑 Download PDFInfo
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- TWI839432B TWI839432B TW108148092A TW108148092A TWI839432B TW I839432 B TWI839432 B TW I839432B TW 108148092 A TW108148092 A TW 108148092A TW 108148092 A TW108148092 A TW 108148092A TW I839432 B TWI839432 B TW I839432B
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Abstract
一種皮膚外用組成物,含有(A)肝素類似物質與(B)維生素B6
,且pH為4以上。一種氣溶膠劑,含有皮膚外用組成物與噴射劑,所述皮膚外用組成物含有(A)肝素類似物質及(C)選自有機酸及其鹽中的一種以上。
Description
本發明是有關於一種含有肝素類似物質及維生素B6的皮膚外用組成物。
本發明是有關於一種含有皮膚外用組成物與噴射劑的氣溶膠劑,所述皮膚外用組成物含有肝素類似物及有機酸或它們的鹽。
健康的肌膚在皮膚表面的角質層中保持有足夠的水分。但是,當覆蓋皮膚表面的皮脂的分泌量下降,或皮膚中的角質層細胞間脂質減少時,角質層的水分量會下降,而成為乾燥肌膚。特別是當由於空氣乾燥、年齡增加、壓力等原因,皮膚乾燥時,皮膚的屏障功能會下降,而發生由來自外部的刺激引起的發紅或發癢等,亦會成為引起乾燥性皮膚疾病等的原因。
先前,在乾燥肌膚的處理中利用了包含保濕成分的護膚製品。在保濕成分中,肝素類似物質是軟骨素(chondroitin)經多硫酸化而成的黏多糖,已知有促進血液循環作用、抗炎症作用、保濕作用、皮膚結構的改善效果等,而且副作用少,因此作為皮膚外用藥的有效成分,被用於乾燥性皮膚疾病的治療藥等(例如,參照專利文獻1)。已知作為肝素類似物質的上位概念的多糖類在酸性條件下會藉由水解而分解,但根據糖的性質,分解的條件大
有不同。含有肝素類似物質的皮膚外用組成物穩定性良好,對阻礙穩定性的因素不甚了解(例如,參照非專利文獻1)。
另一方面,已知維生素B6具有對皮脂分泌作用的抑制/正常化作用,被用於毛髮促進劑、口角炎、脂溢性皮炎的治療藥。已知維生素B6會因熱或光而不穩定,並已知在酸性條件下穩定,在中性~鹼性條件下不穩定。
已知維生素B6藉由添加糖醇類(例如,參照專利文獻2)可提高光穩定性,但其效果不充分,並且存在因添加糖醇類而使用途受到限定的難點。
在皮膚的乾燥狀態持續的情況下,為了進行滋潤而過度分泌的皮脂會堵塞毛孔,由此皮膚表面無法形成皮脂膜,而乾燥更甚。對於此種皮膚乾燥,藉由調配具有皮膚乾燥改善效果的肝素類似物質與具有皮脂分泌抑制/正常化作用的吡哆醇鹽酸鹽等的維生素B6,可期待所述般的皮膚乾燥的改善效果,但並無同時調配該些的例子,甚至並無關於因併用而產生的課題或效果的類推。
而且,含有肝素類似物質的皮膚外用組成物在低溫下長期保存時會產生沈澱物,因此期望組成物的低溫保存穩定性。而且,包含含有肝素類似物質的皮膚外用組成物與噴射劑的氣溶膠劑在肝素類似物質的穩定性上存在問題。
[現有技術文獻]
[專利文獻]
[專利文獻1]日本專利特開昭60-112708號公報
[專利文獻2]日本專利特開平07-206664號公報
[非專利文獻]
[非專利文獻1]喜遼妥(hirudoid)醫藥品採訪表格(Interview Form)
本發明者們發現了在同時調配肝素類似物質與維生素B6的情況下,任一成分的穩定性會顯著下降,在併用兩者的情況下同時進行穩定化是極其困難的這一課題。即,本發明的目的在於提供一種穩定地調配有兩成分的皮膚外用組成物。
而且,本發明的目的在於提供一種穩定調配有肝素類似物質,低溫保存穩定性優異的含有肝素類似物質的皮膚外用組成物。
本發明者們為了達成所述目的進行了積極研究,結果發現,藉由併用肝素類似物質與維生素B6,並且使包含兩者的皮膚外用組成物的pH為4以上,兩者的穩定性會提高,從而完成了本發明。即,根據本發明的皮膚外用組成物,肝素類似物質及維生素B6的穩定性提高,可抑制兩成分的含量隨時間的下降,因此即使長期保存,亦可維持並有效地發揮兩成分的作用。
而且,發現,藉由製成包含含有(A)肝素類似物質及(C)選自有機酸及其鹽中的一種以上的皮膚外用組成物、與噴射劑的氣溶膠劑,肝素類似物質的穩定性提高,並且含有肝素類似物質
的皮膚外用組成物的低溫保存穩定性提高,從而完成了本發明。
因此,本發明提供下述皮膚外用組成物。
1.一種皮膚外用組成物,含有(A)肝素類似物質與(B)維生素B6,且pH為4以上。
2.如1所述的皮膚外用組成物,其中(B)成分為吡哆醇或其藥學上容許的鹽。
3.如1或2所述的皮膚外用組成物,其更含有選自乳酸、磷酸、蘋果酸、硼酸、檸檬酸及該些的鹽中的一種以上。
4.如1至3中任一項所述的皮膚外用組成物,其為乳膏劑、洗劑、凝膠劑、氣溶膠劑、噴霧劑、乳液劑或塗敷劑。
5.一種氣溶膠劑,含有皮膚外用組成物與噴射劑,所述皮膚外用組成物含有(A)肝素類似物質及(C)選自有機酸及其鹽中的一種以上。
6.如5所述的氣溶膠劑,其更含有(D)非離子性界面活性劑,並以泡沫狀噴出。
根據本發明,可提供一種可穩定地調配肝素類似物質與維生素B6各者的皮膚外用組成物。
根據本發明,可提供一種氣溶膠劑,其含有皮膚外用組成物與噴射劑,所述皮膚外用組成物為可穩定地含有肝素類似物質,並且低溫保存穩定性優異的含有肝素類似物質的皮膚外用組成物。
以下,對本發明進行詳細說明。
(I)第1發明是一種皮膚外用組成物,其含有(A)肝素類似物質與(B)維生素B6,且pH為4以上。
(II)第2發明為一種氣溶膠劑,其含有皮膚外用組成物與噴射劑,所述皮膚外用組成物含有(A)肝素類似物質及(C)選自有機酸及其鹽中的一種以上。
以下,有時將第1發明的皮膚外用組成物僅記載為第一組成物(氣溶膠劑的情況下是指原液),以下,有時將第2發明的皮膚外用組成物(原液)僅記載為第二組成物,有時將第一組成物及第二組成物兩者的情況下記載為組成物。
[(A)成分]
(A)成分為肝素類似物質,是具有保濕作用、抗炎症作用、促進血液循環作用、皮膚結構的改善效果等的成分。肝素類似物質(Heparinoid)是多硫酸軟骨素等的黏多糖類的多硫酸酯。本發明中所使用的肝素類似物質的來源並無特別限制,例如可列舉藉由將黏多糖類多硫酸化而獲得者、自食用動物的組織(例如牛或豬等的包括氣管軟骨的肺臟)中提取者等。其中,較佳地使用日本藥典外醫藥品規格(規格編號:108548)中定義的肝素類似物質。
(A)成分的含有比例並無特別限定,就保濕效果的觀點而言,在組成物中較佳為0.01質量%以上,更佳為0.1質量%以上,進而佳為0.3質量%以上。上限並無特別限定,但較佳為設為1質量%以下。藉由設為0.01質量%以上,可期待保濕效果,藉由設為0.3質量%以上,不僅可期待保濕,亦可期待乾皮症的改善效果。
[(B)成分]
(B)成分通稱維生素B6,具有皮脂分泌的正常化、肌膚細胞的活化效果。作為維生素B6,可列舉吡哆醇、吡哆醛、吡哆胺或該些的藥學上容許的鹽,可列舉鹽酸鹽、硫酸鹽、硝酸鹽、氫溴酸鹽、磷酸鹽等。維生素B6可單獨使用一種,或者可將兩種以上適當組合來使用。其中,較佳為吡哆醇鹽酸鹽。
(B)成分的含有比例並無特別限定,可考慮安全性或肌膚乾燥的改善效果而任意設定,在第一組成物中較佳為0.01質量%~2質量%,更佳為0.05質量%~2質量%。藉由設為0.01質量%以上,可期待皮脂分泌的正常化、肌膚的乾燥改善或細胞的活化效果,藉由設為1質量%~2質量%,可期待脂溢性皮炎的改善效果。
(A)成分與(B)成分的含有質量比並無特別限定,可考慮安全性或肌膚乾燥的改善效果而任意設定,但(B)/(A)所表示的含有質量比較佳為0.01~20,更佳為0.1~10。藉由將該比設為0.01以上,可進一步獲得兼具皮脂分泌的正常化與肌膚乾燥
改善的效果。另一方面,藉由設為20以下,在安全性優異的同時,可獲得保濕效果與皮脂分泌的抑制效果。
本發明的第一組成物的pH為4以上。藉由使含有所述(A)成分及(B)成分的第一組成物的pH為4以上,可在第一組成物中穩定地含有(A)肝素類似物質與(B)維生素B6。就該方面而言,第一組成物的pH的下限較佳為4.5以上,更佳為5以上。第一組成物的pH的上限較佳為8以下,更佳為7以下,進而佳為6以下。另外,pH的測定是基於第十七修正日本藥典一般試驗法(測定溫度:20℃)。
只要本發明的第一組成物的pH在所述範圍內,則未必需要含有pH調節劑,可任意含有。在含有pH調節劑的情況下,作為pH調節劑,例如可列舉乳酸、檸檬酸、蘋果酸、磷酸、硼酸、鹽酸、硫酸及該些的鹽、或二異丙醇胺、三乙醇胺、氫氧化鈉、氫氧化鉀等。作為鹽,可列舉鈉鹽、鉀鹽、銨鹽等。具體而言,作為磷酸鹽,可列舉磷酸二氫鈉、磷酸氫二鈉、磷酸三鈉、磷酸二氫鉀等,作為硼酸鹽,可列舉硼砂等,作為檸檬酸鹽,可列舉檸檬酸鈉等。pH調節劑可單獨使用一種,或者可將兩種以上適當組合來使用。其中,就(A)肝素類似物質及(B)維生素B6的穩定性的方面而言,較佳為選自乳酸、磷酸、蘋果酸、硼酸、檸檬酸以及該些的鹽中的一種以上,更佳為選自硼酸、檸檬酸以及該些的鹽中的一種以上。調配pH調節劑時的含有比例以使第一組成物成為目標pH的方式適當選定,在第一組成物中較佳為0.01質
量%~5質量%,更佳為0.05質量%~1質量%。藉由使含有比例為0.01質量%以上,可更穩定地含有(A)肝素類似物質與(B)維生素B6。藉由使含有比例為5質量%以下,pH調節劑難以隨時間推移而析出。
[任意成分]
在本發明的組成物中,在不損害本發明的效果的範圍內,可適量調配醫藥品、准醫藥品以及化妝品等中所使用的任意成分的單獨一種,或者將兩種以上適當組合來適量調配。作為任意成分,可例示下述成分。
作為(A)肝素類似物質、(B)維生素B6以外的醫藥品、准醫藥品以及化妝品等中所使用的各種有效成分,例如可列舉肝素類似物質以外的抗炎症劑、抗組胺劑、止癢劑、創傷治癒劑、局部麻醉劑、維生素B6以外的維生素劑、清涼劑、保濕劑、殺菌劑、血管收縮劑以及胺基酸類等。所述中亦包括生藥成分。
作為抗炎症劑,例如可列舉:甘草次酸(Glycyrrhetinic acid)、甘草酸(glycyrrhizic acid)或其藥學上容許的鹽、甘草提取物、類固醇(steroid)化合物(氫皮質酮(Hydrocortisone)、普賴蘇穠(Prednisolone)、甲基普賴蘇穠、可洛貝他松(Clobetasone)、貝皮質醇(Betamethasone)、地塞米松(dexamethasone)、可體松(cortisone)、氟米松(flumetasone)、倍氯米松(Beclometasone)、氟替卡松(Fluticasone)或該些的衍生物)、吲哚美辛(indometacin)、伊布洛芬(Ibuprofen)、伊布洛芬吡啶甲醇
(Ibuprofen piconol)、丁苯羥酸(bufexamac)、烏芬那酯(Ufenamate)、吡羅昔康(Piroxicam)、酮洛芬(ketoprofen)、水楊酸或其衍生物、二甲基異丙基薁、當歸提取物、紫草根提取物等。
作為抗組胺劑,例如可列舉:苯海拉明(Diphenhydramine)或其藥學上容許的鹽、氯菲安明(Chlorpheniramine)或其藥學上容許的鹽、美喹他嗪(Mequitazine)、氮卓斯汀(Azelastine)、依美斯汀(Emedastine)、酮替芬(Ketotifen)或該些的衍生物等。其中,較佳為苯海拉明、苯海拉明鹽酸鹽、氯菲安明馬來酸鹽等。
作為止癢劑,例如可列舉:克羅米通(Crotamiton)、壬酸香草醯胺(Nonanoic acid vanillylamide)、辣椒素(capsaicin)、菸鹼酸芐酯(benzyl nicotinate)、辣椒酊(Capsicum Tincture)等。
作為創傷治癒劑,例如可列舉尿囊素(Allantoin)、氧化鋅等。
作為局部麻醉劑,例如可列舉:利多卡因(Lidocaine)或其藥學上容許的鹽、待布卡因(Dibucaine)或其藥學上容許的鹽。
作為維生素劑,例如可列舉:維生素A類[維生素A油、視黃醇(retinol)及其衍生物(例如視黃醛(Retinal)、視黃酸(Retinoic acid)、棕櫚酸視黃醇等)]、維生素B1類[硫胺素(thiamine)及其衍生物(例如鹽酸硫胺素、硝酸硫胺素等)]、維生素B2類[核黃素(Riboflavin)及其衍生物(例如,磷酸核黃
素、磷酸核黃素鈉、丁酸核黃素及黃素腺嘌呤二核苷酸鈉(Flavin Adenine Dinucleotide Sodium)等)]、維生素B3類[菸鹼酸及其衍生物(菸鹼酸醯胺、菸鹼酸生育酚、菸鹼酸苄酯等)]、維生素B5類[泛酸(pantothenic acid)及其衍生物(例如,泛酸鈣、泛醇(Panthenol)、泛乙醇(Pantothenyl ethyl alcohol)等)]、維生素B12類[鈷胺(cobalamin)及其衍生物(例如氰基鈷胺、甲鈷胺(Mecobalamin)及鹽酸羥基鈷胺(Hydroxocobalamin)等)]、生物素(biotin)、葉酸或其藥學上容許的鹽、維生素C類[抗壞血酸(ascorbic acid)及其衍生物(例如,異抗壞血酸(Erythorbic acid)、抗壞血酸鈉、抗壞血酸鎂、抗壞血酸2-葡萄糖苷(Glucoside)、棕櫚酸抗壞血酸等)]、維生素D類[鈣化醇(calciferol)及其衍生物(例如,麥角鈣化醇(Ergocalciferol)、膽鈣化醇(cholecalciferol)等)]、維生素E類[生育酚、泛醌(ubiquinone)及其衍生物(例如,生育酚乙酸酯、琥珀酸生育酚鈣等)]、其他維生素類(例如橙皮苷(Hesperidin)、肉鹼(carnitine)、阿魏酸(ferulic acid)、γ-穀維素(γ-oryzanol)、乳清酸(Orotic acid)、芸香苷(Rutin)、聖草次苷(eriocitrin)、肌醇(inositol)及該些藥學上容許的鹽)等。
作為清涼劑,例如可列舉:l-薄荷醇(1-Menthol)、樟腦、冰片(borneol)或該些的類似物質、茴香油、桉葉油、薄荷油等。
作為保濕劑,例如可列舉:天然保濕因子(尿素等)、腦醯胺(ceramide)、植物提取物(母菊提取物、蘆薈提取物等)
等。
作為殺菌劑,例如可列舉:異丙基甲基苯酚、鹽酸氯己定(hydrochloric acid Chlorhexidine)、氯化苯銨松寧(benzethonium chloride)、氯化苄烷銨(benzalkonium chloride)、溴化十六基三甲銨(Cetrimide)等。
作為血管收縮劑,例如可列舉:奈甲嘧唑啉(naphazoline)、四氫唑啉(Tetrahydrozoline)、甲基麻黃鹼(methylephedrine)或其鹽類等。
作為胺基酸類,例如可列舉:麩胺酸、天冬胺酸、甘胺酸、丙胺酸、絲胺酸、胺基乙基磺酸(牛磺酸)及該些的藥學上容許的鹽(例如,鹽酸麻黃鹼、鹽酸甲基麻黃鹼等)。
調配該些有效成分時的含有比例為其有效量的範圍,在組成物中較佳為0.1質量%~20質量%。
作為其他任意成分,例如可列舉:油劑、界面活性劑、多元醇、高分子化合物、有機溶劑、穩定劑、防腐劑、香料、水等。
作為油劑,例如可列舉:凡士林(Vaseline)、石蠟、流動石蠟、角鯊烷(squalane)、地蠟(ceresin)、凝膠化烴及微晶蠟(microcrystalline wax)等烴;硬脂酸、異硬脂酸、肉豆蔻酸、油酸等及山萮酸等高級脂肪酸;鯨蠟醇、硬脂醇、辛基十二烷醇及二十二烷醇等高級脂肪醇;肉豆蔻酸異丙酯、肉豆蔻酸辛基十二烷基酯、棕櫚酸異丙酯及己二酸二異丙酯等脂肪酸酯;三異辛酸
甘油及三(辛酸/癸酸)甘油酯等多元醇脂肪酸酯等。調配油劑時的含有比例在組成物中較佳為1質量%~30質量%。
作為界面活性劑,例如可列舉非離子性界面活性劑、離子性界面活性劑等。
作為非離子性界面活性劑,例如可列舉:單硬脂酸甘油酯、單油酸甘油酯等甘油脂肪酸酯、單月桂酸聚甘油酯(10)、單硬脂酸聚甘油酯(10)、油酸聚甘油酯(10)、五油酸聚甘油酯(10)等聚甘油脂肪酸酯;單硬脂酸聚氧乙烯甘油酯(15)等聚氧乙烯甘油脂肪酸酯;單硬脂酸脫水山梨糖醇、單油酸脫水山梨糖醇、倍半油酸脫水山梨糖醇等脫水山梨糖醇脂肪酸酯、單月桂酸聚氧乙烯脫水山梨糖醇(20)(聚山梨糖醇酯20)、單硬脂酸聚氧乙烯(20)脫水山梨糖醇(聚山梨糖醇酯60)、單油酸聚氧乙烯(20)脫水山梨糖醇(聚山梨糖醇酯80)等聚氧乙烯脫水山梨糖醇脂肪酸酯;單月桂酸聚氧乙烯山梨糖醇(6)、四硬脂酸聚氧乙烯(60)山梨糖醇、四油酸聚氧乙烯(60)山梨糖醇等聚氧乙烯山梨糖醇脂肪酸酯;聚氧乙烯(60)蓖麻油等聚氧乙烯蓖麻油;聚氧乙烯硬化蓖麻油(10)、聚氧乙烯硬化蓖麻油(60)等聚氧乙烯硬化蓖麻油;單月桂酸聚乙二醇(例如10EO)、單硬脂酸聚氧乙烯二醇(4EO)等聚乙二醇脂肪酸酯;聚氧乙烯(9)月桂基醚(聚桂醇(Lauromacrogol))、聚氧乙烯(10)鯨蠟醚及聚氧乙烯油醚等聚氧乙烯烷基醚等。
作為離子性界面活性劑,例如可列舉:月桂基硫酸鈉、鯨蠟
基硫酸鈉等。
調配界面活性劑時的含有比例在組成物中較佳為0.1質量%~10質量%。
作為多元醇,例如可列舉:甘油、丙二醇、1,3-丁二醇及聚乙二醇(聚乙烯二醇(macrogol))等。
調配多元醇時的含有比例在組成物中較佳為0.5質量%~20質量%。
作為高分子化合物,例如可列舉:羧基乙烯基聚合物、羥基丙基纖維素、羥丙甲基纖維素(Hypromellose)、疏水化羥基丙基甲基纖維素、丙烯酸化澱粉300及聚乙烯基吡咯啶酮、阿拉伯膠(Gum arabic)、加拉亞膠(karaya gum)、黃原膠(xanthan gum)、角豆樹膠(Carob Gum)、瓜爾膠(guar gum)、癒瘡木脂(guaiac resin)、榅桲籽膠(quince seed)、達瑪膠(dammar gum)、黃蓍膠(tragacanth)、安息香膠(gum benzoin)、刺槐豆膠(Locust bean gum)、酪蛋白(casein)、瓊脂(agar)、海藻酸(alginic acid)、糊精(dextrin)、類糊精(dextran)、卡拉膠(carageenan)、明膠(gelatin)、膠原蛋白(collagen)、果膠(pectin)、澱粉、聚半乳糖醛酸、甲殼質(chitin)及其衍生物、殼聚糖及其衍生物、彈性蛋白(Elastin)、硫酸乙醯肝素(Heparan sulfate)、透明質酸(Hyaluronic acid)、硫酸軟骨素(chondroitin sulfate)等。
調配高分子化合物時的含有比例在組成物中較佳為0.01質量%~5質量%。
作為有機溶劑,例如可列舉乙醇、異丙醇、丙酮、甲基乙基酮及乙酸乙酯等有機溶劑。
調配有機溶劑時的含有比例在組成物中較佳為1質量%~30質量%。
作為穩定劑,例如可列舉氯化鈉、硫代硫酸鈉、亞硫酸鈉及依地酸鈉等。
調配穩定劑時的含有比例在組成物中較佳為0.01質量%~5質量%。
作為防腐劑,例如可列舉:對羥基苯甲酸甲酯(對羥苯甲酸甲酯(Methylparaben))、對羥基苯甲酸丙酯(對羥苯甲酸丙酯(Propylparaben))、二丁基羥基甲苯、氯化苄烷銨及氯化苯銨松寧等。
調配防腐劑時的含有比例在組成物中較佳為0.01質量%~1質量%。
作為香料,例如可列舉:柑橘(citrus)香、花(Floral)香、玫瑰香等調配香料、或桉葉油、香柑油(Bergamot oil)、茴香油、玫瑰油、薄荷油、歐薄荷油(peppermint oil)、綠薄荷油(spearmint oil)、迷迭香油(rosemary oil)、薰衣草油、檸檬油等精油。作為該些香料中含有的代表性成分,可列舉萜類(Terpenoid)化合物。萜類化合物可列舉萜烯烴、萜烯醇、萜烯醛、萜烯酮。而且,根據碳數,有單萜烯、倍半萜烯、二萜烯、三萜烯、四萜烯,最具代表性的成分是單萜烯。作為較佳的萜類化合物,可列
舉:l-薄荷醇、dl-薄荷醇、d-樟腦、dl-樟腦、d-冰片、dl-冰片、檸檬醛(citral)、香茅醛(citronellal)、檸檬烯(limonene)、香茅醇(citronellol)、桉油醇(cineol)、香葉醇(geraniol)、沈香醇(linalool)、壬醛(nonanal)、丁香酚(eugenol)、異丁香酚、吲哚、苯甲醛(benzaldehyde)、香草醛(vanillin)、檸檬烯(limonene)、加樂麝香(galaxolide)、γ-壬內酯(γ-nonalactone)、γ-甲基紫羅酮(γ-Methylionone)、龍涎酮(Iso E Super)、Z-3-己烯水楊酸酯(Z-3-hexenyl salicylate)、γ-十一酸內酯(γ-Undecalactone)、5-環十六烯-1-酮、2-甲基-4-苯基-2-丁醇、二氫茉莉酮酸甲酯(Methyl Dihydrojasmonate)、甲基-β-萘基酮、桂醯基乙酸酯、苄基乙酸酯、α-萜品醇、己基肉桂醛等。調配香料時的含有比例在組成物中較佳為0.001質量%~1質量%,更佳為0.01質量%~0.1質量%。
調配水時的含有比例是根據劑型自50質量%~90質量%的範圍適當選定。
[製造方法]
本發明的組成物例如可藉由將(A)肝素類似物質與(B)維生素B6按照常規方法,視需要與任意成分一起調配來製備。
[皮膚外用組成物]
只要能夠經皮應用,則本發明的組成物的性狀並無特別限制,可為液狀、固體狀、半固體狀(凝膠狀、軟膏狀、糊狀、泡狀)等中的任一者。而且,製劑形態可為皮膚外用醫藥品、皮膚外用准醫藥品、化妝品、皮膚清洗劑等中的任一製劑形態。
作為本發明的組成物的製劑形態,並無特別限定,例如可列舉:軟膏劑、乳膏劑、洗劑、凝膠劑、乳液劑、液劑、貼附劑、霧狀、泡沫狀噴出的噴霧劑、霧狀、粉末狀、泡沫狀或糊狀噴出的氣溶膠劑、軟膏劑、塗敷劑、沐浴露(Body Shampoo)、洗髮液、護髮素(Rinse)等。其中,較佳為乳膏劑、洗劑、凝膠劑、氣溶膠劑、噴霧劑、乳液劑、塗敷劑,更佳為乳膏劑、洗劑、乳液劑、泡沫狀噴出的氣溶膠劑、泡沫狀噴出的泵噴霧劑。乳膏或乳液劑等的乳化狀態無特別限定,可為W/O、O/W、W/O/W、O/W/O中的任一者。
不含噴射劑的噴霧劑例如包括氣密容器、泵主體、致動器、蓋、第一組成物。作為氣溶膠劑,基本上包括耐內壓的耐壓性容器、閥、致動器、第一組成物(原液)及噴射劑。氣溶膠劑中噴射劑的含有比例相對於第一組成物較佳為1質量%~12質量%,更佳為1質量%~10質量%。作為噴射劑,可列舉:液化氣、壓縮氣體,作為液化氣,可列舉以碳數3~5的烴(丙烷、正丁烷、異丁烷等)為主成分的液化石油氣(liquefied petroleum gas,LPG)、二甲醚、氟化烴,作為壓縮氣體,可列舉二氧化碳、氮、一氧化二氮(nitrous oxide)。其中,較佳為液化石油氣。噴霧劑或氣溶膠劑藉由填充至以泡沫狀進行噴出的容器中,而容易擴散至皮膚。而且,藉由製成氣溶膠劑,可抑制原液中調配的界面活性劑在低溫下的析出。
作為耐內壓的耐壓性容器,例如可使用鋁罐、馬口鐵罐
(Tin can)等,亦能夠在內表面塗佈樹脂等。
本發明的組成物的使用方法並無特別限定,可一天1次~數次,適量擦於患部,或者延展而貼在紗布等上來使用。另外,噴霧劑、氣溶膠劑理想的是以直立~45度左右的角度噴射。
作為本發明的組成物的效果效能,除了乾皮症、兒童的乾燥性皮膚、手指的粗糙、手腳的皸/裂、肘/膝/腳後跟/踝的角化症、凍傷(潰爛除外)、受傷/燒傷後的皮膚的板結/突起(臉面除外)、跌打損傷/扭傷後的腫脹/肌肉痛/關節痛以外,亦可列舉肌膚屏障功能的改善、促進新陳代謝、肌細胞活化、由乾燥引起的肌膚問題(的改善)、治療(臉等的)乾燥等。
(II)第2發明為一種氣溶膠劑,其含有皮膚外用組成物與噴射劑,所述皮膚外用組成物含有(A)肝素類似物質及(C)選自有機酸及其鹽中的一種以上。
[(A)成分]
(A)成分與所述第1發明相同,較佳的成分及範圍亦與第1發明相同。
[(C)成分]
(C)選自有機酸及其鹽中的一種以上,可單獨使用一種或組合兩種以上來使用。藉由調配(C)成分,在包含含有肝素類似物質的皮膚外用組成物與噴射劑的氣溶膠劑中,可穩定地含有肝素類似物質。作為(C)成分,可列舉檸檬酸、乳酸、蘋果酸、酒石酸、己二酸、富馬酸、馬來酸、丙二酸等,其中,較佳為檸檬
酸、蘋果酸、酒石酸。作為鹽,可列舉鈉鹽、鉀鹽、銨鹽等,具體而言,可列舉檸檬酸鈉。(C)成分可為羥基檸檬酸等有機酸的衍生物。
(C)成分的含有比例並無特別限定,在第二組成物中較佳為0.01質量%~5質量%,更佳為0.05質量%~1質量%。藉由設為0.01質量%以上,可穩定地含有(A)肝素類似物質,藉由設為5質量%以下,低溫保存穩定性提高。
[(D)成分]
就提高低溫保存穩定性的方面而言,第二組成物中可調配所述第1發明中記載的(D)非離子性界面活性劑。其中,較佳為聚氧乙烯脫水山梨糖醇脂肪酸酯、聚氧乙烯山梨糖醇脂肪酸酯、聚氧乙烯甘油脂肪酸酯、聚甘油脂肪酸酯、聚氧乙烯硬化蓖麻油,更佳為單月桂酸聚氧乙烯脫水山梨糖醇(20)(聚山梨糖醇酯20)、單硬脂酸聚氧乙烯脫水山梨糖醇(20)(聚山梨糖醇酯60)、單油酸聚氧乙烯脫水山梨糖醇(20)(聚山梨糖醇酯80)等聚氧乙烯脫水山梨糖醇脂肪酸酯、單月桂酸聚氧乙烯山梨糖醇(6)等聚氧乙烯山梨糖醇脂肪酸酯、聚氧乙烯(15)油酸甘油酯等聚氧乙烯甘油脂肪酸酯,進而佳為單硬脂酸聚氧乙烯脫水山梨糖醇(20)(聚山梨糖醇酯60)、單油酸聚氧乙烯脫水山梨糖醇(20)(聚山梨糖醇酯80)等聚氧乙烯脫水山梨糖醇脂肪酸酯、單月桂酸聚氧乙烯山梨糖醇(6)等聚氧乙烯山梨糖醇脂肪酸酯。
(D)成分的含有比例並無特別限定,在第二組成物中
較佳為0.1質量%~10質量%,更佳為1質量%~5質量%。藉由設為0.1質量%以上,低溫保存穩定性進一步提高。藉由設為10質量%以下,黏連變少,使用性提高。
第二組成物的pH較佳為4以上。第二組成物的pH的下限更佳為4.5以上,進而佳為5以上。第二組成物的pH的上限較佳為8以下,更佳為7以下,進而佳為6以下。藉由在所述pH的範圍內,可更穩定地含有(A)肝素類似物質。另外,pH的測定是基於日本藥典一般試驗法(測定溫度:20℃)。
只要本發明的第二組成物的pH在所述範圍內,則未必需要含有pH調節劑,可任意含有。在含有pH調節劑的情況下,作為pH調節劑,例如可列舉:磷酸、硼酸、鹽酸、硫酸及該些的鹽、或二異丙醇胺、三乙醇胺、氫氧化鈉、氫氧化鉀等。作為鹽,可列舉:鈉鹽、鉀鹽、銨鹽等。具體而言,作為磷酸鹽,可列舉磷酸二氫鈉等,作為硼酸鹽,可列舉硼砂等。pH調節劑可單獨使用一種,或者可將兩種以上適當組合來使用。其中,就可穩定地含有(A)肝素類似物質的方面而言,較佳為選自磷酸、硼酸及該些的鹽中的一種以上,更佳為選自硼酸及該些的鹽中的一種以上。調配pH調節劑時的含有比例是以使組成物成為目標pH的方式適當選定,在組成物中較佳為0.01質量%~5質量%,更佳為0.05質量%~1質量%。藉由使含有比例為5質量%以內,pH調節劑難以隨時間推移而析出。
作為第二組成物的其他任意成分,可列舉自所述第1發
明的任意成分中除去(C)及(D)成分以及pH調節劑後的成分。
[噴射劑]
作為噴射劑,可列舉液化氣、壓縮氣體,作為液化氣,可列舉以碳數3~5的烴(丙烷、正丁烷、異丁烷等)為主成分的液化石油氣(LPG)、二甲醚、氟化烴,作為壓縮氣體,可列舉二氧化碳、氮、一氧化二氮。其中,較佳為液化石油氣。
[製造方法]
第二組成物例如可藉由將(A)肝素類似物質與(C)選自有機酸及其鹽中的一種以上按照常規方法,視需要與任意成分一起調配來調製。
[氣溶膠劑]
第二組成物的製劑形態為氣溶膠劑。第二組成物(原液)的乳化狀態並無特別限定,可為W/O、O/W、W/O/W、O/W/O中的任一者。作為包含噴射劑的氣溶膠劑,基本上包括耐內壓的耐壓性容器、閥、致動器、第二組成物(原液)及噴射劑。噴射劑的含有比例相對於第二組成物較佳為1質量%~12質量%。由於藉由填充至適合以泡沫狀噴出的容器,而成為泡沫而噴出,因此容易擴散至皮膚。而且,藉由製成氣溶膠劑,可穩定地含有肝素類似物質,而且,可抑制第二組成物(原液)中調配的界面活性劑在低溫下的析出。
作為耐內壓的耐壓性容器,例如可使用鋁罐、馬口鐵罐等,亦能夠在內表面塗佈樹脂等。
本發明的第二組成物的使用方法及效果效能與第一組成物相同。
[實施例]
以下,示出實施例及比較例來具體說明本發明,但本發明不限於下述實施例。另外,在下述的例子中無特別說明的情況下,組成的「%」表示質量%,比率表示質量比,表中的各成分的量是純成分換算後的量。
[實施例及比較例]
[實施例1-1~實施例1-19及比較例1-1~比較例1-2]
將表1~表3所示的成分溶解於精製水中,製備皮膚外用組成物(液劑)。將所獲得的皮膚外用組成物50g填充至玻璃製瓶(vial)容器(容量50mL)中,蓋上蓋子密閉後,在50℃下保存2個月。基於日本藥典一般試驗法測定保存前後的組成物的pH(測定溫度:20℃),將保存前後的pH之差作為pH變動而算出。利用下述方法測定肝素類似物質及吡哆醇鹽酸鹽在組成物中的含量,並基於下述式算出肝素類似物質及吡哆醇鹽酸鹽的殘存率(%)。
殘存率(%)=保存後的成分含量/初始的成分含量×100
關於肝素類似物質的殘存率,自皮膚外用組成物中精確秤量試樣,加入乙酸鉀的乙醇溶液(亦有時進而加入異辛烷)並
進行振盪,使離心分離而獲得的殘留物堅固後,藉由日本藥典外醫藥品成分規格2002肝素類似物質的定量法(3)記載的有機硫酸基測定法,並藉由紫外可見光吸光度測定法算出含量。吡哆醇鹽酸鹽的殘存率是藉由HPLC法(絕對標準曲線法)而算出含量。
另外,初始的成分含量是指剛製備皮膚外用組成物後(5℃保存、7天以內)測定的成分含量。
基於肝素類似物質的殘存率、吡哆醇鹽酸鹽的殘存率,利用下述評價基準來表示。
〈肝素類似物質的殘存率:肝素類似物質的穩定性〉
不足85%:1分
85%以上且不足90%:2分
90%以上且不足95%:3分
95%以上:4分
兩分以上為及格
〈吡哆醇鹽酸鹽的殘存率:吡哆醇鹽酸鹽的穩定性〉
不足80%:1分
80%以上且不足85%:2分
85%以上且不足90%:3分
90%以上:4分
兩分以上為及格
〈pH變動:pH穩定性〉
1以上:1分
0.5以上且不足1:2分
0.2以上且不足0.5:3分
不足0.2:4分
兩分以上為及格
[實施例1-20]
按照常規方法將表4所示的成分溶解於精製水中,製備洗劑。將所獲得的洗劑50g填充至玻璃製瓶容器(50mL)中,蓋上蓋子密閉後,在50℃下保存2個月。
針對保存前後的洗劑的pH、pH變動、肝素類似物質及吡哆醇鹽酸鹽的殘存率,利用與所述相同的方法進行評價。將結果一併記入至表中。
[實施例1-21~實施例1-26]
按照常規方法將表5所示的成分溶解於精製水中,製備皮膚外用組成物(原液)。向耐內壓的耐壓性罐(內層塗佈有聚醯胺醯亞胺樹脂層;外層塗佈有聚酯樹脂層/印刷塗料層/聚酯胺基樹脂層的鋁罐、30mL)中,填充所獲得的皮膚外用組成物(原液)27.0g~28.5g,在減壓下安裝閥(S13閥、閥杆孔(stem hole)0.5、
殼體孔1.5、(股)三谷閥製造)後,藉由通氣閥(Through valve)方式填充噴射劑1.5g~3.0g,安裝致動器(FD150、(股)三谷閥製造)、蓋子,獲得以泡沫狀噴出的氣溶膠劑。其後,將氣溶膠劑在45℃下保存3個月。保存前後,充分振盪罐子,藉由致動器將氣溶膠劑的內容物取出到蓋嚴的容器中,放置而放出噴射劑後,針對皮膚外用組成物的pH、pH變動、肝素類似物質及吡哆醇鹽酸鹽的殘存率,利用與所述相同的方法進行評價。將結果一併記入至表中。
[實施例1-27]
藉由常規方法使表6所示的成分乳化,獲得水性乳膏。將所獲得的水性乳膏劑24g填充至鋁製管(大成化工股份有限公司製造)中密閉後,在50℃下保存2個月。
針對保存前後的水性乳膏的pH、pH變動、肝素類似物質及吡哆醇鹽酸鹽的殘存率,利用與所述相同的方法進行評價。將結果一併記入至表中。
[實施例1-28]
藉由常規方法使表7所示的成分乳化,獲得油性乳液(W/O乳液)劑。將所獲得的油性乳液30g填充至聚丙烯製瓶容器(30mL)中,蓋上蓋子密閉後,在50℃下保存2個月。
針對保存前後的油性乳液的pH、pH變動、肝素類似物質及吡哆醇鹽酸鹽的殘存率,利用與所述相同的方法進行評價。將結果一併記入至表中。
[實施例2-1~實施例2-3、比較例2-1、比較例2-2]
按照常規方法將表7所示的成分溶解於精製水中,製備皮膚外用組成物(原液)。向耐內壓的耐壓性罐(內層塗佈有聚醯胺醯
亞胺樹脂層;外層塗佈有聚酯樹脂層/印刷塗料層/聚酯胺基樹脂層的鋁罐、30mL)中,填充所獲得的皮膚外用組成物(原液)28.2g,在減壓下安裝閥(S13閥、閥杆孔(stem hole)0.5、殼體孔1.5、(股)三谷閥製造)後,藉由通氣閥(Through valve)方式填充噴射劑1.8g,安裝致動器、蓋子,獲得以泡沫狀噴出的氣溶膠劑。另外,閥及致動器使用與實施例1-21相同者,比較例2-1是依據實施例2-3來製備皮膚外用組成物(原液),將所獲得的皮膚外用組成物50g填充至玻璃製瓶容器(50mL)中,蓋上蓋子密閉。其後,將氣溶膠劑(比較例2-1為原液)在45℃下保存3個月。保存前後,充分振盪罐子,藉由致動器將氣溶膠劑的內容物取出到容器中,放置而放出噴射劑後(比較例2-1的皮膚外用組成物(原液)是直接取出到容器中),針對皮膚外用組成物的pH、pH變動、肝素類似物質的殘存率,利用與所述相同的方法進行評價。將結果一併記入至表中。
低溫穩定性的評價是與所述同樣地填充至耐壓玻璃瓶而非耐壓性罐,在-5℃下保存2個月。自玻璃瓶的外側觀察外觀,2個月後發現析出等沈澱物的情況評價為×,2個月後亦未產生析出等沈澱物的情況評價為○。將結果一併記入至表中。
實施例中使用的原料如下所示。
‧肝素類似物質:日本藥典外醫藥品規格、(股)東理製造
‧吡哆醇鹽酸鹽:日本藥典、DSM(股)製造
‧泛醇:日本藥典外醫藥品規格、DSM(股)製造
‧苯海拉明:日本藥典、金剛化學(股)製造
‧維生素A油:日本藥典、DSM(股)製造
‧生育酚乙酸酯:日本藥典、DSM(股)製造
‧異丙基甲基苯酚:日本准醫藥品原料規格、大阪化成(股)
‧鹽酸:日本藥典、關東化學(股)製造
‧氫氧化鈉:日本藥典、氫氧化鈉「製造專用」、富士膠片和光純藥(股)製造
‧檸檬酸鈉:日本藥典、檸檬酸鈉水合物 扶桑化學工業(股)製造
‧檸檬酸:日本藥典、檸檬酸水合物、(股)3F(Three F)製造
‧乳酸:日本藥典、90%乳酸、昭和化工(股)製造
‧蘋果酸:食品添加劑規格、蘋果酸扶桑L扶桑化學工業(股)製造
‧磷酸二氫鈉:醫藥品添加劑規格、磷酸二氫鈉水合物 富士膠片和光純藥(股)製造
‧硼砂:日本藥典小堺製藥(股)
‧二異丙醇胺:醫藥品添加劑規格、三井精細化學(Mitsui Fine Chemical)(股)
‧甘油:日本藥典、阪本藥品工業(股)
‧丙二醇:日本藥典、(股)艾迪科(ADEKA)
‧1,3-BG:醫藥品添加劑規格、1,3-丁二醇 大賽璐(daicel)化學工業(股)
‧乙醇:日本藥典、乙醇「製造專用」富士膠片和光純藥(股)
‧聚乙烯二醇20000:日本藥典、三洋化成工業(股)
‧硬脂醇:醫藥品添加劑規格、卡璐考璐(kalkol)8098花王(股)
‧辛基十二烷醇:醫藥品添加劑規格、艾奴傑考璐(NJCOL)200A新日本理化(股)
‧角鯊烷:化妝品原料規格、日本界面活性劑工業(NIPPON SURFACTANT INDUSTRIES)(股)
‧肉豆蔻酸異丙酯:醫藥品添加劑規格、尼可魯(NIKKOL)IPM-100日本界面活性劑工業(NIPPON SURFACTANT INDUSTRIES)(股)
‧黃原膠:醫藥品添加劑規格艾可膠T、DSP五協食品及精細化學(股)
‧羧基乙烯基聚合物:醫藥品添加劑規格、CRBOPOL980諾譽公司(Noveon Co.)
‧對羥基苯甲酸甲酯:日本藥典、上野製藥(股)
‧對羥基苯甲酸丙酯:日本藥典、上野製藥(股)
‧二丁基羥基甲苯:醫藥品添加劑規格 富士膠片和光純藥(股)
‧依地酸鈉水合物:日本藥典、依地酸鈉 中部開萊斯特(Chelest)(股)
‧LPG:醫藥品添加劑規格LPG20℃=0.43MPa、大洋液化
氣(股)
‧聚桂醇:日本藥典、尼可魯(NIKKOL)BL-21日本界面活性劑工業(NIPPON SURFACTANT INDUSTRIES)(股)
‧單月桂酸聚乙二醇:醫藥品添加劑規格、尼可魯(NIKKOL)MYL-10日本界面活性劑工業(NIPPON SURFACTANT INDUSTRIES)(股)
‧聚山梨糖醇酯20:醫藥品添加劑規格、尼可魯(NIKKOL)TL-10日本界面活性劑工業(NIPPON SURFACTANT INDUSTRIES)(股)
‧聚山梨糖醇酯60:醫藥品添加劑規格、尼可魯(NIKKOL)TS-10MV日本界面活性劑工業(NIPPON SURFACTANT INDUSTRIES)(股)
‧聚氧乙烯硬化蓖麻油10:醫藥品添加劑規格 尼可魯(NIKKOL)HCO-10日本界面活性劑工業(NIPPON SURFACTANT INDUSTRIES)(股)
‧甘油脂肪酸酯:食品添加劑規格 尼可魯戴卡格林(NIKKOL Decaglyn)5-OV日本界面活性劑工業(NIPPON SURFACTANT INDUSTRIES)(股)
Claims (9)
- 一種皮膚外用組成物,含有(A)肝素類似物質、(B)維生素B6與pH調節劑,(B)/(A)所表示的含有質量比為0.01~20,且pH為4以上、7以下。
- 如請求項1所述的皮膚外用組成物,其中(B)成分為吡哆醇或其藥學上容許的鹽。
- 如請求項1或請求項2所述的皮膚外用組成物,其中,pH調節劑更含有選自乳酸、磷酸、蘋果酸、硼酸、檸檬酸及該些的鹽中的一種以上。
- 如請求項1或請求項2所述的皮膚外用組成物,其為乳膏劑、洗劑、凝膠劑、氣溶膠劑、噴霧劑、乳液劑或塗敷劑。
- 一種氣溶膠劑,其以泡沫狀噴出,含有皮膚外用組成物與噴射劑,所述皮膚外用組成物含有(A)肝素類似物質、(C)選自有機酸及其鹽中的一種以上、(D)非離子性界面活性劑1質量%~5質量%及水。
- 如請求項5所述的氣溶膠劑,其中所述(D)非離子性界面活性劑為選自聚氧乙烯脫水山梨糖醇脂肪酸酯、聚氧乙烯山梨糖醇脂肪酸酯、聚氧乙烯甘油脂肪酸酯、聚甘油脂肪酸酯以及聚氧乙烯蓖麻油的一種以上。
- 如請求項5或請求項6所述的氣溶膠劑,其中噴射劑為液化石油氣。
- 如請求項5或請求項6所述的氣溶膠劑,其中水的 含有比例為50質量%~90質量%。
- 如請求項5或請求項6所述的氣溶膠劑,其中噴射劑的含有比例相對於皮膚外用組成物為1質量%~12質量%。
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---|---|---|---|---|
JPS60112708A (ja) | 1983-11-24 | 1985-06-19 | Maruho Kk | 皮膚用保湿剤 |
JPH07206664A (ja) | 1994-01-13 | 1995-08-08 | Lion Corp | 入浴剤組成物 |
JP5371235B2 (ja) * | 2006-12-06 | 2013-12-18 | ロート製薬株式会社 | 皮膚外用剤 |
JP2011144123A (ja) * | 2010-01-13 | 2011-07-28 | Ikeda Mohando:Kk | 皮膚外用剤 |
JP2013095717A (ja) * | 2011-11-02 | 2013-05-20 | Nikko Chemical Co Ltd | 皮膚外用剤、水中油型エマルション組成物及びこれを含有する皮膚外用剤 |
JP5988406B2 (ja) * | 2014-04-30 | 2016-09-07 | マルホ株式会社 | 起泡性組成物 |
-
2019
- 2019-12-27 KR KR1020217000741A patent/KR20210109515A/ko unknown
- 2019-12-27 TW TW108148092A patent/TWI839432B/zh active
- 2019-12-27 JP JP2020562483A patent/JPWO2020138403A1/ja active Pending
- 2019-12-27 CN CN201980084020.2A patent/CN113286590A/zh active Pending
- 2019-12-27 WO PCT/JP2019/051382 patent/WO2020138403A1/ja active Application Filing
Patent Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2000143518A (ja) * | 1998-11-12 | 2000-05-23 | Lion Corp | 皮膚外用剤 |
JP2004315442A (ja) * | 2003-04-17 | 2004-11-11 | Lion Corp | 白髪防止・改善剤 |
Also Published As
Publication number | Publication date |
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CN113286590A (zh) | 2021-08-20 |
KR20210109515A (ko) | 2021-09-06 |
WO2020138403A1 (ja) | 2020-07-02 |
TW202038949A (zh) | 2020-11-01 |
JPWO2020138403A1 (ja) | 2021-11-11 |
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