TW200812630A - External composition for skin - Google Patents

External composition for skin Download PDF

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TW200812630A
TW200812630A TW96121027A TW96121027A TW200812630A TW 200812630 A TW200812630 A TW 200812630A TW 96121027 A TW96121027 A TW 96121027A TW 96121027 A TW96121027 A TW 96121027A TW 200812630 A TW200812630 A TW 200812630A
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skin
external composition
weight
item
patent application
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TW96121027A
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Chinese (zh)
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TWI392515B (en
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Yoshiyuki Hirayama
Norikazu Sato
Akiko Kuwahara
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Rohto Pharma
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Abstract

The invention provides a skin external preparations, with excellent use feeling, stability and security even containing urea of high concentration. The retinol and/or its derivative is added in the skin external preparations containing 10 to 25 weight% of urea to increase the use feeling and stability, moisture-retention and security. Furthermore, the tocopherol and/or its derivative is added in the skin external preparations to more markedly give player to the said effects.

Description

200812630 (1) 九、發明說明 【發明所屬之技術領域】 本發明係關於使用感優異，穩定性，保濕性，及安全 性優異之皮膚外用組成物。更具體言之，本發明係關於含 ' 有脲，與松香油及/或其衍生物之皮膚外用組成物。 【先前技術】 Φ 脲在保濕劑，滲透補助劑，乾燥皮膚改善劑，皮膚軟 化劑，細胞活化劑等方面爲廣泛使用於皮膚外用組成物之 成分。爲了以脲賦予高度保濕作用或皮膚軟化作用，有必 要使脲在皮膚外用組成物以比較高濃度配合。但是，在每 一組成物使脲爲1 0重量％以上之高濃度配合的組成物， 會有脲易於析出’使得脲原有之藥理作用減弱，或塗佈時 損及使用感之問題發生。因此，爲抑制脲析出則自古以來 一直在探討之中。例如，在日本特開昭63-1 66825號公報 φ ，關於使脲穩定地含有之透明凝膠製劑，則有脲含0.5〜 30重量％，多價醇含25〜80重量％，羧乙烯聚合物含 0.1〜5重量％，pH調節劑含0.02〜3重量％，及水含20 〜70重量％之透明凝膠製劑之報告被發表。 但是’在日本特開昭63- 1 66825號公報，則僅教示單 純適用於透明凝膠製劑之技術，至目前爲止，除了透明凝 膠製劑以外亦可適用者，就使10重量％以上之脲可予以 穩定維持之技術則尙未明暸。再者，會有脲相對於皮膚會 予刺激之情形’或承受水解使氨臭產生之情形，故在高濃 -5- 200812630 (2) 度配合有脲之組成物，其安全性及穩定性之改善則爲所期 望。 一方面，松香油或其衍生物，係與視覺，聽覺等生體 機能之維持相關連，或藉由新陳代謝之促進，而可使皮膚 • 或黏膜等正常的上皮組織之再生機能相關連者已被解明， • 而配合以角化性（keratosic )皮膚疾病（尋常性魚鱗癬（ ichthyosis vulgaris )，毛孔性苔癖，單純性粃糠疹（ φ Pityriasis )等）等疾病之治療用醫藥組成物。又，在松香 油或其衍生物，具有抗氧化作用或防老化作用等之有用作 用’作爲抗皺等防皮膚老化用化粧料之配合成分亦被廣泛 利用。但是，在每一組成物使脲以1 0重量％以上之高濃 度配合之組成物中，就配合松香油或其衍生物者則無任何 報告被發表，又就高濃度之脲與松香油或其衍生物之組合 所致效果亦無從知曉。 容 內 明 發[Technical Field] The present invention relates to a skin external composition excellent in feeling of use, stability, moisture retention, and safety. More specifically, the present invention relates to a skin external composition containing 'urea, and rosin oil and/or a derivative thereof. [Prior Art] Φ urea is a component widely used in external skin compositions in terms of a moisturizing agent, an infiltration aid, a dry skin improving agent, a skin softening agent, and a cell activator. In order to impart a high moisturizing action or a skin softening action by urea, it is necessary to mix the urea external composition with a relatively high concentration. However, a composition having a high concentration of urea of 10% by weight or more per composition may cause urea to be easily precipitated, so that the original pharmacological action of urea is weakened, or the problem of damage and feeling of use during coating occurs. Therefore, it has been under investigation since ancient times to suppress urea precipitation. For example, JP-A-63-1 66825 φ, a transparent gel preparation containing urea stably, has a urea content of 0.5 to 30% by weight, a polyvalent alcohol of 25 to 80% by weight, and a carboxyethylene polymerization. A report containing 0.1 to 5% by weight of a pH adjusting agent containing 0.02 to 3% by weight of a pH adjusting agent and 20 to 70% by weight of a clear gel preparation in water was published. However, the technique of simply applying to a transparent gel preparation is taught by the Japanese Patent Laid-Open Publication No. SHO-63-166825. Up to now, 10% by weight or more of urea can be used in addition to the transparent gel preparation. The technology that can be stably maintained is unclear. Furthermore, there may be cases where urea is irritated with respect to the skin', or it is subjected to hydrolysis to cause ammonia odor. Therefore, the composition of urea is compounded at a concentration of -5 - 12,620,630 (2), and its safety and stability are maintained. The improvement is what is expected. On the one hand, rosin oil or its derivatives are related to the maintenance of biological functions such as vision and hearing, or by the promotion of metabolism, the regenerative function of normal epithelial tissues such as skin or mucous membrane has been associated with It is a medical composition for the treatment of diseases such as keratosic skin diseases ( ichthyosis vulgaris, pores of moss, simple pityriasis, etc.). Further, rosin oil or a derivative thereof has an anti-oxidation effect or an anti-aging effect, and is also used as a compounding component for anti-wrinkle and other cosmetic materials for skin aging. However, in the composition in which each composition is compounded at a high concentration of 10% by weight or more, the rosin oil or its derivative is not reported to be published, and high-concentration urea and rosin oil or The effect of the combination of its derivatives is also unknown. Rong Mingming

示 揭 明 發 FLShow the disclosure

[發明欲解決之課題] 本發明之目的係提供一種，可含有局濃度脲，同時使 用感優異，穩定性，保濕性，及安全性優異之皮膚外用組 成物。 [解決課題之手段] 本發明人等，爲達成上述目的經戮力硏究，結果首先 -6 - 200812630 (3) 發現’在每一組成物含有1〇〜25重量％脲之組成物，配 合以松香油及/或其衍生物時，可提升使用感，進而具備 優異穩定性’保濕性及安全性者。尤其是，在以奶油狀之 形態進行製劑化之情形，除了 1 〇〜25重量％之脲，與松 香油及/或其衍生物，加上配合以高級醇，烴，及聚矽氧 ' 之組合’可使使用感，穩定性，保濕性及安全性等更進一 步顯著地提高。本發明係基於此真知灼見，進而一再重複 φ 改良而完成者。 亦即，本發明係提供一種下述所揭示之皮膚外用組成 物。 項1 · 一種皮膚外用組成物，其特徵爲，含有（a ) 脲10〜25重量％，及（b)選自松香油（retinol)及其衍 生物所成群之至少1種。 項2· ( b )成分係選自乙酸松香油酯，棕櫚酸松香 油酯及δ-松香油酸生育酚酯所成群之至少1種之，項1記 φ 載之皮膚外用組成物。 項3 · ( b )成分爲棕櫚酸松香油酯之，項1記載之 皮膚外用組成物。 項4·對皮膚外用組成物之平均總量，使（b )成分 含0.0 01〜1重量％之比率之，項1記載之皮膚外用組成 物。 項5 ·相對於（b )成分之總量1重量份，脲通常含1 〜3 00重量份之比率之，項1記載之皮膚外用組成物。 項6·進而含有選自，（c)生育酚及其衍生物所成 200812630 (4) 群之至少1種之，項1記載之皮膚外用組成物。 項7. (c)成分爲乙酸生育酚酯之，項6記載之皮 膚外用組成物。 項8.對皮膚外用組成物之平均總量，使（c )成分 ' 含0.001〜5重量％之比率之，項6記載之皮膚外用組成 ' 物。 項9.進而含有選自，鉗合劑，抗氧化劑，抗炎劑， φ 保濕劑，美白劑，細胞活化劑，及除皺劑所成群之至少1 種之，項1記載之皮膚外用組成物。 項1 〇.其爲化粧料或醫藥組成物之，項1記載之皮 膚外用組成物。 項1 1.其爲角質軟化用或保濕用之皮膚外用組成物 之，項1記載之皮膚外用組成物。 項12.其爲奶油狀之形態之，項1記載之皮膚外用 組成物。 Φ 項13.其進而含有，高級醇，烴，及聚矽氧之，項 1 2記載之皮膚外用組成物。 項1 4 .高級醇爲選自硬脂醯基醇及鯨蠟醇之1種或2 種之，項1 3記載之皮膚外用組成物。 項1 5 .對皮膚外用組成物之平均總量，使高級醇含 ' 0.1〜30重量％之比率之，項13記載之皮膚外用組成物。 項1 6.烴爲凡士林之，項1 3記載之皮膚外用組成物 〇 項17.對皮膚外用組成物之平均總量，使烴含0.01 -8- 200812630 (5) 〜50重量％之比率之，項13記載之皮膚外用組成物。 項18.聚矽氧爲二甲基聚砂氧垸之，項13記載之皮 膚外用組成物。 項19·對皮膚外用組成物之平均總量，使聚矽氧含 ' 〇. 〇 〇 1〜1 〇重量％之比率之，項1 3記載之皮膚外用組成物 項2 0.對皮膚外用組成物之平均總量，高級醇含0.5 0 〜15重量％，烴含0.1〜40重量％，及聚矽氧含0.01〜5 重量％之’項1 3記載之皮膚外用組成物。 項2 1 .對皮膚外用組成物之平均總量，硬脂醯基含 醇1〜10重量％，鯨蠟醇含丨〜：^重量％，凡士林含1〜 20重量％，及二甲基聚矽氧烷含〇.;i〜3重量％之，項13 記載之皮膚外用組成物。 進而’本發明係提供一種，下述所揭示之脲之析出抑 制方法。 φ 項22·在含脲10〜25重量％之皮膚外用組成物中於 月尿析出之抑制方法中，使（a )對皮膚外用組成物之平均 總量爲10〜25重量％之脲，與（b)選自松香油及其衍生 %所$群2$少1種在皮膚外用組成物中共存者爲其特徵 之’脲之析出抑制方法。 項23 · ( b )成分係選自乙酸松香油酯，棕櫚酸松香 、油ϋ及（5 -松香油酸生育酚酯所成群之至少1種之，項 22記載之方法。 11 24* ( Μ成分爲棕櫚酸松香油酯之，項22記載 -9- 200812630 (6) 之方法。 項2 5 .對皮膚外用組成物之平均總量，使（b )成分 以含0.001〜1重量％之比率存在之，項22記載之方法。 項26.相對於（b )成分之總量1重量份’使脲通常 • 成爲1〜3 00重量份之比率共存之，項22記載之方法。 • 項2 7.進而，在皮膚外用組成物中使選自（e )生育 酚及其衍生物所成群之至少1種存在之，項22記載之方 • 法。 項28. ( c )成分爲乙酸生育酚酯之，項27記載之 方法。 項29 .對皮膚外用組成物之平均總量，使（c )成分 以含0.001〜5重量％之比率存在之，項27記載之方法。 項3 0 .進而在皮膚外用組成物中，使選自鉗合劑， 抗氧化劑，抗炎劑，保濕劑，美白劑，細胞活化劑，及除 皺劑所成群之至少1種存在之，項22記載之方法。 φ 項3 1 .皮膚外用組成物爲化粧料或醫藥組成物之， 項22記載之方法。 項32·其爲角質軟化用或保濕用之皮膚外用組成物 之，項22記載之方法。 項3 3 ·皮膚外用組成物爲奶油狀形態之，項22記載 之方法。 項3 4.進而，在皮膚外用組成物中，使高級醇，烴 ，及聚矽氧存在之，項3 3記載之方法。 項3 5 .高級醇係選自硬脂醯基醇及鯨蠟醇之1種或2 -10- 200812630 (7) 種之，項3 4記載之方法。 項3 6·對皮膚外用組成物之平均總量，使高級醇以 0.1〜30重量％之比率存在之，項34記載之方法。 項3 7.烴爲凡士林之，項34記載之方法。 - 項3 8 ·對皮膚外用組成物之平均總量，使烴以0 · 〇 1 - 〜50重量％之比率存在之，項34記載之方法。 項39·聚矽氧爲二甲基聚矽氧烷之，項34記載之方 法。 ^ 項4 0.對皮膚外用組成物之平均總量，使聚矽氧以 含0.001〜10重量％之比率存在之，項34記載之方法。 項4 1 .對皮膚外用組成物之平均總量，使高級醇以 0.5〜15重量％，烴以0.1〜40重量％，及聚矽氧以0.01 〜5重量％之比率存在之，項34記載之方法。 項42 ·對皮膚外用組成物之平均總量，使硬脂醯基 醇以1〜1 0重量％，鯨鱲醇以1〜1 0重量％，凡士林以1 φ 〜20重量％，及二甲基聚矽氧烷以〇.1〜3重量％存在之 ，項3 4記載之方法。 接著，本發明進一步係提供一種下述所揭示之松香油 ' 及/或其衍生物之穩定化方法。 項4 3 ·在含有松香油及/或其衍生物之皮膚外用組 成物中，使松香油及/或其衍生物穩定化之方法中，其係 使（a)對皮膚外用組成物之平均總量10〜25重量％之脲 ，與（b )選自松香油及其衍生物所成群之至少1種在皮 膚外用組成物中共存爲其特徵之，穩定化方法。 -11 - 200812630 (8) 項44. ( b )成分爲選自乙酸松香油酯，棕櫚酸松香 油酯及5 -松香油酸生育酚酯所成群之至少1種之，項 4 3記載之方法。 項45· ( b)成分爲棕櫚酸松香油酯之，項43記載 * 之方法。 ' 項46·對皮膚外用組成物之平均總量，使（b )成分 以含0·001〜1重量％之比率存在之，項43記載之方法。 φ 項47·相對於（b )成分之總量1重量份，使脲以通 常1〜3 00重量份之比率共存之，項43記載之方法。 項48.進而，在皮膚外用組成物中使（c)選自生育 ， 酚及其衍生物所成群之至少1種存在之，項43記載之方 法。 項49· ( c )成分爲乙酸生育酚酯之，項48記載之 方法。 項50·對皮膚外用組成物之平均總量，使（c )成分 φ 以含0.001〜5重量％之比率存在之，項49記載之方法。 項5 1 .進而在皮膚外用組成物中，使選自鉗合劑， 抗氧化劑，抗炎劑，保濕劑，美白劑，細胞活化劑，及除 皺劑所成群之至少1種存在之，項43記載之方法。 項52.皮膚外用組成物爲化粧料或醫藥組成物之， 項43記載之方法。 項53.其爲角質軟化用或保濕用之皮膚外用組成物 之，項43記載之方法。 項54.皮膚外用組成物爲奶油狀形態之，項43記載 -12- 200812630 (9) 之方法。 項5 5 ·進而在皮膚外用組成物中，使高級醇，烴， 及聚矽氧存在之，項54記載之方法。 項56.高級醇.係選自硬脂醯醇及鯨蠛醇之丨種或2 * 種之，項5 5記載之方法。 項5 7 ·封皮膚外用組成物之平均總量，使高級醇以 0·1〜30重量％之比率存在之，項55記載之方法。 ^ 項5 8 ·烴爲凡士林之，項5 5記載之方法。 項59·對皮膚外用組成物之平均總量，使烴以0.01 〜50重量％之比率存在之，項55記載之方法。 項60·使聚矽氧爲二甲基聚矽氧烷之，項55記載之 方法。 項6 1 ·對皮膚外用組成物之平均總量，使聚矽氧以 含0.001〜10重量％之比率存在之，項55記載之方法。 項6 2.對皮膚外用組成物之平均總量，使高級醇以 • 〇.5〜15重量％，經以0.1〜40重量％，及聚砂氧以〇.〇1 〜5重量％之比率存在之，項55記載之方法。 項63 .對皮膚外用組成物之平均總量，使硬脂醯醇 以1〜1 0重量％，鯨蠟醇以1〜1 0重量％，凡士林以1〜 20重量％，及二甲基聚矽氧烷以0.1〜3重量％存在之， 項5 5記載之方法。 [發明之效果] 根據本發明之皮膚外用組成物，因含有10〜25重量 -13- 200812630 (10) . %之高濃度脲，同時使用感，穩定性，保濕性及安全性優 異，故基於脲可使有用作用有效地發揮。 再者，本發明之皮膚外用組成物係奶油狀形態，其中 在含有特定高級醇，特定烴，及特定聚矽氧之組合的情形 _ ，因可使使用感或穩定性顯著地提高，故有用性極高。 [實施發明之形態] Φ 本說明書中，皮膚外用組成物之「穩定性」係指，含 於皮膚外用組成物之成分本身不僅可穩定地保持，皮膚外 用組成物之外觀性狀亦可穩定地保持之意。 I.皮膚外用組成物 本發明之皮膚外用組成物，係以含有（a )脲1 0〜2 5 重量％，及（b)松香油及/或其衍生物爲其特徵者。以 下，就本發明之皮膚外用組成物加以詳細說明。 (a)脲 本發明之皮膚外用組成物，對該組成物之總量，脲含 10〜25重量％之比率。如此一來脲可以高濃度配合，而 ' 可使基於脲之保濕作用或皮膚軟化作用可有效果地發揮。 在本發明之皮膚外用組成物中脲之配合比率，可因應該組 成物之形態或用途等在上述範圍內適宜設定，但可舉較佳 爲10〜20重量％，更佳爲15〜20重量％。 -14- 200812630 (11) (b )松香油及/或其衍生物 本發明之皮膚外用組成物係含有，選自松香油及其衍 生物所成群之至少1種（本說明書中，單稱爲r ( b )成 分」）。 松香油衍生物方面’具體言之，可例舉乙酸松香油酯 ' ，丙酸松香油酯，丁酸松香油酯，辛酸松香油酯，月桂酸 松香油酯，棕櫚酸松香油酯，硬脂酸松香油酯，肉豆蔻酸 φ 松香油酯，油酸松香油酯，亞麻酸松香油酯，亞油酸松香 油酯等之松香油脂肪酸酯；維生素A2 ( retinal )，松香 油酸等之松香油氧化物，松香油酸甲酯，松香油酸乙酯， 松香油酸松香油酯，松香油酸生育酚酯（可爲α，^，γ ’ 5之任一異構物）等之松香油酸酯等。該等松香油衍生 物’以鹽之形態獲得者，亦可爲鹽之形態。在以鹽之形態 獲得之松香油衍生物方面，可例舉例如松香油酸鈉等之松 香油酸之鹽。該等松香油衍生物，可單獨使用1種，或亦 % 可組合2種以上使用。 在本發明，（b)成分方面，可含有松香油及其衍生 物之任一種的至少一者，而含有松香油衍生物爲所望。松 香油衍生物中，就可使本發明之前述效果更進一步顯著之 觀點而言，較佳爲乙酸松香油酯，棕櫚酸松香油酯，及δ 一松香油酸生育酚酯，更佳爲可例示棕櫚酸松香油酯。 又用於本發明之松香油及/或其衍生物，可爲自動物 萃取，而精製之天然油（肝油等），亦可爲化學合成者。 又，用於本發明之松香油及/或其衍生物方面，可使用日 -15 - 200812630 (12) 本藥局方記載之維生素A油（每lg含3萬維生素a單位 (IU)以上）。 本發明所用（b)成分之配合比率，在可發揮前述本 發明之效果之範圍’並無特別限定，而可例舉對皮膚外用 組成物之平均總量爲0.001〜1重量％，較佳爲0 01〜0 5 重量％。以此種比率含有松香油及/或其衍生物，而可抑 制脲之析出’可更進一步有效地具備使用感，穩定性，保 濕性及安全性等。 脲與松香油及/或其衍生物之比率 又’在本發明之皮膚外用組成物中，就相對於松香油 及/或其衍生物之脲之比率，在可發揮前述本發明之效果 之車i圍並無特別限定，而相對於松香油及/或其衍生物之 總量1重量份，脲通常爲1〜3〇〇重量份，較佳爲1〇〜 200重量份，特佳爲20〜100重量份。 (c)生育酚及/或其衍生物 在本發明之皮膚外用劑，爲使使用感，穩定性，及保 濕性進一步提高，又爲使製劑更爲穩定化，則可配合選自 生育酚及其衍生物所成群之至少1種（本說明書中，單稱 爲「（ c )成分」）。 本發明中生育酚係指，α 一生育酚，一生育酚，r 一生育酚，及（5-生育酚之任一種，較佳爲以一生育酚， 5 —生育酹。該等生育酚可爲，d體，dl體之任一種。該 -16 - 200812630 (13) 等生育酚，可單獨使用1種，又亦可組合2種以上使用。 又，生育酚衍生物方面，具體言之，可例舉乙酸生育 酚酯，琥珀酸生育酚酯，菸鹼酸生育酚酯，亞麻酸生育酚 酯等之生育酚有機酸酯。生育酚有機酸酯中，有機酸在非 單羧酸之情形可爲鹽之形態。生育酚有機酸酯之鹽之形態 • 方面，可舉例如琥珀酸生育酚鈣鹽等。該等生育酚衍生物 中，可爲d體，dl體之任一種。又，該等生育酚衍生物， φ 可單獨使用1種，又亦可組合2種以上使用。 就可抑制脲之析出，使使用感，穩定性，及保濕性更 進一步提高之觀點而言，該等（c)成分中可例示較佳爲 生育酚衍生物，更佳爲乙酸生育酚酯。 本發明所用（c )成分之配合比率，並無特別限定， 而對皮膚外用組成物之平均總量，爲0.001〜5重量％， 較佳爲〇·〇1〜3重量％，特佳爲0.5〜2重量％。 φ 其他可配合之活性成分 本發明之皮膚外用組成物，因附加有其他有用作用， 故可配合鉗合劑，抗氧化劑，抗炎劑，保濕劑，美白劑， 細胞活化劑’除皺劑等各種活性成分1種或2種以上之組 合。該等各活性成分方面，在醫藥品，輕用藥（quasi-drug )’或化粧品領域中作爲皮膚外用組成物之成分可使 用習知者’又作未來使用者並無特別限制，可適宜選擇任 意之物使用。該等成分中，鉗合劑或抗氧化劑，以可使穩 定性更進一步提高者爲有用。又，對皮膚賦予抗炎作用， -17- 200812630 (14) 或對皮膚細胞予以活化者，在可使皮膚狀態健全的保持上 爲重要，故由此種觀點可例舉，在該等成分中較佳爲抗炎 劑及細胞活化劑者。 鉗合劑方面，可例舉例如乙二胺四乙酸（edetate )， " 乙二胺四乙酸鹽（鈉鹽（乙二胺四乙酸鈉：日本藥局方， - EDTA-2Na等），鉀鹽等），肌醇六磷酸（phytic acid ) ，蔔糖酸（gluconic axid)，聚磷酸，偏磷酸等。該等中 ^ 較佳爲，乙二胺四乙酸，乙二胺四乙酸鈉，乙二胺四乙酸 鉀，肌醇六磷酸。該等鉗合劑可使用1種或2種以上之組 合。在本發明之皮膚外用組成物配合鉗合劑之情形，其配 合比率方面，對皮膚外用組成物之平均總量，通常爲 0.000 3〜20重量％，較佳爲 0.01〜10重量％，更佳爲 0.05〜5重量％。 抗氧化劑方面，可例舉例如丁基羥基苯甲醚，二丁基 羥基甲苯，亞硫酸氫鈉，異抗壞血酸（erythorbic acid ) 0 及其鹽，谷胱甘肽（glutathione )，谷胱甘肽過氧化酶， 谷胱甘肽一 S-轉移酶，過氧化氫酶（catalase )，超氧物 岐化酶（superoxide dismutase )，硫氧化還原蛋白（ thioredoxirx)，牛磺酸（taurine)，硫代牛磺酸，亞牛磺 酸（hypotaurine)等。該等中較佳爲丁基羥基苯甲醚，二 丁基羥基甲苯。該等抗氧化劑可使用1種或組合2種以上 使用。在本發明之皮膚外用組成物配合鉗合劑之情形，其 配合比率方面，並無特別限定，而可舉對皮膚外用組成物 之平均總量，通常爲0.00001〜10重量％，較佳爲0.0001 -18- 200812630 (15) 〜5重量％，更佳爲o.ooi〜5重量％。 抗炎劑方面，例如，indomethacin，水楊酸甲酯，尿[Problem to be Solved by the Invention] An object of the present invention is to provide a skin external composition which can contain a local concentration of urea and which is excellent in feeling, stability, moisture retention, and safety. [Means for Solving the Problem] The inventors of the present invention have found that the composition of the composition contains 1 〇 to 25% by weight of urea in each composition, in the first place -6 - 200812630 (3). When rosin oil and/or its derivatives are used, it can improve the feeling of use, and it has excellent stability, such as moisturizing and safety. In particular, in the case of formulation in the form of a cream, in addition to 1 〇 to 25% by weight of urea, with rosin oil and/or its derivatives, in combination with higher alcohols, hydrocarbons, and polyoxyl The combination 'can further improve the sense of use, stability, moisture retention and safety, etc. The present invention is based on this insight, and is repeated by repeating the φ improvement. That is, the present invention provides a skin external composition disclosed below. Item 1 A skin external composition comprising (a) urea in an amount of 10 to 25% by weight, and (b) at least one selected from the group consisting of rosinol and derivatives thereof. Item 2 (b) is at least one selected from the group consisting of rosin acetate acetate, rosin palmitate oil ester and tocopherol oleate of δ-rosin oleate, and item 1 is a skin external composition of φ. Item 3 (b) is a skin external composition as described in Item 1, wherein the component is a rosin oil palmitate. Item 4: The skin external composition according to Item 1, wherein the component (b) contains an average amount of the external composition of the skin, and the component (b) contains a ratio of 0.011 to 1% by weight. Item 5: The skin external composition according to Item 1, wherein urea is usually contained in an amount of from 1 to 30,000 parts by weight based on 1 part by weight of the total amount of the component (b). Item 6 further includes at least one selected from the group consisting of (c) tocopherol and a derivative thereof, and the skin external composition according to Item 1, which is at least one of the group of 200812630 (4). Item 7. The component (c) is a tocopheryl acetate, and the skin external composition described in Item 6. Item 8. The average total amount of the skin external composition is such that the component (c) contains a ratio of 0.001 to 5% by weight, and the external skin composition of the item 6 is a substance. Item 9. Further comprising at least one selected from the group consisting of: a chelating agent, an antioxidant, an anti-inflammatory agent, a humectant, a whitening agent, a cell activator, and a wrinkle removing agent, the skin external composition according to Item 1. . Item 1 〇. It is a cosmetic or pharmaceutical composition, and the skin external composition described in Item 1. Item 1 1. The skin external composition according to Item 1, which is a skin external composition for moistening or moisturizing. Item 12. The skin external composition according to Item 1, which is in the form of a cream. Φ Item 13. Further, it contains a higher external alcohol, a hydrocarbon, and a polyoxyl oxide, and the external composition for skin described in Item 12. Item 14. The higher alcohol is one or two selected from the group consisting of stearyl alcohol and cetyl alcohol, and the external composition for skin described in Item 13. Item 15. The skin external composition according to Item 13, wherein the higher average amount of the composition for external use of the skin is such that the higher alcohol contains a ratio of 0.1 to 30% by weight. Item 1 6. The hydrocarbon is petrolatum, the skin external composition described in Item 13. The average total amount of the skin external composition is such that the hydrocarbon has a ratio of 0.01 -8 to 200812630 (5) to 50% by weight. The external composition for skin described in Item 13. Item 18. Polyoxymethylene is a dimethyl sulphate composition, and the skin external composition described in Item 13. Item 19: The average total amount of the composition for external use on the skin, such that the polyoxyxide contains a ratio of '〇. 〇〇1 to 1% by weight%, and the skin external composition item of item 1 3 is 0. For external use of the skin The average total amount of the substance, the higher alcohol contains 0.50 to 15% by weight, the hydrocarbon contains 0.1 to 40% by weight, and the polyoxynium oxide contains 0.01 to 5% by weight of the skin external composition described in Item 13. Item 2 1. The average total amount of the external composition for skin, the stearin group contains 1 to 10% by weight of alcohol, the cetyl alcohol contains 丨~:^% by weight, the Vaseline contains 1 to 20% by weight, and the dimethyl group The oxime contains 〇.; i 3% by weight of the skin external composition described in Item 13. Further, the present invention provides a method for suppressing precipitation of urea disclosed below. φ Item 22. In a method for inhibiting the precipitation of urinary tract in a skin external composition containing 10 to 25% by weight of urea, the average total amount of (a) external composition for skin is 10 to 25% by weight of urea, and (b) A method for suppressing the precipitation of urea characterized by a rosin oil and a derivative thereof having a group of 2% less than one of the skin external compositions. Item (23) The component (b) is selected from the group consisting of rosin acetate acetate, rosin palmitate, oil mash, and (5-tocopheryl rosin acid tocopheryl ester), the method described in Item 22. 11 24* ( The bismuth component is palmitic acid rosin oil ester, and the method of -22-200812630 (6) is described in Item 22. The average total amount of the skin external composition is such that the component (b) is contained in an amount of 0.001 to 1% by weight. The ratio is the method described in Item 22. Item 26. The method described in Item 22, in which the total amount of the component (b) is 1 part by weight 'the urea is usually made to be 1 to 30,000 parts by weight. Further, in the external composition for skin, at least one selected from the group consisting of (e) tocopherol and a derivative thereof is present, and the method described in Item 22 is a method. Item 28. (c) Component is acetic acid Tocopherol ester, the method described in Item 27. Item 29. The average total amount of the composition for external use of the skin, wherein the component (c) is present in a ratio of 0.001 to 5% by weight, the method described in Item 27. Item 3 0 Further, in the external composition for skin, it is selected from the group consisting of a chelating agent, an antioxidant, an anti-inflammatory agent, a moisturizing agent, a whitening agent, and a cell living. The method described in Item 22, wherein at least one of the agent and the wrinkle-retaining agent are present. φ Item 3 1 . The skin external composition is a cosmetic or a pharmaceutical composition, and the method described in Item 22. It is a method described in Item 22, which is a skin external composition for keratin softening or moisturizing. Item 3 3 · The skin external composition is in the form of a cream, and the method described in Item 22. Item 3 4. Further, the composition for external use on the skin The method described in Item 3 3, wherein the higher alcohol, the hydrocarbon, and the polyoxyl is present. Item 3 5. The higher alcohol is selected from the group consisting of stearyl alcohol and cetyl alcohol or 2 -10- 200812630 (7) The method described in Item 3 4. Item 3 6· The average total amount of the external composition for skin is such that the higher alcohol is present in a ratio of 0.1 to 30% by weight, and the method described in Item 34. Item 3 7 The hydrocarbon is a method of Vaseline, the method described in Item 34. - Item 3 8 - The average amount of the external composition for skin is such that the hydrocarbon is present in a ratio of from 0 to 5% to 50% by weight, the method described in Item 34. Item 39. Polyoxyl is dimethylpolyoxane, the method described in Item 34. ^ Item 4 0. External composition for skin The average total amount is such that the polyoxoxime is present in a ratio of 0.001 to 10% by weight, the method described in Item 34. Item 4 1. The average total amount of the external composition for skin is 0.5 to 15% by weight of the higher alcohol. The hydrocarbon is present in an amount of from 0.01 to 40% by weight, and the polyoxyxylene is present in a ratio of from 0.01 to 5% by weight, the method described in Item 34. Item 42 - The average total amount of the external composition for the skin is such that the stearyl alcohol is 1 ～10% by weight, whale sterol is 1 to 10% by weight, petrolatum is 1 φ to 20% by weight, and dimethyl polyoxyalkylene is present at 〇1 to 3% by weight, as described in item 3 4 method. Next, the present invention further provides a method for stabilizing a rosin oil 'and/or a derivative thereof disclosed below. Item 4 3 - A method for stabilizing rosin oil and/or a derivative thereof in a skin external composition containing rosin oil and/or a derivative thereof, which is an average total of (a) external composition for skin The method of stabilizing is characterized in that at least one of the components selected from the group consisting of rosin oil and a derivative thereof is present in the external composition for skin, and is contained in an amount of 10 to 25% by weight of urea. -11 - 200812630 (8) Item 44. (b) The composition is at least one selected from the group consisting of rosin acetate acetate, rosin palmitate and tocopheryl 5-rosin oleate. method. Item 45 (b) is a palmitic acid rosin oil ester, and item 43 describes the method of *. Item 46. The average amount of the composition for external use on the skin, wherein the component (b) is present in a ratio of from 0.0001 to 1% by weight, the method described in Item 43. The φ term 47· is a method described in the item 43, wherein the urea is present in a ratio of usually 1 to 300 parts by weight based on 1 part by weight of the total amount of the component (b). Item 48. Further, in the external composition for skin, (c) is a method selected from the group consisting of at least one of a group consisting of a fertility, a phenol, and a derivative thereof. The component (c) is a tocopheryl acetate ester, the method described in item 48. Item 50. The average amount of the composition for external use on the skin, wherein the component (c) is present in a ratio of 0.001 to 5% by weight, and the method described in Item 49. Item 5: Further, in the external composition for skin, at least one selected from the group consisting of a chelating agent, an antioxidant, an anti-inflammatory agent, a moisturizing agent, a whitening agent, a cell activator, and a wrinkle removing agent is present. 43 methods described. Item 52. The skin external composition is a cosmetic or a pharmaceutical composition, the method described in Item 43. Item 53. The method according to Item 43, which is a skin external composition for keratin softening or moisturizing. Item 54. The external composition for skin is in the form of a cream, and Item 43 describes the method of -12-200812630 (9). Item 5 5 Further, in the external composition for skin, a higher alcohol, a hydrocarbon, and a polyoxyl oxide are present, the method described in Item 54. Item 56. Higher alcohol. A method selected from the group consisting of stearyl alcohol and whale sterol or 2*, the method described in Item 5. Item 5 7 - The average total amount of the skin external composition is such that the higher alcohol is present in a ratio of from 0.1 to 30% by weight, the method described in Item 55. ^ Item 5 8 · Hydrocarbon is the method described in Vaseline, item 5 5. Item 59. The method of Item 55, wherein the average amount of the composition for external use on the skin is such that the hydrocarbon is present in a ratio of 0.01 to 50% by weight. Item 60. The method of Item 55, wherein the polyoxymethylene is dimethylpolyoxyalkylene. Item 6 1 - The method of the item 55, wherein the average amount of the external composition for the skin is present in a ratio of 0.001 to 10% by weight. Item 6 2. The average total amount of the composition for external use on the skin is such that the higher alcohol is in a ratio of 〇5 to 15% by weight, 0.1 to 40% by weight, and the ratio of polyaluminum to 〇1 to 5% by weight. There is a method described in Item 55. Item 63. The average total amount of the external composition for skin is 1 to 10% by weight of stearic alcohol, 1 to 10% by weight of cetyl alcohol, 1 to 20% by weight of petrolatum, and dimethyl poly The method described in item 5 5, wherein the oxane is present in an amount of 0.1 to 3% by weight. [Effects of the Invention] The skin external composition according to the present invention contains a high concentration of urea of 10 to 25 weights -13 to 200812630 (10) %, and is excellent in feeling of use, stability, moisture retention and safety, and is therefore based on Urea can make a useful effect work effectively. Further, the external composition for skin of the present invention is in the form of a cream, in which a combination of a specific higher alcohol, a specific hydrocarbon, and a specific polyoxyxide is used, and it is useful because the feeling of use or stability can be remarkably improved. Extremely high. [Form of the invention] Φ In the present specification, the "stability" of the composition for external use of the skin means that the component itself contained in the composition for external use of the skin is not only stably maintained, but also the appearance property of the composition for external use of the skin can be stably maintained. The meaning. I. Skin external composition The skin external composition of the present invention is characterized by containing (a) urea 10 to 25 % by weight, and (b) rosin oil and/or a derivative thereof. Hereinafter, the external composition for skin of the present invention will be described in detail. (a) Urea The skin external composition of the present invention contains urea in a ratio of 10 to 25% by weight based on the total amount of the composition. In this way, urea can be blended at a high concentration, and 'the urea-based moisturizing effect or skin softening effect can be exerted effectively. The compounding ratio of urea in the external composition for skin of the present invention can be appropriately set within the above range depending on the form or use of the composition, but it is preferably 10 to 20% by weight, more preferably 15 to 20% by weight. %. -14- 200812630 (11) (b) rosin oil and/or its derivative The skin external composition of the present invention contains at least one selected from the group consisting of rosin oil and its derivatives (in this specification, the singular name Is the r (b) component"). In terms of rosin oil derivatives, 'specifically, rosin acetate acetate', propionic acid rosin oil ester, rosin butyrate ester, rosin oleic acid ester, rosin oil laurate, rosin oil palmitate, stearin Acid rosin oil ester, myristic acid φ rosin oil ester, oleic acid rosin oil ester, linolenic acid rosin oil ester, linoleic acid rosin oil ester and other rosin oil fatty acid ester; vitamin A2 (retinal), rosin oleic acid, etc. Rosin oil oxide, rosin methyl oleate, rosin oleic acid ethyl ester, rosin oleic acid rosin oil ester, rosin oleic acid tocopherol ester (may be any of α, ^, γ '5 isomers) Balsamic acid ester and the like. The rosin oil derivatives 'obtained in the form of a salt may also be in the form of a salt. The rosin oil derivative obtained in the form of a salt may, for example, be a salt of rosin oleic acid such as rosin sodium oleate. These rosin oil derivatives may be used singly or in combination of two or more. In the present invention, the component (b) may contain at least one of rosin oil and a derivative thereof, and a rosin oil derivative is desirable. In the rosin oil derivative, from the viewpoint of further enhancing the aforementioned effects of the present invention, rosin acetate acetate, rosin palmitate, and δ-rosin oleic acid tocopheryl ester are preferred, and more preferably An example is palmitic rosin oil ester. Further, the rosin oil and/or its derivative used in the present invention may be an extract of an automatic substance, and a purified natural oil (such as liver oil) may be a chemical compound. Further, in the case of the rosin oil and/or its derivative of the present invention, the vitamin A oil (containing 30,000 or more vitamin A units per lg) may be used as the date of the -15 - 200812630 (12) . The blending ratio of the component (b) used in the present invention is not particularly limited as long as it exhibits the effects of the present invention, and the average amount of the external composition for skin is 0.001 to 1% by weight, preferably 0 01~0 5 wt%. The use of rosin oil and/or a derivative thereof in such a ratio suppresses the precipitation of urea, which further provides a feeling of use, stability, moisture retention, safety, and the like. The ratio of urea to rosin oil and/or its derivative is also a vehicle which can exhibit the effects of the present invention in comparison with the ratio of urea to rosin oil and/or its derivative in the external composition for skin of the present invention. The range is not particularly limited, and the urea is usually 1 to 3 parts by weight, preferably 1 to 200 parts by weight, particularly preferably 20 parts by weight based on 1 part by weight of the total of the rosin oil and/or its derivative. ~100 parts by weight. (c) Tocopherol and/or a derivative thereof The skin external preparation of the present invention may further improve the feeling of use, stability, and moisturization, and may be formulated to be selected from tocopherols in order to further stabilize the preparation. At least one of the derivatives is a group (in the present specification, it is simply referred to as "(c) component"). The tocopherol in the present invention means α-tocopherol, monotocopherol, r-tocopherol, and (any of 5-tocopherol, preferably a tocopherol, 5 - fertility quinone. Any one of the d body and the dl body. The tocopherol may be used alone or in combination of two or more. The tocopherol derivative, in particular, Examples are tocopherol acetate esters, tocopheryl succinate esters, tocopheryl nicotinic acid tocopherol esters, tocopherol organic acid esters such as tocopheryl linolenic acid esters. In the case of tocopherol organic acid esters, organic acids are in the case of non-monocarboxylic acids. In the form of a salt, a form of a salt of a tocopherol organic acid ester may, for example, be a tocopheryl succinate calcium salt or the like. The tocopherol derivatives may be either a d-form or a dl-form. These tocopherol derivatives, φ may be used singly or in combination of two or more. It is possible to suppress the precipitation of urea and to improve the feeling of use, stability, and moisture retention. The component (c) may preferably be a tocopherol derivative, more preferably an acetic acid derivative. The compounding ratio of the component (c) used in the present invention is not particularly limited, and the average amount of the external composition for skin is 0.001 to 5% by weight, preferably 〜·〇1 to 3% by weight. Preferably, it is 0.5 to 2% by weight. φ Other active ingredients to be blended The skin external composition of the present invention can be combined with other useful effects, so that it can be combined with a chelating agent, an antioxidant, an anti-inflammatory agent, a moisturizing agent, a whitening agent, and a cell. One or a combination of two or more kinds of active ingredients such as an activator, such as a wrinkle-reducing agent, and the active ingredients can be used as a component for external skin composition in the field of pharmaceuticals, quasi-drugs, or cosmetics. There is no particular limitation on the use of the subject's and the future user, and any one of them may be appropriately selected. Among these components, a chelating agent or an antioxidant may be useful for further improving stability. It is important to impart an anti-inflammatory effect, -17-200812630 (14) or to activate skin cells, and it is important to maintain the skin state. Therefore, it is preferable from the viewpoint that the components are preferably For the inflammatory agent and the cell activator, for example, ethylenediaminetetraacetic acid (edetate), " ethylenediaminetetraacetate (sodium salt (sodium ethylenediaminetetraacetate: Japanese Pharmacopoeia, - EDTA-2Na, etc., potassium salt, etc., phytic acid, gluconic axid, polyphosphoric acid, metaphosphoric acid, etc. These are preferably ethylenediaminetetraacetic acid, B. Sodium diaminetetraacetate, potassium edetate, phytic acid hexaphosphate. These chelating agents may be used alone or in combination of two or more. In the case where the skin external composition of the present invention is combined with a chelating agent, the compounding ratio thereof The average amount of the composition for external use on the skin is usually 0.000 3 to 20% by weight, preferably 0.01 to 10% by weight, more preferably 0.05 to 5% by weight. The antioxidant may, for example, be butyl hydroxyanisole, dibutylhydroxytoluene, sodium hydrogen sulfite, erythorbic acid 0 and its salt, glutathione, glutathione. Oxidase, glutathione-S-transferase, catalase, superoxide dismutase, thioredoxirx, taurine, sulphur Sulfonic acid, hypotaurine, and the like. Preferred among these are butyl hydroxyanisole and dibutyl hydroxytoluene. These antioxidants may be used alone or in combination of two or more. In the case where the external composition for skin of the present invention is blended with a chelating agent, the compounding ratio thereof is not particularly limited, and the average total amount of the composition for external use on the skin is usually 0.00001 to 10% by weight, preferably 0.0001 - 18- 200812630 (15) ~ 5 wt%, more preferably o.ooi ~ 5 wt%. Anti-inflammatory agents, for example, indomethacin, methyl salicylate, urine

囊素（allantoin)，尿囊素泠一甘草亭（glycyrrhetin)， 尿囊素氯經基銘，甘草次酸（glycyrrhetinic acid)，甘 草次酸二鉀鹽，甘草次酸單銨，甘草酸（glyeyrrhetie acid)，甘草酸硬脂醯酯，甘草酸維生素B6(pyridoxine )，氧化鋅，莫（azulene)颯酸，癒創木莫（guai-azulene )颯酸，鹽酸維生素 B6，氯化溶菌酶（Lysozyme )，薄荷醇（menthol)，樟腦等。較佳爲尿囊素，甘草 次酸二鉀鹽，甘草次酸單銨，癒創木莫（azulene )楓酸 ，薄荷醇等。該等抗炎劑可使用1種或組合2種以上使用 。在本發明之皮膚外用組成物配合抗炎劑之情形，其配合 比率方面，並無特別限定，對皮膚外用組成物之平均總量 ，通常爲0.0003〜10重量％，較佳爲〇·〇1〜5重量％， 更佳爲〇·1〜1重量％。 保濕劑方面，可例舉例如丙氨酸，絲氨酸（serine) ，白胺酸，異白胺酸，賴胺酸’甘氨酸，脯胺酸（proline )，經基脯胺酸，天冬醯酸，精胺酸’茶胺酸（theanine )等之胺基酸及其衍生物；乙二醇，丙二醇，丨，3 一丁二 醇，甘油，二乙二醇，三乙二醇，四乙二醇，二丙二醇， 二甘油，聚乙二醇等之多價醇；乙二醇單甲基醚，乙二醇 單乙基醚，乙二醇單丙基醚，二乙二醇單甲基醚，二乙二 醇單乙基醚，二乙二醇單.丙基醚，二乙二醇單丁基醚’丙 二醇單乙基醚，丙二醇單丙基醚，二丙二醇單乙基醚，二 -19- 200812630 (16)Allantoin, allantoin glycyrrhetin, allantoin chloride, glycyrrhetinic acid, glycyrrhetinic acid dipotassium salt, glycyrrhetinic acid monoammonium, glycyrrhizic acid (glyeyrrhetie) Acid), stearic acid glycyrrhizinate, glycidoxine, B2 (pyridoxine), zinc oxide, azulene, guai-azulene, chloric acid, vitamin B6, chlorinated lysozyme (Lysozyme) ), menthol, camphor, etc. Preferred are allantoin, glycyrrhetinic acid dipotassium salt, glycyrrhetinic acid monoammonium, guaiac azulene maple acid, menthol and the like. These anti-inflammatory agents may be used alone or in combination of two or more. In the case where the external composition for skin of the present invention is combined with an anti-inflammatory agent, the compounding ratio thereof is not particularly limited, and the average total amount of the composition for external use on the skin is usually 0.0003 to 10% by weight, preferably 〇·〇1. 〜5% by weight, more preferably 11 to 1% by weight. As the humectant, for example, alanine, serine, leucine, isoleucine, lysine 'glycine, proline, prolinic acid, aspartic acid, Amino acid such as arginine 'theanine' and its derivatives; ethylene glycol, propylene glycol, hydrazine, 3 -butylene glycol, glycerin, diethylene glycol, triethylene glycol, tetraethylene glycol a polyvalent alcohol such as dipropylene glycol, diglycerin or polyethylene glycol; ethylene glycol monomethyl ether, ethylene glycol monoethyl ether, ethylene glycol monopropyl ether, diethylene glycol monomethyl ether, Diethylene glycol monoethyl ether, diethylene glycol monopropyl ether, diethylene glycol monobutyl ether 'propylene glycol monoethyl ether, propylene glycol monopropyl ether, dipropylene glycol monoethyl ether, two-19 - 200812630 (16)

丙二醇單丙基醚等之乙二醇醚；甘露糖醇，山梨糖醇，赤 蘚醇（erythritol )，木糖醇 （xylitol )，海藻糖（ trehalose )等之糖醇；卵磷脂，氫化卵磷脂等之磷脂質； 透明質酸（hyaluronic acid)鈉，乙醯基透明質酸鈉，肝 素類似物質，軟骨素（chondroitin )硫酸鈉等之黏多糖； 膠原，彈性素（elastin )，角蛋白（keratin )，甲殼質（ chitin )，幾丁聚糖，明膠，聚谷氨酸等之高分子化合物 ;乳酸鈉，吡咯啶酮羧酸鈉等之來自NMF (自然潤濕因 子 Natural moisture factor)成分；春黃菊花（kamille) 香精（essence)，蘆薈屬（aloe)香精，蘆薈（aloe vera )香精，金縷梅屬（hamamelis )香精，迷迭香（ rosemary)香精，百里香（thyme)香精，茶香精，紫蘇 香精等之植物萃取香精等。該等中較佳爲甘氨酸，甘油， 1，3 — 丁二醇，二丙二醇，二甘油，二乙二醇單乙基醚， 透明質酸鈉，乙醯基透明質酸鈉，吡咯啶酮羧酸鈉，聚谷 氨酸。該等保濕劑可使用1種或組合2種以上使用。在本 發明之皮膚外用組成物配合保濕劑之情形，其配合比率方 面，並無特別限定，但是對皮膚外用組成物之平均總量， 通常爲0.1〜10重量％，較佳爲0.5〜5重量％，更佳爲 0.5〜5重量％。 美白劑方面，可例舉例如氫醌，熊果苷（arbiitin )等 之醌類；羥乙酸，檸檬酸，蘋果酸，酒石酸，乳酸等之α -羥基酸；抗壞血酸，抗壞血酸四異棕櫚酸酯，抗壞血酸 硬脂酸酯（ascorbyl stearate )，抗壞血酸棕櫚酸酯，磷 -20- 200812630 (17)Glycol ether such as propylene glycol monopropyl ether; mannitol, sorbitol, erythritol, xylitol, trehalose, etc.; lecithin, hydrogenated lecithin Phospholipids; hyaluronic acid sodium, acetylated sodium hyaluronate, heparin-like substance, chondroitin sodium sulfate, etc.; collagen, elastin, keratin ) a polymer compound such as chitin, chitosan, gelatin or polyglutamic acid; sodium lactate, sodium pyrrolidonecarboxylate, etc. derived from NMF (Natural moisture factor); chamomile Flower (essile), aloe essence, aloe vera essence, hamamelis essence, rosemary essence, thyme essence, tea essence, basil Plant extracts such as flavors and the like. Preferred among these are glycine, glycerin, 1,3-butanediol, dipropylene glycol, diglycerin, diethylene glycol monoethyl ether, sodium hyaluronate, sodium acetylsulfate, pyrrolidone carboxylate Sodium, polyglutamic acid. These humectants may be used alone or in combination of two or more. In the case where the skin external composition of the present invention is combined with a moisturizing agent, the compounding ratio thereof is not particularly limited, but the average total amount of the skin external composition is usually 0.1 to 10% by weight, preferably 0.5 to 5 parts by weight. %, more preferably 0.5 to 5% by weight. The whitening agent may, for example, be an anthraquinone such as hydroquinone or arbiitin; an α-hydroxy acid such as glycolic acid, citric acid, malic acid, tartaric acid or lactic acid; ascorbic acid, ascorbyl tetraisopalmitate, Ascorbyl stearate, ascorbyl palmitate, phosphorus-20- 200812630 (17)

酸L-抗壞血酸鎂鹽，抗壞血酸葡糖苷等之維生素C或其 衍生物；鳶尾（i r i s ) ’杏仁（a 1 m ο n d )，蘆薈，銀杏（ ginkgo )，烏龍茶，薔薇果（rose hip)，黃等根（ Scutellaria root )，黃蓮（Coptis j aponica )，弟切草（ hypericum er ectum )，小對葉草(hypericum erectum )， 海藻，葛根（kudzu root)，春黃菊花（chamonile)，甘 草，二循子(cape jasmine )，苦参(sophor a root )，小 麥（wheat)，米，米胚芽（rise germ)，米糠（rice bran ) ’ 紫蘇，苟藥（Chinese peony )，川弯(Cnidium oficnale )，桑白皮（mulberry bark)，大豆（soybean) ，茶，欖仁樹屬（terminalia )，當歸（angelica acutiloba)，唐金盞花，金縷梅屬，紅花（safflower)， 牡丹皮（moutan bark)，薏孩芒（coix seed)，當歸， 復草(Japanese hackberry )，柿子(Diospyros kaki)， 丁子（syzygiumaromaticum)等之來自植物之成分，香精 及精油；胎盤素（placenta extract )，半胱氨酸（ cysteine)，霖花酸（ellagic acid)，曲酸（kojic acid) ，肌醇六磷酸，Rucinol，谷維醇（Oryzanol)等。該等中 較佳爲氫醌，熊果苷，乳酸，抗壞血酸，抗壞血酸四異棕 櫚酸酯，鳶尾草香精，欖仁樹屬（terminalia)香精，半 胱氨酸。該等美白劑可使用1種或2種以上。在本發明之 皮膚外用組成物配合美白劑之情形，其配合比率方面，並 無特別限定，而可舉對皮膚外用組成物之平均總量，通常 爲0.0003〜20重量％，較佳爲0.01〜10重量％，更佳爲 200812630 (18) 0.05〜5重量％。 細胞賦活劑方面，可例舉例如7 -胺基丁酸，ε -胺 基己酸等之胺基酸類；r -谷維醇，二苯醯基硫胺素，二 苯醯基硫胺素鹽酸鹽，硫胺素鹽酸鹽，硫胺素十六基鹽酸 ' 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，硫胺素賴氨酸鹽，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 Φ 酯，硫胺素二磷酸酯鹽酸鹽，硫胺素三磷酸酯，硫胺素三 磷酸酯單磷酸鹽等之維生素Bl類；核黃素，黃素（flavin )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 等之維生素B2類；鹽酸維生素B6 ( pyridoxine)，乙酸 維生素B6，鹽酸維生素B6醛，5’一磷酸維生素以醛，鹽 酸維生素B6胺等之維生素B6類泛酸（pantothenic acid) ，泛酸銘，泛酸基（panto the nyl )醇（泛酸醇），D -^ pantesan，D —雙泛醯硫乙胺（pantethine)，補酵素A， 泛酸基乙基醚等之泛酸類等。該等中較佳爲r 一胺基丁酸 ，ε -胺基己酸，泛酸類。該等細胞活化劑可使用1種或 組合2種以上使用。在本發明之皮膚外用組成物配合細胞 活化劑之情形，其配合比率方面，並無特別限定，而可舉 對皮膚外用組成物之平均總量，通常爲0.0 0 0 3〜1 0重量 %，較佳爲0.01〜5重量％。 除皺劑方面，可舉例如輔酶Q10，激動素（kinetin ) ，羥乙酸，膠原，透明質酸鈉，乙醯基透明質酸鈉，蘆薈 -22- 200812630 (19) 香精，海藻香精，七葉樹（marronnier)香精，迷迭香香 精，矢車草（cornflower )香精等。該等中較佳爲輔酶 Q10，激動素，透明質酸鈉，乙醯基透明質酸鈉，迷迭香 香精。該等除皺劑可使用1種或組合2種以上使用。在本 * 發明之皮膚外用組成物配合除皺劑之情形，其配合比率方 * 面，並無特別限定，而可舉對皮膚外用組成物之平均總量 ，通常爲0.1〜30重量％，較佳爲0.5〜25重量％，更佳 爲1〜20重量％。 爲製劑化而可配合之成分 在本發明之皮膚外用組成物，在不損及保存穩定性或 黏度等之品質，又在不損及本發明之效果之量的及質的範 圍內，可因應需要配合醫藥品，輕用藥或化粧品領域中一 般所使用之各種成分，例如基劑，界面活性劑，增黏劑， 保存劑，pH調整劑，穩定化劑，刺激輕減劑，防腐劑， φ 著色劑，分散劑，香料等。此外，該等成分可單獨1種， 或任意組合2種以上配合亦可。 基劑方面，具體言之，可例舉流動石臘，凝膠化烴， 地蠘（ozocerite)，純地鱲（ceresine)，凡士林，硬式 脂肪（hard fat )，微晶石鱲（microcrystalline )爆等之 烴；月桂酸，肉豆蔻酸，棕櫚酸，硬脂酸，三窬酸（ behenix acid)，異硬脂酸，油酸，亞油酸等之脂肪酸·， 三2—乙基己烷酸甘油酯（trioctanoin)等之三脂肪酸甘 油酯，月桂醇，鯨蠟醇，硬脂醯基醇，油基醇，異硬脂醯 -23- 200812630 (20) 基醇，2 -辛基十二烷醇，三窬醇，2 -己基癸醇等之高級 醇；高聚合甲基聚矽氧烷，二甲基聚矽氧烷，二甲基矽氧 烷•甲基（聚氧乙烯）矽氧烷•甲基（聚氧丙烯）矽氧烷 共聚物，二甲基矽氧烷•甲基（聚氧乙烯）矽氧烷共聚物 * ，二甲基矽氧烷•甲基（聚氧丙烯）矽氧烷共聚物，聚氧 - 乙烯·甲基聚矽氧烷共聚物，聚（氧乙烯•氧丙烯）•甲 基聚矽氧烷共聚物，二甲基矽氧烷·甲基十六基氧矽氧烷 ^ 共聚物，二甲基矽氧烷•甲基硬脂氧矽氧烷共聚物，丙烯 酸烷基共聚物甲基聚矽氧烷酯，交聯型甲基聚矽氧烷，交 聯型甲基苯基聚矽氧烷，交聯型聚醚改性聚矽氧，交聯型 烷基聚醚改性聚矽氧，交聯型烷基改性聚矽氧等之聚矽氧 ;乙二醇單乙酸鹽，乙二醇二乙酸鹽，三乙二醇二乙酸鹽 ，己二醇二乙酸鹽，2 —甲基一 2—丙烯一1，1 一二醇二乙 酸鹽等之乙二醇乙酸鹽；三乙二醇二戊酸酯，2,2,4 一三 甲基一1，3 -戊烷二醇單異丁酸酯（butyrate) ，2,2,4 一三 φ 甲基一 1，3-戊烷二醇二異丁酸酯等之乙二醇酯；乙二醇 二丙烯酸酯（acrylate )，二乙二醇二丙烯酸酯，丙二醇 單丙烯酸酯，2,2—二甲基一三甲二醇二丙烯酸酯，及1，3 一 丁二醇二丙烯酸酯等之乙二醇丙烯酸酯；乙二醇二硝酸 — 酯，二乙二醇二硝酸酯，三乙二醇二硝酸酯，丙二醇二硝 酸酯等之乙二醇二硝酸酯；2,2'- [1，4 一伸苯基二氧]二乙 醇，二噁烷，丁二醇己二酸聚酯等。該等中較佳爲流動石 臘，凡士林，鯨蟾醇，硬脂醯基醇，二甲基聚矽氧烷。該 等之基劑可使用1種或組合2種以上使用。 -24- 200812630 (21) 界面活性劑方面，具體言之，可例舉三梨聚糖單 脂酸酯，山梨聚糖單月桂酸酯，山梨聚糖單棕櫚酸酯 梨聚糖單硬脂酸酯，五- 2-乙基己基酸二甘油山梨 酯，四一 2—乙基己基酸二甘油山梨聚糖酯等之山梨 * 脂肪酸酯類；單硬脂酸甘油酯，單硬脂酸甘油蘋果酸 ' 之甘油脂肪酸類；單異硬脂酸聚甘油酯，二異硬脂酸 油酯等之聚甘油脂肪酸類；單硬脂酸丙二醇酯等之丙 φ 脂肪酸酯類；聚氧乙烯硬化蓖麻油40，聚氧乙烯硬 麻油5 0，聚氧乙烯硬化蓖麻油6 0，聚氧乙烯硬化蓖 8〇等之硬化蓖麻油衍生物；單月桂酸聚氧乙烯（20 梨聚糖酯（聚三梨酸酯20)，單硬脂酸聚氧乙烯（ 山梨聚糖酯（聚三梨酸酯60)，單油酸聚氧乙烯（ 山梨聚糖酯（聚三梨酸酯80)等之聚氧乙烯山梨聚 肪酸酯類；聚氧乙烯單椰子油脂肪酸甘油酯，甘油烷 ，烷基配糖體，聚氧乙烯十六醚，硬脂醯基胺，油基 φ 。該等中較佳爲山梨聚糖單硬脂酸酯，聚氧乙烯硬化 油50，聚氧乙烯硬化蓖麻油60，聚三梨酸酯60。該 面活性劑可使用1種或組合2種以上使用。 增黏劑方面，例如瓜爾豆膠（guar gum )，槐樹 (locust bean gum )，角叉菜膠(carrageenan )，咕 xanthane gum)，葡聚糖（dextran)，甲基纖維素， 纖維素，羧甲基纖維素，羥乙基纖維素，羥乙基纖維 羥丙基纖維素，羥丙基甲基纖維素，褐藻酸（alginic )鈉，褐藻酸丙二醇酯，聚乙烯醇，聚乙烯吡咯啶酮 異硬 ，山 聚糖 聚糖 酯等 聚甘 二醇 化蓖 麻油 )山 20 ) 20 ) 糖脂 基醚 胺等 蓖麻 等界 豆膠 噸（ 乙基 素， acid ，聚 -25- 200812630 (22) 乙烯甲基醚，羧乙烯聚合物，丙烯酸甲基丙烯酸烷 物，聚丙烯酸鈉，聚乙二醇，膨潤土（ bentonite ) 脂肪酸酯，果膠等。該等中較佳爲聚乙烯醇，聚乙 啶酮，羧乙烯聚合物，丙烯酸甲基丙烯酸烷基共聚 等增黏劑可使用1種或組合2種以上使用。 保存劑方面，可例舉例如苯甲酸，苯甲酸鈉， 酸，脫氫乙酸鈉，對羥基苯甲酸異丁酯，對羥基苯 丙酯，對羥基苯甲酸丁酯，對羥基苯甲酸乙酯，對 甲酸丙酯，對羥基苯甲酸苄酯，對羥基苯甲酸甲酯 基乙醇酯，1，2 -己烷二醇等。該等保存劑可使用 組合2種以上使用。 pH調整劑方面，可例舉例如鹽酸，硫酸，磷 磷酸，硼酸等之無機酸；乳酸，乙酸，檸檬酸，酒 蘋果酸，琥珀酸，琥珀酸鈉，草酸，葡糖酸，反丁 ，丙酸，乙酸，天冬氨酸，ε ( episilon ) —胺基 谷氨酸，胺基乙基礪酸等之有機酸；葡萄酸內酯； :碳酸氫鈉，碳酸鈉，氫氧化鉀，氫氧化鈉，氫氧 氫氧化鎂等之無機鹼；單乙醇胺，三乙醇胺，二異 ，三異丙醇胺，賴氨酸等之有機鹼等。該等pH調 使用1種或組合2種以上使用。 該等成分之配合比率，在以不妨礙本發明之效 度，則無特別限定，較佳爲以藥事法上可容許之上 量爲限度來適宜選擇使用。具體言之，對皮膚外用 之平均總星’各成分通常爲0 · 0 0 1〜2 0重量％， 基共聚 ，糊精 烯吡咯 物。該 脫氫乙 甲酸異 羥基苯 ，苯氧 1種或 酸，聚 石酸， 烯二酸 己酸， 乙酸銨 化鈣， 丙醇胺 整劑可 果爲限 限配合 組成物 較佳爲 -26- 200812630 (23) 0.001〜10重量％，更佳爲0.001〜5重量％之範圍 應該組成物之形態或用途等而適宜設定。 此外，本發明之皮膚外用組成物，係使前述配 含有設定之量，其以外之剩餘部分則含水。 皮膚外用組成物之形態 本發明之皮膚外用組成物可調製成各腫形態。 本發明之皮膚外用組成物之形態方面，可舉軟膏狀 (含有油狀，洗劑（lotion )狀，乳液狀，氣溶膠 凝膠狀（含液晶，微晶乳液，核糖核蛋白體），奶 。該等中以軟膏狀，凝膠狀（含液晶，微晶乳液， 蛋白體），或奶油狀之形態爲佳，尤以奶油狀形態 一般在使脲含1 〇重量％以上之高濃度的奶油狀之 ，可表現出不損及穩定性之傾向爲自明。相對於此 本發明之皮膚外用組成物，以奶油狀之形態含有1 %以上之脲之同時，可有效地獲得優異的使用感， 及保濕性。尤其是，本發明之皮膚外用組成物在採 狀形態之情形，以含有後述特定成分之組合者爲恰 又，爲使使用感（黏黏地，伸展，潮濕感等） 好起見，本發明之皮膚外用組成物，以水中油型之 爲所望。 皮膚外用組成物之用途 本發明之皮膚外用組成物，因係使脲以高濃度 ，可因 合成分 例如， ，液狀 狀）， 油狀等 核糖核 最佳。 組成物 ，根據 0重量 穩定性 用奶油 當。 更加良 乳液型 含有， -27- 200812630 (24) 故基於脲可發揮有用藥理作用或生理作用，故可作爲醫藥 組成物或化粧料組成物等使用。 具體言之，本發明之皮膚外用組成物，對手指之乾燥 ，胳臂•膝蓋•腳後跟•腳踝等角化症之治療用；老人等 - 乾皮症之治療用；乾燥皮膚治療用之角質軟化用；美白用 - 等醫藥組成物爲有用。又，本發明之皮膚外用組成物’對 手乾燥，皮膚乾燥，唇乾燥，日曬後之皮膚發燙，皺紋· 0 精神不振等可予以預防至改善之皮膚外用組成物；可調理 皮膚，調理唇之細皺紋之，可使皮膚•唇保持於健康狀態 ，賦予皮膚•唇濕潤之，以保護皮膚•唇等之目的而使用 之皮膚外用組成物；皮膚之乾燥，凍傷，皮膚凍裂，皮膚 皸裂，皮膚生班疹等之作爲預防用皮膚外用組成物亦爲有 用。再者，本發明之皮膚外用組成物，作爲保濕用，角質 軟化用等化粧料組成物亦爲有用。 尤其是，本發明之皮膚外用組成物，與1〇〜25重量 φ %之脲一起，含有松香油及/或其衍生物，藉此可使脲所 致保濕效果相乘地提高而顯示優異角質軟化作用。因此， 本發明之皮膚外用組成物，作爲角質軟化用或保濕用之皮 膚外用組成物，尤其是角質軟化用或保濕用之化粧料組成 物爲有用。 皮膚外用組成物之製造方法及使用方法 本發明之皮膚外用組成物之製造方法，並無特別限制 ，可依照常法來調製成所望之形態。具體言之，本發明之 28- 200812630 (25) 皮膚外用組成物，可適宜選擇前述之配合成分，將各自設 定之量添加混合於水（較佳爲精製水），而可調製成所望 之形態。 又，本發明之皮膚外用組成物，可以對皮膚之塗佈或 — 噴霧而可適用。對皮膚之適用量或用法並無特別限制，可 、 因應該組成物之形態或用途等，而以一日1次至數次，適 量適用於皮膚等之外皮。 奶油狀皮膚外用組成物之恰當實施態樣 本發明之皮膚外用組成物，即使爲奶油狀之形態，亦 可有效地獲得優異使用感，穩定性及保濕性。尤其是，本 發明之皮膚外用組成物在爲奶油狀之情形，基劑係組合高 級醇，烴，及聚矽氧予以使用，藉此可具備格外優異之使 用感，穩定性，保濕性及安全性。 在此，高級醇方面，可使用以該「爲製劑化而可配合 φ 之成分」之欄作爲基劑所使用之高級醇所例舉之物，較佳 爲硬脂醯基醇及鯨蠟醇。該等高級醇可單獨使用1種，亦 可組合2種以上使用。最佳爲硬脂醯醇及鯨蠟醇之倂用。 在倂用硬脂醯醇與鯨躐醇之情形，就各自之比率，並無特 ^ 別限定，而例如相對於硬脂醯醇1 00重量份，鯨鱲醇以1 〜1 0000重量份，較佳爲10〜1 000重量份，更佳爲50〜 5 00重量份之比率可予提高。 該奶油狀皮膚外用組成物中，在高級醇之配合比率方 面，並無特別限制，對皮膚外用組成物之平均總量，以高 -29- 200812630 (26) 級醇總量之〇·1〜30重量％，較佳爲0.5〜15重量％，更 佳爲1〜1 0重量％。 又，烴方面，可使用以該「爲製劑化而可配合之成分 」之欄作爲基劑所使用之烴而列舉者。烴可單獨使用1種 ' 亦可組合2種以上使用。烴方面最佳爲凡士林。 - 該奶油狀之皮膚外用組成物中，烴之配合比率方面， 並無特別限制，對皮膚外用組成物之平均總量，烴以總量 _ 之0.01〜50重量％，較佳爲0.1〜40重量％，更佳爲1〜 20重量％。 又，聚矽氧方面，可使用以該「爲製劑化而可配合之 成分」之欄作爲基劑所使用之聚矽氧所例舉者。聚矽氧可 單獨使用1種，亦可組合2種以上使用。聚矽氧方面最佳 爲二甲基聚矽氧烷。 該奶油狀之皮膚外用組成物中，聚矽氧之配合比率方 面，並無特別限制，對皮膚外用組成物之平均總量，聚矽 Φ 氧以總量之〇·〇〇1〜10重量％，較佳爲0.01〜5重量％， 更佳爲0.1〜3重量％。 該奶油狀之皮膚外用組成物方面，就從使用感，穩定 性及保濕性之觀點而言，特別恰當的具體態樣方面，作爲 ' 基劑可例示具有以下組成者： 對皮膚外用組成物之平均總量，含有高級醇0.5〜1 5 重量％，烴〇·1〜40重量％，及聚矽氧0.01〜5重量％者 更佳爲對皮膚外用組成物之平均總量，含有硬脂醯基 -30- 9 200812630 (27) 醇1〜10重量％，館鱲醇1〜10重量％，凡士林1〜20重 量％，及二甲基聚矽氧烷0.1〜3重量％者。 II·脲之析出抑制方法 進而，本發明係提供一種，在含有1 0〜2 5重量％之 脲之皮膚外用組成物中可抑制脲之析出之方法。該方法係 藉由使（a)脲1〇〜25重量％，及（b)選自松香油及其 衍生物所成群之至少1種在皮膚外用組成物中共存而予以 實施。就關於在該方法中所使用之脲，松香油，松香油衍 生物，其他配合於皮膚外用組成物之成分，該等之配合比 率，皮膚外用組成物之形態或用途等，則與該「L皮膚 外用組成物」之欄記載者相同。 111 ·松香油及/或其衍生物之穩定化方法 再者，本發明亦提供一種，根據後述之試驗例3之結 果，在（b )含有選自松香油及其衍生物所成群之至少i 種的皮膚外用組成物中，使該（b )成分穩定化之方法。 該方法，係使（a)脲10〜25重量％，及（b)選自松香 油及其衍生物所成群之至少1種在皮膚外用組成物中共存 而可實施。該方法中所使用之脲，松香油，松香油衍生物 ，其他配合於皮膚外用組成物之成分，該等配合比率，皮 膚外用組成物之形態或用途等，則與該「I·皮膚外用組 成物」之欄所記載者相同。 200812630 (28) 【實施方式】 [實施例] 以下試例舉實施例具體說明本發明，但本發明並非對 該等之實施例作任何本發明範圍之限定。此外，配合量在 ' 無特別以單位記載時，則均表示重量％。 試驗例1使用感試驗 ^ 依照表1所示處方，將精製水與脲加在一起在70°c經 加溫溶解之水相，將其他全成分在70 °C經加溫溶解之油相 予以一邊攪拌一邊混合，冷卻至室溫，來調製奶油狀之皮 膚外用組成物（實施例1 - 6及比較例1 一 2 )。就各皮膚 外用組成物，對3 0歲女性5名，以製劑塗佈時之使用感 基於下述基準予以評價。 <評價基準> φ 5點：皮膚表面光滑，有濕潤般的光潤觸感 4點：皮膚表面光滑，有乾燥的觸感（dry touch )， 3點：皮膚表面雖光滑，但特別對觸感無感到變化 2點：皮膚表面稍有不光滑觸感 1點：皮膚表面有不光滑觸感 計算上述評價結果之平均點，依照以下判定基準，就 使用感加以判定。 <判定基準> -32- 200812630 (29) ◎ : 4.5以上 〇：3.5 〜4.4 △ : 2 · 5 〜3 · 4 X : 2.4以下 結果合倂於表1表示。比較例1因脲爲1 〇 %故與比 較例2比較，不光滑之程度低，然而在實施例1 一 3中可 I 觀察到使用感之大幅改善。一方面，在比較例2所有人均 • 、 — 、、 回答「不光滑」，而在貫施例4不光滑則被相當地減低， 而在放入乙酸生育酚之實施例5及6，進而改善了使用感 〇 由以上結果可知，本發明之皮膚外用組成物，因使用 感優異，可抑制脲等之析出，故有效成分之藥理效果可充 分地得到爲自明。Acid L-ascorbate magnesium, ascorbyl glucoside, etc., vitamin C or its derivative; iris (als) 'almond (a 1 m ο nd ), aloe vera, ginkgo (ginkgo), oolong tea, rose hip, yellow Scutellaria root, Coptis j aponica, hypericum er ectum, hypericum erectum, seaweed, kudzu root, chamonile, licorice, two-circle (cape jasmine), sophor a root, wheat, rice, rose germ, rice bran, Chinese peony, Cnidium oficnale, Mulberry bark, soybean, tea, terminalia, angelica acutiloba, tangs, hamame, safflower, moutan bark, 薏Coix seed, angelica, Japanese hackberry, Diospyros kaki, syzygiumaromaticum, plant-derived ingredients, essences and essential oils; placenta extract, cysteine Oster (antine), ellagic acid, kojic acid, phytic acid, Rucinol, Oryzanol, and the like. Preferred among these are hydroquinone, arbutin, lactic acid, ascorbic acid, ascorbyl tetraisopalmitate, sage extract, terminalia flavor, cysteine. These whitening agents can be used alone or in combination of two or more. In the case where the external composition for skin of the present invention is blended with a whitening agent, the compounding ratio thereof is not particularly limited, and the average total amount of the composition for external use on the skin is usually 0.0003 to 20% by weight, preferably 0.01%. 10% by weight, more preferably 200812630 (18) 0.05~5 wt%. The cell activator may, for example, be an amino acid such as 7-aminobutyric acid or ε-aminohexanoic acid; r-glutenol, diphenylmercapto thiamine, diphenylsulfonyl thiamine salt Acid salt, thiamine hydrochloride, thiamine hexadecyl hydrochloride' salt, thiamine thiocyanate, thiamine laurate hydrochloride, thiamine nitrate - thiamine monophosphate, Thiamine lysine salt, thiamine triphosphate, thiamine monophosphate phosphate, thiamine monophosphate, thiamine bisphosphate thimate, thiamine diphosphate hydrochloride, sulfur Amine triphosphate, thiamine triphosphate monophosphate, etc. Vitamin B1; riboflavin, flavin mononucleotide, flavin adenine dinucleotide, riboflavin butyrate, nucleus Flavin tetrabutyrate, riboflavin 5'-phosphate sodium, riboflavin tetranicotinate and other vitamin B2; hydrochloric acid vitamin B6 (pyridoxine), acetic acid vitamin B6, hydrochloric acid vitamin B6 aldehyde, 5' one Phosphate vitamins are aldehydes, vitamin B6 amines, etc. Vitamin B6 pantothenic acid, pantothenic acid, panto the nyl alcohol (pantothenic acid) ), D - ^ pantesan, D - bis acyl Pan pantethine (pantethine), complement enzyme A, pantothenic acid, pantothenic acid, ethyl ether, etc. and the like. Preferred among these are r-aminobutyric acid, ε-aminohexanoic acid, and pantothenic acid. These cell activators may be used alone or in combination of two or more. In the case where the composition for external use of the skin of the present invention is combined with a cell activator, the compounding ratio thereof is not particularly limited, and the average total amount of the composition for external use on the skin may be exemplified by 0.00 0 3 to 10% by weight. It is preferably 0.01 to 5% by weight. For the purpose of the wrinkle remover, for example, coenzyme Q10, kinetin, glycolic acid, collagen, sodium hyaluronate, sodium acetylate hyaluronate, aloe-22-200812630 (19) essence, seaweed essence, seven leaves Marronnier flavor, rosemary flavor, cornflower flavor, etc. Preferred among these are coenzyme Q10, kinetin, sodium hyaluronate, sodium acetyl sulfonate, and rosemary flavor. These wrinkle-removing agents can be used singly or in combination of two or more. In the case where the skin external composition of the present invention is blended with a wrinkle-removing agent, the blending ratio thereof is not particularly limited, and the average total amount of the external composition for skin may be exemplified by 0.1 to 30% by weight. It is preferably 0.5 to 25% by weight, more preferably 1 to 20% by weight. The composition for external use of the present invention can be reacted in the skin external composition of the present invention without impairing the quality of storage stability or viscosity, and in the range of the quality which does not impair the effects of the present invention. It is necessary to mix various ingredients commonly used in the fields of pharmaceuticals, light medicines or cosmetics, such as base agents, surfactants, tackifiers, preservatives, pH adjusters, stabilizers, stimulating depressants, preservatives, φ Colorants, dispersants, perfumes, etc. Further, these components may be used alone or in combination of two or more. In terms of a base, specifically, a flowing paraffin, a gelled hydrocarbon, an ozocerite, a pure ceresine, a vaseline, a hard fat, and a microcrystalline explosion may be exemplified. Hydrocarbons such as lauric acid, myristic acid, palmitic acid, stearic acid, behenix acid, isostearic acid, oleic acid, linoleic acid, etc., tris-2-ethylhexane acid Triglyceride (trioctanoin) and other fatty acid glycerides, lauryl alcohol, cetyl alcohol, stearyl alcohol, oleyl alcohol, isostearyl 醯-23- 200812630 (20) base alcohol, 2-octyldodecane a higher alcohol such as an alcohol, a triterpene alcohol or a 2-hexyl decyl alcohol; a highly polymerized methyl polyoxyalkylene, a dimethyl polyoxane, a dimethyl methoxy alkane, a methyl (polyoxyethylene) decane • Methyl (polyoxypropylene) alkane copolymer, dimethyl methoxy oxane • methyl (polyoxyethylene) decane copolymer *, dimethyl methoxy alkane • methyl (polyoxypropylene) 矽Oxyalkane copolymer, polyoxy-ethylene-methyl polyoxyalkylene copolymer, poly(oxyethylene/oxypropylene)•methyl polyoxyalkylene copolymer, dimethylhydrazine Alkylmethylhexadecane oxyalkylene copolymer, dimethyl methoxyalkane, methyl stearyl oxyalkylene copolymer, alkyl acrylate copolymer, polyoxyalkyl methacrylate, crosslinked type A Polyoxyalkylene oxide, crosslinked methylphenyl polyoxyalkylene, crosslinked polyether modified polyfluorene oxide, crosslinked alkyl polyether modified polyfluorene oxide, crosslinked alkyl modified poly Polyoxyl oxide such as helium oxygen; ethylene glycol monoacetate, ethylene glycol diacetate, triethylene glycol diacetate, hexanediol diacetate, 2-methyl-2-propene-1, 1 Ethylene glycol acetate such as diol diacetate; triethylene glycol divalerate, 2,2,4-trimethyl-1,3-pentanediol monoisobutyrate (butyrate), 2 , 2,4, 1,3-methyl-1,3-pentanediol diisobutyrate, etc.; ethylene glycol diacrylate (acrylate), diethylene glycol diacrylate, propylene glycol Acrylate, 2,2-dimethyl-trimethyl glycol diacrylate, and ethylene glycol acrylate such as 1,3-butanediol diacrylate; ethylene glycol dinitrate-ester, diethylene glycol Dinitrate, triethylene glycol dinitrate Nitrate esters of propylene glycol ethylene glycol dinitrate and the like; 2,2 [1,4 stretched phenylenedioxy] diethanol, dioxane, glycol adipate polyesters. Preferred among these are flowing paraffin, petrolatum, whale sterol, stearyl alcohol, dimethyl polyoxyalkylene. These base materials can be used alone or in combination of two or more. -24- 200812630 (21) In terms of the surfactant, specifically, triseninan monoglyceride, sorbitan monolaurate, sorbitan monopalmitate plycan monostearate , bis-ethylhexyl acid diglyceride sorbate, tetram 2-ethylhexyl glycerol sorbitan ester, etc. Yamanashi * fatty acid esters; glyceryl monostearate, monostearic acid glyceryl malate 'glycerol fatty acids; polyglycerol monoisostearate, polyglycerol fatty acids such as diisostearic acid ester; propylene φ fatty acid esters such as propylene glycol monostearate; polyoxyethylene hardened castor oil 40 , polyoxyethylene hard sesame oil 50, polyoxyethylene hardened castor oil 60, polyoxyethylene hardened 蓖8〇 and other hardened castor oil derivatives; monolauric acid polyoxyethylene (20 lyl ester (polytritic acid ester) 20) Polyoxyethylene sorbic acid polyoxyethylene (sorbitan ester (polytritic acid 60), polyoleic acid polyoxyethylene (sorbitan ester (polytritic acid 80)) Ester; polyoxyethylene single coconut oil fatty acid glyceride, glycerol, alkyl glycoside, polyoxyethylene Hexadecane, stearylamine, oil base φ. Preferred among these are sorbitan monostearate, polyoxyethylene hardened oil 50, polyoxyethylene hardened castor oil 60, and polytritic acid ester 60. The surfactant may be used alone or in combination of two or more. Examples of the tackifier include guar gum, locust bean gum, carrageenan, and xanthane gum. , dextran, methyl cellulose, cellulose, carboxymethyl cellulose, hydroxyethyl cellulose, hydroxyethyl cellulose hydroxypropyl cellulose, hydroxypropyl methyl cellulose, alginic acid (alginic) Sodium, propylene glycol alginate, polyvinyl alcohol, polyvinylpyrrolidone iso-hard, polyglycolated castor oil such as glycan ester) Mountain 20) 20) Glycosyl etheramine and other ramie Gum (ethyl acetate, acid, poly-25-200812630 (22) vinyl methyl ether, carboxyvinyl polymer, acrylic acid alkyl methacrylate, sodium polyacrylate, polyethylene glycol, bentonite fatty acid ester , pectin, etc. Among these, polyvinyl alcohol, polyethyl ketone, carboxyvinyl polymerization is preferred. The tackifier may be used alone or in combination of two or more. Examples of the preservative include benzoic acid, sodium benzoate, acid, sodium dehydroacetate, and p-hydroxybenzoic acid. Butyl ester, p-hydroxyphenylpropyl ester, butyl p-hydroxybenzoate, ethyl p-hydroxybenzoate, p-propyl formate, benzyl p-hydroxybenzoate, methyl p-hydroxybenzoate, 1,2 - Alkanediol, etc. These two preservatives can be used in combination of two or more. Examples of the pH adjuster include inorganic acids such as hydrochloric acid, sulfuric acid, phosphoric acid, and boric acid; lactic acid, acetic acid, citric acid, and malic acid; Succinic acid, sodium succinate, oxalic acid, gluconic acid, trans-butyl, propionic acid, acetic acid, aspartic acid, ε ( episilon ) - amino acid glutamic acid, amino acid ethyl phthalic acid, etc.; Lactone; sodium bicarbonate, sodium carbonate, potassium hydroxide, sodium hydroxide, magnesium hydroxide, etc.; organic base of monoethanolamine, triethanolamine, diiso, triisopropanolamine, lysine, etc. Alkali, etc. These pH adjustments are used singly or in combination of two or more. The compounding ratio of the components is not particularly limited as long as the effectiveness of the present invention is not impaired, and it is preferred to use it as a limit in the pharmaceutical method. Specifically, the average total star of the skin for external use is usually 0. 0 0 1 to 2 0% by weight, based on copolymerization, dextrin enepyrrole. The dehydroacetic acid isohydroxybenzene, phenoxy 1 or acid, polyamic acid, enedioic acid caproic acid, calcium acetate ammonium chloride, propanolamine bulking agent can be limited to the composition of the composition is preferably -26- 200812630 (23) The range of 0.001 to 10% by weight, more preferably 0.001 to 5% by weight, is appropriately set depending on the form, use, and the like of the composition. Further, the external composition for skin of the present invention contains the above-mentioned content in a predetermined amount, and the remainder other than the water contains water. Form of Skin External Composition The skin external composition of the present invention can be adjusted to form various swelling forms. The form of the external composition for skin of the present invention may be in the form of an ointment (containing an oil, a lotion, an emulsion, an aerosol gel (containing a liquid crystal, a microcrystalline emulsion, a ribonucleoprotein), and milk. Preferably, the form is in the form of an ointment, a gel (containing a liquid crystal, a microcrystalline emulsion, a protein body), or a creamy form, and in particular, a creamy form generally has a high concentration of more than 1% by weight of urea. In the creamy form, the external composition for skin of the present invention can effectively obtain an excellent feeling of use while containing 1% or more of urea in the form of a cream. In particular, the skin external composition of the present invention is in the form of a picking form, and is preferably a combination of specific components described later, in order to make the feeling of use (sticky, stretched, moist, etc.) good. In view of the above, the external composition for skin of the present invention is expected to be in the form of an oil in water. The use of the external composition for skin of the present invention, because of the high concentration of urea, may be due to a synthetic component, for example, a liquid), Oil and other ribonucleoprotein best. Composition, according to 0 weight stability with cream. More excellent Emulsion type Contains, -27- 200812630 (24) Therefore, urea can exert useful pharmacological or physiological effects, so it can be used as a pharmaceutical composition or a cosmetic composition. Specifically, the external composition for skin of the present invention is used for the treatment of dryness of the fingers, arm, knee, heel, ankle and other keratosis; elderly, etc. - treatment of dry skin disease; keratin softening for dry skin treatment Whitening - and other pharmaceutical compositions are useful. Further, the external composition for skin of the present invention 'adults dry, dry skin, dry lips, hot skin after sun exposure, wrinkles · 0 lack of energy, etc. can be prevented to improve the external composition of the skin; adjust the skin, adjust the lips The fine wrinkles can keep the skin and lips in a healthy state, and give the skin and lips a moist, external composition for the purpose of protecting the skin, lips, etc.; dry skin, frostbite, skin cracking, skin splitting It is also useful as a skin external composition for prevention, such as skin rash. Further, the skin external composition of the present invention is also useful as a cosmetic composition such as moisturizing and keratin softening. In particular, the skin external composition of the present invention contains rosin oil and/or a derivative thereof together with 1 to 25 parts by weight of urea, whereby the moisturizing effect by urea can be multiplied to exhibit excellent keratin. Softening effect. Therefore, the skin external composition of the present invention is useful as a skin external composition for keratin softening or moisturization, particularly a cosmetic composition for keratin softening or moisturizing. The method for producing the external composition for skin and the method for using the same The method for producing the external composition for skin of the present invention is not particularly limited, and can be prepared in a desired form according to a usual method. Specifically, in the present invention, 28-200812630 (25) The external composition for skin can be appropriately selected from the above-mentioned components, and the amount of each of them is added and mixed with water (preferably, purified water), and can be adjusted into a desired form. . Further, the skin external composition of the present invention can be applied to the application or spray of the skin. The amount or usage of the skin is not particularly limited, and may be applied to the skin or the like in an appropriate amount depending on the form or use of the composition, once or several times a day. Appropriate embodiment of the external composition for creamy skin The composition for external use of the skin of the present invention can effectively obtain excellent feeling of use, stability and moisture retention even in the form of a creamy form. In particular, when the composition for external use on skin of the present invention is in the form of a cream, the base is used in combination with a higher alcohol, a hydrocarbon, and a polyoxyxene, thereby providing an excellent use feeling, stability, moisture retention and safety. Sex. Here, as the higher alcohol, those exemplified as the higher alcohol used as the base in the column of "the component which can be formulated into φ can be formulated" can be used, and preferably stearyl alcohol and cetyl alcohol. . These higher alcohols may be used alone or in combination of two or more. The best use is for stearol and cetyl alcohol. In the case of using stearyl alcohol and whale sterol, the respective ratios are not particularly limited, and for example, whalenol is 1 to 1,000,000 parts by weight relative to 100 parts by weight of stearol. The ratio of preferably from 10 to 1 000 parts by weight, more preferably from 50 to 50,000 parts by weight, can be increased. The creamy skin external composition is not particularly limited in terms of the blending ratio of the higher alcohol, and the average total amount of the external composition for the skin is 高·1 of the total amount of the alcohol of the high -29-200812630 (26) grade. 30% by weight, preferably 0.5 to 15% by weight, more preferably 1 to 10% by weight. Further, as the hydrocarbon, those which are used as the base agent in the column of "the component which can be formulated for formulation" can be used. One type of hydrocarbon may be used alone or two or more types may be used in combination. The best in terms of hydrocarbons is Vaseline. - the creamy skin external composition is not particularly limited in terms of the compounding ratio of the hydrocarbon, and the average amount of the external composition for skin is 0.01 to 50% by weight, preferably 0.1 to 40% by weight of the total amount of the hydrocarbon. The weight % is more preferably 1 to 20% by weight. Further, in the case of polyoxymethylene, those which are used as a base for the "component which can be formulated as a formulation" can be used. The polyoxygen oxide may be used singly or in combination of two or more. The best in polyoxymethylene is dimethyl polyoxane. The creamy skin external composition is not particularly limited in terms of the compounding ratio of the polyoxo, and the average total amount of the external composition for the skin is 1 to 10% by weight based on the total amount of the 矽 Φ oxygen. It is preferably 0.01 to 5% by weight, more preferably 0.1 to 3% by weight. The creamy skin external composition is particularly suitable in terms of the feeling of use, stability, and moisture retention, and can be exemplified as a 'base agent' having the following composition: The average total amount, containing 0.5 to 15% by weight of the higher alcohol, 1 to 40% by weight of the hydrocarbon, and 0.01 to 5% by weight of the polyoxyl oxide, more preferably the average total amount of the external composition for the skin, containing stearin Base-30- 9 200812630 (27) 1 to 10% by weight of alcohol, 1 to 10% by weight of sterol, 1 to 20% by weight of petrolatum, and 0.1 to 3% by weight of dimethylpolysiloxane. Further, the present invention provides a method for suppressing precipitation of urea in a skin external composition containing 10 to 25 % by weight of urea. This method is carried out by coexisting at least one selected from the group consisting of (a) urea 1 to 25% by weight, and (b) at least one selected from the group consisting of rosin oil and derivatives thereof. With regard to the urea, the rosin oil, the rosin oil derivative, the other components blended with the external composition for skin, the blending ratio, the form or use of the external composition for skin, and the like, The column for the external composition of skin is the same as that described in the column. 111. Method for Stabilizing Rosin Oil and/or Its Derivatives Further, the present invention provides a method according to Test Example 3 described later, wherein (b) contains at least a group selected from the group consisting of rosin oil and derivatives thereof A method for stabilizing the component (b) in the skin external composition of the invention. This method can be carried out by coexisting at least one selected from the group consisting of (a) urea 10 to 25% by weight, and (b) at least one selected from the group consisting of rosin oil and its derivatives. The urea, the rosin oil, the rosin oil derivative, the other components blended with the external composition for skin, the blending ratio, the form or use of the external composition for skin, and the like, and the external composition of the skin. The same is true in the column of "Materials". [Embodiment] [Embodiment] The following examples are intended to illustrate the invention, but the invention is not intended to limit the scope of the invention. In addition, the blending amount means % by weight when it is not specified in the unit. Test Example 1 Using the sensation test ^ According to the prescription shown in Table 1, the purified water and urea were added together at 70 ° C to dissolve the aqueous phase, and the other components were dissolved at 70 ° C to dissolve the oil phase. The mixture was stirred while stirring, and cooled to room temperature to prepare a cream-like skin external composition (Examples 1-6 and Comparative Examples 1 and 2). For each of the external compositions for skin, five of the 30-year-old women were evaluated based on the following criteria based on the use of the preparation. <Evaluation Criteria> φ 5 points: The skin surface is smooth and has a moist luster. 4 points: The skin surface is smooth and has a dry touch (dry touch). 3 points: Although the skin surface is smooth, it is particularly touching. No change in feeling 2 points: slight unevenness on the surface of the skin 1 point: unevenness on the surface of the skin The average point of the above evaluation results was calculated according to the following criteria. <Criteria for Judging> -32 - 200812630 (29) ◎ : 4.5 or more 〇: 3.5 to 4.4 △ : 2 · 5 〜 3 · 4 X : 2.4 or less The results are collectively shown in Table 1. In Comparative Example 1, since the amount of urea was 1 〇%, the degree of unevenness was low as compared with Comparative Example 2. However, in Examples 1 to 3, a large improvement in the feeling of use was observed. On the one hand, in Comparative Example 2, all people • , , , , answered “not smooth”, while in Example 4, the smoothness was considerably reduced, and in Examples 5 and 6 of tocopherol acetate, the improvement was further improved. From the above results, it is understood that the external composition for skin of the present invention is excellent in the feeling of use and can suppress the precipitation of urea or the like, so that the pharmacological effect of the active ingredient can be sufficiently obtained.

-33 - 200812630 (30) [表1]-33 - 200812630 (30) [Table 1]

g/l〇〇g 實施 實施 實施 比較 實施 實施 實施 比較 例1 例2 例3 例1 例4 例5 例6 例2 脲 10 10 10 10 20 20 20 20 棕櫚酸松香油*1 0.5 0.5 0.5 0.5 0.5 0.5 乙酸生育酚 麵 0.5 2 0.5 2 硬脂醯基醇 3 3 3 3 3 3 3 3 鯨蠟醇 3 3 3 3 3 3 3 3 聚二梨酸酯60 2 2 2 2 2 2 2 2 白色凡士林 1 1 1 1 1 1 1 1 聚氧化乙烯硬化蓖麻油50 0.8 0.8 0.8 0.8 0.8 0.8 0.8 0.8 單硬脂酸二梨聚糖 0.8 0.8 0.8 0.8 0.8 0.8 0.8 0.8 一甲基聚矽氧烷 0.5 0.5 0.5 0.5 0.5 0.5 0.5 0.5 精製水 適量 —適量 適量 適量 適量 i商量 適量 適暈 使用感 〇 〇 ◎ X Λ 〇 ◎ X 1 : 100 萬 IU/g 試驗例2保濕性試驗 在設定於溫度23 士 2 °C，濕度55 土 15%之環境下，將 Ho s : HR-1系雄性無毛鼠（4週歲，1群有8隻）之背部 皮膚表面之導電率（// s ) ’以表角層水分量測定裝置（ SKICON-200EX，IBS公司製）測定（正常値）。 接著’將含有丙酮：醚=1 : 1混合液之脫脂綿保持 6 0秒，在5秒後將含有蒸餾水之脫脂綿進行6 〇秒保持處 理。將此處理空出5小時以上之間隔經2日實施3次，來 製作以人工誘發皮膚乾燥之乾燥皮膚鼠。在此乾燥皮膚鼠 ，將表2記載之各皮膚外用組成物（與表i同樣調製：奶 油狀）以每次5 0 // L，試驗開始時（0小時），約3小時 -34- 200812630 (31) 後，約6小時後，約24小時後，約27小時後，及約30 小時後予以塗佈。皮膚外用組成物塗佈前（初期値），以 及試驗開始24小時後及48小時後，測定鼠之乾燥皮膚上 之導電率。此外，試驗開始24小時後導電率之測定，則 在試驗開始24小時後之皮膚外用組成物之塗佈前加以實 施。又，比較例6係與無塗佈群同樣地實施導電率之測定 〇 _ 結果如表2所示。在比較例3，於試驗開始2 4小時 後及4 8小時後，雖顯示與比較例5同程度之導電率，故 可確認脲之保濕作用缺乏持續性。又，由比較例4及5之 結果可知，松香油衍生物幾乎無保濕作用爲自明。一方面 ，在實施例6，與比較例3及4比較，顯示甚高的導電率 ，藉由脲與松香油衍生物之相乘作用，可改善保濕作用之 持續性，使角質水分含量顯著變高爲自明。 又’就該實施例4之皮膚外用組成物，在同樣地實施 φ 試驗時，與實施例6之情形同樣地顯示高導電率而可確認 保濕作用之持續性。但在本試驗，實施例6則顯示最高角 質水分含量。 -35- 200812630 (32)g/l〇〇g Implementation Implementation Comparison Comparative Implementation Implementation Example Comparative Example 1 Example 2 Example 3 Example 1 Example 4 Case 5 Example 6 Case 2 Urea 10 10 10 10 20 20 20 20 Palmitic acid rosin oil *1 0.5 0.5 0.5 0.5 0.5 0.5 Tocopherol acetate surface 0.5 2 0.5 2 Stearyl alcohol 3 3 3 3 3 3 3 3 Cetyl alcohol 3 3 3 3 3 3 3 3 Poly sorbate 60 2 2 2 2 2 2 2 2 White Vaseline 1 1 1 1 1 1 1 1 Polyoxyethylene hardened castor oil 50 0.8 0.8 0.8 0.8 0.8 0.8 0.8 0.8 Tristearate sulphate 0.8 0.8 0.8 0.8 0.8 0.8 0.8 0.8 Monomethylpolyoxane 0.5 0.5 0.5 0.5 0.5 0.5 0.5 0.5 The amount of refined water - the right amount, the right amount, the right amount, the amount of i, the amount of appropriate amount of shame, use 〇〇 ◎ X Λ 〇 ◎ X 1 : 1 million IU / g Test Example 2 Moisture test at a temperature of 23 ± 2 ° C, humidity In the environment of 15% soil, the electrical conductivity (// s ) of the surface of the back skin of Ho s : HR-1 male hairless rats (4 years old, 8 in group 1) was determined by the surface layer water content. The device (SKICON-200EX, manufactured by IBS) was measured (normal 値). Next, the cotton wool containing the acetone:ether = 1:1 mixture was kept for 60 seconds, and after 5 seconds, the skim cotton containing distilled water was kept for 6 sec. The treatment was vacant for 5 hours or more and was carried out 3 times on the 2nd day to produce a dry skin rat artificially induced to dry the skin. Here, the skin-derived mice were dried, and each skin external composition (described in the same manner as in Table i: creamy) as shown in Table 2 was prepared at a rate of 50 // L each time, at the start of the test (0 hours), and about 3 hours - 34 - 200812630 After (31), it is applied after about 6 hours, after about 24 hours, after about 27 hours, and after about 30 hours. Before the application of the external composition for skin (initial enthalpy), and after 24 hours and 48 hours after the start of the test, the conductivity on the dried skin of the mouse was measured. Further, the measurement of the electrical conductivity after 24 hours from the start of the test was carried out before the application of the external composition for skin 24 hours after the start of the test. Further, in Comparative Example 6, the measurement of the electrical conductivity was carried out in the same manner as in the case of no coating group. The results are shown in Table 2. In Comparative Example 3, although the conductivity was the same as that of Comparative Example 5 after 24 hours and 48 hours after the start of the test, it was confirmed that the moisturizing action of urea was not sustained. Further, as is apparent from the results of Comparative Examples 4 and 5, the rosin oil derivative had almost no moisturizing effect. On the one hand, in Example 6, compared with Comparative Examples 3 and 4, the conductivity was very high, and by multiplying the urea with the rosin oil derivative, the persistence of the moisturizing effect was improved, and the keratin moisture content was significantly changed. High is self-evident. Further, in the case of performing the φ test in the same manner as in the case of Example 6, the skin external composition of Example 4 showed high conductivity and confirmed the persistence of the moisturizing action. However, in this test, Example 6 showed the highest keratin moisture content. -35- 200812630 (32)

[表2] g/l〇〇g 實施例6 比較例3 比較例4 比較例5 比較例6 脲 20 20 棕櫚酸松香油*1 0.5 0.5 dl-α-乙酸生育醇 2 2 2 2 硬脂醯基醇 3 3 3 3 鯨蠟醇 3 3 3 3 . 聚三梨酸酯60 2 2 2 2 白色凡士林 1 1 1 1 聚聚氧化乙烯硬化蓖麻油 50 0.8 0.8 0.8 0.8 - 單硬脂酸三梨聚糖 0.8 0.8 0.8 0.8 二甲基聚矽氧烷 0.5 0.5 0.5 0.5 精製水 適量 適量 適量 適量 讎 正常値 217 206 198 234 269 初期値 29 29 30 29 28 導電率 (μδ) 試驗開始 24小時後 161 48 79 66 66 試驗開始 48小時後 356 127 151 133 72 1 : 100 萬 IU/g 試驗例3穩定性試驗 將表1及2所示實施例3，6及比較例4之皮膚外用 組成物，在40°C經6個月保存後，藉由以下之（〇及（2 )之方法來評價皮膚外用組成物之脲之穩定性。又，棕櫚 酸松香油之殘存量係準照日本藥局方來測定。 (1 )各皮膚外用組成物用〇. 5 g，在玻璃平板上予以 薄薄地均一地塗開以目視確認脲之析出。 -36- 200812630 (33) (2 )各實施例採用1 .〇g，以官能評價氨臭之有無。 結果，在實施例3及6之皮膚外用組成物’均無法觀 察到脲之析出及氨臭，可確認脲可穩定地保持。 又，棕櫚酸松香油之殘存量，在實施例3爲87·5%， ' 實施例6爲88.2%，比較例4爲78.8%，在實施例3及6 - ，與比較例4比較則松香油衍生物之殘存量爲提高約1 0 %。 由以上結果可知，藉由脲與松香油衍生物之組合，不 ^ 僅可抑制脲之析出，松香油衍生物之穩定性本身亦可被改 善，可使穩定性顯著提高爲自明。 試驗例4刺激性試驗 就表1記載之實施例1 - 6之皮膚外用組成物，進行 刺激性有無之評價。具體言之，在各1 3名之監視器之上 腕部塗佈各皮膚外用組成物0.5 g，就塗佈後之皮膚之狀態 φ (有無皮膚發紅），與有無刺激感（感覺到火辣辣，或發 癢或灼熱感）來進行評價。 其結果，在所有之實施例中，1 3名所有監視器並無 感到刺激，而可確認實施例1 - 6之皮膚外用組成物並無 刺激性而爲安全的皮膚外用劑。 試驗例5皮膚乾燥改善效果之評價試驗 就表1記載之實施例6之皮膚外用組成物，來評價皮 膚乾燥改善效果。具體言之，對於手部乾燥嚴重的患部的 -37- 200812630 (34) 3 〇年代女性1 0名，經4週時間，對該患部與正常皮膚狀 態之手之指甲，在就寢前與把乾燥掛在心理之時則適量塗 佈皮膚外用組成物。塗佈開始1週後，2週後及4週後， 將手乾燥患部與手指甲之導電率（/xs)，以表角層水分 量測定裝置（SKICON_200EX，IBS公司製）來測定。 皮膚外用組成物之塗佈前乾燥患部與手指甲之導電率 爲1，計算塗佈開始1週後，2週後及4週後之導電率之 相對値。 結果如表3所示。其結果，藉由實施例6之皮膚外用 組成物之塗佈，可使手乾燥嚴重患部之水分量顯著提升。 又，在全部1 0名之女性中，在4週後，可改善患部之手 乾燥。又，就連手之指甲，與塗佈前比較亦可確認水分量 之增加。 由以上結果可知，在實施例6之皮膚外用組成物，角 質予以正常化，改善手乾燥之效果優異則爲自明。 表3] 導電率之相對値（1 0名之平均値） 1週後 2週後 3週後 手乾燥患部 2.3 4.0 4.3 手指甲 1.7 2.2 3.4 實施例7 - 1 6 以下例舉製劑例。此外，以下實施例中之配合量，就 無特別記載單位下則均表示重量％。 -38- 200812630[Table 2] g/l〇〇g Example 6 Comparative Example 3 Comparative Example 4 Comparative Example 5 Comparative Example 6 Urea 20 20 Palmitic acid rosin oil *1 0.5 0.5 dl-α-tocopheryl acetate 2 2 2 2 Stearic acid Alcohol 3 3 3 3 cetyl alcohol 3 3 3 3 . Polytritic acid ester 60 2 2 2 2 White Vaseline 1 1 1 1 Polyethylene oxide hardened castor oil 50 0.8 0.8 0.8 0.8 - Tristearate 0.8 0.8 0.8 0.8 Dimethylpolyoxane 0.5 0.5 0.5 0.5 Refined water Appropriate amount Appropriate amount 雠 Normal 値 217 206 198 234 269 Initial 値 29 29 30 29 28 Conductivity (μδ) 24 hours after the start of the test 161 48 79 66 66 48 hours after the start of the test 356 127 151 133 72 1 : 1 million IU / g Test Example 3 Stability test The skin external compositions of Examples 3 and 6 and Comparative Example 4 shown in Tables 1 and 2 were subjected to 40 ° C at 40 ° C. After 6 months of storage, the stability of the urea of the external composition for skin was evaluated by the following methods (〇 and (2). Further, the residual amount of palmitic rosin oil was measured by the Japanese Pharmacopoeia. 1) Each skin external composition is applied thinly and uniformly on a glass plate with 〇. 5 g. The precipitation of urea was visually confirmed. -36- 200812630 (33) (2) In each of the examples, 1. 〇g was used to evaluate the presence or absence of ammonia odor. As a result, the external composition for skin of Examples 3 and 6 could not be used. The precipitation of urea and the ammonia odor were observed, and it was confirmed that urea was stably maintained. Further, the residual amount of palmitic rosin oil was 87.5% in Example 3, '88.2% in Example 6, and 78.8 in Comparative Example 4 %, in Examples 3 and 6 -, the residual amount of the rosin oil derivative was increased by about 10% as compared with Comparative Example 4. From the above results, it was found that the combination of urea and rosin oil derivative was not inhibited. The precipitation of urea, the stability of the rosin oil derivative itself can be improved, and the stability can be remarkably improved to be self-evident. Test Example 4 Irritation Test The skin external composition of Example 1-6 described in Table 1 was stimulated. In particular, 0.5 g of each skin external composition was applied to the wrist of each of the 13 monitors, and the state of the skin after application was φ (with or without redness of the skin), and whether or not there was any irritation. (I feel a hot, or itchy or burning sensation) to evaluate. As a result, in all the embodiments, the names of all the 13 monitors no irritation, and confirmed that Example 1 - Skin 6 of the topical composition is not irritating to the skin a safe external preparation. Test Example 5 Evaluation Test for Skin Drying Improvement Effect The skin external preparation composition of Example 6 described in Table 1 was used to evaluate the skin dryness improving effect. Specifically, for the severely dry hand---37-200812630 (34) 3 women in the 3rd century, after 4 weeks, the nail of the affected part and the normal skin condition, before going to bed and drying When hanging in the mind, apply a proper amount to the external composition of the skin. One week after the start of the application, the conductivity (/xs) of the hand-dried affected part and the fingernail was measured by the surface layer moisture content measuring device (SKICON_200EX, manufactured by IBS) after two weeks and four weeks. The conductivity of the affected part and the fingernail before application of the external composition for skin was 1, and the relative enthalpy of conductivity after 2 weeks and 4 weeks after the start of coating was calculated. The results are shown in Table 3. As a result, by the application of the external composition for skin of Example 6, the moisture content of the severely affected part of the hand can be remarkably improved. In addition, in all 10 women, after 4 weeks, the hand of the affected part was dried. Moreover, even with the nail of the hand, the increase in the amount of moisture can be confirmed as compared with before the application. From the above results, it is understood that the skin external composition of Example 6 is normalized to normalize the keratin and to improve the effect of hand drying. Table 3] Relative enthalpy of conductivity (average enthalpy of 10) After 1 week 2 weeks later 3 weeks after hand dry affected part 2.3 4.0 4.3 Fingernails 1.7 2.2 3.4 Example 7 - 1 6 The formulation examples are exemplified below. Further, the blending amounts in the following examples are all by weight unless otherwise specified. -38- 200812630

(35) [表4] g/l〇〇g 實施例7 (軟膏狀） 實施例8 (凝膠狀） 實施例9 (洗劑狀） 脲 10 10 2 0 乙酸松香油* 1 0.01 0.10 - 棕櫚酸松香油$1 - 應 0.3 dl-α-生育酚 - 2.0 δ -生育酚 0.5 1.0 攀 乙二胺四乙酸鈉 0.01 0.0 3 0.1 二丁基羥基甲苯 0.05 0.01 0.1 白色凡士林 20 - 1 流動石臘 10 - 2 石臘蠟 10 - • 1，3-丁二醇 2 20 2 乙醇 - 10 . 鯨蠟醇 6.0 0.2 0.5 單硬脂酸甘油酯 3.0 0.1 0.5 聚氧化乙烯硬化蓖麻 油60 2 0.2 1.5 羧乙烯聚合物 錐 1.0 0.5 羥基丙基甲基纖維素 0.5 0.1 三乙醇胺 师 0.1 0.2 乳酸 0.2 0.0 5 0.1 精製水 適量 適量 適量 * 1 ·· 1 00 萬 IU/g -39- 200812630(35) [Table 4] g/l〇〇g Example 7 (ointment) Example 8 (gelatinous form) Example 9 (washing form) Urea 10 10 2 0 Acetate rosin oil * 1 0.01 0.10 - Palm Acid rosin oil $1 - should be 0.3 dl-α-tocopherol - 2.0 δ - tocopherol 0.5 1.0 sodium diamine tetraacetate 0.01 0.0 3 0.1 dibutylhydroxytoluene 0.05 0.01 0.1 white petrolatum 20 - 1 mobile paraffin 10 - 2 paraffin wax 10 - • 1,3-butanediol 2 20 2 ethanol - 10 . cetyl alcohol 6.0 0.2 0.5 glyceryl monostearate 3.0 0.1 0.5 polyoxyethylene hardened castor oil 60 2 0.2 1.5 carboxyvinyl polymer Cone 1.0 0.5 Hydroxypropylmethylcellulose 0.5 0.1 Triethanolamine 0.1 0.1 Lactic acid 0.2 0.0 5 0.1 Refined water q q q q q q q q q q q q q q q q q q q q q q q q q q q

(36) [表5] g/l〇〇g 實施例 10 實施例 11 實施例 12 實施例 13 實施例 14 實施例 15 實施例 16 脲 10 10 10 20 20 20 20 棕櫚酸松香油” 0.05 0.15 0.4 • . 乙酸松香油*1 0.05 0.15 0.4 δ-松香油酸生育酚 • • • 0.1 乙酸生育酚 2 0.5 0.1 1 2 0.5 δ-生育酚 . • _ 鐘 霉 2 乙二胺四乙酸鈉 0.02 0.05 0.15 0.02 0.05 0.15 0.01 二丁基經基甲苯 0.01 0.01 0.01 0.01 0.01 0.01 0.01 硬脂醯基醇 3 3 3 3 3 3 3 鯨蠟醇 3 3 3 3 3 3 3 聚三梨酸酯60 2 2 2 2 2 2 2 白色凡士林 1 1 1 1 1 1 1 聚氧化乙烯硬化蓖麻油50 0.8 0.8 0.8 0.8 0.8 0.8 0.8 單硬脂酸三梨聚糖 0.8 0.8 0.8 0.8 0.8 0.8 0.8 二甲基聚矽氧烷 0.5 0.5 0.5 0.5 0.5 0.5 0.5 精製水 適量 適量 適量 適量 適量 適量 適量 均爲奶油狀(36) [Table 5] g/l〇〇g Example 10 Example 11 Example 12 Example 13 Example 14 Example 15 Example 16 Urea 10 10 10 20 20 20 20 Palmitic acid rosin oil 0.05 0.15 0.4 • Acetate rosin oil *1 0.05 0.15 0.4 δ-rosin oleic acid tocopherol • • • 0.1 Tocopherol acetate 2 0.5 0.1 1 2 0.5 δ-tocopherol. • _ Zhongmycin 2 Sodium ethylenediaminetetraacetate 0.02 0.05 0.15 0.02 0.05 0.15 0.01 Dibutyl permethyl toluene 0.01 0.01 0.01 0.01 0.01 0.01 0.01 Stearyl alcohol 3 3 3 3 3 3 3 Cetyl alcohol 3 3 3 3 3 3 3 Polytritic acid ester 60 2 2 2 2 2 2 2 White Vaseline 1 1 1 1 1 1 1 Polyoxyethylene hardened castor oil 50 0.8 0.8 0.8 0.8 0.8 0.8 0.8 Trisole monostearate 0.8 0.8 0.8 0.8 0.8 0.8 0.8 Dimethylpolyoxane 0.5 0.5 0.5 0.5 0.5 0.5 0.5 The amount of refined water, the right amount, the right amount, the right amount, the amount is creamy

* 1 : 1 00 萬 IU/g -40-* 1 : 1 million IU/g -40-

Claims (1)

200812630 (1) 十、申請專利範圍 1 · 一種皮膚外用組成物，其特徵爲，含有（a )脲10 〜25重量％，及（b)選自松香油（retinol)及其衍生物 所成群之至少1種。 ¥ 2·如申請專利範圍第1項之皮膚外用組成物，其中 • (b)成分係選自乙酸松香油酯、棕櫚酸松香油酯及5 - 松香油酸生育酚（tocopherol )酯所成群之至少1種。 ^ 3.如申請專利範圍第1項之皮膚外用組成物，其中 (b)成分爲棕櫚酸松香油酯。 4 ·如申請專利範圍第1項之皮膚外用組成物，其中 對皮膚外用組成物之平均總量，（b )成分含0.001〜1重 量％之比率者。 5.如申請專利範圍第1項之皮膚外用組成物，其中 相對於（b )成分之總量1重量份，脲通常含1〜3 00重量 份之比率者。 φ 6.如申請專利範圍第1項之皮膚外用組成物，其進 而含有選自（c )生育酚及其衍生物所成群之至少1種。 7.如申請專利範圍第6項之皮膚外用組成物，其中 ' (c)成分爲乙酸生育酚酯。 ' 8 ·如申請專利範圍第6項之皮膚外用組成物，其中 對皮膚外用組成物之平均總量，（c )成分含0.001〜5重 量％之比率者。 9.如申請專利範圍第1項之皮膚外用組成物，其進 而含有選自鉗合劑、抗氧化劑、抗炎劑、保濕劑、美白劑 -41 - 200812630 (2) 、細胞活化劑、及除皺劑所成群之至少1種。 1 〇.如申請專利範圍第1項之皮膚外用組成物，其爲 化粧料或醫藥組成物者。 1 1 ·如申請專利範圍第1項之皮膚外用組成物，其爲 v 角質軟化用或保濕用之皮膚外用組成物。 • 12·如申請專利範圍第1項之皮膚外用組成物，其爲 奶油狀之形態者。 ^ 1 3 ·如申請專利範圍第1 2項之皮膚外用組成物，其 進而含有高級醇、烴、及聚矽氧者。 1 4 ·如申請專利範圍第i 3項之皮膚外用組成物，其 中高級醇係選自硬脂醯基醇及鯨鱲醇（cetanol )之1種或 2種者。 1 5 .如申請專利範圍第1 3項之皮膚外用組成物，其 中對皮膚外用組成物之平均總量，高級醇含〇. 1〜3 0重量 %之比率者。 φ 1 6 _如申請專利範圍第1 3項之皮膚外用組成物，其 中煙爲凡士林（v a s e 1 i n e )。 1 7 ·如申請專利範圍第1 3項之皮膚外用組成物，其 中對皮膚外用組成物之平均總量，烴含有0.0 1〜5 0重量 %之比率者。 1 8 ·如申請專利範圍第1 3項之皮膚外用組成物，其 中聚矽氧爲二甲基聚矽氧烷者。 19·如申請專利範圍第13項之皮膚外用組成物，其 中對皮膚外用組成物之平均總量，聚矽氧含〇 . 〇 〇 1〜1 〇重 -42- 200812630 (3) 量％之比率者。 2 0 ·如申請專利範圍第1 3項之皮膚外用組成物，其 中對皮膚外用組成物之平均總量，其含高級醇〇. 5〜1 5重 量％、烴0·1〜40重量％、及聚矽氧〇.〇1〜5重量％者。 ’ 21 ·如申請專利範圍第1 3項之皮膚外用組成物，其 ， 中對皮膚外用組成物之平均總量，其含硬脂醯基醇1〜1 0 重量％、黯嫿醇1〜10重量％、凡士林1〜20重量％、及 0 含二甲基聚矽氧烷0.1〜3重量％者。 22· —種脲之析出抑制方法，其爲含有1〇〜25重量 %脲之皮膚外用組成物中之脲析出之抑制方法，其特徵爲 ，使（a )對皮膚外用組成物之平均總量，爲1 0〜25重量 %之脲，與（b )選自松香油及其衍生物所成群之至少1 種，在皮膚外用組成物中共存者。200812630 (1) X. Patent application scope 1 · A skin external composition characterized by containing (a) urea 10 to 25% by weight, and (b) being selected from the group consisting of rosinol and its derivatives At least one of them. ¥ 2· For external skin composition according to item 1 of the patent application, wherein (b) is selected from the group consisting of rosin acetate acetate, rosin palmitate and 5 - rosin oleic acid tocopherol ester At least one of them. ^ 3. The external composition for skin according to claim 1, wherein the component (b) is rosin palmitate. 4. The skin external composition according to item 1 of the patent application, wherein the average amount of the external composition for skin, (b) is 0.001 to 1% by weight. 5. The skin external composition according to claim 1, wherein the urea usually has a ratio of from 1 to 300 parts by weight based on 1 part by weight of the total amount of the component (b). Φ 6. The composition for external use on skin according to item 1 of the patent application, which further comprises at least one selected from the group consisting of (c) tocopherol and a derivative thereof. 7. The external composition for skin according to item 6 of the patent application, wherein the component (c) is tocopheryl acetate. ' 8 . The external composition for skin according to item 6 of the patent application, wherein the average amount of the composition for external use on the skin, (c) is a ratio of 0.001 to 5% by weight. 9. The skin external composition according to claim 1, which further comprises a chelating agent, an antioxidant, an anti-inflammatory agent, a moisturizing agent, a whitening agent-41 - 200812630 (2), a cell activator, and a wrinkle removing agent. At least one of the groups of the agents. 1 如. The skin external composition according to claim 1 of the patent application, which is a cosmetic or a pharmaceutical composition. 1 1 The skin external composition according to the first aspect of the patent application, which is a skin external composition for keratin softening or moisturizing. • 12. The skin external composition according to item 1 of the patent application, which is in the form of a cream. ^ 1 3 · A skin external composition according to Item 12 of the patent application, which further contains a higher alcohol, a hydrocarbon, and a polyoxygen. 1 4 The skin external composition according to item i of the patent application, wherein the higher alcohol is one or more selected from the group consisting of stearyl alcohol and cetyl alcohol. 1 5 . The skin external composition according to claim 13 of the patent application, wherein the average total amount of the composition for external use on the skin, the higher alcohol contains 〇. 1 to 30% by weight. Φ 1 6 _ The external composition for skin of claim 13 of the patent application, wherein the smoke is Vaseline (v a s e 1 i n e ). 1 7 The skin external composition according to Item 13 of the patent application, wherein the average amount of the external composition for the skin is from 0.01 to 50% by weight of the hydrocarbon. 1 8 . The skin external composition according to claim 13 of the patent application, wherein the polyoxyxylene is dimethyl polyoxyalkylene. 19. The skin external composition according to claim 13 of the patent application, wherein the average total amount of the external composition for the skin is 矽 〜 1 〜 1 〇 weight - 42 - 200812630 (3) ratio of the percentage By. 2 0. The skin external composition according to claim 13 of the patent application, wherein the average total amount of the external composition for skin contains a higher alcohol 〇. 5 to 15% by weight, hydrocarbon 0·1 to 40% by weight, And polyoxyl oxime. 〇 1~5 wt%. ' 21 · The skin external composition according to claim 13 of the patent application, wherein the average total amount of the skin external composition comprises 1 to 10% by weight of stearyl alcohol and 1 to 10% of sterol % by weight, 1 to 20% by weight of petrolatum, and 0.1 to 3% by weight of dimethylpolysiloxane. A method for suppressing precipitation of urea, which is a method for suppressing precipitation of urea in a skin external composition containing 1 to 25% by weight of urea, characterized in that (a) the average total amount of the composition for external use on the skin It is a mixture of 10 to 25 wt% of urea and (b) at least one selected from the group consisting of rosin oil and its derivatives, and coexists in the external composition for skin. -43- 200812630 七、指定代表圖： (一） 、本案指定代表圖為：無 (二） 、本代表圖之元件代表符號簡單說明：無-43- 200812630 VII. Designated representative map: (1) The representative representative of the case is: None (2), the representative symbol of the representative figure is simple: no 八、本案若有化學式時，請揭示最能顯示發明特徵的化學 式··8. If there is a chemical formula in this case, please reveal the chemical formula that best shows the characteristics of the invention. -4--4-
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