JP6338435B2 - Topical skin preparation - Google Patents
Topical skin preparation Download PDFInfo
- Publication number
- JP6338435B2 JP6338435B2 JP2014091916A JP2014091916A JP6338435B2 JP 6338435 B2 JP6338435 B2 JP 6338435B2 JP 2014091916 A JP2014091916 A JP 2014091916A JP 2014091916 A JP2014091916 A JP 2014091916A JP 6338435 B2 JP6338435 B2 JP 6338435B2
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- mass
- acid
- fatty acid
- oil
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- 229960004504 chlorhexidine hydrochloride Drugs 0.000 claims description 39
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Landscapes
- Medicinal Preparation (AREA)
- Cosmetics (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Description
本発明は、皮膚外用剤に関するものである。 The present invention relates to an external preparation for skin.
抗菌剤として、クロルヘキシジン塩酸塩を配合した皮膚外用剤が知られている(例えば、特許文献1参照)。 As an antibacterial agent, a skin external preparation containing chlorhexidine hydrochloride is known (see, for example, Patent Document 1).
このクロルヘキシジン塩酸塩は、広範囲な抗菌スペクトルを有しており、抗菌力の持続性が高いことで知られている。しかしながら、クロルヘキシジン塩酸塩は、水に難溶でかつ安定性も悪いことから、グルコン酸塩が多く用いられ、塩酸塩はあまり用いられてこなかった。
このため、クロルヘキシジン塩酸塩の安定配合が望まれている。
This chlorhexidine hydrochloride has a wide antibacterial spectrum and is known for its high antibacterial activity. However, since chlorhexidine hydrochloride is poorly soluble in water and poor in stability, gluconate is often used, and hydrochloride is rarely used.
For this reason, stable blending of chlorhexidine hydrochloride is desired.
本発明の目的は、クロルヘキシジン塩酸塩を安定配合することが可能な皮膚外用剤を提供することにある。 The objective of this invention is providing the skin external preparation which can mix | blend chlorhexidine hydrochloride stably.
このような目的は、下記(1)〜(8)の本発明により達成される。
(1) クロルヘキシジン塩酸塩と、融点が72℃よりも高い高級脂肪酸Aと、融点が72℃以下の高級脂肪酸Bと、を含み、
前記高級脂肪酸Aは、ベヘン酸、アラキジン酸またはリグノセリン酸であり、
前記高級脂肪酸Bは、ステアリン酸、パルミチン酸またはミリスチン酸であることを特徴とする皮膚外用剤。
Such an object is achieved by the present inventions (1) to ( 8 ) below.
(1) viewed contains chlorhexidine hydrochloride, and high higher fatty acid A than a melting point of 72 ° C., and a melting point of 72 ° C. or less of the higher fatty acids B, and,
The higher fatty acid A is behenic acid, arachidic acid or lignoceric acid,
The external preparation for skin , wherein the higher fatty acid B is stearic acid, palmitic acid or myristic acid .
(2) 前記高級脂肪酸Aの配合量をX[質量%]、前記高級脂肪酸Bの配合量をY[質量%]としたとき、0.1≦Y/X≦50の関係を満足する上記(1)に記載の皮膚外用剤。 (2) The above satisfying the relationship of 0.1 ≦ Y / X ≦ 50, where X is the mass of the higher fatty acid A and X is the mass of the higher fatty acid B. The external preparation for skin according to 1).
(3) 前記クロルヘキシジン塩酸塩の配合量は、0.0001〜0.5質量%である上記(1)または(2)に記載の皮膚外用剤。 (3) The external preparation for skin according to (1) or (2) above, wherein the amount of the chlorhexidine hydrochloride is 0.0001 to 0.5% by mass.
(4) 前記高級脂肪酸Aの配合量は、0.01〜10質量%である上記(1)ないし(3)のいずれかに記載の皮膚外用剤。 (4) The external preparation for skin according to any one of (1) to (3), wherein the compounding amount of the higher fatty acid A is 0.01 to 10% by mass.
(5) 前記高級脂肪酸Bの配合量は、0.01〜20質量%である上記(1)ないし(4)のいずれかに記載の皮膚外用剤。 (5) The external preparation for skin according to any one of (1) to (4), wherein the compounding amount of the higher fatty acid B is 0.01 to 20% by mass.
(6) 藻類由来の増粘多糖類を含む上記(1)ないし(5)のいずれかに記載の皮膚外用剤。 ( 6 ) The external preparation for skin according to any one of (1) to ( 5 ), comprising a thickening polysaccharide derived from algae.
(7) 前記増粘多糖類の配合量は、0.01〜10質量%である上記(6)に記載の皮膚外用剤。 ( 7 ) The skin external preparation as described in said ( 6 ) whose compounding quantity of the said thickening polysaccharide is 0.01-10 mass%.
(8) 前記増粘多糖類は、カラギーナンである上記(6)または(7)に記載の皮膚外用剤。 ( 8 ) The external preparation for skin according to ( 6 ) or ( 7 ), wherein the thickening polysaccharide is carrageenan.
本発明によれば、クロルヘキシジン塩酸塩を安定配合することが可能な皮膚外用剤を提供することができる。 ADVANTAGE OF THE INVENTION According to this invention, the skin external preparation which can mix | blend chlorhexidine hydrochloride stably can be provided.
以下、本発明の皮膚外用剤の好適な実施形態について詳細に説明する。
なお、本明細書中における皮膚外用剤は、いかなる形態のものであってもよく、例えば、液状、ゲル(ジェル)状、乳液状、クリーム状等であってもよい。
Hereinafter, preferred embodiments of the external preparation for skin of the present invention will be described in detail.
In addition, the skin external preparation in this specification may be in any form, and may be, for example, liquid, gel (gel), emulsion, cream or the like.
本発明の皮膚外用剤は、クロルヘキシジン塩酸塩と、融点が72℃よりも高い高級脂肪酸Aと、融点が72℃以下の高級脂肪酸Bと、を含んでいる。 The skin external preparation of the present invention contains chlorhexidine hydrochloride, a higher fatty acid A having a melting point higher than 72 ° C, and a higher fatty acid B having a melting point of 72 ° C or lower.
以下、各成分について詳細に説明する。
[クロルヘキシジン塩酸塩]
クロルヘキシジン塩酸塩は、抗菌性の高い成分である。
Hereinafter, each component will be described in detail.
[Chlorhexidine hydrochloride]
Chlorhexidine hydrochloride is a highly antibacterial component.
ところで、クロルヘキシジン塩酸塩は、広範囲な抗菌スペクトルを有しており、抗菌力の持続性が高いことで知られているが、製剤中において安定性が低いといった問題があった。 By the way, chlorhexidine hydrochloride has a wide antibacterial spectrum and is known to have high antibacterial activity, but has a problem of low stability in the preparation.
そこで本発明者らは、鋭意検討した結果、本発明の皮膚外用剤では、クロルヘキシジン塩酸塩の他に、融点が72℃よりも高い高級脂肪酸Aと、融点が72℃以下の高級脂肪酸Bとを配合することにより、クロルヘキシジン塩酸塩の安定性が向上することを見出し、本発明の完成に至った。 Therefore, as a result of intensive studies, the present inventors have determined that in the external preparation for skin of the present invention, in addition to chlorhexidine hydrochloride, higher fatty acid A having a melting point higher than 72 ° C. and higher fatty acid B having a melting point of 72 ° C. or lower. By mixing, it was found that the stability of chlorhexidine hydrochloride was improved, and the present invention was completed.
クロルヘキシジン塩酸塩の配合量は、0.0001〜0.5質量%であるのが好ましく、0.001〜0.2質量%であるのがより好ましい。これにより、クロルヘキシジン塩酸塩の抗菌効果をより効果的に発揮させることができる。 The blending amount of chlorhexidine hydrochloride is preferably 0.0001 to 0.5% by mass, and more preferably 0.001 to 0.2% by mass. Thereby, the antibacterial effect of chlorhexidine hydrochloride can be exhibited more effectively.
[高級脂肪酸A]
高級脂肪酸Aは、融点が72℃よりも高い高級脂肪酸である。
[Higher fatty acid A]
The higher fatty acid A is a higher fatty acid having a melting point higher than 72 ° C.
高級脂肪酸Aは、後述する高級脂肪酸Bとともに配合することで、製剤中におけるクロルヘキシジン塩酸塩の安定性に寄与する成分である。 The higher fatty acid A is a component that contributes to the stability of chlorhexidine hydrochloride in the preparation by blending with the higher fatty acid B described later.
高級脂肪酸Aとしては、例えば、ベヘン酸、アラキジン酸、リグノセリン酸等が挙げられる。これらの中でも、高級脂肪酸Aとしては、ベヘン酸を用いるのが好ましい。これにより、クロルヘキシジン塩酸塩の配合安定性をより高いものとすることができる。 Examples of the higher fatty acid A include behenic acid, arachidic acid, lignoceric acid, and the like. Among these, it is preferable to use behenic acid as the higher fatty acid A. Thereby, the compounding stability of chlorhexidine hydrochloride can be made higher.
高級脂肪酸Aの配合量は、0.01〜10質量%であるのが好ましく、0.5〜3質量%であるのがより好ましい。これにより、クロルヘキシジン塩酸塩の配合安定性をより効果的に向上させることができる。また、皮膚外用剤の使用感を良好なものとすることができる。 The blending amount of the higher fatty acid A is preferably 0.01 to 10% by mass, and more preferably 0.5 to 3% by mass. Thereby, the compounding stability of chlorhexidine hydrochloride can be improved more effectively. Moreover, the usability of the external preparation for skin can be improved.
[高級脂肪酸B]
高級脂肪酸Bは、融点が72℃以下の高級脂肪酸である。
[Higher fatty acid B]
The higher fatty acid B is a higher fatty acid having a melting point of 72 ° C. or lower.
高級脂肪酸Bは、高級脂肪酸Aとともに配合することで、製剤中におけるクロルヘキシジン塩酸塩の安定性に寄与する成分である。 The higher fatty acid B is a component that contributes to the stability of chlorhexidine hydrochloride in the preparation by blending with the higher fatty acid A.
高級脂肪酸Bとしては、例えば、ステアリン酸、パルミチン酸、ミリスチン酸等が挙げられる。これらの中でも、高級脂肪酸Bとしては、ステアリン酸を用いるのが好ましい。これにより、クロルヘキシジン塩酸塩の配合安定性をより高いものとすることができる。 Examples of the higher fatty acid B include stearic acid, palmitic acid, myristic acid, and the like. Among these, as the higher fatty acid B, it is preferable to use stearic acid. Thereby, the compounding stability of chlorhexidine hydrochloride can be made higher.
高級脂肪酸Bの配合量は、0.01〜20質量%であるのが好ましく、1〜10質量%であるのがより好ましい。これにより、クロルヘキシジン塩酸塩の配合安定性をより効果的に向上させることができる。また、皮膚外用剤の使用感を良好なものとすることができる。 The compounding amount of the higher fatty acid B is preferably 0.01 to 20% by mass, and more preferably 1 to 10% by mass. Thereby, the compounding stability of chlorhexidine hydrochloride can be improved more effectively. Moreover, the usability of the external preparation for skin can be improved.
高級脂肪酸Aの配合量をX[質量%]、高級脂肪酸Bの配合量をY[質量%]としたとき、0.1≦Y/X≦50の関係を満足するのが好ましく、0.5≦Y/X≦10の関係を満足するのがより好ましい。このような関係を満足することにより、クロルヘキシジン塩酸塩の配合安定性をさらに効果的に向上させることができる。また、皮膚外用剤の使用感をより良好なものとすることができる。 When the compounding amount of the higher fatty acid A is X [mass%] and the compounding amount of the higher fatty acid B is Y [mass%], it is preferable to satisfy the relationship of 0.1 ≦ Y / X ≦ 50, 0.5 It is more preferable to satisfy the relationship of ≦ Y / X ≦ 10. By satisfying such a relationship, the mixing stability of chlorhexidine hydrochloride can be further effectively improved. Moreover, the usability of the external preparation for skin can be improved.
[増粘多糖類]
本発明の皮膚外用剤は、上記成分の他、増粘多糖類を含んでいてもよい。
[Thickening polysaccharide]
The external preparation for skin of the present invention may contain a thickening polysaccharide in addition to the above components.
増粘多糖類は、皮膚外用剤の使用感を向上させる成分である。また、増粘多糖類は、上述した高級脂肪酸Aおよび高級脂肪酸Bとともに配合することにより、クロルヘキシジン塩酸塩の配合安定性をさらに向上させる成分である。 A thickening polysaccharide is a component which improves the usability | use_condition of a skin external preparation. The thickening polysaccharide is a component that further improves the blending stability of chlorhexidine hydrochloride by blending with the higher fatty acid A and the higher fatty acid B described above.
増粘多糖類としては、例えば、カラギーナン(ι、λ、κ)、アルギン酸、アルギン酸ナトリウム、アルギン酸プロピレングリコールエステル、カルシウム含有アルギン酸ナトリウム、アルギン酸カリウム、アルギン酸カルシウム、アルギン酸アンモニウム等のアルギン酸塩およびその誘導体、キサンタンガム、グァーガム、カチオン化グアガム、ゼラチン、寒天、ヒアルロン酸、ヒアルロン酸ナトリウム等が挙げられ、これらのうち、1種または2種以上を組み合わせて用いることができる。 Examples of thickening polysaccharides include carrageenan (ι, λ, κ), alginic acid, sodium alginate, propylene glycol ester alginate, calcium-containing sodium alginate, potassium alginate, calcium alginate, ammonium alginate and derivatives thereof, xanthan gum , Guar gum, cationized guar gum, gelatin, agar, hyaluronic acid, sodium hyaluronate and the like. Among these, one kind or two or more kinds can be used in combination.
これらの中でも、特に、ι−カラギーナンを用いるのが好ましい。これにより、クロルヘキシジン塩酸塩の配合安定性をさらに向上させることができる。 Among these, it is particularly preferable to use ι-carrageenan. Thereby, the compounding stability of chlorhexidine hydrochloride can be further improved.
高級脂肪酸Aの配合量をX[質量%]、増粘多糖類の配合量をZ[質量%]としたとき、0.01≦X/Z≦300の関係を満足するのが好ましく、0.5≦X/Z≦50の関係を満足するのがより好ましい。このような関係を満足することにより、クロルヘキシジン塩酸塩の配合安定性が特に優れたものとなる。また、皮膚外用剤の使用感をさらに良好なものとすることができる。 When the blending amount of the higher fatty acid A is X [mass%] and the blending amount of the thickening polysaccharide is Z [mass%], it is preferable to satisfy the relationship of 0.01 ≦ X / Z ≦ 300. It is more preferable to satisfy the relationship of 5 ≦ X / Z ≦ 50. By satisfying such a relationship, the blending stability of chlorhexidine hydrochloride is particularly excellent. Moreover, the usability of the external preparation for skin can be further improved.
高級脂肪酸Bの配合量をY[質量%]、増粘多糖類の配合量をZ[質量%]としたとき、0.01≦Y/Z≦500の関係を満足するのが好ましく、0.1≦Y/Z≦100の関係を満足するのがより好ましい。このような関係を満足することにより、クロルヘキシジン塩酸塩の配合安定性が特に優れたものとなる。また、皮膚外用剤の使用感をさらに良好なものとすることができる。 When the blending amount of the higher fatty acid B is Y [mass%] and the blending amount of the thickening polysaccharide is Z [mass%], it is preferable that the relationship of 0.01 ≦ Y / Z ≦ 500 is satisfied. It is more preferable to satisfy the relationship of 1 ≦ Y / Z ≦ 100. By satisfying such a relationship, the blending stability of chlorhexidine hydrochloride is particularly excellent. Moreover, the usability of the external preparation for skin can be further improved.
[その他の成分]
また、本発明の皮膚外用剤には、上記成分の他、目的および剤形に応じて通常用いられる基剤成分並びに薬効成分を配合することができる。
[Other ingredients]
In addition to the above components, a base component and a medicinal component that are usually used according to the purpose and dosage form can be blended with the external preparation for skin of the present invention.
そのような基剤成分並びに薬効成分の例として、ヒアルロン酸、ヒアルロン酸塩、アミノ酸、鉱物・合成油、動植物油、アルコール、界面活性剤、湿潤剤、溶剤、防腐剤、酸化防止剤、pH調整剤、香料などが挙げられ、本発明の効果を損なわない範囲で配合することができる。以下にそれらの具体例を挙げる。 Examples of such base ingredients and medicinal ingredients are hyaluronic acid, hyaluronic acid salts, amino acids, mineral / synthetic oils, animal and vegetable oils, alcohol, surfactants, wetting agents, solvents, preservatives, antioxidants, pH adjustment An agent, a fragrance | flavor, etc. are mentioned, It can mix | blend in the range which does not impair the effect of this invention. Specific examples thereof are given below.
(アミノ酸)
アミノ酸としては、例えば、L−アラニン、L−アルギニン、L−アスパラギン酸、L−グルタミン、L−アスパラギン、L−システイン、L−セリン、L−チロシン、L−プロリン、ピロリドンカルボン酸塩、グリシン、バリン、ロイシン、イソロイシン、トレオニン、メチオニン、フェニルアラニン、トリプトファン、リシン、シスチン、ヒドロキシプロリン、ヒドロキシリジン、オルニチン、ヒスチジン、γ−アミノ酪酸、ε−アミノカプロン酸等が挙げられ、これらのうち、1種または2種以上を組み合わせて用いることができる。
(amino acid)
Examples of amino acids include L-alanine, L-arginine, L-aspartic acid, L-glutamine, L-asparagine, L-cysteine, L-serine, L-tyrosine, L-proline, pyrrolidone carboxylate, glycine, Examples include valine, leucine, isoleucine, threonine, methionine, phenylalanine, tryptophan, lysine, cystine, hydroxyproline, hydroxylysine, ornithine, histidine, γ-aminobutyric acid, ε-aminocaproic acid, and the like. A combination of more than one species can be used.
(鉱物・合成油)
鉱物・合成油としては、例えば、流動パラフィン、流動イソパラフィン、ワセリン、パラフィン、セレシン、マイクロスタリンワックス、α−オレフィンオリゴマー、ポリエチレン、ポリブテン、合成スクワラン等が挙げられ、これらのうち、1種または2種以上を組み合わせて用いることができる。
(Mineral / Synthetic oil)
Examples of the mineral / synthetic oil include liquid paraffin, liquid isoparaffin, petrolatum, paraffin, ceresin, microstalin wax, α-olefin oligomer, polyethylene, polybutene, and synthetic squalane. A combination of the above can be used.
(動植物油)
動植物油としては、例えば、スクワラン、オリブ油、ツバキ油、コムギ胚芽油、ホホバ油、アボガド油、カロット油、シア脂、液状シア脂、パーム油、パーム核油、硬化油、馬油、ラノリン類、卵黄油、チョウジ油、ローズヒップ油、ラベンダー油、ハッカ油、スペアミント油、ローズマリー油、マカデミアナッツ油、杏仁油、サフラワー油、サフラワー油(2)、ヒマワリ油、ヒマワリ油(2)、メドゥホーム油、アーモンド油、エゴマ油、ゴマ油、ボラージ油、カカオ脂、コメヌカ油、コメ胚芽油、ウイキョウ油、オレンジ油、カミツレ油、キューカンバー油、ククイナッツ油、大豆油、ティーツリー油、トウモロコシ油、ナタネ油、パーシック油、ヒマシ油、綿実油、落花生油、タートル油、ミンク油、アルガニアスピノサ核油、クランベアビシニカ種子油、アルモンド油、桃仁油、グレープシード油、エミュー油、ミンク油、アサ種子油、アマニ油、サザンカ油、モクロウ、ヤシ油、月見草油、ピスタシオ種子油、マンゴーバター等が挙げられ、これらのうち、1種または2種以上を組み合わせて用いることができる。
(Animal and vegetable oil)
As animal and vegetable oils, for example, squalane, olive oil, camellia oil, wheat germ oil, jojoba oil, avocado oil, carrot oil, shea fat, liquid shea fat, palm oil, palm kernel oil, hydrogenated oil, horse oil, lanolins Egg yolk oil, clove oil, rosehip oil, lavender oil, peppermint oil, spearmint oil, rosemary oil, macadamia nut oil, apricot oil, safflower oil, safflower oil (2), sunflower oil, sunflower oil (2), Medu home oil, almond oil, sesame oil, sesame oil, borage oil, cacao butter, rice bran oil, rice germ oil, fennel oil, orange oil, chamomile oil, cucumber oil, kukui nut oil, soybean oil, tea tree oil, corn oil, Rapeseed oil, persic oil, castor oil, cottonseed oil, peanut oil, turtle oil, mink oil, Arganian spinosa kernel oil, clay Bare vicinica seed oil, almond oil, peach seed oil, grape seed oil, emu oil, mink oil, Asa seed oil, flaxseed oil, sasanqua oil, owl, coconut oil, evening primrose oil, pistachio seed oil, mango butter, etc. Among them, one kind or a combination of two or more kinds can be used.
(アルコール)
アルコールとしては、例えば、エタノール、イソプロパノール、ブチルアルコール、ベンジルアルコール、ラウリルアルコール、ミリスチルアルコール、セタノール、セトステアリルアルコール、ステアリルアルコール、イソステアリルアルコール、オレイルアルコール、ヘキシルデカノール、ベヘニルアルコール、オクチルドデカノール、ラノリンアルコール、コレステロール、フィトステロール、2−ヘキシルデカノール、2−オクチルドデカノール、バチルアルコール等が挙げられ、これらのうち、1種または2種以上を組み合わせて用いることができる。
(alcohol)
Examples of the alcohol include ethanol, isopropanol, butyl alcohol, benzyl alcohol, lauryl alcohol, myristyl alcohol, cetanol, cetostearyl alcohol, stearyl alcohol, isostearyl alcohol, oleyl alcohol, hexyl decanol, behenyl alcohol, octyldodecanol, lanolin alcohol, cholesterol , Phytosterol, 2-hexyldecanol, 2-octyldodecanol, batyl alcohol, and the like. Among these, one kind or two or more kinds can be used in combination.
(エステル油)
エステル油としては、例えば、トリカプリル酸グリセリル、トリ2−エチルヘキサン酸グリセリル、イソノナン酸イソノニル、ジオクタン酸エチレングリコール、トリ(カプリル・カプリン酸)グリセリル、ミリスチン酸イソプロピル、ミリスチン酸ブチル、パルミチン酸イソプロピル、ステアリン酸エチル、ステアリン酸ブチル、オレイン酸エチル、リノール酸エチル、リノール酸イソプロピル、カプリル酸セチル、ミリスチン酸デシル、ラウリン酸ヘキシル、ミリスチン酸ミリスチル、ミリスチン酸セチル、パルミチン酸セチル、ステアリン酸ステアリル、オレイン酸オレイル、オレイン酸デシル、リシノール酸セチル、ラウリン酸イソステアリル、ミリスチン酸イソトリデシル、ミリスチン酸イソセチル、ミリスチン酸イソステアリル、ミリスチン酸2−オクチルドデシル、パルミチン酸エチルヘキシル、パルミチン酸イソセチル、ステアリン酸エチルヘキシル、ステアリン酸イソセチル、オレイン酸イソデシル、オレイン酸2−オクチルドデシル、リシノール酸2−オクチルドデシル、イソステアリン酸エチル、イソステアリン酸イソプロピル、オクタン酸セチル、オクタン酸セトステアリル、オクタン酸ステアリル、イソステアリン酸ヘキシル、ジオレイン酸エチレングリコール、ジカプリン酸プロピレングリコール、ジ(カプリル・カプリン酸)プロピレングリコール、ジオレイン酸プロピレングリコール、ジカプリン酸ネオペンチルグリコール、ジ2−エチルヘキサン酸ネオペンチルグリコール、トリウンデシル酸グリセリル、トリイソパルミチン酸グリセリル、トリイソステアリン酸グリセリル、トリ2−エチルヘキサン酸トリメチロールプロパン、トリイソステアリン酸トリメチロールプロパン、テトラ2−エチルヘキサン酸ペンタエリスリトール、テトラミリスチン酸ペンタエリスリトール、テトライソステアリン酸ペンタエリスリトール、ネオペンタン酸2−オクチルドデシル、オクタン酸イソセチル、オクタン酸イソステアリル、イソペアルゴン酸エチルヘキシル、ネオデカン酸2−ヘキシルデシル、ネオデカン酸2−オクチルドデシル、イソパルミチン酸エチルヘキシル、イソステアリン酸イソセチル、イソステアリン酸イソステアリル、イソステアリン酸2−オクチルドデシル、乳酸ラウリル、乳酸ミリスチル、乳酸セチル、乳酸2−オクチルドデシル、クエン酸トリエチル、クエン酸アセチルトリエチル、クエン酸アセチルトリブチル、クエン酸トリ2−エチルヘキシル、クエン酸トリイソセチル、クエン酸トリ2−オクチルドデシル、リンゴ酸ジイソステアリル、ヒドロキシステアリン酸2−エチルヘキシル、コハク酸ジオクチル、アジピン酸ジイソプロピル、アジピン酸ジイソブチル、アジピン酸ジオクチル、セバシン酸ジエチル、セバシン酸ジイソプロピル、セバシン酸ジオクチル、セバシン酸ジブチルオクチル、ステアリン酸コレステリル、イソステアリン酸コレステリル、ヒドロキシステアリン酸コレステリル、オレイン酸コレステリル、オレイン酸ジヒドロコレステリル、イソステアリン酸フィトステリル、オレイン酸フィトステリル、ジメチルオクタン酸ヘキシルデシル、乳酸セチル、フタル酸ジエチル、フタル酸ジブチル、炭酸ジアルキル等が挙げられ、これらのうち、1種または2種以上を組み合わせて用いることができる。
(Ester oil)
Examples of ester oils include glyceryl tricaprylate, glyceryl tri-2-ethylhexanoate, isononyl isononanoate, ethylene glycol dioctanoate, glyceryl tri (caprylate / caprate), isopropyl myristate, butyl myristate, isopropyl palmitate, stearin Ethyl acetate, butyl stearate, ethyl oleate, ethyl linoleate, isopropyl linoleate, cetyl caprylate, decyl myristate, hexyl laurate, myristyl myristate, cetyl myristate, cetyl palmitate, stearyl stearate, oleyl oleate , Decyl oleate, cetyl ricinoleate, isostearyl laurate, isotridecyl myristate, isocetyl myristate, isostearyl myristate 2-octyldodecyl myristate, ethylhexyl palmitate, isocetyl palmitate, ethylhexyl stearate, isocetyl stearate, isodecyl oleate, 2-octyldodecyl oleate, 2-octyldodecyl ricinoleate, ethyl isostearate, isopropyl isostearate, octane Cetyl acid, cetostearyl octoate, stearyl octoate, hexyl isostearate, ethylene glycol dioleate, propylene glycol dicaprate, propylene glycol di (capryl / caprate), propylene glycol dioleate, neopentyl glycol dicaprate, di-2- Neopentyl glycol ethylhexanoate, glyceryl triundecylate, glyceryl triisopalmitate, Glyceryl isostearate, trimethylolpropane tri-2-ethylhexanoate, trimethylolpropane triisostearate, pentaerythritol tetra2-ethylhexanoate, pentaerythritol tetramyristate, pentaerythritol tetraisostearate, 2-octyldodecyl neopentanoate, octane Isocetyl acid, isostearyl octoate, ethylhexyl isopearate, 2-hexyldecyl neodecanoate, 2-octyldodecyl neodecanoate, ethylhexyl isopalmitate, isocetyl isostearate, isostearyl isostearate, 2-octyldodecyl isostearate, lauryl lactate, Myristyl lactate, cetyl lactate, 2-octyldodecyl lactate, triethyl citrate, acetyl citrate Rutriethyl, acetyl tributyl citrate, tri-2-ethylhexyl citrate, triisocetyl citrate, tri-2-octyldodecyl citrate, diisostearyl malate, 2-ethylhexyl hydroxystearate, dioctyl succinate, diisopropyl adipate, diisobutyl adipate Dioctyl adipate, diethyl sebacate, diisopropyl sebacate, dioctyl sebacate, dibutyl octyl sebacate, cholesteryl isostearate, cholesteryl hydroxystearate, cholesteryl oleate, dihydrocholesteryl oleate, phytosteryl isostearate, oleic acid Phytosteryl, hexyldecyl dimethyloctanoate, cetyl lactate, diethyl phthalate, phthalic acid Butyl, dialkyl carbonate, and the like, among these, can be used alone or in combination.
(界面活性剤)
界面活性剤としては、例えば、ラウリル硫酸塩、アルキル硫酸塩、ポリオキシエチレンアルキル硫酸塩、テトラデセンスルホン酸塩、ポリオキシエチレンアルキルスルホコハク酸塩、ラウロイルサルコシン塩、アルキルメチル−β−アラニン塩、ポリオキシエチレンアルキルエーテルリン酸塩、脂肪酸石けん、N−アシルグルタミン酸塩、ラウリン酸ジエタノールアミド、ヤシ油脂肪酸ジエタノールアミド、アルキルジメチルアミンオキシド、アルキルメチルタウリン塩、アルキルアミノプロキオン酸塩、ポリオキシエチレンアルキルエーテルカルボン酸塩、アルキルリン酸塩、アルキルグルコシド、ポリエーテル変性シリコーン、塩化アルキルトリメチルアンモニウム、臭化アルキルトリメチルアンモニウム、アミドアミン、塩化ジアルキルジメチルアンモニウムジメチル酢酸ベタイン、アルキルアミドプロピルベタイン、アルキルカルボキシメチルヒドロキシエチルイミダゾリニウムベタイン、レシチン(大豆リン脂質、卵黄レシチン)およびその誘導体(水素添加卵黄レシチン、水素添加大豆リン脂質、卵黄リゾホスファチジルコリン、大豆リゾリン脂質液、水素添加大豆リゾリン脂質、水酸化大豆リン脂質)、プロピレングリコール脂肪酸エステル、グリセリン脂肪酸エステル、ポリグリセリン脂肪酸エステル、ポリオキシエチレングリセリン脂肪酸エステル、ソルビタン脂肪酸エステル、ポリオキシエチレンソルビタン脂肪酸エステル、ポリオキシエチレンソルビット脂肪酸エステル、ポリオキシエチレンラノリン、ポリオキシエチレンラノリンアルコール、ポリオキシエチレンソルビットミツロウ、ポリオキシエチレン硬化ヒマシ油、ポリオキシエチレンフィトステロール、ポリエチレングリコール脂肪酸エステル、ポリオキシエチレンポリオキシプロピレングリコール、ポリオキシエチレンアルキルエーテル、ポリオキシプロピレンアルキルエーテル、ポリオキシエチレンポリオキシプロピレンアルキルエーテル、ポリオキシエチレンアルキルノニルフェニルエーテル、ポリオキシエチレンアルキルエーテルリン酸・リン酸塩、ショ糖脂肪酸エステル等が挙げられ、これらのうち、1種または2種以上を組み合わせて用いることができる。
(Surfactant)
Examples of the surfactant include lauryl sulfate, alkyl sulfate, polyoxyethylene alkyl sulfate, tetradecene sulfonate, polyoxyethylene alkyl sulfosuccinate, lauroyl sarcosine salt, alkylmethyl-β-alanine salt, poly Oxyethylene alkyl ether phosphate, fatty acid soap, N-acyl glutamate, lauric acid diethanolamide, coconut oil fatty acid diethanolamide, alkyl dimethylamine oxide, alkyl methyl taurate, alkyl amino procionate, polyoxyethylene alkyl ether carboxyl Acid salt, alkyl phosphate, alkyl glucoside, polyether-modified silicone, alkyltrimethylammonium chloride, alkyltrimethylammonium bromide, amidoamine, dialkyl chloride Dimethylammonium dimethyl acetate betaine, alkylamidopropyl betaine, alkylcarboxymethylhydroxyethylimidazolinium betaine, lecithin (soybean phospholipid, egg yolk lecithin) and its derivatives (hydrogenated egg yolk lecithin, hydrogenated soybean phospholipid, egg yolk lysophosphatidylcholine, soybean Lysophospholipid solution, hydrogenated soybean lysophospholipid, hydroxylated soybean phospholipid), propylene glycol fatty acid ester, glycerin fatty acid ester, polyglycerin fatty acid ester, polyoxyethylene glycerin fatty acid ester, sorbitan fatty acid ester, polyoxyethylene sorbitan fatty acid ester, poly Oxyethylene sorbite fatty acid ester, polyoxyethylene lanolin, polyoxyethylene lanolin alcohol, polyoxye Tylene sorbite beeswax, polyoxyethylene hydrogenated castor oil, polyoxyethylene phytosterol, polyethylene glycol fatty acid ester, polyoxyethylene polyoxypropylene glycol, polyoxyethylene alkyl ether, polyoxypropylene alkyl ether, polyoxyethylene polyoxypropylene alkyl ether, Polyoxyethylene alkyl nonyl phenyl ether, polyoxyethylene alkyl ether phosphoric acid / phosphate, sucrose fatty acid ester and the like can be mentioned, and among these, one kind or two or more kinds can be used in combination.
これら界面活性剤は、乳化剤・可溶化剤としても用いられるが、保湿成分としても用いられることがある。保湿成分として用いる場合、植物油のEO付加物である非イオン界面活性剤が特に優れており、1種以上を用いることができる。非イオン界面活性剤の中では、例えばポリオキシエチレングリセリン脂肪酸エステル、ポリオキシエチレン硬化ヒマシ油、ポリオキシエチレンポリオキシプロピレングリコールが好ましく用いられる。 These surfactants are used as emulsifiers and solubilizers, but may also be used as moisturizing ingredients. When used as a moisturizing component, nonionic surfactants that are EO adducts of vegetable oils are particularly excellent, and one or more can be used. Among nonionic surfactants, for example, polyoxyethylene glycerin fatty acid ester, polyoxyethylene hydrogenated castor oil, and polyoxyethylene polyoxypropylene glycol are preferably used.
(湿潤剤)
湿潤剤としては、例えば、グリセリン、ジグリセリン、ソルビット液、ポリエチレングリコール、プロピレングリコール、ジプロピレングリコール及び1,3−ブチレングリコールなどの多価アルコールの他、酸化エチレン、エチレングリコールモノエチルエーテル、エチレングリコールモノブチルエーテル、ジエチレングリコールモノエチルエーテル、酸化プロピレン、ポリオキシアルキレンアルキルエーテル等が挙げられ、これらのうち、1種または2種以上を組み合わせて用いることができる。
(Wetting agent)
Examples of the wetting agent include glycerin, diglycerin, sorbit liquid, polyethylene glycol, propylene glycol, dipropylene glycol and 1,3-butylene glycol, as well as ethylene oxide, ethylene glycol monoethyl ether, ethylene glycol. Examples thereof include monobutyl ether, diethylene glycol monoethyl ether, propylene oxide, polyoxyalkylene alkyl ether, and the like. Among these, one kind or two or more kinds can be used in combination.
(溶剤)
溶剤としては、例えば、精製水、常水、イソプロパノール、ベンジルアルコール等が挙げられ、これらのうち、1種または2種以上を組み合わせて用いることができる。
(solvent)
Examples of the solvent include purified water, normal water, isopropanol, benzyl alcohol, and the like. Among these, one kind or a combination of two or more kinds can be used.
(消炎剤)
消炎剤としては、例えば、グリチルリチン酸、グリチルリチン酸ジカリウム、グリチルリチン酸モノアンモニウム、グリチルレチン酸、グリチルレチン酸ステアリル、グアイアズレン、グアイアズレンスルホン酸ナトリウム、アラントイン、ε−アミノカプロン酸等が挙げられ、これらのうち、1種または2種以上を組み合わせて用いることができる。
(Anti-inflammatory agent)
Examples of the anti-inflammatory agent include glycyrrhizic acid, dipotassium glycyrrhizinate, monoammonium glycyrrhizinate, glycyrrhetinic acid, stearyl glycyrrhetinate, guaiazulene, sodium guaiazulenesulfonate, allantoin, and ε-aminocaproic acid. Alternatively, two or more kinds can be used in combination.
(防腐剤)
防腐剤としては、例えば、メチルパラベン、エチルパラベン、プロピルパラベン、ブチルパラベン、イソブチルパラベン、フェノキシエタノール、ビサボロール、ヒノキチオール、安息香酸、安息香酸ナトリウム、サリチル酸、サリチル酸ナトリウム、ソルビン酸、ソルビン酸カリウム、ウンデシレン酸、ピオニン、l−メントール、d−カンフル、イソプロピルメチルフェノール、塩化ベンゼトニウム、塩酸アルキルジアミノエチルグリシン等が挙げられ、これらのうち、1種または2種以上を組み合わせて用いることができる。
(Preservative)
Examples of the preservatives include methyl paraben, ethyl paraben, propyl paraben, butyl paraben, isobutyl paraben, phenoxyethanol, bisabolol, hinokitiol, benzoic acid, sodium benzoate, salicylic acid, sodium salicylate, sorbic acid, potassium sorbate, undecylenic acid, and pionein. , L-menthol, d-camphor, isopropylmethylphenol, benzethonium chloride, alkyldiaminoethylglycine hydrochloride, and the like. Among these, one kind or two or more kinds can be used in combination.
(酸化防止剤)
酸化防止剤としては、例えば、ジブチルヒドロキシトルエン、ブチルヒドロキシアニソール、エリソルビン酸、没食子酸プロピル、アスコルビン酸およびアスコルビン酸誘導体、d−δ−トコフェロール等が挙げられ、これらのうち、1種または2種以上を組み合わせて用いることができる。
(Antioxidant)
Examples of the antioxidant include dibutylhydroxytoluene, butylhydroxyanisole, erythorbic acid, propyl gallate, ascorbic acid and ascorbic acid derivatives, d-δ-tocopherol, etc. Among these, one or more of them are used. Can be used in combination.
(pH調整剤)
pH調整剤としては、例えば、水酸化ナトリウム、水酸化カリウム、L−アルギニン、トリエタノールアミン、ジエタノールアミン、クエン酸、グリコール酸、リンゴ酸、酒石酸、乳酸、コハク酸、リン酸およびその塩等が挙げられ、これらのうち、1種または2種以上を組み合わせて用いることができる。
以上、本発明の皮膚外用剤について説明したが、本発明はこれに限定されない。
(PH adjuster)
Examples of the pH adjuster include sodium hydroxide, potassium hydroxide, L-arginine, triethanolamine, diethanolamine, citric acid, glycolic acid, malic acid, tartaric acid, lactic acid, succinic acid, phosphoric acid and salts thereof. Of these, one or a combination of two or more can be used.
As mentioned above, although the skin external preparation of this invention was demonstrated, this invention is not limited to this.
次に、本発明の具体的実施例について説明する。
(実施例1)
表1に示す成分および配合量を用いて、以下のようにして、クリーム状の皮膚外用剤を製造した。
成分1〜3および成分5〜12を80℃にて均一に加温混合し、混合物1を得た。
Next, specific examples of the present invention will be described.
Example 1
Using the components and blending amounts shown in Table 1, a creamy external preparation for skin was produced as follows.
Components 1 to 3 and components 5 to 12 were uniformly heated and mixed at 80 ° C. to obtain a mixture 1.
次に、成分4、20を混合し、80℃まで加温し、これを混合物1に添加し、乳化した。 Next, the components 4 and 20 were mixed, heated to 80 ° C., added to the mixture 1 and emulsified.
次に、形成した乳化物を40℃まで冷却した後、成分13〜19を順次添加した。
その後、30℃まで冷却することにより、皮膚外用剤を得た。
Next, after cooling the formed emulsion to 40 degreeC, the components 13-19 were added sequentially.
Then, the skin external preparation was obtained by cooling to 30 degreeC.
(実施例2〜11、比較例1〜4)
表1に示す成分および配合量を用いた以外は、前記実施例1と同様にしてクリーム状の皮膚外用剤を製造した。
(Examples 2-11, Comparative Examples 1-4)
A creamy skin external preparation was produced in the same manner as in Example 1 except that the components and amounts shown in Table 1 were used.
(実施例12)
下記成分および配合量を用いて、常法によりゲル状の皮膚外用剤を製造した。
(Example 12)
A gel-like skin external preparation was produced by a conventional method using the following components and blending amounts.
クロルヘキシジン塩酸塩:0.1質量%
ステアリン酸:1.5質量%
ベヘン酸:0.5質量%
カラギーナン:0.5質量%
濃グリセリン:10.0質量%
ポリオキシエチレン硬化ヒマシ油:1.0質量%
パラオキシ安息香酸エステル:0.3質量%
フェノキシエタノール:0.3質量%
精製水:残量
Chlorhexidine hydrochloride: 0.1% by mass
Stearic acid: 1.5% by mass
Behenic acid: 0.5% by mass
Carrageenan: 0.5% by mass
Concentrated glycerin: 10.0% by mass
Polyoxyethylene hydrogenated castor oil: 1.0% by mass
Paraoxybenzoic acid ester: 0.3% by mass
Phenoxyethanol: 0.3% by mass
Purified water: remaining amount
(実施例13)
下記成分および配合量を用いて、常法によりゲル状の皮膚外用剤を製造した。
クロルヘキシジン塩酸塩:0.1質量%
ステアリン酸:1.5質量%
ベヘン酸:0.5質量%
カラギーナン:0.2質量%
キサンタンガム:0.3質量%
濃グリセリン:15.0質量%
1,3−ブチレングリコール:5.0質量%
ポリオキシエチレンポリオキシプロピレンセチルエーテル:1.5質量%
パラオキシ安息香酸エステル:0.3質量%
フェノキシエタノール:0.3質量%
精製水:残量
(Example 13)
A gel-like skin external preparation was produced by a conventional method using the following components and blending amounts.
Chlorhexidine hydrochloride: 0.1% by mass
Stearic acid: 1.5% by mass
Behenic acid: 0.5% by mass
Carrageenan: 0.2% by mass
Xanthan gum: 0.3% by mass
Concentrated glycerin: 15.0 mass%
1,3-butylene glycol: 5.0% by mass
Polyoxyethylene polyoxypropylene cetyl ether: 1.5% by mass
Paraoxybenzoic acid ester: 0.3% by mass
Phenoxyethanol: 0.3% by mass
Purified water: remaining amount
(実施例14)
下記成分および配合量を用いて、常法によりゲル状の皮膚外用剤を製造した。
クロルヘキシジン塩酸塩:0.1質量%
ステアリン酸:2.0質量%
ベヘン酸:0.4質量%
カラギーナン:0.3質量%
キサンタンガム:0.2質量%
濃グリセリン:15.0質量%
1,3−ブチレングリコール:5.0質量%
モノステアリン酸ポリオキシエチレンソルビタン:2.0質量%
パラオキシ安息香酸エステル:0.3質量%
フェノキシエタノール:0.3質量%
精製水:残量
(Example 14)
A gel-like skin external preparation was produced by a conventional method using the following components and blending amounts.
Chlorhexidine hydrochloride: 0.1% by mass
Stearic acid: 2.0% by mass
Behenic acid: 0.4% by mass
Carrageenan: 0.3% by mass
Xanthan gum: 0.2% by mass
Concentrated glycerin: 15.0 mass%
1,3-butylene glycol: 5.0% by mass
Polystearic acid polyoxyethylene sorbitan: 2.0% by mass
Paraoxybenzoic acid ester: 0.3% by mass
Phenoxyethanol: 0.3% by mass
Purified water: remaining amount
(実施例15)
下記成分および配合量を用いて、常法により軟膏状の皮膚外用剤を製造した。
クロルヘキシジン塩酸塩:0.2質量%
ステアリン酸:10.0質量%
ベヘン酸:2.0質量%
カラギーナン:0.3質量%
モノステアリン酸ソルビタン:5.0質量%
ミリスチン酸イソプロピル:35.0質量%
スクワラン:10.0質量%
パラフィン:10.0質量%
ワセリン:25.0質量%
精製水:残量
(Example 15)
An ointment-like external preparation for skin was produced by a conventional method using the following components and blending amounts.
Chlorhexidine hydrochloride: 0.2% by mass
Stearic acid: 10.0% by mass
Behenic acid: 2.0% by mass
Carrageenan: 0.3% by mass
Sorbitan monostearate: 5.0% by mass
Isopropyl myristate: 35.0% by mass
Squalane: 10.0% by mass
Paraffin: 10.0% by mass
Vaseline: 25.0% by mass
Purified water: remaining amount
(実施例16)
下記成分および配合量を用いて、常法により軟膏状の皮膚外用剤を製造した。
クロルヘキシジン塩酸塩:0.1質量%
ステアリン酸:8.0質量%
ベヘン酸:1.5質量%
カラギーナン:0.3質量%
モノイソステアリン酸ソルビタン:4.0質量%
ミリスチン酸イソプロピル:30.0質量%
スクワラン:15.0質量%
パラフィン:15.0質量%
ワセリン:20.0質量%
フェノキシエタノール:0.2質量%
グリセリンモノ2−エチルヘキシルエーテル:0.05質量%
精製水:残量
(Example 16)
An ointment-like external preparation for skin was produced by a conventional method using the following components and blending amounts.
Chlorhexidine hydrochloride: 0.1% by mass
Stearic acid: 8.0% by mass
Behenic acid: 1.5% by mass
Carrageenan: 0.3% by mass
Sorbitan monoisostearate: 4.0% by mass
Isopropyl myristate: 30.0% by mass
Squalane: 15.0 mass%
Paraffin: 15.0% by mass
Vaseline: 20.0 mass%
Phenoxyethanol: 0.2% by mass
Glycerin mono 2-ethylhexyl ether: 0.05% by mass
Purified water: remaining amount
(実施例17)
下記成分および配合量を用いて、常法によりクリーム状の皮膚外用剤を製造した。
クロルヘキシジン塩酸塩:0.1質量%
ステアリン酸:5.0質量%
ベヘン酸:1.5質量%
カラギーナン:0.2質量%
セスキオレイン酸ソルビタン:0.8質量%
モノステアリン酸ポリオキシエチレンソルビタン:2.5質量%
グリセリン脂肪酸エステル:0.5質量%
流動パラフィン:10.0質量%
オリーブ油:2.0質量%
ホホバ油:0.5質量%
スクワラン:1.0質量%
ミリスチン酸ミリスチル1.0質量%
セタノール:2.0質量%
ベヘニルアルコール:0.3質量%
フェノキシエタノール:0.5質量%
グリセリンモノ2−エチルヘキシルエーテル:0.2質量%
濃グリセリン:5.0質量%
1,3−ブチレングリコール:5.0質量%
精製水:残量
(Example 17)
A creamy skin external preparation was produced by a conventional method using the following components and blending amounts.
Chlorhexidine hydrochloride: 0.1% by mass
Stearic acid: 5.0% by mass
Behenic acid: 1.5% by mass
Carrageenan: 0.2% by mass
Sorbitan sesquioleate: 0.8% by mass
Polystearic acid polyoxyethylene sorbitan: 2.5% by mass
Glycerin fatty acid ester: 0.5% by mass
Liquid paraffin: 10.0% by mass
Olive oil: 2.0% by mass
Jojoba oil: 0.5% by mass
Squalane: 1.0% by mass
Myristyl myristate 1.0% by mass
Cetanol: 2.0% by mass
Behenyl alcohol: 0.3% by mass
Phenoxyethanol: 0.5% by mass
Glycerin mono 2-ethylhexyl ether: 0.2% by mass
Concentrated glycerin: 5.0% by mass
1,3-butylene glycol: 5.0% by mass
Purified water: remaining amount
(実施例18)
下記成分および配合量を用いて、常法によりクリーム状の皮膚外用剤を製造した。
クロルヘキシジン塩酸塩:0.2質量%
ステアリン酸:4.0質量%
ベヘン酸:1.0質量%
カラギーナン:0.3質量%
ポリオキシエチレンベヘニルエーテル:2.5質量%
ペンタステアリン酸デカグリセリル:1.0質量%
グリセリン脂肪酸エステル:0.5質量%
水素添加大豆リン脂質:0.2質量%
トリ2−エチルヘキサン酸グリセリル:5.0質量%
ホホバ油:0.5質量%
スクワラン:1.0質量%
イソノナン酸イソノニル:1.0質量%
ステアリルアルコール:1.0質量%
ベヘニルアルコール:0.5質量%
パラオキシ安息香酸エステル:0.5質量%
濃グリセリン:10.0質量%
1,3−ブチレングリコール:3.0質量%
L−アルギニン:0.2質量%
精製水:残量
(Example 18)
A creamy skin external preparation was produced by a conventional method using the following components and blending amounts.
Chlorhexidine hydrochloride: 0.2% by mass
Stearic acid: 4.0% by mass
Behenic acid: 1.0% by mass
Carrageenan: 0.3% by mass
Polyoxyethylene behenyl ether: 2.5% by mass
Decaglyceryl pentastearate: 1.0% by mass
Glycerin fatty acid ester: 0.5% by mass
Hydrogenated soybean phospholipid: 0.2% by mass
Glyceryl tri-2-ethylhexanoate: 5.0% by mass
Jojoba oil: 0.5% by mass
Squalane: 1.0% by mass
Isononyl isononanoate: 1.0% by mass
Stearyl alcohol: 1.0% by mass
Behenyl alcohol: 0.5% by mass
Paraoxybenzoic acid ester: 0.5% by mass
Concentrated glycerin: 10.0% by mass
1,3-butylene glycol: 3.0% by mass
L-arginine: 0.2% by mass
Purified water: remaining amount
(実施例19)
下記成分および配合量を用いて、常法によりクリーム状の皮膚外用剤を製造した。
クロルヘキシジン塩酸塩:0.2質量%
ステアリン酸:2.0質量%
ベヘン酸:0.6質量%
カラギーナン:0.18質量%
モノイソステアリン酸ポリグリセリル:2.0質量%
ミリスチン酸デカグリセリル:2.0質量%
水素添加大豆リン脂質:0.4質量%
トリ(カプリル・カプリン酸)グリセリル:7.0質量%
パルミチン酸2−エチルヘキシル:2.0質量%
スクワラン:2.0質量%
ジカプリン酸ネオペンチルグリコール:1.0質量%
セトステアリルアルコール:3.0質量%
フェノキシエタノール:0.2質量%
パラオキシ安息香酸エステル:0.5質量%
濃グリセリン:6.0質量%
ジプロピレングリコール:5.0質量%
L−アルギニン:0.15質量%
精製水:残量
実施例1〜11および比較例1〜4の配合成分および配合量を表1に示した。
(Example 19)
A creamy skin external preparation was produced by a conventional method using the following components and blending amounts.
Chlorhexidine hydrochloride: 0.2% by mass
Stearic acid: 2.0% by mass
Behenic acid: 0.6% by mass
Carrageenan: 0.18% by mass
Polyglyceryl monoisostearate: 2.0% by mass
Decaglyceryl myristate: 2.0% by mass
Hydrogenated soybean phospholipid: 0.4% by mass
Tri (capryl / capric acid) glyceryl: 7.0% by mass
2-ethylhexyl palmitate: 2.0% by mass
Squalane: 2.0% by mass
Neopentyl glycol dicaprate: 1.0% by mass
Cetostearyl alcohol: 3.0% by mass
Phenoxyethanol: 0.2% by mass
Paraoxybenzoic acid ester: 0.5% by mass
Concentrated glycerin: 6.0% by mass
Dipropylene glycol: 5.0% by mass
L-arginine: 0.15% by mass
Purified water: remaining amount Table 1 shows the blending components and blending amounts of Examples 1 to 11 and Comparative Examples 1 to 4.
<評価>
[クロルヘキシジン塩酸塩の安定性の評価]
製造直後、40℃で6か月放置後の各実施例および各比較例の製剤について、高速液体クロマトグラフィーを用いて、クロルヘキシジンの含量を測定した。製造直後のクロルヘキシジンの含量を100%とし、40℃で6か月後のクロルヘキシジンの割合を求めた。
<Evaluation>
[Evaluation of stability of chlorhexidine hydrochloride]
Immediately after production, the chlorhexidine content of each of the preparations of Examples and Comparative Examples after standing at 40 ° C. for 6 months was measured using high performance liquid chromatography. The content of chlorhexidine immediately after production was taken as 100%, and the proportion of chlorhexidine after 6 months at 40 ° C. was determined.
<評価基準>
A :クロルヘキシジンの安定性が90%以上
B :クロルヘキシジンの安定性が80%以上90%未満
C :クロルヘキシジンの安定性が70%よりも大きく80%よりも小さい
D :クロルヘキシジンの安定性が70%以下
<Evaluation criteria>
A: Stability of chlorhexidine is 90% or more B: Stability of chlorhexidine is 80% or more and less than 90% C: Stability of chlorhexidine is more than 70% and less than 80% D: Stability of chlorhexidine is 70% or less
[使用感の評価]
皮膚への塗布時における各実施例および各比較例の製剤の使用感を、女性6人で下記基準に従い評価し、評価者6人の平均値で示した。
[Evaluation of usability]
The feeling of use of the preparations of each Example and each Comparative Example at the time of application to the skin was evaluated by 6 women according to the following criteria, and indicated by an average value of 6 evaluators.
<評価基準>
A :良い
B :やや良い
C :やや悪い
D :悪い
<Evaluation criteria>
A: Good B: Somewhat good C: Somewhat bad D: Bad
[製剤安定性の評価]
40℃で6か月保存した各実施例および各比較例の製剤について、製造直後の製剤に対する40℃で6か月保存後の製剤の外観変化(褐変、沈殿、二層分離)の有無を観察し、以下の基準に従って評価した。
[Evaluation of formulation stability]
Regarding the preparations of Examples and Comparative Examples stored at 40 ° C. for 6 months, the appearance changes (browning, precipitation, two-layer separation) of the preparations after storage for 6 months at 40 ° C. with respect to the preparations immediately after production were observed. And evaluated according to the following criteria.
<評価基準>
A :褐変、沈殿、二層分離のすべてにおいて変化がほとんど認められなかった。
B :褐変、沈殿、二層分離の1項目において少しの変化が認められた。
C :褐変、沈殿、二層分離の2項目以上において少しの変化が認められた。
D :褐変、沈殿、二層分離の1項目以上において顕著な変化が認められた。
これらの結果を、表2に示した。
<Evaluation criteria>
A: Almost no change was observed in all of browning, precipitation, and two-layer separation.
B: A slight change was observed in one item of browning, precipitation, and two-layer separation.
C: A slight change was observed in two or more items of browning, precipitation, and two-layer separation.
D: Remarkable changes were observed in one or more items of browning, precipitation, and two-layer separation.
These results are shown in Table 2.
表2から明らかなように、本発明の皮膚外用剤は、クロルヘキシジン塩酸塩の安定性に優れたものであった。また、使用感、製剤安定性にも優れていた。これに対して、比較例では、十分な結果が得られなかった。 As apparent from Table 2, the external preparation for skin of the present invention was excellent in the stability of chlorhexidine hydrochloride. Moreover, it was excellent in feeling of use and formulation stability. On the other hand, in the comparative example, sufficient results were not obtained.
Claims (8)
前記高級脂肪酸Aは、ベヘン酸、アラキジン酸またはリグノセリン酸であり、
前記高級脂肪酸Bは、ステアリン酸、パルミチン酸またはミリスチン酸であることを特徴とする皮膚外用剤。 See containing chlorhexidine hydrochloride, and high higher fatty acid A than a melting point of 72 ° C., a melting point of 72 ° C. or less and a higher fatty acid B, and,
The higher fatty acid A is behenic acid, arachidic acid or lignoceric acid,
The external preparation for skin , wherein the higher fatty acid B is stearic acid, palmitic acid or myristic acid .
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JPS61130210A (en) * | 1984-11-28 | 1986-06-18 | Sunstar Inc | Pasta containing stabilized chlorhexidine |
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