JP2023041793A - Composition for external use - Google Patents
Composition for external use Download PDFInfo
- Publication number
- JP2023041793A JP2023041793A JP2023012496A JP2023012496A JP2023041793A JP 2023041793 A JP2023041793 A JP 2023041793A JP 2023012496 A JP2023012496 A JP 2023012496A JP 2023012496 A JP2023012496 A JP 2023012496A JP 2023041793 A JP2023041793 A JP 2023041793A
- Authority
- JP
- Japan
- Prior art keywords
- oil
- composition
- weight
- acid
- hydrochloride
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- 239000000203 mixture Substances 0.000 title claims abstract description 132
- 239000000739 antihistaminic agent Substances 0.000 claims abstract description 49
- 235000015112 vegetable and seed oil Nutrition 0.000 claims abstract description 30
- 239000008158 vegetable oil Substances 0.000 claims abstract description 30
- 239000000839 emulsion Substances 0.000 claims abstract description 24
- 230000000699 topical effect Effects 0.000 claims abstract description 13
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- 230000001387 anti-histamine Effects 0.000 claims description 27
- 239000003921 oil Substances 0.000 abstract description 37
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- 150000003839 salts Chemical class 0.000 abstract description 28
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- 239000000171 lavandula angustifolia l. flower oil Substances 0.000 abstract description 17
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- VBICKXHEKHSIBG-UHFFFAOYSA-N 1-monostearoylglycerol Chemical compound CCCCCCCCCCCCCCCCCC(=O)OCC(O)CO VBICKXHEKHSIBG-UHFFFAOYSA-N 0.000 description 4
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- QFOHBWFCKVYLES-UHFFFAOYSA-N Butylparaben Chemical compound CCCCOC(=O)C1=CC=C(O)C=C1 QFOHBWFCKVYLES-UHFFFAOYSA-N 0.000 description 4
- 201000004624 Dermatitis Diseases 0.000 description 4
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- GYDJEQRTZSCIOI-LJGSYFOKSA-N tranexamic acid Chemical compound NC[C@H]1CC[C@H](C(O)=O)CC1 GYDJEQRTZSCIOI-LJGSYFOKSA-N 0.000 description 1
- 229960000401 tranexamic acid Drugs 0.000 description 1
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- 229960003223 tripelennamine Drugs 0.000 description 1
- 229960000732 tripelennamine hydrochloride Drugs 0.000 description 1
- 229960001593 triprolidine hydrochloride Drugs 0.000 description 1
- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical compound [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 description 1
- 229940052016 turmeric extract Drugs 0.000 description 1
- 239000008513 turmeric extract Substances 0.000 description 1
- 235000020240 turmeric extract Nutrition 0.000 description 1
- 239000010681 turmeric oil Substances 0.000 description 1
- 150000003669 ubiquinones Chemical class 0.000 description 1
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- 229940096998 ursolic acid Drugs 0.000 description 1
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- 229940070710 valerate Drugs 0.000 description 1
- 229940099259 vaseline Drugs 0.000 description 1
- 235000019871 vegetable fat Nutrition 0.000 description 1
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- 229920002554 vinyl polymer Polymers 0.000 description 1
- 239000011653 vitamin D2 Substances 0.000 description 1
- MECHNRXZTMCUDQ-RKHKHRCZSA-N vitamin D2 Chemical compound C1(/[C@@H]2CC[C@@H]([C@]2(CCC1)C)[C@H](C)/C=C/[C@H](C)C(C)C)=C\C=C1\C[C@@H](O)CCC1=C MECHNRXZTMCUDQ-RKHKHRCZSA-N 0.000 description 1
- 235000001892 vitamin D2 Nutrition 0.000 description 1
- 239000011647 vitamin D3 Substances 0.000 description 1
- 235000005282 vitamin D3 Nutrition 0.000 description 1
- QYSXJUFSXHHAJI-YRZJJWOYSA-N vitamin D3 Chemical compound C1(/[C@@H]2CC[C@@H]([C@]2(CCC1)C)[C@H](C)CCCC(C)C)=C\C=C1\C[C@@H](O)CCC1=C QYSXJUFSXHHAJI-YRZJJWOYSA-N 0.000 description 1
- 229940046009 vitamin E Drugs 0.000 description 1
- 235000019165 vitamin E Nutrition 0.000 description 1
- 239000011709 vitamin E Substances 0.000 description 1
- 229940021056 vitamin d3 Drugs 0.000 description 1
- 229960004740 voriconazole Drugs 0.000 description 1
- BCEHBSKCWLPMDN-MGPLVRAMSA-N voriconazole Chemical compound C1([C@H](C)[C@](O)(CN2N=CN=C2)C=2C(=CC(F)=CC=2)F)=NC=NC=C1F BCEHBSKCWLPMDN-MGPLVRAMSA-N 0.000 description 1
- 235000020234 walnut Nutrition 0.000 description 1
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- 239000000811 xylitol Substances 0.000 description 1
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 description 1
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- 229960002675 xylitol Drugs 0.000 description 1
- 239000009538 yokuinin Substances 0.000 description 1
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Landscapes
- Medicinal Preparation (AREA)
- Cosmetics (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
Description
新規性喪失の例外適用申請有り There is an application for exception to loss of novelty
本発明は、安定性に優れる外用組成物に関する。 TECHNICAL FIELD The present invention relates to an external composition having excellent stability.
医薬などの外用組成物の剤型としては、固形剤、散剤、液剤、リニメント剤、ローション剤、クリーム剤、軟膏剤、ゲル剤、スプレー剤、貼付剤などが用いられている。この中で、クリーム剤は、油性物質と水性物質とを含み、水中油型又は油中水型に乳化した半固形の製剤である。また、ローション剤には、乳剤性ローション、溶液性ローション、懸濁性ローション等があるが、乳剤性ローションは、水中油型又は油中水型に乳化した液体ないし流動状の製剤である。このような乳剤は、使用感が良い、良く延びる、水で洗い流せるといったメリットがあり、外用組成物の剤型として多用されている。
しかし、乳剤は、水相と油相とが経時的に分離することがあるため、乳化状態を安定に保つための工夫が必要である。このため、界面活性剤が配合されることが多いが、高濃度の界面活性剤は皮膚刺激などの難点があり、その観点からは配合量は抑えることが望ましい。また、水中油型乳剤では、増粘剤を配合して水相の粘性を向上させることにより、水相と油相との分離を抑制することも行われているが、高濃度の増粘剤の配合によりベタツキが増して、使用感が損なわれることがある。
Solid formulations, powder formulations, liquid formulations, liniment formulations, lotions, cream formulations, ointments, gel formulations, spray formulations, patches and the like are used as dosage forms for topical compositions such as pharmaceuticals. Among these, creams are semi-solid preparations emulsified in oil-in-water or water-in-oil form, containing an oily substance and an aqueous substance. Lotions include emulsion lotions, solution lotions, suspension lotions, etc. Emulsion lotions are oil-in-water or water-in-oil emulsified liquid or fluid preparations. Such emulsions have advantages such as good feeling in use, good spreadability, and rinsability with water, and are often used as formulations of compositions for external use.
However, since the emulsion may separate into an aqueous phase and an oil phase over time, it is necessary to devise ways to keep the emulsified state stable. For this reason, surfactants are often blended, but high-concentration surfactants have drawbacks such as skin irritation. In oil-in-water emulsions, a thickener is added to improve the viscosity of the aqueous phase, thereby suppressing the separation of the aqueous phase and the oil phase. Due to the combination of , stickiness may increase and the feeling of use may be impaired.
このため、従来、乳剤の安定性を向上させるための試みが多数行われている。
例えば、特許文献1は、クロスポビドン、カルメロース、クロスカルメロース、カルボキシメチルスターチといった、通常、固形製剤に配合される崩壊剤を、水中油型乳化組成物に配合することにより、経時的な分離、特に高温環境下における分離が抑制されることを教えている。
しかし、有効成分の種類等に適した乳化安定化技術が求められている。
For this reason, many attempts have been made in the past to improve the stability of emulsions.
For example, Patent Document 1 discloses that disintegrants such as crospovidone, carmellose, croscarmellose, and carboxymethyl starch, which are usually blended in solid preparations, are blended into an oil-in-water emulsion composition, thereby separating over time, It teaches that separation is suppressed, especially in a high temperature environment.
However, there is a demand for an emulsification stabilization technique suitable for the type of active ingredient.
ここで、植物性油は、動物油や鉱物油と異なり、常温で液体のものが多く、分子量が小さいため皮膚に浸透し易く、皮膚上に皮膜を形成し難いため汗腺や皮脂腺からの排泄を妨げ難く、さらに、それ自体ビタミン、ミネラル、抗酸化物質などの有用成分を含むといったメリットがあり、外用組成物の成分として多用されている。 Here, unlike animal oils and mineral oils, many of the vegetable oils are liquid at room temperature, and because of their small molecular weight, they easily permeate the skin. In addition, it has the advantage of containing useful ingredients such as vitamins, minerals, and antioxidants, and is often used as a component of external compositions.
本発明は、乳剤である外用組成物であって、水相と油相の分離が抑制された組成物を提供することを課題とする。 An object of the present invention is to provide an emulsifiable composition for external use in which the separation of an aqueous phase and an oil phase is suppressed.
本発明者は、上記課題を解決するために研究を重ね、以下の知見を得た。
抗ヒスタミン剤又は植物性油を配合した乳剤は、乳化状態が不安定になり易いが、意外にも、抗ヒスタミン剤と植物性油を含有する乳剤であれば、両成分が相乗的に作用して、乳化状態の安定性が向上する。
The present inventor has made extensive research to solve the above problems, and has obtained the following knowledge.
Emulsions containing antihistamines or vegetable oils tend to be unstable in their emulsified state. stability is improved.
本発明は、上記知見に基づき完成されたものであり、下記の外用組成物を提供する。
項1. 抗ヒスタミン剤、及び植物性油を含有し、乳剤である外用組成物。
項2. 抗ヒスタミン剤が、エタノールアミン系抗ヒスタミン剤、及びプロピルアミン系の抗ヒスタミン剤からなる群より選ばれる少なくとも1種である、項1に記載の外用組成物。
項3. 抗ヒスタミン剤の含有量が、組成物の全量に対して、0.01~5重量%である、項1又は2に記載の外用組成物。
項4. 植物性油が精油である、項1~3の何れかに記載の外用組成物。
項5. 植物性油の含有量が、組成物の全量に対して、0.0001~1重量%である、項1~4の何れかに記載の外用組成物。
項6. さらに、局所麻酔剤を含有する、項1~5の何れかに記載の外用組成物。
項7. 局所麻酔剤の含有量が、組成物の全量に対して、0.01~5重量%である、項6に記載の外用組成物。
項8. 水中油型乳剤である、項1~7の何れかに記載の外用組成物。
項9. 水を、組成物の全量に対して、0.1~95重量%含有する、項1~8の何れかに記載の外用組成物。
項10. クリーム剤、又はローション剤である、項1~9の何れかに記載の外用組成物。
項11. 皮膚外用組成物である、項1~10の何れかに記載の外用組成物。
The present invention has been completed based on the above findings, and provides the following composition for external use.
Section 1. A topical composition comprising an antihistamine and a vegetable oil and which is an emulsion.
Section 2. Item 2. The composition for external use according to Item 1, wherein the antihistamine is at least one selected from the group consisting of ethanolamine-based antihistamines and propylamine-based antihistamines.
Item 3. Item 3. The composition for external use according to Item 1 or 2, wherein the content of the antihistamine is 0.01 to 5% by weight relative to the total amount of the composition.
Section 4. Item 4. The composition for external use according to any one of Items 1 to 3, wherein the vegetable oil is an essential oil.
Item 5. Item 5. The composition for external use according to any one of Items 1 to 4, wherein the content of the vegetable oil is 0.0001 to 1% by weight relative to the total amount of the composition.
Item 6. Item 6. The composition for external use according to any one of Items 1 to 5, further comprising a local anesthetic.
Item 7. Item 7. The composition for external use according to Item 6, wherein the content of the local anesthetic is 0.01 to 5% by weight relative to the total amount of the composition.
Item 8. Item 8. The composition for external use according to any one of Items 1 to 7, which is an oil-in-water emulsion.
Item 9. Item 9. The composition for external use according to any one of Items 1 to 8, containing 0.1 to 95% by weight of water relative to the total amount of the composition.
Item 10. Item 10. The composition for external use according to any one of Items 1 to 9, which is a cream or lotion.
Item 11. Item 11. The composition for external use according to any one of Items 1 to 10, which is a composition for external use on the skin.
本発明の外用組成物は、植物性油及び抗ヒスタミン剤を含有することによって、乳化状態の安定性が向上している。本発明の外用組成物は、熱だけでなく光に対しても乳化状態の安定性が向上している。
本発明の組成物は、界面活性剤や増粘剤といった、薬効に不要な添加物の配合のみによらずに、ないしはこれらの添加物に頼らず、乳剤の安定性を向上させることができるため、製剤化の自由度が高くなる。
The composition for external use of the present invention has improved stability in an emulsified state by containing a vegetable oil and an antihistamine. The composition for external use of the present invention has improved emulsified stability against not only heat but also light.
The composition of the present invention can improve the stability of the emulsion without relying solely on the addition of additives such as surfactants and thickeners that are unnecessary for drug efficacy, or without relying on these additives. , increasing the degree of freedom in formulation.
また、本発明の外用組成物は、抗ヒスタミン剤を含むため、痒み症状や皮膚乾燥に起因する症状を示す疾患の治療、予防、又は改善に好適であるところ、植物油(特に、精油)を含むことにより、製剤に香りを付与してリラックス効果を高め、痒みなどに対するストレスを和らげる効果が期待できる。 In addition, since the topical composition of the present invention contains an antihistamine, it is suitable for the treatment, prevention, or amelioration of diseases exhibiting itching symptoms and symptoms caused by dry skin. , It can be expected that the preparation will be scented to enhance the relaxation effect and relieve stress such as itching.
以下、本発明を詳細に説明する。
本発明の外用組成物は、抗ヒスタミン剤と植物性油を含み、乳剤である、外用組成物である。
The present invention will be described in detail below.
The topical composition of the present invention is an emulsifiable composition containing an antihistamine and a vegetable oil.
抗ヒスタミン剤
抗ヒスタミン剤としては、ジフェンヒドラミン、ブロモジフェンヒドラミン、クレマスチン、クロルフェノキサミン、ジフェニルピラリン、ドキシラミン、オルフェナドリン、フェニルトロキサミンのようなエタノールアミン系抗ヒスタミン剤、クロルフェニラミン、ジメチンデン、タラスチンのようなプロピルアミン系抗ヒスタミン剤、メピラミン、メタピリレン、トリペレナミンのようなエチレンジアミン系抗ヒスタミン剤、アリメマジン、ヒドロキシエチルプロメタジン、イソチペンジル、メキタジン、オキソメマジン、プロメタジンのようなフェノチアジン系抗ヒスタミン剤、ブクリジン、セチリジン、ホモクロルシクリジン、シクリジン、ヒドロキシジン、レボセチリジン、メクリジン、オキサトミドのようなピペラジン系抗ヒスタミン剤、ケトチフェン、オロパタジン、フェキソフェナジン、ロラタジン、テルフェナジン、アンタゾリン、アザタジン、バミピン、シプロヘプタジン、デプトロピン、エバスチン、エメダスチン、エピナスチン、メブヒドロリン、ミゾラスチン、ピメチキセン、ピロブタミン、キフェナジン、ルパタジン、トリプロリジン、アクリバスチン、アステミゾール、アゼラスチン、ビラスチン、デスロラタジン、及びこれらの塩などが挙げられる。
Antihistamines Antihistamines include ethanolamine antihistamines such as diphenhydramine, bromodiphenhydramine, clemastine, chlorphenoxamine, diphenylpyraline, doxylamine, orphenadrine and phenyltroxamine, and propylamine antihistamines such as chlorpheniramine, dimethindene and talastine. ethylenediamine antihistamines such as , mepyramine, metapyrylene, tripelennamine, alimemazine, hydroxyethylpromethazine, isothipendyl, phenothiazine antihistamines such as mequitazine, oxomemazine, promethazine, buclizine, cetirizine, homochlorcyclidine, cyclizine, hydroxyzine, levocetirizine, meclizine , piperazine antihistamines such as oxatomide, ketotifen, olopatadine, fexofenadine, loratadine, terfenadine, antazoline, azatadine, vamipine, cyproheptadine, deptropine, ebastine, emedastine, epinastine, mebhydroline, mizolastine, pimethixene, pyrobutamine, kifenadine, rupatadine, triplo Lysine, acrivastine, astemizole, azelastine, bilastine, desloratadine, salts thereof and the like.
塩は、薬学的又は生理学的に許容される塩であればよく、無機酸塩、有機酸塩などが挙げられる。無機酸塩としては、塩酸塩、臭化水素酸塩、硝酸塩、硫酸塩、リン酸塩などが挙げられる。有機酸塩としては、酢酸塩、トリフルオロ酢酸塩、酪酸塩、パルミチン酸塩、ステアリン酸塩のようなモノカルボン酸塩、フマル酸塩、マレイン酸塩、コハク酸塩、マロン酸塩等の多価カルボン酸塩、乳酸塩、酒石酸塩、クエン酸塩のようなオキシカルボン酸塩、メタンスルホン酸塩、トルエンスルホン酸塩、トシル酸塩、ナパジシル酸塩のような有機スルホン酸塩などが挙げられる。
具体的には、ジフェンヒドラミン塩酸塩、ブロモジフェンヒドラミン塩酸塩、クレマスチンマレイン酸塩、クロルフェノキサミン塩酸塩、ジフェニルピラリン塩酸塩、ドキシラミンコハク酸塩、オルフェナドリン塩酸塩、クロルフェニラミンマレイン酸塩、ジメチンデンマレイン酸塩、メタピリレン塩酸塩、トリペレナミン塩酸塩、アリメマジン酒石酸塩、イソチペンジル塩酸塩、セチリジン塩酸塩、ホモクロルシクリジン塩酸塩、シクリジン塩酸塩、ヒドロキシジン塩酸塩、レボセチリジン塩酸塩、メクリジン塩酸塩、ケトチフェンフマル酸塩、オロパタジン塩酸塩、フェキソフェナジン塩酸塩、アンタゾリン塩酸塩、アザタジンマレイン酸塩、シプロヘプタジン塩酸塩、デプトロピンクエン酸塩、エメダスチンフマル酸塩、エピナスチン塩酸塩、メブヒドロリンナパジシル酸塩、ピメチキセンマレイン酸塩、ピロブタミンリン酸塩、キフェナジン塩酸塩、ルパタジンフマル酸塩、トリプロリジン塩酸塩、アゼラスチン塩酸塩などが挙げられる。
塩である抗ヒスタミン剤は、水和物、半水和物、又は無水物であり得る。
The salt may be any pharmaceutically or physiologically acceptable salt, including inorganic acid salts and organic acid salts. Inorganic acid salts include hydrochlorides, hydrobromides, nitrates, sulfates, phosphates and the like. Organic acid salts include monocarboxylic acid salts such as acetate, trifluoroacetate, butyrate, palmitate and stearate; hydroxycarboxylic acid salts such as carboxylates, lactates, tartrates and citrates; organic sulfonates such as methanesulfonates, toluenesulfonates, tosylates and napadisylates; .
Specifically, diphenhydramine hydrochloride, bromodiphenhydramine hydrochloride, clemastine maleate, chlorphenoxamine hydrochloride, diphenylpyraline hydrochloride, doxylamine succinate, orphenadrine hydrochloride, chlorpheniramine maleate, Dimethinedene maleate, metapyrylene hydrochloride, tripelennamine hydrochloride, alimemazine tartrate, isothipendyl hydrochloride, cetirizine hydrochloride, homochlorcyclidine hydrochloride, cyclidine hydrochloride, hydroxyzine hydrochloride, levocetiridine hydrochloride, meclizine hydrochloride , ketotifen fumarate, olopatadine hydrochloride, fexofenadine hydrochloride, antazoline hydrochloride, azatadine maleate, cyproheptadine hydrochloride, deptropine citrate, emedastine fumarate, epinastine hydrochloride, mebhydroline napadisilate, pimethixene maleate, pyrobutamine phosphate, kifenadine hydrochloride, rupatadine fumarate, triprolidine hydrochloride, azelastine hydrochloride, and the like.
Antihistamines that are salts can be hydrates, hemihydrates, or anhydrous.
中でも、エタノールアミン系、プロピルアミン系、エチレンジアミン系といったアミン系抗ヒスタミン剤が好ましく、エタノールアミン系、プロピルアミン系の抗ヒスタミン剤がより好ましく、エタノールアミン系の抗ヒスタミン剤がさらに好ましく、ジフェンヒドラミン、又はその塩(特に、塩酸塩のような無機酸塩)がさらにより好ましく、ジフェンヒドラミン、ジフェンヒドラミン塩酸塩が特に好ましい。
抗ヒスタミン剤は、1種を単独で、又は2種以上を組み合わせて使用できる。
Among them, amine-based antihistamines such as ethanolamine-based, propylamine-based, and ethylenediamine-based are preferable, ethanolamine-based and propylamine-based antihistamines are more preferable, ethanolamine-based antihistamines are more preferable, and diphenhydramine or a salt thereof (particularly, hydrochloric acid Inorganic acid salts such as salts) are even more preferred, and diphenhydramine and diphenhydramine hydrochloride are particularly preferred.
An antihistamine can be used individually by 1 type or in combination of 2 or more types.
抗ヒスタミン剤の含有量は、組成物の全量に対して、0.01重量%以上が好ましく、0.05重量%以上がより好ましく、0.1重量%以上がさらに好ましく、0.5重量%以上がさらにより好ましく、0.8重量%以上が特に好ましい。また、5重量%以下が好ましく、3重量%以下がより好ましく、2重量%以下がさらに好ましく、1.5重量%以下がさらにより好ましく、1.1重量%以下が特に好ましい。1重量%が最も好ましい。この範囲であれば、適切な抗ヒスタミン作用が発揮されると共に、組成物の乳化状態の安定性を十分に向上させることができる。 The content of the antihistamine is preferably 0.01% by weight or more, more preferably 0.05% by weight or more, still more preferably 0.1% by weight or more, and 0.5% by weight or more, relative to the total amount of the composition. Even more preferably, 0.8% by weight or more is particularly preferable. Also, it is preferably 5% by weight or less, more preferably 3% by weight or less, even more preferably 2% by weight or less, even more preferably 1.5% by weight or less, and particularly preferably 1.1% by weight or less. 1% by weight is most preferred. Within this range, an appropriate antihistamine action can be exhibited and the emulsified state stability of the composition can be sufficiently improved.
植物性油
植物性油としては、ラベンダー油、ユーカリ油、ローズマリー油、ローズヒップ油、ローマカミツレ油、カミツレ油(カモマイル油)、ハッカ油、キダチハッカ油、ペパーミント油、スペアミント油、ベチベル油、リトシア・キュベバ油、レモン油、白檀油、ナツメグ油、シナモン油、ヒソップ油、キャラウェー油、オレンジ油、カデ油、ベルガモット油、グレープフルーツ油、ライム油、サルビア油、タイム油、クローブ油、アロエ油、ジャスミン油、ネロリ油、ローズ油、カンファー油、ゼラニウム油、サンダルウッド油、イランイラン油、メリッサ油、バジル油、パチュリー油、ジュニパー油、ジュニパーベリー油、セージ油、黒コショウ油、マージョラム油、アミリス油、ヨモギ油、ニガヨモギ油、アンゲリカ油、ショウガ油、オールスパイス油、カスカリラ油、カラムス油、クラリセージ油、セロリ油、ティーツリー油、キャロット油、パチョリ油、ベチバー油、ホップ油、マスティック油、ミルラ油、ラブダナム油、ウコン油、オリガナム油、ガランガ油、シトロネラ油、ベイ油、ヤロー油、ピメントベリー油、ロベージ油などの精油が挙げられる。
Vegetable oils Vegetable oils include lavender oil, eucalyptus oil, rosemary oil, rosehip oil, Roman chamomile oil, chamomile oil (chamomile oil), peppermint oil, peppermint oil, peppermint oil, spearmint oil, vetiver oil, lithosia.・Cubeba oil, lemon oil, sandalwood oil, nutmeg oil, cinnamon oil, hyssop oil, caraway oil, orange oil, cadet oil, bergamot oil, grapefruit oil, lime oil, salvia oil, thyme oil, clove oil, aloe oil, Jasmine oil, neroli oil, rose oil, camphor oil, geranium oil, sandalwood oil, ylang-ylang oil, melissa oil, basil oil, patchouli oil, juniper oil, juniper berry oil, sage oil, black pepper oil, marjoram oil, amyris oil, wormwood oil, wormwood oil, angelica oil, ginger oil, allspice oil, cascara oil, calamus oil, clary sage oil, celery oil, tea tree oil, carrot oil, patchouli oil, vetiver oil, hops oil, mastic oil, Essential oils such as myrrh oil, labdanum oil, turmeric oil, origanum oil, galanga oil, citronella oil, bay oil, yarrow oil, pimento berry oil, and lobage oil.
また、室温で非揮発性の植物性油も用いることができ、ヒマワリ油、月見草油、アルモンド油、オリーブ油、アボガド油、ホホバ油、コーン油、大豆油、ゼニアオイ油、グレープシード油、ゴマ油、ヘーゼルナッツ油、プルセリン油、パーム油、ヒマシ油、ウォールナッツ油、カシュナッツ油、スイートアルモンド油、ククイナッツ油、サフラワー油、椿油、マカデミアナッツ油、サザンカ油、ラッカセイ油、メドフォーム油、コメ杯芽油、スクワランなどが挙げられる。 Vegetable oils that are non-volatile at room temperature can also be used, such as sunflower oil, evening primrose oil, almond oil, olive oil, avocado oil, jojoba oil, corn oil, soybean oil, mallow oil, grapeseed oil, sesame oil, hazelnut. Oil, Purcellin Oil, Palm Oil, Castor Oil, Walnut Oil, Cashew Oil, Sweet Almond Oil, Kukui Nut Oil, Safflower Oil, Camellia Oil, Macadamia Nut Oil, Camellia Oil, Peanut Oil, Medfoam Oil, Rice Cup Bud Oil, Squalane etc.
中でも、精油は、本願発明の組成物において、乳化状態の安定化効果が特に高く、また、製剤に香りを付与することによってリラックス効果を高め、痒み等に対するストレスを和らげる効果が期待できる観点から、本発明の好適な対象である。特に、ラベンダー油、ユーカリ油、ベルガモット油、カミツレ油が好ましく、ラベンダー油、ユーカリ油がより好ましい。
植物性油は、1種を単独で、又は2種以上を組み合わせて使用できる。
Among them, essential oils have a particularly high effect of stabilizing the emulsified state in the composition of the present invention, and can be expected to have an effect of enhancing relaxation and relieving stress such as itching by adding fragrance to the formulation. It is a preferred subject of the present invention. Lavender oil, eucalyptus oil, bergamot oil and chamomile oil are particularly preferred, and lavender oil and eucalyptus oil are more preferred.
A vegetable oil can be used individually by 1 type or in combination of 2 or more types.
植物性油の含有量は、組成物の全量に対して、0.0001重量%以上が好ましく、0.001重量%以上がより好ましく、0.005重量%以上がさらに好ましく、0.01重量%以上がさらにより好ましい。また、0.03重量%以上、中でも0.05重量%以上とすることもできる。また、1重量%以下が好ましく、0.5重量%以下がより好ましく、0.2重量%以下がさらにより好ましい。また、0.1重量%以下とすることもできる。この範囲であれば、組成物の乳化状態の安定性を十分に向上させることができ、また、適度な香りの付与が可能となる。 The content of the vegetable oil is preferably 0.0001% by weight or more, more preferably 0.001% by weight or more, still more preferably 0.005% by weight or more, and 0.01% by weight, based on the total amount of the composition. The above is even more preferred. Also, it can be 0.03% by weight or more, especially 0.05% by weight or more. Also, it is preferably 1% by weight or less, more preferably 0.5% by weight or less, and even more preferably 0.2% by weight or less. Also, it can be 0.1% by weight or less. Within this range, the stability of the emulsified state of the composition can be sufficiently improved, and an appropriate fragrance can be imparted.
植物性油がラベンダー油である場合には、ラベンダー油が酢酸リナロールを多く含むことから、酢酸リナロールの含有量でラベンダー油の含有量を規定することができる。ラベンダー油は、酢酸リナロールの組成物全量に対する濃度が、0.0001重量%以上、中でも0.0005重量%以上、中でも0.001重量%以上、中でも0.0025重量%以上になるように含まれることが好ましい。また、酢酸リナロールの組成物全量に対する濃度が0.01重量%以上になるように含まれることもできる。また、ラベンダー油は、酢酸リナロールの組成物全量に対する濃度が、1重量%以下、中でも0.5重量%以下、中でも0.1重量%以下、中でも0.05重量%以下になるように含まれることが好ましい。 When the vegetable oil is lavender oil, since lavender oil contains a large amount of linalool acetate, the content of lavender oil can be defined by the content of linalool acetate. Lavender oil is contained so that the concentration of linalool acetate with respect to the total amount of the composition is 0.0001% by weight or more, especially 0.0005% by weight or more, especially 0.001% by weight or more, and especially 0.0025% by weight or more. is preferred. In addition, linalool acetate may be included in a concentration of 0.01% by weight or more relative to the total amount of the composition. In addition, lavender oil is contained so that the concentration of linalool acetate with respect to the total amount of the composition is 1% by weight or less, especially 0.5% by weight or less, especially 0.1% by weight or less, and especially 0.05% by weight or less. is preferred.
植物性油がユーカリ油である場合には、ユーカリ油がシネオールを多く含むことから、シネオールの含有量でユーカリ油の含有量を規定することができる。ユーカリ油は、シネオールの組成物全量に対する濃度が、0.0001重量%以上、中でも0.0005重量%以上、中でも0.001重量%以上、中でも0.005重量%以上になるように含まれることが好ましい。また、シネオールの組成物全量に対する濃度が0.01重量%以上、中でも0.05重量%以上になるように含まれる態様も例示できる。また、ユーカリ油は、シネオールの組成物全量に対する濃度が、1重量%以下、中でも0.5重量%以下、中でも0.1重量%以下になるように含まれることが好ましい。 When the vegetable oil is eucalyptus oil, since eucalyptus oil contains a large amount of cineole, the content of eucalyptus oil can be defined by the content of cineole. Eucalyptus oil is contained so that the concentration of cineol in the total amount of the composition is 0.0001% by weight or more, especially 0.0005% by weight or more, especially 0.001% by weight or more, especially 0.005% by weight or more. is preferred. In addition, an aspect in which cineol is contained so as to have a concentration of 0.01% by weight or more, particularly 0.05% by weight or more, relative to the total amount of the composition can be exemplified. Also, the eucalyptus oil is preferably contained so that the concentration of cineole with respect to the total amount of the composition is 1% by weight or less, especially 0.5% by weight or less, and especially 0.1% by weight or less.
本発明の外用組成物における、抗ヒスタミン剤に対する植物性油の含有比率は特に限定されず、抗ヒスタミン剤及び植物性油の種類、他の配合成分の種類及び含有量、外用組成物の用途及び製剤形態等に応じて適宜設定することができる。抗ヒスタミン剤に対する植物性油の含有比率は、本発明の効果をより一層高める観点から、例えば、抗ヒスタミン剤の総含有量1重量部に対して、植物性油の総含有量が、0.0001~5重量部であることが好ましく、0.001~1重量部であることがより好ましく、0.005~0.5重量部であることがさらにより好ましく、0.01~0.2重量部であることが特に好ましい。 The content ratio of the vegetable oil to the antihistamine in the composition for external use of the present invention is not particularly limited. It can be set as appropriate. From the viewpoint of further enhancing the effects of the present invention, the content ratio of the vegetable oil to the antihistamine is, for example, 0.0001 to 5 parts by weight of the total content of the vegetable oil per 1 part by weight of the total content of the antihistamine. part, more preferably 0.001 to 1 part by weight, even more preferably 0.005 to 0.5 part by weight, and 0.01 to 0.2 part by weight is particularly preferred.
局所麻酔剤
本発明の組成物は、局所麻酔剤を含むことができる。
局所麻酔剤としては、リドカイン、ジブカイン、メピバカイン、ブピバカイン、ロピバカイン、レボブピバカイン、オキセサゼイン、及びこれらの塩のようなアミン構造及びアミド構造を有する局所麻酔剤、コカイン、プロカイン、クロロプロカイン、テトラカイン、及びこれらの塩のようなアミン構造及びエステル構造を有する局所麻酔剤、エステル構造を有するアミノ安息香酸エチル、オキシポリエトキシドデカンなどが挙げられる。
Local Anesthetic The compositions of the present invention may contain a local anesthetic.
Local anesthetics include local anesthetics having amine and amide structures such as lidocaine, dibucaine, mepivacaine, bupivacaine, ropivacaine, levobupivacaine, oxethazaine, and salts thereof, cocaine, procaine, chloroprocaine, tetracaine, and Examples include local anesthetics having an amine structure and an ester structure such as salts of these, ethyl aminobenzoate having an ester structure, oxypolyethoxide decane, and the like.
塩は、薬学的又は生理学的に許容される塩であればよく、無機酸塩、有機酸塩などが挙げられる。無機酸塩としては、塩酸塩、臭化水素酸塩、硝酸塩、硫酸塩、リン酸塩などが挙げられる。有機酸塩としては、酢酸塩、トリフルオロ酢酸塩、酪酸塩、パルミチン酸塩、ステアリン酸塩のようなモノカルボン酸塩、フマル酸塩、マレイン酸塩、コハク酸塩、マロン酸塩のような多価カルボン酸塩、乳酸塩、酒石酸塩、クエン酸塩のようなオキシカルボン酸塩、メタンスルホン酸塩、トルエンスルホン酸塩、トシル酸塩、ナパジシル酸のような有機スルホン酸塩などが挙げられる。
具体的には、リドカイン塩酸塩、ジブカイン塩酸塩、メピバカイン塩酸塩、ブピバカイン塩酸塩、ロピバカイン塩酸塩、レボブピバカイン塩酸塩、オキセサゼイン塩酸塩、コカイン塩酸塩、プロカイン塩酸塩、クロロプロカイン塩酸塩、テトラカイン塩酸塩などが挙げられる。
塩である局所麻酔剤は、水和物、半水和物、又は無水物であり得る。
The salt may be any pharmaceutically or physiologically acceptable salt, including inorganic acid salts and organic acid salts. Inorganic acid salts include hydrochlorides, hydrobromides, nitrates, sulfates, phosphates and the like. Organic acid salts include monocarboxylates such as acetate, trifluoroacetate, butyrate, palmitate and stearate, fumarate, maleate, succinate and malonate. Polycarboxylic acid salts, lactates, tartrates, oxycarboxylic acid salts such as citrates, methanesulfonates, toluenesulfonates, tosylates, organic sulfonates such as napadisic acid, and the like. .
Specifically, lidocaine hydrochloride, dibucaine hydrochloride, mepivacaine hydrochloride, bupivacaine hydrochloride, ropivacaine hydrochloride, levobupivacaine hydrochloride, oxethazaine hydrochloride, cocaine hydrochloride, procaine hydrochloride, chloroprocaine hydrochloride, tetracaine hydrochloride Examples include salt.
Local anesthetics that are salts can be hydrates, hemihydrates, or anhydrous.
中でも、リドカイン、ジブカイン、アミノ安息香酸エチル、オキシポリエトキシドデカン、又はそれらの塩(塩酸塩など)が好ましく、リドカイン又はその塩がより好ましく、リドカイン、塩酸リドカインがさらに好ましく、リドカインがさらにより好ましい。
局所麻酔剤は、1種を単独で、又は2種以上を組み合わせて使用できる。
Among them, lidocaine, dibucaine, ethyl aminobenzoate, oxypolyethoxide decane, or salts thereof (such as hydrochloride) are preferred, lidocaine or salts thereof are more preferred, lidocaine and lidocaine hydrochloride are more preferred, and lidocaine is even more preferred.
A local anesthetic can be used individually by 1 type or in combination of 2 or more types.
局所麻酔剤の含有量は、組成物の全量に対して、0.01重量%以上が好ましく、0.05重量%以上がより好ましく、0.1重量%以上がさらに好ましく、0.5重量%以上がさらにより好ましい。また、1重量%以上とすることもできる。また、5重量%以下が好ましく、3重量%以下がより好ましく、2重量%以下がさらにより好ましい。この範囲であれば、局所麻酔作用が効果的に発揮されると共に、本発明の乳剤の安定性が十分に向上する。 The content of the local anesthetic is preferably 0.01% by weight or more, more preferably 0.05% by weight or more, still more preferably 0.1% by weight or more, and 0.5% by weight, relative to the total amount of the composition. The above is even more preferred. Also, it can be 1% by weight or more. Also, it is preferably 5% by weight or less, more preferably 3% by weight or less, and even more preferably 2% by weight or less. Within this range, the local anesthetic action is effectively exhibited and the stability of the emulsion of the present invention is sufficiently improved.
本発明の外用組成物における、抗ヒスタミン剤に対する局所麻酔剤の含有比率は特に限定されず、抗ヒスタミン剤及び局所麻酔剤の種類、他の配合成分の種類及び含有量、外用組成物の用途及び製剤形態等に応じて適宜設定することができる。抗ヒスタミン剤に対する局所麻酔剤の含有比率は、本発明の効果をより一層高める観点から、例えば、抗ヒスタミン剤の総含有量1重量部に対して、局所麻酔剤の総含有量が、0.01~20重量部であることが好ましく、0.05~10重量部であることがより好ましく、0.1~5重量部であることがさらにより好ましく、0.2~2.5重量部であることが特に好ましい。 The content ratio of the local anesthetic to the antihistamine in the external composition of the present invention is not particularly limited, and depends on the types of antihistamine and local anesthetic, the types and contents of other ingredients, the application and formulation form of the external composition, and the like. It can be set as appropriate. From the viewpoint of further enhancing the effects of the present invention, the content ratio of the local anesthetic to the antihistamine is, for example, 0.01 to 20 parts by weight of the total content of the local anesthetic per 1 part by weight of the total content of the antihistamine. parts, more preferably 0.05 to 10 parts by weight, even more preferably 0.1 to 5 parts by weight, particularly 0.2 to 2.5 parts by weight. preferable.
鎮痒剤
本発明の組成物は、さらに抗ヒスタミン剤以外の鎮痒剤を含むことができる。
抗ヒスタミン剤以外の鎮痒剤としては、クロタミトン、イクタモール、モクタール、チモール、及びそれらの塩などが挙げられる。
塩は、薬学的又は生理学的に許容される塩であればよく、無機酸塩、有機酸塩などが挙げられる。無機酸塩としては、塩酸塩、臭化水素酸塩、硝酸塩、硫酸塩、リン酸塩などが挙げられる。有機酸塩としては、酢酸塩、トリフルオロ酢酸塩、酪酸塩、パルミチン酸塩、ステアリン酸塩のようなモノカルボン酸塩、フマル酸塩、マレイン酸塩、コハク酸塩、マロン酸塩のような多価カルボン酸塩、乳酸塩、酒石酸塩、クエン酸塩のようなオキシカルボン酸塩、メタンスルホン酸塩、トルエンスルホン酸塩、トシル酸塩、ナパジシル酸のような有機スルホン酸塩などが挙げられる。
塩である鎮痒剤は、水和物、半水和物、又は無水物であり得る。
中でも、クロタミトンが好ましい。
抗ヒスタミン剤以外の鎮痒剤は、1種を単独で、又は2種以上を組み合わせて使用できる。
Antipruritics The compositions of the present invention may further contain antipruritic agents other than antihistamines.
Antipruritics other than antihistamines include crotamiton, ictamol, moktar, thymol, salts thereof, and the like.
The salt may be any pharmaceutically or physiologically acceptable salt, including inorganic acid salts and organic acid salts. Inorganic acid salts include hydrochlorides, hydrobromides, nitrates, sulfates, phosphates and the like. Organic acid salts include monocarboxylates such as acetate, trifluoroacetate, butyrate, palmitate and stearate, fumarate, maleate, succinate and malonate. Polycarboxylic acid salts, lactates, tartrates, oxycarboxylic acid salts such as citrates, methanesulfonates, toluenesulfonates, tosylates, organic sulfonates such as napadisic acid, and the like. .
Antipruritic agents that are salts can be hydrates, hemihydrates, or anhydrous.
Among them, crotamiton is preferred.
Antipruritics other than antihistamines can be used singly or in combination of two or more.
抗ヒスタミン剤以外の鎮痒剤の含有量は、組成物の全量に対して、0.01重量%以上が好ましく、0.1重量%以上がより好ましく、1重量%以上がさらに好ましく、3重量%以上がさらにより好ましい。また、20重量%以下が好ましく、10重量%以下がより好ましく、5重量%以下がさらにより好ましい。この範囲であれば、鎮痒作用が効果的に発揮されると共に、本発明の効果が十分に奏される。 The content of the antipruritic agent other than the antihistamine is preferably 0.01% by weight or more, more preferably 0.1% by weight or more, still more preferably 1% by weight or more, and 3% by weight or more, relative to the total amount of the composition. Even more preferred. Also, it is preferably 20% by weight or less, more preferably 10% by weight or less, and even more preferably 5% by weight or less. Within this range, the antipruritic action is effectively exhibited, and the effects of the present invention are sufficiently exhibited.
その他の成分
本発明の組成物は、抗ヒスタミン剤、及び植物性油を含む成分を、医薬品、医薬部外品、又は化粧品に使用される基剤又は担体、及び必要に応じて添加剤や、その他の生理活性又は薬理活性成分と混合して、医薬品、医薬部外品、又は化粧品の外用組成物とすることができる。特に、医薬組成物(医薬外用組成物)であり得る。
Other Ingredients The composition of the present invention contains an antihistamine and a vegetable oil as a base or carrier used in pharmaceuticals, quasi-drugs, or cosmetics, and if necessary, additives and other ingredients. It can be mixed with a physiologically active or pharmacologically active ingredient to prepare an external composition for pharmaceuticals, quasi-drugs, or cosmetics. In particular, it may be a pharmaceutical composition (external pharmaceutical composition).
添加剤としては、例えば、界面活性剤、増粘剤、保存剤、pH調整剤、安定化剤又はキレート剤、紫外線吸収剤又は紫外線散乱剤、刺激軽減剤、着色剤などが挙げられる。
添加剤は、1種を単独で、又は2種以上を組み合わせて使用できる。
また、添加剤は、本発明の効果を損なわない範囲で使用することができる。
Additives include, for example, surfactants, thickeners, preservatives, pH adjusters, stabilizers or chelating agents, UV absorbers or UV scattering agents, irritation reducers, colorants and the like.
An additive can be used individually by 1 type or in combination of 2 or more types.
In addition, additives can be used within a range that does not impair the effects of the present invention.
界面活性剤としては、ソルビタンモノイソステアレート、ソルビタンモノラウレート、ソルビタンモノパルミテート、ソルビタンモノステアレート、ペンタ-2-エチルヘキシル酸ジグリセロールソルビタン、テトラ-2-エチルヘキシル酸ジグリセロールソルビタン等のソルビタン脂肪酸エステル類、モノステアリン酸グリセリン、モノステアリン酸グリセリンリンゴ酸等のグリセリン脂肪酸類、モノイソステアリン酸ポリグリセリル、ジイソステアリン酸ポリグリセリル等のポリグリセリン脂肪酸類、モノステアリン酸プロピレングリコール等のプロピレングリコール脂肪酸エステル類、ポリオキシエチレン硬化ヒマシ油(ポリオキシエチレン硬化ヒマシ油40、ポリオキシエチレン硬化ヒマシ油60、ポリオキシエチレン硬化ヒマシ油80など)等の硬化ヒマシ油誘導体、モノラウリル酸ポリオキシエチレン(20)ソルビタン(ポリソルベート20)、モノステアリン酸ポリオキシエチレン(20)ソルビタン(ポリソルベート60)、モノオレイン酸ポリオキシエチレン(20)ソルビタン(ポリソルベート80)等のポリオキシエチレンソルビタン脂肪酸エステル類、ポリオキシエチレンモノヤシ油脂肪酸グリセリル、グリセリンアルキルエーテル、アルキルグルコシド、ポリオキシエチレンセチルエーテル(セトマクロゴール)、ステアリルアミン、オレイルアミンなどが挙げられる。
界面活性剤は、組成物の全量に対して、例えば0.1~20重量%、好ましくは1~10重量%を配合できる。
Surfactants include sorbitan fatty acids such as sorbitan monoisostearate, sorbitan monolaurate, sorbitan monopalmitate, sorbitan monostearate, diglycerol sorbitan penta-2-ethylhexylate, and diglycerol sorbitan tetra-2-ethylhexylate. Esters, glycerin fatty acids such as glyceryl monostearate, glyceryl monostearate malic acid, polyglycerol fatty acids such as polyglyceryl monoisostearate and polyglyceryl diisostearate, propylene glycol fatty acid esters such as propylene glycol monostearate, polyoxy Hydrogenated castor oil derivatives such as ethylene hydrogenated castor oil (polyoxyethylene hydrogenated castor oil 40, polyoxyethylene hydrogenated castor oil 60, polyoxyethylene hydrogenated castor oil 80, etc.), polyoxyethylene (20) sorbitan monolaurate (polysorbate 20 ), polyoxyethylene sorbitan fatty acid esters such as polyoxyethylene (20) sorbitan monostearate (polysorbate 60), polyoxyethylene (20) sorbitan monooleate (polysorbate 80), polyoxyethylene monococonut fatty acid glyceryl, Glycerin alkyl ether, alkyl glucoside, polyoxyethylene cetyl ether (cetomacrogol), stearylamine, oleylamine and the like.
Surfactants can be blended, for example, in an amount of 0.1 to 20% by weight, preferably 1 to 10% by weight, based on the total amount of the composition.
増粘剤としては、増粘多糖類(グアーガム、ローカストビーンガム、カラギーナン、キサンタンガム、デキストランなど)、セルロース系増粘剤(メチルセルロース、エチルセルロース、カルボキシメチルセルロース、カルボキシエチルセルロース、ヒドロキシメチルセルロース、ヒドロキシエチルセルロース、ヒドロキシプロピルセルロース、ヒドロキシプロピルメチルセルロースなど)、アルギン酸、その塩、及びその誘導体(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など)、ビニル系増粘剤(ポリビニルアルコール、ポリビニルピロリドン、ポリビニルメチルエーテル、カルボキシビニルポリマー、アクリル酸メタクリル酸アルキル共重合体、ポリアクリル酸ナトリウムなど)、ベントナイト、デキストリン脂肪酸エステル、ペクチンなどが挙げられる。
増粘剤は、組成物の全量に対して、例えば0.01~10重量%、好ましくは0.1~5重量%を配合できる。
Thickeners include thickening polysaccharides (guar gum, locust bean gum, carrageenan, xanthan gum, dextran, etc.), cellulose thickeners (methylcellulose, ethylcellulose, carboxymethylcellulose, carboxyethylcellulose, hydroxymethylcellulose, hydroxyethylcellulose, hydroxypropylcellulose , hydroxypropyl methylcellulose, etc.), alginic acid, its salts and derivatives (alginic acid, sodium alginate, propylene glycol alginate, etc.), vinyl thickeners (polyvinyl alcohol, polyvinylpyrrolidone, polyvinyl methyl ether, carboxyvinyl polymer, acrylic acid alkyl methacrylate copolymer, sodium polyacrylate, etc.), bentonite, dextrin fatty acid ester, pectin, and the like.
The thickener can be blended, for example, in an amount of 0.01 to 10% by weight, preferably 0.1 to 5% by weight, based on the total amount of the composition.
保存剤としては、安息香酸、安息香酸ナトリウム、デヒドロ酢酸、デヒドロ酢酸ナトリウム、パラオキシ安息香酸イソブチル、パラオキシ安息香酸イソプロピル、パラオキシ安息香酸ブチル、パラオキシ安息香酸エチル、パラオキシ安息香酸プロピル、パラオキシ安息香酸ベンジル、パラオキシ安息香酸メチル、フェノキシエタノール、BHTなどが挙げられる。 Preservatives include benzoic acid, sodium benzoate, dehydroacetic acid, sodium dehydroacetate, isobutyl parahydroxybenzoate, isopropyl parahydroxybenzoate, butyl parahydroxybenzoate, ethyl parahydroxybenzoate, propyl parahydroxybenzoate, benzyl parahydroxybenzoate, paraoxy Examples include methyl benzoate, phenoxyethanol, and BHT.
pH調整剤としては、無機酸(塩酸、硫酸、リン酸、ポリリン酸、ホウ酸など)、有機酸(乳酸、酢酸、クエン酸、酒石酸、リンゴ酸、コハク酸、コハク酸ナトリウム、シュウ酸、グルコン酸、フマル酸、プロピオン酸、酢酸、アスパラギン酸、イプシロン-アミノカプロン酸、グルタミン酸、アミノエチルスルホン酸など)、グルコノラクトン、酢酸アンモニウム、無機塩基(炭酸水素ナトリウム、炭酸ナトリウム、水酸化カリウム、水酸化ナトリウム、水酸化カルシウム、水酸化マグネシウムなど)、有機塩基(モノエタノールアミン、トリエタノールアミン、ジイソプロパノールアミン、トリイソプロパノールアミン、リジンなど)などが挙げられる。 pH adjusters include inorganic acids (hydrochloric acid, sulfuric acid, phosphoric acid, polyphosphoric acid, boric acid, etc.), organic acids (lactic acid, acetic acid, citric acid, tartaric acid, malic acid, succinic acid, sodium succinate, oxalic acid, gluconate acid, fumaric acid, propionic acid, acetic acid, aspartic acid, epsilon-aminocaproic acid, glutamic acid, aminoethylsulfonic acid, etc.), gluconolactone, ammonium acetate, inorganic bases (sodium bicarbonate, sodium carbonate, potassium hydroxide, hydroxide sodium, calcium hydroxide, magnesium hydroxide, etc.), organic bases (monoethanolamine, triethanolamine, diisopropanolamine, triisopropanolamine, lysine, etc.).
安定化剤又はキレート剤としては、エデト酸ナトリウム、エデト酸四ナトリウム、エデト酸四ナトリウム四水塩などが挙げられる。 Stabilizers or chelating agents include sodium edetate, tetrasodium edetate, tetrasodium edetate tetrahydrate, and the like.
紫外線吸収剤又は紫外線散乱剤としては、パラメトキシケイ皮酸2-エチルヘキシル、2-[4-(ジエチルアミノ)-2-ヒドロキシベンゾイル]安息香酸ヘキシルエステル、2,4,6-トリス[4-(2-エチルヘキシルオキシカルボニル)アニリノ]-1,3,5-トリアジン、t-ブチルメトキシジベンゾイルメタン、ジベンジリデンジオキソイミダゾリジンプロピロン酸エチルヘキシル、エトルヘキシルトリアゾリン、パラアミノ安息香酸およびその誘導体、パラジメチルアミノ安息香酸オクチル、サリチル酸エチレングリコール、ジヒドロキシベンゾフェノン、酸化チタン、酸化亜鉛などが挙げられる。 UV absorbers or UV scattering agents include 2-ethylhexyl paramethoxycinnamate, 2-[4-(diethylamino)-2-hydroxybenzoyl]benzoic acid hexyl ester, 2,4,6-tris[4-(2 -ethylhexyloxycarbonyl)anilino]-1,3,5-triazine, t-butylmethoxydibenzoylmethane, ethylhexyl dibenzylidenedioxoimidazolidinepropyronate, ethlhexyltriazoline, para-aminobenzoic acid and its derivatives, para-dimethylamino octyl benzoate, ethylene glycol salicylate, dihydroxybenzophenone, titanium oxide, zinc oxide and the like.
刺激軽減剤としては、甘草エキス、アルギン酸ナトリウムなどが挙げられる。 Stimulants include licorice extract, sodium alginate and the like.
着色料としては、法定色素ハンドブック(日本化粧品工業連合会編(2004))に記載された色素などが挙げられる。 Examples of the coloring agent include those described in Legal Color Handbook (Edited by Japan Cosmetic Industry Association (2004)).
その他の生理活性又は薬理活性成分(抗ヒスタミン剤、局所麻酔剤、及び抗ヒスタミン剤でない鎮痒剤、以外の生理活性又は薬理活性成分)としては、例えば、抗炎症剤、殺菌剤、抗真菌剤、保湿成分、ビタミン類、ペプチド又はその誘導体、血行促進成分、細胞賦活化成分、老化防止成分、美白成分、アミノ酸、タンパク質、植物エキスなどが挙げられる。
その他の生理活性又は薬理活性成分は、1種を単独で、又は2種以上を組み合わせて使用できる。
また、その他の生理活性又は薬理活性成分は、本発明の効果を損なわない範囲で使用することができる。
Other physiologically active or pharmacologically active ingredients (antihistamines, local anesthetics, and antipruritic agents other than antihistamines) include, for example, anti-inflammatory agents, disinfectants, antifungal agents, moisturizing ingredients, vitamins peptides or derivatives thereof, blood circulation-promoting ingredients, cell-activating ingredients, anti-aging ingredients, whitening ingredients, amino acids, proteins, plant extracts, and the like.
Other physiologically active or pharmacologically active ingredients can be used singly or in combination of two or more.
In addition, other physiologically active or pharmacologically active ingredients can be used as long as they do not impair the effects of the present invention.
抗炎症剤としては、アラントイン、グリチルリチン酸、グリチルレチン酸、吉草酸酢酸プレドニゾロン、酢酸デキサメタゾン、酢酸ヒドロコルチゾン、ウフェナマート、ブフェキサマク、イブプロフェンピコノール、インドメタシン、ジクロフェナク、ピロキシカム、イプシロン-アミノカプロン酸、ベルベリン、リゾチーム、アズレン、ブロメライン、セラペプターゼ、セミアルカリプロティナーゼ、及びそれらの薬学的又は生理学的に許容される塩などが挙げられる。 Anti-inflammatory agents include allantoin, glycyrrhizic acid, glycyrrhetinic acid, prednisolone acetate valerate, dexamethasone acetate, hydrocortisone acetate, ufenamate, bufexamac, ibuprofen piconol, indomethacin, diclofenac, piroxicam, epsilon-aminocaproic acid, berberine, lysozyme, azulene, bromelain, serrapeptase, semi-alkaline proteinase, and pharmaceutically or physiologically acceptable salts thereof;
殺菌剤としては、イソプロピルメチルフェノール、塩化デカリニウム、塩化ベンザルコニウム、塩化ベンゼトニウム、塩酸クロルへキシジン、グルコン酸クロルヘキシジン、塩酸アルキルジアミノエチルグリシン、塩化セチルピリジニウム、安息香酸ナトリウム、エタノール、クロロブタノール、ソルビン酸、ソルビン酸カリウム、デヒドロ酢酸ナトリウム、パラオキシ安息香酸メチル、パラオキシ安息香酸エチル、パラオキシ安息香酸プロピル、パラオキシ安息香酸ブチル、硫酸オキシキノリン、フェネチルアルコール、ベンジルアルコール、及びビグアニド化合物などが挙げられる。 Bactericides include isopropylmethylphenol, decalinium chloride, benzalkonium chloride, benzethonium chloride, chlorhexidine hydrochloride, chlorhexidine gluconate, alkyldiaminoethylglycine hydrochloride, cetylpyridinium chloride, sodium benzoate, ethanol, chlorobutanol, sorbic acid. , potassium sorbate, sodium dehydroacetate, methyl parahydroxybenzoate, ethyl parahydroxybenzoate, propyl parahydroxybenzoate, butyl parahydroxybenzoate, oxyquinoline sulfate, phenethyl alcohol, benzyl alcohol, and biguanide compounds.
抗真菌剤としては、テルビナフィン、ナフチフィン、ブテナフィン、トルナフタート、リラナフタート、ミコナゾール、ラノコナゾール、ルリコナゾール、イソコナゾール、ケトコナゾール、クロトリマゾール、ネチコナゾール、スルコナゾール、ビホナゾール、オキシコナゾール、エコナゾール、フルコナゾール、イトラコナゾール、ホスフルコナゾール、ボリコナゾール、エフィコナゾール、ブトコナゾール、フェンチコナゾール、セルタコナゾールなどが挙げられる。 Antifungal agents include terbinafine, naftifine, butenafine, tolnaftate, lilanaftate, miconazole, lanoconazole, luliconazole, isoconazole, ketoconazole, clotrimazole, neticonazole, sulconazole, bifonazole, oxiconazole, econazole, fluconazole, itraconazole, fosfluconazole, voriconazole , eficonazole, butoconazole, fenticonazole, sertaconazole and the like.
保湿成分としては、グリセリン、ジプロピレングリコール、1,3-ブチレングリコール、プロピレングリコール、ポリエチレングリコール、ジグリセリン、ペンタンジオール、ヘキサンジオール、オクタンジオールのような多価アルコール、トレハロース、キシリトール、ソルビトールのような糖類、ヒアルロン酸ナトリウム、ヘパリン類似物質、コンドロイチン硫酸ナトリウム、ケラチン、キチン、キトサンのような高分子化合物、セラミド、コレステロール、リン脂質のような脂質、カミツレエキス、ハマメリスエキス、チャエキス、アロエエキスのような植物抽出エキスなどが挙げられる。 Moisturizing ingredients include polyhydric alcohols such as glycerin, dipropylene glycol, 1,3-butylene glycol, propylene glycol, polyethylene glycol, diglycerin, pentanediol, hexanediol and octanediol, trehalose, xylitol and sorbitol. Sugars, sodium hyaluronate, heparin analogs, sodium chondroitin sulfate, keratin, chitin, chitosan and other high-molecular compounds, ceramide, cholesterol, lipids such as phospholipids, chamomile extract, hamamelis extract, tea extract, aloe extract Examples include plant extracts.
ビタミン類としては、dl-α-トコフェロール、酢酸dl-α-トコフェロール、コハク酸dl-α-トコフェロール、コハク酸dl-α-トコフェロールカルシウム等のビタミンE類、ユビキノン誘導体及びその薬学的又は生理学的に許容される塩、リボフラビン、フラビンモノヌクレオチド、フラビンアデニンジヌクレオチド、リボフラビン酪酸エステル、リボフラビンテトラ酪酸エステル、リボフラビン5’-リン酸エステルナトリウム、リボフラビンテトラニコチン酸エステル、ニコチン酸dl-α-トコフェロール、ニコチン酸ベンジル、ニコチン酸メチル、ニコチン酸β-ブトキシエチル、ニコチン酸1-(4-メチルフェニル)エチル、アスコルビゲン-A、アスコルビン酸ステアリン酸エステル、アスコルビン酸パルミチン酸エステル、ジパルミチン酸L-アスコルビル、メチルヘスペリジン、エルゴカルシフェロール、コレカルシフェロール、フィロキノン、ファルノキノン、γ-オリザノール、ジベンゾイルチアミン、ジベンゾイルチアミン塩酸塩、チアミン塩酸塩、チアミンセチル塩酸塩、チアミンチオシアン酸塩、チアミンラウリル塩酸塩、チアミン硝酸塩、チアミンモノリン酸塩、チアミンリジン塩、チアミントリリン酸塩、チアミンモノリン酸エステルリン酸塩、チアミンモノリン酸エステル、チアミンジリン酸エステル、チアミンジリン酸エステル塩酸塩、チアミントリリン酸エステル、チアミントリリン酸エステルモノリン酸塩、塩酸ピリドキシン、酢酸ピリドキシン、塩酸ピリドキサール、5’-リン酸ピリドキサール、塩酸ピリドキサミン、シアノコバラミン、ヒドロキソコバラミン、デオキシアデノシルコバラミン、葉酸、プテロイルグルタミン酸、ニコチン酸、ニコチン酸アミド、パントテン酸、パントテン酸カルシウム、パントテニルアルコール(パンテノール)、D-パンテサイン、D-パンテチン、補酵素A、パントテニルエチルエーテル等のパントテン酸類、ビオチン、ビオチシン、アスコルビン酸、アスコルビン酸ナトリウム、デヒドロアスコルビン酸、アスコルビン酸リン酸エステルナトリウム、アスコルビン酸リン酸エステルマグネシウム、カルニチン、フェルラ酸、α-リポ酸、オロット酸、ヘスペリジン、γ-オリザノール、オロチン酸、ルチン、エリオシトリン及びその薬学的又は生理学的に許容される塩などが挙げられる。 Vitamins include vitamin E such as dl-α-tocopherol, dl-α-tocopherol acetate, dl-α-tocopherol succinate, dl-α-tocopherol calcium succinate, ubiquinone derivatives and their pharmacologically or physiologically Acceptable salts, riboflavin, flavin mononucleotide, flavin adenine dinucleotide, riboflavin butyrate, riboflavin tetrabutyrate, riboflavin 5′-phosphate sodium, riboflavin tetranicotinate, dl-α-tocopherol nicotinate, nicotinic acid Benzyl, methyl nicotinate, β-butoxyethyl nicotinate, 1-(4-methylphenyl)ethyl nicotinate, ascorbigen-A, ascorbyl stearate, ascorbate palmitate, L-ascorbyl dipalmitate, methyl hesperidin , ergocalciferol, cholecalciferol, phylloquinone, farnoquinone, γ-oryzanol, dibenzoylthiamine, dibenzoylthiamine hydrochloride, thiamine hydrochloride, thiamine cetyl hydrochloride, thiamine thiocyanate, thiamine lauryl hydrochloride, thiamine nitrate, thiamine monophosphate, thiamine lysine salt, thiamine triphosphate, thiamine monophosphate phosphate, thiamine monophosphate, thiamine diphosphate, thiamine diphosphate hydrochloride, thiamine triphosphate, thiamine triphosphate monophosphate , pyridoxine hydrochloride, pyridoxine acetate, pyridoxal hydrochloride, pyridoxal 5′-phosphate, pyridoxamine hydrochloride, cyanocobalamin, hydroxocobalamin, deoxyadenosylcobalamin, folic acid, pteroylglutamic acid, nicotinic acid, nicotinamide, pantothenic acid, calcium pantothenate, Pantothenyl alcohol (panthenol), D-pantesaine, D-pantethine, coenzyme A, pantothenic acids such as pantothenyl ethyl ether, biotin, biotycin, ascorbic acid, sodium ascorbate, dehydroascorbic acid, ascorbic acid phosphate sodium, magnesium ascorbic acid phosphate, carnitine, ferulic acid, α-lipoic acid, orotic acid, hesperidin, γ-oryzanol, orotic acid, rutin, eriocitrin, and pharmaceutically or physiologically acceptable salts thereof; be done.
ペプチド又はその誘導体としては、ケラチン分解ペプチド、加水分解ケラチン、コラーゲン、ゼラチン、エラスチン、エラスチン分解ペプチド、コラーゲン分解ペプチド、加水分解コラーゲン、加水分解シルクなどが挙げられる。 Peptides or derivatives thereof include keratinolytic peptides, hydrolyzed keratin, collagen, gelatin, elastin, elastinolytic peptides, collagenolytic peptides, hydrolyzed collagen, hydrolyzed silk, and the like.
血行促進成分としては、植物由来成分が好ましく例示される。例えば、オタネニンジン、アシタバ、アルニカ、イチョウ、エンメイソウ、オランダカシ、カロット、ゲンチアナ、ゴボウ、コメ、サンザシ、シイタケ、セイヨウサンザシ、セイヨウネズ、センキュウ、センブリ、タイム、チョウジ、チンピ、トウキ、トウニン、トウヒ、ニンジン、ニンニク、ブッチャーブルーム、ブドウ、ボタン、マロニエ、メリッサ、ユズ、ヨクイニン、ローズマリー、ローズヒップ、モモ、アンズ、クルミ、トウモロコシなどに由来する成分(これらの植物の抽出物など)や、グルコシルヘスペリジンなどが挙げられる。 A plant-derived component is preferably exemplified as the blood circulation-promoting component. For example, Panax ginseng, Angelica keiskei, Arnica, Ginkgo biloba, Tripod, Dutch oak, Carrot, Gentian, Burdock, Rice, Hawthorn, Shiitake mushroom, Hawthorn, Juniper, Neem, Japanese juniper, Thyme, Clove, Chimp, Angelica keiskei, Tonin, Spruce, Carrot, Ingredients derived from garlic, butcher bloom, grapes, peonies, horse chestnut, melissa, yuzu, yokuinin, rosemary, rosehip, peach, apricot, walnut, corn (including extracts of these plants), glucosyl hesperidin, etc. mentioned.
細胞賦活成分としては、γ-アミノ酪酸、γ-アミノ-β-ヒドロキシ酪酸、ε-アミノカプロン酸のようなアミノ酸類、レチノール、チアミン、リボフラビン、塩酸ピリドキシン、パントテン酸類、ビオチンのようなビタミン類、グリコール酸、乳酸のようなα-ヒドロキシ酸類、タンニン、フラボノイド、サポニン、アラントイン、感光素301号、胎盤抽出液、ヒノキチオール、セファランチン、キウイ種子抽出物などが挙げられる。 Cell activating components include amino acids such as γ-aminobutyric acid, γ-amino-β-hydroxybutyric acid, and ε-aminocaproic acid, retinol, thiamine, riboflavin, pyridoxine hydrochloride, pantothenic acids, vitamins such as biotin, and glycol. acids, α-hydroxy acids such as lactic acid, tannins, flavonoids, saponins, allantoin, photosensitizer No. 301, placenta extract, hinokitiol, cepharanthine, kiwi seed extract and the like.
老化防止成分としては、パンガミン酸、カイネチン、ウルソール酸、ウコンエキス、スフィンゴシン誘導体、ケイ素、ケイ酸、N-メチル-L-セリン、メバロノラクトンなどが挙げられる。 Antiaging ingredients include pangamic acid, kinetin, ursolic acid, turmeric extract, sphingosine derivatives, silicon, silicic acid, N-methyl-L-serine, mevalonolactone and the like.
美白成分としては、トコフェロール、アスコルビン酸、トラネキサム酸、アルブチン、4-アルキルレゾルシノ-ル、4-メトキシサリチル酸、ハイドロキノン、コウジ酸、それらの塩、又はそれらの誘導体、胎盤抽出物、オウバク抽出物、ユキノシタ抽出物、アロエ抽出物のような植物抽出物などが挙げられる。 Whitening ingredients include tocopherol, ascorbic acid, tranexamic acid, arbutin, 4-alkylresorcinol, 4-methoxysalicylic acid, hydroquinone, kojic acid, salts or derivatives thereof, placenta extract, and bark extract. , saxifrage extract, plant extract such as aloe extract, and the like.
本発明の外用組成物には、さらに、角質軟化剤を含有させることもできる。角質軟化剤としては、エチルアルコール、イソプロピルアルコール、プロパノール、ブタノール、1,3-ブチレングリコール、プロピレングリコール、ポリエチレングリコール(マクロゴール)、グリセリン、ベンジルアルコール、フェニルエチルアルコール、炭酸プロピレン、ヘキシルドデカノール、アラントイン、ジメチルスルホキシド、ジメチルアセトアミド、ジメチルホルムアミド、トリエタノールアミン、ジイソプロピルアジペート、エチルラウリレート、ラノリン、脂肪酸ジアルキロールアミド、サリチル酸、サリチル酸誘導体、尿素、イオウ、レゾルシン、グリコール酸、フィチン酸、乳酸、乳酸塩、水酸化ナトリウム、水酸化カリウム等が例示される。
一方、本発明の外用組成物は、一態様として、このような角質軟化剤を含まない外用組成物とすることもできる。中でも、尿素を含まない態様が例示される。角質軟化剤を含まない外用組成物は、特に皮膚への負荷が少なく、好ましい。
The composition for external use of the present invention may further contain a keratin softener. Keratin softeners include ethyl alcohol, isopropyl alcohol, propanol, butanol, 1,3-butylene glycol, propylene glycol, polyethylene glycol (macrogol), glycerin, benzyl alcohol, phenylethyl alcohol, propylene carbonate, hexyldodecanol, allantoin. , dimethyl sulfoxide, dimethylacetamide, dimethylformamide, triethanolamine, diisopropyl adipate, ethyl laurylate, lanolin, fatty acid dialkylolamide, salicylic acid, salicylic acid derivatives, urea, sulfur, resorcinol, glycolic acid, phytic acid, lactic acid, lactate , sodium hydroxide, potassium hydroxide and the like.
On the other hand, the composition for external use of the present invention can also be a composition for external use that does not contain such an emollient as one aspect. Among them, an embodiment containing no urea is exemplified. A topical composition containing no keratin softener is particularly preferred because it is less stressful on the skin.
基剤又は担体
基剤又は担体としては、油性基剤、水性基剤が挙げられる。
油性基剤としては、流動パラフィン、ワセリン、ゲル化炭化水素(プラスチベースなど)、オゾケライト、α-オレフィンオリゴマー、及び軽質流動パラフィンのような炭化水素;メチルポリシロキサン、架橋型メチルポリシロキサン、高重合メチルポリシロキサン、環状シリコーン、アルキル変性シリコーン、架橋型アルキル変性シリコーン、アミノ変性シリコーン、ポリエーテル変性シリコーン、ポリグリセリン変性シリコーン、架橋型ポリエーテル変性シリコーン、架橋型アルキルポリエーテル変性シリコーン、シリコーン・アルキル鎖共変性ポリエーテル変性シリコーン、シリコーン・アルキル鎖共変性ポリグリセリン変性シリコーン、ポリエーテル変性分岐シリコーン、ポリグリセリン変性分岐シリコーン、アクリルシリコン、フェニル変性シリコーン、及びシリコーンレジンのようなシリコーン油;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、及びベヘニルアルコールのような高級アルコール;コレステロール、フィトステロール、及びヒドロキシステアリン酸フィトステリルのようなステロール類;シアバター、カルバナロウ、及びキャンデリラロウのような植物脂;ラノリン、オレンジラフィー油、スクワラン、馬油、鯨ロウ、及びミツロウのような動物油脂;エチルセルロース、ヒドロキシプロピルセルロース、ヒドロキシエチルセルロース、ヒドロキシプロピルメチルセルロース、カチオン化グアガム、及びアセチル化ヒアルロン酸のような天然高分子誘導体;ポリビニルピロリドン、カルボキシビニルポリマー、及びアクリル酸メタクリル酸アルキル共重合体のような合成高分子;カラギーナン、アルギン酸、セルロース、キサンタンガム、グアーガム、クインスシード、デキストラン、ジェランガム、及びヒアルロン酸のような天然高分子;ミリスチン酸イソプロピル、ミリスチン酸オクチルドデシル、パルミチン酸イソプロピル、パルミチン酸セチル、イソノナン酸イソノニル、テトラ2-エチルヘキサン酸ペンタエリスリット、及びトリ(カプリル酸/カプリン酸)グリセリルのようなエステル類;デキストリン、及びマルトデキストリンのような多糖類;エチレングリコールモノメチルエーテル、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プロピルエーテル、ジエチレングリコールモノメチルエーテル、ジエチレングリコールモノエチルエーテル、ジエチレングリコールモノプロピルエーテル、ジエチレングリコールモノブチルエーテル、プロピレングリコールモノエチルエーテル、プロピレングリコールモノプロピルエーテル、ジプロピレングリコールモノエチルエーテル、及びジプロピレングリコールモノプロピルエーテルのようなグリコールエーテルなどが挙げられる。
また、水性基剤としては、水、緩衝液の他に、エタノール、及びイソプロパノールのような低級アルコール;ポリエチレングリコール、プロピレングリコール、1,3-ブチレングリコール、グリセリン、イソプレングリコール、ジグリセリン、及びジプロピレングリコールのような多価アルコールなどが挙げられる。
基材又は担体は、1種を単独で、又は2種以上を組み合わせて使用できる。
Bases or Carriers Bases or carriers include oleaginous bases and aqueous bases.
Oily bases include hydrocarbons such as liquid paraffin, vaseline, gelling hydrocarbons (plastibase, etc.), ozokerite, α-olefin oligomers, and light liquid paraffin; Polysiloxane, cyclic silicone, alkyl-modified silicone, cross-linked alkyl-modified silicone, amino-modified silicone, polyether-modified silicone, polyglycerin-modified silicone, cross-linked polyether-modified silicone, cross-linked alkyl polyether-modified silicone, both silicone and alkyl chain Silicone oils such as modified polyether-modified silicone, silicone/alkyl chain co-modified polyglycerin-modified silicone, polyether-modified branched silicone, polyglycerin-modified branched silicone, acrylic silicone, phenyl-modified silicone, and silicone resin; cetanol, cetostearyl alcohol higher alcohols such as , stearyl alcohol, and behenyl alcohol; sterols, such as cholesterol, phytosterols, and phytosteryl hydroxystearate; vegetable fats, such as shea butter, carnaval wax, and candelilla wax; animal fats and oils such as horse oil, whale wax, and beeswax; natural polymer derivatives such as ethylcellulose, hydroxypropylcellulose, hydroxyethylcellulose, hydroxypropylmethylcellulose, cationic guar gum, and acetylated hyaluronic acid; polyvinylpyrrolidone, carboxyvinyl polymer , and synthetic polymers such as acrylic acid methacrylate copolymer; natural polymers such as carrageenan, alginic acid, cellulose, xanthan gum, guar gum, quince seed, dextran, gellan gum, and hyaluronic acid; isopropyl myristate, myristic acid Esters such as octyldodecyl, isopropyl palmitate, cetyl palmitate, isononyl isononanoate, pentaerythrityl tetra-2-ethylhexanoate, and tri(caprylic/capric)glyceryl; Sugars; 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, and dipropylene glycol monopropyl ether.
In addition to water and buffers, aqueous bases include lower alcohols such as ethanol and isopropanol; polyethylene glycol, propylene glycol, 1,3-butylene glycol, glycerin, isoprene glycol, diglycerin, and dipropylene. Examples include polyhydric alcohols such as glycol.
The substrate or carrier can be used singly or in combination of two or more.
基剤又は担体としては、炭化水素、高級アルコール、天然高分子誘導体、合成高分子、天然高分子、エステル類、多価アルコールが好ましい。
基剤又は担体として炭化水素を含む場合の含有量としては、組成物の全量に対して、例えば0.1~20重量%、好ましくは1~15重量%が挙げられる。基剤又は担体として高級アルコールを含む場合の含有量としては、組成物の全量に対して、例えば0.1~10重量%、好ましくは0.5~5重量%が挙げられる。基剤又は担体として天然高分子誘導体を含む場合の含有量としては、組成物の全量に対して、例えば0.01~5重量%、好ましくは0.05~3重量%が挙げられる。基剤又は担体として合成高分子を含む場合の含有量としては、組成物の全量に対して、例えば0.01~5重量%、好ましくは0.1~3重量%が挙げられる。基剤又は担体として天然高分子を含む場合の含有量としては、組成物の全量に対して、例えば0.01~3重量%、好ましくは0.05~1重量%が挙げられる。基剤又は担体としてエステル類を含む場合の含有量としては、組成物の全量に対して、例えば0.1~20重量%、好ましくは0.5~10重量%が挙げられる。基剤又は担体として多価アルコールを含む場合の含有量としては、組成物の全量に対して、例えば0.1~20重量%、好ましくは0.5~10重量%が挙げられる。
Preferred bases or carriers are hydrocarbons, higher alcohols, natural polymer derivatives, synthetic polymers, natural polymers, esters and polyhydric alcohols.
When a hydrocarbon is contained as a base or carrier, the content thereof is, for example, 0.1 to 20% by weight, preferably 1 to 15% by weight, based on the total amount of the composition. When a higher alcohol is contained as a base or carrier, the content thereof is, for example, 0.1 to 10% by weight, preferably 0.5 to 5% by weight, based on the total amount of the composition. When a natural polymer derivative is contained as a base or carrier, the content thereof is, for example, 0.01 to 5% by weight, preferably 0.05 to 3% by weight, based on the total amount of the composition. When a synthetic polymer is contained as a base or carrier, the content thereof is, for example, 0.01 to 5% by weight, preferably 0.1 to 3% by weight, based on the total amount of the composition. When a natural polymer is contained as a base or carrier, the content thereof is, for example, 0.01 to 3% by weight, preferably 0.05 to 1% by weight, based on the total amount of the composition. When an ester is contained as a base or carrier, the content is, for example, 0.1 to 20% by weight, preferably 0.5 to 10% by weight, based on the total amount of the composition. When a polyhydric alcohol is contained as a base or carrier, the content thereof is, for example, 0.1 to 20% by weight, preferably 0.5 to 10% by weight, based on the total amount of the composition.
本発明の組成物は、水を含まず、水以外の水性基剤を用いて乳剤とすることもできるが、水を含むことが好ましい。
水の含有量は、組成物の全量に対して、0.1重量%以上、1重量%以上、5重量%以上、10重量%以上、30重量%以上、又は45重量%以上とすることができる。また、水の含有量は、組成物の全量に対して、95重量%以下、90重量%以下、又は80重量%以下とすることができる。この範囲であれば、植物性油を配合した乳剤が十分に安定なものとなる。
The composition of the present invention does not contain water, and although it can be made into an emulsion using an aqueous base other than water, it preferably contains water.
The water content may be 0.1% by weight or more, 1% by weight or more, 5% by weight or more, 10% by weight or more, 30% by weight or more, or 45% by weight or more with respect to the total amount of the composition. can. Also, the water content can be 95% by weight or less, 90% by weight or less, or 80% by weight or less with respect to the total amount of the composition. Within this range, the emulsion containing the vegetable oil is sufficiently stable.
本発明の組成物は、乳化された組成物である。乳化の型は、水中油型、油中水型の何れでもよいが、植物性油を配合した乳剤の安定性を向上させる上で、水中油型が好ましい。
本発明の剤型は、乳化された剤型であればよく、ローション剤(乳液)、クリーム剤、ゲル剤、フォーム剤、乳剤性軟膏、これらを基材に塗布した貼付剤、吸入剤、点鼻剤(鼻スプレー剤を含む)などが挙げられる。中でも、ローション剤、クリーム剤、これらを基材に塗布した貼付剤のような外用剤が好ましく、ローション剤、クリーム剤がさらに好ましく、クリーム剤が特に好ましい。
また、本発明の外用組成物は、皮膚又は粘膜に適用することができるが、特に皮膚外用組成物であることが好ましい。皮膚には頭皮が含まれる。
The compositions of the invention are emulsified compositions. The emulsification type may be either an oil-in-water type or a water-in-oil type, but the oil-in-water type is preferred in order to improve the stability of the emulsion containing the vegetable oil.
The dosage form of the present invention may be an emulsified dosage form, such as lotions (emulsions), creams, gels, foams, emulsifiable ointments, patches, inhalants, and dots obtained by applying these to a base material. Nasal preparations (including nasal sprays) and the like. Among them, lotions, creams, and preparations for external use such as patches obtained by applying these to a base material are preferable, lotions and creams are more preferable, and creams are particularly preferable.
The composition for external use of the present invention can be applied to the skin or mucous membranes, and is preferably a composition for external use on the skin. The skin includes the scalp.
本発明の組成物のpHは、3以上、4以上、4.5以上、又は5以上とすることができ、また、9以下、8以下、7.5以下、又は7以下とすることができる。この範囲であれば、乳化状態が安定であり、また刺激が少ない。 The pH of the compositions of the present invention can be 3 or higher, 4 or higher, 4.5 or higher, or 5 or higher, and can be 9 or lower, 8 or lower, 7.5 or lower, or 7 or lower. . Within this range, the emulsified state is stable and less irritating.
適用対象
本発明の外用組成物は、抗ヒスタミン剤が治療、予防又は改善効果を奏する症状や疾患に対して用いるのが好ましい。このような症状又は疾患としては、例えば、痒み症状や皮膚の乾燥に起因する症状を示す疾患などが挙げられる。痒み症状や皮膚の乾燥に起因する症状を示す疾患としては、乾皮症、老人性乾皮症、小児乾燥性皮膚、尋常性鱗癬(鮫肌)、アトピー性皮膚炎、アレルギー性皮膚炎、皮脂減少性湿疹、敏感肌、季節性乾皮症、水性掻痒症、主婦湿疹、皮膚炎、かぶれ、じんましん、虫さされ、湿疹、ただれ、あせも、しもやけ等が挙げられる。
APPLICABLE OBJECTS The topical composition of the present invention is preferably used for symptoms and diseases for which antihistamines have therapeutic, preventive or ameliorating effects. Such symptoms or diseases include, for example, diseases exhibiting itching symptoms and symptoms caused by dry skin. Diseases that show itching and symptoms caused by dry skin include xerosis, senile xeroderma, infantile dry skin, scabies vulgaris (shark skin), atopic dermatitis, allergic dermatitis, and sebum. Reduced eczema, sensitive skin, seasonal xeroderma, aqueous pruritus, housewife's eczema, dermatitis, rash, hives, insect bites, eczema, sores, heat rash, frostbite and the like.
相分離抑制方法・乳化状態の安定化方法
本発明は、植物性油を含む乳剤である外用組成物に抗ヒスタミン剤を含ませることにより、この組成物の相分離を抑制する方法を包含する。相分離は、乳化された組成物の一部ないしは全部が、水相と油相に分離している状態である。また、乳化された液滴が少なくとも部分的に合一して大きくなった状態も相分離に該当する。
また、本発明は、植物性油を含む乳剤である外用組成物に抗ヒスタミン剤を含ませることにより、この組成物の乳化状態を安定化する方法、又はこの組成物の安定性を向上させる方法を包含する。
抗ヒスタミン剤の存在により、相分離の低減又は遅延が検出できれば、相分離抑制に該当する。また、抗ヒスタミン剤の存在により、乳化状態の破壊又は変化の低減又は遅延が検出できたり、乳化状態の維持時間が延長されたり、より苛酷な条件で乳化状態が維持されるようになれば、安定化、又は安定性の向上に該当する。
Method for Inhibiting Phase Separation/Method for Stabilizing Emulsified State The present invention includes a method for inhibiting phase separation of a topical composition, which is an emulsion containing vegetable oil, by incorporating an antihistamine into the composition. Phase separation is a state in which part or all of the emulsified composition separates into an aqueous phase and an oil phase. In addition, a state in which the emulsified droplets at least partially coalesce and become larger also corresponds to phase separation.
The present invention also includes a method for stabilizing the emulsified state of a topical composition, which is an emulsion containing vegetable oil, by including an antihistamine in the composition, or a method for improving the stability of the composition. do.
A detectable reduction or delay in phase separation due to the presence of an antihistamine corresponds to inhibition of phase separation. In addition, due to the presence of an antihistamine, it is possible to detect a reduction or delay in the destruction or change of the emulsified state, extend the time to maintain the emulsified state, or maintain the emulsified state under more severe conditions. , or stability improvement.
また、本発明は、抗ヒスタミン剤を含む乳剤である外用組成物に植物性油を含ませることにより、この組成物の相分離を抑制する方法を包含する。また、本発明は、抗ヒスタミン剤を含む乳剤である外用組成物に植物性油を含ませることにより、この組成物の乳化状態を安定化する方法、又はこの組成物の安定性を向上させる方法を包含する。植物性油の存在により、相分離の低減又は遅延が検出できれば、相分離抑制に該当する。また、植物性油の存在により、乳化状態の破壊又は変化の低減又は遅延が検出できたり、乳化状態の維持時間が延長されたり、より苛酷な条件で乳化状態が維持されるようになれば、安定化、又は安定性の向上に該当する。 The present invention also includes a method of suppressing phase separation of a topical composition that is an emulsion containing an antihistamine by including a vegetable oil in the composition. The present invention also includes a method for stabilizing the emulsified state of a topical composition, which is an emulsion containing an antihistamine, by incorporating a vegetable oil into the composition, or a method for improving the stability of the composition. do. A detectable reduction or retardation of phase separation due to the presence of vegetable oil corresponds to inhibition of phase separation. In addition, if the presence of vegetable oil makes it possible to detect a reduction or delay in the destruction or change of the emulsified state, extend the time to maintain the emulsified state, or maintain the emulsified state under more severe conditions, It corresponds to stabilization or stability improvement.
これらの本発明方法において、各成分の種類、使用量、組成物の剤型、pHなどは、本発明の外用組成物について説明した通りである。 In these methods of the present invention, the type and amount of each component used, the dosage form of the composition, the pH, etc. are as described for the topical composition of the present invention.
以下、実施例を挙げて、本発明をより詳細に説明するが、本発明はこれらに限定されない。
(1)保存安定性の評価(熱安定性)
表1に示す組成の外用組成物(水中油型クリーム剤)を、常法に従って調製した。
実施例、及び比較例の各組成物50gを、ガラス製ねじ口ビン(容量50mL)に収容し、遮光下、50℃又は60℃で1週間保存した。
EXAMPLES The present invention will be described in more detail below with reference to Examples, but the present invention is not limited to these.
(1) Evaluation of storage stability (thermal stability)
A composition for external use (oil-in-water cream) having the composition shown in Table 1 was prepared according to a conventional method.
50 g of each composition of Examples and Comparative Examples was placed in a glass screw cap bottle (capacity 50 mL) and stored at 50° C. or 60° C. for 1 week in the dark.
保存前後の組成物の性状を目視で観察し、下記の基準に従って組成物の相分離の程度を評価した。
<分離の評価基準>
◎:全く分離がなく安定である
○:製剤の表面に少量の液体が確認できる。
△:製剤の表面、及びビン内の周縁部に分離した液が確認できる。
×:製剤の一部が液体に変化しており、明らかに分離している。
The properties of the composition before and after storage were visually observed, and the degree of phase separation of the composition was evaluated according to the following criteria.
<Evaluation Criteria for Separation>
A: Stable with no separation O: A small amount of liquid can be observed on the surface of the preparation.
Δ: Separated liquid can be observed on the surface of the preparation and on the periphery of the bottle.
×: A part of the formulation has changed to a liquid and is clearly separated.
結果を、表1に示す。表1中の単位は、表中に記載があるもの以外は全て「重量%」である。
50℃又は60℃における保存試験により、熱に対する安定性を評価することができると共に、常温保存する場合の安定性を予測評価することができる。
ラベンダー油、又はユーカリ油を配合した製剤では、保存後に水相と油相とが分離した(比較例1-2、比較例1-3)。また、ジフェンヒドラミンを配合した製剤も、保存後に水相と油相とが分離した(比較例1-1)。一方、ラベンダー油又はユーカリ油とジフェンヒドラミンを配合した製剤(実施例1-1、実施例1-2)、並びにラベンダー油及びユーカリ油とジフェンヒドラミンを配合した製剤(実施例1-3)は、相分離しなかった。ラベンダー油及び/又はユーカリ油とジフェンヒドラミンとが、相乗作用により、乳剤の相分離を抑制したことが分かる。
A storage test at 50° C. or 60° C. can be used to evaluate the stability against heat, and to predict and evaluate the stability when stored at room temperature.
In formulations containing lavender oil or eucalyptus oil, the aqueous phase and the oil phase separated after storage (Comparative Examples 1-2 and 1-3). In addition, the preparation containing diphenhydramine also separated into an aqueous phase and an oil phase after storage (Comparative Example 1-1). On the other hand, formulations containing lavender oil or eucalyptus oil and diphenhydramine (Examples 1-1 and 1-2), and formulations containing lavender oil and eucalyptus oil and diphenhydramine (Example 1-3) showed phase separation. didn't. It can be seen that lavender oil and/or eucalyptus oil and diphenhydramine inhibited phase separation of the emulsion by synergistic action.
(2)保存安定性の評価(光安定性)
表2に示す実施例2-1~2-3、比較例2-1~2-3の外用組成物(水中油型クリーム剤)を常法に従って調製した。
実施例、及び比較例の各組成物50gを、ガラス製ねじ口ビン(容量50mL)に収容し、サンテスターを用いて、725W/m2の条件で、48時間光照射した。
光照射前後の組成物の性状を目視で観察し、「(1)保存安定性の評価(熱安定性)」と同じ基準で、各組成物の分離の程度を評価した。
結果を表2に示す。表2中の単位は、表中に記載があるもの以外は全て「重量%」である。
(2) Evaluation of storage stability (light stability)
External compositions (oil-in-water type cream formulations) of Examples 2-1 to 2-3 and Comparative Examples 2-1 to 2-3 shown in Table 2 were prepared according to a conventional method.
50 g of each composition of Examples and Comparative Examples was placed in a glass screw cap bottle (capacity 50 mL) and irradiated with light at 725 W/m 2 for 48 hours using a sun tester.
The properties of the composition before and after light irradiation were visually observed, and the degree of separation of each composition was evaluated according to the same criteria as in "(1) Evaluation of storage stability (thermal stability)".
Table 2 shows the results. All units in Table 2 are "% by weight" unless otherwise stated.
ラベンダー油又はユーカリ油を配合した製剤では、光照射後に水相と油相とが分離した(比較例2-2、比較例2-3)。また、ジフェンヒドラミンを配合した製剤も、保存後に水相と油相とが分離した(比較例2-1)。一方、ラベンダー油又はユーカリ油とジフェンヒドラミンを配合した製剤(実施例2-1、実施例2-2)、並びにラベンダー油及びユーカリ油とジフェンヒドラミンを配合した製剤(実施例2-3)は相分離しなかった。ラベンダー油及び/又はユーカリ油とジフェンヒドラミンとが、相乗作用により、乳剤の相分離を抑制したことが分かる。 In formulations containing lavender oil or eucalyptus oil, the water phase and the oil phase separated after light irradiation (Comparative Examples 2-2 and 2-3). In addition, the formulation containing diphenhydramine also separated into an aqueous phase and an oil phase after storage (Comparative Example 2-1). On the other hand, formulations containing lavender oil or eucalyptus oil and diphenhydramine (Examples 2-1 and 2-2) and formulations containing lavender oil or eucalyptus oil and diphenhydramine (Example 2-3) were phase separated. I didn't. It can be seen that lavender oil and/or eucalyptus oil and diphenhydramine inhibited phase separation of the emulsion by synergistic action.
(3)保存安定性の評価(熱安定性、光安定性)
表3に示す組成の外用組成物(実施例3-1~3-5:水中油型クリーム剤、実施例3-6:水中油型ローション剤)を、常法に従って調製した。
実施例の各組成物50gを、ガラス製ねじ口ビン(容量50mL)に収容し、遮光下、50℃又は60℃で1週間保存した。また、実施例の各組成物50gを、ガラス製ねじ口ビン(容量50mL)に収容し、サンテスターを用いて、725W/m2の条件で、48時間光照射した。
保存前後、及び光照射前後の組成物の性状を目視で観察し、「(1)保存安定性の評価(熱安定性)」と同じ基準で、各組成物の分離の程度を評価した。
(3) Evaluation of storage stability (thermal stability, photostability)
External compositions having compositions shown in Table 3 (Examples 3-1 to 3-5: oil-in-water creams, Example 3-6: oil-in-water lotions) were prepared according to a conventional method.
50 g of each composition of Examples was placed in a glass screw cap bottle (capacity 50 mL) and stored at 50° C. or 60° C. for 1 week in the dark. Further, 50 g of each composition of Examples was placed in a glass screw-capped bottle (capacity: 50 mL) and irradiated with light for 48 hours under the condition of 725 W/m 2 using a sun tester.
The properties of the composition before and after storage and before and after light irradiation were visually observed, and the degree of separation of each composition was evaluated according to the same criteria as in "(1) Evaluation of storage stability (thermal stability)".
結果を、表3に示す。表3中の単位は、表中に記載があるもの以外は全て「重量%」である。
ジフェンヒドラミンの含有量を変更した場合、リドカインの含有量を変更した場合、植物油の含有量を変更した場合、抗ヒスタミン剤としてジフェンヒドラミンに代えてジフェンヒドラミン塩酸塩を含有する場合、ローション剤である場合も、50℃又は60℃という高温での保存後、又は光照射後に、相分離しないことが確認された。 When the content of diphenhydramine is changed, when the content of lidocaine is changed, when the content of vegetable oil is changed, and when diphenhydramine hydrochloride is contained instead of diphenhydramine as an antihistamine, the lotion is also treated at 50°C. It was confirmed that no phase separation occurred after storage at a high temperature of 60° C. or after light irradiation.
製剤例
表4、表5に記載の処方で、抗ヒスタミン剤及び植物性油を含有する本発明の外用組成物を調製した(製剤例1~10)。製剤例1~4はクリーム剤であり、製剤例5~10はローション剤である。表4、表5中の単位は、表中に記載があるもの以外は全て「重量%」である。
Formulation Examples External compositions of the present invention containing an antihistamine and a vegetable oil were prepared according to the formulations shown in Tables 4 and 5 (Formulation Examples 1 to 10). Formulation Examples 1-4 are creams, and Formulation Examples 5-10 are lotions. All units in Tables 4 and 5 are "% by weight" unless otherwise stated.
本発明の外用組成物は、乳化剤や増粘剤などの添加物の使用のみによらずに、ないしはこれらの添加物に頼らずに、乳化状態の安定性を高めることができる。従って、処方設計の自由度が高く、商品価値が高いものである。
The composition for external use of the present invention can improve the stability of the emulsified state without relying solely on the use of additives such as emulsifiers and thickeners. Therefore, it has a high degree of freedom in prescription design and a high commercial value.
Claims (1)
A topical composition comprising an antihistamine and a vegetable oil and which is an emulsion.
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