JP5485495B2 - Patch - Google Patents
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- Publication number
- JP5485495B2 JP5485495B2 JP2006308468A JP2006308468A JP5485495B2 JP 5485495 B2 JP5485495 B2 JP 5485495B2 JP 2006308468 A JP2006308468 A JP 2006308468A JP 2006308468 A JP2006308468 A JP 2006308468A JP 5485495 B2 JP5485495 B2 JP 5485495B2
- Authority
- JP
- Japan
- Prior art keywords
- meth
- weight
- patch
- skin
- acrylic acid
- 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.)
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- 125000004079 stearyl group Chemical group [H]C([*])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])[H] 0.000 description 1
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Landscapes
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Description
本発明は、織布や不織布に対する投錨性に優れ且つ皮膚への粘着力が適度な膏体層を有し、使用時の貼付や、皮膚表面からの剥離時における刺激が極めて少ない貼付剤、更に、過酸化脂質抑制作用や美白作用などを有するアスコルビン酸誘導体やイソプロピルメチルフェノールなどの生理活性物質を安定的に保持して継続的に皮膚に作用させることができる貼付剤に関する。 The present invention has a plaster layer that is excellent in anchoring properties to woven fabrics and nonwoven fabrics and has an appropriate adhesive strength to the skin, and is a patch with very little irritation when applied and peeled off from the skin surface, The present invention also relates to a patch capable of stably holding a physiologically active substance such as an ascorbic acid derivative or isopropylmethylphenol having a lipid peroxide inhibitory action or a whitening action and continuously acting on the skin.
アスコルビン酸誘導体は、コラーゲンの生成に関与し、チロシナーゼ阻害活性によるメラニン色素生成の抑制作用などの生理活性作用を有することが知られており、皮膚の美白化やコラーゲンの生成促進を目的として、乳液、ローション、クリーム、含水パックなどの化粧品に配合されている。 Ascorbic acid derivatives are known to be involved in collagen production and have physiological activities such as melanin pigment inhibition by tyrosinase inhibitory activity. For the purpose of whitening the skin and promoting collagen production, Formulated in cosmetics such as lotions, creams, and water-containing packs.
しかしながら、アスコルビン酸誘導体は容易に酸化されるため、種々の安定化剤が試みられているが依然として経時安定性が悪く、ｐＨ調整剤を配合するなどして改良が試みられている。 However, since ascorbic acid derivatives are easily oxidized, various stabilizers have been tried, but the stability over time is still poor, and improvements have been attempted by adding a pH adjuster.
特許文献１には、アスコルビン酸及びその誘導体を含むチロシナーゼ抑制活性を有する薬物成分、薬物の皮膚吸収促進剤、薬物安定化剤、薬物溶解剤及び皮膚副作用緩和剤が、疎水性粘着剤に配合されてなる貼付剤が開示されている。 In Patent Document 1, a drug component having tyrosinase inhibitory activity including ascorbic acid and its derivatives, a drug skin absorption enhancer, a drug stabilizer, a drug solubilizer, and a skin side effect alleviator are blended in a hydrophobic adhesive. Is disclosed.
又、特許文献２には、リン酸Ｌ−アスコルビルマグネシウムと、ビタミンＥ又はその誘導体を併用した水系の美白化粧料が開示されている。 Patent Document 2 discloses a water-based whitening cosmetic that uses L-ascorbyl magnesium phosphate and vitamin E or a derivative thereof in combination.
更に、特許文献３には、カルボキシル基又は水酸基を含有するビニルモノマーからなるアルキル共重合体に、可塑剤と架橋剤とアスコルビン酸テトラ脂肪酸エステルを含有する貼付剤が開示されている。 Furthermore, Patent Document 3 discloses a patch containing a plasticizer, a crosslinking agent, and an ascorbic acid tetra fatty acid ester in an alkyl copolymer made of a vinyl monomer containing a carboxyl group or a hydroxyl group.
しかしながら、特許文献１に開示された貼付剤は、クエン酸、コハク酸及びシュウ酸又は蟻酸などの弱酸の薬物安定化剤や、エタノール、イソプロパノールなどのアルコール類の薬物溶解剤の配合が必要であり、薬物安定化剤や薬物溶解剤は、貼付剤を皮膚に貼付した際に皮膚刺激を生じるといった問題点や、薬物が安定な貼付剤であっても、皮膚から剥離するときの粘着力が強くて痛く、場合によっては皮膚刺激を生じるといった問題点を有していた。 However, the patch disclosed in Patent Document 1 requires the incorporation of a weak acid drug stabilizer such as citric acid, succinic acid and oxalic acid or formic acid, or a drug solubilizing agent such as ethanol or isopropanol. Drug stabilizers and drug solubilizers have problems such as causing skin irritation when the patch is applied to the skin, and have strong adhesive strength when peeling from the skin even if the drug is stable. It has a problem that it causes pain and sometimes causes skin irritation.
又、特許文献２に開示された美白化粧料は、含水系のクリーム、乳液、パックであることから、使用後に衣服や寝具などに付着して、衣服や寝具を汚したり、折角皮膚に塗布された美白化粧料が衣服や寝具に付着してしまい、十分な効果が得られないといった問題点を有していた。 Further, since the whitening cosmetic disclosed in Patent Document 2 is a water-containing cream, milky lotion, and pack, it adheres to clothes and bedding after use, stains the clothes and bedding, and is applied to broken skin. Whitening cosmetics adhere to clothes and bedding, and there is a problem that sufficient effects cannot be obtained.
更に、パックでは、拭き取りや洗浄が必要であり、拭き取りや洗浄によって、折角、皮膚に作用したアスコルビン酸誘導体が拭き取られたり或いは洗い流されたりするため、期待した効果が十分に得られなかった。加えて、上記美白化粧料は含水系であることから、保存安定性を高めるためにパラオキシ安息香酸メチルなどの防腐剤を配合する必要があり、この防腐剤が原因となって美白化粧料の使用時に皮膚刺激が生じるといった問題点があった。 Further, the pack needs to be wiped off and washed, and the ascorbic acid derivative that has acted on the corners and the skin is wiped off or washed away by the wiping and washing, so that the expected effect cannot be obtained sufficiently. In addition, since the above-mentioned whitening cosmetic is a water-containing system, it is necessary to add a preservative such as methyl paraoxybenzoate in order to enhance the storage stability, and the use of the whitening cosmetic due to this preservative. There was a problem that skin irritation sometimes occurred.
特許文献３に開示された貼付剤は、皮膚刺激を軽減するために可塑剤を多量に抗体層に含有させ、多官能性イソシアネート、金属キレート化合物、酸塩化物などの架橋剤を含有させている。しかしながら、アスコルビン酸誘導体は、架橋剤と反応するために充分な安定性が得られないといった問題点を有していた。 The patch disclosed in Patent Document 3 contains a large amount of plasticizer in the antibody layer to reduce skin irritation and contains a cross-linking agent such as polyfunctional isocyanate, metal chelate compound, acid chloride and the like. . However, the ascorbic acid derivative has a problem that sufficient stability cannot be obtained because it reacts with the crosslinking agent.
従って、アスコルビン酸誘導体の安定性を確保しつつ、美白効果や肌の健やかさを向上させる効果を有しながらも、衣服や寝具を汚すことなく、十分な粘着力を有し、使用後の剥離時に皮膚の角質をはぎ取ることなく、緩和に貼付剤を剥がすことが可能で、皮膚への優れた美白作用や肌を健康に保つ作用を奏する貼付剤が求められていた。 Therefore, while ensuring the stability of the ascorbic acid derivative, while having the effect of improving the whitening effect and the health of the skin, it has sufficient adhesive force without polluting clothes and bedding, and peeling after use There has been a need for a patch that can peel off the patch for relaxation without peeling off the skin of the skin, and has an excellent whitening effect on the skin and an effect of keeping the skin healthy.
そして、上記アスコルビン酸誘導体以外の生理活性物質、例えば、ニキビ予防・治療作用を有するイソプロピルメチルフェノールなどを供給するための貼付剤にも、生理活性物質の安定性を確保しつつ、ニキビ予防やニキビ治療などの生理活性を損なうことなく、衣服や寝具を汚すこともなく、充分な粘着力を有し、使用後の剥離時に皮膚の角質を剥ぎ取ることなく、緩和に貼付剤を剥がすことが可能であるといった特徴を有していることが求められている。 In addition, a patch for supplying physiologically active substances other than the ascorbic acid derivatives, such as isopropylmethylphenol having an acne prevention / treatment action, while preventing the acne prevention and acne while ensuring the stability of the physiologically active substance. Without sacrificing physiological activity such as treatment, without soiling clothes and bedding, with sufficient adhesive strength, it is possible to peel the patch for relaxation without peeling off the skin's keratin when peeling after use It is required to have a characteristic such as.
又、貼付剤は、支持体の一面に膏体層が積層一体化されることによって形成されており、支持体としては、合成樹脂フィルム、不織布、織布、或いは、これらを組み合わせたラミネートフィルムが用いられている。 The patch is formed by laminating and integrating a plaster layer on one surface of a support, and the support may be a synthetic resin film, a nonwoven fabric, a woven fabric, or a laminate film combining these. It is used.
そして、支持体としては、柔軟性に優れており人体の所望箇所の皮膚上に円滑に沿わせた状態に安定的に貼付させることができると共に、通気性に優れており皮膚に貼付した時に皮膚から発生した汗や水分の蒸散を円滑に行なうことができる不織布や織布を使用することが望まれている。 And as a support body, it is excellent in flexibility and can be stably applied in a state of being smoothly applied on the skin of a desired part of the human body, and it is excellent in breathability and skin when applied to the skin. It is desired to use a non-woven fabric or a woven fabric that can smoothly evaporate sweat and moisture generated from water.
しかしながら、不織布や織布は、繊維を絡合させ或いは織成してなるものであって、その表面は、合成樹脂フィルムと異なり、繊維が不規則に突出し或いは繊維間の隙間が不規則に形成され、不規則な凹凸面に形成されている。 However, non-woven fabrics and woven fabrics are made by intertwining or weaving fibers, and the surface is different from a synthetic resin film, and fibers protrude irregularly or gaps between fibers are irregularly formed, It is formed on an irregular surface.
従って、不織布や織布からなる支持体上に膏体層を積層させた場合において、膏体層の可塑化が不充分であった時には、膏体層は、不織布や織布の表面の凸面にのみ接触した状態にて一体化されてしまい、膏体層と支持体との接触面積が少なくなって両者の一体化が不充分となり、貼付剤の製造時や使用時に膏体層と支持体とが分離してしまうといった問題点を有していた。 Therefore, when the plaster layer is laminated on a support made of a nonwoven fabric or a woven fabric, when the plaster layer is insufficiently plasticized, the plaster layer is formed on the convex surface of the nonwoven fabric or the woven fabric. Only in contact with each other, the contact area between the paste layer and the support is reduced, and the integration between the two becomes insufficient. Had the problem of separating.
そこで、膏体層の可塑化を進めると、膏体層が不織布や織布の繊維間に過度に進入して繊維間の隙間を埋めてしまい、不織布や織布の長所である通気性を阻害してしまうと共に、膏体層の可塑化に伴って皮膚への粘着力が高くなって貼付剤を皮膚から剥離する際に皮膚に対する刺激を生じ或いは皮膚に膏体層の一部が残留してしまうなどの問題を生じていた。 Therefore, when plasticizing the plaster layer proceeds, the plaster layer excessively enters between the fibers of the nonwoven fabric or woven fabric and fills the gaps between the fibers, impairing the air permeability that is an advantage of the nonwoven fabric or woven fabric. As the paste layer is plasticized, the adhesive strength to the skin increases, causing irritation to the skin when the patch is peeled from the skin, or a part of the paste layer remains on the skin. It caused problems such as.
又、膏体層の粘着力を強くすることによって膏体層と支持体との一体化を強化することも考えられるが、膏体層の粘着力を強くすると、確かに膏体層と支持体との分離は解消できるものの、皮膚に対する粘着力が強すぎて、皮膚に貼付した貼付剤を皮膚から剥離する際に皮膚に痛みを発生させ、発赤や浮腫といった皮膚刺激を生じるといった問題を生じており、支持体として柔軟性や通気性に優れた不織布や織布を用い、製造中或いは使用中に膏体層と支持体とが分離せず、しかも、皮膚から剥離した際に皮膚に膏体層の一部が残留しない貼付剤が求められていた。 It is also conceivable to strengthen the integration of the paste layer and the support by increasing the adhesive strength of the paste layer. However, if the adhesive strength of the paste layer is increased, the paste layer and the support are surely Can be resolved, but the adhesive strength to the skin is too strong, causing pain when peeling the patch applied to the skin from the skin, causing skin irritation such as redness and edema In addition, a non-woven fabric or a woven fabric excellent in flexibility and breathability is used as a support, and the paste layer does not separate from the support during production or use, and the paste remains on the skin when peeled off from the skin. There has been a demand for a patch in which a part of the layer does not remain.
本発明は、織布や不織布に対する投錨性に優れ且つ皮膚への粘着力が適度である膏体層を有し、使用後の皮膚からの剥離時に皮膚の角質を剥ぎ取ることなく剥がすことができる貼付剤、更に、アスコルビン酸誘導体やイソプロピルメチルフェノールなどの生理活性物質の安定性に優れた貼付剤を提供する。 The present invention has a plaster layer that is excellent in anchoring properties to woven fabrics and nonwoven fabrics and has an appropriate adhesive strength to the skin, and can be peeled off without peeling off the keratin of the skin at the time of peeling from the skin after use. Provided is a patch excellent in the stability of physiologically active substances such as patches and further ascorbic acid derivatives and isopropylmethylphenol.
本発明の貼付剤は、不織布又は織布から形成されている支持体の一面に膏体層が積層一体化されてなる貼付剤であって、上記膏体層は、アスコルビン酸誘導体やイソプロピルメチルフェノールなどの生理活性物質、（メタ）アクリル酸アルキルエステル共重合体４０〜７０重量％と、ミリスチン酸イソプロピル及び／又は２−オクチルドデカノールを含む可塑剤１５〜３０重量％と、ポリオキシエチレン硬化ヒマシ油及び／又はポリオキシエチレンポリオキシプロピレングリコールを含む粘着力調整剤５〜２５重量％とを含有する組成物からなり、上記（メタ）アクリル酸アルキルエステル共重合体が、（メタ）アクリル酸２−エチルヘキシル成分を７０〜９５重量％含有し、且つ、（メタ）アクリル酸２−エチルヘキシル以外の、アルキル基の炭素数が６以上の（メタ）アクリル酸アルキルエステル成分を５〜３０重量％含有していることを特徴とする。なお、（メタ）アクリルは、メタクリル又はアクリルを意味する。 The patch of the present invention is a patch in which a plaster layer is laminated and integrated on one surface of a support formed from a nonwoven fabric or a woven fabric, and the plaster layer includes an ascorbic acid derivative or isopropylmethylphenol. A bioactive substance such as (meth) acrylic acid alkyl ester copolymer 40 to 70 % by weight, a plasticizer 15 to 30% by weight containing isopropyl myristate and / or 2-octyldodecanol, and polyoxyethylene-cured castor It consists of a composition containing 5 to 25% by weight of an adhesive strength modifier containing oil and / or polyoxyethylene polyoxypropylene glycol, and the (meth) acrylic acid alkyl ester copolymer is (meth) acrylic acid 2 An alkyl other than 2-ethylhexyl (meth) acrylate containing 70-95% by weight of an ethylhexyl component It contains 5 to 30% by weight of a (meth) acrylic acid alkyl ester component having 6 or more carbon atoms in the group. In addition, (meth) acryl means methacryl or acryl.
上記アスコルビン酸誘導体としては、リン酸Ｌ−アスコルビルマグネシウム、リン酸Ｌ−アスコルビルナトリウム、アスコルビン酸グルコシド、テトラパルミチン酸Ｌ−アスコルビルなどが挙げられ、単独で用いられても二種以上が併用されてもよい。 Examples of the ascorbic acid derivative include L-ascorbyl phosphate phosphoric acid, sodium L-ascorbyl phosphate, glucoside ascorbate, L-ascorbyl tetrapalmitate and the like, and may be used alone or in combination of two or more. Good.
本発明の貼付剤の膏体層中におけるアスコルビン酸誘導体の含有量は、少ないと、アスコルビン酸誘導体の奏する皮膚の美白化やコラーゲンの生成促進が発現しないことがある一方、多いと、膏体層表面に多量のアスコルビン酸誘導体が析出し或いはブリートアウトして貼付剤の貼付性が低下するのに加えて、多くてもリン酸Ｌ−アスコルビルマグネシウムの奏する皮膚の美白化やコラーゲンの生成促進効果に顕著な変化がないので、０．１〜３０重量％が好ましい。 When the content of the ascorbic acid derivative in the plaster layer of the patch of the present invention is small, the skin whitening and the promotion of collagen production performed by the ascorbic acid derivative may not be expressed, whereas when the content is large, the plaster layer In addition to a large amount of ascorbic acid derivative precipitating or burting out on the surface and reducing the adhesiveness of the patch, it is effective for the skin whitening and collagen production promotion effect of L-ascorbyl magnesium phosphate at most. Since there is no remarkable change, 0.1 to 30% by weight is preferable.
又、本発明の貼付剤は、後述のように皮膚の中でも特に敏感な顔面にも適用することができるため、ニキビ予防・治療剤として使用することもできる。このように貼付剤をニキビ予防・治療剤として使用する場合は、膏体層にイソプロピルメチルフェノールなどのニキビの予防や治療の効果を有する生理活性物質が含有される。上記貼付剤の膏体層中における、ニキビの予防や治療の効果を有する生理活性物質の含有量は、少ないと、ニキビの予防及び治療の効果が発現しないことがある一方、多いと、皮膚刺激の原因になることがあるので、０．１〜１０重量％が好ましい。 Moreover, since the patch of the present invention can be applied to a particularly sensitive face in the skin as described later, it can also be used as an acne prevention / treatment agent. Thus, when using the patch as an acne prevention / treatment agent, the plaster layer contains a physiologically active substance having an effect of preventing or treating acne such as isopropylmethylphenol. If the content of the physiologically active substance having an effect of preventing and treating acne in the plaster layer of the above-mentioned patch is small, the effect of preventing and treating acne may not be manifested. 0.1 to 10% by weight is preferable.
なお、上記イソプロピルメチルフェノールなどのニキビの予防や治療の効果を有する生理活性物質は、単独で用いられても、他の生理活性を有する物質と併用されてもよく、ニキビ跡への色素沈着を抑制する作用を付与する目的で、酢酸トコフェロールなどのトコフェロール類及び／又はアスコルビン酸誘導体と共に使用されるのが好ましい。 In addition, the physiologically active substance having an effect of preventing or treating acne such as isopropylmethylphenol may be used alone or in combination with other physiologically active substances, and may cause pigmentation on acne scars. For the purpose of imparting an inhibitory action, it is preferably used together with tocopherols such as tocopherol acetate and / or ascorbic acid derivatives.
そして、本発明の貼付剤は、皮膚の中でも特に敏感な顔面にも適用されるため特別な粘着物性を必要とする。即ち、本発明の貼付剤が、目的とする作用を皮膚に付与するためには、膏体層中の有効成分を皮膚に移行、吸収させるための一定時間以上の継続した皮膚への貼付が必要であり、その実現のためには、一定以上の強さの膏体層の粘着力が必要である。特に、本発明の貼付剤は、皮膚の美白作用などを目的としていることから、就寝中の貼付を想定しており、枕との擦れや、就寝中の無意識な手による払いのけ動作に耐えるだけの粘着力が必要である。このためには、膏体層の粘着力を強くすればよいが，粘着力を強くすると、貼付剤を皮膚から剥離する際に皮膚を引っ張り、皮膚にダメージを与え、ひどくなると、貼付剤を皮膚から剥離する際に角質をも剥ぎ取ってしまい、これも皮膚刺激の原因となる。 And since the patch of this invention is applied also to the especially sensitive face in skin, special adhesive physical property is required. That is, in order for the patch of the present invention to impart the intended action to the skin, it is necessary to apply the active ingredient in the plaster layer to the skin continuously for a certain period of time or longer in order to transfer and absorb it. In order to realize this, the adhesive strength of the plaster layer having a certain strength or more is required. In particular, since the patch of the present invention is intended for skin whitening, etc., it is assumed to be applied while sleeping, and is resistant to rubbing with a pillow and unwiping action by an unconscious hand while sleeping. Only adhesive strength is necessary. For this purpose, the adhesive strength of the plaster layer may be increased. However, if the adhesive strength is increased, the skin is pulled when the patch is peeled off from the skin, and the skin is damaged. When exfoliating from the skin, the skin is also peeled off, which also causes skin irritation.
本発明の貼付剤は、その膏体層中にアスコルビン酸誘導体やイソプロピルメチルフェノールなどの生理活性物質を安定的に含有させておくことができるのに加え、使用中に貼付剤が皮膚から不測に剥がれることがないと共に、貼付剤を皮膚から剥離する際に皮膚刺激を生じず且つ糊残りの生じないことが要求され、この要求を満たすべく、本発明の貼付剤では、その膏体層を構成する粘着成分として、（メタ）アクリル酸２−エチルヘキシル成分を７０〜９５重量％含有し、且つ、（メタ）アクリル酸２−エチルヘキシル以外の、アルキル基の炭素数が６以上の（メタ）アクリル酸アルキルエステル成分を５〜３０重量％含有してなる（メタ）アクリル酸アルキルエステル共重合体、可塑剤及び粘着力調整剤からなるものを用いている。 In addition to being able to stably contain a physiologically active substance such as an ascorbic acid derivative or isopropylmethylphenol in the plaster layer of the patch of the present invention, the patch may unexpectedly come out of the skin during use. In order to satisfy this requirement, the plaster layer of the plaster layer of the present invention does not peel off, and does not cause skin irritation and no adhesive residue when peeling the patch from the skin. (Meth) acrylic acid containing 70 to 95% by weight of (meth) acrylic acid 2-ethylhexyl component and having 6 or more alkyl carbon atoms other than (meth) acrylic acid 2-ethylhexyl What consists of the (meth) acrylic-acid alkylester copolymer formed by containing 5-30 weight% of alkylester components, a plasticizer, and an adhesive force regulator is used.
上記（メタ）アクリル酸２−エチルヘキシル以外の、アルキル基の炭素数が６以上の（メタ）アクリル酸アルキルエステルとしては、特に限定されず、（メタ）アクリル酸ｎ−ヘキシル、（メタ）アクリル酸ｎ−ヘプチル、（メタ）アクリル酸ｎ−オクチル、（メタ）アクリル酸ｎ−ドデシル、（メタ）アクリル酸ラウリル、（メタ）アクリル酸ステアリルなどが挙げられる。 The (meth) acrylic acid alkyl ester having 6 or more carbon atoms in the alkyl group other than the above (meth) acrylic acid 2-ethylhexyl is not particularly limited, and (meth) acrylic acid n-hexyl, (meth) acrylic acid Examples include n-heptyl, n-octyl (meth) acrylate, n-dodecyl (meth) acrylate, lauryl (meth) acrylate, stearyl (meth) acrylate, and the like.
具体的に、膏体層を構成している（メタ）アクリル酸アルキルエステル共重合体としては、例えば、アクリル酸２−エチルヘキシル・メタクリル酸２−エチルヘキシル・メタクリル酸ｎ−ドデシル共重合体などが挙げられる。 Specifically, examples of the (meth) acrylic acid alkyl ester copolymer constituting the plaster layer include 2-ethylhexyl acrylate, 2-ethylhexyl methacrylate, n-dodecyl methacrylate copolymer, and the like. It is done.
そして、上記（メタ）アクリル酸アルキルエステル共重合体の共重合成分の一つである、アルキル基の炭素数が６以上の（メタ）アクリル酸アルキルエステルにおいて、アルキル基の炭素数が６以上である理由は、アルキル基の炭素数が５以下であると、脂溶性の酢酸ｄｌ−α−トコフェロールやパルミチン酸レチノールを膏体層中に含有させた場合に、膏体層の皮膚に対する貼付性が強くなり過ぎ、貼付剤を皮膚から剥離する際に痛みを生じたり或いは糊残りを生じるからであり、更に、架橋剤などの添加で膏体層の粘着力を低減することが可能であるが、架橋剤を添加すると、アスコルビン酸誘導体やイソプロピルメチルフェノールなどの生理活性物質が架橋剤と反応してしまい、アスコルビン酸誘導体やイソプロピルメチルフェノールなどの生理活性物質の安定性が低下してしまうからである。 In the (meth) acrylic acid alkyl ester having 6 or more alkyl carbon atoms, which is one of the copolymer components of the (meth) acrylic acid alkyl ester copolymer, the alkyl group has 6 or more carbon atoms. The reason is that when the carbon number of the alkyl group is 5 or less, when the fat-soluble dl-α-tocopherol acetate or retinol palmitate is contained in the paste layer, the paste layer has a sticking property to the skin. This is because it becomes too strong and causes pain or adhesive residue when the patch is peeled from the skin, and it is possible to further reduce the adhesive strength of the plaster layer by adding a crosslinking agent, When a crosslinking agent is added, bioactive substances such as ascorbic acid derivatives and isopropylmethylphenol react with the crosslinking agent, resulting in ascorbic acid derivatives and isopropylmethylphenol. What stability of the physiologically active substance is lowered.
更に、膏体層を構成している（メタ）アクリル酸アルキルエステル共重合体において、（メタ）アクリル酸２−エチルヘキシル成分の含有量は、少ないと、膏体層が可塑剤の添加で過度に軟化し、膏体層の凝集力が低下し過ぎ、貼付剤を皮膚から剥離した際に糊残りなどを生じることがある一方、多いと、膏体層が硬くなり過ぎて皮膚への充分な粘着力が得られなくなるので、７０〜９５重量％に限定され、７５〜９０重量％がより好ましい。 Furthermore, in the (meth) acrylic acid alkyl ester copolymer constituting the plaster layer, if the content of the (meth) acrylic acid 2-ethylhexyl component is small, the plaster layer is excessively added by the addition of a plasticizer. Softening, cohesive strength of the plaster layer is too low, and adhesive residue may be generated when the patch is peeled from the skin, while in many cases, the plaster layer becomes too hard and sufficient adhesion to the skin Since no force can be obtained, the amount is limited to 70 to 95% by weight, and more preferably 75 to 90% by weight.
同様の理由で、膏体層を構成している（メタ）アクリル酸アルキルエステル共重合体において、（メタ）アクリル酸２−エチルヘキシル以外の、アルキル基の炭素数が６以上の（メタ）アクリル酸アルキルエステル成分の含有量は、５〜３０重量％に限定され、１０〜２５重量％が好ましい。 For the same reason, in the (meth) acrylic acid alkyl ester copolymer constituting the plaster layer, (meth) acrylic acid having 6 or more carbon atoms in the alkyl group other than (meth) acrylic acid 2-ethylhexyl. The content of the alkyl ester component is limited to 5 to 30% by weight, and preferably 10 to 25% by weight.
そして、膏体層中における（メタ）アクリル酸アルキルエステル共重合体の含有量は、少ないと、膏体層の凝集力が低くなり、貼付剤を皮膚から剥離した際に皮膚に糊残りを生じることがある一方、多いと、膏体層が硬くなり過ぎて皮膚への追従性が悪くなり、皮膚刺激の原因となることがあるので、４０〜７０重量％に限定される。 If the content of the (meth) acrylic acid alkyl ester copolymer in the plaster layer is small, the cohesive force of the plaster layer becomes low, and an adhesive residue is left on the skin when the patch is peeled from the skin. On the other hand, if the amount is too large, the plaster layer becomes too hard and the followability to the skin is deteriorated, which may cause skin irritation, so it is limited to 40 to 70 % by weight.
更に、本発明の貼付剤は、皮膚の中でも特に敏感な顔面に貼着させて用いられるので、皮膚への適度な貼付性と皮膚から剥離する際に痛みがないことが必要であり、このために、膏体層を構成する粘着成分中に可塑剤及び粘着力調整剤を含有させている。 Furthermore, since the patch of the present invention is used by being attached to a particularly sensitive face in the skin, it is necessary to have an appropriate sticking property to the skin and no pain when peeling from the skin. Further, a plasticizer and an adhesive strength adjusting agent are contained in the adhesive component constituting the plaster layer.
そして、アスコルビン酸誘導体の安定性を損なわず、皮膚への良好な貼付性を有し、皮膚からの剥離時に痛みがないと共に、後述する織布又は不織布からなる支持体に対する投錨性に優れた膏体層を形成することができる点からも、可塑剤としては、ミリスチン酸イソプロピル、２−オクチルドデカノールが用いられ、ミリスチン酸イソプロピルと２−オクチルドデカノールを併用してもよい。 And the paste which does not impair the stability of the ascorbic acid derivative, has good adhesiveness to the skin, has no pain when peeled from the skin, and is excellent in anchoring properties to a support made of a woven or non-woven fabric described later In view of the ability to form a body layer, isopropyl myristate and 2-octyldodecanol are used as the plasticizer, and isopropyl myristate and 2-octyldodecanol may be used in combination.
又、膏体層中における可塑剤の含有量は、少ないと、膏体層の粘着力が低下し、貼付剤の貼付性が低下することがある一方、多いと、膏体層の粘着力が強くなり過ぎて皮膚から剥離する際に痛みが生じたり、膏体層が軟化し過ぎて皮膚から剥離する際に糊残りが生じることがあるので、１５〜３０重量％に限定されるが、１５〜２５重量％がより好ましい。 In addition, if the content of the plasticizer in the plaster layer is small, the adhesive strength of the plaster layer is lowered and the sticking property of the patch may be lowered. On the other hand, if the content is large, the adhesive strength of the plaster layer is reduced. Since it becomes too strong and pain occurs when peeling from the skin, or the paste layer may be too soft and peel away from the skin when it peels off, it is limited to 15 to 30% by weight. More preferred is ˜25% by weight.
又、粘着力調整剤としては酸化エチレン付加化合物が好ましい。酸化エチレンの数平均重合度は、少ないと、粘着力調整剤としての効果が充分でない一方、多いと、貼付剤を皮膚に貼付する時にべたつきを生じるので、５〜３０が好ましく、１０〜２０がより好ましい。 Further, an ethylene oxide addition compound is preferable as the adhesive strength adjusting agent. When the number average degree of polymerization of ethylene oxide is small, the effect as an adhesive strength modifier is not sufficient, while when it is large, stickiness occurs when the patch is applied to the skin, so 5 to 30 is preferable, and 10 to 20 is preferable. More preferred.
又、上記酸化エチレン付加化合物としては、例えば、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プロピレングリコールなどが挙げられ、アスコルビン酸誘導体やイソプロピルメチルフェノールなどの生理活性物質の安定性を損なわず、皮膚への良好な貼付性を有していると共に皮膚からの剥離時に痛みがなく、更に、後述する織布又は不織布からなる支持体に対する投錨性に優れた膏体層を形成することができる点からも、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、ポリオキシエチレン硬化ヒマシ油がより好ましい。なお、酸化エチレン付加化合物は単独で用いられても二種以上が併用されてもよい。 Examples of the ethylene oxide addition compound include polyoxyethylene hydrogenated castor oil, polyoxyethylene polypropylene glycol, and the like. To the skin without impairing the stability of physiologically active substances such as ascorbic acid derivatives and isopropylmethylphenol. From the point that it has a good adhesive property and has no pain at the time of peeling from the skin, and can form a plaster layer excellent in anchoring property to a support made of a woven fabric or a nonwoven fabric described later. Polyoxyethylene hydrogenated castor oil and polyoxyethylene polyoxypropylene glycol are preferable, and polyoxyethylene hydrogenated castor oil is more preferable. In addition, an ethylene oxide addition compound may be used independently, or 2 or more types may be used together.
そして、膏体層中における粘着力調整剤の含有量は、少ないと、膏体層の粘着力が強くなり過ぎることがある一方、多いと、膏体層表面に粘着力調整剤が多量にブリードアウトしてべたつきを生じることがあるので、５〜２５重量％に限定され、１０〜２５重量％がより好ましく、１５〜２５重量％が特に好ましい。 When the content of the adhesive strength adjusting agent in the plaster layer is small, the adhesive strength of the plaster layer may become too strong. On the other hand, when the content is large, a large amount of adhesive strength adjusting agent bleeds on the surface of the plaster layer. Since it may stick out and cause stickiness, it is limited to 5 to 25% by weight , more preferably 10 to 25% by weight, and particularly preferably 15 to 25% by weight.
膏体層の粘着力の目安として、ＪＩＳ Ｚ０２３７に準拠してステンレス板を用いて測定された１８０°引き剥がし粘着力が挙げられ、この１８０°引き剥がし粘着力が、２０ｇ／１５ｍｍ以下であることが好ましく、１０ｇ／１５ｍｍ以下であることがより好ましい。 As a measure of the adhesive strength of the plaster layer, 180 ° peel adhesive strength measured using a stainless steel plate in accordance with JIS Z0237 can be mentioned, and this 180 ° peel adhesive strength is 20 g / 15 mm or less. Is preferably 10 g / 15 mm or less.
更に、膏体層には、皮膚刺激性が生じないように、アスコルビン酸誘導体の安定化剤及び溶解剤や、膏体成分の防腐剤、抗菌剤及び酸化防止剤を含有していないことが好ましい。 Furthermore, it is preferable that the plaster layer does not contain stabilizers and solubilizers of ascorbic acid derivatives and antiseptics, antibacterial agents and antioxidants of the plaster components so that skin irritation does not occur. .
アスコルビン酸誘導体の安定化剤としては、例えば、亜硫酸水素又はその塩などが挙げられる。アスコルビン酸誘導体の溶解剤としては、例えば、エタノール、メタノール、イソプロパノール、ブタノールなどのアルコールが挙げられる。膏体成分の防腐剤としては、例えば、パラオキシ安息香酸メチル、パラオキシ安息香酸プロピルなどが挙げられる。膏体成分の抗菌剤としては、例えば、塩化ベンゼトニウム、塩化ベンゼルコニウムなどが挙げられる。膏体成分の酸化防止剤としては、例えば、ヒドロキシブチルトルエン、ブチルヒドロキシアニソールなどが挙げられる。 Examples of stabilizers for ascorbic acid derivatives include hydrogen sulfite or a salt thereof. Examples of the ascorbic acid derivative solubilizer include alcohols such as ethanol, methanol, isopropanol, and butanol. Examples of the preservative for the plaster component include methyl paraoxybenzoate and propyl paraoxybenzoate. Examples of the antibacterial agent for the plaster component include benzethonium chloride and benzalkonium chloride. Examples of the antioxidant for the plaster component include hydroxybutyltoluene and butylhydroxyanisole.
更に、膏体層中には、その物性を損なわない範囲内において、使用感を高めるための着香剤や着色剤；界面活性剤；乳化剤；湿潤剤；熱安定剤；光安定剤；紫外線吸収剤；吸収促進剤などの添加剤が添加されてもよい。又、アスコルビン酸誘導体やイソプロピルメチルフェノールなどの生理活性物質の安定性や膏体層の物性を損なわない範囲内において、他のビタミン誘導体や保湿成分が含有されていてもよい。 Furthermore, in the plaster layer, flavoring agents and coloring agents for enhancing the feeling of use within the range not impairing the physical properties; surfactants; emulsifiers; wetting agents; heat stabilizers; light stabilizers; Agents; additives such as absorption promoters may be added. In addition, other vitamin derivatives and moisturizing components may be contained within the range that does not impair the stability of physiologically active substances such as ascorbic acid derivatives and isopropylmethylphenol and the physical properties of the paste layer.
そして、本発明の貼付剤の膏体層に、着色料及び香料を含有させる場合において、着色料及び香料の総添加量は、膏体層の全重量の０．００１〜１０重量％であることが好ましい。これは、着色料及び香料の添加量が少ないと、これらを添加した効果が得られないことがある一方、多いと、膏体層の物性が損なわれることがあるからである。 And in the case where a coloring agent and a fragrance are included in the plaster layer of the patch of the present invention, the total amount of the coloring agent and the fragrance is 0.001 to 10% by weight of the total weight of the plaster layer. Is preferred. This is because if the addition amount of the coloring agent and the fragrance is small, the effect of adding them may not be obtained, whereas if the addition amount is large, the physical properties of the plaster layer may be impaired.
上記膏体層を支持する支持体としては、不織布、織布及びこれらを組み合わせたラミネートフィルムなどが挙げられ、特に、貼付剤を顔面などの動きが多く過敏な部位に用いる場合、柔軟性及び通気性に優れた、不織布又は織布のみから構成するのが好ましい。 The support for supporting the plaster layer, such as laminate film combining nonwoven fabric, woven fabric and these can be mentioned, in particular, when using the patch to the motion number sensitive sites such as the face, flexibility And it is preferable to comprise only the nonwoven fabric or the woven fabric excellent in air permeability.
又、上記織布及び不織布を構成する繊維素材としては、特に限定されず、例えば、綿、麻、毛、又は絹などの天然繊維や、レーヨン、アセテート、アクリル、ナイロン、ポリエステル、ポリ塩化ビニル、アクリル系高分子、ポリプロピレンなどのポリオレフィン、ポリウレタンなどからなる化学繊維などが挙げられ、単独で用いても、２種以上の繊維素材を複合的に用いてもよい。そして、これらの中でも、本発明の貼付剤の膏体層に、最も投錨性を発現させやすい点から、ポリオレフィン繊維及びレーヨン繊維からなる不織布が好ましい。 In addition, the fiber material constituting the woven fabric and the nonwoven fabric is not particularly limited. For example, natural fibers such as cotton, hemp, hair, or silk, rayon, acetate, acrylic, nylon, polyester, polyvinyl chloride, Examples include acrylic polymers, polyolefins such as polypropylene, and chemical fibers made of polyurethane. These may be used alone or in combination of two or more fiber materials. Of these, non-woven fabrics composed of polyolefin fibers and rayon fibers are preferred because the plaster layer of the patch of the present invention is most likely to exhibit anchoring properties.
このように支持体としては、柔軟性及び通気性に優れた不織布や織布が好ましく用いられるが、その表面には、繊維が不規則に突出し或いは繊維が不規則に配設することによって微細な凹凸が形成されている。 As described above, a nonwoven fabric or a woven fabric excellent in flexibility and air permeability is preferably used as the support. However, the surface of the support is fine because fibers protrude irregularly or fibers are irregularly arranged. Unevenness is formed.
そこで、膏体層において、上述のように、粘着成分として特定の（メタ）アクリル酸アルキルエステル共重合体を用い、好ましくは、可塑剤として脂肪酸エステル及び／又はアルコール類を、粘着調整剤として酸化エチレン付加化合物を用いることによって、膏体層の可塑化を適度に行ない、不織布又は織布を構成している繊維間への膏体層の過度な進入を阻止して不織布又は織布の目詰まりを防止し、不織布又は織布の柔軟性及び通気性を確保しつつ、不織布又は織布を構成している繊維間に膏体層を適度に進入させて、膏体層と支持体とを強固に一体化させることができる粘着力を実現し、製造時や使用時に膏体層と支持体とが不測に分離することがないと共に、皮膚に対しては必要以上に強い貼付性を示さず、剥離時に膏体層の残留や皮膚に対する刺激のない貼付剤とすることができる。 Therefore, in the plaster layer, as described above, a specific (meth) acrylic acid alkyl ester copolymer is used as an adhesive component, and preferably, a fatty acid ester and / or alcohol is used as a plasticizer, and an oxidation is used as an adhesion regulator. By using an ethylene addition compound, the plaster layer is appropriately plasticized, and the excessive penetration of the plaster layer between fibers constituting the nonwoven fabric or woven fabric is prevented to clog the nonwoven fabric or woven fabric. The plaster layer is appropriately inserted between the fibers constituting the non-woven fabric or the woven fabric while the softness and breathability of the non-woven fabric or the woven fabric is ensured, and the plaster layer and the support are strengthened. Adhesive strength that can be integrated into the skin, the plaster layer and the support are not unexpectedly separated during production and use, and do not exhibit an unnecessarily strong adhesiveness to the skin. At the time of peeling, It can be irritating patch for peel.
更に、上記貼付剤の膏体層は、輸送中や保管中に膏体層を保護するために剥離シートによって剥離自在に被覆、保護されていることが好ましい。このような剥離シートとしては、膏体層を損なうことなく剥離自在に膏体層を被覆できればよく、例えば、ポリエチレンテレフタレートなどのポリエステル系樹脂フィルム、上質紙、グラシン紙などの剥離基材の少なくとも一面にシリコーンを塗布してなるものが挙げられる。 Furthermore, the plaster layer of the above-mentioned patch is preferably covered and protected by a release sheet in order to protect the plaster layer during transportation and storage. As such a release sheet, it is sufficient that the paste layer can be releasably coated without damaging the paste layer. For example, at least one surface of a release substrate such as a polyester resin film such as polyethylene terephthalate, fine paper, and glassine paper. And those obtained by applying silicone to the above.
次に、上記貼付剤の製造方法について説明する。この貼付剤の製造方法としては、特に限定されず、例えば、(1)（メタ）アクリル酸アルキルエステル共重合体の粘着剤溶液に、アスコルビン酸誘導体やイソプロピルメチルフェノールなどの生理活性物質、可塑剤及び粘着力調整剤、必要に応じて添加剤を配合してなる膏体溶液を支持体上に所定厚みに塗布して乾燥させる貼付剤の製造方法、(2)（メタ）アクリル酸アルキルエステル共重合体の粘着剤溶液に、アスコルビン酸誘導体やイソプロピルメチルフェノールなどの生理活性物質、可塑剤及び粘着力調整剤、必要に応じて添加剤を配合してなる膏体溶液を剥離シート上に所定厚みに塗布して乾燥させた後、この剥離シート上に形成された膏体層を支持体上に転写、積層一体化させる貼付剤の製造方法が挙げられる。 Next, a method for producing the patch will be described. The method for producing this patch is not particularly limited. For example, (1) a (meth) acrylic acid alkyl ester copolymer adhesive solution, a physiologically active substance such as an ascorbic acid derivative or isopropylmethylphenol, or a plasticizer And a method for producing a patch in which a plaster solution containing an adhesive, if necessary, is added to the support to a predetermined thickness and dried, (2) (meth) acrylic acid alkyl ester A plaster solution prepared by blending a polymer adhesive solution with a physiologically active substance such as an ascorbic acid derivative or isopropylmethylphenol, a plasticizer and an adhesive force adjusting agent, and additives as required, has a predetermined thickness on a release sheet. A method of producing a patch in which the paste layer formed on the release sheet is transferred onto a support and laminated and integrated after being applied to and dried.
なお、支持体を織布又は不織布のみからなるものとする場合、貼付剤を上記(1)のように支持体上に膏体溶液を塗布して製造すると、不織布又は織布を構成している繊維間に膏体溶液が過度に浸透し、不織布又は織布の繊維間が膏体層で詰まった状態となって、支持体の通気性や柔軟性が損なわれることあるので、上記(2)のように剥離シート上に膏体溶液を塗布して、乾燥させることにより膏体層を形成させた後、膏体層上に支持体を積層一体化して製造する方法が好ましい。 When the support is made only of woven fabric or non-woven fabric, when the patch is produced by applying the plaster solution on the support as described in (1) above, the non-woven fabric or woven fabric is constituted. Since the paste solution excessively permeates between the fibers and the spaces between the nonwoven fabric or woven fabric are clogged with the paste layer, the air permeability and flexibility of the support may be impaired. As described above, it is preferable to apply the paste solution on the release sheet and dry it to form a paste layer, and then laminate and integrate the support on the paste layer.
上記粘着剤溶液としては、従来から貼付剤の製造で用いられているものが用いられ、例えば、溶剤型粘着剤溶液、エマルジョン型粘着剤溶液等が挙げられる。このような粘着剤溶液としては、例えば、医薬品添加物規格収載品である「アクリル酸２−エチルヘキシル・メタクリル酸２−エチルヘキシル・メタクリル酸ｎ−ドデシル共重合体溶液」がある。 As the pressure-sensitive adhesive solution, those conventionally used in the manufacture of patches are used, and examples thereof include a solvent-type pressure-sensitive adhesive solution and an emulsion-type pressure-sensitive adhesive solution. Examples of such a pressure-sensitive adhesive solution include “2-ethylhexyl acrylate / 2-ethylhexyl methacrylate / n-dodecyl methacrylate copolymer solution” which is a standard product of pharmaceutical additives.
本発明の貼付剤は、支持体の一面に膏体層が積層一体化されてなる貼付剤であって、上記膏体層は、アスコルビン酸誘導体やイソプロピルメチルフェノールなどの生理活性物質、（メタ）アクリル酸アルキルエステル共重合体、可塑剤及び粘着力調整剤を含有する組成物からなり、上記（メタ）アクリル酸アルキルエステル共重合体が、（メタ）アクリル酸２−エチルヘキシル成分を７０〜９５重量％含有し、且つ、（メタ）アクリル酸２−エチルヘキシル以外の、アルキル基の炭素数が６以上の（メタ）アクリル酸アルキルエステル成分を５〜３０重量％含有していることを特徴とするので、アスコルビン酸誘導体やイソプロピルメチルフェノールなどの生理活性物質を安定的に保持して持続的に皮膚に作用させることができ、美白作用や肌を健やかに保つ作用を皮膚に効果的に付与することができる。 The patch of the present invention is a patch in which a plaster layer is laminated and integrated on one surface of a support, and the plaster layer includes a physiologically active substance such as an ascorbic acid derivative or isopropylmethylphenol, (meth) It consists of a composition containing an acrylic acid alkyl ester copolymer, a plasticizer and an adhesive strength modifier, and the above (meth) acrylic acid alkyl ester copolymer contains 70 to 95 wt. Of (meth) acrylic acid 2-ethylhexyl component. 5% to 30% by weight of a (meth) acrylic acid alkyl ester component having 6 or more carbon atoms in the alkyl group other than 2-ethylhexyl (meth) acrylate. , Can stably hold physiologically active substances such as ascorbic acid derivatives and isopropylmethylphenol, and can act on the skin continuously. The healthy keeping act can be effectively applied to the skin.
そして、膏体層が、（メタ）アクリル酸アルキルエステル共重合体、可塑剤及び粘着力調整剤を含有する組成物からなる場合には、膏体層は、織布や不織布のような、投錨性を発揮しにくい、つまり、膏体層を積層一体化させにくい支持体に対しても充分な接着性を有するにもかかわらず、皮膚に対する刺激性が低く、得られる貼付剤は、膏体層と支持体とが強固に積層一体化されていると共に皮膚に対する貼付性に優れている。 And when a paste layer consists of a composition containing a (meth) acrylic-acid alkylester copolymer, a plasticizer, and an adhesive force regulator, a paste layer is thrown in like a woven fabric and a nonwoven fabric. In spite of having sufficient adhesiveness even to a support that is difficult to laminate and integrate the plaster layer, the irritation to the skin is low, and the obtained patch is a plaster layer. And the support are firmly laminated and integrated and have excellent adhesiveness to the skin.
更に、上記貼付剤の支持体を通気性に優れた、織布又は不織布のみから構成することにより、貼付剤の使用時において、皮膚から出る汗や水分によって、貼付部位の皮膚が蒸れて、皮膚に不快感や皮膚障害を発生させるようなことがほとんどない。 Furthermore, the support of the patch is composed only of a woven fabric or a non-woven fabric having excellent air permeability, so that when the patch is used, the skin at the site of application is moistened by sweat or moisture from the skin. Rarely causes discomfort or skin damage.
（参考例１〜１３、比較例２，４〜６）
粘着剤溶液として、アクリル酸２−エチルヘキシル・メタクリル酸２−エチルヘキシル・メタクリル酸ｎ−ドデシル共重合体を酢酸エチル中に溶解してなる粘着剤溶液Ａ（積水化学工業社製 医薬品添加物 １９９８年収載、アクリル酸２−エチルヘキシル・メタクリル酸２−エチルヘキシル・メタクリル酸ｎ−ドデシル共重合体（アクリル酸２−エチルヘキシル成分：９重量％、メタクリル酸２−エチルヘキシル成分：７８重量％、メタクリル酸ｎ−ドデシル成分：１３重量％）４０重量％酢酸エチル溶液）と、アクリル酸メチル・アクリル酸２−エチルヘキシル共重合体エマルジョンからなる粘着剤溶液Ｂ（日本カーバイド工業社製 商品名「ニカゾールＴＳ−６２０」、アクリル酸メチル・アクリル酸２−エチルヘキシル共重合体：６０重量％水溶液）と、アクリル酸２−エチルヘキシル・ビニルピロリドン共重合体を酢酸エチル中に溶解してなる粘着剤溶液Ｃ（積水化学工業社製 医薬品添加物規格収載、３５重量％酢酸エチル溶液）とを用意した。
( Reference Examples 1-13, Comparative Examples 2, 4-6)
Adhesive solution A prepared by dissolving 2-ethylhexyl acrylate / 2-ethylhexyl methacrylate / n-dodecyl methacrylate copolymer in ethyl acetate as an adhesive solution (medicine additive manufactured by Sekisui Chemical Co., Ltd., 1998) , 2-ethylhexyl acrylate, 2-ethylhexyl methacrylate, n-dodecyl methacrylate copolymer (2-ethylhexyl acrylate component: 9% by weight, 2-ethylhexyl methacrylate component: 78% by weight, n-dodecyl methacrylate component) : 13 wt%) 40 wt% ethyl acetate solution) and pressure-sensitive adhesive solution B consisting of a methyl acrylate / 2-ethylhexyl acrylate copolymer emulsion (trade name “Nicazole TS-620” manufactured by Nippon Carbide Industries Co., Ltd.), acrylic acid Methyl acrylate 2-ethylhexyl copolymer: 60 layers % Aqueous solution) and a pressure-sensitive adhesive solution C obtained by dissolving 2-ethylhexyl acrylate / vinylpyrrolidone copolymer in ethyl acetate (Sekisui Chemical Co., Ltd., Pharmaceutical Additive Standards listed, 35 wt% ethyl acetate solution). Prepared.
続いて、アスコルビン酸誘導体として、リン酸Ｌ−アスコルビルマグネシウム（日光ケミカルズ社製）、アスコルビン酸２−グルコシド、テトラパルミチン酸Ｌ−アスコルビルを、粘着力調整剤として、ポリオキシエチレン（１０）硬化ヒマシ油（日光ケミカルズ社製、酸化エチレンの数平均重合度：１０）、ポリオキシエチレン（１２）ポリオキシプロピレン（３５）グリコール（日本油脂製、酸化プロピレンの数平均重合度：約３５、酸化エチレンの数平均重合度：約１２）を、可塑剤として、２−オクチルドデカノール（高級アルコール社製）、ミリスチン酸イソプロピル（日光ケミカルズ社製）を用意し、これらを、上述の粘着剤溶液中の水分又は酢酸エチルを除去した後の組成が表１又は表３に示した組成になるように粘着剤溶液に添加し、均一になるように攪拌混合して膏体溶液を得た。 Subsequently, as an ascorbic acid derivative, L-ascorbyl magnesium phosphate (manufactured by Nikko Chemicals Co., Ltd.), 2-glucoside ascorbic acid, L-ascorbyl tetrapalmitate was used as an adhesive strength modifier, and polyoxyethylene (10) hydrogenated castor oil. (Manufactured by Nikko Chemicals, number average polymerization degree of ethylene oxide: 10), polyoxyethylene (12) polyoxypropylene (35) glycol (manufactured by NOF Corporation, number average polymerization degree of propylene oxide: about 35, number of ethylene oxide 2-Octyldodecanol (manufactured by Higher Alcohol) and isopropyl myristate (manufactured by Nikko Chemicals) are prepared as plasticizers with an average degree of polymerization of about 12). Adhesive solution so that the composition after removal of ethyl acetate is the composition shown in Table 1 or 3 Was added to give a plaster solution was stirred mixed uniformly.
次に、ポリエチレンテレフタレートフィルムからなる剥離基材の一面にシリコーンを塗布してなる剥離シートを用意し、この剥離シートのシリコーン面に上記膏体溶液を乾燥後の厚みが５５μｍとなるように略一定厚みで塗布した後に６０℃で３０分間に亘って乾燥させて水分又は酢酸エチルを除去して膏体層を形成した。 Next, a release sheet is prepared by applying silicone to one surface of a release substrate made of a polyethylene terephthalate film, and the paste solution is dried on the silicone surface of the release sheet so that the thickness after drying is approximately 55 μm. After coating by thickness, it was dried at 60 ° C. for 30 minutes to remove moisture or ethyl acetate to form a paste layer.
そして、ポリエチレンフィルムと、ポリオレフィン繊維及びレーヨン繊維からなる不職布とを積層一体化させてなる支持体を用意し、この支持体と剥離シートとを、支持体のポリエチレンフィルムと膏体層とが対向した状態に重ね合わせ、支持体のポリエチレンフィルム上に膏体層を転写、積層一体化させて貼付剤を得た。 Then, a support is prepared by laminating and integrating a polyethylene film and a non-working cloth made of polyolefin fibers and rayon fibers. The support and the release sheet are made of a polyethylene film and a paste layer of the support. The patch was obtained by superimposing them in an opposed state, transferring the plaster layer onto the polyethylene film of the support, and laminating and integrating them.
（比較例１）
グリセリン１８重量部に、リン酸Ｌ−アスコルビルマグネシウム３重量部、ポリアクリル酸ナトリウム９重量部、珪酸アルミニウム８．８重量部及びパラオキシ安息香酸プロピル０．２重量部を添加し攪拌して均一に分散させて分散液を作製した。
(Comparative Example 1)
To 18 parts by weight of glycerin, 3 parts by weight of L-ascorbyl magnesium phosphate, 9 parts by weight of sodium polyacrylate, 8.8 parts by weight of aluminum silicate, and 0.2 parts by weight of propyl paraoxybenzoate are added and stirred to disperse uniformly. To prepare a dispersion.
一方、水５０重量部にゼラチン９重量部及びポリビニルアルコール２重量部を加温して均一に溶解させた水溶液を作製し、この水溶液と上記分散液とを混合して膏体溶液を作製した。 On the other hand, an aqueous solution in which 9 parts by weight of gelatin and 2 parts by weight of polyvinyl alcohol were heated and dissolved uniformly in 50 parts by weight of water was prepared, and this aqueous solution and the above dispersion were mixed to prepare a plaster solution.
次に、ポリエチレンテレフタレートフィルムからなる剥離基材の一面にシリコーンを塗布してなる剥離シートを用意し、この剥離シートのシリコーン面に上記膏体溶液を乾燥後の厚みが約１ｍｍとなるように略一定厚みで塗布して膏体層を形成した。 Next, a release sheet is prepared by applying silicone to one surface of a release substrate made of a polyethylene terephthalate film, and the thickness after drying the paste solution on the silicone surface of the release sheet is approximately 1 mm. The plaster layer was formed by coating with a constant thickness.
そして、上記剥離シートを支持体となるポリオレフィン繊維及びレーヨン繊維からなる不織布上に膏体層が不織布に対向した状態に重ね合わせた後、４０℃で２日間に亘って熟成し、膏体層を不織布に転写、積層一体化させて貼付剤を作製した。なお、膏体層には水分が多量に残存していた。 And after superimposing the said peeling sheet on the nonwoven fabric which consists of the polyolefin fiber and rayon fiber which become a support body in the state facing the nonwoven fabric, it age | cure | ripens over 2 days at 40 degreeC, A patch was prepared by transferring to a non-woven fabric and integrating the layers. A large amount of water remained in the plaster layer.
（比較例３）
スチレン・イソプレン・スチレンブロック共重合体（シェル化学工業社製 商品名「カリフレックスＴＲ−１１０７」）２７重量部に、流動パラフィン３６重量部、脂環族飽和炭化水素樹脂（荒川化学工業 商品名「アルコンP-90」）３５重量部、ブチルヒドロキシトルエン３重量部、リン酸Ｌ−アスコルビルマグネシウム２重量部及びトルエン２５０重量部を添加して攪拌して均一に混合させて膏体溶液を作製した。
(Comparative Example 3)
Styrene / isoprene / styrene block copolymer (trade name “Califlex TR-1107”, manufactured by Shell Chemical Industry Co., Ltd.) 27 parts by weight, liquid paraffin 36 parts by weight, alicyclic saturated hydrocarbon resin (Arakawa Chemical Industries, trade name “ Alcon P-90 "), 35 parts by weight, 3 parts by weight of butylhydroxytoluene, 2 parts by weight of L-ascorbyl magnesium phosphate and 250 parts by weight of toluene were added and stirred to mix uniformly to prepare a plaster solution.
次に、ポリエチレンテレフタレートフィルムからなる剥離基材の一面にシリコーンを塗布してなる剥離シートを用意し、この剥離シートのシリコーン面に上記膏体溶液を乾燥後の厚みが５５μｍとなるように略一定厚みで塗布した後に６０℃で３０分間に亘って乾燥させてトルエンを略完全に除去して膏体層を形成した。 Next, a release sheet is prepared by applying silicone to one surface of a release substrate made of a polyethylene terephthalate film, and the paste solution is dried on the silicone surface of the release sheet so that the thickness after drying is approximately 55 μm. After coating by thickness, it was dried at 60 ° C. for 30 minutes to remove toluene substantially completely to form a paste layer.
そして、ポリエチレンテレフタレートフィルムとエチレン・酢酸ビニル共重合体フィルムとを積層一体化させてなる支持体を用意し、この支持体と剥離シートとを、支持体のポリエチレンテレフタレートフィルムと膏体層とが対向した状態に重ね合わせ、支持体のポリエチレンテレフタレートフィルム上に膏体層を転写、積層一体化させて貼付剤を得た。 Then, a support is prepared by laminating and integrating a polyethylene terephthalate film and an ethylene / vinyl acetate copolymer film, and the support and release sheet are opposed to the polyethylene terephthalate film and the plaster layer of the support. The plaster layer was transferred onto the polyethylene terephthalate film of the support and laminated and integrated to obtain a patch.
（実施例１〜６、比較例７〜１７）
参考例１〜１３及び比較例２〜６と同様の要領で、剥離シート上に膏体層を形成し、この膏体層と、支持体となるポリオレフィン繊維及びレーヨン繊維からなる不織布とが対向した状態に重ね合わせて、支持体上に膏体層を転写、積層一体化させて貼付剤を得た。
(Examples 1-6 , Comparative Examples 7-17)
In the same manner as in Reference Examples 1 to 13 and Comparative Examples 2 to 6, a paste layer was formed on the release sheet, and this paste layer was opposed to a nonwoven fabric composed of polyolefin fibers and rayon fibers serving as a support. The plaster layer was transferred onto the support and laminated and integrated to obtain a patch.
（実施例７〜３３、比較例１８〜８８）
先ず、粘着剤溶液として、上記粘着剤溶液Ａ〜Ｃに加え、スチレンイソプレンブロック共重合体をトルエン中に溶解してなる粘着剤溶液Ｄ（シェル化学工業社製 商品名「カリフレックスＴＲ−１１０７」、４０重量％トルエン溶液）を用意し、可塑剤として、ミリスチン酸イソプロピル、ミリスチン酸ブチル、オレイン酸デシル、２−オクチルドデカノール、流動パラフィン、イソステアリン酸イソプロピル及びセスキオレイン酸ソルビタン（何れも日光ケミカルズ社製）を用意した。
(Examples 7 to 33 , Comparative Examples 18 to 88)
First, as an adhesive solution, in addition to the above-mentioned adhesive solutions A to C, an adhesive solution D obtained by dissolving a styrene isoprene block copolymer in toluene (trade name “Califlex TR-1107” manufactured by Shell Chemical Industry Co., Ltd.) , 40 wt% toluene solution), and as plasticizers, isopropyl myristate, butyl myristate, decyl oleate, 2-octyldodecanol, liquid paraffin, isopropyl isostearate and sorbitan sesquioleate (all Nikko Chemicals) Prepared).
続いて、粘着力調整剤として、ポリオキシエチレン（１０）硬化ヒマシ油（日光ケミカルズ社製、酸化エチレンの数平均重合度：１０）、ポリオキシエチレン（１００）硬化ヒマシ油（日光ケミカルズ社製、酸化エチレンの数平均重合度：１００）、ポリオキシエチレン（４０）ヒマシ油（日光ケミカルズ社製、酸化エチレンの数平均重合度：４０）、ポリオキシエチレン（２０）硬化ヒマシ油（日光ケミカルズ社製、酸化エチレンの数平均重合度：２０）、ポリオキシエチレンソルビタンモノラウレート（日光ケミカルズ社製）、ポリオキシエチレン（２０）ポリオキシプロピレン（８）セチルエーテル（日光ケミカルズ社製、酸化エチレンの数平均重合度：２０、酸化プロピレンの数平均重合度：８）、ポリオキシエチレンヒマシ油（日光ケミカルズ社製）を用意し、更に、酢酸トコフェロール（理研ビタミン社製）、リン酸Ｌ−アスコルビルマグネシウム（日光ケミカルズ社製）及びイソプロピルメチルフェノール（大阪化成社製）を用意した。 Subsequently, polyoxyethylene (10) hydrogenated castor oil (manufactured by Nikko Chemicals, number average polymerization degree of ethylene oxide: 10), polyoxyethylene (100) hydrogenated castor oil (manufactured by Nikko Chemicals, Number average polymerization degree of ethylene oxide: 100), polyoxyethylene (40) castor oil (manufactured by Nikko Chemicals, number average polymerization degree of ethylene oxide: 40), polyoxyethylene (20) hydrogenated castor oil (manufactured by Nikko Chemicals) The number average degree of polymerization of ethylene oxide: 20), polyoxyethylene sorbitan monolaurate (manufactured by Nikko Chemicals), polyoxyethylene (20) polyoxypropylene (8) cetyl ether (manufactured by Nikko Chemicals, number of ethylene oxides) Average degree of polymerization: 20, number average degree of polymerization of propylene oxide: 8), polyoxyethylene castor oil (day Prepared Chemicals Co. Ltd.), further, tocopherol acetate (manufactured by Riken Vitamin Co., Ltd.), was prepared L- ascorbyl magnesium phosphate (manufactured by Nikko Chemicals Co., Ltd.) and isopropyl methylphenol (manufactured by Osaka Kasei Co., Ltd.).
次に、上述の粘着剤溶液に、可塑剤、粘着力調整剤、酢酸トコフェロール、リン酸Ｌ−アスコルビルマグネシウム及びイソプロピルメチルフェノールを、粘着剤溶液中の水分、酢酸エチル又はトルエンを除去した後の組成が表５〜１３に示した組成になるように添加し、均一になるように攪拌混合して膏体溶液を得た。そして、ポリエチレンテレフタレートフィルムからなる剥離基材の一面にシリコーンを塗布してなる剥離シートを用意し、上記剥離シートのシリコーン塗布面に上記膏体溶液を乾燥後の厚みが６０μｍとなるように略一定厚みで塗布した後、６０℃で３０分間に亘って乾燥させて水分、酢酸エチル又はトルエンを除去して膏体層を形成した。 Next, a composition after removing water, ethyl acetate or toluene in the adhesive solution from the above-mentioned adhesive solution with a plasticizer, an adhesive strength modifier, tocopherol acetate, L-ascorbyl magnesium phosphate and isopropylmethylphenol. Were added so as to have the compositions shown in Tables 5 to 13, and stirred to mix so as to obtain a plaster solution. Then, a release sheet is prepared by applying silicone to one surface of a release substrate made of a polyethylene terephthalate film, and the paste solution is dried on the silicone-coated surface of the release sheet so that the thickness after drying is substantially constant to 60 μm. After coating by thickness, it was dried at 60 ° C. for 30 minutes to remove moisture, ethyl acetate or toluene to form a paste layer.
そして、ポリオレフィン繊維及びレーヨン繊維からなる不織布を用意し、この不織布と剥離シートとを、不織布と膏体層とが対向した状態に重ね合わせ、支持体上に膏体層を転写、積層一体化させて貼付剤を得た。 Then, a non-woven fabric made of polyolefin fiber and rayon fiber is prepared, and the non-woven fabric and the release sheet are overlapped with the non-woven fabric and the paste layer facing each other, and the paste layer is transferred and laminated and integrated on the support. To obtain a patch.
（実施例３４〜３７）
実施例９、１０、１５及び１９と同様の要領で、剥離シート上に膏体層を形成し、この膏体層と、支持体となるポリオレフィン繊維からなる不織布とが対向した状態に重ね合わせて、支持体上に膏体層を転写、積層一体化させて貼付剤を得た。なお、膏体層の組成は表１１に示した。
(Examples 34 to 37 )
In the same manner as in Examples 9, 10, 15 and 19 , a paste layer was formed on the release sheet, and this paste layer and a nonwoven fabric made of polyolefin fibers serving as a support were overlapped with each other. The plaster layer was transferred onto the support and laminated to obtain a patch. The composition of the paste layer is shown in Table 11.
（実施例３８〜４１）
実施例９、１０、１５及び１９と同様の要領で、剥離シート上に膏体層を形成し、この膏体層と、支持体となるレーヨン繊維からなる不織布とが対向した状態に重ね合わせて、支持体上に膏体層を転写、積層一体化させて貼付剤を得た。なお、膏体層の組成は表１１に示した。
(Examples 38 to 41 )
In the same manner as in Examples 9, 10, 15 and 19 , a paste layer was formed on the release sheet, and this paste layer and a non-woven fabric made of rayon fibers serving as a support were overlapped with each other. The plaster layer was transferred onto the support and laminated to obtain a patch. The composition of the paste layer is shown in Table 11.
参考例１〜１３、実施例１〜６、及び比較例１２〜１７で得られた貼付剤についてアスコルビン酸誘導体の皮膚移行量を、参考例１〜１３、実施例１〜６、及び比較例１〜１７で得られた貼付剤について、肌の健やかさ、糊残り、貼付性、剥離時痛さ、着色性、安定性及び粘着力を下記に示した要領で測定し、その結果を表１、２、４に示した。なお、各実施例及び比較例で得られた貼付剤の膏体層中における各成分の含有量を表１〜３に示した。 For the patches obtained in Reference Examples 1 to 13, Examples 1 to 6 , and Comparative Examples 12 to 17, the amount of ascorbic acid derivative transferred to the skin was determined as Reference Examples 1 to 13, Examples 1 to 6 , and Comparative Example 1. About the patch obtained in -17, the health of the skin, adhesive residue, adhesiveness, pain at the time of peeling, colorability, stability and adhesive strength were measured as shown below, and the results are shown in Table 1. 2 and 4. The contents of each component in the plaster layer of the patches obtained in each Example and Comparative Example are shown in Tables 1 to 3.
次に、実施例７〜４１及び比較例１８〜８８で得られた貼付剤について、糊残り、貼付性、剥離時痛さ及び投錨性を下記に示した要領で測定し、その結果を表５〜１３に示した。 Next, with respect to the patches obtained in Examples 7 to 41 and Comparative Examples 18 to 88, the adhesive residue, adhesiveness, peeling pain and anchoring properties were measured as shown below, and the results are shown in Table 5. -13.
そして、実施例３３で得られた貼付剤について、貼付剤中の生理活性物質安定性について下記に示した要領で測定し、その結果を表１４に示した。 And about the patch obtained in Example 33 , the bioactive substance stability in a patch was measured in the way shown below, and the result was shown in Table 14.
（アスコルビン酸誘導体の皮膚移行量）
貼付剤から一辺が２ｃｍの平面正方形状の試験片を切り出し、この試験片を５名の被験者の上腕に貼付し、４時間後に試験片を被験者の上腕から剥離し、貼付前後における試験片の膏体層中のアスコルビン酸誘導体の含有量をＨＰＬＣで定量し、貼付前後における試験片の膏体層中のアスコルビン酸誘導体の含有量の差を算出し、この含有量の差をアスコルビン酸誘導体の皮膚移行量（μｇ／ｃｍ2）とした。
(Amount of ascorbic acid derivative transferred to the skin)
A flat square test piece with a side of 2 cm was cut out from the patch, this test piece was affixed to the upper arms of five subjects, and after 4 hours, the test piece was peeled off from the upper arms of the test subjects. The content of the ascorbic acid derivative in the body layer was quantified by HPLC, the difference in the content of the ascorbic acid derivative in the paste layer of the test piece before and after application was calculated, and the difference in the content was determined as the skin of the ascorbic acid derivative. The amount transferred (μg / cm 2 ).
（肌の健やかさ）
貼付剤から一辺が２ｃｍの平面正方形状の試験片を切り出し、この試験片を１０名の被験者の両腕の上腕内側に貼付して就寝し、起床後に貼付剤を被験者の上腕から剥離した。続いて、試験片の貼付部位の皮膚と、この貼付部位の周囲の皮膚とを比較観察し、被験者が主観的に感じる肌のしっとり感やきめの細かさを評価内容とし、下記基準に基づいて判断した。各被験者の点数の合計を３０で除したものに１００を乗じた値を「肌の健やかさ」とした。
３点・・・試験前よりも肌が著しく健やかだった。
２点・・・試験前よりも肌が健やかだった。
１点・・・試験前と肌に変化がなかった。
０点・・・試験前よりも肌がカサついていた。
(Skin health)
A flat square test piece having a side of 2 cm was cut out from the patch, and the test piece was affixed to the inner side of the upper arms of 10 subjects and slept. After waking up, the patch was peeled from the upper arms of the subjects. Subsequently, the skin at the application site of the test piece and the skin around the application site are compared and observed, and the moist feeling and fineness of the skin that the subject feels subjectively are evaluated, based on the following criteria: It was judged. A value obtained by dividing the total score of each subject by 30 and multiplying by 100 was defined as “skin health”.
3 points: The skin was significantly healthier than before the test.
2 points: Skin was healthier than before the test.
1 point: No change in skin before test.
0 points: The skin was more gritty than before the test.
（糊残り）
貼付剤から一辺が２ｃｍの平面正方形状の試験片を切り出し、この試験片を１０名の被験者の両腕の上腕内側に貼付して就寝し、起床後に貼付剤を被験者の上腕から剥離した。続いて、試験片の貼付部位の皮膚と、この貼付部位の周囲の皮膚とを比較観察し、下記基準に基づいて判断した。各被験者の点数の合計を３０で除したものに１００を乗じた値を「糊残り」とした。
３点・・・膏体層の残り及び肌のべたつき感は認められなかった。
２点・・・膏体層の残りは認められなかったが、肌にべたつき感があった。
１点・・・膏体層の残りが部分的に認められると共に肌にべたつき感があった。
０点・・・膏体層の残りが全面的に認められると共に肌にべたつき感があった。
(Adhesive residue)
A flat square test piece having a side of 2 cm was cut out from the patch, and the test piece was affixed to the inner side of the upper arms of 10 subjects and slept. After waking up, the patch was peeled from the upper arms of the subjects. Subsequently, the skin at the application site of the test piece and the skin around the application site were comparatively observed and judged based on the following criteria. A value obtained by multiplying the total score of each subject by 30 and multiplying by 100 was defined as “adhesive residue”.
3 points: The rest of the plaster layer and the stickiness of the skin were not recognized.
2 points: The rest of the plaster layer was not recognized, but the skin was sticky.
1 point: The rest of the plaster layer was partially recognized and the skin was sticky.
0 point: The rest of the plaster layer was recognized over the entire surface, and the skin was sticky.
（貼付性）
貼付剤から一辺が２ｃｍの平面正方形状の試験片を切り出し、この試験片を１０名の被験者の両腕の上腕内側に貼付して就寝し、起床後における貼付剤の貼付状態を目視にて観察し、下記基準に基づいて判断した。各被験者の点数の合計を３０で除したものに１００を乗じた値を「貼付性」とした。
３点・・・試験終了まで貼付剤が皮膚に全体的に完全に貼付していた。
２点・・・試験終了時に貼付剤のわずかな部分が皮膚から剥離していた。
１点・・・試験終了時に貼付剤の一部が剥がれ、或いは、ずれていた。
０点・・・試験終了までに貼付剤が皮膚から完全に剥がれてしまった。
(Pasteability)
A flat square test piece with a side of 2 cm is cut out from the patch, and the test piece is affixed to the inner side of the upper arm of 10 subjects and asleep, and the applied state of the patch after getting up is visually observed. Judgment was made based on the following criteria. A value obtained by multiplying the total score of each subject by 30 and multiplying by 100 was defined as “stickability”.
3 points: The patch was completely applied to the skin until the end of the test.
2 points: A small part of the patch was peeled off from the skin at the end of the test.
1 point: At the end of the test, a part of the patch was peeled off or shifted.
0 point: The patch had completely peeled off the skin by the end of the test.
（剥離時痛さ）
貼付剤から一辺が２ｃｍの平面正方形状の試験片を切り出し、この試験片を１０名の被験者の両腕の上腕内側に貼付して就寝し、起床後に貼付剤を被験者の上腕から剥離した際の痛みの有無及び程度を下記基準に基づいて判断した。各被験者の点数の合計を３０で除したものに１００を乗じた値を「剥離時痛さ」とした。
３点・・・剥離時全く痛みを感じなかった。
２点・・・剥離時皮膚が少し引っ張られたが痛みはなかった。
１点・・・剥離時少し痛かった（わずかに角質剥離あった）。
０点・・・剥離時痛かった（角質剥離が多数、あった）。
(Pain when peeling)
When a flat square test piece with a side of 2 cm was cut out from the patch, this test piece was applied to the inner side of the upper arm of both subjects of 10 subjects, and the patient was asleep. The presence and extent of pain was judged based on the following criteria. A value obtained by multiplying the total score of each subject by 30 and multiplying by 100 was defined as “pain pain”.
3 points: No pain at the time of peeling.
2 points: The skin was slightly pulled during peeling, but there was no pain.
1 point: Slightly painful during peeling (slightly exfoliated).
0 point: It was painful at the time of exfoliation (there was a lot of exfoliation).
（着色性）
アルミニウム箔の一面にポリエチレンフィルムが積層一体化されてなる包装フィルムを用いて貼付剤を密封して５０℃の雰囲気下に１ヶ月間に亘って保存し、保存後の貼付剤の膏体層の着色度合いを目視観察し、下記基準に基づいて判断した。
○・・・着色はなかった
△・・・僅かに着色した
×・・・著しく着色した
(Colorability)
The patch is sealed using a packaging film in which a polyethylene film is laminated and integrated on one surface of an aluminum foil, and is stored in an atmosphere at 50 ° C. for one month. The degree of coloring was visually observed and judged based on the following criteria.
○ ... not colored △ ・ ・ ・ slightly colored × ・ ・ ・ remarkably colored
（安定性）
貼付剤から一辺が５ｃｍの平面正方形状の試験片を切り出し、この試験片を、アルミニウム箔の一面にポリエチレンフィルムが積層一体化されてなる包装フィルムを用いて密封して５０℃の雰囲気下に２週間放置した後、試験片の膏体層中のアスコルビン酸誘導体の残存率を液体クロマトグラフ法によって測定した。
(Stability)
A flat square test piece having a side of 5 cm is cut out from the patch, and the test piece is sealed with a packaging film in which a polyethylene film is laminated and integrated on one surface of an aluminum foil, and the test piece is placed under an atmosphere of 50 ° C. After leaving for a week, the residual rate of the ascorbic acid derivative in the paste layer of the test piece was measured by liquid chromatography.
（粘着力）
貼付剤の粘着力の１８０°引き剥がし粘着力をＪＩＳ Ｚ０２３７に準拠してステンレス板を用いて測定した。
(Adhesive force)
The adhesive strength of the adhesive patch was peeled off by 180 °, and the adhesive strength was measured using a stainless steel plate according to JIS Z0237.
（投錨性）
貼付剤から一辺が２ｃｍの平面正方形状の試験片を切り出し、この試験片を５名の被験者の両腕の上腕内側に貼付して就寝し、起床時に支持体のみを指先で把持して貼付剤を皮膚から引き剥がした際の支持体と膏体層の状態を目視観察し、下記基準に基づいて判断した。各被験者の点数の合計を１５で除したものに１００を乗じた値を「投錨性」とした。
３点・・・支持体と膏体層は分離しなかった。
２点・・・支持体と膏体層が全体の半分未満の部分において分離した。
１点・・・支持体と膏体層が全体の半分以上の部分において分離した。
０点・・・支持体と膏体層が全面的に分離してしまった。
(Throwing property)
A flat square test piece with a side of 2 cm is cut out from the patch, this test piece is attached to the inside of the upper arm of both arms of five subjects, and then the bed is taken. The state of the support and the paste layer when the film was peeled off from the skin was visually observed and judged based on the following criteria. A value obtained by dividing the total score of each subject by 15 and multiplying by 100 was defined as “throwing ability”.
3 points: The support and the paste layer were not separated.
2 points: The support and the paste layer were separated in less than half of the whole.
1 point: The support and the paste layer were separated in more than half of the whole.
0 point: The support and the paste layer were completely separated.
（生理活性物質安定性）
実施例１００で得られた貼付剤を４枚用意し、先ず、そのうちの１枚の貼付剤中における生理活性物質の含有量をＨＰＬＣによって測定した。次に、他の３枚の貼付剤をアルミニウム箔の一面にポリエチレンフィルムが積層一体化されてなる包装フィルムを用いて密封し、６０℃の雰囲気下にて、それぞれ１週間、２週間、４週間保存した後、それぞれの貼付剤中の生理活性物質の含有量をＨＰＬＣによって測定し、保存前の貼付剤中における各生理活性物質の含有量に対する残存率（％）を求めた。
(Bioactive substance stability)
Four patches obtained in Example 100 were prepared. First, the content of the physiologically active substance in one of the patches was measured by HPLC. Next, the other three patches were sealed using a packaging film in which a polyethylene film was laminated and integrated on one surface of an aluminum foil, and each was for 1 week, 2 weeks, 4 weeks in an atmosphere at 60 ° C. After storage, the content of the physiologically active substance in each patch was measured by HPLC, and the residual rate (%) relative to the content of each physiologically active substance in the patch before storage was determined.
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|---|---|---|---|---|
| JP3276194B2 (en) * | 1993-03-09 | 2002-04-22 | 積水化学工業株式会社 | Medical patch |
| JP3448780B2 (en) * | 1993-03-09 | 2003-09-22 | 積水化学工業株式会社 | Nitroglycerin patch |
| JPH0984869A (en) * | 1995-09-25 | 1997-03-31 | Lion Corp | Plastering agent |
| JP2005008627A (en) * | 2003-05-23 | 2005-01-13 | Sekisui Chem Co Ltd | Plaster |
| JP2005170938A (en) * | 2003-11-21 | 2005-06-30 | Sekisui Chem Co Ltd | Patch |
-
2006
- 2006-11-14 JP JP2006308468A patent/JP5485495B2/en active Active
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| JP2007326844A (en) | 2007-12-20 |
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