JPH1147233A - Plaster agent and preservation method thereof - Google Patents
Plaster agent and preservation method thereofInfo
- Publication number
- JPH1147233A JPH1147233A JP21922897A JP21922897A JPH1147233A JP H1147233 A JPH1147233 A JP H1147233A JP 21922897 A JP21922897 A JP 21922897A JP 21922897 A JP21922897 A JP 21922897A JP H1147233 A JPH1147233 A JP H1147233A
- Authority
- JP
- Japan
- Prior art keywords
- patch
- packaging container
- deoxygenation
- agent
- pack container
- 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
Abstract
Description
【０００１】[0001]
【発明の属する技術分野】本発明は、医薬品、医薬部外
品および化粧品などとして皮膚に適用する貼付剤および
貼付剤の保存方法に関し、さらに詳しくは、空気などに
よって変化しやすい薬効成分を貼付剤に用いる場合でも
薬効成分の安定性に優れた貼付剤、および貼付剤の安定
性を確保するための保存方法に関する。BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a patch and a method for preserving the patch which are applied to the skin as pharmaceuticals, quasi-drugs and cosmetics, and more particularly to a patch comprising a medicinal component which is easily changed by air or the like. The present invention relates to a patch having excellent stability of a medicinal ingredient even when used in a pharmaceutical preparation, and a storage method for ensuring the stability of the patch.
【０００２】[0002]
【従来の技術】医薬品、医薬部外品および化粧品の中に
は、空気などの影響により変化しやすい薬効成分を含有
するものがある。例えば、アスコルビン酸若しくはアス
コルビン酸誘導体又はレチノイド類などが日光等外部環
境から損傷を受けた人間の皮膚を局部的に治療する薬効
成分として、また、レゾルシンなどが治療用の殺菌剤と
して、軟膏、クリーム、ローション等のスキンケアー組
成物などに添加されているが、これらの薬効成分は、酸
素、ｐＨ、温度、光などの影響により物性の変化を受け
やすい。特に着色を伴う変化が生じると製品の品質を見
た目にも著しく損なうこととなる。そこで、上記のよう
な欠点を改善するために、上記製剤では遮光容器に保存
したり、処方上も酸化防止剤を添加する等の工夫がなさ
れている。2. Description of the Related Art Some pharmaceuticals, quasi-drugs and cosmetics contain medicinal ingredients which are easily changed by the influence of air or the like. For example, ascorbic acid or ascorbic acid derivatives or retinoids and the like as a medicinal ingredient for locally treating human skin damaged from the external environment such as sunlight, resorcinol and the like as a disinfectant for treatment, ointments, creams , Lotions and the like, but these medicinal components are susceptible to changes in physical properties under the influence of oxygen, pH, temperature, light and the like. In particular, when a change accompanied by coloring occurs, the appearance of the product is significantly impaired. Therefore, in order to improve the above-mentioned drawbacks, the above-mentioned preparations have been devised by storing them in a light-shielding container or adding an antioxidant also in the formulation.
【０００３】貼付剤の場合も、アスコルビン酸などの薬
効成分の安定化を図る方法として、各種の薬効成分を含
む薬効組成物に酸化防止剤を添加するなどの方法が従来
採られていた。しかし、酸化防止剤の添加は、軟膏、ク
リーム、ローション等の充填型の製剤においてはある程
度効果があるものの、貼付剤のような開放型の製剤では
充填型の製剤ほどには効果を得ることができず、薬効組
成物の変色を防ぐことも困難であった。さらに、温度が
高い条件下でその傾向は顕著である。In the case of patches, as a method of stabilizing a medicinal ingredient such as ascorbic acid, a method of adding an antioxidant to a medicinal composition containing various medicinal ingredients has conventionally been adopted. However, although the addition of antioxidants is effective to a certain extent in filling-type preparations such as ointments, creams and lotions, it can be more effective in open-type preparations such as patches than in filling-type preparations. It was difficult to prevent discoloration of the medicinal composition. Furthermore, the tendency is remarkable under high temperature conditions.
【０００４】特に、アスコルビン酸若しくはアスコルビ
ン酸誘導体はｐＨ４〜７では極めて不安定とされてお
り、また微量金属にも敏感に反応するため、製剤の物性
上および皮膚への安全性上、至適ｐＨが４〜７であり且
つ水溶性高分子の架橋に金属を必須とする貼付剤におい
ては、アスコルビン酸などを安定した状態に保つことが
困難であった。[0004] In particular, ascorbic acid or ascorbic acid derivative is extremely unstable at pH 4 to 7, and reacts sensitively to trace metals. Is 4 to 7, and it is difficult to keep ascorbic acid and the like in a stable state in a patch which requires a metal for crosslinking of the water-soluble polymer.
【０００５】また、ブチルヒドロキシトルエン（ＢＨ
Ｔ）等の酸化防止剤は、皮膚への安全性など点から使用
量が制限される場合があり、このような酸化防止剤では
十分な量の使用が実用上困難な場合があった。Further, butylhydroxytoluene (BH
The use amount of antioxidants such as T) may be limited in view of safety to the skin and the like, and it is sometimes difficult to use a sufficient amount of such antioxidants in practice.
【０００６】[0006]
【発明が解決しようとする課題】本発明は、上記のよう
な観点からなされたものであり、薬効成分の安定性に優
れた貼付剤、および貼付剤の薬効成分の安定性に優れた
保存方法を提供することを課題とする。DISCLOSURE OF THE INVENTION The present invention has been made from the above-mentioned viewpoints, and a patch having excellent stability of a medicinal component and a storage method having excellent stability of a medicinal component of the patch. The task is to provide
【０００７】[0007]
【課題を解決するための手段】我々は上記課題を解決す
べく鋭意検討を行った結果、貼付剤を脱酸素能を有する
包装容器内に封入することにより、貼付剤の薬効成分の
酸化を長期にわたり抑制でき、薬効成分を長期間安定し
た状態に保てることを見出した。Means for Solving the Problems As a result of intensive studies to solve the above-mentioned problems, by enclosing the patch in a packaging container having a deoxidizing ability, the oxidation of the medicinal component of the patch can be prevented for a long time. Over a long period of time, and found that the medicinal ingredient can be kept in a stable state for a long period of time.
【０００８】すなわち、本発明は、シート状支持体の一
方の面に薬効組成物が保持されており、脱酸素能を有す
る包装容器内に封入された貼付剤である。脱酸素能を有
する包装容器としては、酸素透過性を有しない包装容器
内に脱酸素剤が同封されたものが好適である。[0008] That is, the present invention is a patch in which a medicinal composition is held on one surface of a sheet-like support and is enclosed in a packaging container having deoxidizing ability. As the packaging container having a deoxidizing ability, a packaging container in which an oxygen absorber is enclosed in a packaging container having no oxygen permeability is preferable.
【０００９】また、本発明は、前記薬効組成物が、アス
コルビン酸若しくはアスコルビン酸誘導体又はレチノイ
ド類を含有する前記貼付剤である。また、本発明は、前
記薬効組成物がレゾルシンを含有する前記貼付剤であ
る。[0009] The present invention is also the above patch, wherein the medicinal composition contains ascorbic acid, an ascorbic acid derivative, or retinoids. The present invention is also the above patch, wherein the medicinal composition contains resorcin.
【００１０】また、本発明は、前記薬効組成物のｐＨが
４〜７である前記貼付剤である。また、本発明は、シー
ト状支持体の一方の面に薬効組成物が保持された貼付剤
を、脱酸素能を有する包装容器内に封入することを特徴
とする貼付剤の保存方法である。[0010] The present invention is also the above patch, wherein the pH of the medicinal composition is 4 to 7. Further, the present invention is a method for storing a patch, wherein the patch having the medicinal composition held on one surface of the sheet-like support is enclosed in a packaging container having a deoxidizing ability.
【００１１】[0011]
【発明の実施の形態】以下、本発明を詳細に説明する。
本発明の貼付剤は、シート状支持体の一方の面に薬効組
成物が保持された貼付剤であって、脱酸素能を有する包
装容器内に封入されたものである。DESCRIPTION OF THE PREFERRED EMBODIMENTS The present invention will be described below in detail.
The patch of the present invention is a patch in which a medicinal composition is held on one surface of a sheet-like support, and is enclosed in a packaging container having a deoxidizing ability.
【００１２】まず「脱酸素能を有する包装容器」につい
て説明する。本発明において「脱酸素能」とは、酸素を
除去する能力のことである。すなわち、本発明で用いる
包装容器は、包装容器内に存在する気体中から酸素を除
去することができるものであればよい。脱酸素能を有す
る包装容器としては、例えば、酸素透過性を有しない包
装容器内に脱酸素剤が同封されたものを好適に用いるこ
とができる。First, the "packaging container having deoxidizing ability" will be described. In the present invention, “deoxygenation ability” refers to the ability to remove oxygen. That is, the packaging container used in the present invention may be any one that can remove oxygen from the gas present in the packaging container. As the packaging container having a deoxidizing ability, for example, a packaging container in which an oxygen scavenger is enclosed in a packaging container having no oxygen permeability can be suitably used.
【００１３】同封される脱酸素剤は、包装容器内に入
れ、脱酸素剤が包装容器内の気体に接し得る状態とす
る。具体的には、（１）包装容器内に脱酸素剤を直に同
封する、（２）酸素透過性のある包装材の中に脱酸素剤
を入れて、これを貼付剤を収納する包装容器内に同封す
る、（３）包装容器の内面に脱酸素剤を含む組成物から
なる層を設ける、などの手段を好ましく例示でき、
（３）の手段が特に好ましい。（１）または（２）の場
合、脱酸素剤は、例えば、粉末状、粒状もしくは固形の
もの等を単に包装容器内に入れるだけでもよいし、包装
容器内に添付して固定してもよい。また、（２）の酸素
透過性のある包装材としては、ポリエチレン、ポリエス
テル、ポリ塩化ビニルなどで形成した包装材を用いるこ
とができる。（３）のように脱酸素剤を含む組成物から
なる層を設けるには、脱酸素剤を含む組成物でフィルム
を形成しこれを積層する、脱酸素剤を含む組成物を含浸
させたフィルムを積層する、脱酸素剤を含む液状の組成
物を塗布して層を形成するなどの一般的な方法により行
うことができる。The enclosed oxygen absorber is placed in a packaging container so that the oxygen absorber can come into contact with the gas in the packaging container. Specifically, (1) a packaging container in which an oxygen absorber is directly enclosed in a packaging container, and (2) an oxygen absorber is put in an oxygen-permeable packaging material, and this is used as a packaging container for storing a patch. And (3) providing a layer made of a composition containing an oxygen scavenger on the inner surface of the packaging container.
The means (3) is particularly preferred. In the case of (1) or (2), the oxygen scavenger may be, for example, a powdery, granular, or solid one simply put in the packaging container, or may be attached and fixed in the packaging container. . Further, as the packaging material having oxygen permeability of (2), a packaging material formed of polyethylene, polyester, polyvinyl chloride, or the like can be used. In order to provide a layer comprising a composition containing an oxygen scavenger as in (3), a film is formed from the composition containing the oxygen scavenger and laminated, and the film impregnated with the composition containing the oxygen scavenger is laminated. Or by applying a liquid composition containing an oxygen scavenger to form a layer.
【００１４】脱酸素剤は、一般に用いられているものを
用いることができ、速効性のもの（脱酸素日数の速いも
の）が好ましい。また、脱酸素剤は、自己反応型であっ
ても水分依存型であってもよい。さらに、無機系では鉄
粉を主剤とするもの、有機系ではアスコルビン酸系、多
価アルコール系、活性炭系なども例示できる。また、用
いられる脱酸素剤の量は、貼付剤の量、包装容器内の容
量などに応じて適宜調整することができる。具体的に
は、酸素吸収量が１００ｍｌ〜１２０ｍｌであるような
量が例示できる。As the oxygen scavenger, those generally used can be used, and those having a rapid effect (one having a short oxygen scavenging time) are preferred. Further, the oxygen scavenger may be a self-reacting type or a water-dependent type. Further, inorganic powders containing iron powder as a main component, and organic powders containing ascorbic acid, polyhydric alcohols, activated carbon and the like can be exemplified. In addition, the amount of the oxygen absorber used can be appropriately adjusted according to the amount of the patch, the capacity in the packaging container, and the like. Specifically, an amount such that the oxygen absorption amount is 100 ml to 120 ml can be exemplified.
【００１５】本発明で用いる包装容器は酸素透過性を有
しない素材で形成されることが好ましい。ここで「酸素
透過性を有しない」とは、包装容器内の気体から脱酸素
剤により酸素を除去できる程度に、包装容器内への酸素
の進入を抑制できればよいことを意味する。すなわち、
貼付剤が封入された状態において、酸素の進入を抑制
し、脱酸素剤の作用と相まって包装容器内の酸素を除去
した状態を維持できればよい。具体的には酸素透過度
が、好ましくは０〜３（ml/m2・24Hr・atm）、特に好まし
くは０〜１（ml/m2・24Hr・atm）である素材を用いること
が好適である。例えば包装容器の素材として好ましく
は、アルミ箔の層を有する積層フィルムが挙げられ、ア
ルミ箔に合成樹脂などを積層したものがより好ましい。
アルミ箔を用いたフィルムは遮光性を有する点からも好
適である。具体的には、紙またはポリエチレンテレフタ
レート（ＰＥＴ）／ポリエチレン（ＰＥ）／アルミ箔／
ＰＥが順次積層された積層フィルムを好ましく例示でき
る。この場合、紙またはＰＥＴ側を外側とする。さら
に、包装容器の素材となるフィルムには、包装容器の内
面に上記のように脱酸素剤を含む組成物からなる層が積
層されていてもよい。なお、包装容器の形状、大きさな
どは、内側に貼付剤を収納することができるものであれ
ば特に制限はない。The packaging container used in the present invention is preferably formed of a material having no oxygen permeability. Here, “having no oxygen permeability” means that it is only necessary to suppress the entry of oxygen into the packaging container to such an extent that oxygen can be removed from the gas in the packaging container by the oxygen absorber. That is,
In the state where the patch is enclosed, it is only necessary to suppress the entry of oxygen and maintain a state in which oxygen in the packaging container is removed in combination with the action of the oxygen scavenger. Specifically oxygen permeability is preferably 0~3 (ml / m 2 · 24Hr · atm), particularly preferably is preferable to use a material which is 0~1 (ml / m 2 · 24Hr · atm) is there. For example, as a material for the packaging container, a laminated film having an aluminum foil layer is preferably used, and a material obtained by laminating a synthetic resin or the like on an aluminum foil is more preferable.
A film using an aluminum foil is preferable from the viewpoint of having a light-shielding property. Specifically, paper or polyethylene terephthalate (PET) / polyethylene (PE) / aluminum foil /
A preferred example is a laminated film in which PE is sequentially laminated. In this case, the paper or PET side is the outside. Furthermore, the film used as the material of the packaging container may have a layer made of the composition containing the oxygen scavenger laminated on the inner surface of the packaging container as described above. The shape and size of the packaging container are not particularly limited as long as the patch can be stored inside.
【００１６】本発明の貼付剤は、上記包装容器に封入さ
れる。すなわち、貼付剤は包装容器内に収納され、包装
容器は密封される。密封の程度は、空気、特に酸素が透
過しない程度が好ましい。なお、密封された包装容器を
一旦開封した後であっても、開口部分を再び密封すれ
ば、一度も開封しない場合ほどではないが本発明の効果
は得られる。また、例えば袋状の包装容器で、一旦開封
した後に開口部分を折り畳むなどして包装容器の内外の
空気の出入りを抑制すれば、密封した場合ほどではない
が本発明の効果は得られる。The patch of the present invention is enclosed in the above-mentioned packaging container. That is, the patch is stored in the packaging container, and the packaging container is sealed. The degree of sealing is preferably such that air, particularly oxygen, does not permeate. Even after the sealed packaging container is once opened, if the opening is sealed again, the effect of the present invention can be obtained, though not so much as when the opening is never opened. Further, for example, if the opening and closing portion of the bag is once opened in a bag-shaped packaging container to suppress the inflow and outflow of air inside and outside the packaging container, the effects of the present invention can be obtained although not as much as in the sealed case.
【００１７】次に貼付剤自体について説明する。貼付剤
自体は、主にシート状支持体と薬効組成物とからなり、
シート状支持体の少なくとも一方の面に薬効組成物が保
持されているものである。Next, the patch itself will be described. The patch itself consists mainly of a sheet-like support and a medicinal composition,
The medicinal composition is held on at least one surface of the sheet-like support.
【００１８】本発明の貼付剤に用いられるシート状支持
体は、通常貼付剤に用いられているものであれば特に制
限なく用いることができる。例えば、不織布、ポリウレ
タンフィルム、ナイロンフィルムなどが挙げられ、これ
らのうちのいくつかを積層させたものでもよい。薬効組
成物を支持体に保持させるには、例えば、薬効組成物を
シート状支持体に積層させる、または含浸させるなど貼
付剤で通常行われる方法に従えばよい。The sheet-like support used for the patch of the present invention can be used without any particular limitation as long as it is generally used for patches. For example, a nonwoven fabric, a polyurethane film, a nylon film and the like can be mentioned, and a laminate of some of these may be used. In order to hold the medicinal composition on the support, for example, a method usually used for a patch, such as laminating or impregnating the medicinal composition on a sheet-like support, may be used.
【００１９】一般に貼付剤は、使用前の状態では保持さ
れた薬効組成物の表面全体を覆う着脱可能なフィルムが
備えられており、使用する際に前記フィルムを剥がして
患部に貼付して用いられる。本発明の貼付剤において
も、収納の便宜上などから、着脱可能なフィルムを備え
ることが望ましい。保持された薬効組成物を覆うフィル
ムは、通常貼付剤で用いられているものを用いることが
できる。例えば、ポリエチレンフィルム、ポリプロピレ
ンフィルム、ポリエチレンテレフタレートフィルムなど
が例示できる。In general, a patch is provided with a removable film covering the entire surface of the medicinal composition held before use, and is used by peeling off the film and attaching it to an affected part when used. . The patch of the present invention also desirably includes a removable film for convenience of storage and the like. As the film covering the held efficacious composition, a film usually used for a patch can be used. For example, a polyethylene film, a polypropylene film, a polyethylene terephthalate film and the like can be exemplified.
【００２０】本発明の貼付剤に用いられる薬効組成物に
は、通常貼付剤に用いられる各種の薬効成分を配合する
ことができ、酸素との接触により変化、変色する薬効成
分であっても好適に用いることができる。薬効組成物に
配合できる薬効成分として好ましくは、例えば、アスコ
ルビン酸若しくはアスコルビン酸誘導体、レチノイド類
などのビタミン類、レゾルシンなどの殺菌剤、などを例
示できる。アスコルビン酸またはその誘導体の配合量と
して好ましくは、薬効組成物の全重量の０．１〜２０．
０重量％、特に好ましくは０．５〜１０重量％の範囲で
ある。また、レチノイド類の配合量として好ましくは、
薬効組成物の全重量の０．０１〜５．０重量％、特に好
ましくは０．０５〜１重量％の範囲である。また、レゾ
ルシンの配合量として好ましくは、薬効組成物の全重量
の０．０１〜５．０重量％、好適には、０．０５〜２重
量％の範囲である。The medicinal composition used in the patch of the present invention can contain various medicinal ingredients usually used for patches, and even if the medicinal ingredient changes or discolors upon contact with oxygen, it is suitable. Can be used. Preferred examples of the medicinal component that can be incorporated into the medicinal composition include, for example, ascorbic acid or ascorbic acid derivatives, vitamins such as retinoids, and bactericides such as resorcin. Preferably, the amount of ascorbic acid or a derivative thereof is 0.1 to 20.% of the total weight of the pharmaceutical composition.
0% by weight, particularly preferably 0.5 to 10% by weight. Further, preferably as a compounding amount of retinoids,
It is preferably in the range of 0.01 to 5.0% by weight, particularly preferably 0.05 to 1% by weight, based on the total weight of the medicinal composition. The amount of resorcinol is preferably 0.01 to 5.0% by weight, and more preferably 0.05 to 2% by weight based on the total weight of the medicinal composition.
【００２１】薬効組成物中には、上記のような薬効成分
の他、通常貼付剤に処方される任意成分を、必要に応じ
て配合することができる。例えば、任意成分としては、
基剤、硬化剤、キレート化剤、界面活性剤、ｐＨ調製
剤、凝集剤、増粘剤などが挙げられる。In the medicinal composition, in addition to the medicinal components as described above, optional components usually formulated in patches can be blended as required. For example, as an optional component,
Bases, curing agents, chelating agents, surfactants, pH adjusters, flocculants, thickeners and the like can be mentioned.
【００２２】具体的には、アルギン酸ナトリウム、ゼラ
チン、ポリビニルピロリドン、ポリアクリル酸およびそ
の塩、ポリビニルアルコール、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ナトリウム
（ＣＭＣナトリウム）、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等の１種または２種以上
の水溶性高分子を配合することができ、これらの水溶性
高分子の配合量は通常、薬効組成物の全重量に対して３
〜３０重量％が好ましい。Specifically, sodium alginate, gelatin, polyvinylpyrrolidone, polyacrylic acid and salts thereof, polyvinyl alcohol, methylcellulose, ethylcellulose, sodium carboxymethylcellulose (sodium CMC), hydroxyethylcellulose,
One or more water-soluble polymers such as hydroxypropylcellulose can be compounded, and the amount of these water-soluble polymers is usually 3 to the total weight of the medicinal composition.
~ 30% by weight is preferred.
【００２３】さらに、カオリン、ベントナイト、酸化チ
タン、酸化亜鉛、水酸化アルミニウムなどの無機塩およ
びグリセリン、ソルビトール、ポリエチレングリコー
ル、プロピレングリコール、１，３ブタンジオールなど
の多価アルコールが配合可能であり、無機塩および多価
アルコールの配合量は、薬効組成物の全重量に対して５
〜６５％が好ましく、より好ましくは３０〜７０％であ
る。Further, inorganic salts such as kaolin, bentonite, titanium oxide, zinc oxide and aluminum hydroxide and polyhydric alcohols such as glycerin, sorbitol, polyethylene glycol, propylene glycol and 1,3 butanediol can be blended. The amount of the salt and the polyhydric alcohol is 5 to the total weight of the medicinal composition.
It is preferably from 65 to 65%, more preferably from 30 to 70%.
【００２４】薬効組成物のｐＨは、貼付時の皮膚への安
全性を考慮し４〜７が望ましい。上記のアスコルビン酸
およびその誘導体は、ｐＨ４〜７では極めて不安定と考
えられるが、本発明の貼付剤においてはこのｐＨ範囲で
あっても安定した状態を維持できる。ｐＨの調製には、
酒石酸等が用いられる。The pH of the medicinal composition is preferably from 4 to 7 in consideration of safety on the skin at the time of application. The above ascorbic acid and its derivatives are considered to be extremely unstable at pH 4 to 7, but the patch of the present invention can maintain a stable state even in this pH range. To adjust the pH,
Tartaric acid or the like is used.
【００２５】本発明の貼付剤は、医薬品、医薬部外品、
化粧品などの用途には特に制限はない。また、貼付剤
は、パップ剤、貼付型パップ製剤、テープ剤などのいず
れの形態であってもよい。The patch of the present invention can be used for drugs, quasi-drugs,
There are no particular restrictions on uses such as cosmetics. The patch may be in any form such as a cataplasm, a cataplasm, a tape and the like.
【００２６】本発明の貼付剤の保存方法は、脱酸素能を
有する包装容器内に貼付剤を封入することを特徴とす
る。貼付剤は、シート状支持体の一方の面に薬効組成物
が保持されたものであり、詳細は上記貼付剤と同様であ
る。また脱酸素能を有する包装容器も既に上記した包装
容器と同様である。この包装容器の内側に貼付剤を封入
する。すなわち、貼付剤を包装容器内に入れ、その後包
装容器を密封すればよい。密封の方法は、包装容器の種
類にもよるが、ヒートシールなど、一般的な方法に従っ
て行えばよい。The method for storing a patch of the present invention is characterized in that the patch is enclosed in a packaging container having a deoxidizing ability. The patch is one in which the medicinal composition is held on one surface of a sheet-like support, and details thereof are the same as those of the above-mentioned patch. Further, the packaging container having a deoxidizing ability is the same as the packaging container already described above. A patch is sealed inside the packaging container. That is, the patch may be placed in a packaging container, and then the packaging container may be sealed. The sealing method depends on the type of the packaging container, but may be performed according to a general method such as heat sealing.
【００２７】密封の程度は、空気、特に酸素が透過しな
い程度が好ましい。なお、密封された包装容器を一旦開
封した後であっても、開口部分を再び密封すれば、一度
も開封しない場合ほどではないが本発明の効果は得られ
る。また、例えば袋状の包装容器で、一旦開封した後に
開口部分を折り畳むなどして包装容器の内外の空気の出
入りを抑制すれば、密封した場合ほどではないが本発明
の効果は得られる。The degree of sealing is preferably such that air, especially oxygen, does not permeate. Even after the sealed packaging container is once opened, if the opening is sealed again, the effect of the present invention can be obtained, though not so much as when the opening is never opened. Further, for example, if the opening and closing portion of the bag is once opened in a bag-shaped packaging container to suppress the inflow and outflow of air inside and outside the packaging container, the effects of the present invention can be obtained although not as much as in the sealed case.
【００２８】[0028]
【実施例】以下、実施例により本発明を具体的に説明す
る。ただし、本発明は以下の実施例に限定されるもので
はない。The present invention will be described below in detail with reference to examples. However, the present invention is not limited to the following examples.
【００２９】＜実施例１〜６＞表１に示す組成の薬効組
成物を用い通常の製法に従ってパップ剤を調製し、これ
を脱酸素能を有する包装容器内に封入して保存した。<Examples 1 to 6> A poultice was prepared by using a medicinal composition having the composition shown in Table 1 in accordance with a usual production method, and the cataplasm was sealed in a deoxygenating packaging container and stored.
【００３０】なお、各実施例のパップ剤の支持体として
不織布、支持体に保持された薬効組成物を覆うフィルム
としてポリプロピレンフィルムを用いた。また、各実施
例における、脱酸素能を有する包装容器の種類を表２に
示した。表２中の「脱酸素包装材」とは、ポリエチレン
テレフタレート（ＰＥＴ）／ポリエチレン（ＰＥ）／ア
ルミ箔／ＰＥを順次積層したフィルム（以下「フィルム
Ａ」という）のＰＥ側に、さらに脱酸素剤（還元鉄：東
亜合成（株）製「バイタロン」）を含む組成物のフィル
ム（東洋製罐（株）製、「オキシガードパウチ」）を、
前記混合組成物からなる層を内側にして形成された袋状
の包装容器（１５５ｍｍ×１２５ｍｍ）の最内層に積層
したものである。A nonwoven fabric was used as a support for the poultice in each example, and a polypropylene film was used as a film covering the medicinal composition held on the support. Table 2 shows the types of packaging containers having a deoxygenating ability in each example. “Oxygen-absorbing packaging material” in Table 2 refers to a polyethylene terephthalate (PET) / polyethylene (PE) / aluminum foil / PE laminated film (hereinafter, referred to as “film A”) on the PE side and a deoxidizer. (Reduced iron: Toa Gosei Co., Ltd. "Vitalon") containing a composition film (Toyo Seikan Co., Ltd., "Oxyguard Pouch")
It is laminated on the innermost layer of a bag-like packaging container (155 mm × 125 mm) formed with the layer made of the mixed composition inside.
【００３１】また、「脱酸素剤」とあるのは、酸素透過
性のあるポリエチレン製の小袋に脱酸素剤を６ｇ入れた
ものを同封したものを用いた場合のことを示す。袋状の
包装容器の大きさは上記「脱酸素包装材」の場合と同様
である。The term "deoxidizer" refers to the case where an oxygen-permeable polyethylene bag containing 6 g of an oxygen absorber is enclosed. The size of the bag-shaped packaging container is the same as that of the above-mentioned "deoxygenated packaging material".
【００３２】[0032]
【表１】 [Table 1]
【００３３】[0033]
【表２】 [Table 2]
【００３４】＜比較例１〜６＞表３に示す組成の薬効組
成物を用い通常の製法に従ってパップ剤を調製し、脱酸
素能を有しない包装容器内に封入して保存した。包装容
器は上記フィルムＡで形成した袋状の包装容器（１５５
ｍｍ×１２５ｍｍ）を用いた。また、パップ剤の支持
体、支持体に保持された薬効組成物を覆うフィルムは上
記実施例と同じである。<Comparative Examples 1 to 6> A poultice was prepared from the medicinal compositions having the compositions shown in Table 3 in accordance with a usual production method, and sealed and stored in a packaging container having no deoxidizing ability. The packaging container is a bag-shaped packaging container (155) formed of the film A.
mm × 125 mm). The support for the cataplasm and the film covering the medicinal composition held on the support are the same as those in the above examples.
【００３５】[0035]
【表３】 [Table 3]
【００３６】＜変色度の試験＞実施例１〜６、比較例１
〜６の製剤を４０℃で保存し、薬効組成物の経時的な変
色の度合いを下記判定基準に従って判定した。結果を表
４に示す。<Test of Discoloration Degree> Examples 1 to 6, Comparative Example 1
The preparations of Nos. To 6 were stored at 40 ° C., and the degree of discoloration of the medicinal composition over time was determined according to the following criteria. Table 4 shows the results.
【００３７】判定基準 ＋＋＋：茶褐色に変色した ＋＋ ：黄褐色に変色した ＋ ：黄色に変化した ± ：少し黄色した − ：白色（変色を認めなかった）Judgment Criteria +++: Discolored to brown ++: Discolored to tan +: Changed to yellow ±: Slightly yellow-: White (no discoloration was observed)
【００３８】[0038]
【表４】 [Table 4]
【００３９】上記の結果から、実施例１〜６のパップ剤
では、薬効成分が不安定になりやすい条件下でも長期間
にわたり変色をほとんど生じないことが明かとなった。From the above results, it was clarified that the cataplasms of Examples 1 to 6 hardly discolored for a long period of time even under the condition that the medicinal components tended to be unstable.
【００４０】[0040]
【発明の効果】本発明によれば、酸素、ｐＨ、温度、光
などの影響、特に酸素の影響を受け易い貼付剤であって
も、薬効成分の酸化を抑制し、変色などの発生を抑制す
ることができる。すなわち貼付剤を長期間安定した状態
で保存することが可能である。さらに、本発明によれ
ば、ブチルヒドロキシトルエン（ＢＨＴ）等の酸化防止
剤を薬効組成物に添加しなくても薬効成分の酸化を抑制
でき、貼付剤の皮膚への安全性の向上も図れる。According to the present invention, even for a patch which is easily affected by oxygen, pH, temperature, light, etc., especially oxygen, the oxidation of the medicinal component is suppressed and the occurrence of discoloration is suppressed. can do. That is, the patch can be stored in a stable state for a long time. Furthermore, according to the present invention, the oxidation of the medicinal component can be suppressed without adding an antioxidant such as butylhydroxytoluene (BHT) to the medicinal composition, and the safety of the patch on the skin can be improved.
───────────────────────────────────────────────────── フロントページの続き (51)Int.Cl.6 識別記号 ＦＩ // Ｃ０９Ｋ 15/00 Ｂ６５Ｄ 1/00 ──────────────────────────────────────────────────続 き Continued on the front page (51) Int.Cl. 6 Identification symbol FI // C09K 15/00 B65D 1/00
Claims (6)
が保持されており、脱酸素能を有する包装容器内に封入
された貼付剤。1. A patch wherein a medicinal composition is held on one surface of a sheet-like support and enclosed in a packaging container having a deoxidizing ability.
素剤が同封された請求項１に記載の貼付剤。2. The patch according to claim 1, wherein an oxygen scavenger is enclosed in a packaging container having no oxygen permeability.
くはアスコルビン酸誘導体又はレチノイド類を含有する
請求項１または２に記載の貼付剤。3. The patch according to claim 1, wherein the medicinal composition contains ascorbic acid, an ascorbic acid derivative, or retinoids.
請求項１〜３のいずれかに記載の貼付剤。4. The patch according to claim 1, wherein the pharmaceutical composition contains resorcinol.
求項１〜４のいずれかに記載の貼付剤。5. The patch according to claim 1, wherein the medicinal composition has a pH of 4 to 7.
が保持された貼付剤を、脱酸素能を有する包装容器内に
封入することを特徴とする貼付剤の保存方法。6. A method for preserving a patch, wherein the patch having the medicinal composition held on one surface of a sheet-like support is enclosed in a packaging container having a deoxygenating ability.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP21922897A JPH1147233A (en) | 1997-07-30 | 1997-07-30 | Plaster agent and preservation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP21922897A JPH1147233A (en) | 1997-07-30 | 1997-07-30 | Plaster agent and preservation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| JPH1147233A true JPH1147233A (en) | 1999-02-23 |
Family
ID=16732217
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP21922897A Pending JPH1147233A (en) | 1997-07-30 | 1997-07-30 | Plaster agent and preservation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JPH1147233A (en) |
Cited By (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2003051355A1 (en) * | 2001-12-19 | 2003-06-26 | Takeda Chemical Industries, Ltd. | Solid compositions containng compounds unstable to oxygen and method for stabilization thereof |
| JP2004075672A (en) * | 2002-06-19 | 2004-03-11 | Showa Denko Kk | Water-containing gel material, method for producing the water-containing gel material and use of the same |
| JP2006298774A (en) * | 2005-04-15 | 2006-11-02 | Lead Chemical Co Ltd | Percutaneous absorption type free radical-inhibiting preparation |
| JP2007254423A (en) * | 2006-03-24 | 2007-10-04 | Dhc Co | Sheet-form pack material and method for keeping quality of sheet-form pack material |
| WO2008066184A1 (en) | 2006-12-01 | 2008-06-05 | Nitto Denko Corporation | Method for prevention of coloration in donepezil-containing skin adhesive preparation, and method for reducing the production of donepezil analogue in donepezil-containing skin adhesive preparation |
| JPWO2009107478A1 (en) * | 2008-02-27 | 2011-06-30 | 久光製薬株式会社 | Patches and packaging |
| JP2012051875A (en) * | 2010-08-03 | 2012-03-15 | Hisamitsu Pharmaceut Co Inc | Method for storing transdermally/transmucosally absorbable preparation, and package of transdermally/transmucosally absorbable preparation |
| JP2012509325A (en) * | 2008-11-21 | 2012-04-19 | エーセルリクス ファーマシューティカルズ，インク． | Sufentanil solid dosage form containing oxygen scavenger and method of use thereof |
| US8580849B2 (en) | 2002-06-19 | 2013-11-12 | Showa Denko K.K. | Hydrous gel and production process and use of the hydrous gel |
| US8580281B2 (en) | 2008-02-27 | 2013-11-12 | Hisamitsu Pharmaceutical Co., Inc. | Medicated patch |
| EP2711174A1 (en) | 2012-09-21 | 2014-03-26 | Toyo Seikan Group Holdings, Ltd. | Packaging material and package structure using the same |
| US9320710B2 (en) | 2006-01-06 | 2016-04-26 | Acelrx Pharmaceuticals, Inc. | Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain |
| US10342762B2 (en) | 2006-01-06 | 2019-07-09 | Acelrx Pharmaceuticals, Inc. | Small-volume oral transmucosal dosage forms |
-
1997
- 1997-07-30 JP JP21922897A patent/JPH1147233A/en active Pending
Cited By (23)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2003051355A1 (en) * | 2001-12-19 | 2003-06-26 | Takeda Chemical Industries, Ltd. | Solid compositions containng compounds unstable to oxygen and method for stabilization thereof |
| JP2004075672A (en) * | 2002-06-19 | 2004-03-11 | Showa Denko Kk | Water-containing gel material, method for producing the water-containing gel material and use of the same |
| US8580849B2 (en) | 2002-06-19 | 2013-11-12 | Showa Denko K.K. | Hydrous gel and production process and use of the hydrous gel |
| JP4693340B2 (en) * | 2002-06-19 | 2011-06-01 | 昭和電工株式会社 | Hydrous gel body, method for producing the hydrogel body, and use thereof |
| JP2006298774A (en) * | 2005-04-15 | 2006-11-02 | Lead Chemical Co Ltd | Percutaneous absorption type free radical-inhibiting preparation |
| US10245228B2 (en) | 2006-01-06 | 2019-04-02 | Acelrx Pharmaceuticals, Inc. | Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain |
| US9320710B2 (en) | 2006-01-06 | 2016-04-26 | Acelrx Pharmaceuticals, Inc. | Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain |
| US9744129B2 (en) | 2006-01-06 | 2017-08-29 | Acelrx Pharmaceuticals, Inc. | Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain |
| US10507180B2 (en) | 2006-01-06 | 2019-12-17 | Acelrx Pharmaceuticals, Inc. | Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain |
| US10342762B2 (en) | 2006-01-06 | 2019-07-09 | Acelrx Pharmaceuticals, Inc. | Small-volume oral transmucosal dosage forms |
| JP2007254423A (en) * | 2006-03-24 | 2007-10-04 | Dhc Co | Sheet-form pack material and method for keeping quality of sheet-form pack material |
| WO2007111233A1 (en) * | 2006-03-24 | 2007-10-04 | Dhc Corporation | Sheet-form pack and method of maintaining quality of sheet-form pack |
| WO2008066185A1 (en) | 2006-12-01 | 2008-06-05 | Nitto Denko Corporation | Method for prevention of discoloration with time of donepezil-containing skin adhesive preparation |
| WO2008066184A1 (en) | 2006-12-01 | 2008-06-05 | Nitto Denko Corporation | Method for prevention of coloration in donepezil-containing skin adhesive preparation, and method for reducing the production of donepezil analogue in donepezil-containing skin adhesive preparation |
| JP5546013B2 (en) * | 2008-02-27 | 2014-07-09 | 久光製薬株式会社 | Patches and packaging |
| US8871249B2 (en) | 2008-02-27 | 2014-10-28 | Hisamitso Pharmaceutical Co., Inc. | Medicated patch |
| US9155725B2 (en) | 2008-02-27 | 2015-10-13 | Hisamitsu Pharmaceutical Co., Inc. | Adhesive skin patch and packaged product |
| US8580281B2 (en) | 2008-02-27 | 2013-11-12 | Hisamitsu Pharmaceutical Co., Inc. | Medicated patch |
| JPWO2009107478A1 (en) * | 2008-02-27 | 2011-06-30 | 久光製薬株式会社 | Patches and packaging |
| JP2012509325A (en) * | 2008-11-21 | 2012-04-19 | エーセルリクス ファーマシューティカルズ，インク． | Sufentanil solid dosage form containing oxygen scavenger and method of use thereof |
| JP2012051875A (en) * | 2010-08-03 | 2012-03-15 | Hisamitsu Pharmaceut Co Inc | Method for storing transdermally/transmucosally absorbable preparation, and package of transdermally/transmucosally absorbable preparation |
| KR20140038893A (en) | 2012-09-21 | 2014-03-31 | 도요세이칸 그룹 홀딩스 가부시키가이샤 | Packaging material and package structure using the same |
| EP2711174A1 (en) | 2012-09-21 | 2014-03-26 | Toyo Seikan Group Holdings, Ltd. | Packaging material and package structure using the same |
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