JP2008001642A - Medicine-containing patch - Google Patents
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- JP2008001642A JP2008001642A JP2006173018A JP2006173018A JP2008001642A JP 2008001642 A JP2008001642 A JP 2008001642A JP 2006173018 A JP2006173018 A JP 2006173018A JP 2006173018 A JP2006173018 A JP 2006173018A JP 2008001642 A JP2008001642 A JP 2008001642A
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Abstract
Description
本発明は、皮膚に貼付して用いる薬物含有貼付剤に関する。より具体的には、本発明は、支持体及び被覆材に印刷表示（特に、薬物含有貼付剤の製品名及び／又は含有薬物の薬効の印刷表示）が施された薬物含有貼付剤に関する。 The present invention relates to a drug-containing patch used by being applied to the skin. More specifically, the present invention relates to a drug-containing patch in which a support and a covering material are printed and displayed (in particular, the product name of the drug-containing patch and / or the medicinal effect of the contained drug).
薬物を生体内へ投与する手段として薬物を含有する粘着シートを皮膚に貼付する方法が一般的に知られており、パップ剤、プラスター剤などの局所作用を目的とするものや、虚血性心疾患治療効果、喘息治療効果など全身的効果を目的とするものなど、多種多様な薬物含有貼付剤が汎用されている。 As a means of administering a drug into a living body, a method of sticking a pressure-sensitive adhesive sheet containing the drug to the skin is generally known, such as a topical action such as a poultice or a plaster, or ischemic heart disease A wide variety of drug-containing patches are widely used, such as those intended for systemic effects such as therapeutic effects and asthma therapeutic effects.
薬物含有貼付剤が一般に認知され、普及する中、薬物の情報提供義務の法制化などにより、薬物含有貼付剤を封入する包装材には製品名が従来から表記されているものの、薬物含有貼付剤自体へ製品名などを表記させた例は数少ない。
従って、患者が貼付している状態の薬物含有貼付剤の薬効は医療従事者であっても判別ができないため、これが、特に急患の場合には、迅速で適切な処置の妨げとなるという問題点があった。
医療現場からも、医薬品使用の安全性確保や患者の服薬指導の面から、薬物含有貼付剤の薬効や製品名を確認できるよう薬物含有貼付剤自体への製品名等の表記が求められ、厚生労働省からも医薬品による医療事故防止に向けた対策をとるよう医薬品製造業界に対して求めが出されていた。
While drug-containing patches are generally recognized and popularized, the product name is conventionally written on packaging materials that enclose drug-containing patches due to legal restrictions on drug information provision. There are few examples where the product name is written on itself.
Therefore, the medicinal effect of the drug-containing patch in the state that the patient is affixed cannot be determined even by a healthcare professional, and this impedes prompt and appropriate treatment, particularly in the case of emergency patients. was there.
From the viewpoint of ensuring the safety of drug use and patient compliance guidance, the medical site also requires notation of the product name etc. on the drug-containing patch itself so that the efficacy and product name of the drug-containing patch can be confirmed. The Ministry of Labor demanded the pharmaceutical manufacturing industry to take measures to prevent medical accidents caused by pharmaceuticals.
特許文献１には、貼付剤自体への表記に関して、不織布からなる支持体にエンボス加工により文字を刻印した外用貼付剤が開示されているが、エンボス加工による文字の刻印は、視認性の点で印刷に劣るという問題点があった。 Patent Document 1 discloses an external patch in which characters are engraved on a support made of a nonwoven fabric by embossing with respect to the notation on the patch itself. There was a problem that it was inferior to printing.
製品への塵、毛髪、昆虫などの異物混入は、特に医薬品においては重大な不良であるが、通常、製品に印刷表示を施すことは異物の検出を困難にするという問題を生じる。つまり、印刷表示を施すことで製品の外観が複雑化するため、印刷物の表面に生じる汚れや印刷物内部に混入した塵等の異物などを検査する場合には、印刷部の影響が排除された異物検査が必要となる。印刷部の影響が排除された異物検査としては、印刷部をいわば消去（印刷部の色情報を消去）して全面を検査する方法と、印刷部を検査対象から除外して検査する方法とが知られている。
特許文献２には、印刷部をいわば消去して全面を検査する方法として、印刷部が単色の印刷のみからなる場合には、光学フィルタを用いて印刷部の色情報を消去する方法が記載されている。
上述の印刷部をいわば消去して全面を検査する方法により、支持体と被覆材とを備える薬物含有貼付剤を検査する場合、支持体と被覆材の印刷表示が同色である場合が最も検出能力への影響が小さい。しかしながら、支持体と被覆材の印刷表示が同色であると、使用時に被覆材を剥離する際、使用者にとって支持体側と被覆材側の識別が困難であるため、使用者が貼付前に貼付剤の粘着面に必要以上に触れてしまい、貼付剤の皮膚接着性が損なわれてしまうという問題点があった。
Contamination of foreign matters such as dust, hair, and insects into a product is a serious defect particularly in pharmaceuticals, but usually, a printed display on a product causes a problem that it is difficult to detect foreign matters. In other words, the appearance of the product is complicated by the printing display, so when inspecting dirt generated on the surface of the printed matter or foreign matter such as dust mixed in the printed matter, the foreign matter from which the influence of the printing part has been eliminated. Inspection is required. As a foreign matter inspection in which the influence of the printing part is eliminated, there are a method of inspecting the entire surface by erasing the printing part (erasing the color information of the printing part), and a method of inspecting the printing part by excluding it from the inspection target. Are known.
Patent Document 2 describes a method of erasing the print portion and inspecting the entire surface, as a method of erasing the color information of the print portion using an optical filter when the print portion is composed of only a single color print. ing.
When inspecting a drug-containing patch comprising a support and a coating material by erasing the above-mentioned printed part and inspecting the entire surface, the detection ability is most when the printed display on the support and the coating material are the same color The impact on is small. However, if the printed display of the support and the covering material are the same color, it is difficult for the user to distinguish between the support side and the covering material side when peeling the covering material during use. There was a problem that the adhesive surface was touched more than necessary, and the skin adhesiveness of the patch was impaired.
支持体と被覆材の印刷表示が同色である場合には、文字サイズを変えたり、一方の表示を文字ではなく図柄にしたりすることで、それぞれの面の識別を容易にさせることは可能であるが、貼付剤のサイズが小さい場合や使用者が高齢の場合には十分な識別効果が得られにくい。従って、支持体面と被覆材面の最も識別が容易な方法は、支持体と被覆材に、それぞれ異なる印刷色で印刷表示を施すことであると言える。
しかしながら、支持体と被覆材の印刷表示に異なる色を使用した場合には、上述の印刷部をいわば消去して全面を検査する方法では、光学フィルタによる印刷部の色情報の消去が不十分となるため、上述の印刷部を検査対象から除外して検査する方法を採用することとなる。
When the printed display of the support and the covering material are the same color, it is possible to easily identify each surface by changing the character size or changing the display of one of them to a pattern instead of a character. However, when the size of the patch is small or the user is elderly, it is difficult to obtain a sufficient discrimination effect. Therefore, it can be said that the easiest way to distinguish between the support surface and the covering material surface is to perform printing display with different printing colors on the support and the covering material.
However, when different colors are used for the print display of the support and the covering material, the above-described method for erasing the entire printed surface and inspecting the entire surface is insufficient for erasing the color information of the printed portion by the optical filter. For this reason, a method for inspecting the above-described printing unit by excluding it from the inspection target is adopted.
印刷部を検査対象から除外して検査する方法としては、いわゆるパターンマッチングによって印刷部を検出し、当該検出した印刷部をマスクして検査する方法や、印刷部が長手方向に周期的に配列されたシート状被検材について、前回の印刷部を検査した際の撮像画像に基づき今回の検査の際の印刷部をマスクする方法（特許文献３）が知られている。
しかし、これらの方法では、マスクに要する処理時間が長くなり効率の良い検査が行えないことが懸念される。また、特許文献３に記載の方法は、印刷部が周期的に配列されていることが必須であるため、汎用性に乏しい。
However, in these methods, there is a concern that the processing time required for the mask becomes long and efficient inspection cannot be performed. Further, the method described in Patent Document 3 is poor in versatility because it is essential that the printing units are arranged periodically.
本発明は、上述の問題点に鑑みてなされたものであり、製品名や薬効などの印刷表示により医療事故防止に寄与し、さらには異物混入品の市場への流出を防止するための検査が効率的に実施でき、かつ支持体側と被覆材側との識別性にも優れた薬物含有貼付剤を提供することを課題とする。 The present invention has been made in view of the above-mentioned problems, and contributes to preventing medical accidents by printing display such as product names and medicinal effects, and further, inspection for preventing leakage of foreign matter mixed products to the market is performed. It is an object of the present invention to provide a drug-containing patch that can be carried out efficiently and has excellent discrimination between the support side and the coating material side.
本発明者らは鋭意検討を行った結果、単色の印刷表示が施された支持体と、薬物含有粘着剤層と、該薬物含有粘着剤層の表面を被覆する被覆材であって支持体への印刷色とは異なる単色の印刷表示が施された被覆材とを備える薬物含有貼付剤において、該支持体及び該被覆材に施された印刷表示の色度差及び色差を特定の範囲に最適化することにより、反射光を用いた異物検査においても異物検出感度への影響が小さく、かつ支持体側と被覆材側が識別し易い貼付剤が得られることを見出し、本発明を完成するに至った。
すなわち、本発明は以下の通りである。
〔１〕 単色の印刷表示が施された支持体と、薬物含有粘着剤層と、該薬物含有粘着剤層の表面を被覆する被覆材であって支持体への印刷色とは異なる単色の印刷表示が施された被覆材とを備える薬物含有貼付剤であって、
該支持体に施された印刷表示と該被覆材に施された印刷表示とのＬａｂ表色系における色度差｜△ａ｜及び｜△ｂ｜がそれぞれ２０以下であり、かつ、色差ΔＥ＝｛（ΔＬ）２＋（Δａ）２＋（Δｂ）２｝１／２が１０以上３０以下であることを特徴とする、薬物含有貼付剤。
〔２〕 最高透過率波長が３６０〜４７０ｎｍである光学フィルタを用いた、反射光による異物検査において、支持体の印刷表示及び被覆材の印刷表示の映り込みが生じない、上記〔１〕記載の薬物含有貼付剤。
〔３〕 被覆材の印刷表示のＬａｂ表色系における色度ａ値及びｂ値がともに負の値である、上記〔２〕記載の薬物含有貼付剤。
〔４〕 支持体及び被覆材への印刷表示が硬化性のインキを用いて施されたものである、上記〔１〕記載の薬物含有貼付剤。
〔５〕 支持体への印刷表示が薬物含有粘着剤層側と反対側の面に施されている、上記〔１〕記載の薬物含有貼付剤。
〔６〕 支持体に施された印刷表示が薬物含有貼付剤の製品名及び／又は含有薬物の薬効である、上記〔１〕記載の薬物含有貼付剤。
As a result of intensive studies, the present inventors have found that a support having a single color printed display, a drug-containing pressure-sensitive adhesive layer, and a coating material that covers the surface of the drug-containing pressure-sensitive adhesive layer are provided on the support. In a drug-containing patch comprising a coating material with a single color printing indication different from the printing color of the above, the chromaticity difference and the color difference of the printing indication applied to the support and the coating material are optimal for a specific range As a result, it was found that a patch having a small influence on the foreign matter detection sensitivity even in the foreign matter inspection using the reflected light and easily distinguishable between the support side and the covering material side was obtained, and the present invention was completed. .
That is, the present invention is as follows.
[1] Single color printing different from the printed color on the support, which is a support on which a single color printed display is given, a drug-containing pressure-sensitive adhesive layer, and a coating material covering the surface of the drug-containing pressure-sensitive adhesive layer A drug-containing patch comprising a coating with a label,
The chromaticity differences | Δa | and | Δb | in the Lab color system between the printed display applied to the support and the printed display applied to the covering material are each 20 or less, and the color difference ΔE = {(ΔL) 2 + (Δa) 2 + (Δb) 2 } 1/2 is 10 or more and 30 or less, and a drug-containing patch.
[2] In the foreign matter inspection by reflected light using an optical filter having a maximum transmittance wavelength of 360 to 470 nm, the printed display of the support and the printed display of the coating material are not reflected. Drug-containing patch.
[3] The drug-containing patch according to [2] above, wherein both the chromaticity a value and the b value in the Lab color system of the printed display of the coating material are negative values.
[4] The drug-containing patch according to the above [1], wherein printing on the support and the coating material is performed using a curable ink.
[5] The drug-containing patch according to the above [1], wherein the printed display on the support is provided on the surface opposite to the drug-containing pressure-sensitive adhesive layer side.
[6] The drug-containing patch according to the above [1], wherein the printed indication on the support is the product name of the drug-containing patch and / or the medicinal effect of the contained drug.
本発明によれば、従来の薬物含有貼付剤に比べ医療事故防止効果が期待できるとともに、異物検査において検出感度を低下させることがなく効率的な検査が行えるので、異物混入品の市場への流出リスクを抑制することができる。
また、急患で、医療従事者との意思疎通が困難な状態であっても、医療従事者が、何の薬剤を貼付しているのかを即座に判別することができる。
According to the present invention, a medical accident prevention effect can be expected as compared with a conventional drug-containing patch, and an effective inspection can be performed without deteriorating detection sensitivity in the foreign substance inspection. Risk can be suppressed.
Moreover, even if the patient is in an emergency and difficult to communicate with the medical staff, it is possible to immediately determine what medicine the medical staff is applying.
本発明の薬物含有貼付剤は、単色の印刷表示が施された支持体と、薬物含有粘着剤層と、該薬物含有粘着剤層の表面を被覆する被覆材であって支持体への印刷色とは異なる単色の印刷表示が施された被覆材とを備える薬物含有貼付剤である。
本発明の薬物含有貼付剤において、支持体に施された印刷表示と被覆材に施された印刷表示とのＬａｂ表色系における色度差｜△ａ｜及び｜△ｂ｜はそれぞれ２０以下であり、色差ΔＥ＝｛（ΔＬ）２＋（Δａ）２＋（Δｂ）２｝１／２が１０以上３０以下である。好ましくは、支持体に施された印刷表示と被覆材に施された印刷表示とのＬａｂ表色系における色度差｜△ａ｜及び｜△ｂ｜はそれぞれ１０以下であり、色差ΔＥは２０以上２６以下である。｜△ａ｜及び｜△ｂ｜が上記の範囲を外れる場合ならびにΔＥが３０を超える場合は、異物検査での光学フィルタを介した撮像において、支持体又は被覆材のいずれか一方の印刷が白く又は黒く写り、いずれの場合にもこれらが異物として検出されてしまう。一方、ΔＥが１５を下回る場合は、支持体に施された印刷表示と被覆材に施された印刷表示との色差が小さすぎるため、それぞれの面を識別しにくくなる。
The drug-containing patch of the present invention comprises a support having a single color printed display, a drug-containing pressure-sensitive adhesive layer, and a coating material that covers the surface of the drug-containing pressure-sensitive adhesive layer, and is printed on the support And a coating material with a single color printed display different from the above.
In the drug-containing patch of the present invention, the chromaticity differences | Δa | and | Δb | in the Lab color system between the printed display applied to the support and the printed display applied to the coating material are 20 or less, respectively. Yes, the color difference ΔE = {(ΔL) 2 + (Δa) 2 + (Δb) 2 } 1/2 is 10 or more and 30 or less. Preferably, the chromaticity differences | Δa | and | Δb | in the Lab color system between the printed display applied to the support and the printed display applied to the covering material are each 10 or less, and the color difference ΔE is 20 It is 26 or less. When | Δa | and | Δb | are out of the above ranges and ΔE exceeds 30, printing of either the support or the covering material is white in imaging through the optical filter in the foreign substance inspection. Or, it appears black, and in either case, these are detected as foreign matters. On the other hand, when ΔE is less than 15, the color difference between the printed display applied to the support and the printed display applied to the covering material is too small, making it difficult to identify each surface.
本発明の薬物含有貼付剤の異物検査を行う場合、印刷表示の影響を受けない異物検査であればいかなる方法も用いることができるが、薬物含有貼付剤に光を照射する過程と、光学フィルタを介してその反射光を撮像する過程と、撮像した画像を２値化等の画像処理を施すことによって異常を顕在化させる過程とを含む方法による異物検査が特に効果的である。ここで使用される光学フィルタとしては、ＨＯＹＡ ＣＡＮＤＥＯ ＯＰＴＲＯＮＩＣＳ（株）社製の赤色光を選択的に透過するＲ−６２、青系統の色を選択的に透過するＢ−４１０、緑系統の色を選択的に透過するＧ−５３０など、市販のフィルタを印刷表示の色に応じて適宜用いることができるが、最高透過率波長が３６０〜４７０ｎｍの光学フィルタが好ましい。
例えば、上記色度の条件を満たしかつ被覆材の印刷表示のＬａｂ表色系における色度ａ値及びｂ値がともに負の値をとるような青系統の色を印刷色として選択した場合は、Ｂ−３９０の光学フィルタを用いて印刷部を消去することができる。
When the foreign substance inspection of the drug-containing patch of the present invention is performed, any method can be used as long as it is a foreign substance inspection that is not affected by the printed display. In particular, a foreign matter inspection by a method including a process of imaging the reflected light through the process and a process of revealing an abnormality by performing image processing such as binarization on the captured image is particularly effective. Optical filters used here include R-62 that selectively transmits red light manufactured by HOYA CANDEO OPTRONICS Co., Ltd., B-410 that selectively transmits blue color, and green color. A commercially available filter such as G-530 that selectively transmits can be appropriately used depending on the color of the print display, but an optical filter having a maximum transmittance wavelength of 360 to 470 nm is preferable.
For example, when a blue color that satisfies the above chromaticity condition and has negative chromaticity a value and b value in the Lab color system of the printing display of the covering material is selected as the printing color, The printed part can be erased using the optical filter B-390.
支持体及び被覆材への印刷表示は、硬化性のインキを用いて施すことが好ましい。硬化性のインキを用いることにより、本発明の薬物含有貼付剤の保存中における、粘着剤中の液状成分等のしみ出しによるインキの溶解、本発明の薬物含有貼付剤の貼付中における、入浴や発汗などによるインキの滲み及び皮脂成分によるインキの溶解を防ぐことが可能となる。 The print display on the support and the covering material is preferably performed using a curable ink. By using a curable ink, during storage of the drug-containing patch of the present invention, dissolution of ink due to exudation of liquid components and the like in the adhesive, bathing during application of the drug-containing patch of the present invention, It is possible to prevent ink bleeding due to perspiration and the like, and dissolution of ink by sebum components.
インキの硬化性の種類は、ＵＶ硬化性や、硬化剤の添加により付与した任意の硬化性など特に限定されない。
本発明の薬物含有貼付剤の製造において用いられる硬化性のインキとしては、例えば、ウレタン系、エポキシ系、アクリル系、ポリエステル系の樹脂から構成されるインキが挙げられる。なかでも、ウレタン系インキであって、鉛、六価クロム、カドミウム、水銀などの重金属やモノクロロベンゼン、テトラクロロエチレンなどのハロゲン化合物を含まないものが特に好ましい。
The type of ink curability is not particularly limited, such as UV curability or any curability imparted by the addition of a curing agent.
Examples of the curable ink used in the production of the drug-containing patch of the present invention include inks composed of urethane-based, epoxy-based, acrylic-based, and polyester-based resins. Of these, urethane-based inks that do not contain heavy metals such as lead, hexavalent chromium, cadmium, and mercury, and halogen compounds such as monochlorobenzene and tetrachloroethylene are particularly preferable.
支持体及び被覆材の印刷表示は、単色での印刷であれば、文字、図柄、これらの組み合わせのいずれであってもよい。 The printed display of the support and the covering material may be any of characters, designs, and combinations thereof as long as printing is performed in a single color.
支持体に施された印刷表示は、薬物含有貼付剤の製品名及び／又は含有薬物の薬効であることが好ましい。 The printed indication given to the support is preferably the product name of the drug-containing patch and / or the medicinal effect of the contained drug.
支持体及び被覆材への印刷表示は、薬物含有粘着剤層側と反対側の面（すなわち、薬物含有粘着剤層と接触する面と反対側の面）に施されていることが好ましい。印刷表示が薬物含有粘着剤層側に施されている場合は、粘着剤層中の成分と印刷表示に用いるインキなどの相互作用によりインキの溶解、又は粘着剤に含有される薬物の分解などを引き起こす可能性がある。 The printed indication on the support and the covering material is preferably provided on the surface opposite to the drug-containing pressure-sensitive adhesive layer side (that is, the surface opposite to the surface in contact with the drug-containing pressure-sensitive adhesive layer). When printing indication is given on the drug-containing pressure-sensitive adhesive layer side, the dissolution of the ink or the decomposition of the drug contained in the pressure-sensitive adhesive is caused by the interaction between the components in the pressure-sensitive adhesive layer and the ink used for the printing indication. May cause.
支持体及び被覆材へ印刷表示を施す方法は特に限定されず、グラビア印刷、オフセット印刷、フレキソ印刷など一般的な印刷方法を用いることができるが、支持体への印刷はフレキソ印刷が好ましく、被覆材への印刷はグラビア印刷が好ましい。貼付剤に用いられる支持体は薄くて柔軟であることが望ましく、不織布を積層したものも多いが、樹脂製の印刷版を使用するフレキソ印刷はこのような素材への印刷を容易に行うことができる。 A method for performing printing display on the support and the coating material is not particularly limited, and general printing methods such as gravure printing, offset printing, and flexographic printing can be used. The printing on the material is preferably gravure printing. It is desirable that the support used for the patch is thin and flexible, and there are many laminated non-woven fabrics, but flexographic printing using a resin printing plate can easily print on such materials. it can.
本発明に用いられる支持体は、支持体上に薬物含有粘着層を形成可能なものであれば特に限定されないが、柔軟で薬物含有粘着剤層中の成分を非透過性のフィルム、シート又は不織布であることが好ましい。そのような支持体としては、例えば、ポリエステル、ポリアミド、ポリオレフィン、可塑化ポリ塩化ビニル、可塑化酢酸ビニル−塩化ビニル共重合体、ポリ塩化ビニリデン、エチレン−酢酸ビニル共重合体、酢酸セルロース、エチルセルロース、エチレン−アクリル酸エチル共重合体、ポリテトラフルオロエチレンなどの単独フィルム、シート、不織布、あるいはこれらの積層体などが挙げられる。なかでも、ポリエステル製のフィルム、シート、不織布、及びこれらの積層体が好ましい。
支持体の厚みは、特に限定されないが、貼付剤としてのソフト感を損なわない点から、通常２〜２００μｍ、好ましくは５〜１００μｍである。
The support used in the present invention is not particularly limited as long as it can form a drug-containing adhesive layer on the support, but it is a flexible, non-permeable film, sheet or non-woven fabric component in the drug-containing adhesive layer. It is preferable that Examples of such a support include polyester, polyamide, polyolefin, plasticized polyvinyl chloride, plasticized vinyl acetate-vinyl chloride copolymer, polyvinylidene chloride, ethylene-vinyl acetate copolymer, cellulose acetate, ethyl cellulose, Examples thereof include a single film such as an ethylene-ethyl acrylate copolymer and polytetrafluoroethylene, a sheet, a nonwoven fabric, and a laminate thereof. Of these, polyester films, sheets, nonwoven fabrics, and laminates thereof are preferred.
Although the thickness of a support body is not specifically limited, From the point which does not impair the soft feeling as a patch, it is 2-200 micrometers normally, Preferably it is 5-100 micrometers.
本発明に用いられる被覆材は、薬物含有粘着層の成分を非透過性のものであれば特に限定されないが、例えば、薬物含有粘着剤層との接触面に易剥離処理を施したプラスチック製または紙製のシート又はフィルムが挙げられる。特に、ポリエステル製のシート又はフィルムが好ましい。 The coating material used in the present invention is not particularly limited as long as the components of the drug-containing pressure-sensitive adhesive layer are impermeable. For example, the coating material is made of a plastic having a contact surface with the drug-containing pressure-sensitive adhesive layer subjected to easy peeling treatment or A paper sheet or film may be mentioned. In particular, a polyester sheet or film is preferred.
薬物含有粘着剤層を構成する粘着剤は、薬物を含有させることが可能な粘着剤であれば特に限定されないが、例えば、アクリル系、ゴム系、シリコーン系、ビニルエーテル系、ウレタン系、酢酸ビニル系などの重合体粘着剤が挙げられる。なかでも、アクリル系粘着剤、ゴム系粘着剤、シリコーン系粘着剤が好ましい。 The pressure-sensitive adhesive constituting the drug-containing pressure-sensitive adhesive layer is not particularly limited as long as it is a pressure-sensitive adhesive capable of containing a drug. For example, acrylic, rubber-based, silicone-based, vinyl ether-based, urethane-based, vinyl acetate-based Polymer adhesives such as Of these, acrylic adhesives, rubber adhesives, and silicone adhesives are preferable.
粘着剤層に含有される薬物は、経皮吸収性を有するものであれば特に限定されず、全身作用及び局所作用のいずれを期待する薬物であってもよい。本発明で使用される薬物としては、例えば、全身麻酔薬、催眠・鎮静薬、抗てんかん薬、解熱鎮痛消炎薬、鎮暈薬、精神神経用薬、局所麻酔薬、骨格筋弛緩薬、自律神経用薬、鎮痙薬、抗パーキンソン薬、抗ヒスタミン薬、強心薬、不整脈用薬、利尿薬、血圧降下薬、血管収縮薬、冠血管拡張薬、末梢血管拡張薬、動脈硬化用薬、循環器用薬、呼吸促進薬、鎮咳去痰薬、ホルモン薬、化膿性疾患用外用薬、鎮痛・鎮痒・収斂・消炎用薬、寄生性皮膚疾患用薬、止血用薬、痛風治療用薬、糖尿病用薬、抗悪性腫瘍用薬、抗生物質、化学療法薬、麻薬などが挙げられる。 The drug contained in the pressure-sensitive adhesive layer is not particularly limited as long as it has transdermal absorbability, and may be a drug that expects a systemic action or a local action. Examples of the drug used in the present invention include general anesthetics, hypnotics / sedatives, antiepileptics, antipyretic analgesics, antipruritics, antipsychotics, local anesthetics, skeletal muscle relaxants, and autonomic nerves. Drugs, antispasmodics, antiparkinson drugs, antihistamines, cardiotonic drugs, arrhythmic drugs, diuretics, antihypertensive drugs, vasoconstrictor drugs, coronary vasodilator drugs, peripheral vasodilator drugs, arteriosclerosis drugs, cardiovascular drugs, Respiratory stimulant, antitussive expectorant, hormonal drug, topical suppurative drug, analgesic / antipruritic / astringent / anti-inflammatory drug, parasitic skin disease drug, hemostatic drug, gout treatment drug, diabetes drug, antimalignant Examples include tumor drugs, antibiotics, chemotherapeutic drugs, and narcotics.
さらに、薬物含有粘着剤層には、必要に応じ、様々な添加剤を添加することができる。添加剤の例としては、経皮吸収促進剤、可塑剤、粘着付与剤、安定化剤などが挙げられる。 Furthermore, various additives can be added to the drug-containing pressure-sensitive adhesive layer as necessary. Examples of additives include transdermal absorption accelerators, plasticizers, tackifiers, stabilizers, and the like.
以下に実施例を用いて、本発明をより具体的に説明するが、本発明はこれらに限定されるものではない。なお、以下において部および％は、重量部および重量％をそれぞれ意味する。 Hereinafter, the present invention will be described more specifically with reference to examples. However, the present invention is not limited to these examples. In the following, parts and% mean parts by weight and% by weight, respectively.
［実施例１〜４及び比較例１〜４］
（粘着剤溶液の調製）
アクリル酸２・エチルへキシル９５部、アクリル酸５部を不活性ガス雰囲気下、酢酸エチル中で重合させて、アクリル系粘着剤溶液を調製した。
[Examples 1 to 4 and Comparative Examples 1 to 4]
(Preparation of adhesive solution)
An acrylic pressure-sensitive adhesive solution was prepared by polymerizing 95 parts of 2-ethylhexyl acrylate and 5 parts of acrylic acid in ethyl acetate under an inert gas atmosphere.
（印刷表示された支持体の製造）
ポリエステル製フィルム（厚さ５μｍ）にポリエステル系接着剤をグラビアコーターによって乾燥塗布量が５ｇ／ｍ２になるように塗布し、加熱しながらポリエステル不織布（２０ｇ／ｍ２）を圧着することによってラミネートした。この支持体の不織布面に、フレキソ用油性インキ（フレキソＮＣＩ又はフレキソＰＳ、大阪印刷インキ製造（株）製）を表１の印刷色に調合し、フレキソ印刷により印刷した。
(Manufacture of printed support)
A polyester adhesive was applied to a polyester film (thickness: 5 μm) with a gravure coater so that the dry coating amount was 5 g / m 2 , and laminated by pressing a polyester nonwoven fabric (20 g / m 2 ) while heating. . Flexographic oil ink (Flexo NCI or Flexo PS, manufactured by Osaka Printing Ink Manufacturing Co., Ltd.) was prepared in the printing colors shown in Table 1 and printed by flexographic printing on the nonwoven fabric surface of the support.
（印刷表示された被覆材の製造）
ポリエステル製フィルム（厚さ７５μｍ）にグラビア印刷によって印刷を施し、印刷面と反対の面に易剥離処理を施した。
(Manufacture of printed coating materials)
A polyester film (thickness 75 μm) was printed by gravure printing, and an easy peeling treatment was performed on the surface opposite to the printed surface.
（薬物含有貼付剤の製造）
上記で得られた粘着剤溶液に、薬物としてツロブテロールを５％添加し、混合して膏体溶液を得た。表１に示した各被覆材上に乾燥後の厚みが４０μｍとなるように塗布し、乾燥して薬物含有粘着剤層を作製した。次に、この粘着剤層上に表１に示した印刷を施した各支持体を積層し、本発明の薬物含有貼付剤を得た。
(Manufacture of drug-containing patches)
To the adhesive solution obtained above, 5% of tulobuterol as a drug was added and mixed to obtain a plaster solution. It apply | coated so that the thickness after drying might be set to 40 micrometers on each coating | covering material shown in Table 1, and it dried and produced the medicine containing adhesive layer. Next, each support body which gave printing shown in Table 1 on this adhesive layer was laminated, and the medicine containing patch of the present invention was obtained.
Ａ：ポリエステルフィルム（厚さ６μｍ）−ポリエステル不織布（目付け量２０ｇ／ｍ２）の積層体
（ポリエステルフィルム側に粘着剤層を積層する）
Ｂ：ポリエステルフィルム（厚さ２μｍ）−ポリエステル不織布（目付け量１２ｇ／ｍ２）の積層体
（不織布側に粘着剤層を積層する）
Ｃ：白色ポリエステルフィルム（厚さ７５μｍ）
A: Polyester film (thickness 6 μm) -polyester nonwoven fabric (weight per unit area 20 g / m 2 ) laminate (adhesive layer is laminated on the polyester film side)
B: Laminated body of polyester film (thickness 2 μm) -polyester nonwoven fabric (weight per unit area 12 g / m 2 ) (adhesive layer is laminated on the nonwoven fabric side)
C: White polyester film (thickness 75 μm)
色度測定条件
測定機器：カラーアナライザーＴＣ−１８００ＭＫ−ＩＩ（東京電色製）
測定方法：反射光
視野 ：２度視野
標準光 ：Ｄ６５
Chromaticity measurement condition measuring instrument: Color analyzer TC-1800MK-II (manufactured by Tokyo Denshoku)
Measurement method: Reflected light Field of view: 2 degree field of view Standard light: D65
［実験例１］
実施例及び比較例で得られた薬物含有貼付剤を、ＫＰ−Ｆ１００Ｂ（日立国際電気社製）を用い、Ｂ−３９０光学フィルタを介して撮像し、得られた画像に支持体または被覆材の印刷が写りこむかどうかを評価した（ｎ＝３）。
[Experimental Example 1]
The drug-containing patches obtained in Examples and Comparative Examples were imaged through a B-390 optical filter using KP-F100B (manufactured by Hitachi Kokusai Electric Co., Ltd.). It was evaluated whether or not the print was reflected (n = 3).
［実験例２］
実施例及び比較例で得られた薬物含有貼付剤について、支持体側と被覆材側の識別しやすさを目視で評価した（ｎ＝３）。
[Experiment 2]
The drug-containing patches obtained in Examples and Comparative Examples were visually evaluated for ease of discrimination between the support side and the coating material side (n = 3).
実施例１〜４で得られた薬物含有貼付剤は、光学フィルタを介した撮像において、印刷が映り込むことがないため、薬物含有貼付剤の異物検査に影響しないことが分かる。また、実施例1〜４で得られた薬物含有貼付剤は、支持体側と被覆材側とが識別しやすかった。一方、比較例１〜３で得られた薬物含有貼付剤は、支持体側と被覆材側は識別しやすいものの、比較例１及び２は印刷の｜Δａ｜又は｜Δｂ｜が大きすぎるため、また比較例３はΔＥが大きすぎるため、光学フィルタを介しても支持体の印刷の映り込みが認められた。比較例４で得られた薬物含有貼付剤は印刷の映り込みはないものの、支持体と被覆材の印刷表示の色差が小さいため、それぞれの面を識別し難かった。 It can be seen that the drug-containing patches obtained in Examples 1 to 4 do not affect the foreign matter inspection of the drug-containing patch because printing does not appear in the imaging through the optical filter. In addition, the drug-containing patches obtained in Examples 1 to 4 were easy to distinguish between the support side and the coating material side. On the other hand, the drug-containing patches obtained in Comparative Examples 1 to 3 are easy to distinguish between the support side and the coating material side, but Comparative Examples 1 and 2 have too large | Δa | or | Δb | In Comparative Example 3, since ΔE was too large, reflection of printing on the support was recognized even through the optical filter. Although the drug-containing patch obtained in Comparative Example 4 had no print reflection, the color difference between the printed display of the support and the covering material was small, and it was difficult to distinguish each surface.
Claims (6)
該支持体に施された印刷表示と該被覆材に施された印刷表示とのＬａｂ表色系における色度差｜△ａ｜及び｜△ｂ｜がそれぞれ２０以下であり、かつ、色差ΔＥ＝｛（ΔＬ）２＋（Δａ）２＋（Δｂ）２｝１／２が１０以上３０以下であることを特徴とする、薬物含有貼付剤。 A support having a single color printed display, a drug-containing pressure-sensitive adhesive layer, and a coating material for covering the surface of the drug-containing pressure-sensitive adhesive layer, which is different from the color printed on the support. A drug-containing patch comprising a coated coating material,
The chromaticity differences | Δa | and | Δb | in the Lab color system between the printed display applied to the support and the printed display applied to the covering material are each 20 or less, and the color difference ΔE = {(ΔL) 2 + (Δa) 2 + (Δb) 2 } 1/2 is 10 or more and 30 or less, A drug-containing patch.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2006173018A JP2008001642A (en) | 2006-06-22 | 2006-06-22 | Medicine-containing patch |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2006173018A JP2008001642A (en) | 2006-06-22 | 2006-06-22 | Medicine-containing patch |
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|---|---|
| JP2008001642A true JP2008001642A (en) | 2008-01-10 |
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| JP2006173018A Pending JP2008001642A (en) | 2006-06-22 | 2006-06-22 | Medicine-containing patch |
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| JP2012183096A (en) * | 2011-03-03 | 2012-09-27 | Medorekkusu:Kk | Plaster for external use |
| WO2018235362A1 (en) * | 2017-06-22 | 2018-12-27 | 教裕 南郷 | Needle for dissolving into skin and needle device |
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