JPH0920665A - Plaster for bedsore and its production - Google Patents

Abstract

PURPOSE: To easily obtain a plaster excellent in the preventive effect for bacterial infection on bedsore wound surface and in granulation promoting effect, capable of mitigating patients' pain, and easy to handle, by screen printing of a specific medicinal layer for bedsore on a release sheet. CONSTITUTION: This plaster is in the form of a laminate composed of a substrate 1, a medicinal layer 2 for bedsore comprising (A) white sugar, (B) silver sulfadiazine and (C) a tamarind seed polysaccharide-based consistency-imparting agent, and a release sheet 3 covering the layer 2. This plaster is obtained by the following process: the layer 2 is continuously subjected to screen printing to a specified shape on the sheet 3 fed band-fashion, and the band-like substrate 1 is laminated so as to cover the printed surface of the sheet 3, and the resultant laminate is cut into pieces at specified points. It is preferable that the layer 2 comprise 50-80w/v% of the component A, 1-5w/v% of the component B, and 7-23w/v% of the component C.

Description

【発明の詳細な説明】Detailed Description of the Invention

【０００１】[0001]

【産業上の利用分野】本発明は、褥瘡、所謂「床ずれ」
や皮膚潰瘍の治療を目的とした褥瘡用貼付剤及びその製
法に関するものである。BACKGROUND OF THE INVENTION The present invention relates to pressure ulcers, so-called "bed sores".
The present invention relates to a patch for pressure ulcer intended for the treatment of skin ulcers and a method for producing the same.

【０００２】[0002]

【従来の技術】褥瘡や皮膚潰瘍は、骨突出部の皮膚及び
皮下組織が外部の物体との間で持続的あるいは頻繁に圧
迫され、阻血性壊死を起こした状態である。この褥瘡や
皮膚潰瘍は二次感染を併発し易く、治療においては創傷
の治療と共に創傷面の細菌感染の除去或いは予防が重要
といわれている。2. Description of the Related Art A pressure ulcer or skin ulcer is a condition in which the skin and subcutaneous tissue of a bone protruding portion are continuously or frequently pressed against an external object to cause ischemic necrosis. This pressure ulcer or skin ulcer is likely to cause secondary infection, and it is said that removal of or prevention of bacterial infection on the wound surface is important in the treatment as well as treatment of the wound.

【０００３】従来より、民間療法として褥瘡の治療に白
糖が用いられており、白糖を有効成分とする褥瘡用治療
軟膏も既に市販されているが、白糖には創傷治療作用が
あることが最近になって確認された。Conventionally, sucrose has been used for the treatment of pressure ulcer as a folk remedy, and a pressure ulcer treatment ointment containing sucrose as an active ingredient has already been marketed, but sucrose has recently been found to have a wound healing action. Was confirmed.

【０００４】すなわち、この褥瘡用治療軟膏について
は、欠損創及び皮膚潰瘍モデルで肉芽新生及び表皮再生
の促進と共に治癒日数の短縮を、また、ラットの切創モ
デルで相対張力の増加を認め、各モデル共に明らかな創
傷治療作用が示された。[0004] That is, regarding this therapeutic ointment for pressure ulcer, in the defect wound and the skin ulcer model, the promotion of granulation and epidermal regeneration and the shortening of the healing days were observed, and in the rat wound model, the increase of the relative tension was observed. Both models showed a clear wound healing effect.

【０００５】尚、白糖の創傷治療過程に対する影響は、
ラット欠損創治療過程の検討で、表皮においては***期
表皮細胞の増加が、真皮においては創傷早期に線維芽細
胞の増殖を促進させるヒアルロン酸の増加が認められ
た。また、ラット切創治療過程の組織学的検討では、創
傷部の浮腫が軽度で、新生血管及び線維芽細胞に富み、
膠原線維の再生を伴なう発達した肉芽組織が認められ
た。The effect of sucrose on the wound healing process is as follows:
Examination of the rat defect wound healing process revealed an increase in mitotic epidermal cells in the epidermis and an increase in hyaluronic acid in the dermis, which promotes fibroblast proliferation in the early stage of wounding. In addition, histological examination of the rat incision treatment process revealed that the edema of the wound was mild and rich in new blood vessels and fibroblasts.
Developed granulation tissue with collagen fiber regeneration was observed.

【０００６】要約すれば、白糖を有効成分とする褥瘡用
治療軟膏には、局所的浸透圧の上昇による浮腫軽減作用
及び線維芽細胞を活性化する作用があり、褥瘡の治療に
有効であることが確認されている。[0006] In summary, a therapeutic ointment for pressure ulcer containing sucrose as an active ingredient has an effect of reducing edema due to an increase in local osmotic pressure and an action of activating fibroblasts, and is effective in treating pressure ulcer. Has been confirmed.

【０００７】[0007]

【発明が解決しようとする課題】しかしながら、この褥
瘡用治療軟膏には、取扱上、著しい困難な問題が存在し
ている。すなわち、褥瘡用治療軟膏をガーゼ等の支持体
に展延操作を行う際、軟膏の粘性が容易に変化して「ぼ
そぼそ」の状態となるため、軟膏を適切な状態に均一の
厚さを保って支持体上に円滑に展延、載置するためには
相当の熟練した技術を必要とする。このため、薬剤を処
方、調合する者あるいは看護に当たる者の労力には多大
なものがある。また、褥瘡患部に貼付した軟膏の更新、
取替時に蒙る患者の苦痛も無視することは出来ない。更
に、軟膏の有する褥瘡創面における細菌感染の防止効果
及び肉芽形成促進効果自体についても、なお改善される
べき点の存するものと思惟される。However, this therapeutic ointment for pressure ulcer has a serious problem in handling. That is, when the treatment for pressure ulcers is spread on a support such as gauze, the viscosity of the ointment easily changes and becomes a "poggy" state, so keep the ointment in an appropriate state and uniform thickness. In order to smoothly spread and place it on the support, a considerable skill is required. Therefore, the labor of a person who prescribes and prepares a medicine or a person who is involved in nursing is enormous. In addition, renewal of the ointment attached to the pressure ulcer affected area,
The patient's suffering during replacement cannot be ignored. Furthermore, it is considered that there is a point that the effect of preventing bacterial infection on the pressure ulcer wound surface of the ointment and the effect of promoting granulation itself should be improved.

【０００８】本発明は、既知の褥瘡治療薬剤に比較して
一段と褥瘡創面における細菌感染の防止効果及び肉芽形
成促進効果に優れ、患者の苦痛を軽減可能であり、なか
んずく、特にその取扱が容易で、薬剤を処方、調合する
者あるいは看護に当たる者の労力を顕著に低減し得る褥
瘡用貼付剤及び製造が容易な褥瘡用貼付剤の製法を得る
ことを目的とする。INDUSTRIAL APPLICABILITY The present invention is more excellent in the effect of preventing bacterial infection on the pressure ulcer wound surface and the effect of accelerating granulation formation, as compared with known agents for treating pressure ulcer, and can reduce the pain of the patient, and above all, it is easy to handle. An object of the present invention is to obtain a patch for pressure ulcer that can remarkably reduce the labor of a person who prescribes and mixes drugs or a person who is involved in nursing, and a method for producing a pressure ulcer patch that is easy to manufacture.

【０００９】[0009]

【課題を解決するための手段】本発明に係る褥瘡用貼付
剤は、支持体と、該支持体上に形成された白糖とスルフ
ァジアジン銀（Silver Sulfadiazine 、以下ＳＳＤと記
載する）とタマリンド種子多糖系粘稠性付与剤を含有・
調合した褥瘡用薬剤層と、該褥瘡用薬剤層を被覆する剥
離シートとを備えたものである。The patch for pressure ulcers according to the present invention comprises a support, sucrose formed on the support, silver sulfadiazine (hereinafter referred to as SSD), and a tamarind seed polysaccharide system. Contains viscosity-improving agent
It is provided with a prepared drug layer for pressure ulcer and a release sheet for covering the drug layer for pressure ulcer.

【００１０】上記の通り、白糖には褥瘡治癒効果、具体
的には肉芽増殖作用、局所浸透圧の上昇による浮腫の軽
減作用及び細菌増殖防止作用が認められている。また、
白糖は、特に記載するまでもなく、古くより砂糖の形態
で食品または調味料として多用されている安全性の高い
物質である。ＳＳＤは、グラム陽性菌、グラム陰性菌並
びに真菌に対し優れた抗菌活性を有し、しかも副作用の
ほとんど認められない薬剤として知られている。ＳＳＤ
は、それ自体、薬剤標品として購入することもできる
が、スルファジアジンおよび適当な銀化合物、例えば硝
酸銀から調製することも出来る。また、本発明者らは、
ＳＳＤは白糖の有する肉芽増殖作用及び局所浸透圧の上
昇による浮腫の軽減作用を相互依存的に向上せしめるこ
とを此度新たに発見した。タマリンド種子多糖は、耐酸
性、耐熱性及び耐塩性に優れ、安定な粘度を維持し得る
多糖であって、古くより食品として利用されてきた安全
性の高い物質である。この多糖の水溶液は、強い保水
力、優れたゲル形成能及びゲル内浸潤環境を有する。さ
らにタマリンド種子多糖の水溶液は、その種々の特性を
保持したまま他の物質とも容易に混和する特性も有して
いる。As described above, sucrose has been recognized to have a pressure ulcer healing effect, specifically, a granuloproliferative effect, an edema reducing effect due to an increase in local osmotic pressure, and a bacterial growth preventing effect. Also,
Sucrose is a highly safe substance that has been used frequently as a food or seasoning in the form of sugar for a long time, without particular mention. SSD is known as a drug having an excellent antibacterial activity against Gram-positive bacteria, Gram-negative bacteria and fungi, and having few side effects. SSD
Can be purchased as such as a drug standard, but it can also be prepared from sulfadiazine and a suitable silver compound such as silver nitrate. Also, the present inventors,
It was newly discovered that SSD can mutually improve the granuloproliferative action of sucrose and the edema-reducing action due to an increase in local osmotic pressure. Tamarind seed polysaccharide is a polysaccharide that is excellent in acid resistance, heat resistance and salt resistance and can maintain a stable viscosity, and is a highly safe substance that has been used as a food for a long time. The aqueous solution of this polysaccharide has a strong water retention ability, an excellent gel forming ability, and an infiltration environment in the gel. Furthermore, the aqueous solution of tamarind seed polysaccharide has the property of being easily mixed with other substances while retaining its various properties.

【００１１】タマリンド種子多糖系粘稠性付与剤は、白
糖及びＳＳＤと混合した場合、混合後、数分間は粘稠な
状態を維持し、その後にゲル形成が開始されると云う性
質を有する。このため、本発明の褥瘡用薬剤では、十分
な時間にわたって必要な粘稠性を保持した状態で施用操
作を行うことが可能であり、しかも患部に施用した後は
速やかに適度の硬さを有するゲルに変化する特性を有す
る。この特性のため、褥瘡用薬剤の取扱いは極めて容易
となる利点が有る。また、患部に施用してゲルに変化し
た薬剤は、適度の硬さ、柔軟性、粘着性を兼ね備えてい
るので、患部に程良く適合し、外部からの圧力、刺激に
対しクッションの効果をも果たすことができる。更に本
褥瘡用薬剤層の有する適度な柔軟性と粘着性は、薬剤層
を患部にぴったりと付着せしめる役目を果たし、被施用
者、患者の使用感を良好ならしめる効果がある。同時
に、褥瘡用貼付剤の施用時、更新時における患者の苦痛
を著しく軽減することが出来る。更にタマリンド種子多
糖系粘稠性付与剤は、ゲルの保水能を調整する目的のた
めに添加され、あるいはその他の目的のために添加され
ることも有る他の物質、例えばグリセリンなどとも容易
に混和可能である。The tamarind seed polysaccharide thickening agent has a property that, when mixed with sucrose and SSD, it remains viscous for a few minutes after mixing and then gel formation is started. Therefore, with the agent for pressure ulcer of the present invention, it is possible to perform the application operation while maintaining the necessary consistency for a sufficient period of time, and yet, after being applied to the affected area, it quickly has an appropriate hardness. It has the property of changing into a gel. This property has the advantage that the pressure ulcer drug is very easy to handle. In addition, since the drug applied to the affected area and converted into a gel has appropriate hardness, flexibility and adhesiveness, it fits the affected area moderately and also has a cushioning effect against external pressure and irritation. Can be fulfilled Further, the moderate flexibility and adhesiveness of the drug layer for pressure ulcer play a role of allowing the drug layer to be attached to the affected area exactly, and have an effect of improving the usability of the recipient and the patient. At the same time, the pain of the patient at the time of applying and renewing the patch for pressure ulcer can be significantly reduced. Further, the tamarind seed polysaccharide thickening agent is added for the purpose of adjusting the water retention capacity of the gel, or easily mixed with other substances that may be added for other purposes, such as glycerin. It is possible.

【００１２】また、本発明に係る褥瘡用貼付剤の製法で
は、帯状に供給される剥離シート上に白糖とＳＳＤとタ
マリンド種子多糖系粘稠性付与剤とを混合した褥瘡用薬
剤層を所定の形状に連続してスクリーン印刷の手法によ
り展着・載置し、剥離シートの印刷面を覆うように帯状
の支持体を張り合せ、張り合せた帯状物を所定の箇所で
切断するものである。Further, in the method for producing a pressure ulcer patch according to the present invention, a pressure ulcer drug layer obtained by mixing sucrose, SSD and a tamarind seed polysaccharide-based viscosity imparting agent on a release sheet supplied in the form of a strip is predetermined. The shape is continuously spread and placed by a screen printing method, a strip-shaped support is attached so as to cover the printing surface of the release sheet, and the attached strip is cut at a predetermined location.

【００１３】更に、本発明に係る褥瘡用貼付剤の製法で
は、その褥瘡用薬剤層の組成を、好ましくは白糖５０〜
８０％、ＳＳＤ１〜５％、タマリンド種子多糖系粘稠性
付与剤の３％水溶液 ７〜２３％を含有する組成とす
る。なお、これらの構成比は、以下特に記載のない限
り、重量／容量百分比（％）を表す。また、この組成以
外の構成比に関する記載についても、重量／容量百分比
（％）による。Further, in the method for producing a pressure ulcer patch according to the present invention, the composition of the pressure ulcer drug layer is preferably 50 to 50% sucrose.
The composition contains 80%, 1-5% SSD, and 7-23% 3% aqueous solution of a tamarind seed polysaccharide-based thickening agent. In addition, these composition ratios represent the weight / volume percentage ratio (%) unless otherwise specified. Further, the description regarding the composition ratio other than this composition is also based on the weight / volume percentage ratio (%).

【００１４】[0014]

【作用】本発明においては、支持体と、該支持体上に形
成された白糖とＳＳＤとタマリンド種子多糖系粘稠性付
与剤とを混合した褥瘡用薬剤層と、該褥瘡用薬剤層を被
覆する剥離シートとを備えたものであるため、施用に当
っては、剥離シートを剥離・除去し、褥瘡用薬剤層の面
を患部創面に直接貼付するだけで良い。従って、施用は
迅速に行い得るため、褥瘡用貼付剤の施用時、更新時に
おける患者の苦痛を著しく軽減するばかりでなく、その
取扱いが容易で、看護に当たる者や薬剤を処方する者の
労力は顕著に低減される。In the present invention, a support, a pressure ulcer drug layer containing sucrose formed on the support, SSD and a tamarind seed polysaccharide thickening agent, and the pressure ulcer drug layer are coated. In order to apply, it is only necessary to peel off and remove the release sheet and apply the surface of the pressure ulcer drug layer directly to the wound surface of the affected area. Therefore, since the application can be performed quickly, not only does the pain of the patient at the time of application and renewal of the pressure ulcer patch be remarkably reduced, but also the handling thereof is easy, and the labor of the person who is nursing and the person who prescribes the drug are labor-saving. Significantly reduced.

【００１５】本発明において使用するタマリンド種子多
糖系粘稠性付与剤は、薬剤用タマリンド種子多糖、例え
ば「グリロイド６Ｃ」［大日本製薬（株）製品］の水溶
液である。また、その水溶液濃度は３〜３０％程度が適
当である。すなわち、他の成分とともに褥瘡用薬剤層を
形成した場合、タマリンド種子多糖系粘稠性付与剤の３
％水溶液の構成比に換算して７〜２３％の範囲に調製し
得るように、予め、適当な水溶液濃度を設定し、調製し
ておくと良い。また、この水溶液は、褥瘡用薬剤層の調
製直前に、必要により適宜加温しても良い。The tamarind seed polysaccharide thickening agent used in the present invention is an aqueous solution of a pharmaceutical tamarind seed polysaccharide, for example, "Glyloid 6C" [a product of Dainippon Pharmaceutical Co., Ltd.]. Further, it is suitable that the concentration of the aqueous solution is about 3 to 30%. That is, when a pressure ulcer drug layer is formed together with other components, the tamarind seed polysaccharide-based thickener 3
It is advisable to set and prepare an appropriate aqueous solution concentration in advance so that it can be prepared in the range of 7 to 23% in terms of the composition ratio of the% aqueous solution. In addition, this aqueous solution may be appropriately heated immediately before the preparation of the pressure ulcer drug layer.

【００１６】また、褥瘡用薬剤層ゲルの保水能を調整す
る目的あるいはその他の目的のために、白糖、ＳＳＤ及
びタマリンド種子多糖系粘稠性付与剤以外の物質、例え
ばグリセリンなどを褥瘡用薬剤層の構成成分として必要
により添加してもよい。グリセリンには、褥瘡用薬剤層
と患部創面とを、一層、ぴったりと接触せしめる作用が
有る。For the purpose of adjusting the water retention capacity of the gel for pressure ulcer layer or for other purposes, substances other than sucrose, SSD and tamarind seed polysaccharide thickener, such as glycerin, are used for the pressure ulcer layer. If necessary, it may be added as a component. Glycerin has a function of further closely contacting the pressure ulcer drug layer and the affected area wound surface.

【００１７】本発明の褥瘡用貼付剤を小規模あるいは臨
床的に製造する方法としては、通常のガーゼや不織布等
の支持体上に、調剤用スパチュラ等の適当な器具を用い
て、白糖、ＳＳＤ及びタマリンド種子多糖系粘稠性付与
剤などを均一に混和した褥瘡用薬剤を展延して褥瘡用薬
剤層を形成する方法が採用できる。この際、タマリンド
種子多糖系粘稠性付与剤及びグリセリン等の一部が支持
体中に浸透・拡散し、薬剤層中の有効成分の濃度の変化
または減少を来すことが有る。このため、粘稠性付与剤
が支持体に浸透して薬剤層中から移行し去る量を勘案
し、その分を増量した薬剤を展延しておき、支持体に粘
稠性付与剤の一部が移行した後に薬剤層中の成分が最も
好ましい薬剤組成となるよう調整することが肝心であ
る。As a method for producing the patch for pressure ulcer of the present invention on a small scale or clinically, sucrose and SSD are prepared on a usual support such as gauze or non-woven fabric by using an appropriate device such as a spatula for preparation. Alternatively, a method of forming a pressure ulcer drug layer by spreading a pressure ulcer drug in which a tamarind seed polysaccharide-based thickening agent and the like are uniformly mixed can be adopted. At this time, a part of the tamarind seed polysaccharide-based viscosity imparting agent, glycerin and the like may permeate and diffuse into the support, resulting in a change or decrease in the concentration of the active ingredient in the drug layer. Therefore, considering the amount of the viscosity imparting agent penetrating the support and migrating away from the drug layer, the amount of the increased amount of the agent is spread, and the viscosity imparting agent It is essential to adjust the components in the drug layer to have the most preferable drug composition after the transfer.

【００１８】また、好ましい製法としては、白糖とＳＳ
Ｄとタマリンド種子多糖系粘稠性付与剤などを混合した
褥瘡用薬剤層を所定の形状、例えば長方形、四隅を曲線
で裁断した長方形、楕円形、卵形等の形状に形成しつ
つ、スクリーン印刷の手法により、帯状に供給される剥
離シート上に連続して展着・載置し、その直後に剥離シ
ートの印刷面を覆うように帯状の支持体を張り合せ、次
いで張り合せのなされた帯状物を所定の箇所で切断する
方法がある。この方法によって褥瘡用貼付剤を連続的に
製造することが出来、大量生産規模の製造が可能とな
る。[0018] As a preferred production method, sucrose and SS
Screen-printing while forming a pressure ulcer drug layer in which D and a tamarind seed polysaccharide thickening agent are mixed into a predetermined shape, for example, a rectangle, a rectangle with four corners cut by a curve, an ellipse, an egg shape, or the like. Method, continuously spread and place on a release sheet supplied in a strip shape, immediately after that, a strip-shaped support is attached so as to cover the print surface of the release sheet, and then the attached strip-shaped There is a method of cutting an object at a predetermined place. By this method, the patch for pressure ulcer can be continuously produced, and production on a mass production scale becomes possible.

【００１９】この場合も褥瘡用薬剤の粘稠性付与剤の一
部は、支持体に浸透・拡散して移行するため、移行分に
相当する薬剤を予め増量して調製する。この場合の好ま
しい褥瘡用薬剤層の組成は、白糖５０〜８０％、ＳＳＤ
１〜５％、タマリンド種子多糖系粘稠性付与剤７〜２３
％であり、更に好ましい褥瘡用薬剤層の組成は、白糖７
０％、ＳＳＤ２〜３％、タマリンド種子多糖系粘稠性付
与剤１０〜２０％である。In this case as well, a part of the viscosity-imparting agent for pressure ulcers migrates by penetrating and diffusing into the support, so that the amount of the drug corresponding to the amount of migration is increased in advance. In this case, the composition of the drug layer for pressure ulcer is preferably 50 to 80% of white sugar and SSD.
1 to 5%, tamarind seed polysaccharide thickening agent 7 to 23
%, And a more preferable composition of the pressure ulcer drug layer is sucrose 7
0%, SSD 2 to 3%, and tamarind seed polysaccharide thickening agent 10 to 20%.

【００２０】[0020]

【実施例】以下、実施例により本発明を詳細に説明す
る。なお、実施例は本発明の思想を限定するものではな
い。The present invention will be described in detail below with reference to examples. The embodiments do not limit the idea of the present invention.

【００２１】実施例１ ＝試験薬剤の調製及び検定並びに動物実験＝ （１−１）白糖：製剤用白糖［小堺製薬（株）製品］を
選択して使用した。Example 1 = Preparation and Assay of Test Agent and Animal Experiment = (1-1) Sucrose: Sucrose for pharmaceutical [Product of Kosakai Pharmaceutical Co., Ltd.] was selected and used.

【００２２】（１−２）ＳＳＤの調製：水酸化ナトリウ
ム［和光純薬工業（株）製品］に精製水を加えて溶解
し、撹拌しながらスルファジアジン［シグマケミカルカ
ンパニ−（Sigma Chemical Co.)製品］を等モル量添加
した。混合液は白濁した後、僅かに黄色に濁った。この
液に等モル量の希薄な硝酸銀［和光純薬工業（株）製
品］水溶液を撹拌しながら徐々に添加した。添加後、間
もなくＳＳＤの結晶が析出した。該結晶をブフナー漏斗
に載置した濾紙上に分取し、冷水で洗浄した。乾燥後の
ＳＳＤは暗色広口瓶内に保存した。(1-2) Preparation of SSD: Purified water was added to sodium hydroxide [Wako Pure Chemical Industries, Ltd. product] and dissolved, and sulfadiazine [Sigma Chemical Co. product was stirred and stirred. ] Was added in an equimolar amount. The mixture became cloudy and then slightly yellow. An equimolar amount of dilute silver nitrate [Wako Pure Chemical Industries, Ltd. product] aqueous solution was gradually added to this solution while stirring. Shortly after the addition, SSD crystals were precipitated. The crystals were collected on a filter paper placed on a Buchner funnel and washed with cold water. The dried SSD was stored in a dark wide-mouthed bottle.

【００２３】（１−３）ＳＳＤの同定：「第十一改正日
本薬局方」記載のＳＳＤの確認試験法に従い、調製した
ＳＳＤを試料濃度０．００１％になるように、０．００
５％アンモニア溶液［原液の２５％アンモニア水は和光
純薬工業（株）製品］に溶解した。吸光光度計２２０Ａ
［（株）日立製作所製品］を使用して、該溶液の紫外部
吸収スペクトルを測定した。スペクトルには２４１ｎｍ
及び２５５ｎｍ波長位に吸収極大が存在し、調製したＳ
ＳＤ試料が局方記載のＳＳＤのスペクトルの吸収極大波
長位と一致することから、調製したＳＳＤ試料は局方記
載の要件を満足するＳＳＤであることを確認した。(1-3) Identification of SSD: According to the SSD confirmation test method described in "The 11th Japanese Pharmacopoeia", the prepared SSD is adjusted to a sample concentration of 0.001% by 0.00
A 5% ammonia solution [a 25% aqueous solution of undiluted solution was a product of Wako Pure Chemical Industries, Ltd.] was dissolved. Absorption photometer 220A
The ultraviolet absorption spectrum of the solution was measured using [Hitachi Ltd. product]. 241 nm in the spectrum
And the absorption maximum exists at the wavelength of 255 nm, and the prepared S
Since the SD sample coincides with the absorption maximum wavelength position of the spectrum of SSD written in the Japanese Pharmacopoeia, it was confirmed that the prepared SSD sample was an SSD satisfying the requirements written in Japanese Pharmacopoeia.

【００２４】（１−４）ＳＳＤの純度の検定：「第十一
改正日本薬局方」記載のＳＳＤの純度試験法に従い、調
製したＳＳＤ０．０５０ｇをエタノール・強アンモニア
水混液（混合容量比、３：２）に溶解した。この溶液５
μＬを蛍光剤を含有する薄層クロマトグラフ用シリカゲ
ルから調製した薄層板にスポットした。次いで本スポッ
ト試料をクロロホルム・メタノール・強アンモニア水混
液（混合容量比、１０：５：２）［混液の各成分とも和
光純薬工業（株）製品］よりなる展開溶媒を使用して室
温下で約１５ｃｍの距離を展開した。展開後、薄層板を
室温下で風乾した。紫外線（主波長２５４ｎｍ）照射下
に検出したスポットのＲｆ値は０．４であった。また、
他にスポットを検出しなかったので、調製したＳＳＤ試
料は局方記載の要件を満足する高純度のＳＳＤであるこ
とを確認した。(1-4) SSD Purity Assay: 0.050 g of SSD prepared according to the SSD purity test method described in "The 11th revised Japanese Pharmacopoeia" was mixed with ethanol / strong ammonia water (mixing volume ratio: 3). : 2). This solution 5
μL was spotted on a thin layer plate prepared from thin layer chromatographic silica gel containing a fluorescent agent. Next, this spot sample was mixed with a chloroform / methanol / strong ammonia water mixture (mixing volume ratio 10: 5: 2) [each component of the mixture was a product of Wako Pure Chemical Industries, Ltd.] at room temperature using a developing solvent. Deployed a distance of about 15 cm. After the development, the thin layer plate was air dried at room temperature. The Rf value of the spot detected under irradiation with ultraviolet rays (main wavelength 254 nm) was 0.4. Also,
Since no other spots were detected, it was confirmed that the prepared SSD sample was a high-purity SSD satisfying the requirements of the Japanese Pharmacopoeia.

【００２５】（１−５）タマリンド系種子多糖基剤の調
製：室温下で、マグネチックスタ−ラ−により撹拌中の
精製水に、タマリンド種子系多糖「グリロイド６Ｃ」
［大日本製薬（株）製品］を少量ずつ添加し、均一にな
るまで撹拌した。「グリロイド６Ｃ」水溶液の濃度は３
％に調製した。(1-5) Preparation of Tamarind Seed Polysaccharide Base: Tamarind seed polysaccharide "Glyloid 6C" was added to purified water under stirring with a magnetic stirrer at room temperature.
[Dainippon Pharmaceutical Co., Ltd. product] was added little by little and stirred until uniform. The concentration of "Glyloid 6C" aqueous solution is 3
%.

【００２６】（１−６）本発明の褥瘡用貼付剤薬剤組成
物の調製：上記の「グリロイド６Ｃ」水溶液に対して５
０％量に相当する白糖及び１００号（１５０μｍ）の篩
を通過した１％相当量のＳＳＤを乳鉢中で均一になるま
で磨り合わせた。該磨合物を上記の「グリロイド６Ｃ」
水溶液に添加後、均一状態になるまで充分に練り合わせ
た。練合物の流動性が維持されている間に、５ｃｍ×５
ｃｍ×２ｍｍの空間を形成可能なテフロン［重合四弗化
エチレンの商品名、デュポン社(E. I. Du Pont de Nemo
urs & Co.,Inc.) 製品］製の枠を置いたガーゼの上に流
し込み、無菌環境・室温下に３０分間保持した。３０分
後に無菌操作により、テフロン枠より取りはずし、無菌
環境・室温下に保存した。なお、ＳＳＤの配合量を１％
に設定したのは、現在、臨床で広く使用されているＳＳ
Ｄ含有外用剤「ゲーベンクリーム」［東京田辺製薬
（株）製品］の配合量に準じたものである。本外用剤中
のＳＳＤ含有量は１１．３ｇ／５ｃｍ³ である。表１に
本発明の褥瘡用貼付剤薬剤組成物の処方を示す。(1-6) Preparation of a patch medicinal composition for pressure ulcers of the present invention: 5 to the above-mentioned "Glyloid 6C" aqueous solution
Sucrose corresponding to 0% amount and SSD corresponding to 1% which passed through No. 100 (150 μm) sieve were rubbed in a mortar until uniform. The polishing product was treated with the above "Glyroid 6C".
After adding to the aqueous solution, they were thoroughly kneaded until a uniform state was obtained. 5cm × 5 while the fluidity of the kneaded product is maintained
Teflon capable of forming a space of cm x 2 mm [trade name of polymerized tetrafluoroethylene, EI Du Pont de Nemo
urs & Co., Inc.) product] was poured onto a gauze with a frame, and kept in a sterile environment and room temperature for 30 minutes. After 30 minutes, it was removed from the Teflon frame by aseptic operation and stored in a sterile environment at room temperature. The SSD content is 1%
Is set to SS, which is currently widely used clinically
This is in accordance with the compounding amount of the D-containing external preparation "Geven Cream" [product of Tokyo Tanabe Seiyaku Co., Ltd.]. The SSD content in the external preparation is 11.3 g / 5 cm ³ . Table 1 shows the formulation of the patch pharmaceutical composition for pressure ulcer of the present invention.

【００２７】[0027]

【表１】 [Table 1]

【００２８】（１−７）褥瘡用貼付剤基剤組成物の調
製：ＳＳＤの添加を省略した他は、全て本発明の褥瘡用
貼付剤薬剤組成物の調製法に準じて、褥瘡用貼付剤基剤
組成物を調製した。表２に褥瘡用貼付剤基剤組成物の処
方を示す。(1-7) Preparation of patch-based patch base composition for pressure ulcer: Except that the addition of SSD was omitted, the patch-based patch for pressure ulcer was prepared according to the method for preparing the patch-based patch pharmaceutical composition of the present invention. A base composition was prepared. Table 2 shows the prescription of the patch base composition for pressure ulcer.

【００２９】[0029]

【表２】 [Table 2]

【００３０】（１−８）褥瘡用貼付剤比較対照製剤組成
物の調製：「ゲーベンクリーム」を比較対照製剤とし、
同一施用条件下で、本発明の褥瘡用貼付剤薬剤組成物と
同量のＳＳＤを投与可能な様に、すなわち、「ゲーベン
クリーム」を５ｃｍ×５ｃｍ×４ｍｍの空間に展張し貼
付可能な様に、褥瘡用貼付剤比較対照製剤組成物を調製
した。(1-8) Preparation of patch comparative control preparation composition for pressure ulcer: "Geben cream" was used as a comparative control preparation,
Under the same application conditions, so that the same amount of SSD as the patch pharmaceutical composition for pressure ulcers of the present invention can be administered, that is, "Geben cream" can be spread and applied to a space of 5 cm x 5 cm x 4 mm. A patch comparative control formulation composition for pressure ulcer was prepared.

【００３１】（１−９）ラットを用いた褥瘡モデルの作
成：ウレタン［アルドリッチ・ケミカル・カンパニ−
（Aldrich Chemical Co.) 製品］７５０ｍｇ／ｋｇ・体
重量を腹腔内注射により投与して麻酔した体重２７０ｇ
内外の雄のウイスター（Wistar) 系ラット［（株）埼玉
実験動物 製品］を、右側転子部が水平になるように横
臥位に保定した後、背部の皮膚を直径２ｃｍの円形状に
切除し、さらに垂直方向からアセトン・ドライアイスで
約−７０℃に５分間処置した。尚、冷却器具の先端の直
径は２ｃｍとし、器具の先端を薄いプラスチック・フィ
ルムで被覆して凍結による器具と組織との固着を防止し
た。図１はラットの背部に処置を施し作成した褥瘡モデ
ルの部位を示す模式図である。(1-9) Preparation of pressure ulcer model using rat: Urethane [Aldrich Chemical Company
(Aldrich Chemical Co.) product] 750 mg / kg-body weight 270 g anesthetized by intraperitoneal injection
Internal and external male Wistar rats [Saitama Experimental Animal Products Co., Ltd.] were held in a recumbent position so that the right trochanter was horizontal, and the back skin was excised into a circular shape with a diameter of 2 cm. Further, it was treated with acetone / dry ice from the vertical direction at about −70 ° C. for 5 minutes. The tip of the cooling device had a diameter of 2 cm, and the tip of the device was covered with a thin plastic film to prevent the device from sticking to the tissue due to freezing. FIG. 1 is a schematic diagram showing the site of a pressure ulcer model created by treating the back of a rat.

【００３２】（１−１０）褥瘡モデル・ラットへの投与
実験：上記の通り、褥瘡モデルの処置を行ったラット
を、各群４頭宛で、ａ）無処置群、ｂ）基剤投与群、
ｃ）本発明の薬剤組成物投与群、及びｄ）比較対照薬剤
組成物投与群の４群に分類した。各群のラットのモデル
褥瘡患部に、所定の試験薬剤組成物を、毎日１回、投与
した。但し、無処置群ａ）に対しては、ガーゼのみを投
与した。投与後は、直ちに患部を粘着包帯を用いて固定
し、さらに、その上をテーピング・テープにより再固定
した。(1-10) Administration experiment to pressure ulcer model rats: As described above, 4 rats each were treated with the pressure ulcer model, a) untreated group, b) base administration group ,
It was classified into four groups: c) the drug composition administration group of the present invention and d) the comparative control drug composition administration group. The predetermined test drug composition was administered once daily to the model pressure sore affected area of the rats in each group. However, only gauze was administered to the untreated group a). Immediately after the administration, the affected area was fixed with an adhesive bandage and further fixed thereon with a tape.

【００３３】（１−１１）褥瘡モデル・ラットの観察：
毎日１回あての試験薬剤組成物の投与時に、イ）患部と
試験薬剤組成物の接触状態、ロ）創面の長径長及び短径
長の計測、ハ）創面の深さの目視、ニ）創面の性状の観
察（色調、滲出液の量・色・粘稠度・肉芽形成の程
度）、ホ）創面形態の記録（創面の輪郭を透明なラップ
材上へトレ−ス転写及び創面の写真撮影）、ヘ）患部周
辺及び全身体の浮腫の有無、ト）ラットの行動性及び
チ）糞便の状態の８項目について観察、記録した。(1-11) Observation of pressure ulcer model rat:
When the test drug composition is administered once a day, b) contact state of the test drug composition with the affected part, b) measurement of the major and minor lengths of the wound surface, c) visual inspection of the depth of the wound surface, and d) the wound surface Observation of the properties (color tone, amount of exudate / color / viscosity / granulation), e) Recording of wound morphology (trace of wound surface on transparent wrap material, and photograph of wound surface) ), F) the presence or absence of edema around the affected area and the whole body, g) the behavior of rats and h) the fecal condition, 8 items were observed and recorded.

【００３４】なお、創面の面積の経時的変化は、次の式
１で示す創面面積比で表示した。 Ｒ＝ Ｔｎ／Ｔｉ ×１００ …（式１） （但し、Ｒ＝創面面積比（％）、Ｔｎ＝観測日における
創面の長径長×短径長、Ｔｉ＝試験開始・観測第１日に
おける創面の長径長×短径長）The change over time in the area of the wound surface was expressed as the ratio of the area of the wound surface shown in the following formula 1. R = Tn / Ti × 100 (Equation 1) (where, R = wound surface area ratio (%), Tn = long diameter of wound surface on observation day × minor axis length, Ti = start of test / of wound surface on observation day 1) Major axis length x minor axis length)

【００３５】（１−１２）投与結果（モデル褥瘡面の面
積の経時的変化）：図２に試験薬剤組成物を投与した後
の各群における創面の面積の経時的変化、即ち、試験薬
剤組成物を投与した後の各経過日における創面の面積の
減少・治癒状態を示す。図２において、縦軸は創面の面
積の減少比（％）を、横軸は経過日次（日）を表す。ま
た中央に黒小点を有する白色四角点は無処置群ａ）を、
黒色四角点は基剤投与群ｂ）を、中央に白小点を有する
黒色四角点は本発明の薬剤投与組成物群ｃ）を、白色四
角点は比較対照薬剤組成物投与群ｄ）を示す。なお、各
点とも、測定値から算出した平均値±標準偏差を意味す
る。(1-12) Administration results (change in area of model pressure ulcer surface with time): Change in area of wound surface in each group after administration of test drug composition in FIG. 2, that is, test drug composition The reduction of the wound surface area and the healing state on each lapse of day after the administration of the substance are shown. In FIG. 2, the vertical axis represents the reduction ratio (%) of the wound surface area, and the horizontal axis represents the elapsed day (day). The white square point with a black dot in the center is the untreated group a),
The black square points indicate the base administration group b), the black square points having a white small dot in the center indicate the drug administration composition group c) of the present invention, and the white square points indicate the comparative control drug composition administration group d). . In addition, each point means the average value ± standard deviation calculated from the measured values.

【００３６】（１−１３）投与結果イ（モデル褥瘡面の
面積の縮小率の比較）：表３に、モデル褥瘡処置後、３
日目、４日目または５日目における本発明の薬剤組成物
投与群ｃ）の縮小率と基剤投与群ｂ）の縮小率との差及
び同数値差の検定結果、並びに本発明の薬剤組成物投与
群ｃ）の縮小率と比較対照薬剤組成物投与群ｄ）の縮小
率との差及び同数値差の検定結果を示す。(1-13) Administration Results B (Comparison of reduction rate of area of model decubitus surface): Table 3 shows 3 after the model decubitus treatment.
The difference between the reduction rate of the pharmaceutical composition administration group c) of the present invention and the reduction rate of the base administration group b) on the day 4, the fourth or the fifth day, and the test results of the same numerical difference, and the agent of the present invention The difference between the reduction rate of the composition administration group c) and the reduction rate of the comparative control drug composition administration group d) and the test results of the same numerical difference are shown.

【００３７】[0037]

【表３】 [Table 3]

【００３８】（１−１４）投与結果ロ（治癒指標からの
観察結果）：図３に、創面の回復の程度、即ち創面の面
積が処置直後の面積の５０％以下になった日次を示すＸ
軸、創面の乾燥化の程度、即ち滲出液による浸潤が認め
られなくなった日次を示すＹ軸、及び創面における肉芽
形成の程度、即ち創の深さが０．５ｍｍ以下となった日
次を示すＺ軸から構成される三元軸図を示す。なお、図
３中、白色菱形点は無処置群ａ）を、白四角点は基剤投
与群ｂ）を、黒色四角点は本発明の薬剤組成物投与群
ｃ）を、黒色菱形点は比較対照薬剤組成物投与群ｄ）を
各々意味する。(1-14) Administration Results b (Observation Results from the Healing Index): FIG. 3 shows the degree of recovery of the wound surface, that is, the day when the area of the wound surface became 50% or less of the area immediately after the treatment. X
Axis, degree of dryness of wound surface, that is, Y axis showing daily infiltration by exudate is not observed, and degree of granulation formation on wound surface, that is, daily depth of wound is 0.5 mm or less Figure 3 shows a ternary axis diagram consisting of the Z axis shown. In FIG. 3, the white diamond points are the untreated group a), the white square points are the base administration group b), the black square points are the pharmaceutical composition administration group c) of the present invention, and the black diamond points are the comparison. Each means the control drug composition administration group d).

【００３９】（１−１５）投与結果ハ（総括）：図２に
示すごとく、本発明の薬剤組成物投与群ｃ）では、処置
後３〜５日にかけて創面の縮小が最も顕著であった。そ
の縮小率の程度には、表３に示す如く、基剤投与群ｂ）
あるいは比較対照薬剤組成物投与群ｄ）の縮小率に比較
して明瞭な数値差が存在することを認め、また、それら
の数値差は有意であることが確認された。さらに図３に
示す如く、本発明の薬剤組成物投与群ｃ）では、その黒
色四角点が最も内部位に存在することで示される通り、
創面の縮小速度、創面の乾燥化及び肉芽形成度の何れの
観察指標にあっても、基剤投与群ｂ）あるいは比較対照
薬剤組成物投与群ｄ）のそれらよりも、短日期間内に施
用効果が発現し、有効であったことを認めた。(1-15) Administration Results C (Summary): As shown in FIG. 2, in the pharmaceutical composition administration group c) of the present invention, the reduction of the wound surface was most remarkable 3 to 5 days after the treatment. As shown in Table 3, the degree of reduction is based on the base administration group b).
Alternatively, it was confirmed that there was a clear numerical difference as compared with the reduction rate of the comparative control drug composition administration group d), and it was also confirmed that these numerical differences were significant. Further, as shown in FIG. 3, in the pharmaceutical composition administration group c) of the present invention, as shown by the black square points being present at the innermost site,
Application within a shorter period of time than those of the base administration group b) or the comparative control drug composition administration group d) regardless of the observation index of the wound surface reduction rate, the wound surface dryness and the degree of granulation formation The effect was exhibited and it was confirmed that it was effective.

【００４０】実施例２ ＝本発明の褥瘡用貼付剤の製造＝ （２−１）本発明の褥瘡用貼付剤の構成例：図４は本発
明の褥瘡用貼付剤の一実施例の構成を示す説明図であ
る。図４中、（ａ）はその斜視図、（ｂ）はその断面図
である。図４に示す通り、褥瘡用貼付剤は、支持体１
と、この支持体１上に形成された褥瘡用薬剤層２と、こ
の褥瘡用薬剤層２を被覆する剥離シート３とを備えた構
成である。Example 2 = Production of patch for pressure ulcer of the present invention = (2-1) Example of constitution of patch for pressure ulcer of the present invention: Fig. 4 shows the constitution of one example of the patch for pressure ulcer of the present invention. It is an explanatory view shown. In FIG. 4, (a) is a perspective view thereof and (b) is a sectional view thereof. As shown in FIG. 4, the patch for pressure ulcer has a support 1
And a pressure ulcer drug layer 2 formed on the support 1, and a release sheet 3 covering the pressure ulcer drug layer 2.

【００４１】（２−２）褥瘡用薬剤の組成：本発明の褥
瘡用貼付剤は、通常のガーゼや不織布等の支持体に、褥
瘡用薬剤を調剤用スパチュラ等を用いて展延して製造し
てもよい。その際、「グリロイド６Ｃ」水溶液及びグリ
セリン等の粘稠性付与剤の一部が支持体中に浸透して、
薬剤中の濃度が減少することがある。この事態を予想し
て、粘稠性付与剤が支持体に浸透、移行する量を勘案、
増量した処方による薬剤組成による調剤を展延し、支持
体に粘稠性付与剤の一部が移行した後にあって、患部に
接触する薬剤層の薬剤組成を最適の薬剤組成となるよう
調整することが肝心である。この配慮のもとに褥瘡用貼
付剤の褥瘡用薬剤を処方し、表４に示す各組成の製剤を
試作した。(2-2) Composition of drug for pressure ulcer: The patch for pressure ulcer of the present invention is produced by spreading the drug for pressure ulcer on a support such as ordinary gauze or non-woven fabric by using a spatula for preparation. You may. At that time, part of the "Glyloid 6C" aqueous solution and a viscosity-imparting agent such as glycerin penetrated into the support,
The concentration in the drug may be reduced. In anticipation of this situation, considering the amount of the viscosity imparting agent that permeates and migrates into the support,
Dispensing the drug composition according to the increased formulation and adjusting the drug composition of the drug layer in contact with the affected area to be the optimum drug composition after a part of the viscosity-imparting agent is transferred to the support. That is the point. Based on this consideration, the pressure ulcer drug as a patch for pressure ulcer was prescribed, and a formulation having each composition shown in Table 4 was produced as a trial.

【００４２】なお、製剤用白糖、「グリロイド６Ｃ」及
びＳＳＤは実施例１と同一品を使用した。濃グリセリン
は花王（株）の製品を使用した。The same white sugar as that used in Example 1 was used as the sucrose for formulation, "Glyloid 6C" and SSD. The concentrated glycerin used was a product of Kao Corporation.

【００４３】[0043]

【表４】 [Table 4]

【００４４】（２−３）試作した褥瘡用貼付剤の物性試
験：実施例２で取得した各々の製剤を用いた褥瘡用貼付
剤について種々の物性を調べた。それらの結果を表５に
示す。なお、比較のために、市販の褥瘡治療用軟膏［コ
ーワ製薬（株）社製品］を他の処方試験例と同一の支持
体に塗布した試作貼付剤についても、同様の物性を調べ
た。(2-3) Physical property test of prototype patch for pressure ulcer: Various physical properties were examined for the patch for pressure ulcer using each preparation obtained in Example 2. Table 5 shows the results. For comparison, the same physical properties were also examined for a trial patch prepared by applying a commercially available ointment for treating pressure ulcer [product of Kowa Pharmaceutical Co., Ltd.] to the same support as in other prescription test examples.

【００４５】[0045]

【表５】 [Table 5]

【００４６】なお、表５中に記載する針入距離とは、一
定の応力に達するまでの距離をレオメーターで測定した
針入距離である。即ち、レオメーターのアダプター（ア
ダプターを使用）が試料の表面に接触してから一定応
力（２００ｇ）に達するまでの時間を記録チャートから
読取り、試料台の上昇した距離に換算し、針入距離とし
た。アダプターは直径２０ｍｍの円柱形をなす。使用
した試料用容器は直径５０ｍｍ×高さ５０ｍｍであり、
試料台の上昇速度は６０ｍｍ／ｍｉｎ、チャート・スピ
ードは１２０ｍｍ／ｍｉｎであった。The penetration distance shown in Table 5 is a penetration distance measured by a rheometer until a certain stress is reached. That is, the time from the contact of the rheometer adapter (using the adapter) to the surface of the sample until it reaches a constant stress (200 g) is read from the recording chart and converted to the elevated distance of the sample stand to determine the needle penetration distance. did. The adapter has a cylindrical shape with a diameter of 20 mm. The sample container used has a diameter of 50 mm and a height of 50 mm,
The rising speed of the sample table was 60 mm / min, and the chart speed was 120 mm / min.

【００４７】以上のように、展延性（塗布の容易さ）お
よび裏抜け等の状況から、最も良好な貼付剤処方は、白
糖７０％、「グリロイド６Ｃ」３％水溶液２０％、ＳＳ
Ｄ２％、グリセリン１３％のＮｏ．２処方であった。な
お、支持体を選択することにより裏抜けを実質的に防止
し得る場合には、本発明の褥瘡用貼付剤に展延する褥瘡
用薬剤層の組成は白糖５０〜８０％、ＳＳＤ１〜５％、
「グリロイド６Ｃ」３％水溶液７〜２３％の範囲にある
ものを選択するとよい。As described above, from the standpoint of spreadability (ease of application) and strike-through, the best patch formulation is sucrose 70%, "Glyloid 6C" 3% aqueous solution 20%, SS
D2%, glycerin 13% No. It was 2 prescriptions. In the case where strike-through can be substantially prevented by selecting a support, the composition of the pressure ulcer drug layer spread on the pressure ulcer patch of the present invention is sucrose 50 to 80%, SSD 1 to 5%. ,
"Glyloid 6C" A 3% aqueous solution in the range of 7 to 23% may be selected.

【００４８】（２−４）褥瘡用貼付剤の製法：褥瘡用貼
付剤を大量生産する場合、好ましい製法として、帯状に
供給される剥離シート上に白糖とＳＳＤと「グリロイド
６Ｃ」３％水溶液（粘稠性付与剤）とを混合した褥瘡用
薬剤層を所定の形状に連続してスクリーン印刷し、その
直後、剥離シートの印刷面を覆うように帯状の支持体を
張り合せ、張り合せた帯状物を所定の箇所で切断する方
法を挙げ得る。この方法によるときは、本発明の褥瘡用
貼付剤を大量、且つ、連続的に製造することが出来る。(2-4) Method for producing pressure ulcer patch: In the case of mass producing pressure ulcer patch, as a preferred method, sucrose, SSD and 3% aqueous solution of "Glyloid 6C" (on a release sheet supplied in strips) A pressure-sensitive agent layer mixed with a viscosity-imparting agent) is continuously screen-printed into a predetermined shape, and immediately after that, a belt-shaped support is laminated so as to cover the printed surface of the release sheet, and the laminated belt-shaped. A method of cutting an object at a predetermined place may be mentioned. According to this method, the patch for pressure ulcer of the present invention can be continuously manufactured in a large amount.

【００４９】（２−５）褥瘡用貼付剤を大量生産する製
法の構成例（イ）：図５は本発明の褥瘡用貼付剤の製法
の一実施例の構成を示す説明図である。図５に示す通
り、帯状の剥離シート１３に、平板状のスクリーン１４
の上方からスキージ１５で褥瘡用薬剤層を次々と印刷
し、その上に帯状の支持体１１をかぶせて、カッター１
６で褥瘡用薬剤間を切断して、褥瘡用貼付剤を得た。(2-5) Example of structure of manufacturing method for mass-producing patch for pressure ulcer (a): FIG. 5 is an explanatory view showing the structure of one example of the method for manufacturing the patch for pressure ulcer of the present invention. As shown in FIG. 5, a strip-shaped release sheet 13 and a flat screen 14
The squeegee 15 is used to print the pressure ulcer drug layer one after another from above, and the strip-shaped support 11 is placed on it to form the cutter 1.
The pressure ulcer drug was cut at 6 to obtain a pressure ulcer patch.

【００５０】（２−６）褥瘡用貼付剤を大量生産する製
法の構成例（ロ）：図６は本発明の褥瘡用貼付剤の製法
の別の実施例の構成を示す説明図である。図６に示す通
り、帯状の剥離シート２３にスクリーンドラム２４の上
方からスキージ２５で褥瘡用薬剤層を次々と印刷し、そ
の上に帯状の支持体２１をかぶせ、ダイロールカッター
２６で褥瘡用薬剤間を切断して褥瘡用貼付剤を得た。(2-6) Example of composition of manufacturing method for mass-producing patch for pressure ulcer (b): FIG. 6 is an explanatory view showing the structure of another embodiment of the method for manufacturing the patch for pressure ulcer of the present invention. As shown in FIG. 6, a belt-shaped release sheet 23 is sequentially printed with a squeegee 25 from above the screen drum 24 using a squeegee drug layer, a belt-shaped support 21 is covered thereon, and a die roll cutter 26 is used to treat the pressure ulcer agent. The space was cut to obtain a pressure ulcer patch.

【００５１】これら連続的生産にあっても、粘稠性付与
剤の一部は薬効成分を伴って支持体に浸透、移行するた
め、移行する量を予め勘案し、その分を増量して調製す
る。連続的生産の場合における褥瘡用薬剤層の好ましい
組成は、白糖５０〜８０％、ＳＳＤ１〜５％、「グリロ
イド６Ｃ」３％水溶液７〜２３％であり、更に好ましい
褥瘡用薬剤層の組成は、白糖７０％、ＳＳＤ２〜３％、
「グリロイド６Ｃ」３％水溶液１０〜２０％である。Even in these continuous productions, a part of the thickening agent permeates and transfers to the support together with the medicinal component, so the amount to be transferred is taken into consideration in advance and the amount is increased. To do. The preferred composition of the pressure ulcer drug layer in the case of continuous production is sucrose 50 to 80%, SSD 1 to 5%, and "Glyloid 6C" 3% aqueous solution 7 to 23%, and the more preferred composition of the pressure ulcer drug layer is 70% white sugar, 2-3% SSD,
"Glyloid 6C" is a 10% to 20% 3% aqueous solution.

【００５２】[0052]

【発明の効果】【The invention's effect】

（イ）白糖５０〜８０％、ＳＳＤ１〜５％、タマリンド
種子系多糖３％水溶液７〜２３％を含有する本発明の褥
瘡用薬剤組成物は、他の白糖を含有し類似する褥瘡用薬
剤に比較して、患部からの体液の滲出を減少せしめ、肉
芽形成を促進する効果において格段に優れている、(A) The pharmaceutical composition for pressure ulcer of the present invention containing 50 to 80% of sucrose, 1 to 5% of SSD, and 7 to 23% of 3% aqueous solution of tamarind seed-based polysaccharide is used as a similar drug for pressure ulcer containing sucrose. In comparison, the exudation of body fluid from the affected area is reduced, and it is remarkably excellent in the effect of promoting granulation.

【００５３】（ロ）本発明の褥瘡用薬剤は、支持体と、
該支持体上に形成された白糖とＳＳＤとタマリンド種子
系多糖水溶液とを混合した褥瘡用薬剤層と、該褥瘡用薬
剤層を被覆する剥離シートとを備えたものであり、施用
時には、剥離シートを剥して患部に貼付するだけで良い
と云う簡便さを有する。このため、施用処置を迅速に行
い被施用者の苦痛を著しく軽減することが出来る。ま
た、その取扱が容易で、看護に当たる者や薬剤の処方を
する者の労力は著しく低減される。(B) The pressure ulcer drug of the present invention comprises a support,
A pressure-sensitive agent layer for pressure ulcer, which is formed by mixing sucrose, SSD, and an aqueous solution of a tamarind seed-based polysaccharide formed on the support, and a release sheet for coating the pressure-sensitive agent layer for pressure ulcer, and the release sheet at the time of application. It has the convenience of simply peeling off and attaching it to the affected area. For this reason, it is possible to rapidly perform the application treatment and remarkably reduce the pain of the applied person. Moreover, the handling thereof is easy, and the labor of the person who cares and who prescribes the medicine is significantly reduced.

【００５４】（ハ）また、好ましい製法としては、帯状
に供給される剥離シート上に白糖とＳＳＤとタマリンド
種子系多糖水溶液とを混合した褥瘡用薬剤層を所定の形
状に連続してスクリーン印刷し、該剥離シートの印刷面
を覆うように帯状の支持体を張り合せ、該張り合せた帯
状物を所定の箇所で切断するものであるため、連続的に
製造することが出来、大量生産が可能となる。(C) As a preferred production method, a pressure ulcer drug layer, which is a mixture of sucrose, SSD and an aqueous solution of tamarind seed-based polysaccharide, is screen-printed continuously in a predetermined shape on a release sheet supplied in strips. Since a strip-shaped support is laminated so as to cover the printed surface of the release sheet and the laminated strip is cut at a predetermined position, continuous production is possible and mass production is possible. Becomes

【図面の簡単な説明】[Brief description of drawings]

【図１】ラットの背部に処置を施し作成した褥瘡モデル
の部位を示す模式図である。FIG. 1 is a schematic view showing the site of a pressure ulcer model created by treating the back of a rat.

【図２】試験薬剤組成物を投与後の各群における創面の
面積の減少、治癒状態を示す線図である。FIG. 2 is a diagram showing the reduction of the wound surface area and the healing state in each group after administration of the test drug composition.

【図３】創面の回復程度、創面の乾燥化の程度、創面に
おける肉芽形成の程度を示す三元軸図である。FIG. 3 is a ternary axis diagram showing the degree of recovery of the wound surface, the degree of drying of the wound surface, and the degree of granulation formation on the wound surface.

【図４】本発明の褥瘡用貼付剤の一実施例の構成を示す
説明図であり、（ａ）はその斜視図、（ｂ）はその断面
図である。FIG. 4 is an explanatory view showing the constitution of an embodiment of the patch for pressure ulcer of the present invention, (a) is a perspective view thereof, and (b) is a sectional view thereof.

【図５】本発明の褥瘡用貼付剤の製法の一実施例の構成
を示す説明図である。FIG. 5 is an explanatory view showing the constitution of an example of a method for producing the pressure ulcer patch of the present invention.

【図６】本発明の褥瘡用貼付剤の製法の別の実施例の構
成を示す説明図である。FIG. 6 is an explanatory view showing the constitution of another example of the method for producing the patch for pressure ulcer of the present invention.

───────────────────────────────────────────────────── フロントページの続き (51)Int.Cl.⁶ 識別記号 庁内整理番号 ＦＩ 技術表示箇所 Ａ６１Ｋ 31/635 ＡＤＺ Ａ６１Ｋ 31/635 ＡＤＺ Ｃ０７Ｄ 239/69 Ｃ０７Ｄ 239/69 (72)発明者 石黒 淳一 富山県富山市水橋畠等花井173−３ 大協 薬品工業株式会社内─────────────────────────────────────────────────── ─── Continuation of front page (51) Int.Cl. ⁶ Identification number Internal reference number FI Technical display location A61K 31/635 ADZ A61K 31/635 ADZ C07D 239/69 C07D 239/69 (72) Inventor Junichi Ishiguro 173-3 Hanai Mizuhashi Hatake, Toyama City, Toyama Prefecture Daikyo Pharmaceutical Co., Ltd.

Claims (3)

【特許請求の範囲】[Claims] 【請求項１】 支持体と、該支持体上に形成された白糖
とスルファジアジン銀とタマリンド種子多糖系粘稠性付
与剤とを含有する褥瘡用薬剤層と、該褥瘡用薬剤層を被
覆する剥離シートとを備えたことを特徴とする褥瘡用貼
付剤。1. A pressure ulcer drug layer containing a support, sucrose, silver sulfadiazine, and a tamarind seed polysaccharide-based viscosity-imparting agent formed on the support, and a peeling agent coating the pressure ulcer drug layer. A patch for pressure ulcer characterized by comprising a sheet. 【請求項２】 帯状に供給される剥離シート上に白糖と
スルファジアジン銀とタマリンド種子多糖系粘稠性付与
剤とを含有する褥瘡用薬剤層を所定の形状に連続してス
クリーン印刷し、該剥離シートの印刷面を覆うように帯
状の支持体を張り合せ、この張り合せた帯状物を所定の
箇所で切断することを特徴とする褥瘡用貼付剤の製法。2. A pressure-sensitive agent layer for pressure ulcer containing sucrose, silver sulfadiazine and a tamarind seed polysaccharide-based thickening agent is continuously screen-printed in a predetermined shape on a release sheet supplied in strips, and the release is performed. A method for producing a pressure ulcer patch, comprising laminating a belt-shaped support so as to cover a printing surface of a sheet, and cutting the laminated belt at a predetermined position. 【請求項３】 スクリーン印刷する褥瘡用薬剤層の組成
を、重量／容量比で白糖５０〜８０％、スルファジアジ
ン銀１〜５％、タマリンド種子多糖系粘稠性付与剤７〜
２３％を含有する組成とすることを特徴とする請求項２
に記載の褥瘡用貼付剤の製法。3. The composition of the pressure ulcer drug layer to be screen-printed has a weight / volume ratio of 50 to 80% sucrose, 1 to 5% silver sulfadiazine, and a tamarind seed polysaccharide thickener 7 to
A composition containing 23% is included.
The method for producing a patch for pressure ulcer according to [4].