JP2002226381A - Preparation for wound treatment - Google Patents
Preparation for wound treatmentInfo
- Publication number
- JP2002226381A JP2002226381A JP2001022924A JP2001022924A JP2002226381A JP 2002226381 A JP2002226381 A JP 2002226381A JP 2001022924 A JP2001022924 A JP 2001022924A JP 2001022924 A JP2001022924 A JP 2001022924A JP 2002226381 A JP2002226381 A JP 2002226381A
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- Prior art keywords
- preparation
- iodine
- formulation examples
- content
- gum
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Description
【０００１】[0001]
【発明の属する技術分野】本発明は皮膚・粘膜における
限局性の組織欠損、やけど、傷、床ずれ等創傷の治療に
用いる安定な製剤に関する。BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a stable preparation for use in treating localized tissue defects in the skin and mucous membranes, burns, wounds, bedsores and other wounds.
【０００２】[0002]
【従来の技術】従来から、床ずれ治療用製剤の一つとし
て、白糖とポビドンヨードを院内製剤として調剤し、投
与する例が知られている。しかしこの院内製剤は安定性
が悪く用時調製する必要があると共に、調剤に手間がか
かり、長期間の保存や使用には不適当であった。これを
改善するものとして、白糖とポビドンヨードを、水、緩
衝剤およびある種の多糖類（保形剤）と共に軟膏剤とす
る技術が提案され（特公平１−３２２１０号公報）、実
用化されている。2. Description of the Related Art It has been known that sucrose and povidone-iodine are prepared and administered as in-hospital preparations as one of the preparations for treating bedsores. However, this in-hospital formulation is inferior in stability and must be prepared at the time of use, and requires a lot of preparation, and is unsuitable for long-term storage and use. In order to improve this, a technique has been proposed in which sucrose and povidone-iodine are used as an ointment together with water, a buffer and certain polysaccharides (shape preservatives) (Japanese Patent Publication No. 1-302210) and put into practical use. I have.
【０００３】その後、緩衝剤を用いずに安定化させた軟
膏剤が提案され（特開２０００−３８３４２号公報）後
発医薬品として実用化されている。白糖とポビドンヨー
ドを有効成分とする褥瘡・皮膚潰瘍治療用製剤を開示し
た公知例としては、軟膏について特公平１−３２２１０
号公報の他に特開平９−４０５６３号公報、特開平１１
−１００３２３号公報、特開２０００−３８３４２号公
報があり、また粉末状の製剤即ち散剤について、特開平
８−１２５８２号公報および特開平９−１６９６５５号
公報がある。[0003] Thereafter, an ointment stabilized without using a buffer was proposed (JP-A-2000-38342) and has been put to practical use as a generic drug. As a known example of a preparation for treating pressure ulcers and skin ulcers containing sucrose and povidone-iodine as active ingredients, Japanese Patent Publication No.
JP-A-9-40563, JP-A-9-40563
There are JP-A-100323 and JP-A-2000-38342, and there are JP-A-8-12582 and JP-A-9-169655 regarding powdery preparations, that is, powders.
【０００４】軟膏剤の場合、患部に適用する際多くはガ
ーゼ等に展延、塗布し使用されるが、現在市販されてい
る軟膏剤はガーゼ等に展延、塗布するには硬く伸展性が
悪いため展延、塗布しにくい、均一に展延、塗布できな
い、使用量を一定にできない等の問題がある。このこと
は特に薬剤の取り扱いに不慣れな在宅における介護者が
取り扱う場合は大きな問題となる。さらに軟膏を不織布
等の基布またはフィルム上に展延することも可能である
が、この場合でもポケット状の創部への適用が難しい、
べたつくなど治療上および取り扱い上の問題がある。[0004] In the case of ointments, most of them are spread on gauze or the like when applied to the affected area and used. However, currently marketed ointments are spread on gauze or the like and are hard and extensible for application. There are problems such as poor spreading and application, poor uniform spreading and application, and inconsistent usage. This poses a significant problem, especially when handled by caregivers at home who are unfamiliar with handling drugs. It is also possible to spread the ointment on a base cloth or film such as a non-woven fabric, but even in this case, it is difficult to apply to a pocket-shaped wound,
There are therapeutic and handling problems such as stickiness.
【０００５】一方、粉末状の製剤即ち散剤の場合、患部
またはガーゼ等にふりかけるため周囲に粉末が飛び散り
易く、無駄が生じる、軟膏同様使用量を一定にできない
等の問題がある。また軟膏剤および散剤は患部の滲出液
によって短時間で流れ落ちてしまったり、ガーゼ等にし
みこんでしまうため製剤の使用量を必要以上に多く使用
されることもあり臨床上好ましくない。これらの点は特
に在宅においては問題となる。[0005] On the other hand, in the case of a powdery preparation, ie, a powder, there are problems such that the powder is easily scattered around the affected part or gauze due to sprinkling on the affected part or gauze, causing waste, and the amount of use cannot be kept constant like an ointment. In addition, ointments and powders run down in a short period of time due to exudate from the affected area, or soak in gauze or the like, so that the use amount of the preparation may be used more than necessary, which is not clinically preferable. These points are especially problematic at home.
【０００６】[0006]
【発明が解決しようとする課題】本発明の目的は上記し
た従来技術の問題点を解決することにある。特に治療上
においては創部の滲出液により短時間で流れ落ちること
がなく、治療上問題となるポケット状の創部にも使用可
能であり、患部に必要量を均一に適用可能であり、また
使用上においては使用直前に介護者がガーゼに展延、塗
布する必要がなく、簡便に使用でき、周囲を汚染するこ
とのない製剤を提供するという治療上および使用上の両
面で優れた効果をもつポビドンヨード・白糖系製剤を提
供することにある。SUMMARY OF THE INVENTION An object of the present invention is to solve the above-mentioned problems of the prior art. Especially on treatment, it does not flow down in a short time due to the exudate of the wound, it can be used for pocket-shaped wounds that are a problem in treatment, it is possible to apply the required amount uniformly to the affected area, and Povidone-iodine, which has an excellent therapeutic and use effect, provides a formulation that is easy to use and does not contaminate the surroundings, without requiring caregivers to spread and apply the gauze immediately before use. It is to provide a sucrose-based preparation.
【０００７】[0007]
【課題を解決するための手段】本発明は糖類及びヨード
ホールを必須成分として含有すると共に、テクスチャー
アナライザーによる２３℃、６５％ＲＨにおける硬度が
１０００〜５００００ｇの範囲にあり、かつスプレッド
メーターによる伸展性試験における４０℃での直径が２
５ｍｍ以下である組成物の成形体からなることを特徴と
する創傷治療用製剤である。本発明の創傷治療用製剤は
皮膚・粘膜における限局性の組織欠損、やけど、傷、床
ずれ等の治療、特に在宅での治療に極めて有用なもので
ある。The present invention contains saccharides and iodine as essential components, has a hardness at 23 ° C. and 65% RH measured by a texture analyzer in the range of 1,000 to 50,000 g, and has an extensibility measured by a spread meter. The diameter at 40 ° C in the test is 2
A wound treatment preparation comprising a molded product of a composition having a size of 5 mm or less. The preparation for treating wounds of the present invention is extremely useful for treating localized tissue defects in the skin and mucous membranes, burns, wounds, bedsores, and the like, particularly for treatment at home.
【０００８】[0008]
【発明の実施の形態】本発明の創傷治療用製剤は糖類お
よびヨードホールを必須成分とするものであり、これら
の成分は従来から知られている適宜のものを用いうる。
糖類としては、ヨードホール中のヨウ素を安定に保つた
めに、非還元性の糖が望ましい。例えば、ショ糖、トレ
ハロース、グルコン酸、ソルビトール、デキストリン等
があげられる。糖類の含有量は通常５０〜９０ｗ／ｗ％
であり、特に６０〜８０ｗ／ｗ％が好ましい。BEST MODE FOR CARRYING OUT THE INVENTION The preparation for treating wounds of the present invention contains saccharides and iodophor as essential components, and these components may be any of those conventionally known.
As the saccharide, a non-reducing saccharide is desirable in order to stably maintain iodine in the iodohole. For example, sucrose, trehalose, gluconic acid, sorbitol, dextrin and the like can be mentioned. Sugar content is usually 50-90% w / w%
And particularly preferably 60 to 80 w / w%.
【０００９】ヨードホールとしては、ヨウ素とポリビニ
ルピロリドンの複合体であるポビドンヨードや、ヨウ素
とポリデキストロースの複合体等があげられる。ヨード
ホールの含有量は通常０．５〜１０ｗ／ｗ％であり、特
に１〜６ｗ／ｗ％が好ましい。[0009] Examples of the iodine hole include povidone iodine which is a complex of iodine and polyvinylpyrrolidone, and a complex of iodine and polydextrose. The content of iodohole is usually 0.5 to 10 w / w%, and particularly preferably 1 to 6 w / w%.
【００１０】本発明ではこれらの必須成分を含有すると
共に、テクスチャーアナライザーによる２３℃、６５％
ＲＨにおける硬度が１０００〜５００００ｇでかつスプ
レッドメーターによる４０℃における伸展性の試験を行
ったときその直径が２５ｍｍ以下である組成物即ち膏体
をシートを典型例とする成形体にすることを要する。テ
クスチャーアナライザーによる２３℃、６５％ＲＨにお
ける硬度は１０００〜５００００ｇであることを要し、
特に３０００〜３００００ｇであることが好ましい。ス
プレッドメーターによる４０℃における伸展性は直径２
５ｍｍ以下であることを要し、特に２０ｍｍ以下である
ことが好ましい。In the present invention, these essential components are contained, and at 23 ° C., 65%
A composition having a hardness at RH of 1,000 to 50,000 g and a diameter of 25 mm or less when a test for extensibility at 40 ° C. is carried out by a spread meter, that is, a plaster is required to be formed into a molded product having a sheet as a typical example. The hardness at 23 ° C. and 65% RH by a texture analyzer needs to be 1000 to 50,000 g,
In particular, it is preferably 3000 to 30000 g. Extensibility at 40 ° C with a spread meter is 2 mm in diameter
It needs to be 5 mm or less, and particularly preferably 20 mm or less.
【００１１】本発明の製剤は、上記した要件を満足した
上で、さらに天然ガム及び多価アルコールを含有するこ
とが望ましく、これらの配合により安定性が一層向上す
る。天然ガムとしては、アルギン酸ナトリウム、キサン
タンガム、アラビアゴム、トラガントガム、カラヤガ
ム、ローカストビーンガム等があげられるが、特にアル
ギン酸ナトリウム、キサンタンガム、アラビアゴムが好
ましい。天然ガムは単独で用いても、２種以上を併用し
てもよい。天然ガムの含有量は通常０．５〜１０ｗ／ｗ
％、好ましくは０．７〜５ｗ／ｗ％、さらに好ましくは
０．９〜３ｗ／ｗ％である。The preparation of the present invention desirably satisfies the above-mentioned requirements and further contains a natural gum and a polyhydric alcohol, and the combination thereof further improves the stability. Examples of natural gums include sodium alginate, xanthan gum, gum arabic, tragacanth gum, karaya gum, locust bean gum and the like, with sodium alginate, xanthan gum and gum arabic being particularly preferred. Natural gums may be used alone or in combination of two or more. The content of natural gum is usually 0.5 to 10 w / w.
%, Preferably 0.7 to 5 w / w%, more preferably 0.9 to 3 w / w%.
【００１２】多価アルコールとしては、濃グリセリン、
グリセリン、プロピレングリコール、１．３ブタンジオ
ール等があげられる。多価アルコールの含有量は通常１
０〜５０ｗ／ｗ％、好ましくは１３〜３０ｗ／ｗ％、さ
らに好ましくは１５〜２５ｗ／ｗ％である。As the polyhydric alcohol, concentrated glycerin,
Glycerin, propylene glycol, 1.3 butanediol and the like can be mentioned. The content of polyhydric alcohol is usually 1
0 to 50 w / w%, preferably 13 to 30 w / w%, more preferably 15 to 25 w / w%.
【００１３】本発明の製剤には必要に応じ製剤学上許容
される適宜の添加成分を配合することができる。これら
の任意成分としては、製剤学上通常用いられる基剤、添
加剤、溶剤等がある。具体的には例えば親水性軟膏や吸
水性軟膏をはじめとする乳剤性基剤、ポリエチレングリ
コール等の水溶性基剤、高級アルコール等の油脂性基
剤、メチルセルロース、エチルセルロース、カルボキシ
メチルセルロース、ヒドロキシプロピルセルロース、ヒ
ドロキシプロピルメチルセルロース、ポリアクリル酸、
ポリビニルアルコール等の水溶性高分子、ポロクサマ
ー、ポリオキシエチレンアルキルエーテル類、ポリオキ
シエチレン硬化ヒマシ油類、ポリオキシエチレンソルビ
タン脂肪酸エステル類、ラウリル硫酸ナトリウム、四級
アンモニウム塩、水添レシチン等の乳化剤、ヨウ化カリ
ウム等の安定化剤、低級アルコール等の溶剤等があげら
れる。これら任意成分の量は通常３０ｗ／ｗ％以下であ
る。The preparation of the present invention may contain, if necessary, pharmaceutically acceptable additives. These optional components include bases, additives, solvents and the like which are usually used in pharmacology. Specifically, for example, emulsion bases such as hydrophilic ointments and water-absorbing ointments, water-soluble bases such as polyethylene glycol, oily bases such as higher alcohols, methylcellulose, ethylcellulose, carboxymethylcellulose, hydroxypropylcellulose, Hydroxypropyl methylcellulose, polyacrylic acid,
Water-soluble polymers such as polyvinyl alcohol, poloxamers, polyoxyethylene alkyl ethers, polyoxyethylene hydrogenated castor oils, polyoxyethylene sorbitan fatty acid esters, sodium lauryl sulfate, quaternary ammonium salts, emulsifiers such as hydrogenated lecithin, Examples thereof include stabilizers such as potassium iodide and solvents such as lower alcohols. The amount of these optional components is usually 30% w / w or less.
【００１４】本発明の製剤においては水は実質上存在さ
せないことが望ましく、より具体的には水の含有量は１
ｗ／ｗ％以下であることが望ましい。本発明の製剤は基
本的にはｐＨ調節を要しないが、必要に応じ、塩酸、水
酸化ナトリウム、水酸化カリウム、炭酸水素ナトリウ
ム、クエン酸、乳酸等のｐＨ調整剤を用いて、ｐＨの調
整を行うこともできる。In the preparation of the present invention, it is desirable that substantially no water is present, and more specifically, the water content is 1%.
It is desirable that the ratio be w / w% or less. The formulation of the present invention basically does not require pH adjustment, but if necessary, pH adjustment using a pH adjuster such as hydrochloric acid, sodium hydroxide, potassium hydroxide, sodium hydrogen carbonate, citric acid, lactic acid, etc. Can also be performed.
【００１５】本発明の製剤は成形体であることを要す
る。成形体の製造は、上記した成分と硬度および伸展性
の要件を満足する組成物を所定形状に賦型するだけで十
分である。かくして自己支持性のある適度の硬さと粘性
をもつ成形体が得られる。The preparation of the present invention needs to be a molded article. In the production of a molded article, it is sufficient to mold a composition satisfying the above-mentioned components and the requirements of hardness and extensibility into a predetermined shape. In this way, a self-supporting molded article having appropriate hardness and viscosity is obtained.
【００１６】成形体の形状としてシート形状、球状形
状、棒状形状等がある。シートの場合、厚さは０．５〜
５ｍｍ程度が一般的である。大きさの例としては一辺が
２〜２０ｃｍの四角形のシートを例示できる。体積でみ
ると、０．５〜２００ｃｍ3 程度が一般的である。また
より大きい成形体、即ちシートの場合はより表面積が大
きいもの、棒状体の場合はより長いものをつくり、使用
時に必要な大きさに切断して用いることも可能である。The shape of the molded product includes a sheet shape, a spherical shape, a rod shape and the like. In the case of a sheet, the thickness is 0.5 ~
About 5 mm is common. As an example of the size, a square sheet having a side of 2 to 20 cm can be exemplified. The volume is generally about 0.5 to 200 cm 3 . Also, it is possible to make a larger molded body, that is, a sheet having a larger surface area, and a rod-shaped body having a longer surface, and cut it into a necessary size for use.
【００１７】これら成形体は不織布等の基布やフィルム
等の支持体に支持させることも可能だが、通常は剥離性
フィルム間に挟持する等の一時保護部材で保護してお
き、使用時にこれらから成形体を分離して使用に供され
る。本発明の創傷治療用製剤は、軟膏、散剤のように使
用直前に展延、塗布する必要がなく、患部に必要量を均
一に適用でき周囲を汚染することがない。また治療中最
適の湿潤状態を保持できる。即ち患部に適用することに
より、経時的に滲出液によって適度に軟化変形し、長時
間最適の治療状態を維持できる。These molded products can be supported on a base material such as a nonwoven fabric or a support such as a film. However, they are usually protected by a temporary protective member such as being sandwiched between peelable films, so that they can be protected from these during use. The molded body is separated for use. The preparation for treating wounds of the present invention does not need to be spread and applied immediately before use as in ointments and powders, and the required amount can be uniformly applied to the affected part, and the surroundings are not contaminated. Also, the optimal wet state can be maintained during the treatment. That is, by being applied to the affected area, the softening and deformation can be appropriately performed by the exudate with time, and the optimal treatment state can be maintained for a long time.
【００１８】[0018]
【実施例】１．膏体（組成物）の製造 濃グリセリンに処方量の天然ガムを加え、別に処方外の
精製水にヨウ化カリウムを溶かし、濃グリセリンおよび
天然ガムに加え混合した。その後、水分を減圧留去しポ
ビドンヨード、白糖を加え混合し、表１記載の本発明の
処方例２および３の膏体を得た。濃グリセリンに処方量
の天然ガムを加え、別に処方量の精製水にヨウ化カリウ
ムを溶かし、濃グリセリンおよび天然ガムに加え混合し
た。その後、ポビドンヨード、白糖を加え混合し、表１
記載の本発明の処方例１および４、５の膏体を得た。DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Manufacture of plaster (composition) A prescribed amount of natural gum was added to concentrated glycerin, potassium iodide was dissolved in purified water separately, and added to concentrated glycerin and natural gum. Thereafter, water was distilled off under reduced pressure, and povidone iodine and sucrose were added and mixed to obtain plasters of Formulation Examples 2 and 3 of the present invention shown in Table 1. The prescribed amount of natural gum was added to the concentrated glycerin, and potassium iodide was dissolved in purified water of the prescribed amount separately, and added to the concentrated glycerin and the natural gum and mixed. Then, povidone-iodine and sucrose were added and mixed.
The plasters of Formulation Examples 1, 4 and 5 of the invention described were obtained.
【００１９】[0019]
【表１】 [Table 1]
【００２０】処方として、ポビドンヨード及び白糖を必
須成分とする市販の軟膏剤であるユーパスタコーワ（興
和新薬（株））（比較処方例１）及びスクロードパスタ
（共和薬品工業（株））（比較処方例２）を用い、さら
に比較処方例３、４を調製した。As prescriptions, commercially available ointments containing povidone-iodine and sucrose as essential components, Eupasta Kowa (Kowa Shinyaku Co., Ltd.) (Comparative Prescription Example 1) and Scroll Pasta (Kyowa Pharmaceutical Co., Ltd.) (Comparative Prescription) Using Example 2), Comparative Formulation Examples 3 and 4 were further prepared.
【００２１】[0021]
【表２】 [Table 2]
【００２２】２．硬度の測定 本発明の製剤を製造するための膏体の硬度を明らかにす
る目的で、処方例１〜５、比較処方例１〜４について次
の実験を行った。膏体（処方例１〜５）２００ｇを胴径
５５ｍｍ、高さ９５ｍｍのマヨネーズビンに入れテクス
チャーアナライザー（Ｔｅｘｔｕｒｅ Ａｎａｌｙｓｅ
ｒ： ＳＭＳ）を用い２３℃、６５％ＲＨの条件下で直
径１ｃｍのプローブを０．３ｍｍ／ｓの速さで試料に進
入させた。それぞれの試料についてプローブの進入距離
が１ｃｍになったときの荷重（ｇ）を測定し膏体の硬度
とした。また比較処方例１〜４については２３℃、６５
％ＲＨで３０回攪拌後実施例１および２で製造した膏体
（処方例１〜５）と同様に測定した。その結果（ｎ＝３
の平均値）を表３および４に示す。2. Measurement of Hardness For the purpose of clarifying the hardness of the plaster for producing the preparation of the present invention, the following experiments were performed on Formulation Examples 1 to 5 and Comparative Formulation Examples 1 to 4. 200 g of the plaster (formulation examples 1 to 5) was placed in a mayonnaise bottle having a body diameter of 55 mm and a height of 95 mm, and a texture analyzer (Texture Analysis) was used.
r: SMS), a probe having a diameter of 1 cm was allowed to enter the sample at a speed of 0.3 mm / s under the conditions of 23 ° C. and 65% RH. With respect to each sample, the load (g) when the approach distance of the probe became 1 cm was measured and defined as the hardness of the plaster. 23 ° C., 65
After stirring at 30% RH for 30 times, it was measured in the same manner as in the plasters prepared in Examples 1 and 2 (Formulation Examples 1 to 5). As a result (n = 3
Are shown in Tables 3 and 4.
【００２３】[0023]
【表３】 [Table 3]
【００２４】[0024]
【表４】 [Table 4]
【００２５】３．伸展性の測定 本発明の製剤を製造するための膏体の保形性、伸展性を
明らかにする目的で、処方例１〜５および比較処方例１
〜４について次の実験を行った。製造後２４時間以上経
過した本発明の膏体（処方例１〜５）および各軟膏剤
（比較処方例１〜４）について４０℃で保温した試料を
３０回攪拌した。この試料をスプレッドメーターの試料
孔に充填し４０℃で試験を行った。また評価は広がった
膏体の直径を測定することで保形性、伸展性の評価を行
った。その結果を表５および６に示す。3. Measurement of Extensibility In order to clarify the shape retention and extensibility of the plaster for producing the preparation of the present invention, Formulation Examples 1 to 5 and Comparative Formulation Example 1
The following experiment was performed for 〜4. A sample kept at 40 ° C. for the plaster of the present invention (Formulation Examples 1 to 5) and each ointment (Comparative Formulation Examples 1 to 4) which had passed for 24 hours or more after production was stirred 30 times. This sample was filled in a sample hole of a spread meter and tested at 40 ° C. In addition, the shape retention and extensibility were evaluated by measuring the diameter of the spread plaster. The results are shown in Tables 5 and 6.
【００２６】[0026]
【表５】 [Table 5]
【００２７】[0027]
【表６】 [Table 6]
【００２８】上記の測定結果から明らかなように本発明
の膏体（処方例１〜５）は軟膏剤（比較処方例１〜４）
に比べ２３℃における硬さは硬く、軟膏剤のような伸展
性をほとんど示さず、また製造後の形状変化はほとんど
なく保形性に優れていることがわかった。As is clear from the above measurement results, the plaster of the present invention (Formulation Examples 1 to 5) is an ointment (Comparative Formulation Examples 1 to 4).
The hardness at 23 ° C. was harder than that of Comparative Example 1 and hardly exhibited extensibility like an ointment, and it was found that there was almost no change in shape after production and the shape retention was excellent.
【００２９】４．ポビドンヨードの安定性 本発明の膏体（処方例１〜５）中ポビドンヨードの安定
性を明らかにする目的で、処方例１〜５および比較処方
例１〜４について次の実験を行った。有効成分の一つで
あるポビドンヨードの安定性を評価するために、処方例
１〜５の膏体および比較処方例１〜４を６０℃で保存
し、１１日後に有効ヨウ素の含量を定量した。また試験
開始前の含量から残存率を算出した。その結果を表７お
よび８に示す。4. Stability of Povidone-Iodine In order to clarify the stability of povidone-iodine in the plaster of the present invention (Formulation Examples 1 to 5), the following experiments were performed for Formulation Examples 1 to 5 and Comparative Formulation Examples 1 to 4. In order to evaluate the stability of povidone-iodine, which is one of the active ingredients, the plasters of Formulation Examples 1 to 5 and Comparative Formulation Examples 1 to 4 were stored at 60 ° C., and the content of effective iodine was quantified after 11 days. The residual ratio was calculated from the content before the start of the test. The results are shown in Tables 7 and 8.
【００３０】[0030]
【表７】 [Table 7]
【００３１】[0031]
【表８】 [Table 8]
【００３２】６０℃１１日間における本発明の膏体（処
方例１〜５）中ポビドンヨードの安定性は市販軟膏剤、
比較処方例３および４に比べ明らかに改善されており、
安定性においても本発明品は優れていた。The stability of povidone-iodine in the ointment of the present invention (Formulation Examples 1 to 5) at 60 ° C. for 11 days was determined by using a commercially available ointment,
It is clearly improved as compared with Comparative Formulation Examples 3 and 4,
The product of the present invention was also excellent in stability.
【００３３】５．成形体 処方例１〜５の膏体および比較処方例１〜４の軟膏剤を
７０℃に加温し、シート状または棒状の製剤を作製し
た。製造後２４時間室温放置した製剤を室温で約１１４
ｇのガラス板で荷重をかけ形状の変化を観察した。その
結果を表９に示す。5. Molded articles The plasters of Formulation Examples 1 to 5 and the ointments of Comparative Formulation Examples 1 to 4 were heated to 70 ° C to prepare sheet-like or rod-like preparations. The preparation was left at room temperature for 24 hours after production,
A change in shape was observed by applying a load to the glass plate of g. Table 9 shows the results.
【００３４】[0034]
【表９】 [Table 9]
【００３５】処方例１〜５によって製した製剤は形状の
変化は観察されなかったが、比較処方例１〜４によって
製造した製剤は製造時の形状を維持することはできなか
った。処方例１〜５によって製造したシート状製剤の場
合、剥離性フィルムの剥がれもよく形状の変化は見られ
なかったが、比較処方例１〜４によってシート状の製剤
に製したものは剥離フィルムにくっついてしまい形状を
保つことができなくシート状の製剤とすることはできな
かった。また比較処方例１〜４によって製造した棒状の
製剤もシート状製剤と同様に製造時の形状を保つことは
できなかった。No change in the shape was observed in the preparations produced by Prescription Examples 1 to 5, but the preparations produced by Comparative Preparative Examples 1 to 4 could not maintain the shape at the time of production. In the case of the sheet-form preparations manufactured by Formulation Examples 1 to 5, the release film was well peeled and no change in shape was observed. It could not keep the shape because of sticking and could not be made into a sheet-like preparation. Also, the rod-shaped preparations produced according to Comparative Formulation Examples 1 to 4 could not maintain the shape at the time of production like the sheet-shaped preparations.
【００３６】６．使用 本発明の処方例１〜５の膏体から製造したシートを患部
に適用したところ、患部の滲出液との相互作用により適
度に軟化・変形していき、最適の治療効果を示した。6. Use When the sheets produced from the plasters of Formulation Examples 1 to 5 of the present invention were applied to the affected area, they were appropriately softened and deformed due to the interaction with the exudate of the affected area, and showed an optimal therapeutic effect.
フロントページの続き (51)Int.Cl.7 識別記号 ＦＩ テーマコート゛(参考） Ａ６１Ｋ 47/36 Ａ６１Ｋ 47/36 Ａ６１Ｐ 17/02 Ａ６１Ｐ 17/02 Ｆターム(参考） 4C076 AA71 BB31 CC18 DD38 EE23 EE30 EE36 FF12 FF17 FF36 4C086 AA01 AA02 EA01 HA09 MA02 MA03 MA04 MA05 MA32 MA63 NA03 NA10 ZA89 Continued on the front page (51) Int.Cl. 7 Identification symbol FI Theme coat II (reference) A61K 47/36 A61K 47/36 A61P 17/02 A61P 17/02 F term (reference) 4C076 AA71 BB31 CC18 DD38 EE23 EE30 EE36 FF12 FF17 FF36 4C086 AA01 AA02 EA01 HA09 MA02 MA03 MA04 MA05 MA32 MA63 NA03 NA10 ZA89
Claims (6)
含有すると共に、テクスチャーアナライザーによる２３
℃、６５％ＲＨにおける硬度が１０００〜５００００ｇ
の範囲にあり、かつスプレッドメーターによる伸展性試
験における４０℃での直径が２５ｍｍ以下である組成物
の成形体からなることを特徴とする創傷治療用製剤。1. It contains sugar and iodine as essential components and has a texture analyzer.
Hardness at 1000C and 65% RH is 1000 to 50000 g
And a molded product of a composition having a diameter at 40 ° C. of 25 mm or less in a spreadability test using a spread meter.
１記載の製剤。2. The preparation according to claim 1, wherein the molded article has a sheet shape.
る請求項１または２記載の製剤。3. The preparation according to claim 1, which comprises a polyhydric alcohol and a natural gum.
ードホールの含有量が０．５〜１０ｗ／ｗ％、多価アル
コールの含有量が１０〜５０ｗ／ｗ％、天然ガムの含有
量が０．５〜１０ｗ／ｗ％である請求項３記載の製剤。4. A saccharide content of 50 to 90 w / w%, an iodohole content of 0.5 to 10 w / w%, a polyhydric alcohol content of 10 to 50 w / w%, and a natural gum content The formulation according to claim 3, wherein the amount is 0.5 to 10 w / w%.
ずれか１項記載の製剤。5. The preparation according to claim 1, which contains substantially no water.
ビアゴムまたはキサンタンガムである請求項３〜５のい
ずれか１項記載の製剤。6. The preparation according to any one of claims 3 to 5, wherein the natural gum is sodium alginate, gum arabic or xanthan gum.
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| JP2001022924A JP4841733B2 (en) | 2001-01-31 | 2001-01-31 | Wound treatment formulation |
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|---|---|---|---|
| JP2001022924A JP4841733B2 (en) | 2001-01-31 | 2001-01-31 | Wound treatment formulation |
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|---|---|
| JP2002226381A true JP2002226381A (en) | 2002-08-14 |
| JP4841733B2 JP4841733B2 (en) | 2011-12-21 |
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Cited By (6)
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| WO2004011032A1 (en) * | 2002-07-26 | 2004-02-05 | Mikasa Seiyaku Co., Ltd. | External preparation |
| WO2004043473A1 (en) * | 2002-11-11 | 2004-05-27 | Kowa Co., Ltd. | Composition for restoring damaged skin |
| WO2004078186A1 (en) * | 2003-03-04 | 2004-09-16 | Kowa Co., Ltd. | Ointment preparation for repairing injured skin |
| CN102885852A (en) * | 2012-10-23 | 2013-01-23 | 武汉迪奥药业有限公司 | Povidone iodine ointment and preparation method thereof |
| JP2015516189A (en) * | 2012-03-21 | 2015-06-11 | フォンダツィオーネ・イスティトゥート・イタリアーノ・ディ・テクノロジャＦｏｎｄａｚｉｏｎｅ Ｉｓｔｉｔｕｔｏ Ｉｔａｌｉａｎｏ Ｄｉ Ｔｅｃｎｏｌｏｇｉａ | Polymer composites having antibacterial and biodegradable properties and uses thereof |
| JP2018535267A (en) * | 2015-11-24 | 2018-11-29 | エルジー ハウスホールド アンド ヘルスケア リミテッド | Formulation for attachment to teeth or teeth |
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| JP2018535267A (en) * | 2015-11-24 | 2018-11-29 | エルジー ハウスホールド アンド ヘルスケア リミテッド | Formulation for attachment to teeth or teeth |
| JP7023852B2 (en) | 2015-11-24 | 2022-02-22 | エルジー ハウスホールド アンド ヘルスケア リミテッド | Formulation for adhering to the tooth or the periphery of the tooth |
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