JP2640681B2 - Bandage plaster containing chlorhexidine gluconate and its production method - Google Patents
Bandage plaster containing chlorhexidine gluconate and its production methodInfo
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- JP2640681B2 JP2640681B2 JP63225839A JP22583988A JP2640681B2 JP 2640681 B2 JP2640681 B2 JP 2640681B2 JP 63225839 A JP63225839 A JP 63225839A JP 22583988 A JP22583988 A JP 22583988A JP 2640681 B2 JP2640681 B2 JP 2640681B2
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- plaster
- macrogol
- chlorhexidine gluconate
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- weight
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- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Compositions Of Macromolecular Compounds (AREA)
Description
【発明の詳細な説明】 産業上の利用分野 本発明は、抗菌力に優れたグルコン酸クロルヘキシジ
ン微粉末入りばんそう膏に関する。Description: TECHNICAL FIELD The present invention relates to a plaster containing chlorhexidine gluconate fine powder having excellent antibacterial activity.
従来の技術 従来、ばんそう膏に消毒、殺菌性および炎症防止効果
等を付与するために、マーキユロクロム水溶液当はアク
リノール等を担持させた特殊ばんそう膏が製造されてい
る(特公昭39−19718号、特公昭59−13864号)。2. Description of the Related Art Conventionally, in order to impart disinfecting, bactericidal, and anti-inflammatory effects to a bandage plaster, a special bandage plaster loaded with acrinol or the like has been produced for an aqueous solution of macchiurochrome (Japanese Patent Publication No. 39-19718). No. 59-13864).
発明が解決しようとする問題点 上記のマーキユロクロム入りばんそう膏では、マーキ
ユロクロムの放出が十分行われず、殺菌消毒効果、炎症
防止効果等が十分に発揮されないという欠点があった。
マーキユロクロムの含有量を高めて放出量を多くすれ
ば、抗菌性は増強される。しかし、マーキユロクロムが
1%を超えると成分量、水及びアルコールの量が増加し
て、ばんそう膏本来の品質、性状、粘着力等が規格をは
ずれ、等に経時変化も早くなるので、実用性がない。ま
た、マーキユロクロムはグラム陰性菌には抗菌性がある
が、黄色ブドウ球菌等のグラム陽性菌に対しては抗菌力
がない。Problems to be Solved by the Invention The above-mentioned plaster containing macchiurochrome has a drawback that the macchiurochrome is not sufficiently released, and the bactericidal effect, the anti-inflammatory effect and the like are not sufficiently exhibited.
The antimicrobial activity is enhanced by increasing the amount of markurochrome and increasing the release. However, when the amount of macchiurochrome exceeds 1%, the amount of ingredients, the amount of water and alcohol increases, and the original quality, properties, adhesive strength, etc. of the plaster fall off of the standard, and the change over time becomes faster, so that it is practical. There is no. In addition, although marquiurochrome has antibacterial activity against Gram-negative bacteria, it has no antibacterial activity against Gram-positive bacteria such as Staphylococcus aureus.
また、アクリノール入りばんそう膏は、黄色ブドウ球
菌等のグラム陽性菌に対して抗菌力を有するが、緑濃菌
などのグラム陰性菌に対しては抗菌力がない。Further, a bandage plaster containing acrinol has an antibacterial activity against Gram-positive bacteria such as Staphylococcus aureus, but does not have an antibacterial activity against Gram-negative bacteria such as green bacterium.
一方、グルコン酸クロルヘキシジンは(以下、GCHと
略称するとがある)は広範囲の微生物に作用する殺菌消
毒性を有することが知られており、水に溶解し易いた
め、その20%水溶液は日局に収載され、殺菌消毒液に、
また軟膏、クリーム、硬膏剤に添加して用いられてい
る。GCHを無水物の形体で用いた例はない。かかるGCH液
をばんそう膏に混和した場合、その80%は水分であるた
め、ばんそう膏剤の粘着力等の特性が著しく損われ、商
品性に難点があつた。これを解決するには20%液を濃縮
し水分を少なくすれば特性が維持できるが、残存水分の
ため、GCHが水分共存のもとに膏体成分分子間に強固に
保持され、系外に放出しにくくなり、実用性のある殺菌
消毒効果を発揮することが困難であつた。また無水物の
市販品はないので、20%GCH液を蒸発乾固しても、飴様
塊状物となるに止まり、分散性のよい粉末体を得るに至
らなかった。On the other hand, chlorhexidine gluconate (hereinafter, abbreviated as GCH) is known to have a bactericidal and disinfecting effect on a wide range of microorganisms and is easily dissolved in water. Listed on the disinfectant,
It is also used in ointments, creams and plasters. There is no example of using GCH in anhydrous form. When such a GCH solution is mixed with a plaster, 80% of the water is water, so that the properties such as the adhesive force of the plaster are significantly impaired, and there is a problem in commercialization. To solve this problem, the characteristics can be maintained by concentrating the 20% solution and reducing the water content.However, due to residual water, GCH is firmly held between the plaster component molecules in the presence of water, It has been difficult to release them, and it has been difficult to exhibit a practical sterilizing and disinfecting effect. In addition, since there is no commercially available anhydrous product, even if the 20% GCH solution was evaporated to dryness, the product only turned into a candy-like mass and did not lead to a powder having good dispersibility.
一般に軟膏剤等から有効成分を放出する能力を高める
ために、補助剤としてグリコール類(グリセリン、ヂエ
チレングリコール、プロピレングリコール等)を用いる
ことがある。しかし、ばんそう膏は皮膚に貼着固定して
用いるため、強い粘着力が要求されるので、これらのグ
リコール類を用いる例はない。In general, glycols (glycerin, ethylene glycol, propylene glycol, etc.) may be used as an adjuvant in order to enhance the ability to release an active ingredient from an ointment or the like. However, since the plaster is used by sticking it to the skin, a strong adhesive force is required, and there is no example of using these glycols.
問題点を解決するための手段 本発明者は、グリコン酸クロルヘキシジン(GCH)の
無水物粉末体を製造するための特殊な方法を開発し、そ
して該微粉末体をマクロゴールと共にばんそう膏膏体成
分に混和した場合、物質に分散され、そのためGCHの放
出性が増大し、抗菌性が著しく増大されたばんそう膏が
得られることを見出した。Means for Solving the Problems The present inventor has developed a special method for producing an anhydrous powder of chlorhexidine gluconate (GCH), and said fine powder together with macrogol is a plaster plaster. It has been found that, when incorporated into the ingredients, a plaster is obtained which is dispersed in the substance, thereby increasing the release of GCH and significantly increasing the antibacterial properties.
即ち、本発明によつて、ばんそう膏膏体形成成分に、
該膏体成分全体の重量を基準にして粉末粒度150ミクロ
ン以下のグルコン酸クロルヘキシジン粉末0.1〜1.0重量
%およびマクロゴール1.5〜10重量%を混和したことを
特徴とする、グルコン酸クロルヘキシジン入りばんそう
膏が提供される。That is, according to the present invention, the composition for forming a plaster
A chlorhexidine gluconate-containing bandage plaster comprising 0.1 to 1.0% by weight of chlorhexidine gluconate powder having a particle size of 150 μm or less and 1.5 to 10% by weight of macrogol based on the total weight of the plaster component. Is provided.
上記のばんそう膏は、ばんそう膏膏体形成成分に、該
成分の重量を基準にして粒度150ミクロン以下のグルコ
ン酸クロルヘキシジン微粉末0.1〜1.0重量%およびマク
ロゴール1.5〜10重量%を混和し、得られた混合物を35
゜〜65℃の範囲内の使用したマクロゴールの凝固点の温
度に加温溶解して泥状粘稠な展膏液を調製し、該展膏液
をばんそう膏基材上に塗布乾燥することにより製造し得
る。The above-mentioned plaster plaster is prepared by mixing 0.1 to 1.0% by weight of chlorhexidine gluconate fine powder having a particle size of 150 μm or less and 1.5 to 10% by weight of macrogol with a plaster composition for forming a plaster, based on the weight of the component. , 35 of the resulting mixture
Preparing a muddy viscous plaster solution by heating and dissolving to the temperature of the freezing point of the used macrogol within the range of ゜ to 65 ° C., and applying and drying the plaster solution on a plaster base material Can be produced.
発明の詳しい記述 グルコン酸クロルヘキシジン(GCH): 本発明に使用するGCHは、粒度約150ミクロン以下、好
ましくは60〜70ミクロンの実質的に無水の粉末体であ
る。粒度が150ミクロンを越えると、膏体内に分散するG
CHにバラツキを生じ、放出量および抗菌力が不均一とな
る。GCHの無水物は市販されていない。20%液を濃縮
し、結晶化し、そして微粉末化したものが使用され、詳
しくは、以下の方法によつてGCH粉末を得ることができ
る: 20%GCH液を水浴上減圧濃縮する。大部分の水が蒸発
するにしたがい発泡著しく、減圧操作困難となれば、得
られた飴状物を流動性のあるうちにバツトに採り、デシ
ケーターに入れて室温にて真空乾燥する。飴状物は気泡
の多いガス状薄層に固化するから、バツト内で粗砕し、
更に真空乾燥し、これを粉砕すれば容易に粉末となり篩
過して150ミクロン以下、特に60〜70ミクロンの粒度と
する。定量値は98%以上とする。DETAILED DESCRIPTION OF THE INVENTION Chlorhexidine gluconate (GCH): GCH used in the present invention is a substantially anhydrous powder having a particle size of about 150 microns or less, preferably 60-70 microns. When the particle size exceeds 150 microns, G dispersed in the plaster
CH varies, resulting in uneven release and antimicrobial activity. The anhydride of GCH is not commercially available. The 20% liquid is concentrated, crystallized and finely divided, and in particular the GCH powder can be obtained by the following method: The 20% GCH liquid is concentrated under reduced pressure on a water bath. If most of the water evaporates as the water evaporates, foaming becomes remarkable, and if the decompression operation becomes difficult, the obtained candy is taken in a bucket while it is fluid, placed in a desiccator, and vacuum dried at room temperature. Since the candy solidifies into a gaseous thin layer with many air bubbles, it is crushed in a bucket,
Further, it is vacuum-dried, and if it is pulverized, it easily becomes a powder and sieved to a particle size of 150 microns or less, particularly 60 to 70 microns. The quantitative value should be 98% or more.
GCHの配合量は、膏体成分全体の0.1〜1.0重量%であ
り、そして特に0.1〜0.3重量%の範囲で十分に抗菌力を
示す。GCHは抗菌性が大であるため、低濃度で有効であ
る。The compounding amount of GCH is 0.1 to 1.0% by weight of the whole plaster component, and particularly in the range of 0.1 to 0.3% by weight, it shows a sufficient antibacterial activity. GCH is effective at low concentrations due to its high antibacterial properties.
マクロゴール: マクロゴールは、酸化エチレンと水との縮重合体であ
り、重合度が増すにつれて、液体状から固体状に移行す
る。各称のあとに数字を付けるが、この数字は大体の平
均分子量を示す。これらは200〜20000まで約10種類あ
り、日局または日局外医薬品成分規格に収載されてい
る。マクロゴールは、軟膏、クリームなどの基剤として
医薬品、化粧品等に使用されている。化学成分としては
ポリエチレングリコールであり、皮膚への浸透性がよ
く、また刺激性がなく安全性の高い材料である。マクロ
ゴールはGCHと親和性が良く、膏体成分内でGCHの放出性
を高め、GCHを単独で使用した場合に比して、GCHの抗菌
力を著しく増大させることが本発明で見出された。マク
ロゴールの使用条件は以下の通りである: (1)マクロゴールの全種類が適用できるが、一斑に20
0〜10000のものが使用され、そして1000〜6000の範囲が
好ましい。ちなみに、マクロゴール400は炭素数7〜
9、粘液体で凝固点4〜8℃程度であり、そしてマクロ
ゴール6000は炭素数165〜200、凝固点56゜〜64℃程度で
ある。Macrogol: Macrogol is a condensation polymer of ethylene oxide and water, and changes from a liquid state to a solid state as the degree of polymerization increases. Each number is followed by a number that indicates the approximate average molecular weight. There are about 10 types of these, from 200 to 20,000, and they are listed in the Japanese Pharmacopoeia or the Pharmaceutical Ingredients outside of Japan. Macrogol is used in pharmaceuticals, cosmetics, and the like as a base for ointments and creams. As a chemical component, polyethylene glycol is a highly safe material that has good permeability to the skin and has no irritation. It has been found in the present invention that macrogol has a good affinity for GCH, enhances the release of GCH in the plaster component, and significantly increases the antibacterial activity of GCH as compared to the case where GCH is used alone. Was. The conditions for using Macrogol are as follows: (1) All types of Macrogol can be applied, but 20
Ones from 0 to 10000 are used, and a range from 1000 to 6000 is preferred. By the way, Macrogol 400 has 7 or more carbon atoms.
9. The viscous liquid has a freezing point of about 4-8 ° C, and Macrogol 6000 has 165-200 carbon atoms and a freezing point of about 56 ° -64 ° C.
(2)配合量は、膏体成分全量の1.5〜10重量%、好ま
しい範囲は2〜6重量%程度である。マクロゴールの配
合濃度に比例してGCHの放出も増大するが、10%を超過
するとばんそう膏の重要物性である粘着力が低下し、規
格から外れる。(2) The compounding amount is 1.5 to 10% by weight of the total amount of the plaster component, and a preferable range is about 2 to 6% by weight. The release of GCH also increases in proportion to the concentration of macrogol, but if it exceeds 10%, the adhesive property, which is an important physical property of the plaster, will fall off the specification.
膏体形成成分: 膏体形成成分としては、従来ばんそう膏用膏体に用い
られたものを使用できる。一般には、弾性体として天然
ゴムや合成ゴム、またはアクリル系樹脂、充填剤として
酸化亜鉛、軟化剤としてプロセスオイル、粘着性付与剤
としてロジン、ダンマル樹脂、石油樹脂等の粘着性の天
然又は合成樹脂等が使用される。Plaster-forming component: As the plaster-forming component, those conventionally used for plasters for plasters can be used. Generally, natural rubber or synthetic rubber or an acrylic resin as an elastic body, zinc oxide as a filler, process oil as a softener, and a sticky natural or synthetic resin such as rosin, dammar resin, petroleum resin as a tackifier. Etc. are used.
膏体形成成分用溶剤: 該溶剤としては揮発油、ベンゼン、トルエン、メチル
エチルケトン、ヘキサン、ヘプタン等が使用される。Solvent for plaster-forming component: As the solvent, volatile oil, benzene, toluene, methyl ethyl ketone, hexane, heptane and the like are used.
ばんそう膏基材: ばんそう膏基材としては、天然繊維または合成繊維製
シート、合成樹脂製シート等が使用される。Bandage base material: As the bandage base material, a sheet made of natural fiber or synthetic fiber, a sheet made of synthetic resin or the like is used.
グルコン酸クロルヘキシジン(GCH)およびマクロゴー
ルの添加法: GCHとマクロゴールは相互に親和性がよい。このため
両者の混溶物は親油性に乏しく50%のゴム発揮油等の溶
剤に溶かした膏体形成成分に対して、かえつて溶解能と
分散性がわるくなる。一旦溶解しても、ややもすれば分
離を起こしてGCHが局在し、均一な分散性が期待できな
い。How to add chlorhexidine gluconate (GCH) and macrogol: GCH and macrogol have good affinity for each other. For this reason, the mixed solution of the two is poor in lipophilicity, so that the dissolving ability and dispersibility of the paste-forming component dissolved in a solvent such as 50% of a rubber exhibiting oil become worse. Once dissolved, even if it dissolves a little, GCH is localized and uniform dispersibility cannot be expected.
この難点を解消すべく研究を重ねた結果、両者を膏体
形成成分に常温で配合し、マクロゴールの凝固点付近で
撹拌混合し常温に戻して製品とすれば、均一に分散する
ことがわかった。As a result of repeated research to solve this difficulty, it was found that if both were mixed with the plaster-forming component at room temperature, stirred and mixed near the solidification point of Macrogol, and returned to room temperature, the product was uniformly dispersed. .
したがつてマクロゴールの規格は好ましくは分子量10
00〜6000であつて、溶解温度は35゜〜65℃の範囲内の、
使用したマクロゴールの凝固点の温度が好ましい結果を
得る。なお、各種マクロゴールの凝固点は以下の通りで
ある。Therefore, the specification of Macrogol is preferably a molecular weight of 10
The melting temperature is in the range of 35 ° C to 65 ° C,
The temperature of the freezing point of the used macrogol gives favorable results. The solidification points of various macrogoals are as follows.
発明の作用および効果 ばんそう膏は本来皮膚に貼着するつよい粘着力が不可
欠であると同時に、使用後は容易に剥離する性質を併せ
もつべきものである。また、適当な保持力(膏体内の結
合力)が必要である。 Effects and Effects of the Invention A plaster must have a property that it must have a good adhesive strength to adhere to the skin and, at the same time, easily peel off after use. Also, an appropriate holding force (coupling force within the plaster) is required.
一般にばんそう膏の膏体成分に異質の成分を添加混合
すると、上記の粘着力、剥離性、保持力等の必要なバラ
ンスが失われることは業界の常識である。本発明者は、
抗菌剤としてグルコン酸クロルヘキシジンを無水物粉体
の形体で使用し、そしてグルコン酸クロルヘキシジンと
親和性のよいマクロゴールを更に混和することによつ
て、予想外にもばんそう膏に必要な上記のバランスを維
持してグルコン酸クロルヘキシジン粉末の放出性が向上
され、その結果抗菌性が著しく改善されたばんそう膏が
得られた。すなわち、マクロゴールの低重合体は、水、
アルコール、アセトン、クロロホルム等に溶けやすく、
芳香族炭化水素にも溶けやすく、脂肪酸炭化水素にすこ
し溶ける。高重合体となるに従って親油性となる。この
様にマクロゴールは多彩な溶解能を持つので、薬剤の溶
解性が高く、膏体成分のゴム、樹脂類との親和性がよい
という作用により、上記の効果が得られたものと考えら
れる。このようにして、膏体の粘着力、剥離力および保
持力をそこなわずにグルコン酸クロルヘキシジンの放出
能力を高める効果が達成される。グルコン酸クロルヘキ
シジン入りばんそう膏を皮膚に貼着すると、マクロゴー
ルの浸透性に同伴してグルコン酸クロルヘキシジンが徐
々に放出し、長時間にわたつて患部に殺菌消毒域を維持
することが出来る。In general, it is common knowledge in the industry that when a foreign component is added to and mixed with a plaster component of a plaster, the necessary balance of the above-mentioned adhesive strength, releasability, and holding power is lost. The inventor has
By using chlorhexidine gluconate as an antimicrobial agent in the form of an anhydrous powder and further admixing chlorhexidine gluconate with macrogol having a good affinity, the above balance required for the plaster is unexpectedly obtained. Was maintained, the release of chlorhexidine gluconate powder was improved, and as a result, a plaster with significantly improved antibacterial properties was obtained. That is, the low polymer of macrogol is water,
Easy to dissolve in alcohol, acetone, chloroform, etc.
It is easily soluble in aromatic hydrocarbons and slightly soluble in fatty acid hydrocarbons. The higher the polymer, the more lipophilic. As described above, since macrogol has various dissolving abilities, it is considered that the above effect was obtained by the action that the solubility of the drug is high and the affinity of the plaster component with rubber and resins is good. . In this way, the effect of increasing the release ability of chlorhexidine gluconate is achieved without impairing the adhesive strength, peeling power and holding power of the plaster. When a bandage plaster containing chlorhexidine gluconate is adhered to the skin, chlorhexidine gluconate is gradually released along with the permeability of macrogol, and the sterilized area can be maintained in the affected area for a long time.
実施例 以下に、本発明を実施例により具体的に説明する。下
記の例中、%は重量%を意味する。Examples Hereinafter, the present invention will be specifically described with reference to Examples. In the following examples,% means% by weight.
実施例1 成 分 A 天然ゴム 100 g エステルガム 93 g 酸化亜鉛 95.1g 流動パラフイン 4 g BHT 1 g 成 分 B グルコン酸クロルヘキシジン結晶粉末(粒度60〜70ミク
ロン) 0.9g(0.3%) マクロゴール1500 6 g(2.0%) 合 計 300 g(100%) 上記の膏体成分Aの一部をロール上で練って切断し、
これにゴム揮発油410mlを加えて、残りの成分Aと共に
撹拌混合し、均質粘稠な膏体現液を調製した。これに成
分Bを混和し、39゜〜41℃に加温溶解して泥状粘稠な展
膏液を調整した。このものを予め下塗処理した綿布(幅
50cm×長さ500cm)に厚さ80μで展膏し50゜60℃で乾燥
して溶剤を除去した後、巻芯に巻取りカツターで幅12mm
に切断して、ばんそう膏の性能規格に適合し、しかも長
期保存に耐えるグルコン酸クロルヘキシジン入りばんそ
う膏を得た。Example 1 Ingredient A Natural rubber 100 g Ester gum 93 g Zinc oxide 95.1 g Liquid paraffin 4 g BHT 1 g Ingredient B Chlorhexidine gluconate crystal powder (particle size 60-70 micron) 0.9 g (0.3%) Macrogol 1500 6 g (2.0%) Total 300 g (100%) A part of the plaster component A was kneaded on a roll and cut.
To this, 410 ml of rubber volatile oil was added, and the mixture was stirred and mixed with the remaining component A to prepare a homogeneous viscous salve liquid. The component B was mixed with the mixture, and the mixture was heated and dissolved at 39 ° to 41 ° C. to prepare a slurry-like viscous plaster solution. Cotton cloth (width:
After plastering with a thickness of 80μ on a 50cm x 500cm length and drying at 50-60 ° C to remove the solvent, it is wound on a core and 12mm wide with a cutter.
To obtain a plaster containing chlorhexidine gluconate which conforms to the performance standard of the plaster and which can withstand long-term storage.
実施例2 成 分 A アクリル系粘着剤 400g (固形分 200g) 炭化水素系樹脂 96g 成 分 B グルコン酸クロルヘキシジン結晶粉末(粒度60〜70ミク
ロン) 0.3g(0.1%) マクロゴール4000 12.0 g(4.0%) 合 計 300 g(100%) 上記の膏体成分Aをトルエン180mlに撹拌溶解し均質
粘稠な膏体原液を調整した。これに成分Bを混和し53゜
〜63℃に加温溶解して展膏液とした。Example 2 Component A Acrylic adhesive 400 g (solid content 200 g) Hydrocarbon resin 96 g Component B Chlorhexidine gluconate crystal powder (particle size 60-70 microns) 0.3 g (0.1%) Macrogol 4000 12.0 g (4.0% A total of 300 g (100%) of the above-mentioned plaster component A was stirred and dissolved in 180 ml of toluene to prepare a homogeneous and viscous plaster stock solution. This was mixed with Component B and dissolved by heating at 53 ° -63 ° C. to give an plaster solution.
このものを展膏器によりポリ塩化ビニールフイルム上
に実施例1と同様にして展膏し、乾燥して溶剤を除去し
てグルコン酸クロルヘキシジン入りばんそう膏を得た。
このばんそう膏は引張り試験を除き、ばんそう膏の性能
規格に適合した。また長期保存に十分に耐えた。This was plastered on a polyvinyl chloride film using a plaster in the same manner as in Example 1, dried and the solvent was removed to obtain a plaster containing chlorhexidine gluconate.
Except for the tensile test, this bandage plaster met the performance standards of the bandage plaster. In addition, it was well tolerated for long-term storage.
比較例1〜2: 実施例1の膏体成分Aの一部をロール上で練って切断
し、これにゴム揮発油410mlを加えて残りの成分Aと共
に撹拌混合して、均質粘稠な膏体原液を調製した。Comparative Examples 1-2: A portion of the plaster component A of Example 1 was kneaded on a roll and cut, and 410 ml of a rubber volatile oil was added thereto, followed by stirring and mixing with the remaining component A to obtain a homogeneous viscous plaster. A stock solution was prepared.
これに20%GCH液1.5g又は4.5g(GCH0.3g又は0.9g,膏
体の成分全体の0.1%又は0.3%に相当)を加え40゜〜45
℃に加温溶解し泥状粘稠な展膏液を調整した。Then add 1.5 g or 4.5 g of 20% GCH solution (0.3 g or 0.9 g of GCH, corresponding to 0.1% or 0.3% of the whole component of the plaster) and add 40 g to 45 g.
The mixture was heated and dissolved at a temperature of ℃ to prepare a muddy viscous plaster solution.
実施例1と同様に処理して、ばんそう膏の性能規格に
適合した製品を得たが、このものは経時変化試験ではそ
の残存水分から巻巣状の空洞が発生し、また粘着物質が
層の背面に移行して凝集破壊を起こした。The product was processed in the same manner as in Example 1 to obtain a product conforming to the performance standard of the plaster. In the time-dependent change test, a wound-like cavity was generated from the residual moisture, and the adhesive substance was not coated. Cohesive failure occurred at the back of the specimen.
比較例3: 実施例1の膏体成分Aを常法のとおり処理して膏体原
液を調整した。これに粒度60〜70ミクロンのGCH0.9g
(膏体成分全体の0.3%に相当)を加え、40゜〜45℃に
加温溶解して、泥状粘稠な展膏液を調整した。Comparative Example 3: The paste component A of Example 1 was treated in a conventional manner to prepare a paste concentrate. GCH 0.9g with a particle size of 60 to 70 microns
(Equivalent to 0.3% of the whole plaster component) was added, and the mixture was heated and dissolved at 40 ° C. to 45 ° C. to prepare a mud-like viscous plaster solution.
実施例1と同様に処理して、ばんそう膏の性能規格に
適合する製品を得た。経時変化試験に異常はなかつた。The product was processed in the same manner as in Example 1 to obtain a product conforming to the performance standard of the plaster. There was no abnormality in the aging test.
比較例4: 実施例1にしたがつて成分Aからなる膏体原液をつく
り、150〜250ミクロンの粒度のGCH0.9g(膏体成分全体
の0.3%)及びマクロゴール6000を6.0g混和し、56゜〜6
4℃にて撹拌混和して、粘稠な展膏液を得た。これを常
法にしたがつて展膏し、GCH入りばんそう膏を製造し
た。ばんそう膏の物理的性能は規格に適合したが、膏体
面にはGCHの粒子による斑点が認められ、定量値は規格
の0.3±0.03%に適合しない部分があつた。Comparative Example 4: A plaster stock solution comprising the component A was prepared according to Example 1, and 0.9 g of GCH (0.3% of the whole plaster component) having a particle size of 150 to 250 microns and 6.0 g of Macrogol 6000 were mixed. 56 ゜ -6
The mixture was stirred and mixed at 4 ° C. to obtain a viscous plaster solution. This was plastered according to a conventional method to produce a GCH-containing plaster. Although the physical performance of the plaster conformed to the standard, spots due to GCH particles were observed on the plaster surface, and the quantitative value was partially incompatible with 0.3 ± 0.03% of the standard.
抗菌力試験 前記の実施例および比較例で得られたばんそう膏につ
いて、以下のようにして抗菌力試験を行った。Antibacterial activity test The antibacterial activity test was performed on the plasters obtained in the above Examples and Comparative Examples as follows.
概要: 細菌を接種した試験用平板培地の表面に検体片及び対
照片を置き、37℃で培養した。培養開始24時間後に検体
片及び対照片を取り除き、菌の発育阻止帯の有無の肉眼
観察により判定した。Outline: A test piece and a control piece were placed on the surface of a test plate medium inoculated with bacteria, and cultured at 37 ° C. 24 hours after the start of the culture, the test piece and the control piece were removed, and the presence or absence of a growth inhibition zone was determined by visual observation.
試験方法: 1)試験菌株:黄色ブドウ球菌 2)培地: イ増菌用培地;AATCC液体培地、 ロ測定用培地;AATCC寒天培地。Test method: 1) Test strain: Staphylococcus aureus 2) Medium: a) Enrichment medium; AATCC liquid medium; b) Measurement medium; AATCC agar medium.
3)試験用平板培地の作成: 試験菌株を増菌用培地に接種して37℃にて一夜培養し
て菌液とする。菌液を測定用培地150mlに対して1mlの割
合で添加し、各型シャーレに30ml分注し、固化させて培
地を作成した。3) Preparation of test plate medium: The test strain is inoculated into an enrichment medium and cultured overnight at 37 ° C to obtain a bacterial solution. The bacterial solution was added at a ratio of 1 ml to 150 ml of the measurement medium, and 30 ml was dispensed into each type petri dish and solidified to prepare a medium.
4)試験片の作製: 検体片は試料を12×24mmに切断した。対照片はろ紙
(12×24mm)に主薬(グルコン酸クロルヘキシジン液)
25μgまたは6.25μgを浸み込ませた。4) Preparation of test piece: For the test piece, the sample was cut into 12 × 24 mm. The control strip is filter paper (12 x 24 mm) and the main drug (chlorhexidine gluconate solution)
25 μg or 6.25 μg was impregnated.
判定: 菌の発育阻止帯は次の基準で判定した。Judgment: The growth inhibition zone of the bacteria was judged according to the following criteria.
判定 判定基準 A 菌の発育を全く阻止しない B 接触部分の菌の発育をわずかに阻止する C 接触部分の菌の発育を阻止する D 菌の発育阻止帯が周辺までわずかに(1mm未満)及
ぶ E 菌の発育阻止帯が周辺まで明らかに及ぶ(阻止帯の
大きさ測定) 以上の測定結果からわかるように、実施例1の試料は
黄色ブドウ球菌に対して菌の発育阻止帯が明らかに周辺
まで及ぶ。実施例2の試料は黄色ブドウ球菌および緑濃
菌に対して、接触部分の菌の発育を阻止する。これに対
して、GCH20%液を使用した比較例1および2の試料
は、黄色ブドウ球菌に対して接触部分の菌の発育をわず
かに阻止する程度であり、緑濃菌に対して全く阻止しな
い。また、GCHの微粉体を使用したがマクロゴールを併
用しない比較例3の試料は、黄色ブドウ球菌に対して接
触部分の菌の発育を阻止する判定(C)を得たが、GCH
を同じ濃度(0.3%)で使用した実施例1の試料と比べ
て両者の菌に対して抗菌力が劣っている。Judgment Criteria A Does not inhibit the growth of bacteria at all. B Slightly inhibits the growth of bacteria in the contact area. C Inhibits the growth of bacteria in the contact area. D The growth inhibition zone extends slightly (less than 1 mm) to the periphery. E The growth inhibition zone clearly extends to the periphery (measurement of the size of the inhibition zone) As can be seen from the above measurement results, in the sample of Example 1, the growth inhibition zone of Staphylococcus aureus clearly extends to the periphery. The sample of Example 2 inhibits Staphylococcus aureus and Pseudomonas aeruginosa from growing at the contact portion. On the other hand, the samples of Comparative Examples 1 and 2 using the GCH20% solution only slightly inhibited the growth of the bacteria in contact with Staphylococcus aureus and did not inhibit the green bacterium at all. . In addition, the sample of Comparative Example 3 using the fine powder of GCH but not using macrogol obtained the judgment (C) that the growth of the bacteria in contact with Staphylococcus aureus was obtained.
Is inferior in antibacterial activity to both bacteria as compared with the sample of Example 1 using the same concentration (0.3%).
なお、比較例4のばんそう膏はGCH粒子の粒度が大き
いため抗菌力試験はバラツキが大きく、判定が不明確で
あつた。In addition, since the bandage plaster of Comparative Example 4 had a large particle size of GCH particles, the antibacterial activity test had large variations, and the judgment was unclear.
Claims (7)
体の重量を基準にして粒度150ミクロン以下のグルコン
酸クロルヘキシジン粉末0.1〜1.0重量%およびマクロゴ
ール1.5〜10重量%を混和したことを特徴とする、グル
コン酸クロルヘキシジン入りばんそう膏。1. A composition for forming a plaster plaster with 0.1 to 1.0% by weight of chlorhexidine gluconate powder having a particle size of 150 μm or less and 1.5 to 10% by weight of macrogol, based on the total weight of the plaster component. A plaster containing chlorhexidine gluconate, characterized in that:
粒度が60〜70ミクロンである、請求項1のばんそう膏。2. The plaster of claim 1 wherein said chlorhexidine gluconate powder has a particle size of 60 to 70 microns.
00の範囲のマクロゴールから選ばれる、請求項1又は2
のばんそう膏。3. The above-mentioned macrogol has an average molecular weight of 200 to 100.
3. The method according to claim 1, wherein the macro goal is selected from the range of 00 to 00.
Noban plaster.
00の範囲のマクロゴールから選ばれる、請求項2のばん
そう膏。4. The macrogol has an average molecular weight of 1,000 to 60.
3. The plaster of claim 2 selected from macrogol in the range of 00.
量が膏体成分全体の0.1〜0.3重量%である、請求項1〜
4のいずれかのばんそう膏。5. The method according to claim 1, wherein the amount of the chlorhexidine gluconate powder is 0.1 to 0.3% by weight based on the whole paste component.
4. The plaster of any of 4.
2〜6重量%である、請求項1〜5のいずれかのばんそ
う膏。6. The plaster according to claim 1, wherein the amount of said macrogol is 2 to 6% by weight of the whole plaster component.
成分全体の0.1〜1.0重量%の量の粒度150ミクロン以下
のグルコン酸クロルヘキシジン粉末および1.5〜10重量
%の量のマクロゴールを常温にて混和し、得られた混合
物を35゜〜65℃の範囲内の該マクロゴールの凝固点の温
度で加温溶解し、得られた展膏液を基材上に塗布しそし
て乾燥することを特徴とする、グルコン酸クロルヘキシ
ジン入りばんそう膏の製造法。7. Chlorhexidine gluconate powder having a particle size of 150 μm or less in an amount of 0.1 to 1.0% by weight of the whole paste component and macrogol in an amount of 1.5 to 10% by weight are added to the paste forming component and the solvent for the component. Mixing at room temperature, heating and dissolving the resulting mixture at a temperature of the freezing point of the macrogol within the range of 35 ° C to 65 ° C, applying the resulting plaster solution on a substrate and drying. A method for producing a bandage salve containing chlorhexidine gluconate, characterized by the following.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP63225839A JP2640681B2 (en) | 1988-09-09 | 1988-09-09 | Bandage plaster containing chlorhexidine gluconate and its production method |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP63225839A JP2640681B2 (en) | 1988-09-09 | 1988-09-09 | Bandage plaster containing chlorhexidine gluconate and its production method |
Publications (2)
Publication Number | Publication Date |
---|---|
JPH0273013A JPH0273013A (en) | 1990-03-13 |
JP2640681B2 true JP2640681B2 (en) | 1997-08-13 |
Family
ID=16835633
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP63225839A Expired - Lifetime JP2640681B2 (en) | 1988-09-09 | 1988-09-09 | Bandage plaster containing chlorhexidine gluconate and its production method |
Country Status (1)
Country | Link |
---|---|
JP (1) | JP2640681B2 (en) |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
GB9113448D0 (en) * | 1991-06-21 | 1991-08-07 | Smith & Nephew | Adhesive compositions and products |
-
1988
- 1988-09-09 JP JP63225839A patent/JP2640681B2/en not_active Expired - Lifetime
Also Published As
Publication number | Publication date |
---|---|
JPH0273013A (en) | 1990-03-13 |
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