JP5690398B2 - 抗菌性ゲル - Google Patents
抗菌性ゲル Download PDFInfo
- Publication number
- JP5690398B2 JP5690398B2 JP2013504854A JP2013504854A JP5690398B2 JP 5690398 B2 JP5690398 B2 JP 5690398B2 JP 2013504854 A JP2013504854 A JP 2013504854A JP 2013504854 A JP2013504854 A JP 2013504854A JP 5690398 B2 JP5690398 B2 JP 5690398B2
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- JP
- Japan
- Prior art keywords
- antibacterial
- mixture
- mass
- silver
- gel
- 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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Description
本発明は、とりわけ微生物発育を阻止する抗菌性組成物、とりわけ前記組成物から製造される抗菌性ゲル、微生物発育を阻止するための抗菌性ゲルを含むさまざまなタイプ包帯剤、並びに創傷の治療及び微生物発育の阻止のためのさまざまなタイプの生成物における抗菌性ゲルの使用に関する。
方法Fに従って実施されるが、また他の適した方法及び標準を用いてもよい。抗菌性ゲルは、患者に適用する前に包帯剤と合わせるか又はその中に組み込んでもよいが、それを必要とする患者に抗菌性ゲルを直接適用することもまた本発明の精神の範囲内にある。
塩化ナトリウム(NaCl)8.298g及び塩化カルシウム二水和物(CaCl2・2H2O)0.368gを脱イオン水中に溶解し、そしてメスフラスコ中で1リットルまで満たす。
以下の材料を本発明の抗菌性組成物及びゲルの製造に用いた。0.18〜0.26質量パーセントのビニルを含む1000mPa.s粘度を有するビニル1000Aジメチルビニルシロキシ−末端ポリジメチルシロキサン、25〜30モル%のMeHSiOを含む25〜35mPa.sの粘度を有する連鎖延長剤トリメチルシロキシ末端メチルハイドロジェンポリジメチルシロキサン、及びMeHSiOとして25〜30モル%を含む25〜35mPa.sの粘度を有する架橋剤トリメチルシロキシ末端メチルハイドロジェンポリジメチルシロキサンをABCR GmbH & Co. KG(それぞれAB109358, AB109366, 及びAB109380)から入手した。白金触媒、Cat 511は、Hanse Chemieから入手し、シリカ、H15は、Wacker Chemieから入手し、マンニトールは、Sigma Aldrichから入手し、ポリエチレングリオール3000 Sは、Clariantから入手し(以下、PEG 3000と称する)、Pluriol 6005及びPluriol 8005は、BASFから入手し(それぞれPEG 6000及びPEG 8000と称する)、硫酸銀(Ag2SO4)は、Alpha Aesar(ストック番号11417)から入手し、そしてVelvesil plus及びVelvesil 125は、Momentiveから入手した。
成分を下に記載された量で一緒に混合することによってシリコーンゲル組成物を製造した。最初に、シリコーンゲル製剤を製造し、それを抗菌剤及び放出増強性添加剤と共に用いた。
硬化過程前に触媒と架橋剤/連鎖延長剤とを隔てておくため、シリコーンゲルは、二成分系で製造した。成分Aは、とりわけ、以下の成分を含んでもよい:
1.ビニル末端のPDMS(Vin 1000)及びシリカ(HDK, H15)を広口瓶中で混合し、そしてスピードミキサーで5分間ブレンドした。
2.触媒を加え、そして混合物をスピードミキサー中で2分間ブレンドした。
1.Vin 1000を含むポリマー、Cl及びCEを広口瓶中で混合し、そしてスピードミキサー中で2分ブレンドした。
以下の工程を含む方法を用いて製剤を製造した:
1)実施例1に従ってシリコーン成分A(3.75g)をPEG 8000(3g)と共に広口瓶中に加えた。
2)PEGが溶融するまで80℃で加熱した。
その後、乳濁液が形成されるまでスピードミキサー中で相を混合した(約2分の時間枠)。
3)広口瓶中で銀粉末及びVelvesilを混合し、そしてスピードミキサーでブレンドすることによってAg2SO4(3g)及びVelvesil plus(1.5g)のペーストを調製した。
4)銀ペーストを成分Aに加え、そして混合した。
5)阻害剤(0.015g)をシリコーンBに加え、そして混合した。
6)シリコーン成分B(3.75g)を加えた。
以下の工程を含む方法を用いて製剤を製造した:
1)マンニトール(4.5g)入りの広口瓶中に実施例1に従ってシリコーン成分A(3g)を入れた。
2)懸濁液が形成されるまでスピードミキサー中で相を混合した(約2分)。
3)広口瓶中で銀粉末及びVelvesilを混合し、そしてスピードミキサーでブレンドすることによってAg2SO4(3g)及びVelvesil plus(1.5g)のペーストを調製した。
4)銀ペーストを成分Aに加え、そして混合した。
5)阻害剤(0015g)を加えてシリコーンBにそして混合した。
6)シリコーン成分B(3.75g)を加えた。
以下の工程を含む方法を用いて製剤を製造した:
1)CMC Akucell AF 2781W(1.5g)入りに広口瓶中に実施例1に従ってシリコーン成分A(5.92g)を入れた。
2)懸濁液が形成されるまでスピードミキサー中で相を混合した(約2分)。
3)成分Aの混合物にAg2SO4(1.5g)及びVelvesil plus(0.15g)を加え、そしてスピードミキサーでブレンドした(約2分)。
4)シリコーン成分B(5.92g)を混合物に加え、そしてスピードミキサー中で混合した(約2分)。
1)シリコーンゲル(Dow Corning 7-9900)の成分A80gに、硫酸銀10g及びCMC(Akucell 2781)10gを加え、そしてスピードミキサー中で2分間ブレンドした。
2)この混合物にシリコーンポリエーテル0.2g(Dow Corning FZ 2233)を加え、そしてスピードミキサー中で2分間ブレンドした。
3)この混合物に成分B(Dow corning 7-9900)80gを加え、そしてミキサー中でブレンドした。
4)サンプルを室温で硬化させた。
サンプルを硬化してゲルにした。
1)シリコーンゲル(Dow Corning 7-9900)の成分A80gに硫酸銀10g及びCMC(Akucell 2781)10gを加え、そしてスピードミキサー中で2分間ブレンドした。
2)この混合物にシリコーンポリエーテルクロスポリマー(Momentive, Velvesil plus)1gを加え、そしてスピードミキサー中で2分間ブレンドした。
3)この混合物に成分B(Dow corning 7-9900)80gを加え、そしてミキサー中でブレンドした。
4)サンプルを室温で硬化させた。
サンプルを硬化してゲルにした。
下の表5にまとめたように異なる処方による多くのゲルについて、本発明の抗菌性ゲルの抗菌作用を評価した。少なくとも1つの(場合により銀の放出を増強する)親水性成分(下の表5中のサンプル2N1及び2N2参照)を省いたときに、本質的に抗菌活性がないことがわかった。さらに、本発明に関する抗菌性生成物の膨潤を全く増強しない親水性成分は、同様に本質的に抗菌作用を生じない。従って、本発明に関する親水性成分によって仲介される膨潤作用により、抗菌有効性が増強されることは明らかである。
自由膨潤吸収法を用いて本発明によるさまざまな抗菌性ゲル及び架橋組成物の膨潤性を分析した。表6から分かるように、本発明の(場合により銀の放出を増強する)親水性成分は、実質的な膨潤を仲介し、銀放出の改善及び/又は抗菌有効性の増強をもたらす。
Claims (23)
- 少なくとも1つのアルケニル−及び/又はアルキニル−置換ポリシロキサン、ケイ素結合水素原子を含む少なくとも1つのポリシロキサン、及び少なくとも1つのヒドロシリル化触媒を含む抗菌性組成物であって、ここにおいて該組成物は、少なくとも1つの銀塩及び少なくとも1つの親水性成分をさらに含み、そして該少なくとも1つの親水性成分は、架橋した場合、該抗菌性組成物を塩化ナトリウム8.298g/L及び塩化カルシウム二水和物0.368g/Lを含有する溶液中で、自由膨潤吸収法で測定して、24時間後少なくとも5%(質量/質量)膨潤させる、上記組成物。
- 少なくとも1つの親水性成分が、単、二及び/若しくは多糖類、糖アルコール、ポリオール、ポリエーテル、ポリエステル、ポリアミド、並びに/又はペンダントカルボン酸基及び/若しくはペンダントスルホナート基を含むポリマーを含む群から選ばれる、請求項1に記載の抗菌性組成物。
- 少なくとも1つの親水性成分が、グルコース、キシリトール、ソルビトール、マンニトール、シクロデキストリン、セルロース、ヘミセルロース、カルボキシメチル化セルロース、キトサン、デキストラン、キチン、アミロース、アミロペクチン、ポリエチレングリコール、ポリプロピレングリコール、ポリエチレングリコール及びポリプロピレングリコールのコポリマー、ポリグリセリン、ポリ(アクリル酸)、アクリル酸及びC10−C30アルキルアクリレートのコポリマー、ポリ(アクリルアミド)、無水マレイン酸ポリマー及びコポリマー、カルボキシメチルセルロース、メチルセルロース、ヒドロキシメチルプロピルセルロース、エチルセルロース、カルボキシエチルセルロース、ヒドロキシプロピルセルロース、ヒドロキシエチルセルロース、カルボキシメチルセルロース、セルロースアルキルスルホナート、ポリスチレンスルホナート、ビニル酸並びにビニルアルコールを含む群から選ばれる、請求項1又は2に記載の抗菌性組成物。
- 前記少なくとも1つの親水性成分の濃度が、3%〜40%(質量/質量)である、請求項1〜3のいずれか1項に記載の抗菌性組成物。
- 1%〜5%(質量/質量)のシリカ粒子をさらに含む、請求項1〜4のいずれか1項に記載の抗菌性組成物。
- 少なくとも1つの銀塩が、Ag2SO4、Ag2SO3、AgNO3、Ag2CO3、Ag3PO4、銀ジルコニウム、及び/若しくはクエン酸銀、酢酸銀、乳酸銀のような有機銀塩、並びに/又はそれらの組み合わせ若しくは混合物を含む群から選ばれる、請求項1〜5のいずれか1項に記載の抗菌性組成物。
- 銀塩濃度が1%〜30%(質量/質量)である、請求項1〜6のいずれか1項に記載の抗菌性組成物。
- 少なくとも1つのシロキサンポリマーネットワーク及び少なくとも1つのシロキサンポリエーテル(SPE)を含む群から選ばれる、少なくとも1つのシロキサン含有コポリマーをさらに含む、請求項1〜7のいずれか1項に記載の抗菌性組成物であって、ここで少なくとも1つのシロキサン含有コポリマーが0.1%〜30%(質量/質量)の濃度で存在する、上記抗菌性組成物。
- ゲルが少なくとも1つのアルケニル−及び/又はアルキニル−置換ポリシロキサン及びケイ素結合水素原子を含む少なくとも1つのポリシロキサンの架橋を通して製造される、請求項1〜8のいずれか1項に記載の組成物から製造された抗菌性ゲル。
- ポリシロキサンの架橋が、硬化を用いて行なわれる、請求項9に記載の抗菌性ゲル。
- シロキサン含有コポリマー及びシリカ粒子を含む群から選ばれる1つ又はそれ以上の賦形剤をさらに含む、請求項9又は10に記載の抗菌性ゲル。
- 補正された阻止帯(CZoI)として定義される、前記抗菌性ゲルによってもたらされる微生物発育阻止が、24時間で少なくとも2mmである、請求項9〜11のいずれか1項に記載の抗菌性ゲル。
- 2−コンパートメント試験法を用いて評価された、直径約20mm及び約500g/m2のコート質量を有する前記抗菌性ゲルの円形サンプルを、37℃の温度で細菌含有化学的模擬創傷液4mlに暴露すると、黄色ブドウ球菌のコロニー形成単位(CFU)数を24時間で106から少なくとも105に減少させることができる、請求項9〜12のいずれか1項に記載の抗菌性ゲル。
- 前記ゲルが、ASTM国際標準D3330/D3330M-04方法Fで測定して、0.1〜2Nのスチールとの接着性を有する、請求項9〜13のいずれか1項に記載の抗菌性ゲル。
- 請求項9〜14のいずれか1項に記載の抗菌性ゲルを含み、創傷包帯剤、オストミー包帯剤、オストミーベースプレート、切開フィルム、手術用被布、パッチ、包帯、救急絆創膏、プラスター、接着剤、接着テープ、絆創膏、粘着性プラスター、及びコートプラスター、並びにそれらの任意の組み合わせを含む群から選ばれる、抗菌性包帯剤であって、ここで抗菌性ゲルが基材上に塗布される、上記抗菌性包帯剤。
- 請求項9〜14のいずれか1項に記載の抗菌性ゲルの製造方法であって、以下:
(a)(i)少なくとも1つのアルケニル−及び/又はアルキニル−官能性ポリシロキサン、少なくとも1つのヒドロシリル化触媒;
(ii)少なくとも1つのアルケニル−及び/又はアルキニル−官能性ポリシロキサン、少なくとも1つのCE及び/又は少なくとも1つのCL;
(iii)少なくとも1つの銀塩及び少なくとも1つのシロキサン含有コポリマー;を含む3つの混合物(i)、(ii)及び(iii)を、同時に若しくは順次に又は(i)、(ii)及び(iii)の任意の組み合わせのいずれかで調製する工程;
(b)少なくとも1つの親水性成分を混合物(i)及び/又は混合物(ii)と混合する工程;
(c)混合物(iii)を混合物(i)及び/又は混合物(ii)と混合する工程;
(d)混合物(i)及び混合物(ii)を混合する工程;
(e)工程(d)で得た混合物を硬化し、それによって前記抗菌性ゲルを得る工程;
を含む、上記製造方法。 - シリカ粒子が混合物(i)及び/又は混合物(ii)に添加される、請求項16に記載の抗菌性ゲルの製造方法。
- 工程(b)に続いて親水性成分を溶融するために、少なくとも1つの親水性成分が加えられた混合物を加熱する工程を行う、請求項16又は17に記載の抗菌性ゲルの製造方法。
- 請求項15に記載の抗菌性包帯剤の製造方法であって、以下:
(a)(i)少なくとも1つのアルケニル−及び/又はアルキニル−官能性ポリシロキサン、少なくとも1つのヒドロシリル化触媒;
(ii)少なくとも1つのアルケニル−及び/又はアルキニル−官能性ポリシロキサン、少なくとも1つのCE及び/又は少なくとも1つのCL;
(iii)少なくとも1つの銀塩及び少なくとも1つのシロキサン含有コポリマー;
を含む3つの混合物(i)、(ii)及び(iii)を、同時に若しくは順次に又は(i)、(ii)及び(iii)の任意の組み合わせのいずれかで調製する工程;
(b)少なくとも1つの親水性成分を混合物(i)及び/又は混合物(ii)と混合する工程;
(c)混合物(iii)を混合物(i)及び/又は混合物(ii)と混合する工程;
(d)混合物(i)及び混合物(ii)を混合する工程;
(e)工程(d)で得た混合物を基材にコーティングする工程;
(f)工程(e)の基材上にコーティングされた混合物を硬化し、それによって上記抗菌性包帯剤を得る工程;
を含む、上記製造方法。 - シリカ粒子が混合物(i)及び/又は混合物(ii)に添加される、請求項19に記載の抗菌性ゲルの製造方法。
- 工程(b)に続いて親水性成分を溶融するために、少なくとも1つの親水性成分が加えられた混合物を加熱する工程を行う、請求項19又は20に記載の抗菌性ゲルの製造方法。
- 基材が創傷包帯剤、オストミー包帯剤、オストミーベースプレート、切開フィルム、手術用被布、パッド、パッチ、包帯、救急絆創膏、プラスター、接着剤、接着テープ、絆創膏、粘着性プラスター及びコートプラスター、及びそれらの任意の組み合わせを含む群から選ばれるか、又は基材がフィルム、布地、発泡体、不織布フィルム、繊維ネットワーク、編地及び同様のものを含む群から選ばれる、上記基材の任意の1つを製造するための成分である、請求項19に記載の方法。
- 熱傷、瘢痕、細菌感染、ウイルス感染及び/又は真菌感染の治療に使用するための医薬を製造するための請求項9〜14のいずれか1項に記載の抗菌性ゲル又は請求項15に記
載の抗菌性包帯剤の使用。
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RU2535013C2 (ru) | 2014-12-10 |
EP2558132A1 (en) | 2013-02-20 |
AU2011241171C1 (en) | 2014-06-05 |
MX2012011452A (es) | 2012-11-23 |
KR101446992B1 (ko) | 2014-10-06 |
EP2558132A4 (en) | 2015-12-23 |
BR112012026330A2 (pt) | 2015-09-22 |
EP3738619A1 (en) | 2020-11-18 |
CA2796137A1 (en) | 2011-10-20 |
RU2012143888A (ru) | 2014-05-20 |
AU2011241171B2 (en) | 2014-01-09 |
EP2558132B1 (en) | 2020-10-14 |
CN102892440B (zh) | 2014-10-29 |
AU2011241171A1 (en) | 2012-10-11 |
CA2796137C (en) | 2015-02-10 |
BR112012026330B1 (pt) | 2018-11-06 |
KR20130023245A (ko) | 2013-03-07 |
US9492549B2 (en) | 2016-11-15 |
JP2013523879A (ja) | 2013-06-17 |
US20130101633A1 (en) | 2013-04-25 |
CN102892440A (zh) | 2013-01-23 |
WO2011129759A1 (en) | 2011-10-20 |
US10111959B2 (en) | 2018-10-30 |
US20170080090A1 (en) | 2017-03-23 |
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