JP6589364B2 - 外用剤組成物及び抗炎症作用増強剤 - Google Patents
外用剤組成物及び抗炎症作用増強剤 Download PDFInfo
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- JP6589364B2 JP6589364B2 JP2015097345A JP2015097345A JP6589364B2 JP 6589364 B2 JP6589364 B2 JP 6589364B2 JP 2015097345 A JP2015097345 A JP 2015097345A JP 2015097345 A JP2015097345 A JP 2015097345A JP 6589364 B2 JP6589364 B2 JP 6589364B2
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Description
[1].(A)ウフェナマート、(B)クロタミトン、及び(C)抗ヒスタミン剤を含有し、前記(C)成分が、ジフェンヒドラミン、クロルフェニラミン、メキタジン及びイソチペンジルから選ばれる1種以上であり、前記(B)成分の配合量が0.2〜2質量%であり、(C)/(B)で表わされる前記(B)成分と前記(C)成分との配合比率が0.25〜2.5である外用剤組成物。
[2].(C)成分が、ジフェンヒドラミンである[1]記載の外用剤組成物。
[3].(C)/(A)で表わされる前記(A)成分と前記(C)成分との配合比率が0.1〜1である[1]又は[2]記載の外用剤組成物。
[4].抗炎症剤である[1]〜[3]のいずれかに記載の外用剤組成物。
[5].(A)成分の配合量が0.2〜10質量%、(C)成分の配合量が0.1〜5質量%である[1]〜[4]のいずれかに記載の外用剤組成物。
[6].(A)ウフェナマート及び(B)クロタミトンを含有する外用剤組成物に配合する、(C)抗ヒスタミン剤を有効成分とする抗炎症作用増強剤であって、前記(C)成分が、ジフェンヒドラミン、クロルフェニラミン、メキタジン及びイソチペンジルから選ばれる1種以上であり、前記(B)成分の配合量が外用剤組成物中0.2〜2質量%であり、(C)/(B)で表わされる前記(B)成分と前記(C)成分との外用剤組成物中の配合比率が0.25〜2.5である抗炎症作用増強剤。
(A)ウフェナマート
ウフェナマートは非ステロイド系消炎鎮痛剤の1種で、炎症症状を緩和する作用を有する薬剤である。
クロタミトンは経皮吸収促進効果を有し、(A)ウフェナマートの抗炎症効果をより発揮することができる。
抗ヒスタミン剤としてはその種類は特に限定されず、1種単独で又は2種以上を適宜組み合わせて用いることができる。具体的には、ジフェンヒドラミン、クロルフェニラミン、メキタジン、アゼラスチン、プロメタジン、エメダスチン、ケトチフェン、イソチペンジル及びそれらの塩等が挙げられる。中でも、ジフェンヒドラミン、クロルフェニラミン、メキタジン、イソチペンジル及びそれらの塩が好ましく、ジフェンヒドラミン及びその塩がより好ましい。後述する実施例の結果からも明らかであるように、(C)ジフェンヒドラミンには、ほとんど抗炎症作用は示されていない。にもかかわらず、(A)ウフェナマート及び(B)クロタミトンを配合した場合に比べ、(A)ウフェナマート、(B)クロタミトン及び(C)ジフェンヒドラミンを配合すると、抗炎症の相乗効果が確認された。つまり、(A)ウフェナマート及び(B)クロタミトンの抗炎症効果を、(C)抗ヒスタミン剤が著しく増強させることが確認された。本発明の効果は、ステロイド抗炎症剤と同等、それ以上の効果が期待される。
(A)〜(C)成分をエタノールに溶解し、100gの溶液とし、下記表1,2に示す組成の外用剤組成物を調製した。得られた外用剤組成物について下記評価を行った。結果を表1,2に併記する。なお、実施例2は参考例である。
試料(外用剤組成物)を、ラット足蹠に塗布し、起炎4時間後の足蹠容積を測定した。
(1)SD系雄性ラットの4週齢を1週間予備飼育後、試験に供した(各群:5匹)
(2)試料(外用剤組成物)
(3)起炎剤の調製:カラゲニン0.15gを秤量し、マグネチックスターラーで撹拌しながら生理食塩水を加え、10mLとした。なお、撹拌操作は、室温にて12時間以上行った。
(4)試料の投与
起炎2時間及び1時間前に、試料を100μL/回、ポリプロピレン製ディスポーザブル注射筒を用いて右側後肢足蹠に塗布した。コントロール群は試料の塗布は行わない。
(5)起炎剤の投与(起炎)
右側後肢足蹠皮下に、1.5w/v%カラゲニン(起炎剤)を0.1mL/siteで投与し、炎症を惹起させた。
(6)足蹠容積の測定
起炎4時間後、足蹠容積測定装置を用いて右側後肢足蹠容積(mL)を測定した。得られた結果から、下記式にて浮腫率、抑制率(コントロール群に対する浮腫の減少率)を算出した。
式1:浮腫率(%)=([起炎4時間後の足蹠容積(mL)]−[初期の足蹠容積(mL)])/[初期の足蹠容積(mL)]×100
*初期:試料及び起炎剤の投与前
式2:抑制率(%)=([コントロール群の平均浮腫率(%)]−[各試験群の平均浮腫率(%)])/[コントロール群平均浮腫率(%)]×100
上記で得られた抑制率から、下記判定基準で浮腫抑制効果を示す。
◎:30%以上
○:25%以上30%未満
△:20%以上25%未満
×:20%未満
(A)〜(C)成分をエタノールに溶解し、100gの溶液とし、下記表3に示す組成の外用剤組成物を調製した。得られた外用剤組成物について、上記と同様の評価を行った。結果を表3に併記する。なお、実施例6,7は参考例である。
[処方例1]
下記組成のクリーム剤を得た。
組成 %
(A)ウフェナマート 5.0
(B)クロタミトン 2.0
(C)ジフェンヒドラミン 1.0
ペンタオレイン酸デカグリセリル 2.0
ポリオキシエチレン硬化ヒマシ油(10E.O.) 8.0
オレイルアルコール 2.0
スクワラン 10.0
DL−リンゴ酸 0.4
精製水 69.6
合計 100.0
下記組成のクリーム剤を得た。
組成 %
(A)ウフェナマート 5.0
(B)クロタミトン 2.0
(C)ジフェンヒドラミン 1.0
ポリオキシエチレン硬化ヒマシ油(10E.O.) 10.0
オレイルアルコール 2.0
マクロゴール(ポリエチレングリコール)20000 2.0
セレシン 1.0
スクワラン 10.0
精製水 67.0
合計 100.0
下記組成のクリーム剤を得た。
組成 %
(A)ウフェナマート 4.0
(B)クロタミトン 2.0
(C)ジフェンヒドラミン 1.0
ペンタオレイン酸デカグリセリル 2.0
ポリオキシエチレン硬化ヒマシ油(10E.O.) 8.0
オレイルアルコール 2.0
スクワラン 10.0
DL−リンゴ酸 0.4
精製水 70.6
合計 100.0
下記組成のクリーム剤を得た。
組成 %
(A)ウフェナマート 6.0
(B)クロタミトン 2.0
(C)ジフェンヒドラミン 1.0
ポリオキシエチレン硬化ヒマシ油(10E.O.) 10.0
オレイルアルコール 2.0
マクロゴール(ポリエチレングリコール)20000 2.0
セレシン 1.0
スクワラン 10.0
精製水 66.0
合計 100.0
・ウフェナマート:塩野フィネス (株)ウフェナマート
・クロタミトン:住友化学(株) クロタミトン
・ジフェンヒドラミン:金剛化学(株) 日局ジフェンヒドラミン
Claims (6)
- (A)ウフェナマート、(B)クロタミトン、及び(C)抗ヒスタミン剤を含有し、前記(C)成分が、ジフェンヒドラミン、クロルフェニラミン、メキタジン及びイソチペンジルから選ばれる1種以上であり、前記(B)成分の配合量が0.2〜2質量%であり、(C)/(B)で表わされる前記(B)成分と前記(C)成分との配合比率が0.25〜2.5である外用剤組成物。
- (C)成分が、ジフェンヒドラミンである請求項1記載の外用剤組成物。
- (C)/(A)で表わされる前記(A)成分と前記(C)成分との配合比率が0.1〜1である請求項1又は2記載の外用剤組成物。
- 抗炎症剤である請求項1〜3のいずれか1項記載の外用剤組成物。
- (A)成分の配合量が0.2〜10質量%、(C)成分の配合量が0.1〜5質量%である請求項1〜4のいずれか1項記載の外用剤組成物。
- (A)ウフェナマート及び(B)クロタミトンを含有する外用剤組成物に配合する、(C)抗ヒスタミン剤を有効成分とする抗炎症作用増強剤であって、前記(C)成分が、ジフェンヒドラミン、クロルフェニラミン、メキタジン及びイソチペンジルから選ばれる1種以上であり、前記(B)成分の配合量が外用剤組成物中0.2〜2質量%であり、(C)/(B)で表わされる前記(B)成分と前記(C)成分との外用剤組成物中の配合比率が0.25〜2.5である抗炎症作用増強剤。
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