JP6817733B2 - 内出血治療用製剤 - Google Patents
内出血治療用製剤 Download PDFInfo
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- JP6817733B2 JP6817733B2 JP2016135353A JP2016135353A JP6817733B2 JP 6817733 B2 JP6817733 B2 JP 6817733B2 JP 2016135353 A JP2016135353 A JP 2016135353A JP 2016135353 A JP2016135353 A JP 2016135353A JP 6817733 B2 JP6817733 B2 JP 6817733B2
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- oil
- internal bleeding
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Description
項1. ニコチン酸ベンジル及び液状油を含み、油中水型乳化形態である、内出血治療用製剤。
項2. ポリエチレンスルホン酸ナトリウムを含む、項1に記載の内出血治療用製剤。
項3. 青あざの治療に使用される、項1又は2に記載の内出血治療用製剤。
本発明の内出血治療用製剤は、内出血治療のための有効成分としてニコチン酸ベンジルを含有する。ニコチン酸ベンジルとは、血行促進作用、細胞賦活作用等が知られている公知の化合物である。ニコチン酸ベンジルは、油性成分であるため、本発明の内出血治療用製剤では油相中に含有される。
本発明の内出血治療用製剤は、油中水型の乳化形態における油相を構成する基材成分として液状油を含有する。
本発明の内出血治療用製剤は、更にポリエチレンスルホン酸ナトリウムを含有してもよい。ポリエチレンスルホン酸ナトリウムが含まれる場合には、血行促進作用を更に向上させて、より優れた内出血治療効果を奏することが可能になる。更にポリエチレンスルホン酸ナトリウムが含まれる場合には、油中水型の乳化形態の乳化安定性を向上させつつ製剤の粘度の向上も認められるので、適度な硬さを有する安定な高粘度タイプの乳化製剤にすることもできる。
本発明の内出血治療用製剤は、油中水型の乳化形態における油相を構成する基材成分として、液状油に加えて、固形油を含んでいてもよい。
本発明の内出血治療用製剤は、油中水型の乳化形態における油相を構成する基材成分として、更に高級アルコールを含んでいてもよい。特に、ポリエチレンスルホン酸ナトリウムと共に高級アルコールを含む場合には、乳化安定性の向上、粘度の向上をより一層効果的に図ることができる。
本発明の内出血治療用製剤には、油中水型の乳化形態における水相を構成する基剤成分として水が含まれる。本発明の乳化組成物における水の含有量について、内出血治療用製剤の形態等に応じて適宜設定すればよいが、例えば、30〜90重量%、好ましくは40〜80重量%、更に好ましくは50〜70重量%が挙げられる。
本発明の内出血治療用製剤は、油中水型の乳化形態に調製するためにノニオン性界面活性剤が含まれていることが好ましい。
本発明の内出血治療用製剤には、保湿性の付与等のために、必要に応じて多価アルコールが含まれていてもよい。
本発明の内出血治療用製剤は、前述する成分の他に、必要に応じて、他の薬理成分を含有していてもよい。このような薬理成分としては、例えば、抗ヒスタミン剤(ジフェンヒドラミン、塩酸ジフェンヒドラミン等)、局所麻酔剤(プロカイン、テトラカイン、ブピパカイン、メピパカイン、クロロプロカイン、プロパラカイン、メプリルカイン又はこれらの塩、オルソカイン、オキセサゼイン、オキシポリエントキシデカン、ロートエキス、ペルカミンパーゼ、テシットデシチン等)、抗炎症剤(インドメタシン、フェルビナク、ジクロフェナクナトリウム、ロキソプロフェンナトリウム等)、皮膚保護剤(コロジオン、ヒマシ油等)、血行促進成分(ノニル酸ワニリルアミド、ニコチン酸ベンジルエステル、カプサイシン、トウガラシエキス、γ−オリザノール、ビタミンA類(レチノールパルミチン酸エステル等)、ビタミンE類(酢酸トコフェロール等)等)、清涼化剤(メントール、カンフル、ボルネオール、ハッカ水、ハッカ油等)、ムコ多糖類(コンドロイチン硫酸ナトリウム、グルコサミン等)等が挙げられる。
また、本発明の内出血治療用製剤の粘度としては、ポリエチレンスルホン酸ナトリウムの添加の有無、使用する油性基剤の種類や量等に応じて異なるが、例えば、25℃における粘度として、1万mPa・s以上、好ましくは1万〜100万mPa・s、更に好ましくは10万〜50万mPa・sが挙げられる。ここで、25℃における粘度は、乳化組成物45gをスクリュー管(50ml)に充填し、ブルックフィールド回転粘度計(B型粘度計、BROOK Field社製DV-II)にて、使用スピンドルT−E、回転数20rpm、回転開始から3分後の条件で測定することによって求められる値である。
本発明の内出血治療用製剤の乳化形態は油中水型である。このように、ニコチン酸ベンジルと液状油を含み、且つ油中水型の乳化形態にすることによって、優れた血行促進作用を発揮でき、皮下で生じる内出血を効果的に治療することが可能になる。
1.乳化組成物の製造
表1に示す組成の乳化組成物(クリーム剤)を調製した。具体的な製造方法は、以下の通りである。
油性成分、界面活性剤、高級アルコール、及び液状油を混合し、80℃で加熱溶解することにより、油相原料を調製した。また、別途、水性成分、多価アルコール、及び水性基剤を混合し、80℃で加熱溶解することにより、水相原料を調製した。80℃に加熱した水相原料に、80℃に加熱した油相原料を徐々に添加しホモミキサーを用いて乳化させた。その後、撹拌しながら35度まで冷却することにより、水中油型乳化組成物を得た。
油性成分、界面活性剤、高級アルコール、液状油、及び固形油を混合し、80℃で加熱溶解することにより、油相原料を調製した。また、別途、水性成分、多価アルコール、及び水性基剤を混合し、80℃で加熱溶解することにより、水相原料を調製した。80℃に加熱した油相原料に対して、80℃に加熱した油相原料をディスパーをかけながら徐々に添加して乳化を行った。その後、撹拌しながら35度まで冷却することにより、油中水型乳化組成物を得た。
得られた各乳化組成物を用いて、血行促進作用の評価を行った。具体的には、先ず、被験者の前腕内側に1cm四方の枠を作成し、試験開始前の色差をANTERA 3D(ガデリウス・メディカル株式会社製)を用いて測定した。次いで、1cm四方の枠に各乳化組成物0.05gを塗布し、8分後に塗布部の色差をANTERA 3Dを用いて測定した。測定にて得られたa値及びΔE値を、試験開始前の値と比較し、8分後の変化量を算出した。
得られた結果を表1に示す。この結果から、ニコチン酸ベンジル及び液状油を含み、且つ油中水型の乳化形態の場合には、優れた血行促進作用が認められた(実施例1〜4)。特に、ポリエチレンスルホン酸ナトリウムを更に含む場合には、格段顕著な血行促進作用が認められた(実施例2及び4)。即ち、ニコチン酸ベンジル及び液状油を含み、且つ油中水型の乳化形態の製剤は、血行促進作用が高く、優れた内出血の治療効果が認められ得ることが明らかとなった。
実施例4の油中水型乳化組成物の内出血の治療効果を評価した。具体的には、被験者が打ち身によって内出血(青あざ、3cm2程度)を発症した直後から、12日間にわたって、1日2回の頻度で、1回当たり約0.1g(ニコチン酸ベンジル量:約0.042mg/cm2)の油中水型乳化組成物を内出血の患部に塗布した。油中水型乳化組成物の塗布前、塗布開始から4日後、7日後及び12日後に、内出血の患部を皮膚評価デバイス(ANTERA 3D、ガデリウス・メディカル株式会社製)を用いて撮影し、カラーイメージの像と画像処理によるヘモグロビン量を可視化した像を得た。
1.試験方法
試験例1で調製した油中水型乳化組成物(実施例1〜4)について、乳化安定性及び粘度の評価を行った。具体的な評価方法は以下の通りである。
各油中水型乳化組成物をスクリュー管(容量13.5ml)に充填し、60℃での3日間保存後の乳化安定性、高温サイクル試験後の乳化安定性、及び低温サイクル試験後の乳化安定性について評価した。
<乳化安定性の判定基準>
◎:油相と液相の分離が認められず、性状も変化していない。
○:油相と液相の分離は認められないが、性状がやや変化している。
△:油相と液相の分離がやや認められる。
×:油相と液相の分離が認められる。
各油中水型乳化組成物の25℃における粘度の測定を行った。25℃における粘度の測定は、各油中水型乳化組成物45gをスクリュー管(50ml)に充填し、ブルックフィールド回転粘度計(B型粘度計、BROOK Field社製DV-II)にて、使用スピンドルT−E、回転数20rpm、回転開始から3分後の条件で測定することによって求めた。
得られた結果を表2に示す。この結果から、ニコチン酸ベンジル及び液状油を含む油中水型乳化組成物において、ポリエチレンスルホン酸ナトリウムを更に含む場合には、乳化安定性が向上しており、しかも粘度が高くなっていた(実施例2及び4)。特に、安定性及び粘度上昇に寄与すると考えられる固形油を含有しない場合でも、ニコチン酸ベンジル、液状油、及びポリエチレンスルホン酸ナトリウムを含む油中水型乳化組成物では、優れた乳化安定性を備えつつ、高い粘度を有していた(実施例2)。
表3に示す組成の油中水型乳化組成物(クリーム剤)製造した。具体的な製造方法は、前記試験例1で製造した油中水型乳化組成物の場合と同様である。得られた油中水型乳化組成物のうち、処方例1、3、5、7及び8について、試験例1と同様の方法で血行促進作用の評価を行ったところ、いずれも優れた血行促進作用が認められた。更に、得られた油中水型乳化組成物(処方例1〜11)について、試験例3と同様の方法で乳化安定性及び粘度の評価を行ったところ、いずれも優れた乳化安定性を備え、且つ高い粘度を有していた。
Claims (3)
- ニコチン酸ベンジル及び液状油を含み、前記液状油がエステル油を含む、油中水型乳化形態である、内出血治療用製剤。
- ポリエチレンスルホン酸ナトリウムを含む、請求項1に記載の内出血治療用製剤。
- 青あざの治療に使用される、請求項1又は2に記載の内出血治療用製剤。
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