JP2014094959A - 歯周病用歯磨組成物 - Google Patents
歯周病用歯磨組成物 Download PDFInfo
- Publication number
- JP2014094959A JP2014094959A JP2014008499A JP2014008499A JP2014094959A JP 2014094959 A JP2014094959 A JP 2014094959A JP 2014008499 A JP2014008499 A JP 2014008499A JP 2014008499 A JP2014008499 A JP 2014008499A JP 2014094959 A JP2014094959 A JP 2014094959A
- Authority
- JP
- Japan
- Prior art keywords
- water
- periodontal disease
- mass
- hydrogel particles
- 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.)
- Granted
Links
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Abstract
【解決手段】(A)薬効成分を分散して含有する、平均粒径50〜500μmのハイドロゲル粒子、(B)粘結剤、及び(C)水を含有する歯周病用歯磨組成物。
【選択図】なし
Description
従って、本発明の課題は、薬効成分を歯肉溝に送達し、その歯肉溝で薬効成分を効率的に作用させることのできる歯磨組成物を提供することにある。
すなわち、本発明は、(A)薬効成分を含有する、平均粒径50〜500μmのハイドロゲル粒子、(B)粘結剤、及び(C)水を含有する歯周病用歯磨組成物を提供するものである。
本発明の歯磨組成物に含まれるハイドロゲル粒子は、薬効成分を分散状態又は乳化状態で含有するものである。薬効成分としては、歯周病に対して予防又は改善効果を有するものであればよく、抗炎症剤、血行促進剤、抗菌剤、殺菌剤、止血剤、抗酸化剤などが挙げられる。これらの薬効成分は、油溶性でも水溶性でもよく、油溶性薬効成分であれば溶剤(油剤)に溶解させて、また水溶性薬効成分であれば、例えば、ポリマーと混合することで水に不溶性の複合体を形成させて、ハイドロゲル粒子中に分散させることができる。
分散剤又は乳化剤としては、高分子乳化分散剤、非イオン性界面活性剤、アニオン性界面活性剤、カチオン性界面活性剤及び両性界面活性剤からなる群より選ばれる1種以上が挙げられる。
分散剤及び乳化剤の濃度は、油溶性薬効成分を均一に分散させる観点からハイドロゲル粒子全重量を基準として、0.001〜10質量%、更に0.005〜5質量%、特に0.01〜2質量%が好ましい。
陰イオン界面活性剤としては、例えばアシルグルタミン酸ナトリウム、アシルサルコシンナトリウム等のアシルアミノ酸塩、アルキルリン酸ナトリウム等のアルキルリン酸塩、アルキル硫酸エステル塩、高級脂肪酸スルホン化モノグリセリド塩、イセチオン酸の脂肪酸エステル塩、N−メチル長鎖アシルタウリンナトリウム塩、ポリオキシエチレンモノアルキルリン酸塩等が挙げられる。
具体的には、水溶性薬効成分としてはポリフェノール類が好ましい。当該ポリフェノール類はポリマーAにより水不溶性の複合体を形成させて、ハイドロゲル粒子に含有させることができる。
カテキン類としては、例えばカテキン、ガロカテキン、カテキンガレート、ガロカテキンガレート等の非エピ体カテキン類;エピカテキン、エピガロカテキン、エピカテキンガレート、エピガロカテキンガレート等のエピ体カテキン類などが挙げられる。フラバノール類としては、ケンフェロール、ケルセチン、ミリセチン等が挙げられる。フラボン類としては、アビゲニン、ステオリン、ジオスメチン等が挙げられる。ロイコアントシアニジン類としては、フラバン−3−オール、フラバン−3,4−ジオール等が挙げられ、アントシアニジン類としては、シアニジン、デルフィニジン等が挙げられる。プロアントシアニジン類は縮合型タンニンのオリゴマーの総称であり、代表的なものとしてウーロン茶ポリフェノール、紅茶ポリフェノール、ブドウ種子ポリフェノール、松樹皮ポリフェノール、ホップポリフェノール、リンゴポリフェノール、クランベリーポリフェノール、ブルーベリーポリフェノール、落花生渋皮ポリフェノール、黒豆ポリフェノール、カカオポリフェノール、柿タンニン等が挙げられる。
カテキン類は、茶葉から熱水もしくは水溶性有機溶媒により抽出された緑茶抽出物を濃縮、精製等を行うことによって得ることができる。また、市販の三井農林(株)「ポリフェノン」、伊藤園(株)「テアフラン」、太陽化学(株)「サンフェノン」などの緑茶抽出物の濃縮物を用い、成分調整を行うことにより、本発明の目的に適うカテキン類を得ることができる。
プロアントシアニジン類は、様々な植物や果実に含まれ、例えば、発酵茶葉、ブドウ種子、松樹皮、ホップ、リンゴ、クランベリー、ブルーベリー、落花生渋皮、黒豆、カカオ、柿などを水もしくは水溶性有機溶媒により抽出された植物抽出物を濃縮、精製等を行うことによって得ることができる。また、市販の丸善製薬「ウーロン茶エキス」、研光通商(株)「松樹皮エキス」、「ブドウ種子エキス」、「クランベリーパウダー」、アサヒビール(株)「アップルフェノン」、リリース科学工業(株)「パンシル」などの植物抽出物の濃縮物を用い、成分調整を行うことにより、本発明の目的に適うプロアントシアニジン類を得ることができる。
ポリマーAの重量平均分子量は、水溶性薬効成分、例えばポリフェノール類の変色を効果的に抑制する観点から、6,000以上が好ましく、60,000以上がより好ましく、400,000以上が更に好ましく、1,200,000以上が特に好ましい。また、水不溶性の複合体が塊状の凝集物となることを抑制し微細な水不溶性の複合体を得る観点から、3,000,000以下が好ましく、2,000,000以下がより好ましい。
本発明において、ポリマーAの重量平均分子量は、一般的な重量平均分子量測定法である粘度法によって測定された値である。尚、重量平均分子量は光散乱法等によって測定することもできる。本発明において、ポリマーAがポリビニルピロリドンである場合は、粘度の測定値からFikentscherの公式に基づいて計算されたK−値によって重量平均分子量を決定する。
本発明のハイドロゲル粒子中のゲル形成剤の含有量は、ハイドロゲル粒子を歯磨組成物へ配合する時の壊れを防止する観点から、0.25〜5質量%が好ましく、0.5〜4質量%がより好ましく、1〜4質量%が更に好ましい。
糖類としては、グルコース、ガラクトース、フルクトース、マンノース、マンニトール、サッカロース、マルトース、ラクトース等が挙げられる。
多価アルコールとしては、グリセリン、ソルビトール、エチレングリコール、プロピレングリコール、オリゴサッカライド等が挙げられる。
本発明の歯磨組成物は、上記のようなハイドロゲル粒子、粘結剤及び水を含有する。
本発明に用いられる粘結剤としては、例えば、アルギン酸ナトリウム、カルボキシメチルセルロースナトリウム、カラギーナン、キサンタンガム、ポリアクリル酸ナトリウム、ヒドロキシエチルセルロース、ヒドロキプロピルセルロース、ペクチン、トラガントガム、アラビアガム、グアーガム、カラヤガム、ローカストビーンガム、ジェランガム、タマリンドガム、サイリウムシードガム、ポリビニルアルコール、コンドロイチン硫酸ナトリウム及びメトキシエチレン無水マレイン酸共重合体等が挙げられ、特にカルボキシメチルセルロースナトリウム、カラギーナン及びキサンタンガムが好ましい。
エリスリトールの粒子径は、口腔内で冷涼感が長く続くという観点から45μm以上355μm未満が好ましく、53μm以上300μm未満がより好ましく、75μm以上250μm未満が更に好ましい。エリスリトールの粒子径が45μm以上のものは、口の中で瞬時に溶けることがなく、冷涼感が長く続き好ましい。また355μm未満のものは、口腔内で溶けやすく冷涼感を発揮することができる。
篩:JIS標準篩 φ75mm
目開き:上段より、それぞれ500μm、355μm、250μm、180μm、125μm、90μm及び45μmの目開きを有する篩の下に受器を有する。
振盪機:ミクロ型電磁振動機M−2型(筒井理化学器機(株))方法:試料15gを500μm篩上に載せ、電磁振動機にて5分間分級する。250μm、180μm、125μm、90μm及び45μmの目開きを有する篩上に存在するエリスリトールの合計量を粒子径45μm以上355μm未満のエリスリトールとする。
イオン交換水319gに寒天(伊那食品工業(株)、UP−37)を15g、ポリビニルピロリドン(ISP社、PVP K−90、重量平均分子量1300000)を16g溶解させて調整した水溶液(85℃)と、イオン交換水140gに茶エキス(太陽化学(株)、サンフェノン100S、カテキン類含有量60〜70%)10g、L−アスコルビン酸(第一製薬(株)、アスコルビン酸)、アクリル酸・メタクリル酸アルキル共重合体(ノベオン社、ペムレンTR−2)を溶解させて調製した水溶液(20℃)と、ジカプリン酸ネオペンチルグリコール(日清オイリオ(株)、エステモールN−01)及びトリクロサン(チバ・ジャパン(株)、イルガケアMP)とを、ホモミキサーによって混合(8000r/min、1分)して、カテキンとポリビニルピロリドンの複合体の水分散液を得て、これを気相中に噴霧することによって表1に示す組成のハイドロゲル粒子aを得た。ハイドロゲル粒子aの平均粒径は200μmであった。
表1に示すトリクロサンを含有するハイドロゲル粒子を配合した歯磨組成物A(本発明品)と、ハイドロゲル粒子を含有せず、歯磨組成物中に直接トリクロサンを配合した歯磨組成物B(比較例)とを調製した(表2)。得られた歯磨組成物A及びBについて下記方法で歯肉溝モデル14に付着したトリクロサンの量を比較した。なお、ハイドロゲル粒子aは、歯肉溝モデル14への送達性を確認するために着色料を配合している。
歯肉溝へのハイドロゲル粒子、及び薬効成分の送達性を以下のような歯モデル1を用いて評価を行った。図1に示すように、歯モデル1は、透明なアクリル板を歯のモデル12として用い、歯肉の硬度に類似するウレタンゴム(半透明)を歯肉モデル13として用いた。
歯肉モデル13のウレタンゴムは、厚みが2mm、硬さがAの30度(西東京精密株式会社のゴム硬度計A WR104Aで測定 JIS K 6253準拠のタイプAデュロメーター)のものを使用し、ウレタンゴムの上端角部はR6mmのアールを形成している。ウレタンゴムの上端のアールを形成した部分と、ウレタンゴムとアクリル板とが密着した部分の境界Pよりもアクリル板とウレタンゴムが密着した下方側を歯肉溝モデル14として送達性を評価した。歯肉モデル13に用いたウレタンゴムは、ヒトの歯肉と同様にブラッシングによってわずかに動き、アクリル板と密着した部分に数ミクロンの隙間を形成しうる。
尚、回収液中のトリクロサンの歯肉溝への送達割合は、ブラッシングに用いた歯磨組成物中に含まれる量と同量のハイドロゲル粒子を移動層で10分間超音波抽出をかけ、濾過した液中のトリクロサン濃度を100%とし、本ブラッシングを行う前の歯肉溝モデル14内部を綿棒で擦過したものの回収液中のトリクロサン濃度を0%として、歯肉溝モデル14へのトリクロサン送達割合を算出した。
高速液体クロマトグラフィー(HPLC)を適用した。HPLCのカラムは内径4〜10mm、長さ10〜30cmのステンレス管を用い、液体クロマトグラフ用オクタデシルシリル化シリカゲル(平均粒径4〜10μm)を用い、溶離液はメタノール及び水の混液(70:30)に0.1w/v%になるようにリン酸を加えたものを1.0mL/分の溶出速度で用いた。トリクロサンの検出は紫外吸光光度計で254nmの吸光度測定により行った。調整した試験溶液、及びトリクロサン標準溶液20μLを各々正確にとり、上記の液体クロマトグラフ法の試験を行い、それぞれの液のトリクロサンのピーク面積をトリクロサンの理論段数を4000段以上、テーリング係数を0.8〜1.5として求め、トリクロサン標準溶液のピーク面積を検量線として比較し、次式により本品中のトリクロサン含量を算出した。
本品中のトリクロサン含量=(Y×Z)/X
X:トリクロサン標準溶液の試験により得られたトリクロサンのピーク面積
Y:試験溶液の試験により得られたトリクロサンのピーク面積
Z:トリクロサン標準溶液の濃度
その結果を図2に示す。図2のグラフには、歯磨組成物A、Bのそれぞれについて5回評価を行ったトリクロサンの送達の割合の平均値を示す。図2に示すように、トリクロサンをハイドロゲル粒子に含有しない歯磨組成物Bに比べてハイドロゲル粒子にトリクロサンを配合した歯磨組成物Aは、歯肉溝モデル14内部への薬効成分(トリクロサン)の送達量が約4倍である結果が得られた。
次に、図3(a)〜(b)に透明なアクリル板を用いた歯モデル12の側から、ハイドロゲル粒子が歯肉溝モデル14に入りこむ状態を歯磨組成物Aを用いてブラッシング等を行った状態の写真により示す。図3(a)は、歯磨組成物Aをのせてブラッシングを行った状態である。図3(a)から理解できるように、ハイドロゲル粒子が境界Pよりも下方、約2mmまで殆ど破壊されないで送達している。これは、ブラッシングによって歯肉モデル13がわずか動き、歯のモデル12との間にできた数ミクロンの隙間にハイドロゲル粒子が押し込まれ、押し込まれたハイドロゲル粒子が歯肉モデル13と歯のモデル12との間に挟まれて保持されたためと考えられる。図3(b)は、ブラッシング後にマッサージを2回行い、水洗いをした状態である。図3(b)に示す歯肉溝モデル14は透明又は半透明であるため、歯肉溝モデル14に白く移った領域Qを観察することができた。領域Qは、マッサージによりハイドロゲル粒子が破壊されて歯肉溝モデル14に油剤が付着された状態を示している。
製造例1と同様な方法で、表3〜表8に示すハイドロゲル粒子c〜ハイドロゲル粒子hを製造した。ハイドロゲル粒子c〜hについても、歯肉溝モデル14への送達性を確認するため着色料を配合した。こららのハイドロゲル粒子はいずれも平均粒径は140〜240μmの範囲であった。更に表9、10に示す歯磨組成物C〜歯磨組成物Hを製造し、実施例1と同様に図1に示した歯モデル1を用いてブラッシングを行った。その結果、歯磨組成物C〜歯磨組成物Hのいずれを用いた場合でも、境界Pよりも下方、約2mmまでハイドロゲル粒子が送達されることを観察することができた。
Claims (10)
- (A)薬効成分を分散又は乳化して含有する、平均粒径100〜500μmであるハイドロゲル粒子 0.1〜15質量%、(B)粘結剤、及び(C)水 5〜40質量%を含有し、かつ
薬効成分として、成分(A)中の含有量が0.01〜10質量%である油溶性薬効成分、又は成分(A)中の含有量が0.001〜10質量%である水溶性薬効成分を含有するとともに、ゲル形成剤として、成分(A)中の含有量が0.5〜5質量%である寒天を含有する歯周病用練歯磨組成物。 - ハイドロゲル粒子が、薬効成分として油溶性薬効成分を含有し、乳化剤及び/又は分散剤を含有する請求項1に記載の歯周病用練歯磨組成物。
- 油溶性薬効成分が、アズレン類、トコフェロール類、グリチルレチン酸類、トリクロサン、イソプロピルメチルフェノール、ヒノキチオール及びジヒドロコレステロールから選ばれる1種以上である請求項2に記載の歯周病用練歯磨組成物。
- ハイドロゲル粒子が、薬効成分として水溶性薬効成分であるポリフェノール類を含有し、さらに水溶性薬効成分と水不溶性の複合体を形成する、ポリビニルピロリドン、ヒドロキシエチルセルロース及びヒドロキシプロピルセルロースから選ばれるポリマーを含有する請求項1に記載の歯周病用練歯磨組成物。
- ポリフェノール類が、カテキン類である請求項4に記載の歯周病用練歯磨組成物。
- ポリフェノール類が、プロアントシアニジン類である請求項4に記載の歯周病用練歯磨組成物。
- 粘結剤の含有量が、0.2〜2質量%である請求項1〜6のいずれか1項記載の歯周病用練歯磨組成物。
- 粘結剤が、アルギン酸ナトリウム、カルボキシメチルセルロースナトリウム、カラギーナン、キサンタンガム、ポリアクリル酸ナトリウム、ヒドロキシエチルセルロース、ヒドロキプロピルセルロース、ペクチン、トラガントガム、アラビアガム、グアーガム、カラヤガム、ローカストビーンガム、ジェランガム、タマリンドガム、サイリウムシードガム、ポリビニルアルコール、コンドロイチン硫酸ナトリウム及びメトキシエチレン無水マレイン酸共重合体から選ばれる少なくとも1種である請求項1〜7のいずれか1項記載の歯周病用練歯磨組成物。
- 予め製造したハイドロゲル粒子を含有させることにより得られる請求項1〜8のいずれか1項記載の歯周病用練歯磨組成物。
- ハイドロゲル粒子が滴下法又は噴霧法により製造されたものである請求項1〜9のいずれか1項記載の歯周病用練歯磨組成物。
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JP2009196987A (ja) | 2009-09-03 |
JP2016094468A (ja) | 2016-05-26 |
JP5883042B2 (ja) | 2016-03-09 |
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