JP2016527236A - 歯の石灰化のための組成物および方法 - Google Patents
歯の石灰化のための組成物および方法 Download PDFInfo
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- A61K8/19—Cosmetics or similar toiletry preparations characterised by the composition containing inorganic ingredients
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- A61K8/21—Fluorides; Derivatives thereof
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A—HUMAN NECESSITIES
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- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
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- A—HUMAN NECESSITIES
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- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/19—Cosmetics or similar toiletry preparations characterised by the composition containing inorganic ingredients
- A61K8/24—Phosphorous; Compounds thereof
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- A—HUMAN NECESSITIES
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- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
- A61K8/64—Proteins; Peptides; Derivatives or degradation products thereof
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Abstract
Description
(i)少なくとも1種類のホスホペプチドを含む溶液を得るステップと;
(ii)pHを約7.0以下に維持しながら、カルシウムイオン、ホスフェートイオン、および水酸化物イオンを含む溶液を混合するステップと
を含む方法によって製造することができる。
(i)少なくとも1種類のホスホペプチドを含む溶液を得るステップと;
(ii)pHを約7.0以下に維持しながら、カルシウムイオン、ホスフェートイオン、水酸化物イオン、およびフッ化物イオンを含む溶液を混合するステップと、
を含む方法によって製造することができる。
a)カルシウムイオンを含む第1の溶液、ホスフェートイオンを含む第2の溶液、および任意選択によりフッ化物イオンを含む第3の溶液を、ホスホペプチドおよび溶媒を含む溶液と、約5から7未満のpHで混合するステップと;
b)水酸化物イオンを加えることによって、混合中の溶液のpHを約5.0から7.0未満に維持するステップと
によって得ることができる、または得られる場合とを含むことができる。
(i)カルシウム、無機ホスフェート、およびフッ化物(任意選択)を含む溶液を得るステップと;
(ii)(i)を、PP−ACPを含む溶液と混合するステップと
を含む方法によって生成されるホスホペプチドまたはリンタンパク質(PP)安定化非晶質リン酸カルシウム(ACP)または非晶質フッ化リン酸カルシウム(ACFP)複合体も提供する。
(i)PP−ACPおよび/またはPP−ACFP複合体を含む粉末を得るステップと;
(ii)有効量のリン酸カルシウムと乾式ブレンドするステップと;
(iii)乾式ブレンドしたPP−ACPおよび/またはPP−ACFPおよびリン酸カルシウム混合物から口腔ケア配合物を配合するステップと
を含む方法によって製造することができる。
(i)歯の表面にタンパク質破壊剤を接触させるステップと、
(ii)歯の表面に本発明の組成物を接触させるステップと
を含む方法をも提供する。
GluおよびAspの場合の2−アミノアジピン酸(Aad);
GluおよびAspの場合の2−アミノピメリン酸(Apm);
Met、Leu、および別の脂肪族アミノ酸の場合の2−アミノ酪(Abu)酸;
Met、Leu、および別の脂肪族アミノ酸の場合の2−アミノヘプタン酸(Ahe);
Glyの場合の2−アミノイソ酪酸(Aib);
ValおよびLeuおよびIleの場合のシクロヘキシルアラニン(Cha);
ArgおよびLysの場合のホモアルギニン(Har);
Lys、ArgおよびHisの場合の2,3−ジアミノプロピオン酸(Dpr);
Gly、Pro,およびAlaの場合のN−エチルグリシン(EtGly);
Asn、およびGlnの場合のN−エチルアスパリギン(N−ethylasparigine)(EtAsn);
Lysの場合のヒドロキシルリシン(Hyl);
Lysの場合のアロヒドロキシルリシン(AHyl);
Pro、Ser、およびThrの場合の3−(および4)ヒドロキシプロリン(3Hyp、4Hyp);
Ile、Leu,およびValの場合のアロイソロイシン(Alle);
Alaの場合のρ−アミジノフェニルアラニン;
Gly、Pro、Alaの場合のN−メチルグリシン(MeGly、サルコシン)。
Ileの場合のN−メチルイソロイシン(MeIle);
Metおよび別の脂肪族アミノ酸の場合のノルバリン(Nva);
Metおよび別の脂肪族アミノ酸の場合のノルロイシン(Nle);
Lys、ArgおよびHisの場合のオルニチン(Orn);
Thr、AsnおよびGlnの場合のシトルリン(Cit)およびメチオニンスルホキシド(MSO);
Pheの場合のN−メチルフェニルアラニン(MePhe)、トリメチルフェニルアラニン、ハロ(F、Cl、BrおよびI)フェニルアラニン、トリフロウリルフェニルアラニン(triflourylphenylalanine)。
水
グリセロール
CPP−ACP
D−ソルビトール
二酸化ケイ素
カルボキシメチルセルロースナトリウム(CMC−Na)
プロピレングリコール
二酸化チタン
キシリトール
リン酸
グアーガム
酸化亜鉛
サッカリンナトリウム
p−ヒドロキシ安息香酸エチル
酸化マグネシウム
p−ヒドロキシ安息香酸ブチル
p−ヒドロキシ安息香酸プロピル
CPP−ACFPおよびCPP−ACP溶液の調製
3.25MのCaCl2、1.25MのNa2HPO4、1MのNaOH、および1MのNaFのストック溶液を、約30のアリコートで、おおよそ78mMのCa2+、48mMのホスフェート、および12mMのフッ化物濃度の最終濃度が得られるまで、10〜15%w/vのカゼインのトリプシン消化物に加えた。溶液はゆっくり加えた(すなわち、1分当たり約1体積%未満の添加)。最初にホスフェート溶液のアリコートを加え、続いてカルシウム溶液のアリコートを加えた。十分に混合しながらNaOHを用いて、pHを7.0、6.5、6.0、5.5、および5.0に維持した。通常はカルシウムイオンをそれぞれ加えた後に、水酸化物イオンを加えるpHスタットによって水酸化ナトリウム溶液を自動的に加えた。カルシウムイオン、ホスフェートイオン、水酸化物イオン、およびフッ化物イオンの添加後、溶液を0.1ミクロンにフィルターで濾過し、1〜2倍に濃縮した。希望するなら、保持液を水で洗浄して、塩および不活性(および苦みのある)ペプチドを除去することができる。CPP−ACP溶液は、フッ化物を加えずに上記のように調製した。
緩くおよび強く結合したカルシウムおよびホスフェートの測定
実施例1の各pHの場合での滴定および濾過の終了後、各保持液の試料を採取し、3000の分子量カットオフのCentriprep 3限外濾過膜を用いた濾液として10%未満を集めた。試料を含有するCentriprepを、Beckman J2−21遠心分離機中、JA 10.5ローターを用いて1,000gで15分間遠心分離した。Centriprepの遠心分離前の元の試料と、Centriprepの遠心分離具の濾液の試料とを、カルシウム、ホスフェート、およびフッ化物の濃度の分析用に採取した。元の試料の分析から、全体のカルシウム、ホスフェート、およびフッ化物のイオン濃度が得られ、濾液の分析から、緩く結合したカルシウム、ホスフェート、およびフッ化物の濃度が得られた。全体の濃度と緩く結合した濃度との間の差が、CPPによるCa、Pi、およびFの強く結合した濃度となる。
CPP−ACFPおよびCPP−ACP溶液の調製
Recaldent(登録商標)(CPP−ACP)をRecaldent Pty Ltd,Victoria,Australiaより購入した。この製品(#841117)は、重量基準で14.3%のカルシウム、22.3%のホスフェート、および47%のカゼインホスホペプチドを含有した。この製品を0.5%で溶解させ、HClを加えることでpH5.5に調整した。次に、2.5MのNaOHを加えてpHを5.5に維持しながら、3.25MのCaCl2および2MのNaH2PO4を滴定することによって、カルシウムイオンおよびホスフェートイオンを加えた。溶液が半透明になるまで、カルシウムイオンおよびホスフェートイオンの滴定を続けた。加えたカルシウムおよびホスフェートの濃度を記録した。カルシウムイオンおよびホスフェートイオンを0.5%CPP−ACP溶液中に滴定し、リン酸カルシウムをさらに加えることによってpHを5.5まで下げることによって、溶液を形成することもできる。
CPP−ACPおよびリン酸カルシウムの配合物の調製
別の一例において、Recaldent(登録商標)(CPP−ACP)粉末をCaHPO4粉末と、CPP−ACP:CaHPO4の重量比1:10で乾式ブレンドした。次にこの粉末を無糖ガムおよび練り歯磨きの配合物に1〜5%w/wで加えた。
本発明により以下の成分を有する局所用クリームを製造することができる。
水
グリセロール
安定化ACPおよび/またはACFP
溶液のpHの上昇または維持が可能な化合物
D−ソルビトール
カルボキシメチルセルロースナトリウム(CMC−Na)
プロピレングリコール
二酸化ケイ素
二酸化チタン
キシリトール
リン酸
フッ化ナトリウム
香味料
サッカリンナトリウム
p−ヒドロキシ安息香酸エチル
プロピルp−ヒドロキシベゾエート(propyl p−hydroxybezoate)
p−ヒドロキシ安息香酸ブチル
本発明により以下の組成を有するマウスリンス配合物が製造される。
水
アルコール
Poloxamer 407
ラウリル硫酸ナトリウム
安定化ACPおよび/またはACFP
溶液のpHの上昇または維持が可能な化合物
フッ化ナトリウム
香味料
サッカリンナトリウム
p−ヒドロキシ安息香酸エチル
p−ヒドロキシ安息香酸プロピル
p−ヒドロキシ安息香酸ブチル
本発明により以下の組成を有する無糖チューインガム配合物が製造される。
結晶ソルビトール/マンニトール/キシリトール
ガムベース
炭酸カルシウム
グリセリン
安定化ACPおよび/またはACFP
溶液のpHの上昇または維持が可能な化合物
フッ化ナトリウム
香味油
水
本発明の有効性は、後述の実験によって示すことができた。Royal Dental Hospital of Melbourne,Australiaの10〜28歳の健康な患者から歯科矯正の理由で抜歯した歯からFLE(Thylstrup Fejerskov Index、TF=3)を有する7つの小臼歯を選択することができた。抜歯した歯に関して患者の同意を得るべきであり、Human Research Ethics Committee of the University of Melbourneにより研究プロトコルの承認を受けるべきである。次にすべての試験片は、付着軟組織を切除し、18%w/v酢酸ホルマリン溶液中室温で保管すべきである。
CPP−ACPによるエナメル質表面下再石灰化に対するハイポクロライトの影響
Reynolds,(1997).J Dent Res 76:1587−1595の方法を用いて、ヒトの歯のエナメル質の脱灰表面下病変を作製した。すべての吸着タンパク質を除去するために研磨することによってエナメル質表面を除去した。これによって、約50〜100μmのエナメル質が除去されて、研究用の研磨された被覆されないエナメル質表面が露出した。さらに、表面下病変を得るために使用した酸緩衝液はタンパク質を含有せず、そのためタンパク質はこれらの表面下病変に入らなかった。実施例1のようにpH5.0で作製されるCPP−ACPの商業的供給源であるRecaldent(登録商標)[Kraft Foods]を用いて、1%w/vCPP−ACPのpH5.0溶液を調製した。すべてのブロックを、37℃において1%CPP−ACPのpH5溶液を7日用いて再石灰化させた。しかし、半分は、1%v/v次亜塩素酸ナトリウム溶液に、CPP−ACP再石灰化期間の開始時に1分間曝露した。言い換えると、次亜塩素酸ナトリウムおよびCPP−ACPを表面下病変に同時に曝露した。再石灰化後、Reynolds(1997)に記載のように、エナメル質ブロックを埋め込み、切断して、横方向のマイクロラジオグラフィおよびデンシトメーター画像解析を行って、表3に示されるようなパーセント無機質含有量増加(%再石灰化)を求めた。Tukey HSD事後比較を用いて求めた平均の差の分散の一元分析から、ハイポクロライトを用いた処理によって、CPP−ACP溶液による再石灰化量が31%だけ大幅に増加したことが示された。
4NaClO+2H2O→4Na++4OH−+2Cl2+O2
・Fejerskov O,Baelum V,Manji F,Moller I (1988).Dental Fluorosis − A handbook for health workers Copenhagen:Munksgard.
・Reynolds EC(1998).Anticariogenic complexes of amorphous calcium phosphate stabilized by casein phosphopeptides:a review.Spec Care Dentist 18:8−16.
・Reynolds EC,Cai F,Shen P,Walker GD(2003).Retention in plaque and remineralization of enamel lesions by various forms of calcium in a mouthrinse or sugar−free chewing gum.J Dent Res 82:206−11.
・Shen P,Cai F,Nowicki A,Vincent J,Reynolds EC(2001).Remineralization of enamel subsurface lesions by sugar−free chewing gum containing casein phosphopeptide−amorphous calcium phosphate.J Dent Res 80:2066−70.
Claims (23)
- 歯の表面または表面下の石灰化方法であって、前記歯の表面または表面下に、溶液のpHの上昇または維持が可能な化合物と石灰化剤とを接触させるステップを含む、方法。
- 前記歯の表面が、齲蝕、歯牙酸蝕症、またはフッ素症によって生じるエナメル質中の病変である、請求項1に記載の方法。
- 前記石灰化剤が、安定化非晶質リン酸カルシウム(ACP)および/または非晶質フッ化リン酸カルシウム(ACFP)である、請求項1または2に記載の方法。
- 前記安定化非晶質リン酸カルシウム(ACP)および/または非晶質フッ化リン酸カルシウム(ACFP)が、練り歯磨き、歯磨き粉、液体歯磨き、マウスウォッシュ、マウスリンス、マウススプレー、バーニッシュ、歯科用セメント、トローチ、チューインガム、ロゼンジ、歯科用軟膏、歯肉マッサージクリーム、うがい用錠剤、乳製品、およびその他の食品の形態である、請求項3に記載の方法。
- 溶液のpHの上昇または維持が可能な前記化合物と前記石灰化剤とが、同時に前記歯の表面または表面下に接触する、請求項1〜4のいずれか一項に記載の方法。
- 前記石灰化剤の後に、溶液のpHの上昇または維持が可能な前記化合物が前記歯の表面または表面下に接触する、請求項1〜4のいずれか一項に記載の方法。
- 溶液のpHの上昇または維持が可能な前記化合物が水酸化物イオンを生成可能である、請求項1〜6のいずれか一項に記載の方法。
- 前記化合物が溶液のpHを7〜9の間、好ましくは約7.5に維持可能である、請求項1〜7のいずれか一項に記載の方法。
- 前記化合物が、歯の病変の病変内液のpHを6から7.5に上昇させるのに有効な量で供給される、請求項1〜7のいずれか一項に記載の方法。
- 歯の表面または表面下の石灰化に使用するための組成物であって、
前記歯の表面または表面下に接触する溶液のpHの上昇または維持に有効なある量の塩基と、
石灰化剤と
を含む、組成物。 - 前記溶液が表面下病変中に含まれる、請求項10に記載の組成物。
- 溶液のpHの上昇または維持が可能な前記化合物が、重炭酸ナトリウム、次亜塩素酸ナトリウム、または尿素である、請求項1〜9のいずれか一項に記載の方法。
- 前記重炭酸ナトリウムがマウスリンスまたはマウスウォッシュの形態で提供される、請求項12に記載の方法。
- 前記表面下の歯の表面が、家畜、コンパニオンアニマル、または動物園の動物のものである、請求項1〜9のいずれか一項に記載の方法。
- 前記コンパニオンアニマルがネコまたはイヌである、請求項14に記載の方法。
- 前記家畜が、ウシ、ヒツジ、ウマ、および家禽からなる群から選択される、請求項14に記載の方法。
- 前記塩基が、重炭酸ナトリウム、次亜塩素酸ナトリウム、ハイポフルオライト、または尿素である、請求項10または11に記載の組成物。
- 前記石灰化剤が、安定化非晶質リン酸カルシウム(ACP)および/または非晶質フッ化リン酸カルシウム(ACFP)である、請求項10、11、または17のいずれか一項に記載の組成物。
- 練り歯磨き、歯磨き粉、液体歯磨き、マウスウォッシュ、マウスリンス、マウススプレー、バーニッシュ、歯科用セメント、トローチ、チューインガム、ロゼンジ、歯科用軟膏、歯肉マッサージクリーム、うがい用錠剤、乳製品、およびその他の食品からなる群から選択される、請求項10、11、17、または18のいずれか一項に記載の組成物。
- 家畜、コンパニオンアニマル、または動物園の動物に使用するための、請求項10、11または17〜19のいずれか一項に記載の組成物。
- 前記コンパニオンアニマルがネコまたはイヌである、請求項20に記載の組成物。
- 前記家畜がウシ、ヒツジ、ウマ、および家禽からなる群から選択される、請求項20に記載の組成物。
- 齲蝕、フッ素症、および歯牙酸蝕症の1つ以上の処置または予防のためのキットであって、(a)溶液のpHの上昇または維持が可能な化合物と、(b)薬学的に許容される担体中のCPP−ACPまたはCPP−ACFP複合体とを含む、キット。
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JP6621406B2 (ja) | 2013-07-23 | 2019-12-18 | ザ ユニバーシティー オブ メルボルンThe University of Melbourne | 歯の石灰化のための組成物および方法 |
EP3086751B1 (en) | 2013-12-24 | 2023-07-12 | The University Of Melbourne | Stabilized stannous compositions |
JP7142943B2 (ja) | 2017-03-14 | 2022-09-28 | ザ ユニバーシティー オブ メルボルン | 歯肉炎の処置 |
US20220183810A1 (en) * | 2019-03-13 | 2022-06-16 | The University Of Melbourne | Concealment of hypomineralised lesions |
KR20210139321A (ko) * | 2019-03-13 | 2021-11-22 | 더 유니버시티 오브 멜버른 | 광화를 촉진하기 위한 조성물 및 방법 |
WO2021059215A2 (en) | 2019-09-25 | 2021-04-01 | Church & Dwight Co., Inc. | Oral care composition |
CN112426376B (zh) * | 2020-12-21 | 2023-07-25 | 深圳爱尔创数字口腔有限公司 | 一种漱口水及其制备方法 |
CA3220437A1 (en) | 2021-05-20 | 2022-11-24 | Smile Makers, Llc | Oral hygiene compositions and methods of use |
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