TW201509412A - 精胺酸與特定共軛酸之鹽類、含有其之口腔護理組成物及其用途 - Google Patents
精胺酸與特定共軛酸之鹽類、含有其之口腔護理組成物及其用途 Download PDFInfo
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- TW201509412A TW201509412A TW103118200A TW103118200A TW201509412A TW 201509412 A TW201509412 A TW 201509412A TW 103118200 A TW103118200 A TW 103118200A TW 103118200 A TW103118200 A TW 103118200A TW 201509412 A TW201509412 A TW 201509412A
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- Prior art keywords
- salt
- acid
- teeth
- arginine
- oral care
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Abstract
本發明係關於新穎精胺酸鹽類、含其組成物及其用途。
Description
本申請案主張2008年2月9日申請之美國專利第61/027,442號、2008年2月8日申請之美國專利第61/027,432號、2008年2月8日申請之美國專利第61/027,431號及2008年2月8日申請之美國專利第61/027,420號之權利，將該等申請案之內容以引用方式併入本文中。
本發明係關於精胺酸之新穎鹽類及含其組成物。
曾提出精胺酸及其他鹼性胺基酸可用於口腔護理並咸信其在對抗蛀孔形成及牙齒敏感性上具有顯著益處。然而，已證明這些鹼性胺基酸與具有口腔護理益處之礦物質，如氟化物及鈣組合以形成具有可接受長期安定性之口腔護理產品係受到質疑。具體言之，鹼性胺基酸可提高pH並幫助可與氟離子反應形成不溶沉澱物之鈣離子解離。此外，較高pH具有引發刺激之可能性。然而，在中性pH或酸性pH下，利用精胺酸碳酸氫鹽(技術教學偏好使用的)之系統可釋放出二氧化碳，導致容器氣脹及爆炸。此外，可預期將pH降低至中性或酸性條件將因精胺酸可形成一對牙齒表面具有較差親和力之不溶精胺酸-鈣錯合物而降低調配物之效能，再者，降低pH可能降低調配物可具有對緩衝口中致齲齒乳酸之任何作用。部分因為這些未解決
的調配物問題且部分因為技術上一般已將精胺酸視為氟化物之可能替代物而非共同作用者，製造包含精胺酸及氟化物之口腔護理產品的動機極微小。抗菌劑之添加可能引起其他問題。市售精胺酸基質牙膏，如(例如)ProClude®及DenClude®包含精胺酸碳酸氫鹽及碳酸鈣，但無氟化物或任何抗菌劑。
同時，抗菌劑，如三氯沙在牙膏中的價值已為許多牙科醫師所認可。然而，這些試劑必須以有效量遞送至牙齒及牙齦而且其溶解度、遞送及牙齒上之滯留係視調配物而定。例如，三氯沙(5-氯-2-(2,4-二氯苯氧基)酚)僅微溶於水中。
因此，對一提供精胺酸以及較佳遞送性之有益礦物質如氟化物及鈣和溶解度差之活性劑之安定口腔護理產品有需求。
已令人驚訝地發現這些問題可利用精胺酸之功能性鹽類解決。
本發明因此在一具體例中提供一種精胺酸與下列陽離子中之一或多者之鹽i. 一酸性聚合物，如聚羧酸酯聚合物；ii. 一陰離子界面活性劑之共軛酸，如月桂醯基硫酸；iii. 一多磷酸或多膦酸，如六偏磷酸；或一酸性抗菌劑，如沒食子酸。
在其他具體例中，本發明提供含有本發明鹽類之口腔及個人護理產品及製造和利用該鹽類及該等產品之方法。
該鹽可用於組成物中以促進口腔健康及/或如藉由降低經由口腔組織造成全身感染之可能性而促進全身健康，包括心血管健康。
在第一具體例(鹽1.0)中，本發明提供一種精胺酸與酸性聚合物，如聚羧酸酯聚合物之鹽，例如，
1.0.1 鹽1.0，其中該聚羧酸酯聚合物係順丁烯二酸酐或酸與另一可聚合乙烯系不飽和單體之1：4至4：1共聚物。
1.0.2 鹽1.0.1，其中該聚羧酸酯包含由順丁烯二酸酐與甲基乙烯基醚在pH 7下所形成之單元，如下所描繪者：
1.0.3 鹽1.0.2，其中該甲基乙烯基醚/順丁烯二酸酐具有約30,000至約1,000,000之分子量(M.W.)。
1.0.4 鹽1.0.3，其中該甲基乙烯基醚/順丁烯二酸酐具有約700,000之分子量(M.W.)。
在另一具體例中，本發明提供一精胺酸及陰離子界面活性劑鹽之共軛酸之鹽(鹽2.0)。例如，本發明提供如下之鹽類：
2.0.1 鹽2.0，其中該共軛酸為選自下列各者之陰離子界面活性劑鹽之共軛酸a. 較高碳數之脂肪酸單甘油酯單硫酸鹽之水溶性鹽類(如氫化椰子油脂肪酸之單硫酸化單甘油酯之鹽如N-甲基N-椰醯基牛磺酸鈉、cocomo-甘油酯硫酸鈉)，b. 較高碳數之烷基硫酸鹽，如月桂基硫酸鈉，c. 較高碳數之烷基-醚硫酸鹽，如具式CH3(CH2)mCH2(OCH2CH2)nOSO3X者，其中m為6-16，如10，n為1-6，如2、3或4且X為Na或K(例如月桂醇醚-2硫酸鈉
(CH3(CH2)10CH2(OCH2CH2)2OSO3Na))，d. 較高碳數之烷基芳基磺酸鹽(如十二基苯磺酸鈉(月桂基苯磺酸鈉))，e. 較高碳數之烷基磺乙酸鹽(如月桂基磺乙酸鈉(十二基磺乙酸鈉)、1,2-二羥基丙烷磺酸鹽之較高碳數脂肪酸酯、sulfocolaurate(N-2-月桂酸乙基酯乙醯磺胺鉀)及月桂基肌胺酸鈉)，f. 及其混合物；其中以”較高碳數之烷基”指C6-30烷基，例如C8-18。
2.0.2 鹽2.0或2.0.1，其係精胺酸與月桂醯基硫酸之鹽。
在另一具體例中，本發明提供精胺酸多磷酸鹽或聚膦酸鹽類(鹽3.0)，例如：
3.0.1 鹽3.0，其係精胺酸與聚乙烯基膦酸之鹽。
3.0.2 鹽3.0，其係精胺酸與多磷酸之鹽。
3.0.3 鹽3.0，其係精胺酸與六偏磷酸之鹽。
3.0.4 鹽3.0，其係精胺酸與焦磷酸之鹽。
3.0.5 鹽3.0，其係精胺酸與三聚磷酸鹽之鹽。
在另一具體例中，本發明提供精胺酸與抗菌酸之鹽類(鹽4.0)。在一特定具體例(鹽4.0.1)中，本發明提供精胺酸與視情況經羧基及/或一或多個，如1、2或3個羥基取代之苯甲酸，如苯甲酸、苯二甲酸、水楊酸或三羥基苯甲酸，例如沒食子酸之鹽類。
本發明另外提供一種口腔護理組成物(組成物1.1)，其包含鹽1.0-1.0.4、2.0-2.0.2、3.0-3.0.5或4.0-4.0.1中任一者，如
1.1.1 組成物1.1，其另外包含一抗菌劑。該抗菌劑可選自鹵化二苯基醚(如三氯沙)、草本萃取物及精油(如迷迭香萃取物、茶萃取物、木蘭萃取物、瑞香草酚、薄荷腦、桉樹油、香葉草醇、香旱芹酚、檸檬醛、扁柏酚、兒茶酚、水楊酸甲基酯、沒食子兒茶素-3-沒食子酸酯、沒食子兒茶素、沒食子酸、miswak萃取物、沙棘萃取物)、雙胍殺菌劑(如氯己定、阿來西定或奧替尼啶)、四級銨化合物(如氯化十
六基吡錠(CPC)、氯化苯二甲烴銨、氯化十四基吡錠(TPC)、氯化N-十四基-4-乙基吡錠(TDEPC)、酚系殺菌劑、海克西定、奧替尼啶、血根鹼、普維酮、地莫匹醇、salifluor、金屬離子(如鋅鹽，例如檸檬酸鋅、亞錫鹽、銅鹽、鐵鹽)、血根鹼、蜂膠及氧化劑(如過氧化氫、經緩衝之過氧硼酸鈉或過氧碳酸鹽)、苯二甲酸及其鹽、monoperthalic酸及其鹽和酯、硬脂酸抗壞血酸酯、油醯基肌胺酸、硫酸烷基酯、磺琥珀酸二辛基酯、柳醯胺苯、度米芬、地莫匹醇、辛哌醇及其他哌啶基衍生物、nicin製劑、亞氯酸鹽及任何上述物之混合物。
1.1.2 組成物1.1.1，其中該抗菌劑係三氯沙。
1.1.3 任何前述組成物，其包含三氯沙及Zn2+離子源，如檸檬酸鋅。
1.1.4 任何前述組成物，其另外包含一防結石劑。
1.1.5 任何前述組成物，其另外包含一防結石劑，其為如呈鈉鹽形式之多磷酸鹽，如焦磷酸鹽、三聚磷酸鹽或六偏磷酸鹽。
1.1.6 任何上述組成物，其另外包含一氟離子源。
1.1.7 組成物1.1.6，其中該氟離子源係一可溶氟化物鹽，其係選自氟化亞錫、氟化鈉、氟化鉀、單氟磷酸鈉、氟矽酸鈉、氟矽酸銨、氟化胺(如N’-十八基三亞甲基二胺-N,N,N’-參(2-乙醇)-二氫氟化物)、氟化銨、氟化鈦、六氟硫酸鹽及其組合。
1.1.8 任何上述組成物，其另外包含一界面活性劑。
1.1.9 任何該等化合物，其另外包含一干擾或防止細菌黏附之試劑，如solbrol或甲殼素。
1.1.10 任何上述組成物，其係呈視情況另外包含水、研磨劑、界面活性劑、發泡劑、維生素、聚合物、酶、保濕劑、增稠劑、抗菌劑、防腐劑、調味劑、著色劑及/或其組合中之一或多者的牙膏形式。
本發明另外包括一種改善口腔健康之方法，其包括將有效量之
鹽1.0-1.0.4、2.0-2.0.2、3.0-3.0.5或4.0-4.0.1中任一者或組成物1.1-1.1.9中任一者施用在需其受檢者之口腔中以i 減少或抑制齲齒之形成，ii 降低、修護或抑制早期琺瑯質損傷，iii 降低或抑制牙齒之去礦化並促進其再礦化，iv 減少牙齒之過敏反應，v 減少或抑制牙齦炎，vi 促進口中疼痛或切口之復原，vii 降低生酸菌之量，viii 增加溶精胺酸菌之相對量，ix 抑制口腔中微生物之生物膜之形成，x 在糖攻擊後，提高及/或保持溶菌斑pH在至少pH約5.5之值，xi 降低溶菌斑累積，xii 治療、減輕或減少口腔乾燥；xiii 潔白牙齒，xiv 如藉由降低經由口腔組織造成全身感染之可能性而提高全身健康，包括心血管健康，xv 降低牙齒侵蝕，xvi 使牙齒對致齲齒菌免疫及/或xvii 清潔牙齒及口腔。
本發明另外提供鹽1.0-1.0.4、2.0-2.0.2、3.0-3.0.5或4.0-4.0.1中任一者或組成物1.1-1.1.9中任一者在上列適應症中任一者的用途。
在本發明組成物之各個具體例中，該鹼性胺基酸係以總組成物重量之約0.5重量%至約20重量%，總組成物重量之約1重量%至約10重量%，例如總組成物重量之約1.5重量%、約3.75重量%、約5重量%或約7.5重量%之量存在。
該口腔護理組成物可另外包含一或多個氟離子源，如可溶氟化物源。種類繁多之氟離子產生物質可用於本發明組成物中作為可溶
氟化物源。適合的氟離子產生物質之實例係在頒予Briner等人之美國專利第3,535,421號；頒予Parran,Jr等人之美國專利第4,885,155號；及頒予Widder等人之美國專利第3,678,154號中找到，將該等案以引用方式併入本文中。
代表性氟離子源包括(但不限於)氟化亞錫、氟化鈉、氟化鉀、單氟磷酸鈉、氟矽酸鈉、氟矽酸銨、氟化胺、氟化銨及其組合。在某些具體例中，該氟離子源包括氟化亞錫、氟化鈉、單氟磷酸鈉以及其混合物。
在某些具體例中，本發明口腔護理組成物亦可包含一量足以供應約25ppm至約25,000ppm之氟離子，一般至少約500ppm，如約500至約2000ppm，如約1000至約1600ppm，如約1450ppm之氟離子或供氟成分來源。氟化物之適當用量將視特定應用而定。例如，漱口水一般將具有約100至約250ppm氟化物。一般消費者用途之牙膏一般將具有約1000至約1500ppm，其中小兒牙膏含量稍微較低。專業應用之牙粉或塗料可具如約5,000或甚至約25,000ppm般多之氟化物。
氟離子源在一具體例中可以該組成物之約0.01重量%至約10重量%之量或在另一具體例中以該組成物之約0.03重量%至約5重量%之量或在另一具體例中以該組成物之約0.1重量%至約1重量%之量加入本發明組成物中。提供適當量之氟離子之氟化物鹽的重量將根據該鹽中相反離子之重量而有顯著變化。
本發明組成物可包含磷酸鈣研磨劑，如磷酸三鈣(Ca3(PO4)2)、氫氧磷灰石(Ca10(PO4)6(OH)2)或磷酸二鈣二水合物(CaHPO4˙2H2O，有時在本文中亦稱為Dical)或焦磷酸鈣。
該等組成物可包含一或多種額外研磨劑，例如矽石研磨劑如平均粒徑高達約20微米之沉澱矽石，如J.M.Huber所販賣之Zeodent 115®。其他適用的研磨劑亦包含偏磷酸鈉、偏磷酸鉀、矽酸鋁、煅燒氧化鋁、膨潤土或其他含矽物質或其組合。
本文適用之矽石研磨拋光物質以及其他研磨劑一般具有約0.1至約30微米，約5至約15微米之平均粒徑。矽石研磨劑可源自沉澱矽
石或矽石凝膠，如頒予Pader等人之美國專利第3,538,230號及頒予Digiulio等人之美國專利第3,862,307號中所述之矽石乾凝膠，將兩案以引用方式併入本文中。特定矽石乾凝膠係由W.R.Grace & Co.,Davison化學部門以Syloid®之商標名稱販售。沉澱矽石物質包括彼等由J.M.Huber Corp.以Zeodent®之商標名稱販賣者，包括命名為Zeodent 115及119之矽石。這些矽石研磨劑係描述於頒予Wason之美國專利第4,340,583號中，將該案以引用方式併入本文中。
在某些具體例中，適用於實施根據本發明口腔護理組成物之研磨物質包括油吸收值約小於100毫升/100克矽石或約45毫升/100克矽石至約70毫升/100克矽石之矽膠及沉澱非晶質矽石。油吸收值係利用ASTM Rub-Out方法D281所量得。在某些具體例中，矽石係平均粒徑為約3微米至約12微米及約5微米至約10微米之膠體顆粒。
在特定具體例中，該等研磨物質包含大比率之極小顆粒，如具有小於約5微米之d50，例如，d50為約3-4微米之小矽石顆粒(SPS)，例如Sorbosil AC43®(Ineos)。此類小顆粒係特別適用於目標在於降低過敏反應之調配物。小顆粒組分可與第二大之顆粒研磨劑組合存在。在某些具體例中，例如，該調配物包含約3至約8%SPS及約25%至約45%之慣用研磨劑。
特別適用於實施本發明之低油吸收矽石研磨劑係W.R.Grace & Co.之Davison化學部門，Baltimore,MD.21203以Syloden XWA®之商標名稱販售。Syloden 650 XWA®(一種由水含量為29重量%、平均直徑為約7至約10微米且油吸收值小於約70毫升/100克矽石之膠體矽石顆粒所組成的矽石水凝膠)係適用於實施本發明之低油吸收矽石研磨劑的實例。該研磨劑在本發明口腔護理組成物中係以約10至約60重量%，在其他具體例中，約20至約45重量%且在另一具體例中，約30至約50重量%之濃度存在。
本發明口腔護理組成物亦可包含一試劑以增加刷洗口腔時所產生之泡沫量。
增加泡沫量之試劑的說明性實例包括(但不限於)聚氧乙烯及包
括(但不限於)褐藻酸鹽聚合物之某些聚合物。
聚氧乙烯可增加本發明口腔護理載體組份所產生之泡沫量及泡沫厚度。聚氧乙烯亦為普遍已知之聚乙二醇(“PEG”)或聚環氧乙烷。適合用於本發明之聚氧乙烯將具有約200,000至約7,000,000之分子量。在一具體例中，分子量將為約600,000至約2,000,000且在另一具體例中將為約800,000至約1,000,000。Polyox®係Union Carbide所製造之高分子量聚氧乙烯的商標名稱。
聚氧乙烯可以本發明口腔護理組成物之口腔護理載體組分之約1至約90重量%之量，在一具體例中以約5至約50重量%之量且在另一具體例中以約10至約20重量%之量存在。發泡劑在口腔護理組成物中之劑量(即單劑量)係約0.01至約0.9重量%，約0.05至約0.5重量%且在另一具體例中係約0.1至約0.2重量%。
本發明口腔護理組成物中視情況所含之另一試劑係界面活性劑或相容界面活性劑之混合物。適合的界面活性劑係彼等在整個寬pH範圍內相當安定者，例如陰離子、陽離子、非離子或兩性離子界面活性劑。
適合的界面活性劑係更完整地描述於(例如)頒予Agricola等人之美國專利第3,959,458號；頒予Haefele等人之美國專利第3,937,807號；及頒予Gieske等人之美國專利第4,051,234號中，將該等案以引用方式併入本文中。
在某些具體例中，本文適用之陰離子界面活性劑包括烷基具有約10至約18個碳原子之硫酸烷基酯的水溶性鹽及具有約10至約18個碳原子之脂肪酸之磺酸化單甘油酯的水溶性鹽。月桂基硫酸鈉、月桂醯基肌胺酸鈉及椰子油酸單甘油酯磺酸鈉皆為此類型之陰離子界面活性劑的實例。亦可利用陰離子界面活性劑之混合物。
在另一具體例中，本發明適用之陽離子界面活性劑可廣泛地定義為具有含約8至約18個碳原子之長鏈烷基之脂族四級銨化合物的衍生物如月桂基三甲基氯化銨、十六基氯化吡錠、十六基三甲基溴化銨、二異丁基苯氧基乙基二甲基芐基氯化銨、椰子油酸烷基三甲
基亞硝酸銨、十六基氟化吡錠及其混合物。
說明性陽離子界面活性劑係頒予Briner等人之美國專利第3,535,421號中所描述之四級銨氟化物，將該案以引用方式併入本文中。某些陽離子界面活性劑亦可在該等組成物中作為殺菌劑。
可將可用於本發明組成物中之說明性非離子界面活性劑廣泛地定義為環氧烷基(親水性本質)與可為脂族或烷基芳族本質之有機疏水性化合物縮合所產生之化合物。適合的非離子界面活性劑實例包括(但不限於)Pluronics、烷基酚之聚環氧乙烷縮合物、衍生自環氧乙烷與環氧丙烷及伸乙二胺之反應產物縮合的產物、脂族醇之環氧乙烷縮合物、長鏈三級胺氧化物、長鏈三級膦氧化物、長鏈二烷基亞碸及此類物質之混合物。
在某些具體例中，可將適用於本發明中之兩性離子合成界面活性劑廣泛地描述成脂族四級銨、鏻及鋶化合物之衍生物，其中該等脂族基團可為直鏈或支鏈且其中脂族取代基中之一者包含約8至約18個碳原子且一者包含陰離子水溶基團，如羧基、磺酸鹽、硫酸鹽、磷酸鹽或膦酸鹽。適合用於包含在該組成物中之界面活性劑的說明性實例包括(但不限於)烷基硫酸鈉、月桂醯基肌胺酸鈉、椰油醯胺丙基甜菜鹼及聚山梨醇酯20及其組合。
在一特定具體例中，本發明組成物包含一陰離子界面活性劑，如月桂基硫酸鈉。
界面活性劑或相容界面活性劑之混合物可以總組成物之約0.1%至約5.0重量%，在另一具體例中以約0.3重量%至約3.0重量%且在另一具體例中以約0.5重量%至約2.0重量%存在於本發明組成物中。
本發明口腔護理組成物亦可包含一調味劑。可用於實施本發明之調味劑包括(但不限於)精油以及各種調味醛、酯、醇及類似物質。精油之實例包括綠薄荷、薄荷、冬青、黃樟、丁香、鼠尾草、桉樹、馬鬱蘭、肉桂、檸檬、萊姆、葡萄柚及橙花之油。亦適用者為如薄荷腦、香旱芹酮及茴香腦之化學物質。某些具體例使用薄荷及綠薄
荷之油。
調味劑係以約0.1至約5重量%及約0.5至約1.5重量%之濃度摻入口腔組成物中。調味劑在個別口腔護理組成物中之劑量(即單劑量)係約0.001重量%至約0.05重量%，在另一具體例中係約0.005重量%至約0.015重量%。
本發明口腔護理組成物亦可視情況包含一或多種可錯合細菌之細胞壁中所發現之鈣的鉗合劑。此鈣接合弱化細菌之細胞壁並增加細菌溶解。
另一類適合用於本發明中作為鉗合劑之試劑為可溶焦磷酸鹽。用於本發明組成物中之焦磷酸鹽可為鹼金屬焦磷酸鹽中任一者。在某些具體例中，鹽包括四鹼金屬焦磷酸鹽、二鹼金屬二酸焦磷酸鹽、三鹼金屬單酸焦磷酸鹽及其混合物，其中該鹼金屬係鈉或鉀。該等鹽之水合及非水合形式皆適用。適用於本發明組成物中之焦磷酸鹽的有效量一般係足以提供至少約1.0重量%焦磷酸根離子，約1.5重量%至約6重量%，約3.5重量%至約6重量%之此類離子。
本發明口腔護理組成物亦視情況包含一或多種聚合物，如聚乙二醇、聚乙烯基甲基醚順丁烯二酸共聚物、多糖(如纖維素衍生物，例如羧基甲基纖維素或多糖膠，例如三仙膠或鹿角菜膠)。酸性聚合物，例如聚丙烯酸酯凝膠可以其游離酸或經部分或完全中和之水溶性鹼金屬(鉀或鈉)或銨鹽形式提供。
特別係非陽離子抗菌劑或抗菌劑如三氯沙係包含在任一牙粉組分中時，較佳係亦包含從約0.05%至約5%促進該等試劑至口腔面之遞送及滯留且其於口腔面上滯留之試劑。此類適用於本發明之試劑係揭示於美國專利第5,188,821號及第5,192,531號；且包含合成陰離子聚合聚羧酸酯，如順丁烯二酸酐或酸與另一可聚合乙烯系不飽和單體，較佳係分子量(M.W.)為約30,000至約1,000,000，最佳係約30,000至約800,000之甲基乙烯基醚/順丁烯二酸酐之1：4至4：1共聚物。這些共聚物係(例如)可以Gantrez，如AN 139(M.W.500,000)、AN
119(M.W.250,000)且較佳係獲自ISP Technologies,Inc.,Bound Brook,N.J.08805之S-97醫藥級(M.W.700,000)獲得。該等促進劑在存在時係以約0.05至約3重量%之量存在。
其他操作聚合物包括彼等如順丁烯二酸酐與丙烯酸乙基酯之1：1共聚物、甲基丙烯酸羥基乙基酯、N-乙烯基-2-吡咯啶酮或乙烯，後者可(例如)以Monsanto EMA No.1103,M.W.10,000及EMA等級61獲得及丙烯酸與甲基丙烯酸甲基酯或甲基丙烯酸羥基乙基酯之1：1共聚物、丙烯酸甲基酯或丙烯酸乙基酯、異丁基乙烯基醚或N-乙烯基-2-吡咯啶酮。
一般適合者為含有一經活化碳對碳之烯烴雙鍵及至少一個羧基之經烯烴系或乙烯系聚合之不飽和羧酸，換言之，含有烯烴雙鍵之酸，其中該烯烴雙鍵因其在單體分子中係以相對於羧基之α-β位置或終端亞甲基團之一部分的形式存在而易在聚合反應中發揮作用。此類酸之說明實例係丙烯酸、甲基丙烯酸、乙基丙烯酸、α-氯丙烯酸、巴豆酸、β-丙烯醯氧基丙酸、山梨酸、α-氯山梨酸、肉桂酸、β-苯乙烯基丙烯酸、黏康酸、伊康酸、焦檸檬酸、中康酸、戊烯二酸、烏頭酸、α-苯基丙烯酸、2-芐基丙烯酸、2-環己基丙烯酸、白芷酸、繖形酸、反丁烯二酸、順丁烯二酸及酐。其他可與此類羧酸單體共聚合之不同烯烴單體包括乙烯基乙酸酯、氯化乙烯、順丁烯二酸二甲基酯及類似物。共聚物包含足夠羧酸鹽基而具水溶性。
另一類型之聚合物試劑包括一含經取代丙烯醯胺之均聚物及/或不飽和磺酸及其鹽之均聚物的組成物，特別係頒予Zahid於1989年6月27日申請之美國專利第4,842,847號中所描述，其中聚合物係以選自丙烯醯胺烷磺酸之不飽和磺酸如分子量為約1,000至約2,000,000之2-丙烯醯胺2-甲基丙烷磺酸為基質，將該案以引用方式併入本文中。
另一適用類型之聚合物試劑包括聚胺基酸，特別係如頒予Sikes等人之美國專利第4,866,161號中所揭示彼等含有一定比例之陰離子表面活性胺基酸如天冬胺酸、麩胺酸及磷絲胺酸者，將該案以引用方式併入本文中。
製備口腔護理組成物時，有時必須添加一些增稠物質以提供所需稠度或安定或提高調配物的性能。在某些具體例中，該等增稠劑係羧基乙烯基聚合物、鹿角菜膠、羥基乙基纖維素及纖維素醚之水溶性鹽如羧基甲基纖維素鈉及羧基甲基羥基乙基纖維素鈉。亦可摻入天然膠如梧桐膠、阿拉伯膠及黃著樹膠。可使用膠體狀矽酸鎂鋁或細微矽石作為增稠組成物之組分以進一步改善組成物之組織。在某些具體例中，使用量為總組成物之約0.5重量%至約5.0重量%之增稠劑。
本發明口腔護理組成物亦可視情況包含一或多種酶。適用酶包括可用蛋白酶、葡萄糖水解酶、內切糖苷酶、澱粉酶、葡聚糖變構水解酶、脂酶及黏蛋白酶或其相容混合物中任一者。在某些具體例中，該酶係蛋白酶、聚葡糖酶、內切糖苷酶及葡聚糖變構水解酶。在另一具體例中，該酶係木瓜酶、內切糖苷酶或聚葡糖酶與葡聚糖變構水解酶之混合物。適合用於本發明之額外酶係揭示於頒予Dring等人之美國專利第5,000,939號、美國專利第4,992,420號、美國專利第4,355,022號、美國專利第4,154,815號、美國專利第4,058,595號、美國專利第3,991,177號及美國專利第3,696,191號，將該等案全部以引用方式併入本文中。本發明中數種相容酶之混合物之酶在一具體例中構成約0.002%至約2.0%或在另一具體例中構成約0.05%至約1.5%或在另一具體例中構成約0.1%至約0.5%。
水亦可存在於本發明口腔組成物中。製備市售口腔組成物所用之水應經去離子且不含有機不純物。水通常構成組成物之剩餘部分並佔該口腔組成物之約10重量%至約90重量%，約20重量%至約60重量%或約10重量%至約30重量%。此水量包含所加之自由水加上隨其他物質如隨山梨醇或本發明任何組份所導入之量。
在某些口腔組成物之具體例內，亦希望摻入保濕劑以防止組成物在暴露於空氣中後硬化。某些保濕劑亦可賦予牙粉組成物所需甜
度或氣味。以純保濕劑計，該保濕劑在一具體例中一般佔該牙粉組成物之約15重量%至約70重量%或另一具體例中佔約30重量%至約65重量%。
適合的保濕劑包括食用多元醇如甘油、山梨醇、木糖醇、丙二醇以及其他多元醇和這些保濕劑之混合物。甘油與山梨醇之混合物可用於某些具體例中作為本文牙膏組成物之保濕劑組分。
除了上述組分之外，本發明具體例可包含多種視情況選用之牙粉成分，其部分係描述於下。視情況選用之成分包括，例如(但不限於)黏附劑、泡沫劑、調味劑、甜味劑、額外抗斑劑、研磨劑及著色劑。這些及其他視情況選用之組分係另外描述於頒予Majeti等人之美國專利第5,004,597號；頒予Agricola等人之美國專利第3,959,458號及頒予Haefele等人之美國專利第3,937,807號，將該等案全部以引用方式併入本文中。
本發明組成物可利用口腔產品領域中常見之方法製成。
在一說明性具體例中，該鹽類係藉由以該共軛酸中和凝膠相中之精胺酸並混合形成預混物1，調整pH至所需值，然後與其他成分組合所製成。將活性物質如(例如)維生素、CPC、氟化物、研磨劑及任何其他所需活性成分加入預混物1中並混合形成預混物2。最終產品為牙膏時，將牙膏基質，例如磷酸二鈣或矽石加入預混物2中並混合之。使最終漿液形成一口腔護理產品。
本發明在其方法態樣中包括將一安全且有效量之本文所述組成物施用於口腔中。
根據本發明組成物及方法係適用於一種藉由幫助修護及再礦化，特別係減少或抑制齲齒形成、降低或抑制牙齒之去礦化並促進其再礦化，減少牙齒之過敏反應並如藉由定量光誘導螢光(QLF)或電子齲齒監測(ECM)所偵測，降低、修護或抑制早期琺瑯質損傷以保護牙齒之方法。
定量光誘導螢光係一可偵測早期損傷並縱向監測發展或退化之
可見光螢光。正常牙齒可發出可見光之螢光；已去礦化牙齒無法或僅發出較低程度之螢光。去礦化區域可經量化並可監測其發展。使用藍色雷射光以使牙齒自動發出螢光。已流失礦物質之區域具有較低螢光且相較於健康牙齒面出現較深顏色。利用軟體量化源自白點之螢光或與損傷有關之面積/體積。一般，僱用具有現有白點損傷之受檢者作為參加者。以實際牙齒進行活體內測量。在臨床實驗開始時測量損傷之面積/體積。結束6個月之產品使用期時測量損傷面積/體積之降低(改善)。經常將數據紀錄成相對於基線之改善百分比。
電子齲齒監測係一種以電阻為基礎用於測量牙齒之礦物質含量的技術。電導測量係利用去礦化後露出充液管及侵蝕琺瑯質電導之事實。隨牙齒流失礦物質，其因孔隙率提高而對電流的抗性降低。因此，患者牙齒之電導的增加指示去礦化。一般，在具有現有損傷之齒底面進行研究。以實際牙齒進行活體內測量。測量6個月處理前後之電阻變化。而且，利用接觸式探針完成對齒底面之典型齲齒分級。將硬度分成三等級：硬、皮質或軟。在此類研究中，一般將結果記錄為ECM測量之電阻(數值愈高愈佳)及以接觸式探針級數為基礎之損傷的硬度。
本發明組成物因此適用於一種相較於缺乏有效量之氟及/或精胺酸之組成物可降低早期琺瑯質損傷(如藉由QLF或ECM所量得)的方法。
本發明組成物另外適用於減少口腔中有害細菌之方法，例如減少或抑制牙齦炎、降低生酸菌之量、增加溶精胺酸菌之相對量、抑制口腔中生物膜之形成、在糖攻擊後，提高及/或保持溶菌斑pH在至少約pH5.5之值、降低溶菌斑累積及/或清潔牙齒及口腔之方法。
最後，藉由提高口中pH並消除病源菌，本發明組成物適用於促進口中疼痛發炎或刺痛之復原。
可將本發明組成物及方法併入用於護理口及牙齒之口腔組成物如牙膏、透明糊、凝膠、漱口水、噴液及口香糖中。
當口腔組織可為全身感染之途徑時，促進口腔健康亦提供全身健康之益處。良好的口腔健康亦與全身健康，包括心血管健康有關。
本發明組成物及方法提供特定益處，因為鹼性胺基酸，特別係精胺酸係供應NO合成途徑並因此提高口腔組織之微循環之氮源。提供一酸性較低之口腔環境亦有助於降低胃痛並產生一較不利於與胃潰瘍有關之幽門螺旋桿菌的環境。精胺酸特別係為特異免疫細胞受體，例如T-細胞受體之高表現所需要的，以致精胺酸可提高有效免疫反應。本發明組成物及方法因此適用於提高全身健康，包括心血管健康。
整體使用時，使用範圍作為簡略表達以描述該範圍內之各值及每一值。該範圍內之任一值皆可選作該範圍之端值。而且，可將本文所用之所有參考文獻之全文以引用方式併入本文中。在本發明揭示內容之定義與所用參考文獻之定義者有衝突的情況下，由本發明揭示內容控制。應了解當描述調配物時，如技術中常見般，可依據其成分描述之並欲以所述調配物涵蓋此類產品，儘管這些成分可能在實際調配物製造、儲存及使用時彼此反應。
Claims (3)
- 一種精胺酸與酸性聚合物之鹽，其中該酸性聚合物係聚羧酸酯聚合物；其中該鹽其係呈固體形式；且其中該聚羧酸酯聚合物係一甲基乙烯基醚與順丁烯二酸酐之共聚物。
- 一種口腔護理組成物，其包含如申請專利範圍第1項之鹽。
- 一種如申請專利範圍第1項之鹽或如申請專利範圍第2項之口腔護理組成物用於製造藥劑之用途，該藥劑係用於i 減少或抑制齲齒之形成，ii 降低、修護或抑制早期琺瑯質損傷，iii 降低或抑制牙齒之去礦化並促進其再礦化，iv 減少牙齒之過敏反應，v 減少或抑制牙齦炎，vi 促進口中疼痛或切口之復原，vii 降低生酸菌之量，viii 增加溶精胺酸菌之相對量，ix 抑制口腔中微生物之生物膜的形成，x 在糖攻擊後，提高及/或保持溶菌斑pH在至少pH約5.5之值，xi 降低溶菌斑累積，xii 治療、減輕或減少口腔乾燥；xiii 潔白牙齒， xiv 提高全身健康，包括心血管健康，xv 降低牙齒侵蝕，xvi 使牙齒對致齲齒菌免疫及/或xvii 清潔牙齒及口腔。
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| SA08290178B1 (ar) | 2011-11-16 |
| CN102036649A (zh) | 2011-04-27 |
| CO6300927A2 (es) | 2011-07-21 |
| MX367367B (es) | 2019-08-16 |
| AU2008349846A1 (en) | 2009-08-13 |
| EP3100716B1 (en) | 2018-09-26 |
| JP2011511065A (ja) | 2011-04-07 |
| US20090202456A1 (en) | 2009-08-13 |
| CA2706351A1 (en) | 2009-08-13 |
| RU2010137265A (ru) | 2012-03-20 |
| CL2008000897A1 (es) | 2009-08-14 |
| EP2249785B1 (en) | 2016-12-14 |
| CN102036649A8 (zh) | 2018-05-08 |
| WO2009099451A1 (en) | 2009-08-13 |
| MY155564A (en) | 2015-10-30 |
| SG188132A1 (en) | 2013-03-28 |
| ZA201003688B (en) | 2015-08-26 |
| TW200934480A (en) | 2009-08-16 |
| BRPI0821858A2 (pt) | 2014-09-30 |
| AU2008349846B2 (en) | 2012-05-31 |
| MY166789A (en) | 2018-07-23 |
| AR069724A1 (es) | 2010-02-17 |
| EP2249785B2 (en) | 2019-09-25 |
| JP2015042660A (ja) | 2015-03-05 |
| EP2249785A1 (en) | 2010-11-17 |
| MX337177B (es) | 2016-02-16 |
| MX2010005191A (es) | 2010-06-07 |
| EP3100716A1 (en) | 2016-12-07 |
| CA2706351C (en) | 2013-11-12 |
| CN110302085A (zh) | 2019-10-08 |
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