TWI519315B - 用於治療齲齒的組成物及方法 - Google Patents
用於治療齲齒的組成物及方法 Download PDFInfo
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- TWI519315B TWI519315B TW102142174A TW102142174A TWI519315B TW I519315 B TWI519315 B TW I519315B TW 102142174 A TW102142174 A TW 102142174A TW 102142174 A TW102142174 A TW 102142174A TW I519315 B TWI519315 B TW I519315B
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- Prior art keywords
- composition
- arginine
- acid
- sweet
- weight
- Prior art date
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Description
本文係描述包括游離或鹽形式之鹼性胺基酸及倍半萜醇(sesquiterpene alcohol)之口腔組成物；以及製造和使用彼等之方法。
齲齒例如為硬質的牙結構和組織，包括琺瑯質、牙本質和牙骨質之去礦化及變質。齲齒的主要原因為細菌將堆積在牙齒表面之食物碎片發酵所產生的酸。據悉，牙齒暴露在酸性環境(低pH)之頻率影響齲齒發生的可能性。
因此，對於可有效維持口腔內適當的pH和降低齲齒發生及/或惡化之口腔保健組成物仍有需求。本發明之具體實施例係關於此等方面。
本發明之某些實施例係關於包括游離或鹽形式之鹼性胺基酸及倍半萜醇之口腔保健組成物。本發明之其他實施例係關於使用文中所述的組成物治療或預防齲齒之方法。
如全文所用，範圍係用於速記供描述在此範圍內的各個和每個值。在此範圍內的任何值皆可選作此範圍的最終值。此外，所有文中所引述的參考文獻其全文係以引用的方式併入本文中。在本揭示文與所引述的參考文獻的定義有衝突時，則以本揭示文為主。請了解，當描述調配物時，其可就其成份來描述，因為在本項技術中為常用的，儘管這些成份當在製造時於實際的調配物中可能會相互反應，但希望此等產品係涵蓋在所述的調配物中。
本發明之某些實施例係關於包括游離或鹽形式之鹼性胺基酸及倍半萜醇之口腔保健組成物。在某些實施例中，倍半萜醇係包括一單環倍半萜醇。在某些實施例中，此單環倍半萜醇係包括甜沒藥萜醇(bisabolol)。在某些實施例中，此單環倍半萜醇係包括α-(-)-甜沒藥萜醇。在某些實施例中，此單環倍半萜醇係包括α-(-)-甜沒藥萜醇和α-(+)-甜沒藥萜醇之混合物。在某些實施例中，鹼性胺基酸為精胺酸。在某些實施例中，此精胺酸為L-精胺酸。
在某些實施例中，倍半萜醇為甜沒藥萜醇而胺基酸為精胺酸。在某些實施例中，此甜沒藥萜醇和精胺酸係以介於1：2至2：1甜沒藥萜醇對精胺酸重量/重量(w/w)之比例存在。
在某些實施例中，倍半萜醇和鹼性胺基酸之組成物的總濃度為1%重量比或更低。
在某些實施例中，此組成物為選自糊膏、膠、液體(例如漱口水)和凝膠之形式。
本發明之某些實施例係提供治療或預防齲齒之方法，其包括將任一文中所述之組成物投予有此需要之對象的口腔。
可用於本發明組成物和方法中之鹼性胺基酸不僅包括天然
生成的鹼性胺基酸，例如精胺酸、離胺酸和組胺酸，亦包括任何在分子中具有羧基基團和胺基基團之胺基酸，其為水溶性並提供帶有約7或更高之pH的水溶液。
因此，鹼性胺基酸包括(但不限於)精胺酸、離胺酸、瓜胺酸、鳥胺酸、肌胺酸、組胺酸、二胺基丁酸、二胺基丙酸、其鹽類或其組合物。在特定的實施例中，此鹼性胺基酸係選自精胺酸、瓜胺酸和鳥胺酸。
在特定的實施例中，此鹼性胺基酸為精胺酸，例如1-精胺酸或其鹽。
本發明之組成物希望供口部之局部使用，且因此用於本發明之鹽類，就所提供的量和濃度，對於此用途應為安全的。適合的鹽類包括本項技術中已知為醫藥上可接受的鹽類，就所提供的量和濃度，一般被認為生理上可接受。生理上可接受的鹽類包括該等衍生自醫藥上可接受的無機或有機酸或鹼之鹽類，例如由形成生理上可接受陰離子之酸所形成的酸加成鹽，例如鹽酸或溴化鹽，及由形成生理上可接受陽離子之鹼所形成的鹼加成鹽，例如該等衍生自鹼金屬例如鉀和鈉或鹼土金屬例如鈣和鎂之鹽類。生理上可接受鹽類可使用本項技術中已知的標準製程來製得，例如藉由將足夠的鹼性化合物例如胺與提供生理上可接受陰離之適合的酸反應。
在各種實施例中，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%存在。
口腔保健組成物可進一步包括一或多種氟化物離子來源，例如可溶性氟化鹽。可應用多種氟化物離子-產生物質作為本發明組成物之可溶性氟化物來源。適合的氟化物離子-產生物質之實例可參見Briner等人之美國專利第3,535,421號；Parran,Jr.等人之美國專利第4,885,155號及Widder
等人之美國專利第3,678,154號，其係以引用的方式併入本文中。
代表性的氟化物離子來源包括(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、氟化銨及其組合物。在特定的實施例中，此氟化物離子來源包括氟化亞錫、氟化鈉、單氟磷酸鈉以及其混合物。
在特定的實施例中，本發明之口腔保健組成物亦可含有足以供應約25ppm至約5,000ppm氟化物離子，一般至少約500ppm，例如約500至約2000ppm，例如約1000-約1600ppm，例如約1450ppm之量的氟化物離子來源或氟-提供成份。
氟化物離子來源在一實施例中可以約0.01重量%至約10重量%之量加到本發明之組成物中，及在另一實施例中為組成物重量之約0.1重量%至約1重量%。提供適當量氟化物離子之氟化鹽重量明顯地將以鹽中相對離子之重量為基準而變。
當組成物包括碳酸氫鈣時，就安定性因素，單氟磷酸鈉優於氟化鈉。
本發明之某些實施例提供口腔保健組成物其進一步係包括有效降低牙本質敏感之量的生理上可接受鉀鹽。在某些實施例中，此鉀鹽係選自硝酸鉀和氯化鉀。
本發明之組成物可包括沉澱碳酸鈣(PCC)研磨劑、磷酸鈣研磨劑，例如磷酸三鈣(Ca3(PO4)2)、羥磷灰石(Ca10(PO4)6(OH)2)或磷酸二鈣二水合物(CaHPO4˙2H2O，有時候在文中亦稱為DiCal)。
本發明可包括一或多種另外的研磨劑，例如矽氧研磨劑如具有高至約20微米之平均粒子大小的沉澱矽氧，例如J.M.Huber所販售之Zeodent 115®。其他有用的研磨劑亦包括偏磷酸鈉、偏磷酸鉀、矽酸鋁、煅
燒氧化鋁、澎潤土或其他矽質材料或其組合物。
可用於文中之研磨性拋光物質，一般具有約0.1及約30微米，約5及約15微米之平均粒子大小。矽氧研磨劑可來自沉澱矽氧或矽膠，例如描述於Pader等人之美國專利第3,538,230號及Digiulio之美國專利第3,862,307號之矽氧乾凝膠(silica xerogel)，二者係以引用的方式併入本文中。特別的矽氧乾凝膠係由W.R.Grace & Co.,Davison Chemical Division公司以Syloid®商標名稱所販售。沉澱矽氧物質包括該等由J.M.Hube公司以Zeodent®商標名稱所販售，包括稱為Zeodent 115和119之矽氧。這些矽氧研磨劑係描述於Wason等人之美國專利第4,340,583號中，其係以引用的方式併入本文中。
在特定的實施例中，可用於本發明口腔保健組成物施行中之研磨劑物質包括矽膠和具有約低於100cc/100g矽氧及在約45cc/100g至約70cc/100g矽氧範圍內之吸油值的沉澱非晶矽氧。吸油值係使用ASTA Rub-Out Method D281所測量。在特定的實施例中，矽氧為具有約3微米至約12微米，及約5至約10微米之平均粒子大小的膠狀粒子。
在特定的實施例中，研磨劑物質係包括非常小的粒子，例如具有低於約5微米之d50。例如具有約3-約4微米之d50的小粒子矽氧(SPS)，例如Sorbosil AC43®(Ineos)。此等小粒子在針對降低過敏性之調配物中特別有用。此等小粒子組份可與第二較大粒子研磨劑組合存在。在特定的實施例中，例如，此調配物係包括約5至約25%小粒子例如SPS，及約10至約30%的習用研磨劑。
特別可用於本發明施行中之低吸油矽氧研磨劑為Davison Chemical Division of W.R.Grace & Co.,Baltimore,Md.21203所販售的商品名稱Sylodent XWA®。Sylodent 650 XWA®，一種由膠狀矽氧粒子所組成的
矽氧水凝膠，具有約29%重量比之水含量，平均直徑約7至約10微米，及低於約70cc/100g矽氧之吸油性，為可用於本發明施行中之低吸油矽氧研磨劑。此研磨劑係以約10至約60%重量比之濃度存在於本發明之口腔保健組成物中，在其他的實施例中約20至約45%重量比，及在另外的實施例中約30至約50%重量比。
本發明之口腔保健組成物可包括當刷洗口腔時增加所產生的泡沫量之試劑。
增加泡沫量之試劑的說明性實例包括(但不限於)聚氧乙烯及特定的聚合物，包括(但不限於)海藻酸鹽聚合物。
聚氧乙烯可增加泡沫量及由本發明之口腔保健載劑成份所產生的泡沫厚度。聚氧乙烯一般亦稱為聚乙二醇("PEG")或聚環氧乙烷。適用於本發明之聚氧乙烯應具有約200,000至約7,000,000之分子量。在一實施例中，分子量為約600,000至約2,000,000及在另外的實施例中約800,000至約1,000,000。Polyox®為由Union Carbide所製造之高分子量聚氧乙烯的商品名稱。
聚氧乙烯，以本發明口腔保健組成物的口腔保健載劑成份之重量計，可以約1%至約90%之量存在，在一實施例中約5%至約50%及在另外的實施例中約10%至約20%。口腔保健組成物之起泡劑的劑量(亦即單一劑量)為約0.01至約0.9%重量比，約0.05至約0.5%重量比，及在另外的實施例中約0.1至約0.2%重量比。
視需要包括在本發明之口腔保健組成物中的另外試劑為界面活性劑或相容性界面活性劑之混合物。適合的界面活性劑為該等在整個廣泛pH範圍中相當穩定之界面活性劑，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Agricola等人之美國專利第3,959,458號；Haefele之美國專利第3,937,807號；及Gieske等人之美國專利第4,051,234號，其係以引用的方式併入本文中。
在特定的實施例中，可用於文中之陰離子界面活性劑包括在烷基中具有約10至約18個碳原子之硫酸烷基酯的水溶性鹽類及具有約10至約18個碳原子之脂肪酸的磺酸單甘油酯之水溶性鹽類。月桂基硫酸鈉、月桂醯肌胺酸鈉及椰油酸單甘油酯磺酸鈉為此類陰離子界面活性劑之實例。亦可利用陰離子界面活性劑之混合物。
在另外的實施例中，可用於本發明之陽離子界面活性劑可為廣泛定義為具有含約8至約18個碳原子之長鏈烷基鏈之脂肪系四級銨化合物的衍生物，例如月桂基三甲基氯化銨、氯化十六烷基吡錠、十六烷基三甲基溴化銨、二-異丁基苯氧基乙基二甲基苯甲基氯化銨、椰子烷基三甲基亞硝酸銨、氟化十六烷基吡錠及其混合物。
說明性之陽離子界面活性劑有Briner等人之美國專利第3,535,421號中所描述的四級氟化銨，其係以引用的方式併入本文中。特定的陽離子界面活性劑亦可作為組成物中的殺菌劑。
可用於本發明組成物中之說明性非離子界面活性劑可廣泛的定義為由環氧烷烴基團(親水性質)與有機疏水性化合物(可為脂肪系或烷基芳香系性質)縮合所產生的化合物。適合的非離子界面活性劑之實例包括(但不限於)普朗羅尼(Pluronic)、烷基酚之聚環氧乙烷縮合物、衍生自環氧乙烷與環氧丙烷和乙二胺反應產物之縮合作用的產物、脂肪系醇類之環氧乙烷縮合物、長鏈三級氧化胺、長鏈三級氧化膦、長鏈二烴基亞碸及此等物質之混合物。
在特定的實施例中，可用於本發明之兩性離子合成界面活性
劑可廣義地描述為脂肪系四級銨、鏻和鋶化合物之衍生物，其中該脂肪系基團可為直鏈或支鏈，且其中脂肪系取代基之一係含有約8至約18個碳原子及另一含有陰離子水溶性基團，例如羧基、磺酸基、硫酸基、磷酸基或膦酸基。適合包括在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、月桂醯基胺酸鈉、椰油醯胺甜菜鹼和聚山梨醇酯20，以及其組合物。
在一特定的實施例中，本發明之組成物係包括一陰離子界面活性劑，例如月桂基硫酸鈉。
界面活性劑或相容的界面活性劑之混合物，以總組成物的重量計，可以約0.1%至約5.0%存在於本發明之組成物中，在另外的實施例約0.3%至約3.0%，及在另外的實施例約0.5%至約2.0%。
本發明之口腔保健組成物亦可包括調味劑。用於本發明施行之調味劑包括(但不限於)精油以及各種調味醛類、酯類、醇類和類似物質。精油的實例包括綠薄荷油、椒薄荷油、冬青油、黃樟油、丁香油、鼠尾草油、大葉按油、馬鬱蘭油、肉桂油、檸檬油、萊姆油、葡萄柚油和柑橘油。亦可用如薄荷醇、香芹酮和茴香腦等化學物。特定的實施例係應用椒薄荷油和綠薄荷油。
調味劑係以約0.1至約5%重量比和約0.5至約1.5%重量比之濃度併入口腔組成物中。在個別的口腔保健組成物劑量中之調味劑的劑量(亦即單一劑量)為約0.001至約0.05%重量比，及在另外的實施例約0.005至約0.015%重量比。
本發明之口腔保健組成物亦可包括一或多種能與細菌細胞壁中發現的鈣錯合之螯合劑。與此鈣結合能弱化細菌的細胞壁並增加細菌溶離。
在本發明中適合用作螯合劑之另外的試劑群為可溶性焦磷酸鹽。用於本發明之焦磷酸鹽可為任何鹼金屬焦磷酸鹽類。在特定的實施例中，鹽類包括四鹼金屬焦磷酸鹽、二鹼金屬焦磷酸二氫鹽、三鹼金屬焦磷酸一氫鹽及其混合物，其中鹼金屬為鈉或鉀。此等鹽類可用的為其水合和非水合二種形式。可用於本組成物之焦磷酸鹽的有效量一般係足夠提供至少約1.0重量%焦磷酸離子，約1.5重量%至約6重量%、約3.5重量%至約6重量%此等離子。
本發明之口腔保健組成物視需要亦包括一或多種聚合物，例如聚乙二醇、聚乙烯甲基醚馬來酸共聚物、多糖類(例如纖維素衍生物，例如羧甲基纖維素，或多糖膠，例如三仙膠或鹿角菜膠)。酸聚合物，例如聚丙烯酸凝膠，可以其游離酸或部分或完全中和的水溶性鹼金屬(例如鉀或鈉)或銨鹽形式來提供。特定的實施例包括1：4至4：1的馬來酸酐或酸與另外的可聚合乙烯化不飽和單體，例如具有約30,000至約1,000,000分子量(M.W.)之甲基乙烯基醚(甲氧乙烯)的共聚物。這些共聚物可用的有例如Gantrez AN 139(M.W.500,000)、AN 119(M.W.250,000)和GAF化學公司之S-97醫藥等級(M.W.70,000)。
其他可用的聚合物包括該等例如馬來酸酐與丙烯酸乙酯、甲基丙烯酸羥乙酯、N-乙烯基-2-吡咯烷酮或乙烯之1：1共聚物，後者可用的有例如孟山都(Monsanto)EMA編號1103,M.W.10,000及EMA等級61，以及丙烯酸與甲基丙烯酸甲酯或羥乙基酯、丙烯酸甲酯或乙酯、異丁基乙烯醚或N-乙烯基-2-吡咯烷酮之1：1共聚物。
一般適合的為含有一活化碳-碳烯烴雙鍵和至少一羧基基團之聚合烯烴化或乙烯化不飽和羧酸，亦即含有在聚合作用中容易運作之烯烴雙鍵的酸，因為其係以相對於羧基基團的α-β位置或為末端伸甲基基團之
部分存在單體分子中。此等酸之示例有丙烯酸、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(muconic)、衣康酸(itaconic)、檸康酸(citraconic)、中康酸(mesaconic)、戊烯二酸、烏頭酸、α-苯基丙烯酸、2-苯甲基丙烯三、2-環己基丙烯酸、當歸酸、傘形酸、延胡索酸、馬來酸及酸酐。可與此等羧酸單體共聚化之其他不同的烯烴單體包括乙烯基乙酸、氯化乙烯、馬來酸二甲酯及其類似物。共聚物含有供溶於水之足夠的羧酸鹽基團。
另一類聚合劑包括含有經取代丙烯醯胺均聚物及/或不飽和磺酸及其鹽類之均聚物的組成物，特別是其中聚合物係以選自丙烯醯胺基烷磺酸，例如具有約1,000至約2,000,000之分子量的2-丙烯醯胺2甲基丙磺酸之不飽和磺酸為基礎，其係描述於1989年6月27日Zahid之美國專利第4,842,847號，該專利係以引用的方式併入本文中。
另外可用的聚合劑種類包括聚胺基酸，特別是該等含有陰離子界面活性胺基酸部分，例如天門冬胺酸、麩胺酸和磷絲胺酸之聚胺基酸，其係描述於Sikes等人之美國專利第4,866,161號中，該專利係以引用的方式併入本文中。
在製備口腔保健組成物中，有時需要加入一些增稠物質以提供所欲的稠度或安定或增進調配物的性能。在特定的實施例中，增稠劑為羧乙烯聚合物、鹿角菜膠、羥乙基纖維素和纖維素醚之水溶性鹽類，例如羧甲基纖維素鈉和羧甲基羥乙基纖維素鈉。亦可併入天然膠例如刺梧桐膠、阿拉伯膠和黃蓍膠。膠狀矽酸鎂鋁或細粉狀矽氧可用作增加組成物稠度之組份，以進一步改善組成物之質地。在特定的實施例中，以總組成物的重量計，係使用約0.5%至約5.0%之量的增稠劑。
水亦可存在本發明之口腔組成物中。用於製備市售口腔組成
物的水應去離子化且無有機雜質。水一般係填補組成物的餘量，且以總組成物的重量計，係包括約10%至約90%，約20%至約60%或約10%至約30%。此水量係包括添加的游離水加上隨其他物質例如隨山梨醇或任何本發明組份共同導入的水量。
在特定的口腔組成物之實施例中，亦希望併入一保濕劑以防止組成物因暴露於空氣中而硬化。特定的保濕劑亦可能給予潔牙組成物所欲的甜味或風味。保濕劑，以純保濕劑為基準，在一實施例中，以潔牙組成物的重量計，一般係包括約15%至約70%，或在另一實施例約30%至約65%。
適合的保濕劑包括可食用多元醇例如甘油、山梨醇、木糖醇、丙二醇和其他多醇類以及這些保濕劑之混合物。甘油和山梨醇之混合物可用於特定的實施例中作為文中牙膏組成物之保濕劑組份。
除了上述組份外，本發明之實施例可含有各種某些下述之視需要的潔牙成份。視需要的成份包括，例如，但不限於黏合劑、起泡劑、調味劑、甜味劑、另外的抗牙菌斑劑、研磨劑及調色劑。這些及其他的視需要組份係進一步描述於Majeti之美國專利第5,004,597號；Agricola等人之美國專利第3,959,458號；Haefele之美國專利第3,937,807號中，其全部係以引用的方式併入本文中。
本發明之組成物和方法對於藉由幫助修復和再礦化保護牙齒之方法為有效的，特別是降低或抑制齲齒形成、降低或抑制去礦化和促進牙齒再礦化、降低牙齒過敏及降低、修復或抑制琺瑯質齲前腐蝕病灶，例如定量光學螢光(QLF)或電子齲蝕監測器(ECM)所偵測。
定量光學螢光為一種可早期偵測病灶及縱貫性監測進程或退化之可見光螢光。正常的牙齒在可見光發出螢光；去礦化的牙齒則否或
程度較低。去礦化的面積可經量化並監測其進程。使用藍色雷射光使牙齒自動發出螢光。相較於良好的牙齒表面，已經失去礦物質之面積具有較低的螢光且明顯較暗。使用軟體將來自白斑或與病灶有關的面積/體積之螢光量化。一般而言係招募存有白斑病灶之對象作為小組成員。於活體內以真實的牙齒進行測量。在臨床開始時測量病灶面積/體積。在產品使用6個月結束時測量病灶面積/體積之降低量(改善量)。數據通常係以對照基線的百分比改善量提出。
電子齲蝕偵測為一種以電阻為基準用於測量牙齒之礦物質含量的技術。電導測量發現因去礦化而暴露之填充流體的小管及琺瑯導電之質腐蝕的事實。因牙齒失去礦物質，由於多孔性增加使其變得對電流阻抗較低。因此病患牙齒的電導增加可代表去礦化。一般而言，係進行一現有病灶之牙根表面的研究。於活體內以真實的牙齒進行測量。找出6個月治療前後之電阻變化。此外，係使用感觸探測做出牙根表面之經典的齲蝕得分。硬度係以三分量表來分類：硬、革質或軟。在此類的研究中，典型地，結果係以ECM測量之電阻及以感觸探測分數為基準之病灶硬度的改善提出報告(數字越高越好)。
本發明之組成物因此可用於相對缺乏有效量之氟及/或精胺酸之組成物，降低琺瑯質之齲前病灶(如以QLF或ECM測量)之方法中。
本發明之組成物另外可用於降低口腔中有害細菌之方法中，例如降低或抑制牙齦炎之方法，降低產酸菌的量，增加精胺酸分解菌之相對量，抑制口腔中微生物生物膜形成，在施用糖後提高及/或維持牙菌斑pH在至少pH 5.5的程度，降低牙菌斑堆積，及/或清潔牙齒和口腔。
最後，藉由增加口中的pH及阻礙病原性細菌，本發明之組成物可用於促進口中傷口或割傷之癒合。
促進口腔健康亦可提供全身性健康之利益，因為口腔組織可能為全身性感染之入口。良好的口腔健康係與全身性健康有關，包括心血管健康。本發明之組成物和方法係提供特別的利益，因為鹼性胺基酸，特別是精胺酸為供應NP合成路徑之氮來源且因此增進口腔組織的微循環。提供較少的酸性口腔環境亦對降低胃痛有幫助並創造一個與胃潰瘍有關的螺旋菌較不欲的環境。精胺酸特言之係為特定高表現之免疫細胞受體所需，例如T-細胞受體，所以精胺酸可增進有效的免疫反應。本發明之組成物和方法因此可用於促進全身性健康，包括心血管健康。
在本發明的某些實施例中，口腔保健組成物係包括甜沒藥萜醇和精胺酸之混合物。文中之甜沒藥萜醇係指α-(-)-甜沒藥萜醇、α-(+)-甜沒藥萜醇及/或其混合物。文中之甜沒藥萜醇亦指稱為β-甜沒藥萜醇之較不常見的甜沒藥萜醇形式，其與α-甜沒藥萜醇之差異僅在於醇功能基基團之位置。
在另外的實施例中，口腔保健組成物係藉由形成一倍半萜醇及鹼性胺基酸之混合物並將其與適合的載劑組合所製造。
在某些實施例中，口腔保健組成物係使用牙刷、電動牙刷、澆灌系統、凝膠條片或任何其他適合的遞送工具施用於口腔內的牙齒和牙齦。然後於一段時間後，使用，例如水將至少一部份的口腔保健組成物從口腔沖洗出。
本發明之組成物可根據口腔保健領域中已知的各種方法來製造。
在本發明之某些實施例中係供製造文中所述的口腔保健組成物之方法。在某些實施例中，這些方法係包括：a)形成倍半萜醇和鹼性胺基酸之混合物；及b)將此倍半萜醇和鹼性胺基酸之混合物與載劑組合。
本發明之某些實施例係提供治療或預防口腔內齲齒，其包括：a)將一口腔保健組成物施予口腔內的牙齒，其中該口腔保健組成物係包括倍半萜醇和鹼性胺基酸與包括一或多種糊膏、膠、液體和凝膠之載劑的混合物；及b)以沖洗從口腔移除部分的口腔保健組成物，其中該口腔保健組成物係降低口腔內的pH以控制齲齒。
某些實施例係提供包括將有效量之如文中所述的口腔保健組成物施予有此需要之對象口腔的方法，用以降低、修復或抑制琺瑯質之齲前病灶、降低或抑制去礦化作用並促進牙齒再礦化、降低牙齒敏感、降低或抑制牙齦炎、促進口中傷口或割傷之癒合、降低產酸菌的量、增加精胺酸分解菌之相對量、抑制口腔中微生物生物膜形成、在施用糖後提高及/或維持牙菌斑pH在至少pH 5.5的程度、降低牙菌斑堆積、治療、舒緩或降低口乾、清潔牙齒和口腔降低齲蝕、給予牙齒對抗致齲性細菌之免疫力；及/或促進全身健康，包括心血管健康。
下列實例係進一步描述及驗證本發明範圍內之說明性實施例。此等實例僅用作說明且不應視為本發明之限制，因為在不悖離其精神和範圍下可能有許多變化。除了文中所顯示和描述的外，本發明之各種修改對於熟習本項技術者為顯而易見的並希望落在所附的申請專利範圍內。
為了評估單獨的精胺酸、精胺酸和甜沒藥萜醇之混合物以及單獨的甜沒藥萜醇之效用，係以口腔細菌存在下氨的產生，進行下列程序。將刺激的全唾液收集於冰上並以4000rpm離心15分鐘，得到一團塊及唾
液上清液。此團塊，稱為唾液沉澱物，係含有口腔中發現的口腔微生物之代表性布署。藉由以4000rpm離心10分鐘將此團塊以冷的過濾殺菌去離水清洗二次。
然後將唾液沉澱物以冷的過濾殺菌去離水稀釋至50%。製作溶於過濾殺菌去離水之1%精胺酸和1%蔗糖之儲存溶液，以及製作溶於乙醇之1%甜沒藥萜醇的儲存溶液。試驗的反應混合物係含有16.7%最終濃度唾液沉澱物，0.1%最終濃度蔗糖和0.0871%最終濃度精胺酸。對照的反應混合物僅含有溶於唾液上清液基底之唾液沉澱物、蔗糖和精胺酸。試驗溶液分別具有0.05和0.1之最終濃度的甜沒藥萜醇。然後將反應混合物於輕微震盪下以攝氏37度培養30分鐘，之後測定氨產量。使用標準的診斷性氨分析套組來定量所產生的氨。
表1(下表)係描述上述程序之結果，其中氨產生係依每毫克之毫微莫耳(nm/mg)所測量。
表1之A欄係描述由三個含有唾液沉澱物和唾液上清液帶有0.1%蔗糖和0.0871% L-精胺酸最終濃度之L-精胺酸(對照組)反應混合物試驗所收集到的數據。表1之B欄係描述由三個含有唾液沉澱物和唾液上清液帶有0.1%蔗糖、0.05%甜沒藥萜醇和0.0871% L-精胺酸最終濃度之0.05%甜沒藥萜醇加上精胺酸反應混合物試驗所收集到的數據。表1之C欄係描述由三個含有唾液沉澱物和唾液上清液帶有0.1%蔗糖和0.05%甜沒藥萜醇最終濃度之0.05%甜沒藥萜醇反應混合物試驗所收集到的數據。表1之D欄係描述由三個含有唾液沉澱物和唾液上清液帶有0.1%蔗糖、0.05%甜沒藥萜醇和0.0871% L-精胺酸最終濃度之0.1%甜沒藥萜醇加上精胺酸反應混合物試驗所收集到的數據。表1之E欄係描述由三個含有唾液沉澱物和唾液上清液帶有0.1%蔗糖和0.1%甜沒藥萜醇最終濃度之0.1%甜沒藥萜醇反應混合物試驗所收集到的數據。
表1中所描述的數據驗證了鹼性胺基酸(例如精胺酸)和倍半萜醇(例如甜沒藥萜醇)之組合提供了協同性增加口腔細菌之胺產生。
Claims (26)
- 一種口腔保健組成物，係包括倍半萜醇(sesquiterpene alcohol)和游離或鹽形式之鹼性胺基酸，其中該倍半萜醇係以從0.01至0.5%之濃度存在。
- 如申請專利範圍第1項之組成物，其中該倍半萜醇係包括一單環倍半萜醇。
- 如申請專利範圍第2項之組成物，其中該單環倍半萜醇係包括甜沒藥萜醇(bisabolol)。
- 如申請專利範圍第3項之組成物，其中該單環倍半萜醇係包括α-(-)-甜沒藥萜醇。
- 如申請專利範圍第3項之組成物，其中該單環倍半萜醇係包括α-(-)-甜沒藥萜醇和α-(+)-甜沒藥萜醇之混合物。
- 如申請專利範圍第1至5項中任一項之組成物，其中該鹼性胺基酸為游離或鹽形式之精胺酸。
- 如申請專利範圍第6項之組成物，其中該精胺酸係選自L-精胺酸、精胺酸碳酸氫鹽、精胺酸磷酸鹽和其二或多種組合。
- 如申請專利範圍第1至5項中任一項之組成物，其中該倍半萜醇為甜沒藥萜醇而該胺基酸為精胺酸，其中甜沒藥萜醇和精胺酸係以1：2和2：1甜沒藥萜醇對精胺酸重量/重量(w/w)之比例存在。
- 如申請專利範圍第1至5項中任一項之組成物，其中該鹼性胺基酸係以從0.01至10%重量比之濃度存在。
- 如申請專利範圍第1至5項中任一項之組成物，其中該組成物為選自糊膏、膠、液體和凝膠之形式。
- 如申請專利範圍第1至5項中任一項之組成物，其進一步係包括一研磨 劑。
- 如申請專利範圍第11項之組成物，其中該研磨劑係選自：矽氧、氧化鋁、偏磷酸鈣、碳酸鈣和磷酸氫鈣。
- 如申請專利範圍第12項之組成物，其中該研磨劑係選自碳酸鈣和磷酸氫鈣。
- 如申請專利範圍第13項之組成物，其中該研磨劑為碳酸鈣。
- 如申請專利範圍第14項之組成物，其中該碳酸鈣係選自天然的碳酸鈣和沉澱碳酸鈣。
- 如申請專利範圍第1至5項中任一項之組成物，其進一步係包括一pH調變劑。
- 如申請專利範圍第16項之組成物，其中該pH調變劑係包括碳酸氫鈣。
- 如申請專利範圍第1項之組成物，其又包括包含研磨劑且包含至少約5%調配物重量比之小粒子分量，其中該小粒子分量(fraction)之粒子係具有低於約5um之d50。
- 如申請專利範圍第18項之組成物，其中該小粒子分量係包括碳酸鈣、矽氧或其組合物。
- 如申請專利範圍第18或19項之組成物，其中該小粒子分量係包括碳酸鈣。
- 如申請專利範圍第1至5項中任一項之組成物，其進一步係包括一陰離子界面活性劑。
- 如申請專利範圍第21項之組成物，其中該陰離子界面活性劑係包括月桂基硫酸鈉。
- 如申請專利範圍第1至5項中任一項之組成物，其進一步係包括一氟化 物離子來源。
- 如申請專利範圍第23項之組成物，其中該氟化物離子來源係選自氟化亞錫、氟化鈉、氟化鉀、單氟磷酸鈉、氟矽酸鈉、氟矽酸銨、氟化胺、氟化銨及其二或多種組合物。
- 如申請專利範圍第23項之組成物，其中該氟化物離子來源係包括單氟磷酸鈉。
- 一種如申請專利範圍第1至25項中任一項之組成物之用途，係用於製造供治療或預防齲齒之口腔保健產品。
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| AU2019270966B2 (en) * | 2018-05-14 | 2021-11-11 | The Procter & Gamble Company | Unit-dose oral care compositions |
| TWI707294B (zh) * | 2019-12-05 | 2020-10-11 | 國立聯合大學 | 田間湛水感測裝置、田間湛水感測系統、及田間湛水感測方法 |
| EP4014948A1 (de) * | 2020-12-18 | 2022-06-22 | Ivoclar Vivadent AG | Zusammensetzung zur remineralisation von zähnen |
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