TWI461218B - 口腔保健產品及其使用方法與製造(一) - Google Patents
口腔保健產品及其使用方法與製造(一) Download PDFInfo
- Publication number
- TWI461218B TWI461218B TW097112581A TW97112581A TWI461218B TW I461218 B TWI461218 B TW I461218B TW 097112581 A TW097112581 A TW 097112581A TW 97112581 A TW97112581 A TW 97112581A TW I461218 B TWI461218 B TW I461218B
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- Taiwan
- Prior art keywords
- arginine
- composition
- oral
- weight
- acid
- Prior art date
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- 238000004519 manufacturing process Methods 0.000 title claims description 11
- 238000000034 method Methods 0.000 title description 27
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- 229960003121 arginine Drugs 0.000 claims description 73
- ODKSFYDXXFIFQN-BYPYZUCNSA-P L-argininium(2+) Chemical compound NC(=[NH2+])NCCC[C@H]([NH3+])C(O)=O ODKSFYDXXFIFQN-BYPYZUCNSA-P 0.000 claims description 72
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- CETPSERCERDGAM-UHFFFAOYSA-N ceric oxide Chemical compound O=[Ce]=O CETPSERCERDGAM-UHFFFAOYSA-N 0.000 claims description 3
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Description
[0001]
本申請案主張於2008年02月08日申請之U.S.Ser.No.61/027,432、於2008年02月08日申請之U.S.Ser.No.61/027,431、以及於2008年02月08日申請之U.S.Ser.No.61/027,420之權益,彼等之內容被併入於此為參考。
[0002]
本發明相關於包含一種呈游離或鹽型式的鹼性胺基酸、一種陰離子界面活性劑、及選擇之另外的物質之口腔保健組成物,以及使用與製造這類組成物之方法。
[0003]
已有提議使用精胺酸及其他的鹼性胺基酸用於口腔保健,且一般相信,彼等對於對抗蛀牙齒形成及牙齒敏感性應具有益處,無論如何,想將這些胺基酸類與具有口腔保健益處之礦物質(例如,氟化物及鈣)組合以形成一種具有可被接受的長期安定性的口腔保健產品,經證明具有挑戰性,特別的,鹼性胺基酸可能提高pH並幫助鈣離子之解離,使之與氟離子起作用形成一種不溶的沈澱;此外,此較高的pH可能造成刺激性,然而,在中性或酸性pH下,利用精胺酸碳酸氫鹽的系統(為本技藝中認為係較佳方式)可能釋放二氧化碳,導致鼓脹及爆玻容器,此外,可被預期的是,由於精胺酸在中性或酸性條件下可形成一種不溶的精胺酸-鈣之複合物,其對牙齒表面具有較低的親和力,
故降低pH成中性或酸性的情況將減少配製劑的效力,而且,另外的,降低pH將減少配製劑可能對口中之具有緩衝生齲的乳酸之任何效力,部分地由於這些未被滿足的配製劑之障礙,且部分地由於在本技藝的回顧中,精胺酸通常被認為係一種氟化物之替代物而非一種共-活性物,已有少許的推展以製造包含精胺酸及氟化物兩者之口腔保健產品,另外的困難為可能地加入之抗微生物劑;市面上可購得之含精胺酸之牙膏,例如,ProClude及DenClude,其含有精胺酸碳酸氫鹽及碳酸鈣,但不含氟化物或任何抗微生物劑。
[0004]
在同時,於牙膏中使用抗微生物劑(例如,三氯沙),已經許多牙醫生確認具有其價值,然而這些藥劑如何被輸送有效量至牙齒及牙床上係極富挑戰性的,且要視彼等之溶解性、輸送及滯留於牙齒的性質而定,例如,三氯沙[triclosan(5-氯-2-(2,4-二氯苯氧基)苯酚)]為僅略溶於水。
[0005]
因此,有需要一種安定的口腔保健產品,其能提供一種鹼性胺基酸、有益處的礦物(例如,氟化物及鈣)、對抗細菌之增進的活性、以及抗微生物劑之改善的輸送。
[0006]
目前令人驚喜地發現,一種鹼性胺基酸,例如,精胺酸,併用一種陰離子界面活性劑,可減少細菌的粘附及生物膜之形成及額外地戲劇性地增進溶解性、輸送性、滯
留性及抗菌劑(例如,三氯沙)之抗菌的有效性。
[0007]
本發明於是包含口腔保健組成物及使用其之方法,其為有效於抑制或減少斑塊的蓄積、產少產酸的(生齲的)細菌之數值、使牙齒再礦化(remineralizing)、及抑制或減少齒齦炎者;本發明也包含用於清潔口腔及提供促進口腔健康及/或全身健康(包括心血管健康,例如,藉由減少潛在的經口腔組織之全身性感染)之組成物及方法。
[0008]
本發明因此包含一種口腔保健組成物(一種本發明之組成物),例如,一種潔牙劑(dentifrice),包含i.一種有效量的呈游離或鹽型式之一種鹼性胺基酸,例如,精胺酸;ii.一種有效量之一種陰離子界面活性劑,例如,月桂基硫酸鈉;及一種另外的添加劑,係挑選自一或多種的抗菌劑,例如,一種鹵化的二苯基醚,例如,三氯沙(triclosan);一種有效量的氟化物源,例如,一種可溶的氟化物鹽;及/或一種陰離子聚合物,例如,一種甲基乙烯基醚及順丁烯二酸酐之共聚物(PVM/MA);本發明因此於一具體實施例之牙膏中,包括一種精胺酸鹽,例如,精胺酸鹽酸鹽、精胺酸磷酸鹽或精胺酸碳酸氫鹽;三氯沙;一種陰離子界面活性劑,例如,月桂基硫酸鈉;一種可溶的氟化物鹽,例如,單氟磷酸鈉或氟化鈉。
[0009]
一具體實施例中,本發明包含本發明的組成物(組成物1.1),另包含一種微粒(particulate),此組成物具有一種
RDA為少於約200,例如,少於約160,例如,約40至約140,例如包含至少約5%,例如,至少20%的微粒為具有一種d50為少於約5微米,例如,具有一種d50為約3至約4微米之二氧化矽或具有一種d50為約0.5至約3微米之沈澱的碳酸鈣。
[0010]
一特別的具體實施例中,本發明的組成物係呈包含挑選自一或多種下述額外成分之潔牙劑形式:水、磨蝕劑、界面活性劑、泡沫劑、維生素、聚合物、酵素、保濕劑、增稠劑、抗微生物劑、防腐劑、風味劑、著色劑及/或彼等之組合劑。
[0011]
並非想以特殊的理論進行解釋,但可假設,精胺酸之所以具有明顯效益係精胺酸及其他的鹼性胺基酸可被某些類型的的細菌(例如,血鏈球菌(S.sanguis
))代謝,其不是生齲的細菌(cariogenic)且其會與生齲的細菌(例如,轉醣鏈球菌(S.mutans
))在牙齒上及口腔中競爭,此分解精胺酸的細菌可利用精胺酸及其他鹼性胺基酸以產生氨,於是提高其生活環境之pH,而生齲的細菌代謝糖以產生乳酸,其傾向降低斑塊pH及去礦化牙齒,最後導致蛀牙,一般相信,規則地使用本發明的組成物經一段時間,將相對地增加分解精胺酸之細菌與相對地的減少生齲的細菌,導致一種較高的斑塊pH,影響牙齒產生免疫以對抗生齲的細菌及彼等有害的影響,一般相信,此pH-提升的效果可被機制地分開於及補充氟化物的效果以促進再礦化及強化牙齒琺瑯質。
[0012]
然而,不考慮到精確機制下,令人驚訝地發現,組
合使用氟化物與一種鹼性胺基酸(例如,精胺酸)於根據本發明之一特別的具體實施例之一種口腔保健產品內,產生令人意想不到的益處,其促進再礦化、修補前-蛀牙損傷、及促進口腔健康方面,遠大於且品質極不同於使用包含有效量之分開的個別的化合物被觀察到者,也被發現,此作用可經添加小粒子之磨蝕劑再被提升,此磨蝕劑的作用為用於幫助充填牙齒象牙質中之微小管(microtubules)。
[0013]
一種鹼性胺基酸併用一種陰離子界面活性劑的存在也令人驚訝地發現有用於減少細菌粘附至牙齒表面。
[0014]
特別適宜於本發明的,此鹼性胺基酸一起與一種陰離子界面活性劑,實質地提升活性劑(例如,抗微生物劑,例如,三氯沙)的溶解度、釋放、輸送、澱積、及有效性。
[0015]
減少細菌的粘附及一種抗菌劑(例如,三氯沙)之改善的輸送及滯留,被一種陰離子聚合物(例如,一種聚碳酸酯,例如,PVM/MA)之存在而再被提升,本發明因此再包含方法,用於(i)減少或抑制齲齒之形成,(ii)減少、修復或抑制早期之琺瑯質損傷,例如,藉由定量的光-誘發之螢光法(quantitative light-induced fluorescence,QLF)或電的齲齒測量法(ECM)所偵測得者,(iii)減少或抑制牙齒之去礦化及促進牙齒之再礦化,(iv)減少牙齒之敏感性,(v)減少或抑制齒齦炎,(vi)促進口中酸痛或口腔內傷口之癒合,(vii)減少產酸菌之數量,(viii)增加分解精胺酸的細菌之相對量,(ix)抑制於口腔內之微生物膜形成,(x)在吃過糖後,能提升及/或維持斑塊的pH於至少pH 5.5,(xi)減少菌斑蓄積,(xii)
治療口乾,(xiii)促進全身健康,包括心血管健康,例如,藉由減少經由口腔組織之全身性感染潛力,(xiv)減少牙齒之侵蝕,及/或(xv)清潔及/或潔白牙齒以及清潔口腔,包括施用本發明的組成物至口腔,例如,藉由施用一種本發明的組成物至有需要處理的患者之口腔。
[0016]
本發明於是包含一種口腔保健組成物(組成物1.0),係包含i.一種有效量的鹼性胺基酸,例如,呈游離或鹽型式之精胺酸;ii.一種陰離子界面活性劑,例如,月桂基硫酸鈉;及iii.一種另外的添加劑,係挑選自一或多種有效量的活性劑,例如,一種抗微生物劑,例如,三氯沙(triclosan);一種有效量的氟化物源,例如,一種可溶的氟化物鹽;及/或一種陰離子聚,例如,一種甲基乙烯基醚及順丁烯二酸酐之共聚物。
例如,下述任一組成物:1.0.1.組成物1.0,其中鹼性胺基酸為精胺酸、離胺酸(lysine)、瓜胺酸(citrullene)、鳥胺酸(ornithine)、肌胺酸(creatine)、組胺酸(histidine)、二胺基丁酸、二胺基丙酸、彼等之鹽類及/或彼等之組合物。
1.0.2.組成物1.0或1.0.1,其中鹼性胺基酸具有L-組態。
1.0.3.任何前述組成物,以包含鹼性胺基酸之一種二-或三-肽的鹽型式被提供。
1.0.4.任何前述組成物,其中鹼性胺基酸為精胺酸。
1.0.5.任何前述組成物,其中鹼性胺基酸為L-精胺酸。
1.0.6.任何前述組成物,其中鹼性胺基酸為部分地或全部地呈鹽型式。
1.0.7.組成物1.0.6,其中鹼性胺基酸為精胺酸磷酸鹽。
1.0.8.組成物1.0.6,其中鹼性胺基酸為精胺酸鹽酸鹽之型式。
1.0.9.組成物1.0.6,其中鹼性胺基酸為精胺酸硫酸鹽。
1.0.10.組成物1.0.6,其中鹼性胺基酸為精胺酸碳酸氫鹽。
1.0.11.任何前述組成物,其中鹼性胺基酸之鹽為當場經由以一種酸或一種酸的鹽中和此鹼性胺基酸而形成。
1.0.12.任何前述組成物,其中鹼性胺基酸之鹽為藉由中和鹼性胺基酸以形成一種預混合物後,再與氟化物鹽組合。
1.0.13.任何前述組成物,其中鹼性胺基酸之存在量為相當於總組成物重量之約0.1至約20%,例如,約1 wt%至約10 wt%,例如,約3%至約10%,鹼性胺基酸的重量係以游離鹼型式被計算。
1.0.14.化合物1.0.11,其中鹼性胺基酸之存在量為相當於總組成物重量之約7.5 wt%。
1.0.15.化合物1.0.11,其中鹼性胺基酸之存在量為相當於
總組成物重量之約5 wt%。
1.0.16.化合物1.0.11,其中鹼性胺基酸之存在量為相當於總組成物重量之約3.75 wt%。
1.0.17.化合物1.0.11,其中鹼性胺基酸之存在量為相當於總組成物重量之約1.5 wt%。
1.0.18.任何前述組成物,其中氟化物鹽為氟化亞錫、氟化鈉、氟化鉀、單氟磷酸鈉、氟矽酸鈉、氟矽酸銨、氟化胺(例如,N'-十八烷基三亞甲基二胺-N,N,N'-三(2-乙醇)-二氫氟化物);氟化銨、氟化鈦、六氟硫酸鹽、及彼等之組合物。
1.0.19.任何前述的組合物,其中氟化物鹽為一種氟磷酸鹽。
1.0.20.任何前述的組合物,其中氟化物鹽為一種單氟磷酸鹽。
1.0.21.任何前述的組合物,其中氟化物鹽為氟化鈉。
1.0.22.任何前述的組合物,其中氟化物鹽存在的量為相當於總組成物重量之約0.01 wt%至約2 wt%。
1.0.23.任何前述的組合物,其中氟化物鹽提供氟離子的量為相當於總組成物重量之約0.1 wt%至約2 wt%。
1.0.24.任何前述的組合物,其中可溶的氟化物鹽提供氟離子的量為自約50至約25,000 ppm。
1.0.25.任何前述的組合物,其為一種具有100至約250 ppm有效氟離子之漱口水。
1.0.26.任何前述的組合物,其為一種具有約750至約2000 ppm有效氟離子之一種潔牙劑。
1.0.27.任何前述的組合物,其中組成物包含約750至約2000 ppm的氟離子。
1.0.28.任何前述的組合物,其中組成物包含約1000至約1500 ppm的氟離子。
1.0.29.任何前述的組合物,其中組成物包含約1450 ppm的氟離子。
1.0.30.任何前述的組合物,其中pH為約6至約9,例如,約6.5至約7.4或約7.5至約9。
1.0.31.任何前述的組合物,其中pH為約6.5至約7.4。
1.0.32.任何前述的組合物,其中pH為約6.8至約7.2。
1.0.33.任何前述的組合物,其中pH為接近中性。
1.0.34.任何前述的組合物,其再包含一種磨蝕劑或微粒體。
1.0.35.前一組成物,其中磨蝕劑或微粒體係被挑選自:碳酸氫鈉、磷酸鈣(例如,磷酸二鈣二水合物)、硫酸鈣、碳酸鈣(例如,沈澱的碳酸鈣)、二氧化矽(例如,水合的二氧化矽)、氧化鐵、羥基磷灰石、氧化鋁、珍珠岩(perlite)、塑膠粒子,例如,聚乙烯、以及彼等之組合物。
1.0.36.前一組成物,其中磨蝕劑或微粒體係被挑選自一種磷酸鈣(例如,磷酸二鈣二水合物)、硫酸鈣、沈澱的碳酸鈣、二氧化矽(例如,水合的二氧化矽)、
以及彼等之組合物。
1.0.37.任何前述的組合物,其中包含的磨蝕劑的量為相當於總組成物重量之約15 wt%至約70 wt%。
1.0.38.任何前述的組合物,其中包含小顆粒的磨蝕劑部分為至少約5%具有一種d50為少於約5微米。
1.0.39.前述之任一組成物,具有一種RDA為少於150,例如,約40至約140。
1.0.40.前述之任一組成物,另包含一種抗-結石劑。
1.0.41.前述之任一組成物,另包含一種抗-結石劑,其為一種聚磷酸鹽,例如,焦磷酸鹽、三聚磷酸鹽、或六偏磷酸,例如,呈鈉鹽型式。
1.0.42.任何前述的組合物,其中陰離子界面活性劑為挑選自:a.高級脂肪酸單甘油酯單硫酸鹽之水-可溶的鹽類(例如,氫化的椰子油脂肪酸之單硫酸化的單甘油酯之鈉鹽,例如,N-甲基N-椰醯基牛磺酸鈉、椰基單-甘油酯硫酸鈉),b.高級烷基硫酸酯類,例如,月桂基硫酸鈉,c.高級烷基-醚硫酸酯類,例如,具式CH3
(CH2
)m
CH2
(OCH2
CH2
)n
OSO3
X者,其中,m為6-16,例如,10,n為1-6,例如,2、3或4,且X為Na或K(例如,月桂基-2硫酸鈉(CH3
(CH2
)10
CH2
(OCH2
CH2
)2
OSO3
Na)),d.高級烷基芳基磺酸酯類(例如,月桂基苯磺酸
鈉(sodium lauryl benzene sulfonate)),e.高級的烷基磺基乙酸鹽類[例如,月桂基磺基乙酸鈉(十二烷基磺基乙酸鈉)、1,2-二羥基丙烷磺酸之高級脂肪酸酯類、月桂酸磺基酯(N-2-乙基月桂酸鉀磺基乙醯胺)及月桂醯基肌胺酸鈉],f.以及彼等之混合物。
所謂之"高級的烷基"係指,例如,C6-30
烷基,一特別的具體實施例中,陰離子界面活性劑係挑選自月桂基硫酸鈉及月桂醯基硫酸醚鈉。
1.0.43.任何前述的組合物,其中陰離子界面活性劑係挑選自月桂基硫酸鈉、月桂醯基硫酸醚鈉、及其混合物。
1.0.44.任何前述的組合物,其中陰離子界面活性劑存在的量為自約0.3%至約4.5%重量計,1.0.45.任何前述的組合物,另外包含挑選自陽離子、兩性離子、及非離子、以及其混合物的界面活性劑。
1.0.46.任何前述的組合物,尚包含至少一種保濕劑(humectant)。
1.0.47.任何前述的組合物,尚包含至少一種挑選自甘油、山梨糖醇、及其組合物之一種保濕劑。
1.0.48.任何前述的組合物,尚包含木糖醇(xylitol)。
1.0.49.任何前述的組合物,尚包含至少一種聚合物。
1.0.50.任何前述的組合物,尚包含至少一種挑選自下述
之一種聚合物:聚乙二醇、聚乙烯基甲基醚順丁烯二酸共聚物、多醣類(例如,纖維素衍生物類,例如,羧甲基纖維素、或多醣類膠質,例如,黃原膠(xanthan gum)或鹿角菜膠(carrageenan gum)、及彼等之組合物。
1.0.51.任何前述的組合物,尚包含膠質條或斷片(fragments)。
1.0.52.任何前述的組合物,尚包含風味劑(flavoring)、芳香劑(fragrance)及/或著色劑(coloring)。
1.0.53.任何前述的組合物,尚包含水。
1.0.54.任何前述的組合物,尚包含一種挑選自下述之抗菌劑:經鹵化的二苯基醚(例如,三氯沙)、草本萃取物類及精油類[例如,迷迭香萃取物(rosemary extract)、茶萃取物(tea extract)、木蘭屬植物萃取物(magnolia extract)、百里香(thymol)、薄荷醇(menthol)、桉葉醇(eucalyptol)、香葉草醇(geraniol)、香芹酚(carvacrol)、檸檬醛(citral)、扁柏酚(hinokitol)、兒茶酚(catechol)、水楊酸甲酯、表沒食子兒茶素沒食子酸酯(epigallocatechin gallate)、表沒食子兒茶素(epigallocatechin)、沒食子酸(gallic acid)、miswak萃取物、沙棘萃取物(sea-buckthorn extract)]、雙胍防腐劑類(bisguanide antiseptics)[例如,氯海克替啶(chlorhexidine)、阿來西啶(alexidine)或奧替尼啶(octenidine)]、季銨化
合物類[例如,十六烷基氯化吡啶(cetylpyridinium chloride,CPC)、氯化苯二甲羥銨(benzalkonium chloride)、十四烷基氯化吡啶(tetradecylpyridinium chloride,TPC)、N-十四烷基-4-乙基氯化吡啶(N-tetradecyl-4-ethylpyridinium chloride,TDEPC)]、酚性防腐劑類(phenolic antiseptics)、海克替啶(hexetidine)、奧替尼啶(octenidine)、血根鹼(sanguinarine)、聚乙烯咯酮碘(povidone iodine)、得莫品醇(delmopinol)、salifluor、金屬離子類(例如,鋅鹽類,例如,檸檬酸鋅、亞錫鹽類、銅鹽類、鐵鹽類)、血根鹼(sanguinarine)、蜂膠及氧化劑類(例如,過氧化氫、緩衝的過氧硼酸鈉或過氧碳酸鈉)、苯甲二酸及其鹽類、單過苯甲二酸及其鹽類及其酯類、抗壞血醯基硬脂酸酯、油醯基肌胺酸(oleoyl sarcosine)、烷基硫酸酯(alkyl sulfate)、二辛基磺基琥珀酸酯(dioctyl sulfosuccinate)、水楊醯苯胺(salicylanilide)、溴杜滅芬(domiphen bromide)、得莫品醇(delmopinol)、辛哌醇(octapinol)及其他的六氫吡啶基衍生物類、nicin配製劑類(nicin preparations)、亞氯酸鹽類(chlorite salts)、以及前述任一化合物之混合物。
1.0.55.任何前述的組合物,尚包含一種消炎的化合物,例如,挑選自下述之至少一種前-發炎因子之抑制劑:基質金屬蛋白酶(matrix metalloproteinases,
MMP's)、環氧化酶(cyclooxygenases,COX)、PGE2、介白素1(interleukin 1,IL-1)、IL-1β轉換酶(ICE)、轉化生長因子β1(transforming growth factor β1,TGF-β1)、可誘發的一氧化氮合成酶(iNOS)、玻糖醛酸酶(hyaluronidase)、細胞自溶酵素(cathepsins)、核因子kappa B(NF-B)、及IL-1受體相關的激酶(Receptor Associated Kinase,IRAK),例如,挑選自阿斯匹靈、ketorolac(一種非類固醇消炎劑)、氟比普芬(flurbiprofen)、布洛芬(ibuprofen)、奈普生(naproxen)、吲哚美辛(indomethacin)、阿斯匹靈(aspirin)、酮基普芬(ketoprofen)、比羅昔康(piroxicam)、甲氯芬那酸(meclofenamic acid)、去甲二氫癒創木酸(nordihydoguaiaretic acid)、及彼等之混合物。
1.0.56.任何前述的組合物,尚包含一種抗氧化劑,例如,挑選自包括:輔酶Q10、PQQ、維生素C、維生素E、維生素A、茴香腦(anethole)-二硫代硫酮(dithiothione)、及彼等之混合物。
1.0.57.任何前述的組合物,其中抗菌的物質之溶解度極低,例如,不會大於三氯沙之溶解度。
1.0.58.任何前述的組合物,另包含三氯沙(triclosan)。
1.0.59.任何前述的組合物,另包含三氯沙及木醣醇(xylitol)。
1.0.60.任何前述的組合物,尚包含三氯沙、木醣醇
(xylitol)、及沈澱的碳酸鈣。
1.0.61.任何前述的組合物,尚包含三氯沙及一種Zn2+
離子源(例如,檸檬酸鋅)。
1.0.62.任何前述的組合物,尚包含一種抗菌劑,其量為相當於總組成物重量之約0.01至約5 wt%。
1.0.63.任何前述的組合物,尚包含三氯沙,其量為相當於總組成物重量之約0.01至約1 wt%。
1.0.64.任何前述的組合物,尚包含三氯沙,其量為相當於總組成物重量之約0.0.3%。
1.0.65.任何前述的組合物,尚包含三氯沙及一種Zn2+
離子源,例如,檸檬酸鋅。
1.0.66.任何前述的組合物,尚包含一種潔白劑(whitening agent)。
1.0.67.任何前述的組合物,尚包含一種挑選自包括下述之潔白劑:過氧化物類、金屬亞氯酸鹽類(metal chlorites)、過硼酸鹽類(perborates)、過碳酸鹽類(percarbonates)、過氧酸類(peroxyacids)、次氯酸鹽類(hypochlorites)、及彼等之混合物。
1.0.68.任何前述的組合物,尚包含過氧化氫或一種過氧化氫源,例如,尿素過氧化物或一種過氧化物鹽或複合物(例如,過氧磷酸鹽、過氧碳酸鹽、過硼酸鹽、過矽酸鹽、或過硫酸鹽類;例如,過氧磷酸鈣、過硼酸鈉、碳酸鈉過氧化物、過氧磷酸鈉、及過磷酸鉀),或過氧化氫聚合物複合物,例如,
過氧化氫-聚乙烯基吡咯酮聚合物複合物。
1.0.69.前述之任一組成物,另包含一種會干擾或阻止細菌附著之物質,例如,solbrol(一種添加劑/配料)或幾丁聚醣(chitosan)。
1.0.70.前述之任一組成物,另包含一種鈣及磷酸鹽源,係挑選自:(i)鈣-玻璃複合物,例如,磷矽酸鈣鈉,及(ii)鈣-蛋白質複合物,例如,酪蛋白磷肽-不定形的磷酸鈣。
1.0.71.前述之任一組成物,另包含一種可溶的鈣鹽,例如,挑選自硫酸鈣、氯化鈣、硝酸鈣、乙酸鈣、乳酸鈣、及彼等之組合物。
1.0.72.前述之任一組成物,另包含生理上可接受的鉀鹽,例如,硝酸鉀或氯化鉀,其量為有效於減少牙齒的敏感性。
1.0.73.前述之任一組成物,另包含自約0.1%至約7.5%的生理上可接受的鉀鹽,例如,硝酸鉀及/或氯化鉀。
1.0.74.前述之任一組成物,其為包含一種下述物質之牙膏:一種精胺酸鹽(例如,精胺酸鹽酸鹽、糊胺酸磷酸鹽或精胺酸碳酸氫鹽)、三氯沙、一種陰離子界面活性劑,例如,月桂基硫酸鈉、及一種可溶的氟化物鹽,例如,單氟磷酸鈉或氟化鈉。
1.0.75.前述之任一組成物,在被施用(例如,藉由刷上)至口腔內後,有效用於(i)減少或抑制齲齒之形成,(ii)減少、修後或抑制琺瑯質之前-蛀牙損傷,
例如,藉由定量的光-誘發的螢光(QLF)或電的齲齒測量(ECM)所偵測到者,(iii)減少或抑制牙齒之去礦化及促進牙齒之再礦化,(iv)減少牙齒之敏感性,(v)減少或抑制齒齦炎,(vi)促進嘴中酸痛或傷口之癒合,(vii)減少產酸菌之數量,(viii)增加分解精胺酸的細菌之相對數量,(ix)抑制於口腔內之微生物膜形成,(x)在吃過後,能提升或維持斑塊pH於至少pH 5.5,(xi)減少菌斑蓄積,(xii)處理、釋放或減少嘴乾,(xiii)清潔牙齒及口腔,(xiv)減少牙齒侵蝕,(xv)使牙齒潔白,(xvi)增加牙齒免疫力以對抗生齲菌,及/或(xvii)促進全身健康,包括心血管健康,例如,藉由減少經由口腔組織之全身性感染潛力。
1.0.76.一種組成物,其係得自或可得自藉由組合前述之任一組成物中之成分者。
1.0.77.前述之任一組成物,其型式為挑選自:漱口水、牙膏、牙凝膠、牙粉、非-磨蝕的凝膠、慕斯(mousse)、泡沫、嘴噴液(mouth spray)、糖錠(lozenge)、口含片(oral tablet)、牙器械(dental implement)、及寵物保健產品(pet care product)。
1.0.78.前述之任一組成物,其中組成物為牙膏。
1.0.79.前述之任一組成物,其中的組成物為一種牙膏,其選擇地再包含一或多種的水、磨蝕劑、界面活性劑、泡沫劑、維生素、聚合物、酵素、保濕劑、
增稠劑、抗微生物劑、防腐劑、風味劑、著色劑及/或彼等之組合物。
1.0.80.任一前述組成物1.0-1.0.78,其中組成物係一種漱口水。
1.0.81.前述任一組成物,另包含一種口氣清新劑、芳香劑或風味劑。
[0017]
另一具體實施例中,本發明包含本發明的一種組成物(組成物1.1),例如,根據前述任一組成物1.0-1.0.81,包含i.一種有效量的一種鹼性胺基酸的一種鹽;ii.一種有效量的可溶的氟化物鹽;iii.一種陰離子界面活性劑,例如,月桂基硫酸鈉;iv.一種陰離子聚合物,例如,一種甲基乙烯基醚與順丁烯二酸酐的共聚物;及v.一種抗菌劑,例如,三氯沙(triclosan)。
[0018]
另一具體實施例中,本發明包含本發明的一種組成物(組成物1.2),例如,根據前述任一組成物1.0-1.0.81,包含i.一種有效量的一種鹼性胺基酸的一種鹽;ii.一種抗菌劑,例如,三氯沙(triclosan);iii.一種有效量的可溶的氟化物鹽;及iv.小顆粒的磨蝕劑,使得組成物具有一種RDA為少於約160,例如,約40至約140,例如,包含至少約5%,例如,至少約20%的磨蝕劑為具有一種d50為少於約5
微米,例如,一種具有d50為約3至約4微米之二氧化矽。
[0019]
另一具體實施例中,本發明包含一種用於改進口腔健康之方法(方法2),係包括施用組成物1.0,1.1或1.2下之任一具體實施例的有效量之口腔組成物至有需要的對象之口腔,例如,一種方法用於i.減少或抑制齲齒的形成,ii.減少、修復或抑制早期之琺瑯質損傷,例如,藉由定量的光-誘發之螢光法(quantitative light-induced fluorescence,QLF)或電的齲齒測量法(ECM)能偵測得者,iii.減少或抑制牙齒之去礦化及促進牙齒之再礦化,iv.減少牙齒之敏感性,v.減少或抑制齒齦炎,vi.促進口中酸痛或口腔內傷口之癒合,vii.減少產酸菌之數量,viii.增加分解精胺酸的細菌之相對量,ix.抑制於口腔內之微生物膜形成,x.吃糖後,提升及/或維持斑塊pH於至少約pH 5.5,xi.減少菌斑蓄積,xii.治療口乾,xiii.促進全身健康,包括心血管健康,例如,藉由減少經由口腔組織之全身性感染潛力,xiv.使牙齒潔白,
xv.減少牙齒之侵蝕,xvi.增強牙齒免疫以對抗生齲菌,及/或xvii.清潔牙齒以及口腔。
[0020]
本發明也包含使用精胺酸用於製造本發明的一種組成物之用途,例如,供使用於方法2中說明之任一指示。
[0021]
本發明也提供一種包含呈游離或鹽型式之一種鹼性胺基酸以及一種陰離子界面活性劑的口腔保健組成物,供降低細菌附著於對象口腔中之牙齒表面。
[0022]
本發明另提供呈游離或鹽型式之一種鹼性胺基酸,在包含陰離子界面活性劑之口腔保健組成物中,供降低細菌附著於對象口腔中之牙齒表面的用途。
[0023]
本發明另提供呈游離或鹽型式之一種鹼性胺基酸,供製造一種包含陰離子界面活性劑,被用於降低細菌附著於對象口腔中牙齒表面的一種醫藥品之用途。
[0024]
本發明另提供用於減少細菌附著於對象口腔中牙齒表面的一種方法,此方法包括以一種包含呈游離或鹽型式之一種鹼性胺基酸以及一種陰離子界面活性劑的口腔保健組成物處理口腔。
[0025]
於是,從事口腔保健技藝的資深開業者,從此配製物,及使用根據本發明之一或多種目的之口腔保健組成物(例如,一種潔牙劑),其係針對於提供活性組分或成分之組合,且在組成物內具有較佳的個別量者,可看到令人驚訝的技術效果及降低細菌附著於牙齒表面的優點。
[0026]
活性組分的量將根據遞送系統的本質及特殊的活性
而變化,例如,鹼性胺基酸的存在量可為自,例如,約0.1至約20 wt%(以游離鹼表示),例如,漱口劑可使用約0.1至約3 wt%,消費者牙膏使用約1至約10 wt%,專業者或處方用產品使用包含約7至約20 wt%之量;氟化物之存在量可為,例如,約25至約25,000 ppm,例如,漱口劑使用約25至約250 ppm,一般消費者牙膏使用約750至約2,000 ppm,專業者或處方用產品使用約2,000至約25,000 ppm;抗菌劑的值也有類似的改變,在牙膏中可使用,例如,約5至約15倍多於漱口劑中之值,例如,在三氯沙漱口劑內可含有,例如,約0.03 wt%的三氯沙,而三氯沙牙膏可含有,例如,約0.3 wt%的三氯沙。
[0027]
可被使用於本發明的組成物及方法中之鹼性胺基酸包含不僅僅是天然出現的鹼性胺基酸,例如,精胺酸、離胺酸、及組胺酸,也包含分子中具有一種羧基及一種胺基之任一種鹼性胺基酸,其為水-可溶解的且可提供一種pH為約7或更高的水溶液。
[0028]
因此,鹼性胺基酸包括,但不限於,精胺酸、離胺酸(lysine)、瓜胺酸(citrullene)、鳥胺酸(ornithine)、肌胺酸(creatine)、組胺酸(histidine)、二胺基丁酸、二胺基丙酸、彼等之鹽類或彼等之組合物,一特別的具體實施例中,此鹼性胺基酸類係挑選自精胺酸、瓜胺酸、及烏胺酸。
[0029]
某一具體實施例中,此鹼性胺基酸為精胺酸,例如,
L-精胺酸,或其鹽。
[0030]
一些具體實施例中,此鹼性胺基酸包含至少一種於精胺酸脫亞胺酶(arginine deiminase)系統中產生之中間物,於此精胺酸脫亞胺酶系統中產生之中間物可能有用於在一種口腔保健組成物內用於中和菌斑塊以便控制蛀牙及/或預防蛀牙;精胺酸是可在口腔中被發現之一種中性的鹼性胺基酸,口腔中之精胺酸可被某些牙斑菌利用以便其存活,例如,血鏈球菌(S.sanguis
)、S.gordonii
、S.parasanguis
、玄鼠鏈球菌(S.rattus
)、密氏鏈球菌(S.milleri
)、咽峽炎鏈球菌(S.anginosus
)、糞鏈球菌(S.faecalis
)、納氏放線菌(A.naeslundii
)、A.odonolyticus
、纖維二糖乳桿菌(L.cellobiosus
)、短乳桿菌(L.brevis
)、乳酸桿菌(L.fermentum
)、P.gingivaliis
、及T.denticola
等菌,這類微生物可能在鄰近牙齒表面的酸性環境(由產酸的及耐酸的生齲菌株利用糖後產生之有機酸類所造成)下被消滅,於是,這些精胺酸分解的菌株可裂解精胺酸成氨以提供鹼性便於存活,再者,緩衝菌斑並可對生齲系統製造一種不友善的環境。
[0031]
這樣的精胺酸分解的微生物可藉由內部的細胞的酵素路徑,所謂之"精胺酸脫亞胺酶系統(arginine deiminase system)",降解代謝精胺酸而形成中間物於此路徑中,此路徑中,L-精胺酸可被精胺酸脫亞胺酶分降成L-瓜胺酸(citrullene)與氨,L-瓜胺酸可在無機的磷酸鹽存在下,再經鳥胺酸轉胺基甲酸酶分解成L-烏胺酸及胺基甲酸基磷酸酯;胺基甲酸激酶(Carbamate kinase)可再破壞胺基甲酸基
磷酸酯以形成另一個氨分子及二氧化碳,且在此過程中也形成ATP(腺苷5'-三磷酸),ATP可被精胺酸分解菌作為一種生長能源,因此,當被利用時,此精胺酸脫亞胺酶系統可產生兩分子之氨。
[0032]
已發現,在一些具體實施例中,此氨有助於中和口腔斑塊pH以控制及/或預防牙齒蛀蝕。
[0033]
本發明的一些具體實施例之口腔保健組成物可包含在精胺酸脫亞胺酶系統中產生之中間物,這樣的中間物可包括瓜胺酸、鳥胺酸、及胺基甲酸基磷酸酯;一些具體實施例中,其他的口腔保健組成物包含瓜胺酸(citrullene),一些具體實施例中,此口腔保健組成物包括鳥胺酸(ornithine),一些具體實施例中,此口腔保健組成物包含胺基甲酸基磷酸酯,其他的具體實施例中,此口腔保健組成物包含瓜胺酸、鳥胺酸、胺基甲酸磷酸酯、及/或其他藉由精胺酸脫亞胺酶系統產生的中間物之任一種組合。
[0034]
此口腔保健組成物可包括有效量的上述中間物,一些具體實施例中,此口腔保健組成物包括約1毫莫耳/L至約10毫莫耳/L的中間物,另一具體實施例中,此口腔保健組成物包括約3毫莫耳/L至約7毫莫耳/L的中間物,另一具體實施例中,此口腔保健組成物包括約5毫莫耳/L的中間物。
[0035]
本發明的組成物意欲供局部使用於口中,故供使用於本發明的鹽類在被提供的量及濃度下,應是能安全供這類用途者,適當的鹽類包括本技藝中已知為藥學上可接受
的鹽類,其通常被認為在被提供的量及濃度上是生理上可接受的,生理上可接受的鹽類包括那些衍生自藥學上可接受的無機或有機酸類或鹼類者,例如,藉由與形成生理可接受的陰離子之酸類形成之酸加成鹽類,例如,氫氯酸鹽或溴化物鹽,以及藉由形成生理可接受的陽離子的鹼類形成之鹼加成鹽類,例如,那些衍生自鹼金屬(例如,鉀與鈉)或鹼土金屬(例如,鈣與鎂)者,生理上可接受的鹽類可得自:使用本技藝中已知之標準程序,例如,令足量的鹼性化合物(例如,胺)與一種提供生理上可接受的陰離子之適當的酸反應。
[0036]
在多種的具體實施例中,鹼性胺基酸存在的量為相當於總組成物重量之約0.5 wt%至約20 wt%、相當於總組成物重量約1 wt%至約10 wt%,例如,相當於總組成物重量之約1.5 wt%、3.75 wt%、5 wt%、或7.5 wt%。
[0037] RDA
:RDA是放射活性牙質磨蝕(radioactive dentin abrasion)之一種縮寫,用於測量一種相對的磨蝕性(abrasivity),典型地,拔出人類或母牛牙齒,於一種中子通量(neutron flux)中被照射,架設於甲基異丁烯酸酯(骨膠,bone glue)內,剥去琺瑯質、插入至刷洗-機器,以American Dental Association(ADA)標準法刷洗(參考牙刷,150克壓力,1500次擊打(strokes),4-對-1之水-牙膏漿),再經測量及記錄淋洗水中的放射性,就實驗對照組方面,試驗係以由焦磷酸鈣作成之一種ADA參考牙膏進行同樣試驗,以此測量取得100之值以校正相對的尺標。
[0038]
此口腔保健組成物可再包含一或多種氟化物離子源,例如,可溶的氟化物鹽類;有各式各樣可產生氟化物離子之原料可被應用作為存在於本發明的組成物中之可溶的氟化物源,適當的產生氟化物離子的材料之實例可得知於:給Briner et al.之U.S.Pat.No.3,535,421、給Parran,Jr.et al.之U.S.Pat.No.4,885,155、及給Widder et al.之U.S.Pat.No.3,678,154,彼等被併入於此為參考。
[0039]
代表性的氟化物離子源包括,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、及彼等之組合物,某一具體實施例中,氟化物離子源包括氟化亞鍚、氟化鈉、單氟磷酸鈉以及彼等之混合物。
[0040]
某些具體實施例中,本發明之此口腔保健組成物可能也含有一種氟化物
離子源或供應氟的成分,其量為足以供應約25 ppm至約25,000 ppm的氟化物離子,通常為至少約500 ppm,例如,500至2000 ppm,例如,1000-1600 ppm,例如,約1450 ppm,氟化物之適當的量將視特殊的應用而定,例如,漱口劑中,典型地將具有100-250 ppm的氟化物,一般供消費者使用的牙膏中典型地具有1000-1500 ppm,兒童用的牙膏中含有較其為少之量;專業用潔牙劑或塗覆物可具有多達約5,000或更高值約25,000 ppm的氟化物。
[0041]
氟化物離子源可被加入至本發明的組成物中之量,在一具體實施例中為相當於組成物的重量之約0.01 wt%至
約10 wt%,或在另一具體實施例中為約0.03 wt%至約5 wt%,且於另一具體實施例中為約0.1 wt%至約1 wt%,用於提供適當量的氟離子之氟化物鹽類之重量顯然要根據鹽中之抗衡離子的重量而變化。
[0042]
本發明的組成物可包含一種磷酸鈣磨蝕劑,例如,磷酸三鈣(Ca3
(PO4
)2
)、羥基磷灰石(Ca10
(PO4
)6
(OH)2
)、磷酸二鈣二水合物(CaHPO4
.2H2
O,在此有時候也稱之為DiCal)、或焦磷酸鈣,或者,也可採用碳酸鈣,且特別是沈澱的碳酸鈣,作為一種磨蝕劑。
[0043]
此組成物可包含一或多種另外的磨蝕劑類,例如,二氧化矽磨蝕劑,例如具有平均粒子大小為至高達約20微米的沈澱之二氧化矽,例如,Zeodent 115,由J.M.Huber銷售者;其他有用的磨蝕劑也包括偏磷酸鈉、偏磷酸鉀、矽酸鋁、鍛燒的氧化鋁(calcined alumina)、皂土、或其他含矽的材料,或彼等之組合物。
[0044]
有用於此之二氧化矽磨蝕拋光材料,以及其他的磨蝕劑類,通常具有一種平均粒子大小範圍為約0.1-約30微米、約5-約15微米,此二氧化矽磨蝕劑可得自沈澱的二氧化矽或矽膠,例如,半結晶乾膠(silica xerogels),描述於給Pader et al.之U.S.Pat.No.3,538,230,以及給Digiulio之U.S.Pat.No.3,862,307,兩者都被併入於此為參考;特殊的半結晶乾膠(silica xerogels)為以商品名Syloid,由W.
R.Grace & Co.,Davison Chemical Division所販售者;沈澱的二氧化矽材料包括那些由J.M.Huber Corp.以商品名Zeodent被販售者,包括標示為Zeodent 115及119之二氧化矽;這些二氧化矽磨蝕劑被揭露於給Wason之U.S.Pat.No.4,340,583,其被併入於此作為參考。
[0045]
於某些具體實施例中,有用於根據本發明之實際之口腔保健組成物的磨蝕材料包括矽膠(silica gels)及具有一種油吸收值為約少於約100 cc/100克二氧化矽,及範圍為約45 cc/100克至約70 cc/100克二氧化矽之沈澱的無定形之二氧化矽;油吸收值係使用ASTM Rub-Out Method D281的方法測定;某些具體實施例中,此二氧化矽為具有平均粒子大小為約3微米至約12微米,及約5至約10微米之膠體粒子。
[0046]
特別的具體實施例中,磨蝕劑材料包含一大部分的極小粒子,例如,具有一種d50少於約5微米者,例如,具有一種d50為約3-約4微米之小粒子二氧化矽(SPS),例如,Sorbosil AC43(Ineos),這樣的小粒子特別有用於在減少敏感性之配製物中;此小粒子之組分可能與第二種具較大粒子之磨蝕劑併存於組成物內,於某些具體實施例中,例如,配製物內包含約3至約8%的小粒子磨蝕劑,例如,小粒子二氧化矽與約10至約45%的傳統的磨蝕劑。
[0047]
特別有用於本發明的實際產品之低油質吸收二氧化矽磨蝕劑為以Sylodent XWA之名稱為Davison Chemical Division of W.R.Grace & Co.,Baltimore,Md.21203銷售
者,Sylodent 650 XWA係一種二氧化矽水合膠,組成自具有水含量為約29%重量計,粒子直徑平均為約7至約10微米,及油吸收為少於約70 cc/100克二氧化矽之膠體二氧化矽,係一種有用於本發明的實際產品之具低油吸收二氧化矽磨蝕劑;此磨蝕劑存在於本發明的口腔保健組成物中之濃度為約10至約60%重量計,於另外的具體實施例中,為約20至約45%重量計,且於另一具體實施例中為約30至約50%重量計。
[0048]
某些具體實施例中,鹼性胺基酸被加入至一種具有包含碳酸鈣(且特別是沈澱的碳酸鈣)作為一種磨蝕劑的鹼性配方之潔牙劑組成物時,L-精胺酸及精胺酸鹽類,例如,精胺酸碳酸氫鹽,本身帶有明顯的苦味,且摻雜一種魚腥味,因此,當L-精胺酸或精胺酸鹽類被加入至口腔保健產品使潔牙劑配製物在參與抗蛀牙效力及釋放敏感性為有效的濃度下,典型地用量為相當於潔牙劑配製物總重量之自2至10 wt%,相較於相同配方但未添加L-精胺酸或精胺酸鹽類之配製物,此潔牙劑配製物之氣味及口感將被降級。
[0049]
然而,令人驚訝地發現,根據本發明之各方面,添加L-精胺酸或精胺酸鹽類至包含碳酸鈣之鹼性潔牙劑配製物內,可對潔牙劑配製物提供氣味及口感的明顯提升及消費者對產品之整體接受性。
[0050]
本發明的口腔保健組成物也可包括當在刷洗口腔時用於增加泡沫的物質。
[0051]
用於增加泡沫的物質之示範實例包括,但不限於,聚氧乙烯及某些聚合物,包括,但不限於,藻酸鹽聚合物類。
[0052]
聚氧乙烯可增加被本發明的口腔保健載劑組分產生的泡沫之量及泡沫濃度,聚氧乙烯通常也稱之為聚氧乙烯甘醇("PEG")或聚氧化乙烯,適於供本發明使用之聚氧乙烯類為具有分子量為約200,000至約7,000,000者,一具體實施例中,分子量為約600,000至約2,000,000,而另一具體實施例中為約800,000至約1,000,000者;Polyox是一種高分子量聚氧乙烯的商品名,由Union Carbide出產。
[0053]
此聚氧乙烯的存在量可為約1%至約90%,一具體實施例中,為本發明的口腔保健組成物之口腔保健載劑組分重量之約5%至約50%,而另一具體實施例中為約10%至約20%重量計;在口腔保健組成物(即,一種單劑量)中起泡劑的劑量為約0.01至約0.9%重量計、約0.05至約0.5%重量計、以及另一具體實施例中,為約0.1至約0.2%重量計。
[0054]
本發明含有陰離子界面活性劑,例如,i.高級脂肪酸單甘油酯單硫酸鹽之水-可溶的鹽類,例如,氫化的椰子油脂肪酸之單硫酸化的單甘油酯之鈉鹽,例如,N-甲基N-椰醯基牛磺酸鈉、椰基單-甘油酯
硫酸鈉,ii.高級烷基硫酸酯類,例如,月桂基硫酸鈉,iii.高級烷基-醚硫酸酯類,例如,具式CH3
(CH2
)m
CH2
(OCH2
CH2
)n
OSO3
X者,其中,m為6-16,例如,10,n為1-6,例如,2、3或4,且X為Na或K,例如,月桂基-2硫酸鈉(CH3
(CH2
)10
CH2
(OCH2
CH2
)2
OSO3
Na),iv.高級烷基芳基磺酸酯類,例如,月桂基苯磺酸鈉(sodium lauryl benzene sulfonate),v.高級的烷基磺基乙酸鹽類,例如,月桂基磺基乙酸鈉(十二烷基磺基乙酸鈉)、1,2-二羥基丙烷磺酸之高級脂肪酸酯類、月桂酸磺基酯(N-2-乙基月桂酸鉀磺基乙醯胺)及月桂醯基肌胺酸鈉。
所謂之"高級的烷基"係指,例如,C6-30
烷基,特別的具體實施例中,陰離子界面活性劑係挑選自月桂基硫酸鈉及月桂醯基硫酸醚鈉。
[0055]
此陰離子界面活性劑的量為一種有效量,例如,大於約配製劑重量之0.01%,但不會造成口腔組織刺激之濃度,例如,少於約10%,且最適當的濃度視特殊的配製物及特別的界面活性劑而定,例如,被使用在漱口液中之濃度,典型地為相當於被用在牙膏中的濃度之十分之一,一具體實施例中,陰離子界面活性劑在在於牙膏中之量為自約0.3%至約4.5%重量計,例如,約1.5%。
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本發明的組成物可選擇地含有界面活性劑的混合物,包含陰離子界面活性劑及其他的界面活性劑,其可能
為陰離子、陽離子、兩性離子或非離子類型;通常,界面活性劑為那些在相當廣的pH範圍下為相當的安定者,界面活性劑被更詳述於,例如,給Agricola et al.之U.S.Pat.No.3,959,458、給Haefele之U.S.Pat.No.3,937,807、及給Gieske et al.之U.S.Pat.No.4,051,234,其等被併入於此作為參考。
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於某些具體實施例中,有用於此之陰離子界面活性劑包括其中烷基為具有約10至約18個碳原子之烷基硫酸酯之水-可溶的鹽類以及具有約10至約18個碳原子之脂肪酸之磺化的單酸甘油酯類之水-可溶的鹽類;這類型之陰離子界面活性劑之實例為:月桂基硫酸鈉、月桂醯基肌胺酸鈉及椰子單酸甘油酯磺酸鈉,也可利用陰離子界面活性劑類之混合物。
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於另外的具體實施例中,有用於本發明之陽離子界面活性劑可被廣範地被定義為:具有含有約8至約18個碳原子的一個長烷基鏈的脂肪族季銨化合物之衍生物,例如,氯化月桂基三甲基銨、氯化鯨蠟基吡啶(cetyl pyridinium chloride)、溴化鯨蠟基三甲基銨(cetyl trimethylammonium bromide)、氯化二-異丁基苯氧基乙基二甲基苯甲基銨、椰子烷基三甲基銨硝酸化物、氟化鯨蠟基吡啶、以及彼等之混合物。
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可被舉之為例之陽離子界面活性劑為季銨氟化物類,被揭露於給Briner et al.之U.S.Pat.No.3,535,421,其被併入於此為參考,某些在組成物中之陽離子界面活性劑也可作用為殺菌劑(germicides)。
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可被使用在本發明的組成物中之範例性非離子界面活性劑可被廣義地被定義為:藉由縮合烯烴氧化物基(本質為親水性的)與一種有機疏水化合物(本質為脂肪族或烷基芳族的)產生的化合物;適當的非離子界面活性劑的實例包括,但不限於:Pluronics、烷基酚類之聚氧化乙烯縮合物、衍生自氧化乙烯的縮合物與氧化丙烯及乙二胺的反應產物之產品、脂肪族醇類之氧化乙烯縮合物、長鏈三級胺氧化物類、長鏈三級膦氧化物類、長鏈二烷基亞碸類、以及這類材料之混合物。
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某些具體實施例中,有用於本發明之兩性離子合成的界面活性劑可被廣義地描述為脂肪族季銨、鏻(phosphomium)、及硫鎉(sulfonium)化合物之衍生物,其中脂肪族基可為直鏈或支鏈,且其中脂肪族取代基之一含有約8至約18個碳原子且一個含有一種陰離子性水-助溶的基,例如,羧基、磺酸基、硫酸基、磷酸基或膦酸基,適於加入至此組成物內之界面活性劑之示範性實例包括,但不限於,烷基硫酸鈉、月桂醯基肌胺酸鈉、可可醯胺基丙基內鹽及聚山梨醇酐20、及其混合物。
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一特別的具體實施例中,本發明的組成物包含月桂基硫酸鈉。
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此界面活性劑或相容的界面活性劑之混合物可存在於本發明的組成物中之量為相當於總組成物重量之約0.1%至約5%,另一具體實施例中,為約0.3%至約3%,且於另一具體實施例中,為約0.5%至約2%。
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本發明之此種口腔保健組成物也可包含一種風味劑(flavoring agent),被使用於本發明實施例中之風味劑包括,但不限於,精油類以及各種具風味之醛類、酯類、醇類、及類似的材料;精油的實例包括綠薄荷(spearmint)、薄荷(peppermint)、冬青樹(wintergreen)、黃樟(sassafras)、丁香(clove)、山艾(sage)、桉屬植物(eucalyptus)、墨角蘭(marjoram)、肉桂(cinnamon)、檸檬(lemon)、酸橙(lime)、葡萄柚(grapefruit)、及橘子(orange)之油質,也有使用像是下述物質之化學品:薄荷腦(menthol)、香芹酮(carvone)、及茴香醚(anethole),某些具體實施例中應用薄荷(peppermint)及綠薄荷(spearmint)的油質。
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風味劑被加入至口腔組成物內之濃度為約0.1至約5%重量計,及約0.5至約1.5%重量計,在個別的口腔保健組成物劑量型式(即,單劑量)中之風味劑之劑量為約0.001至0.05%重量計,而於另一具體實施例中,為約0.005至0.015%重量計。
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本發明的口腔保健組成物也可選擇地包含能複合細菌的細胞壁中發現之鈣的一或多種螫合劑,藉由結合此鈣而弱化細菌的細胞壁並增強細菌的溶解。
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適於在本發明中被使用作為螫合劑之另一類物質為可溶的焦磷酸鹽類,被使用在本發明的組成物內之焦磷酸鹽類可以是任一種鹼金屬焦磷酸鹽類;某一具體實施例
中,鹽類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,其中鹼金屬為鈉或鉀;此有用的鹽類包含彼等之水合物或無水合的型式兩者,有用於本組成物內之焦磷酸鹽之有效量為:通常能提供至少約1 wt%焦磷酸鹽離子、約1.5 wt%至約6 wt%、約3.5 wt%至約6 wt%的這種離子者。
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本發明的口腔保健組成物也選擇地包含一或多種聚合物,例如,聚乙烯甘醇類、聚乙烯基甲基醚順丁烯二酸共聚物類、多醣類(例如,纖維素衍生物類,例如,羧甲基纖維素、或多醣類膠質,例如,黃原膠(xanthan gum)或鹿角菜膠(carrageenan gum)),酸性聚合物類,例如,聚丙烯酸凝膠,可以其游離酸或部分地或完全地被中和的水溶性鹼金屬(例如,鉀及鈉)或銨鹽型式被提供。
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特別地,當非陽離子抗菌劑或抗菌劑,例如,三氯沙,被包含於任一潔牙劑組分中時,較佳地,也應包含自約0.05至約5%能提升藥劑的遞送及物質滯留至口腔表面的物質,這樣的有用於本發明的物質,被揭露於U.S.Pat.Nos.5,188,821及5,192,531內;且包括合成的陰離子聚合的聚羧酸酯類,例如,約1:4至約4:1的順丁烯二酸酐或酸與另種可聚合的乙烯性不飽和的單體所成共聚物,較佳地為具有分子量(M.W.)為約30,000至約1,000,000、最佳為具有約30,000至約800,000之甲基乙烯基醚/順丁烯二酸
酐共聚物,這些共聚物可得自,例如,作為Gantrez,例如,AN 139(M.W.500,000)、AN 119(M.W.250,000)及較佳地,S-97醫藥品級(M.W.700,000),得自ISP Technologies,Inc.,Bound Brook,N.J.08805,當此種增強劑存在時,其存在量範圍為自約0.05至約3%重量計。
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其他可被用的聚合物包括那些,例如:順丁烯二酸酐與丙烯酸乙酯之1:1共聚物、羥基乙基異丁烯酸酯、N-乙烯基-2-吡咯酮、或乙烯,後者可得自,例如,Monsanto EMA No.1103,M.W.10,000及EMA Grade 61,及丙烯酸與甲基或羥基乙基異丁烯酸酯之1:1的共聚物、甲基或乙基丙烯酸酯、異丁基乙烯基醚或N-乙烯基-2-吡咯酮。
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一般適當地,為含有一種活化的碳-對-碳烯烴雙鍵與至少一個羧基之聚合化的烯烴的或乙烯地不飽和的羧酸類,即,一種含烯烴雙鍵之一種酸,因烯烴鍵存在於單體分子相對於羧基為alpha或beta位置或為一種末端次烷基之一部分,使其容易地在聚合反應下有作用,可舉之為例的這類酸類為:丙烯酸、異丁烯酸、乙基丙烯酸、alpha-氯丙烯酸、巴豆酸(crotonic)、beta-丙烯氧基丙酸、山梨酸(sorbic)、alpha-氯山梨酸(chlorsorbic)、肉桂酸(cinnamic)、beta-苯乙烯基丙烯酸、己二烯二酸(muconic)、分解烏頭酸(itaconic)、順式甲基丁烯二酸(citraconic)、反式甲基丁烯二酸(mesaconic)、戊烯二酸(glutaconic)、烏頭酸(aconitic)、alpha-苯基丙烯酸、2-苯甲基丙烯酸、2-環己基丙烯酸、當歸酸(angelic)、繖形酸(umbellic)、反丁烯二酸、順丁烯二酸
及酸酐類,其他與這類羧酸性單體可共聚之不同的烯烴單體類包括:乙烯基乙酸酯、氯化乙烯、順丁烯二酸二甲酯等等;共聚物含有充分的羧酸鹽基供水-溶解性。
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另一類的聚合性物質包括一種含有經取代的丙烯基醯胺類均聚物及/或不飽和的磺酸類及其鹽類均聚物之組成物特別是,其中聚合物為挑選自下述不飽和的磺酸類為主者:丙烯基醯胺基烷磺酸類(acrylamidoalykane sulfonic acids),例如,具有分子量為約1,000至約2,000,000之2-丙烯基醯胺2甲基丙烷磺酸,被揭露於給Zahid之U.S.Pat.No.4,842,847,Jun.27,1989,其被併入於此為參考。
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另一類有用的聚合性物質包括聚胺基酸類,特別是那些含有一定比例的陰離子界面-活性胺基酸類者,例如,門冬胺酸、穀胺酸及磷絲胺酸,如被揭露於給Sikes et al.之U.S.Pat.No.4,866,161中者,其被併入於此作為參考。
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製備口腔保健組成物中,有時候必須加入一些增稠的材料以提供一種必要的粘稠性或用於安定或提升配製物之性能,某些具體實施例中,此增稠劑為羧乙烯基聚合物類、鹿角菜膠(carrageenan)、羥乙基纖維素及纖維素醚類之水可溶的鹽類,例如,羧甲基纖維素及羧甲基羥乙基纖維素鈉,也可加入天然的膠質類,例如,卡拉膠(karaya)、阿拉伯膠(gum Arabic)、及特拉加康斯樹膠(gum tragacanth);也可使用膠體矽酸鋁鎂或細分之二氧化矽作為增稠劑組成物之組分,以進一步改善組成物的質地;某一具體實施例中,增稠劑的量為相當於所用的組成物總重量之約0.5%至
約5.0%。
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本發明的此種口腔保健組成物也可選擇地包含一或多種酵素,有用的酵素包括任何可取得的蛋白酶類(proteases)、葡聚醣水解酶類(glucanohydrolases)、醣內分解酶(endoglycosidases)、澱粉酶(amylases)、變位酶(mutanases)、解脂酶(lipases)及粘蛋白溶解酶(mucinases)或其相容的混合物,某一具體實施例中,此酵素為一種蛋白酶、葡聚醣酶(dextranase)、醣內分解酶(endoglycosidases)及變位酶(mutanases);於另一具體實施例中,此酵素為木瓜酵素(papain)、醣內分解酶(endoglycosidases)或葡聚醣酶(dextranase)與變位酶(mutanases)之一種混合物;適於供使用於本發明之另外的酵素類被揭露於給Dring et al.之U.S.Pat.No.5,000,939、U.S.Pat.No.4,992,420、U.S.Pat.No.4,355,022、U.S.Pat.No.4,154,815、U.S.Pat.No.4,058,595、U.S.Pat.No.3,991,177、及U.S.Pat.No.3,696,191,彼等全部被併入於此作為參考,本發明之許多相容的酵素之混合物佔約0.002%至約2%於一具體實施例中,或在另一具體實施例中為約0.05%至約1.5%,或於另一具體實施例中,為約0.1%至約0.5%。
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水也可能存在於本發明之口腔組成物內,被應用在
商業口腔組成物的配製物中之水應是去離子水且不帶有機的不純物者,水通常用於補足組成物之平衡且使用量為相當於口腔組成物重量之約10%至約90%、約20%至約60%或約10%至約30%重量計,水的量包括游離的水及與其他材料一起加入者,例如與山梨糖醇或本發明之任一組分一起被加入者。
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口腔組成物之某具體實施例中,也有必要加入一種保濕劑以防止組成物在曝露至空氣後硬化,某些保濕劑也可參與想要的甜味或風味至潔牙劑組成物內,此保濕劑,以純保濕劑為計算標準,通常相當於牙齒組成物重量之約15%至約70%的量於一具體實施例中,或為包含約30%至約65%的量於另種具體實施例中。
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適當的保濕劑類包括可食用之多羥基醇類,例如,甘油、山梨糖醇、木糖醇、丙二醇以及其他多醇類及這些保濕劑之混合物,甘油及山梨糖醇的混合物可被使用在某些具體實施例中,作為在此之牙膏組成物之保濕劑組分。
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除了上述描述之組分,本發明之具體實施例中可含有各式各樣之選項的潔牙劑成分,其中一些成分被描述如下,選項的組成分包括,例如,但不限於,粘著劑、起泡劑(sudsing agents)、風味劑(flavoring agents)、甜味劑、另外的抗斑劑、磨蝕劑、及著色劑,這些及選項的組分被再描述於給Majeti之U.S.Pat.No.5,004,597;給Agricola et al.
之U.S.Pat.No.3,959,458及給Haefele之U.S.Pat.No.3,937,807,所有被併入於此作為參考。
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本發明的組成物可利用一般製備口腔產品領域中之方法製備。
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於一說明用之具體實施例中,此口腔保健組成物的製備係以酸,例如,磷酸、氫氯酸或碳酸,藉由中和或部分地中和在凝膠相中之精胺酸,並混合以形成預混合物1(Premix 1)。
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活性物,例如,維生素類、CPC、氟化物、磨蝕劑、以及任一其他所要的活性成分,被加入至預混合物1內並予以混合成預混合物2(Premix 2)。
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例如,當最後的產品為一種牙膏時,則加入一種牙膏基質,例如,磷酸二鈣或二氧化矽,至預混合物2(Premix 2)內,並予以混合,最後的漿液被作成一種口腔保健產品。
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本發明的方法包含向口腔施用一種安全又有效量的被描述於此之組成物。
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根據本發明之組成物及方法為有用於保護牙齒之方法,係藉由幫助修復及再礦化,特別是降低或抑制蛀牙形成、減少或抑制牙齒之去礦化及促進牙齒之再礦化、減少牙齒之敏感性、及減少、修復或抑制早期琺瑯質損傷[例如,
可藉由定量的光-誘發的螢光(QLF)或電的蛀牙監測儀(ECM)偵測得者]的方式。
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定量的光-誘發的螢光係一種可偵測早期損傷及縱向地監測進展或復元之一種可視光螢光;正常的牙齒在可視光下散發螢光;去礦化的牙齒不發出或僅散發極少的螢光,去礦化的地帶可被定量且其進展可被監測,藍色雷射光被用於使牙齒自動發出螢光,已損失礦物質的地帶相較於合理的牙齒表面具有較低的螢光且顯現較為暗淡;使用軟體以定量來自一種白點或與損傷相關的面積/體積,通常,帶有已存在的白點損失之對象被徵求作為專題討論參與者,以真正的牙齒進行測量,在臨床開始時測量損害地區/體積,在使用產品六個月後,測定減少的損害地區/體積(改進),此數據常以相對於基準線的改進百分比表示。
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電的蛀牙監測法(Electrical Caries Monitoring)是利用電的阻抗性以測量牙齒的礦物含量之一種技術,電的傳導性測量係利用充滿流體的小管暴露在去礦化及侵蝕的琺瑯質導電之事實進行,由於牙齒損失礦物質後,增加的孔洞使其變得較不耐電流,病人牙齒的傳導性增加因此可能顯示脫礦質(demineralization),通常,在已存在損害之牙根表面進行研究,以真正的牙齒在體內進行測量,測量開始時及經處理六個月後電阻之變化,另外,牙根表面之典型的蛀牙評分係使用一根有觸覺的探針(tactile probe)進行,硬度以三分尺度被分類:硬、似皮革硬、軟;此類型研究中,典型地,結果就ECM測量以電阻抗性(較高的數目較好)被
報告且損害的硬度之改善係根據有觸覺的探針評分。
[0088]
本發明的組成物因此有用於一種方法,相較於缺乏有效量之氟及/或精胺酸之組成物,用於減少琺瑯質之早期的損傷(藉由QLF或ECM偵測得者)。
[0089]
本發明的組成物也額外地有用於減少口腔中有害的細菌之方法,例如,用於減少或抑制齒齦炎之方法、減少產酸菌之量、增加精胺酸分解菌之相對值、抑制微生物生物膜形成於口腔、在吃糖後,能提升及/或維持斑塊pH值於至少約pH 5.5、降低菌斑之蓄積、及/或清潔牙齒及口腔。
[0090]
最後,藉由增加口中的pH並防止病原菌,本發明的組成物有用於促進口中之酸痛或傷口癒合。
[0091]
提升口腔健康也提供益處給全身健康,由於口腔組織可能是全身感染之大門,良好的口腔健康與全身健康(包括心血管健康)息息相關,本發明的組成物及方法提供特別的益處,係由於鹼性胺基酸類,尤其是精胺酸,為提供NO合成路徑之一種氮源並因此提升口腔組織內之微循環;提供較少酸性的口腔環境也有助於降低胃的疼痛及產生較不利於與胃潰瘍有關之幽門螺桿菌(Heliobacter)的生長環境;精胺酸特別需要供射定的免疫細胞受體類之高度表現,例如,T-細胞受體類,如此,精胺酸可增進一種有效的免疫反應,本發明的組成物及方法因此有用於增強全身的健康,包括心血管健康。
[0092]
根據本發明的組成物及方法可被加入至供口腔及牙齒保健之口腔組成物內,例如,牙膏、透明的糊狀物、凝
膠類、漱口劑、噴劑及口香糖(chewing gum)。
[0093]
就全文中所使用的,範圍常被使用供描述在範圍內之各個及每一個值之簡略代表值,任一在範圍間的值可被選擇作為範圍之終點值,此外,被引用於此之所有參考資料係以其整體被併入於此作為參考;當本發明中的定義與被引用的參考資料中之定義相左時,採用本發明中之定義,可理解的,當配製劑被描述時,它們可根據彼等之成分被描述,如同本技藝中通常的方式,儘管這些成分可能在真正的配製劑中,於被製造、被儲放及被使用中彼此發生反應,且這樣的產品被涵蓋於所描述的配製劑內。
[0094]
下述實例再描述及證明本發明範圍內之說明性具體實施例,此實例的提供僅為說明起見且由於本發明仍有許多不失本發明的精神及其範圍之變造物,故彼等不可被推定為本發明僅及於此,本技藝中的行家了解,除了那些被顯示及被描述於此之外的各種本發明之修飾物,均屬本發明所主張的範圍。
[0095]
配製物使用商業的牙膏被配製,其包含,i.a.、0.3%重量計之三氯沙、0.243%重量計之氟化鈉、月桂基硫酸鈉、及甲基乙烯基醚與順丁烯二酸酐之一種共聚物(PVM/MA),對其添加0、1%、3%、及5%的L-精胺酸鹽酸鹽(PH 7.0)。
[0096]
加入L-精胺酸至商用的配製物,提升可得自配製物之可溶的三氯沙之量,自約70%(含0%精胺酸)至約80%(含1%的精胺酸)、85%(含3%精胺酸)、及95%(含5%精胺酸)。
[0097]
此配製物於被設計用於測量細菌附著至牙膏-處理過的羥基磷灰石(HAP)盤經24小時期間之一種人工口腔模式的體外方式進行測試,通常如被Gaffar,A.et al.揭露於American Journal of Dentistry
,vol.3,September 1990中之方式,經修改處為:經唾液-塗覆的羥基磷灰石盤先以潔牙劑漿液處理後,再曝露給細菌,經證明,加入L-精胺酸至商業的配製物,提升三氯沙被遞送至盤上達約50%,在30分鐘的取用下,增加自約40微克的三氯沙/盤(對照組),至約60微克三氯沙(含5%精胺酸配製物),在24小時後,對照組盤具有保留的約10微克/盤量,相對於含5%精胺酸之配製物,為約20微克,明顯有增強效果,使用組胺酸或離胺酸替代精胺酸,達到類似的結果。
[0098]
此增強的遞送導致配製物之直接的抗菌效果之提升,使用含5%精胺酸之配製物相對於對照組,對於抑制A.viscosus
菌之生長減少約15%之量,具統計上明顯意義。
[0099]
包含5%精胺酸於以二氧化矽為主之牙膏配製物,被配製如下:
[00100]
三氯沙攝入之研究係藉由施用潔牙劑於經唾液-塗覆的羥基磷灰石盤上,在37℃下經一定時間,將盤子淋洗以除去在表面上之過量潔牙劑,被溶解進入盤中之活性物再被溶出並藉由HPLC分析進行,以具有類似上述配方II的商業的牙膏作為正對照組,其包含i.a.,0.3%重量計之三氯沙、0.243%重量計之氟化鈉、月桂基硫酸鈉、及一種甲基乙烯基醚與順丁烯二酸酐之共聚物,但不含精胺酸;此正的對照組可攝入三氯沙為32.7微克/盤;對照於含精胺酸的配方II為58.8;帶有精胺酸者之攝入量為高於商業配製物之79.8%。
[00101]
於一種抗-附著試驗中,配方II(減少0.1845)勝過正對照組(有三氯沙,不含精胺酸,減少0.1809)一點點,無明顯邊際,及勝過配方I(有精胺酸,不含三氯沙,減少0.1556)較0守的邊際;於抗菌的試驗中,配方(減少0.1980)勝過正對照組(減少0.1789)及配方I(減少0.1891)。
[00102]
製備包含2%精胺酸碳酸氫鹽的配製物如下:
前面實例中被描述之攝入分析中,配方A顯現57.86微克的三氯沙於盤上,相對的,配方C為22.88微克(不帶精胺酸之對照組)。
[00103]
牙膏配製物被配製如下:
含精胺酸及SLS兩者之配方I,進行體外(in vitro)試驗下,顯現明顯的抗-附著效果,配方I係在上述之人造的口腔模式下進行體外測試,測試有多少細菌可在24小時期間附著
至經牙膏處理過之HAP盤,結果被與不含精胺酸之對照組牙膏相比;此體外的試驗顯示,以配方I處理之HAP盤,相較於對照的樣品,有減少27%的細菌附著,而含有精胺酸但不含有SLS之配方2,相較於對照的樣品,僅顯現10%的減少,這表示,SLS加精胺酸經合提供意想不到的好處用於抑制細菌的抗-附著,配方I具有類似於含有一種已制定的抗-附著劑之正對照組牙膏的結果。
[00104]
製備一種配製物,其係包含精胺酸、月桂基硫酸鈉及一種甲基乙烯基醚及順丁烯二酸酐之一種陰離子共聚物(PVM/MA-Gantrez S-97):
此配製物顯現極佳的抗附著性質,相對於對照組,可減少超過40%的附著。
[00105]
使用下述成分配製本發明的漱口劑配製物:帶有氟化物、SLS、PMV/MA、及三氯沙之含精胺酸淋洗液
此配製物有效於抑制細菌附著。
[00106]
受過試驗潔牙劑配製物之感官屬性訓練之消費者試驗員之評審者,被給予被使用在雙盲消費者試驗條件下之不同的潔牙劑配製物以複製消費者使用潔牙劑配製物。
[00107]
評判小組被要求照慣例地使用此潔牙劑配製物,然後評比各種感官的特性,基本的潔牙劑配製物包含沈澱的碳酸鈣(PCC),已知的配製物被作為一種安慰的對照組,也測試另外包含1、2、3或5 wt%的精胺酸碳酸氫鹽之相關的配製物,令人驚訝地發現,包含精胺酸碳酸氫鹽之PCC配製物,就風味度、清涼及易起泡之屬性,消費者的接受度有增加,此外,另包含2 wt%精胺酸碳酸氫鹽之配製物在總體喜歡、氣味的總體喜歡、刷牙時的氣味及刷牙後氣味均呈現增加,此外,配製物額外地包含精胺酸碳酸氫鹽者,
全部印象屬性,包括察覺的有效性、嘴巴/牙齒的清深感覺、產品適當性、氣味及整體產品的品質,明顯地較安慰劑對照組為較佳。
[00108]
相對地,當配製物具有磷酸二鈣而非沈澱的碳酸鈣(PCC)時,以此為基質被測試時,添加精胺酸碳酸氫鹽者,相較於相同配方但未添加精胺酸碳酸氫鹽者,並未呈現明顯的改進之感官特性。
[00109]
此實例顯示,添加一種鹼性胺基酸,像是精胺酸,特別是其碳酸氫鹽,卻令人驚訝地發現,可提升潔牙劑配製物的感官特性,最特別的是具有沈澱的碳酸鈣(PCC)為基本的配製劑被使用於本發明的口腔保健組成物中者。
[00110]
在37℃下將S.sanguis
培養於胰化酪蛋白大豆培養汁(trypticase soy broth,Becton Dickinson,Sparks,MD)內過夜,在5,000 rpm下將培養基離心5分鐘,一次一毫升,至預稱重的試管內以收集約5毫克之濕丸粒,將丸粒再懸浮至20毫莫耳濃度之磷酸鉀緩衝液(JT Baker,Phillipsburg,NJ),pH 4.0,以模擬一種受壓的環境供細菌產生氨以便存活,最後的濃度為5毫克/毫升,對此最後的濃度,加入5毫莫耳最後濃度之L-精胺酸、L-瓜胺酸、或L-鳥胺酸,以及0.1%最後濃度之蔗糖(VWR,West Chester,PA),再將此混合物培育於37℃之振搖的水浴中經30分鐘,再測定氨產量。
[00111]
為分析氨,使用得自Diagnostic Chemicals Limited(Oxford,CT)之一種氨分析套組(Ammonia Assay kit),此具體的套組係要用於供試管定量血漿中之氨,但此方法被修改以便測定及定量在斑塊中及/或細菌中之氨產量。
[00112]
下面的表顯示,如上述的,在pH 4.0下,使用S.sanguis
自6個分開的試驗氨產生值,此結果確認,精胺酸脫亞胺酶系統產生之中間物可被使用以產生氨供細胞存活。
[00113]
此實例顯示,異於精胺酸之鹼性胺基酸也有效於在口腔內產生氨,並因此當被使用在本發明之口腔保健組成物內時,可用於增加斑塊之pH。
[00114]
就全文中所使用的,範圍常被使用供描述在範圍內之各個及每一個值之簡略代表值,任一在範圍間的值可被
選擇作為範圍之終點值,此外,被引用於此之所有參考資料係以其整體被併入於此作為參考;當本發明中的定義與被引用的參考資料中之定義相左時,採用本發明中之定義,可理解的,當配製劑被描述時,它們可根據彼等之成分被描述,如同本技藝中通常的方式,儘管這些成分可能在真正的配製劑中,於被製造、被儲放及被使用中彼此發生反應,且這樣的產品被涵蓋於所描述的配製劑內。
Claims (15)
- 一種包含下述成分之口腔保健組成物:一種有效量之鹼性胺基酸,其係呈鹽型式且為選自精胺酸磷酸鹽、精胺酸碳酸氫鹽、及精胺酸鹽酸鹽,其中該有效量為總組成物重量之自1至10重量%;一種陰離子界面活性劑,係選自月桂基硫酸鈉及月桂醇醚硫酸鈉(sodium laureth sulfate)及其混合物,且其量為總組成物重量之自0.01至10重量%;一種有效量的三氯沙(triclosan),其中該有效量為總組成物重量之自0.01至5重量%;有效量的甲基乙烯基醚與順丁烯二酸酐的共聚物;及有效量的氟化物源,係選自氟化鈉及單氟磷酸鈉。
- 根據申請專利範圍第1項的組成物,其中陰離子界面活性劑之存在量為自約0.3至約4.5重量%。
- 根據申請專利範圍第1項之組成物,再包含木糖醇(xylitol)。
- 根據申請專利範圍第1項之組成物,其包含選自二氧化矽及碳酸鈣之微粒材料。
- 根據申請專利範圍第1項之組成物,其中放射活性牙質磨蝕(RDA)為少於約150。
- 根據申請專利範圍第1項之組成物,其呈一種牙膏型式,另包含一或多種的水、磨蝕劑、界面活性劑、泡沫劑、維生素類、聚合物、酵素、保濕劑、增稠劑、抗微生物劑、防腐劑、風味劑、著色劑及/或彼等之組合。
- 一種根據申請專利範圍第1至6項中任一項之組成物用於製造口腔保健產品之用途,其係用於:a.減少或抑制齲齒的形成,b.減少、修復或抑制早期之琺瑯質損傷,c.減少或抑制牙齒之去礦化及促進牙齒之再礦化,d.減少牙齒之過敏性,e.減少或抑制齒齦炎,f.促進口中酸痛或口腔內傷口之癒合,g.減少產酸菌之數量,h.增加分解精胺酸的細菌之相對量,i.抑制於口腔內細菌的附著或微生物的生物膜形成,j.吃糖後,提升及/或維持斑塊pH值於至少約pH 5.5,k.減少菌斑蓄積,l.治療口乾,m.潔白牙齒,n.促進全身健康,包括心血管健康,例如,藉由減少經由口腔組織之全身性感染潛力,o.減少牙齒之侵蝕,p.增強牙齒免疫以對抗生齲菌,及/或q.清潔牙齒以及口腔。
- 根據申請專利範圍第7項之用途,用於抑制細菌的附著或微生物的生物膜形成。
- 根據申請專利範圍第1項之口腔保健組成物,其中抗菌劑存在的量為相當於總組成物重量之自0.01至1wt%。
- 根據申請專利範圍第1項之口腔保健組成物,其中該氟化物源的量為用於在總組成物重量中得以提供50至25,000ppm重量計之氟化物離子。
- 根據申請專利範圍第1項之口腔保健組成物,再包含一種磨蝕劑材料,此磨蝕劑材料包含一種小粒子部分,其相當於總組成物重量之至少約5wt%,其中小粒子部分具有一種d50為少於5微米。
- 根據申請專利範圍第11項之口腔保健組成物,其中小粒子部分相當於總組成物重量之至少約20wt%。
- 根據申請專利範圍第11或12項之口腔保健組成物,其中磨蝕材料係選自碳酸鈣、二氧化矽、及其混合物。
- 根據申請專利範圍第11或12項之口腔保健組成物,其中磨蝕材料的量為相當於總組成物重量之自15至70wt%。
- 一種根據申請專利範圍第1至6及9至14項中任一項之組成物用於製造口腔保健產品之用途,其用於減少細菌附著至對象的口腔中之牙齒表面。
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TW097112580A TWI426924B (zh) | 2008-02-08 | 2008-04-07 | 口腔保健產品及其使用方法與製造 |
TW103119316A TW201513889A (zh) | 2008-02-08 | 2008-04-07 | 口腔保健產品及其使用方法與製造(一) |
TW097112584A TWI461222B (zh) | 2008-02-08 | 2008-04-07 | 口腔護理產品及其使用方法與製造 |
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TW097112584A TWI461222B (zh) | 2008-02-08 | 2008-04-07 | 口腔護理產品及其使用方法與製造 |
TW103120785A TWI584821B (zh) | 2008-02-08 | 2008-04-07 | 口腔護理產品及其使用方法與製造 |
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