TWI566782B - 口腔保健產品及其使用方法與製造 - Google Patents
口腔保健產品及其使用方法與製造 Download PDFInfo
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- TWI566782B TWI566782B TW103115501A TW103115501A TWI566782B TW I566782 B TWI566782 B TW I566782B TW 103115501 A TW103115501 A TW 103115501A TW 103115501 A TW103115501 A TW 103115501A TW I566782 B TWI566782 B TW I566782B
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- Prior art keywords
- fluoride
- arginine
- weight
- salt
- present
- Prior art date
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- 238000000034 method Methods 0.000 title description 38
- 238000004519 manufacturing process Methods 0.000 title description 12
- 239000000203 mixture Substances 0.000 claims description 282
- KRHYYFGTRYWZRS-UHFFFAOYSA-M Fluoride anion Chemical compound [F-] KRHYYFGTRYWZRS-UHFFFAOYSA-M 0.000 claims description 87
- 239000004475 Arginine Substances 0.000 claims description 69
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 claims description 68
- 150000003839 salts Chemical group 0.000 claims description 64
- 238000009472 formulation Methods 0.000 claims description 58
- -1 hydrogen calcium dihydrate Chemical class 0.000 claims description 44
- 210000003298 dental enamel Anatomy 0.000 claims description 37
- 230000036541 health Effects 0.000 claims description 33
- 239000000551 dentifrice Substances 0.000 claims description 30
- 210000000214 mouth Anatomy 0.000 claims description 28
- 241000894006 Bacteria Species 0.000 claims description 25
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical compound [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 claims description 24
- 150000004673 fluoride salts Chemical class 0.000 claims description 23
- PUZPDOWCWNUUKD-UHFFFAOYSA-M sodium fluoride Chemical compound [F-].[Na+] PUZPDOWCWNUUKD-UHFFFAOYSA-M 0.000 claims description 18
- 208000002925 dental caries Diseases 0.000 claims description 17
- 230000009885 systemic effect Effects 0.000 claims description 12
- XGRSAFKZAGGXJV-UHFFFAOYSA-N 3-azaniumyl-3-cyclohexylpropanoate Chemical compound OC(=O)CC(N)C1CCCCC1 XGRSAFKZAGGXJV-UHFFFAOYSA-N 0.000 claims description 10
- 206010036790 Productive cough Diseases 0.000 claims description 10
- 229960004711 sodium monofluorophosphate Drugs 0.000 claims description 10
- 208000024794 sputum Diseases 0.000 claims description 10
- 210000003802 sputum Anatomy 0.000 claims description 10
- 238000005115 demineralization Methods 0.000 claims description 9
- 230000002328 demineralizing effect Effects 0.000 claims description 9
- 239000011775 sodium fluoride Substances 0.000 claims description 9
- 235000013024 sodium fluoride Nutrition 0.000 claims description 9
- 229960000414 sodium fluoride Drugs 0.000 claims description 9
- 238000011282 treatment Methods 0.000 claims description 9
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 claims description 8
- 230000002401 inhibitory effect Effects 0.000 claims description 8
- 238000012544 monitoring process Methods 0.000 claims description 8
- 235000000346 sugar Nutrition 0.000 claims description 7
- WCUXLLCKKVVCTQ-UHFFFAOYSA-M Potassium chloride Chemical compound [Cl-].[K+] WCUXLLCKKVVCTQ-UHFFFAOYSA-M 0.000 claims description 6
- 230000015572 biosynthetic process Effects 0.000 claims description 6
- 229910000019 calcium carbonate Inorganic materials 0.000 claims description 6
- XAAHAAMILDNBPS-UHFFFAOYSA-L calcium hydrogenphosphate dihydrate Chemical compound O.O.[Ca+2].OP([O-])([O-])=O XAAHAAMILDNBPS-UHFFFAOYSA-L 0.000 claims description 6
- 230000003902 lesion Effects 0.000 claims description 6
- NROKBHXJSPEDAR-UHFFFAOYSA-M potassium fluoride Chemical compound [F-].[K+] NROKBHXJSPEDAR-UHFFFAOYSA-M 0.000 claims description 6
- 230000036996 cardiovascular health Effects 0.000 claims description 5
- 229910000147 aluminium phosphate Inorganic materials 0.000 claims description 4
- 208000007565 gingivitis Diseases 0.000 claims description 4
- ANOBYBYXJXCGBS-UHFFFAOYSA-L stannous fluoride Chemical compound F[Sn]F ANOBYBYXJXCGBS-UHFFFAOYSA-L 0.000 claims description 4
- 229960002799 stannous fluoride Drugs 0.000 claims description 4
- DDFHBQSCUXNBSA-UHFFFAOYSA-N 5-(5-carboxythiophen-2-yl)thiophene-2-carboxylic acid Chemical compound S1C(C(=O)O)=CC=C1C1=CC=C(C(O)=O)S1 DDFHBQSCUXNBSA-UHFFFAOYSA-N 0.000 claims description 3
- 230000032770 biofilm formation Effects 0.000 claims description 3
- 206010013781 dry mouth Diseases 0.000 claims description 3
- 230000036039 immunity Effects 0.000 claims description 3
- 150000002500 ions Chemical class 0.000 claims description 3
- 230000000813 microbial effect Effects 0.000 claims description 3
- ZVVSSOQAYNYNPP-UHFFFAOYSA-N olaflur Chemical compound F.F.CCCCCCCCCCCCCCCCCCN(CCO)CCCN(CCO)CCO ZVVSSOQAYNYNPP-UHFFFAOYSA-N 0.000 claims description 3
- 229960001245 olaflur Drugs 0.000 claims description 3
- 230000007406 plaque accumulation Effects 0.000 claims description 3
- 239000001103 potassium chloride Substances 0.000 claims description 3
- 235000011164 potassium chloride Nutrition 0.000 claims description 3
- 239000011698 potassium fluoride Substances 0.000 claims description 3
- 235000003270 potassium fluoride Nutrition 0.000 claims description 3
- 230000001737 promoting effect Effects 0.000 claims description 3
- 206010052428 Wound Diseases 0.000 claims description 2
- 208000027418 Wounds and injury Diseases 0.000 claims description 2
- 239000011737 fluorine Substances 0.000 claims description 2
- 229910052731 fluorine Inorganic materials 0.000 claims description 2
- 230000035876 healing Effects 0.000 claims description 2
- 229910001414 potassium ion Inorganic materials 0.000 claims 2
- FGIUAXJPYTZDNR-UHFFFAOYSA-N potassium nitrate Chemical compound [K+].[O-][N+]([O-])=O FGIUAXJPYTZDNR-UHFFFAOYSA-N 0.000 claims 2
- 206010010904 Convulsion Diseases 0.000 claims 1
- PXGOKWXKJXAPGV-UHFFFAOYSA-N Fluorine Chemical compound FF PXGOKWXKJXAPGV-UHFFFAOYSA-N 0.000 claims 1
- NPYPAHLBTDXSSS-UHFFFAOYSA-N Potassium ion Chemical compound [K+] NPYPAHLBTDXSSS-UHFFFAOYSA-N 0.000 claims 1
- 206010044038 Tooth erosion Diseases 0.000 claims 1
- 208000025865 Ulcer Diseases 0.000 claims 1
- 230000002053 acidogenic effect Effects 0.000 claims 1
- 230000000172 allergic effect Effects 0.000 claims 1
- 208000010668 atopic eczema Diseases 0.000 claims 1
- 230000036461 convulsion Effects 0.000 claims 1
- 238000003682 fluorination reaction Methods 0.000 claims 1
- 229910052739 hydrogen Inorganic materials 0.000 claims 1
- 239000001257 hydrogen Substances 0.000 claims 1
- 208000036595 non-bacterial tooth erosion Diseases 0.000 claims 1
- 239000004323 potassium nitrate Substances 0.000 claims 1
- 235000010333 potassium nitrate Nutrition 0.000 claims 1
- 208000024891 symptom Diseases 0.000 claims 1
- YWYZEGXAUVWDED-UHFFFAOYSA-N triammonium citrate Chemical compound [NH4+].[NH4+].[NH4+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O YWYZEGXAUVWDED-UHFFFAOYSA-N 0.000 claims 1
- 231100000397 ulcer Toxicity 0.000 claims 1
- 229940024606 amino acid Drugs 0.000 description 86
- 235000001014 amino acid Nutrition 0.000 description 86
- 150000001413 amino acids Chemical class 0.000 description 84
- 229940091249 fluoride supplement Drugs 0.000 description 68
- 235000009697 arginine Nutrition 0.000 description 63
- 229960003121 arginine Drugs 0.000 description 63
- ODKSFYDXXFIFQN-BYPYZUCNSA-P L-argininium(2+) Chemical compound NC(=[NH2+])NCCC[C@H]([NH3+])C(O)=O ODKSFYDXXFIFQN-BYPYZUCNSA-P 0.000 description 62
- 238000002360 preparation method Methods 0.000 description 42
- QGZKDVFQNNGYKY-UHFFFAOYSA-N Ammonia Chemical compound N QGZKDVFQNNGYKY-UHFFFAOYSA-N 0.000 description 30
- 239000002253 acid Substances 0.000 description 23
- 239000000606 toothpaste Substances 0.000 description 22
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- 239000000047 product Substances 0.000 description 17
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- 229910021529 ammonia Inorganic materials 0.000 description 15
- 229910000420 cerium oxide Inorganic materials 0.000 description 15
- BMMGVYCKOGBVEV-UHFFFAOYSA-N oxo(oxoceriooxy)cerium Chemical compound [Ce]=O.O=[Ce]=O BMMGVYCKOGBVEV-UHFFFAOYSA-N 0.000 description 15
- 229910052708 sodium Inorganic materials 0.000 description 15
- 239000002245 particle Substances 0.000 description 14
- 239000004094 surface-active agent Substances 0.000 description 14
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- 235000019333 sodium laurylsulphate Nutrition 0.000 description 13
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 13
- RHGKLRLOHDJJDR-BYPYZUCNSA-N L-citrulline Chemical compound NC(=O)NCCC[C@H]([NH3+])C([O-])=O RHGKLRLOHDJJDR-BYPYZUCNSA-N 0.000 description 12
- XEFQLINVKFYRCS-UHFFFAOYSA-N Triclosan Chemical compound OC1=CC(Cl)=CC=C1OC1=CC=C(Cl)C=C1Cl XEFQLINVKFYRCS-UHFFFAOYSA-N 0.000 description 12
- 159000000007 calcium salts Chemical class 0.000 description 12
- 239000002324 mouth wash Substances 0.000 description 12
- 229940088417 precipitated calcium carbonate Drugs 0.000 description 12
- 239000000523 sample Substances 0.000 description 12
- 229960003500 triclosan Drugs 0.000 description 12
- 239000003082 abrasive agent Substances 0.000 description 11
- 239000003945 anionic surfactant Substances 0.000 description 11
- 239000001506 calcium phosphate Substances 0.000 description 11
- 239000000543 intermediate Substances 0.000 description 11
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 description 10
- 229940051866 mouthwash Drugs 0.000 description 10
- 229920000642 polymer Polymers 0.000 description 10
- 235000019640 taste Nutrition 0.000 description 10
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 9
- AHLPHDHHMVZTML-BYPYZUCNSA-N L-Ornithine Chemical compound NCCC[C@H](N)C(O)=O AHLPHDHHMVZTML-BYPYZUCNSA-N 0.000 description 9
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- 229910052500 inorganic mineral Inorganic materials 0.000 description 9
- 235000010755 mineral Nutrition 0.000 description 9
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- QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 description 8
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- 239000011575 calcium Substances 0.000 description 7
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Description
本發明係關於口腔保健之方法,其係使用包含呈游離或鹽類形式之鹼性胺基酸以及氟化物來源之組成物,亦關於使用及製造這些組成物的方法。
精胺酸及其他鹼性胺基酸業經推薦用於口腔保健且據信在抗齲齒調配物及牙齒敏感性方面具有顯著的益處。將這些鹼性胺基酸與具有口腔保健益處的礦物質(例如:氟化物及鈣)合併以形成具有可接受之長期安定性口腔保健產品,無論如何業經證明是件艱鉅的事,特別是鹼性胺基酸可能提高pH值並促使鈣離子游離,而鈣離子會與氟化物離子反應生成不可溶的沉澱物;再者,較高的pH值具有引起刺激性的潛能,無論如何在中性pH值或酸性pH值下,利用精胺酸碳酸氫鹽(此方面技藝教示為較佳者)的系統可能釋出二氧化碳,導致容器膨脹及爆炸;此外,可預期的是,降低pH值至中性或酸性條件將會減低調配物的功效,因為精胺酸可形成精胺酸-不溶性鈣複合物,其對牙齒表面的親合性較差,而且降低pH值將減低調配物在口腔中可能對齲蛀因素的乳酸的緩衝效應。部分由於這些未經安排的調配物束,且部分由於精胺酸在此方面技藝通常被視為氟化物之一種潛在替代物而不是共存活性成份,鮮少動機會製造出同時含有精胺酸與氟化物的口腔保健產品,商業上可取得之以精胺酸為基礎的牙膏,例如:DenClude®及ProClude®,包括CaviStat®,例如包含精胺酸碳酸氫鹽及碳酸
鈣,但未含氟化物或任何抗微生物劑。
定量光導螢光技術是一種可見螢光,其可偵測早期的珐瑯質損害並縱向監視發展或退化情形,正常的牙齒在以藍光照射時會發綠色螢光;去礦物質的琺瑯質會阻斷這種螢光,而該去礦物質的區域便在牙齒上呈現出黑暗區塊,因此其大小可被量化並監視其發展,那些流失礦物質的區域具有較低的螢光性,在與健康牙齒表面相較下顯得較暗,軟體是經由一白點或伴隨損害的面積/體積來定量螢光程度,一般而言,係招募具有已存在白點損害的個體作為專案研究參加者,這些測量係於活體內用真實牙齒進行,損害的面積/體積在臨床開始時便予以測量,在損害的面積/體積中還原(改善)情形是在產品使用6個月結束後測量,此等資料經常是用改善情形對基線的百分比加以報告。
電流齲齒監測法是一種根據電阻來測量牙齒之礦物質含量的技術,導電性測量開發出以下事實:由琺瑯質與象牙質的去礦物質與腐蝕作用所引起的多孔性且經液體填充的區域,其導電度乃優於健康區域。當牙齒失去礦物質時,由於增加的多孔性,其對電流的電阻變小,因此病患牙齒的導電性增加可顯示去礦物質現象。一般而言,研究是在具有損害的根部表面進行,這些測量係於活體內用真實牙齒進行,測量為期6個月的治療前後差異,再者,根部表面的典型的齲齒指數係利用接觸式探針完成,其硬度係以三點量尺分類:硬、皮般強韌、或者柔軟。於此類研究中,典型地,其結果係以EMC測量的電阻(數值越高越好)以及以接觸式探針量指數為基礎的損害部位硬度改善情形加以報告。
本案意外地發現鹼性胺基酸(例如精胺酸)與氟化物合併時可提供無法預期的益處以減輕、修護或抑制早期的琺瑯質損害,例如藉定量光導螢光技術(QLF)或電流齲齒監測法(ECM)
檢測者。
因此相較於缺乏有效量氟及/或精胺酸之組成物,本發明組成物可用於減輕早期的琺瑯質損害(例如藉QLF或ECM檢測者)之方法中。
在未受特定理論限制的前題下,經推斷,精胺酸之有利效應之重要因素為精胺酸與其他的鹼性胺基酸可被某些類型的細菌代謝,例如血鏈球菌(S.sanguis),其並非齲蛀因素但會與齲蛀因素細菌(如:變形鏈球菌(S.mutans))競爭牙齒上或口腔內的位置,精胺酸分解菌可利用精胺酸及其他的鹼性胺基酸以產生氨,進而提高其環境的pH值,然而齲蛀因素細菌則代謝糖以產生乳酸,其則傾向降低齒菌斑pH值並將牙齒去礦物質,最後導致齲齒,據信經常性使用本發明組成物,假以時日,將導致精胺酸分解菌相對增加且齲蛀因素細菌相對減少,進而造成較高的齒菌斑pH值,使得牙齒得具免疫性以對抗齲蛀因素細菌及其不利效應,據信此種提高pH值的效應可機械式地由氟化物之促進再礦物質化及強化牙齒琺瑯質效應分離出並與其互補。
辜且不論真正的機制為何,本案發現將氟化物與鹼性胺基酸(例如精胺酸)與氟化物合併於口腔保健產品中可產生無法預期的益處,乃超出且品質上異於那些使用包含有效量個別化合物之組成物所觀察到者,在空洞形成過程已進行至象牙質前促進再礦物質化、修護早期琺瑯質損害,因而增進口腔健康;再者,經發現此等作用可藉由添加小顆粒研磨劑進一步提升,該研磨劑可協助填充琺瑯質之微小縫隙及象牙質的微小管。
因此本發明包含一種處理或減輕早期琺瑯質齲蛀之方法,包括將有效量之口腔組成物施用至有需要的個體之口腔中,該組成物係包含呈游離或鹽類形式之鹼性胺基酸(例如精胺酸)以及有效量之氟化物。
於一具體範疇中,早期之琺瑯質齲齒係藉定量光導螢光技術(QLF)或電流齲齒監測法(ECM)予以檢測。
於另一具體範疇中,本發明提供一種改善例如與早期琺瑯質損害相互關聯之QLF或ECM值之方法,包括將有效量之游離或鹽類形式鹼性胺基酸(例如精胺酸)與有效量之氟化物施用於有需要之個體之口腔中。
於另一具體範疇中,本發明提供一種對抗蛀洞之保護方法,包括測量患者之QLF或ECM值,及為此患者改善QLF或ECM值至一比使用無精胺酸的氟化物或使用無氟化物之精胺酸所能獲致者更高的程度。
於另一具體範疇中,本發明提供一種減少例如藉QLF或ECM值量測之既有早期琺瑯質損害大小之方法,包括將有效量之游離或鹽類形式鹼性胺基酸(例如精胺酸)與有效量之氟化物施用於有需要之個體之口腔中。
於另一具體範疇中,本發明提供一種增進系統健康(例如心血管健康)之方法,其係透過經常性(例如每天)施用一口腔保健產品而進行,包括將有效量之游離或鹽類形式鹼性胺基酸(例如精胺酸)與有效量之氟化物施用於個體之口腔中。
鹼性胺基酸與氟化物可被分開地、連續地或同時地施用,於一具體範疇中,它們係以單一組成物(組成物1.0)的一部分型式施用至有需要之個體之口腔中,組成物係包括有效量之游離或鹽類形式鹼性胺基酸(例如精胺酸)與有效量之氟化物,例如下列組成物中任一種:
1.0.1. 組成物1.0,其中鹼性胺基酸為精胺酸、離胺酸、瓜胺酸、鳥胺酸、肌酸、組胺酸、二胺基丁酸、二胺基丙酸,其鹽類及/或其組合物。
1.0.2. 組成物1.0或1.0.1,其中鹼性胺基酸具有L-構型。
1.0.3. 前述組成物中任一種,其係以鹽類或含有鹼性胺基酸之二肽或三肽型式提供。
1.0.4. 前述組成物中任一種,其中鹼性胺基酸為精胺酸。
1.0.5. 前述組成物中任一種,其中鹼性胺基酸為L-精胺酸。
1.0.6. 前述組成物中任一種,其中鹼性胺基酸係部分或全部呈鹽類形式。
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,其中鹼性胺基酸係呈精胺酸鹽酸鹽型式。
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. 前述組成物中任一種,其中鹼性胺基酸之鹽類係藉由酸或酸的鹽類中和鹼性胺基酸的方式在調配物中原處生成。
1.0.12. 前述組成物中任一種,其中鹼性胺基酸之鹽類係在與氟化物合併前藉由中和鹼性胺基酸以形成一預混合物的方式生成。
1.0.13. 前述組成物中任一種,其中鹼性胺基酸的存在量係佔組成物總重量之約0.1至約20%,例如約1重量%至約10重量%,鹼性胺基酸的重量係以游離鹼形式計算。
1.0.14. 組成物1.0.11,其中鹼性胺基酸的存在量係佔組成物總重量之約7.5重量%。
1.0.15. 組成物1.0.11,其中鹼性胺基酸的存在量係佔組成物總重量之約5重量%。
1.0.16. 組成物1.0.11,其中鹼性胺基酸的存在量係佔組成物總重量之約3.75重量%。
1.0.17. 組成物1.0.11,其中鹼性胺基酸的存在量係佔組成物總重量之約1.5重量%。
1.0.18. 前述組成物中任一種,其中氟化物鹽為氟化亞錫、氟化鈉、氟化鉀、單氟磷酸鈉、氟代矽酸鈉、氟代矽酸銨、胺氟化物(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,及其組合物。
1.0.19. 前述組成物中任一種,其中氟化物鹽為氟代磷酸鹽。
1.0.20. 前述組成物中任一種,其中氟化物鹽為單氟磷酸鈉。
1.0.21. 前述組成物中任一種,其中氟化物鹽為氟化鈉。
1.0.22. 前述組成物中任一種,其中氟化物鹽的存在量係佔組成物總重量之約0.01重量%至約2重量%。
1.0.23. 前述組成物中任一種,其中氟化物鹽所提供之氟化物離子存在量係佔組成物總重量之約0.1重量%至約0.2重量%。
1.0.24. 前述組成物中任一種,其中可溶性氟化物鹽所提供之氟化物離子存在量係佔組成物總重量之約50至約10,000ppm。
1.0.25. 前述組成物中任一種,其係具有約100至約250ppm有效之氟化物離子之漱口藥。
1.0.26. 前述組成物中任一種,其係具有約750至約2000ppm有效之氟化物離子之潔齒劑。
1.0.27. 前述組成物中任一種,其中組成物含有約750至約2000ppm之氟化物離子。
1.0.28. 前述組成物中任一種,其中組成物含有約1000至約1500ppm之氟化物離子。
1.0.29. 前述組成物中任一種,其中組成物含有約1450ppm之氟化物離子。
1.0.30. 前述組成物中任一種,其中pH值為約6至約9,例如約6.5至約7.4或約7.5至約9。
1.0.31. 前述組成物中任一種,其中pH值為約6.5至約7.4。
1.0.32. 前述組成物中任一種,其中pH值為約6.8至約7.2。
1.0.33. 前述組成物中任一種,其中pH值為接近中性。
1.0.34. 前述組成物中任一種,其進一步包含一研磨劑或顆粒物。
1.0.35. 前一種組成物,其中研磨劑或顆粒物係選自碳酸氫鈉、磷酸鈣(例如磷酸氫鈣二水合物)、硫酸鈣、沉澱之碳酸鈣、二氧化矽(例如水合之二氧化矽)、氧化鐵、氧化鋁、珍珠岩、塑膠顆粒(例如聚乙烯),及其組合物。
1.0.36. 前一種組成物,其中研磨劑或顆粒物係選自磷酸鈣
(例如磷酸氫鈣二水合物)、硫酸鈣、沉澱之碳酸鈣、二氧化矽(例如水合之二氧化矽),及其組合物。
1.0.37. 前述組成物中任一種,其包含佔組成物總重量之約15重量%至約70重量%之研磨劑。
1.0.38. 前述組成物中任一種,其包含佔至少約5重量%且d50為<5微米之小顆粒研磨劑組份。
1.0.39. 前述組成物中任一種,其具有少於約150(例如約40至約140)之RDA。
1.0.40. 前述組成物中任一種,其中陰離子性界面活性劑係選自a. 高級脂肪酸單甘油酯單硫酸鹽之水溶性鹽類(例如氫化椰子油脂肪酸之單硫酸化單甘油酯之鈉鹽,如:N-甲基N-椰油醯基牛磺酸鈉、椰油-甘油酯硫酸鈉),b. 高級烷基硫酸鹽,例如月桂基硫酸鈉,c. 高級烷基-醚硫酸鹽,例如化學式CH3(CH2)mCH2-(OCH2CH2)nOSO3X,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(如:月桂醚-2硫酸鈉(CH3(CH2)10CH2(OCH2CH2)2OSO3Na)),d. 高級烷基芳基磺酸鹽,例如十二烷基苯磺酸鈉(月桂基苯磺酸鈉),e. 高級烷基磺基乙酸鹽,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鹽之高級脂肪酸酯類、磺基椰子月桂酸鹽(N-2-乙基月桂酸鉀磺基乙醯胺)及月桂醯肌胺酸鈉,f. 及其混合物。
“高級烷基”意指,例如,C6-30烷基;於特定之具體範疇中,陰離子性界面活性劑係選自月桂基硫酸鈉及乙醚月桂基硫酸鈉。
1.0.41. 前述組成物中任一種,其中陰離子性界面活性劑係選自月桂基硫酸鈉、乙醚月桂基硫酸鈉及其混合物。
1.0.42. 前述組成物中任一種,其中陰離子性界面活性劑之存在量為約0.3%至約4.5%以重量計。
1.0.43. 前述組成物中任一種,其亦含有選自下列之界面活性劑:陽離子、兩性離子、非離子性界面活性劑,及其混合物。
1.0.44. 前述組成物中任一種,其進一步含有至少一種濕潤劑。
1.0.45. 前述組成物中任一種,其進一步含有至少一種選自下列之濕潤劑:甘油、山梨糖醇、木糖醇及其組合物。
1.0.46. 前述組成物中任一種,其進一步含有木糖醇。
1.0.47. 前述組成物中任一種,其進一步含有至少一種聚合物。
1.0.48. 前述組成物中任一種,其進一步含有至少一種選自下列之聚合物:聚乙烯乙二醇、聚乙烯基甲基醚馬來酸共聚物、聚醣類(例如:纖維素衍生物,如:羧甲基纖維素,或聚醣膠類,如:黃原膠或角叉膠),及其組合物。
1.0.49. 前述組成物中任一種,其含有膠條或碎片。
1.0.50. 前述組成物中任一種,其進一步含有矯味劑、香料及/或色素。
1.0.51. 前述組成物中任一種,其進一步含有水。
1.0.52. 前述組成物中任一種,其進一步含有選自下列之抗菌劑:鹵化之二苯基醚(如:三氯沙)、草本萃取物及香精油(如:迷迭香萃取物、茶萃取物、木蘭花萃取物、百里香酚、薄荷醇、桉樹腦、香葉草醇、香芹酚、檸檬醛、日檜醇、兒茶酚、水楊酸甲酯、表沒食子兒茶素沒食子酸酯、表沒食子兒茶素、沒食子酸、健齒樹(miswak)萃取物、沙棘萃取物)、雙胍防腐劑(如:氯己啶(chlorhexidine)、阿來西啶(alexidine)或奧替尼啶(octenidine))、季銨化合物(如:鯨蠟基吡啶鎓氯化物(CPC)、氯化苯二甲烴銨、四癸基吡啶鎓氯化物(TPC)、N-四癸基-4-乙基吡啶鎓氯化物(TDEPC))、酚系防腐劑、海克替啶(hexetidine)、奧替尼啶(octenidine)、血根鹼
(sanguinarine)、聚維酮碘(povidone iodine)、地莫匹醇(delmopinol)、沙力弗洛(salifluor)、金屬離子(例如:鋅鹽,如:檸檬酸鋅,錫鹽、銅鹽、鐵鹽)、血根鹼(sanguinarine)、蜂膠及氧化劑(如:過氧化氫、緩衝之過氧硼酸或過氧碳酸鈉)、酞酸及其鹽類、單棓太酸(monoperthalic acid)及其鹽類與酯類、抗壞血酸硬脂酸酯、油醯肌胺酸、烷基硫酸酯、二辛基磺基琥珀酸酯、水楊醯苯胺、杜美芬(domiphen bromide)、地莫匹醇(delmopinol)、辛哌醇(octapinol)及其他哌啶并衍生物、尼辛(nicin)製劑、亞氯酸鹽;以及前述任一項之混合物。
1.0.53. 前述組成物中任一種,其進一步含有一抗炎性化合物,例如選自下列宿主前炎性因子中任一項的抑制劑:基質金屬蛋白酶(MMP’s)、環氧合酶(COX)、PGE2、細胞白介素1(IL-1)、IL-1β轉換酶(ICE)、轉形生長因子β1(TGF-β1)、可誘導之氧化氮合成酶(iNOS)、透明質酸酶、細胞自溶酵素、核因子kB(NF-kB),及IL-1受體關聯之激酶(IRAK),例如選自阿司匹林、酮洛芬(ketoprofen)、皮羅西康(piroxicam)、甲氯芬那酸(meclofenamic acid)、去甲二氫化癒創木酸(nordihydroguaiaretic acid),及其混合物。
1.0.54. 前述組成物中任一種,其進一步含有抗氧化劑,例如選自下列者:輔酶Q10、PQQ、維生素C、維生素E、維生素A、茴香腦-二硫代硫酮,及其混合物。
1.0.55. 前述組成物中任一種,其中抗菌劑係難溶者。
1.0.56. 前述組成物中任一種,其進一步含有三氯沙。
1.0.57. 前述組成物中任一種,其進一步含有三氯沙及木糖醇。
1.0.58. 前述組成物中任一種,其進一步含有三氯沙、木糖醇及沉澱之碳酸鈣。
1.0.59. 前述組成物中任一種,其進一步含有佔組成物總重量約0.01至約5重量%之抗菌劑。
1.0.60. 前述組成物中任一種,其進一步含有佔組成物總重量約0.01至約1重量%之三氯沙。
1.0.61. 前述組成物中任一種,其進一步含有佔組成物總重量約0.3%之三氯沙。
1.0.62. 前述組成物中任一種,其進一步含有美白劑。
1.0.63. 前述組成物中任一種,其進一步含有選自下列之美白劑:過氧化物、金屬亞氯酸鹽、過硼酸鹽、過碳酸鹽、過氧酸、次氯酸鹽,及其組合物。
1.0.64. 前述組成物中任一種,其進一步含有過氧化氫或過氧化氫來源,例如:過氧化脲或過氧化物鹽類或複合物(例如:過氧磷酸鹽、過氧碳酸鹽、過硼酸鹽、過氧矽酸鹽、或過硫酸鹽;例如:過氧磷酸鈣、過硼酸鈉、碳酸鈉過氧化物、過氧磷酸鈉及過硫酸鉀)。
1.0.65. 前述組成物中任一種,其進一步含有干擾或防止細菌附著之製劑,例如:搜布羅(solbrol)或甲殼素。
1.0.66. 前述組成物中任一種,其進一步含有選自下列之鈣及磷酸鹽的來源:(i)鈣-玻璃複合物,如:磷酸矽酸鈣鈉,及(ii)鈣-蛋白質複合物,如:酪朊磷酸肽-無定形磷酸鈣。
1.0.67. 前述組成物中任一種,其進一步含有可溶性鈣鹽,例如選自硫酸鈣、氯化鈣、硝酸鈣、醋酸鈣、乳酸鈣,及其組合物。
1.0.68. 前述組成物中任一種,其進一步含有可有效減輕象牙質敏感性含量之生理上可接受之鉀鹽,例如硝煙鉀或氯化鉀。
1.0.69. 前述組成物中任一種,其進一步含有約0.1%至約7.5%之生理上可接受之鉀鹽,例如硝煙鉀及/或氯化鉀。
1.0.70. 前述組成物中任一種,其係包含下列成份之牙膏: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;陰離子性界面活性劑,如:月桂基硫酸鈉;及可溶性氟化物鹽,如:單氟磷酸鈉或氟化鈉。
1.0.71. 前述組成物中任一種,其於施用至口腔時,例如刷牙,可有效(i)減少或抑制齲齒形成,(ii)減輕、修護或抑制琺瑯質蛀牙前損害,例如:藉定量光導螢光技術(QLF)或電流齲齒監測法(ECM)檢測者,(iii)減輕或抑制牙齒去礦物質化現象及促進牙齒再礦物質化,(iv)減輕牙齒過敏性,(v)減輕或抑制齒齦炎,(vi)促進口腔內潰瘍或傷口的癒合,(vii)減少產酸細菌的含量,(viii)增加精胺酸分解性(arginolytic)細菌的相對含量,(ix)抑制口腔內微生物生物膜的形成,(x)提高及/或維持齒菌斑pH在糖侵犯後處於至少pH 5.5的水準,(xi)減少齒菌斑累積,(xii)治療、緩和或減輕乾口症,(xiii)清潔牙齒及口腔,(xiv)減少腐蝕現象,(xv)美白牙齒,(xvi)增強牙齒免疫力以對抗致齲蛀細菌;及/或(xvii)促進系統性健康,包括心血管健康,例如藉減輕經由口部組織之系統化感染潛在可能而達成。
1.0.72. 一種組成物,其係或可藉由合併前述組成物之任一項中所述之成份而獲得。
1.0.73. 前述組成物中任一種,其係呈選自下列之型式:漱口水、牙膏、齒膠、牙粉、非研磨性膠、牙齒乳膏(mousse)、泡沫、口腔噴劑、糖錠、口服錠、牙科器具,以及寵物保健產品。
1.0.74. 前述組成物中任一種,其中組成物為牙膏。
1.0.75. 前述組成物中任一種,其中組成物為牙膏,其選擇地進一步含有一或多種選自下列之物質:水、研磨劑、界面活性劑、發泡劑、維生素、聚合物、酵素、濕潤劑、增稠劑、抗菌劑、防腐劑、矯味劑、色素及/或其組合物。
1.0.76. 前述組成物1.0-1.0.73中任一種,其中組成物為漱口藥。
1.0.77. 前述組成物中任一種,其進一步含有口部芳香劑、香精或矯味劑。
1.0.78. 前述組成物中任一種,其進一步含有抗結石劑。
1.0.79. 前述組成物中任一種,其進一步含有下列之抗結石劑:聚磷酸鹽,例如焦磷酸鹽、三聚磷酸鹽、或六偏磷酸鹽,例如呈鈉鹽型式者。
1.0.80. 前述組成物中任一種,其進一步包含有效量之鹼性胺基酸鹽;有效量之可溶性氟化物鹽;陰離子性界面活性劑,例如月桂基硫酸鈉;陰離子性聚合物,如:甲基乙烯基醚與馬來酸酐之共聚物;以及抗菌劑(如:三氯沙)。
1.0.81. 前述組成物中任一種,其進一步包含有效量之鹼性胺基酸鹽;抗菌劑,如:三氯沙;有效量之可溶性氟化物鹽;小顆粒研磨劑,以至於組成物具有RDA<160(例如約40至約140),例如包含至少約5%(例如至少約20%)之具有d50<5微米之研磨劑,如:具有d50約3至約4微米之二氧化矽。
本發明進一步提供(i)一種合併之製劑,其包含游離或鹽類形式鹼性胺基酸,及氟化物,供同時、連續或分開施用至一個體口腔中以治療、減輕或抑制早期琺瑯質損害;及(ii)一種合併之製劑,其包含游離或鹽類形式鹼性胺基酸,及氟化物,供同時、連續或分開施用至一個體口腔中以增進與早期琺瑯質損害相互關聯之QLF或ECM值,此等合併之製劑係例如前面描述之組成物或者
1.0.82. 一種合併之製劑,其包含游離或鹽類形式鹼性胺基酸,及氟化物,供同時、連續或分開施用至一個體口腔中以治療、減輕或抑制早期琺瑯質損害。
1.0.83. 根據前述任一具體範疇之合併製劑,其中鹼性胺基酸的存在量係佔合併製劑總重量之約0.1至約20重量%。
1.0.84. 根據前述任一具體範疇之合併製劑,其中鹼性胺基酸的存在量係佔合併製劑總重量之約1至約10重量%。
1.0.85. 根據前述任一具體範疇之合併製劑,其中鹼性胺基酸包括精胺酸。
1.0.86. 根據前述任一具體範疇之合併製劑,其中精胺酸係以無機含氧酸的鹽類形式存在。
1.0.87. 根據前述任一具體範疇之合併製劑,其中無機含氧酸為磷酸。
1.0.88. 根據前述任一具體範疇之合併製劑,其中氟化物係以可溶性氟化物鹽形式存在,存在量為佔合併製劑總重量之0.01至2重量%。
1.0.89. 根據前述任一具體範疇之合併製劑,其中氟化物提供一氟化物離子存在量佔合併製劑中氟化物離子總重量之約50至約25,000ppm的來源。
1.0.90. 根據前述任一具體範疇之合併製劑,其中可溶性氟化物鹽或氟化物離子來源係選自氟化鈉、單氟磷酸鈉,及其混合物。
1.0.91. 根據前述任一具體範疇之合併製劑,其進一步含有無機酸之鈣鹽,其中鈣鹽的存在量為佔合併製劑總重量之10至60重量%。
1.0.92. 根據前述任一具體範疇之合併製劑,其中鈣鹽為無機含氧酸的鹽。
1.0.93. 根據前述任一具體範疇之合併製劑,其中鈣鹽包括磷酸鈣。
1.0.94. 一種合併之製劑,其包含游離或鹽類形式鹼性胺基酸,及氟化物,供同時、連續或分開施用至一個體口腔中以增進與早期琺瑯質損害相互關聯之QLF或ECM值。
1.0.95. 根據前述任一具體範疇之合併製劑,其中鹼性胺基酸的存在量係佔合併製劑總重量之約0.1至約20重量%。
1.0.96. 根據前述任一具體範疇之合併製劑,其中鹼性胺基酸的存在量係佔合併製劑總重量之約1至約10重量%。
1.0.97. 根據前述任一具體範疇之合併製劑,其中鹼性胺基酸包括精胺酸。
1.0.98. 根據前述任一具體範疇之合併製劑,其中精胺酸係以無機含氧酸的鹽類形式存在。
1.0.99. 根據前述任一具體範疇之合併製劑,其中無機含氧酸
為磷酸。
1.0.100. 根據前述任一具體範疇之合併製劑,其中氟化物係以可溶性氟化物鹽形式存在,存在量為佔合併製劑總重量之0.01至2重量%。
1.0.101. 根據前述任一具體範疇之合併製劑,其中氟化物提供一氟化物離子存在量佔合併製劑中氟化物離子總重量之約50至約25,000ppm的來源。
1.0.102. 根據前述任一具體範疇之合併製劑,其中可溶性氟化物鹽或氟化物離子來源係選自氟化鈉、單氟磷酸鈉,及其混合物。
1.0.103. 根據前述任一具體範疇之合併製劑,其進一步含有無機酸之鈣鹽,其中鈣鹽的存在量為佔合併製劑總重量之10至60重量%。
1.0.104. 根據前述任一具體範疇之合併製劑,其中鈣鹽為無機含氧酸的鹽。
1.0.105. 根據前述任一具體範疇之合併製劑,其中鈣鹽包括磷酸鈣。
因此本發明提供一種方法(方法1)以治療或減輕早期琺瑯質損害,其包含將有效量之包含游離或鹽類形式鹼性胺基酸及有效量氟化物之口腔用組成物或合併製劑施用至口腔內,例如其中之鹼性胺基酸為精胺酸,例如其中組成物或合併製劑係根據前述1.0.1-105中任一項。
1.0.106. 前述該方法,其中早期琺瑯質齲蛀情形係藉定量光導螢光技術(QLF)或電流齲齒監測法(ECM)予以檢測。
1.0.107. 一種改善與早期琺瑯質損害相互關聯之QLF或ECM值之方法,其包括將有效量之游離或鹽類形式鹼性胺基酸(例如精胺酸)及有效量之氟化物施用至個體之口腔內。
1.0.108. 前述該方法,其中鹼性胺基酸為精胺酸。
1.0.109. 一種對抗蛀洞的保護方法,其包括為患者測量QLF或ECM值,並為該患者改善QLF或ECM值至一種大於使
用無精胺酸之氟化物或使用無氟化物之精胺酸所能獲致的程度。
1.0.110. 一種減少既有之早期琺瑯質損害大小的方法,其包括將有效量之鹼性胺基酸及有效量之氟化物施用至個體之口腔內。
1.0.111. 前述該方法,其中鹼性胺基酸為精胺酸。
1.0.112. 一種透過經常性施用口腔保健產品以增進系統性健康之方法,其包括將有效量之鹼性胺基酸及有效量之氟化物施用至個體之口腔內。
1.0.113. 前述該方法,其中鹼性胺基酸為精胺酸。
1.0.114. 如前所述之方法,其亦可有效a. 減輕或抑制齲齒的形成,b. 減輕或抑制牙齒之去礦物質化作用及增進牙齒之再礦物質化作用,c. 減輕牙齒之過敏現象,d. 減輕或抑制齒齦炎,e. 促進口內潰瘍或傷口的癒合,f. 減少產酸細菌的含量,g. 增加精胺酸分解性細菌之相對含量,h. 抑制口腔內微生物生物膜生成,i. 提高及/或維持齒菌斑pH在糖侵犯後處於至少約pH 5.5的水準,j. 減少齒菌斑累積,k. 治療、緩和或減輕乾口症,l. 美白牙齒,m. 促進系統性健康,包括心血管健康,n. 減少牙齒腐蝕現象,o. 增強牙齒免疫力或保護其以對抗致齲蛀細菌,及/或p. 清潔牙齒及口腔。
本發明進一步提供一種利用鹼性胺基酸於生產供前述方
法使用之組成物或合併製劑的用法,例如(i)利用游離或鹽類形式之鹼性胺基酸,及氟化物,於生產一供同時、連續或分開施用至一個體口腔中以治療、減輕或抑制早期琺瑯質損害之合併製劑;(ii)利用游離或鹽類形式之鹼性胺基酸,及氟化物,於生產一供同時、連續或分開施用至一個體口腔中以減少早期琺瑯質損害大小之合併製劑;及(iii)利用游離或鹽類形式之鹼性胺基酸,及氟化物,於生產一供同時、連續或分開施用至一個體口腔中以增進系統性健康之合併製劑,例如
1.0.115. 利用游離或鹽類形式之鹼性胺基酸,及氟化物,於生產一供同時、連續或分開施用至一個體口腔中以治療、減輕或抑制早期琺瑯質損害之組成物或合併製劑,其中早期琺瑯質齲蛀情形係藉定量光導螢光技術(QLF)或電流齲齒監測法(ECM)予以檢測。
1.0.116. 利用游離或鹽類形式之鹼性胺基酸,及氟化物,於生產一供同時、連續或分開施用至一個體口腔中以改善與早期琺瑯質損害相互關聯之QLF或ECM值之方法。
1.0.117. 前述該用法,其中鹼性胺基酸為精胺酸。
1.0.118. 利用游離或鹽類形式之鹼性胺基酸,及氟化物,於生產一供同時、連續或分開施用至一個體口腔中以保護對抗蛀洞的保護方法,其係為患者測量QLF或ECM值,並為該患者改善QLF或ECM值至一種大於使用無精胺酸之氟化物或使用無氟化物之精胺酸所能獲致的程度。
1.0.119. 前述用法,其中鹼性胺基酸包含精胺酸,且存在量係佔合併製劑總重量之約0.1至約20重量%。
1.0.120. 前述用法,其中氟化物係以可溶性氟化物鹽形式存在,存在量為佔合併製劑總重量之0.01至2重量%。
1.0.121. 前述用法,其中作為氟化物離子來源之氟化物其存在量佔合併製劑中氟化物離子總重量之約50至約25,000ppm。
1.0.122. 前述用法,其中可溶性氟化物鹽或氟化物離子來源係
選自氟化鈉、單氟磷酸鈉,及其混合物。
1.0.123. 前述用法,其中組成物或合併製劑進一步含有鈣鹽,其存在量為佔合併製劑總重量之10至60重量%。
1.0.124. 前述用法,其中鈣鹽為無機含氧酸的鹽。
1.0.125. 前述用法,其中鈣鹽包括磷酸鈣。
1.0.126. 利用游離或鹽類形式之鹼性胺基酸,及氟化物,生產一供同時、連續或分開施用至一個體口腔中以減少早期琺瑯質損害大小之合併製劑的方法。
1.0.127. 前述用法,其中鹼性胺基酸包含精胺酸,且存在量係佔合併製劑總重量之約0.1至約20重量%,且氟化物係以可溶性氟化物鹽形式存在,存在量為佔合併製劑總重量之0.01至2重量%或佔合併製劑中氟化物離子總重量之約50至約25,000ppm。
1.0.128. 利用游離或鹽類形式之鹼性胺基酸,及氟化物,生產一供同時、連續或分開施用至一個體口腔中以增進系統性健康之合併製劑的方法。
1.0.129. 前述用法,其中鹼性胺基酸包含精胺酸,且存在量係佔合併製劑總重量之約0.1至約20重量%,且氟化物係以可溶性氟化物鹽形式存在,存在量為佔合併製劑總重量之0.01至2重量%或佔合併製劑中氟化物離子總重量之約50至約25,000ppm。
經發現,前述之合併製劑及組成物因此可用來治療、減輕或抑制早期琺瑯質損害,及/或改善與早期琺瑯質損害相互關聯之QLF或ECM值,且經如此採用後可產生無法預期的有利效應;所以可被熟練的口腔保健技藝從業者預期的是,許多不同但令人驚訝的技術上效應與利益,可由根據本發明一或多方面的口腔保健組成物,例如牙膏,其調配物與用法而產生,其係教示活性組成或成份之不同組合及,較佳地,其在組成物中之個別含量。
活性成份的含量將根據傳遞系統之性質及特定之活性而
改變,例如:鹼性胺基酸的存在量可由例如約0.1至約20重量%(以游離鹼的重量計算),例如對漱口水而言約0.1至約3重量%,對消費者牙膏而言約1至約10重量%,或對專業或處方治療產品而言約7至約20重量%。氟化物的存在量可由例如約25至約25,000ppm,例如對漱口水而言約25至約250ppm,對消費者牙膏而言約750至約2,000ppm,或對專業或處方治療產品而言約2,000至約25,000ppm。抗菌劑的存在量亦隨著牙膏中的使用量以類似的方式變動,例如約5至約15倍於漱口水中所使用者,例如,三氯沙漱口水可包含例如約0.03重量%之三氯沙,然而三氯沙牙膏可包含例如約0.3重量%之三氯沙。
可用於本發明組成物及方法中之鹼性胺基酸不僅包括天然生成之鹼性胺基酸,例如精胺酸、離胺酸及組胺酸,亦包括任何在分子中具有羧基與胺基的鹼性胺基酸,其為水溶性且提供pH值約7或更高的水溶液。
因此,鹼性胺基酸包括但不受限於精胺酸、離胺酸、瓜胺酸、鳥胺酸、肌酸、組胺酸、二胺基丁酸、二胺基丙酸,其鹽類及/或其組合物;於特定之具體範疇中,鹼性胺基酸係選自精胺酸、瓜胺酸及鳥胺酸。
於某些具體範疇中,鹼性胺基酸為精胺酸,例如L-精胺酸或其鹽類。
於某些具體範疇中,鹼性胺基酸包含至少一種於精胺酸去亞胺酶系統中產生之中間體,於精胺酸去亞胺酶系統中產生之中間體在口腔保健組成物中可用來提供齒菌斑中和作用供齲蛀控制及/或防範,精胺酸是天然的鹼性胺基酸,其可於口腔內發現,口中的精胺酸可被某些齒斑菌種利用以資存活,例如:血鏈球菌(S.sanguis)、革登氏鏈球菌(S.gordonii)、副血鏈球菌(S.parasanguis)、鼠鏈球菌(S.rattus)、米氏鏈球菌(S.milleri)、咽峽炎鏈球菌(S.anginosus)、糞鏈球菌(S.faecalis)、
內氏放線菌(A.naeslundii)、齲齒放線菌(A.odonolyticus)、纖維二糖乳桿菌(L.cellobiosus)、短乳桿菌(L.brevis)、發酵乳桿菌(L.fermentum)、牙齦卟啉單胞菌(P.gingivalis)、及齒密螺旋體(T.denticola),此等有機體可能在酸性環境下消滅,此種環境可能存在於接近齒表的區域,該處之引起酸化及嗜酸之齲齒產生菌可利用糖以產生有機酸,因此這些精胺酸分解性菌種可分解精胺酸產生氨以提供鹼度以便生存,並且緩衝齒菌斑及造成對齲齒產生系統不友善的環境。
此等精胺酸分解性有機體可藉由內部細胞酵素途徑系統,即所謂的“精胺酸去亞胺酶系統”,代謝分解精胺酸,從而使中間體在該途徑中生成,於此途徑中,L-精胺酸可被精胺酸去亞胺酶分解成L-瓜胺酸及氨,接著L-瓜胺酸可在無機磷酸鹽存在下被鳥胺酸氨甲醯轉化酶分解為L-鳥胺酸及氨甲醯基磷酸酯;然後氨甲酸激酶可分解氨甲醯基磷酸酯產生另一氨分子及二氧化碳,並於過程中亦產生ATP(腺核苷5’-三磷酸),ATP可被精胺酸分解菌利用作為生長的能量來源,於是在利用時,精胺酸去亞胺酶系統可產生兩分子氨。
經發現在某些具體範疇中,氨可幫助中和口腔齒菌斑pH值以控制及/或防止牙齒齲蛀。
本發明某些具體範疇之口腔保健組成物可包含於精胺酸去亞胺酶系統中產生之中間體,此類中間體可包括瓜胺酸、鳥胺酸及氨甲醯基磷酸酯;於某些具體範疇中,其他的保健組成物係包含瓜胺酸;於某些具體範疇中,保健組成物係包含鳥胺酸;於某些具體範疇中,保健組成物係包含氨甲醯基磷酸酯;於其他具體範疇中,口腔保健組成物係包含下列物質之任何組合物:瓜胺酸、鳥胺酸、氨甲醯基磷酸酯、及/或其他由精胺酸去亞胺酶系統產生之其他中間體。
該口腔保健組成物可包含有效量之上述中間體,於某些具體範疇中,該口腔保健組成物包含約1毫莫耳/升至約10毫莫耳/升中間體;於其他具體範疇中,該口腔保健組成物包含
約3毫莫耳/升至約7毫莫耳/升中間體;於其他具體範疇中,該口腔保健組成物包含約5毫莫耳/升中間體。
本發明組成物係欲供局部用於口中,因此用於本發明中之鹽類以其提供的用量與濃度應係對此種用法安全者,適合之鹽類包括此方面技藝已知之藥學上可接受之鹽類,其所提供的用量與濃度通常是被視為生理上可接受的,生理上可接受之鹽類包括那些衍生自藥學上可接受之無機或有機酸或鹼,例如由會形成生理上可接受之陰離子的酸所產生的酸加成鹽,如:氫氯酸或氫溴酸鹽,以及由會形成生理上可接受之陽離子的鹼所產生的鹼加成鹽,像是那些衍生自鹼金屬(如:鉀及鈉)或鹼土金屬(如:鈣及鎂);生理上可接受之鹽類可利用此方面技藝已知之標準程序獲得,例如藉足夠鹼性的化合物(如:胺)與提供生理上可接受之陰離子的適當酸反應。
於各種具體範疇中,鹼性胺基酸的存在量為佔組成物總重量之約0.5重量%至約20重量%,佔組成物總重量之約1重量%至約10重量%,例如佔組成物總重量之約1.5重量%、約3.75重量%、約5重量%、或約7.5重量%。
RDA:RDA係放射性象牙質磨損的縮寫,一種磨損度的相對度量,典型地,拔出的人齒或牛齒係以中子流照射,以甲基異丁烯酸酯(骨膠)架置好,剝除琺瑯質,插入一刷拂機,以美國牙科協會(ADA)標準刷(參考牙刷,150g壓力,1500抽,4-比-1水-牙膏漿),然後測量並記錄沖洗水的放射性;實驗控制組係使用ADA參考牙膏(由焦磷酸鈣製造)重覆該測試,藉此測量提供一100的數值以校準相對尺度。
氟化物離子來源:該等口腔保健組成物可進一步包含一或多種氟化物離子來源,例如可溶性氟化物鹽,廣泛的氟化物離子-產生物質可作為本發明組成物中可溶性氟化物的來源,適合之氟化物離子-產生物質的例子可參見美國專利第3,535,421號(Briner等人)、美國專利第4,885,155號(Parran,Jr.等人)及美國專利第3,678,154號(Widder等人),乃以參考方式
併入本案。
代表性氟化物離子來源包括但不侷限於氟化亞錫、氟化鈉、氟化鉀、單氟磷酸鈉、氟代矽酸鈉、氟代矽酸銨、胺氟化物、氟化銨,及其組合物。於某些具體範疇中,氟化物離子來源包括氟化亞錫、氟化鈉、單氟磷酸鈉及其混合物。
於某些具體範疇中,本發明口腔保健組成物亦可包含氟化物離子來源或提供氟之成份,其含量為足以提供約25ppm至約25,000ppm氟化物離子,通常為至少約500ppm,例如約500至約2000ppm,例如約1000至約1600ppm,例如約1450ppm;氟化物之適當含量將視特定之應用而定,例如漱口水典型地含有約100至約250ppm的氟化物,一般消費者使用的牙膏典型地含有約1000至約1500ppm的氟化物,兒童用牙膏則含量較低些;專業使用的潔齒劑或塗覆物則可含有高達約5,000或者甚至於約25,000ppm的氟化物。
本發明組成物中氟化物離子來源的添加量在一具體範疇中可為約0.01重量%至約10重量%、或約0.03重量%至約5重量%,或於另一具體範疇中可為約0.1重量%至約1重量%,明顯地,提供適當量氟化物離子的氟化物鹽重量將根據鹽中抗衡離子的重量而改變。
本發明組成物可包含磷酸鈣研磨劑,例如:磷酸三鈣(Ca3(PO4)2)、羥基磷灰石(Ca10(PO4)6(OH)2)、或磷酸氫鈣二水合物(CaHPO4‧2H2O,本案有時候寫成DiCal)或焦磷酸鈣,選擇地,研磨劑亦可採用碳酸鈣,特別是沉澱之碳酸鈣。
該等組成物可包含一或多種其他的研磨劑,例如:二氧化矽研磨劑,例如平均顆粒大小至高達約20微米之沉澱之二氧化矽,例如由J.M.Huber販售之Zeodent 115®,其他可用的研磨劑亦包括偏磷酸鈉、偏磷酸鉀、矽酸鋁、煅燒之礬土、膨潤土或其他矽質材料,或其組合物。
可用於本案之二氧化矽研磨拋光物質以及其他的研磨劑
通常具有的平均顆粒大小介於約0.1至約30微米間,約5至約15微米間,二氧化矽研磨劑可選自沉澱之二氧化矽或二氧化矽凝膠,例如美國專利第3,538,230號(Pader等人)及美國專利第3,862,307號(Digiulio等人)中所述之二氧化矽乾凝膠,兩者皆以參考方式併入本案。特定之二氧化矽乾凝膠係以商標Syloid®由W.R.Grace & Co.的Davision化學部門販售;沉澱之二氧化矽物質包括那些由J.M.Huber Corp.以商標Zeodent®販售者,包括被命名為Zeodent 115及119之二氧化矽。這些二氧化矽研磨劑業經描述於美國專利第4,340,583號(Wason)中,乃以參考方式併入本案。
於某些具體範疇中,於實施本發明口腔保健組成物時可使用之研磨物質包括二氧化矽凝膠及沉澱之無定形二氧化矽,其具有的油吸收值低於約100cc/100g二氧化矽及約45cc/100g至約70cc/100g二氧化矽的範圍;油吸收值的測量係採用ASTA Rub-Out Method D281。於某些具體範疇中,該等二氧化矽係膠體狀顆粒,其平均顆粒大小為約3微米至約12微米,及約5至約10微米。
於特定具體範疇中,研磨物質包括大比例之極小顆粒,例如具d50<5微米者,例如具d50為約3至約4微米之小顆粒二氧化矽(SPS),如:Sorbosil AC43®(Ineos),此等小顆粒在以降低過敏性為目標的調配物中特別有利;這種小顆粒組成份可與第二種較大顆粒研磨劑合併存在,例如於某些具體範疇中,調配物即含有約3至約8% SPS及約25至約45%習用研磨劑。
特別有利於實施本發明之低油吸收性二氧化矽研磨劑係以商標Sylodent XWA®由巴爾的摩港市(Md.21203)W.R.Grace & Co.的Davision化學部門販售;Sylodent 650 XWA®為一種二氧化矽水凝膠,其係由具有水含量29重量%直徑平均約7至約10微米的膠凝狀二氧化矽顆粒組成,且油吸收性少於約70cc/100g二氧化矽,其係可用來實施本發明之低油吸收性二氧
化矽研磨劑例子,該研磨劑在本發明口腔保健組成物中係以約10至約60重量%之濃度存在,在其他具體範疇中則以約20至約45重量%之濃度存在,以及在另一具體範疇中則以約30至約50重量%之濃度存在。
於某些具體範疇中,鹼性胺基酸係併入含有作為研磨劑之鹽基調配物之潔齒組成物中,該鹽基調配物包括碳酸鈣,特別是沉澱之碳酸鈣,L-精胺酸及精胺酸鹽類(例如精胺酸碳酸氫鹽)本身在味覺上有明顯的苦味,且在水溶液中亦可散發魚腥味,因此可預期的是,當L-精胺酸或精胺酸鹽類以有效濃度被併入口保健產品(例如潔齒調配物)內以提供抗齲齒功效及緩解過敏性時,其典型地係以佔潔齒調配物總重量之2至10重量%存在,潔齒調配物的味道及口感在與未添加L-精胺酸或精胺酸鹽類之相同調配物相較下將是降級的。
無論如何,本發明意外地發現,添加L-精胺酸或精胺酸鹽類至含有碳酸鈣之鹽基潔齒調配物中,可讓潔齒調配物的味道及口感明顯改善並增加產品對消費者的整體可接受度。
本發明口腔保健組成物亦可包含一試劑以增加口腔在刷洗時產生的起泡量。
增加起泡量之試劑之說明性實例包括但非侷限於聚氧乙烯,以及某些包括但非侷限於精胺酸鹽聚合物之聚合物。
聚氧乙烯可增加起泡數量及本發明之口腔保健載劑成份所產生的泡沫濃密度,聚氧乙烯通常亦指聚乙烯乙二醇(“PEG”)或聚氧化乙烯,適合本發明之聚氧乙烯類為具分子量約200,000至約7,000,000者,於一具體範疇中,分子量為約600,000至約2,000,000,且於另一具體範疇中,分子量為約800,000至約1,000,000;Polyox®為Union Carbide生產之高分子量聚氧乙烯的商標名稱。
聚氧乙烯的存在量可為佔本發明口腔保健組成物之口腔保健載劑成份重量之約1%至約90%,於一具體範疇中為約5%
至約50%,及於另一具體範疇中為約10%至約20%;於口腔保健組成物劑(即一劑)中之起泡劑劑量為約0.01至約0.9重量%,約0.05至約0.5重量%,及於另一具體範疇中約0.1至約0.2重量%。
可用於本發明之組成物可包含陰離子性界面活性劑,例如i. 高級脂肪酸單甘油酯單硫酸酯之水溶性鹽類,例如氫化椰子油脂肪酸之單硫酸化單甘油酯之鈉鹽,如:N-甲基N-椰油醯基牛磺酸鈉、椰油-甘油酯硫酸鈉,ii. 高級烷基硫酸鹽,例如月桂基硫酸鈉,iii. 高級烷基-醚硫酸鹽,例如化學式CH3(CH2)mCH2-(OCH2CH2)nOSO3X,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,如:月桂醚-2硫酸鈉(CH3(CH2)10CH2(OCH2CH2)2OSO3Na),iv. 高級烷基芳基磺酸鹽,例如十二烷基苯磺酸鈉(月桂基苯磺酸鈉),v. 高級烷基磺基乙酸鹽,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鹽之高級脂肪酸酯類、磺基椰子月桂酸鹽(N-2-乙基月桂酸鉀磺基乙醯胺)及月桂醯肌胺酸鈉。
“高級烷基”意指,例如,C6-30烷基,於特定之具體範疇中,陰離子性界面活性劑係選自月桂基硫酸鈉及乙醚月桂基硫酸鈉。
陰離子性界面活性劑可以一有效量存在,例如佔調配物重量>0.01%,但濃度不至於刺激口腔組織者,例如<10%,且適宜的濃度乃視特定調配物及特定界面活性劑而定,例如:採用的濃度或漱口水典型地是牙膏用量的十分之一,於一具體範疇中,陰離子性界面活性劑在牙膏中的存在量為約0.3%至約4.5%以重量計,例如約1.5%。
本發明組成物可選擇地含有界面活性劑混合物,包含陰
離子性界面活性劑及其他界面活性劑,其可為陰離子性、陽離子性、兩性離子或非離子性。一般而言,界面活性劑為那些在寬廣pH範圍內皆呈合理安定者,界面活性劑在如下專利中描述得更完整:美國專利第3,959,458號(Agricola等人)、美國專利第3,937,807號(Haefele等人)、及美國專利第4,051,234號(Gieske等人),其皆以參考方式併入本案。
於某些具體範疇中,此處適用的陰離子性界面活性劑包括烷基部分具約10至約18個碳原子之烷基硫酸酯的水溶性鹽類,以及具約10至約18個碳原子之脂肪酸的磺化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-甘油酯硫酸鈉皆為此種類型的陰離子性界面活性劑,亦可利用陰離子性界面活性劑的混合物。
於另一具體範疇中,適用於本發明之陽離子性界面活性劑可被廣泛地界定為具有含約8至約18個碳原子之長鏈烷基之脂族季銨化合物的衍生物,例如月桂基三甲銨氯化物、鯨蠟基吡啶鎓氯化物、鯨蠟基三甲銨溴化物、二異丁基苯氧基乙基二甲基苄基銨氯化物、椰子烷基三甲基銨亞硝酸鹽、鯨蠟基吡啶鎓氟化物,及其混合物。
說明性陽離子性界面活性劑為描述於美國專利第3,535,421號(Briner等人)之季銨氟化物,其乃以參考方式併入本文,某些陽離子性界面活性劑在組成物中亦可扮演殺菌劑的角色。
可用於本發明組成物之非離子性界面活性劑可被廣泛地界定為藉由烯化氧基(親水性)與有機之疏水性化合物(本質上可為脂族或烷芳族)縮合而製得之化合物,適合之非離子性界面活性劑例子包括但非侷限於Pluronics®三嵌段共聚物、烷基苯酚之聚乙烯氧化物縮合物、由乙烯氧化物與一丙烯氧化物與乙烯二胺的反應產物縮合衍生的產物、脂族醇的乙烯氧化物縮合物、長鏈之第三胺氧化物、長鏈之第三膦氧化物、長鏈之二烷亞碸、及這些物質之混合物。
於某些具體範疇中,適用於本發明之兩性離子合成性界面活性劑可被廣泛地界定為脂族季銨、鏻、及鋶化合物的衍生物,其中脂族基團可為直鏈或分支狀,且其中脂族取代基中之一含有約8至約18個碳原子且一個含有一陰離子性水-增溶基,例如羧基、磺酸鹽、硫酸鹽、磷酸鹽或膦酸鹽,適合併入組成物中之界面活性劑說明性實例包括但非侷限於烷基硫酸鈉、月桂醯肌胺酸鈉、椰子醯胺丙基甜菜鹼及聚山梨酯20,及其組合物。
於一特定之具體範疇中,用於本發明方法中之組成物包含月桂基硫酸鈉。
界面活性劑或相容之界面活性劑混合物於本發明組成物中之存在量為佔組成物總重量之約0.1%至約5.0%,於另一具體範疇中為約0.3%至約3.0%,於另一具體範疇中為約0.5%至約2.0%。
本發明口腔保健組成物亦可包含一矯味劑,可用來實施本發明的矯味劑包括但不侷限於精油以及各種調味之酐、酯類、醇類、及類似物質;精油之例子包括綠薄荷、薄荷、冬青樹、黃樟、丁香、香紫蘇、桉樹、墨角蘭、月桂、檸檬、菩提樹、葡萄柚及柳橙的油;亦有用者為例如薄荷腦、香芹酮及茴香腦之化學品,某些具體範疇係採用薄荷及綠薄荷之油。
矯味劑係以約0.1至約5%以重量計及約0.5至約1.5%以重量計之濃度併入口腔組成物中,於個別口腔保健組成物劑(即一劑)中之矯味劑劑量為約0.001至0.05%以重量計,而於另一具體範疇中為約0.005至約0.015%以重量計。
本發明口腔保健組成物亦可選擇地含有一或多種能夠複合細菌之細胞壁中發現的鈣之螯合劑,結合此鈣可弱化細菌之細胞壁並造成細菌溶解。
另一適用於本發明作為螯合劑之族群為可溶性焦磷酸
鹽,該等用於本發明組成物之焦磷酸鹽可為任一鹼金屬焦磷酸鹽,於某些具體範疇中,該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,其中鹼金屬為鈉或鉀,該等鹽類以其水合及未水合形式皆有效,可用於本發明組成物中之焦磷酸鹽其有效使用量為大致足以提供至少約1.0重量%之焦磷酸鹽離子、約1.5重量%至約6重量%、約3.5重量%至約6重量%之此種離子。
本發明口腔保健組成物亦選擇地包括一或多種聚合物,例如聚乙烯乙二醇、聚乙烯基甲基醚馬來酸共聚物、多醣類(例如纖維素衍生物,如:羧甲基纖維素,或多醣膠類,如:黃原膠或角叉膠);酸性聚合物,例如聚丙烯酸酯膠,可以其游離酸或部分或完全中和之水溶性鹼金屬(例如鉀及鈉)或銨鹽形式提供。
特別地,當非陽離子性抗菌劑或抗菌劑(例如三氯沙)被添加至任一種潔齒組成時,宜亦添加約0.05至約5%之可促進試劑傳遞及保持至口腔表面且保留其上之試劑。可用於本發明之此類試劑乃揭示於美國專利第5,188,821及5,192,531號;且包括合成性陰離子性聚合之聚羧酸酯類,例如馬來酸酐或酸與另一可聚合之乙烯系未飽和單體之1:4至4:1共聚物,宜為甲基乙烯基醚/馬來酸酐,其具有分子量(M.W.)約30,000至約1,000,000,更宜具約30,000至約800,000,這些共聚物可獲自例如Gantrez,例如AN 139(M.W.700,000)、AN 119(M.W.250,000)及宜為S-97醫藥級(M.W.700,000),其可獲自ISP科技公司,Bound Brook,N.J.08805;該促進劑若存在時,其存在量為約0.05至約3%以重量計。
其他有效的聚合物包括那些例如馬來酸酐與丙烯酸乙酯、異丁烯酸羥基乙酯、N-乙烯基-2-吡咯啶酮、或乙烯的1:1共聚物,後者可獲自例如孟山都EMA No.1103,M.W.10,000及EMA等級61,以及馬來酸與異丁烯酸甲酯或羥基乙酯、丙烯酸甲酯或
乙酯、異丁基乙烯基醚或N-乙烯基-2-吡咯啶酮的1:1共聚物。
一般適合者為聚合之烯屬或乙烯系未飽和羧酸類,其含有一活化之碳-對-碳烯屬雙鍵及至少一個羧基,亦即一種含有容易在聚合反應中起作用之烯屬雙鍵的酸,因為其存在於單體分子中相對於羧基的α-β位置或為末端亞甲基編組的一部分,此類酸的說明性實例為丙烯酸、異丁烯酸、乙基丙烯酸、α-氯代丙烯酸、丁烯酸、β-丙烯氧基丙酸、山梨酸、α-氯代山梨酸、月桂酸、β-苯乙烯基丙烯酸、己二烯二酸、衣康酸、檸康酸、甲基富馬酸、戊烯二酸、烏頭酸、α-苯基丙烯酸、2-苄基丙烯酸、2-環己基丙烯酸、白芷酸、2,4-二羥基桂皮酸、富馬酸、馬來酸及酐,其他可與此等羧酸單體共聚合之不同烯屬單體包括乙烯基乙酸酯、乙烯基氯化物、馬來酸二甲酯等,共聚物含有足夠羧酸鹽基以利水溶解性。
另一類聚合劑包括一組成物,其包含經取代丙烯醯胺之均聚物及/或不飽和磺酸及其鹽類之均聚物,特定而言,其中的聚合物係根據選自下列之不飽和磺酸:丙烯醯胺烷磺酸,例如2-丙烯醯胺2-甲基丙烷磺酸,其具有分子量約1,000至約2,000,000,描述於美國專利第4,842,847號(1989年6月27日,Zahid),以參考方式併入本文。
另一類有用的聚合劑包括聚胺基酸,特別是那些含有某些比例之陰離子性界面活性胺基酸,例如門冬胺酸、谷胺酸及磷酸絲胺酸,如美國專利第4,866,161號(Sikes等人)中所揭示者,其以參考方式併入本文。
於製備口腔保健組成物時,有時候必須添加一些增稠劑以提供所需的黏稠度或用來安定或提高調配物的表現,於某些具體範疇中,增稠劑為羧乙烯基聚合物、角叉膠、羥乙基纖維素及纖維素醚類之水溶性鹽類,例如羧甲基纖維素鈉及羧甲基羥乙基纖維素鈉;天然的膠類,如:刺梧桐膠、阿拉伯膠及黃芪膠,亦可併入,凝膠狀矽酸鎂鋁或微細分離之二氧化矽亦可用作稠化組成物的成份,以進一步增進組成物的質地,於某些具體範疇中,增稠劑的使用量為佔組成物總重量之約0.5%至
約5.0%。
本發明口腔保健組成物亦可選擇地包含一或多種酵素,可用的酵素包括任一種可取得之蛋白酶、葡聚醣水解酶、內切醣苷酶、澱粉酶、變位酶、脂肪酶及黏蛋白酶或其相容的混合物,於某些具體範疇中,該酵素為蛋白酶、葡聚醣酶、內切醣苷酶及變位酶,於另一具體範疇中,該酵素為木瓜蛋白酶、內切醣苷酶或葡聚醣酶與變位酶的混合物,其他適合用於本發明之酵素乃描述於美國專利第5,000,939號(Dring等人)、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,所有皆以參考方式併入本文;於本發明中數種相容的酵素之酵素混合物,其組成量於一具體範疇為約0.002%至約2.0%,於另一具體範疇中為約0.05%至約1.5%,或於另一具體範疇中為約0.1%至約0.5%。
水亦可存在於本發明口腔組成物中,於市售口腔組成物中採用的水須經去離子且不含有機雜質,水皆係用來補足組成物的平衡,且包括佔口腔組成物重量之約10%至約90%、約20%至60%或約10%至30%,此等水含量包括與其他物質(例如山梨糖醇)或本發明任一組成份一起添加的自由水。
在某些口腔組成物的具體範疇中,亦可添加濕潤劑以防止組成物在曝露至空氣時硬化,有些濕潤劑亦可將所需甜味或味道賦予潔齒組成物,就純濕潤劑而論,該濕潤劑在一具體範疇中通常包括佔潔齒組成物重量之約15%至約70%,或於另一具體範疇中包括佔潔齒組成物重量之約30%至約65%。
適合之濕潤劑包括可食性多羥基醇,例如:甘油、山梨糖醇、木糖醇、丙二醇以及其他多醇類,及這些濕潤劑的混合物,甘油與山梨糖醇的混合物可用於某些具體範疇中作為本案
牙膏組成物的濕潤劑成份。
除了上述組成份外,本發明的具體例亦可包含各種選擇性潔齒成份,一部分說明如下,選擇性成份包括但不侷限於例如膠黏劑、泡沫類洗滌劑(sudsing agents)、矯味劑、甜味劑、增添的抗菌斑生成劑、研磨劑及增色劑,這些及其他選擇性成份乃進一步描述於美國專利第5,004,597號(Majeti等人)、美國專利第3,959,458號(Agricola等人)及美國專利第3,937,807號(Haefele),所有皆以參考方式併入本文。
本發明組成物可採用口腔產品領域中習用的方法製造。
於一說明性具體例中,口腔保健組成物的製造係利用酸,例如磷酸、氫氯酸或碳酸,中和或部分中和凝膠相中之精胺酸,並混合生成預混物1而進行。
將活性成份,例如維生素、CPC、氟化物、研磨劑及任何其他所需之活性成份,添加至預混物1中並混合生成預混物2。
當終產物為牙膏時,添加牙膏鹽基例如磷酸二鈣或二氧化矽至預混物2中並予混合,將最終漿狀物製成口腔保健產品。
根據本發明之組成物及方法可併入保健口齒之口腔組成物中,例如牙膏、透明膏、凝膠、漱口水、噴霧及口嚼膠。
本發明提供一種相對於缺乏有效量氟及/或精胺酸的組成物可減輕琺瑯質早期損害(如QLF或ECM所量測者)的方法。
這些方法亦可減少口腔內有害細菌,例如減輕或抑制齒齦炎、減少產生細胞的酸含量、增加精胺酸分解性細菌的相對含量、抑制口腔內微生物之生物膜形成、在糖分侵犯後提高及/或維持齒菌斑pH值於至少約pH5.5、減輕齒菌斑累積、及/或清潔牙齒及口腔。
最後,經由增加口內pH值及防阻引起疾病之細菌,本發明方法有利於促進口內潰瘍或傷口的癒合。
提昇口腔健康亦有助於系統性健康,因為口腔組織可為系統性感染的途徑,良好的口腔健康乃與系統性健康(包括心血
管健康)相關聯;本發明組成物及方法可提供特定利益,因為鹼性胺基酸,尤其是精胺酸,其乃提供NO合成途徑的氮來源,因此提高口腔組織內的微循環,提供一較不酸的口腔環境亦有助於減輕胃部不適並營造一較不利於與胃潰瘍相關聯之幽門螺旋桿菌的環境;精胺酸乃特別需要用於高度表達特定的免疫細胞受體,例如T-細胞受體,因此精胺酸可提高有效的免疫反應,所以本發明組成物及方法有利於提昇系統性健康,包括心血管健康。
正如全文所使用者,各種範圍係以簡略表達的方式來說明個別及每一個介於範圍內的數值,任何落入範圍內的數值可被選為範圍的端點,再者,所有在本文內引用的參考案乃以參考方式全部併入,倘若在本案揭露的定義與引用的參考案定義有所衝突時,以本案揭露者為準。據了解,當調配物被提及時,其可能是由其成份的觀點加以描述,正如此方面技藝所習知者,雖然這些成份在製造、儲存及使用時可能與實際調配物中的其他成份反應,但此等產物仍為所述調配物所涵蓋。
下列實例進一步描述及闡釋本發明範圍內的說明性具體例,這些實例完全是供說明用而不應推斷為限制本發明,因為在未偏離本發明的精神與範圍下,有許多變化皆為可行的,除了那些已於本案中顯示及描述者之外,本發明之各種改變應係精於此方面技藝者所顯而易見者,因此亦屬於本案申請專利範圍內。
以臨床研究去礦化作用/再礦化作用之方式測試經中和之磷酸二鈣/精胺酸磷酸鹽/氟化物調配物相對於不含精胺酸之磷酸二鈣/氟化物調配物。
去礦化/再礦化研究是一種短期研究,用來評估抗齲齒技
術,於此模式中,琺瑯質樣本乃經歷口中去礦化作用及再礦化作用之條件,去礦化條件係藉由將樣本浸泡在糖溶液內的方式創造,齲蛀性細菌生成酸並造成pH下降;於此模式中,製備經拋光磨平成鏡面的牛樣本塊,採用一微硬度測試器在基線(M1)上量測琺瑯質樣本的硬度,該微硬度測試器係使用尖端裝附鑽石的探針在具已知且固定負載量之琺瑯質樣本中創造V形凹口,V形凹口的長度係與琺瑯質硬度呈相反的關係,琺瑯質硬度則與礦物質含量直接相關聯,樣本是用達克龍網覆蓋,然後放置在保持器上,將樣本每天溫熱24小時歷時5天,在這5天期間,參加者將其保持器浸入蔗糖溶液中每天4次,此項處理會造成pH變動,參加者在保持器於口中時每天用指定的牙膏刷牙兩次,經5天後,將樣本由保持器移出並進行微硬度測試器測量(M2)。齒菌斑則可進一步分析齒菌斑生態或齒菌斑代謝測量,由於藉浸泡樣本至糖水每天4次所創造的高度齲蛀條件,大部分的處理在處理5天後皆傾向經歷礦物質淨損,因此稱之為“去礦化/再礦化模式”;最佳的處理損失最少的礦物質,但無論如何,有些狀況是利用特別有效的處理獲致硬度的淨增。
統計分析是一種雙因子分析,其利用個體及處理作為因子,其結果可表達為硬度改變%(M2-M1)/M1 x 100或硬度的淨改變M2-M1,若係採用改變百分比,則採用雙因子ANOVA,若係採用硬度的淨改變,則一雙因子ANCOVA係利用M1作為共變量而進行;若達到95%信任度則差異度即被視為有意義的,典型地,一250ppm氟化物(或非氟化物)及一含標準量氟化物的牙膏乃經併入作為負及正控制組,並用以確認該模式,於正控制組之氟化物含量多半是1000、1100或1450ppm氟化物,所選擇之控制組係視待測潔齒劑的氟化物含量而定;當正控制組顯示明顯優於負控制組時,該模式即被視為有效,一旦模式有效,受測產品即與負控制組比較,應注意的是,參加者效應通常很明顯,因此使用不同的研究人口,並不預期相同的
處理將獲得相同的數字結果。
(實施例3)
註:Dical=磷酸二鈣二水合物
MFP=單氟磷酸鈉,單位為ppm氟化物
在此項臨床研究中,經中和之磷酸二鈣/精胺酸磷酸鹽/氟化物調配物是唯一顯示有確實增加礦化作用之調配物。
可用於本發明之漱口水係採用下列成份製備:
精胺酸漱口水,含氟化物、SLS、PMV/MA及三氯沙
令一組經試驗潔齒調配物感覺訓練的消費者測試員試用不同潔齒調配物,其係於複製消費者使用潔齒調配物之雙盲消費者試驗條件下使用。
該組測試員係被要求以習慣方式使用潔齒調配物,然後評量感覺特徵,對一含有沉澱之碳酸鈣(PCC)之鹽基潔齒調配物而言,已知之調配物係扮演安慰劑控制組,及對應之亦包含1、2、3或5重量%精胺酸碳酸氫鹽之調配物亦進行測試。令人驚訝的是,發現含精胺酸碳酸氫鹽之PCC調配物在味道強度、清涼感及易起泡性方面皆展現消費者接受度增加,此外亦包含2重量%精胺酸碳酸氫鹽之調配物,在整體喜好度、整體味道喜好度、刷牙時的味道及刷牙後的味道皆有提昇,再者,亦包含精胺酸碳酸氫鹽之調配物感覺上在所有的印象乃明顯優於安慰劑控制組,包括感知效果、口/齒的清潔感、產品適合性、味覺及整體產品品質。
本實施例顯示添加鹼性胺基酸(例如精胺酸),特別是碳酸氫鹽形式者,在用於本發明口腔保健組成物中時,可令人驚訝地提昇潔齒調配物的感覺特徵,尤其是含有沉澱之碳酸鈣(PCC)之鹽基調配物的感覺特徵。
令血鏈球菌(S.sanguis)之隔夜培養基於37℃下在胰化酪蛋白大豆培養液中生長(Becton Dickinson,Sparks,MD),將培養基一次1毫升以5,000rpm離心5分鐘並置入預先稱重的試管中以便累積約5毫克溼丸粒重,然後將此丸粒再懸浮於20
毫莫耳磷酸鉀緩衝液中(JT Baker,Phillipsburg,NJ),pH 4.0,以模擬細菌的受壓環境,於該環境中會產生氨以便存活,其最終濃度為每毫升5毫克,為達此最終濃度,終濃度5毫莫耳之L-精胺酸、L-瓜胺酸、或L-鳥胺酸乃與終濃度0.1%之蔗糖(VWR,West Chester,PA)一起添加,然後令此混合物於37℃下在振盪水浴中培育30分鐘,接著測定氨的產生量。
為了分析氨,採用來自Diagnostic Chemicals Limited(牛津,CT)的氨分析套件,此特定套件的預定用途係用於活體外定量血漿中氨含量,但其步驟乃經修改以便測定及定量血漿及/或細菌中的氨產量。
下表顯示來自6個使用血鏈球菌在pH 4.0下以上述方式分開試驗的氨產生值,其結果確認由精胺酸去亞胺酶系統產生的中間體可被用來生產氨供細胞存活。
本實施例顯示除了精胺酸以外的鹼性胺基酸在口腔中亦可有效產生氨,因此可增加齒菌斑pH值,從而在用於本發明口腔保健組成物中時可減少早期琺瑯質損害。
Claims (8)
- 一種潔齒劑組成物用於治療早期琺瑯質齲蛀之用途,其中該潔齒劑組成物係包含具有碳酸鈣或磷酸氫鈣二水合物之調配物,該潔齒劑組成物進一步包含呈游離或鹽類形式之精胺酸與有效量之氟化物離子源,其中該精胺酸的含量為1至10重量%;及其中該氟化物離子源係呈氟化物鹽,其存在量係佔組成物總重量之0.01至2重量%。
- 根據申請專利範圍第1項之用途,其進一步包括以定量光導螢光技術(QLF)或電流齲齒監測法(ECM)檢測早期琺瑯質齲蛀。
- 一種潔齒劑組成物用於改善與早期琺瑯質損害相互關聯之定量光導螢光技術(QLF)或電流齲齒監測法(ECM)值之用途,其中該潔齒劑組成物係包含具有碳酸鈣或磷酸氫鈣二水合物之調配物,該潔齒劑組成物進一步包含呈游離或鹽類形式之精胺酸與有效量之氟化物離子源,其中該精胺酸的含量為1至10重量%;及其中該氟化物離子源係呈氟化物鹽,其存在量係佔組成物總重量之0.01至2重量%。
- 一種潔齒劑組成物用於減少既有之早期琺瑯質損害大小之用途,其中該潔齒劑組成物係包含具有碳酸鈣或磷酸氫鈣二水合物之調配物,該潔齒劑組成物進一步包含呈游離或鹽類形式之精胺酸與有效量之氟化 物離子源,其中該精胺酸的含量為1至10重量%;及其中該氟化物離子源係呈氟化物鹽,其存在量係佔組成物總重量之0.01至2重量%。
- 根據申請專利範圍第1至4項中任一項之用途,其亦可有效a.減輕或抑制齲齒的形成,b.減輕或抑制牙齒之去礦物質化作用及增進牙齒之再礦物質化作用,c.減輕牙齒之過敏現象,d.減輕或抑制齒齦炎,e.促進口內潰瘍或傷口的癒合,f.減少產酸細菌的含量,g.增加精胺酸分解性(arginolytic)細菌之相對含量,h.抑制口腔內微生物生物膜生成,i.提高及/或維持齒菌斑pH在糖侵犯後處於至少約pH 5.5的水準,j.減少齒菌斑累積,k.治療、緩和或減輕乾口症,l.美白牙齒,m.促進系統性健康,包括心血管健康,n.減少牙齒腐蝕現象,o.增強牙齒免疫力或保護其以對抗齲蛀因素的細 菌,及/或p.清潔牙齒及口腔。
- 根據申請專利範圍第1至4項中任一項之用途,其中該氟化物離子源係選自氟化亞錫、氟化鈉、氟化鉀、單氟磷酸鈉、氟代矽酸鈉、氟代矽酸銨、胺氟化物、氟化銨、及其組合物。
- 根據申請專利範圍第1至4項中任一項之用途,其中該潔齒劑組成物進一步包含鉀離子源。
- 根據申請專利範圍第7項之用途,其中該鉀離子源鹽係選自硝煙鉀與氯化鉀。
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- 2009-02-06 BR BRPI0906463-0A patent/BRPI0906463B1/pt not_active IP Right Cessation
- 2009-02-06 TW TW098103764A patent/TWI451878B/zh not_active IP Right Cessation
- 2009-02-06 WO PCT/US2009/033296 patent/WO2009100269A2/en active Application Filing
- 2009-02-06 TW TW103115501A patent/TWI566782B/zh not_active IP Right Cessation
- 2009-02-06 AR ARP090100437A patent/AR070591A1/es unknown
- 2009-02-06 CA CA2706355A patent/CA2706355C/en active Active
- 2009-02-06 AU AU2009212325A patent/AU2009212325B2/en active Active
- 2009-02-06 US US12/866,786 patent/US20100330003A1/en not_active Abandoned
- 2009-02-06 JP JP2010544486A patent/JP5624477B2/ja not_active Expired - Fee Related
- 2009-02-06 CN CN201510253098.6A patent/CN104940037A/zh active Pending
- 2009-02-06 MX MX2010004903A patent/MX2010004903A/es active IP Right Grant
- 2009-02-06 EP EP21196031.5A patent/EP3943064A1/en active Pending
- 2009-02-06 EP EP09708641.7A patent/EP2249792A4/en not_active Ceased
- 2009-02-06 RU RU2010137318/15A patent/RU2503442C2/ru active
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2010
- 2010-05-24 ZA ZA2010/03690A patent/ZA201003690B/en unknown
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WO2009100269A2 (en) | 2009-08-13 |
JP2011510093A (ja) | 2011-03-31 |
MX360815B (es) | 2018-11-15 |
CA2706355A1 (en) | 2009-08-13 |
EP2249792A4 (en) | 2014-01-08 |
JP5624477B2 (ja) | 2014-11-12 |
CO6290626A2 (es) | 2011-06-20 |
AU2009212325B2 (en) | 2012-11-08 |
CN104940037A (zh) | 2015-09-30 |
AR070591A1 (es) | 2010-04-21 |
CA2706355C (en) | 2014-11-18 |
TWI451878B (zh) | 2014-09-11 |
ZA201003690B (en) | 2015-08-26 |
WO2009100269A3 (en) | 2009-11-05 |
EP2249792A2 (en) | 2010-11-17 |
TW201000142A (en) | 2010-01-01 |
BRPI0906463A2 (pt) | 2015-07-14 |
US20100330003A1 (en) | 2010-12-30 |
TW201444582A (zh) | 2014-12-01 |
AU2009212325A1 (en) | 2009-08-13 |
CN101938987A (zh) | 2011-01-05 |
MY160687A (en) | 2017-03-15 |
RU2503442C2 (ru) | 2014-01-10 |
RU2010137318A (ru) | 2012-03-20 |
MX2010004903A (es) | 2010-05-27 |
BRPI0906463B1 (pt) | 2021-03-30 |
EP3943064A1 (en) | 2022-01-26 |
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