CN1062463A - 口腔用抗齿垢组合物 - Google Patents
口腔用抗齿垢组合物 Download PDFInfo
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- CN1062463A CN1062463A CN91111742A CN91111742A CN1062463A CN 1062463 A CN1062463 A CN 1062463A CN 91111742 A CN91111742 A CN 91111742A CN 91111742 A CN91111742 A CN 91111742A CN 1062463 A CN1062463 A CN 1062463A
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- China
- Prior art keywords
- oral cavity
- composition
- weight
- approximately
- tooth
- Prior art date
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- 239000000203 mixture Substances 0.000 title claims abstract description 72
- 230000002272 anti-calculus Effects 0.000 title description 3
- 210000000214 mouth Anatomy 0.000 claims abstract description 45
- 239000002253 acid Substances 0.000 claims abstract description 24
- 150000003839 salts Chemical class 0.000 claims abstract description 24
- TVHALOSDPLTTSR-UHFFFAOYSA-H hexasodium;[oxido-[oxido(phosphonatooxy)phosphoryl]oxyphosphoryl] phosphate Chemical class [Na+].[Na+].[Na+].[Na+].[Na+].[Na+].[O-]P([O-])(=O)OP([O-])(=O)OP([O-])(=O)OP([O-])([O-])=O TVHALOSDPLTTSR-UHFFFAOYSA-H 0.000 claims abstract description 13
- 239000000606 toothpaste Substances 0.000 claims abstract description 13
- 229940034610 toothpaste Drugs 0.000 claims abstract description 13
- 210000003296 saliva Anatomy 0.000 claims abstract description 12
- KRHYYFGTRYWZRS-UHFFFAOYSA-M Fluoride anion Chemical compound [F-] KRHYYFGTRYWZRS-UHFFFAOYSA-M 0.000 claims abstract description 11
- 230000007062 hydrolysis Effects 0.000 claims abstract description 10
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- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 21
- -1 alkali metal salt Chemical class 0.000 claims description 20
- 150000001875 compounds Chemical class 0.000 claims description 19
- 239000003795 chemical substances by application Substances 0.000 claims description 13
- FQENQNTWSFEDLI-UHFFFAOYSA-J sodium diphosphate Chemical compound [Na+].[Na+].[Na+].[Na+].[O-]P([O-])(=O)OP([O-])([O-])=O FQENQNTWSFEDLI-UHFFFAOYSA-J 0.000 claims description 12
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- 235000011180 diphosphates Nutrition 0.000 claims description 8
- 238000000034 method Methods 0.000 claims description 8
- RYCLIXPGLDDLTM-UHFFFAOYSA-J tetrapotassium;phosphonato phosphate Chemical compound [K+].[K+].[K+].[K+].[O-]P([O-])(=O)OP([O-])([O-])=O RYCLIXPGLDDLTM-UHFFFAOYSA-J 0.000 claims description 8
- 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 claims description 8
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- UNXRWKVEANCORM-UHFFFAOYSA-I triphosphate(5-) Chemical compound [O-]P([O-])(=O)OP([O-])(=O)OP([O-])([O-])=O UNXRWKVEANCORM-UHFFFAOYSA-I 0.000 claims description 5
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- 229910052588 hydroxylapatite Inorganic materials 0.000 description 12
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 11
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- 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 5
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- PXGOKWXKJXAPGV-UHFFFAOYSA-N Fluorine Chemical compound FF PXGOKWXKJXAPGV-UHFFFAOYSA-N 0.000 description 4
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- XPPKVPWEQAFLFU-UHFFFAOYSA-N diphosphoric acid Chemical group OP(O)(=O)OP(O)(O)=O XPPKVPWEQAFLFU-UHFFFAOYSA-N 0.000 description 4
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- 229910052731 fluorine Inorganic materials 0.000 description 4
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 description 4
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- XGRSAFKZAGGXJV-UHFFFAOYSA-N 3-azaniumyl-3-cyclohexylpropanoate Chemical compound OC(=O)CC(N)C1CCCCC1 XGRSAFKZAGGXJV-UHFFFAOYSA-N 0.000 description 3
- MOMKYJPSVWEWPM-UHFFFAOYSA-N 4-(chloromethyl)-2-(4-methylphenyl)-1,3-thiazole Chemical compound C1=CC(C)=CC=C1C1=NC(CCl)=CS1 MOMKYJPSVWEWPM-UHFFFAOYSA-N 0.000 description 3
- 241001354782 Nitor Species 0.000 description 3
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- XAEFZNCEHLXOMS-UHFFFAOYSA-M potassium benzoate Chemical compound [K+].[O-]C(=O)C1=CC=CC=C1 XAEFZNCEHLXOMS-UHFFFAOYSA-M 0.000 description 1
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- KCXFHTAICRTXLI-UHFFFAOYSA-N propane-1-sulfonic acid Chemical class CCCS(O)(=O)=O KCXFHTAICRTXLI-UHFFFAOYSA-N 0.000 description 1
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- UGTZMIPZNRIWHX-UHFFFAOYSA-K sodium trimetaphosphate Chemical compound [Na+].[Na+].[Na+].[O-]P1(=O)OP([O-])(=O)OP([O-])(=O)O1 UGTZMIPZNRIWHX-UHFFFAOYSA-K 0.000 description 1
- 235000020354 squash Nutrition 0.000 description 1
- ANOBYBYXJXCGBS-UHFFFAOYSA-L stannous fluoride Chemical compound F[Sn]F ANOBYBYXJXCGBS-UHFFFAOYSA-L 0.000 description 1
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- 239000001577 tetrasodium phosphonato phosphate Substances 0.000 description 1
- YUOWTJMRMWQJDA-UHFFFAOYSA-J tin(iv) fluoride Chemical class [F-].[F-].[F-].[F-].[Sn+4] YUOWTJMRMWQJDA-UHFFFAOYSA-J 0.000 description 1
- 210000001519 tissue Anatomy 0.000 description 1
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- 235000019731 tricalcium phosphate Nutrition 0.000 description 1
- YNJBWRMUSHSURL-UHFFFAOYSA-N trichloroacetic acid Chemical compound OC(=O)C(Cl)(Cl)Cl YNJBWRMUSHSURL-UHFFFAOYSA-N 0.000 description 1
- 239000013638 trimer Substances 0.000 description 1
- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical compound [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 description 1
- 235000019801 trisodium phosphate Nutrition 0.000 description 1
- SOBHUZYZLFQYFK-UHFFFAOYSA-K trisodium;hydroxy-[[phosphonatomethyl(phosphonomethyl)amino]methyl]phosphinate Chemical compound [Na+].[Na+].[Na+].OP(O)(=O)CN(CP(O)([O-])=O)CP([O-])([O-])=O SOBHUZYZLFQYFK-UHFFFAOYSA-K 0.000 description 1
- AZJYLVAUMGUUBL-UHFFFAOYSA-A u1qj22mc8e Chemical group [F-].[F-].[F-].[F-].[F-].[F-].[F-].[F-].[F-].[F-].[F-].[F-].[F-].[F-].[F-].[F-].[F-].[F-].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+].[Mg+2].[Mg+2].[Mg+2].[Mg+2].[Mg+2].[Mg+2].[Mg+2].[Mg+2].[Mg+2].[Mg+2].[Mg+2].[Mg+2].[Mg+2].[Mg+2].[Mg+2].[Mg+2].O=[Si]=O.O=[Si]=O.O=[Si]=O.O1[Si](O2)([O-])O[Si]3([O-])O[Si]1([O-])O[Si]2([O-])O3.O1[Si](O2)([O-])O[Si]3([O-])O[Si]1([O-])O[Si]2([O-])O3.O1[Si](O2)([O-])O[Si]3([O-])O[Si]1([O-])O[Si]2([O-])O3.O1[Si](O2)([O-])O[Si]3([O-])O[Si]1([O-])O[Si]2([O-])O3.O1[Si](O2)([O-])O[Si]3([O-])O[Si]1([O-])O[Si]2([O-])O3.O1[Si](O2)([O-])O[Si]3([O-])O[Si]1([O-])O[Si]2([O-])O3 AZJYLVAUMGUUBL-UHFFFAOYSA-A 0.000 description 1
- 238000000214 vapour pressure osmometry Methods 0.000 description 1
- 125000000391 vinyl group Chemical group [H]C([*])=C([H])[H] 0.000 description 1
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- 239000000811 xylitol Substances 0.000 description 1
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- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 description 1
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- GFQYVLUOOAAOGM-UHFFFAOYSA-N zirconium(iv) silicate Chemical compound [Zr+4].[O-][Si]([O-])([O-])[O-] GFQYVLUOOAAOGM-UHFFFAOYSA-N 0.000 description 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/19—Cosmetics or similar toiletry preparations characterised by the composition containing inorganic ingredients
- A61K8/24—Phosphorous; Compounds thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/19—Cosmetics or similar toiletry preparations characterised by the composition containing inorganic ingredients
- A61K8/20—Halogens; Compounds thereof
- A61K8/21—Fluorides; Derivatives thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/72—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
- A61K8/81—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds obtained by reactions involving only carbon-to-carbon unsaturated bonds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
- A61Q11/00—Preparations for care of the teeth, of the oral cavity or of dentures; Dentifrices, e.g. toothpastes; Mouth rinses
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
- A61K2800/80—Process related aspects concerning the preparation of the cosmetic composition or the storage or application thereof
- A61K2800/92—Oral administration
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Abstract
一种口腔用组合物，例如牙膏(包括凝胶和霜
剂)，含漱剂，糖锭剂，口香糖和牙粉，组合物中含有齿
垢抑制量的线型分子脱水聚磷酸盐和作为对抗唾液
中酶对该聚磷酸盐水解的抑制剂的一种合成的聚乙
烯膦酸盐。氟离子源也可存在以进一步抑制对该聚
磷酸盐的酶促水解作用。
Description
本发明涉及含有抗齿垢剂的口腔用组合物。
齿垢是在牙齿上形成的坚硬的矿质化的生成物，有规律地刷牙有助于防止这种沉积物的迅速生成。但即使有规律地刷牙也不足以除去附着在牙齿上的所有齿垢沉积。当磷酸钙结晶开始沉积在牙斑的表皮和细胞外基质上并成为足够密致的敛集在一起的聚集物而且对变形作用有抗阻性时，在牙齿上就会形成齿垢。关于钙和正磷酸盐最终变成称作羟基磷灰石（HAP）的结晶性物质的机理，尚无完全一致的意见。不过一般认为在较高的饱和度即高于临界饱和限度时，结晶性的HAP的前体是无定形的或微晶性的磷酸钙。“无定形磷酸钙”虽然与羟基磷灰石有关，但在原子结晶、颗粒的形态学和化学计量学上不同于羟基磷灰石。无定形的磷酸钙的X-线衍射图，显示典型的无定形物质的宽峰，它缺乏所有结晶性物质（包括HAP）所特有的长程有序特征。因此，有效地干扰HAP结晶形成的药剂显然是有效的抗齿垢药物。关于本发明的抗齿垢药物的抑制齿垢形成的作用机理可能是提高了活化能垒，因而抑阻了无定形磷酸钙前体转变成HAP。研究表明，倘若能阻止HAP结晶生长的化合物在唾液中稳定并对唾液及其成分是惰性的，则它在体外抑阻HAP生长的能力与其在体内阻止钙化的能力有良好的相关性。
对本领域熟悉者皆知，水溶性的六偏磷酸盐，三聚磷酸盐和焦磷酸盐等是钙和镁离子的有效阻断剂、抑制剂、多价螯合剂和/或螯合剂，在体外是HAP形成的有效抑制剂。在1985年5月7日授权的美国专利No4515772由Parran等公开了含有氟离子源和可溶性的焦磷酸二碱金属盐的口腔用抗齿垢组合物并提出权利要求。许多公知的现有技术和在本发明中引用的参考文献都表明了迄今提出的口腔组合物中焦磷酸盐的许多用途和功能。
然而，正如上述专利中部分地承认、并在以后Gaffar等于美国专利4627877（1986年12月9日授权）中以及Gaffar等在1989年2月21日授权的美国专利4806340中证明，线型分子的脱水的聚磷酸（即六偏磷酸盐，三聚磷酸盐，焦磷酸盐等）进入口腔和（或）唾液中，一般会被唾液酶（磷酸酶）明显地水解成正磷酸，它对HAP的形成没有抑制作用。
美国专利4627977和4806340表明使用聚合的多聚羧酸盐及氟离子源可成功地克服掉唾液磷酸酶对线型分子的脱水聚磷酸盐抗齿垢剂的水解作用。这样，聚羧酸盐抑制碱性磷酸酶对焦磷酸的水解;氟离子源抑制酸性磷酸酶和焦磷酸酶对焦磷酸盐的水解。
本发明的目的是用非聚羧酸型聚合物更有效地抑制唾液中酶对抗齿垢的聚磷酸盐药物的作用。
本发明的另一目的是提供一种口腔用组合物，它可抑制无定形的磷酸钙转变成通常与齿垢有关的HAP结晶状结构。
本发明的再一个目的是提供一种抑制齿垢形成的改良方法。
在说明书中还会说明其它的内容和优点。
根据这些内容，本发明涉及一种口腔用组合物，是在口腔用基质中含有抗齿垢有效量的至少一种线型分子脱水聚磷酸盐作为主要的抗齿垢剂，并且含有有效量的对抗唾液中对该药物进行酶水解的抑制剂，大约高达4%的合成阴离子型聚乙烯膦酸盐，它有如下的重复基团：
其平均分子量大约为1000或更大;式中M和M1是氢，碱金属或铵离子，M和M1可以相同或不相同。
这种聚乙烯膦酸盐的分子量是由粘度或光散射法测定的。合成的阴离子型聚乙烯膦酸盐本身作为抗齿垢药以前被Shedlovsky公开于美国专利No3429963。然而该专利未公开这种聚乙烯膦酸盐作为抑制唾液对线型聚磷酸水解作用的应用。
线型分子脱水聚磷酸盐，例如六偏磷酸盐，三聚磷酸盐和焦磷酸盐，皆知还在用作抗齿垢剂，一般是以其完全或部分地被中和的水溶性碱金属（如钾或钠）或铵盐或它们的混合物的形式应用。有代表性的例子包括有六偏磷酸钠，三聚磷酸钠，焦磷酸二酸二钠，焦磷酸一酸三钠和焦磷酸四钠等等;例如线型分子脱水聚磷酸盐可含有大约2-125个磷原子。它们一般以已配制好的口腔用组合物的形式应用，大约重量为0.1-7%，优选为2-6%。前已指出，这些盐类作为抗齿垢剂公开于美国专利No4627977和4806340。
使用焦磷酸盐时，最好用焦磷酸四钾和焦磷酸四钠的混合物，用量以焦磷酸四钾为主。若只用焦磷酸四钠，会有些不溶，使得该口腔用组合物在外观和感觉上显得粗糙。因此，按重量比含有大约4.3-7%的焦磷酸四钾和焦磷酸四钠的混合物，其优选的组合是焦磷酸四钾占主要量，这就会大大减低其粗糙。四钾-四钠盐的优选比例范围大约是由4.3∶2.7到大约6∶1，尤以4.5∶1.5为好。可以根据需要只单独用大约4.3-7%的焦磷酸四钾，或者最多有2.7%的焦磷酸四钠。另一种优选的具体例是用略小于抗齿垢有效量的焦磷酸四钠，例如用大约按重量计的0.1-2%，此时能够全溶。本发明的一个内容也包括有焦磷酸二碱金属盐，例如，其含量（按重量计）根据需要可大约为0.1%到0.4%或者是1.0%。
聚乙烯膦酸盐可以其水溶性酸型或盐型（包括酸式盐）形式存在。盐类包括碱金属盐，最好是钠、钾或铵水溶性盐，聚合物的平均分子量至少是大约1000，有代表性的是大约1000-1000000，更优选的是大约6000-100000。该聚合物可根据已知的方法由乙烯基膦酰氯经自由基聚合作用而生成，聚乙烯膦酸盐使用的抑制唾液对线型分子脱水聚磷酸盐的酶促水解的有效量高达重量计的4%。在组合物中一般用量为大约重量的0.05-4%，通常是0.05-3%，优选为0.05-2%，更优选为0.1-2%（重量计）。含重量至少大约占1%时，有代表性的是用于牙齿用组合物中。表示口腔用组合物一般含有牙科磨料并用于刷牙，例如包括有凝胶和霜剂型的牙膏和牙粉，用量超过4%（重量）可用作增稠和胶凝的目的。
聚乙烯膦酸盐除可抑制唾液中碱性磷酸酶对聚磷酸盐的水解外，氟离子源的存在可以有另一种水解抑制作用，是由于抑制了唾液中的酸性磷酸酶和焦磷酸酶的水解作用。氟离子源最好是存在，它也有减少龋齿形成的作用。
氟离子源即给出氟的化合物，它的存在是作为组合的酶抑制剂，在此领域中已知是抗龋剂，所以在本发明中实际上它也起这种作用。这些化合物可略溶于或完全溶于水。它们具有这样的特征：在水中能够释放出氟离子但不会与该口腔用组合物中其它化合物有不希望的反应。这其中有无机氟盐，如可溶性碱金属盐，碱土金属盐，例如氟化钠，氟化钾，氟化铵，氟化钙，氟化铜类如氟化亚铜，氟化锌，氟化钡，氟硅酸钠，氟硅酸铵，氟锆酸钠，一氟磷酸钠，一氟一和二氟磷酸铝和氟化的焦磷酸钙钠。氟化锡类尤其是碱金属氟化物如氟化钠，碱金属的一氟磷酸盐（MFP），例如MFP钠以及它们的混合物是优选的氟离子源。
提供氟的化合物如果存在时，其用量在某种程度上取决于化合物的类型，溶解度和口腔用组合物的类型，但必须是无毒剂量，一般在组合物中含大约0.005-3.0%。在牙膏制剂中，例如凝胶剂，霜剂，牙膏或牙粉中，能释放出高达约2000ppm（制剂重量）离子的氟的化合物用量被认为是合适的。这类化合物可以用到任何合适的最低量，但优选的用量是足以能释放出大约300-2000ppm的氟离子，更优选的是大约800-1500ppm。有代表性的是在碱金属氟化物和氟化亚锡情况下，该成分的存在量可达到大约2%（重量），优选的范围是大约0.05%到1%（按制剂的重量计）。用一氟磷酸钠时，用量大约为0.1-3%，较有代表性的是大约0.76%。
在诸如含漱剂、糖锭剂和口香糖的口腔用制剂中，当存在有供氟化合物时，有代表性的用量是足以释放出高达500ppm（按重量计）的氟离子，优选量为大约25-300ppm。通常这样的化合物含量大约为0.005-1%（按重量计）。
本发明的某些非常优选的剂型中，口腔用组合物可主要是液体，例如漱口水或冲洗液。这种制剂的基质有代表性的是水-醇混合物，按照需要可包含下述的湿润剂。水与醇的重量比一般在约1∶1至20∶1的范围，优选的大约为2∶1-10∶1，更优选的是大约4∶1-6∶1。这种制剂的水-醇混合物总量有代表性的范围是大约制剂重量的70%到99.9%。
本发明的这种液体或其它制剂的pH一般在大约4.5-9的范围，有代表性的是在大约5.5-8。优选的pH范围是大约6-8.0。值得注意的是本发明的组合物用于口腔时的pH低于5时，没有明显的脱钙或损伤牙釉的作用。pH可用酸（如柠檬酸或苯甲酸）、或碱（如氢氧化钠）或缓冲液调整（如柠檬酸钠，苯甲酸钠，碳酸氢钠，或磷酸钠，磷酸氢二钠，磷酸二氢钠等）。
在本发明的另一些所希望的剂型中，口腔用组合物可以主要是固体或膏剂，例如牙粉，牙科用片剂或牙膏（包括凝胶或牙科用霜剂）。这类固体或膏状口腔用制剂的基质一般含有牙科用的水不溶性的磨光材料。磨光材料的实例是水不溶性的偏磷酸钠，偏磷酸钾;磷酸三钙，二水合的磷酸二钙，无水磷酸二钙，焦磷酸钙，正磷酸镁，磷酸三镁，碳酸钙，硅酸铝，硅酸锆，含硅的磨光剂，膨润土和它们的混合物。其它适宜的磨光材料包括有美国专利No3070510（1962年12月15日）中叙述的颗粒状热固定树脂，例如三聚氰胺-、酚性-和尿素-甲醛，交联聚环氧化物和聚酯类。优选的磨光材料包括有结晶性氧化硅颗粒大小最大为大约5微米，平均颗粒大小为大约1.1微米，表面积高达大约50000cm2/g，还有硅胶，胶体氧化硅和复合的无定形的铝硅酸碱金属盐。
当使用澄明的、半透明的或不透明的凝胶时，特别有用的是含硅的胶体氧化硅磨光剂，例如以商品名SYLOID（如Syloid72和Sy-loid74）、ZEODENT（如Zeodent113和Zeodent115）和SANTOCEL（如Santocel100）出售的氧化硅，以及碱金属铝硅酸盐复合物或含结合型氧化铝的氧化硅，例如Zeo49A或Zeo49B，因为它们与通常用于牙科制剂的水和（或）湿润剂有相近的折光率。
许多所谓“水不溶性”的磨光材料是阴离子型的，但也包括有少数可溶性物质。如不溶性的偏磷酸钠可按《Thorpe's应用化用辞典》第9卷，第4版，510-511页中所述的适宜方法生成。不溶性的偏磷酸钠的产品称作马德里盐和古乐尔盐，是另外的适宜的材料。这些偏磷酸盐在水中只有微小的溶解度，因而一般称作不溶性的偏磷酸盐（IMP）。有很少量的可溶性磷酸盐作为杂质存于其中，一般最高可达重量的4%。可溶性的磷酸盐包括有可溶性的三偏磷酸钠，如若需要，可用水洗以除去或减少其含量。不溶性的偏磷酸碱金属盐有代表性地是使用粉状制剂，其颗粒大小规定大于大约37微米的物质不得多于大约1%。
在固体和膏状组合物中的磨光剂一般含量为重量浓度的大约10%到99%。优选的在牙膏中其含量范围大约是10%-75%，牙粉中大约是70%-99%。
牙膏中的液体基质由水和湿润剂构成，其含量范围典型的是制剂重量的大约10%-90%。可做范例的适宜的湿润剂载体例如有甘油，丙二醇，山梨醇，聚丙二醇和（或）聚乙二醇（例如400-600）。水、甘油和山梨醇的液体混合物也是有利的。对澄明的凝胶，折光率是重要的考虑因素，最好用大约3-30%（重量）的水，0-大约80%重量）的甘油和大约20-80%（重量）的山梨醇。
牙膏（包括霜剂和凝胶剂）典型地含有天然或合成的增稠剂或胶凝剂，比例为大约0.1-10%，优选为大约0.5-5%（重量）。适宜的增稠剂是合成的水辉石，一种合成的胶体状镁碱金属硅酸盐络合陶土，例如由Laporte有限公司以Laponite（例如CP，SP2002，D）商品名出售的。LaponiteD经分析表明大约按重量计：58.00%SiO2，25.40%MgO，3.05%Na2O，0.98%Li2O及一些水分和痕量金属。它的实比重是2.53，表观堆积密度（于8%湿度时g/ml）为1.0。
其它适宜的胶凝剂包括有角叉菜胶，西黄蓍胶，淀粉，聚乙烯吡咯烷酮，羟乙基丙基纤维素，羟丁基甲基纤维素，羟丙基甲基纤维素，羟乙基纤维素（例如商品Natrosol），羧甲基纤维素钠，苍耳烷（Xanthan）和胶体二氧化硅，例如细磨的Syloid（例如244）。如前所提及，合成的阴离子型聚乙烯膦酸盐也有增稠或胶凝性质。胶体二氧化硅，例如细磨的Syloid（如244）也是适宜的增稠剂。
口腔用制剂常规上是以适宜的有标记的包装方式进行出售或发送。含漱剂的瓶上要贴标签，大体对它作为漱口水及其用法进行说明;牙膏、霜剂或凝胶剂通常放于可折迭的管中，典型的是用铅或塑料衬里的铝管，或用其它挤压式的、泵推或压力型的分散器，计量地放出内容物，要对作为牙膏、凝胶剂或牙科用霜剂的产品用标签作大体说明。
本发明的组合物使用有机表面活性剂以增加其预防作用，并有助于抗齿垢剂完全彻底地分散在全部口腔中，而且使即时组合物作为美容品更易被人接受。有机表面活性物质优选为阴离子型、非离子型和两性物质，最好是用洗涤剂，可使本组合物有清洁和发泡沫性质。适宜的阴离子表面活性剂的实例是高级脂肪酸单甘油酯的单硫酸的水溶性盐，例如氢化的椰油脂肪酸单甘油酯的单硫酸化的钠盐，高级烷基磺乙酸盐，1，2-二羟基丙磺酸盐的高级脂肪酸酯，以及主要是低级脂族氨基羧酸的饱和高级脂肪酰胺化合物，例如在脂肪酸，烷基或酰基上有12-16个碳原子的化合物等。后面提及的酰胺的实例是N-月桂酰肌氨酸以及N-月桂酰，N-肉豆蔻酰或N-棕榈酰肌氨酸的钠盐、钾盐和乙醇胺盐，它们基本上不应含有肥皂或类似的高级脂肪酸类物质。本发明的口腔用组合物中用这些肌氨酸盐化合物有特殊的优点，因为这些物质除能降低牙釉在酸性溶液中的溶解度外，还对抑制口腔中酸性物质的生成有长效和显效作用，酸性物质是碳水化合物分解而来的。水溶性的非离子型表面活性剂的实例是，环氧乙烷与具有长疏水链（如大约12-20个碳原子的脂肪链）的各种有反应活性的含氢化合物的缩合产物，这些缩合产物（“ethoxamers”）含有亲水的聚氧乙烯片段，例如聚（环氧乙烷）与脂肪酸，脂肪醇，脂肪酰胺，多羟基醇（如脱水山梨醇单硬脂酸酯）和聚环氧丙烷（如嵌段共聚物Pluronic物质）的缩合产物。
本发明的口腔用制剂可加入其它各种物质，如增白剂，防腐剂，聚硅氧烷，叶绿素化合物，其它抗齿垢剂和（或）含氨基物质，如尿素，磷酸二铵及它们的混合物。当在制剂中存在这些辅料时，加入量不要对所需的性质和特性有明显不利的影响。若有相当量的锌、镁和其它金属盐和物质会与本发明的有效成分发生络合作用，需加以避免。
各种适宜的增香或生甜物质也可以使用。适宜香料成分的实例有香料油类，例如留兰香、薄荷、冬青、黄樟、丁香、鼠尾草、桉树、甘牛至草、肉桂;柠檬，柑桔油和水杨酸甲酯。适宜的生甜剂包括蔗糖、乳糖、麦芽糖，山梨醇、木糖醇，环己烷氨基磺酸钠，紫苏亭，APM（门冬酰苯基丙氨酸甲酯）和糖精等，香料和生甜剂在制剂中总共可占大约0.1%到5%或更多。
本发明优选实际应用中的口腔用组合物，如含有前述聚磷酸盐和抑制剂组合的能有效地抑制牙齿表面齿垢的有效量的含漱水或牙膏，最好是按规定用于牙釉上，例如，每隔一天或隔二天或最好是每天1-3次，pH大约是4.5-9，一般大约为5.5-8，最好是大约6-8，至少用2周到8周，或更长直到终生使用。
本发明的组合物可制成糖锭剂、口香糖或其它产品，例如搅拌混到热胶基中或覆盖在胶基的外表面上，有代表性的胶基可提及耶路顿胶，橡胶，聚乙酸乙烯酯树脂等，按需要加入常规的增塑剂或软化剂，糖或其它生甜剂或碳水化合物，例如葡萄糖，山梨醇等。
下面的实施例对本发明的特征作进一步说明，但要知道本发明并不只限于此。除非另外指明这里以及权利要求书中提到的所有的量和比例都是以重量计，温度是摄氏度。
实施例1
PVPA和PVMEMA对碱性磷酸酶的抑制作用
反应混合物中含0.05单位的大肠杆菌碱性磷酸酶与100mMTris-HCl缓冲液（pH8.0），总体积为0.5ml，最后使焦磷酸四钠的浓度为0.5mM。加入焦磷酸盐后于37℃进行不同时间反应。聚乙烯膦酸盐分子量10000（PVPA），多聚羧酸，聚乙烯基甲基醚/马来酸酐，GAF公司出售称作Gantrez S-97（PVME/ME），报导其分子量大约为70000（用蒸气压渗透压测定法;但用凝胶渗透层析法测定的分子量大约为1090000）。在加到反应混合物中（0.5%）之前，将pH预调到8.0。加入20%冷的三氯乙酸0.5ml以中止反应。释放出的正磷酸盐量列于下面表1内，其计算方法如下：
每摩尔被水解的焦磷酸离子（ppi），释放出2摩尔的正磷酸离子，按如下方程计算：
按重量计，被水解的ppi量（g)= (P2O7的分子量)/(2×PO4的分子量) ×生成的PO4量（g)
表1 被水解的平均焦磷酸盐（μg/ml）
反应时间（分钟） 对照（无抑制剂） +PVME/MA +PVPA
4.0 20.53 7.94 4.62
8.0 27.04 7.92 5.28
数据表明，PVPA对碱性磷酸酶的抑制程度大于PVME/MA。
实施例2
体内抗齿垢作用
用大鼠齿垢模型测定水和指定的溶液，结果列于表2。
表2
处理组 平均齿垢表面 变化%
严重程度指数±标准误差
A.水 61.8（±10.4）
B.6.2%K4P2O7， 27.8（±8.6） -55%
1%PVPA
+0.24%NaF
显然，处理组B对体内齿垢的生成有高度的抑制作用。
大鼠齿垢研究按如下进行：
21日龄雄性刚断奶的Sprague-Dawley大鼠随机分成处理组，每组12只鼠，以致齿垢饲料（RC-16）喂养大鼠，在试验全过程中，可随意饮用去离子水。在实验处理开始之前，所有动物都接种S.mutans（6715）和A.viscosus（OMZ-105-NYL）悬浮液以刺激齿斑和齿垢的生成。大鼠除周末外，每天一次用自动移液器给0.2ml溶液。
本实验用盲法进行，实验组编码并对参与实验者是未知的。处理21天后处死大鼠。取出上下颌，按常规方法（SPI TOX626）打分。在处理前和处死前称体重。用在“钙化组织研究”第11卷，10-22页（1973）中报导的Briner和Francis法评价每只大鼠的上颌和下颌四分体上的齿垢，这是齿垢表面严重程度指数（CSSI）。数据进行统计学分析，用ANOVA加Student-Newman-Keuls测验。
实施例3
牙膏的制备如下：
| 部分 | |
| A B C D | |
| 去离子水甘油山梨醇（70％）聚乙二醇600焦磷酸四钠焦磷酸四钾三聚磷酸钠六偏磷酸钠苍耳烷（Xanthano羧乙基纤维素钠氧化硅增稠剂PVPA一氟磷酸钠氟化钠 | 42.42 27.46 26.14 20.1225.00 10.00 10.00 25.00- 25.00 25.00 -- 3.00 3.00 -2.0 1.50 - -- 4.50 - -- - 6.00 -- - - 6.001.00 - - 1.00- 1.20 1.20 -3.00 - - 3.000.50 0.50 1.00 0.500.76 - 0.76 0.76- 0.24 - - |
实施例3（续）
| 部分 | |
| A B C D | |
| 含氧化硅的结合性氧化铝（Zeo 49B)胶体氧化硅（Zeodentll3)焦磷酸钙苯甲酸钠二氧化钛糖精钠香料十二烷基硫酸钠氢氧化钠（50％） | 21.50 - - -- 23.00 23.00 -- - - 40.000.50 0.50 0.50 0.500.50 0.30 0.30 0.300.30 0.30 0.30 0.301.00 1.00 1.00 1.001.20 1.20 1.20 1.200.32 0.30 0.60 0.32 |
实施例4
含漱剂的制备如下：
部分
A B
乙醇 10.00 10.00
甘油 10.00 10.00
糖精钠 0.03 0.03
嵌段共聚物Pluronic 2.00 2.00
F108
焦磷酸四钠 2.00 1.00
焦磷酸四钾 - 1.00
焦磷酸二钠 - 0.10
PVPA 0.05 0.05
一氟磷酸钠 0.15 0.15
香料 0.40 0.40
水 适量到100.00 适量到100.00
实施例5
糖锭剂
糖 78-98
玉米浆 1-20
香料油 0.1-1.0
片剂润滑剂 0.1-5
多聚磷酸盐 0.1-5
PVPA 0.05-3
NaF 0.01-0.05
水 0.01-0.2
实施例6
口香糖
胶基 10to50
结合剂 3to10
填充剂 5to80
（山梨醇，甘露醇或两
者的组合）
人工生甜剂 0.1to5
多聚磷酸盐 0.1to5
PVPA 0.1to1.0
NaF 0.01-0.05
香料 0.1to5
关于某些优选的具体实例本发明已作叙述，但应了解到本专业领域的技术人员对它进行改动或变换仍包括在本申请和权利要求书的范围内。
Claims (21)
1、一种抑制无定形的磷酸钙转变成通常与齿垢有关的HAP结晶结构的口腔用组合物，它包含有的口腔用基质中抗齿垢有效量的至少一种线型分子脱水的聚磷酸盐作为主要抗齿垢剂，以及有效量的抑制唾液中酶对上述药物水解的含量最高到大约4%的合成阴离子型聚乙烯膦酸盐，它具有如下重复单位：
其平均分子量大约为1000或更大；式中M和M1相同或不同，为氢，碱金属或铵。
2、按照权利要求1的口腔用组合物，其中聚乙烯膦酸盐的存在量按重量计大约为0.05-4%。
3、按照权利要求1或2的口腔用组合物，其中聚乙烯膦酸盐的分子量大约为1000-1000000。
4、按照权利要求1或2的口腔用组合物，其中聚乙烯膦酸盐的分子量大约为6000-100000。
5、按照权利要求3的口腔用组合物，其中聚乙烯膦酸盐的存在量按重量计大约为0.05-3%。
6、按照权利要求5的口腔用组合物，其中聚乙烯膦酸盐用量按重量计大约为0.1-2%。
7、按照权利要求1或2的口腔用组合物，其中聚磷酸盐的存在量按重量计大约为0.1-70%。
8、按照权利要求1或2的口腔用组合物，其中聚磷酸盐由下述中选择：六偏磷酸盐，三聚磷酸盐，焦磷酸盐及它们的混合物。
9、按照权利要求1或2的口腔用组合物，其中聚磷酸盐由下述中选择：焦磷酸四钠，焦磷酸四钾及它们的混合物。
10、按照权利要求1或2的口腔用组合物，其中聚磷酸盐的存在量按重量计大约是4.3-7%，是焦磷酸四钾和焦磷酸四钠的混合物，焦磷酸四钾的用量比焦磷酸四钠的量多。
11、按照权利要求1的口腔用组合物，其中聚磷酸盐是焦磷酸四钠，其存在量按重量计大约是0.1-2%。
12、按照权利要求1或2的口腔用组合物，其中聚磷酸盐是三聚磷酸盐。
13、按照权利要求1或2的口腔用组合物，其中聚磷酸盐是六偏磷酸盐。
14、按照权利要求1或2的口腔用组合物，其中基质是由大约10%-90%（重量）的水和湿润剂构成的液体基质和大约0.1-10%（重量）的胶凝剂所构成，其中含有大约10-75%（重量）的牙科用水不溶性磨光剂;该口腔用组合物是牙膏。
15、按照权利要求14的口腔用组合物，其中磨光剂是含硅的磨光剂。
16、按照权利要求1或2的口腔用组合物，其中基质是按重量计大约70-99.9%的水-醇混合物，水与醇的重量比是由大约1∶1到大约20∶1;该口腔用组合物是含漱剂。
17、按照权利要求1或2的口腔用组合物，其中氟离子源的存在量是足以能提供出大约25-2000ppm的无毒量的氟离子，作为抗龋齿剂以及进一步抑制酶对所说的主要抗齿垢剂的水解作用。
18、按照权利要求17的口腔用组合物，其中氟离子源由下述中选择：碱金属氟化物和一氟磷酸碱金属盐。
19、按照权利要求18的口腔用组合物，其中氟离子源是氟化钠。
20、一种抑制牙齿齿垢的方法，它包括将权利要求1或2的口腔用抑制齿垢量的组合物用于牙齿上，该口腔用组合物的pH大约是4.5-9。
21、一种抑制牙齿齿垢的方法，它包括将权利要求17的口腔用抑制齿垢量的组合物用于牙齿上，该口腔用组合物的pH大约是4.5-9。
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| US07/631,302 US5094844A (en) | 1990-12-20 | 1990-12-20 | Anticalculus oral composition |
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| US20070041914A1 (en) * | 2005-08-17 | 2007-02-22 | Colgate-Palmolive Company | Inhibition of bacterial deposition on oral surfaces |
| KR100739996B1 (ko) * | 2005-09-30 | 2007-07-16 | 장정만 | 고 순도 규사를 이용한 액체치약 조성물과 제조방법 |
| US10123953B2 (en) | 2012-06-21 | 2018-11-13 | The Procter & Gamble Company | Reduction of tooth staining derived from cationic antimicrobials |
| MX2021005301A (es) | 2018-11-07 | 2021-06-23 | Procter & Gamble | Composiciones para el cuidado bucal que comprenden polifosfatos de longitud media. |
| US11191709B2 (en) | 2019-04-26 | 2021-12-07 | The Procter & Gamble Company | Reduction of tooth staining derived from cationic antimicrobials |
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| US3429963A (en) * | 1964-06-09 | 1969-02-25 | Colgate Palmolive Co | Dental preparation containing polymeric polyelectrolyte |
| ZA717486B (en) * | 1970-11-19 | 1973-06-27 | Colgate Palmolive Co | Treatment of teeth |
| US4138477A (en) * | 1976-05-28 | 1979-02-06 | Colgate Palmolive Company | Composition to control mouth odor |
| US4427652A (en) * | 1980-12-31 | 1984-01-24 | Colgate-Palmolive Company | Antigingivitis composition |
| US4816245A (en) * | 1983-12-28 | 1989-03-28 | Colgate-Palmolive Company | Antiplaque/antigingivitis method using certain polyphosphonic acids |
| US4921692A (en) * | 1986-12-08 | 1990-05-01 | Colgate-Palmolive Company | Anticalculus oral composition |
| US4877603A (en) * | 1987-12-18 | 1989-10-31 | The Procter & Gamble Company | Oral compositions |
| US4915937A (en) * | 1988-08-01 | 1990-04-10 | The Bf Goodrich Company | Dental antihydrolysis agent |
| GB2224204B (en) * | 1988-10-25 | 1992-06-03 | Colgate Palmolive Co | Dental composition comprising polyvinyl phosphonic acid |
| SE507731C2 (sv) * | 1988-12-29 | 1998-07-06 | Colgate Palmolive Co | Antibakteriell oral antiplaquekomposition |
-
1990
- 1990-12-20 US US07/631,302 patent/US5094844A/en not_active Expired - Lifetime
-
1991
- 1991-12-03 AU AU88814/91A patent/AU649088B2/en not_active Ceased
- 1991-12-04 ZA ZA919580A patent/ZA919580B/xx unknown
- 1991-12-07 MY MYPI91002270A patent/MY107462A/en unknown
- 1991-12-09 NZ NZ240914A patent/NZ240914A/xx not_active IP Right Cessation
- 1991-12-16 PT PT99817A patent/PT99817B/pt not_active IP Right Cessation
- 1991-12-16 CA CA002057697A patent/CA2057697C/en not_active Expired - Fee Related
- 1991-12-18 MX MX9102665A patent/MX9102665A/es unknown
- 1991-12-19 BR BR919105532A patent/BR9105532A/pt not_active Application Discontinuation
- 1991-12-19 DE DE69117034T patent/DE69117034T2/de not_active Expired - Fee Related
- 1991-12-19 EP EP91311818A patent/EP0492997B1/en not_active Expired - Lifetime
- 1991-12-19 AT AT91311818T patent/ATE133853T1/de not_active IP Right Cessation
- 1991-12-19 HU HU914051A patent/HU212441B/hu not_active IP Right Cessation
- 1991-12-19 RU SU5010396/14A patent/RU2092162C1/ru not_active IP Right Cessation
- 1991-12-19 SG SG1996004822A patent/SG48983A1/en unknown
- 1991-12-19 YU YU195791A patent/YU195791A/sh unknown
- 1991-12-19 RO RO148986A patent/RO110674B1/ro unknown
- 1991-12-19 DK DK91311818.8T patent/DK0492997T3/da active
- 1991-12-19 NO NO915038A patent/NO180433C/no unknown
- 1991-12-19 KR KR1019910023761A patent/KR100221157B1/ko not_active IP Right Cessation
- 1991-12-19 GR GR910100506A patent/GR1001273B/el not_active IP Right Cessation
- 1991-12-19 PL PL91292865A patent/PL167491B1/pl not_active IP Right Cessation
- 1991-12-20 SK SK3994-91A patent/SK279232B6/sk unknown
- 1991-12-20 CN CN91111742A patent/CN1062463A/zh active Pending
- 1991-12-20 CZ CS913994A patent/CZ284259B6/cs not_active IP Right Cessation
- 1991-12-20 JP JP33867791A patent/JP3643382B2/ja not_active Expired - Fee Related
- 1991-12-20 FI FI916053A patent/FI916053A/fi not_active Application Discontinuation
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1992
- 1992-01-22 TW TW081100434A patent/TW209835B/zh active
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1997
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107252396A (zh) * | 2010-11-12 | 2017-10-17 | 高露洁-棕榄公司 | 口腔护理产品及其使用和制备方法 |
| CN110559211A (zh) * | 2019-10-10 | 2019-12-13 | 重庆登康口腔护理用品股份有限公司 | 一种抑菌防龋组合物及其制备方法和应用 |
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