CN101909596A - 用于牙齿组织再矿化的凝胶 - Google Patents
用于牙齿组织再矿化的凝胶 Download PDFInfo
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- CN101909596A CN101909596A CN2009801014649A CN200980101464A CN101909596A CN 101909596 A CN101909596 A CN 101909596A CN 2009801014649 A CN2009801014649 A CN 2009801014649A CN 200980101464 A CN200980101464 A CN 200980101464A CN 101909596 A CN101909596 A CN 101909596A
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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
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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
- A61K8/02—Cosmetics or similar toiletry preparations characterised by special physical form
- A61K8/04—Dispersions; Emulsions
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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
- A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
- A61K8/33—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
- A61K8/34—Alcohols
- A61K8/345—Alcohols containing more than one hydroxy group
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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
- A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
- A61K8/55—Phosphorus compounds
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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
- A61K8/72—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
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- A—HUMAN NECESSITIES
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- 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
- A61K8/73—Polysaccharides
- A61K8/737—Galactomannans, e.g. guar; Derivatives thereof
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- A—HUMAN NECESSITIES
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/02—Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
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- 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
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- Life Sciences & Earth Sciences (AREA)
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- Inorganic Chemistry (AREA)
- Oral & Maxillofacial Surgery (AREA)
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Abstract
本发明的技术成果通过含有易获得的组分的有效再矿化制剂的实际使用来实现，所述有效再矿化制剂可以被患者在无需任何帮助的情况下使用，用于龋齿预防、非龋性病症治疗、牙齿过敏治疗以及牙齿视觉外观(颜色和光泽)的改善。所提出的问题可以通过制备凝胶来解决，该凝胶包含作为活性组分的木糖醇2-25wt.％、甘油磷酸钙0.1-3.0wt.％、镁离子源0.01-0.50wt.％和瓜尔豆胶0.03-0.30wt.％，以及同样用于牙齿凝胶制备的惰性组分，本文使用氯化镁、硫酸镁或硝酸镁作为镁离子源。
Description
应用领域
本发明涉及口腔医学和香料工业，具体地涉及用于牙齿组织再矿化的凝胶。
发明背景
已知为牙齿组织再矿化设计的含有葡萄糖酸钙、纤维素胶、二甲亚砜、呋喃西林、甘油和水的制剂(SUA3第1774870号，IPC 5 A61K 6/02，1992)。
所制备的制剂被干燥，并且然后以弹性膜的形式用于牙齿的受损害部分的涂敷，牙齿的受损害部位的表面之前已经被清洁以除去牙齿沉积物。所涂敷的膜被唾液润湿，转化成凝胶，并且逐步分解60-120分钟，从而提供再矿化物质的长时间释放及其对固体牙齿组织的扩展的效果。膜用具的必要性和溶解的持续时间使患者难以在家中使用所述制剂。
发明内容
本发明的技术成果通过含有易获得的组分的有效再矿化制剂的实际使用来实现，所述有效再矿化制剂可以被患者在无需任何帮助的情况下使用，用于龋齿预防、非龋性病症治疗、牙齿过敏治疗以及牙齿视觉外观(颜色和光泽)的改善。
该技术成果可以通过用于牙齿组织再矿化的凝胶得到加强，所述凝胶包含作为活性组分的木糖醇2-25wt.％、甘油磷酸钙0.1-3.0wt.％、镁离子源0.01-0.50wt.％和瓜尔豆胶0.03-0.30wt.％，以及同样用于牙齿凝胶制备的惰性组分。
使用完全或部分离解为离子的镁盐作为镁离子源，具体地使用以下盐的其中之一：氯化镁、硫酸镁或硝酸镁。
木糖醇在所述制剂中具有几种功能：作为增甜剂，木糖醇改进制剂的味觉性质；作为多元醇，木糖醇起保水组分的作用。木糖醇的涉及链球菌的生物化学新陈代谢的机制的特征在于致死合成，导致减弱的病原微生物活性和改善的口腔器官条件。木糖醇促进生物活性组分向牙齿组织的转变。(Tanzer J.M./Xylitol chewing gum and dental caries(木糖醇口香糖和龋齿).//Int.Dent.J.，1995年2月；45(1 Suppl 1)：65-76)。
甘油磷酸钙是对牙齿和牙周膜组织的活性磷和钙供给的来源，并且促进珐琅质/唾液系统中的矿化的生理过程。甘油磷酸钙改善制剂的防龋齿效果以及非龋齿病症中的再矿化。此外，甘油磷酸钙增强这样的组织中的合成代谢过程，该组织对于牙齿疾病预防来说是重要的。
镁是牙齿的结构组成部分。镁作为微量元素被结合进复合制剂中，微量元素是磷酸酶的辅因子。在这些酶的影响下，提高了磷酸酯向固体牙齿组织中的结合。
向制剂中加入含有矿物添加剂的瓜尔豆胶以用于提高牙齿膜的稠度，并且也用于提高该膜向固体组织的附着。瓜尔豆胶粉末由瓜尔豆(Cyamopsis tetraganoloba)种子的胚乳生产，瓜尔豆是一种植物，被称为瓜尔豆(guar)。根据瓜尔豆胶的化学成分，瓜尔豆胶是植物成因的非离子性多糖(non-ionique polysaccaride)。分子结构是直链的，由半乳糖和甘露糖形成，因此瓜尔豆胶是半乳糖甘露聚糖，具有约2∶1的甘露糖与半乳糖比率。如果瓜尔豆胶被溶解于冷水或热水中，那么其形成高黏度凝胶(由Whistler R.L.和BeMiller J.N.编辑的Industrial Gums(工业胶)，第三版；Academic Press 1993)。
优选地，发明实现要求凝胶包含作为惰性组分的以下组分，wt.％
甘油 2-20
山梨糖醇 2-20
羟乙基纤维素 1.5-3.0
非离子表面活性组分 0.2-1.5
防腐剂 0.01-0.30
香精 0.02-0.50
饮用水 余量
在凝胶制备过程中，可以利用聚山梨醇酯-20、PEG-40氢化蓖麻油(聚氧化乙烯(40)氢化蓖麻油)、烷基多苷作为非离子表面活性组分。
可以使用例如尼泊金甲酯、尼泊金丙酯、或它们的钠盐、以及苯氧乙醇、苯甲酸(benzole acid)、苯甲酸钠、山梨酸钾、百里酚的组分作为防腐剂。
因此，发明了以凝胶的形式的高效率制剂，所述制剂在一系列2-4周测试(取决于临床情况)中每天清理软牙垢之后用于口腔中，用于龋齿预防、非龋性病症治疗、牙齿过敏治疗以及用于牙齿视觉外观(颜色和光泽)的改善。
发明的实现
发明实现的可能性通过具体制剂的实施例确定。各组分的比率在表1中示出。
该制剂以下列方式制备。
在计量斗中将所需量的水加热直至75-80℃，然后将加热过的水供入混合器中。
加入尼泊金甲酯、氯化镁(或者在实施例3和实施例4中为硫酸镁)、木糖醇、山梨糖醇。
混合20分钟直到形成透明溶液。
在甘油中分别地制备羟乙基纤维素、瓜尔豆胶和甘油磷酸钙的悬浮液。
冷却水溶液至50-55℃，加入悬浮液并且混合30分钟直到形成均质体(homogeneous mass)。
分别地加热聚山梨醇酯-20(或者在实施例1和实施例4中为PEG-40氢化蓖麻油)至45-50℃。加入香精并且搅拌10分钟直到形成均质混合物。
将该混合物加入之前获得的均质体并且混合20-30分钟直到形成均质凝胶。
在混合过程中冷却所获得的凝胶至20-25℃并且将其包装于由聚合物材料制造的管中。
表1
制造方法和操作顺序在所有制剂实施例中是相同的，并且根据专利权利要求，对于本发明覆盖的其他情况，这些制造方法和操作顺序也是如此。
涂敷技术。
涂敷可以以两种方式进行：
-使用标准牙托(tray)
-不使用牙托，使用棉签或不使用棉签
对于强烈矿化(intense mineralization)(在急性龋齿、腐蚀和其他非龋性病症治疗的情况中)，使用刷或任何其他手段将凝胶的薄平层涂敷在牙齿上并且然后用牙托覆盖。涂敷花费12-15分钟，然后吐出过量的凝胶。在涂敷之后，患者在一小时内不应进食或饮用，也不应漱口，以提供扩展的效果。
不使用牙托的牙齿涂敷以下列方式进行：使用棉签隔离面颊、唇和舌头的软组织，在牙齿上涂敷制剂的薄平层7-12分钟。在涂敷之后吐出棉签和过量的凝胶。不建议在一小时内进食或饮用以及漱口。
制剂的施用的实施例
实施例1
患者X，38岁，抱怨过敏和不满意的美容性牙齿外观。
在2005年4月4日的第一次检查期间，确定：
HI(卫生指数)*)-1.95分
ITHP*)-54％
ITHI*)-2.8分
*)-Yu.A.Fedorov，V.A.Drozhzhina，Clinical course，diagnostics and treatment of noncarious lesions of teeth(牙齿非龋性损伤的临床发病历程、诊断和治疗).Novoe v stomatologii，No.10(60)，1997，特刊.)。
根据Vita尺度的牙齿颜色-C3，光泽不足
给予患者一个四周的疗程的使用隔离棉签的制剂涂敷。
下一次检查在4周之后的2005年5月3日进行。没有抱怨。
客观资料：
HI(卫生指数)-1.57分
ITHP-6.2％
ITHI-0
根据Vita尺度的牙齿颜色-C1，光泽变得更强烈。
实施例2
患者Y，28岁，在2005年6月9日抱怨牙齿过敏、部分缺少光泽和不满意的牙齿颜色。
客观资料：
HI-2.17分
ITHP-62.5％
ITHI-2.1分
不能测定牙齿颜色，但是注意到黄色调较白色调占优势。
推荐使用标准牙托在3周内每日进行制剂涂敷。
下一次检查在3周之后的2005年7月8日进行。没有抱怨，患者注意到在吃非常冷的食物(冰淇淋)时可忽略的反应。
客观数据
HI(卫生指数)-1.5分
ITHP-9.3％
ITHI-1.1分
从视觉上注意到牙齿变白，牙齿光泽变得更强烈，使患者满足。
实施例3
患者Z，36岁，抱怨在家中漂白过程之后的牙齿过敏。在2005年8月2日的第一次检查期间，测定：
根据Vita尺度的牙齿颜色-C2，光泽不足
HI-1.9分
ITHI-2.1分
ITHP-62.5％
推荐使用标准牙托在4周内每日进行制剂涂敷。下一次检查在4周之后的2005年8月31日进行。没有抱怨。
根据Vita尺度的牙齿颜色-A1，牙齿光泽变得更强烈。
ITHP，ITHI-0
HI-1.2分
在对再矿化凝胶效果的观察之后汇总的结果已经与用在现今的实践中为了这些目的所更频繁使用的含氟牙膏和凝胶进行的实验中获得的数据相互关联。
主要组(再矿化凝胶)
关联组(含氟牙膏和凝胶)
比较结果在表2给出。
所检查的患者的超过89.7％已经肯定地评价了牙齿颜色(牙齿已经变得更白)并且珐琅质光泽已经改善，这揭示该制剂的活跃的再矿化效果。
表2
Claims (4)
1.用于牙齿组织再矿化的凝胶，所述凝胶包含作为活性组分的木糖醇2-25wt.％、甘油磷酸钙0.1-3.0wt.％、镁离子源0.01-0.50wt.％和瓜尔豆胶0.03-0.30wt.％，以及同样用于牙齿凝胶制备的惰性组分，本文使用选自包括氯化镁、硫酸镁或硝酸镁的组的组分之一作为镁离子源。
2.根据权利要求1所述的凝胶，其特征在于含有作为惰性组分的以下组分，wt.％：
甘油 2-20
山梨糖醇 2-20
羟乙基纤维素 1.5-3.0
非离子表面活性组分 0.2-1.5
防腐剂 0.01-0.30
香精 0.02-0.50
饮用水 余量
3.根据权利要求2所述的凝胶，其特征在于含有作为非离子表面活性组分的选自以下的组的组分之一：聚山梨醇酯-20、PEG-40氢化蓖麻油、烷基多苷。
4.根据权利要求2所述的凝胶，其特征在于含有作为防腐剂的选自以下的组的组分之一：尼泊金甲酯、尼泊金丙酯或它们的钠盐、以及苯氧乙醇、苯甲酸、苯甲酸钠、山梨酸钾、百里酚。
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| EA200800988A EA200800988A1 (ru) | 2008-02-07 | 2008-02-07 | Гель для реминерализации тканей зубов |
| EP200800988 | 2008-02-07 | ||
| PCT/RU2009/000011 WO2009099350A1 (en) | 2008-02-07 | 2009-01-21 | Gel for teeth tissues remineralization |
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| EP (1) | EP2249795A4 (zh) |
| CN (1) | CN101909596A (zh) |
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| CN105726408A (zh) * | 2016-03-28 | 2016-07-06 | 北京世纪鸿成商贸有限公司 | 牙凝胶 |
| CN113509394A (zh) * | 2021-07-14 | 2021-10-19 | 上海市第十人民医院 | 一种矿化甘油凝胶、制备方法及应用 |
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| FR3024019B1 (fr) * | 2014-07-28 | 2017-11-24 | Yvan Erbs | Complement alimentaire pour ameliorer le fonctionnement des cellules vivantes et procede associe |
| RU2691960C1 (ru) * | 2019-01-10 | 2019-06-19 | Федеральное государственное бюджетное образовательное учреждение высшего образования "Кубанский государственный медицинский университет" Министерства здравоохранения Российской Федерации (ФГБОУ ВО КубГМУ Минздрава России) | Гидрогель для реминерализации твердых тканей зубов |
| US20230034815A1 (en) * | 2019-12-26 | 2023-02-02 | Svetlana Konstantinovna Matelo | Composition for remineralizing tooth enamel |
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| GB2082062B (en) * | 1980-08-19 | 1984-07-11 | Colgate Palmolive Co | Dentifrices containing xanthan and guar gum |
| US5630999A (en) * | 1993-06-16 | 1997-05-20 | Colgate Palmolive Company | Oral composition containing anionic surfactants having reduced adverse reaction to oral tissue |
| RU2075965C1 (ru) * | 1994-09-29 | 1997-03-27 | Гарник Алексанович Чухаджян | Средство для лечения заболеваний полости рта |
| RU2113842C1 (ru) * | 1995-05-26 | 1998-06-27 | Производственно-коммерческая фирма "Линда" | Зубная паста |
| US7250174B2 (en) * | 1999-12-07 | 2007-07-31 | Schott Ag | Cosmetic, personal care, cleaning agent, and nutritional supplement compositions and methods of making and using same |
| US6602490B1 (en) * | 2002-03-04 | 2003-08-05 | Richard A. Cloonan | Dental cleaning formulation and manufacturing process |
| US8858920B2 (en) * | 2004-12-21 | 2014-10-14 | Colgate-Palmolive Company | Anti-caries oral care composition with xylitol |
| RU2293551C1 (ru) * | 2005-05-23 | 2007-02-20 | Ооо "Вдс" | Состав для профилактики заболеваний полости рта |
| US20060280694A1 (en) * | 2005-06-09 | 2006-12-14 | John Peldyak | Composition for the mineralization of dental hard tissues and the reduction of caries-inducive microflora |
| EP1952801B1 (en) * | 2005-11-25 | 2018-07-25 | "WDS" Company | Oral cavity care curative and prophylactic composition |
| RU2311168C2 (ru) * | 2006-01-26 | 2007-11-27 | Общество С Ограниченной Ответственностью "Вдс" | Состав для реминерализации тканей зубов |
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| CN105726408A (zh) * | 2016-03-28 | 2016-07-06 | 北京世纪鸿成商贸有限公司 | 牙凝胶 |
| CN113509394A (zh) * | 2021-07-14 | 2021-10-19 | 上海市第十人民医院 | 一种矿化甘油凝胶、制备方法及应用 |
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| US20100278758A1 (en) | 2010-11-04 |
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| EA011254B1 (ru) | 2009-02-27 |
| EA200800988A1 (ru) | 2009-02-27 |
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