CN103596543B - 口腔护理组合物 - Google Patents
口腔护理组合物 Download PDFInfo
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- CN103596543B CN103596543B CN201280029074.7A CN201280029074A CN103596543B CN 103596543 B CN103596543 B CN 103596543B CN 201280029074 A CN201280029074 A CN 201280029074A CN 103596543 B CN103596543 B CN 103596543B
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- Prior art keywords
- catechin
- composition
- toothpaste
- oral care
- purposes
- Prior art date
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Abstract
本发明涉及包含儿茶素的口腔护理组合物。我们已经发现，由于其在牙膏的高pH下发生的氧化，儿茶素倾向于使白垩基牙膏的颜色变暗。一旦儿茶素氧化并使牙膏颜色变暗，它们不再可照此提供抗炎益处。本发明的一个目的是提供不会由于儿茶素的氧化而显著变暗的白垩基牙膏制剂。本发明人在研究包含儿茶素，优选绿茶儿茶素以提供抗炎益处的口腔护理组合物时，令人惊讶地发现一些选定的锌盐在以特定量添加时不会导致牙膏颜色变暗，并且在储存时也能输送绿茶儿茶素。
Description
发明领域:
本发明涉及口腔护理组合物，本发明更特别涉及包含儿茶素的口腔护理组合物。
发明背景:
口腔护理和口腔卫生是人类生活中最重要的事情之一。大多数人每天刷牙以使自己保持口腔卫生。大多数人每天刷牙至少两次，有时甚至更多。另一方面，由于缺乏恰当的牙齿护理，许多人的牙龈发炎，这造成刺激和口腔问题。
最公知的口腔护理组合物是牙膏。全世界的人为了他们的口腔健康和卫生使用牙膏。牙膏可以以许多形式提供。最常见的形式是白垩基牙膏制剂。
已努力在牙膏组合物中掺入不同的植物提取物和/或抗菌剂以对抗口腔炎症。
US2006/0140881 (COLGATE-PALMOLIVE COMPANY, 2006)公开了一种口腔护理组合物，其含有：游离-B-环类黄酮和黄烷；以及至少一种生物利用率增强剂。还提供了使用该口腔组合物的方法。
US2006/0141072 (COLGATE-PALMOLIVE COMPANY, 2006)公开了含有各种植物提取物的低水牙膏。该口腔或牙膏组合物含有保湿剂、磨料化合物和各种植物提取物，如迷迭香和绿茶提取物，以及附加的抗氧化剂组分。抗氧化剂的实例包括亚锡化合物、焦亚硫酸钠、BHT、硫酸铵和锡酸钾。该组合物抗褐变。本发明还提供增进动物对象的口腔健康的方法，包括将如上论述的组合物施加到动物的口腔表面上。
儿茶素通常以其健康益处为人所知。在茶的世界中，绿茶的健康益处也是公知的。绿茶儿茶素，包括表没食子儿茶素、表没食子儿茶素没食子酸酯等已知提供抗炎益处。我们已经发现，笼统而言儿茶素，例如绿茶中存在的那些，由于其在牙膏的高pH下发生的氧化，倾向于使白垩基牙膏的颜色变暗。一旦儿茶素氧化并使牙膏颜色变暗，它们不再可照此提供抗炎益处。
因此需要开发在白垩基牙膏制剂中利用儿茶素的益处而基本不使牙膏颜色变暗的口腔护理组合物。
发明目的：
考虑到上文，本发明的一个目的是提供包含儿茶素的口腔护理组合物。
本发明的另一目的是提供利用儿茶素的抗炎益处的口腔护理组合物。
本发明的另一目的是提供不会由于儿茶素的氧化而显著变暗的白垩基牙膏制剂。
本发明的再一目的是提供不会由于绿茶儿茶素的氧化而显著变暗的含绿茶儿茶素的白垩基牙膏制剂。
本发明人在研究包含儿茶素，优选绿茶儿茶素以提供抗炎益处的口腔护理组合物时，令人惊讶地发现一些选定的锌盐在以特定量添加时不会导致牙膏颜色变暗，并且在储存时也能输送（deliver）绿茶儿茶素。
发明概述：
根据本发明的第一方面，提供口腔护理组合物，其包含：
a) 0.1至4重量%的一种或多种儿茶素；
b) 0.1至10重量%的选自氯化锌、硝酸锌和乙酸锌或其混合物的锌盐；和
c) 口腔可接受的基料（base），包括碳酸钙。
根据第二方面，本发明提供第一方面的口腔护理组合物用于抗炎益处的用途。
根据第三方面，本发明提供选自氯化锌、硝酸锌和乙酸锌或其混合物的锌盐用于稳定包含碳酸钙的口腔护理组合物中的儿茶素的用途。
根据一个优选方面，本发明提供第一方面的口腔护理组合物，其中儿茶素来源是绿茶提取物。
本领域普通技术人员在阅读下列详述时容易看出这些和其它方面、特征和优点。为避免疑问，本发明的一个方面的任何特征可用于本发明的任何其它方面。要指出，下列说明书中给出的数值旨在阐明本发明而无意将本发明限于这些数值本身。类似地，除非另行指明，所有百分比是重量/重量百分比。除在实施例和对比例中外或除非明确地另行指明，本说明书中指示材料量或反应条件、材料的物理性质和/或用途的所有数值应被理解为用词语“大约”修饰。以“x至y”的格式表示的数值范围应被理解为包括x和y。当对特定特征而言以“x至y”的格式描述多个优选范围时，要理解的是，也考虑组合不同端点的所有范围。
发明详述：
本发明提供口腔护理组合物，其包含：
a) 0.1至4重量%的一种或多种儿茶素；
b) 0.1至10重量%的选自氯化锌、硝酸锌和乙酸锌或其混合物的锌盐；和
c) 口腔可接受的基料，包括碳酸钙。
本发明的口腔护理组合物包含0.1至4重量%的一种或多种儿茶素。该口腔护理组合物更优选包含1至4重量%的一种或多种儿茶素。儿茶素的优选来源是绿茶提取物。本发明的口腔护理组合物优选包含1至5%的绿茶提取物，更优选包含1至4 %的绿茶提取物。绿茶提取物是儿茶素的优选来源，但该口腔护理组合物不仅限于绿茶儿茶素。也优选使用儿茶素的任何其它合适的来源。
绿茶是茶的世界中公知的。通常通过在采摘后立即蒸烘(steaming)或炒干(pan-firing)茶叶制造绿茶，以抑制酶作用和使茶叶中的内源性组分在产物中保持基本不变。因此，口味主要取决于株系（clone）、采摘时间、芽成熟度（shoot maturity）和栽培方法的选择。绿茶多酚的主要成分是(-)表儿茶素，(-) 表没食子儿茶素，(-)表儿茶素没食子酸酯和表没食子儿茶素没食子酸酯(EGCG)。
本发明的组合物优选包含绿茶提取物。该绿茶提取物来自Camellia sinensisvar. sinensis和/或Camellia sinensis var. assamica。优选通过在热水中萃取市售绿茶制造绿茶提取物。热水优选是指40至100℃的水。或者，粉末形式的市售绿茶提取物也优选直接用于制造口腔护理制剂。绿茶优选是细粒状的并包含没食子酸、儿茶素和它们的衍生物，即没食子酸、EGC、ECG、EGCG、咖啡因和儿茶素。这些粉末中的典型EGCG含量为25 -40%，而总多酚含量为45至70干重量%不等。在更优选的绿茶粉末中，EGCG含量为30至35干重量%。
或者，可以使用纯化绿茶儿茶素代替绿茶提取物。
优选用于制造本发明的口腔护理制剂的绿茶提取物优选按干重量计包含20至80%的儿茶素，更优选40至60%的儿茶素。
本发明的口腔护理组合物还包含锌盐。锌盐选自氯化锌、硝酸锌和乙酸锌。或者，在该制剂中可以使用两种或更多种这些锌盐的混合物。
锌盐的量为本发明的口腔护理组合物的0.1至10重量%。锌盐的优选范围为该口腔护理组合物的1至8%，更优选1至5重量%。
口腔可接受的基料是指能施加在人口腔中的基料制剂。本发明的口腔护理组合物包含碳酸钙。任意形式的碳酸钙都可用于该口腔护理组合物，但碳酸钙的最优选形式是细磨天然白垩（FGNC）。本发明的口腔护理组合物中碳酸钙的优选量为该口腔护理组合物的20至80重量%。最优选范围是该口腔护理组合物的30至60重量%。
本发明的口腔护理组合物还可包含任选成分，如可药用载体，如淀粉、蔗糖、水或水/醇体系等。也可以包括少量表面活性剂，如阴离子型、非离子型和两性表面活性剂。
该口腔护理组合物可包含通常5至60重量%的量的微粒磨料，如二氧化硅、氧化铝、磷酸二钙、焦磷酸钙、羟磷灰石、三偏磷酸盐、不溶性六偏磷酸盐和附聚微粒磨料等。
此外，该口腔护理制剂可包含保湿剂，如甘油、山梨糖醇、丙二醇、木糖醇、乳糖醇等。
也可以包括粘合剂和增稠剂，如羧甲基纤维素钠、黄原胶、阿拉伯树胶等，以及合成聚合物，如聚丙烯酸酯和羧基乙烯基聚合物，如Carbopol ®。
还可以包括香料，如薄荷和留兰香油，以及防腐剂、pH-调节剂、甜味剂等。
还可以包括抗菌剂，如三氯生、氯己定、铜。抗菌剂的其它实例是季铵化合物，如十六烷基氯化吡啶鎓；双胍，如氯己定二葡糖酸盐、海克替啶、奥替尼啶、阿来西定；卤代双酚化合物，如2,2'亚甲基双-(4-氯-6-溴苯酚)。还可以包括可增强抗菌剂的输送的聚合化合物。
还可以包括抗龋剂，如氟化钠和氟化亚锡、氟化胺、氟磷酸单钠、酪蛋白、菌斑缓冲剂，如尿素、乳酸钙、甘油磷酸钙和聚丙烯酸锶。其它任选成分包括维生素，如维生素C。还可以包括脱敏剂，如柠檬酸钾、氯化钾、酒石酸钾、碳酸氢钾、草酸钾、硝酸钾以及锶盐。
还可以包括缓冲剂和用于缓冲该组合物的pH和离子强度的盐。该组合物的pH通常为5-10，优选6-9，尤其优选7-8.5。
此外，该口腔组合物可包含抗结石剂（anti-calculus），如碱金属焦磷酸盐、含次磷酸盐的聚合物、有机膦酸盐、磷酸柠檬酸盐（phosphocitrates）等。
此外，该组合物可包含功能生物分子，如细菌素、抗体、酶等。
可包括的其它任选成分是例如泡腾体系（effervescing system），如碳酸氢钠/柠檬酸体系。
本发明的口腔护理组合物优选为牙膏形式。该牙膏的优选颜色是白色。
本发明提供本发明的口腔护理组合物用于抗炎益处的用途。本发明的口腔护理组合物可用于抗炎益处。
本发明还提供选自氯化锌、硝酸锌和乙酸锌或其混合物的锌盐用于稳定包含碳酸钙的口腔护理组合物中的儿茶素的用途。
现在借助实施例例示本发明。下列实施例仅用于举例说明而非以任何方式限制本发明的范围。
实施例：
用于测量牙膏制剂中的EGCG的HPLC方法
将250毫克牙膏制剂与5毫升蒸馏水混合。然后将该混合物在声波浴(sonicatorbath)中声处理15分钟。然后，加入0.1毫升浓HCl（盐酸），该内容物再声处理15分钟。此后向其中加入5毫升HPLC级甲醇，接着声处理15分钟。然后将内容物在~12000 rpm (G-force(g) ~3225)下离心15分钟，其上清液用于HPLC注射。
使用HPLC（高效液相色谱法）使用ISO 14502-2:2005(E)方法测量牙膏制剂中的EGCG。如下给出细节。
HPLC条件:
仪器: Agilent HPLC (1100 Series)
柱: Phenomenex Luna Phenyl hexyl 5 , 250 x 4.60mm，配有来自Phenomenex的C18保护盒(guard cartridge)
流动相: A - 9 % (体积分数)乙腈，2 % (体积分数)乙酸，含20微克/毫升EDTA.
B - 80 % (体积分数)乙腈，2 % (体积分数)乙酸，含20微克/毫升EDTA.
流速: 1ml/min
柱温: 35℃
检测器: 二极管阵列检测器 & 检测波长278nm。
对于这一分析，使用咖啡因作为标准并如ISO 14502-2:2005(E)方法中所描述。EGCG相对于咖啡因的相对响应因子（RRF）用于样品中的EGCG量化。
口腔护理组合物的制备:
根据下表1制造牙膏组合物。在该表中，提到实施例中的六种组合物，即A、B、C、1、2和3。如实施例A中提到的组合物不用任何锌盐制造。根据实施例B、C、1、2和3的组合物分别用硫酸锌、柠檬酸锌、乙酸锌、氯化锌和硝酸锌制造。
遵循下列程序制造根据表1的组合物。
将羧甲基纤维素钠（SCMC）添加到水中，然后将该溶液在混合器中搅拌15分钟以证实其完全溶解。然后依次加入硝酸钠、糖精和70%山梨糖醇溶液，接着混合。在加入各成分后进行混合。此后向其中加入十二烷基硫酸钠（SLS）并充分混合直至其完全溶解。依次加入细磨天然白垩（FGNC）、二氧化硅（商品名- Mfil®，供应商- Madhu silica pvt. Ltd.,India）、硅酸钠和单氟磷酸钠（SMFP）并充分混合以证实该糊的均匀性。此后加入绿茶提取物粉末（商品名– Sunphenone®，具有~31干重量%的EGCG含量，供应商- Taiyo GreenPower Co Ltd., Japan）并将其混合5分钟。
在含锌盐的牙膏制剂，即实施例B、C、1、2和3中，紧邻在加入绿茶粉末之前加入锌盐。
表1
EGCG稳定化和变色的比较:
测试根据表1制成的组合物中的EGCG含量及外观。
所有组合物（实施例号A、B、C、1、2和3）根据上文公开的程序制造。然后将组合物在湿热室（温度45 ±5 ℃，相对湿度: 77 ±5）中存储4周。4周后，将组合物从湿热室中取出，然后根据上述方法测量组合物中的剩余EGCG百分比。也观察该组合物的颜色。在0至5的量表上比较该组合物的颜色，其中‘0’是指具有绿茶但没有锌盐的白垩基牙膏（实施例A，4周后）的深棕色，‘5’是指无任何绿茶的常规白垩基牙膏制剂的白色。结果概括在下表中：
表2
从表2中看出，根据实施例号1、2和3制成的组合物（分别含乙酸锌、氯化锌和硝酸锌）具有比根据实施例号A、B和C制成的组合物（分别不含锌盐、含硫酸锌和柠檬酸锌）高得多的4周后（保持在如上文所述的湿热条件下）剩余EGCG百分比。对于实施例号1、2和3，4周后该组合物的颜色也好得多。
因此，通过本发明，确实可以制造可输送改进量的儿茶素而不会使牙膏颜色明显变暗的含绿茶儿茶素的牙膏组合物。
Claims (10)
1.锌盐用于稳定包含碳酸钙的口腔护理牙膏组合物中的儿茶素类化合物的用途，其中所述锌盐选自氯化锌，硝酸锌和乙酸锌或其混合物，其中所述组合物包含0.1至4重量％的一种或多种儿茶素类化合物和0.1至10重量％的所述锌盐。
2.如权利要求1中所述的用途，其中所述儿茶素类化合物源自绿茶提取物。
3.如权利要求2中所述的用途，其中所述口腔护理牙膏组合物包含1至5重量％的绿茶提取物。
4.如权利要求2或3中所述的用途，其中所述绿茶提取物是水提取物。
5.如权利要求2或3中所述的用途，其中所述绿茶水提取物是粉末形式。
6.如权利要求1或2中所述的用途，其中所述锌盐占组合物的1.5至8重量％。
7.如权利要求1或2中所述的用途，其中所述组合物的pH为5至10。
8.如权利要求1或2中所述的用途，其中所述口腔护理组合物是牙膏。
9.如权利要求1或2中所述的用途，其中所述碳酸钙的来源是细磨天然白垩(FGNC)。
10.如权利要求9中所述的用途，其中所述细磨天然白垩(FGNC)的量为所述组合物的20至80重量％。
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| GB2535989A (en) * | 2015-02-26 | 2016-09-07 | Dr Heff's Products Ltd | Dental product, use of a dental product and methods of use of a dental product |
| BR112018069620B1 (pt) * | 2016-03-31 | 2022-04-26 | Unilever Ip Holdings B.V. | Composição de pasta de dente |
| JP2019112329A (ja) * | 2017-12-22 | 2019-07-11 | ライオン株式会社 | 口腔用組成物及びその変色抑制方法 |
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