CN1225234C - 包含与活性成分共研磨的载体的水基牙膏 - Google Patents
包含与活性成分共研磨的载体的水基牙膏 Download PDFInfo
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- CN1225234C CN1225234C CN01814401.2A CN01814401A CN1225234C CN 1225234 C CN1225234 C CN 1225234C CN 01814401 A CN01814401 A CN 01814401A CN 1225234 C CN1225234 C CN 1225234C
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- abrasive material
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- oral cavity
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Abstract
包含至少两种成分、共研磨时不使用溶剂的共研磨物的口腔组合物，其中该共研磨物包含的至少两种成分中每一种的含量至少是共研磨物总重量的5wt%，特征在于该组合物是水基组合物。
Description
技术领域
本发明涉及一种包含共研磨物的口腔组合物。
背景技术
共研磨产品已知在制药领域用于给特定药剂提供改进的溶解性。此种产品具有打湿时改进的溶解速率。典型的产品描述在EP 0 371 431(Vectorpharma)中，其中活性物质与载体物质彼此混合并在磨中进行共研磨。最终产品随后干燥，于是便可使用。
共研磨产品还曾被公开用于局部美容的目的。WO 99/17736(Telos)描述，与采用结晶形式相比，活性成分是如何通过在过饱和条件下的无定形化而大大提高增溶动力学特性的。共研磨物典型地包含由可以是也可以不是惰性的载体与通常溶解特性很差的美容活性材料所组成的二元体系。这两种物质在无溶剂条件下一起研磨。建议用于共研磨的美容活性成分是固体，或者已通过吸收、包合或包微胶囊等手段而转变为固体。适合用于活性成分共研磨的载体包括有机材料如淀粉、聚乙烯基吡咯烷酮和磷脂，仅举几个例子而已，而无机材料的例子则包括滑石粉、二氧化钛、氧化锌、高岭土、沸石、二氧化硅、硅胶、磷酸钙、碳酸钙等。该篇现有技术文章还公开共研磨物是如何通过研磨，优选在高能磨中研磨来制备的。
现有技术还公开在US 4 098 878(Baines)中，共研磨是众多牙膏中使用的磨料颗粒以脂肪酸进行表面改性可采取的路线之一。磨料，据公开，在选择的加工期间进行改性时具有不同反应性能。实质上，该表面改性是一种掩盖磨料颗粒的反应性基团的手段，而表面改性剂则仅以非常少的数量加入，优选尽可能少，只要包覆磨料颗粒即可。从某种意义上，这是一种胶囊形式。该专利还提到，改性剂的加入量是磨料颗粒的0.1～5wt％。
US 4 346 072(Baines)公开一种类似技术但指出，表面改性剂的用量是磨料的0.1～0.5wt％。
我们已惊奇地发现，共研磨技术可成功地用于口腔护理制剂中，该制剂包含水并且其中共研磨物包含至少两种成分，其中每一种以大于总共研磨物重量的5wt％存在。据现有技术(Telos)公开，该共研磨物具有改进的可湿性，以致相当令人惊奇地，它们竟能被包括在水基制剂中。事实上，共研磨成分加入到口腔护理制剂中后可具有惊人的稳定性，尽管有水，表面活性剂和离子材料这样一些干扰材料稳定性的成分存在。该现有技术主要教导可配制一种粉末，当它与湿表面接触时具有改进的稳定性/可湿性等特性。该现有技术还教导共研磨可用来将少量表面改性剂施加到磨料颗粒上。
因此，本发明是口腔护理方面特别有用的技术进步，因为法规管制事宜和消费者感官体验对成分的选择起到很大作用。例如，有许多材料，虽具有比较高的效力，但其味道令消费者不能接受因而就不能用。例如，洗必泰是高效抗菌材料，但从来就很少用在口腔护理组合物中，原因就在于味道不好，这显然给大多数消费者以否定的印象。另一方面，有一些材料在口腔护理技术中实际上不可或缺，但对其他可为消费者提供好处的材料具有明显负面影响。例如，月桂基硫酸钠(SLS)是一种口腔护理组合物中的优选发泡剂。遗憾的是，SLS对诸如十六烷基氯化吡啶鎓之类的阳离子抗微生物材料的效力具有负面影响。因此，此类材料不能在口腔护理中使用以充分发挥其特长。
于是，我们惊奇地发现，共研磨产品在口腔护理制剂中的加入可提供给消费者有利的改进，具体视共研磨物中所选择的成分而定。例如，香料在共研磨物中的应用可提供改进或甚至长效的香味释放。一些当存在常用口腔护理成分如表面活性剂时不稳定的活性成分，现在可用于共研磨物中以提供以前达不到的好处了。这样做带来的另一个优点是，原来在彼此存在下不稳定因而只好独立贮存在分开的腔内直至使用的成分，现在可配制成单一管从而提供更便宜的产品。再有，由于感官体验不良，此前市售口腔护理产品没有包括的成分，例如，由于味道或发泡低，现在可以以一种改变感觉特性的共研磨物形式包括在内并提供给消费者改进的好处。
发明内容
因此，本发明第一方面提供一种包含至少两种成分的共研磨物的口腔组合物，该成分是不使用溶剂共研磨的，共研磨物的至少两种成分中的至少一种是磨料二氧化硅，另一种成分选自维生素C，甘油单油酸酯，抗菌活性成分、例如洗必泰、三氯生和锌，月桂基硫酸钠，白垩，氟化钠及其混合物，并且其中共研磨物包含的至少两种成分中每一种的含量占共研磨物总重量的至少5wt％，特征在于，该组合物是水基组合物。
本发明的组合物可以为牙膏形式。
具体实施方式
本发明组合物是一种水基组合物，包含1～80wt％，优选3～50wt％，更优选5～30wt％水。
所谓“共研磨物”指的是至少两种材料(一种载体和一种活性成分)在一个磨中研磨，研磨中不使用溶剂，正如WO 99/17736中所述，在此将其内容收作参考，尤其指共研磨物的性质和制备而言。然而，为清楚起见，共研磨物是一种研磨颗粒，它包含至少两种成分，它们是在没有溶剂的情况下一起研磨的。
共研磨加工在传统设备中，例如球磨、圆筒式磨、回转磨、研磨机或振动磨中，进行数分钟到数小时的时间，例如30min～8h。优选的是，共研磨加工在一种将振动能量传递给共研磨中的材料的磨中进行。
该磨由不锈钢圆筒形的腔组成，外包有聚氨酯包覆层。腔内放置由非常硬的材料制成的小的高度充填的研磨介质。
研磨介质的粒度和材质的选择取决于待加工材料的性质以及成品所要求的特性。
改变某些操作参数可导致从磨向混合物不同能量的转移并从而导致不同的产品最终特性。
振动机构由连接两个不平衡配重的特殊电机组成。全部零件构成的整体直接连接在研磨腔底板上，并由高张力钢弹簧悬吊着，以便能量可直接传给研磨介质。
该体系的运动产生的振动根据两个与物理有关的尺度规定：频率和振幅。特殊之处在于，该振动是三维类型的，因为它用水平和垂直两个分量来表征。前者可通过改变研磨角，即通过改变两个配重之一的位置来改变。
这样，便可达到不同的载荷运动，另外，传递给研磨介质的能量也可得到调节。
在振动磨中，共研磨加工的效果由多个可由本领域技术人员根据要求的目标调节的参数来调节。所述参数包括腔内装料料位，以及研磨介质的形状、体积和密度。
决定共研磨加工中使用的比能量的另一个重要因素是待研磨材料的质量与研磨介质质量之比。倘若该比值大大地向研磨介质倾斜，则能量将比较高。
恰当的加工时间明显地依赖于待共研磨材料的化学和物理特性以及上面所描述的诸多因素。
最后，共研磨诸成分之间的重量比的选择逻辑上依赖于原料的化学和物理特性，并依赖于所要求的最终目标。
本发明的共研磨物包含至少两种材料，各自以大于共研磨物重量的5wt％存在。因此，这意味着允许常常存在于此类成分中的杂质以通常含量存在。优选的是，至少一种成分以共研磨物的10～95wt％，更优选20～85wt％，尤其优选30～75wt％，最优选共研磨物的40～65wt％的数量存在。本发明共研磨物因而构成一种包含所述成分的附聚物，而正是该附聚物，当用于包含水的制剂时能令人惊奇地不解体。
该共研磨物还可包含两种以上不含杂质的成分。例如，共研磨物可包含3、4或甚至5或6种不同成分。还可以先制备一种由两种成分组成的共研磨物，然后该产品再用于另一个共研磨步骤中以增加成分数目并很可能改变最终产品的特性。当共研磨物包含两种以上成分时，它也可以通过所有成分在一个步骤中的共研磨来制备。
显然，在要采用两种以上成分的情况下，第三以及以后的成分不必以大于共研磨物重量的5wt％的数量存在。
还可将口腔护理组合物的一种成分既包括在共研磨物中，也包括在口腔护理组合物的其余部分中。因而，本发明一种实施方案的适当例子将包含一种活性成分如氟化钠，它既在共研磨物中，也在制剂的其余部分中，从而先在刷牙期间提供一股猛烈的氟离子，又在刷牙之后一段时间内提供更长的、缓慢的氟化物释放。
典型地，口腔组合物可包含0.001～50wt％的上述共研磨物。优选的是，该口腔组合物将包含0.01～25wt％，最优选0.1～10wt％的上述共研磨物。
共研磨物中使用的成分可以是任何给组合物提供有益效果的成分。它们可以是香料、香料增强剂、抗菌活性成分、磨料、增稠剂、缓释剂、着色剂等。口腔组合物的其余部分可包含任何通常用于口腔护理制剂的材料，不论作为共研磨物中的活性成分抑或作为组合物其余部分中的活性成分。它们包括：
抗菌剂，例如三氯生、洗必泰、铜-、锌-和亚锡盐，如柠檬酸锌、硫酸锌、甘氨酸锌、柠檬酸锌钠和焦磷酸亚锡、血根草提取物、甲硝唑、季铵化合物如乙烯基氯化吡啶鎓；双胍(bis-guanides)，如洗必泰二葡糖酸盐、合克替啶、癸双辛胺啶、双胍啶和卤代双酚化合物如2，2’-亚甲基双-(4-氯-6-溴苯酚)；
消炎药剂如布洛芬、氟比洛芬、阿司匹林、吲哚美辛等；
抗龋药剂如钠-、钙-、镁-和亚锡的氟化物、胺氟化物、二钠一氟磷酸盐、三偏磷酸钠和酪蛋白；
菌斑缓冲剂如脲、乳酸钙、甘油磷酸钙和聚丙烯酸锶；
维生素如维生素C；
植物提取物；
脱敏剂，例如柠檬酸钾、氯化钾、酒石酸钾、碳酸氢钾、草酸钾、硝酸钾和锶盐；
抗结石药剂如含次磷酸酯的聚合物、有机膦酸酯和磷酸柠檬酸酯等；
牙龈保护剂如植物油，例如向日葵油、菜籽油、豆油和红花油；硅油；以及烃油。牙龈保护剂可以是一种能改进牙龈防渗能力的药剂。有关能改进牙龈防渗能力药剂的全面描述可见诸于我们的共同未决申请PCT/EP99/03368；
生物分子，例如杆菌素、抗体、酶等；
香料，例如薄荷和荷兰薄荷油；
防腐剂；
不透明剂；
着色剂；
pH调节剂；
甜味剂；
药学可接受载体，例如淀粉、蔗糖、水或水/醇体系等；
表面活性剂，例如阴离子、非离子、阳离子和两性离子或两性表面活性剂；
粒状磨料如二氧化硅、氧化铝、碳酸钙、磷酸二钙、焦磷酸钙、羟基磷灰石、三偏磷酸盐、不溶性六偏磷酸盐等，包括附聚的粒状磨料；
润湿剂，例如甘油、山梨醇、丙二醇、木糖醇、乳糖醇；
粘结剂和增稠剂如羧甲基纤维素钠、黄原酸胶、阿拉伯树胶等，以及合成聚合物如聚丙烯酸酯和羧乙烯基聚合物如Carbopol；
缓冲剂和盐；以及
其他可包括的任选成分例如是漂白剂，例如过氧化物，例如过二磷酸钾、泡腾体系，例如碳酸氢钠/柠檬酸体系、变色体系等。
该共研磨物中尤其优选的成分包括在碱金属阴离子表面活性剂存在下不稳定的那些活性成分。此种成分包括三氯生、十六烷基氯化吡啶鎓、洗必泰和其他离子物质。
特别适合本发明的成分包括二氧化硅、亲水或亲油聚合物，例如，聚乙烯聚吡咯烷酮、胶质、右旋糖苷、聚乙烯基吡咯烷酮、纤维素及其衍生物、淀粉及其衍生物、环糊精、磷脂、脂肪酸、糖及其混合物。优选的载体是磨料二氧化硅。
另一些共研磨物的例子包括：
-维生素C与磨料二氧化硅的共研磨物，以改进维生素C长期稳定性。这还可包括焦磷酸亚锡，用于改进共研磨物的稳定性。典型的例子包括：
50％维生素C
25％磨料二氧化硅
25％焦磷酸亚锡
63％维生素C
33％磨料二氧化硅
4％焦磷酸亚锡
33％维生素C
67％聚乙烯基吡咯烷酮
20％维生素C
10％焦磷酸亚锡
40％磨料二氧化硅
30％聚乙烯基吡咯烷酮
20％维生素C
70％磨料二氧化硅
10％焦磷酸亚锡
50％维生素C
9％焦磷酸亚锡
41％磨料二氧化硅
50％维生素C
16.7％焦磷酸亚锡
33.3％磨料二氧化硅
-甘油单油酸酯(GMO)与磨料二氧化硅配合，以防止SLS对GMO的牙齿过敏效果的抑制；
-抗菌活性成分与磨料二氧化硅配合，例如，洗必泰、三氯生、锌等，以改善在口腔内的保持时间以及防止它们与组合物其余部分中的材料之间相互作用；
-SLS与磨料二氧化硅共研磨以改进SLS的发泡效果；
-白垩与磨料二氧化硅共研磨以改进白垩与其他成分之间的相容性。
现在，结合下面的实施例来说明本发明的具体实施方案：
实施例1
包含活性成分氟化钠与载体凡士林的共研磨物的本发明产品按照WO99/17736(Telos)所描述的方法制备。利用此种共研磨物替代氟化钠按照通常方式放入到组合物中，可延长氟化物的释放。
| 成分 | ％w/w | ||||
| 1 | 2 | 3 | 4 | 5 | |
| 水山梨醇PEG-32糖精钠着色剂 | 26.794550.171 | 26.434550.171 | 25.434550.171 | 23.434550.171 | 27.11 |
| 45 | |||||
| 5 | |||||
| 0.17 | |||||
| 1 | |||||
| 羧甲基纤维素钠月桂基硫酸钠水合二氧化硅 | 0.91.518 | 0.91.518 | 0.91.518 | 0.91.518 | 0.91.518 |
| 香料 | 1 | 1 | 1 | 1 | 1 |
| 氟化钠 | 0.32 | ||||
| 共研磨物：氟化钠、凡士林(50∶50) | 0.64 | 1 | 2 | 4 | |
针对上面给出的5个例子的每一个，就氟化物随时间的释放量进行分析。
下面是测定氟化物的标准程序，此乃本领域技术人员熟知的。
1)刷牙前，小组参加者被要求吐出一个唾液样品以便获得基线含量；
2)每个小组参加者用1.5g产品刷牙40s；
3)用10ml去离子水漱口2次，每次5s；
4)刷牙后1、2、3h后，从每个患者收集3～5ml吐出的唾液；
5)唾液样品与TisabIII一起在80℃培养过夜。
随后，采用标定后的特定电极测定氟化物。
下表表明，与非共研磨样品(5)相比，共研磨样品(1～4)对应的短时间(3h)后口腔中残留氟化物量高得多，说明刷牙后有更多的氟化物残留。因此，包含氟化物的共研磨物具有氟化物缓释功能。
表
| 样品 | 基线 | 1h | 2h | 3h |
| 5 | 0.058 | 0.378 | 0.228 | 0.166 |
| 1 | 0.051 | 0.371 | 0.294 | 0.198 |
| 2 | 0.059 | 0.349 | 0.231 | 0.175 |
| 3 | 0.065 | 0.421 | 0.319 | 0.209 |
| 4 | 0.052 | 0.445 | 0.262 | 0.175 |
实施例2
本发明还可参考共研磨物用于改进维生素C在口腔组合物中稳定性的试验进一步说明。
制剂A、B、C和D基本相同，只是，在C中存在占总组合物6wt％的一种含33％维生素C、64％氢化棕榈油，其余为焦磷酸亚锡的共研磨物。D包含一种33％维生素C与其余数量为磨料二氧化硅的共研磨物。A和B虽也包含6wt％维生素C但不是共研磨物维生素C。
A B C D
| 成分 | ％W/W | |||
| 水 | 至100 | 至100 | 至100 | 至100 |
| 山梨醇 | 58 | 58 | 58 | 58 |
| 糖精钠 | 0.2 | 0.2 | 0.2 | 0.2 |
| 氟化钠 | 0.32 | 0.32 | 0.32 | 0.32 |
| CI 77891 | 1 | 1 | 1 | 1 |
| PEG-32 | 2 | 2 | 2 | 2 |
| 焦磷酸亚锡 | 1 | 1 | 1 | 1 |
| 氢氧化钠 | 0.18 | 0.18 | 0.18 | 0.18 |
| 水 | 1.5 | 1.5 | 1.5 | 1.5 |
| 羧甲基纤维素钠 | 0.6 | 0.6 | 0.6 | 0.6 |
| 水合二氧化硅 | 8 | 8 | 8 | 8 |
| 水合二氧化硅 | 10 | 10 | 10 | 10 |
| 月桂基硫酸钠 | 1.5 | 1.5 | 1.5 | 1.5 |
| 抗坏血酸 | 6 | 6 | 0 | 0 |
| 共研磨物维生素C(33％)、氢化棕榈油(63％)、焦磷酸亚锡(4％) | 0 | 0 | 6 | 0 |
| 共研磨物维生素C(33％)和磨料二氧化硅(67％) | 0 | 0 | 0 | 6 |
维生素C在25℃的稳定性按标准滴定法测定。
| 剩余维生素C含量(％) | ||||
| 时间，(月) | A | B | C | D |
| 0 | 100 | 100 | 100 | 100 |
| 1 | 29 | 35 | ||
| 3 | 91 | 87 | ||
| 6 | 89 | 82 | ||
很清楚，维生素C在共研磨物中的存在延长了其在口腔护理组合物中的效力，原因就在于以共研磨物形式存在它将稳定得多。
Claims (7)
1.一种包含至少两种成分的共研磨物的口腔组合物，该成分是不使用溶剂共研磨的，共研磨物的至少两种成分中的至少一种是磨料二氧化硅，另一种成分选自维生素C，甘油单油酸酯，抗菌活性成分，月桂基硫酸钠，白垩，氟化钠及其混合物，并且其中共研磨物包含的至少两种成分中每一种的含量占共研磨物总重量的至少5wt％，特征在于，该组合物是水基组合物。
2.权利要求1的口腔组合物，其中该组合物为牙膏形式。
3.权利要求1或2的口腔组合物，其中抗菌活性成分选自洗必泰、三氯生和锌。
4.权利要求1或2的口腔组合物，该组合物包含表面活性剂。
5.权利要求1或2的口腔组合物，其中共研磨物是至少两种成分的附聚物。
6.权利要求1或2的口腔组合物，其中共研磨物包含数量占10～95％的至少两种成分中的至少一种。
7.权利要求1或2的口腔组合物，其中至少两种成分的至少一种在表面活性剂存在下不稳定。
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| JPS5025011B2 (zh) * | 1971-10-09 | 1975-08-20 | ||
| US4098878A (en) * | 1974-10-29 | 1978-07-04 | Colgate-Palmolive Company | Toothpaste containing milled alpha-alumina trihydrate |
| DE2555454A1 (de) * | 1974-12-13 | 1976-06-16 | Colgate Palmolive Co | Zahnpaste |
| GB8403359D0 (en) * | 1984-02-08 | 1984-03-14 | Erba Farmitalia | Pharmaceutical compositions |
| JPS61225115A (ja) * | 1985-03-29 | 1986-10-06 | Lion Corp | ２重カプセル及び該カプセルを含有する口腔用組成物 |
| JP2704883B2 (ja) * | 1988-06-07 | 1998-01-26 | 株式会社資生堂 | メタケイ酸アルミン酸マグネシウム被覆粉末及びそれを用いた皮膚外用剤、消臭剤、口腔用組成物 |
| JPS646213A (en) * | 1987-06-27 | 1989-01-10 | Sangi Kk | Composition for preventing denting caries |
| US5160737A (en) * | 1988-05-03 | 1992-11-03 | Perio Products Ltd. | Liquid polymer composition, and method of use |
| US5059416A (en) * | 1989-06-26 | 1991-10-22 | Warner-Lambert Company | Zinc compound delivery system with improved taste and texture |
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| IT1295289B1 (it) * | 1997-10-07 | 1999-05-04 | Telos S R L | Co-macinati per uso cosmetico e dermatologico |
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| PL361339A1 (en) | 2004-10-04 |
| AU2001291705A1 (en) | 2002-03-04 |
| CA2415777A1 (en) | 2002-02-28 |
| AR030374A1 (es) | 2003-08-20 |
| WO2002015856A1 (en) | 2002-02-28 |
| PL204877B1 (pl) | 2010-02-26 |
| JP2004506670A (ja) | 2004-03-04 |
| BR0113357A (pt) | 2003-07-29 |
| HUP0302823A2 (hu) | 2004-03-29 |
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| ZA200300516B (en) | 2004-01-22 |
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