CN115531225A - 含有桧木醇的口腔用组合物 - Google Patents
含有桧木醇的口腔用组合物 Download PDFInfo
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- CN115531225A CN115531225A CN202210739661.0A CN202210739661A CN115531225A CN 115531225 A CN115531225 A CN 115531225A CN 202210739661 A CN202210739661 A CN 202210739661A CN 115531225 A CN115531225 A CN 115531225A
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- CN
- China
- Prior art keywords
- pyrophosphate
- oral
- oral composition
- composition
- hinokitiol
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
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- 239000000203 mixture Substances 0.000 title claims abstract description 73
- FUWUEFKEXZQKKA-UHFFFAOYSA-N beta-thujaplicin Chemical compound CC(C)C=1C=CC=C(O)C(=O)C=1 FUWUEFKEXZQKKA-UHFFFAOYSA-N 0.000 title claims abstract description 71
- TUFYVOCKVJOUIR-UHFFFAOYSA-N alpha-Thujaplicin Natural products CC(C)C=1C=CC=CC(=O)C=1O TUFYVOCKVJOUIR-UHFFFAOYSA-N 0.000 title claims abstract description 36
- 229930007845 β-thujaplicin Natural products 0.000 title claims abstract description 36
- XPPKVPWEQAFLFU-UHFFFAOYSA-J diphosphate(4-) Chemical compound [O-]P([O-])(=O)OP([O-])([O-])=O XPPKVPWEQAFLFU-UHFFFAOYSA-J 0.000 claims abstract description 29
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- -1 alkali metal pyrophosphate Chemical class 0.000 claims description 17
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- 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 4
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- NPVRQFSVAKOSQN-UHFFFAOYSA-K dipotassium;sodium;[hydroxy(oxido)phosphoryl] phosphate Chemical compound [Na+].[K+].[K+].OP([O-])(=O)OP([O-])([O-])=O NPVRQFSVAKOSQN-UHFFFAOYSA-K 0.000 claims description 2
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Abstract
本发明涉及含有桧木醇的口腔用组合物。本发明的口腔用组合物使用水溶性焦磷酸盐，因此可以确保剂型内桧木醇的经时稳定性，同时在口腔疾病的预防、缓解和治疗方面实现协同效果。
Description
技术领域
本发明涉及含有桧木醇(hinokitiol)的口腔用组合物。
背景技术
随着牙齿健康的理念转变为社会生活理念，对口腔健康的关注正在增加，并且实情是不仅对口腔疾病的预防和治疗，而且对进行社会生活时成为重要人际关系的障碍的口臭的关注也正在提高。
牙齿组织由牙釉质、牙骨质和牙本质构成。暴露于外部的牙齿的外侧由牙釉质覆盖，位于牙槽骨内的牙根部分的外侧由牙骨质覆盖，在其内部存在牙本质。在牙本质中，称为牙本质小管的微细的管经由整个牙本质而分布。
据悉，口腔疾病中的龋齿和牙周病是诱发疼痛、咀嚼功能障碍、牙周组织的破坏和口臭等多种临床症状并导致牙齿丧失的主要因素，并且实情是由于饮食生活的变化，龋齿的原因因素正在进一步增加。
作为对栖息在牙菌斑内并诱发龋齿、牙周病和口臭的口腔致病菌增殖进行抑制的方法，开发出包括对这些细菌具有杀菌和抑菌作用的抗生素在内的多种多样的抗菌制剂作为蛀牙、牙周病、牙髓和根尖周感染的抑制和治疗剂。
据悉，桧木醇因优异的抗菌、抗炎作用而可预防和治疗牙周病并且具有收敛伤口的作用和预防口臭的效果。然而，桧木醇因化学上不稳定而具有如果配制在口腔用组合物中，则无法显示出充分的功效活性并且储存稳定性下降，因此如果长期储存，则因时间流逝而导致的桧木醇的残存率极度降低的问题。
因此，实情是需要开发一种含有在口腔用组合物内抑制桧木醇的反应性的同时提高稳定性从而在口腔内应用时具有活性的稳定化的桧木醇的口腔用组合物。
在整个本说明书中，参考了许多文献并标明了其引用。所引用的文献的公开内容以其整体通过参考并入本说明书中，因此更明确地说明本发明所属技术领域的水平和本发明的内容。
[现有技术文献]
[专利文献]
韩国注册专利公报第10-2208440号
发明内容
要解决的课题
本发明的发明人确认了当在含有桧木醇的口腔用组合物中包含水溶性焦磷酸盐时，可以在确保剂型内桧木醇的经时稳定性的同时实现口腔功效的协同效果，从而完成了本发明。
因此，本发明的目的在于提供一种口腔用组合物，其含有桧木醇或其盐并确保剂型内桧木醇的经时稳定性。
本发明的另一目的在于提供一种口腔用组合物，其可以在确保剂型内桧木醇的经时稳定性的同时实现口腔功效的协同效果。
本发明的又一目的在于提供一种口腔用产品，其包含上述含有桧木醇的口腔用组合物。
本发明的其他目的以及优点通过以下发明的详细说明、权利要求书将变得更加明确。
解决课题的手段
本发明的一个观点在于提供一种口腔用组合物，其包含(i)桧木醇或其盐和(ii)水溶性焦磷酸盐。
在本发明中，上述组合物可以用于预防、缓解或治疗口腔疾病。
在本发明中，上述口腔疾病是包括例如口臭、牙齿过敏、龋齿、牙龈炎、牙周炎、口腔内黏膜溃疡和根尖周病等的总括性概念，但不限于此。
本说明书中使用的术语“预防”是指通过利用上述口腔用组合物来抑制或延迟疾病的所有行为。另外，本说明书中使用的术语“治疗”是指通过利用上述口腔用组合物来缓解或治愈疾病症状的所有行为。
另外，本说明书中使用的术语“缓解”是指如上所述的口腔疾病症状等减少或减轻，并且可以理解为包括改善、预防、治疗等在内的广义的概念。
另外，本说明书中使用的术语“改善”可以理解为广义的概念，是指通过治疗口腔疾病等来使症状恢复到接近原来的状态。
本说明书中使用的术语“口臭”可通过后天性全身疾病或者唾液中的蛋白质、食物残渣等在口腔内被微生物分解而生成的物质分解从而生成诱发恶臭的物质而产生，但不限于此。作为诱发口臭的首要原因的口腔内微生物中可以包括链球菌(Streptococcus)属、卟啉单胞菌(Porphyromonas)属、放线菌(Actinomyces)属、放线杆菌(Actinobacillus)属等，但不限于此。
本说明书中使用的术语“龋齿”是指牙齿被口腔内细菌损伤从而产生蛀牙，但不限于此。例如，在牙齿表面生成的作为生物膜的牙菌斑(plaque)可能是原因。上述口腔内细菌可以是链球菌(Streptococcus)属、卟啉单胞菌(Porphyromonas)属等。
本说明书中使用的术语“牙龈炎”和“牙周炎”可以是存在于龈下菌斑中的链球菌(Streptococcus)属、卟啉单胞菌(Porphyromonas)属等的细菌在形成适当的生长条件时通过对牙龈部位的软组织造成感染来发展成牙龈炎或牙周炎的牙周病从而引起牙龈的炎症的口腔疾病，但不限于此。
本说明书中使用的术语“口腔内黏膜溃疡”也称为口炎(stomatitis)，是指因口腔内细菌、病毒、真菌等引起的感染导致在口腔内黏膜(舌头、牙龈、嘴唇、脸颊内侧等)出现炎症的疾病，并且上述细菌可以是链球菌(Streptococcus)属、卟啉单胞菌(Porphyromonas)属等的细菌，但不限于此。
本说明书中使用的术语“根尖周病”可以是指在表示牙齿的根端的根尖周处发生炎症，但不限于此。作为根尖周病，有根尖周囊肿、根尖周脓肿、根尖周骨肉瘤等，并且可由链球菌(Streptococcus)属、卟啉单胞菌(Porphyromonas)属等的细菌引起，但不限于此。
本说明书中使用的术语“牙齿过敏”是指与蛀牙或其他病理原因不同，对外部刺激出现敏锐以及暂时性或持续性疼痛的所有现象，但不限于此。上述外部刺激通常是指温度刺激，并且一般在寒冷的温度刺激下出现症状，但在炽热的温度下也会出现疼痛。除了这种温度刺激之外，还可能因牙齿的干燥、与外部物质的接触、通过甜或酸食物的渗透压等的刺激而出现疼痛。这不仅全面出现在整个牙齿上，还限于上颚或下颚、或右侧或左侧等特定部位而出现，并且还伴有牙本质知觉过敏症(dentine hyperesthesia)、龋齿、牙髓炎症。
作为这种牙齿过敏症状的原因，可考虑牙本质小管的入口暴露。
如果牙釉质或牙骨质被破坏，并且牙本质小管的入口被暴露于外部，则刺激通过牙本质小管的细胞突起、神经和牙本质液向牙髓方向传递，因此可感到疼痛。
本发明的发明人确认了包含(i)桧木醇或其盐和(ii)水溶性焦磷酸盐的口腔用组合物可以确保剂型内桧木醇的经时稳定性，同时在前述的口腔疾病的预防、缓解和治疗方面实现协同效果。
本发明的上述桧木醇或其盐可以是桧木醇本身或由酸或碱形成的盐。
作为由酸形成的盐，由游离酸(free acid)形成的酸加成盐是有用的，并且酸加成盐可以获自诸如盐酸、硝酸、磷酸、硫酸、氢溴酸、氢碘酸、亚硝酸或亚磷酸等无机酸类和诸如脂肪族一元和二元羧酸盐、苯基取代的链烷酸盐、羟基链烷酸盐和链烷二酸盐、芳香族酸类、脂肪族和芳香族磺酸类等无毒性有机酸。作为这些无毒的盐类，有硫酸盐、焦硫酸盐、硫酸氢盐、亚硫酸盐、亚硫酸氢盐、硝酸盐、磷酸盐、磷酸一氢盐、磷酸二氢盐、偏磷酸盐、焦磷酸盐氯化物、溴化物、碘化物、氟化物、乙酸盐、丙酸盐、癸酸盐(decanoate)、辛酸盐、丙烯酸盐、甲酸盐、异丁酸盐、癸酸盐(caprate)、庚酸盐、丙炔酸盐、草酸盐、丙二酸盐、琥珀酸盐、辛二酸盐、癸二酸盐、富马酸盐、马来酸盐、丁炔-1,4-二酸盐、己烷-1,6-二酸盐、苯甲酸盐、氯苯甲酸盐、甲基苯甲酸盐、二硝基苯甲酸盐、羟基苯甲酸盐、甲氧基苯甲酸盐、邻苯二甲酸盐、对苯二甲酸盐、苯磺酸盐、甲苯磺酸盐、氯苯磺酸盐、二甲苯磺酸盐、苯基乙酸盐、苯基丙酸盐、苯基丁酸盐、柠檬酸盐、乳酸盐、β-羟基丁酸盐、乙醇酸盐、苹果酸盐、酒石酸盐、甲烷磺酸盐、丙烷磺酸盐、萘-1-磺酸盐、萘-2-磺酸盐或扁桃酸盐，但不限于此。
另外，还可以包括使用碱形成的桧木醇金属盐。碱金属或碱土金属盐例如可以通过将桧木醇化合物溶解在过量的碱金属氢氧化物或碱土金属氢氧化物溶液中，过滤非溶解化合物盐，蒸发、干燥滤液而获得。
相对于组合物的总重量，上述桧木醇或其盐的含量可以为0.001至1重量％，优选0.005至0.5重量％，更优选0.01至0.2重量％，甚至更优选0.01至0.1重量％。
本发明的口腔用组合物中包含的上述水溶性焦磷酸盐可以是选自由焦磷酸的碱金属盐(alkali metal pyrophosphate salts)和焦磷酸的碱土金属盐(alkali earthmetal pyrophosphate salts)组成的组中的一种以上，具体地，可以是选自由焦磷酸钠(焦磷酸四钠，tetrasodium pyrophosphate；TSPP；Na4P2O7)、焦磷酸钾(焦磷酸四钾，tetrapotassium pyrophosphate；K4P2O7)、酸性焦磷酸钠(酸式焦磷酸钠，sodium acidpyrophosphate；SAPP；Na2H2P2O7)、焦磷酸二氢二钾(dipotassium dihydrogenpyrophosphate；K2H2P2O7)和焦磷酸二钾二钠(disodium dipotassium pyrophosphate；Na2K2P2O7)组成的组中的一种以上。
相对于组合物的总重量，上述水溶性焦磷酸盐的含量可以为0.01至10重量％，优选0.05至8重量％，更优选0.1至5重量％。
本发明的口腔用组合物包含上述水溶性焦磷酸盐，因此与不包含它的组合物相比，桧木醇的剂型内稳定性(基于50℃，储存1个月)可以提高至少1.5倍、至少2倍、至少3倍、至少4倍或至少5倍。
在一个实施例中，本原发明的口腔用组合物可以不包含诸如EDTA等螯合剂、羧酸型两性表面活性剂和/或诸如乙醇等成分。
虽然EDTA是人体有害物质，并且羧酸型两性表面活性剂和乙醇存在婴儿黏膜刺激性争议，但为了确保常规桧木醇的组合物内经时稳定性，这些成分也包含在口腔组合物中。本原发明的组合物使用水溶性焦磷酸盐，因此具有即使不包含存在上述有害性乃至婴儿黏膜刺激性争议的上述成分也可以确保显著高的桧木醇的经时稳定性的效果。
本发明的发明人确认了本发明的口腔用组合物对选自由链球菌(streptococcus)属和卟啉单胞菌(Porphyromonas)属微生物组成的组中的一种以上的微生物具有抗菌效果，更具体地，确认了本发明的口腔用组合物对选自由变形链球菌(streptococcusmutans)、血液链球菌(streptococcus sanguis)、血链球菌(Streptococcus sanguinis)、唾液链球菌嗜热亚种(Streptococcus salivarius subsp.thermophils)和牙龈卟啉单胞菌(Porphyromonas gingivalis)组成的组中的一种以上的细菌具有卓越的抗菌效果，因此对口腔疾病的预防和治疗具有优异的效果。
更优选地，本发明的口腔用组合物可以对变形链球菌(streptococcus mutans)和/或牙龈卟啉单胞菌(Porphyromonas gingivalis)细菌具有卓越的抗菌效果。
另外，本发明的口腔用组合物包含上述水溶性焦磷酸盐，因此与不包含它的组合物相比，对口腔致病菌株(基于变形链球菌和/或牙龈卟啉单胞菌)的抗菌效果可以提高至少2倍、至少5倍、至少10倍、至少50倍、至少100倍、至少500倍、至少1000倍、至少5000倍、至少1万倍。
本发明的口腔用组合物除了前述的成分之外，根据其剂型和使用目的，通常还可以包含作为成分的湿润剂、研磨剂、药效剂、甜味剂、pH调节剂、防腐剂、结合剂、香料、起泡剂等。
作为湿润剂，可以将选自由浓缩甘油、甘油、山梨醇水溶液、非结晶性山梨醇水溶液、聚乙二醇类和丙二醇组成的组中的成分单独或混合而使用，并且相对于口腔用组合物的总重量，其使用量可以包含1至70重量％。
作为研磨剂，可以使用选自由沉淀二氧化硅、硅胶、硅酸锆、磷酸一氢钙、无水磷酸一氢钙、含水氧化铝、轻质碳酸钙、重质碳酸钙、焦磷酸钙、不溶性偏磷酸盐和硅酸铝组成的组中的一种等。相对于口腔用组合物的总重量，这种研磨剂的使用量通常可以为1至60重量％。另外，作为少量使用的添加剂，可以包括作为通常使用的成分的甜味剂、pH调节剂、防腐剂、着色剂、结合剂。
作为药效剂，可以将氟化钠、单氟磷酸钠、氟化亚锡(stannous fluoride)、氯己定、尿囊素氯羟基铝酸盐(allantoin chlorohydroxyaluminate)、氨基己酸、氯化锌、盐酸吡哆醇、乙酸生育酚、酶类等单独或两种以上混合而使用。
作为结合剂，可以使用羧甲基纤维素钠、卡波姆、角叉菜胶、黄原胶、藻酸盐类等，作为起泡剂，可以将烷基硫酸钠、月桂基硫酸钠、蔗糖脂肪酸酯、失水山梨醇脂肪酸酯等的阴离子和非离子表面活性剂单独或两种以上混合而使用。相对于口腔用组合物的总重量，这种结合剂的使用量通常可以为0.1至3重量％，优选0.5至2重量％。
作为甜味剂，可以使用糖精、木糖醇、赤藓糖醇、阿斯巴甜等，并且相对于口腔用组合物的总重量，这种甜味剂的使用量通常可以为0.05至2重量％。
作为pH调节剂，可以使用磷酸钠、磷酸二钠、柠檬酸、三乙醇胺(Triethanol amine(TEA))等。
作为防腐剂，可以使用苯甲酸、对羟基苯甲酸甲酯、对羟基苯甲酸丙酯、苯甲酸钠等。作为香料，也可以将薄荷油、留兰香油、薄荷醇(menthol)等混合而使用，作为其他添加剂，也可以使用葡聚糖酶等的酶类。
作为起泡剂，可以使用作为阴离子性表面活性剂的月桂基硫酸钠、作为非离子性表面活性剂的聚氧乙烯聚氧丙烯的共聚物(泊洛沙姆)、聚氧乙烯氢化蓖麻油、聚氧乙烯失水山梨醇脂肪酸酯等。相对于口腔用组合物的总重量，这种起泡剂的使用量通常可以为0.5至5重量％，优选0.5至3.5重量％。
此外，可以包含余量的水。
根据本发明的又一实施例，本发明提供了一种包含上述组合物的口腔用产品。
根据本发明的口腔用组合物通常作为为了口腔健康而制备、市售的产品中均可以包含的口腔用组合物，对所应用的口腔用产品没有限制。例如，作为上述口腔用产品，包括牙膏、口腔喷雾、口腔清洗剂、口腔用软膏、口腔清洁剂、漱口产品、口香糖等，但不限于此。本发明的口腔用产品可以是液态、固态、悬浮液、凝胶状、气溶胶(aerosol)形式，但不限于此。
本发明中记载的所有成分优选不超过韩国、中国、美国、欧洲、日本等的相关法规、规范(例如，化妆品安全标准等相关规定(韩国)、化妆品安全技术规范(中国))等中规定的最大使用值。即，优选地，根据本发明的口腔用组合物或个人护理用组合物以各国或欧洲的相关法规、规范中允许的含量限度包含根据本发明的成分。
发明效果
本发明的口腔用组合物使用水溶性焦磷酸盐，因此可以确保剂型内桧木醇的经时稳定性，同时在口腔疾病的预防、缓解和治疗方面实现协同效果。
具体实施方式
以下，将通过实施例更详细地说明本发明。这些实施例仅用于更具体地说明本发明，并且对于本发明所属技术领域的普通技术人员显而易见的是，本发明的范围不限于这些实施例。
实施例
制备例1：口腔用组合物的制备
为了评价剂型内桧木醇的经时稳定性和口腔功效，如下表1所示制备了牙膏组合物。
[表1]
实验例1：经时含量稳定性评价试验
将上表1的牙膏组合物填充到牙膏管中，在50℃下储存1个月。从分析刚制备后和储存后的桧木醇含量而获得的值中基于下式计算出桧木醇残存率(％)。
残存率(％)＝(储存后的桧木醇含量/刚制备后的桧木醇含量)X100
测量结果示于下表2中。
[表2]
| 残存率(％) | |
| 实施例1 | 100 |
| 实施例2 | 100 |
| 实施例3 | 100 |
| 实施例4 | 100 |
| 实施例5 | 100 |
| 比较例2 | 47 |
| 比较例4 | 71 |
| 比较例5 | 47 |
焦磷酸钙通常是牙膏组合物中用作研磨剂的不溶性的钙盐。实验结果，对于添加水溶性焦磷酸盐的实施例1～5，确认了桧木醇的残存率为100％，可以确保剂型内桧木醇的经时稳定性，相反，对于添加不溶性的焦磷酸钙的比较例5，确认了与未添加磷酸盐的比较例2相同，剂型内桧木醇的经时稳定性非常低。
对于添加单磷酸盐(磷酸二氢钠)而不是焦磷酸盐的比较例4，确认了与未添加磷酸盐的比较例2相比，桧木醇的残存率更高，但远不及实施例1～5。
因此，根据本发明的口腔用组合物可以优选实质上不包含水不溶性焦磷酸钙或单磷酸盐，但在因水溶性焦磷酸盐的添加而可维持桧木醇的残存率的范围、例如在残存率可维持50％以上、60％以上、70％以上、80％以上、90％以上或100％的范围内也可以将焦磷酸钙等的水不溶性焦磷酸盐或单磷酸盐等的除水溶性焦磷酸盐以外的磷酸盐与水溶性焦磷酸盐一起配制。
实验例2：抗菌效果实验
通过抗菌力比较试验，确认了利用作为龋齿和牙周病代表诱发细菌的革兰氏阳性菌变形链球菌和革兰氏阴性菌即牙龈卟啉单胞菌是否具有抑制菌株的效果。将实施例1至5和比较例1至3溶解成10％浓度来制备试料。在准备好的试管中各放入4.5ml培养基，仅在第一个试管中将准备好的试料以2％浓度各放入5ml，然后依次各稀释2倍。将各菌株100μl添加到各个试管中使得在该稀释液中达到2x105 CFU/ml，在下表3的按各菌株的最佳条件下培养16小时以上，然后测量不显示浊度的最小抑菌浓度MIC。其结果示于下表4中。
[表3]
[表4]
实验结果，未添加桧木醇和水溶性焦磷酸盐两者全部的比较例1、仅添加桧木醇的比较例2以及仅添加水溶性焦磷酸盐的比较例3的牙膏组合物显示出低的抗菌效果，相反，对于添加桧木醇和水溶性焦磷酸盐两者全部的实施例1～5，抗菌效果显著上升，确认了桧木醇和水溶性焦磷酸盐的组合带来的协同效果。
实验例3：牙龈炎症形成抑制效果
为了确认实施例和比较例组合物的牙龈炎症形成抑制效果，以牙列整齐、无缺损牙齿的牙龈炎症患者为对象，按年龄从20岁至50岁，以10岁为间隔，根据性别对各40人实施精密的口腔检查，筛选出160名实验对象群，然后分成各20人，进行对牙龈炎症治疗效果的临床试验。进行教育，以使其在饭后经过2小时后，在入睡前每天使用3次，实施洁治术(oralprophylaxis)，对初始牙龈炎指数进行分数化，并使其使用各个牙膏组合物，在经过1周、1个月和3个月后实施口腔检查，检查牙龈炎指数。牙龈炎指数的测量方法是将牙周探针(periodontal probe)插入龈沟(gingival sulcus)内，以不施加力的状态燃烧各牙齿周围并进行探查，在经过30秒后测量出血的状态，用下表5所示的方法记录分数，并且测量的牙龈炎症抑制效果结果示于下表6中。
[表5]
| 分数 | 内容 |
| 0分 | 无出血状态 |
| 1分 | 正常出血状态 |
| 2分 | 线状出血状态 |
| 3分 | 齿间部位三角形出血状态 |
| 4分 | 牙龈整体出血状态 |
[表6]
实验例4：牙齿过敏现象抑制程度比较
为了比较实施例和比较例组合物的牙齿过敏抑制程度，将同意参加本实验的志愿者160名(是具有知觉过敏牙齿的从20岁至50岁的人)作为研究对象，将实验对象群分成各20名，进行对牙齿过敏现象抑制效果的临床实验。总试验期间设为2周。
用施加温度刺激后测量患者的反应的方法来实施试验。在实施试验前，预先检查各志愿者的知觉过敏牙齿的过敏部位，用滴管在牙齿的过敏部位滴下约5℃的冷水进行评分后，使其在2周期间每天使用3次各个组合物，经过2周后，再次用滴管滴下约5℃的冷水进行评分。刺激后患者的反应评分标准设定如下。(0分：无任何不适感，1分：稍微不适或凉，2分：非常凉，3分：疼)。2周后的对温度刺激的反应分数如下表7所示。
[表7]
实验例5：口臭去除效果实验
为了比较口臭去除程度，以没有龋齿的人为对象，选定从20岁至50岁年龄的男女160名作为研究对象，将实验对象群分成各20名，进行对口臭去除效果的临床实验。将市售的大蒜粉分散在水中并放置24小时，然后稀释使口气测量仪(Halimeter)测量值为700ppb以上，并将上述稀释液用作口臭诱发源。用大蒜粉稀释液15ml漱口30秒后，1分钟后用口气测量仪测量口臭程度，然后使用各个实验组合物牙膏刷牙30秒～1分钟。刷牙后，经过1分钟、5分钟、30分钟后，用口气测量仪测量口臭程度以测量口臭抑制是否持续。其结果如下表8所示。
[表8]
实验例6：牙结石和牙菌斑去除效果实验
为了确认实施例和比较例组合物的牙结石去除效果和牙菌斑去除效果，选出平时牙结石多的从20岁至50岁的男女160名进行实验。将实验对象群分成各20名后，使其用市售的简单氟牙膏使用一周，此时，记录牙结石指数和牙菌斑指数，并将其设为初始指数值。提供各个实验组合物，培训相同的口腔卫生管理法后，使其使用3个月后，评价牙结石指数(末期牙结石指数值)和牙菌斑指数(末期牙菌斑指数值)，并基于下式计算出减少率。
牙结石减少率(％)＝{(初始牙结石指数-末期牙结石指数)/初始牙结石指数}x100
牙菌斑减少率(％)＝{(初始牙菌斑指数-末期牙菌斑指数)/初始牙菌斑指数}x100
其结果如下表9所示。
[表9]
通过以上6种实验，确认了当将水溶性焦磷酸盐复合处方时剂型内桧木醇的经时稳定性得到确保，并且确认了焦磷酸盐增强桧木醇的口腔功效从而产生协同效果。
对于比较例的牙膏组合物，各个口腔效果完全不存在或不显著，并且对于实施例1至5的牙膏组合物，与比较例1至3的牙膏组合物相比，口腔效果更优异。
由此，判断水溶性焦磷酸盐是通过在改善桧木醇的稳定性的同时改善桧木醇的抗菌、牙龈疾病、牙齿过敏、口臭、牙结石和牙菌斑去除效果来有效地维持并改善口腔健康的优异组合物。
Claims (10)
1.一种口腔用组合物，其包含(i)桧木醇或其盐和(ii)水溶性焦磷酸盐。
2.根据权利要求1所述的口腔用组合物，其特征在于，所述水溶性焦磷酸盐是选自由焦磷酸的碱金属盐(alkali metal pyrophosphate salts)和焦磷酸的碱土金属盐(alkaliearth metal pyrophosphate salts)组成的组中的一种以上。
3.根据权利要求1所述的口腔用组合物，其特征在于，所述水溶性焦磷酸盐是选自由焦磷酸钠(焦磷酸四钠，tetrasodium pyrophosphate；TSPP；Na4P2O7)、焦磷酸钾(焦磷酸四钾，tetrapotassium pyrophosphate；K4P2O7)、酸性焦磷酸钠(酸式焦磷酸钠，sodium acidpyrophosphate；SAPP；Na2H2P2O7)、焦磷酸二氢二钾(dipotassium dihydrogenpyrophosphate；K2H2P2O7)和焦磷酸二钾二钠(disodium dipotassium pyrophosphate；Na2K2P2O7)组成的组中的一种以上。
4.根据权利要求1所述的口腔用组合物，其特征在于，所述口腔用组合物用于预防、缓解或治疗口腔疾病。
5.根据权利要求4所述的口腔用组合物，其特征在于，所述口腔疾病是选自由口臭、牙齿过敏、龋齿、牙龈炎、牙周病、口腔内黏膜溃疡、根尖周病以及牙结石和牙菌斑附着组成的组中的一种以上的疾病。
6.根据权利要求1所述的口腔用组合物，其特征在于，相对于组合物的总重量，所述桧木醇或其盐的含量为0.001至1重量％。
7.根据权利要求1所述的口腔用组合物，其特征在于，相对于组合物的总重量，所述水溶性焦磷酸盐的含量为0.01至10重量％。
8.根据权利要求1所述的口腔用组合物，其特征在于，所述组合物对选自由链球菌(streptococcus)属和卟啉单胞菌(Porphyromonas)属微生物组成的组中的一种以上的微生物具有抗菌效果。
9.一种口腔用产品，其包含权利要求1至8中任一项所述的口腔用组合物。
10.根据权利要求9所述的口腔用产品，其特征在于，所述口腔用产品是选自由牙膏、漱口产品、口香糖、口腔喷雾、口腔用软膏、口腔清洗剂和口腔清洁剂组成的组中的一种以上。
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