CN115484923A - 口腔用组合物 - Google Patents
口腔用组合物 Download PDFInfo
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- CN115484923A CN115484923A CN202180032501.6A CN202180032501A CN115484923A CN 115484923 A CN115484923 A CN 115484923A CN 202180032501 A CN202180032501 A CN 202180032501A CN 115484923 A CN115484923 A CN 115484923A
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- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical compound [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 description 4
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Abstract
本发明的问题是提供一种可以降低抑制污渍附着于牙齿的成分等刺激成分的刺激感、且可以发挥刺激成分本来的效果的口腔用组合物，本发明提供一种含有(A)成分：选自缩合磷酸、植酸及它们的盐中的1种以上，以及(B)成分：N‑(2‑(2‑吡啶基)乙基)‑2‑异丙基‑5‑甲基环己烷甲酰胺的口腔用组合物；含有N‑(2‑(2‑吡啶基)乙基)‑2‑异丙基‑5‑甲基环己烷甲酰胺的、口腔用组合物的刺激成分的刺激缓和剂；及含有刺激成分及N‑(2‑(2‑吡啶基)乙基)‑2‑异丙基‑5‑甲基环己烷甲酰胺的口腔用组合物。
Description
技术领域
本发明涉及一种口腔用组合物。
背景技术
已知缩合磷酸盐具有抑制污渍附着于牙齿的效果，但存在对口腔粘膜的刺激性强的问题，特别是在漱口剂等液体制剂中该问题明显。专利文献1中公开了为了缓和焦磷酸及多磷酸盐的刺激而使用特定的香料成分。专利文献2提出了混合羟烷基纤维素通过粘度抑制刺激感的制剂及通过香料成分掩蔽刺激感等方案。
现有技术文献
专利文献
专利文献1：日本特开2011-98917号公报
专利文献2：日本专利第6217628号公报
发明内容
发明要解决的问题
但是，专利文献1的技术中，口腔用组合物、特别是液体制剂无法得到充分的效果，特别是在漱口剂或口腔喷雾等不用水冲洗的制剂会残留强刺激，在刺激缓和的持续性方面也存在问题。另外，在专利文献2的技术中存在偏好性降低及不能长时间掩蔽等问题。
本发明的目的在于提供一种能够减轻由抑制污渍向牙齿附着的成分等刺激性成分引起的刺激感、并且能够发挥刺激性成分本来的效果的口腔用组合物。
用以解决问题的手段
本发明提供下述的〔1〕～〔11〕。
〔1〕一种口腔用组合物，其含有：
(A)成分：选自缩合磷酸、植酸及它们的盐中的1种以上，以及
(B)成分：N-(2-(2-吡啶基)乙基)-2-异丙基-5-甲基环己烷甲酰胺。
〔2〕根据〔1〕所述的口腔用组合物，(A)成分是选自焦磷酸、三聚磷酸、六偏磷酸、超磷酸、植酸以及它们的盐中的1种以上。
〔3〕根据〔1〕或〔2〕所述的口腔用组合物，(A)成分的量为0.05～2质量％。
〔4〕根据〔1〕～〔3〕中任一项所述的口腔用组合物，(B)成分的量为0.00001～0.01质量％。
〔5〕根据〔1〕～〔4〕中任一项所述的口腔用组合物，其进一步含有(C)成分：选自碳原子数3～6的有机酸及其盐的1种以上。
〔6〕根据〔5〕所述的口腔用组合物，(C)成分是选自苹果酸、酒石酸、柠檬酸、乳酸、琥珀酸、富马酸及它们的盐中的1种以上。
〔7〕根据〔5〕或〔6〕所述的口腔用组合物，(C)成分的量为0.05～3质量％。
〔8〕根据〔1〕～〔7〕中任一项所述的口腔用组合物，其是液体口腔用组合物。
〔9〕一种口腔用组合物的刺激成分的刺激缓和剂，其含有N-(2-(2-吡啶基)乙基)-2-异丙基-5-甲基环己烷甲酰胺。
〔10〕根据〔9〕所述的刺激缓和剂，刺激成分是选自缩合磷酸、植酸以及它们的盐中的1种以上。
〔11〕一种口腔用组合物，其含有刺激成分及N-(2-(2-吡啶基)乙基)-2-异丙基-5-甲基环己烷甲酰胺。
发明效果
根据本发明，提供一种口腔用组合物，由于其可以抑制牙齿的污渍附着，另外可以抑制刺激感且可以使抑制效果持续，良好地表现香味，提高制剂的外观稳定性，因此可以实际感受到这些效果。
具体实施方式
以下，本发明参照其优选实施方式详细地说明。另外，在本说明书中，各成分的含量是将制备组合物时的各成分的投入量作为基准的值。
[1.口腔用组合物]
本发明的口腔用组合物含有(A)及(B)成分，可以进一步含有(C)成分。以下对(A)～(C)成分进行说明。
＜(A)成分＞
(A)成分是选自缩合磷酸、植酸以及它们的盐中的1种以上。口腔用组合物通过(A)成分可以发挥污渍附着抑制效果。
作为缩合磷酸，例如可列举焦磷酸、三聚磷酸、四聚磷酸等的直链状多聚磷酸；三偏磷酸、四偏磷酸、六偏磷酸等环状多聚磷酸；及超磷酸等网状多聚磷酸，作为直链状多聚磷酸，优选焦磷酸及三聚磷酸，作为环状多聚磷酸，优选六偏磷酸。作为缩合磷酸，优选直链状多聚磷酸。缩合磷酸、植酸可以是盐的形态，作为盐，例如可列举碱金属盐(例如钠盐、钾盐)、碱土金属盐(例如钙盐、镁盐)、铜盐、锌盐、铝盐及铵盐等无机碱盐；三乙基铵盐、三乙醇铵盐、吡啶鎓盐、二异丙基铵盐等有机碱盐，优选为碱金属盐、碱土金属盐，更优选为钠盐、钾盐、钙盐，进一步优选为钠盐或钾盐。(A)成分优选含有选自直链状多聚磷酸及植酸中的1种以上，更优选含有选自焦磷酸、三聚磷酸的钠盐及植酸中的1种以上。
(A)成分可以是选自缩合磷酸、植酸以及它们的盐中的单独的1种，此外也可以是2种以上的组合。作为2种以上的组合，优选选自多聚磷酸及其盐中的2种以上，优选组合中含有一种直链状多聚磷酸及其盐的1种以上。作为如上所述的组合，可列举选自直链状多聚磷酸及其盐中的1种以上和、选自环状环状多聚磷酸、网状多聚磷酸及它们的盐中的1种以上的组合；以及选自直链状多聚磷酸及其盐中的2种以上的组合。此外，作为(A)成分的缩合磷酸、植酸以及它们的盐可以制成与它们以外的磷酸或磷酸盐的混合物而混入口腔用组合物中。
(A)成分的量相对于口腔用组合物总量通常为0.05质量％以上，优选为0.1质量％以上。由此，可以表现出更良好的污渍附着抑制效果。上限通常为2质量％以下，优选为1质量％以下。由此可以抑制口腔用组合物对口腔粘膜的刺激感的表现，可以抑制口腔用组合物的香味表现性及外观稳定性的降低。因此，(A)成分的量通常为0.05～2质量％，优选为0.1～1质量％。
＜(B)成分＞
(B)成分是N-(2-(2-吡啶基)乙基)-2-异丙基-5-甲基环己烷甲酰胺。通过含有(B)成分，可以抑制口腔用组合物的刺激感的发生，进一步可以使刺激感的抑制持续。
(B)成分的量没有特别限制，但相对于口腔用组合物总量通常为0.00001质量％以上，优选为0.0001质量％以上。由此可以抑制口腔用组合物的刺激感，且可以持续地得到抑制效果。上限通常为0.01质量％以下，优选为0.005质量％以下。由此，可以抑制强刺激感的表现，可以抑制香味表现性的降低。因此，(B)成分的量通常为0.00001～0.01质量％，优选为0.0001～0.005质量％。
(A)成分的量相对于(B)成分的量的比(A/B)通常为20以上，优选为50以上，更优选为80以上。上限通常为30,000以下，优选为20,000以下，更优选为10,000以下。
＜(C)成分＞
(C)成分选是自碳原子数3～6的有机酸及其盐中的1种以上。通过含有(C)成分，口腔用组合物可以发挥更良好的污渍附着抑制效果。
作为碳原子数3～6的有机酸，例如可列举一元羧酸、二元羧酸、三元羧酸、羟基羧酸，优选为苹果酸、酒石酸、柠檬酸、乳酸、琥珀酸、富马酸。作为盐，例如可列举碱金属盐(例如钠盐、钾盐)、碱土金属盐(例如钙盐、镁盐)、铵盐等无机碱盐；三乙基铵盐、三乙醇铵盐、吡啶鎓盐、二异丙基铵盐等有机碱盐，优选为碱金属盐、碱土金属盐，更优选为钠盐、钾盐、钙盐，进一步优选为钠盐或钾盐。
(C)成分的量相对于口腔用组合物总量通常为0.05质量％以上，优选为0.1质量％以上。由此，可以进一步提高污渍附着抑制效果。上限通常为3.0质量％以下，优选为1.5质量％以下。大于3.0质量％时，有外观稳定性及香味表现性降低的可能性。因此，(C)成分的量通常为0.05～3质量％，优选为0.1～1.5质量％。
＜剂形＞
作为口腔用组合物的剂形，没有特别限定，例如可列举固体、糊剂、液体，它们之中优选液体。本说明书中，将剂型是液体的口腔用组合物称作液体口腔用组合物。液体口腔用组合物可以作为漱口剂(例如含漱剂、漱口液)、液体牙膏、口中清涼剂等液剂而制备，根据需要可以是浓缩型。口腔用组合物可以是药品、准药品(医薬部外品)、化妆品、食品中的任意者。
＜任意成分＞
本发明的口腔用组合物中除了上述成分之外还可以根据需要含有上述成分以外的任意成分。任意成分可以根据口腔用组合物的用途、剂型适当选择。例如，当口腔组合物为液体时，作为任意成分，可列举表面活性剂、润湿剂、pH调节剂、防腐剂、甜味剂、香料、有效成分、溶剂。另外，当口腔用组合物为液体以外的剂型时，作为先前示例的任选成分以外的成分，例如可列举粘结剂、研磨剂。任意成分的含量没有特别限定，在不损害本发明的效果的范围内，可以设定为通常的口腔用组合物中使用的量。
(表面活性剂)
作为表面活性剂，例如可列举阴离子表面活性剂、非离子表面活性剂、阳离子表面活性剂、两性表面活性剂，优选含有阴离子表面活性剂及非离子表面活性剂中的至少任1种。口腔用组合物通过含有阴离子表面活性剂，可以进一步提高污渍附着抑制效果。口腔用组合物通过含有非离子表面活性剂，可以得到油溶成分的可溶化效果。
作为阴离子表面活性剂，例如可列举烷基硫酸盐、N-酰基氨基酸盐、α-烯烃磺酸盐、N-酰基磺酸盐、N-酰基牛磺酸盐、甘油脂肪酸酯硫酸盐，优选烷基硫酸盐、N-酰基牛磺酸盐。作为烷基硫酸盐，例如可列举碳原子数12～14的烷基硫酸盐(例如月桂基硫酸的碱金属盐、肉豆蔻基硫酸的碱金属盐)。作为N-酰基氨基酸盐，例如可列举具有饱和或不饱和烃基(例如可以是碳原子数为8～18、优选为12～16；直链或支链的任意种)的、酰基谷氨酸盐、酰基肌氨酸盐等酰基氨基酸盐。作为酰基牛磺酸盐，可列举具有饱和或不饱和烃基(例如可以是碳原子数为8～18、优选为12～16；直链或支链的任意种)的N-酰基甲基牛磺酸盐。作为α-烯烃磺酸盐，例如可列举十四碳烯磺酸盐等碳原子数为10～16的α-烯烃磺酸盐。作为这些盐，优选钠盐、钾盐等碱金属盐。
阴离子表面活性剂的量相对于口腔用组合物总量通常为0.01质量％以上。由此可以表现出更良好的污渍附着抑制效果。上限通常为3质量％以下，优选为0.5质量％以下，更优选为0.3质量％以下。由此，可以抑制强的刺激感的表现。因此，阴离子表面活性剂的量通常为0.01～3质量％，优选为0.01～0.5质量％，优选为0.01～0.3质量％。
作为非离子表面活性剂，例如可列举聚氧乙烯氢化蓖麻油、聚氧乙烯甘油脂肪酸酯、聚氧乙烯脱水山梨糖醇脂肪酸酯等聚氧乙烯脂肪酸酯；聚氧乙烯烷基醚等聚氧乙烯高级醇醚；糖醇脂肪酸酯；脱水山梨糖醇脂肪酸酯；聚甘油脂肪酸酯；聚氧乙烯脱水山梨糖醇脂肪酸酯。聚氧乙烯氢化蓖麻油的环氧乙烷平均加成摩尔数通常为20～150摩尔，优选为20～130摩尔，更优选为40～110摩尔。
非离子表面活性剂的量相对于口腔用组合物总量通常为0.1质量％以上，优选为0.3质量％以上。上限通常为1质量％以下，优选为0.8质量％以下。通过在这些范围内，可以得到油溶成分的更良好的可溶化效果。因此，非离子表面活性剂的量优选为0.1～1质量％，优选为0.3～0.8质量％。
作为阳离子表面活性剂，例如可列举烷基铵化合物、烷基苄基铵化合物等季铵化合物。作为两性表面活性剂，例如可列举烷基酰胺基甜菜碱型两性表面活性剂；烷基二甲基氨基乙酸甜菜碱、脂肪酸酰胺丙基二甲基氨基乙酸甜菜碱等乙酸甜菜碱型两性表面活性剂；N-脂肪酸酰基-N-羧甲基-N-羟乙基乙二胺盐等咪唑啉型两性表面活性剂。
(润湿剂)
通过在口腔组合物中含有润湿剂，可以进一步提高使用感。作为润湿剂，例如可列举山梨糖醇、赤藓糖醇、麦芽糖醇、乳糖醇、木糖醇等糖醇；及甘油、丙二醇、乙二醇、聚乙二醇等多元醇。多元醇优选是甘油、丙二醇，糖醇优选是山梨糖醇、木糖醇。
润湿剂的量相对于口腔用组合物总量通常为3质量％以上，优选为5质量％以上。上限通常为40质量％以下，优选为30质量％以下，更优选为15质量％以下。通过设为这些范围内，可以得到使用感更良好的提高效果。因此，润湿剂的量通常为3～40质量％，优选为3～30质量％，更优选为5～15质量％。
(pH调节剂)
口腔用组合物通过含有pH调节剂，可以确保制剂的pH稳定性。本发明的所述(A)及(C)成分在组合物中也作为pH调节剂发挥作用，但根据需要可以进一步使用其他的任意的pH调节剂。作为所述任意的pH调节剂，例如可举出邻苯二甲酸、正磷酸、乙酸、碳酸、核糖核酸、它们的盐(优选的例子与(A)相同，优选为钾盐、钠盐、铵盐)、氢氧化钠、盐酸等，优选为正磷酸或其盐，更优选的是磷酸二氢钠、磷酸一氢钠、磷酸二氢钾、磷酸一氢钾。使用任意的pH调节剂时，其量可以设为能够将25℃下的pH调节为5.5～8.5的量，优选为能够将25℃下的pH调节为6～8的量。pH调节优选使用枸橼酸或其盐，优选进一步并用正磷酸盐。pH可通过刚制备口腔用组合物后立刻使用东亚DKK株式会社制造的pH计(型号HM-25R)在25℃下、3分钟后测定。通过将本发明的口腔用组合物的pH设为上述范围，由此可以抑制牙齿的牙釉质的脱矿，可以保持有效性及稳定性。
(防腐剂)
口腔用组合物通过含有防腐剂，可以确保制剂的防腐力。作为防腐剂，例如可列举对羟基苯甲酸甲酯、对羟基苯甲酸乙酯等对羟基苯甲酸酯；苯甲酸钠；盐酸烷基二氨基乙基甘氨酸；山梨酸钾。
(甜味剂)
口腔用组合物通过含有甜味剂，可以进一步提高使用感。作为甜味剂，例如可列举木糖醇、麦芽糖醇、赤藓糖醇、山梨糖醇等糖醇；及糖精、阿斯巴甜、三氯蔗糖、乙酰磺胺酸钾、甜叶菊、新橙皮苷氢化查耳酮、甘草甜素、紫苏葶、对甲氧基肉桂醛、奇异果甜蛋白等高甜味度甜味料。
(香料)
口腔用组合物通过含有香料，可以提高使用感，可以抑制使用后初期的刺激。作为香料，例如可列举含有薄荷醇和香芹酮的香料，但只要是口腔用组合物中使用的香料就可以是任意的香料，没有特别限定。含有薄荷醇和香芹酮的香料中的薄荷醇和香芹酮的含量，优选为10～80质量％。也可以使用含有它们的胡椒薄荷油(peppermint oil)、日本薄荷油、留兰香油等精油。香料的量相对于口腔用组合物的总量通常为0.00001质量％以上，上限通常为3质量％以下，但没有特别限定。
(有效成分)
作为有效成分，例如可列举氨甲环酸、ε-氨基己酸等抗炎剂；葡聚糖酶、淀粉酶、蛋白酶、变聚糖酶、溶菌酶、LeTech酶(リテックエンザイム)等酶；氟化钠、单氟磷酸钠、氟化亚锡等含氟化合物；尿囊素水合氯化铝、尿囊素等的尿囊素或其衍生物；抗坏血酸等维生素C类；百里香、黄芩、丁香、北美金缕梅等植物提取物；氯化锶、硝酸钾、乳酸铝等感觉过敏抑制剂；甘菊蓝、溶菌酶氯化物、二氢胆固醇、甘草次酸盐类、甘草次酸类、氢化胆固醇、叶绿素、叶绿素铜钠、葡萄糖酸铜、海狗氨基酸(Carropeptide)、水溶性无机磷酸化合物、聚乙二醇、聚乙烯吡咯烷酮、月桂酰肌氨酸钠、防牙石剂、防牙垢剂，只要是用于口腔组合物中的有效成分就可以是任意的物质，没有特别限定。上述有效成分的含量可以根据常规方法适当设定有效量。
(溶剂)
口腔用组合物为液状的剂形时，通常含有溶剂。作为溶剂，例如可列举水(例如纯化水)、醇(例如乙醇等低级一元醇)，通常为水，根据需要可以混合醇，只要是用于剂型为液体的口腔用组合物中的溶剂就可以是任意的溶剂，没有特别限定。作为溶剂添加乙醇时，其量相对于口腔用组合物总量通常为30质量％以下，优选为20质量％以下，但即使不添加也可以。通过在该范围，可以提高使用中的口臭抑制实际感觉。
(粘合剂)
作为粘合剂，可以使用目前公知的任意优选的有机粘合剂，例如可列举多糖类、纤维素系粘结剂(例如羧甲基纤维素(CMC)、羟乙基纤维素、羟丙基纤维素、羟丙基甲基纤维素、甲基纤维素、阳离子化纤维素等)、其他多糖系增稠剂(例如黄原胶、瓜尔胶、结冷胶、黄蓍胶、刺梧桐胶、阿拉伯胶、刺槐豆胶、角叉菜胶、海藻酸钠)、合成水溶性高分子(例如聚丙烯酸钠、羧基乙烯基聚合物、聚乙烯吡咯烷酮、聚乙烯醇、海藻酸丙二醇酯)。此外，还可以含有增稠性二氧化硅、硅酸铝等无机粘结剂。混合粘合剂时的含量相对于口腔用组合物的总量通常为0.01～10质量％。
(研磨剂
研磨剂可以为无机研磨剂及有机研磨剂中的任意种。作为无机研磨剂，例如可举出沉淀性二氧化硅、硅酸铝、硅酸锆、结晶性硅酸锆、钛结合性二氧化硅等研磨性二氧化硅；磷酸氢钙·2水合物或无水物、磷酸二氢钙、磷酸三钙、焦磷酸钙等磷酸钙系化合物；碳酸钙等碳酸钙系研磨剂；氢氧化钙、硫酸钙等碳酸/磷酸以外的钙系研磨剂；氧化铝、氢氧化铝、矾土(alumina)等铝系材料；硅酸酐、沸石、硅酸锆等硅酸系材料；碳酸镁、磷酸镁等镁系材料；羟基磷灰石、氟磷灰石、无钙磷灰石等磷灰石系材料；二氧化钛、云母钛、氧化钛等钛系材料；膨润土等矿物。作为有机研磨剂，例如可列举聚甲基丙烯酸甲酯、合成树脂系研磨剂。它们之中，优选二氧化硅系研磨剂。混合研磨剂时的含量相对于口腔用组合物的总量通常为70质量％以下，优选为50质量％以下，更优选为8～50质量％。
本发明的口腔用组合物的使用方法没有特别规定。液体口腔用组合物时，例如可列举在口中以包含适量漱口几十秒的方法。另外，漱口后也可以刷牙。
＜用途＞
口腔用组合物通过将口腔用组合物适用于牙齿，可以抑制污渍附着，因此在污渍附着改善剂的用途中有用。适用对象没有特别限定。例如，可举出想要改善由红茶、绿茶、咖啡等饮食品引起的污渍附着的对象，没有出现这些症状但想要预防的对象等。
＜口腔用组合物的制造方法＞
本发明的口腔用组合物可以通过混合上述的成分来制造。混合成分的顺序没有特别限定，优选使其均匀地混合。
[2.刺激缓和剂]
上述的作为(B)成分的N-(2-(2-吡啶基)乙基)-2-异丙基-5-甲基环己烷甲酰胺，作为口腔用组合物中包含的刺激成分的刺激缓和剂有用。作为刺激成分，例如，除了上述的作为(A)成分的选自缩合磷酸、植酸以及它们的盐中的1种以上以外，还可以列举与这些结构类似的刺激成分，但若是口腔用组合物中可以包含的成分中在使用时产生刺激的成分，就没有特别限定。刺激缓和剂的使用量只要是抑制口腔用组合物中的刺激成分导致的刺激的量即可，只要是作为上述(B)成分的量例示的量即可。另外，口腔用组合物只要是包含刺激成分的口腔用组合物即可，刺激成分为(A)成分时，优选含有作为上述的(A)成分的量例示的量的口腔用组合物。口腔用组合物的剂型、根据需要可以包含的任意成分没有特别限定。
[3.包含刺激成分的口腔用组合物]
上述的作为(B)成分的N-(2-(2-吡啶基)乙基)-2-异丙基-5-甲基环己烷甲酰胺，作为刺激缓和剂有用，因此可以将其作为刺激缓和成分与刺激成分一起设为口腔用组合物的必须成分。刺激成分只要是刺激缓和剂中的说明中例示的量即可。
实施例
以下，将通过实施例详细地说明本发明。以下的实施例是为了更好地说明本发明，而非限定本发明。“％”除非另有说明否则是指“质量％”。下表所示的各成分的混合量是换算成纯粹成分的值(AI)。此外，水量(余量)包含各成分带入的水量。
以下，使用的主要的原料信息如下所示。
·焦磷酸钠(太平化学产业株式会社制造)
·Evercool(注册商标)190(N-(2-(2-吡啶基)乙基)-2-异丙基-5-甲基环己烷甲酰胺，Givaudan-Japan株式会社制造)
·Evercool(注册商标)180((1R,2S,5R)-N-(4-(氰基甲基)苯基)-2-异丙基-5-甲基环己烷-甲酰胺，Givaudan-Japan株式会社制造)
·WS-3(N-乙基-对薄荷烷-3-甲酰胺，德之馨(Symrise)日本公司制造)
·月桂酰肌氨酸钠(川研精细化学株式会社制)
·甘油(坂本药品工业株式会社制造)
·山梨糖醇液(三菱商事生命科学株式会社制造)
·乙醇(日本alcohol产业株式会社制造)
·糖精钠(爱三化学工业株式会社制造)
·聚氧乙烯氢化蓖麻油100E.O.(日本乳液株式会社制造)
·聚氧乙烯氢化蓖麻油60E.O.(日本乳液株式会社制造)
·月桂基硫酸钠(PT BASF Indonesia制造)
·柠檬酸(小松屋株式会社制造)
·柠檬酸钠(小松屋株式会社制造)
·香料
使用了表1记载的组成的香料。
[表1]
表1香料组成(质量％)
| 成分名称 | 含量(质量％) |
| 胡椒薄荷油 | 30 |
| 日本薄荷油 | 10 |
| 薄荷醇 | 30 |
| 茴香醚 | 5 |
| 乙醇 | 25 |
| 总计 | 100 |
·纯化水(小堺制药株式会社制造)
关于其他成分，使用符合医药部外品原料规格2006的成分。
[实施例1～20及比较例1～4]
＜漱口液的制备方法＞
按照表2～5所示的组成(表中的各成分的含量的单位：质量％)，通过将各成分均匀地混合，制成漱口液。具体而言，将POE氢化蓖麻油加入到乙醇中并搅拌，然后准备溶解有香料的油层，将油层加入至其他成分溶解在纯化水中的水层，使用三合一马达(BL1200，HEIDON公司制造)使其均匀地溶解而制备漱口液。制备的漱口液的pH(25℃)为6.5～8.0。
＜评价方法＞
(1.污渍附着抑制效果)
用研磨纸对未处置的羟基磷灰石颗粒(HAP)表面(HOYA株式会社制造，直径7mm×厚度3.5mm)进行处理，用超声波清洗机清洗，然后用测色色差计(UV-1800，由岛津制作所制造)测定初期色差。接着，将该HAP在37℃下在唾液上清液中浸渍30分钟后，在(1)粘蛋白1％人工唾液水溶液(50℃，10分钟)，(2)白蛋白1％人工唾液溶液(50℃，10分钟)、(3)样品(室温下30秒钟)，(4)污渍溶液(1％红茶粉水溶液)(50℃，10分钟)的条件下将(1)～(4)重复10次。之后，测定了进行水洗并干燥的HAP的着色后色差。由L*a*b*色系中的Δb，根据下式计算污渍附着抑制率。此外，式中的对照是通过使用纯化水代替样品并进行与上述相同的一系列操作获得的，并且测定该HAP的色差，同样地求出Δb。
一系列的实验操作对各实施例和比较例以N＝3进行，通过下式计算各HAP的污渍附着抑制率，计算其平均值，按照下述评价基准评价污渍附着抑制效果。
(式)
污渍附着抑制率(％)＝{1-(样品的色差变化量Δb/对照的色差变化量Δb)}×100
·污渍附着抑制效果的判定基准
+++：污渍附着抑制率为90％以上且100％以下
++：污渍附着抑制率为70％以上且小于90％
+：污渍附着抑制率为50％以上且小于70％
±：污渍附着抑制率为30％以上且小于50％
-：污渍附着抑制率小于30％
(2.刺激感的有无)
用以下4个阶段对口中含20mL漱口剂漱口20秒后的刺激感的有无进行评价，按照以下基准，以++、+、±、-显示10人的平均分。
·刺激感的有无的评价基准
4分：没有感觉到刺激感
3分：几乎感觉不到刺激感
2分：感觉到刺激感
1分：感到非常强烈的刺激感
·刺激感的有无的判定基准
++：平均分3.5分以上且4.0分以下
+：平均分3.0分以上且小于3.5分
±：平均分2.0分以上且小于3.0分
-：平均分小于2.0分
(3.刺激感的有无的持续性)
用以下4个阶段对口中含20mL漱口剂漱口20秒后感受不到“刺激感”的时间进行评价，按照以下基准，以++、+、±、-显示10人的平均分。
漱口剂
·刺激感的有无的持续性的评价基准
4分：25分钟以上(没有感到刺激)
3分：15分钟以上且小于25分钟
2分：5分钟以上且小于15分钟
1分：小于5分钟
·刺激感的有无的持续性的判定基准
++：平均分3.5分以上且4.0分以下
+：平均分3.0分以上且小于3.5分
±：平均分2.0分以上且小于3.0分
-：平均分小于2.0分
(4.香味表现的良好度)
用以下4个阶段对口中含20mL漱口剂漱口20秒后洗口中的香味表现的良好度进行评价，按照以下基准，以++、+、±、-显示10人的平均分。
·香味表现的良好度的评价基准
4分：香味表现非常良好
3分：香味表现良好
2分：香味表现不太良好
1分：香味表现不好
·香味表现的良好度的判定基准
++：平均分为3.5分以上且4.0分以下
+：平均分为3.0分以上且小于3.5分
±：平均分为2.0分以上且小于3.0分
-：平均分为1.0分以上且小于2.0分
(5.制剂的外观稳定性评价)
将制备的制剂填充到容量为80mL的容器中，在-5℃的温度条件下静置1个月，目视评价外观、性状进行判定。
·制剂的外观稳定性的判定基准
++：未观察到析出物或浑浊
+：几乎观察不到析出物或浑浊
±：观察到析出物和浑浊
-：观察到明显的析出物和浑浊
[表2]
[表3]
[表4]
[表5]
在不含有A成分和B成分中的任一者的比较例1～4中，存在无污渍附着抑制效果、有刺激感、或者多少无刺激感但也不持续这样的问题，相对于此，在含有A成分和B成分的实施例1～20中，在污渍附着抑制效果、刺激感的有无及刺激感的有无的持续性的评价方面均获得良好的结果，进一步地，香味表现、制剂的外观稳定性方面也获得良好的结果。这表明本发明的口腔用组合物可以抑制牙齿的污渍附着，此外可以抑制刺激感，并且可以使抑制效果持续。
作为处方例于表6显示牙膏的处方例。
[表6]
表6处方例(牙膏剂)
Claims (11)
1.一种口腔用组合物，其含有：
(A)成分：选自缩合磷酸、植酸及它们的盐中的1种以上，以及
(B)成分：N-(2-(2-吡啶基)乙基)-2-异丙基-5-甲基环己烷甲酰胺。
2.根据权利要求1所述的口腔用组合物，(A)成分是选自焦磷酸、三聚磷酸、六偏磷酸、超磷酸、植酸以及它们的盐中的1种以上。
3.根据权利要求1或2所述的口腔用组合物，(A)成分的量为0.05～2质量％。
4.根据权利要求1～3中任一项所述的口腔用组合物，(B)成分的量为0.00001～0.01质量％。
5.根据权利要求1～4中任一项所述的口腔用组合物，其进一步含有(C)成分：选自碳原子数3～6的有机酸及其盐的1种以上。
6.根据权利要求5所述的口腔用组合物，(C)成分是选自苹果酸、酒石酸、柠檬酸、乳酸、琥珀酸、富马酸及它们的盐中的1种以上。
7.根据权利要求5或6所述的口腔用组合物，(C)成分的量为0.05～3质量％。
8.根据权利要求1～7中任一项所述的口腔用组合物，其是液体口腔用组合物。
9.口腔用组合物的刺激成分的刺激缓和剂，其含有N-(2-(2-吡啶基)乙基)-2-异丙基-5-甲基环己烷甲酰胺。
10.根据权利要求9所述的刺激缓和剂，刺激成分为选自缩合磷酸、植酸以及它们的盐中的1种以上。
11.一种口腔用组合物，其含有刺激成分及N-(2-(2-吡啶基)乙基)-2-异丙基-5-甲基环己烷甲酰胺。
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| JP7023161B2 (ja) * | 2018-04-03 | 2022-02-21 | 花王株式会社 | 液体口腔用組成物 |
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