CN103249391A - 抗微生物漱口水组合物 - Google Patents
抗微生物漱口水组合物 Download PDFInfo
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- CN103249391A CN103249391A CN2011800590338A CN201180059033A CN103249391A CN 103249391 A CN103249391 A CN 103249391A CN 2011800590338 A CN2011800590338 A CN 2011800590338A CN 201180059033 A CN201180059033 A CN 201180059033A CN 103249391 A CN103249391 A CN 103249391A
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- microemulsion
- water
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Abstract
本发明涉及一种透明的/半透明液体抗微生物漱口水组合物，其基本上不含低分子量醇。一个问题是将天然来源(精油)的抗微生物活性成分(其通常基本是水不溶性材料)包括在透明或半透明的含水组合物中。将这样的油包括在水中，同时确保透明性的一种方式是将它们配制到微乳液组合物中。但是微乳液组合物通常需要大量的表面活性剂和溶剂，特别是低分子量醇。因此一个挑战是配制漱口水组合物，其一方面能够有效的杀灭微生物，同时另一方面具有透明/半透明外观，同时基本上不含低分子量醇。本发明人已经解决了这个问题和提出了一种微乳液漱口水组合物，其满足全部的上述目标，同时能够特别有效的杀灭变形链球菌(S.mutans)，一种导致口腔疾病的细菌。
Description
技术领域
本发明涉及一种透明/半透明液体抗微生物漱口水组合物，其基本上不含低分子量醇。
发明背景
口腔卫生是消费者个人护理中最重要的方面之一。全球的消费者使用不同类型的口腔护理产品。人们通常用牙刷和洁牙剂每日至少两次来刷他们的牙齿，洁牙剂可以是牙膏或牙粉。采用这样的刷牙通过使得晚上睡觉的过程中或白天人们进食和喝饮料过程中聚集在口中的口腔细菌最小化来确保保持良好的口腔卫生。刷牙，因此使得诸如蛀牙、牙垢、牙龈炎、龋齿和口腔异味(也称作口臭)之类的问题最小化。
尽管每日两次刷牙，但是许多人仍然遭受不同形式的一种或多种上述疾病，并且这据信是由于细菌在刷牙之间的大约12小时期间内作用于口腔黏膜引起的。在这样的时间期间，人们依靠抗微生物漱口水来冲口/漱口。
虽然大部分抗微生物漱口水是水基的，但是它们中有许多包含大量的醇(例如乙醇或异丙醇)，其是最广为人知的抗微生物活性成分，其确保了快速杀菌动力学。但是，有许多国家，由于文化或其他原因，人们不愿意在漱口水中使用醇。大部分已知的抗微生物活性成分不能提供如醇那样快的杀菌效果。此外，人们更愿意漱口水具有透明或半透明的外观。
本发明人已经在WO20101046238中公开了一种快速作用抗微生物组合物，其包含麝香草酚和萜品醇。如何将这些或其他抗微生物活性成分(其通常是基本水不溶性的材料)包含在含水组合物中(其是透明或半透明的)是一个问题。将油包含在水中，同时确保透明性的一种方式是将它们配制到微乳液组合物中。但是微乳液组合物通常需要大量的表面活性剂和溶剂，特别是低分子量醇。因此一个挑战是配制漱口水组合物，其一方面能够有效地杀灭微生物，另一方面具有透明/半透明外观，同时基本上不含低分子量醇。
US5283056公开一种无醇的透明的漱口水，其由无醇漱口水基物、水和稳定的透明的水包油微乳液风味浓缩物组成，该浓缩物的组成为：(i)水；(ii)一种或多种疏水风味油；和(iii)一种或多种表面活性剂，并且不存在低级烷醇，其中水、油和表面活性剂的混合比是根据US5283056的图1-A所示的相图的阴影区来定义的。这个专利使用了大量的表面活性剂，通常高于10%且在大部分情况下是20-30%量级的表面活性剂，其大部分是非离子表面活性剂，来保持微乳液稳定性。
本发明人致力于解决提供微乳液漱口水组合物的问题，其包括低量的表面活性剂，同时满足特别有效地杀灭变形链球菌(S.mutans) (一种导致口腔疾病的细菌)的目标。该组合物不仅由于其具有透明/半透明外观而是吸引人的，而且还仅包括了大多数人不排斥用于清洁他们的嘴的成分。
发明内容
根据本发明的一个方面，提供一种微乳液形式的透明/半透明液体抗微生物漱口水组合物，其基本上不含C1-C3醇，该组合物包含：
(i) 0.05%-10%的抗微生物活性成分，其选自萜烯、精油、阳离子油、C6-C10脂肪酸、脂肪酸甲基酯或有机过酸，其在25℃下在水中的溶解度小于2000ppm；
(ii) 0.05-10%的阳离子或阴离子表面活性剂；
(iii) 0.01-50%的电解质；和
(iv) 50-99.9%的水。
根据本发明的另一方面，提供本发明的组合物用于消毒口腔黏膜的用途。
根据本发明的又一方面，提供一种消毒口腔黏膜的方法，其包含用本发明的组合物冲洗口/口腔黏膜的步骤。
具体实施方式
通过阅读下面的详细说明书和附加的权利要求，这些和其它方面、特征和优点对于本领域技术人员来说将变得显而易见。为了避免疑义，本发明的一个方面的任何特征都可以用于本发明的任何其它方面中。措词“包含”目的是表示“包括”，但不必需是“由…组成”或“由…构成”。换句话说，所列出的步骤或选项不必是穷举的。应当注意在下面的说明书中给出的例子目的是阐明本发明，而非打算将本发明限制到这些例子本身。类似地，除非另外指出，全部的百分比都是重量/重量百分比。
除了在操作和比较例中，或在其它明确指明之处，本说明书中表示材料量或反应条件、材料的物理性能和/或用途的全部的数字被理解为是用措词“大约”来修饰的。除非另外指出，否则以“从x到y”的形式表示的数值范围被理解为包括x和y。当对于某一特定特征，以“从x到y”的形式描述了多个优选的范围时，应当理解也预期了组合不同端点的所有范围。
本发明提供微乳液形式的透明/半透明液体抗微生物组合物，其能够作为漱口水用于消毒口腔。该组合物的特别之处在于它基本上不含低沸点醇，如乙醇或IPA(异丙醇)，同时确保了在短时间范围内的高杀灭微生物效果。该组合物可以直接使用(不稀释)也可以在冲洗或清洗嘴之前用水稀释。该组合物包含抗微生物活性成分、表面活性剂、电解质和水。
本发明的微乳液组合物优选是透明的。这种形式的组合物是特别优选的，因为透明形式产生了吸引消费者的视觉效果。在一个优选的方面，该微乳液中的分散相滴的尺寸范围为6-125nm，更优选尺寸范围为6-15nm。
该抗微生物活性成分选自萜烯、精油、阳离子油、C6-C10脂肪酸、脂肪酸甲基酯或有机过酸，其在25℃下在水中的溶解度小于2000ppm。在上述种类中，更优选的活性成分是萜烯、精油、C6-C10脂肪酸或有机过酸，进一步更优选的种类包括萜烯、精油或有机过酸，最优选的活性成分是萜烯或精油。
下面是每一类活性成分的优选列表。
萜烯/精油：
水杨酸戊酯，香芹酚，伞花烃(例如对异丙基苯)，二氢丁子香酚，丁子香酚，己基丁子香酚，水杨酸己酯，异丁子香酚，甲基丁子香酚，甲基异丁子香酚，水杨酸甲酯，叔丁基甲酚，麝香草酚和香草醛。萜类化合物的非芳族精油的例子包括柏木烯，桉树脑，柠檬醛(包括香叶醛和橙花醛)，香茅醛，香茅醇，桉油精(也称作1，8桉树脑)，对二氢里哪醇，二氢月桂烯醇(DH香叶烯醇)，金合欢醇，香叶醇，己基肉桂醛，羟基香茅醇(citronallol)，羟基香茅醛，异柠檬醛，柠檬烯，优选d-柠檬烯，里哪醇，长叶烯，薄荷醇，橙花醇，橙花油二醇(nerolidiol)，蒎烯(例如 α-蒎烯)，侧柏烯(phellendrene)，萜品烯(例如α-萜品烯和γ-萜品烯)，萜品醇(例如γ-萜品醇和萜品-4-醇)，和四氢月桂烯醇(THM)。
阳离子油
：
季铵阳离子植物油和化学式(CH3)3-Si-[Si(CH3)2-O]-[Si(CH3)-((CH2)3-NH-(CH2)2-NH2)-O]2-Si-(CH3)3的带电的氨基聚二甲基硅烷。
脂肪酸：
具有通用结构R-COOH，其中R是烃链，其可以是支链的或直链的，具有6-10个碳原子。
脂肪酸甲基酯：
具有通用结构R-COOR’，其中R和R’是烃链，其可以是支链的或直链的，碳原子数满足使R和R’中的碳原子总和大于或等于7。
有机过酸：
适用于本发明的组合物的有机酸的例子是ε-苯二甲酰亚氨基过氧化己酸(ε-phthalimidoperoxyhexanoic acid)，二过氧化缩酮，过氧化二碳酸酯过氧酯，二酰基过氧化物，过氧化苯甲酰，酮过氧化物，二烷基过氧化物，氢过氧化物。
更优选的抗微生物活性成分是萜品醇，麝香草酚，丁子香酚，龙脑，柠檬烯，异龙脑，桉油精，樟脑或其混合物。最优选的抗微生物活性成分是萜品醇，麝香草酚，丁子香酚，龙脑或柠檬烯。一种特别优选的组合物包含麝香草酚和萜品醇。一种更进一步优选的组合物包含麝香草酚，萜品醇和丁子香酚。抗微生物活性成分以微乳液组合物重量的0.05-10%，更优选0.05-5%，更优选0.1-5%的量存在。
本发明的微乳液组合物包含0.05-10%，优选0.05-8%，更优选0.5-5%的表面活性剂，基于该组合物的重量。该表面活性剂是阳离子或阴离子类的，更优选阳离子类的。当存在阴离子表面活性剂时，它优选选自烷基磺酸、脂肪酸的碱金属或碱土金属盐，或烷基醚硫酸盐。当存在阳离子表面活性剂时，它是苯扎氯胺，烷基吡啶氯化物或季铵gemini表面活性剂。
不希望受限于理论，据信本发明的优点来自于所用低浓度的阴离子/阳离子表面活性剂和用于在口腔中提供期望的抗微生物效果的抗微生物剂之间的协同作用，同时低浓度的表面活性剂与电解质相互作用提供了期望的微乳液稳定性。
本发明的微乳液组合物基本上不含低分子量醇，即C1-C3醇，例如乙醇或异丙醇。术语基本上不含低分子量醇表示所述醇的存在量不会明显影响杀灭微生物的效果。优选C1-C3醇的存在量小于2%，更优选小于1%和最优选不存在于本发明的组合物中。
本发明的组合物优选包含50-99.9%，优选50-80%，进一步更优选50-70%的水，基于组合物的重量。
本发明的组合物包括占组合物的0.01-50重量%的电解质。优选的电解质可以选自碱金属、碱土金属或过渡金属的氯化物、硫酸盐、乙酸盐或碳酸盐。在它们中，多价电解质是特别优选的。更有用的电解质包括碱土金属的氯化物、硫酸盐或乙酸盐。可用于包含在本发明的组合物中的电解质的例子是氯化钙、氯化钠、氯化镁、硫酸锌、氯化铝或乙酸锌。更优选的电解质是氯化钙、氯化镁、硫酸锌或乙酸锌，而最优选的电解质是硫酸锌或乙酸锌。电解质优选以组合物重量的0.01-30%，更优选0.01-10%，进一步更优选0.05-5%的量存在。不希望受限于理论，据信除了满足本发明的全部目标之外，将电解质包含在本发明的微乳液组合物中的另一优点是确保了组合物中基本不存在低分子量醇。
本发明的微乳液组合物被用于消毒口腔黏膜，其是通过直接使用该组合物(即，不稀释)或是在用水稀释该组合物后使用来进行的。对于稀释步骤来说，组合物与水的优选重量比在1：1-1：200的范围，更优选1：5-1：50和最佳地1：15-1：30和理想地大约1：20。术语透明或半透明组合物表示该组合物的浊度值是0-200 NTU。
本发明的组合物优选在25℃下pH为3-8，更优选3.5-8。
根据本发明的另一方面，提供一种消毒口腔黏膜的方法，其包含步骤：用本发明的组合物冲洗口/口腔黏膜。本发明的组合物优选在冲洗步骤之前用水以1：1-1：200的比例稀释。用该组合物冲洗口/口腔黏膜的预定时间可以高到2分钟，优选高到1分钟和更优选高到30s。
根据本发明的另一方面，提供了本发明组合物的用途，其用于消毒口腔黏膜。该用途优选是非治疗性的。
本发明现在将借助于下面的非限定性实施例来说明。
实施例
实施例1-5：不同的漱口水组合物在1分钟的悬浮液接触测试中抗变形链球菌的效果
变形链球菌(Streptococcu smutans(S.mutans))是一种人类口腔中常见的革兰氏阳性的兼性厌氧菌。变形链球菌是全球龋齿(牙齿损坏)的首要原因，并且被认为是所有口腔链球菌中最生龋齿的细菌，变形链球菌黏附到牙齿表面上，并且依靠碳水化合物的多种基团而存活。虽然代谢糖和其他能量源，但是该微生物产生引起牙齿蛀牙的酸。
制备了表–1所示的不同的组合物。
使用下面的程序，将表–1所列的组合物用于测试在1分钟的悬浮液接触测试中作为抗微生物漱口水组合物抗变形链球菌的效力。
将传代培养变形链球菌以37g/L(gpl)用于BHI培养液中，并且使它在37℃于CO2培养器(15%CO2)中生长15小时。将该变形链球菌培养物在620 nm下的光密度调整到0.3(~108 cfu/ml)。取9ml的期望的组合物，加入到1ml的培养物中并混合。在与该培养物接触1分钟的时间之后，将它们在D/E培养液中中和，并且在连续稀释后，将它们在BHI琼脂(52gpl)中涂板。将所述板在CO2培养器中培养。在培养48小时后计数残留的菌落。所述效力是与对照样品相比较的。
测量了所述细菌的数量级降低量，并且该数据汇总在表–1中。
表–1
| 成分 | 实施例1 Wt% | 实施例2 Wt% | 实施例3 Wt% | 实施例4 Wt% | 实施例5 Wt% |
| 萜品醇 | - | 0.125 | 0.125 | - | - |
| 麝香草酚 | 0.06 | 0.250 | 0.250 | - | - |
| 丁子香酚 | - | 0.025 | 0.025 | - | - |
| SLES# | - | 0.400 | - | 0.400 | - |
| 硫酸锌 | - | 0.120 | - | - | 0.120 |
| 桉油精 | 0.09 | - | - | - | - |
| 薄荷醇 | 0.04 | - | - | - | - |
| 乙醇 | 21.6 | - | - | - | - |
| 水 | 到100 | 到100 | 到100 | 到100 | 到100 |
| 数量级降低 | 7.6 | 7.6 | 3.8 | 0.2 | 0.2 |
实施例–1是在商标名Listerine下销售的一种公知的漱口水所用的组合物
# SLES是阴离子表面活性剂月桂基醚硫酸钠。
表–1的数据表明本发明的组合物(实施例–2)的抗微生物效力与市售的具有高醇含量的组合物(实施例–1)相当。进一步地，该数据还表明在水中的抗微生物活性成分混合物(实施例–3)、表面活性剂(实施例-4)、电解质(实施例–5)它们本身都没有有效地提供抗微生物效力。
实施例6-12：不同的漱口水组合物在30秒的悬浮液接触测试中抗变形链球菌的效力
制备了表 –2所示的不同的组合物。
将表–2所列的组合物用于在30秒的悬浮液接触测试中测试作为抗微生物漱口水组合物抗变形链球菌的效力，其使用了与实施例1-5所用相同的程序，除了接触时间为30s而非1分钟。数据汇总在表–2中。
表-2
| 成分 | 实施例6 Wt% | 实施例Wt% | 实施例Wt% | 实施例Wt% | 实施例Wt% | 实施例& Wt% |
| 萜品醇 | 0.125 | - | - | 0.125 | 0.603 | - |
| 麝香草酚 | 0.250 | - | - | 0.250 | 0.125 | 0.06 |
| 丁子香酚 | 0.025 | - | - | 0.025 | 0.013 | - |
| SLES | - | 0.400 | - | 0.400 | 0.200 | - |
| 硫酸锌 | - | - | 0.120 | 0.120 | 0.06 | - |
| 桉油精 | - | - | - | - | - | 0.09 |
| 薄荷醇 | - | - | - | - | - | 0.04 |
| 乙醇 | - | - | - | - | - | 21.6 |
| 水 | 到100 | 到100 | 到100 | 到100 | 到100 | 到100 |
| 数量级降低 | 1.0 | 0.2 | 0.3 | 7.1 | 7.1 | 7.1 |
&实施例–11是Listerine组合物。
表-2的数据表明表–1的结果甚至对于30秒的测试也是有效的。
实施例12-17：不同的漱口水组合物抗变形链球菌生物膜的效力
制备了表–3所示的不同的组合物。
使用下面的程序，将表–3所列的组合物用于测试抗变形链球菌生物膜的效力。
使BHI培养液中的传代培养变形链球菌(37gpl)在37℃于CO2培养器(15%CO2)中生长15小时。加工该培养物，并将在620nm下在BHI培养液中的光密度调整到为0.3(~108 cfu/ml)。将葡萄糖(2%)加入到该加工的培养物中，并且将它分配到6孔板上，让它在CO2培养器中生长。每24小时更换一次培养基来产生3天大的生物膜。除去该培养基，将大约2ml的表 –3的不同组合物加入该生物膜中。在1分钟的接触时间后，除去该组合物，立即加入2ml的中和剂。用细胞刮棒除去生物膜细胞。混合该生物膜细胞，并且在D/E中和剂中连续稀释和双1ml的样品中在BHI琼脂中涂板。将该板在CO2培养器中培养48h，并且计数菌落。
该漱口水组合物的效力以数量级降低汇总在表–3中。
表-3
| 成分 | 实施例Wt% | 实施例Wt% | 实施例Wt% | 实施例Wt% | 实施例Wt% | 实施例& Wt% |
| 萜品醇 | 0.125 | - | - | 0.125 | 0.603 | - |
| 麝香草酚 | 0.250 | - | - | 0.250 | 0.125 | 0.06 |
| 丁子香酚 | 0.025 | - | - | 0.025 | 0.013 | - |
| SLES# | - | 0.400 | - | 0.400 | 0.200 | - |
| 硫酸锌 | - | - | 0.120 | 0.120 | 0.06 | - |
| 桉油精 | - | - | - | - | - | 0.09 |
| 薄荷醇 | - | - | - | - | - | 0.04 |
| 乙醇 | - | - | - | - | - | 21.6 |
| 水 | 到100 | 到100 | 到100 | 到100 | 到100 | 到100 |
| 数量级降低 | 0.9 | 0.9 | 0.1 | 5.6 | 3.8 | 5.6 |
表-3中的数据表明表-1和表 –2的结果甚至当在生物膜上测试时也是有效的。
实施例18-23：本发明的各种其他的优选漱口水组合物
如表–4所示制备了本发明的各种漱口水组合物，并且发现它们具有期望的效力。
表-4
| 实施例 | 18 | 19 | 20 | 21 | 22 | 23 |
| 萜品醇 | 0.25 | 1 | 0.25 | 1 | 1 | |
| 麝香草酚 | 0.125 | 0.5 | 0.125 | 0.5 | 0.5 | - |
| 丁子香酚 | 0.025 | 0.1 | 0.025 | 0.1 | 0.1 | - |
| 辛酸甲酯 | - | - | - | - | - | 6 |
| SLES | 0.4 | - | 0.4 | - | - | - |
| 苯扎氯胺(使用时稀释比>=1：20) | 0 | 3 | - | 3 | 3 | 3 |
| 硫酸锌 | 0.06 | - | - | - | - | 0.6 |
| 氯化钠 | - | 0.2 | 0.13 | 0 | 0 | - |
| 氯化镁 | - | - | - | - | 0.85 | - |
| 氯化钙 | - | - | - | 0.6 | - | - |
| 水 | 到100 | 到100 | 到100 | 到100 | 到100 | 到100 |
本发明由此提供了漱口水组合物，其是非常有效的却基本上不含醇。该组合物也是非常吸引人的，因为它具有透明的外观。
Claims (9)
1.一种微乳液形式的透明/半透明液体抗微生物漱口水组合物，其基本上不含C1-C3醇，所述组合物包含：
(i) 0.05%-10%的抗微生物活性成分，其选自萜烯、精油、阳离子油、C6-C10脂肪酸、脂肪酸甲基酯或有机过酸，其在25℃下在水中的溶解度小于2000ppm；
(ii) 0.05-10%的阴离子或阳离子表面活性剂；
(iii) 0.01-50%的电解质；和
(iv) 50-99.9%的水。
2.权利要求1的组合物，其中所述表面活性剂是烷基磺酸或脂肪酸的碱金属或碱土金属盐；或烷基醚硫酸盐。
3.权利要求1或2的组合物，其中所述抗微生物活性成分是萜品醇、麝香草酚、丁子香酚、龙脑或柠檬烯。
4.前述任一项权利要求的组合物，其包含0.01-10%的电解质。
5.前述任一项权利要求的组合物，其中所述电解质选自碱金属、碱土金属或过渡金属的氯化物、硫酸盐、乙酸盐或碳酸盐。
6.前述任一项权利要求的组合物，其中所述电解质是二价或多价电解质。
7.前述任一项权利要求的组合物的用于对口腔黏膜进行消毒的用途。
8.一种对口腔黏膜进行消毒的方法，其包含用权利要求1-6任一项的组合物冲洗嘴或口腔黏膜的步骤。
9.权利要求8的方法，其中在冲洗步骤之前，将所述组合物用水以1：1-1：200的比例稀释。
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| PCT/EP2011/070093 WO2012076295A1 (en) | 2010-12-07 | 2011-11-15 | An antimicrobial microemulsion mouthwash composition |
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| CN106491414A (zh) * | 2016-10-30 | 2017-03-15 | 长沙华晨生物科技有限公司 | 一种不含防腐剂的漱口水 |
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| US20130344120A1 (en) * | 2012-06-21 | 2013-12-26 | Douglas Craig Scott | Mouth Rinse Emulsions |
| US20190327963A1 (en) * | 2013-03-15 | 2019-10-31 | Purdue Research Foundation | Non-irritating antimicrobial compositions and methods of use |
| BR112020003233B1 (pt) | 2017-12-20 | 2023-11-07 | Firmenich S.A. | Composições para cuidado oral |
| BR112022018127A2 (pt) * | 2020-03-13 | 2022-10-25 | Unilever Ip Holdings B V | Composição antimicrobiana, método de desinfecção de uma superfície, uso de uma composição e uso não terapêutico de uma composição |
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- 2011-11-15 US US13/990,475 patent/US20130280180A1/en not_active Abandoned
- 2011-11-15 EP EP11784639.4A patent/EP2648678B1/en not_active Not-in-force
- 2011-11-15 CN CN201180059033.8A patent/CN103249391B/zh not_active Expired - Fee Related
- 2011-11-15 EA EA201300675A patent/EA023790B1/ru not_active IP Right Cessation
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- 2011-11-15 MX MX2013006197A patent/MX352770B/es active IP Right Grant
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| US4992259A (en) * | 1990-01-03 | 1991-02-12 | Johnson & Johnson Consumer Products, Inc. | Stable oral composition of zinc |
| US5474761A (en) * | 1993-04-08 | 1995-12-12 | The Procter & Gamble Company | Oral compositions for treating plaque and gingivitis |
| US5283056A (en) * | 1993-07-01 | 1994-02-01 | International Flavors & Fragrances Inc. | Transparent oil-in-water microemulsion flavor or fragrance concentrate, process for preparing same, mouthwash or perfume composition containing said transparent microemulsion concentrate, and process for preparing same |
| WO1995012379A1 (en) * | 1993-11-02 | 1995-05-11 | Givaudan-Roure (International) S.A. | Perfume formulations |
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| EA201300675A1 (ru) | 2013-10-30 |
| EP2648678A1 (en) | 2013-10-16 |
| BR112013014028A2 (pt) | 2016-07-12 |
| CN103249391B (zh) | 2015-02-11 |
| MX352770B (es) | 2017-12-07 |
| MX2013006197A (es) | 2013-07-22 |
| US20130280180A1 (en) | 2013-10-24 |
| EA023790B1 (ru) | 2016-07-29 |
| EP2648678B1 (en) | 2017-10-04 |
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