CN1192134A - 含有溶液化和稳定化壬二酸的局部用赋形剂 - Google Patents
含有溶液化和稳定化壬二酸的局部用赋形剂 Download PDFInfo
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Abstract
在二元醇基质中的壬二酸的完全溶液化局部用组合物,其在常温常压下是稳定的,并可用作壬二酸分散制剂的商业上的替代品。
Description
本发明涉及含有壬二酸和二元醇的局部用组合物,特别是新的、改进的、含有稳定化和完全溶液化壬二酸的组合物。
发明背景
本发明涉及在常温和标准大气压下壬二酸的完全溶液化和稳定的局部用制剂。壬二酸局部用制剂已用于治疗许多生理疾病,包括痤疮、色素沉着过多型皮肤病、脱发、起皱纹、多汗症、非痤疮炎性皮肤病、传染性皮肤病和鱼鳞癣。
不过,目前已知的壬二酸的局部用制剂只有分散剂。分散剂以未溶解状态传送壬二酸。当用于皮肤时,未溶解的壬二酸不易吸收,因此需要过量的壬二酸才能有效。壬二酸的浓度越高,越容易对皮肤产生刺激(灼伤、刺痛和发红)。
因而需要完全溶液化壬二酸局部用制剂。因为溶解状态的壬二酸更易被皮肤吸收,所以溶液化壬二酸对皮肤刺激较小。这样,当壬二酸以产生效果的必需量存在于制剂中时,将降低对皮肤的刺激。
尽管壬二酸微溶于水、润肤油和醇,这些溶剂都有较大的限制性。水仅在一定程度上溶解壬二酸,于是水和壬二酸溶液将含有最大约0.24%(w/w)的壬二酸,这不可能足以产生效果。壬二酸在润肤油中溶解很少或不溶。醇是良溶剂,但它并不令人满意,因为局部用组合物中的大量醇例如异丙醇有不希望的、令皮肤干燥的负作用。某些醇如乙醇将使壬二酸在常温和大气压下不稳定,结果产生完全无效的组合物。
美国专利No.4,292,326(Nazzaro-Porro,1981年9月29日)、No.4,386,104(Nazzaro-Porro,1983年5月31日)和No.4,818,768(Nazzaro-Porro,1989年4月4日)均提出了含有10%-20%(w/w)壬二酸的非溶液化壬二酸的分散剂。
美国专利No.4,713,394(Thornfeldt,1987年12月15日)和No 4,885,282(Thornfeldt,1989年12月5日)中均提出了壬二酸的两种制剂,A和B。制剂A是含有大量乙醇的壬二酸制剂。乙醇溶解了壬二酸,同时也使壬二酸在常温和大气压下不稳定,这意味着可进入市场的产品是不可能的。制剂B是壬二酸的分散剂。
日本专利No.59,020,213(Shiseido)提出了一种不含壬二酸,但含有壬二酸的化学衍生物的头发化妆品乳剂。该衍生物是未完全溶液化的,仅部分溶于水-二元醇基质。
Berova,N.等人在“预防和治疗寻常痤疮的低过敏性壬二酸化妆品乳剂”,Berova,N.、Nkiolova,A.、Kratchanov,Chr.和Popova,M.,应用美容学杂志,12卷,第3期,51页(1994)中提出了在水、苹果胶和葵花油基质中含有10-20%浓度壬二酸的乳剂。Berova等人认为他们的制剂之所以是温和的,是因为使用了象苹果胶和葵花油这样的天然成分来代替壬二酸赋形剂中的非天然物质。由Berova等人提出的这种乳剂是未完全溶液化的,与Nazzaro-Porro和Thornfeldt制剂存在相同的问题,由于壬二酸未完全溶液化,因此制剂中壬二酸的重量百分数比所需要的高。
我们已发现一种在常温和大气压下完全溶液化壬二酸的制剂,该溶液化壬二酸的稳定性未受损失。溶液化壬二酸必须在常温和大气压下保持稳定以提供可进入市场的产品。
若壬二酸不稳定、未完全溶液化,则对于因接触高浓度未溶解壬二酸分散剂而使皮肤灼伤、刺痛和发红的许多使用者来说,壬二酸的益处是不可能得到的。本发明提供了在常温常压下、在二元醇基质中完全溶液化和稳定的壬二酸制剂,其储存期限使其成为可进入市场的产品,并降低了使用者必须接触以发挥作用的壬二酸的用量。
发明概述
本发明涉及壬二酸的局部用制剂,特别是含有稳定化和完全溶液化壬二酸和二元醇、可治疗多种皮肤病的组合物。本发明将壬二酸以完全溶液化且稳定的形式传送到皮肤,由此确保其被皮肤很好地吸收并显著降低皮肤刺激的发生。
壬二酸是9个碳原子的直链二羧酸,在水中和常用润肤油中的溶解度有限。低浓度壬二酸(约0.5%(w/w)-约10%(w/w))可完全溶于二元醇(约20%(w/w)-约60%(w/w))并维持稳定溶液。所使用的二元醇可以是下述一种或多种:丙二醇、聚丙二醇、二丙二醇、丁二醇、聚乙二醇、甲氧聚乙二醇、乙氧基二甘醇、聚丙二醇醚和己二醇,不过也可选用易溶解壬二酸的其他二元醇。
因此,本发明的主要目的是提供含有壬二酸的稳定并完全溶液化的制剂。
另一个目的是提供较低但有效浓度的壬二酸局部用制剂,其对使用者的皮肤产生刺激的可能性很小。
本发明的另一个目的是提供可在常温和大气压下长期储存的稳定的、溶液化的壬二酸制剂。
本发明的又一个目的是提供可治疗多种皮肤病的、含有壬二酸的完全溶液化和稳定化的局部用制剂。
这些以及将在下文中出现的其他目的是通过本发明以非常意想不到的方式完成的,当下述特别优选的实施方案的详细描述与所附的几个实施例一起阅读时,通过仔细研究很容易了解这些方式。
优选实施方案的描述
本发明涉及含有在二元醇基质中稳定化和完全溶液化的壬二酸的局部用润肤制剂。该制剂可用于治疗多种皮肤疾病,而对皮肤的刺激很小或没有刺激。该二元醇可容易地且完全溶解壬二酸,而不会影响壬二酸的稳定性。乙醇或其他去稳定溶剂的不存在确保壬二酸保持稳定。
所使用的二元醇可以是下述一种或多种:丙二醇、聚丙二醇、聚丙二醇醚、己二醇、二丙二醇、丁二醇、聚乙二醇、甲氧聚乙二醇和乙氧基二甘醇,不过也可选用易溶解壬二酸的其他二元醇。二元醇的量可在约20%-60%(w/w)范围内变化。20%(w/w)二元醇是使有效量壬二酸溶液化所需的最小量。60%(w/w)可能是完全不损伤制剂的化妆品效果而可使用的最大浓度。在这一范围的中间值附近是最理想的。
优选用约1-10%(w/w)壬二酸溶于约20-60%(w/w)二元醇中制成乳膏或凝胶局部用溶液。如果使用较低浓度(约0.5%-约2.5%(w/w))的壬二酸,则可降低二元醇的浓度并形成润肤油的常规乳剂。用浓度大于30%(w/w)的二元醇将损伤乳剂的稳定性。但使用约20%-约30%(w/w)浓度的二元醇,带有增水成分的乳剂的稳定性是可接受的。另外,加入增水成分大大改善了乳膏和凝胶的美学性能。
为了进一步帮助理解本发明,给出下述非限制性实施例:
实施例1
在本发明的一个应用和我们优选的实施方案中,通过下述过程制备局部用乳膏:将约20.0-60.0%(w/w)乙氧基二甘醇、约3%(w/w)己二酸二异丙酯和约1.0%(w/w)-10.0%(w/w)壬二酸混合直到形成澄清溶液。在另一个容器中,将适量蒸馏水与约5.0%(w/w)PEG-60杏仁甘油酯混合并加热到70℃。向该混合物中加入约8%(w/w)二硬酯酸甘油酯,维持温度在70℃的同时将这三种成分混合,直到整体形成白色均匀流体。将该混合物冷却到40℃并向其中加入己二酸壬二酸-乙氧基二甘醇-二异丙酯混合物。然后加入约2.5%(w/w)聚丙烯酰胺、C13-C14异链烷烃和聚乙二醇单十二醚(Laureth 7)的混合物,(该混合物可以从Seppic Department Cosmetique-Pharacie,Paris,France以SEPIGEL 305名称得到),整个混合直到得到稠密而均匀的乳膏。
从上述制剂中去除二硬脂酸甘油酯可制成半透明凝胶。
实施例2
在本发明的另一个优选的应用中,通过下述过程制备局部用乳膏:将约1.0%(w/w)-10.0%(w/w)壬二酸与约20.0-60.0%(w/w)二丙二醇混合,并将该混合物加热到约60℃直到形成澄清溶液。然后将该溶液冷却,并保持在40℃。在另一个容器中,将约5.0%(w/w)PEG-60杏仁甘油酯与适量蒸馏水混合,并加热到约70℃。向该混合物中加入约8.0%(w/w)二硬酯酸甘油酯,维持温度在70℃的同时将这三种成分混合,直到整体形成白色均匀流体。将该混合物冷却到40℃,并向其中加入壬二酸-二丙二醇混合物,混匀。然后加入约2.0%(w/w)聚丙烯酰胺、C13-C14异链烷烃和聚乙二醇单十二醚的混合物(SEPIGEL 305),整个混合直到得到稠密而均匀的乳膏。
从上述制剂中去除二硬脂酸甘油酯可制成半透明凝胶。
实施例3
在本发明的又一个应用中,用常用的润肤油制备乳膏,过程是:将约0.5%-2.5%(w/w)壬二酸与约20.0-30.0%(w/w)二丙二醇和适量蒸馏水混合,然后将该混合物加热到70℃直到产生澄清溶液。在另一个容器中,将约10.0%(w/w)C12-C15苯甲酸烷基酯、约3.0%(w/w)异十二烷、约6.0%(w/w)cyclomethicone、约2.5%(w/w)十八烷醇、约4.0%(w/w)硬脂酸甘油酯和PEG-100硬脂酸酯的商业混合物(ARLACEL 165,可从ICI AmericanInc.,Wilmington,Delaware得到)和约0.1%(w/w)对羟苯甲酸异丙酯、对羟苯甲酸异丁酯和对羟苯甲酸丁酯的商业混合物(LIQUAPAPOIL,可从Sutton Laboratories,Chatham,N.J.得到)混合并加热到约70℃。向该混合物中加入壬二酸-二丙二醇-水混合物(在70℃下)并使之混匀,同时维持温度在70℃。然后将该混合物冷却到45℃。最后加入约0.8%(w/w)SEPIGEL 305,并混合直到其稠密而均匀。
在上述实施例中制备的每个产品,在下文中称为“制剂1”、“制剂2”和“制剂3”(每个制剂数对应制备其的实施例),将它们分别按照下面资料中所述方法进行测试:Grove,G.L.,Soschin,A.M.和Kligman,A.M.,“面部刺痛测试方法指南”,可从皮肤研究中心,SimonGreenburg Foundation,3901 Market Street,费城,宾州和Duhring实验室,皮肤科,宾西法尼亚大学医学院,费城,宾州19140得到,并在此结合参考。
以皮肤发红或色素沉着过多的17个病人为一组,测试制剂1的效果。利用MINOLTA CHROMAMETER Model CR-200检测皮肤的褪色。应用制剂1进行皮肤褪色的小组成员每天用一次,持续4周。在4周结束时再用MINOLTA CHROMAMETER检测皮肤褪色情况。结果显示:从小组平均来看,皮肤褪色显著。
以18人为一组测试制剂2和3的温和度,18人中有一些属于“刺痛者”。“刺痛者”是在脸的鼻唇部区域应用了5%乳酸溶液后出现刺痛、灼伤或发痒的患者。这些“刺痛者”具有敏感性皮肤。测试结果显示:利用Kligman’s scale评价方法评价两种配方均是温和的。
显然从上文中可看出,本文描述并阐明了一种含有溶液化和稳定化壬二酸的新的、独特的局部用赋形剂,它以极意想不到的方式实现了本发明的所有前述目的。当然对于本领域技术人员来说,在仅被所附的权利要求限制的本发明的精神实质内简单地进行改进、变化或调整是可以理解的。
Claims (14)
1.一种局部用组合物,包含在二元醇中完全溶液化的壬二酸,其中所述溶液化壬二酸在常温和标准大气压下是稳定的。
2.按照权利要求1的组合物,其中所述二元醇选自下列成员:丙二醇、聚丙二醇、二丙二醇、丁二醇、聚乙二醇、甲氧聚乙二醇、聚丙二醇醚、己二醇和乙氧基二甘醇。
3.按照权利要求1的组合物,包含约0.5%-约10%(w/w)所述壬二酸。
4.按照权利要求3的组合物,包含约20.0%-约60.0%(w/w)所述二元醇。
5.按照权利要求4的组合物,其中所述二元醇选自下列成员:丙二醇、聚丙二醇、二丙二醇、丁二醇、聚乙二醇、甲氧聚乙二醇、聚丙二醇醚、己二醇和乙氧基二甘醇。
6.按照权利要求1的组合物,包含约0.5%-约2.5%(w/w)所述壬二酸。
7.按照权利要求6的组合物,包含约20%-约30%(w/w)所述二元醇。
8.按照权利要求7的组合物,其中所述二元醇选自下列成员:丙二醇、聚丙二醇、二丙二醇、丁二醇、聚乙二醇、甲氧聚乙二醇、聚丙二醇醚、己二醇和乙氧基二甘醇。
9.按照权利要求6的组合物,进一步包含约20.0%-约30%(w/w)二丙二醇,约10.0%(w/w)C12-C15苯甲酸烷基酯,约3.0%(w/w)异十二烷,约6.0%(w/w)cyclomethicone,约2.5%(w/w)十八烷醇,约4.0%(w/w)硬脂酸甘油酯和PEG-硬脂酸酯的混合物,约0.1%(w/w)对羟苯甲酸异丙酯、对羟苯甲酸异丁酯和对羟苯甲酸丁酯的混合物,约0.8%(w/w)聚丙烯酰胺、C13-C14异链烷烃和聚乙二醇单十二醚的混合物,以及适量蒸馏水。
10.按照权利要求1的组合物,包含约1%-约10%(w/w)所述壬二酸。
11.按照权利要求10的组合物,包含约20.0%-约60%(w/w)所述二元醇。
12.按照权利要求11的组合物,其中所述二元醇选自下列成员:丙二醇、聚丙二醇、二丙二醇、丁二醇、聚乙二醇、甲氧聚乙二醇、聚丙二醇醚、己二醇和乙氧基二甘醇。
13.按照权利要求10的组合物,进一步包含约20%-约60%乙氧基二甘醇,约3.0%(w/w)己二酸二异丙酯,约5.0%(w/w)PEG-60杏仁甘油酯,约8.0%(w/w)二硬脂酸甘油酯,约2.5%(w/w)聚丙烯酰胺、C13-C14异链烷烃和聚乙二醇单十二醚的混合物,以及适量蒸馏水。
14.按照权利要求10的组合物,进一步包含约20%-约60%二丙二醇,约5.0%(w/w)PEG-60杏仁甘油酯,约8.0%(w/w)二硬脂酸甘油酯,约2.0%(w/w)聚丙烯酰胺、C13-C14异链烷烃和聚乙二醇单十二醚的混合物,以及适量蒸馏水。
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US46947495A | 1995-06-06 | 1995-06-06 | |
US08/469,474 | 1995-06-06 |
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CN96195897A Pending CN1192134A (zh) | 1995-06-06 | 1996-06-05 | 含有溶液化和稳定化壬二酸的局部用赋形剂 |
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US (1) | US5925679A (zh) |
EP (1) | EP0831768A1 (zh) |
JP (1) | JPH11507350A (zh) |
KR (1) | KR19990022343A (zh) |
CN (1) | CN1192134A (zh) |
AU (1) | AU708824B2 (zh) |
BR (1) | BR9608989A (zh) |
CA (1) | CA2223383A1 (zh) |
CO (1) | CO4700435A1 (zh) |
CZ (1) | CZ387097A3 (zh) |
MA (1) | MA23889A1 (zh) |
NZ (1) | NZ309677A (zh) |
PL (1) | PL323716A1 (zh) |
TN (1) | TNSN96082A1 (zh) |
UY (1) | UY24246A1 (zh) |
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-
1996
- 1996-05-31 UY UY24246A patent/UY24246A1/es unknown
- 1996-06-04 CO CO96028804A patent/CO4700435A1/es unknown
- 1996-06-05 ZA ZA9604688A patent/ZA964688B/xx unknown
- 1996-06-05 PL PL96323716A patent/PL323716A1/xx unknown
- 1996-06-05 TN TNTNSN96082A patent/TNSN96082A1/fr unknown
- 1996-06-05 WO PCT/US1996/009545 patent/WO1996039119A1/en active Search and Examination
- 1996-06-05 JP JP9501844A patent/JPH11507350A/ja active Pending
- 1996-06-05 NZ NZ309677A patent/NZ309677A/en unknown
- 1996-06-05 MA MA24259A patent/MA23889A1/fr unknown
- 1996-06-05 KR KR1019970708823A patent/KR19990022343A/ko not_active Application Discontinuation
- 1996-06-05 AU AU59903/96A patent/AU708824B2/en not_active Ceased
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- 1996-06-05 EP EP96917267A patent/EP0831768A1/en not_active Withdrawn
- 1996-06-05 CZ CZ973870A patent/CZ387097A3/cs unknown
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Also Published As
Publication number | Publication date |
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PL323716A1 (en) | 1998-04-14 |
ZA964688B (en) | 1997-12-05 |
WO1996039119A1 (en) | 1996-12-12 |
MA23889A1 (fr) | 1996-12-31 |
CA2223383A1 (en) | 1996-12-12 |
US5925679A (en) | 1999-07-20 |
NZ309677A (en) | 1999-10-28 |
EP0831768A1 (en) | 1998-04-01 |
UY24246A1 (es) | 1996-06-14 |
TNSN96082A1 (fr) | 1998-12-31 |
BR9608989A (pt) | 1999-06-29 |
AU5990396A (en) | 1996-12-24 |
CO4700435A1 (es) | 1998-12-29 |
JPH11507350A (ja) | 1999-06-29 |
AU708824B2 (en) | 1999-08-12 |
KR19990022343A (ko) | 1999-03-25 |
CZ387097A3 (cs) | 1998-06-17 |
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