CN113069373A - 一种干眼眼霜、制备方法及应用 - Google Patents
一种干眼眼霜、制备方法及应用 Download PDFInfo
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Abstract
本发明属于皮肤护理制剂的研发技术领域,尤其涉及一种干眼眼霜、制备方法及应用。本发明将右旋龙脑(龙脑樟提取物)用于制备眼霜,成分简单,可以辅助干眼治疗,还能消肿止痛,其气味还可以提神醒脑,消费面广,相比于滴眼液、护眼贴而言,使用更方便,且眼霜属于护肤品,使用时能够降低患者的心理压力。本发明制备的眼霜包括A相:聚二甲基硅油烷0.80~1.25%;矿酯4.0~15.0%;B相:丙三醇2.80~5.50%;1,2‑戊二醇0.6~1.7%;水6.5~14.0%;C相:三乙醇胺0.06~2.02%;鲸蜡硬脂醇0.07~1.05%;D相:右旋龙脑0.05~0.50%;E相:余量水;pH为5.0~7.0。
Description
技术领域
本发明属于皮肤护理制剂的研发技术领域,尤其涉及一种干眼眼霜、制备方法及应用。
背景技术
人体皮肤最薄的部位即是眼周皮肤,约为脸部皮肤厚度的四分之一。由于皮脂腺和汗腺的缺乏,供给的油脂含量少,不能满足眼周皮肤天然的滋润需求,使得眼周皮肤非常容易干燥。同时眼周皮下柔软而富有弹性疏松结缔组织的纤维结构中分布着极为丰富的毛细血管和神经末稍,这些毛细血管的管壁非常薄,并且有一定的渗透性,因此容易充血,积水,形成血肿或水肿。
干眼症指的是各种原因造成的泪液减少,导致泪膜稳定性下降,引起眼部不适的疾病,是一种较为常见的眼部疾病。按病因分为以下五种类型:①水液缺乏型干眼症,主要原因在于水液性泪液生成不足或质量异常,从而难以维持正常需求;②脂质缺乏型干眼症,眼部脂质层出现质或量的改变,没有脂质层的保护,水分容易蒸发,导致泪膜不稳定;③泪液动力学异常型干眼症,由于泪液不能均匀地分布在眼的表面,从而影响泪膜的正常功能;④黏蛋白缺乏型干眼症,由于患者缺乏黏蛋白分泌而导致的干眼。⑤混合型干眼症,由于以上两种或两种以上病因导致的干眼,是最为常见的一种类型。
综合上述,因眼周皮肤问题而影响的主要为①②⑤型。
右旋龙脑(龙脑樟提取物)即天然冰片是一种非常珍贵的医药材料。《海药本草》记载:“主内外障眼,治五痔、明目、镇心。”因其制作工艺复杂,用途十分广泛,可以开窍醒神,清热止痛,活血化瘀,素有“软黄金”之称。因右旋龙脑(龙脑樟提取物)渗透性强,无添加防腐剂,对护眼疗效甚佳,具有明目去翳之功效。
然而,市面上主要将右旋龙脑(龙脑樟提取物)用于滴眼液和护眼贴,用其制作的眼霜产品几乎没有。并且已有的发明专利或者生产产品主要针对的仅有以下几个方面:①眼部护理,如去除黑眼圈、淡化雀斑、消除水肿、改善眼袋、去皱和紧致、抗衰老等;②缓解由各种眼病引起的眼睛发干、发涩、眼部胀痛等视力疲劳症状;③防止和减少长时间佩戴隐形眼镜或镜垢引起的不适;操作电脑、看书、看电视或游泳、尘埃、花粉及汗水等引起的眼部干涩、痒痛等日常抑菌护理;④治疗因血热、内热蕴结所致的疮疡肿疖等症以及各类眼疾。
因此,尽管有少部分关于右旋龙脑(龙脑樟提取物)用于干眼症的探究,如吴一仙等人(吴一仙,高合意,曾飒,张革.天然冰片在药妆品中的应用研究进展[J].广州化工,2016,44(24):9-11.)从治疗干眼症方面介绍了右旋龙脑(龙脑樟提取物)在药妆品中的功效;文勇(文勇.珍珠明目滴眼液质量控制及治疗干眼症的药效及作用机理研究[D].广州中医药大学,2017.)研究了珍珠明目滴眼液中治疗干眼的药效物质珍珠液或珍珠层粉液与冰片液能够促进干眼患者的泪液分泌,提高眼表上皮细胞损伤修复,保护泪膜蛋白结晶形态完整性,降低眼表细胞炎症的作用机理。但是真正将右旋龙脑(龙脑樟提取物)用于缓解干眼症状的发明专利和生产产品在市面上少之又少,所以本申请设计了这款一种以右旋龙脑(龙脑樟提取物)为主要成分的眼霜来用于缓解干眼症状,填补亟待解决的市场空白。
发明内容
针对现有技术存在的问题,本发明提供了一种干眼眼霜、制备方法及应用,目的在于解决现有技术中的一部分问题或至少缓解现有技术中的一部分问题。
本发明是这样实现的,一种干眼眼霜,pH为5.0~7.0,包括以下重量体积百分比的组分:
A相:聚二甲基硅油烷0.80~1.25%;矿酯4.0~15.0%;
B相:丙三醇2.80~5.50%;1,2-戊二醇0.6~1.7%;水6.5~14.0%;
C相:三乙醇胺0.06~2.02%;鲸蜡硬脂醇0.07~1.05%;
D相:右旋龙脑0.05~0.50%;
E相:余量水。
本发明还提供了一种干眼眼霜的制备方法,包括以下步骤:
将A相组分在水浴锅中搅拌溶解,保温备用;
将B相组分搅拌混合均匀;
将D相组分在水浴锅中搅拌溶解,保温备用;
在水浴条件下将溶解好的D相加入至A相中,混合均匀,之后加入B相,充分混合;
将A相、B相和D相混合物冷却,缓慢加入C相及E相得到混合体系,搅拌,冷却。
进一步地,A相组分的溶解温度为75℃~80℃。
进一步地,B相组分的溶解温度为室温。
进一步地,D相组分的溶解温度为35℃~45℃。
进一步地,在75℃~80℃水浴条件下将溶解好的D相加入至A相中。
进一步地,将A相、B相和D相混合物冷却至38℃~45℃时,加入C相及E相。
进一步地,混合体系冷却至20℃~28℃,得到干眼眼霜。
本发明还提供了如上述的一种干眼眼霜在制备治疗干眼症的皮肤护理制剂中的应用。
A相中聚二甲基硅油烷对右旋龙脑具有缓释定香作用,化学稳定性良好且不影响其它化学成分的活性与稳定性。矿酯是一种常见的保湿物质,可以在皮肤变面形成透明屏障,防止皮肤水分丢失的同时延长右旋龙脑的作用时间,增加局部皮肤对右旋龙脑的吸收。
B相中丙三醇为一种常见的保湿剂,对局部皮肤刺激性小,同时也可以增加眼霜中其它成分的溶解性。1,2-戊二醇可以增加其它化学成分在体系中的溶解性,同时还具有抗菌作用,可以减少眼霜在使用过程中的细菌污染,保证使用过程中的安全性,延长使用时间。
C相中三乙醇胺为一种pH调节剂,使霜体的pH接近眼周局部皮肤,减少对皮肤和眼的刺激性。鲸蜡硬脂醇作为一种增稠剂、乳化剂、表面活性剂,可以促进眼霜中的有效成分渗透进入局部皮肤,同时使产品更容易涂抹。
D相中右旋龙脑为本发明主要作用成分。
综上所述,本发明的优点及积极效果为:
1.含有右旋龙脑。右旋龙脑是龙脑樟的提取物,其渗透性强,无添加防腐剂,对护眼疗效甚佳,具有明目去翳之功效。有研究表明右旋龙脑可以促进泪液分泌,提高眼表上皮细胞损伤修复,保护泪膜蛋白结晶形态完整性,降低眼表细胞炎症的作用,这些机理证明其在干眼的治疗上的功效。
2.具有治疗功效。由于疫情期间,大部分人选择的消遣方式变成“宅在家”,长时间对着手机,电脑等视频终端,使得出现干眼症状的人越来越多。常规的治疗方式包括人工泪液,抗炎治疗等。同时一些辅助治疗也表现出了较好的效果,如湿房镜。眼部的皮肤非常薄,外用眼霜可以渗透到皮下组织腺体,从而进行干眼治疗。
3.创新。市面上主要将右旋龙脑(龙脑樟提取物)用于滴眼液和护眼贴,用其制作的眼霜产品还没有。市面上含有右旋龙脑的滴眼液,如珍珠明目滴眼液,10mL滴眼液含右旋龙脑约为2.23-3.06mg。(林琦.气相色谱法测定珍珠明目滴眼液中龙脑含量[J].中国药业,2013,18.)护眼贴里龙脑含量为5g(申请专利号:CN201810567918.2),但眼贴需要考虑使用地点还有敷贴时间。
4.心理负担小。临床上有些干眼患者在使用人工泪液或其他抗炎症的眼药水时会有心理负担,害怕滴眼药水。还存在一些患者一个人无法完成滴眼药水。眼霜的使用类似护肤品,能够降低这类患者的心理压力。
5.不同年龄段都适用。俗话说眼睛是心灵的一扇窗,而现在正值疫情防控阶段,人们的焦点越来越多的转移到了眼部。随着“口罩装”的大火,眼部保健护理的关注度也逐渐提高。其中眼部护肤品最常见的就是眼霜。常规的眼霜有不同功能,比如抗“黑眼圈”,去“眼袋”,祛皱等功效。不同功效的眼霜是针对某一些特定人群。而干眼眼霜老少皆宜,适用人群面更广。
6.使用方便。不像湿房镜等辅助治疗方式,干眼眼霜使用方式更简单且不受时间地点的限制。使用方法也更容易学会。
7.结构简单。相比市面上大品牌的眼霜,本干眼眼霜成分简单,可以辅助干眼治疗,消费面更广。
8.成本低。虽然右旋龙脑制作工艺复杂,可用途非常广泛。现在已经有工厂可以大规模生产。
9.功效多。右旋龙脑除了可以针对干眼有很好的疗效,还能消肿止痛,其气味还可以提神醒脑。
附图说明
图1是泪液分泌实验结果;
图2是角膜荧光素钠染色结果;
图3是角膜神经纤维密度统计结果;
图4是角膜神经纤维分支数量统计结果;
图5是角膜曲率统计结果;
图6是角膜上皮基底细胞数量统计结果;
图7是角膜炎症细胞数量统计结果。
具体实施方式
为了使本发明的目的、技术方案及优点更加清楚明白,以下结合实施例,对本发明进行进一步详细说明,各实施例及试验例中所用的设备和试剂如无特殊说明,均可从商业途径得到。此处所描述的具体实施例仅用以解释本发明,并不用于限定本发明。
根据本申请包含的信息,对于本领域技术人员来说可以轻而易举地对本发明的精确描述进行各种改变,而不会偏离所附权利要求的精神和范围。应该理解,本发明的范围不局限于所限定的过程、性质或组分,因为这些实施方案以及其他的描述仅仅是为了示意性说明本发明的特定方面。实际上,本领域或相关领域的技术人员明显能够对本发明实施方式作出的各种改变都涵盖在所附权利要求的范围内。
为了更好地理解本发明而不是限制本发明的范围,在本申请中所用的表示用量、百分比的所有数字、以及其他数值,在所有情况下都应理解为以词语“大约”所修饰。因此,除非特别说明,否则在说明书和所附权利要求书中所列出的数字参数都是近似值,其可能会根据试图获得的理想性质的不同而加以改变。各个数字参数至少应被看作是根据所报告的有效数字和通过常规的四舍五入方法而获得的。本发明中,“约”指给定值或范围的10%以内,优选为5%以内。
本发明披露了一种干眼眼霜、制备方法及应用,具体如下实施例所示。
实施例1-5
实施例1-5所涉及的配方组分如表1所示。
表1实施例1-5的配方
制备方法如下:
1)制备龙脑樟提取物(右旋龙脑):通过水蒸气蒸馏法提取龙脑樟中的右旋龙脑。具体过程描述为:称取100g龙脑樟树叶,蒸馏水洗净后用剪刀绞碎,放入三口烧瓶中,加入蒸馏水800mL,控制温度115℃恒温加热,1h后停止加热,用乙酸乙酯对过滤得到的溶液进行洗涤,加入适量无水硫酸钠进行干燥,真空干燥得到天然冰片粗品。使用石油醚-乙酸乙酯(质量比为200:1)的硅胶柱层析梯度洗脱粗制品后得到冰片(右旋龙脑)。
2)按照上表所示准备相应重量物质;
3)将A相中各组分置于75℃~80℃水浴锅中搅拌30~35分钟,使其溶解,保温备用;
4)将B相中各组分在室温下缓慢混合,边混合边搅拌;
5)将D相中各组分置于35℃~45℃水浴条件下混合搅拌10分钟,使其溶解混合均匀;
6)将溶解好的D相在75℃~80℃水浴条件下加入A相使其分散均匀,然后加入预先准备好的B相;
7)将上述混合产物搅拌25~30分钟后静置使其冷却并监测温度,当温度达到38℃~45℃时将C相及E相缓慢加入并持续搅拌,直至混合体系温度降至20℃~28℃;
8)停止搅拌,出料,即可得到所述眼霜。
实施例6右旋龙脑眼霜的稳定性、安全性和动物实验疗效评价
右旋龙脑眼霜对干眼小鼠的治疗作用
建立苯扎溴铵干眼模型:10-12周龄的雌性C57BL/6小鼠,用1g/L浓度苯扎溴铵点眼7天,每天3次。干预组采用实施例1的操作方法制备右旋龙脑眼霜。溶剂组采用实施例1的操作方法,增加E相含量代替龙脑樟。点眼方式:用刮毛器将小鼠双眼眼周毛发剔除后使用上述眼霜进行,每天3次,涂于双眼眼周。
将右旋龙脑眼霜涂于苯扎溴铵碱诱导的干眼模型小鼠的眼周,比较干眼组(DryEye)、溶剂组(Vehicle)和右旋龙脑眼霜组(Borneol camphor)在治疗前(0周)、干预1周、干预2周后各项指标的变化:
评价指标与操作方法:
1、泪液分泌实验:用眼科持针器夹酚红棉线轻轻插入小鼠内眦部结膜囊处,25秒后,取下酚红棉线测量变色长度。
2、角膜荧光素钠染色:用移液枪将0.5μL荧光素钠染色溶液滴入小鼠下结膜囊内,手动瞬目,1分钟后用1mL生理盐水冲洗结膜囊,活体荧光显微镜下观察并拍摄角膜上皮荧光染色情况。
3、角膜共聚焦显微镜观察:将小鼠麻醉后,用眼部表面麻醉滴双眼,卡波姆凝胶涂布眼表后,置于角膜共聚焦显微镜下观察,分析并统计各组小鼠角膜神经纤维密度、神经纤维分支、角膜曲率评分、角膜上皮基底细胞数量和炎症细胞数量。
实验结果与结论:
1、泪液分泌实验结果显示,与干眼组和溶剂组相比,右旋龙脑眼霜干预2周后,泪液分泌量显著升高。结果说明:右旋龙脑眼霜可显著增加泪液分泌量。(如图1所示)
2、角膜荧光素钠染色结果显示,与干眼组和溶剂组相比,右旋龙脑眼霜干预1周和2周后,角膜荧光素钠染色评分明显降低。结果说明:右旋龙脑眼霜可显著减轻角膜上皮损伤,具有保护角膜上皮屏障的效果。(如图2所示)
3、角膜神经纤维密度结果显示,与干眼组和溶剂组相比,右旋龙脑眼霜干预2周后,角膜神经纤维密度升高。(如图3所示)
4、角膜神经纤维分支数量结果显示,与干眼组和溶剂组相比,右旋龙脑眼霜干预1周和2周后,角膜神经纤维分支数量未见明显改变。(如图4所示)
5、角膜曲率结果显示,与干眼组和溶剂组相比,右旋龙脑眼霜干预1周和2周后,角膜曲率未见明显改变。(如图5所示)
6、角膜上皮基底细胞数量统计结果显示,与干眼组和溶剂组相比,右旋龙脑眼霜干预1周和2周后,角膜上皮基底细胞数量未见明显改变。(如图6所示)
7、角膜炎症细胞数量统计结果显示,与干眼组和溶剂组相比,右旋龙脑眼霜干预2周后,角膜炎症细胞数量显著降低。(如图7所示)
以上所述仅为本发明的较佳实施例而已,并不用以限制本发明,凡在本发明的精神和原则之内所作的任何修改、等同替换和改进等,均应包含在本发明的保护范围之内。
Claims (9)
1.一种干眼眼霜,其特征在于,包括以下重量体积百分比的组分:
A相:聚二甲基硅油烷0.80~1.25%;矿酯4.0~15.0%;
B相:丙三醇2.80~5.50%;1,2-戊二醇0.6~1.7%;水6.5~14.0%;
C相:三乙醇胺0.06~2.02%;鲸蜡硬脂醇0.07~1.05%;
D相:右旋龙脑0.05~0.50%;
E相:余量水;
pH为5.0~7.0。
2.如权利要求1所述的一种干眼眼霜的制备方法,其特征在于,包括以下步骤:
将A相组分在水浴锅中搅拌溶解,保温备用;
将B相组分搅拌混合均匀;
将D相组分在水浴锅中搅拌溶解,保温备用;
在水浴条件下将溶解好的D相加入至A相中,混合均匀,之后加入B相,充分混合;
将A相、B相和D相混合物冷却,缓慢加入C相及E相得到混合体系,搅拌,冷却。
3.根据权利要求2所述的一种干眼眼霜的制备方法,其特征在于:A相组分的溶解温度为75℃~80℃。
4.根据权利要求2所述的一种干眼眼霜的制备方法,其特征在于:B相组分的溶解温度为室温。
5.根据权利要求2所述的一种干眼眼霜的制备方法,其特征在于:D相组分的溶解温度为35℃~45℃。
6.根据权利要求2所述的一种干眼眼霜的制备方法,其特征在于:在75℃~80℃水浴条件下将溶解好的D相加入至A相中。
7.根据权利要求2所述的一种干眼眼霜的制备方法,其特征在于:将A相、B相和D相混合物冷却至38℃~45℃时,加入C相及E相。
8.根据权利要求2所述的一种干眼眼霜的制备方法,其特征在于:混合体系冷却至20℃~28℃,得到干眼眼霜。
9.如权利要求1所述的一种干眼眼霜在制备治疗干眼症的皮肤护理制剂中的应用。
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