CN114558069A - 一种眼部舒缓涂抹液及其制备方法 - Google Patents
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Abstract
本发明的目的在于提供一种眼部舒缓涂抹液组合物及其制备方法,该组合物,包括具有调节眼部微循环、眼压及缓解视疲劳的A相、具有补充眼部营养成分的B相、助剂和纯化水。其中,A相以质量计,包括西药组分一和中药组分二,其中:西药组分一包括阿托品0.1g、后马托品0.1g、托吡卡胺0.1g中的至少一种;中药组分二包括决明子提取物0.5g、桑叶提取物0.5g、万寿菊花提取物0.2g、合欢花提取物0.5g、小米草提取物0.5g、洋地黄提取物0.2g中的至少一种;B相以质量计,包括如下组分:维生素A1g、维生素B10.5g、维生素B20.005g、维生素B120.001g、三磷酸腺苷0.5g、欧洲越桔籽油1g和叶黄素0.001g;助剂和纯化水1~100g。本发明具有外用涂抹、安全无刺激及效果佳的优点。
Description
技术领域
本发明涉及眼部护理技术领域,具体涉及一种眼部舒缓涂抹液及其制备方法。
背景技术
《人民日报》2021年5月31日发表“预防近视保护未成年人美好“视”界”文章,核心内容为:世界卫生组织近日呼吁高度重视儿童青少年近视问题。通过常规检查做到早预防、早护理、早治疗,可有效避免眼部疾患。当前,一些国家正综合采取各种举措,加强未成年人近视防控。世界卫生组织发布的《世界视力报告》显示,目前全球近视人数约26亿,其中19岁以下近视人数达3.12亿。儿童青少年近视率近年来不断上升,并且在未来几十年内还将继续大幅增长。报告分析,现代社会人们长时间待在室内从事大量“近距离工作”,导致全球近视人群数量呈增长趋势。世卫组织总干事谭德塞表示,将眼科保健纳入国家卫生计划和基本卫生保健服务是每个国家实现全民健康覆盖的重要组成部分。
随着电子产品的大量普及,在为人们生活带来便利的同时也更容易造成人们用眼疲劳,尤其是对一些需要长时间在电脑前工作的上班族而言,眼睛干涩、困乏、酸胀等用眼疲劳的症状十分常见。对此,人们通常会选择滴眼液来缓解用眼疲劳的症状,以预防和改善青少年中出现的高近视率的问题。而且眼睛在长时间疲劳状态下,容易导致干眼症、结膜炎、沙眼、麦粒肿等眼部炎症问题,从而引发甚至加重为散光、迎风流泪、青光眼、飞蚊症、血盲症、黄斑病变等眼部疾病问题。
但是市面上传统产品在使用时,需要滴入眼部,容易对眼球造成刺激,引起人体不适。除此之外,由于眼睛内部构造特殊,比起皮肤更难抵御外来细菌,若是滴眼液使用不当很容易引起眼部炎症。因此,针对现实的需要以及市面上产品的缺点,急需一款不需进入眼球、外用涂抹即可有效缓解眼睛干涩、困乏、酸胀等用眼疲劳的症状的眼部舒缓涂抹产品,这是亟待解决的问题。
发明内容
本发明的目的是提供一种眼部舒缓涂抹液及其制备方法,该眼部舒缓涂抹液具有外用涂抹,安全无刺激及效果佳的优点。
为了实现上述目的,本发明提供如下技术方案:
一种眼部舒缓涂抹液,包括具有调节眼部微循环、眼压及缓解视疲劳的A 相、具有补充眼部营养成分的B相、助剂和纯化水。
其中,A相以质量计,包括西药组分一和中药组分二;
其中:西药组分一包括阿托品0.01~2g、后马托品0.01~2g、托吡卡胺0.01~2g中的至少一种,其中单个组分比例为0.01~10g,优选为0.5~6g,更优选为0.1~3g;
中药组分二包括决明子提取物0.1~1g、桑叶提取物0.2~1g、万寿菊花提取物0.1~0.5g、合欢花提取物0.2~0.8g、小米草提取物0.1~1g和洋地黄提取物 0.1~0.3g中的至少一种,其中单个组分比例为0.1~6g,优选为0.1~3g,更优选为 0.1~1g;
B相以质量计,包括如下组分:维生素B2 0.001~0.01g、维生素B12 0.001~0.01g、叶黄素0.001g~0.01g;维生素A 0.5~1.5g、维生素B1 0.1~1g、三磷酸腺苷0.2~1g和欧洲越桔籽油0.5~2g,其中单一比例为0.1~6g,优选为 0.1~3g,更优选为0.1~2g;
助剂,以质量计:氢化蓖麻油0.1~10g,优选为0.2~8g,更优选为1-6g;鲸蜡醇乙基己酸酯为1~10g,优选为2~5g;苯氧乙醇比例为0.1~2g,优选为0.2~1g,更优选为0.2~0.8g;
纯化水1~100g。
作为优选,助剂还包括透明质酸钠、胞外多糖、小核菌胶中的一种,或是它们的混合物。
作为优选,A相还包括枸杞提取物、金银花提取物、菊花提取物、天麻根提取物、丹参提取物、黄芩提取物以及党参提取物中的一种,或是它们的混合物。
作为优选,A相还包括菟丝子提取物、女贞子提取物、当归提取物、夏枯草提取物以及苍术提取物中的一种,或是它们的混合物。
作为优选,A相还包括密蒙花提取物、谷精草提取物、青葙子提取物、人参提取物及石斛提取物中的一种,或是它们的混合物。
作为优选,该眼部舒缓涂抹液包括如下组分:具有调节眼部微循环、眼压及缓解视疲劳的A相、具有补充眼部营养成分的B相、助剂和纯化水。其中:
A相以质量计,包括西药组分一和中药组分二,其中:西药组分一包括阿托品0.1g;
中药组分二包括决明子提取物0.5g、桑叶提取物0.5g、万寿菊花提取物 0.2g、合欢花提取物0.5g、小米草提取物0.5g、党参提取物0.2g、洋地黄提取物0.2g、菟丝子提取物0.5g、青葙子提取物0.5g、密蒙花提取物0.5g;
B相以质量计,包括如下组分:维生素A 1g、维生素B1 0.5g、维生素B2 0.005g、维生素B12 0.001g、三磷酸腺苷0.5g、欧洲越桔籽油1g和叶黄素 0.001g;
助剂以质量计,包括如下组分:透明质酸钠0.1g、胞外多糖0.1g、氢化蓖麻油6g、鲸蜡醇乙基己酸酯1g和苯氧乙醇0.6g。
纯化水84.993g;
本发明还提供了一种眼部舒缓涂抹液的制备方法,该制备方法包括如下步骤:
S01、精确称取水相:纯化水84.993g、阿托品0.1g、决明子提取物0.5g、桑叶提取物0.5g、万寿菊花提取物0.2g、合欢花提取物0.5g、小米草提取物0.5g、党参提取物0.2g、洋地黄提取物0.2g、菟丝子提取物0.5g、青葙子提取物0.5g、密蒙花提取物0.5g、维生素B10.5g、维生素B2 0.005g、维生素B12 0.001g、三磷酸腺苷0.5g、透明质酸钠0.1g、胞外多糖0.1g;
S02、精确称取油相:氢化蓖麻油6g、鲸蜡醇乙基己酸酯1g、欧洲越桔籽油1g、维生素A1g、叶黄素0.001g;
S03、添加相:苯氧乙醇0.6g;
S04、将水相中的各组分混合搅拌至溶解,加热温度至50~95℃,优选为 60~90℃,更优选为70~80℃;
S05、将油相中的各组分混合搅拌均匀,加热温度至50~95℃,优选为 60~90℃,更优选为70~80℃,搅拌,转速范围为200~2500rpm,优选为 300~1500rpm,更优选为300~1000rpm;
S06、在搅拌或均质的条件下,将水相缓缓加入油相中,搅拌5~30分钟;其中,上述搅拌子的转速转速范围为200~2500rpm,优选为300~2000rpm,更优选为300~1500rpm,搅拌时的温度为50~95℃,优选为60~90℃,更优选为70~80℃;
S07、降低转速搅拌并降温至30~50℃,最后加入添加相,搅拌至室温,得到眼部舒缓涂抹液;其中,上述搅拌的转速为200~600rpm。
作为优选,步骤S04中,温度为72~80℃。
作为优选,步骤S05中,温度为72~80℃,转速为300~950rpm。
作为优选,步骤S06中,搅拌时间为5~15分钟,搅拌的转速为500~1500rpm,搅拌时的温度为72~80℃。
作为优选,步骤S07中,搅拌的转速为250~500rpm,搅拌时的温度为 35~45℃。
与现有技术相比,本发明提供的技术有如下效果和优点:
A相中部分组分功效例举如下:阿托品:调节眼压,加速新陈代谢。
万寿菊花提取物:促进视网膜细胞中视紫质的再生成,能预防重度近视及视网膜剥离,能增进视力、保护视力;还能有效缓解视物模糊、眼干涩、眼胀、眼痛、畏光等问题,通过提高晶状体的抗氧化能力去保护视力健康。
洋地黄提取物:洋地黄苷可以激活视网膜色素上皮细胞中色素上皮酶的活性,增强眼部脂质代谢、恢复感光细胞,能治疗视物模糊、重影,可通过增加睫状体血流量来增强睫状肌收缩力和调节能力。缓解肌源性眼疲劳引发的视物模糊等问题。
小米草提取物:有效清除体内的氧自由基,这种抗氧化作用可以消除眼睛疲劳,增进视力及眼部机能,明眸再现。
B相中部分组分功效例举如下:维生素A:维生素A最早被认识的功能是在视觉细胞内参与维持暗视感光物质循环。视网膜上的杆状细胞含有的视紫红质,其对暗光敏感。视紫红质感光后,11-顺式视黄醛转变为全反式视黄醛并与视蛋白分离,产生视觉电信号。要维持良好的暗光视觉,就需要源源不断地向杆状细胞供给充足的11-顺式视黄醛。维生素A缺乏时,11-顺式视黄醛供给减少,暗适应时间延长。
维生素B2:缺乏时可引起如睑缘炎、怕光、易流泪、易有倦怠感、视物模糊、结膜充血、角膜毛细血管增生、引起结膜炎等等眼部问题。
维生素B12:缺乏可引起眼睛发黄。
三磷酸腺苷:是一种高能磷酸化合物,在细胞中,它能与二磷酸腺苷的相互转化实现贮能和放能,从而保证了细胞各项生命活动的能量营养供应。
欧洲越桔籽油:促进视网膜细胞中的视紫质再生,预防近视,增进视力。
叶黄素:能够帮助眼睛的视网膜抵御紫外线。对于眼睛来说,叶黄素是一种重要的发挥作用的抗氧化剂。向人体补充大量叶黄素,有助于维护视力持久度,提高视觉反应时间,减少视觉伤害。对于近视者来说,补充叶黄素可以延缓其近视度数的增加。
A相与B相各组分之间协同增效,在即时缓解视疲劳的同时,调节眼压,补充眼部营养成分,让封闭的眼部环境更加湿润,修复眼部内微循环,相辅相成、协同增效。
并有如下优点:
1、仅在上下眼皮上按摩滚动,精准递送,不进入眼睛内,不到达视网膜,对眼睛无刺激无伤害。
2、渗透率高,吸收速度快,吸收速率接近百分之百。
3、使用后立即缓解眼睛干、涩、困、乏、酸、胀等症状,效果明显。
4、有安全保障,不含激素、麻醉药等有害成分。
附图说明
图1为实施例1B使用涂抹液4周效果图;
图2为实施例2B使用涂抹液4周效果图;
图3为实施例3B使用涂抹液4周效果图;
图4为实施例4使用涂抹液4周效果图;
图5为实施例5使用涂抹液4周效果图;
图6为实施例6使用涂抹液4周效果图;
图7是阿托品低浓度样品稳定性评测结果统计表;
图8为阿托品高浓度样品稳定性评测结果统计表;
图9为后马托品低浓度样品稳定性测评结果统计表;
图10为后马托品高浓度样品稳定性测评结果统计表;
图11为托吡卡胺低浓度样品稳定性测评结果统计表;
图12为托吡卡胺高浓度样品稳定性测评结果统计表;
图13为中药组合物1样品稳定性测评结果统计表;
图14为中药组合物2样品稳定性测评结果统计表;
图15为中药组合物3样品稳定性测评结果统计表。
具体实施方式
我们已经开展了许多实验和验证,下面仅列举一些典型的对本发明实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例仅仅是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。
1、使用NDJ-79A数字旋转粘度计(上海昌地地质仪器有限公司)测定粘度(mpa·s)。
测试了在以下三种常见条件下的稳定性:
1)室温(25℃,T=0,1个月,3个月,6个月);
2)高温(40℃,T=0,1个月);
3)冷藏(5℃,T=0,1个月,3个月,6个月)。
每一个时间点测定的数据包括粘度、外观表征(是否分层、颜色是否改变) 等指标,具体结果见各实施例后的附表。
2、制备好的涂抹液对部分体验者进行了初步试用,效果明显。
3、使用方法:头微后仰,眼皮闭上,将眼部舒缓涂抹液载体(例如滚珠) 接触眼皮肌肤,使其呈顺时针或逆时针转动至少10圈,直至感受有液体停留在眼皮表面。使用期间,需保持每天多次使用,尤其在长时间用眼后(如开车、看手机、看电脑、看书),使用效果最佳;每天至少10次。
实施例1A:低浓度阿托品(0.1%)
一种眼部舒缓涂抹液,由具有调节眼部微循环、眼压及缓解视疲劳的A相、具有补充眼部营养成分的B相、助剂和纯化水混制而成,其中:
A相以质量计,包括阿托品0.1g;
B相以质量计,包括如下组分:维生素A1g、维生素B1 0.5g、维生素B2 0.005g、维生素B12 0.001g、三磷酸腺苷0.5g、欧洲越桔籽油1g和叶黄素 0.001g;
助剂以质量计,包括如下组分:透明质酸钠0.1g、胞外多糖0.1g、氢化蓖麻油6g、鲸蜡醇乙基己酸酯1g和苯氧乙醇0.6g。
纯化水89.093g。
将上述组分分为油相、水相和添加相,如下:
水相:纯化水89.093g、阿托品0.1g、维生素B1 0.5g、维生素B2 0.005g、维生素B120.001g、三磷酸腺苷0.5g、透明质酸钠0.1g、胞外多糖0.1g。
油相:氢化蓖麻油6g、鲸蜡醇乙基己酸酯1g、欧洲越桔籽油1g、维生素A 1g、叶黄素0.001g。
添加相:苯氧乙醇0.6g。
制备方法:水相中组分加入纯化水中,加热至80℃;油相中组分混合搅拌均匀,加热至80℃;在高速搅拌下(1500rpm),油相缓缓加入水相中,高速搅拌10分钟后,降低转速搅拌并降温至40℃,最后加入添加相,搅拌至室温,停止搅拌。得到淡黄色的液体。
稳定性得到结果如图7。
实施例1B:高浓度阿托品(2%)
阿托品涂抹液(高浓度2%)的具体组分和制备方法与上述实施例1A一致,只是阿托品的浓度为高浓度,即阿托品的用量为2%(水相中为2g)。最后可制备得到黄色的液体。
稳定性得到结果如图8。
低浓度阿托品涂抹液缓解视疲劳效果明显,对近视效果不明显;高浓度阿托品涂抹液缓解视疲劳效果很明显,对近视效果明显,使用涂抹液4周左右,左眼度数由350度降为325度,下降25度,右眼度数由400度降为375度,下降25度(见图1)。
实施例2A:低浓度后马托品(0.1%)
一种眼部舒缓涂抹液,由具有调节眼部微循环、眼压及缓解视疲劳的A相、具有补充眼部营养成分的B相、助剂和纯化水混制而成,其中:
A相以质量计,包括后马托品0.1g;
B相以质量计,包括如下组分:维生素A1g、维生素B1 0.5g、维生素B2 0.005g、维生素B12 0.001g、三磷酸腺苷0.5g、欧洲越桔籽油1g和叶黄素0.001g;
助剂以质量计,包括如下组分:透明质酸钠0.1g、胞外多糖0.1g、氢化蓖麻油6g、鲸蜡醇乙基己酸酯1g和苯氧乙醇0.6g。
纯化水89.093g。
将上述组分分为油相、水相和添加相,如下:
水相:纯化水89.093g、后马托品0.1g、维生素B1 0.5g、维生素B2 0.005g、维生素B12 0.001g,三磷酸腺苷0.5g、透明质酸钠0.1g、胞外多糖0.1g;
油相:氢化蓖麻油6g、鲸蜡醇乙基己酸酯1g、欧洲越桔籽油1g、维生素A 1g、叶黄素0.001g。
添加相:苯氧乙醇0.6g。
制备方法:水相中组分加入纯化水中,加热至75℃;油相中组分混合搅拌均匀,加热至75℃;在高速搅拌下(1450rpm),油相缓缓加入水相中,高速搅拌15分钟后,降低转速搅拌并降温至39℃,最后加入添加相,搅拌至室温,停止搅拌,得到淡黄色的液体。
稳定性得到结果如图9。
实施例2B:高浓度后马托品(2%)
后马托品涂抹液(高浓度2%)的具体组分和制备方法与上述实施例2A一致,只是后马托品的浓度为高浓度,即后马托品的用量为2%(水相中为2g),最后可制备得到黄色的液体。
稳定性得到结果如图10。
低浓度后马托品涂抹液缓解视疲劳效果明显,对近视效果不明显;高浓度后马托品涂抹液缓解视疲劳效果很明显,对近视效果明显,使用涂抹液4周左右,左眼度数由675度降为600度,下降25度(见图2)。
实施例3A:低浓度托吡卡胺(0.1%)
一种眼部舒缓涂抹液,由具有调节眼部微循环、眼压及缓解视疲劳的A相、具有补充眼部营养成分的B相、助剂和纯化水混制而成,其中:
A相以质量计,包括托吡卡胺0.1g;
B相以质量计,包括如下组分:维生素A 1g、维生素B1 0.5g、维生素B2 0.005g、维生素B12 0.001g、三磷酸腺苷0.5g、欧洲越桔籽油1g和叶黄素 0.0010g;
助剂以质量计,包括如下组分:透明质酸钠0.1g、胞外多糖0.1g、氢化蓖麻油6g、鲸蜡醇乙基己酸酯1g和苯氧乙醇0.6g;
纯化水89.093g。
将上述组分分为油相、水相和添加相,如下:
水相:纯化水89.093g、托吡卡胺0.1g、维生素B1 0.5g、维生素B2 0.005g、维生素B12 0.001g,三磷酸腺苷0.5g、透明质酸钠0.1g、胞外多糖0.1g。
油相:氢化蓖麻油6g、鲸蜡醇乙基己酸酯1g、欧洲越桔籽油1g、维生素A 1g、叶黄素0.0010g。
添加相:苯氧乙醇0.6g。
制备方法:水相中组分加入纯化水中,加热至65℃;油相中组分混合搅拌均匀,加热至65℃;在高速搅拌下(1600rpm),油相缓缓加入水相中,高速搅拌10分钟后,降低转速搅拌并降温至46℃,最后加入添加相,搅拌至室温,停止搅拌。得到淡黄色的液体。
稳定性得到结果如图11。
实施例3B:高浓度托吡卡胺(2%)
托吡卡胺涂抹液(高浓度2%)的具体组分与上述实施例3A一致,只是托吡卡胺的浓度为高浓度,即托吡卡胺的用量为2%(水相中为1g,油相中为1g),最后可制备得到黄色的液体。
稳定性得到结果如图12。
低浓度托吡卡胺涂抹液缓解视疲劳效果明显,对近视效果不明显;高浓度托吡卡胺涂抹液缓解视疲劳效果很明显,对近视效果明显,使用涂抹液4周左右,左眼度数由375度降为350度,下降25度,右眼度数由475度降为450度,下降25度(见图3)。
实施例4:西药阿托品(0.1%)+中药组分
一种眼部舒缓涂抹液,由具有调节眼部微循环、眼压及缓解视疲劳的A相、具有补充眼部营养成分的B相、助剂和纯化水混制而成,其中:
A相以质量计,包括西药组分一和中药组分二,其中:西药组分一包括阿托品0.1g;
中药组分二包括决明子提取物0.5g、桑叶提取物0.5g、万寿菊花提取物0.2g、合欢花提取物0.5g、小米草提取物0.5g、洋地黄提取物0.2g、枸杞提取物0.5g、金银花提取物0.2g、菊花提取物0.5g、天麻根提取物0.5g、丹参提取物0.2g以及党参提取物0.2g;
B相以质量计,包括如下组分:维生素A 1g、维生素B1 0.5g、维生素B2 0.005g、维生素B12 0.001g、三磷酸腺苷0.5g、欧洲越桔籽油1g和叶黄素0.001g;
助剂以质量计,包括如下组分:透明质酸钠0.1g、胞外多糖0.1g、氢化蓖麻油6g、鲸蜡醇乙基己酸酯1g和苯氧乙醇0.6g;
纯化水84.593g。
将上述组分分为油相、水相和添加相,如下:
水相:纯化水84.593g、阿托品0.1g、决明子提取物0.5g、桑叶提取物0.5g、万寿菊花提取物0.2g、合欢花提取物0.5g、小米草提取物0.5g、洋地黄提取物 0.2g、枸杞提取物0.5g、金银花提取物0.2g、菊花提取物0.5g、天麻根提取物0.5g、丹参提取物0.2g、党参提取物0.2g、维生素B1 0.5g、维生素B2 0.005g、维生素 B12 0.001g、三磷酸腺苷0.5g、透明质酸钠0.1g、胞外多糖0.1g。
油相:氢化蓖麻油6g、鲸蜡醇乙基己酸酯1g、欧洲越桔籽油1g、维生素A 1g、叶黄素0.001g。
添加相:苯氧乙醇0.6g。
制备方法:水相中组分加入纯化水中,加热至85℃;油相中组分混合搅拌均匀,加热至85℃;在高速搅拌下(1400rpm),油相缓缓加入水相中,高速搅拌10分钟后,降低转速搅拌并降温至45℃,最后加入添加相,搅拌至室温,停止搅拌,最后得到棕色的液体。
稳定性得到结果如图13。
此中药组合物对缓解视疲劳效果明显,对近视明显效果明显,使用涂抹液4 周左右,左眼度数由525度降为325度,下降200度,右眼由200度降为175 度,下降25度(见图4)。
实施例5:西药阿托品(0.1%)+中药组分
一种眼部舒缓涂抹液,由具有调节眼部微循环、眼压及缓解视疲劳的A相、具有补充眼部营养成分的B相、助剂和纯化水混制而成,其中:
A相以质量计,包括西药组分一和中药组分二,其中:西药组分一包括阿托品0.1g;
中药组分二包括决明子提取物0.5g、桑叶提取物0.5g、万寿菊花提取物0.2g、合欢花提取物0.5g、小米草提取物0.5g、洋地黄提取物0.2g、密蒙花提取物0.5g、谷精草提取物0.5g、青葙子提取物0.5g、人参提取物0.1g以及石斛提取物0.5g;
B相以质量计,包括如下组分:维生素A1g、维生素B1 0.5g、维生素B2 0.005g、维生素B12 0.001g、三磷酸腺苷0.5g和欧洲越桔籽油1g、叶黄素0.001g;
助剂以质量计,包括如下组分:透明质酸钠0.1g、胞外多糖0.1g、氢化蓖麻油6g、鲸蜡醇乙基己酸酯1g和苯氧乙醇0.6g;
纯化水84.593g。
将上述组分分为油相、水相和添加相,如下:
水相:纯化水84.593g、阿托品0.1g、决明子提取物0.5g、桑叶提取物0.5g、万寿菊花提取物0.2g、合欢花提取物0.5g、小米草提取物0.5g、洋地黄提取物 0.2g、密蒙花提取物0.5g、谷精草提取物0.5g、青葙子提取物0.5g、人参提取物 0.1g、石斛提取物0.5g、维生素B1 0.5g、维生素B2 0.005g、维生素B12 0.001g、三磷酸腺苷0.5g、透明质酸钠0.1g、胞外多糖0.1g。
油相:氢化蓖麻油6g、鲸蜡醇乙基己酸酯1g、欧洲越桔籽油1g、维生素A 1g、叶黄素0.001g。
添加相:苯氧乙醇0.6g。
制备方法:水相中组分加入纯化水中,加热至80℃;油相中组分混合搅拌均匀,加热至80℃;在高速搅拌下(2000rpm),油相缓缓加入水相中,高速搅拌10分钟后,降低转速搅拌并降温至40℃,最后加入添加相,搅拌至室温,停止搅拌,最后得到棕色的液体。
稳定性得到结果如图14。
此中药组合物对缓解视疲劳效果明显,对近视效果明显,对近视效果明显,使用涂抹液3周后,左眼度数由375度降为275度,下降100度,右眼度数由 275度降为250度,下降25度(见图5)。
实施例6:中药组分
一种眼部舒缓涂抹液,由具有调节眼部微循环、眼压及缓解视疲劳的A相、具有补充眼部营养成分的B相、助剂和纯化水混制而成,其中:
A相以质量计,包括中药组分二,包括如下组分:决明子提取物0.5g、桑叶提取物0.5g、万寿菊花提取物0.2g、合欢花提取物0.5g、小米草提取物0.5g、洋地黄提取物0.2g、菟丝子提取物0.5g、女贞子提取物0.5g、当归提取物0.2g、夏枯草提取物0.5g以及苍术提取物0.5g;
B相以质量计,包括如下组分:维生素A 1g、维生素B1 0.5g、维生素B2 0.005g、维生素B12 0.001g、三磷酸腺苷0.5g和欧洲越桔籽油1g、叶黄素0.001g;
助剂以质量计,包括如下组分:透明质酸钠0.1g、胞外多糖0.1g、氢化蓖麻油6g、鲸蜡醇乙基己酸酯1g和苯氧乙醇0.6g;
纯化水84.593g。
将上述组分分为油相、水相和添加相,如下:
水相:纯化水84.593g、决明子提取物0.5g、桑叶提取物0.5g、万寿菊花提取物0.2g、合欢花提取物0.5g、小米草提取物0.5g、洋地黄提取物0.2g、菟丝子提取物0.5g、女贞子提取物0.5g、当归提取物0.2g、夏枯草提取物0.5g、苍术提取物0.5g、维生素B1 0.5g、维生素B2 0.005g、维生素B12 0.001g,三磷酸腺苷0.5g、透明质酸钠0.1g、胞外多糖0.1g。
油相:氢化蓖麻油6g、鲸蜡醇乙基己酸酯1g、欧洲越桔籽油1g、维生素A 1g、叶黄素0.001g。
添加相:苯氧乙醇0.6g。
制备方法:水相中组分加入纯化水中,加热至78℃;油相中组分混合搅拌均匀,加热至78℃;在高速搅拌下(1500rpm),油相缓缓加入水相中,高速搅拌15分钟后,降低转速搅拌并降温至40℃,最后加入添加相,搅拌至室温,停止搅拌。最后得到棕色的液体。
稳定性得到结果如图15。
此中药组合物对缓解视疲劳效果明显,对近视明显效果明显,使用涂抹液4 周左右,左眼度数由300度降为225度,下降75度,右眼由300度降为225度,下降75度(见图6)。
Claims (10)
1.一种眼部舒缓涂抹液,其特征在于,以质量计,包括具有调节眼部微循环、眼压及缓解视疲劳的A相、具有补充眼部营养成分的B相、助剂和纯化水,总计100g;
其中,A相以质量计,包括西药组分一和中药组分二;
其中:西药组分一包括阿托品0.01~2g、后马托品0.01~2g、托吡卡胺0.01~2g中的至少一种,其中单个组分比例为0.01~10g,优选为0.5~6g,更优选为0.1~3g;
中药组分二包括决明子提取物0.1~1g、桑叶提取物0.2~1g、万寿菊花提取物0.1~0.5g、合欢花提取物0.2~0.8g、小米草提取物0.1~1g和洋地黄提取物0.1~0.3g中的至少一种,其中单个组分比例为0.1~6g,优选为0.1~3g,更优选为0.1~1g;
B相以质量计,包括如下组分:维生素B20.001~0.01g、维生素B120.001~0.01g、叶黄素0.001g~0.01g;维生素A 0.5~1.5g、维生素B10.1~1g、三磷酸腺苷0.2~1g和欧洲越桔籽油0.5~2g,其中单个组分比例为0.1~6g,优选为0.1~3g,更优选为0.1~2g;
助剂,以质量计:氢化蓖麻油0.1~10g,优选为0.2~8g,更优选为1-6g;鲸蜡醇乙基己酸酯为1~10g,优选为2~5g;苯氧乙醇比例为0.1~2g,优选为0.2~1g,更优选为0.2~0.8g;
纯化水1~100g。
2.根据权利要求1所述的一种眼部舒缓涂抹液,其特征在于,助剂还包括透明质酸钠、胞外多糖、小核菌胶中的一种,或是它们的混合物。
3.根据权利要求1所述的一种眼部舒缓涂抹液,其特征在于,A相还包括枸杞提取物、金银花提取物、菊花提取物、天麻根提取物、丹参提取物、黄芩提取物以及党参提取物中的一种,或是它们的混合物。
4.根据权利要求1所述的一种眼部舒缓涂抹液,其特征在于,A相还包括菟丝子提取物、女贞子提取物、当归提取物、夏枯草提取物以及苍术提取物中的一种,或是它们的混合物。
5.根据权利要求1所述的一种眼部舒缓涂抹液,其特征在于,A相还包括密蒙花提取物、谷精草提取物、青葙子提取物、人参提取物以及石斛提取物中的一种,或是它们的混合物。
6.根据权利要求1~5任一所述的一种眼部舒缓涂抹液,其特征在于,包括如下组分:具有调节眼部微循环、眼压及缓解视疲劳的A相、具有补充眼部营养成分的B相、助剂和纯化水;
其中,A相以质量计,包括西药组分一和中药组分二,其中:西药组分一包括阿托品0.1g;
中药组分二包括决明子提取物0.5g、桑叶提取物0.5g、万寿菊花提取物0.2g、合欢花提取物0.5g、小米草提取物0.5g、党参提取物0.2g、洋地黄提取物0.2g、菟丝子提取物0.5g、青葙子提取物0.5g、密蒙花提取物0.5g;
B相以质量计,包括如下组分:维生素A1g、维生素B10.5g、维生素B20.005g、维生素B120.001g、三磷酸腺苷0.5g、欧洲越桔籽油1g和叶黄素0.001g;
助剂以质量计,包括如下组分:透明质酸钠0.1g、胞外多糖0.1g、氢化蓖麻油6g、鲸蜡醇乙基己酸酯1g和苯氧乙醇0.6g;
纯化水84.993g。
7.一种眼部舒缓涂抹液的制备方法,其特征在于,包括如下步骤:
S01、精确称取水相:纯化水84.993g、阿托品0.1g、决明子提取物0.5g、桑叶提取物0.5g、万寿菊花提取物0.2g、合欢花提取物0.5g、小米草提取物0.5g、党参提取物0.2g、洋地黄提取物0.2g、菟丝子提取物0.5g、青葙子提取物0.5g、密蒙花提取物0.5g、维生素B10.5g、维生素B20.005g、维生素B120.001g、三磷酸腺苷0.5g、透明质酸钠0.1g、胞外多糖0.1g;
S02、精确称取油相:氢化蓖麻油6g、鲸蜡醇乙基己酸酯1g、欧洲越桔籽油1g、维生素A1g、叶黄素0.001g;
S03、添加相:苯氧乙醇0.6g
S04、将水相中的各组分混合搅拌至溶解,加热温度至50~95℃,优选为60~90℃,更优选为70~80℃;
S05、将油相中的各组分混合搅拌均匀,加热温度至50~95℃,优选为60~90℃,更优选为70~80℃,搅拌,转速范围为200~2500rpm,优选为300~1500rpm,更优选为300~1000rpm;
S06、在搅拌或均质的条件下,将水相缓缓加入油相中,搅拌5~30分钟;其中,上述搅拌子的转速转速范围为200~2500rpm,优选为300~2000rpm,更优选为300~1500rpm,搅拌时的温度为50~95℃,优选为60~90℃,更优选为70~80℃;
S07、降低转速搅拌并降温至30~50℃,最后加入添加相,搅拌至室温,得到眼部舒缓涂抹液;其中,上述搅拌的转速为200~600rpm。
8.根据权利要求7所述的一种眼部舒缓涂抹液的制备方法,其特征在于,步骤S04中,温度为72~80℃;
步骤S05中,温度为72~80℃,转速为300~950rpm;
步骤S06中,搅拌时间为5~15分钟,搅拌的转速为500~1500rpm,搅拌时的温度为72~80℃;
步骤S07中,搅拌的转速为250~500rpm,搅拌时的温度为35~45℃。
9.权利要求1~6任一所述的眼部舒缓涂抹液,其特征在于,根据浓度、粘度等实验参数可以相应制备成喷雾剂、精华液、霜剂、贴剂、凝胶、乳剂、凝露等制剂形式。
10.权利要求1~6任一所述的眼部舒缓涂抹液能有效防治眼底黄斑病变、视力模糊、视力老花、近视、散光、眼压异常、眼部炎症、眼干、眼痒、眼球晶状体浑浊以及眼睛迎风流泪症状。
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CN114053407A (zh) * | 2020-09-17 | 2022-02-18 | 温州医科大学 | 一种通过调节眼巩膜脂代谢来抑制近视的应用 |
CN113855557A (zh) * | 2021-09-10 | 2021-12-31 | 杭州芙源生物制药有限公司 | 一种具有舒缓眼部干涩疲劳功能的组合物及眼部舒缓液装纳瓶 |
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