CN115607534A - 一种mlct替代睑酯油及其制备方法 - Google Patents
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Abstract
本发明提供一种由MLCT替代睑酯油及其制备方法,一种MLCT替代睑酯油,其组成按质量百分比,由月桂酸40%~60%、豆蔻酸10%~30%、棕榈酸10%~20%、硬脂酸1%~10%、油酸1%~10%、亚油酸1%~10%和0.8%~3%组成。本发明配方独特,成分和工艺安全,适用人群广泛,疗效显著;品名、作用原理符合医疗器械的典型特征,比隐形眼镜护理液安全。
Description
技术领域
本发明涉及医学药物技术领域,具体涉及一种MLCT替代睑酯油及其制备方法。
背景技术
随着“读屏”时代的到来,人们使用各种智能手机等电子屏幕的时间越来越长,随之而来的用眼时长、不良用眼习惯也增加,干眼症也逐渐成为新的国民健康问题。按2020年中国干眼共识中,大部分干眼症患者的病因是脂质异常所致,通俗讲就是缺油。近年来人眼睑板腺分泌的睑酯的成分检测分析已成为全球眼科的研究热点,人眼睑板腺分泌的睑酯主要为甘油三酯(Triglyceride,简称TG),甘油三酯属中性脂肪,是人体脂类的重要组成部分,在几种天然植物中存在于人眼睑板腺分泌的睑酯重合的甘油三酯,但是对这些重合的甘油三酯如何进行分类组合,如何从中碳链脂肪酸甘油三酯(Medium ChainTriglycerides,简称MCT),到中长碳链脂肪酸甘油三酯(Medium&Long ChainTriglyceride,简称MLCT),到长碳链脂肪酸甘油三酯(Long Chain Triglyceride,简称LCT)的制备还存在诸多困难。
发明内容
针对现有技术存在的问题,本发明提供了一种由MLCT替代睑酯油及其制备方法。
一种MLCT替代睑酯油,其组成按质量百分比,由月桂酸8%~90%、豆蔻酸8%~90%和水0.8%~3%组成。
进一步,一种MLCT替代睑酯油,其组成按质量百分比,由月桂酸8%~90%、棕榈酸8%~90%和水0.8%~3%组成。
进一步,一种MLCT替代睑酯油,其组成按质量百分比,由月桂酸8%~90%、硬脂酸8%~90%和水0.8%~3%组成。
进一步,一种MLCT替代睑酯油,其组成按质量百分比,由月桂酸10%~90%、豆蔻酸4%~50%、棕榈酸4%~40%和水0.8%~3%组成。
进一步,一种MLCT替代睑酯油,其组成按质量百分比,由月桂酸10%~90%、棕榈酸4%~50%、硬脂酸4%~10%和水0.8%~3%组成。
进一步,一种MLCT替代睑酯油,其组成按质量百分比,由月桂酸40%~60%、豆蔻酸10%~30%、棕榈酸10%~20%、硬脂酸1%~10%和水0.8%~3%组成。
进一步,一种MLCT替代睑酯油,其组成按质量百分比,由豆蔻酸40%~60%、棕榈酸10%~30%、硬脂酸10%~20%、油酸1%~10%、亚油酸1%~10%和水0.8%~3%组成。
进一步,一种MLCT替代睑酯油,其组成按质量百分比,由月桂酸40%~60%、豆蔻酸10%~30%、棕榈酸10%~20%、硬脂酸1%~10%、油酸1%~10%、亚油酸1%~10%和水0.8%~3%组成。
进一步,一种MLCT替代睑酯油,其组成按质量百分比,由月桂酸40%、豆蔻酸10%、棕榈酸20%、硬脂酸10%、油酸10%、亚油酸8%和水2%组成。
进一步,一种MLCT替代睑酯油,其组成按质量百分比,由月桂酸60%、豆蔻酸30%、棕榈酸2%、硬脂酸2%、油酸2%、亚油酸2%和水2%组成。
进一步,一种MLCT替代睑酯油,其组成按质量百分比,由月桂酸50%、豆蔻酸30%、棕榈酸7%、硬脂酸3%、油酸4%、亚油酸3%和水3%组成。
进一步,一种MLCT替代睑酯油,所述的MLCT替代睑酯油比重为0.915~0.918,粘度2~3Pa.s,PH值为7.0。
一种MLCT替代睑酯油的制备方法,包括以下步骤:
S101,对原材料进行检验,将通过检验的原材料进行脱包、静置、称量;
S102,将称量好的原材料加热至40~120℃后,静置,冷却至室温后,过滤,灌装熔封;
S103,进行包装,对包装后的成品进行检验,入库。
进一步,所述S101对原材料进行紫外线照射20分钟。
进一步,所述S102过滤后进行紫外线照射20分钟。
进一步,所述S102的灌装熔封还包括对内包材进行检验,脱包静置。
进一步,所述S103的包装后进行辐照灭菌。
本发明的目的在于提供一种预防或治疗干眼症的应用,还可以在眼睑部按摩或睑板腺理疗中,用脂质替代疗法治疗干眼症的运用;在治疗视疲劳、眼干涩、眼异物感、畏光畏风、睁眼困难、灼热痛、无法固视电子屏幕等眼表治疗护理中的运用。
本发明的有益效果为:在眼睑部按摩或睑板腺理疗中,不用再挤压睑板腺,直接施用替代睑酯油补充满足患者对眼睑的正常需要量,避免了对患者的损伤和痛苦,为脂质替代疗法治疗干眼症开辟了一条新的途径,替代睑酯油在治疗视疲劳、眼干涩、眼异物感、畏光畏风、睁眼困难、灼热痛、无法固视电子屏幕等眼表治疗护理中取得良好显著的治疗效果。
附图说明
图1是本发明制备方法流程图;
图2是本发明制备方法详细流程图。
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,对本发明进一步详细说明。应当理解的是:此处所描述的具体实施例,仅仅用于解释本发明,并不用于限定本发明。
实施例
一种MLCT替代睑酯油,其组成按质量百分比,由月桂酸90%、豆蔻酸8%和水2%组成。
一种MLCT替代睑酯油,其组成按质量百分比,由月桂酸90%、棕榈酸8%和2%组成。
一种MLCT替代睑酯油,其组成按质量百分比,由月桂酸90%、硬脂酸8%和水2%组成。
一种MLCT替代睑酯油,其组成按质量百分比,由月桂酸90%、豆蔻酸4%、棕榈酸4%和水2%组成。
一种MLCT替代睑酯油,其组成按质量百分比,由月桂酸90%、棕榈酸4%、硬脂酸4%和水2%组成。
一种MLCT替代睑酯油,其组成按质量百分比,由月桂酸40%、豆蔻酸10%、棕榈酸20%、硬脂酸10%、油酸10%、亚油酸8%和水2%组成。
一种MLCT替代睑酯油,其组成按质量百分比,由月桂酸60%、豆蔻酸30%、棕榈酸2%、硬脂酸2%、油酸2%、亚油酸2%和水2%组成。
一种MLCT替代睑酯油,其组成按质量百分比,由豆蔻酸60%、棕榈酸30%、硬脂酸4%、油酸2%、亚油酸2%和水2%组成。
一种MLCT替代睑酯油,其组成按质量百分比,由月桂酸50%、豆蔻酸30%、棕榈酸7%、硬脂酸3%、油酸4%、亚油酸3%和水3%组成。
一种MLCT替代睑酯油,所述的MLCT替代睑酯油比重为0.915~0.918,粘度2~3Pa.s,PH值为7.0。
一种MLCT替代睑酯油的制备方法,包括以下步骤:
S101,对原材料进行检验,将通过检验的原材料进行脱包、静置、称量;
S102,将称量好的原材料加热至40~120℃后,静置,冷却至室温后,过滤,灌装熔封;
S103,进行包装,对包装后的成品进行检验,入库。
所述S101对原材料进行紫外线照射20分钟。
所述S102过滤后进行紫外线照射20分钟。
所述S102的灌装熔封还包括对内包材进行检验,脱包静置。
所述S103的包装后进行辐照灭菌。
月桂酸为C12:0,豆蔻酸为C14:0,棕榈酸为C16:0,硬脂酸为C18:0,油酸为C18:1,亚油酸为C18:2,其中12、14、16、18为碳键,0、1、2为不饱和键。
随着读屏时代的到来,电子产品的普及和不合理使用,眼睛在长时间观看电子屏幕时,脂质层会破裂,泪液失去了脂质层的屏障作用,泪液向外部蒸发,泪液蒸发的同时带走了油液,导致眼表完全干涸而形成干眼症,又称角结膜干燥症,中、重度干眼症患者,大多有以下症状:眼部异物感强烈,砂砾似地干疼,视力下降;无法固视手机、电脑、电视等视频终端;眼球发红,感觉膨胀、刺痛、灼热痛;畏光畏风,害怕强光,看见强光眼睛疼痛,睁眼困难,严重时完全无法睁眼;引发失眠、焦虑等症。中重度干眼症严重干扰了人们的正常生活和工作,轻则头痛失眠、眼睛疼痛,重则无力工作、焦虑抑郁、轻生厌世。角膜在干涸的非正常状态下,代谢所需的养料无法输送进入表层细胞,代谢废物也无法运走,角膜的表层上皮细胞、弹力层细胞开始凋亡、脱落,形成角膜炎,引发神经性疼痛和多种病理性反应。
实验分析,产品配方论证,不同脂肪酸甘油三酯分类,如表1所示,
表1 不同脂肪酸甘油三酯分类表
分类 | 碳原子数 | 名称 | |
短链脂肪酸甘油三酯(SCT) | 2 | 醋酸 | |
4 | 丁酸 | ||
中链脂肪酸甘油三酯(MCT) | 6 | 已酸 | |
8 | 辛酸 | ||
10 | 癸酸 | ||
12 | 月桂酸 | ||
长链脂肪酸甘油三酯(LCT) | 14 | 豆蔻酸 | |
16 | 棕榈油 | ||
18 | 硬脂酸 | ||
18 | 油酸 | ||
18 | 亚油酸 | ||
20 | 花生四烯酸 | ||
20 | 二十碳五烯酸 | ||
22 | 二十二碳六烯酸 |
表1中,通常认为中长链脂肪酸甘油三酯(MLCT)是由中链脂肪酸甘油三酯和长链脂肪酸甘油三酯组合而成,研究人员选取的月桂酸、豆蔻酸、棕榈酸、硬脂酸、油酸、亚油酸这六种甘油三酯,是属于中长链脂肪酸甘油三酯(MLCT)分类的,招募20位亚洲人志愿者,取出他们的睑酯进行了检测分析,并与中长链脂肪酸甘油三酯组成的替代睑酯油进行了交叉对比,发现这20位志愿者的睑酯与替代睑酯油重合的甘油三酯(TG)数量达762种,接着研究人员对替代睑酯油梳理了替代睑酯油的理化性质,见表2,形成结论:中长链脂肪酸甘油三酯组成的替代睑酯油,是人体睑酯的主要成分,是良好的替代天然人眼睑酯的产品。替代睑酯油中的组成成分月桂酸,现有研究表明有抑菌的作用,对替代睑酯油中的抑菌活性成分有贡献。替代睑酯油生产所需要的原材料,如月桂酸、豆蔻酸、棕榈酸、硬脂酸、油酸、亚油酸等,经现有技术可以从棕榈油和椰子油当中提取出来,所有成分均属于中长链脂肪酸甘油三酯(MLCT),经检测机构检测纯度达97%~100%,其中有0.8%~3%是生产过程中引入的纯化水,对产品性质无影响,其性状为环境温度在低于23℃时为白色固态,高于23℃融化为液态,液态时颜色为淡黄色透明;比重0.915~.0918,粘度为2~3Pa.s,PH值为7.0。产品的成分锁定在中长链脂肪酸甘油三酯(MLCT)中进行配方设计开发输出:见表3成分设计,表4配比设计。
表2 中长链脂肪酸甘油三酯(MLCT)的理化性质
表3 产品成分设计
表4 配比设计
从表3和表4可以看出,产品配方为:月桂酸(C12:0)40%~60%、豆蔻酸(C14:0)10%~30%、棕榈酸(C16:0)10%~20%、硬脂酸(C18:0)1%~10%、油酸(C18:1)1%~10%、亚油酸(C18:2)1%~10%和医用纯化水0.8%~3%。其理化性质同时满足:环境温度在低于23℃时为白色固态,高于23℃融化为液态,液态时颜色为淡黄色透明;比重0.915~0.918,粘度为2~3Pa.s,PH值为7.0,效果最好。
MLCT替代睑酯油产品成分和人眼睑板腺分泌的脂质是大部分重合的,有“人造睑酯”之称。使用它能形成眼表脂质层,替代天然睑酯;它能抗菌抑菌,重建仿生泪膜,相当于重建角膜的血液循环系统,恢复角膜的正常代谢功能和健康。它让干眼症等不治之症成为历史,让相关的角膜疾病不再难治。它是单独用于人体眼表的脂质材料,含有人眼脂质的天然活性成分,是不能被人眼所吸收的,不含发挥药理学、免疫学或者代谢作用的成分,虽然它不是药物,但它是治疗人体眼表疾病所需的重要医疗物质,也是人类眼表疾病治疗史上的重大发现。
经大量的毒理性实验和临床研究表明,MLCT是一种无毒、安全性极高的功能性油脂,对动物的发育、血液、尿检查及各脏器均无不良影响。国内有研究人员用MLCT做过降血脂作用研究,其结论为:用自制的中长链脂肪酸甘油三酯进行小鼠的降血脂作用研究,餐后血脂实验中,中长链脂肪酸甘油三酯组小鼠血清TG含量显著低于大豆油组。在小鼠的成长实验中,中长链脂肪酸甘油三酯具有降低小鼠血清TG、TC和LDL—C含量作用,可改善血脂和脂蛋白水平,抑制体重的增长并且不会对器官造成明显影响。由此可见,在健康饮食条件下,中长链脂肪酸甘油三酯可作为降血脂油脂被广泛推广。单月桂酸甘油酯具有抑菌作用,在人体母乳内含有大量的月桂酸,现有技术在研究时仅对单月桂酸甘油酯在食品上的抑菌作用,并未对该成分在人眼表的抑菌作用进一步研究。抑菌作用是MLCT的固有作用,所以对人眼表的微生物也同样有抑菌作用。
不同类型干眼患者泪膜脂质厚度与干眼临床特征的关系研究表明:替代睑酯/增加睑酯厚度能够显著缓解干眼症:按照专业干眼症检查科目,当睑酯的数量足够,脂质层厚度大于80nm时,眼睛的泪河高度大于0.2mm,泪破时间(BUT泪膜破裂时间)大于14秒,满足正常眼的检查科目标准。
在本发明中,MLCT替代睑酯油能替代睑酯的屏障作用与润滑作用、控制蒸发作用、抑菌作用。MLCT替代睑酯油配方独特、安全、适用人群广泛、效用显著,其作用原理符合医疗器械的典型特征;比隐形眼镜护理液安全,产品技术要求严谨,工艺设计合理。表明甘油三酯即脂肪的组成单元,人体广泛分布,眼部使用甘油三酯,生物相容性毫无风险。
Claims (17)
1.一种MLCT替代睑酯油,其组成按质量百分比,由月桂酸8%~90%、豆蔻酸8%~90%和水0.8%~3%组成。
2.一种MLCT替代睑酯油,其组成按质量百分比,由月桂酸8%~90%、棕榈酸8%~90%和水0.8%~3%组成。
3.一种MLCT替代睑酯油,其组成按质量百分比,由月桂酸8%~90%、硬脂酸8%~90%和水0.8%~3%组成。
4.一种MLCT替代睑酯油,其组成按质量百分比,由月桂酸10%~90%、豆蔻酸4%~50%、棕榈酸4%~40%和水0.8%~3%组成。
5.一种MLCT替代睑酯油,其组成按质量百分比,由月桂酸10%~90%、棕榈酸4%~50%、硬脂酸4%~10%和水0.8%~3%组成。
6.一种MLCT替代睑酯油,其组成按质量百分比,由月桂酸40%~60%、豆蔻酸10%~30%、棕榈酸10%~20%、硬脂酸1%~10%和水0.8%~3%组成。
7.一种MLCT替代睑酯油,其组成按质量百分比,由豆蔻酸40%~60%、棕榈酸10%~30%、硬脂酸10%~20%、油酸1%~10%、亚油酸1%~10%和水0.8%~3%组成。
8.一种MLCT替代睑酯油,其组成按质量百分比,由月桂酸40%~60%、豆蔻酸10%~30%、棕榈酸10%~20%、硬脂酸1%~10%、油酸1%~10%、亚油酸1%~10%和水0.8%~3%组成。
9.如权利要求1所述的一种MLCT替代睑酯油,其特征在于:其组成按质量百分比,由月桂酸40%、豆蔻酸10%、棕榈酸20%、硬脂酸10%、油酸10%、亚油酸8%和水2%组成。
10.如权利要求1所述的一种MLCT替代睑酯油,其特征在于:其组成按质量百分比,由月桂酸60%、豆蔻酸30%、棕榈酸2%、硬脂酸2%、油酸2%、亚油酸2%和水2%组成。
11.如权利要求1所述的一种MLCT替代睑酯油,其特征在于:其组成按质量百分比,由月桂酸50%、豆蔻酸30%、棕榈酸7%、硬脂酸3%、油酸4%、亚油酸3%和水3%组成。
12.如权利要求1-11任一所述的一种MLCT替代睑酯油,其特征在于,所述的MLCT替代睑酯油比重为0.915~0.918,粘度2~3Pa.s,PH值为7.0。
13.一种MLCT替代睑酯油的制备方法,包括以下步骤:
S101,对原材料进行检验,将通过检验的原材料进行脱包、静置、称量;
S102,将称量好的原材料加热至40~120℃后,静置,冷却至室温后,过滤,灌装熔封;
S103,进行包装,对包装后的成品进行检验,入库。
14.如权利要求13所述的MLCT替代睑酯油的制备方法,其特征在于:所述S101对原材料进行紫外线照射20分钟。
15.如权利要求13所述的MLCT替代睑酯油的制备方法,其特征在于:所述S102过滤后进行紫外线照射20分钟。
16.如权利要求13所述的MLCT替代睑酯油的制备方法,其特征在于:所述S102的灌装熔封还包括对内包材进行检验,脱包静置。
17.如权利要求13所述的MLCT替代睑酯油的制备方法,其特征在于:所述S103的包装后进行辐照灭菌。
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