CN106727440A - 一种岩藻黄素软胶囊及其制备方法 - Google Patents
一种岩藻黄素软胶囊及其制备方法 Download PDFInfo
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- CN106727440A CN106727440A CN201610980579.1A CN201610980579A CN106727440A CN 106727440 A CN106727440 A CN 106727440A CN 201610980579 A CN201610980579 A CN 201610980579A CN 106727440 A CN106727440 A CN 106727440A
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Classifications
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- A61K9/00—Medicinal preparations characterised by special physical form
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- A—HUMAN NECESSITIES
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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/336—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having three-membered rings, e.g. oxirane, fumagillin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
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- A61K9/4816—Wall or shell material
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
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- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
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- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
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Abstract
本发明公开了一种岩藻黄素软胶囊及其制备方法,包括包合物和包合材料,所述包合物为岩藻黄素,所述包合材料为α‑环糊精,β‑环糊精,羟基β‑环糊精,羟丙基β‑环糊精的一种或几种,所述包合物与包合材料的重量比例为2:1‑1:2,还包括油相、非离子乳化剂和助化剂;该发明具有增加了降低胆固醇,抗癌和减肥的功效,同时满足了广大人群的需求,开拓了岩藻黄素的价值空间,使岩藻黄素的应用领域更加广泛。
Description
技术领域
本发明涉及岩藻黄素加工领域,更具体的说,是一种岩藻黄素软胶囊及其制备方法。
背景技术
岩藻黄质(fucoxanthin)亦称褐藻黄素,也可称为岩藻黄素,是自可食用褐藻中,如裙带菜(翅藻科,Undaria pinnatifida)、海带(Laminaria japonica Aresch)中提取出来的天然类胡萝卜素,在其刚性全反式长链的两端分别有一个化学性质活泼的5,6-环氧非饱和丙二烯键结构,因而又异于其他类胡萝卜素分子,具有很强的生物活性。近年来,它的多种生物学活性已被证实,一些潜在的活性也正在被科学家们积极探求之中,目前己成为当今海洋药物研究与开发的主攻热点之一。
岩藻黄质具有抗肿瘤、抗炎、抗氧化、减肥等多种生物活性。首先,在抗肿瘤方面,1990年Okuzumi等首次报道,岩藻黄质10μg/mL孵育3天后可降低62%的成人神经母细胞瘤细胞株(GOTO)的增殖。Okuztllni等研究证实,岩藻黄质可抑制由强皮肤促癌物十四烷酞佛波醋酸酷(TPA)诱导的小鼠表皮鸟氨酸脱梭酶活性增强,据此推测其可能对皮肤癌有抑制作用。1993年okuzumi等报道,岩藻黄质对N-乙基-N’-硝基-亚硝基胍诱导的十二指肠癌形成具有抑制作用。Masashi等报道了岩藻黄质对急性髓性白血病HL-60细胞株的作用,结果显示岩藻黄质对HL-60细胞可发挥显著的增殖抑制作用。Elichi等研究发现,岩藻黄质可明显降低前列腺癌细胞存活率,并诱导细胞凋亡。Swadesh K等人研究发现岩藻黄质对人肝癌HePG2细胞的生长具有抑制作用,因此,岩藻黄质对多种肿瘤细胞具有不同程度的抑制作用。其次,研究发现岩藻黄质还具体外抗氧化活性,其抗氧化活性甚至强于维生素C和E。此外,Kenjis等发现质抑制内毒素诱导的大鼠眼葡萄膜炎(Elu),且其抗炎作用与尼松龙相当。特别是近年来研究发现,岩藻黄质能够显著的燃烧脂肪细胞,消除脂肪堆积的作用,从而起到显著的减肥效果,更使岩藻黄质在减肥药市场中占据重要的地位,因此,岩藻黄质是一个用途广泛的海洋活性物质。
然而岩藻黄质性质不稳定,因此不利于岩藻黄质的开发利用,且岩藻黄素制成的软胶囊并没有相关报道。
发明内容
为了弥补以上不足,本发明提供了一种岩藻黄素软胶囊及其制备方法以填补岩藻黄素领域的空白。
本发明的方案是:
一种岩藻黄素软胶囊,包括包合物和包合材料,所述包合物为岩藻黄素,所述包合材料为α-环糊精,β-环糊精,羟基β-环糊精,羟丙基β-环糊精的一种或几种,所述包合物与包合材料的重量比例为2:1-1:2,还包括油相、非离子乳化剂和助化剂。
作为优选的技术方案,所述油相为天然植物油或脂肪酸酯其中的一种。
作为优选的技术方案,所述非离子乳化剂为亲水亲油平衡值在9-20的非离子表面活性剂。
作为优选的技术方案,所述非离子表面活性剂为乙氧基聚氧乙稀甘油酯、聚氧乙烯油酸酯、吐温80、吐温85、聚氧乙烯蓖麻油、聚氧乙烯氢化蓖麻油、杏仁油酸聚乙二醇甘油酯、聚氧乙烯(25)山梨醇油酸酯、聚乙二醇-8-甘油辛酸和葵酸酯中的其中一种。
作为优选的技术方案,所述助化剂为中链醇或短链醇其中的一种。
作为优选的技术方案,所述助化剂为丙二醇或二甲基异山梨酯或它们的混合物。
本发明还提供一种制备岩藻黄素软胶囊的方法,包括步骤:
1)将岩藻黄素与包合材料在投入水或含水乙醇介质中,按一定比例,反应,将所得溶液经微孔滤膜过滤至澄清,从混合物中分离出包合物;
2)将包合物、油相、乳化剂和助乳化剂加入容器,混合搅拌,超声,震荡,超声的温度为30-45℃,超声的时间为20-50min,震荡时间为1-3小时,得到岩藻黄素自乳化剂;放冷至室温;
3)取药用干明胶、甘油、三氧化铁、二氧化钛、尼泊金乙酯、山梨糖醇液、纯化水适量,混合成胶液,将所述胶液按常规加热脱水后进入隧道式干燥器进行干燥、造粒,压膜成型后脱掉内膜芯,制成软胶囊壳;
4)将步骤2)中放冷的岩藻黄素自乳化剂封入步骤3)制成的软胶囊壳中,得到岩藻黄素软胶囊。
由于采用了上述技术方案,一种岩藻黄素夹心糖果及其制备方法,包括步骤:1)将岩藻黄素与包合材料在投入水或含水乙醇介质中,按一定比例,反应,将所得溶液经微孔滤膜过滤至澄清,从混合物中分离出包合物;2)将包合物、油相、乳化剂和助乳化剂加入容器,混合搅拌,超声,震荡,超声的温度为30-45℃,超声的时间为20-50min,震荡时间为1-3小时,得到岩藻黄素自乳化剂;放冷至室温;3)取药用干明胶、甘油、三氧化铁、二氧化钛、尼泊金乙酯、山梨糖醇液、纯化水适量,混合成胶液,将所述胶液按常规加热脱水后进入隧道式干燥器进行干燥、造粒,压膜成型后脱掉内膜芯,制成软胶囊壳;4)将步骤2)中放冷的岩藻黄素自乳化剂封入步骤3)制成的软胶囊壳中,得到岩藻黄素软胶囊,该发明弥补了产业空白,开拓了岩藻黄素的应用领域,提升了岩藻黄素的应用价值,大大增强了岩藻黄素的利用率,对岩藻黄素的推广有着积极的效果同时,掩盖不良味道,降低刺激性;增加药物溶出度与生物利用度;提高药物稳定性。
该发明的优点:避免岩藻黄素的口感因素影响人们的食欲,使人们更愿意去食用,其次岩藻黄素本身具有一定的减肥效果,有利于肥胖人群在不丧失口感的情况下进行减肥,而且,岩藻黄素具有抗癌效果和降低胆固醇的作用,因此可以作为保健食品食用,更容易得到广大人群的接受,从而使岩藻黄素的市场空间更加广阔,同时,本发明能保持岩藻黄素的原有特色。
具体实施方式
为了弥补以上不足,本发明提供了一种岩藻黄素软胶囊及其制备方法,以解决上述背景技术中的问题。
一种岩藻黄素软胶囊,包括包合物和包合材料,所述包合物为岩藻黄素,所述包合材料为α-环糊精,β-环糊精,羟基β-环糊精,羟丙基β-环糊精的一种或几种,所述包合物与包合材料的重量比例为2:1-1:2,还包括油相、非离子乳化剂和助化剂。
作为优选的技术方案,所述油相为天然植物油或脂肪酸酯其中的一种。
作为优选的技术方案,所述非离子乳化剂为亲水亲油平衡值在9-20的非离子表面活性剂。
作为优选的技术方案,所述非离子表面活性剂为乙氧基聚氧乙稀甘油酯、聚氧乙烯油酸酯、吐温80、吐温85、聚氧乙烯蓖麻油、聚氧乙烯氢化蓖麻油、杏仁油酸聚乙二醇甘油酯、聚氧乙烯(25)山梨醇油酸酯、聚乙二醇-8-甘油辛酸和葵酸酯中的其中一种。
作为优选的技术方案,所述助化剂为中链醇或短链醇其中的一种。
作为优选的技术方案,所述助化剂为丙二醇或二甲基异山梨酯或它们的混合物。
本发明还提供一种制备岩藻黄素软胶囊的方法,包括步骤:
1)将岩藻黄素与包合材料在投入水或含水乙醇介质中,按一定比例,反应,将所得溶液经微孔滤膜过滤至澄清,从混合物中分离出包合物;
2)将包合物、油相、乳化剂和助乳化剂加入容器,混合搅拌,超声,震荡,超声的温度为30-45℃,超声的时间为20-50min,震荡时间为1-3小时,得到岩藻黄素自乳化剂;放冷至室温;
3)取药用干明胶、甘油、三氧化铁、二氧化钛、尼泊金乙酯、山梨糖醇液、纯化水适量,混合成胶液,将所述胶液按常规加热脱水后进入隧道式干燥器进行干燥、造粒,压膜成型后脱掉内膜芯,制成软胶囊壳;
4)将步骤2)中放冷的岩藻黄素自乳化剂封入步骤3)制成的软胶囊壳中,得到岩藻黄素软胶囊。
为了使本发明实现的技术手段、创作特征、达成目的与功效易于明白了解,下面结合具体实施例,进一步阐述本发明。
实施例一:
1)将岩藻黄素与包合材料在投入水或含水乙醇介质中,按一定比例,反应,将所得溶液经微孔滤膜过滤至澄清,从混合物中分离出包合物;
2)将包合物、油相、乳化剂和助乳化剂加入容器,混合搅拌,超声,震荡,超声的温度为30℃,超声的时间为20min,震荡时间为1小时,得到岩藻黄素自乳化剂;放冷至室温;
3)取药用干明胶、甘油、三氧化铁、二氧化钛、尼泊金乙酯、山梨糖醇液、纯化水适量,混合成胶液,将所述胶液按常规加热脱水后进入隧道式干燥器进行干燥、造粒,压膜成型后脱掉内膜芯,制成软胶囊壳;
4)将步骤2)中放冷的岩藻黄素自乳化剂封入步骤3)制成的软胶囊壳中,得到岩藻黄素软胶囊。
实施例二:
1)将岩藻黄素与包合材料在投入水或含水乙醇介质中,按一定比例,反应,将所得溶液经微孔滤膜过滤至澄清,从混合物中分离出包合物;
2)将包合物、油相、乳化剂和助乳化剂加入容器,混合搅拌,超声,震荡,超声的温度为45℃,超声的时间为50min,震荡时间为3小时,得到岩藻黄素自乳化剂;放冷至室温;
3)取药用干明胶、甘油、三氧化铁、二氧化钛、尼泊金乙酯、山梨糖醇液、纯化水适量,混合成胶液,将所述胶液按常规加热脱水后进入隧道式干燥器进行干燥、造粒,压膜成型后脱掉内膜芯,制成软胶囊壳;
4)将步骤2)中放冷的岩藻黄素自乳化剂封入步骤3)制成的软胶囊壳中,得到岩藻黄素软胶囊。
实施例三:
1)将岩藻黄素与包合材料在投入水或含水乙醇介质中,按一定比例,反应,将所得溶液经微孔滤膜过滤至澄清,从混合物中分离出包合物;
2)将包合物、油相、乳化剂和助乳化剂加入容器,混合搅拌,超声,震荡,超声的温度为40℃,超声的时间为40min,震荡时间为2小时,得到岩藻黄素自乳化剂;放冷至室温;
3)取药用干明胶、甘油、三氧化铁、二氧化钛、尼泊金乙酯、山梨糖醇液、纯化水适量,混合成胶液,将所述胶液按常规加热脱水后进入隧道式干燥器进行干燥、造粒,压膜成型后脱掉内膜芯,制成软胶囊壳;
4)将步骤2)中放冷的岩藻黄素自乳化剂封入步骤3)制成的软胶囊壳中,得到岩藻黄素软胶囊。
以上显示和描述了本发明的基本原理、主要特征及本发明的优点。本行业的技术人员应该了解,本发明不受上述实施例的限制,上述实施例和说明书中描述的只是说明本发明的原理,在不脱离本发明精神和范围的前提下,本发明还会有各种变化和改进,这些变化和改进都落入要求保护的本发明范围内。本发明要求保护范围由所附的权利要求书及其等效物界。
Claims (7)
1.一种岩藻黄素软胶囊,其特征在于:包括包合物和包合材料,所述包合物为岩藻黄素,所述包合材料为α-环糊精,β-环糊精,羟基β-环糊精,羟丙基β-环糊精的一种或几种,所述包合物与包合材料的重量比例为2:1-1:2,还包括油相、非离子乳化剂和助化剂。
2.如权利要求1所述的一种岩藻黄素软胶囊,其特征在于:所述油相为天然植物油或脂肪酸酯其中的一种。
3.如权利要求1所述的一种岩藻黄素软胶囊,其特征在于:所述非离子乳化剂为亲水亲油平衡值在9-20的非离子表面活性剂。
4.如权利要求3所述的一种岩藻黄素软胶囊,其特征在于:所述非离子表面活性剂为乙氧基聚氧乙稀甘油酯、聚氧乙烯油酸酯、吐温80、吐温85、聚氧乙烯蓖麻油、聚氧乙烯氢化蓖麻油、杏仁油酸聚乙二醇甘油酯、聚氧乙烯(25)山梨醇油酸酯、聚乙二醇-8-甘油辛酸和葵酸酯中的其中一种。
5.如权利要求1所述的一种岩藻黄素软胶囊,其特征在于:所述助化剂为中链醇或短链醇其中的一种。
6.如权利要求1所述的一种岩藻黄素软胶囊,其特征在于:所述助化剂为丙二醇或二甲基异山梨酯或它们的混合物。
7.一种制备岩藻黄素软胶囊的方法,其特征在于,包括下列步骤:
1)将岩藻黄素与包合材料在投入水或含水乙醇介质中,按一定比例,反应,将所得溶液经微孔滤膜过滤至澄清,从混合物中分离出包合物;
2)将包合物、油相、乳化剂和助乳化剂加入容器,混合搅拌,超声,震荡,超声的温度为30-45℃,超声的时间为20-50min,震荡时间为1-3小时,得到岩藻黄素自乳化剂;放冷至室温;
3)取药用干明胶、甘油、三氧化铁、二氧化钛、尼泊金乙酯、山梨糖醇液、纯化水适量,混合成胶液,将所述胶液按常规加热脱水后进入隧道式干燥器进行干燥、造粒,压膜成型后脱掉内膜芯,制成软胶囊壳;
4)将步骤2)中放冷的岩藻黄素自乳化剂封入步骤3)制成的软胶囊壳中,得到岩藻黄素软胶囊。
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