CN103750323A - 一种叶黄素口腔速溶膜及其制备方法 - Google Patents
一种叶黄素口腔速溶膜及其制备方法 Download PDFInfo
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- CN103750323A CN103750323A CN201410037191.9A CN201410037191A CN103750323A CN 103750323 A CN103750323 A CN 103750323A CN 201410037191 A CN201410037191 A CN 201410037191A CN 103750323 A CN103750323 A CN 103750323A
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- Prior art keywords
- lutein
- oral instant
- mixture
- instant membrane
- water
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- 235000012680 lutein Nutrition 0.000 title claims abstract description 60
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- KBPHJBAIARWVSC-XQIHNALSSA-N trans-lutein Natural products CC(=C/C=C/C=C(C)/C=C/C=C(C)/C=C/C1=C(C)CC(O)CC1(C)C)C=CC=C(/C)C=CC2C(=CC(O)CC2(C)C)C KBPHJBAIARWVSC-XQIHNALSSA-N 0.000 title claims abstract description 60
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Abstract
本发明公开了一种叶黄素口腔速溶膜及其制备方法,用于改善叶黄素的使用性能。所述速溶膜组分内含有叶黄素(或其衍生物)、水溶性高分子辅料、添加剂以及水,各组份的含量按质量份计为:叶黄素(或其衍生物)0.5~30%,高分子成膜辅料35~98%,添加剂0~55%,水2~15%。本发明解决了现有叶黄素(或其衍生物)产品服用体积较大、含糖量高,幼儿、老年人及糖尿病患者不适用,且在没有水的情况下服用不便等问题。本产品服用后可迅速崩解溶化,无需用水,起效迅速,生物利用度提高,且无窒息、噎喉等隐患,适用人群广泛、携带服用便利。
Description
技术领域
本发明涉及一种活性成分的口腔速溶膜及其制备方法,具体涉及一种叶黄素(及其衍生物)的口腔速溶膜,特别是医药技术领域及保健品和食品领域。
技术背景
叶黄素(Lutein)又名“植物黄体素”,是一种广泛存在于植物中的天然含氧类胡萝卜素。叶黄素是α-胡萝卜素的衍生物,分子式为C40H56O2,分子量568.85。叶黄素具有多种顺反式异构体,且多以脂肪酸酯化形式存在。
叶黄素不仅是一种天然的食品色素,又是一种很好的食品营养剂,具有保护视力、预防动脉硬化、抗氧化、抗癌等药理作用。广泛应用于食品、保健品、化妆品、医药、烟草和动禽类饲料等多个领域。美国食品药品管理局早在1995年就已批准叶黄素作为食品补充剂。
目前商品叶黄素主要是从万寿菊油树脂中提取分离制得。但叶黄素不溶于水,在油中也仅微溶,且本身极易氧化,生物利用度很低。上述特性极大地限制了叶黄素晶体的应用。
除了作为食品添加剂之外,叶黄素还是多种视力保护产品的主要活性组分,相关产品类型主要有压片糖果、凝胶糖果、软胶囊。CN102578346A中公布了叶黄素酯软糖,这些产品需要嚼食或吞服,配方常添加蔗糖以及大量其他辅料,服用体积较大。不适于糖尿病患者以及吞咽功能较差的少儿和老人服用,在没有水的情况下也不便服用。
发明内容
本发明的目的是克服现有技术不足,提供一种服用方便、起效迅速、便于保存、性质稳定的叶黄素口腔速溶膜,并提供这种叶黄素口腔速溶膜的制备方法。
本发明的目的是通过以下技术方案予以实现:
一种叶黄素的口腔速溶膜,组份内含有叶黄素、水溶性高分子成膜材料、添加剂以及水;各组份的含量按质量份计为:叶黄素0.5~30%,高分子成膜辅料35~98%,添加剂0~55%,水2~15%;
上述叶黄素包括来源于天然或合成途径的各种叶黄素异构体或叶黄素衍生物中的一种或其混合物;
上述水溶性高分子材料包括聚乙烯醇、聚氧乙烯、聚维酮、羟丙基甲基纤维素、羟丙基纤维素、丙烯酸树脂、邻苯二甲酸醋酸纤维素、聚乙二醇、海藻酸钠、壳聚糖、聚丙烯酸、瓜尔豆胶、黄原胶、卡拉胶、明胶、虫胶、阿拉伯胶、琼脂、改性淀粉、糊精中的一种或其混合物;
上述添加剂为调味剂、着色剂、遮光剂、增塑剂、防腐剂、唾液刺激剂、崩解剂、抗氧剂,各组份的含量按质量份计为;调味剂0~30%;着色剂0~5%;遮光剂0~5%;增塑剂0~20%;防腐剂0~5%;唾液刺激剂0~10%;崩解剂0~20%;抗氧剂0~10%;
上述调味剂选自甜味剂、芳香剂中的一种或其混合物;上述甜味剂选自阿斯巴甜、甘露醇、木糖醇、山梨醇、三氯蔗糖、甜菊苷、甘草甜素、糖精钠、蔗糖、果糖波拉克邻钾、聚苯乙烯磺酸钠、果糖、麦芽糖、玉米糖浆、谷氨酸钠中的一种或其混合物;
上述芳香剂选自各种香精、香料,如甜橙油、薄荷油、薄荷醇、香橙香精、草莓香精、蓝莓香精中的一种或其混合物;
上述着色剂选自色淀、色素、FD&C染料中的一种或其混合物;
上述增塑剂选自丙二醇、甘油、吐温、蓖麻油、聚乙二醇、硅油、邻苯二甲酸二乙酯或二丁酯、甘油一酸酯、甘油二酸酯中的一种或其混合物;
上述遮光剂为二氧化钛;
上述防腐剂选自苯甲酸钠、山梨酸钾、尼泊金甲酯、尼泊金乙酯中的一种或其混合物;
上述唾液刺激剂选自柠檬酸、乳酸、苹果酸、抗坏血酸、琥珀酸、己二酸、富马酸或酒石酸中的一种或其混合物;
上述崩解剂选自微晶纤维素、羧甲基淀粉钠、交联羧甲基纤维素钠、预胶化淀粉、交联聚维酮或低取代羟丙基纤维素中的一种或其混合物;
上述抗氧剂选自维生素C、乙二胺四乙酸中的一种或其混合物;
一种叶黄素口腔速溶膜的制备方法,包括如下步骤:
a.将除水溶性高分子材料以外的组份在搅拌下分散于0~90%的乙醇中,使其溶解或高度分散;
b.将水溶性高分子材料在搅拌下加入上述溶液中,充分分散得凝胶液,脱气;
c.将步骤b.所得的凝胶均匀涂布于平板上,干燥,切割,包装,得叶黄素的口腔速溶膜。
上述叶黄素口腔速溶膜在37℃水中的崩解时间小于60秒。其在应用时可以置于舌面上或舌面下、遇唾液迅速崩解溶散,或分散在水、饮料中之后饮用。
本发明的有益效果:本发明制备的叶黄素口腔速溶膜解决了目前叶黄素压片糖果和软胶囊产品难以下咽、不适用于幼儿和老人,或者叶黄素凝胶糖果蔗糖含量高、不利于保护牙齿、不适于高血糖人群等问题。本发明所述产品能迅速溶化,不存在噎塞咽喉的隐患,活性成分稳定性佳、吸收好、起效快,且产品口感好、体积小、携带服用方便。
具体实施方式
以下通过实施例对本发明的技术方案做进一步的说明:
实施例1:
处方:叶黄素 5g,聚乙烯醇 30g,甘油1g,甘露醇4g,三氯蔗糖 0.5g,薄荷油0.2g,二氧化钛0.8g,柠檬酸0.2g,香橙香精0.3g,药用无水乙醇100g,纯化水 30g。共制1000片(规格5mg/片)。
制备工艺:称取叶黄素分散于无水乙醇中得到体系A;称取甘露醇置于适当容器中,搅拌待完全溶解,加入聚乙烯醇,搅拌溶解得到溶液B;在持续搅拌下将A逐渐加入B中,搅拌均一;加入甘油、薄荷醇、柠檬酸、三氯蔗糖、香橙香精、二氧化钛,搅拌均一。在10000rpm下高速剪切3分钟,反复5次,在真空条件下静置6h以除去气泡,即得刮涂用凝胶。将此胶液刮涂至平板上,在70℃下鼓风烘干。然后剥离刮涂得到的膜剂,剪切分装,即得。
实施例2:
处方:叶黄素酯 1g,羟丙基甲基纤维素(5厘泊) 50g,聚乙二醇400 0.6g,阿斯巴甜 0.5 g,甜橙油0.2g,苹果酸0.2g,柠黄0.2g,苯甲酸钠0.3g,药用无水乙醇100g,纯化水 30g。共制500片(规格2mg/片)。
制备工艺:将叶黄素酯、阿斯巴甜、苹果酸、柠黄、甜橙油、聚乙二醇400、苯甲酸钠在搅拌下分散于乙醇和水的混合液中,超声处理使其溶解;将羟丙基甲基纤维素在搅拌下加入上述溶液中,充分分散得到凝胶,脱气后即得刮涂用凝胶。将此胶液均匀涂布于平板上,60℃干燥,剥离、切割、分装,即得。
实施例3:
处方:叶黄素 0.5g,羟丙基甲基纤维素(15厘泊) 60g,麦芽糖糊精30g,药用无水乙醇 50g,纯化水 150g。共制500片(规格1mg/片)。
制备工艺:将羟丙基甲基纤维素、麦芽糖糊精在搅拌下溶于水;将叶黄素酯分散于乙醇中,在搅拌下加入上述水溶液中,充分分散得到凝胶;脱气、涂布、干燥,剥离、切割、分装,即得。
实施例4:
处方:叶黄素 5g,聚维酮18g,吐温80 1g,甜菊苷0.1g,二氧化钛0.7g,蓝莓香精0.2g,维生素C0.1g,药用无水乙醇900g,纯化水 100g。共制250片(规格20mg/片)。
制备工艺:称取叶黄素、聚维酮、吐温、二氧化钛均匀分散于乙醇中;称取甜菊苷、维生素C加水溶解,将该溶液在搅拌下逐渐加入上述乙醇体系中,搅拌均一。在8000rpm下高速剪切2分钟,反复3次,在真空条件下静置8h以除去气泡,即得刮涂用凝胶。将此胶液刮涂至平板上,在60℃下鼓风干燥。然后剥离刮涂得到的膜剂,剪切分装,即得。
实施例5:
处方:叶黄素酯 1g,聚氧乙烯20g,丙二醇2g,山梨醇 15 g,乳糖10g薄荷素油0.2g,酒石酸0.2g,莓红0.2g,尼泊金甲酯0.3g,药用无水乙醇100g,纯化水50g。共制100片(规格10mg/片)。
制备工艺:称取叶黄素、聚氧乙烯、丙二醇、薄荷素油均匀分散于乙醇中;称取山梨醇、乳糖、酒石酸、莓红、尼泊金甲酯加水溶解,将该溶液在搅拌下逐渐加入上述乙醇体系中,搅拌均一;真空脱气、涂布、干燥,剥离、切割、分装,即得。
实施例6:
处方:叶黄素1.5g,明胶4g,海藻酸钠6g,甘油0.3g,阿斯巴甜0.1g,微晶纤维素0.8g,草莓香精0.2g,水 150g。共制100片(规格15mg/片)。
制备工艺:将叶黄素、甘油、阿斯巴甜、草莓香精在搅拌下分散于水中;将明胶、海藻酸钠在搅拌下加入上述溶液中,充分分散得到凝胶;加入微晶纤维素并充分搅拌使之分散均匀,真空脱气后即得刮涂用凝胶。将此胶液均匀涂布于平板上,70℃干燥,剥离、切割、分装,即得。
Claims (16)
1.一种叶黄素的口腔速溶膜,其特征在于:组份内含有叶黄素、水溶性高分子成膜材料、添加剂以及水;
各组份的含量按质量份计为:叶黄素0.5~30%,高分子成膜辅料35~98%,添加剂0~55%,水2~15%。
2.如权利要求1所述的叶黄素口腔速溶膜,其特征在于:所述叶黄素包括来源于天然或合成途径的各种叶黄素异构体或叶黄素衍生物中的一种或其混合物。
3.如权利要求1所述的叶黄素口腔速溶膜,其特征在于:所述水溶性高分子材料是聚乙烯醇、聚氧乙烯、聚维酮、羟丙基甲基纤维素、羟丙基纤维素、丙烯酸树脂、邻苯二甲酸醋酸纤维素、聚乙二醇、海藻酸钠、壳聚糖、聚丙烯酸、瓜尔豆胶、黄原胶、卡拉胶、明胶、虫胶、阿拉伯胶、琼脂、改性淀粉、糊精中的一种或其混合物。
4.如权利要求1所述的叶黄素口腔速溶膜,其特征在于:所述添加剂是调味剂、着色剂、遮光剂、增塑剂、防腐剂、唾液刺激剂、崩解剂、抗氧剂中的一种或其混合物;各组份的含量按质量份计为:调味剂0~30%;着色剂0~5%;遮光剂0~5%;增塑剂0~20%;防腐剂0~5%;唾液刺激剂0~10%;崩解剂0~20%;抗氧剂0~10%。
5.如权利要求4所述的叶黄素口腔速溶膜,其特征在于:所述调味剂选自甜味剂、芳香剂中的一种或其混合物。
6.如权利要求5所述的叶黄素口腔速溶膜,其特征在于:所述甜味剂选自阿斯巴甜、甘露醇、木糖醇、山梨醇、三氯蔗糖、甜菊苷、甘草甜素、糖精钠、蔗糖、果糖波拉克邻钾、聚苯乙烯磺酸钠、果糖、麦芽糖、玉米糖浆、谷氨酸钠中的一种或其混合物。
7.如权利要求5所述的叶黄素口腔速溶膜,其特征在于:所述芳香剂选自各种香精或香料。
8.如权利要求7所述的叶黄素口腔速溶膜,其特征在于:香精或香料是甜橙油、薄荷油、薄荷醇、香橙香精、蓝莓香精、草莓香精中的一种或其混合物。
9.如权利要求4所述的叶黄素口腔速溶膜,其特征在于:所述着色剂选自色淀、色素、FD&C染料中的一种或其混合物。
10.如权利要求4所述的叶黄素口腔速溶膜,其特征在于:所述增塑剂选自丙二醇、甘油、吐温、蓖麻油、聚乙二醇、硅油、邻苯二甲酸二乙酯或二丁酯、甘油一酸酯、甘油二酸酯中的一种或其混合物。
11.如权利要求4所述的叶黄素口腔速溶膜,其特征在于:所述遮光剂是二氧化钛。
12.如权利要求4所述的叶黄素口腔速溶膜,其特征在于:所述防腐剂选自苯甲酸钠、山梨酸钾、尼泊金甲酯、尼泊金乙酯中的一种或其混合物。
13.如权利要求4所述的叶黄素口腔速溶膜,其特征在于:所述唾液刺激剂选自柠檬酸、乳酸、苹果酸、抗坏血酸、琥珀酸、己二酸、富马酸或酒石酸中的一种或其混合物。
14.如权利要求4所述的叶黄素口腔速溶膜,其特征在于:所述崩解剂选自微晶纤维素、羧甲基淀粉钠、交联羧甲基纤维素钠、预胶化淀粉、交联聚维酮或低取代羟丙基纤维素中的一种或其混合物。
15.如权利要求4所述的叶黄素口腔速溶膜,其特征在于:所述抗氧剂选自维生素C、乙二胺四乙酸中的一种或其混合物。
16.一种如权利要求1~14任意一项所述的叶黄素口腔速溶膜的制备方法,包括如下步骤:
a.将除水溶性高分子材料以外的组份在搅拌下分散于0~90%的乙醇中,使其溶解或高度分散;
b.将水溶性高分子材料在搅拌下加入上述溶液中,充分分散得凝胶液,脱气;
c.将步骤b所得的凝胶均匀涂布于平板上,干燥,切割,包装,得叶黄素的口腔速溶膜。
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