CN103181566A - 脂溶性活性成分的粉末状制剂 - Google Patents

脂溶性活性成分的粉末状制剂 Download PDF

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CN103181566A
CN103181566A CN2013100747960A CN201310074796A CN103181566A CN 103181566 A CN103181566 A CN 103181566A CN 2013100747960 A CN2013100747960 A CN 2013100747960A CN 201310074796 A CN201310074796 A CN 201310074796A CN 103181566 A CN103181566 A CN 103181566A
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艾勒格·范纳
托斯滕·休贝尔
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Abstract

本发明涉及脂溶性活性成分的粉末状制剂。具体地，本发明公开了稳定的粉末状制剂，其中含有处于天然羽扇豆蛋白质组合物基质中的脂溶性活性成分，例如维生素A。

Description

脂溶性活性成分的粉末状制剂
本申请是2004年3月24日递交的中国发明专利申请200480009212.0（PCT/EP2004/003110）的分案申请。
本发明涉及新颖的稳定粉末状制剂，所述制剂含有脂溶性活性成分，本发明还涉及制备所述制剂的方法。本发明的新颖的组合物可被用作食品、饮料、动物饲料、化妆品或药物的添加剂，以将所述脂溶性成分包括到上述应用形式中。
更具体地，本发明涉及稳定的粉末状制剂，其中含有处于天然羽扇豆蛋白质（native lupin protein）组合物基质中的脂溶性活性成分。
本文中使用的术语“天然羽扇豆蛋白质”是指在天然产物（例如，羽扇豆种子）中所发现的羽扇豆蛋白质，其未经过水解的修饰。但是，术语“天然羽扇豆蛋白质”应被理解为包括经历了后等电沉淀的、通常被称作“重构”蛋白质的羽扇豆蛋白质，见国际专利申请WO 99/11143及其包含的参考文献。
术语“天然羽扇豆蛋白质组合物”指任何包含可从天然羽扇豆蛋白质源获得的天然羽扇豆蛋白质的组合物。此类天然羽扇豆蛋白质组合物的例子是羽扇豆蛋白质浓缩物，其蛋白质含量为60%至90%，按重量计（下文中用wt.-%表示），通常为50-96wt.-%之间，典型地，大约65-70wt.-%之间的蛋白质；以及羽扇豆蛋白质分离物，该术语在本领域中通常用于定义含有超过大约90wt.-%蛋白质的蛋白质制剂。此类浓缩物和分离物的其它组分（4-50wt.-%）除水和油之外，主要是植物纤维。
就本发明的目的而言，具有大约60-90wt.-%的蛋白质含量的羽扇豆浓缩物、具有超过90wt.-%的蛋白质含量的分离物以及具有大约40-60wt.-%的蛋白质含量的粉状物是优选的。作为蛋白质组合物的来源，所有已知的羽扇豆种，例如Lupine Angustifolius、Lupine Albus和Lupine Luteus，都可使用。但是，从Lupine Angustifolius和Lupine Albus获得的蛋白质组合物是优选的。
本文中使用的术语“脂溶性活性成分”指任何可溶于脂类但不溶于水或者很少溶于水的生理活性物质。此类脂溶性活性成分的例子是：脂溶性维生素，例如维生素A、D、E和K及其衍生物，例如维生素A的酯，例如维生素A乙酸酯和维生素A棕榈酸酯，和维生素E的酯，例如生育酚乙酸酯；类胡萝卜素和类胡萝卜素的衍生物，例如α-或β-胡萝卜素、8’-apo-β-胡萝卜醛、8’-apo-β-胡萝卜素酸酯例如乙酯、角黄素、虾青素、虾青素酯、番茄红素、叶黄素、玉米黄质或藏花酸及它们的衍生物；多不饱和脂肪酸，例如二十二碳六烯酸（docosahexaenoic acid）、二十碳五烯酸（eicosapentaenoic acid）、花生四烯酸和γ-亚麻酸和/或乙酯。脂溶性活性成分可以以大约0.1wt.-%至大约80wt.-%的量存在于制剂中，尤其是大约0.5wt.-%至大约60wt.-%，上述的量基于组合物的总重量。
在本发明的优选方面，所述新颖的制剂额外含有还原糖，例如，葡萄糖、果糖或木糖，其含量为大约0.1wt.-%至大约70wt.-%，尤其是大约1.0wt.-%至大约10wt.-%，上述含量基于组合物的总重量。
此类制剂可经热处理以在Maillard型反应中使糖和蛋白质交联。交联还可以通过用转谷氨酰胺酶等酶进行处理来获得，处理方法是已知的，例如见US 5,156,956。交联制剂被发现具有增加的稳定性。
根据本发明，所述新颖的制剂可以通过包含如下步骤的方法来获得：制备脂溶性活性成分和天然羽扇豆蛋白质组合物的乳液，如果需要的话，加入还原糖，将所述乳液转化为干粉，且如果加入了还原糖的话，通过热处理或用交联酶处理使干粉中的糖和蛋白质交联。
适合地，在本发明方法的第一步，将蛋白质组合物分散于水中。之后，将脂溶性活性成分乳化到蛋白质的水性分散剂中，适合地，在液体状态，即在适当温热和/或作为合适溶剂的溶液中。或者，可通过适当的手段例如碾磨来制得固体活性悬浮物。然后对乳液进行喷雾干燥，可选地，在取出过量溶剂之后再进行喷雾干燥。可用传统的喷雾干燥技术、与流化床颗粒化（该技术通常被称为流化喷雾干燥或FSD）组合的喷雾干燥来进行喷雾干燥，或者可以通过粉末捕捉技术来进行，其中，在吸附剂床上捕捉被喷雾的乳液滴，吸附剂例如淀粉或硅酸钙，然后再干燥。
在本发明的另一个方面，所述新颖的制剂可以额外含有其它蛋白质或经水解的蛋白质作为保护性胶体，例如大豆蛋白或水解大豆蛋白。此类额外的蛋白质可以以10-50wt.-%的量存在于本发明的制剂中，所述的量基于制剂中蛋白质的总含量。
最后，在又一个方面，本发明涉及包含本发明的新颖的制剂的食品、饮料、动物饲料、化妆品和药物。
本发明的新颖的制剂可以进一步地含有佐剂和/或赋形剂，例如单糖、二糖、寡糖或多糖，甘油三酯，水溶性抗氧化剂，脂溶性抗氧化剂，硅酸，硅酸钙，碳酸钙和水中的一种或多种。
可存在于本发明制剂中的单糖和二糖的例子是蔗糖、转化糖（invertsugar）、葡萄糖、果糖、乳糖和麦芽糖。可存在于本发明组合物中的寡糖或多糖的例子是淀粉、经修饰的淀粉和淀粉水解产物，例如糊精和麦芽糊精，尤其是在5-65葡萄糖当量（下文中以DE表示）范围内的，以及葡萄糖浆，尤其是在20-95DE范围内的。术语“葡萄糖当量”（DE）表示水解的程度，并以基于干重的被计算为D-葡萄糖的还原糖的量来量度。天然淀粉具有接近于0的DE，而葡萄糖的DE=100。
适合的甘油三酯为植物油或脂肪，例如玉米油、向日葵油、大豆油、红花油、菜籽油、花生油、棕榈油、棕仁油、棉籽油或椰子油（cocosoil）。
水溶性抗氧化剂可以是抗坏血酸及其盐，例如抗坏血酸钠等。脂溶性抗氧化剂可以是：生育酚，例如dl-α-生育酚（即合成生育酚）、d-α-生育酚（即天然生育酚）、β-和γ-生育酚和它们的混合物；脂肪酸的抗坏血酸酯，例如抗坏血酸棕榈酸酯或硬脂酸酯；丁基羟基甲苯（BHT）；丁基羟基茴香醚（BHA）；没食子酸丙酯；叔丁基羟基喹啉；或6-乙氧基-1,2-二羟基-2,2,4-三甲基喹啉（EMQ）。
下述实施例将进一步地阐述本发明。
实施例1  粉末状维生素A制剂的制备
将62.4g来自Lup.Angustifolius的羽扇豆蛋白质分离物（蛋白质含量96.2%）和10.9g的甘油加入到230ml水中。将混合物温热至60°C，直到溶解。然后向该溶液中加入12.3g果糖，将溶液pH调为6.5±0.2。之后，将49.3g维生素A乙酸酯（2.1x106IE维生素A/g，用乙氧基喹啉稳定过）乳化到基质溶液中，在60°C对混合物搅拌60分钟。之后，乳液的内相（inner phase）显示出了大约580nm的平均颗粒尺寸。然后用约25ml的水稀释乳液，在大约5°C通过旋转式喷雾嘴将大约300g的乳液喷雾到硅酸钙床上的喷雾盘中。通过筛滤将获得的珠粒与过量的硅酸钙分离，并对其进行干燥。获得了约100g的干粉，其维生素A含量为约850,000IEA/g。
实施例2  热交联
在135°C对实施例1中获得的维生素A干粉进行35分钟的搅拌。由此得到的产物不溶于热水，维生素A含量为约570,000IEA/g。
实施例3  制备apo-胡萝卜素酸乙酯（ethyl apo-carotenoate）干粉
a）在50°C，将16g来自Lup.Angustifolius的羽扇豆蛋白质分离物（蛋白质含量96.2%）溶于130ml水中。向该溶液中加入1.6g抗坏血酸棕榈酸酯，通过加入20wt.-%的氢氧化钠溶液将溶液pH调为7.5±0.2。
b）将9gβ-apo-8’-胡萝卜素酸乙酯、5.5g玉米油和0.6g乙氧基喹啉溶于50ml氯仿中。
c）在45°C，将b）中获得的β-apo-8’-胡萝卜素酸乙酯溶液乳化到a）中获得的溶液中，进行30分钟。之后，乳液的内相显示出大约280nm的平均颗粒尺寸。然后在50°C于减压下蒸发氯仿，用与实施例1中类似的手段在淀粉床上对乳液进行喷雾干燥。获得了42g干粉，其β-apo-8’-胡萝卜素酸乙酯含量为11.4wt.-%。

Claims (12)

1.稳定的粉末状制剂，包含处于天然羽扇豆蛋白质组合物基质中的脂溶性活性成分，其中的蛋白质是经交联的。
2.如权利要求1所述的制剂，其中所述羽扇豆蛋白质组合物是蛋白质含量超过90wt.-%的羽扇豆蛋白质分离物。
3.如权利要求1所述的制剂，其中所述羽扇豆蛋白质组合物是蛋白质含量在大约60-90wt.-%之间的羽扇豆蛋白质浓缩物。
4.如权利要求1所述的制剂，其中所述羽扇豆蛋白质组合物是蛋白质含量在大约40-60wt.-%之间的羽扇豆蛋白质粉状物。
5.如权利要求1所述的制剂，包含如权利要求2-4所定义的天然羽扇豆蛋白质组合物的混合物。
6.如权利要求1所述的制剂，其中所述脂溶性活性成分是维生素A、D、E或K，或类胡萝卜素，或多不饱和脂肪酸或其酯，或上述物质的混合物。
7.如权利要求1所述的制剂，其中所述脂溶性活性成分是植物油或动物油或脂肪，特别是向日葵油、棕榈油或玉米油。
8.如权利要求1所述的制剂，还包含还原糖，尤其是葡萄糖、果糖或木糖。
9.包含如权利要求1-8中任意一项所述的制剂的食品、饮料、动物饲料、化妆品或药物。
10.制备如权利要求1-8中任意一项所述的制剂的方法，其中包括：制备脂溶性活性成分和天然羽扇豆蛋白质组合物的乳液，如果需要的话，加入还原糖，将所述乳液转化为干粉，并且如果需要的话，通过热处理或用交联酶处理使干粉中的蛋白质交联。
11.如权利要求10所述的方法，其中加入还原糖，并通过加热对所述组合物进行交联。
12.如权利要求10所述的方法，其中通过交联酶，特别是转谷氨酰胺酶的处理来对所述组合物进行交联。
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