CN107735078A - 新颖的挤出物 - Google Patents
新颖的挤出物 Download PDFInfo
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- CN107735078A CN107735078A CN201680038143.9A CN201680038143A CN107735078A CN 107735078 A CN107735078 A CN 107735078A CN 201680038143 A CN201680038143 A CN 201680038143A CN 107735078 A CN107735078 A CN 107735078A
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- A—HUMAN NECESSITIES
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- A—HUMAN NECESSITIES
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Landscapes
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Abstract
本发明涉及生产特定挤出制剂(=挤出物)的方法,其中所述挤出制剂包含大量脂溶性化合物;本发明还涉及所述制剂以及所述制剂在食品、饲料和个人护理应用中的用途。
Description
本发明涉及生产特定挤出制剂(=挤出物)的挤出方法,其中所述挤出制剂包含大量脂溶性化合物;本发明还涉及所述制剂以及所述制剂在食品、饲料和个人护理应用中的用途。
存在许多配制脂溶性化合物的方式和方法。
脂溶性化合物有例如油和维生素。制剂的类型取决于,即这些制剂在最终应用中的用途以及所使用的材料(成分)的种类。
配制脂溶性化合物的一种方式是干燥乳剂或干燥分散体。脂溶性化合物分散在在水包油乳剂中,其中水相包含基质材料和/或合适的乳化剂。干燥后,脂溶性化合物被包埋在所述基质材料中。
制备乳剂/分散体的已知技术例如有转子-定子系统、高压均质机或超声装置。这些技术的主要缺点为:需要相对低的粘度(通常低于1Pas),从而导致乳剂分散体中大量的水,这些水需要在方法结束时被除去。
挤出方法(和挤出机)在制剂领域众所周知。它们可被用于许多不同种类的材料。该技术首先被用于生橡胶(天然树胶)工业。但一段时间后,食品和饲料行业也采用这种技术用于实现它们的目的。
使用挤出技术的主要优点为:可配制高粘度溶液并可使用较少水(或甚至不使用水)用于乳剂/分散体,这在挤出后需要较少干燥以获得干燥产品。在本发明的上下文中,干燥产品是指:基于挤出物的总重量,水含量小于5重量%(wt-%)。
此外,挤出方法可作为连续方法运行。
目前,挤出领域的一个限制因素是可以使用和挤出的脂溶性化合物的量。因为脂溶性化合物是这种制剂中的重要成分(活性成分),所以高浓度脂溶性化合物是期望的。当挤出物较高浓缩时(关于活性成分),由于需要较少挤出物来配制最终产品,所以更利于其进一步使用。
采用现有技术的公知方法(和组合物),不能显著增加脂溶性化合物的量而不使获得的实施方式(挤出物)的质量(稳定性)变差。
本发明的目标是找到一种生产具有增加量的至少一种脂溶性化合物的挤出物的方法。脂溶性化合物为例如脂质、类胡萝卜素和/或脂溶性维生素。
出乎意料地发现:当将至少一种吸附剂材料加入乳剂中时,可显著增加挤出物中脂溶性化合物的量。
因此,本发明涉及一种生产挤出物的挤出方法,其中在50-300℃的温度下挤出组合物,所述组合物包含至少一种脂溶性化合物和基于挤出物的总重量,至少5重量%的至少一种吸附剂。
术语“脂质”涵盖油、脂肪和蜡。
在本发明的上下文中,吸附剂是具有以下性质的化合物:
·高表面面积(通常且优选具有至少100m2g-1、多至500m2g-1的BET,优选为200-400m2g-1和300-400m2g-1的范围;根据DIN-ISO 9277中所述的方法测量BET值)
·高吸油量(通常且优选为1ml/g-6ml/g)
·高孔隙度
·可与其他赋形剂相互作用的官能团(例如用于氢键的硅醇,用于离子-偶极相互作用的阳离子)。
一组优选的吸附剂是硅酸盐组,例如硅酸钙或硅酸镁铝。
可使用任何已知和有用的脂溶性化合物作为脂溶性化合物。脂溶性化合物是可溶于非极性物质(例如醚、氯仿和油)中的化合物。脂溶性化合物的实例即脂质、维生素和类胡萝卜素。
脂质(油、脂肪和蜡)可来自任何来源。它们可以是天然的、改性的或合成的。
如果脂肪/油是天然的,那么它们可以是植物油或动物油。合适的油即椰子油,玉米油,棉籽油,橄榄油,棕榈油,花生油,菜籽油,芥花油,红花籽油,芝麻油,大豆油,葵花籽油,榛果油,杏仁油,腰果油,澳洲坚果油,檬戈果油(mongongo nut oil),巴卡斯油(pracaxi oil),山核桃油,松子油,开心果油,印加果(南美油藤(Plukenetia volubilis))油,胡桃油,多不饱和脂肪酸(例如甘油三酯和/或乙酯、(例如花生四烯酸、二十碳五烯酸、二十二碳六烯酸和γ-亚麻酸和/或乙酯)和油性营养制剂(例如迷迭香萃取物、牛至萃取物、酒花萃取物和其它亲脂性植物萃取物)。
使用合成的脂肪/油也是合适的,合成的脂肪/油通常能够商购获得,例如聚乙二醇、聚环氧乙烷、甘油单酯、甘油二酯、甘油三酯、聚乙二醇单酯、聚乙二醇二酯、聚乙二醇15羟基硬脂酸酯、聚乙二醇甘油酯(macrogolglycerides)、甘油单硬脂酸酯和甘油二硬脂酸酯。
脂溶性维生素例如维生素A或其酯(例如维生素A乙酸酯和维生素A棕榈酸酯)、维生素E或其酯(例如维生素E乙酸酯)、维生素K(植物甲萘醌)和维生素D3(胆钙化醇)在本发明中被考虑。所述维生素可易于从商业来源获得。另外,它们可由本领域技术人员通过常规方法制备。维生素可以以纯净形式或者在合适的稀释剂例如脂肪或油中被使用。
当在本文中使用时,术语“类胡萝卜素”包括天然的或合成的胡萝卜素或者结构相关的多烯化合物,其可被用作功能性健康成分或食物的着色剂,例如α-或β-胡萝卜素、8'-阿朴-β-胡萝卜素醛、8'-阿朴-β-胡萝卜素酸酯例如乙酯、角黄素、虾青素、番茄红素、叶黄素、玉米黄素或藏红花酸、或它们的混合物。优选的类胡萝卜素是β-胡萝卜素、番茄红素和叶黄素以及它们的混合物,尤其是β-胡萝卜素。
因此,本发明的一个优选实施方式涉及如上所述的生产挤出物的挤出方法,其中类胡萝卜素选自α-胡萝卜素、β-胡萝卜素、8'-阿朴-β-胡萝卜素醛、8'-阿朴-β-胡萝卜素酸酯例如乙酯、角黄素、虾青素、番茄红素、叶黄素、玉米黄素和藏红花酸。
在一个特别优选的挤出方法中,类胡萝卜素是β-胡萝卜素。
本发明的一个优选实施方式涉及如上所述的挤出方法,其中所述脂溶性化合物是至少一种脂质和至少一种类胡萝卜素的混合物。
此外,挤出物通常包含至少一种聚合物载体材料。这种载体材料可以是天然的也可以是合成的。
合适的聚合物载体材料是聚环氧乙烷;聚乙烯吡咯烷酮;聚环氧丙烷;聚乙烯吡咯烷酮-共聚-乙酸乙烯酯;丙烯酸酯和甲基丙烯酸酯共聚物;聚乙烯;聚己内酯;聚乙烯-共聚-聚丙烯;烷基纤维素,如甲基纤维素;羟烷基纤维素诸如羟甲基纤维素,羟乙基纤维素,羟丙基纤维素(HPC)和羟丁基纤维素;羟烷基烷基纤维素如羟乙基甲基纤维素和羟丙基甲基纤维素;淀粉,果胶;多糖诸如黄芪胶(tragacanth),阿拉伯胶,瓜尔胶,蔗糖硬脂酸酯,黄原胶,甘油单酯、甘油二酯和甘油三酯,鲸蜡醇,硬脂醇(steryl alcohol)等,聚烯烃(包括木糖醇、甘露醇和山梨醇),α-羟基酸(包括柠檬酸和酒石酸、己二酸、马来酸、苹果酸、柠檬酸),肠溶聚合物,例如CAP、HPMC AS、虫胶,以及它们的组合。
在本发明的上下文中,优选的聚合物载体材料是纤维素基聚合物如乙基纤维素(EC)、羟丙基甲基纤维素(HPMC),羟丙基纤维素(HPC)或藻酸盐,壳聚糖,玉米或马铃薯淀粉,这都是天然聚合物的例子。聚乙烯吡咯烷酮(PVP),聚乙酸乙烯酯(PVA),聚乳酸(PLA)或共聚物诸如聚(甲基丙烯酸-共聚-丙烯酸乙酯)(购自Evonik Industries的)和聚乙烯基己內酰胺-聚乙酸乙烯酯-聚乙二醇接枝共聚物(购自BASF的)常被用作合成的聚合物。
如上所述的每种化合物的所有优选也适用于所有以下实施方式。
一个优选的实施方式涉及一种挤出方法,其中在50-300℃的温度下挤出组合物,所述组合物包含:
(i)基于所述挤出物的总重量,至少5重量%的至少一种吸附剂,和
(ii)基于所述挤出物的总重量,至少5重量%的至少一种脂质,和
(iii)基于所述挤出物的总重量,至少0.5重量%的至少一种类胡萝卜素(优选β-胡萝卜素),和
(iv)基于所述挤出物的总重量,至少45重量%的至少一种聚合物载体材料。
一个更优选的实施方式涉及一种挤出方法,其中在50-300℃的温度下挤出组合物,所述组合物包含:
(i)基于所述挤出物的总重量,至少10重量%的至少一种吸附剂,和
(ii)基于所述挤出物的总重量,至少10重量%的至少一种脂质,和
(iii)基于所述挤出物的总重量,至少1重量%的至少一种类胡萝卜素(优选β-胡萝卜素),和
(iv)基于挤出物的总重量,至少50重量%的至少一种聚合物载体材料。
一个进一步更优选的实施方式涉及一种挤出方法,其中在50-300℃的温度下挤出组合物,所述组合物包含:
(i)基于所述挤出物的总重量,5-30重量%的至少一种吸附剂,和
(ii)基于所述挤出物的总重量,5-20重量%的至少一种脂质,和
(iii)基于所述挤出物的总重量,0.5-10重量%的至少一种类胡萝卜素(优选β-胡萝卜素)和
(iv)基于所述挤出物的总重量,50-78重量%的至少一种聚合物载体材料。
所有百分比总是合计为100。
还可以向组合物中添加其他成分(助剂),然后将其挤出以形成挤出物。这种助剂可用于挤出工艺和/或用于挤出物和/或用于产品(或应用),其中随后使用挤出物。
这种助剂为例如抗氧化剂(例如抗坏血酸或其盐、生育酚(合成的或天然的))、丁羟甲苯(BHT);丁羟茴醚(BHA);没食子酸丙酯;叔丁基羟基喹啉和/或脂肪酸的抗坏血酸酯);乙氧喹;塑化剂;稳定剂;湿润剂(例如甘油、山梨醇、聚乙二醇);保护胶体;染料,香料;填充剂和缓冲剂。
任选地加入这些助剂。当加入时,那么基于挤出物的总重量,助剂的量为0.1-50重量%(wt.-%)。
通过热熔挤出来制备根据本发明的挤出物。
热熔挤出方法在现有技术中是已知的。
本文中使用术语“热熔挤出”来描述一种方法,其中赋形剂共混物被加热到熔融状态并随后被压过孔口,在孔口处使被挤出的产品形成其最终形状,在冷却后以最终形状被固化。共混物通常由螺旋机械装置传送经过多种加热区。螺杆通过圆柱形筒内的变速马达来被旋转,在圆柱形筒中在螺杆的外直径与筒的内直径之间仅存在小的间隙。在这种构造中,在筒壁处和螺杆螺纹之间产生高剪切,借此粉末共混物的各种组分被非常好地混合和解聚。热熔挤出装置通常是单螺杆或双螺杆设备,但能够由超过两个螺杆元件构成。典型的热熔挤出设备顺次包含混合/传送区、加热/熔融区和泵送区到孔口。在混合/传送区,通过螺杆元件和筒之间的剪切力,使粉末共混物混合,并且聚集体被减小成初级颗粒。在加热/熔融区,温度处于或高于共混物中聚合物载体的熔点或玻璃转化温度,以使传送的固体穿过该区时变为熔融的。聚合物载体起基质的作用,一种或多种活性物和其它功能成分被分散在该基质中;或者起粘合剂的作用,使用该粘合剂使它们结合在一起,以使在在出口孔口处形成连续的复合物。一旦处于熔融状态,均匀的共混物穿过维持共混物熔融状态的另一个加热区被泵送到孔口。在孔口处,熔融的共混物可以被形成股线、柱或膜。然后通常通过空气冷却方法使挤出的挤出物固化。一旦固化,然后可以将挤出物进一步处理,以形成粒、球、细粉末、片状物等。
合适的挤出机为例如KraussMaffei Berstorff的型号ZE 25 UTX或ThermoScientific Haake Polylab OS Rheodrive7/Haake Rheomex OS PTW 16。
温度是考虑所提出的发明时的一个重要的方法变量。
优选采用的热熔挤出方法是在升高的温度下进行,即挤出机的一个或多个加热区高于室温(约20℃)。选择操作温度范围是重要的,其会使处理过程中化合物的降解或分解最小化。操作温度范围通常在约50℃至约300℃的范围内,其通过一个或多个挤出机加热区和/或螺杆速度的设定来确定。被热熔挤出的混合物的温度将不超过300℃并且优选地将不超过250℃。
因此,本发明还涉及如上所述的生产挤出物的热熔挤出方法,其中对于挤出机的一个或多个加热区来说,操作温度范围通常在约50℃至约300℃的范围内,优选地,被热熔挤出的混合物的温度将不超过300℃并且更优选地将不超过250℃。
所有成分均使用纯的(不添加溶剂),被置于混合器或料斗内并被搅拌(共混)直至完全混合。然后将该混合物以足以使聚合物载体材料熔融或软化的速率和温度热熔挤出,以使组分的降解最小化并形成挤出物,随后将挤出物磨碎或切碎成合适的颗粒。
应当考虑到制剂组分被进料到挤出机的方式。在一些实施方式中,在被进料到挤出机之前,所有制剂组分被共混在一起,以形成共混的混合物。这可以通过任何传统的混合或共混技术来实现。或者,如果同时进料并在挤出机的混合/传送区中制剂组分充分混合的条件下,可以将制剂组分单独进料。
通常并且优选地,在热熔挤出中不使用溶剂。
在挤出过程中许多条件可以改变,以获得特别有利的制剂。这类条件包括例如制剂组成、进料速率、操作温度、螺杆设计、挤出机螺杆RPM、停留时间、模构造、加热区长度和挤出机扭矩和/或压力。优化这类条件的方法对于本领域技术人员来说是已知的。
通过在制剂中包含塑化剂和任选地抗氧化剂,可以降低处理温度、压力和/或扭矩。塑化剂(以及抗氧化剂)并不是实施本发明所必需的。将它们添加到制剂中被考虑为在本发明的范围内。
本发明的另一个实施方式涉及通过上述方法获得的挤出物。
通过如上所述的本发明的方法获得的挤出物可以被用作食品、饲料产品和/或膳食补充剂或用于食品、饲料产品和/或膳食补充剂中。这取决于所使用的成分。
也可以在预混物制剂中使用通过本发明的方法获得的挤出物,然后将预混物制剂用于配制最终产品。
因此,本发明还涉及通过本发明的方法获得的挤出物在食品、饲料产品和/或膳食补充剂中的用途。
因此,本发明还涉及用于食品、饲料产品和/或膳食补充剂的预混物,其包含至少一种通过如上所述的本发明的方法获得的挤出物。
通过下面的实施例来说明本发明。所有温度均以℃给出,并且所有份数和百分比均涉及重量。
实施例
实施例1:含有Labrafac PG和Neusilin US2的挤出物
使用Thermo Scientific Haake MiniLab II圆锥形、同向旋转、双螺杆微混合机进行热熔挤出(HME)方法。将羟丙基纤维素(HPC;Klucel EF Pharm;来自Ashland)、Labrafac PG(LPG;丙二醇二辛酰基癸酸酯(Propylene glycol dicaprylocaprate);来自Gattefossé)和Neusilin US2(US2;来自Fuji Chemical Industry)称重并以不同比例预混合(参见表1)。
将预混物进料到挤出机中。将筒温度设置为180℃。将进料步骤期间的螺杆速度设置为50rpm,随后是250rpm,持续1分钟。然后通过打开挤出机的旁通阀来收集挤出物。通过观察股线表面上和筒中是否存在痕量的油来评估油负载能力。添加吸附剂(Neusilin US2,其是硅酸铝镁的超轻细粒(CAS No 12511-31-8))允许增加油负载。分别含有73/15/12重量%(w/w)和65/20/15重量%的HPC/US2/LPG的制剂未显示任何痕量的油(表1)。
表1.脂质含量增加的挤出物的组成。
成分 | 挤出物1a的含量,重量% | 制剂1b的含量,重量% |
羟丙基纤维素 | 73 | 65 |
Labrafac PG | 12 | 15 |
Neusilin US2 | 15 | 20 |
当使用相同的方法来生产不含任何吸附剂(仅HPC和Labrafac PG)的挤出物时,只能加入不超过10重量%的Labrafac PG。更高量的油导致挤出物表面上存在油滴。
实施例2:含有Labrafac PG、Neusilin US2和β-胡萝卜素的挤出物
如实施例1所述进行添加结晶β-胡萝卜素(BC,DSM Nutritional Products Ltd.)的热熔挤出(HME)方法。能够向实施例1中所述的制剂成分中添加BC,而不导致油性挤出物。典型的制剂分别由70/15/12/3重量%和65/20/10/5重量%的HPC/US2/LPG/BC构成(参见表2)。
表2.包含β-胡萝卜素的挤出物的组成。
实施例3:含有Compritol 888 ATO和Neusilin US2的挤出物
使用Thermo Scientific Haake MiniLab II圆锥形、同向旋转、双螺杆微混合机进行热熔挤出(HME)方法。将羟丙基纤维素(HPC;Klucel EF Pharm;来自Ashland)、Compritol 888 ATO(Compritol;甘油二山嵛酸酯;来自Gattefossé)和Neusilin US2(US2;来自Fuji Chemical Industry)称重并预混合(参见表3)。
将预混物进料到挤出机中。将筒温度设置为180℃。将进料步骤期间的螺杆速度设置为50rpm,随后是250rpm,持续1分钟。然后通过打开挤出机的旁通阀来收集挤出物。通过观察挤出物的表面上和筒中是否存在痕量的油来评估脂质负载能力。
在含有65/20/15重量%的HPC/US2/Compritol的挤出物上未观察到油的痕迹。
表3.脂质含量增加的挤出物的组成。
成分 | 制剂3的含量 |
羟丙基纤维素 | 65 |
Compritol 888 ATO | 15 |
Neusilin US2 | 20 |
当使用相同的方法来生产不含任何吸附剂(仅HPC和Compritol)的挤出物时,只能加入不超过10重量%的Compritol。更高量的油导致挤出物表面上存在油滴。
实施例4:含有Compritol 888 ATO、Neusilin US2和β-胡萝卜素的挤出物
如实施例3所述进行添加结晶β-胡萝卜素(BC,DSM Nutritional Products Ltd.)的热熔挤出(HME)方法。能够向实施例3中所述的制剂成分中添加BC,而不导致油性股线。典型的制剂由64/18/15/3重量%和65/20/10/5重量%的HPC/US2/Compritol/BC构成(参见表4)。
表4.包含β-胡萝卜素的挤出物的组成。
成分 | 制剂4a的含量,重量% | 制剂4b的含量,重量% |
羟丙基纤维素 | 64 | 60 |
Compritol 888 ATO | 15 | 15 |
Neusilin US2 | 18 | 20 |
β-胡萝卜素 | 3 | 5 |
实施例5:含有Compritol 888 ATO、Neusilin US2和β-胡萝卜素的挤出物
如实施例3所述进行添加结晶β-胡萝卜素(BC,DSM Nutritional Products Ltd.)的热熔挤出(HME)方法,但使用更少的吸附剂。与实施例4中所示的制剂相比,当降低Neusilin US2含量时,获得了油性挤出物。
实施例6:含有硬脂酸和Neusilin US2的挤出物
使用Thermo Scientific Haake MiniLab II圆锥形、同向旋转、双螺杆微混合机进行热熔挤出(HME)方法。将羟丙基纤维素(HPC;Klucel EF Pharm;来自Ashland)、硬脂酸(SA;来自Sigma Aldrich)和Neusilin US2(US2;来自Fuji Chemical Industry)称重并预混合(参见表5)。
将预混物手动进料到挤出机中。将筒温度设置为180℃。将进料步骤期间的螺杆速度设置为50rpm,随后是250rpm,持续1分钟。然后通过打开挤出机的旁通阀来收集挤出物。通过观察股线表面上和筒中是否存在痕量的油来评估脂质负载能力。由65/20/15重量%的HPC/US2/SA构成的挤出物没有显示出油的痕迹。
表5.脂质比例增加的挤出物的组成。
成分 | 制剂6的含量,重量% |
羟丙基纤维素 | 65 |
硬脂酸 | 15 |
Neusilin US2 | 20 |
当使用相同的方法来生产不含任何吸附剂(仅HPC和硬脂酸)的挤出物时,只能加入不超过10重量%的硬脂酸。更高量导致挤出物表面上存在油滴。添加吸附剂允许增加挤出物中的脂质负载。
实施例7:含有硬脂酸和Neusilin US2的挤出物
如实施例6中所述进行热熔挤出(HME)方法。发现:Neusilin US2抑制硬脂酸(SA)在制剂中的重结晶(表6)。在分别由70/20/10重量%和65/20/15重量%的HPC/US2/SA构成的制剂中,在X射线粉末衍射图(XRPD,Bruker D2相位仪,快速线性1-D Lynxeye检测器,1.8kW Co KFL管,Fe滤器,30kV,10mA)中未能观察到约26°(2θ)处的SA结晶峰。此外,傅里叶变换红外(FTIR)分析证实了SA和US2之间的相互作用。1700-1500cm-1区域中的二聚体峰随着US2量的增加而移动并明显消失,在1585cm-1处出现新的峰。后者是羧酸盐形成的特征。这表明SA羧基与US2硅烷醇基以及US2表面上存在的铝和镁离子相互作用。此外,可以通过FTIR分析来证实SA晶格的破坏,与XRPD谱中SA结晶峰的消失一致。
表6.不含结晶硬脂酸的挤出物的组成。
成分 | 制剂7a的含量,重量% | 制剂7b的含量,重量% |
羟丙基纤维素 | 65 | 70 |
硬脂酸 | 15 | 10 |
Neusilin US2 | 20 | 20 |
实施例8:含有硬脂酸和Neusilin US2的挤出物
如实施例6中所述进行热熔挤出(HME)方法。发现:与实施例7相比,在制剂中,硬脂酸(SA)结晶度胜过更低含量的Neusilin US2。在分别由80/10/10重量%的HPC/US2/SA构成的制剂中,在X射线粉末衍射图(XRPD,Bruker D2相位仪,快速线性1-D Lynxeye检测器,1.8kW Co KFL管,Fe滤器,30kV,10mA)中能够观察到约26°(2θ)处的SA结晶峰。
实施例9:含有硬脂酸、Neusilin US2和β-胡萝卜素的挤出物
如实施例6所述,在160℃、170℃和180℃下进行添加结晶β-胡萝卜素(BC,DSMNutritional Products Ltd.)的热熔挤出(HME)方法。能够向实施例6中所述的制剂成分中添加BC,而不导致油性挤出物。
典型的挤出物由67/20/10/3重量%的HPC/US2/SA/BC构成(表7)。此外,在X射线粉末衍射图(Bruker D2相位仪,快速线性1-D Lynxeye检测器,1.8kW Co KFL管,Fe滤器,30kV,10mA)中未能观察到约17°、19°、20°和22°(2θ)处的BC结晶峰,指示无定形的BC制剂。这适用于在所有温度下处理的挤出物。在挤出之后,通过HPLC评估股线中的异构化程度以及BC含量。160℃或180℃下的HME方法之后的BC存留分别为87%和73%。因此,衍射图中没有BC结晶峰不是由于高的BC降解。160℃或180℃下的HME方法之后的全反式含量分别为45%和31%。
表7.包含β-胡萝卜素的挤出物的组成。
成分 | 制剂9的含量,重量% |
羟丙基纤维素 | 67 |
硬脂酸 | 10 |
Neusilin US2 | 20 |
-胡萝卜素 | 3 |
相反,不含Neusilin US2(分别为87/0/10/3重量%的HPC/US2/SA/BC)时,在于160℃下挤出之后,结晶BC峰是可见的。
实施例10:含有Maisine35-1和Syloid XDP3050的挤出物
使用DSM Xplore MC5圆锥形、同向旋转、双螺杆微混合机进行热熔挤出(HME)方法。将羟丙基纤维素(HPC;Klucel EF;来自Ashland)、Maisine 35-1(M35-1;来自Gattefossé)和Syloid XDP 3050(SXDP;来自Grace)称重并用抹刀以不同比例预混合。将预混物手动进料到挤出机中。将筒温度设置为160℃。将进料步骤和1分钟混合步骤期间的螺杆速度设置为300rpm。然后通过打开挤出机的旁通阀以200rpm的螺杆速度收集挤出物。通过观察股线表面上和筒中是否存在痕量的油来评估脂质负载能力。在仅含HPC和LPG的样品中,能够负载最多10%的脂质。更高的脂质含量导致湿的粉末预混物,其难以进料到桶中并且还导致油性股线。添加吸附剂SXDP允许获得干燥的自由流动粉末并且增加挤出物中的脂质负载。分别由78/12/10%和55/25/20%的HPC/SXDP/M35-1构成的制剂容易进料,并且股线没有显示出油的痕迹(表8)。
表8.脂质比例增加的挤出物的组成。
成分 | 含量,重量% | 含量,重量% |
羟丙基纤维素 | 78 | 55 |
SXDP | 12 | 25 |
M35-1 | 10 | 20 |
实施例11:含有Maisine35-1、Syloid XDP3050和β-胡萝卜素的挤出物
如实施例10中所述进行添加结晶β-胡萝卜素(BC,DSM Nutritional ProductsLtd.)的热熔挤出(HME)方法。能够向实施例1中所述的制剂成分中添加β-胡萝卜素,而不导致油性股线。典型的制剂分别由75/12/10/3%、52/25/20/3%、50/25/20/5%和48/25/20/7%(w/w)的HPC/SXDP/M35-1/BC构成(表11)。此外,在X射线粉末衍射图(Bruker D2相位仪,快速线性1-D Lynxeye检测器,1.8kW Co KFL管,Fe滤器,30kV,10mA)中未能观察到约17°、19°、20°和22°(2θ)处的β-胡萝卜素结晶峰,指示无定形的β-胡萝卜素制剂。相反,不含SXDP(分别为87/0/10/3的HPC/SXDP/M35-1/BC)时,在挤出之后,结晶β-胡萝卜素峰是可见的。在挤出之后,通过HPLC评估股线中的异构化程度以及β-胡萝卜素含量。HME方法之后的β-胡萝卜素存留为75%。因此,衍射图中没有β-胡萝卜素结晶峰不是由于高的β-胡萝卜素降解。HME方法之后的全反式含量为35%。
表11.脂质比例增加的挤出物的组成。
实施例12:含有Labrafac PG、Aeroperl 300和β-胡萝卜素的制剂
使用DSM Xplore MC5圆锥形、同向旋转、双螺杆微混合机进行热熔挤出(HME)方法。将羟丙基纤维素(HPC;Klucel EF;来自Ashland)、Labrafac PG(LPG;来自Gattefossé)、Aeroperl 300(Aeroperl;来自Evonik Industries)和β-胡萝卜素(BC,DSM NutritionalProducts Ltd.)称重并用抹刀以不同比例预混合。将预混物手动进料到挤出机中。将筒温度设置为160℃。将进料步骤和1分钟混合步骤期间的螺杆速度设置为300rpm。然后通过打开挤出机的旁通阀以200rpm的螺杆速度收集挤出物。通过观察股线表面上和筒中是否存在痕量的油来评估脂质负载能力。在仅含HPC和LPG的样品中,能够负载最多10%的脂质。更高的脂质含量导致湿的粉末预混物,其难以进料到桶中并且还导致油性股线。添加吸附剂Aeroperl允许获得干燥的自由流动粉末并且增加挤出物中的总脂质负载(β-胡萝卜素和LPG)。分别由75/12/10/3%、70/15/10/5%和65/18/10/7%(w/w)的HPC/Aeroperl/LPG/β-胡萝卜素构成的制剂容易进料,并且股线没有显示出油的痕迹(表12)。此外,在X射线粉末衍射图(Bruker D2相位仪,快速线性1-D Lynxeye检测器,1.8kW Co KFL管,Fe滤器,30kV,10mA)中未能观察到约17°、19°、20°和22°(2θ)处的β-胡萝卜素结晶峰,指示无定形的β-胡萝卜素制剂。相反,不含SXDP(分别为87/0/10/3的HPC/Aeroperl/LPG/β-胡萝卜素)时,在挤出之后,结晶β-胡萝卜素峰是可见的。在挤出之后,通过HPLC评估股线中的异构化程度以及β-胡萝卜素含量。HME方法之后的β-胡萝卜素存留>85%。因此,衍射图中没有β-胡萝卜素结晶峰不是由于高的β-胡萝卜素降解。HME方法之后的全反式含量>40%。
表12.脂质比例增加的挤出物的组成。
成分 | 含量,重量% | 含量,重量% | 含量,重量% |
羟丙基纤维素 | 75 | 70 | 65 |
Aeroperl 300 | 12 | 15 | 18 |
Labrafac PG | 10 | 10 | 10 |
β-胡萝卜素 | 3 | 5 | 7 |
Claims (15)
1.一种生产挤出物的挤出方法,所述挤出物包含至少一种脂溶性化合物和基于所述挤出物的总重量至少5重量%的至少一种吸附剂,其中在50-300℃的温度下挤出包含所述至少一种脂溶性化合物和至少一种吸附剂的组合物。
2.根据权利要求1所述的挤出方法,其中所述吸附剂是硅酸盐,优选硅酸钙和/或硅酸镁铝。
3.根据权利要求1或权利要求2所述的挤出方法,其中所述脂溶性化合物选自脂质、维生素和类胡萝卜素。
4.根据权利要求3所述的挤出方法,其中所述脂质是油、脂肪或蜡。
5.根据权利要求4所述的挤出方法,其中所述脂质选自椰子油,玉米油,棉籽油,橄榄油,棕榈油,花生油,菜籽油,芥花油,红花籽油,芝麻油,大豆油,葵花籽油,榛果油,杏仁油,腰果油,澳洲坚果油,檬戈果油,巴卡斯油,山核桃油,松子油,开心果油,印加果(南美油藤)油,胡桃油,多不饱和脂肪酸(例如甘油三酯和/或乙酯),油性营养制剂,聚乙二醇,聚环氧乙烷,甘油单酯,甘油二酯,甘油三酯,聚乙二醇单酯,聚乙二醇二酯,聚乙二醇15羟基硬脂酸酯,聚乙二醇甘油酯,甘油单硬脂酸酯和甘油二硬脂酸酯。
6.根据权利要求3所述的挤出方法,其中所述脂溶性维生素选自维生素A或其酯(维生素A乙酸酯和维生素A棕榈酸酯)、维生素E或其酯(维生素E乙酸酯)、维生素K(植物甲萘醌)和维生素D3(胆钙化醇)。
7.根据权利要求3所述的挤出方法,其中所述类胡萝卜素选自α-胡萝卜素、β-胡萝卜素、8'-阿朴-β-胡萝卜素醛、8'-阿朴-β-胡萝卜素酸酯例如乙酯、角黄素、虾青素、番茄红素、叶黄素、玉米黄素和藏红花酸。
8.根据权利要求3所述的挤出方法,其中所述类胡萝卜素是β-胡萝卜素。
9.根据前述权利要求中任一项所述的挤出方法,其中所述脂溶性化合物是至少一种脂质和至少一种类胡萝卜素的混合物。
10.根据前述权利要求中任一项所述的挤出方法,其中挤出包含以下的组合物:
(i)基于所述挤出物的总重量,至少5重量%的至少一种吸附剂,和
(ii)基于所述挤出物的总重量,至少5重量%的至少一种脂质,和
(iii)基于所述挤出物的总重量,至少0.5重量%的至少一种类胡萝卜素(优选β-胡萝卜素),和
(iv)基于所述挤出物的总重量,至少45重量%的至少一种聚合物载体材料。
11.根据前述权利要求1-9中任一项所述的挤出方法,其中挤出包含以下的组合物:
(i)基于所述挤出物的总重量,至少10重量%的至少一种吸附剂,和
(ii)基于所述挤出物的总重量,至少10重量%的至少一种脂质,和
(iii)基于所述挤出物的总重量,至少1重量%的至少一种类胡萝卜素(优选β-胡萝卜素),和
(iv)基于所述挤出物的总重量,至少50重量%的至少一种聚合物载体材料。
12.根据前述权利要求1-9中任一项所述的挤出方法,其中挤出包含以下的组合物:
(i)基于所述挤出物的总重量,5-30重量%的至少一种吸附剂,和
(ii)基于所述挤出物的总重量,5-20重量%的至少一种脂质,和
(iii)基于所述挤出物的总重量,0.5-10重量%的至少一种类胡萝卜素(优选β-胡萝卜素)和
(iv)基于所述挤出物的总重量,50-78重量%的至少一种聚合物载体材料。
13.通过根据权利要求1-12中任一项所述的方法获得的挤出物。
14.至少一种通过根据权利要求1-12所述方法获得的挤出物在食品、饲料产品和/或膳食补充剂中的用途。
15.食品、饲料产品和/或膳食补充剂,其包含至少一种通过根据权利要求1-12所述的方法获得的挤出物。
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AU2002226098A1 (en) * | 2000-10-30 | 2002-05-15 | The Board Of Regents, The University Of Texas System | Spherical particles produced by a hot-melt extrusion/spheronization process |
WO2012002253A1 (ja) * | 2010-06-29 | 2012-01-05 | 旭化成ケミカルズ株式会社 | セルロースと無機化合物を含む複合粒子 |
-
2016
- 2016-07-01 US US15/740,567 patent/US20180184703A1/en not_active Abandoned
- 2016-07-01 CN CN201680038143.9A patent/CN107735078A/zh active Pending
- 2016-07-01 EP EP16733607.2A patent/EP3316858A1/en not_active Withdrawn
- 2016-07-01 BR BR112017028160A patent/BR112017028160A8/pt active Search and Examination
- 2016-07-01 WO PCT/EP2016/065477 patent/WO2017005622A1/en active Application Filing
Patent Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
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US4031267A (en) * | 1971-12-23 | 1977-06-21 | General Foods Corporation | Expanded protein product and method of making same |
WO2006125591A1 (en) * | 2005-05-23 | 2006-11-30 | Phares Pharmaceutical Research N.V. | Direct dissolution |
WO2010111397A1 (en) * | 2009-03-24 | 2010-09-30 | Adds Pharmaceuticals Llc | Stabilized solubility-enhanced formulations for oral delivery |
WO2015071394A1 (en) * | 2013-11-15 | 2015-05-21 | Dsm Ip Assets B.V. | Formulation of sparingly soluble compounds by hot-melt extrusion |
Also Published As
Publication number | Publication date |
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US20180184703A1 (en) | 2018-07-05 |
BR112017028160A8 (pt) | 2023-02-14 |
BR112017028160A2 (pt) | 2018-08-28 |
EP3316858A1 (en) | 2018-05-09 |
WO2017005622A1 (en) | 2017-01-12 |
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