CN109069433B - 新颖的叶黄素和/或玉米黄质的可片剂化制剂 - Google Patents
新颖的叶黄素和/或玉米黄质的可片剂化制剂 Download PDFInfo
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Abstract
本发明涉及固体制剂,其包含经研磨的类胡萝卜素、至少一种水胶体、葡萄糖浆、蔗糖和至少一种水溶性抗氧化剂(优选抗坏血酸钠),其中所述类胡萝卜素选自叶黄素和玉米黄质及其任何混合物,其中所述水胶体选自改性食物淀粉及其任何混合物,并且其中所述经研磨的类胡萝卜素具有以下粒度分布:D[3,2]在0.6‑1.5μm范围内,且D[v,0.5]在1.1‑3.5μm范围内,所有D值均是根据Fraunhofer散射模型通过激光衍射(英国马尔文Malvern Instruments Ltd的Mastersizer 3000)测量的。该固体制剂为颗粒形式,所述颗粒被用于膳食补充剂和药物,例如,多种维生素和/或多种矿物质的片剂。出乎意料地,这些片剂显示出低压缩损失。
Description
本发明涉及固体制剂,其包含经研磨的类胡萝卜素、至少一种水胶体、葡萄糖浆、蔗糖和至少一种水溶性抗氧化剂(优选抗坏血酸钠),其中所述类胡萝卜素选自叶黄素和玉米黄质及其任何混合物,其中所述水胶体选自改性食物淀粉及其任何混合物,并且其中所述经研磨的类胡萝卜素具有以下粒度分布:
D[3,2]在0.6-1.5μm的范围内,D[v,0.5]在1.1-3.5μm的范围内,所有D值均是根据Fraunhofer散射模型通过激光衍射(英国马尔文Malvern Instruments Ltd的Mastersizer3000)测量的。
优选地,根据本发明的固体制剂中不存在除改性食物淀粉之外的其他水胶体。
优选地,在用超声处理再分散的制剂并离心后测量粒度分布。
优选地,D[3,2]在0.8-1.2μm的范围内,更优选地D[3,2]在0.8-1.1μm的范围内,D[3,2]是根据Fraunhofer散射模型通过激光衍射(英国马尔文Malvern Instruments Ltd的Mastersizer 3000)测量的。
D[v,0.5]优选在1.1-2.6μm的范围内,更优选地D[v,0.5]在1.1-2.1μm的范围内,D[v,0.5]是根据Fraunhofer散射模型通过激光衍射(英国马尔文Malvern Instruments Ltd的Mastersizer 3000)测量的。
该固体制剂为颗粒形式,所述颗粒被用于膳食补充剂和药物。这些膳食补充剂和药物分别优选为片剂(例如,多种维生素和/或多种矿物质的片剂)形式。
颗粒的粒度分布优选如下:
D[3,2]在200-300μm的范围内(优选在230-270μm的范围内),且D[v,0.5]在220-320μm的范围内(优选在240-290μm的范围内),所有D值均是根据Fraunhofer散射模型通过激光衍射(英国马尔文Malvern Instruments Ltd的Mastersizer 3000)测量的。
优选地,类胡萝卜素是叶黄素。叶黄素对眼睛健康起着重要作用。因此,存在对包含叶黄素的膳食补充剂、特别是片剂形式的这种膳食补充剂的巨大需求。片剂通常不含叶黄素本身,而是包含制剂形式的叶黄素,其中叶黄素包埋在水胶体基质中,所述水胶体基质保护叶黄素免于降解和氧化。迄今为止,市场上的此类叶黄素片剂具有显示出高压缩损失的缺点。
压缩损失被定义为:在限定的条件下片剂化之后,可被有机溶剂提取出制剂的类胡萝卜素(尤其是叶黄素)的百分比。
压缩损失是(药物)片剂的保质期的相关参数,即(药物)片剂中类胡萝卜素(尤其是叶黄素)的稳定性的参数。如果压缩损失较小,则片剂的保质期较长。
通过下述方法来测定压缩损失:
○使用研钵,将片剂小心研磨成混合物,使得制剂本身不被破坏;
○用合适的溶剂(例如二氯甲烷或石油醚)处理所述混合物,使得仅被压出来的类胡萝卜素(尤其是叶黄素)溶解;
○用另一溶剂(环己烷或异丙醇)稀释所述溶液(溶剂+类胡萝卜素,尤其是叶黄素),以及
○通过测量溶液的吸光度,对溶剂中的类胡萝卜素(尤其是叶黄素)进行分析测定,以及
○计算压出的类胡萝卜素(尤其是叶黄素)的总量百分比。
重要事项:制剂的基质一定不能溶于有机溶剂。
本发明的制剂特别适用于制备叶黄素的稳定片剂/膳食补充剂。
这种片剂优选显示出类胡萝卜素(尤其是叶黄素)的压缩损失≤12%,优选≤10%(即压缩损失在0-10%的范围内),即存在于包含根据本发明的制剂的片剂表面的类胡萝卜素(尤其是叶黄素)的量≤12重量%,优选≤10重量%,所述重量%是基于片剂中类胡萝卜素(尤其是叶黄素)的总重量。存在于这种片剂表面的类胡萝卜素(尤其是叶黄素)是一个很大的劣势,因为所述类胡萝卜素(特别是叶黄素)不再受到水胶体的抗氧化保护。对于大多数目的而言,在5-12.5重量%范围内的压缩损失是完全可接受的。
根据本发明的膳食补充剂/片剂
根据本发明的制剂特别适用于制造膳食补充剂,尤其是片剂形式的膳食补充剂,其中优选项如上所述。
因此,本发明还涉及包含根据本发明的制剂的片剂。
所述片剂可进一步包含维生素、矿物盐和/或微量元素。
维生素的实例有维生素E、维生素C、维生素K、维生素B1、维生素B2、维生素B6、维生素B12、维生素D、生物素、叶酸、烟酸、烟酰胺、泛酸和/或泛酸盐/酯。也可以使用相应的衍生物(例如,这些化合物的酯和盐)来代替这些化合物。
矿物盐的实例有钙盐、磷盐、镁盐、钾盐和氯盐。
微量元素的实例有铬、钴、铁、氟(以氟化物盐的形式摄取)、碘(以碘盐形式摄取)、铜、锰、钼、硒、硅和锌。
现在更详细地描述根据本发明的固体制剂。
根据本发明的制剂
叶黄素
作为起始材料,最优选使用可从Kemin Foods(US)获得的具有50-80重量%的叶黄素含量的所谓“叶黄素饼”。该叶黄素饼是通过提取万寿菊花(Marigold Flowers)获得的。叶黄素饼还含有玉米黄质,其中叶黄素与玉米黄质的摩尔比为约9:1。
也可以使用从任何其他天然来源获得的或通过发酵或通过化学合成获得的叶黄素。
在本发明的一个优选实施方式中,不存在除叶黄素和/或玉米黄质之外的其他类胡萝卜素。这种例外不包括可能已经微量存在于起始材料中(例如“叶黄素饼”中)的类胡萝卜素。
类胡萝卜素的量
基于颗粒的总重量,类胡萝卜素的量优选为1-30重量%,更优选为5-25重量%,甚至更优选为5-17重量%,最优选为10-17重量%。
如果类胡萝卜素是叶黄素和玉米黄质的混合物,则它们的摩尔比优选在20:1-2:1的范围内,更优选它们的摩尔比在10:1-4:1的范围内。
水胶体
水胶体选自改性食物淀粉及其任何混合物。优选的是所谓的OSA淀粉。
“改性食物淀粉”
改性食物淀粉是已通过已知方法化学改性,以具有向其提供亲水性部分和亲脂性部分的化学结构的食物淀粉。优选地,改性食物淀粉具有长烃链作为其结构的一部分(优选C5-C18)。
优选使用至少一种改性食物淀粉来制造本发明的固体制剂,但可以在一种固体制剂中使用两种或更多种不同的改性食物淀粉的混合物。
淀粉是亲水性的,因此不具有乳化能力。然而,改性食物淀粉由通过已知化学方法被疏水性片段取代的淀粉制成。例如,可以用环状二羧酸酐(例如,琥珀酸酐)处理,用烃链取代淀粉(见O.B.Wurzburg(编辑),"Modified Starches:Properties and Uses,CRCPress,Inc.Boca Raton,Florida,1986,以及随后的版本)。本发明的一种特别优选的改性食物淀粉具有下式(I)
其中St是淀粉,R是亚烷基原子团,R'是疏水性基团。优选地,R是低级亚烷基原子团,例如二亚甲基或三亚甲基。R'可以是烷基或烯基,优选具有5-18个碳原子。优选的式(I)化合物是“OSA-淀粉”(辛烯基琥珀酸淀粉钠)。取代度(即,酯化羟基数与游离的未酯化羟基数之比)通常在0.1%至10%的范围内,优选在0.5%至4%的范围内,更优选在3%至4%的范围内变化。
术语“OSA-淀粉”表示用辛烯基琥珀酸酐(OSA)处理的任何淀粉(来自任何天然来源,例如玉米、蜡质玉蜀黍、蜡质玉米、小麦、木薯和马铃薯,或合成的)。取代度(即,用OSA酯化的羟基数与游离的未酯化羟基数之比)通常在0.1%至10%的范围内,优选在0.5%至4%的范围内,更优选在3%至4%的范围内变化。OSA淀粉也被称为“改性食物淀粉”。
术语“OSA-淀粉”还包括这样的淀粉,其可例如从National Starch/Ingredion以商品名HiCap 100,Capsul(辛烯基琥珀酸酯淀粉糊精),Capsul HS,Purity Gum 2000,Clear Gum Co03,UNI-PURE,HYLON VII购得;分别从National Starch和Roquette Frères购得;从CereStar/Cargill以商品名C*EmCap购得或从Tate&Lyle购得。
至少一种水胶体(改性淀粉/OSA淀粉)的量
基于制剂的总重量,改性食物淀粉(优选OSA淀粉)的量优选为10-50重量%,更优选为25-45重量%。
葡萄糖浆
葡萄糖浆可以原样使用或以干燥形式使用。两者都是可商购的淀粉水解物,即单糖、寡糖和多糖的混合物。根据本发明,优选使用干燥的葡萄糖浆。关于干燥的葡萄糖浆给出的优选项也适用于未干燥的葡萄糖浆。
术语“右旋糖当量”(DE)表示水解度,其是基于干重以D-葡萄糖计算的还原糖的量的量度;标度基于DE接近0的天然淀粉和DE为100的葡萄糖。
干燥的葡萄糖浆以及未干燥的葡萄糖浆通常按其DE值(高于20)分类。根据本发明,优选使用DE在20至95的范围内、更优选在20至30的范围内、最优选在20至23的范围内的干燥的葡萄糖浆。
在本发明的另一个实施方式中,使用两种葡萄糖浆的混合物,其中一种葡萄糖浆具有低DE,优选DE≤25,更优选DE在20-25的范围内,另一种葡萄糖浆具有高DE,优选DE≥90,更优选DE在90-100的范围内。
干燥的葡萄糖浆的量
基于制剂的总重量,干燥的葡萄糖浆的量在0.1-40重量%的范围内,优选在5-40重量%的范围内,更优选在10-30重量%的范围内,最优选在15-25重量%的范围内。
如果使用未干燥的葡萄糖浆,则其使用量相同。
蔗糖
在本发明的一个优选实施方式中,改性食物淀粉:干燥的葡萄糖浆:蔗糖的重量比为(1.5-2.5):(0.5-1.5):(0.5-1.5),更优选为(1.8-2.2)至(0.8-1.2):(0.8-1.2),最优选为2:1:1。
蔗糖的量
基于制剂的总重量,蔗糖的量在0.1-40重量%的范围内,优选在5-40重量%的范围内,更优选在10-30重量%的范围内,最优选在15-25重量%的范围内。
在本发明的一个优选实施方式中,干燥的葡萄糖浆的量与蔗糖的量相同(以千克计)。在本发明的另一个优选实施方式中,改性食物淀粉的量(以千克计)与干燥的葡萄糖浆和蔗糖的总量(以千克计)相同。
水溶性抗氧化剂
优选地,水溶性抗氧化剂是抗坏血酸钠,但也可以使用食品级的并因此适合人类消费的其它水溶性抗氧化剂。
水溶性抗氧化剂的量
基于制剂的总重量,水溶性抗氧化剂(尤其是抗坏血酸钠)的量优选为0.1-10重量%,更优选为2-7重量%,最优选为4-6重量%。
本发明的制剂还可含有至多7重量%的水,优选其含有至多5重量%的水,所述重量%是基于制剂的总重量。
在本发明的一个优选实施方式中,基于制剂的总重量,经研磨的类胡萝卜素的量、至少一种改性食物淀粉的量、干燥的葡萄糖浆的量、蔗糖的量和水溶性抗氧化剂(优选是抗坏血酸钠)的量优选总计为至少90重量%,优选至少95重量%。
在本发明的一个甚至更优选的实施方式中,制剂由经研磨的类胡萝卜素、至少一种改性食物淀粉、干燥的葡萄糖浆、蔗糖、水溶性抗氧化剂(优选是抗坏血酸钠)和水组成。
在本发明的另一个优选实施方式中,使用叶黄素含量为50-80重量%的叶黄素饼,其中叶黄素饼与由改性食物淀粉+干燥的葡萄糖浆+蔗糖组成的基质的重量比为1:(4-6),优选1:(4.8-5.5),更优选1:(5-5.3)。
在本发明的另一个优选实施方式中,使用叶黄素含量为50-80重量%的叶黄素饼,其中叶黄素饼与改性食物淀粉的重量比为1:(1.5-4),优选1:(2-3),更优选1:(2.5-2.7)。
在本发明的另一个优选实施方式中,使用叶黄素含量为50-80重量%的叶黄素饼,其中叶黄素饼与干燥的葡萄糖浆的重量比为1:(0.5-2),优选1:(1.0-1.5),更优选1:(1.25-1.35)。
在本发明的另一个优选实施方式中,使用叶黄素含量为50-80重量%的叶黄素饼,其中叶黄素饼与蔗糖的重量比为1:(0.5-2),优选1:(1.0-1.5),更优选1:(1.25-1.35)。
优选地,不存在其他化合物。优选地,不存在除改性食物淀粉之外的其他水胶体,并且不存在其他乳化剂。
优选不存在的化合物是以下这些:
-水解的卵磷脂产品,尤其是WO 2009/071295的第5页第5-19行所公开的那些;
-金合欢胶;阿拉伯胶,如例如WO 2007/009601中所公开;还如WO 2008/110225中所公开的那样改性;
-印度胶(Gum Ghatti),如例如WO 2009/147158中所述;
-蛋白质,例如明胶(鱼明胶、猪明胶、牛明胶);
-纤维素衍生物,例如羧甲基纤维素;
-植物蛋白;
-乳蛋白;
-木素磺酸盐;
-植物胶和改性食物淀粉的缀合物,尤其是WO 2011/039336中公开的那些;
-十二烷基硫酸钠和其他烷基硫酸钠;
-脂溶性抗氧化剂,例如dl-α-生育酚;
-异麦芽酮糖醇,如例如US 2008/0026124的方法中使用的异麦芽酮糖醇;
-α-玉米胡萝卜素;
-β-玉米胡萝卜素。
在本发明的一个特别优选的实施方式中,制剂中不存在下列化合物中的任何一种:
-水解的卵磷脂产品,尤其是WO 2009/071295的第5页第5-19行所公开的那些;
-阿拉伯胶,如例如WO 2007/009601中所公开;
-脂溶性抗氧化剂,例如dl-α-生育酚;
-异麦芽酮糖醇,如例如US 2008/0026124的方法中使用的异麦芽酮糖醇;
-α-玉米胡萝卜素;
-β-玉米胡萝卜素。
在一个优选的实施方式中,本发明的固体制剂不含油。术语“油”不包括可能存在于制剂中的任何亲脂性物质,因为它们是用作叶黄素来源的叶黄素饼的一部分。
在本发明的上下文中,术语“油”涵盖甘油和任何甘油三酯例如植物油或脂肪如玉米油、向日葵油、大豆油、红花油、菜籽油、花生油、棕榈油、棕榈仁油、棉籽油、橄榄油或椰子油或MCT(中链甘油三酯)及其任何混合物。
油可来自于任何来源。它们可以是天然的、经改性的或合成的。因此在本发明的上下文中,术语“油”还涵盖芥花油、芝麻油、榛子油、扁桃仁油、腰果油、澳洲坚果油、梦梗果油(mongongo nut oil)、巴卡斯果油、美洲山核桃油、松子油、开心果油、印加果(Plukenetiavolubilis)油或胡桃油。
虽然未明确提及,但本发明还涵盖本专利申请中提及的经研磨的类胡萝卜素的任何优选特征与改性食物淀粉、干燥的葡萄糖浆、蔗糖、水溶性抗氧化剂的任何优选特征以及它们的优选重量比和本说明书中提及的制剂的任选的其他成分的任何组合。
因此,虽然未明确提及,但本发明涵盖本发明优选实施方式的任何组合。
本发明的优选制剂是这样的固体制剂,所述固体制剂包含经研磨的类胡萝卜素,其量为1-30重量%(优选5-25重量%);至少一种水胶体,其量为10-50重量%(优选25-45重量%);干燥的葡萄糖浆,其量为0.1-40重量%(优选10-30重量%);蔗糖,其量为0.1-40重量%(优选10-30重量%);至少一种水溶性抗氧化剂(优选抗坏血酸钠),其量为0.1-10重量%(优选2-7重量%);和水,其量为0-7重量%,所有量均基于制剂的重量,其中所述类胡萝卜素选自叶黄素和玉米黄质及其任何混合物,其中所述水胶体选自改性食物淀粉及其任何混合物,并且其中所述经研磨的类胡萝卜素具有以下粒度分布:
D[3,2]在0.6-1.5μm的范围内,D[v,0.5]在1.1-3.5μm的范围内,所有D值均是根据Fraunhofer散射模型通过激光衍射(英国马尔文Malvern Instruments Ltd的Mastersizer3000)测量的。
上文已经给出了本发明制剂的化合物(经研磨的类胡萝卜素、改性食物淀粉、葡萄糖浆、蔗糖、水溶性抗氧化剂和水)的进一步优选项。
制备根据本发明的固体制剂的方法
根据以下方法获得根据本发明的制剂:
a)提供至少一种改性食物淀粉、葡萄糖浆和蔗糖的水溶液;
b)将类胡萝卜素加入步骤a)的溶液中,从而获得了悬浮物;
c)研磨步骤b)的悬浮物,直至经研磨的类胡萝卜素达到以下粒度分布:
D[3,2]在0.6-1.5μm的范围内,D[v,0.5]在1.1-3.5μm的范围内,两个D值均是根据Fraunhofer散射模型通过激光衍射(英国马尔文Malvern Instruments Ltd的Mastersizer3000)测量的;
d)将步骤c)的悬浮物喷雾造粒以获得根据本发明的固体制剂;
其中在该方法期间加入水溶性抗氧化剂(优选为抗坏血酸钠)。
任选地,可以在步骤c)之后进行pH调节至pH在2.5-4.0的范围内(优选在2.9-3.5的范围内)。在本发明的一个优选实施方式中,进行该pH调节步骤。
通过该方法,获得了颗粒形式的固体制剂。这些颗粒优选具有以下粒度分布:
D[3,2]在200-300μm的范围内(优选在230-270μm的范围内),D[v,0.5]在220-320μm的范围内(优选在240-290μm的范围内),两个D值均是根据Fraunhofer散射模型通过激光衍射(英国马尔文Malvern Instruments Ltd的Mastersizer 3000)测量的。
在本发明的一个优选实施方式中,藉由通过流化床造粒干燥在步骤c)中获得的悬浮物来进行步骤d)。
本发明的制剂和片剂的优点
本发明的固体制剂具有优异的流动性,因此可以容易地在片剂的制备过程中添加。
本发明的制剂特别显示出通过直径为5mm的孔的流动性为至少100g/min,且/或通过直径为7mm的孔的流动性为至少250g/min,且/或通过直径为9mm的孔的流动性为至少500g/min,且/或通过直径为10mm的孔的流动性为至少700g/min,且/或通过直径为15mm的孔的流动性为至少2000g/min。
在一个优选的实施方式中,本发明的制剂显示出通过直径为5mm的孔的流动性为100g/min至150g/min,且/或通过直径为7mm的孔的流动性为250g/min至350g/min,且/或通过直径为9mm的孔的流动性为500g/min至750g/min,且/或通过直径为10mm的孔的流动性为700g/min至850g/min,且/或通过直径为15mm的孔的流动性为2000g/min至3000g/min。
包含本发明制剂的多种维生素-多种矿物质的片剂优选在施加10kN的压缩力时显示出压碎力为至少70N的硬度,且/或在施加15kN的压缩力时显示出压碎力为至少120N的硬度,且/或在施加17.5kN的压缩力时显示出压碎力为至少140N的硬度,且/或在施加20kN的压缩力时显示出压碎力为至少170N的硬度,且/或在施加25kN的压缩力时显示出压碎力为至少200N的硬度,且/或在施加30kN的压缩力时显示出压碎力为至少230N的硬度,且/或在施加35kN的压缩力时显示出压碎力为至少255N的硬度,且/或在施加40kN的压缩力时显示出压碎力为至少285N的硬度。
此外,包含本发明制剂的多种维生素-多种矿物质的片剂还在脆性(friability)和崩解性(distintegration)方面显示出良好的片剂性质,并显示出良好的类胡萝卜素的化学稳定性和低的类胡萝卜素压缩损失。
现在在以下非限制性实施例中进一步阐释本发明。
实施例
使用以下缩略语:RH=室内湿度。
粒度的测量
使用英国Malvern Instruments Ltd.的“Mastersizer 3000”,通过激光衍射技术测定本发明固体粒子的所有粒度。关于该粒度表征方法的进一步信息可以例如在"Basicprinciples of particle size analytics",Dr.Alan Rawle,Malvern InstrumentsLimited,Enigma Business Part,Grovewood Road,Malvern,Worcestershire,WR14 1XZ,UK和“Malvern粒度分析仪手册”中找到。具体参考用户手册编号MAN 0096,第1.0期,1994年11月。
用于粉末和片剂表征的分析设备
粉末特征包括粉末密度(堆积密度和振实密度)和流动性的分析。根据EP<2.9.34>和USP<616>,通过在量筒中测量,用Engelsmann JEL粉末振实密度测定仪(德国路德维希港的J.Engelsmann AG)测定堆积密度(ρ堆积)和振实密度(ρ振实)。用Pharmatest PTG-S4自动粉末表征仪(德国海恩堡的Pharma Test Apparatebau AG)测定粉末流动性。通过流过孔的方法测定质量流速(g/min)。流速被解释为指定量的粉末(100g)流过具有不同直径的孔所需的时间。自由流动的粉末应该能够流过直径5mm、7mm、9mm、10mm和15mm的整组。流速与孔直径的关系图被称为流动曲线。进行三次平行测量以确定流速。
片剂化之后,进行压缩片剂的表征,包括片剂硬度、脆性、崩解性和含量均匀性。如USP<1217>和EP<2.9.8.>中所述利用UTS4 1测定仪(德国Darmstadt的KraemerElektronik GmbH)测量片剂的破碎强度(硬度)。测量轴向破坏片剂所需的力。所展示的总是10次测量的平均值。
与片剂硬度密切相关的脆性是指机械磨损期间重量损失的程度。最大损失不超过初始片剂重量的1%被认为是可接受的(USP<1216>,EP<2.9.7.>)。在AE-1脆性仪(Friabilator)(瑞士Zuchwill的Charles Ischi AG Pharma Prüftechnik)中检测10个片剂,转速为25rpm,持续4分钟。记录片剂的重量损失。
在37℃下,在900mL脱矿质水中,使用DISI-1崩解测定仪(瑞士Zuchwill的CharlesIschi PG Pharma Prüftechnik),根据USP<701,2040>表征片剂崩解。进行六次平行测量。未包衣片剂的崩解时间上限为30分钟(USP<2040>)。
通过从每个系列10次单独测定计算的标准偏差RSD(%)评估含量均匀性。
在25℃/60%RH(长期研究,长达36个月)、30℃/65%RH(中间稳定性,12个月)和40℃/75%RH(加速/应力测试,6个月)下监测片剂应用中原型的稳定性。将片剂储存在密封的聚乙烯(PE)盒中,并在预定的时间点进行分析。
粒度分布的测量
在用超声分别处理实施例1、2和3的再分散制剂并离心后测量粒度分布。
实施例1:制备根据本发明的叶黄素和玉米黄质的固体制剂
将150kg OSA-淀粉、75kg干燥的葡萄糖浆和75kg蔗糖溶解在440升72℃的预热水中,持续至少30分钟(基质)。然后在36℃和20℃之间的温度下,在搅拌条件下将60kgFloraGlo叶黄素晶体(可得自美国得梅因的Kemin Foods)加入基质中。在将所得悬浮物的pH调节至pH为3.5后,将所得的经pH调节的悬浮物加入研磨微粒(直径为0.3mm)中,并在几个通道(passages)中进行研磨。向所得悬浮物中加入18kg抗坏血酸钠。然后加入水并开始喷雾干燥造粒。获得了275kg固体制剂。
实施例2:制备根据本发明的叶黄素和玉米黄质的固体制剂
将160kg OSA-淀粉、80kg干燥的葡萄糖浆和80kg蔗糖溶解在480升72℃的预热水中,持续至少30分钟(基质)。然后在36℃和29℃之间的温度下,在搅拌条件下将60kgFloraGlo叶黄素晶体(可得自美国得梅因的Kemin Foods)加入基质中。在将所得悬浮物的pH调节至pH为2.9后,将所得的经pH调节的悬浮物加入研磨微粒(直径为0.3mm)中,并在几个通道中进行研磨。向所得悬浮物中加入20kg抗坏血酸钠。然后加入水并开始喷雾干燥造粒。获得了305kg固体制剂。
实施例3:制备根据本发明的叶黄素和玉米黄质的固体制剂
将160kg OSA-淀粉、80kg干燥的葡萄糖浆和80kg蔗糖溶解在480升72℃的预热水中,持续至少30分钟(基质)。然后在39℃和21℃之间的温度下,在搅拌条件下将60kgFloraGlo叶黄素晶体(可得自美国得梅因的Kemin Foods)加入基质中。在将所得悬浮物的pH调节至pH为3.03后,将所得的经pH调节的悬浮物加入研磨微粒(直径为0.3mm)中,并在几个通道中进行研磨。向所得悬浮物中加入18kg抗坏血酸钠。然后加入水并开始喷雾干燥造粒。获得了330kg固体制剂。
实例4:对比例
作为对比例,使用可商购的Lutemax2020TM(叶黄素和玉米黄质素食多功能微粒5%)(印度的OmniActive Health Technologies)。它是一种标准化的万寿菊(Tagetes种)干花的提取物,形式为包封在亲水性载体、纤维素衍生物和天然抗氧化剂的基质中的纯化的游离叶黄素浓缩物。
流动性
根据实施例1-3制备的所有三种制剂都显示出优异的流动性(参见下表1)。
表1:
密度
如下表2所示,所有三个实施例的堆积密度和振实密度都很高。
表2:
实施例1 | 实施例2 | 实施例3 | |
堆积密度 | 0.71g/cm<sup>3</sup> | 0.71g/cm<sup>3</sup> | 0.71g/cm<sup>3</sup> |
振实密度 | 0.79g/cm<sup>3</sup> | 0.79g/cm<sup>3</sup> | 0.79g/cm<sup>3</sup> |
实施例5:片剂化方法和设备
通过下述方法制备片剂混合物:在Turbula混合器(Willy A.BachofenMaschinenfabrik)中以23rpm分别混合和筛分(筛网直径为1mm)表3和表4中给出的成分,持续15分钟,然后在转鼓(7.5升)中以20rpm(每分钟转数)混合15分钟。
表3:维生素预混物(每片的剂量,以mg计)
表4:矿物质预混物(每片的剂量,以mg计)
用Korsch XL 100旋转式压片机(德国柏林的Korsch AG)压制片剂。在片剂化过程中,用不同的压缩力(10-40kN)压缩片剂混合物,并测量片剂的破碎力。绘制片剂硬度与压缩力以构建压缩曲线。基于所获得的压缩曲线,确定最佳压缩力(20kN),并制备具有下表5中给出的组成的片剂。
表5:包含根据实施例1、2或3的制剂或根据对比例4的制剂的多种维生素-多种矿
物质的片剂1-3和对比片剂4的片剂组成
压缩曲线(见表6)
所有三种片剂1-3的压缩曲线彼此相似。对比例展示出较低的可压缩性,这体现在片剂化需要较高的压缩力-对于对比片剂4为至少25kN,而对于根据本发明的片剂1-3为20kN。
表6:
片剂特征
根据本发明的所有三种片剂1-3在硬度、脆性和崩解度方面显示出令人满意的片剂性质(参见表7)。这意味着:当施加20kN-25kN的压缩力时,具有根据本发明的制剂的多种维生素-多种矿物质的片剂显示出压碎力为至少160N的硬度。
与根据本发明的片剂1-3相比,对比片剂4展示出较长的崩解时间。所有产生的根据本发明的片剂中的含量均匀性都是令人满意的(RSD<5%)。
表7
包含分别根据实施例1、2和3制备的制剂的片剂的稳定性试验
在以下条件下测量包含根据实施例1-3的制剂的三种片剂的叶黄素和玉米黄质含量以及包含对比例4的形式的片剂的叶黄素和玉米黄质含量:
25℃,60%RH;30℃,65%RH;和40℃,75%RH。
结果如下表8-10所示。
表8:25℃,60%RH
表9:30℃,65%RH
表10:40℃,75%RH
Claims (19)
1.一种固体制剂,其包含经研磨的类胡萝卜素、至少一种水胶体、葡萄糖浆、蔗糖和水溶性抗氧化剂,
其中所述类胡萝卜素选自叶黄素和玉米黄质及其任何混合物,
其中所述水胶体选自改性食物淀粉及其任何混合物,
并且其中所述经研磨的类胡萝卜素具有以下粒度分布:
D[3,2]在0.6-1.5μm的范围内,且D[v,0.5]在1.1-3.5μm的范围内,所有D值均是根据Fraunhofer散射模型通过激光衍射测量的;
其中所述固体制剂为颗粒形式,是通过喷雾造粒得到的,并且其中所述颗粒具有以下粒度分布:
D[3,2]在200-300μm的范围内,且D[v,0.5]在220-320μm的范围内,所有D值均是根据Fraunhofer散射模型通过激光衍射测量的。
2.根据权利要求1所述的固体制剂,其中所述固体制剂是根据以下方法获得的:
a)提供至少一种改性食物淀粉、葡萄糖浆和蔗糖的水溶液;
b)将所述类胡萝卜素加入步骤a)的溶液中,从而获得了悬浮物;
c)研磨步骤b)的悬浮物,直至达到根据权利要求1所述的经研磨的类胡萝卜素的粒度分布;
d)将步骤c)的悬浮物喷雾造粒以获得根据权利要求1所述的固体制剂;
其中在该方法期间加入水溶性抗氧化剂。
3.根据权利要求1-2中任一项所述的固体制剂,其中基于所述制剂的总重量,所述蔗糖的量在0.1-40重量%的范围内。
4.根据权利要求1-2中任一项所述的固体制剂,其中基于所述制剂的总重量,所述类胡萝卜素的量在1-30重量%的范围内。
5.根据权利要求1-2中任一项所述的固体制剂,其中所述类胡萝卜素是叶黄素和玉米黄质的混合物,并且其中叶黄素与玉米黄质的摩尔比在20:1-2:1的范围内。
6.根据权利要求1-2中任一项所述的固体制剂,其中基于所述制剂的总重量,所述改性食物淀粉的量在10-50重量%的范围内。
7.根据权利要求1-2中任一项所述的固体制剂,其中基于所述制剂的总重量,所述葡萄糖浆的量在0.1-40重量%的范围内。
8.根据权利要求1-2中任一项所述的固体制剂,其中基于所述制剂的总重量,所述水溶性抗氧化剂的量在0.1-10重量%的范围内。
9.根据权利要求1-2中任一项所述的固体制剂,其中基于所述制剂的总重量,所述经研磨的类胡萝卜素的量、所述至少一种改性食物淀粉的量、所述葡萄糖浆的量、所述蔗糖的量和所述水溶性抗氧化剂的量总计至少90重量%。
10.根据权利要求1-2中任一项所述的固体制剂,其中所述制剂不含任何油。
11.根据权利要求1-2中任一项所述的固体制剂,其中所述制剂不包含任何下列化合物:水解的卵磷脂产品、阿拉伯胶、脂溶性抗氧化剂、异麦芽酮糖醇、α-玉米胡萝卜素和β-玉米胡萝卜素。
12.一种膳食补充剂,其包含根据前述权利要求中任一项所述的固体制剂。
13.根据权利要求12所述的膳食补充剂,其还包含维生素、矿物盐和/或微量元素。
14.根据权利要求12或13所述的膳食补充剂,其中所述膳食补充剂为片剂形式。
15.根据权利要求14所述的膳食补充剂,其中基于类胡萝卜素的总量,所述片剂的压缩损失小于类胡萝卜素的12%。
16.根据权利要求14所述的膳食补充剂,其中当施加20-25kN的压缩力时,所述片剂具有压碎力为至少160N的硬度。
17.根据权利要求14所述的膳食补充剂,其中所述片剂是在施加10kN的压缩力时显示出压碎力为至少70N的硬度的多种维生素-多种矿物质的片剂。
18.根据权利要求1-11中任一项所述的固体制剂作为膳食补充剂的添加剂的用途。
19.根据权利要求1-11中任一项所述的固体制剂作为片剂形式的膳食补充剂的添加剂的用途。
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US20190098924A1 (en) | 2019-04-04 |
US20240023589A1 (en) | 2024-01-25 |
KR20180126025A (ko) | 2018-11-26 |
KR102416361B1 (ko) | 2022-07-04 |
TW201806586A (zh) | 2018-03-01 |
JP2019510763A (ja) | 2019-04-18 |
ES2917212T3 (es) | 2022-07-07 |
TWI736605B (zh) | 2021-08-21 |
AU2017242919A1 (en) | 2018-10-18 |
EP3435986A1 (en) | 2019-02-06 |
BR112018069697A2 (pt) | 2019-01-29 |
PL3435986T3 (pl) | 2022-08-22 |
JP7388608B2 (ja) | 2023-11-29 |
WO2017168005A1 (en) | 2017-10-05 |
NZ746666A (en) | 2023-01-27 |
EP3435986B1 (en) | 2022-04-27 |
MY193047A (en) | 2022-09-26 |
CN109069433A (zh) | 2018-12-21 |
AU2017242919B2 (en) | 2020-03-26 |
AU2018101536A4 (en) | 2018-11-15 |
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