CN114521107A - 洋姜的造粒 - Google Patents
洋姜的造粒 Download PDFInfo
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- CN114521107A CN114521107A CN202080070941.6A CN202080070941A CN114521107A CN 114521107 A CN114521107 A CN 114521107A CN 202080070941 A CN202080070941 A CN 202080070941A CN 114521107 A CN114521107 A CN 114521107A
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- jerusalem artichoke
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Classifications
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L19/00—Products from fruits or vegetables; Preparation or treatment thereof
- A23L19/09—Mashed or comminuted products, e.g. pulp, purée, sauce, or products made therefrom, e.g. snacks
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L19/00—Products from fruits or vegetables; Preparation or treatment thereof
- A23L19/10—Products from fruits or vegetables; Preparation or treatment thereof of tuberous or like starch containing root crops
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23K—FODDER
- A23K10/00—Animal feeding-stuffs
- A23K10/30—Animal feeding-stuffs from material of plant origin, e.g. roots, seeds or hay; from material of fungal origin, e.g. mushrooms
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23K—FODDER
- A23K40/00—Shaping or working-up of animal feeding-stuffs
- A23K40/10—Shaping or working-up of animal feeding-stuffs by agglomeration; by granulation, e.g. making powders
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23K—FODDER
- A23K50/00—Feeding-stuffs specially adapted for particular animals
- A23K50/10—Feeding-stuffs specially adapted for particular animals for ruminants
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23K—FODDER
- A23K50/00—Feeding-stuffs specially adapted for particular animals
- A23K50/30—Feeding-stuffs specially adapted for particular animals for swines
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23K—FODDER
- A23K50/00—Feeding-stuffs specially adapted for particular animals
- A23K50/50—Feeding-stuffs specially adapted for particular animals for rodents
-
- A—HUMAN NECESSITIES
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Abstract
公开了从发酵的洋姜糖浆生产颗粒的方法。该方法的产品为具有高含量的例如菊粉和低聚果糖等碳水化合物的可自由流动的颗粒。还公开了该颗粒的有用的应用。
Description
在家畜养殖中,通常在有限的空间条件下饲养动物。这导致动物对细菌感染的高度脆弱性(vulnerability),结果是给饲养者带来严重的经济损失。为了对抗这些细菌感染,对动物饲喂大量的抗生素。这样,抗生素进入食物链。然而,最大的问题是抗生素耐药性的发展。此类耐药菌是对抗生素在人类和动物的细菌感染的治疗中的功效的巨大威胁。因此,需要寻找减少或彻底避免在家畜养殖中使用抗生素的解决方案。
一种途径是使用益生元。益生元为用作有益细菌的底物的不可消化的纤维物质,其促进肠道细菌菌群(intestinal bacterial microflora)的生长。这些有益细菌可以阻碍致病细菌(pathogenic bacteria)的生长。因此,将会有较少的由致病菌(pathogenicgerm)引起的感染和/或炎症。结果,可以使添加至家畜食品中的抗生素的量大幅降低或者甚至免除。
最受欢迎的益生元之一是菊粉。菊粉作为储存多糖(storagepolysaccharide)包含在许多植物中并且通常在根或根茎中发现。具有高含量的菊粉的植物包括龙舌兰、芦笋、香蕉、牛蒡、克美莲(camas)、菊苣(chicory)、松果菊、闭鞘姜(costus)、蒲公英、土木香、大蒜、朝鲜蓟、菊芋(Jerusalem artichoke)(洋姜(topinambur))、豆薯、韭菜、山金车(leopard’s bane)、艾蒿根、燕麦、洋葱、车前草、大豆、小麦、野山药和菊薯(yacón)。
对于工业用途,它最常来自菊芋块茎、也来自菊苣(菊苣(Cichorium intybus))。菊芋(菊芋(Helianthus tuberosus))为发源于北美的菊科的多年生草本植物。其主要被称为洋姜(topinambur)。块茎由水(75-79%)、碳水化合物(15-16%)、蛋白质(2-3%)、脂肪(2-3%)和高达鲜重的0.5%的微量元素构成(Negro等人,(2006)Appl BiochemBiotechnol 132:922-932)。在碳水化合物中,菊粉占80%以上。其余的糖主要为果糖、蔗糖和葡萄糖(Kaldy等人,(1980)Econ Bot 34:352-357)。
菊粉是归类为果聚糖的多糖混合物。其由多达100个果糖单体和一个末端葡萄糖单体构成。其为由通过(2→1)α键与果糖键合的D-葡萄糖分子终止的β(2,1)糖苷键连接的D-果糖的线性聚合物(De Leenheer(1996)in:van Bekkum等人,(编)Carbohydrates asorganic raw materials III,Wiley)。聚合度(DP)取决于培养条件并且范围可以为2-60个果糖残基。其为水溶性纤维,在转移至块茎中之前首先在洋姜的茎中发现(Negro等人,(2006)Appl Biochem Biotechnol132:922-932)。
菊粉无法由人类小肠消化酶消化,但是借助乳酸盐和短链脂肪酸由大肠中的某些细菌(例如双歧杆菌和乳酸菌)发酵(Alles等人,(1996)Brit J Nutr 76:211-221)。因此,其改变了肠道菌群(gut microflora)的组成。
发现菊粉及其水解产物选择性地刺激人结肠中天然存在的双歧杆菌的生长(Gibson等人,(1995)Gastroenterology 108:975-982;Roberfroid等人,(1998)J Nutr128:11-19)。
认为双歧杆菌促进积极的健康影响,例如降低血液中的胆固醇水平、降低血液中的氨水平、诱导例如叶酸等B族维生素的产生、在使用抗生素治疗后重建肠道菌群、和通过产生例如乙酸盐、丙酸盐和丁酸盐等短链脂肪酸(SCFA)来抑制致病菌的生长(参见Gibson和Roberfroid(1995)J Nutr 125:1401-1412)。数项研究可以显示菊粉的口服应用增加了丁酸盐的产生(Scheppach等人,(1992)J Parenter Enteral Nutr 16:43-48;Scheppach等人,(1995)Eur J Cancer 31A:1077-1080;Younes等人,(1996)Br J Nutr 75:301-314;Campbell等人,(1997)J Nutr 127:130-136)。
例如大肠杆菌(E.coli ssp.)、梭状芽孢杆菌(Clostridium ssp.)、沙门氏菌(Salmonella spp.)、弯曲杆菌(Campylobacter)、拟杆菌(Bacteroides spp.)、肠球菌(Enterococcus)、肠杆菌(Enterobactericea)、变形杆菌(Proteus spp.)等致病菌在它们的生长中受到SCFA阻碍(参见Gibson和Wang(1994)FEMS Microbiol Lett 118:121-127)。
Samanta等人,(2012)Braz J Microbiol 44:1-14记载了含菊粉的饮食对反刍动物和非反刍动物的肠道菌群的有益影响。其中包括家禽、鸡、鹅、鸭、马、驴、兔、猪、牛(cattle)、小牛(calves)、奶牛(cow)、水牛、绵羊、山羊、大额牛(gayal)和骆驼。根据需要,这也适用于繁殖的印度跑鸭(Indian runner duck)、火鸡、珍珠鸡、鸽子、鸵鸟、骡子、瘤牛、牦牛、单峰骆驼和羊驼(lama)。在使菊粉作为饲料添加剂的猪中,肠道蠕虫的负担显著降低(Petkevicius等人,(1997)Parasitol 114:555-568)。
DE 10 2008 006 363A1中记载了用于马的、用于改善肠道菌群的食品组合物。该食品组合物由两种组分构成。其中之一为例如洋姜等益生元组分。
在使用洋姜块茎的在糖尿病大鼠中进行的营养研究中,发现血清葡萄糖水平、总胆固醇、LDL胆固醇和甘油三酯的降低(Zacky等人,(2009)Environ Sci 5:682-688)。在链脲佐菌素(STZ)诱导的糖尿病大鼠中,洋姜处理通过修复由STZ引起的肝损伤而导致糖尿病症状的缓解(Wang等人,(1997)Arch Toxicol 71:638-645)。
菊粉的吸收导致改善的钙平衡,这是预防骨质疏松症的主要目标(Luo等人,(1996)Am J Clin Nutr 63:939-945)。
在EP 1269857 A2中,公开了一种物质,其适合于填充、涂覆或覆盖例如饼干、巧克力、三明治和薯片等食品。该物质可以含有例如洋姜等益生元物质。
RU 2377844 C1揭示了生产作为咖啡替代品的洋姜-梨饮品的方法。需要液氮提取并且通过在沉淀的氮气中低温粉碎来获得饮料。
存在各种各样的从洋姜块茎中分离菊粉的方法。用于菊粉提取的最佳条件为85℃60分钟,其中水固比为1:20(v/w)。通过用乙醇或丙酮沉淀来实现最佳产率。在pH 2.0下、在100℃下90分钟后实现菊粉的完全水解(Abozed等人,(2009)Ann Agric Sci 54:417-423)。
US 5,968,365提供通过超滤来净化具有高聚合度的粗菊粉提取物的方法。该方法包括分离、酶变性、净化、纯化和分级的步骤。
WO 2010/058104揭示了具有活性物质和作为唯一的造粒赋形剂的菊粉的药物组合物。通过湿法造粒来获得这些组合物。需要造粒溶剂并且造粒溶剂与活性物质之比为0.1-0.4。
在WO 2011/128906 A1中,公开了生产环丙沙星的掩味干糖浆组合物的方法。为此目的,使用在例如丙醇等溶剂中的甲基丙烯酸酯共聚物。
可选地,在造粒时可以使用枣糖浆作为片剂粘合剂(Alanazi(2010)SaudiPharmac J 18:81-89)。然而,枣中的菊粉并不丰富。
EP 0153447 A1公开了通过短时间快速加热从饱和的糖溶液生产干的可倾倒糖产品以生产糖浆、随后经历快速结晶的方法。该方法需要在强制流通的螺旋管中进行。未提及洋姜或菊粉。
WO 2016/210169公开了处理水溶液(其中包括糖浆)的方法和系统,以产生具有超过95重量%的固体的过饱和溶液。该方法和设备复杂,并且不涉及洋姜或菊粉。
虽然菊粉和洋姜的有益作用得到广泛认可,但是仍然缺少合适的用于家畜饲喂的组合物。洋姜块茎自身无法直接饲喂。另外,切碎的洋姜块茎对家畜没有吸引力或者菊粉含量过低而使得要饲喂相当大的量。另一方面,从洋姜块茎中分离菊粉会是繁琐的过程。由于其必须具有家畜食品质量,因此某些化学成分无法用于该过程,或者此后必须通过额外的步骤将它们除去。由于家畜饲喂或肉类生产是具有狭窄利润空间的竞争激烈的领域,因此分离的菊粉由于过于昂贵而无法使用。因此,需要寻找易于生产、不需要关键化学品并且最重要的是适合于大量生产并且廉价的菊粉的给予形式。
一种解决方案是提供正在经历发酵以用于保存的洋姜提取物。在生物学和生物技术中,将发酵定义为将有机物质微生物转化或酶转化为酸、气体或醇的过程。
在DE 10 2007 032 832A1中公开了此类用于洋姜的发酵方法。由此可以使洋姜块茎中的菊粉含量大大增加约16%(w/w)。结果是可以添加至家畜的饮用水中的高度浓缩的糖浆。
然而,该糖浆面临家畜尤其是鸡的严重的接受性问题。该发酵糖浆的味道或气味显然对它们有强烈的排斥作用。当添加了该发酵糖浆时,鸡普遍远离饮用水。因此,摄入不足的菊粉量。结果,未达到预期的结果。
因此,任务是寻找克服该问题的来自洋姜块茎的发酵提取物的组合物。本发明出乎意料地解决了该任务。发现可以从洋姜块茎的此类发酵提取物生产颗粒。
用于从洋姜糖浆生产颗粒的方法包括以下步骤:
a)提供高剪切造粒机,所述高剪切造粒机包括混合床、混合床的入口、用于混合床的加热装置、混合机、均化器、干燥床和用于干燥床的加热装置,
b)在室温和大气压下将适合于造粒的固体水不溶性粘合剂填充至高剪切造粒机的混合床中,
c)使混合机以40rpm至120rpm的混合速度运行,
d)在不运行均化器的情况下将洋姜糖浆的第一部分添加至混合床中,其中固体水不溶性粘合剂与全部洋姜糖浆之比在4:1至2:3(w/v)的范围内,并且全部洋姜糖浆的第一部分总计为全部洋姜糖浆的20%-30%(v/v),
e)将混合床的温度设定在5℃至40℃的范围内,
f)以60rpm的速度启动均化器,
g)以全部洋姜糖浆的1%至15%(v/v)的份量添加洋姜糖浆的其它部分直至添加了全部洋姜糖浆,
其中在达到混合物的均质性之后添加洋姜糖浆的后续部分,
h)将颗粒输送至干燥床,并且
i)将颗粒在10℃至40℃的温度下干燥直至颗粒的水含量小于4重量%,
其特征在于,该方法不需要使用造粒液的润湿步骤、载气、赋形剂的添加、洋姜糖浆的酶处理,并且特征在于,不进行造粒混合物的加热步骤。
结果是自由流动的洋姜颗粒,其特征在于一种洋姜颗粒,其特征在于,最少30重量%的碳水化合物含量、最少20重量%的固体水不溶性粘合剂和小于4重量%的水含量,其中固体水不溶性粘合剂与总碳水化合物含量之比在3:1至2:3(w/v)的范围内。
在优选的实施方案中,根据本发明的洋姜颗粒的碳水化合物含量为最少40重量%,更优选碳水化合物含量为最少50重量%。
碳水化合物的组成取决于所使用的发酵的洋姜糖浆。菊粉含量可以变化。糖浆还可以包含菊粉的降解产物的主要部分,例如低聚果糖以及其它糖类。这还取决于是否将酶处理用于生产发酵的洋姜糖浆。然而,本发明的方法不依赖于所使用的发酵的洋姜糖浆各自的碳水化合物组成而运行。
发现根据本发明的该洋姜颗粒基本上具有尺寸为0.5mm至2mm的粒径,如在标准分级试验中所评估的。粒度分布显示令人惊讶的均匀。
根据本发明的方法的固体水不溶性粘合剂可以选自所有已知的作为营养学上或药学上可接受的赋形剂的非水溶性粘合剂。优选微晶纤维素(E460(i);MCC)和硅藻土(diatomaceous earth)(D.E.;硅藻土(diatomite);硅藻土(kieselgur))。特别优选微晶纤维素。
微晶纤维素为由通过1-4个β糖苷键连接的葡萄糖单元构成的天然存在的聚合物。聚合度通常小于400。按照定义,以直径计的粒径小于5μm的MCC不应当占比超过10重量%。
硅藻土为可以粉碎成微细的白色粉末的天然存在的、柔软的硅质沉积岩。烘干的硅藻土的通常的化学组成包含80-90%二氧化硅、2-4%氧化铝和0.5-2%氧化铁。通常的粒径以直径计的范围为10至200μm。
高剪切造粒机(混合器(blender)、混合机(mixer))将一种相或成分(液体、固体、气体)分散或输送至通常与其不混溶的主连续相(液体)中。在包含要混合的溶液的罐中或者在溶液通过的管道中使用转子或叶轮以及称为定子(stator)的固定组件或者转子和定子的阵列,以产生剪切。其在食品和制药工业中用于乳化、均质化、减小粒径和分散。
用于将固体水不溶性粘合剂和洋姜糖浆的第一部分混合的混合床的混合速度在40rpm(每分钟转数)至120rpm的范围内,优选50rpm至80rpm,最优选55rpm至70rpm。
混合机可以为本领域已知的任何混合装置。通常,其为叶轮。
洋姜糖浆的第一部分达到全部洋姜糖浆的20%至30%(v/v),优选25%至30%(v/v),最优选30%(v/v)。
固体水不溶性粘合剂与全部洋姜糖浆之比在3:1至2:3(w/v)的范围内,优选2:1至1:1.25(w/v),更优选1.5:1至1:1.1(w/v),最优选1:1(w/v)。
将混合床的温度设定为5℃至40℃,优选25℃至40℃,更优选30℃至40℃并且最优选35℃至38℃。
当启动均化器时,其以60rpm的速度运行。任选地,均化器可以包括额外的栅格和/或切碎机(chopper)部分。
以全部洋姜糖浆的1%至15%(v/v)的份量、优选以2%至10%(v/v)的份量、最优选以5%(v/v)的份量添加洋姜糖浆的其它部分直至添加了全部洋姜糖浆。在达到混合物的均质性之后添加洋姜糖浆的后续部分。通常,由操作者通过目视来估计均质性的状态。可选地,可以使用本领域已知的技术手段来代替。通常,在0.5min至5min后、优选在1.5min至4min后、最优选在2.5min至3min后添加下一份。
任选地,可以通过安培计来监测造粒过程。当达到颗粒化时,电流增大至特征值。由此,可以监测造粒过程。
通过打开滑动窗将所得颗粒从混合床中输送出去。混合机的移动将颗粒连续地从混合床中输送出去。其在干燥装置上被接收。在大多数情况下,这些为干燥托盘。通常将这些干燥托盘设置在干燥室中。
干燥温度在10℃至40℃、优选20℃至40℃、更优选30℃至38℃、最优选35℃的范围内。
令人惊讶的是,结果是可以在不添加造粒液的情况下生产根据本发明的颗粒。在例如流化床造粒、混合器造粒和压实等湿法造粒方法中,总是存在需要添加的一种以上的造粒液。造粒液包含必须是挥发性的溶剂或载体材料,其在干燥步骤期间将被除去。常见的造粒液为水、乙醇、异丙醇、丙酮及其水溶液或者聚乙烯吡咯烷酮(PVP)。
在湿法造粒方法中,通常包括加热步骤以使造粒液蒸发。由于根据本发明的方法在没有造粒液的情况下运行,因此此类加热步骤是没有意义的。因此,根据本发明的方法的进一步特征在于,不进行造粒混合物的加热步骤。
根据本发明的方法的特征在于,不需要载气例如空气、氮气、非活性气体或氢气。
在各种各样的洋姜加工方法中,添加例如菊粉酶(β-呋喃果糖苷酶)、果胶酶、蔗糖酶、α-淀粉酶、麦芽糖酶、果糖基转移酶或转化酶等酶以将多糖结构分解为寡糖或单糖(例如DE 4426662 C2)。在根据本发明的造粒方法期间不需要此类处理。因此,根据本发明的方法的进一步特征在于,不需要洋姜的酶处理。
在湿法造粒中使用的赋形剂通常包括稀释剂、粘合剂、崩解剂和润滑剂,同时还可以包括其它稳定剂和颜料。用于湿法造粒的通常的赋形剂包括而不限于羟丙基甲基纤维素(HPMC)、羧甲基纤维素(CMC)、黄原胶、糖、明胶、聚乙烯吡咯烷酮、丙烯酸酯、麦芽糖糊精、乳糖一水合物、蔗糖和淀粉。令人惊讶的是,对于发酵的洋姜糖浆的造粒,不需要这些赋形剂。因此,根据本发明的方法的进一步特征在于,不需要添加赋形剂。
在另一方面,本发明涉及根据本发明的洋姜颗粒在家畜养殖中作为食品添加剂的用途。
此类家畜选自包括而不限于家禽、鸡、鹅、鸭、火鸡、兔、猪、小牛和奶牛的组。优选用于鸡的用途。
在进一步的方面,本发明涉及根据本发明的洋姜颗粒作为通过测定肾小球滤过率来测量肾功能的诊断剂的用途。作为洋姜的主要组分的菊粉在慢性肾病的疾病进展的诊断和监测中是已建立的工具。认为菊粉清除率的测定是最好且最精确的方法之一。菊粉由肾小球过滤。其在肾小管中既不重吸收也不分泌。也不存在代谢降解。因此,其只是惰性地通过肾脏并且可以容易地定量。基于该测量,可以计算肾小球滤过率(GFR)(参见K/DOQIclinical practice guidelines for chronic kidney disease:evaluation,classification,and stratification.In:American Journal of Kidney Diseases(2002)39:S1–266;Kim等人,(2015)Clin Nephrol 84:331-338)。代替分离的菊粉,可以将洋姜颗粒给予此类患者。
洋姜、各菊粉制剂广泛地用作益生元膳食补充剂(参见Rubel等人,(2014)FoodRes Int 62:59-65;Szewczyk等人,(2019)Ann Agric Envir Med 26:24-28)。实例包括膳食补充散剂、注射剂、丸剂、胶囊剂、片剂、滴剂、颗粒剂以及例如酸奶等食品的添加剂。因此,本申请还涉及根据本发明的洋姜颗粒作为益生元膳食补充剂的用途。
因此,本申请还涉及用于医药的根据本发明的洋姜颗粒。
特别地,本申请还涉及用于骨折、皮肤伤口、肿胀、疼痛、乳腺癌、肺癌、结肠癌、上皮癌、代谢综合征、甲氨蝶呤诱导的肝毒性、1型糖尿病、2型糖尿病、骨质疏松症和真菌病的预防和治疗的根据本发明的洋姜颗粒。
在另一方面,本申请涉及包含根据本发明的洋姜颗粒和至少一种药学上可接受的赋形剂的药物组合物。例如,根据本发明的洋姜颗粒可以用于胶囊剂或片剂。
术语“药学上可接受的赋形剂”是指与根据本发明的洋姜颗粒一起添加至药物制剂中的天然的或合成的化合物。它们可以有助于使制剂增大、提高制剂所需的药代动力学性质或稳定性以及有利于制造过程。
至少一种适当的药学上可接受的赋形剂可以选自包括而不限于载体、粘合剂、润滑剂、助流剂、崩解剂、着色剂、防腐剂、抗氧化剂、酸化剂、增稠剂、填料、芳香物质和调味物质、甜味剂的组。
符合条件的是本领域已知的所有载体及其组合。在固体剂型中,它们可以为例如植物和动物脂肪、蜡、石蜡、淀粉、西黄蓍胶、纤维素衍生物、聚乙二醇、硅酮、膨润土、二氧化硅、滑石、氧化锌。对于液体剂型和乳剂,适当的载体为例如溶剂、增溶剂、乳化剂,例如水、乙醇、异丙醇、碳酸乙酯、乙酸乙酯、苯甲醇、苯甲酸苄酯、丙二醇、1,3-丁二醇、棉籽油、花生油、橄榄油、蓖麻油、芝麻油、甘油脂肪酸酯、聚乙二醇、山梨聚糖的脂肪酸酯。
术语粘合剂是指将粉末粘合或将它们胶粘在一起、通过颗粒形成使它们内聚(cohesive)的物质。它们用作制剂的“胶水”。粘合剂增加所提供的稀释剂或填料的内聚强度。
适当的粘合剂为例如来自小麦、玉米、大米或马铃薯的淀粉,明胶,例如葡萄糖、蔗糖或β-乳糖等天然存在的糖,来自玉米的甜味剂,例如阿拉伯胶、西黄蓍胶或海藻酸钙铵等天然和合成树胶,海藻酸钠、羧甲基纤维素、羧甲基纤维素钠、羟丙基羧甲基纤维素、聚乙二醇、聚乙烯吡咯烷酮、硅酸铝镁、蜡和其它。组合物中的粘合剂的百分比的范围可以为1-30重量%,优选2-20重量%,更优选3-10重量%并且最优选3-6重量%。
术语润滑剂是指添加至剂型中以促进片剂、颗粒等从压模或出口喷嘴脱模的物质。它们减少摩擦或磨耗。通常在压制前不久添加润滑剂,这是由于它们应当存在于颗粒的表面上以及颗粒与压模的部件之间。组合物中的润滑剂的量可以在0.05重量%和15重量%之间、优选在0.2重量%和5重量%之间、更优选在0.3重量%和3重量%之间、最优选在0.3重量%和1.5重量%之间变化。
适当的润滑剂为油酸钠,例如硬脂酸钠、硬脂酸钙、硬脂酸钾和硬脂酸镁等金属硬脂酸盐,硬脂酸,苯甲酸钠,乙酸钠,氯化钠,硼酸,具有高熔点的蜡,聚乙二醇。
助流剂为防止各试剂的烘干并且改善颗粒的流动特性以使流动平滑且恒定的材料。适当的助流剂包括二氧化硅、硬脂酸镁、硬脂酸钠、淀粉和滑石。组合物中的助流剂的量可以在0.01重量%和10重量%之间、优选在0.1重量%和7重量%之间、更优选在0.2重量%和5重量%之间、最优选在0.5重量%和2重量%之间变化。
术语崩解剂是指添加至组合物中以促进其解体(breaking apart)的物质。适当的崩解剂可以选自包括以下物质的组:淀粉,冷水可溶性淀粉例如羧甲基淀粉,纤维素衍生物例如甲基纤维素和羧甲基纤维素钠,微晶纤维素和交联微晶纤维素例如交联羧甲基纤维素钠,天然和合成树胶例如瓜尔胶、琼脂、梧桐树胶(karaya)(印度西黄蓍胶)、刺槐豆胶、西黄蓍胶,粘土例如膨润土,黄原胶,海藻酸盐例如海藻酸和海藻酸钠,发泡组合物。由例如淀粉、纤维素衍生物、海藻酸盐、多糖、葡聚糖和交联聚乙烯吡咯烷酮支持水分膨胀。组合物中的崩解剂的量可以在1重量%和40重量%之间、优选在3重量%和20重量%之间、最优选在5重量%和10重量%之间变化。
着色剂为赋予饮品组合物、各剂型着色的赋形剂。这些赋形剂可以为食品着色剂。它们可以被吸附在适当的吸附手段(means)例如粘土或氧化铝上。着色剂的量可以在药物组合物的0.01重量%和10重量%之间、优选在0.05重量%和6重量%之间、更优选在0.1重量%和4重量%之间、最优选在0.1重量%和1重量%之间变化。
适当的药用着色剂为例如姜黄素、核黄素、核黄素-5’-磷酸盐、酒石黄、紫草红(alkannin)、喹啉黄WS、坚牢黄AB、核黄素-5’-磷酸钠、黄色2G、日落黄FCF、橙色GGN、胭脂虫红(cochineal)、胭脂红酸、柑橘红2、酸性红(carmoisine)、苋菜(amaranth)、丽春红4R、丽春红SX、丽春红6R、赤藓红、红色2G、诱惑红AC、阴丹士林蓝RS、专利蓝V(Patent blue V)、靛蓝胭脂红(indigo carmine)、亮蓝FCF、叶绿素和叶绿酸(chlorophyllins)、叶绿素和叶绿酸的铜络合物、绿色S、坚牢绿FCF、普通焦糖(Plain caramel)、苛性亚硫酸盐焦糖(Causticsulphite caramel)、氨焦糖(ammonia caramel)、亚硫酸氨焦糖(sulphite ammoniacaramel)、黑色PN、炭黑、植物碳(vegetable carbon)、棕色FK、棕色HT、α-胡萝卜素、β-胡萝卜素、γ-胡萝卜素、胭脂树红(annatto)、胭脂素(bixin)、降胭脂树素(norbixin)、辣椒红色素(paprika oleoresin)、辣椒黄素(capsanthin)、辣椒红素(capsorubin)、番茄红素(lycopene)、β-脂蛋白-8’-胡萝卜素醛(beta-apo-8’-carotenal)、β-脂蛋白-8’-胡萝卜酸乙酯、毛莨黄素(flavoxanthin)、叶黄素、隐黄质(cryptoxanthin)、玉红黄质(rubixanthin)、紫黄质(violaxanthin)、紫杉紫素(rhodoxanthin)、角黄素(canthaxanthin)、玉米黄质(zeaxanthin)、枳橙黄质(citranaxanthin)、虾青素、甜菜苷、花色素苷(anthocyanins)、藏红花、碳酸钙、二氧化钛、氧化铁、氢氧化铁、铝、银、金、颜料宝石红(pigment rubine)、鞣酸、地衣红(orcein)、葡萄糖酸亚铁、乳酸亚铁。
防腐剂可以选自包括但不限于如下物质的组:山梨酸、山梨酸钾、山梨酸钠、山梨酸钙、对羟基苯甲酸甲酯、对羟基苯甲酸乙酯、对羟基苯甲酸甲基乙酯、对羟基苯甲酸丙酯、苯甲酸、苯甲酸钠、苯甲酸钾、苯甲酸钙、对羟基苯甲酸庚酯、对羟基苯甲酸甲酯钠、对羟基苯甲酸乙酯钠、对羟基苯甲酸丙酯钠、苯甲醇、苯扎氯铵、苯乙醇、甲酚、氯化十六烷基吡啶、氯丁醇、硫柳汞(2-(乙基汞硫基)苯甲酸钠)、二氧化硫、亚硫酸钠、亚硫酸氢钠、焦亚硫酸钠、焦亚硫酸钾、亚硫酸钾、亚硫酸钙、亚硫酸氢钙、亚硫酸氢钾、联苯、邻苯酚、邻苯酚钠、噻苯达唑(thiabendazole)、乳酸链球菌肽(nisin)、游霉素(natamycin)、甲酸、甲酸钠、甲酸钙、六胺、甲醛、二碳酸二甲酯、亚硝酸钾、亚硝酸钠、硝酸钠、硝酸钾、乙酸、乙酸钾、乙酸钠、二乙酸钠、乙酸钙、乙酸铵、脱氢乙酸、脱氢乙酸钠、乳酸、丙酸、丙酸钠、丙酸钙、丙酸钾、硼酸、四硼酸钠、二氧化碳、苹果酸、富马酸、溶菌酶、硫酸铜(II)、氯、二氧化氯和本领域技术人员已知的其它适当的物质或组合物。
适当的增稠剂可以选自包括但不限于以下物质的组:聚乙烯吡咯烷酮、甲基纤维素、羟丙基甲基纤维素、羟丙基纤维素、糊精、聚葡萄糖、改性淀粉、碱性改性淀粉、漂白淀粉、氧化淀粉、酶处理淀粉、磷酸单淀粉、用三偏磷酸钠或磷酰氯酯化的磷酸二淀粉、磷酸二淀粉磷酸酯、乙酰化磷酸二淀粉、用乙酸酐酯化的淀粉乙酸酯、用乙酸乙烯酯酯化的淀粉乙酸酯、乙酰化二淀粉己二酸酯、乙酰化二淀粉甘油酯、二淀粉甘油酯、羟丙基淀粉、羟丙基二淀粉甘油酯、羟丙基磷酸二淀粉、羟丙基二淀粉甘油酯、辛烯基琥珀酸淀粉钠、乙酰化氧化淀粉、羟乙基纤维素。
填料为添加至药物中以处理最少量的活性药剂的非活性物质。填料的实例为水、甘露醇、预糊化淀粉、淀粉、微晶纤维素、粉末状纤维素、硅化微晶纤维素、二水合磷酸氢钙、磷酸钙、碳酸钙、羟丙基纤维素、羟乙基纤维素、羟丙基甲基纤维素、聚乙二醇、黄原胶、阿拉伯树胶或其任意组合。
抗氧化剂的适当的实例包括焦亚硫酸钠、α-生育酚、抗坏血酸、马来酸、抗坏血酸钠、抗坏血酸棕榈酸酯、丁基羟基茴香醚、丁基羟基甲苯、富马酸或没食子酸丙酯。优选使用焦亚硫酸钠。
酸化剂通常为产生酸或变成酸的无机化学品。适当的实例为氯化铵、氯化钙。
适当的芳香物质和调味物质首先包括可以用于该目的的精油。通常,该术语是指具有各自的特征性气味的、来自植物或植物的一部分的挥发性提取物。可以通过蒸汽蒸馏从植物或植物的一部分中提取它们。
实例为:精油,分别为来自以下物质的芳香物质:鼠尾草、丁香、洋甘菊(chamomile)、大茴香、八角茴香、百里香、茶树、薄荷、薄荷油、薄荷醇、桉树脑、桉叶油(eucalyptus oil)、芒果、无花果、薰衣草油、洋甘菊花(chamomile blossoms)、松针、柏树、柑橘、红木、李子(plum)、红醋栗(currant)、樱桃、白桦叶、肉桂、酸橙、葡萄柚、橘子、杜松、缬草、香蜂草(lemon balm)、柠檬草(lemon grass)、玫瑰草(palmarosa)、蔓越莓、石榴、迷迭香、生姜、凤梨、番石榴、紫锥菊、常春藤叶提取物、蓝莓、柿子、甜瓜等或其混合物,以及薄荷醇、薄荷和八角茴香油的混合物或者薄荷醇和樱桃香料的混合物。
相对于总组成,可以在0.0001重量%至10重量%(特别是在组合物中)、优选0.001重量%至6重量%、更优选0.001重量%至4重量%、最优选0.01重量%至1重量%的范围内包含这些芳香物质或调味物质。与应用或单个情况相关,使用不同的量会是有利的。
适当的甜味剂可以选自包括但不限于以下物质的组:甘露醇、甘油、乙酰磺胺酸钾(acesulfame potassium)、阿斯巴甜、甜蜜素、异麦芽酮糖醇(isomalt)、异麦芽糖醇(isomaltitol)、糖精及其钠盐、钾盐和钙盐、三氯蔗糖、阿力甜(alitame)、奇异果甜蛋白、甘草甜素、新橙皮苷二氢查尔酮(neohesperidine dihydrochalcone)、甜菊糖苷、纽甜(neotame)、阿斯巴甜-乙酰舒泛盐(aspartame-acesulfame salt)、麦芽糖醇、麦芽糖醇糖浆、乳糖醇、木糖醇、赤藓糖醇。
实施例:
70%可溶性干物质;71%总干质量;1%总酸;60%总碳水化合物,具有5%菊粉、42%低聚果糖、8%糖类、4%果糖、1%葡萄糖;38g/kg粗灰分;46g/kg粗蛋白(rawprotein);2.2g/kg粗纤维;<1g/kg粗脂肪(crude oils);0.06mg/100g维生素A;0.95mg/100g维生素B1;0.3mg/100g维生素B2;6.2mg/100g烟酸;20mg/100g维生素C;水分含量30%。有机物质中以mg/100g计的矿物质:2013钾、50镁、123钙、12铁、546磷、13钠、3硝酸盐。中性气味。
实施例1:
在室温和大气压下,在高剪切造粒机的混合床中提供10kg微晶纤维素(MCC;PH-102;DFE pharma,Goch,Germany)。将混合速度设定为60rpm。然后添加发酵的洋姜糖浆的第一部分(3升)。现在将混合床的温度设定至35℃。当达到该温度时,启动均化器。当达到混合物的均质性(通过目视控制来评估)时,添加发酵的洋姜糖浆的下一部分(1升)。在约3分钟之后,再次达到均质性。重复发酵的洋姜糖浆的这种逐步添加,直至混合物中总计有10升发酵的洋姜糖浆。在最终均质化后,将所得颗粒输送至干燥床。将干燥床的温度设定为35℃。继续干燥步骤直至颗粒的水含量小于4重量%(约3小时后)。用红外残余水分天平(infrared residual moisture balance)(Mettler-Toledo MA960;Mettler-Toledo GmbH,Giessen,Germany)来评估水含量。结果为均质的、自由流动的颗粒。
实施例2:
除了改变以下工艺参数以外,实施例1的实验设置几乎保持不变。将叶轮的混合速度设定为100rpm。发酵的洋姜糖浆的第一部分为2升,所有后续部分为500ml。混合床的温度为38℃。在该设置下,分别在约2.5min之后达到均质化。将干燥床的温度设定为30℃。因此,干燥步骤的时间为约4小时。所得颗粒在宏观上与实施例1的颗粒类似。
实施例3:
除了改变以下工艺参数以外,实施例1的实验设置几乎保持不变。将叶轮的混合速度设定为40rpm。发酵的洋姜糖浆的第一部分为3升,所有后续部分为500ml。混合床的温度为30℃。在该设置下,分别在约4min之后达到均质化。将干燥床的温度设定为40℃。干燥步骤的时间为约3小时。所得颗粒在宏观上与实施例1和2的颗粒类似。
实施例4:
借助筛分分析(Retsch GmbH,Haan,Germany)来分析来自实施例1的所得颗粒的粒径。结果是几乎所有颗粒(至少>95%)以直径计的尺寸范围均为0.5mm至2mm。粒度分布惊人地非常均匀。
实施例5:
将三只来亨母鸡(leghorn hen)(约2岁)在坚固的沙质土壤上的围栏鸡舍(约2m×2m)中户外饲养两天。给予它们标准食物和额外20g实施例1的洋姜颗粒(每天10g),撒在土壤上。可以观察到,所有三只母鸡均采食洋姜颗粒,与它们的标准食物颗粒没有区别。在第二天早上,分别地,几乎所有洋姜颗粒均被母鸡吃掉。未观察到不良反应。
Claims (15)
1.一种洋姜颗粒,
其特征在于,最少30重量%的碳水化合物含量、最少20重量%的固体水不溶性粘合剂和小于4重量%的水含量,其中所述固体水不溶性粘合剂与总碳水化合物含量之比在3:1至2:3(w/v)的范围内。
2.根据权利要求1所述的洋姜颗粒,其特征在于最少40%的碳水化合物含量。
3.根据权利要求1或2所述的洋姜颗粒,其特征在于以直径计的粒径为0.5mm至2mm。
4.一种用于生产洋姜颗粒的方法,其包括以下步骤:
a)提供高剪切造粒机,所述高剪切造粒机包括混合床、所述混合床的入口、用于所述混合床的加热装置、混合机、均化器、干燥床和用于所述干燥床的加热装置,
b)在室温和大气压下将适合于造粒的固体水不溶性粘合剂填充至所述高剪切造粒机的所述混合床中,
c)使所述混合机以40rpm至120rpm的混合速度运行,
d)在不运行所述均化器的情况下将洋姜糖浆的第一部分添加至所述混合床中,
其中所述固体水不溶性粘合剂与全部洋姜糖浆之比在3:1至2:3(w/v)的范围内,
并且所述全部洋姜糖浆的第一部分总计为所述全部洋姜糖浆的20%-30%(v/v),
e)将所述混合床的温度设定在5℃至40℃的范围内,
f)以60rpm的速度启动所述均化器,
g)以所述全部洋姜糖浆的1%至15%(v/v)的份量添加所述洋姜糖浆的其它部分直至添加了所述全部洋姜糖浆,
其中在达到混合物的均质性之后添加所述洋姜糖浆的后续部分,
h)将所述颗粒输送至所述干燥床,并且
i)将所述颗粒在10℃至40℃的温度下干燥直至所述颗粒的水含量小于4重量%,
其特征在于,所述方法不需要使用造粒液的润湿步骤、载气、赋形剂的添加、所述洋姜糖浆的酶处理,并且特征在于,不进行造粒混合物的加热步骤。
5.根据权利要求4所述的方法,其中所述固体水不溶性粘合剂为微晶纤维素或硅藻土。
6.根据权利要求4或5所述的方法,其中所述固体水不溶性粘合剂与所述洋姜糖浆的重量比为1:1。
7.如权利要求1至3中任一项所述的洋姜颗粒在家畜养殖中作为食品添加剂的用途。
8.根据权利要求7所述的洋姜颗粒的用途,其中所述家畜选自包括家禽、鸡、鹅、鸭、火鸡、兔、猪、小牛和奶牛的组。
9.如权利要求1至3中任一项所述的洋姜颗粒作为益生元膳食补充剂的用途。
10.如权利要求1至3中任一项所述的洋姜颗粒在抗真菌组合物中的用途。
11.如权利要求1至3中任一项所述的洋姜颗粒作为通过测定肾小球滤过率来测量肾功能的诊断剂的用途。
12.如权利要求1至3中任一项所述的洋姜颗粒,其用于医药。
13.根据权利要求12所述的洋姜颗粒,其用于骨折、皮肤伤口、肿胀、疼痛、乳腺癌、肺癌、结肠癌、上皮癌、代谢综合征、甲氨蝶呤诱导的肝毒性、1型糖尿病、2型糖尿病、骨质疏松症和真菌病的预防和治疗。
14.一种药物组合物,其包含如权利要求1至3中任一项所述的洋姜颗粒和至少一种赋形剂。
15.根据权利要求12所述的药物组合物,其用于骨折、皮肤伤口、肿胀、疼痛、乳腺癌、肺癌、结肠癌、上皮癌、代谢综合征、甲氨蝶呤诱导的肝毒性、1型糖尿病、2型糖尿病、骨质疏松症和真菌病的预防或治疗。
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WO2018011672A1 (en) * | 2016-07-13 | 2018-01-18 | Gangwal Chemicals Private Limited | Process for directly compressible co-processed excipient for modified release application |
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2019
- 2019-10-11 EP EP19000465.5A patent/EP3804531A1/en active Pending
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2020
- 2020-10-06 EP EP20808014.3A patent/EP4040985A1/en active Pending
- 2020-10-06 WO PCT/EP2020/000172 patent/WO2021069090A1/en unknown
- 2020-10-06 CN CN202080070941.6A patent/CN114521107A/zh active Pending
- 2020-10-06 US US17/768,080 patent/US20240000877A1/en active Pending
- 2020-10-06 BR BR112022006716A patent/BR112022006716A2/pt unknown
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Also Published As
Publication number | Publication date |
---|---|
EP3804531A1 (en) | 2021-04-14 |
US20240000877A1 (en) | 2024-01-04 |
EP4040985A1 (en) | 2022-08-17 |
WO2021069090A1 (en) | 2021-04-15 |
BR112022006716A2 (pt) | 2022-10-11 |
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