CN101815509A - 营养剂量单位 - Google Patents
营养剂量单位 Download PDFInfo
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- CN101815509A CN101815509A CN200880101810A CN200880101810A CN101815509A CN 101815509 A CN101815509 A CN 101815509A CN 200880101810 A CN200880101810 A CN 200880101810A CN 200880101810 A CN200880101810 A CN 200880101810A CN 101815509 A CN101815509 A CN 101815509A
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- FDJOLVPMNUYSCM-WZHZPDAFSA-L cobalt(3+);[(2r,3s,4r,5s)-5-(5,6-dimethylbenzimidazol-1-yl)-4-hydroxy-2-(hydroxymethyl)oxolan-3-yl] [(2r)-1-[3-[(1r,2r,3r,4z,7s,9z,12s,13s,14z,17s,18s,19r)-2,13,18-tris(2-amino-2-oxoethyl)-7,12,17-tris(3-amino-3-oxopropyl)-3,5,8,8,13,15,18,19-octamethyl-2 Chemical compound [Co+3].N#[C-].N([C@@H]([C@]1(C)[N-]\C([C@H]([C@@]1(CC(N)=O)C)CCC(N)=O)=C(\C)/C1=N/C([C@H]([C@@]1(CC(N)=O)C)CCC(N)=O)=C\C1=N\C([C@H](C1(C)C)CCC(N)=O)=C/1C)[C@@H]2CC(N)=O)=C\1[C@]2(C)CCC(=O)NC[C@@H](C)OP([O-])(=O)O[C@H]1[C@@H](O)[C@@H](N2C3=CC(C)=C(C)C=C3N=C2)O[C@@H]1CO FDJOLVPMNUYSCM-WZHZPDAFSA-L 0.000 claims abstract description 50
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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Abstract
本发明公开了在消化道内的有利位置处向使用者供应营养素的营养增补剂系统。一种类型的剂量单位被配制为在上胃肠道的胃和肠内有利地以大于维生素B12的DV(日剂量值)或处于维生素B12的DV(日剂量值)的多倍水平下的量释放维生素B12。
Description
相关申请的交叉参考
本申请要求2007年8月3日提交的美国临时申请60/953,934和2007年8月3日提交的美国临时申请60/953,944的优先权,该两篇文献作为参考被并入本文。
背景和概述
本文描述了用于递送维生素、矿物质和/或益生菌(probiotics)用于维持人受试者的健康的营养增补剂系统。
本文特别地描述了用于递送维生素B 12至人受试者的系统。
维生素和矿物质制备物常作为一般的营养增补剂被给予。微量营养素是以少量或痕量存在于食品和药草中的元素或化合物。这些营养素包括维生素、矿物质或其它元素,以及在食品中被发现的物质。大量营养素包括碳水化合物、脂肪和蛋白质,其提供营养素和卡路里。一些元素诸如钙、钠、钾、氯和磷以相对大的量被消耗,而许多元素诸如铁、碘和锌以少量被消耗。维生素诸如维生素B12和叶酸以及矿物质铜、硒和铬以极少量或痕量被消耗。
由于人体不能合成人体所必需的许多化合物,因此某些维生素、矿物质和其它营养素只能从两个来源即食品和补充剂被获得。所有营养素的主要来源是食品。然而,许多人不能从它们所吃的食品中获得最佳量的必需化合物与元素。因此,营养增补成为共识的保持良好健康的方法。
摄取益生菌增补剂也可有益于人类福祉。已经承认一过性或慢性消化症状可由肠内菌丛受损或失调所引起。摄取含有合适的微生物的营养增补剂制备物通常足以缓解或消除由肠内菌丛失调或受损所引起的症状。
本文使用的“益生菌”是指在食品增补剂中被递送的活微生物,其通过改善宿主动物的肠微生物平衡而对该宿主动物产生有利影响。抗生素和其它相关化合物不被包含在此定义中。(J.Nutr.1995;125:1401-12)。对于人类,乳酸杆菌常作为益生菌,作为单种或与其它细菌混合的培养物被提供。已经使用的其它菌是双歧杆菌(bifidobacteria)和链球菌(streptococci)。“益生素(prebiotics)”是指不易消化的食品成分,其通过选择性刺激结肠内细菌的生长和/或活性而对宿主产生有益的影响。
许多现有的营养增补剂系统存在的问题是它们提供不完全的营养或者必须在多个不同时间摄取多个剂量的营养素以为使用者实现营养素的充分均衡和适时递送。现有的营养增补剂系统在一些情况下将被递送的营养素递送到消化道部位,在该消化道部位,尽管有效地用于营养素的吸收,但是引起使用者不适。在其它情况下,一种或多种营养素在对于身体吸收并非最佳的部位处被释放。当营养素或益生菌在不利的部位处被释放时,导致生物活性降低。例如,益生菌在暴露于胃酸下时通常不能存活。
在用于递送维生素B12的补充剂的制剂中,存在的具体问题是,已发现维生素B12的吸收要求从胃的细胞内称分泌被称为“内在因子”的糖蛋白。正常情况下,维生素B12在小肠的最后一部分(回肠)被容易被吸收,回肠通往大肠。然而,为了被吸收,该维生素必须与内在因子相组合。由于穿过胃,维生素B12结合至内在因子用于转移。该维生素和内在因子的这一组合然后可被回肠受体所“捕获”。如果没有内在因子,大量维生素B12可留在肠内并在粪便中被排泄。先前已经想到,为了使维生素B12的吸收最大化,补充剂应被配制为在胃内递送维生素B12以使其与内在因子的结合最大化并使内在因子/B12复合物的吸收最佳化。但是这些增补剂在胃内提供维生素B12的迅速释放方面存在困难。
因此仍然需要用于向身体有效地递送有益物质的用户友好的系统。
响应于这一需要,提供了在消化道内的合适部位处供应营养素的营养增补剂系统。
特别地,配制了用于在上胃肠道的胃和肠二者内经时释放维生素B12的剂量单位。
详细说明
四组分口服营养增补剂系统可以有利地在人受试者的整个消化道的最佳位置处供应营养素和/或益生菌的组合,用于有效的营养利用和使用者的舒适性和方便性。
所述系统包括第一剂量单位,该第一剂量单元被配制为在人受试者的胃内迅速地释放一种或多种营养素。该剂量单位有利地包括维生素和矿物质或其它的饮食增补剂成分,它们受益于在胃内的释放和暴露于胃酸下、或者不会不利地受这些释放或暴露的影响、和/或适当地分散在胃内用于进一步沿胃肠道向下的最佳吸收。该剂量单位有利地为通过压缩形成的片剂或锭剂(caplet)的形式。该片剂可被含有一种或多种最好是在胃内被特别迅速地递送的营养素的层所包衣。通常,第一剂量单位不应含有不被胃所充分耐受或被胃的酸性环境所破坏的物质;这些物质应该在本文所述的其它的剂量单位之一中进行递送。
第二剂量单位被配制为包含不要求在胃内释放和暴露于胃酸下用于有效消化和吸收的营养素,并且所述营养素当在胃内被释放时可引起耐受性问题(反复的,胃不适,恶心)或生物活性丧失。该剂量单位有利地被用于递送某些营养油,特别是鱼油组分,其它的含ω-3脂肪酸的油,并且还可包括不要求胃消化的脂溶性微量营养素诸如维生素A、D、E和类胡萝卜素。该剂量单位有利地是密封的明胶胶囊,其在释放被囊封的营养素之前可穿行通过胃。
具有特别意义的是,第三剂量单位被配制为包含水溶性营养素和其它营养素,这些营养素通常被极迅速地吸收从而通过持续释放实现最佳递送,以便在体内保持提高的经时浓度。该剂量单位被设计为以一般是线性的方式缓慢地释放维生素B12。该剂量单位还可被配制为释放一种或多种水溶性营养素,特别是其它的B族维生素和维生素C。这些营养素的释放最初发生在胃内并持续进入上胃肠道的肠内。
第四剂量单位含有诸如益生菌的营养素和/或其它增补剂成分,它们不利地受到暴露于胃酸或胃消化下的影响,并且应被递送进小肠的更下方部分内,用于在大肠内发挥完全的活性。该剂量单位被配制为在该剂量单位穿行通过胃期间保护益生菌微生物免受可能致命的酸的破坏。其有利地为三层胶囊的形式。
所述剂量单位有利地采取与立即释放赋形剂或包衣在一起的各种形式的延迟释放赋形剂或包衣,以在各种最佳释放速率下递送各种维生素和矿物质增补剂。例如,可采用叶酸微包衣以在进入胃后在几分钟内从多维生素和矿物质增补剂释放叶酸。凝胶扩散技术可用于使维生素B和C的肠吸附最大化,历时十二小时。在延迟释放胶囊中提供鱼油导致在上胃肠道的肠内迅速释放,这提供了最大的生物利用度和最小的胃不适。并且三层胶囊系统向下胃肠道提供了益生菌的靶向释放。
通常,本领域普通技术人员知晓如何配制具有各种不同的释放模式的剂量单位。营养增补剂剂量单位可采用一种或多种释放形式,包括但不限于立即释放,延长释放,脉冲释放,可变释放,受控释放,定时释放,持续释放,延迟释放,长效,及其组合。多种释放类型可使用公知的过程和技术来完成。
用于组分释放的时间释放特征可通过调节层的组成(包括调节可存在的赋形剂或包衣中的任一种)得以改变。例如,改变覆盖层或包衣层的组成或量,可控制组分的释放。类似地,当通过包含特定的基质材料而便于调节释放时,控制调节释放基质材料的选择和量可以控制活性组分的释放。基质材料可存在于组合物的单独组分的周围或位于组合物的层上,其量为足以获得在组分释放之间的所需的时间释放或时间滞后。
可使用以所需的方式调节组分的释放的各种包衣材料。特别地,适用于实践的包衣材料包括但不限于聚合物包衣材料、水凝胶和凝胶形成材料以及亲水性聚合物。优选的聚合物包衣材料是醋酸邻苯二甲酸纤维素,醋酸三马来酸纤维素,羟丙基甲基纤维素邻苯二甲酸酯,聚醋酸乙烯邻苯二甲酸酯,氨基甲基丙烯酸酯共聚物诸如Eudragit.RTM.RS和RL,聚丙烯酸以及聚丙烯酸酯和甲基丙烯酸酯共聚物诸如Eudragit.RTM.S和L,聚乙烯基乙缩醛二乙基氨基乙酸酯,醋酸琥珀酸羟丙基甲基纤维素,和虫胶。
优选的水凝胶和凝胶形成材料包括聚羧乙烯,藻酸钠,羧甲纤维素钠,羧甲纤维素钙,羧甲基淀粉钠,聚乙烯醇,羟乙基纤维素,甲基纤维素,明胶,淀粉,和其中交联度低以便于吸附水和聚合物基质膨胀的基于纤维素的交联聚合物,羟丙基纤维素,羟丙基甲基纤维素,交联淀粉,微晶纤维素,壳多糖,氨基丙烯酰基-甲基丙烯酸酯共聚物(Eudragit.RTM.RS-PM),支链淀粉(pullulan),胶原蛋白,酪蛋白,琼脂,阿拉伯树胶,可溶胀的亲水性聚合物诸如羧甲基纤维素钠,聚(甲基丙烯酸羟烷基酯)(分子量约5k-5,000k),聚乙烯吡咯烷酮(分子量约10k-360k),阴离子和阳离子水凝胶,具有低乙酸残留的聚乙烯醇,琼脂和羧甲基纤维素的可溶胀混合物,马来酐和苯乙烯的共聚物,乙烯、丙烯或异丁烯果胶(分子量约30k-300k),多糖诸如琼脂,阿拉伯胶,刺梧桐树胶,黄蓍胶,褐藻胶和瓜尔豆胶,聚丙烯酰胺,Polyox.RTM.聚环氧乙烷(分子量约100k-5,000k),AquaKeep.RTM.丙烯酸酯聚合物,聚葡萄糖(polyglucan)的二酯,交联聚乙烯醇和聚N-乙烯基-2-吡咯烷酮,和淀粉羟基乙酸钠(例如,Explotab.RTM.)。
优选的亲水性聚合物包括多糖,甲基纤维素,羧甲基纤维素钠或羧甲基纤维素钙,羟丙基甲基纤维素,羟丙基纤维素,羟乙基纤维素,硝化纤维,羧甲基纤维素,纤维素醚,聚环氧乙烷(例如Polyox.RTM.,Union Carbide),甲基乙基纤维素,乙基羟基乙基纤维素,醋酸纤维素,丁酸纤维素,丙酸纤维素,明胶,胶原蛋白,淀粉,麦芽糖糊精,支链淀粉(pullulan),聚乙烯吡咯烷酮,聚乙烯醇,聚乙酸乙烯酯,脂肪酸甘油酯,聚丙烯酰胺,聚丙烯酸,甲基丙烯酸的共聚物或甲基丙烯酸(例如,Eudragit.RTM.),其它的丙烯酸衍生物,山梨糖醇酐酯,天然胶类,卵磷脂,果胶,藻酸盐,藻酸铵,藻酸钠,藻酸钙,藻酸钾,丙二醇藻酸酯,琼脂,和胶类诸如阿拉伯树胶,刺槐树树胶,刺槐豆胶,黄蓍胶,角叉菜胶,胍尔豆胶,黄原胶,硬葡聚糖及其混合物和共混物。
赋形剂诸如增塑剂、润滑剂、溶剂等等可被加入到包衣中。合适的增塑剂包括例如羟基化大豆卵磷脂,乙酰化单甘油酯,丁基邻苯二甲酰基乙醇酸丁酯,酒石酸二丁酯,邻苯二甲酸二乙酯,邻苯二甲酸二甲酯,乙基邻苯二甲酰基乙醇酸乙酯,甘油,丙二醇,三醋汀,柠檬酸酯,三丙酸甘油酯,二醋精,邻苯二甲酸二丁酯,乙酰基单甘油酯,聚乙二醇,蓖麻油,柠檬酸三乙酯,多元醇,甘油,乙酸酯,三乙酸甘油酯,乙酰柠檬酸三乙酯,邻苯二甲酸二苄酯,邻苯二甲酸二己酯,邻苯二甲酸丁辛酯,邻苯二甲酸二异壬酯,邻苯二甲酸丁辛酯,壬二酸二辛酯,环氧化树脂酸酯,偏苯三酸三异辛酯,邻苯二甲酸二乙基己基酯,邻苯二甲酸二正辛酯,邻苯二甲酸二异辛酯,邻苯二甲酸二异癸酯,邻苯二甲酸二正十一烷酯,邻苯二甲酸二正十三烷酯,偏苯三酸酯三-2-乙基己基酯,己二酸二-2-乙基己基酯,癸二酸二-2-乙基己基酯,壬二酸二-2-乙基己基酯,癸二酸二丁酯。
包衣层可为任何合适的调节释放基质材料或调节释放基质材料的适当组合。这些材料是本领域技术人员公知的。适用于本发明实践的调节释放基质材料包括但不限于微晶纤维素,羧甲基纤维素钠,羟烷基纤维素(例如,羟丙基甲基纤维素和羟丙基纤维素),聚环氧乙烷,烷基纤维素(例如,甲基纤维素和乙基纤维素),聚乙二醇,聚乙烯吡咯烷酮,醋酸纤维素,醋酸丁酸纤维素,醋酸邻苯二甲酸纤维素,醋酸偏苯三酸纤维素,聚乙酸乙烯邻苯二甲酸酯,聚甲基丙烯酸烷基酯,聚乙酸乙烯酯,及其混合物。
剂量形式的溶出特征不仅可以通过在最终剂量形式中的赋形剂的量和最终剂量形式的大小进行控制,而且可以通过从所给出的各种分子量的聚合物或聚合物中进行审慎选择和共混得以控制,这对于本领域技术人员是已知的。
薄膜包衣片剂可通过使用诸如旋转锅包衣法或气体悬浮法以将邻接的薄膜层沉积到片剂上的技术来对片剂进行包衣来制备。进行这一过程通常改善片剂的样式美观性,但是还可进行这一过程来改善片剂的吞咽,掩蔽令人不快的气味或味道,改善不好看的无包衣片剂的普通性。压缩片剂,例如,但不限于,可通过将组分与意在附加结合或崩解品质的赋形剂混合来制备。该混合物被直接压缩或造粒然后进行压缩,使用制药工业技术人员公知的方法和机械。
本文所述的营养增补剂系统的一种或多种剂量单位还可用于递送益生素。示例性的益生素包括寡糖诸如葡萄糖诸如葡萄糖,果糖,木糖,半乳糖,乳糖,甘露糖,阿糖,D-岩藻糖,L-岩藻糖,鼠李糖,Actilight,Biotose,巴拉金糖(Palatinose),IMO,纤维二糖,龙胆二糖,果聚糖,麦芽糖糊精,麦芽糖,蜜二糖,棉子糖,乳糖,panorich,松三糖,raftiline,raftilose,水苏糖,蔗糖,塔格糖,木聚糖,果寡糖(FOS),半乳寡醣(GOS),大豆寡糖,乳果寡醣,麦芽低聚糖,寡木糖,菊粉和分馏菊粉以及一种或多种食用纤维组分诸如椰子(包括椰子胚乳纤维,甜菜渣(诸如甜菜浆),菊苣(包括菊苣浆),燕麦糠浓缩物,米糠,酸豆,塔尔哈胶和胍尔豆胶。
营养增补剂系统参考以下的具体讨论和实施例得以更好地进行了解,这些实施例详细描述了用于制备所述的剂量单位的某些过程。所有的关于具体实施例的描述仅用于说明目的。它们不限制本发明的范围和性质。
第三剂量单位被配制为包含一种或多种水溶性营养素和/或其它营养素,这些营养素通常被极迅速地吸收并从而通过持续释放实现最佳递送,以便在体内保持提高的经时浓度。
某些被迅速吸收的、通常是水溶性的营养素通过持续释放实现最佳递送,以便在体内保持提高的经时浓度。这些营养素包括B族维生素和维生素C。如果在立即释放剂量单位中提供,则这些维生素在体内的浓度在最初的峰值后迅速下降。另外,在肠壁内的吸收部位和营养吸收机制经受不住由立即释放剂量单位所带来的高的肠营养浓度,已知这可减少可由身体所吸收的总量。这些维生素的持续释放剂量单位可用于解决这些问题。但是这些维生素的持续释放剂量单位通常不包含维生素B12,因为已经意识到需要向胃递送整个剂量的维生素B12以便维生素B12与内在因子相组合。
目前的试验表明,与维生素B12在胃内的立即释放相比,通过持续释放被递送的维生素B12可以导致维生素B12的生物利用度有所改善。在所进行的具体的试验中,对受试者给予含有9.8mg维生素B1、11.5mg维生素B2、13.1mg维生素B6、90μg维生素B12和518mg维生素C的片剂。关于B族维生素,摄取可比较的立即释放制剂在摄取后的2小时产生维生素B1、B2和B6的峰血浆浓度,在摄取后的3小时产生维生素B12的峰血清浓度。B族维生素浓度然后从峰浓度迅速下降,对于B1和B6截止6小时恢复到基线,对于B2和B12截止12小时恢复到基线。相比之下,摄取持续释放制剂导致B1和B2的血清和血浆浓度延迟4小时,B6和B12的血清和血浆浓度延迟5小时。与立即释放递送相比,发现持续释放片剂递送改善维生素C和至少三种B族维生素(包括维生素B12在内)的生物利用度。
第三剂量单位因此被配制为在上胃肠道的胃和肠内有利地以大于维生素B12的DV(日剂量值)或处于维生素B12的DV(日剂量值)的多倍水平下的量释放维生素B12。这通过包含3mcg到500mcg的量的维生素B12来实现,在6mcg到500mcg的量的维生素B12得到最好结果。
维生素B12的最好递送结果使用以下的剂量单位来实现,该剂量单位根据USP溶出装置,在37℃下,在50RPM桨速下,在900ml的0.1N HCl中测定时,在6小时内连续地和一般是线性地释放维生素B12。对于剂量单位而言,特别有利地是被配制为允许维生素B12的至少15%在37℃的900ml的0.1N HCl中在1小时内溶出。该剂量形式在被受试者摄取后将保持维生素B12的血浆水平历时12小时。使用例如总重量为350mg到1500mg的第三剂量单位片剂实现维生素B12的良好递送,其中该片剂含有20mcg到100mcg的维生素B12并含有5重量%到20重量%的HPMC K100/E15。使用含9.5%到14%HPMCK100/E15的片剂获得优异的结果。
第三剂量单位还可用于递送一种或多种其它的水溶性营养素,特别是B族维生素和维生素C,当适用时其量有利地高于它们的DV(日剂量值)或处在它们的DV(日剂量值)的多倍水平下。因此该剂量单位有利地包含30mg到1000mg的维生素C,1mg到40mg的维生素B1,1mg到40mg的维生素B2,10mg到300mg的烟酸,10mg到300mg的维生素B5和1mg到40mg的维生素B6。特别有用的制剂包括30mg到750mg的维生素C,25mg到400mg的钙,1mg到40mg的维生素B1,1mg到40mg的维生素B2,10mg到300mg的维生素B5,1mg到40mg的维生素B6,6mcg到500mcg的维生素B12,1mg到100mg的生物类黄酮复合物,和5mg到300mg的槲皮素。
第三剂量单位被设计为以一般是线性的方式缓慢地释放这些水溶性营养素中的一种或多种。水溶性营养素的释放一般将在胃和小肠(十二指肠、空肠和回肠)内发生。
一般地,当增补剂与食物一起被摄取时,根据一般推荐,其需要约6-12小时以穿行通过胃和小肠。因此,水溶性维生素从第三剂量单位的释放将在摄取后延长至少三个小时,有利地在摄取后延长高达完全十二个小时。第三剂量单位还有利地被配制为释放维生素B12,从而使得维生素B12的血浆水平在摄取后持续至少6小时,当被配制为使得维生素B12的血浆水平在摄取后保持至少30分钟到24小时时获得最佳结果。
第三营养增补剂剂量单位的示例性制剂,作为持续释放片剂的形式,如下表所示:
将片剂组分混合,并从得到的混合物形成片剂。将包衣成分混合,使用得到的混合物将片剂包衣。
鉴于可根据本发明所公开的原则实施许多可能的实施方案,因此可认为,所说明的实施方案只是本发明的优选实施例,不对本发明的范围构成限制。相反,本发明的范围由权利要求书进行限定。
Claims (17)
1.用于人受试者的口服营养增补剂剂量单位,其中:
该剂量单位包括维生素B12;和
该剂量单位是持续释放剂量单位,其在胃内开始提供维生素B12的持续释放并持续进入人受试者的小肠内历时一定时段。
2.权利要求1的剂量单位,其被配制为提供维生素B12的提高的血浆水平在摄取后历时至少12小时。
3.权利要求1的剂量单位,其被配制为允许维生素B12的至少15%在37℃的900ml的0.1N HCl中在1小时内溶出。
4.权利要求1的剂量单位,另外包括:
一种或多种另外的B族维生素;和
维生素C。
5.权利要求1的剂量单位,包括:
30mg到750mg的维生素C,
25mg到400mg的钙,
1mg到40mg的维生素B1,
1mg到40mg的维生素B2,
10mg到300mg的维生素B5,
1mg到40mg的维生素B6,
6mcg到500mcg的维生素B12,
1mg到100mg的生物类黄酮复合物,和
5mg到300mg的槲皮素。
6.权利要求5的剂量单位,其被配制为允许B族维生素和维生素C的至少15%在37℃的900ml的0.1N HCl中在1小时内溶出。
7.权利要求1的剂量单位,其为片剂或锭剂的形式。
8.权利要求7的剂量单位,另外包括外部薄膜包衣。
9.用于人受试者的口服营养增补剂剂量单位,其中:
该剂量单位是片剂或锭剂,包括:
30mg到750mg的维生素C,
25mg到400mg的钙,
1mg到40mg的维生素B1,
1mg到40mg的维生素B2,
10mg到300mg的维生素B5,
1mg到40mg的维生素B6,
6mcg到500mcg的维生素B12,
1mg到100mg的生物类黄酮复合物,和
5mg到300mg的槲皮素;和
该剂量单位是持续释放剂量单位,其在胃内开始提供维生素B12的持续释放并持续进入人受试者的小肠内历时足以提供维生素B 12的提高的血浆水平在摄取后历时至少12小时的时段。
10.向人受试者递送维生素B12的方法,该方法包括对人受试者口服给予持续释放营养增补剂剂量单位,其中:
该剂量单位包括维生素B12;和
该剂量单位被配制为在胃内开始释放维生素B12并持续进入上肠道内。
11.权利要求10的方法,其中该剂量单位被配制为提供维生素B 12的提高的血浆水平在摄取后历时至少12小时。
12.权利要求10的方法,其中该剂量单位被配制为允许维生素B12的至少15%在37℃的900ml的0.1N HCl中在1小时内溶出。
13.权利要求10的方法,其中剂量单位另外包括:
一种或多种另外的B族维生素;和
维生素C。
14.权利要求13的方法,其中剂量单位被配制为允许B族维生素和维生素C的至少15%在37℃的900ml的0.1N HCl中在1小时内溶出。
15.权利要求14的方法,其中剂量单位为片剂或锭剂的形式。
16.权利要求15的方法,其中剂量单位具有外部薄膜包衣。
17.向人受试者递送维生素B12的方法,该方法包括对人受试者口服给予持续释放营养增补剂剂量单位,其中:
该剂量单位是片剂或锭剂,包括:
30mg到750mg的维生素C,
25mg到400mg的钙,
1mg到40mg的维生素B1,
1mg到40mg的维生素B2,
10mg到300mg的维生素B5,
1mg到40mg的维生素B6,
6mcg到500mcg的维生素B12,
1mg到100mg的生物类黄酮复合物,和
5mg到300mg的槲皮素;和
该剂量单位被配制为在胃内开始释放维生素B12并持续进入上肠道内,足以提供维生素B12的提高的血浆水平在摄取后历时至少12小时。
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