CN116157114A - 含脱辅基水母蛋白的泡腾制剂 - Google Patents
含脱辅基水母蛋白的泡腾制剂 Download PDFInfo
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- CN116157114A CN116157114A CN202180055656.1A CN202180055656A CN116157114A CN 116157114 A CN116157114 A CN 116157114A CN 202180055656 A CN202180055656 A CN 202180055656A CN 116157114 A CN116157114 A CN 116157114A
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- carbonate
- apoaequorin
- acid
- calcium
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Abstract
本发明总体上涉及可用于维持钙稳态的组合物。具体地,本发明涉及含脱辅基水母蛋白的泡腾组合物,其可用于预防和/或缓解与钙失衡相关的疾病或症状。本发明的某些实施方式还含有活性成分,包括至少一种兴奋剂(例如咖啡因)和/或维生素D。
Description
关于联邦资助研究或开发的声明
不适用。
相关申请的交叉引用
本申请要求2020年8月20日提交的美国临时申请号63/068,084的优先权,其全部内容通过引用纳入本文。
技术领域
本发明总体上涉及可用于维持钙稳态的组合物。具体地,本发明涉及含脱辅基水母蛋白(apoaequorin)的泡腾组合物,其可用于预防和/或缓解与钙失衡相关的疾病或症状。
背景技术
钙是人体中第五丰富的元素,主要存在于骨骼中。体内超过99%的钙储存在骨骼中,骨骼不断与溶解在体液和软组织(如血液)中的剩余1%交换供应。这种交换的控制很大程度上取决于内分泌系统,该系统感知血浆中离子钙的浓度并引导钙交换以维持这种临界平衡。间质液和软组织中1%的钙中只有一小部分是可电离的和可溶的。体液和组织中剩余的钙与蛋白质结合,特别是钙结合蛋白(CaBP)。已知CaBP在维持钙稳态方面起作用。
由于身体需要特定浓度的钙离子来进行必要的生理过程,因此维持钙稳态对身体健康至关重要。医学界认为血浆和体液中适当的离子钙浓度对身体功能(包括但不限于神经元兴奋性、肌肉收缩、膜通透性、细胞分裂、激素分泌和骨矿化)至关重要。钙稳态的破坏,即钙失衡,与许多疾病、综合征和病症有关,包括但不限于癌症、心脏病和神经退行性疾病。
过去,阻断钙在细胞内部和组织液之间流动的钙通道拮抗剂已被广泛描述为用于预防钙相关疾病,包括高血压、心绞痛、哮喘、偏头痛和神经恶化的药物制剂。例如,已发现尼莫地平通过缓解导致神经恶化的钙失衡来改善痴呆的临床症状和认知功能。然而,许多这种钙通道拮抗剂具有不希望的副作用,包括但不限于不适、体液潴留、烧心、心率不稳定、头晕、胃部不适,在极少数情况下,还会出现昏厥、发烧和出血过多。
尽管取得了这些进展,但仍需要新的和替代的组合物来缓解或预防钙失衡。特别是,希望能有与先前的试剂相比具有减少的副作用的药物或营养保健品组合物,如果被发现,将满足医疗和营养健康界的长期需求。
此外,这些药物或营养保健品组合物必须施用于所有年龄和健康水平的人,这通常是一个挑战。特别是,患者通常不愿意吞咽药丸、片剂、胶囊或其他固体剂量药物制剂,特别是当该个体的吞咽行为有问题时。例如,由于咽部和食管动力问题引起的全面歇斯底里和哽咽,使吞咽疼痛,并经常导致对吞咽制剂的厌恶。此外,对于患有咽炎和/或明显肿胀或其他严重受刺激的咽部的患者,例如由于细菌感染,通常使该患者难以和/或不可能吞咽固体药物制剂。因为药物制剂的大小、形状和味道、对摄入行为的心理厌恶和/或个人选择不吞咽制剂,患者也不愿意摄入药物制剂。年轻患者在这方面尤其成问题。然而,接受药物治疗方案和/或需要制剂中治疗活性成分的患者必须自行给药或被给予所述剂量。因此,持续需要提供一种更好的方法来施用治疗有效剂量的组合物(包括制剂)来治疗钙失衡。
发明内容
本发明提供了优于现有组合物和方法的各种优点,因为它提供了对象精神和身体健康的总体改善。
在第一方面,本发明涉及泡腾片形式的补充剂,用于治疗与钙失衡相关的症状或病症。这样的治疗方法包括施用含有有效量的脱辅基水母蛋白和泡腾对(effervescentcouple)的泡腾片,其中所述泡腾对包括酸性组分和碱性组分。所述酸性组分可以是柠檬酸、酒石酸、苹果酸、富马酸、己二酸、琥珀酸或其盐,而碱性组分可以是碳酸钠、碳酸氢钠、倍半碳酸钠、碳酸钾、碳酸氢钾、倍半碳酸钾、碳酸镁、甘氨酸碳酸钠、L-赖氨酸碳酸盐、精氨酸碳酸盐、无定形碳酸钙、碳酸铵或碳酸氢铵。
在一个实施方式中,所述补充剂还可以包括至少一种兴奋剂,其可以是咖啡因、马黛茶(yerba maté)、麻黄碱、瓜拉那(guarana)或人参。在本发明的又一个实施方式中,所述补充剂还可以包括维生素D。维生素D可以是D3胆钙化醇的形式。
在本发明的另一方面,治疗性泡腾组合物可用于治疗与钙失衡相关的症状或病症。治疗性泡腾组合物包括有效量脱辅基水母蛋白、有效量的维生素D、至少一种兴奋剂和包括至少一种酸和至少一种碱化合物的泡腾系统。所述至少一种酸性组分可选自柠檬酸、酒石酸、苹果酸、富马酸、己二酸、琥珀酸或其盐。所述至少一种碱性组分可选自碳酸钠、碳酸氢钠、倍半碳酸钠、碳酸钾、碳酸氢钾、倍半碳酸钾、碳酸镁、甘氨酸碳酸钠、L-赖氨酸碳酸盐、精氨酸碳酸盐、无定形碳酸钙、碳酸铵或碳酸氢铵。所述至少一种兴奋剂可以选自咖啡因、马黛茶、麻黄碱、瓜拉那或人参。所述维生素D可以是D3胆钙化醇的形式。
在本发明的又一方面,用于治疗与钙失衡相关的症状或病症的方法包括向需要这种治疗的对象施用含有脱辅基水母蛋白和如上所述的其它组分的治疗性泡腾组合物或补充剂,其中脱辅基水母蛋白不与其辅助因子腔肠素(coelenterazine)一起施用。与钙失衡相关的症状或疾病可能与睡眠有关、与能量有关、与情绪有关、与疼痛有关或与记忆有关。向对象给予脱辅基水母蛋白改善睡眠质量,能量质量,情绪质量,缓解疼痛或改善记忆力,如标准化认知评估分数的提高所示。与钙失衡相关的症状或疾病可能进一步与神经元兴奋性、肌肉收缩、膜通透性、细胞分裂、激素分泌、骨矿化或缺血后的细胞死亡有关,其中症状或疾病在给予脱辅基水母蛋白后得到改善。补充剂或泡腾组合物可用于治疗与钙失衡相关的任何这些症状或病症。补充剂或泡腾组合物可用作药物。
在阅读以下说明书和权利要求之后,本发明的其他目的、特征和优点将显而易见。
具体实施方式
I.概述
在描述本发明的材料和方法之前,应理解的是,本发明不限于所描述的具体方法和材料,因为这些可以变化。还应理解,本文所用术语的目的仅是描述具体实施方式,不应用来限制本发明的范围,本发明的范围仅受所附权利要求书的限制。
必须注意到,本文和所附权利要求书所用的单数形式“一个”、“一种”和“所述”包括复数含义,除非上下文另有明确说明。因此,术语“一个”(或“一种”)、“一种或多种”和“至少一种”在本文中可以互换使用。还应当注意,术语“包括”、“包含”、和“具有”可以互换使用。
除非另外定义,否则,本文中所使用的所有技术和科学术语都具有本发明所属领域普通技术人员通常所理解的同样含义。虽然可采用与本文所述类似或等同的任何方法和材料实施或测试本发明,但在此描述的是优选的方法和材料。本文特别提及的所有出版物和专利均通过引用并入本文,目的包括描述和公开可能与本发明结合使用的出版物中报告的化学品、仪器、统计分析和方法。本说明书引用的所有参考文献都应看作对本领域技术水平的指示。本文中所有内容均不应解释为承认本发明不是先于这些公开内容的在先发明。
II.本发明的内容
水母蛋白是一种最初从发光水母和其他海洋生物中分离出来的光感蛋白。水母蛋白复合物包含分子量为22,285道尔顿的脱辅基水母蛋白、分子氧和发光体腔肠素。当三个Caf-离子与该复合物结合时,腔肠素被氧化成腔肠酰胺,同时释放出二氧化碳和蓝光。水母蛋白不由细胞输出或分泌,也不会被分隔或隔离在细胞内。因此,水母蛋白测量已被用于检测在较长时间内发生的Ca2+变化。在几个实验系统中,水母蛋白的发光在细胞加载后数小时到数天都可以检测到。还已知水母蛋白也不会破坏细胞功能或胚胎发育。
由于其依赖于Ca2÷-的发光,水母蛋白复合物已被广泛用作细胞内Ca2+指示剂。发光水母(Aequorea victoria)水母蛋白已专门用于:(1)分析单个肾上腺嗜铬细胞对烟碱型胆碱能激动剂的分泌反应;(2)阐明Ca2+释放在心肌损伤中的作用;(3)证明受精过程中Ca2+的大量释放;(4)研究发育中的鸡成肌细胞中肌浆网Ca2+泵表达的调控;(5)校准微量移液器,其进样量低至3皮升。
脱辅基水母蛋白的分子量约为22kDa。脱辅基水母蛋白可用于通过还原脱辅基水母蛋白中的二硫键来再生水母蛋白。负载钙的脱辅基水母蛋白保留了与含有结合底物的未反应光感蛋白相同的紧凑结构和整体折叠样式。
从发光水母(Aequorea victoria)中常规纯化水母蛋白需要费力的提取工序,有时会产生基本上异质的制剂或对研究中的生物体有毒的制剂。两吨水母通常会产生大约125mg的纯化光感蛋白。相反,重组水母蛋白优选通过从转基因大肠杆菌(Escherichiacoli)中纯化脱辅基水母蛋白,然后在体外用纯腔肠素重构水母蛋白复合物来生产。可用于本发明的脱辅基水母蛋白已在文献中描述并且可通过本领域技术人员已知的纯化方案和/或合成商业获得,如S.Inouye,S.Zenno,Y.Sakaki,和F.Tsuji.,“脱辅基水母蛋白的高水平表达和纯化(High level expression and purification of apoaequorin)”(1991)蛋白质表达和纯化2,122-126。
本发明涉及向对象施用含脱辅基水母蛋白的泡腾组合物,以纠正或维持该对象中的钙平衡。维持血浆和体液中离子钙的浓度被认为对多种身体功能至关重要,包括但不限于神经元兴奋性、肌肉收缩、膜通透性、细胞分裂、激素分泌、骨矿化或预防缺血后细胞死亡。钙稳态的破坏,即钙失衡,被认为是导致和/或与许多疾病、综合征和病症相关的。这些疾病、综合征和病症包括与睡眠质量、能量质量、情绪质量、记忆质量和疼痛感知相关的疾病、综合征和病症。对CaBP的研究已经使它们被认为是维持适当离子钙水平的保护因子。
本发明还涉及施用含脱辅基水母蛋白的泡腾组合物。含脱辅基水母蛋白的泡腾组合物的优选实施方式还含有至少一种兴奋剂。所述至少一种兴奋剂的非限制性例子可以包括咖啡因、马黛茶、麻黄碱、瓜拉那和人参。在又一个优选的实施方式中,含脱辅基水母蛋白的泡腾组合物还可含有维生素D。在又一个实施方式中,含脱辅基水母蛋白的泡腾组合物的优选实施方案同时含有至少一种兴奋剂和维生素D。
维生素D是一组脂溶性类固醇,负责增加肠道对钙、铁、镁、磷酸盐和锌的吸收。维生素D是在皮肤暴露于阳光紫外线时由身体产生的。它也存在于天然食物如鱼、鱼肝油、蛋黄中,以及强化乳制品和谷物产品中。在膳食补充剂中,维生素D的两种最常见的复合形式是维生素D3(胆钙化醇)和维生素D2(麦角钙化醇)。
维生素D是一种具有生物惰性的脂溶性维生素,必须在体内经历两次羟基化才能激活。第一次发生在肝脏中,将维生素D转化为25-羟基维生素D[25(OH)D],也称为骨化二醇。第二次主要发生在肾脏中,形成生理活性的1,25-二羟基维生素D[1,25(OH)2D],也称为骨化三醇。维生素D的活性形式(骨化三醇)作为激素在血液中循环,调节血流中钙和磷酸盐的浓度,促进骨骼的健康生长和重塑。
维生素D促进钙的吸收,维持足够的血清钙和磷酸盐浓度,使骨骼正常矿化,防止低钙性手足搐搦。它还用于成骨细胞和破骨细胞的骨骼生长和骨骼重塑。它还被证明在调节细胞生长、神经肌肉和免疫功能以及减少炎症方面发挥作用。
本发明的一个优选制剂涉及向对象施用含脱辅基水母蛋白和维生素D的泡腾组合物,以纠正或维持该对象中的钙平衡和维生素D水平。维生素D缺乏可能导致钙失衡。维持血浆和体液中离子钙的浓度被认为对多种身体功能至关重要,包括但不限于神经元兴奋性、肌肉收缩、膜通透性、细胞分裂、激素分泌、骨矿化或预防缺血后细胞死亡。钙稳态的破坏,即钙失衡,被认为是导致和/或与许多疾病、综合征和病症相关的。这些疾病、综合征和病症包括与睡眠质量、能量质量、情绪质量、记忆质量和疼痛感知相关的疾病、综合征和病症。对CaBP的研究已经使它们被认为是维持适当离子钙水平的保护因子。
维生素D水平的维持被认为对钙吸收、调节细胞生长、神经肌肉和免疫功能以及减少炎症至关重要。维生素D缺乏与佝偻病最相关,佝偻病是一种骨组织不能适当矿化的疾病,导致骨骼软骨和骨骼畸形。医学研究所的指南规定,维生素D对1-70岁成年人的推荐膳食摄入量(RDA)为600国际单位(IU),对大于70岁的成年人为800IU,以优化骨骼健康。
因此,在某些实施方式中,本发明的方法包括以泡腾制剂施用脱辅基水母蛋白(和任选的维生素D和/或至少一种兴奋剂)作为治疗钙失衡的活性成分,用于延缓钙失衡的进展,预防钙失衡的发生,以及预防和/或治疗钙失衡的复发。在其他实施方式中,本发明提供的方法包括将泡腾制剂形式的脱辅基水母蛋白与一种或多种具有已知治疗或营养价值的其他药剂组合给药。脱辅基水母蛋白特别优选的应用是治疗与睡眠质量、能量、情绪、记忆和疼痛知觉有关的一种或多种症状和病症。
如本文所用,术语“治疗”包括预防性治疗以及疾病缓解治疗。如本文所用,术语“减少”、“缓解”、“压制”和“抑制”具有通常理解的减少或降低的含义。如本文所用,术语“进展”意指范围或严重性增加、进展、增长或变得更糟。如本文所用,术语“复发”是指疾病缓解后复发。
如本文所用,术语“给药”是指使患者、组织、器官或细胞与脱辅基水母蛋白接触。如本文所用,给药可以在体外,即在试管中,或在体内,即在活生物体例如人的细胞或组织中完成。在优选的实施方式中,本发明包括将可用于本发明的泡腾制剂或组合物向患者或对象给药。“患者”或“对象”,在本文中等同使用,是指哺乳动物,优选人,其:(1)患有钙失衡相关疾病,可通过给予脱辅基水母蛋白来治愈或治疗;或(2)易患钙失衡相关疾病,可通过给予脱辅基水母蛋白来预防。
如本文所用,术语“有效量”和“治疗有效量”是指足以产生所需的治疗反应而没有过度不良副作用例如毒性、刺激或过敏反应的活性剂的量。显然,具体的“有效量”将视各种因素而不同,例如进行治疗的特定病症、患者的身体状况、进行治疗动物的类型、治疗的持续时间、并行治疗(如果有)的性质和所用具体制剂以及化合物或其衍生物的结构。在这种情况下,如果导致以下一种或多种情况,则被认为是治疗有效的量:(1)钙失衡相关疾病的预防;(2)钙失衡相关疾病的逆转或稳定。最优有效量可以由本领域普通技术人员通过常规实验容易地确定。
在某些用于向对象口服给药的优选泡腾组合物中,脱辅基水母蛋白以约10mg/剂的剂量配制成药物制剂,对象的推荐剂量约为10mg/天(即每天一粒胶囊)。在用于口服给药的其它优选含脱辅基水母蛋白的泡腾组合物中,该组合物或制剂还含有至少一种兴奋剂。
为了提高摄入和/或吸收活性药物成分的可能性,可以使用含有泡腾成分的药物制剂。制剂或组合物可以是固体形式,例如片剂、散剂、胶囊、丸粒,在被口服消化之前进一步与水性载体混合。本发明可施用的组合物可以通过已知的溶解、混合、造粒或片剂形成工艺制备。对于口服给药,将脱辅基水母蛋白或其生理耐受的衍生物如盐,酯,N-氧化物等与为此目的的常用添加剂(例如载体,稳定剂或惰性稀释剂)混合,并通过常规方法转化为合适的给药形式,例如片剂,包衣片剂,硬或软明胶胶囊,水性溶液,酒精溶液或油性溶液。将制剂置于含有最少量的水(例如至少约0.1毫升水)的水性载体(例如水性食品或饮料)中,并且可以进行搅动或搅拌。载体可以由护理人员选择或由患者选择,或者可能只是直接摄入时患者口腔中的唾液和/或其他含水液体。将泡腾制剂添加到载体中时,产生会引起泡腾的气体并随着制剂在载体中分解释放活性药物成分。然后患者口服摄入所述载体以施用活性药物成分。
术语“泡腾”通常意味着气体从液体或混合物中逸出(霍利化学词典(Hawley’sChemical Dictionary),第432页,2001年)。因此,本文所用的术语“泡腾制剂”旨在通常表示在适当条件下,例如在与水接触时放出一种或多种气体的组合物或组分的混合物。
在本文中,术语“水性载体”意在表示含有至少最少量的水的介质或载体,例如食品。因此,所述水性载体可以是含有少量水的低水载体,或者可以是含有丰富水的载体。
本文中使用的术语“食品”旨在表示任何安全的、可消耗的液体、半固体或固体物质。因此,食品将包括任何饮料和任何食物,所有类别和年龄的哺乳动物都可以食用。
为了形成含有脱辅基水母蛋白的泡腾制剂,该制剂可以放置在惰性载体,例如片剂,散剂,胶囊,丸粒中。合适的惰性载体的例子是常规片剂基料如乳糖、蔗糖或玉米淀粉与粘合剂如阿拉伯胶、玉米淀粉、明胶的组合,与崩解剂如玉米淀粉、马铃薯淀粉、海藻酸的组合,或与润滑剂如硬脂酸或硬脂酸镁的组合。
合适的油性载体或溶剂的例子是植物油或动物油,例如葵花籽油或鱼肝油。组合物既可以为干颗粒,也可以为湿颗粒。实例为无菌液体,例如水和油,添加或不添加表面活性剂和其他药学上可接受的佐剂。示例性的油是石油、动物油、植物油或合成来源的油,例如花生油、大豆油或矿物油。通常,水、盐水、葡萄糖水溶液和相关糖溶液,以及二醇如丙二醇或聚乙二醇是优选的液体载体。
产生泡腾的气体几乎总是二氧化碳,它来自酸和碱之间的反应。因此,泡腾系统或泡腾对通常包括至少一种酸和至少一种碱化合物。因此,泡腾片由至少三组分组成:(1)活性成分;(2)酸;(3)碱化合物。
已知许多酸性和碱性成分在水的存在下反应生成气体。例如,酸,如柠檬酸、酒石酸、苹果酸、富马酸、己二酸、琥珀酸等,以及它们的组合与碳酸盐或其来源在水中反应以生成CO2气体。合适的酸包括但不限于食品酸、酸酐和酸性盐。食品酸的实例包括柠檬酸、酒石酸、苹果酸、富马酸、己二酸、琥珀酸等。上述酸的酸酐也可以用作通常在水的存在下降解以生成活性酸的酸酐。酸性盐通常在水中解离,或在水性载体所含的水中解离,以提供活性酸物质。合适的酸性盐的例子包括但不限于磷酸二氢钠、焦磷酸二氢二钠、酸性柠檬酸盐和亚硫酸氢钠。酸或其来源在水中的总体溶解度会有所不同,这是本领域技术人员所理解的。酸在产生气体方面的有效性以及产生的气体量通常取决于泡腾制剂中所述酸形式的水溶性。
碳酸盐的合适来源包括但不限于金属(例如钠、钾、锂、钙和镁)的干固体碳酸盐、碳酸氢盐和倍半碳酸氢盐。合适的碳酸盐的实例包括但不限于碳酸钠、碳酸氢钠、倍半碳酸钠、碳酸钾、碳酸氢钾、倍半碳酸钾、碳酸镁、甘氨酸碳酸钠、L-赖氨酸碳酸盐、精氨酸碳酸盐和无定形碳酸钙。碳酸铵和碳酸氢铵也是合适的碳酸盐。此外,上述碳酸盐来源的任意组合可用作制剂中的碱性组分。过量的碱性组分具有优势,包括提供碱性载体和/或碱性口腔环境、掩味特性和许多其他好处。在含有泡腾组分的药物制剂的实例中,产生气体的泡腾组分通常应占组合物总重量的约5%至约85%。
泡腾片的组合物还可以包括优选选自水溶性化合物的润滑剂以形成澄清溶液。这种润滑剂的例子为苯甲酸钠、乙酸钠、富马酸、高于4000的聚乙二醇(PEG)、丙氨酸和甘氨酸。
可以将常规赋形剂例如稀释剂、配体、缓冲剂、甜味剂、调味剂、着色剂、增溶剂、崩解剂、润湿剂和其他常用赋形剂添加到制剂中。合适的调味剂包括天然香料、人造香料和薄荷,例如椒样薄荷、薄荷醇、人造香草、肉桂、各种水果香料,可单独和混合等使用。调味剂的使用量通常变化,取决于单个调味剂,例如,可以在最终组合物重量的约0.5至约3重量%的范围内变化。
在使用甜味剂的情况下,本发明可包括本领域熟知的那些甜味剂,包括天然和人造甜味剂。因此,可以从以下非限制性列表中选择额外的甜味剂:糖,例如蔗糖、葡萄糖(玉米糖浆)、转化糖、果糖及其混合物;糖精及其各种盐类,如钠盐或钙盐;环己基氨基磺酸及其钠盐等各种盐类;二肽甜味剂,如阿斯巴甜;二氢查耳酮;甘草甜素;甜叶菊(Steviarebaudiana)(甜菊糖苷);以及糖醇,例如山梨糖醇、山梨糖醇糖浆、甘露糖醇、木糖醇等。还考虑作为附加甜味剂的是美国专利No.Re 26,959中描述的不可发酵糖替代物(氢化淀粉水解物)。还考虑的是德国专利第2,001,017.7号中描述的合成甜味剂3,6-二氢-6-甲基-1-1-2,3-噁噻嗪-4-酮-2,2-二氧化物,特别是其钾盐(安赛蜜-K)、钠盐和钙盐。通常,甜味剂的用量会根据甜味剂的类型和最终产品的所需口味而变化。例如,天然甜味剂的用量可高达约5重量%,而人造甜味剂的用量可高达约1重量%。
可用于本发明的着色剂包括颜料,例如二氧化钛,其掺入量可高达约1重量%,优选高达约0.6重量%。此外,着色剂可包括其他适用于食品、药物和化妆品应用的染料,称为F.D.&C.染料等。上述使用中可接受的材料优选是水溶性的。说明性实例包括靛蓝染料,称为F.D.&C.蓝2号,它是5,5'-靛蓝二磺酸的二钠盐。类似地,被称为F.D.&C绿1号的染料包含三苯甲烷染料,是4-[4-N-乙基-对-磺基苄基氨基)二苯基亚甲基][1-(N-乙基-N-对-锍苄基)-2,5-环己二烯亚胺]的单钠盐。类似地,被称为F.D.&C绿1号的染料包含三苯甲烷染料,是4-[4-N-乙基-对-磺基苄基氨基)二苯基亚甲基][1-(N-乙基-N-对-锍苄基)-2,5-环己二烯亚胺]的单钠盐。
药物制剂组合物还可以包括液体或冻干的或以其他方式干燥的制剂,并包括各种缓冲液内容物(例如Tris-HCl、乙酸盐、磷酸盐)、pH和离子强度的稀释剂,添加剂如白蛋白或明胶以防止表面吸收、洗涤剂(例如Tween 20、Tween80、Pluronic F68、胆汁酸盐)、增溶剂(例如甘油、聚亚乙基甘油(polyethylene glycerol))、抗氧化剂(例如抗坏血酸、焦亚硫酸钠)、防腐剂(例如硫柳汞、苯甲醇、对羟基苯甲酸酯)、填充物质或渗透压调节剂(例如乳糖、甘露醇)、聚合物(例如聚乙二醇)与蛋白质的共价连接、与金属离子的络合,或将材料掺入或掺至聚合物(例如聚乳酸、聚乙醇酸或水凝胶)的颗粒制剂中,或掺至脂质体、微乳液、胶束、层状或多层囊泡、红细胞血影或原生质球。这样的组合物将影响物理状态、溶解度、稳定性、体内释放速率和体内清除速率。控释或缓释组合物包括在亲脂贮库(例如脂肪酸、蜡、油)中的制剂。
已知通过水溶性聚合物(如聚乙二醇、聚乙二醇和聚丙二醇的共聚物、羧甲基纤维素、葡聚糖、聚乙烯醇、聚乙烯吡咯烷酮或聚脯氨酸)的共价连接而改性的化学实体在静脉注射后在血液中的半衰期明显长于相应的未改性化合物。这种改性还可以增加化学实体在水性溶液中的溶解度,消除聚集,增强化合物的物理和化学稳定性,并大大降低化合物的免疫原性和反应性。结果,与未改性的实体相比,可以通过施用这种聚合物实体外展(abduct)以频率更低或剂量更低的方式来实现所需的体内生物活性。
本领域容易理解包含活性成分的组合物的制备。活性治疗成分通常与赋形剂混合,赋形剂是药学上可接受的并与该活性成分相容。合适的赋形剂包括,例如,水,盐水,右旋糖,甘油,乙醇等及其任意组合。此外,该组合物可含有少量辅助物质,例如湿润剂或乳化剂、pH缓冲剂,其增强或保持活性成分的有效性。
可以将活性成分配制成中和的药学上可接受的盐形式的泡腾组合物。药学上可接受的盐包括酸加成盐,其由无机酸例如盐酸或磷酸,或有机酸诸如乙酸、酒石酸、扁桃酸等形成。由游离羧基基团形成的盐还可以衍生自无机碱,例如,钠、钾、铵、钙或铁氢氧化物,和有机碱诸如异丙胺、三甲胺、2-乙氨基乙醇、组氨酸、普鲁卡因等。
脱辅基水母蛋白的盐优选为药学上可接受的盐。然而,其他盐也可用于制备根据本发明的泡腾组合物或其药学上可接受的盐。合适的药学上可接受的盐包括酸加成盐,其可以例如通过将脱辅基水母蛋白的溶液与药学上可接受的酸例如盐酸、硫酸、甲磺酸、富马酸、马来酸、琥珀酸、乙酸、苯甲酸、草酸、柠檬酸、酒石酸、碳酸或磷酸的溶液混合而形成。
此外,本文中描述的含脱辅基水母蛋白的泡腾组合物可以以营养保健品组合物的形式提供,其中脱辅基水母蛋白可以预防发生或减少或稳定各种有害的钙失衡相关病症。此外,出于本说明书的目的,“营养”或“营养组合物”是指提供医疗健康益处(包括预防和/或治疗疾病)的食品或食品的一部分。根据本发明的营养组合物可以仅包含脱辅基水母蛋白作为活性成分,或者,可以进一步包括与膳食补充剂混合,所述膳食补充剂包括维生素、辅酶、矿物质、草本植物、氨基酸等,通过增加该物质的总摄入量补充饮食。
因此,本发明提供了向患者提供健康益处的方法,包括向患者给予包含脱辅基水母蛋白的营养泡腾组合物的步骤。此类组合物通常包括“营养上可接受的载体”,如本文所指,其是适用于口服递送的任何载体,包括上述适用于口服途径的药学上可接受的载体。因此,本发明提供了一种以比先前递送更方便和对患者更友好的介质向患者口服递送药物的更有利的机制,该患者可能没有以其他方式摄入该药物。
在某些实施方式中,根据本发明的营养泡腾组合物包含膳食补充剂,其基于功能进行定义,包括免疫增强剂、抗炎剂、抗氧化剂、抗病毒剂或它们的混合物。
免疫增强剂和/或抗病毒剂可用于加速伤口愈合和改善免疫功能;它们包括松果菊属的提取物或紫锥菊(Echinacea)属的草本植物、接骨木(Sambuca)属的草本植物提取物和白毛茛提取物。黄芪(Astragalus)属草本植物也是有效的免疫增强剂,无论是其天然形式还是加工形式。黄芪刺激骨髓和淋巴组织活性免疫细胞中干细胞的发育。锌及其生物活性盐,如葡萄糖酸锌和醋酸锌,在治疗普通感冒时也可作为免疫增强剂。
抗氧化剂包括天然的含硫氨基酸大蒜素,可增加血液中抗氧化酶的水平。含有大蒜素的草本植物或草本植物提取物,如大蒜,也是有效的抗氧化剂。儿茶素和含有儿茶素的草本植物如绿茶的提取物也是有效的抗氧化剂。黄芪属的提取物也显示出抗氧化活性。生物类黄酮,例如槲皮素、橙皮苷、芦丁及其混合物,也可有效作为抗氧化剂。生物类黄酮的主要有益作用可以是保护维生素C在体内免受氧化。这使得更多的维生素C或抗坏血酸可供身体使用。
生物类黄酮如槲皮素也是有效的抗炎剂,并且可以原样用于本发明的组合物中。抗炎草本补充剂和源自植物或草本植物的抗炎化合物也可用作本发明组合物中的抗炎剂。这些包括菠萝蛋白酶(一种在菠萝中发现的蛋白水解酶);茶和荨麻提取物;姜黄,姜黄提取物,或姜黄素(一种从姜黄中分离出来的黄色色素)。
可用于本发明的另一种补充剂是生姜,其衍生自生姜(Zingiber)属的草本植物。由于姜酚和相关的化合物姜烯酚等化合物,已发现其具有强心活性,并在治疗头晕和前庭疾病方面提供益处。生姜在治疗恶心和其他胃病方面也很有效。
有助于重建软组织结构,特别是重建软骨的补充剂可用于治疗关节炎和其他关节疾病疼痛的组合物中。氨基葡糖、硫酸氨基葡糖、软骨素可以来源于多种来源,例如麋鹿鹿茸。还已知海洋脂质复合物、欧米茄3脂肪酸复合物和鱼油可用于治疗与关节炎相关的疼痛。
可用于治疗偏头痛的补充剂包括小白菊(feverfew)和银杏叶(Gingko biloba)。小白菊中的主要活性成分是倍半萜内酯小白菊内酯,它抑制前列腺素的分泌,而前列腺素又通过血管中的血管痉挛活动引起疼痛。小白菊还具有抗炎特性。鱼油由于其血小板稳定和抗血管痉挛作用,也可用于治疗偏头痛。草本植物银杏还通过稳定动脉和改善血液循环来帮助治疗偏头痛。
尽管以上列出的一些补充剂已经描述了其药理作用,但本发明中也可以使用其他添加剂,并且它们的作用在科学文献中有充分的记载。
在考虑以下非限制性实施例的基础上,能够更完整地理解本发明。
III.实施例
实施例1.含脱辅基水母蛋白的泡腾组合物的优选制剂
该实施例描述了一种特别优选的含脱辅基水母蛋白的组合物,包括13.8毫克脱辅基水母蛋白、27.8毫克维生素D3(胆钙化醇)干100,000IU/g、135毫克无水颗粒咖啡因EP、500毫克山梨糖醇BP、417木糖醇DC、80毫克玉米淀粉、2毫克核黄素5-磷酸钠、45毫克糖精钠BP、250毫克(天然)橙风味剂,40毫克红甜菜粉,1450毫克无水柠檬酸和1040毫克碳酸氢钠。木糖醇DC组分含有木糖醇和羧甲基纤维素钠。维生素D3组分含有蔗糖、阿拉伯胶、玉米淀粉、中链甘油三酯、二氧化硅、维生素D3和DLα生育酚。(天然)橙风味剂组分含有麦芽糖糊精、调味制剂、二氧化硅、天然调味物质和维生素E。红甜菜粉组分含有甜菜根汁浓缩物、麦芽糖糊精和柠檬酸。片剂的总重量为4,000mg。
Claims (23)
1.一种用于治疗与钙失衡相关的症状或病症的泡腾片形式的补充剂,包括有效量的脱辅基水母蛋白和泡腾对,该泡腾对包括酸性组分和碱性组分。
2.如权利要求1所述的补充剂,其中所述补充剂还包括至少一种兴奋剂。
3.如权利要求2所述的补充剂,其中所述至少一种兴奋剂选自咖啡因、马黛茶、麻黄碱、瓜拉那或人参。
4.如权利要求1-3中任一项所述的补充剂,其中所述酸性组分选自柠檬酸、酒石酸、苹果酸、富马酸、己二酸、琥珀酸或其盐。
5.如权利要求1-4中任一项所述的补充剂,其中所述碱性组分选自碳酸钠、碳酸氢钠、倍半碳酸钠、碳酸钾、碳酸氢钾、倍半碳酸钾、碳酸镁、甘氨酸碳酸钠、L-赖氨酸碳酸盐、精氨酸碳酸盐、无定形碳酸钙、碳酸铵或碳酸氢铵。
6.如权利要求1-5中任一项所述的补充剂,其中所述补充剂还包括维生素D。
7.如权利要求6所述的补充剂,其中所述维生素D是D3胆钙化醇的形式。
8.一种用于治疗与钙失衡相关的症状或病症的治疗性泡腾组合物,其包括:
有效量的脱辅基水母蛋白;
有效量的维生素D;
至少一种兴奋剂;和
包括至少一种酸和至少一种碱性化合物的泡腾系统。
9.如权利要求8所述的治疗性泡腾组合物,其中所述至少一种酸性组分选自柠檬酸、酒石酸、苹果酸、富马酸、己二酸、琥珀酸或其盐。
10.如权利要求8或9中任一项所述的治疗性泡腾组合物,其中所述至少一种碱性组分选自碳酸钠、碳酸氢钠、倍半碳酸钠、碳酸钾、碳酸氢钾、倍半碳酸钾、碳酸镁、甘氨酸碳酸钠、L-赖氨酸碳酸盐、精氨酸碳酸盐、无定形碳酸钙、碳酸铵或碳酸氢铵。
11.如权利要求8-10中任一项所述的治疗性泡腾组合物,其中所述至少一种兴奋剂选自咖啡因、马黛茶、麻黄碱、瓜拉那或人参。
12.如权利要求8-11中任一项所述的治疗性泡腾组合物,其中所述维生素D是D3胆钙化醇的形式。
13.一种用于治疗与钙失衡相关的症状或病症的方法,所述方法包括向需要这种治疗的对象施用如权利要求1-12中任一项所述的含有脱辅基水母蛋白的治疗性泡腾组合物或补充剂,其中所述脱辅基水母蛋白不与其辅因子腔肠素一起施用。
14.如权利要求13所述的方法,其中所述与钙失衡相关的症状或病症与睡眠相关,并且将脱辅基水母蛋白给予所述对象以改善所述对象的睡眠质量。
15.如权利要求13所述的方法,其中所述与钙失衡相关的症状或病症与能量相关,并且将脱辅基水母蛋白给予所述对象以改善所述对象的能量质量。
16.如权利要求13所述的方法,其中所述与钙失衡相关的症状或病症与情绪相关,并且将脱辅基水母蛋白给予所述对象以改善所述对象的情绪质量。
17.如权利要求13所述的方法,其中所述与钙失衡相关的症状或病症与疼痛相关,并且将脱辅基水母蛋白给予所述对象以缓解所述对象的疼痛。
18.如权利要求13所述的方法,其中所述与钙失衡相关的症状或病症与记忆相关,并且将脱辅基水母蛋白给予所述对象以改善记忆,如标准化认知评估分数的提高所示。
19.如权利要求13所述的方法,其特征在于,所述与钙失衡相关的症状或病症与神经元兴奋性、肌肉收缩、膜通透性、细胞分裂、激素分泌、骨矿化或缺血后的细胞死亡有关。
20.如权利要求1-7中任一项所述的补充剂,用于治疗对象的睡眠质量、对象的能量质量、对象的情绪质量、缓解对象的疼痛、改善对象的记忆力、或与神经元兴奋性、肌肉收缩、膜通透性、细胞分裂、激素分泌、骨矿化或缺血后细胞死亡相关的与钙失衡有关的症状或病症。
21.如权利要求8-12中任一项所述的泡腾组合物,用于治疗对象的睡眠质量、对象的能量质量、对象的情绪质量、缓解对象的疼痛、改善对象的记忆力、或与神经元兴奋性、肌肉收缩、膜通透性、细胞分裂、激素分泌、骨矿化或缺血后细胞死亡相关的与钙失衡有关的症状或病症。
22.如权利要求1-7中任一项所述的补充剂,其用作药物。
23.如权利要求8-12中任一项所述的泡腾组合物,其用作药物。
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US202063068084P | 2020-08-20 | 2020-08-20 | |
US63/068,084 | 2020-08-20 | ||
PCT/US2021/046614 WO2022040380A1 (en) | 2020-08-20 | 2021-08-19 | Effervescent formulation containing apoaequorin |
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EP (1) | EP4199901A1 (zh) |
JP (1) | JP2023538917A (zh) |
KR (1) | KR20230053649A (zh) |
CN (1) | CN116157114A (zh) |
AU (1) | AU2021328384A1 (zh) |
BR (1) | BR112023002303A2 (zh) |
CA (1) | CA3192050A1 (zh) |
IL (1) | IL300510A (zh) |
MX (1) | MX2023001830A (zh) |
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NL137813C (zh) | 1963-05-06 | 1900-01-01 | ||
US6936283B2 (en) * | 2003-07-25 | 2005-08-30 | Langeland Bjoern T. | Composition for stimulation of specific metallo-enzymes |
CA2717322C (en) * | 2008-03-11 | 2017-07-11 | Quincy Bioscience, Llc | Apoaequorin-containing compositions and methods of using same |
US20110300216A1 (en) * | 2010-06-03 | 2011-12-08 | First Eric R | Chewable, swallowable and effervescent solid dosage form for oral delivery of pharmaceutical actives |
JP2019532936A (ja) * | 2016-09-23 | 2019-11-14 | クインシー バイオサイエンス,リミティド ライアビリティ カンパニー | アポエクオリンおよびビタミンd含有組成物およびそれらの使用方法 |
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- 2021-08-19 AU AU2021328384A patent/AU2021328384A1/en active Pending
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- 2021-08-19 EP EP21769282.1A patent/EP4199901A1/en active Pending
- 2021-08-19 CN CN202180055656.1A patent/CN116157114A/zh active Pending
- 2021-08-19 CA CA3192050A patent/CA3192050A1/en active Pending
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WO2022040380A1 (en) | 2022-02-24 |
KR20230053649A (ko) | 2023-04-21 |
EP4199901A1 (en) | 2023-06-28 |
US20230293633A1 (en) | 2023-09-21 |
JP2023538917A (ja) | 2023-09-12 |
BR112023002303A2 (pt) | 2023-03-21 |
CA3192050A1 (en) | 2022-02-24 |
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