CN118042939A - 睡眠产品 - Google Patents
睡眠产品 Download PDFInfo
- Publication number
- CN118042939A CN118042939A CN202280053716.0A CN202280053716A CN118042939A CN 118042939 A CN118042939 A CN 118042939A CN 202280053716 A CN202280053716 A CN 202280053716A CN 118042939 A CN118042939 A CN 118042939A
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- China
- Prior art keywords
- sleep
- supplement composition
- extract
- dosage unit
- melatonin
- Prior art date
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- A—HUMAN NECESSITIES
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- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
- A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
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- A—HUMAN NECESSITIES
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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
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Abstract
一种睡眠补充组合物,包含缬草提取物、柠檬香蜂草提取物和L‑茶氨酸。在一些实施例中,该组合物还包含褪黑激素。
Description
本申请要求2021年8月10日提交的美国申请第17/398,811号的权益。
背景技术
膳食补充剂是旨在补充饮食的产品。膳食补充剂可以包含一种或多种膳食成分,包括维生素、矿物质、草本、氨基酸和其他物质。膳食补充剂可以以药丸、胶囊、片剂或液体的形式口服,且通常可以在前面板上标明为膳食补充剂。
发明内容
本文在一个实施例中公开一种睡眠补充剂组合物,包含50mg至275mg的缬草提取物(valerian extract)、20mg至140mg的柠檬香蜂草提取物(lemon balm extract)和1.0mg至13.0mg的L-茶氨酸(L-theanine)。
还公开了一种剂量单元,包含50mg至275mg的缬草提取物、20mg至140mg的柠檬香蜂草提取物和1.0mg至13.0mg的L-茶氨酸,其中,该剂量单元呈用于促进睡眠的软胶囊的形式。
进一步公开了一种方法,包括通过对有需要的个体以口服方式施用本文所述的睡眠补充组合物或剂量单元来促进个体的睡眠。
具体实施方式
术语
提供术语和方法的以下解释,以便较好地描述本发明的化合物、组合物和方法,并且在本发明的实践中指导本领域技术人员。还应当理解,本发明中所用的术语仅出于描述具体实施例和示例的目的且并不旨在是限制性的。
如本文所使用的,“给药”包括由他人对个体进行给药或个体自行给药。
“有效量”是指足以在个体中实现所需作用的指定药剂的量。
组合物
本文公开的是呈膳食补充剂形式的组合物,尤其用于帮助个体诱导及维持睡眠,促进自然睡眠,改善睡眠品质,减少入睡所需的时间,和/或实现深眠和安眠。该组合物包括缬草提取物、柠檬香蜂草提取物和L-茶氨酸。在一些实施例中,该组合物还包括褪黑激素。在一些实施例中,褪黑激素、缬草提取物、柠檬香蜂草提取物和L-茶氨酸是该组合物中仅有的睡眠诱导活性成分。
在一些实施例中,褪黑激素的量可以至少为0.5、1.0、1.5、2.0、2.5或3mg。在一些实施例中,褪黑激素的量可以至多为1.0、1.5、2.0、2.5、3.0、3.5、4.0、4.5、5.0或5.5mg。在一些实施例中,褪黑激素的量为0.5至5.5mg,更具体地为1.0至4.0mg。
在一些实施例中,缬草提取物的量可以至少为50、75、100、125、150、175、200或225mg。在一些实施例中,缬草提取物的量可以至多为75、100、125、150、175、200、225、250或275mg。在一些实施例中,缬草提取物的量为50至275mg,更具体地为100至200mg。
在一些实施例中,柠檬香蜂草提取物的量可以至少为20、30、40、50、60、70、80、90或100mg。在一些实施例中,柠檬香蜂草提取物的量可以至多为40、50、60、70、80、90、100、110、120、130或140mg。在一些实施例中,柠檬香蜂草提取物的量为20至140mg,更具体地为50至120mg。
在一些实施例中,L-茶氨酸的量可以至少为1.0、2.0、3.0、4.0、5.0、6.0、7.0或8.0mg。在一些实施例中,L-茶氨酸的量可以至多为4.0、5.0、6.0、7.0、8.0、9.0、10.0、11.0、12.0或13.0mg。在一些实施例中,L-茶氨酸的量为1.0至13.0mg,更具体地为6.0至11.0mg。
在一些实施例中,缬草提取物、柠檬香蜂草提取物和L-茶氨酸的组合量为100mg至400mg,更具体地为150mg至300mg。
在一些实施例中,缬草提取物来自缬草(valeriana officinalis)的根。
在一些实施例中,柠檬香蜂草提取物来自柠檬香蜂草(melissa officinalis)的叶。
该组合物可以在药物学上可接受的载体中配制成,例如,以膳食补充剂剂型(例如,片剂或胶囊)、液体(例如,饮料或凝胶)和可食用产品(例如,与液体混合的食物或粉末)的形式生产营养制品。
该组合物可包括至少一种赋形剂。在一些实施例中,赋形剂为用作该组合物的活性成分的载体的非活性物质。赋形剂可包括用于使具有极有效活性成分的制剂胀大、允许适宜和准确的剂量、稳定活性成分,并使递送系统在光学和/或器官感觉上可接受。药物赋形剂的示例包括淀粉、葡萄糖、乳糖、蔗糖、明胶、麦芽、大米、面粉、白垩、硅胶、硬脂酸钠、甘油单硬脂酸酯、滑石、氯化钠、脱脂奶粉、甘油、丙烯、乙二醇、水、乙醇等。
E.W.Martin的“Remington's Pharmaceutical Sciences(Mack Publishing Co.,Easton,PA,第19版(1995))”描述了适用于药物递送一或多种组合物的组合物和制剂。使用药学上可接受的赋形剂并不暗示如此制造的产品仅适用于制药目的。相反,这暗示产品适合于给受试者施用或由受试者食用,例如,作为适合于由受试者口服摄入的药物或营养制品。
一般来说,赋形剂的性质将取决于所采用的具体给药方式。例如,肠胃外制剂通常包括可注射的液体,其包括作为载体的在药学和生理学上可接受的液体,例如水、生理盐水、平衡盐溶液、葡萄糖水溶液、甘油等。对于固体组合物(例如,粉末、丸剂、片剂或胶囊形式),常规的无毒固体载体可包括例如药物级甘露醇、乳糖、淀粉或硬脂酸镁。除了生物中性载体之外,待给药的组合物可以含有少量无毒的辅助物质,例如,润湿剂或乳化剂、防腐剂和pH缓冲剂等,例如,乙酸钠或脱水山梨醇单月桂酸酯。
所公开的组合物可以封装在多剂量或单剂量容器中。该组合物也可以以试剂盒的形式提供,例如,包括可以组装使用的组成部分。例如,一种或多种所公开的成分可以以冻干形式提供,合适的稀释剂可以作为分开的成分提供,以用于在使用前组合。容器优选适用于所需的给药方式,包括但不限于用于口服给药的片剂、凝胶胶囊、缓释胶囊等。
药学上可接受的载体中包含的活性成分的量足以在对受治疗者没有不良副作用的情况下发挥治疗上有用的效果。通过在已知的体外和体内模型系统中测试化合物,可以凭经验确定治疗有效浓度。在一些示例中,该成分的治疗有效量是减轻或改善至少一种病症(针对其施用组合物)的量。通常,组合物被配制成用于单剂量给药。组合物中的活性成分的浓度将取决于活性成分的吸收、失活和排泄速率、剂量方案和给药量以及本领域技术人员已知的其他因素。
在一些示例中,活性成分与至少一种生理学上可接受的载体和/或赋形剂以剂量单元形式混合。这些组合物或制剂中活性物质的量使得获得在所示范围内的合适剂量。术语“剂量单元”是指适合作为用于人类受试者和其他哺乳动物的单元剂量的物理上离散的单元,每个单元含有计算出的用于产生所需治疗效果的预定量的活性物质,以及合适的药物赋形剂。
所公开的组合物可以作为单剂量给药,或者可以分成多个小剂量间隔给药。该组合物可以以单剂量递送给药、长时间连续递送给药、重复给药方案(例如,多日、每日、每周或每月重复给药方案)给药。
当作为混悬剂口服给药时,这些组合物是根据药物制剂领域众所周知的技术制备的,并且可以含有用于赋予体积的微晶纤维素、作为悬浮剂的海藻酸或海藻酸钠、作为粘度增强剂的甲基纤维素以及甜味剂/调味剂。作为速释片剂,这些组合物可以含有微晶纤维素、磷酸二钙、淀粉、硬脂酸镁和乳糖和/或其他赋形剂、粘合剂、增充剂、崩解剂、稀释剂和润滑剂。如果希望口服给药,通常以保护其免受胃的酸性环境影响的组合物的形式来提供该组合物。例如,该组合物可以配制在肠溶衣中,该肠溶衣在胃中保持其完整性并在肠中释放活性化合物。该组合物也可以与抗酸剂或其他这种成分组合配制成。
口服组合物通常包含惰性稀释剂或可食用载体,并可被压制成片剂或封装在明胶胶囊中。为了口服治疗性给药的目的,活性成分可以与赋形剂合并,以片剂、胶囊或锭剂的形式使用。药物相容的粘合剂和辅料可以作为组合物的一部分被包括。片剂、丸剂、胶囊、锭剂等可以含有下列成分或类似性质的化合物中的任一种:粘合剂,例如但不限于黄蓍胶、阿拉伯胶、玉米淀粉或明胶;赋形剂,例如,微晶纤维素、淀粉或乳糖;崩解剂,例如但不限于海藻酸和玉米淀粉;润滑剂,例如但不限于硬脂酸镁;助流剂,例如但不限于胶体二氧化硅;甜味剂,例如,蔗糖或糖精;调味剂,例如,薄荷、水杨酸甲酯或水果调味剂。
当剂量单元形式是胶囊时,除了上述类型的物质外,还可以含有液体载体,例如,脂肪油。此外,剂量单元形式可以包含各种其他物质,这些物质改变剂量单元的物理形式,例如,糖和其他肠溶剂的包衣。
当口服给药时,该组合物可以以用于口服给药的剂型给药。这些剂型包括片剂和胶囊的常用固体单元剂型以及比如溶液、悬浮液和酏剂等液体剂型。当使用固体剂型时,优选地是缓释型,使得化合物每天只需给药一次或两次。在一些示例中,每日对个体给药1次、2次、3次、4次或更多次口服剂型。
对于固体组合物,例如,粉末、丸剂、片剂或胶囊形式,常规的无毒固体载体可包括例如药物级甘露醇、乳糖、淀粉或硬脂酸镁。除了生物中性载体外,待给药的药物组合物可以可选含有少量无毒的辅助物质或赋形剂,例如,润湿剂或乳化剂、防腐剂和pH缓冲剂等;例如,乙酸钠或脱水山梨醇单月桂酸酯。其他非限制性赋形剂包括非离子增溶剂,例如,聚氧乙烯蓖麻油,或者包括蛋白质,例如,人血清白蛋白。
在一些实施例中,提供了一种胶囊,其包含填充物组合物和包裹填充物的外壳。填充组合物可以是本文所述的任何睡眠组合物。填充组合物还可以包括液体载体成分,如下文更详细描述的。可选地,可以在外壳周围提供包衣。
胶囊防止填充组合物降解,并允许在室温下储存几个月的时间。该胶囊适于个人自行给药。胶囊被摄入后,胶囊外壳在消化道中溶解或崩解,从而释放治疗组合物,以被摄入该胶囊的个体的身体吸收。
胶囊外壳通常由基于动物的或基于植物的成分制成,这些成分在摄入后容易溶解或分解。基于动物的成分可包括由动物皮和/或骨的胶原蛋白制成的明胶。在一些实施例中,胶囊由明胶制成。其他合适的基质物质(例如,具有类似明胶性质的全合成聚合物化学品)可用于制造胶囊。基于植物的成分可包括植物淀粉、纤维素、羟丙甲纤维素(由纤维素制成的聚合物)或支链淀粉(由木薯淀粉制成的多糖聚合物)。在一些实施例中,基于植物的成分可包括卡拉胶、马铃薯淀粉、木薯淀粉、玉米淀粉、竹芋粉或其组合。胶囊外壳的成分、制造和使用在本领域是众所周知的。
在一些实施例中,胶囊在本文中也被称为软胶囊。软胶囊尤其适用于容纳基于液体的成分,例如,被溶解、分散和/或悬浮在液体载体中的治疗成分。对于需要完全隔绝空气和光线的物质,软胶囊也具有具体优势。例如,软胶囊可以阻挡大量(例如,至少90%、至少99%或高达100%)的UV光透过。
软胶囊的一个优点是提高了吸收率和吸收程度,并降低了每剂量的可变性,尤其是对于水溶性药物而言。软胶囊的另一个优点是比例如片剂或硬壳胶囊更容易吞咽。另一个优点是没有与比如片剂或硬壳胶囊等替代品相关的不良味道、余味、尖锐边缘或其他感官问题。与片剂和硬壳胶囊相比,另一个优点是改善了患者的依从性。
另一个优点是容易和方便口服必须配制成液体剂型的药物。另一个优点是与固体或粉末形式相比,控制液体治疗剂的精确量的能力提高。另一个优点是在配制后和给药前不易篡改和/或改变剂量。另一个优点是活性治疗剂是气密密封的。
另一个优点是与片剂、颗粒或粉末制剂相比,制剂的均匀性提高。另一个优点是软胶囊中治疗剂的稳定性增强。与硬壳胶囊相比,软胶囊的另一个优点是易于储存和延长保存期。另一个优点是软胶囊在给药后迅速崩解,从而提高了治疗剂的吸收率,因此与例如片剂相比,提高了治疗效果。另一个优点是治疗剂的血浆变异性显著降低,因此与片剂和硬壳胶囊相比,给药时生物有效度水平提高。
软胶囊的外壳通常由基于动物的和/或基于植物的成分与增塑剂(例如,甘油)和溶剂(例如,水)结合制成。在一些示例中,可以使用基于植物的成分,例如,纤维素、羟丙甲纤维素、植物淀粉、木薯淀粉、卡拉胶、马铃薯淀粉、木薯淀粉、玉米淀粉、竹芋粉或其组合,代替明胶来制备素食软胶囊。也可以使用性质类似于明胶或淀粉的适于聚合或活化交联的其他基于动物的或基于植物的成分。软胶囊外壳壳通常在本领域已知的连续过程中制备并填充治疗制剂。
术语“增塑剂”是指添加到明胶或淀粉中以形成软胶囊的物质。增塑剂可包括甘油、山梨醇、丙二醇、其他合适的多元醇或其组合。可以调整增塑剂的量,以获得具有所需柔软度和柔韧性水平的软胶囊外壳。一些实施例可以包括约30至约50重量%的基于植物的成分;至少18重量%,优选高达约40重量%的增塑剂;和约20至约50重量%的水。当形成为胶囊并干燥时,这些制剂将产生含有约40至约75重量%的基于植物的成分;约18重量%至约40重量%的增塑剂;和约5至约15重量%的水的软胶囊。可以通过在合适的容器中组合适量的基于植物的成分、水、增塑剂和任何可选的成分,并在加热的同时搅拌和/或搅动直至获得均匀的溶液,来制备软胶囊外壳。
在一些实施例中,软胶囊外壳包括层或包衣。包衣可以包括薄膜包衣或肠溶包衣,其允许在给药时控制释放、延迟释放或持续释放胶囊的内容物。
术语“防腐剂”是指用于防止细菌、真菌、霉菌和其他微生物生长的化合物。这些化合物因其相应的抗菌(破坏和抑制细菌生长)、抗真菌(破坏和抑制真菌生长)、抗微生物、抗支原体、抗病毒和/或抗朊病毒特性而使用。合适的防腐剂可包括但不限于苯扎氯铵、苄索氯铵、氯己定、苯酚、间甲酚、苯甲醇、对羟基苯甲酸烷基酯(对羟基苯甲酸甲酯、对羟基苯甲酸乙酯、对羟基苯甲酸丙酯、对羟基苯甲酸丁酯等)、脱氢乙酸钠、邻甲酚、对甲酚、氯甲酚、硝酸苯汞、硫柳汞、苯甲酸中的至少一种以及一种或多种防腐剂的任何混合物。参见,例如,Wallhauser,K.,Develop.Biol.Standard.24,第9-28页(巴塞尔,S.Krager,1974)。在一些实施例中,软的明胶外壳可以包含防腐剂,以防止真菌生长。在一些实施例中,防腐剂可以包括对羟基苯甲酸酯类(例如,对羟基苯甲酸甲酯、对羟基苯甲酸丙酯、对羟基苯甲酸异丙酯、对羟基苯甲酸丁酯和对羟基苯甲酸异丁酯及其盐,例如,对羟基苯甲酸丁酯钠)、苯甲酸及其盐和酯、苯甲醇、脲衍生物(例如,重氮菲啶基脲、咪唑烷基脲和DMDM乙内酰脲)、山梨酸及其盐等。在各种实施例中,可以不存在防腐剂。
术语“遮光剂”是指一种试剂或试剂混合物,当加入到制剂中时,使随后的系统不透明。代表性的遮光剂包括但不限于药学上可接受的金属氧化物,尤其是二氧化钛。一些实施例可以包含与软胶囊的基于植物的成分质量混合的约0.2重量%至约1.2重量%的遮光剂。在一些实施例中,可以不存在遮光剂。
术语“食用香料”是指提供所需味道和/或气味的化合物。食用香料可以是天然或人工化合物,并且可以是油溶性的,但不是必须是油溶性的。食用香料包括乙酸异戊酯(或其他香蕉味食用香料)、苯甲醛(或其他杏仁味食用香料)、肉桂醛(或其他肉桂味食用香料)、柠檬酸或丙酸乙酯(或其他水果味食用香料)、邻氨基苯甲酸甲酯(或其他葡萄味食用香料)、柠檬烯(或其他橙子味食用香料)、癸二烯酸乙酯(或其他梨味食用香料)、己酸烯丙酯(或其他菠萝味食用香料)、乙基麦芽酚(或其他糖或棉花糖味食用香料)、乙基香兰素(或其他香草味食用香料)、水杨酸甲酯(或其他冬青味食用香料)、单乙酸甘油酯(E1516食品添加剂)、二乙酸甘油酯(E1517食品添加剂)及其组合。一些实施例可以包括大约0.1重量%至约2重量%的食用香料。
术语“着色剂”是指赋予颜色的组合物或化合物,例如但不限于颜料、染料和调色剂。典型的着色剂可包括类胡萝卜素(E160、E161、E164)、叶绿酸(E140、E141)、花青素(E163)和甜菜红素(E162)。还可以使用其他着色剂,例如,胭脂树橙(E160b)(一种由胭脂树籽制成的红橙色染料)、由焦糖制成的焦糖色素(E150a-d)、胭脂红(E120)(一种源自胭脂虫(Dactylopius coccus)的红色染料)、接骨木果汁(E163)、番茄红素(E160d)、辣椒粉(E160c)和姜黄(E100)。
本文使用的术语“赋形剂”包括但不限于如上所述的防腐剂、增塑剂、遮光剂、着色剂和食用香料或其任意组合。术语赋形剂还可包括溶剂、粘合剂、表面活性剂、乳化剂、湿润剂、悬浮剂或其任意组合。可用于软胶囊制剂的合适赋形剂或添加剂的描述见例如Lachman等人的“The Theory and Practice of Industrial Pharmacy(第4版(2013))”;Rowe等人的“Handbook of Pharaceutical Excipients(第8版(2017))”;Remington的“The Scienceand Practice of Pharmacy(第22版(2015))”。从法规角度来看,本文所述的软胶囊制剂中使用的所有赋形剂和添加剂应优选被批准用于口服药物剂型。
胶囊的软胶囊外壳填充有睡眠组合物。睡眠组合物可以与液体载体混合、溶解、分散、悬浮或乳化。液体载体的特性可以是亲水性或亲脂性的。在一些实施例中,液体载体可以包括亲水性物质和亲脂性物质的组合。在各种实施例中,亲水性物质、亲脂性物质或其组合以预浓缩物的形式被包封在软胶囊外壳内。在一些实施例中,预浓缩物还包括一种或多种表面活性剂。在一些实施例中,在口服软胶囊之前、期间或之后,液体载体的成分以乳剂的形式存在。在各种实施例中,乳剂包括微乳液、纳米乳液及其组合。
在一些实施例中,液体载体可以包括一种或多种油,例如,硅油、植物油、甘油、氢化植物油、卵磷脂、蜂蜡、生育酚、聚乙二醇(例如,PEG 200、300、400或600)、聚氧乙烯-聚氧丙烯共聚物(泊洛沙姆)、丙二醇、中链脂肪酸的甘油三酯、ω油、大豆油、菜籽油、葵花籽油、夏威夷果油、花生油、葡萄籽油、南瓜籽油、亚仁油、亚麻籽油、橄榄油、玉米油、红花油、芝麻油、松仁油、共轭亚麻油酸、扁桃仁油、桃仁油、杏核油、核桃油、菜籽油、覆盆子籽油、越橘籽油、蔓越莓籽油、石榴籽油和其他水果籽油、沙棘油、奇亚籽油、紫苏油、甘油二酯(DAG)油、ω3的植物来源、二十碳五烯酸(EPA)的发酵来源、二十二碳六烯酸(DHA)的发酵来源、EPA、DHA和其他ω3(包括鱼油和hill油)的组合的发酵来源、γ-亚麻酸(GLA)或亚麻油酸(SA)的来源、分馏椰子油及其组合。DHA、EPA和α-亚油酸(ALA)的来源包括但不限于鱼油、酵母或其他微生物或单细胞来源以及植物油,主要是亚麻籽、大豆和菜籽油。GLA的来源包括但不限于月见草油、黑醋栗籽油、琉璃苣油和蓝蓟油。
鉴于所公开的发明的原理可以应用于许多可能的实施例,应该认识到,所示的实施例仅仅是本发明的优选示例,并且不应该被视为限制本发明的范围。
Claims (22)
1.一种睡眠补充组合物,包含50mg至275mg的缬草提取物、20mg至140mg的柠檬香蜂草提取物和1.0mg至13.0mg的L-茶氨酸。
2.根据权利要求1所述的睡眠补充组合物,其中,所述睡眠补充组合物还包含褪黑激素。
3.根据权利要求2所述的睡眠补充组合物,其中,所述睡眠补充组合物包含0.5mg至5.5mg的褪黑激素。
4.根据权利要求2所述的睡眠补充组合物,其中,所述睡眠补充组合物包含1.0mg至4.0mg的褪黑激素。
5.根据权利要求1所述的睡眠补充组合物,其中,所述睡眠补充组合物包含100mg至200mg的缬草提取物。
6.根据权利要求1所述的睡眠补充组合物,其中,所述睡眠补充组合物包含50mg至120mg的柠檬香蜂草提取物。
7.根据权利要求1所述的睡眠补充组合物,其中,所述睡眠补充组合物包含6.0mg至11.0mg的L-茶氨酸。
8.根据权利要求2所述的睡眠补充组合物,其中,所述睡眠补充组合物包含1.0mg至4.0mg的褪黑激素、100mg至200mg的缬草提取物、50mg至120mg的柠檬香蜂草提取物和6.0mg至11.0mg的L-茶氨酸。
9.根据权利要求1所述的睡眠补充组合物,其中,缬草提取物、柠檬香蜂草提取物和L-茶氨酸的组合量为100mg至400mg。
10.根据权利要求2所述的睡眠补充组合物,其中,褪黑激素、缬草提取物、柠檬香蜂草提取物和L-茶氨酸是所述组合物中仅有的睡眠诱导活性成分。
11.根据权利要求8所述的睡眠补充组合物,其中,褪黑激素、缬草提取物、柠檬香蜂草提取物和L-茶氨酸是所述组合物中仅有的睡眠诱导活性成分。
12.根据权利要求1所述的睡眠补充组合物,其中,所述睡眠补充组合物还包含至少一种赋形剂。
13.一种剂量单元,包含50mg至275mg的缬草提取物、20mg至140mg的柠檬香蜂草提取物和1.0mg至13.0mg的L-茶氨酸,其中,所述剂量单元呈用于促进睡眠的软胶囊的形式。
14.根据权利要求13所述的剂量单元,其中,所述剂量单元还包含褪黑激素。
15.根据权利要求14所述的剂量单元,其中,所述剂量单元包含0.5mg至5.5mg的褪黑激素。
16.根据权利要求14所述的剂量单元,其中,所述剂量单元包含1.0mg至4.0mg的褪黑激素、100mg至200mg的缬草提取物、50mg至120mg的柠檬香蜂草提取物和6.0mg至11.0mg的L-茶氨酸。
17.根据权利要求16所述的剂量单元,其中,褪黑激素、缬草提取物、柠檬香蜂草提取物和L-茶氨酸是所述剂量单元中仅有的睡眠诱导活性成分。
18.根据权利要求14所述的剂量单元,其中,所述软胶囊包含外壳和填充组合物,其中所述外壳包含至少一种基于植物的成分,并且所述填充组合物包含缬草提取物、柠檬香蜂草提取物、L-茶氨酸和褪黑激素。
19.根据权利要求18所述的剂量单元,其中,所述填充组合物还包含中链脂肪酸的甘油三酯。
20.一种方法,包括通过对有需要的个体以口服方式施用根据权利要求1所述的睡眠补充组合物来促进所述个体的睡眠。
21.一种方法,包括通过对有需要的个体以口服方式施用根据权利要求8所述的睡眠补充组合物来促进所述个体的睡眠。
22.一种方法,包括通过对有需要的个体以口服方式施用根据权利要求13所述的剂量单元来促进所述个体的睡眠。
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