CN102369007A - 口服用组合物 - Google Patents
口服用组合物 Download PDFInfo
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- CN102369007A CN102369007A CN2010800116313A CN201080011631A CN102369007A CN 102369007 A CN102369007 A CN 102369007A CN 2010800116313 A CN2010800116313 A CN 2010800116313A CN 201080011631 A CN201080011631 A CN 201080011631A CN 102369007 A CN102369007 A CN 102369007A
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- Prior art keywords
- oral administration
- composition
- functional
- sodium glutamate
- prevention
- Prior art date
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Abstract
根据本发明，提供可以更有效地预防或改善功能性消化道障碍、特别是上消化道的功能障碍、尤其是功能性消化不良，而且安全性高并适于长期摄取的口服用组合物。本发明的口服用组合物以摩尔比1:1含有谷氨酸钠和精氨酸盐酸盐。上述组合物可以以功能性消化道障碍的预防或改善用口服剂的形式提供，或者也可以以含有其的饮食品的形式提供。
Description
技术领域
本发明涉及具有功能性消化道障碍的预防或改善效果的口服用组合物，特别是涉及以下的口服用组合物：其作为功能性消化不良、胃食管反流病这类上消化道的功能障碍，特别是呈现出餐后腹胀感、早期饱腹感等餐后不适或心窝部痛等的功能性消化不良的预防或改善用是有效的。
背景技术
功能性消化不良(Functional dyspepsia；FD)是指来自上消化道的症状，但是不存在病理状态，或病理状态不明确，又或即使存在病理状态也得不到足以说明临床状态的观察结果的状态。若根据对于功能性消化道障碍的诊断基准的Rome III基准，则慢性地(严格地说为3个月以上)可见与餐后腹胀感、早期饱腹感这类餐后不适综合征(Postprandial distress syndrome；PDS)相关的症状，以及与心窝部痛、心窝部灼热感这类心窝部痛综合征(Epigastric pain syndrome；EPS)相关的症状中的至少一种症状，且器质性疾病被排除的情况诊断为FD。
另外，胃食管反流病(Gastro-esophageal reflux disease；GERD)是指胃内容物反流到食管，意味着下食管括约肌的功能障碍。与胃食管接合部的功能相关的主要因素有固有的括约肌收缩压、贲门食管接合部的角度、横膈膜的活动以及重力(患者直立时)。应予说明，GERD有时导致食管炎。
在日本，上述功能性消化不良或胃食管反流病这类消化道、特别是上消化道的功能障碍(Functional gastrointestinal disorders；FGIDs)的各病例迄今为止作为与器质性的观察结果无关的“伴随慢性胃炎的上腹部消化道不适”，在临床上习惯地诊断为“胃炎”或“慢性胃炎”。
另一方面，在伴随有反流性食管炎、消化性溃疡、急性胃炎、消化器官癌等器质性病变的情况下，可见腹痛或不适感、餐后的胃积食、恶心/呕吐等，这些不适症状的改善对于患者的生活质量(QOL)提高来说是当务之急。若将功能性消化不良和伴随便秘的排便困难感、残便感、腹痛、腹部膨胀感等下腹部消化道不定主诉症状合并，则推测在日本国内总人口的约30%～约50%经历过某些消化道的不定主诉症状。认为上述消化道的不定主诉症状的发病受到性别、衰老、压力或肥胖的影响，但作为其发生机制，仅限于暗示了消化道运动功能的降低，还未得到完全阐明。
此外，帕金森氏病、亨廷顿舞蹈病、橄榄体脑桥小脑萎缩症等进行性脑变性疾病或脑血管障碍患者大多并发消化道运动功能障碍，认为存在很多由于语言障碍、意识障碍等而不能自己主诉不适症状的患者，对器质性的功能障碍进行护理的同时，实施除去腹部的不适症状的护理对于患者的QOL提高来说是重要的。
迄今为止，在功能性消化不良、胃食管反流病的治疗中，一直使用多巴胺D2受体拮抗剂、5-HT4受体激动剂等。例如西沙必利、甲氧氯普胺通过对多巴胺D2受体进行拮抗或刺激存在于消化道壁内神经丛的5-HT4受体，增加乙酰胆碱的游离，促进消化道运动及胃排空，从而改善腹部膨胀感等腹部不适症状。然而，已知西沙必利有QT(从心室去极化开始到心室复极化结束的时间)延长、室性心律失常、帕金森症状(震颤、肌肉强直、运动减退、曳行步态)等严重的副作用，或对于中枢的多巴胺D2受体的锥体外路症状(运动失调、肌肉和手足的痉挛、斜颈)这类副作用。此外，对于甲氧氯普胺，除了痉挛、迟发性运动障碍等之外，还发现锥体外路症状等副作用。此外，还使用柠檬酸莫沙必利等，但是有时效果不足，此外有时还出现腹泻等副作用。进一步地，还使用H2受体拮抗剂、质子泵抑制剂等，但是长期摄取时的安全性不明，有报告称质子泵抑制剂的长期摄取会导致骨折等的危险性增大。
另一方面，有报告指出谷氨酸发挥作为功能性消化道障碍的预防或改善剂的作用。进一步地，公开了谷氨酸的精氨酸盐作为消化道障碍的预防/改善剂是有用的(专利文献1)。此外，本申请人对于通过将谷氨酸或其盐与精氨酸或其盐并用，可以有效地改善功能性消化不良等功能性消化道障碍提出申请。
现有技术文献
专利文献1：WO2006/030980号小册子。
发明内容
因此，本发明的目的在于，提供可以更有效地预防或改善功能性消化道障碍、特别是上消化道的功能障碍、尤其是功能性消化不良，而且安全性高并且适于长期摄取的口服用组合物。
为了解决上述课题而进行了深入研究，结果本发明人发现，通过以摩尔比1:1使用谷氨酸钠和精氨酸盐酸盐，得到功能性消化道障碍的预防或改善效果，特别是对于功能性消化不良等上消化道的功能障碍，得到优异的预防或改善效果，从而完成了本发明。
即，本发明涉及以下的[1]～[16]。
[1] 口服用组合物，以摩尔比1:1含有谷氨酸钠和精氨酸盐酸盐。
[2] 上述[1]中所述的口服用组合物，其含有以总量计为0.05g～10g的谷氨酸钠和精氨酸盐酸盐。
[3] 上述[1]中所述的口服用组合物，其含有以总量计为0.1g～5g的谷氨酸钠和精氨酸盐酸盐。
[4] 上述[1]中所述的口服用组合物，其含有以总量计为0.3g～3g的谷氨酸钠和精氨酸盐酸盐。
[5] 上述[1]～[4]中任一项所述的口服用组合物，其中，成人每1天的谷氨酸钠和精氨酸盐酸盐的摄取量以总量计为0.3g～10g。
[6] 上述[1]～[5]中任一项所述的口服用组合物，其中，以1次～3次摄取每1天的摄取量。
[7] 上述[1]～[6]中任一项所述的口服用组合物，其用于连续摄取7天以上。
[8] 上述[1]～[7]中任一项所述的口服用组合物，其为颗粒剂。
[9] 上述[1]～[8]中任一项所述的口服用组合物，其为功能性消化道障碍的预防或改善用口服剂。
[10] 上述[9]中所述的口服用组合物，其中，功能性消化道障碍为上消化道的功能障碍。
[11] 上述[10]中所述的口服用组合物，其中，上消化道的功能障碍为功能性消化不良。
[12] 饮食品，其含有上述[1]～[11]中任一项所述的口服用组合物。
[13] 功能性消化道障碍的预防或改善方法，其包括对于呈现出功能性消化道障碍的患者，口服给药足以预防或改善功能性消化道障碍的量的上述[1]中所述的口服用组合物。
[14] 上消化道的功能障碍的预防或改善方法，其包括对于呈现出上消化道的功能障碍的患者，口服给药足以预防或改善上消化道的功能障碍的量的上述[1]中所述的口服用组合物。
[15] 功能性消化不良的预防或改善方法，其包括对于功能性消化不良患者，经口给药足以预防或改善功能性消化不良的量的上述[1]中所述的口服用组合物。
[16] 商业性包装，其包括上述[1]～[12]中任一项所述的口服用组合物、和所述了为了预防或改善功能性消化道障碍而可以使用或应该使用该口服用组合物的文件。
通过本发明，可以提供可有效地改善呈现出消化道的功能降低的消化道功能障碍的口服用组合物。此外，本发明涉及的口服用组合物由于安全性高、适于长期摄取，因此对于预防消化道功能障碍的出现也是有效的。本发明涉及的口服用组合物特别是对于上消化道的功能障碍、其中的功能性消化不良的各种症状的预防或改善是有效的。进一步地，本发明涉及的口服用组合物可以长期减轻呈现出功能性消化不良等消化道功能障碍的各种症状的患者的不适感，从而可以提高这些患者的QOL。
具体实施方式
本发明涉及的口服用组合物的特征在于，以摩尔比1:1含有谷氨酸钠和精氨酸盐酸盐，对降低患者的QOL的具有重现性的功能性消化道障碍进行预防或改善，可以有效地用作功能性消化道障碍的预防或改善用口服剂。
本发明中的“功能性消化道障碍”是指尽管没有明显的器质性变化，但是消化道功能降低的状态，是指消化道即咽、食管、胃、小肠(十二指肠、空肠、回肠)、大肠的所有功能的降低。在Rome III中，对于本定义划分为A～H，可以举出功能性食管障碍、功能性十二指肠障碍、功能性肠障碍、功能性腹痛综合征、功能性胆囊/奥狄氏括约肌障碍、功能性直肠肛门障碍、新生儿及婴幼儿的功能性障碍、儿童及青年期的功能性障碍。
本发明涉及的口服用组合物特别是对于上消化道的功能障碍的预防或改善是有效的。其中，“上消化道”是指咽、食管、胃、十二指肠，作为“上消化道的功能障碍”，可以举出上述功能性消化不良和胃食管反流病。本发明涉及的口服用组合物尤其对于功能性消化不良的预防或改善是有效的。
作为通过本发明涉及的口服用组合物可以预防或改善的功能性消化道障碍的具体的症状，可以举出恶心、呕吐、作呕、胃灼热、腹胀感、胃积食、嗳气、胸闷、胸痛、胃部不适感、食欲不振等代表性的上消化道不定主诉症状，腹痛、便秘、腹泻等下消化道不定主诉症状以及相关的主诉症状，例如气喘、气闷、情绪低落、咽阻塞/异物感(中医所称的“梅核气”)、易疲劳感、肩发僵、紧张、口渴/口干、呼吸急促、四肢热感/冷感、注意力不集中、焦躁感、睡眠障碍、头痛、全身倦怠感、心悸、盗汗、不安感、摇晃感、眩晕感、热感、潮红、发汗、腹痛、便秘、抑郁感等。本发明涉及的口服用组合物对于其中的上消化道不定主诉症状的预防或治疗是有效的，特别是对于餐后腹胀感、早期饱腹感这类餐后不适或心窝部痛、心窝部灼热感这类心窝部痛的预防或改善是有效的。
本发明涉及的口服用组合物中，作为谷氨酸钠和精氨酸盐酸盐，可以使用L体、D体和DL体中的任意一种，但是最适宜使用L体。此外，谷氨酸钠和精氨酸盐酸盐可以使用从含有它们的动植物等萃取并纯化而得到的谷氨酸钠和精氨酸盐酸盐，或通过化学合成法、发酵法、基因重组法得到的谷氨酸钠和精氨酸盐酸盐中的任意一种，还可以从味の素株式会社、シグマ-アルドリッチ社等购入市售品。
本发明涉及的口服用组合物以摩尔比1:1含有谷氨酸钠和精氨酸盐酸盐。使摩尔比为1:1是为了在各自以盐的形式配合作为酸性氨基酸的谷氨酸和作为碱性氨基酸的精氨酸时， 减少pH的影响，减轻对胃粘膜的刺激性。作为组合物中的谷氨酸钠和精氨酸盐酸盐的含量，以它们的总量计优选为0.05g～10g，更优选为0.1g～5g，特别优选为0.3g～3g。这是由于在本发明中谷氨酸钠和精氨酸盐酸盐表现出用量依赖性的效果，另一方面，若谷氨酸钠和精氨酸盐酸盐的含量增多，则依从性方面难以通过口服进行摄取。
此外，本发明涉及的口服用组合物中，谷氨酸钠和精氨酸盐酸盐的摄取量根据摄取者的年龄、体重、性别、饮食、功能性消化道障碍的症状及程度、诱发消化道功能障碍的危险性、消化道的器质性障碍的有无及程度等而不同，对于成人每1天0.3g～10g是适当的，此摄取量可以1次摄取，也可以分数次摄取。本发明涉及的口服用组合物特别是在长期摄取时等，每1天摄取1次～3次从防止漏服方面考虑是优选的。
由于功能性消化道障碍多表现为慢性的情况，为了对其进行预防或改善，优选本发明涉及的口服用组合物长期连续地摄取，为了得到显著的预防或改善效果，优选连续摄取7天以上。
本发明涉及的口服用组合物还可以使人以外的动物摄取。作为人以外的动物，可以举出牛、马、猪、羊、鸟等家畜或家禽，狗、猫、兔等宠物，小鼠或大鼠等实验动物等。
作为本发明涉及的口服用组合物，可以直接摄取有效量的谷氨酸钠和精氨酸盐酸盐，也可以与可药用的药物载体一起制剂化、以功能性消化道障碍的预防或改善用口服剂的形式提供。本发明中，若为适于通过口服而摄取的剂型则可以选择任意一种剂型，例如可以形成酏剂、悬浊剂、糖浆剂、乳剂、安瓿剂等液态制剂；凝胶剂、咀嚼剂、滴剂、散剂、颗粒剂、丸剂、片剂(包括糖衣片、薄膜包衣片)、胶囊剂、分包剂等固体状制剂等。此外，还可以形成凝胶被覆制剂、多重被覆制剂等缓释制剂，幽门部崩解制剂等定位释放制剂等。应予说明，在本发明中，从制剂化的容易性、成本、制剂稳定性、摄取的容易性等观点考虑，优选形成颗粒剂。
作为本发明中可使用的可药用的药物载体，可以举出水、醇、乳剂等液态载体；凝胶、粉末等固态载体；微囊、脂质体等微粒体等，可以添加可药用的各种添加剂。作为各种添加剂，可以举出结晶纤维素、羟丙基纤维素等纤维素及其衍生物，小麦淀粉、玉米淀粉、羧甲基淀粉钠、糊精等淀粉及其衍生物，阿拉伯树胶、藻酸钠等天然高分子化合物，葡萄糖、麦芽糖、山梨糖醇、麦芽糖醇、甘露糖醇等糖及其衍生物，氯化钠、碳酸钙、硅酸镁等无机盐类等赋型剂；瓜尔胶、合成硅酸铝、硬脂酸、高分子聚乙烯吡咯烷酮、乳糖等粘合剂；滑石、硬脂酸镁、聚乙二醇6000等润滑剂；己二酸、硬脂酸钙、蔗糖等崩解剂；蔗糖脂肪酸酯、大豆卵磷脂、聚氧乙烯氢化蓖麻油、聚氧乙烯单硬脂酸酯等表面活性剂；羧甲基纤维素钠、卡波姆、黄原酸胶、明胶等增稠剂；丙烯酸乙酯/甲基丙烯酸甲酯共聚物分散液、焦糖、巴西棕榈蜡、紫胶、蔗糖、支链淀粉等涂布剂；柠檬酸、柠檬酸钠、乙酸、乙酸钠、氢氧化钠等pH调节剂；抗坏血酸、醋酸生育酚、天然维生素E、没食子酸丙酯等抗氧化剂；天冬甜素、甘草浸液、糖精等矫味剂；苯甲酸钠、依地酸钠、山梨酸、山梨酸钠、对羟基苯甲酸甲酯、对羟基苯甲酸丁酯等防腐剂；氧化铁、氧化铁黄、氧化铁黑、胭脂红、食用蓝色1号、食用黄色4号、食用黄色4号铝色淀、食用红色2号、叶绿素铜钠盐等着色剂等。
本发明涉及的口服用组合物中还可以并用其他的药物。作为上述药物，可以举出西咪替丁、雷尼替丁、法莫替丁、尼扎替丁等H2受体拮抗剂；奥美拉唑、兰索拉唑、雷贝拉唑等质子泵抑制剂；柠檬酸莫沙必利等5-HT4受体作用药；甲氧氯普胺、多潘立酮等多巴胺D2拮抗剂；替喹溴铵、盐酸哌仑西平等毒蕈碱受体拮抗剂；丙谷胺、尿抑胃素等抗胃泌素药；盐酸乙哌苯乙酯、溴丙胺太林、丁溴东莨菪碱等抗胆碱药；莨菪提取物、硫酸阿托品等颠茄生物碱；奥诺前列素、恩前列素、迷索前列醇等前列腺素制剂；替普瑞酮、普劳诺托、瑞巴派特、氯化甲硫氨基酸、硫糖铝、聚普瑞锌、薁磺酸钠、乙哌仑钠、尿囊素铝、乙酰谷酰胺铝、盐酸西曲酸酯、甘草浸液、索法酮、吉法酯、海藻酸钠、曲昔匹特、盐酸贝萘克酯β-环糊精、马来酸伊索拉定、依卡倍特钠等防御因子增强药；美沙拉秦、倍他米松磷酸钠、泼尼松龙磷酸钠这类甾体类；英夫单抗等炎症性大肠炎治疗药等，可以从它们中选择1种或2种以上来使用。
进一步地，本发明涉及的口服用组合物可以直接或添加通常在饮食品中使用的添加剂，例如以液态、乳状、果冻状、胶状、粉末状、颗粒状、薄片状、胶囊状、片状等形态，以特定保健用食品、营养功能食品这类保健功能食品，营养辅助食品，其他健康食品等饮食品的形式来提供。作为上述添加剂，可以举出例如甜味剂、着色剂、保存剂、增稠稳定剂、抗氧化剂、发色剂、漂白剂、防霉剂、香糖胶基、苦味料、酶、光泽剂、酸味料、调味料、乳化剂、强化剂、制造用剂、香料、香辛料萃取物等。此外，本发明涉及的口服用组合物还可以添加到饮料、清凉饮料、酸奶、果冻、乳饮料等已知的食品中，在摄取食物时与食物一起摄取。
在提供含有本发明涉及的口服用组合物的饮食品时，每一饮食品组合物中的谷氨酸钠和精氨酸盐酸盐的含量，以它们的总量计为0.05g～10g是适当的，更优选为0.1g～5g，特别优选为0.3g～3g。此外，作为成人每1天的摄取量，以谷氨酸钠和精氨酸盐酸盐的总量计为0.3g～10g，可以在1天内将其1次或分为数次来摄取。
制成含有本发明涉及的口服用组合物的饮食品时，可以制成含有上述的每1次的摄取量的谷氨酸钠和精氨酸盐酸盐的1餐摄取量单位的包装形态。“1餐摄取量单位的包装形态”是指预先规定每1餐摄取的饮食品的量的形态，例如在饮料、糖果、口香糖、果冻、布丁、酸奶等情况下，可以举出通过包、瓶、箱等容器包装一定量的形态，在颗粒、粉末、浆状等食品的情况下，可以举出通过包或袋等分别包装一定量的形态。特别是在饮食品为特定保健用食品、营养功能食品等保健功能食品、营养辅助食品、其他健康食品等的情况下，可以举出谷氨酸钠和精氨酸盐酸盐以每1餐的摄取单位量的方式包装的形态，或悬浊或溶解有谷氨酸钠和精氨酸盐酸盐的饮料以每1餐饮尽的方式填充到瓶等中的形态等。作为谷氨酸钠和精氨酸盐酸盐的每1次的摄取单位量，根据上述成人每1天的摄取量可知，作为它们的总量，0.1g～10g是适当的。
此外，本发明中提供功能性消化道障碍的预防或改善方法，该方法包括对于呈现出功能性消化道障碍的患者，口服给药足以预防或改善功能性消化道障碍的量的本发明涉及的口服用组合物。作为“足以预防或改善功能性消化道障碍的量”，根据患者的年龄、性别、体重、功能性消化道障碍的症状和程度等而不同，作为谷氨酸钠和精氨酸盐酸盐的总量，通常对于成人来说为每1天0.3g～10g。优选将上述量以1天1～3次口服给药。功能性消化道障碍表现为慢性时，优选连续给药7天以上。
应予说明，本发明涉及的上述功能性消化道障碍的预防或改善方法特别可用作上消化道的功能障碍的预防或改善方法。作为上消化道的功能障碍，特别是可以举出功能性消化不良作为适应症。
进一步地，本发明中，可以提供商业性包装，该包装含有本发明涉及的口服用组合物、和记载了为了预防或改善功能性消化道障碍而可以使用或应该使用该口服用组合物的文件。作为本发明涉及的商业性包装，可以举出含有作为功能性消化道障碍的预防或改善用口服剂的本发明的口服用组合物和上述文件的药物包装，包括含有本发明的口服用组合物的饮食品和上述文件的饮食品包装等。在上述文件中，以本发明的口服用组合物对于功能性消化道障碍的预防或改善有效的内容为主，记载了适应的功能性消化道障碍的具体的病例，给药或摄取的对象，每1次的服用或摄取量，每1天的服用或摄取次数，服用或摄取的方法等说明。
实施例
接着，通过实施例对本发明进行详细地说明。
[实施例1]
对于每1次的摄取份，将L-谷氨酸钠0.057g、L-精氨酸盐酸盐0.067g和部分α化淀粉1.116g各自用粉碎机粉碎，进行混合，然后添加乙醇用捏和机捏和，利用挤出造粒机造粒，得到颗粒剂。每1次的L-谷氨酸钠和L-精氨酸盐酸盐的摄取量各自为0.3mmol(总计摄取量为0.124g)。
[实施例2]
对于每1次的摄取份，将L-谷氨酸钠0. 57g和L-精氨酸盐酸盐0.67g各自用粉碎机粉碎，进行混合，然后添加乙醇用捏和机捏和，利用挤出造粒机造粒，得到颗粒剂。每1次的L-谷氨酸钠和L-精氨酸盐酸盐的摄取量各自为3.4mmol和3.2mmol(总计摄取量为1.24g)。
[比较例]
对于每1次的摄取份，将玉米淀粉1.24g用粉碎机粉碎后，添加乙醇用捏和机捏和，利用挤出造粒机造粒，得到颗粒剂。
[试验例]
对于本发明的实施例1 和2以及比较例的颗粒剂，通过功能性消化不良患者进行临床试验。临床试验以尽管在内窥镜检查中没有器质性变化，但是餐后腹胀感、早期饱腹感、中等程度以上的心窝部痛或心窝部灼热感这类上消化道的症状在6个月以上之前开始，且最近3个月持续，满足功能性消化不良的诊断基准的20岁～65岁的患者作为受试者来进行。受试者分为3组，双盲条件下各自摄取实施例1、实施例2和比较例的各颗粒剂。实施例和比较例的各颗粒剂1天3次、在14天中在即将吃饭之前摄取，对于上消化道的症状，以每天患者日志进行评价。各组的受试者数量为实施例1的颗粒剂摄取组10人，实施例2的颗粒剂摄取组9人，比较例的颗粒剂摄取组10人。
作为上消化道的症状，举出下述所示的8个项目，各自通过满分10分制的整数，以“0分：无症状”、“10分：症状重”进行评价，进行评分。应予说明，下述上消化道的症状中，1～3的项目为与Rome III基准中的餐后不适综合征(Postprandial distress syndrome；PDS)相关的项目，4～6的项目为与心窝部痛综合征(Epigastric pain syndrome；EPS)相关的项目。
[上消化道的症状]
1. 餐后胃感到膨胀
2. 吃饱了、吃不完
3. 感到胃沉
4.心窝部附近发闷
5. 心窝部附近疼痛
6. 心窝部附近感到灼烧
7. 感到不舒服想吐
8. 胸后部感到灼烧
临床试验结果为，对于各受试者，对于上述上消化道的各症状的评分， 分别将PDS(1～3)、EPS(4～6)、PDS+EPS(1～6)、全部症状(1～8)每天合计，以各摄取组的平均值示于表1中。
[表1]
表1中，在实施例1的颗粒剂摄取组中，对于PDS症状在摄取开始第2天以后发现上消化道的各症状的改善趋势，对于EPS症状在摄取开始第6天以后发现上消化道的各症状的改善趋势。在实施例2的颗粒剂摄取组中发现更显著的改善，在PDS症状和EPS症状的总计评分中，从摄取开始第3天以后直至第14天，与比较例的颗粒剂摄取组相比明显降低。对于PDS症状，第14天的评分为，相对于比较例的颗粒剂摄取组的8.5分，实施例2的颗粒剂摄取组中为3.5分，以平均分计降低5分。此外，对于EPS症状，第14天的评分为，相对于比较例的颗粒剂摄取组的5.0分，实施例2的颗粒剂摄取组中为2.1分，以平均分计降低2.9分。这样，对于L-谷氨酸钠和L-精氨酸盐酸盐，发现用量依赖性地改善上消化道症状的趋势。
由上述可知，在本发明的实施例的颗粒剂摄取组中，与比较例的颗粒剂摄取组相比，观察到上消化道的症状的减轻趋势。应予说明，上消化道症状中，特别是在与餐后不适综合征(PDS)相关的项目中发现改善趋势。
产业实用性
根据本发明，可以提供可有效地预防或改善呈现出消化道的功能降低的消化道功能障碍的口服用组合物。本发明涉及的口服用组合物可以以消化道功能障碍的预防剂或改善剂的形式提供，此外可以使其在饮食品中含有来提供。
本申请基于在日本提交的日本特愿2009-062016，将其内容全部合并于本说明书中。
Claims (16)
1. 口服用组合物，其以摩尔比1:1含有谷氨酸钠和与精氨酸盐酸盐。
2. 如权利要求1所述的口服用组合物，其含有以总量计为0.05g～10g的谷氨酸钠和精氨酸盐酸盐。
3. 如权利要求1所述的口服用组合物，其含有以总量计为0.1g～5g的谷氨酸钠和精氨酸盐酸盐。
4. 如权利要求1所述的口服用组合物，其含有以总量计为0.3g～3g的谷氨酸钠和精氨酸盐酸盐。
5. 如权利要求1所述的口服用组合物，其中，成人每1天的谷氨酸钠和精氨酸盐酸盐的摄取量以总量计为0.3g～10g。
6. 如权利要求1所述的口服用组合物，其中，以1次～3次摄取每1天的摄取量。
7. 如权利要求1所述的口服用组合物，其用于连续摄取7天以上。
8. 如权利要求1所述的口服用组合物，其为颗粒剂。
9. 如权利要求1所述的口服用组合物，其为功能性消化道障碍的预防或改善用口服剂。
10. 如权利要求9所述的口服用组合物，其中，功能性消化道障碍为上消化道的功能障碍。
11. 如权利要求10所述的口服用组合物，其中，上消化道的功能障碍为功能性消化不良。
12. 饮食品，其含有权利要求1所述的口服用组合物。
13. 功能性消化道障碍的预防或改善方法，其包括对于呈现出功能性消化道障碍的患者，口服给药足以预防或改善功能性消化道障碍的量的权利要求1所述的口服用组合物。
14. 上消化道的功能障碍的预防或改善方法，其包括对于呈现出上消化道的功能障碍的患者，口服给药足以预防或改善上消化道的功能障碍的量的权利要求1所述的口服用组合物。
15. 功能性消化不良的预防或改善方法，其包括对于功能性消化不良患者，口服给药足以预防或改善功能性消化不良的量的权利要求1所述的口服用组合物。
16. 商业性包装，其包括权利要求9～12中任一项所述的口服用组合物、和记载了为了预防或改善功能性消化道障碍而可以使用或应该使用该口服用组合物的文件。
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2009062016 | 2009-03-13 | ||
| JP2009-062016 | 2009-03-13 | ||
| PCT/JP2010/054236 WO2010104175A1 (ja) | 2009-03-13 | 2010-03-12 | 経口用組成物 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN102369007A true CN102369007A (zh) | 2012-03-07 |
Family
ID=42728460
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN2010800116313A Pending CN102369007A (zh) | 2009-03-13 | 2010-03-12 | 口服用组合物 |
Country Status (5)
| Country | Link |
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| US (1) | US20120065266A1 (zh) |
| EP (1) | EP2407162A4 (zh) |
| JP (1) | JPWO2010104175A1 (zh) |
| CN (1) | CN102369007A (zh) |
| WO (1) | WO2010104175A1 (zh) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104042783A (zh) * | 2014-06-24 | 2014-09-17 | 俞天阳 | 一种用于治疗餐后不适综合征的中药 |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP6384068B2 (ja) * | 2013-03-21 | 2018-09-05 | 味の素株式会社 | アミノ酸含有顆粒及びその製造方法 |
| US10076550B2 (en) * | 2014-06-25 | 2018-09-18 | Council Of Scientific & Industrial Research | Synergistic pharmaceutical composition for gastroinestinal disorders |
| RU2697836C2 (ru) | 2015-06-26 | 2019-08-21 | Кореа Юнайтед Фарм. Инк. | Комбинированный препарат мозаприда и рабепразола |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2008115185A (ja) * | 2004-09-17 | 2008-05-22 | Ajinomoto Co Inc | 機能性消化管障害予防・改善剤及び食品 |
| JP2008255033A (ja) * | 2007-04-03 | 2008-10-23 | Meiji Milk Prod Co Ltd | アミノ酸組成物及び飲食物 |
Family Cites Families (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2000319177A (ja) * | 1999-05-14 | 2000-11-21 | Taisho Pharmaceut Co Ltd | ストレス改善剤 |
| US20050090554A1 (en) * | 2003-09-12 | 2005-04-28 | John Devane | Treatment of gastroparesis and nonulcer dyspepsia with GABAB agonists |
| EP1806134B1 (en) * | 2004-09-17 | 2012-07-11 | Ajinomoto Co., Inc. | Agent and food for preventing/improving functional digestive disorder |
| US8445536B2 (en) * | 2005-03-31 | 2013-05-21 | Ajinomoto Co., Inc. | Arginine-containing compositions and methods for increasing blood flow using same |
| US20080153825A1 (en) * | 2006-12-22 | 2008-06-26 | Allergan Inc. | Alpha-2b receptor agonist and 5ht4 serotonin receptor compositions for treating gastrointestinal motility disorders |
| JP4979520B2 (ja) | 2007-09-10 | 2012-07-18 | 芦森工業株式会社 | トノカバー装置 |
-
2010
- 2010-03-12 JP JP2011503879A patent/JPWO2010104175A1/ja active Pending
- 2010-03-12 EP EP10750926.7A patent/EP2407162A4/en not_active Withdrawn
- 2010-03-12 CN CN2010800116313A patent/CN102369007A/zh active Pending
- 2010-03-12 WO PCT/JP2010/054236 patent/WO2010104175A1/ja active Application Filing
-
2011
- 2011-09-13 US US13/230,958 patent/US20120065266A1/en not_active Abandoned
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2008115185A (ja) * | 2004-09-17 | 2008-05-22 | Ajinomoto Co Inc | 機能性消化管障害予防・改善剤及び食品 |
| JP2008255033A (ja) * | 2007-04-03 | 2008-10-23 | Meiji Milk Prod Co Ltd | アミノ酸組成物及び飲食物 |
Non-Patent Citations (1)
| Title |
|---|
| MASAHIRO OCHI ET AL.: "NO Gosei Sogaizai ni yoru Ihaishutsu Chien Model to FD Shorei ni Taisuru Kakushu Yakuzai Koka", 《GASTROENTEROLOGY》 * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104042783A (zh) * | 2014-06-24 | 2014-09-17 | 俞天阳 | 一种用于治疗餐后不适综合征的中药 |
Also Published As
| Publication number | Publication date |
|---|---|
| US20120065266A1 (en) | 2012-03-15 |
| EP2407162A4 (en) | 2013-09-18 |
| JPWO2010104175A1 (ja) | 2012-09-13 |
| WO2010104175A1 (ja) | 2010-09-16 |
| EP2407162A1 (en) | 2012-01-18 |
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Application publication date: 20120307 |