CN104619331A - 保护脑神经细胞及预防、缓和或治疗脑部疾病的含有麝鼠香的组合物 - Google Patents
保护脑神经细胞及预防、缓和或治疗脑部疾病的含有麝鼠香的组合物 Download PDFInfo
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Abstract
本发明涉及一种保护脑神经细胞、预防及缓和或治疗脑部疾病的组合物，所述组合物作为有效成分含有麝鼠香的组合物，所述组合物对于改善神经再生、抑制神经细胞的损伤、预防及治疗阿尔茨海默痴呆有着卓越的药效。
Description
技术领域
本发明涉及一种保护脑神经细胞及预防、缓和或治疗脑部疾病的组合物,所述组合物作为有效成分含有麝鼠香。
背景技术
脑部退行性疾病是指由于发生认知功能的障碍引发记忆力减退的疾病，包括老年痴呆、铂金森病、脑卒中等多种疾病。目前全世界随着老年人口的增加各种老年人退行性疾病成为严重的社会及经济问题。并且，在现社会随着人口老龄化老年痴呆等脑部退行性疾病也一同增加，成为严重的社会首要问题，但到目前还未研发出对于此疾病的准确发病期及有效预防方法或治疗方法。代表性的脑部退行性疾病为痴呆,痴呆是在全体认知功能上发生障碍引发的疾病由普通慢性、或进行性脑部疾病而引起，并且，在记忆力、思考、理解、计算、学习、语言判断等多个高水平的大脑功能上发生障碍。
目前还未明确痴呆的准确原因，但可推算出根据大脑的胆碱(chol ine)神经细胞损伤、神经传递物质的减少、因炎症反应而引起的比压值-记忆力减退与神经细胞上合成的神经传递物质有着密切的关联(Zarow，C et al.，Arch.Neurol，60，pp337-341,2003)。在交感神经中与酪氨酸(tyros ine)合成的二茶酚胺类(catecholamine)、与色氨酸(tryptophan)合成的吲哚胺类(indolamine)为在多处的身体部位上与其代谢产物一起发现，在神经细胞内这些物质的浓度可作为对交感神经界功能的生物化学指标来使用。尤其，若根据老化的进行能推算出脑中胺类及代谢产物的浓度、对于收容体的作用能力，则能诊断出脑部老化现象及关联疾病。脑中谷氨酸盐(glutamate)或GABA(gammaaminobutyric acid)的含量测定应用于脑部退行性疾病或阿尔茨海默病的诊断。这是由于谷氨酸盐及天冬氨酸盐(aspartate)等的EAA(excitatory amino acids)在中枢神经系统上作为主要兴奋性传递物质,在神经元存活(neuronal survival)、突触发生(synaptogenesis)、学习及记忆、神经元可塑性(neuronal plasticity)等各种生理作用起着重要角色(Bowen，D.M.et al.，Brain，99，pp459-496，1976)。但这些在细胞外液中以高浓度积累时显示出神经毒素，尤其，谷氨酸盐在低血糖症(hypoglycemia)、癫痫持续状态(status epilepticus)、局部缺血(ischemia)、低氧(hypoxia)、头部创伤(head trauma)、肝脑障碍中会引发神经元细胞(neuronal cell)的坏死(Masotto，C etal.，Phamacol.Res.Commun，17，pp749-772，1985)。并且，关于脑部退行性疾病或阿尔茨海默等脑中谷氨酸盐或GABA会引发神经系统的损伤(Choi，D.W.，Neurosci，7，P369,1987)。
另一方面，逐渐消失认知功能的老年痴呆与中枢神经系统的胆碱性神经细胞的活性有关联，主要原因是由于在脑中乙酰胆碱及胆碱乙酰转移酶(cholineacetyltransferase)的活性显著降低。目前发现60多种的神经传递物质，并在学习和记忆的多方面乙酰胆碱、儿茶酚胺、谷氨酸盐、GABA起着重要角色(Cummings JL et al.，Neurology，44，PP2308-14，1994)。
痴呆或认知障碍(dementia)是在成长期保持正常水准，但后天性地发生认知功能的损伤及人格上发生变化的疾患。
以多种原因破坏脑神经，使得发生记忆力障碍、语言能力障碍、便尿失禁、多疑症、失语症等神经功能的障碍，并在病变进行过程中会出现忧郁症、人格障碍、攻击性等精神医学上的问题。在医学界除了发生在老年层老化为主要原因，还会发生由于酒精过度引起的酒精性痴呆、青少年的极少痴呆，但此情况看作是由于遗传性的隐性基因的出现导致发病的，准确的发病原因及治疗方法是到目前还未确定。
阿尔茨海默(Alzheimer's disease(AD))是属于一种脑部退行性疾病，根据老化脑组织失去功能，并逐渐衰退精神功能。在记忆力和情绪方面出现严重的障碍为特征。在现代医学上还未发现显著的治疗方法。阿尔茨海默与痴呆可同时发病，但痴呆不仅根据埃尔茨海默还会根据高血压、糖尿病、心脏疾病等成人病为发病原因。
这是痴呆主要发生在老年人身上的原因之一。在病理组织学上主要特征为脑全体的萎缩、脑室的扩张、神经纤维的多发性病变、神经斑点等。
【先行技术文献】
【专利文献】
(专利文献1)韩国授权专利第1160217号
(专利文献2)韩国公开专利第2010-0035961号
【非专利文献】
(非专利文献1)Davies et al.，Lancet，21，p1403，1976；Rocher et al.，J.Biol.Chem.，273，p 29719，1988；Coyle et al.，Science，262，p689，1993
(非专利文献2)Zarow，C et al.，Arch.Neurol，60，pp 337-341，2003
(非专利文献3)Bowen，D.M.et al.，Brain，99，pp 459-496，1976
(非专利文献4)Choi，D.W.，J.Neurosci，7，p 369，1987
(非专利文献5)Cummings JL et al.，Neurology，44，pp 2308-14，1994
发明内容
本发明经研究确认老鼠摄取作为有效成分含有麝鼠香的组合物后空间认知功能变高，并通过此研究能确认此组合物对保护脑神经细胞及预防、缓和或治疗脑部疾病有着显著的效果，在这前提下完成了此发明。
并且，本发明的目的在于，提供一种保护脑神经细胞及预防、缓和或治疗脑部疾病的含有麝鼠香的组合物，从而能改善神经再生、抑制神经细胞损伤、预防及治疗阿尔茨海默痴呆症。
为了实现所述目的，本发明提供一种作为有效成分含有麝鼠香的保护脑神经细胞及预防、缓和或治疗脑部疾病的组合物。
麝鼠香是在麝香鼠上提取的一种麝香。麝香鼠(麝香,muskrat)属于一种仓鼠科，学名为Ondatra zibethicus。与旅鼠或巢鼠长相差不多但身体非常大，身长约15-40cm，尾长约25cm。身上盖着柔和的灰褐色毛。嘴巴尖又长，眼睛小，尾巴上长着长毛。可适合水中生活，尾巴截面朝上下长椭圆形便于划水，并可调整方向。生活栖息地为水草茂盛的沼泽地和湖水，主活动期为春季到晚秋，冬天活动极少但不冬眠。麝香鼠作为草食动物主要摄取树皮、水草、芦根、白菜、红萝卜等，并用一雌一雄的方式饲养，但为了提取麝鼠香会把雄性分开饲养，并为了繁殖在研究如野生的一雄多雌的饲养方法。
雄性麝香鼠下腹部的香囊上通过副生殖腺分泌繁殖症状时的麝鼠香。
麝鼠香为肤色的液体并具有香味，出生后过两年的雄性麝香鼠上可提取麝鼠香。具体的提取对象为一般繁育的麝香鼠为主，从三月开始麝香囊变坚硬会进行一次提取，之后过15天为间隔到九月末提取年间8-10次。一般在一只麝香鼠身上可提取3-5g/年的麝鼠香，在麝香鼠身上提取麝香的技术人员必须是接受一定期间的教育而熟练的人。
麝鼠香的一般成分为水分8.46％、粗脂肪87.0％、灰分0.01％、总糖质0.024％以及蛋白质为1％，并含降香酮(normuscone)、麝香酮(muscone)、二氢灵猫酮(dihydrocivetone)、香猫酮(civetone)、灵猫醇(civetol)、二氢灵猫醇(dihydrocivetol)、二甲基(dimethyl)、辛烯基(octenyl)、环已烯酮(cyclohexenone)等多数香气成分。
本发明的作为有效成分含有所述麝鼠香保护脑神经细胞及预防、缓和或治疗脑部疾病的组合物能改善神经再生、抑制神经细胞的损伤、预防及治疗阿尔茨海默痴呆有着卓越的药效。
所述脑部疾病包括阿尔茨海默痴呆症、脑血管性痴呆症、(皮克病)、克雅氏病(Creutzfeldt-jakob)、因头部损伤的痴呆或铂金森病(Parkinson)，优选地包括阿默茨海默痴呆症、脑血管性痴呆症。所述脑部疾病可为从阿尔茨海默疾病发生的痴呆症。
本发明的组合物可进一步包括通常制造药学组合物时使用的适当的载体、赋形剂及稀释剂。
本发明的组合物分别根据通常的方法以散剂、颗粒、片剂、胶囊、悬浮液、乳胶、糖浆、气雾剂等形态通过口服、剂型、外用药、栓剂以及以灭菌注射溶液来剂型化使用，作为组合物的载体、赋形剂以及稀释剂可举，乳糖、葡萄糖、蔗糖、山梨糖醇、甘露醇、木糖醇、赤藓糖醇、麦芽糖醇、淀粉、洋槐树胶、藻酸盐、明胶、磷酸钙、硅酸钙、纤维素、甲基纤维素、微晶纤维素、聚乙烯吡咯烷酮、水、甲基羟苯酸酯、丙基羟苯酸酯、滑石粉、硬脂酸镁以及矿物油。要调制制剂化时一般使用填充剂、增量剂、结合剂、润湿剂、崩解剂、界面活性剂等的稀释剂或赋形剂来调剂。
口服固体制剂有片剂、丸剂、散剂、颗粒、胶囊等，这些固体制剂在所述提取物上混合一个以上的赋形剂来制造，例如，淀粉、碳酸钙(calcium carbonate)、蔗糖(sucrose)或乳糖(lactose)、明胶等并且，除了简单的赋形剂还可以使用镁、硬脂酸盐、滑石粉等的润滑剂。口服液态制剂有悬浮剂、內用液剂、油剂、糖浆等，但普遍使用的简单稀释剂为水、液体石蜡以外还包括各种赋形剂，例如润湿剂、甜味剂、芳香剂、保鲜剂等。用于非口服的制剂有灭菌的水溶液、非水性溶剂、悬浮剂、油剂、冻结干燥制剂、栓剂。作为水性溶剂、悬浮剂可使用丙二醇(propyleneglycol)、聚乙二醇、橄榄油等植物性油、油酸乙酯等可注射的酯。栓剂制剂有witepsol、聚乙二醇(witepsol)吐温(tween)61、可可豆脂、三月桂酸甘油酯、甘油明胶等。
本发明组合物的服用量为根据患者的状态、体重、疾病程度、药物形态、服用渠道及期间分别不同，但根据技术人员可适当调整。但为了最佳效果，本发明的组合物的服用量为以健康成年人为准一天1至1000mg/kg，最佳效果是50至500mg/kg。服用方法为一天一次或分着几次都可以。所述服用量为在任何方面不限定本发明的范围。
本发明的组合物可通过各种渠道适用于老鼠、家鼠、家畜、人等各种哺乳动物。服用方式为例如口服、直肠或静脉、肌肉、皮下、子宫内硬膜或通过脑血管内(intracerebroventricular)注射进行。
本发明的组合物里含有的麝鼠香为刚提取时粘度很高。因此，为了提高麝鼠香的保存性，在有机或无机溶剂里将麝鼠香的浓度以0.0001重量％至30重量％的浓度稀释后可冷藏保管。优选地溶剂可选肉豆蔻酸异丙酯。冷藏保管时由于粘度下降会发生悬浮，因此，在常温下放5-6小时后除掉稀释的麝鼠香的悬浮后可使用。
所述麝鼠香以0.0001至30％的浓度稀释，并稀释液可冷藏保管，冷藏保管的稀释液在常温下除掉悬浮后可使用。
本发明的组合物可通过提取的方法获取，提取时可利用本领域的常用方法即常温提取、加热提取、环流冷却提取或超声波提取等。溶剂为弱酸、弱碱、水、C1-C4的酒精或这些的混合溶剂的提取物，较优选地可为以弱酸或乙醇作为溶剂提取的提取物。更优选地选用以弱酸作为溶剂的超声波提取物。
所述麝鼠香进一步经过弱酸-超声波提取、低温处理以及离心分离的顺次执行阶段。所述弱酸包括柠檬酸、乳酸、苹果酸、醋酸、富马酸、葡萄糖酸等的有机酸以及无机酸，但不局限于此，优选的所述弱酸为KH2PO4。
所述麝鼠香进一步经过乙醇-超声波提取、离心分离以及真空浓缩的顺次执行阶段。此时提取的组合物可放于常温，然后进一步经过浓缩或冻结干燥等处理。
本发明的组合物可为混合麝鼠香10重量部、鹿茸65重量部、当归65重量部、山茱萸65重量部、红参65重量部以及蜂蜜180重量部的混合物。这些混合物可作成丸形制剂来使用，优选地在所述丸形制剂上涂抹具备1至400mm的粒度分布的纯金0.001至0.1重量部的共振丹形态来使用。
本发明的组合物可为混合麝鼠香10重量部、三七根40重量部的混合物，这些放入胶囊里以胶囊的形态使用。
本发明能以健康食品形态使用，该健康食品作为有效成分含有对脑功能以及认知功能有着改善效果的所述提取物。本发明的健康食品的形态包括片剂、胶囊、丸剂或液剂等，可以添加本发明的组合物的食品有例如各种食品类、饮料、口香糖、茶、维生素复合体、健康食品类等。
并且，改善脑功能及认知功能为目的可添加到食品或饮料。此时，食品或饮料中的所述组合物的量为占全体食品重量的0.01至15重量％，以100ml为准，以0.02至10g，优选地0.3至1g比率添加健康饮料组合物。
本发明的健康饮料为以指定的比率包含必须成分的所述提取物，除此之外，在液体成分没有特别的限制，与通常的饮料一样可包含多种香味剂或天然碳水化合物等附加成分。所述天然碳水化合物有例如单糖类，例如葡萄糖、果糖等的二塘，例如麦芽糖、蔗糖等脂多糖，例如糊精、环糊精等的通常的糖以及木糖醇、山梨醇、赤藓糖醇等的糖醇。
除了所述以外的香味剂也可使用天然香味剂(奇异果甜蛋白、甜叶菊提取物(例如，莱苞迪甙A，甘草酸等)以及合成香味剂(糖精、天冬甜素等)。相对于本发明的组合物100mg，所述天然碳水化合物的比率一般占1至20g，优选约5至12g。
除了所述以外，本发明的组合物还可以包括，多种营养剂、维生素、矿物(电解质)、合成风味剂以及天然风味剂等的风味剂、着色剂以及增进剂(奶酪、巧克力等)、果胶酸以及其盐，褐藻算以及盐，有机酸、保护性胶体增调剂、PH调节剂、稳定剂、防腐剂、甘油、酒精、用于碳酸饮料的碳酸剂等。此外，本发明的组合物还可以包括用于制造天然水果汁、水果果汁饮料以及蔬菜饮料的果肉。这些成分可以独立或组合使用。这些添加剂的比率可根据所需适当调整使用，在本发明的组合物100重量部上一般选择0至约20重量部的范围内。
本发明提供通过服用含有麝鼠香的组合物来保护脑神经细胞及预防、缓和或治疗脑部疾病的方法。所述脑部疾病包括，阿尔茨海默痴呆、脑血管性痴呆症、皮克病、克雅氏病(Creutzfeldt-jakob)、关于头部损伤的痴呆或铂金森病，优选地包括阿默茨海默痴呆症、脑血管性痴呆症。所述脑部疾病可为从阿尔茨海默疾病的痴呆症发生。
在所述治疗方法中，所述组合物里含有的麝鼠香为刚提取时粘度很高。因此，为了提高麝鼠香的保存性，在有机或无机溶剂里以0.0001重量％至30重量％的浓度稀释麝鼠香后可冷藏保管。优选地，溶剂可选肉豆蔻酸异丙酯。冷藏保管时由于粘度下降会发生悬浮，因此，在常温下放5-6小时后除掉稀释的麝鼠香的悬浮后可使用。
在所述治疗方法中，所述麝鼠香以0.0001至30％的浓度稀释，并稀释液可冷藏保管，冷藏保管的稀释液在常温下除掉悬浮后可使用。
在所述治疗方法中，本发明的组合物可为混合麝鼠香10重量部、鹿茸65重量部、当归65重量部、山茱萸65重量部、红参65重量部以及蜂蜜180重量部的混合物。这些混合物可作成丸形制剂来使用，优选地在所述丸形制剂上涂抹具备1至400mm的粒度分布的纯金0.001至0.1重量部的共振丹形态来使用。
在所述治疗方法中，本发明的组合物为混合麝鼠香10重量部、三七根40重量部的混合物，这些放入胶囊里以胶囊的形态使用。
发明效果
根据本发明的组合物有能改善记忆力及空间认知功能的效果，并保护脑神经细胞以及预防、缓和或治疗脑部疾病有着显著的效果。
具体实施方式
以下，根据以下制造例、实施例以及制剂例详细说明本发明。
但，以下的制造例、实施例以及制剂例并不限定本发明的范围，应解释为为了本发明的理解而提出的。
本制造例、实施例以及制剂例所使用的药材为栽培的，可在市中材料商上购买，使用的试药在适马，奥德里奇上购买的。
制造例1.麝鼠香样品制造
购买在饲养的麝香鼠20只((株)麝香国)的下腹部的香囊上提取的麝鼠香60g。提取的麝鼠香中将10g没有任何处理的状态下利用于样品。
制造例2.稀释的麝鼠香样品的制造
在所述制造例1中提取的麝鼠香60g中取30g利用肉豆蔻酸异丙酯(CASNO.110-27-0，FEMA.3556)稀释到麝鼠香1重量％的浓度，然后冷藏保管六小时，冷藏保管的稀释液再放到常温六小时，除掉悬浮后使用。
制造例3.精制麝鼠香样品的制造
在所述制造例2中稀释的麝鼠香样品30g中取20g混合到1.5M KH2PO4(PH 4.5)20ml后用超声波((株)J.M ultrasonic cleaner 4020,40KHZ)处理30分钟，然后在4℃低温下处理两个小时。结束所述低温处理后，在20,000rpm下进行离心分离20分钟后制造出精制的麝鼠香样品。
制造例4.精制麝鼠香样品提取物的制造
在所述制造例3中精制的麝鼠香样品20g中取10g混合到乙醇100g后用超声波处理30分钟后进行提取，然后将提取物在20,000rpm下进行离心分离20分钟后收集上等液。全部收集通过反复所述乙醇-超声波提取及离心分离5次获取的上等液后，为了除掉乙醇进行真空浓缩，然后获取精制的麝鼠香样品提取物。
制造例5.含有麝鼠香的共振丹的制造
在所述制造例1中提取的麝鼠香60g中使用10g混合鹿茸65g、当归65g、山茱萸65g、红参65g以及蜂蜜180g后制造450g的共振丹组合物。将所述共振丹组合物以每个4.5g的大小制造规定大小的球形丸100个。在制造的100个球形丸的每一个共振丹涂抹被细微粉碎成粒度分布100mm且纯度99％以上的纯金0.01g。
制造例6.含有麝鼠香的胶囊的制造
在所述制造例1中提取的麝鼠香60g中使用10g混合三七根40g制造胶囊组合物50g。所述胶囊组合物每个按500mg分到100个胶囊((Suheung capsule)，韩国)制造胶囊制剂。
制剂例1.片剂
含有制造例1的麝鼠香的组合物50g上混合乳糖175.9g、土豆淀粉180g以及胶体硅酸32g。在此混合物上添加10％明胶溶液后粉碎，然后通过14网眼后干燥，并且，添加土豆淀粉160g、滑石50g以及硬脂酸镁5g后获取的混合物可制造片剂。
制剂例2.注射剂
含有制造例1的麝鼠香的组合物50mg溶解到蒸馏水制造成100ml。将此溶液放入瓶后，在20℃的温度下加热30分钟进行灭菌，并根据常规的注射剂制造方法以所述成分含量制造每安瓶(2ml)。
制剂例3.健康食品
含有制造例1的麝鼠香的组合物1000mg上混合适量维生素混合物、维生素A醋酸酯70μg、维生素E 1.0mg、维生素B10.13mg、维生素B20.15mg、维生素B60.5mg、维生素B120.2μg、维生素C 10mg、生物素10μg、烟酰胺1.7mg、叶酸50μg,泛酸钙0.5mg、无机混合物适量、硫酸亚铁1.75mg、氧化锌0.82mg、碳酸镁25.3mg、磷酸二氢钾15mg磷酸盐55mg、柠檬酸钾90mg、碳酸钙100mg、氯化镁24.8mg按照现有健康食品的制造方法混合所述成分后制造颗粒，并制造健康食品组合物。
所述维生素及矿物质混合物组成比为比较适合健康食品成分的优选实施例的比率，但其配合比可任意变形。
制剂例4.健康饮料
含有制造例1的麝鼠香的组合物1000mg中混合柠檬酸1000mg、寡糖100g、维生素C 500mg、蔗糖10mg、精制水后根据现有健康饮料的制造方法混合全体900ml的所述成分后，在85℃温度下搅拌加热约一个小时，然后过滤所述溶液后放到灭菌处理的2□的容器里密封灭菌，经过冷藏保管可以制造本发明的健康饮料组合物。
组成比为适合各种饮料成分的优选实施例混合比，但根据需要阶层、需要国家、使用用途等地区、民族、嗜好可变形配合比。
实施例1.确认对脑损伤老鼠的麝鼠香的功效
实施例1-1.准备实验动物
实验动物将选至(株)大韩实验动物上购买的18至20g的雄性ICR老鼠45只，具体地，将各组包括5只分开放到罐笼里投放充分的水和饲料后，实验期间将温度(24±1℃)、相对湿度(55±5％)以及能调整明暗(06:00-18:00,light)的条件下饲养。动物分别分为无处理群、乙醇群、他克林群以及制造例1至制造例6群的9个群。
实施例1-2.被动回避实验(Passive avoidance test)
为了观察制造例1至6的组合物对记忆和学习效果进行被动回避实验。此实验利用动物本能地钻进黑暗地方的习性，钻进黑暗地方后给予电刺激，使动物钻不进去黑暗地方，然后测定根据电刺激的短期记忆力。
进行被动回避实验前4天，对除无处理群和乙醇群之外的其他7个群体上一天一次经口服用他克林以及制造例1至制造例6的物质。用药最后一天第四天给予他克林及制造例1至制造例6的组合物后30分钟后，将用于损伤老鼠的记忆力的乙醇经口服用给除无处理群的其他8个群上。
被动回避实验在具有同样的构造、各房噪音为60dB以下，有照明的房间与无照明的房间(宽20cm、长20cm、高20cm)用截止门(guillotin door)连接的装置下进行(Jungdo Bio&Plant Co.Ltd，Seoul，Korea)。将老鼠放到有照明的房间10秒钟后打开房间门以便进到黑暗的房间，此时测定进到黑暗房间所耗的时间(学习试验；acquisition trial)老鼠进到黑暗房间后门会自动关闭，并通过地板上的铁网(stainless grid)以0.6mA电流电刺激5秒钟。
通过所述学习试验后为了确认本发明的组合物影响于长期记忆的认知功能恢复效果，经过24小时后将老鼠重新放到照明房间，并测定进入受到电刺激的黑暗房间所耗的时间(step-through latencytime:到达时间)为300秒(保持试验:retention trial).进入黑暗房间的时间越长表示被动回避的学习和记忆越好。表1表示其结果。
【表1】
| 样品 | 学习试验的到达时间(s) | 保持试验的到达时间(s) |
| 无处理群 | 25 | 254 |
| 乙醇 | 12 | 21 |
| 他克林+乙醇 | 20 | 85 |
| 制造例1+乙醇 | 25 | 250 |
| 制造例2+乙醇 | 27 | 243 |
| 制造例3+乙醇 | 25 | 247 |
| 制造例4+乙醇 | 24 | 251 |
| 制造例5+乙醇 | 23 | 248 |
| 制造例6+乙醇 | 26 | 238 |
如表1所示，经口服用本发明制造例1至6的组合物的群比乙醇服用群在学习试验及维持实验中到达时间明显增加。这比他克林群也能看出明显的数值，可以确认本发明制造例1至6的组合物比他克林有着明显改善学习和认知功能的效果。此现象是由于服用含有本发明的麝鼠香的组合物比他克林明显减少老鼠的记忆力损伤程度有关。并且，能确认出乙醇用药群的学习试验及保持试验到达时间比无处理群明显减少，这是显示实验动物进入受到电刺激的黑暗房间的时间越长被动回避的学习和认知功能越好的现象，并能确认实验按正常进行。
实施例1-3水迷宫实验(Morris water-maze test)
水迷宫实验是为了测定本发明的组合物对实验动物的空间感觉能力及短期、长期记忆力恢复影响程度的实验。
进行水迷宫实验前4天，除了无处理群和乙醇群，在其他7个群体上一天一次经口服用他克林以及制造例1至制造例6的物质。用药最后一天第四天给予他克林及制造例1至制造例6的组合物后30分钟后，将用于损伤老鼠的记忆力的乙醇经口服用给除无处理群的其他8个群上。
水迷宫装置为装满不透明水的水箱里(直径120cm，高45cm)投放水(水温22±2℃)32cm，在四分面的一个区域里设置逃避架(escape platform，直径10cm，高度30cm)至水面2cm下方位置，并投放脱脂奶粉以便看不清晰。实验进行五天，并一天三次在不同的三个地方入水，使得最小化偶然找到逃避架的可能性。实验动物找到逃避架停留10秒以上时，找逃避架所耗的时间定为逃避时间(escape latency)，并一天实施3次后将平均值定为平均逃避时间(mean escape latency)。水-迷宫实验是实验动物记住水槽周边的标志物来找到位置的实验，因此，为了保持周边环境，在实验期间将标志物的位置保持到一定位置，若在120秒钟内找不到逃避架，则将实验动物引诱到逃避架，并且停留10秒钟以便记住位置。
实验最后一天除掉逃避架后，进行在逃避架的位置设置测定停留时间(时间平台象限)的探头测试。其结果如表2所示。
【表2】
| 样品 | 平均逃脱时间(s) | 四分面滞留时间(s) |
| 无处理群 | 21 | 38 |
| 乙醇 | 121 | 18 |
| 他克林+乙醇 | 56 | 28 |
| 制造例1+乙醇 | 35 | 34 |
| 制造例2+乙醇 | 32 | 35 |
| 制造例3+乙醇 | 31 | 35 |
| 制造例4+乙醇 | 29 | 32 |
| 制造例5+乙醇 | 32 | 31 |
| 制造例6+乙醇 | 33 | 33 |
如表2所示，经口服用本发明的制造例1至6的组合物的群比乙醇群明显减少平均逃避时间，并且，除掉逃避架后停留在逃避架的四分面的时间为明显增加。这与他克林群比较时也能看出明显的数值，可以确认本发明制造例1至6的组合物比他克林有着明显改善学习和认知功能的效果。此现象是由于服用含有本发明的麝鼠香的组合物比他克林明显减少老鼠的记忆力损伤程度有关。并且，能确认出乙醇用药群比无处理群增加平均逃避时间，并减少四分面停留时间，这是显示实验动物找到逃避架所耗的时间越短，即记住逃避架所在位置的时间越长短期记忆力与空间认知功能越好的现象，并能确认实验按正常进行。
实施例2.确认麝鼠香对于记忆力减退、语言障碍及忧郁症的麝鼠香的功效确认
患有记忆力减退、语言障碍以及忧郁症的男女各21名共42名为对象各群男女患者各3名共6名，一共分为7个组，除了无处理群，其他6个组分别一天一次服用本发明的制造例1至6的组合物，一周后实施患者症状好转程度的评价。评价项目为记忆力的恢复程度、语言能力的恢复程度以及忧郁症的改善程度，症状评价评分以无处理群为准1分(与无处理群一样)至5分(比无处理群有好转)，使用5分制。其结果如表3所示。
【表3】
| 样品 | 记忆力恢复程度 | 语言能力恢复程度 | 忧郁症改善程度 |
| 无处理群 | 1 | 1 | 1 |
| 制造例1 | 3.2 | 3.3 | 3.8 |
| 制造例2 | 3.8 | 3.4 | 4.1 |
| 制造例3 | 4.0 | 3.3 | 3.7 |
| 制造例4 | 3.3 | 4.2 | 3.8 |
| 制造例5 | 3.3 | 3.6 | 4.0 |
| 制造例6 | 3.7 | 3.6 | 3.6 |
如所述表3所示，可以看出服用含有本发明的麝鼠香的组合物比无处理群有着明显改善记忆力恢复、语言能力恢复及忧郁症的效果。因此，本发明的含有麝鼠香的组合物对保护脑神经及痴呆等的脑部疾病有着预防、缓和及治疗的优秀功效。
因此，本发明的组合物对于改善神经再生、抑制神经细胞的损伤、阿尔茨海默痴呆的预防及治疗有着卓越的药效。
Claims (11)
1.一种保护脑神经细胞、预防及缓和或治疗脑部疾病的组合物，其中，作为有效成分含有麝鼠香。
2.根据权利要求1所述的组合物，其中，所述脑部疾病为痴呆症。
3.根据权利要求1所述的组合物，其中，所述痴呆症为从阿尔茨海默疾病所发生。
4.根据权利要求1所述的组合物，其中，所述麝鼠香为以0.0001至30重量％的浓度稀释。
5.根据权利要求1所述的组合物，其中，相对于麝鼠香10重量部，混合鹿茸65重量部、当归65重量部、山茱萸65重量部、红参65重量部以及蜂蜜180重量部。
6.根据权利要求5所述的组合物，其中，所述组合物为丸形态。
7.根据权利要求6所述的组合物，其中，所述丸为涂抹纯金0.001至0.1重量部的共振丹，所述纯金的粒度分布为1至400mm。
8.根据权利要求1所述的组合物，其中，所述组合物相对于麝鼠香10重量部含有三七根40重量部。
9.一种包含权利要求8所述的组合物的胶囊制剂。
10.一种保护脑神经细胞、预防或改善脑部疾病的健康食品，其中，作为有效成分含有麝鼠香。
11.一种保护脑神经细胞、预防或改善脑部疾病的饮料，其中，作为有效成分含有麝鼠香。
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| KR1020120099541A KR101476750B1 (ko) | 2012-09-07 | 2012-09-07 | 머스크랫의 사향을 함유하는 뇌신경세포 보호 및 뇌질환 예방, 완화 또는 치료용 조성물 |
| KR10-2012-0099541 | 2012-09-07 | ||
| PCT/KR2013/008045 WO2014038878A2 (ko) | 2012-09-07 | 2013-09-06 | 머스크랫의 사향을 함유하는 뇌신경세포 보호 및 뇌질환 예방, 완화 또는 치료용 조성물 |
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| CN111991423A (zh) * | 2020-09-30 | 2020-11-27 | 中国农业科学院特产研究所 | 一种鹿茸醇提取物的制备方法及其应用 |
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| KR20140032805A (ko) | 2014-03-17 |
| US20150238539A1 (en) | 2015-08-27 |
| KR101476750B1 (ko) | 2014-12-26 |
| WO2014038878A3 (ko) | 2014-05-08 |
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