CN104474251B - 具有健脑固本功能的组合物及其制剂和应用 - Google Patents
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Abstract
本发明公开了具有健脑固本功能的组合物及其制剂和应用，组合物按重量份计由党参9‑30份、熟地黄9‑30份、麦冬6‑20份、生枣仁10‑15份、远志3‑10份、山茱萸6‑12份、茯神10‑15份和菖蒲3‑10份组成，配方合理，均采用药食两用中药，安全性好，具有健脑补血、益智、益气健脾肾的成分，能够用于健脑固本。
Description
技术领域
本发明属于保健品，具体涉及具有健脑固本功能的组合物，还涉及以该组合物为有效成分的制剂和该制剂的应用。
背景技术
记忆功能减退是轻度认知损害的标志症状，也是老年性痴呆的最早期症状和必要特征。随着人类平均寿命的不断延长和人口增长率的逐步减低，世界人口老龄化趋势日益明显，有资料表明我国已初步进入老龄化社会。伴随老龄化的进程，尤以脑功能老化而出现学习记忆和认知功能障碍最为显著，严重影响老年人的生活质量。延缓衰老、保证老年人的生活质量已成为全社会关注的一个重点问题。改善记忆功能可以在一定程度上扭转脑老化的发展趋势，对痴呆等脑功能减退性疾病的防治，具有防微杜渐的作用。传统中医药在改善记忆、增智健脑等方面具有数千年的历史，积累了大量行之有效的实践经验。中医认为脾肾两虚、元气不足、痰蒙清窍是AD的主要病理病机之一，固本培元、脾肾双补、化痰开窍法是防治老年性痴呆的有效方法。因此，运用中医药特有的理论体系和思维方法防治健忘，已经成为一种潮流。
现有技术中也有较多改善记忆力的保健品，虽然能够获得一定的效果，但是效果甚微，仍需探索更好的中药配方，以提高人们的健康水平，改善人们的生活。
发明内容
有鉴于此，本发明的目的之一在于提供具有健脑固本功能的组合物，配方合理，具有改善记忆、益智的功能；本发明的目的之二在于提供具有健脑固本功能的组合物的提取物；本发明的目的之三在于提供该提取物的制备方法；本发明的目的之四在于提供以组合物或提取物为有效成分的制剂；本发明的目的之五在于提供组合物、提取物或制剂的应用。
为实现上述发明目的，本发明提供如下技术方案：
1、具有健脑固本功能的组合物，按重量份计由党参9-30份、熟地黄9-30份、麦冬6-20份、生枣仁10-15份、远志3-10份、山茱萸6-12份、茯神10-15份和菖蒲3-10份组成。
优选的，按重量份计由党参30份，熟地30份，麦冬20份，生枣仁15份，远志10份，山茱萸12份，茯神15份和菖蒲10份组成。
本发明中党参性味甘、平，入脾、肺经，健脾益肺，养血生津。用于脾肺气虚，气血不足，面色萎黄，心悸气短。是补气健脾之要药。
所述熟地黄性微温，味甘，入经肝经、肾经，补血滋润；益精填髓。主要用于血虚萎黄，心悸怔忡，肝肾阴虚，腰膝酸软，耳鸣耳聋，头目昏花，眩晕，耳鸣，须发早白。
所述麦冬性微苦、甘，微温，归脾，胃，肝经，养阴生津，润肺清心。用于津伤口渴，内热消渴，心烦失眠，肠燥便秘。
所述生枣仁性甘、酸，平，归肝、胆、心经，有养心补肝，宁心安神，敛汗，生津的功效。用于虚烦不眠，惊悸多梦。
所述远志性味苦、辛，温。归心、肾、肺经，具有安神益智的功能，用于心肾不交引起的失眠多梦、健忘惊悸、神志恍惚。
所述山茱萸味酸、涩，微温，归肝、肾经，具有补益肝肾，收涩固脱的功效。用于腰膝酸痛，头晕耳鸣，健忘，腰膝酸痛等。
所述茯神性味甘、淡平。归心、脾经，有健脾、宁心、安神等功能。用于健忘、失眠。
所述菖蒲味辛、苦，温。归心、胃经，具有开心窍、益心智、安心神、聪耳明目开窍豁痰，醒神益智，化湿开胃。用于神昏癫痫，健忘失眠，耳鸣耳聋等。治健忘证，菖蒲常与党参、茯苓、远志等配伍。
2、所述具有健脑固本功能的组合物的提取物。
3、所述提取物的制备方法，取药材，加水浸泡30分钟，煎煮3次，第1次加水量相当于中药材总重量的10倍，煎煮1小时，过滤，收集滤液；第2次加水量相当于中药材总重量的8倍，煎煮1小时，过滤，收集滤液；第3次加水量相当于中药材总重量的8倍，煎煮1小时，过滤，收集滤液，合并三次滤液，浓缩，得提取物。
4、以所述的组合物或权利要求3所述的提取物为有效成分的制剂。
优选的，所述制剂为口服液、颗粒剂、胶囊剂或片剂。
5、所述的组合物或所述的提取物或所述的制剂在制备健脑固本的保健品中的应用。
优选的，所述健脑固本为改善记忆或/和益智。
本发明的有益效果在于：本发明公开了具有健脑固本功能的组合物，配方合理，完全采用药食两用中药，安全性好，并且组合物中含有多种氨基酸、植物蛋白、维生素等营养成分，具有健脑补血、益智、补气的成分，能达到调和气血、健脑固本、调节内分泌、滋补肝肾等的功效，能够用于制备健脑固本的保健品，并且效果好。
具体实施方式
下面将结合优选实施例对本发明进行详细的描述。实施例中未注明具体条件的实验方法，通常按照常规条件或按照制造厂商所建议的条件。
实施例1
具有健脑固本功能的组合物，具体组分如下：
高剂量组：党参30g，熟地30g，麦冬20g，生枣仁15g，远志10g，山茱萸12g，茯神15g和菖蒲10g。
低剂量组：党参9g、熟地黄9g、麦冬6g、生枣仁10g、远志3g、山茱萸6g、茯神10g和菖蒲3g。
为方便使用，可以将具有健脑固本功能的组合物制备成常规制剂，如口服液、颗粒剂、胶囊剂、片剂等。
口服液的制备方法为：按处方取药材，加水浸泡30分钟，煎煮3次，第1次加水量相当于中药材总重量的10倍，煎煮1小时，过滤，收集滤液；第2次加水量相当于中药材总重量的8倍，煎煮1小时，过滤，收集滤液；第3次加水量相当于中药材总重量的8倍，煎煮1小时，过滤，收集滤液，合并三次滤液，浓缩成250ml的药液(高剂量生药142g；低剂量生药56g)，50ml分装5瓶，4℃冰箱储存备用。
胶囊剂的制备方法为：按处方称取药材，洗净，晾干，加水煎煮3次，第1次加水量是中药材总量的10倍，煎煮1小时，过滤，收集滤液；第2次加水量是中药材总量的8倍，煎煮1小时，过滤，收集滤液；第3次加水量是中药材总量的8倍，煎煮1小时，过滤，收集滤液，合并三次滤液，浓缩至相对密度1.1～1.3的浸膏，然后加入辅料制成胶囊制剂，每粒装0.5g。
实施例2
具有健脑固本功能的组合物的小鼠记忆功能评价：
将50只昆明小鼠，小鼠随机分为5组。分别为正常组(生理盐水)，模型(东莨菪碱)组，奥拉西坦组(105mg·kg-1)，低剂量组和高剂量组。给药前药物用生理盐水稀释，给药剂量换算为10ml·kg-1，均采用腹腔注射。正常组按10ml·kg-1注射生理盐水，模型组按2mg·kg-1注射东莨菪碱，奥拉西坦组按105mg·kg-1注射奥拉西坦，低剂量组按650mg·kg-1注射低剂量具有健脑固本功能的组合物药液、高剂量组按1650mg·kg-1注射低剂量具有健脑固本功能的组合物药液，每日一次，连续注射30d。
1、水迷宫记忆训练与测试
实验前，连续三天进行Morris水迷宫训练与测试，淘汰出逃避潜伏期有显著差异的小鼠后。除正常组注射生理盐水外，其余均注射丁溴东莨菪碱造成小鼠记忆障碍模型，注射量为2mg·kg-1；低剂量组和高剂量组在注射丁溴东莨菪碱前分别灌服低剂量具有健脑固本功能的组合物药液和高剂量具有健脑固本功能的组合物药液、奥拉西坦组注射丁溴东莨菪碱前按105mg·kg-1注射奥拉西坦，然后进行水迷宫测试。Morris水迷宫由圆形水池和自动录像及分析系统两部分组成，圆形水池(直径80cm，高30cm)加水后用黑墨水滴成黑色使水不透明，且将迷宫均分为4个象限，水温保持在25℃左右。另有一个黑色圆形平台(直径10cm，高28cm)，置于某一个象限中央，位于水面下1～2cm左右。测试时，选择象限作为入水点，将小鼠面向池壁放入水中，根据水迷宫跟踪系统记录动物寻找并爬上平台所需时间即逃避潜伏期(escape latency)，120s内未找到平台则将动物引至平台，逃避潜伏期记为120s。实验进行三天，每只小鼠每天训练4次(包括4个象限入水点)，每次训练间隔将小鼠放在平台上停留10s，然后统计数据，数据采用均数±标准差表示，采用SPSS11.0统计软件进行分析，结果如表1所示。
表1、具有健脑固本的保健品对小鼠水迷宫实验逃避潜伏期的影响
结果显示，与正常组相比，使用2mg·kg-1东莨菪碱后，小鼠的平均逃避潜伏期明显延长(106.27±29.67 vs 88.27±28.48，p<0.05)，表明2mg·kg-1东莨菪碱成功引起小鼠学习记忆障碍；经药物治疗后，与模型组比较，奥拉西坦组第2d小鼠的逃避潜伏期均显著缩短(p＜0.05)，奥拉西坦、低剂量组和高剂量组第2d和第3d小鼠的逃避潜伏期剂量依赖性地较模型组显著缩短(p<0.05)，但仍未达到正常组水平，与正常组比较，逃避潜伏期长，具有显著性差异(p<0.05)。第3d时，高剂量组与奥拉西坦组比较，小鼠的逃避潜伏期无显著性差异(p>0.05)。由此可以得出，本发明的组合物能够改善小鼠的记忆力，并且高剂量组的效果优于低剂量组的效果。
2、检测脑BDNF、ChAT、AchE和Ach含量
水迷宫测试结束后，将各组小鼠快速断头取脑，于冰盘上分离大脑皮质和海马，精确称重，将皮质与海马用生理盐水按1：9制成10％冰浴匀浆，4000rpm离心10min，取上清液作为待测样品备用。按照ELISA试剂盒说明书实验步骤测定Ach(乙酰胆碱)和BDNF(脑源性神经营养因子)含量；按照ChAT(胆碱乙酰转移酶)、AchE(乙酰胆碱酯酶)检测试剂盒说明书实验步骤测定ChAT和AchE含量，数据采用均数±标准差表示，采用SPSS11.0统计软件进行分析，结果如表2所示。
表2、具有健脑固本功能的组合物对小鼠皮层与海马BDNF、ChAT、AchE、Ach的影响
由表2可知，与模型组相比，高剂量组、低剂量组和奥拉西坦组小鼠大脑皮质和海马BDNF含量与模型组相比均显著性增加(p<0.05)，但与正常组比较无显著性差异(p>0.05)；奥拉西坦组和高剂量组、低剂量组ChAT含量均较模型组显著升高(p<0.05)，但AchE含量仅有奥拉西坦组显著下降；Ach含量检测结果显示奥拉西坦组和高剂量组、低剂量组均较模型组有显著升高(p<0.05)，但与正常组比较无显著性差异(p>0.05)。
根据上述结果可以推测，本发明改善记忆可能机制：(1)组合物对大脑皮层与海马区乙酰胆碱通路的调节作用有关，即与抑制乙酰胆碱酯酶，减少乙酰胆碱分解，增加乙酰胆碱合酶，促进乙酰胆碱合成有关；(2)组合物对大脑皮层与海马区脑源性神经营养因子BDNF上调有关。
实施例3
具有健脑固本功能的组合物的应用：
选择确诊为痴呆患者10名，男4名，女6名，平均年龄65岁。主要表现为近期记忆力减退，并渐进加重，5例患者出现思维迟钝，注意力难以集中，动作笨拙，伴有不同程度的情绪异常。采用西医治疗，效果不明显，后改用中药治疗，采用该方药汤剂治疗1月，6例显效，近期记忆力改善，3例情绪得到控制；后期采用本方提取物制备的胶囊，1.0g，qdx3次，巩固服用一月后，10名患者上述症状均有不同程度好转。
其中，王xx，男，56岁，近一年来记忆力明显减退，尤其是近期记忆力减退明显，常有失眠现象，每晚口服安定1片才能入睡，患有高血压，脑动脉硬化，空腹血糖高于正常，为7.5mmol/L。予上述方法制备的胶囊，1.0g，qdx3次，服用一月后，记忆力减退明显得到改善，睡眠良好，安定剂量减半，逐渐递减，10d递减1/2的量，1月后撤掉安定口服药，睡眠仍然维持6h。空腹血糖控制在6.5～7.0之间。
最后说明的是，以上优选实施例仅用以说明本发明的技术方案而非限制，尽管通过上述优选实施例已经对本发明进行了详细的描述，但本领域技术人员应当理解，可以在形式上和细节上对其作出各种各样的改变，而不偏离本发明权利要求书所限定的范围。
Claims (8)
1.具有健脑固本功能的组合物，其特征在于：按重量份计由党参9-30份、熟地黄9-30份、麦冬6-20份、生枣仁10-15份、远志3-10份、山茱萸6-12份、茯神10-15份和菖蒲3-10份组成。
2.根据权利要求1所述具有健脑固本功能的组合物，其特征在于：按重量份计由党参30份，熟地30份，麦冬20份，生枣仁15份，远志10份，山茱萸12份，茯神15份和菖蒲10份组成。
3.权利要求1或2所述具有健脑固本功能的组合物的提取物。
4.权利要求3所述提取物的制备方法，其特征在于：取药材，加水浸泡30分钟，煎煮3次，第1次加水量相当于中药材总重量的10倍，煎煮1小时，过滤，收集滤液；第2次加水量相当于中药材总重量的8倍，煎煮1小时，过滤，收集滤液；第3次加水量相当于中药材总重量的8倍，煎煮1小时，过滤，收集滤液，合并三次滤液，浓缩，得提取物。
5.以权利要求1～2任一项所述的组合物或权利要求3所述的提取物为有效成分制成的制剂。
6.根据权利要求5所述的制剂，其特征在于：所述制剂为口服液、颗粒剂、胶囊剂或片剂。
7.权利要求1～2任一项所述的组合物或权利要求3所述的提取物或权利要求5～6任一项所述的制剂在制备健脑固本的保健品中的应用。
8.根据权利要求7所述的应用，其特征在于：所述健脑固本为改善记忆或/和益智。
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