CN111939237B - 一种改善记忆的组合物及其制备方法 - Google Patents
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Abstract
本发明提供了一种具有改善记忆保健功能的药食同源的保健食品。该组合物由刺五加等多味中药材组成,通过动物试验证明,本品安全无毒,经人群试验证实本品在改善记忆方面取得了很好的效果,适宜推广应用。
Description
技术领域
本发明涉及一种改善记忆的组合物及其制备方法,该组合物中所含成分都为可用于保健食品的物品名单中所列品种,属于药品保健品相关领域。
背景技术
记忆是人脑对过去经历和发生过的事物的重现,包括铭记、保持、回忆与认知(再现)的过程,在这个过程中对事物进行分类、概括、对比,联系等加工。因此,回忆是人脑对以往经历事物经加工后的再现,故有部分或完全性失真或错误。 临床工作中可按回忆时间的长短将记忆分为以下3种: ①即刻记忆(immediate memory):指对事物仅能保持不到1分钟的记忆,一般易遗忘。给被检查者一串数字后请其背出或倒背出。受试者必须注意力正常,能处理的信息容量有限,仅7位数左右。 ②近事记忆(recent memory):对几分钟至几天内事物的记忆, ③远事记忆(remote memory):对几个月至多年前事物的记忆。
常见的记忆障碍表现为:
1.记忆增强(hypermnesia),临床常见轻躁狂患者联想加速,“过目不忘”,而且对平时不能回忆的往事细节也能回忆起来,抑郁障碍患者也存在类似情况,主要表现为对既往细小过错的记忆犹新,病情缓解后以上现象消失。
2.记忆减弱(hypomnesia),记忆过程全面的功能减退,最常见于脑器质性精神障碍如痴呆患者,也可见于正常老年人。
3.遗忘(amnesia),对某一事件或某段经历不能回忆,称为回忆空白,可保留再认功能,分为顺行性遗忘,逆行性遗忘,进行性遗忘,心因性遗忘,前两类多见于脑损伤,进行性遗忘主要见于痴呆,心因性遗忘具有选择性遗忘的特点,即所遗忘的事情选择性地限于痛苦经历或可能引起心理痛苦的事情,多在重大心理应激后发生,常见于分离性障碍,急性应激障碍(acute stress disorder)等。
4.错构(paramnesia),一种记忆错误,患者在回忆自己亲身经历的事件时,对地点尤其是时间的记忆出现错误或混淆,如将此时间段内发生的事情回忆成在另外时间里发生的。
5.虚构(confabulation),也是一种记忆错误,患者对某段亲身经历发生遗忘,而用完全虚构的故事来填补和代替之,随之坚信,有些患者所谈内容大部分为既往记忆的残余,在提问者的诱导下串联在一起,丰富生动又显得荒诞不经,但转瞬即忘,临床上称为虚谈症,多见于脑器质性精神障碍如痴呆患者和慢性酒中毒性精神病。
6.潜隐记忆(kryptomnsia),又称歪曲记忆,患者将别人的经历以及自己曾经的所见所闻回忆成自己的亲身经历,或者将本人的真实经历回忆成自己所见所闻的别人经历。
造成记忆障碍(memory disorders)的疾病很多,脑部各种变性病(如Alzheimer病),脑外伤和拳击手痴呆;皮质下动脉硬化性脑病,腔隙性梗塞,脑梗塞和脑出血等脑血管病后;脑炎后;一氧化碳中毒等脑缺氧后;营养缺乏性脑病(如Wernicke脑病);酒精中毒和生化代谢障碍性脑病等均可引起,记忆障碍是一个复杂的病理过程,上述任何一原因累及额叶,颞叶,海马回,丘脑,扣带回,间脑和中脑网状结构等均可有记忆障碍,精神病患者也有记忆障碍。
学习、记忆障碍属于中医“健忘”范畴,春秋战国时期《素问·五常政大论》将其称之为“善忘”、“喜忘”,隋代巢元方《诸病源候论》称其为“多忘”,唐代孙思邈《千金要方》曰其“好忘”,至宋《太平圣惠方》以“忘”命名沿用至今。中医学认为,肾藏精生髓而上通于脑。脑居颅内,由髓汇聚而成,李时珍将脑称为“元神之府”,人之记忆存在于脑中。林佩琴于《类证治裁·健忘》就认为“脑为元神之府,精髓之海,实记性所凭也”,王清任在《医林改错》也明确提出:“灵机记性不在心,在脑”,可见脑为神机之源,一身之主,参与神经、意识、思维活动,司感觉、知觉和记忆。《医林改错》提出“小儿无记性者,脑髓未满;高年无记性者,脑髓渐空”。说明脑主神的物质基础是脑髓。只有脑髓充足,脑神得养,脑的听、嗅、视觉及精神活动才能正常发挥作用,反之就会出现障碍。《类证治裁》亦指出:“夫人之神,宅于心,心之精依于肾,而脑为元神之府,精髓之海,实记性所凭也。”唐容川在《中西汇通医经精义》中也说:“事物之所以不忘,赖此记性,记在何处,则在肾精。益肾生精,化为髓,而藏之于脑中”。因此可见“健忘”病位在脑,与脑髓、肾精的充盛密切相关。
由于先天禀赋不足,精血亏损,脑髓失养,则心无所虑,神无所依,神机失控而使理智活动能力下降,记忆减退。正如《见闻录》指出“人之记性,皆在脑中。小儿善忘者,脑未满也,老人健忘者,脑渐空也。”或因后天失养、七情内伤、久病耗损、年老神衰,或久服某种药物导致气、血、痰、瘀等病邪为患,导致精血不足,髓海失聪。《黄帝内经》中记载“上气不足”,“邪轻心火”,“肾盛怒不止则伤志,志伤则喜忘所言”,“血并于下,气并于上,乱而善忘”,不难看出古代医家已认识到“健忘”与精、气、血、阴的亏虚有重要关系。
目前尚无有效的方法治疗记忆障碍。含卵磷脂食品、神经递质的前体、利他林、双氢麦角碱类的扩血管药等疗效难定。记忆功能的训练有一定帮助。记忆恢复决定于病变性质、部位、严重和广泛程度。急性疾病如脑外伤和分脑炎,治疗后记忆功能一般在6~12月恢复。
一年后恢复机会很少。维生素B1缺乏造成Wernicke脑病,早期用维生素B1治疗记忆会恢复。慢性器质性疾病造成的记忆障碍一般恢复很困难。假性痴呆的精神源性遗忘可通过精神治疗获得好转。
经检索发现,临床上应用刺五加、人参、益智仁等原料相互配伍制成的药物在治疗智力障碍方面均获得一些疗效。但多用于治疗老年期血管性痴呆。如何通过合理的配伍选用合适的计量达到治疗和预防学习、记忆障碍,目前还没有好的治疗方法。
发明内容
根据学习、记忆障碍中医病因病机分析论治,发明人认为,脑神失养为健忘之关键病机,本虚标实,虚实夹杂。基于上述病机认识,以益气生津、补肾填精、健脑益智为主要治疗原则,发明人提供了一种可以改善记忆障碍的保健食品,采用人参大补元气、安神益智,刺五加、益智仁益气养神、补肾固精,五味子益气生津、滋肾健脑,诸药合用,共达标本兼治,以达到恢复正气,改善学习、记忆的治疗目的。
方中君药人参,味甘、微苦、平,归脾、肺、心经。具有大补元气,复脉固脱,补脾益肺,安神益智的功效。最早见于《神农本草经》列为上品,谓其:“主补五脏,安精神,止惊悸,除邪气,明目,开心益智。”古称“为治虚劳内伤第一要药”《药性论》亦记载了人参:“主五脏气不足,五劳七伤,虚损瘦弱……补五脏六腑,保中守神”。《滇南本草》曰其:“治阴阳不足,肺气虚弱”。现代研究表明人参的主要生理活性成分是人参皂苷,人参皂苷对中枢神经系统的调节作用主要表现在对兴奋神经的促进与抑制作用,使之趋于平衡,可提高人体记忆力,抗老年痴呆,减轻人体疲劳。此外,人参在提升免疫力、抗肿瘤、改善心血管、抗氧化、抗衰老、抗老年痴呆等多个方面发挥显著作用。
臣药刺五加,辛、微苦,温,入脾、肾、心经。具有益气健脾、补肾安神、活血通络的功效。《神农本草经》将其列为上品,谓其“补中益精,坚筋骨,强志意,久服轻身耐老”。《太清经》记载久服“令人耳目聪明,齿落更生,发白更黑,身体轻健”。《本草纲目》谓其:“添精补髓,久服延年益老”,且可“健气力、不忘事”,同时益气健脾,与君药人参配伍,加强补益后天之本,培护先天之精的作用,兼以活血通络,针对痰瘀等病理产物阻滞络脉,发挥络脉通畅,精气血上濡脑髓,精神充沛,记忆恢复的作用。现在研究结果显示刺五加含有刺五加甙、胡萝卜甙、丁香甙等,具有改善空间学习能力,提高记忆力的作用。
臣药益智仁,辛,温,入脾,肾经。补肾固精,行阳退阴补肾精不足,暖肾固精,《本草经疏》谓其:“益智子仁,以其敛摄,故治肾气不固之证也……敛摄脾肾之气”,《本草拾遗》载其:“益气安神,补不足,利三焦,调诸气”,王好古则谓其:“益脾胃,理元气,补肾虚”,藏纳归源,对于肾精不足所致智能减退,思维迟钝、遇事多忘,懈惰思卧者均有显效,与君药合用加强填精益髓,养精固肾的功效。现代研究显示益智仁中主要含有萜类、黄酮类、二苯庚烷类、甾醇类、酚类等。可以明显抑制神经元乙酰胆碱酯酶的活性,提高模型大鼠脑部蛋白质的含量,促进记忆障碍功能恢复。
佐药五味子性酸、甘,味温。归肺、心、肾经。具有收敛固涩,益气生津,补肾宁心的功效。《神农本草经》:“主益气,咳逆上气,劳伤羸度,补不足,强阴,益男子精。”晋《抱朴子》记载“常服能返老还童、延年益寿。”李杲谓其:“生津止渴。治泻痢,补元气不足,收耗散之气。”《名医别录》:“养五脏,除热,生阴中肌。”明《本草纲目》记载:“补虚劳,令人身体悦泽、明目。”现代研究表明五味子含有五味子甲素、五味子酚、五味子酯戊、五味子醇甲、五味子醇乙等主要成分,具有改善记忆、保护神经细胞、镇静安神等作用。
现代社会生活压力大,生活节奏快导致大量的年轻人出现记忆功能障碍;学业繁重,学习压力过大导致的学生出现的记忆功能障碍;脑器质性精神障碍多发的老年患者,大量的患者急需一种可以日常服用的,副作用小的保健食品用于改善记忆。本发明目的是提供一种具有改善记忆保健功能的药食同源的保健食品,由于其采用的药材都属于药食同源,因此可以用于日常服用。
该组合物由以下重量份的中药材组成:
刺五加640-960份;人参214-320份;益智仁214-320份;五味子142-214份。
优选的,该组合物由如下重量份的中药材制成:
刺五加640份;人参320份;益智仁214份;五味子214份。
优选的,该组合物还可以由如下重量份的中药材制成:
刺五加960份;人参214份;益智仁320份;五味子142份。
优选的,该组合物也可以由如下重量份的中药材制成:
刺五加800份;人参267份;益智仁267份;五味子178份。
优选的,该组合物也由如下重量份的中药材制成:
刺五加700份;人参250份;益智仁280份;五味子200份。
该组合物活性组分制备包括以下步骤:
(1)原料处理:取刺五加、益智仁、五味子饮片,洗净备用;人参,粉碎,过80目筛;
(2)称量:按配方比例称取刺五加、益智仁、五味子及人参粉,备用;
(3)提取:将称取的的刺五加、益智仁、五味子加水提取,提取液备用;
(4)浓缩:提取液浓缩成稠膏;
(5)干燥 :稠膏干燥,所得干膏备用;
(6)粉碎:干膏进行粉碎,得干膏粉;
干膏粉和人参粉共同构成了本发明活性组分。
本发明组合物可制备成药品或保健食品,其制剂剂型为胶囊剂、片剂、丸剂、散剂或膏剂。
胶囊剂制备方法为:
(1)原料处理:取刺五加、益智仁、五味子饮片,洗净备用;人参粉碎,过80目筛,60Co辐照灭菌,辐照剂量3kGy,备用;
(2)称量:按配方比例称取刺五加、益智仁、五味子及人参粉,备用;
(3)提取:将称量好的刺五加、益智仁、五味子,加水提取3次,每次1小时,第一次加9倍水,第二、三次分别加8倍水,提取液滤过,合并,备用;
(4)浓缩:提取液减压浓缩,浓缩温度60~80℃,真空度为0.04~0.08MPa,浓缩至至60℃热测相对密度1.05~1.10的清膏;
(5)真空干燥:采用真空烘箱干燥,温度55~70℃,真空度为0Mpa,先烘干2小时,然后打开真空阀门进行真空干燥,温度55~70℃,真空度为0.04~0.08Mpa,收集干膏,水分应控制在4%以内,备用;
(6)干膏粉碎:将干膏粉碎,过80目筛网,收集细粉,备用;
(7)将干膏粉、人参灭菌粉混合,加入辅料制粒、整粒、总混后,填充胶囊即得。
胶囊剂优选制备方法为:
(1)原料处理:取刺五加、益智仁、五味子饮片,洗净备用;人参粉碎,过80目筛,60Co辐照灭菌,辐照剂量3kGy,备用;
(2)称量:按配方比例称取刺五加、益智仁、五味子及人参粉,备用;
(3)提取:将称量好的刺五加、益智仁、五味子,加水提取3次,每次1小时,第一次加9倍水,第二、三次分别加8倍水,提取液滤过,合并,备用;
(4)浓缩:提取液减压浓缩,浓缩温度60~80℃,真空度为0.04~0.08MPa,浓缩至至60℃热测相对密度1.05~1.10的清膏;
(5)真空干燥:采用真空烘箱干燥,温度55~70℃,真空度为0Mpa,先烘干2小时,然后打开真空阀门进行真空干燥,温度55~70℃,真空度为0.04~0.08Mpa,收集干膏,水分应控制在4%以内,备用;
(6)干膏粉碎:将干膏粉碎,过80目筛网,收集细粉,备用;
(7)将干膏粉、人参灭菌粉混合均匀,加入玉米淀粉干法制粒,整粒、总混后,填充胶囊即得。
本发明所述的药品或保健食品在制备辅助改善记忆组合物中的应用。
本发明组合物中,作为活性组分的原料药的拉丁名及其加工方法来自《中药大辞典》(1977年7月,第一版,上海科学技术出版社)和《中国药典》(2005年版,化学工业出版社)。
本发明保健食品可以按常规的制剂工艺,例如,范碧亭《中药药剂学》(上海科学出版社1997年12月第1版)记载的制备工艺,制成药剂学可接受的任意常规剂型,例如胶囊剂、片剂、丸剂、散剂、软胶囊剂或膏剂等。
本发明的应用中,所述保健食品为胶囊剂、片剂、丸剂、散剂、软胶囊剂或膏剂制剂中的一种,为使上述剂型能够实现,需在制备这些剂型时加入药学可接受的辅料,例如:填充剂、崩解剂、润滑剂、助悬剂、粘合剂、甜味剂、矫味剂、防腐剂、基质等。填充剂包括:淀粉、预胶化淀粉、乳糖、甘露醇、甲壳素、微晶纤维素、蔗糖等;崩解剂包括:淀粉、预胶化淀粉、微晶纤维素、羧甲基淀粉钠、交联聚乙烯吡咯烷酮、低取代羟丙纤维素、交联羧甲基纤维素钠等;润滑剂包括:硬脂酸镁、十二烷基硫酸钠、滑石粉、二氧化硅等;助悬剂包括:聚乙烯吡咯烷酮、微晶纤维素、蔗糖、琼脂、羟丙基甲基纤维素等;粘合剂包括,淀粉浆、聚乙烯吡咯烷酮、羟丙基甲基纤维素等;甜味剂包括:糖精钠、阿斯帕坦、蔗糖、甜蜜素、甘草次酸等;矫味剂包括:甜味剂及各种香精;防腐剂包括:尼泊金类、苯甲酸、苯甲酸钠、山梨酸及其盐类、苯扎溴铵、醋酸氯乙定、桉叶油等;基质包括:PEG6000,PEG4000,虫蜡等。为使上述剂型能够实现中药药剂学,需在制备这些剂型时加入药学可接受的其它辅料(范碧亭《中药药剂学》,上海科学出版社1997年12月第1版中各剂型记载的辅料)。
该方以人参为君药,大补元气、补肾益精、安神益智,配以刺五加助君药补益后天之本,培护先天之精,配以益智仁助君药填精益髓、温肾固精,同时以五味子益气生津,既有增强人参、刺五加、益智仁补肾固涩之功效,又能防治补益太过,滋腻于肾,益气生津。诸药合用补虚益肾、固精增髓以治其本,益气生津、活血通络标本兼治,以达改善、提高学习、记忆能力之效,临床应用取得了很好的疗效。
为证实本发明组合物改善记忆的作用,委托南京医科大学卫生分析检测中心用按实施例1方法制得的胶囊剂(以下称本发明组合物)进行了下列临床试验。
采用双盲对照随机法,将101例受试者按记忆商随机分为2组,其中51例服用本发明组合物为试食组,另50 例服用安慰剂为对照组,服用方法为口服,每日3 次,每次3 粒。连续观察30天。试食前受试者胸透、B超、心电图检查基本在正常范围,试食前后受试者的血、尿常规及血生化指标基本在正常范围。试食期间保持平日的生活和饮食习惯,试食过程中未见不良反应。试食前两组指向记忆量表分、联想学习量表分、图象自由回忆量表分、无意义图形再认量表分、人像特点联系回忆量表分和记忆商相比较,差异均无统计学意义( P>0.05 ) 。组间比较、试食组试食后指向记忆量表分、联想学习量表分、图象自由回忆量表分、无意义图形再认量表分、人像特点联系回忆量表分及记忆商均高于对照组,差异有统计学意义(P<0.05 )。自身配对比较,试食组指向记忆量表分、联想学习量表分、图象自由回忆量表分、无意义图形再认量表分、人像特点联系回忆量表分及记忆商试食后均高于试食前,差异有统计学意义P<0.05 )。
对照组联想学习量表分试食后低于试食前,差异有统计学意义(P<0.05 ),其它指标对照组自身配对比较差异均无统计学意义( P>0.05 )。
根据《保健食品检验与评价技术规范)) (2003 年版)辅助改善记忆功能人体试食试验的结果判定,本发明组合物具有辅助改善记忆功能。
具体试验方法:
1 材料和方法
1. 1 样品:本发明组合物及安慰剂,规格: 0.4g/粒x 36 粒/瓶,生产批号:150501.由石家庄以岭药业股份有限公司提供,人体推荐剂量3.6g/人/天。服用方法为口服,每日3 次,每次3 粒。
1.2 选择受试者的原则
从比较集中、各方面影响因素大致相同的群体中挑选自愿受试者;文化程度基本一致;属同一年龄组,如不在同一年龄组,则应对量表分进行校正;未接受过类似测试者;排除短期内服用与受试功能有关的物品,对结果有影响者。
1.3 试验方法
按照《保健食品检验与评价技术规范)) (2003年版)中辅助改善记忆功能的人体试食试验规程进行,采用临床记忆量表按测试要求测定受试者的记忆商。
1.4 测试量表
采用中国科学院心理研究所1996 年修订的"临床记忆量表"。
1.5 试食设计与分组
南京医科大学卫生分析检测中心与安徽武警总院共同进行人体试食试验,选择年龄在18 - 65岁,身体健康状况良好,志愿受试保证配合的人群。受试对象实施知情同意。采用自身和组间两种对照设计。根据记忆商数(MQ) 随机分为试食组和对照组,尽可能考虑影响结果的主要因素如年龄、性别等,进行均衡性检验,以保证组间的可比性。完成试食并纳入统计者为101 人,其中试食组51人,对照50人。
1.6 服用剂量及时间
试食组服用受试样品,对照组服用安慰剂。服用方法为口服,每日3次,每次3粒,试食观察时间30天。试食开始日期为2016年8月30曰。
1.7 主要仪器
全自动生化分析仪(科华卓越400 );全自动血液分析仪( BC-3000PLus 国产,迈瑞) ;尿液化学分析仪(优利特300) ; B超机(GE C5); X线透视机(航天中兴LDR-O lB-5KW );心电图机(日本光电9130p) 。
1.8 观察指标
1.8.1 安全性指标
1.8.1.1 一般状况:精神、睡眠、饮食、大小便、心率、血压等。
1.8.1.2 血、尿常规检查:血常规项目包括白细胞、红细胞、血红蛋白、血小板。
1.8.1.3 血生化检查:检查项目包括血清总蛋白、白蛋白、谷丙转氨酶、谷草转氨酶、尿素、肌由于、胆固醇、甘油三醋、血糖。
1.8.1.4 胸透、心电图、腹部B 超检查:仅在试验开始前检查一次。
1.8.2 功效性指标
使用临床记忆量表。包括指向记忆量表分,联想学习量表分,图象自由回忆量表分,无意义图形再认量表分,人像特点联系回忆量表分。用测试后的各分测验原始分查量表分,各分测验量表分相加得总量表分,用总量表分查记忆商。
1.9 数据统计
组间平行比较采用两样本均数的t检验,自身对照数据采用配对t检验,方差不齐时进行数据转换或用t'检验、秩和检验。有效率及总有效率采用χ2 检验进行检验。四格表总例数小于40,或总例数等于或大于40,但出现理论数等于或小于1 时,改用确切概率法。
1.10 结果判定
在试验前两组记忆商均衡的前提下,试食后试食组的记忆商高于对照组,且差异有显著性,同时试食组试验后的记忆商高于其试验前的记忆商,且差异有显著性,可以判定该受试样品具有辅助改善记忆功能的作用。
2 结果
2.1 试食组与对照组均衡性比较
纳入统计者101例,其中试食组51例,男性20例、女性31例,平均年龄46.49岁;对照组50例,男性26例、女性24例,平均年龄45.3 6岁。由表1可见,MQ、年龄、性别、文化程度试食组与对照组比较,差异无统计学意义(P>O.05 )。表明两组试食前MQ、年龄、性别、文化程度具有均衡可比性。试食前两组受试者胸透、心电图、腹部B超检查,均未见明显异常。
2.2 安全性指标
2.2.1 试食组与对照组一般情况比较
对受试者精神、睡眠、饮食、大小便等情况进行了问诊调查,按好、一般、差分级统计,并测定血压、心率。由表2 可见,试食期间本发明组合物对人体精神、睡眠、饮食、血压、心率等一般情况无不良影响。
2.2.2 本发明组合物对人体血、尿常规及血生化指标的影响由表3 可见,试食组、对照组试食前后各项血液学及血生化指标均基本在正常范围。试食组与对照组试食前后尿常规均基本正常。表明本发明组合物对人体血、尿常规和血生化指标无不良影响。
2.3 功效指标
2.3.1 本发明组合物对受试者指向记忆量表分的影响
由表4可见,试食前试食组指向记忆量表分与对照组比较差异无统计学意义(P>O.05 )。试食后试食组指向记忆量表分高于对照组,差异有统计学意义(P<O.05 )。试食前后自身配对比较,试食组指向记忆量表分试食后高于试食前,差异有统计学意义(P<O.05 );对照组指向记忆量表分试食后与试食前比较,差异无统计学意义(P>O.05 )。
2.3.2 本发明组合物对受试者联想学习量表分的影响
由表5 可见,试食前试食组联想学习量表分与对照组比较差异无统计学意义(P>O.05 )。试食后试食组联想学习量表分高于对照组,差异有统计学意义(P<O.05 )。试食前后自身配对比较,试食组联想学习量表分试食后高于试食前,差异有统计学意义(P<O.05 );对照组联想学习量表分试食后低于试食前,差异有统计学意义(P<O.05 )。
2.3.3 本发明组合物对受试者图象自由回忆量表分的影响
由表6可见,试食前试食组图象自由回忆量表分与对照组比较,差异无统计学意义(P>O.05 )。试食后试食组图象自由回忆量表分高于对照组,差异有统计学意义(P<O.05 )。试食前后自身配对比较,试食组图象自由回忆量表分试食后高于试食前,差异有统计学意义(P<O.05 );对照组图象自由回忆量表分试食后与试食前比较,差异无统计学意义(P>O.05)。
2.3.4本发明组合物对受试者无意义图形再认量表分的影响
由表7可见,试食前试食组无意义图形再认量表分与对照组比较,差异无统计学意义(P>O.05 )。试食后试食组无意义图形再认量表分高于对照组,差异有统计学意义(P<O.05 )。试食前后自身配对比较,试食组无意义图形再认量表分试食后高于试食前,差异有统计学意义(P<O.05 );对照组无意义图形再认量表分试食后与试食前比较,差异无统计学意义(P>O.05 )。
2.3.5 本发明组合物对受试者人像特点联系回忆量表分的影响
由表8可见,试食前试食组人像特点联系回忆量表分与对照组比较,差异无统计学意义(P>O.05 )。试食后试食组人像特点联系回忆量表分高于对照组,差异有统计学意义(P<O.05 )。试食前后自身配对比较,试食组人像特点联系回忆量表分试食后高于试食前,差异有统计学意义(P<O.05 );对照组人像特点联系回忆量表分试食后与试食前比较,差异无统计学意义(P>O.05 )。
2.3.6 本发明组合物对受试者记忆商的影响
由表9可见,试食前试食组记忆商与对照组比较,差异无统计学意义(P>O .05 )。试食后试食组记忆商高于对照组,差异有统计学意义(P<O.05 )。试食前后自身配对比较,试食组记忆商试食后高于试食前,差异有统计学意义(P<O.05 );对照组记忆商试食后与试食前比较,差异无统计学意义(P>O.05 )。
3 小结
3.1 安全性指标
试食前全部受试者经胸透、心电图、B 超检查基本正常。试食者试食本发明组合物前后红细胞、白细胞、血红蛋白、血小板、血清总蛋白、白蛋白、谷丙转氨酶、谷草转氨酶、肌所、尿素、胆固醇、甘油三醋、血糖、尿常规等均基本在正常范围,说明本发明组合物对人体无不良影响。试食过程未见有不良反应。
3.2 功效性指标
3.2.1 组间比较:试食后指向记忆量表分、联想学习量表分、图像自由回忆量表分、无意义图形再认量表分、人像特点联系回忆量表分、记忆商试食组均高于对照组,差异有统计学意义(P<0.05)。
3.2.2 自身配对比较: 试食组指向记忆量表分、联想学习量表分、图像自由回忆量表分、无意义图形再认量表分、人像特点联系回忆量表分、记忆商试食后均高于试食前,差异有统计学意义(P<0.05)。对照组联想学习量表分试食后低于试食前,差异有统计学意义(P<0.05),其它指标自身配对比较差异均无统计学意义(P>0.05)。
3.3 脱失率:试食开始选择人群107 例,试食组54 例,对照组53 例。完成试食并纳入统计者共101,其中试食组51,对照组50。试食结束试食组失访3 例,对照组失访3 例,总失访率5.61% 。根据《保健食品检验与评价技术规范)) (2003 年版)辅助改善记忆功能人体试食试验的结果判定,本发明组合物具有辅助改善记忆的功能。
具体实施方式
实施例1:
刺五加800g;人参267g;益智仁267g;五味子178g
(1)原料处理:取刺五加、益智仁、五味子饮片,洗净备用;人参粉碎,过80目筛,60Co辐照灭菌,辐照剂量3kGy,备用;
(2)称量:按配方比例称取刺五加、益智仁、五味子及人参粉,备用;
(3)提取:将称量好的刺五加、益智仁、五味子,加水提取3次,每次1小时,第一次加9倍水,第二、三次分别加8倍水,提取液滤过,合并,备用;
(4)浓缩:提取液减压浓缩,浓缩温度60~80℃,真空度为0.04~0.08MPa,浓缩至至60℃热测相对密度1.05~1.10的清膏;
(5)真空干燥:采用真空烘箱干燥,温度55~70℃,真空度为0Mpa,先烘干2小时,然后打开真空阀门进行真空干燥,温度55~70℃,真空度为0.04~0.08Mpa,收集干膏,水分应控制在4%以内,备用;
(6)干膏粉碎:将干膏粉碎,过80目筛网,收集细粉,备用;
(7)将干膏粉、人参灭菌粉混合均匀,加入玉米淀粉13g干法制粒,整粒、总混后,填充胶囊即得。
实施例2:
刺五加960g;人参214g;益智仁320g;五味子142g
(1)原料处理:取刺五加、益智仁、五味子饮片,洗净备用;人参粉碎,过80目筛,60Co辐照灭菌,辐照剂量3kGy,备用;
(2)称量:按配方比例称取刺五加、益智仁、五味子及人参粉,备用;
(3)提取:将称量好的刺五加、益智仁、五味子,加水提取3次,每次1小时,第一次加9倍水,第二、三次分别加8倍水,提取液滤过,合并,备用;
(4)浓缩:提取液减压浓缩,浓缩温度60~80℃,真空度为0.04~0.08MPa,浓缩至至60℃热测相对密度1.05~1.10的清膏;
(5)真空干燥:采用真空烘箱干燥,温度55~70℃,真空度为0Mpa,先烘干2小时,然后打开真空阀门进行真空干燥,温度55~70℃,真空度为0.04~0.08Mpa,收集干膏,水分应控制在4%以内,备用;
(6)干膏粉碎:将干膏粉碎,过80目筛网,收集细粉,备用;
(7)将干膏粉、人参灭菌粉混合均匀,加入玉米淀粉干法制粒,整粒、总混后,压片即得。
实施例3:
刺五加640g;人参320g;益智仁214g;五味子214g
(1)原料处理:取刺五加、益智仁、五味子饮片,洗净备用;人参粉碎,过80目筛,60Co辐照灭菌,辐照剂量3kGy,备用;
(2)称量:按配方比例称取刺五加、益智仁、五味子及人参粉,备用;
(3)提取:将称量好的刺五加、益智仁、五味子,加水提取3次,每次1小时,第一次加9倍水,第二、三次分别加8倍水,提取液滤过,合并,备用;
(4)浓缩:提取液减压浓缩,浓缩温度60~80℃,真空度为0.04~0.08MPa,浓缩至至60℃热测相对密度1.05~1.10的清膏;
(5)真空干燥:采用真空烘箱干燥,温度55~70℃,真空度为0Mpa,先烘干2小时,然后打开真空阀门进行真空干燥,温度55~70℃,真空度为0.04~0.08Mpa,收集干膏,水分应控制在4%以内,备用;
(6)干膏粉碎:将干膏粉碎,过80目筛网,收集细粉,备用;
(7)将干膏粉、人参灭菌粉混合均匀,加入玉米淀粉干法制粒,整粒即得颗粒剂。
实施例4:
刺五加700g;人参250g;益智仁280g;五味子200g
(1)原料处理:取刺五加、益智仁、五味子饮片,洗净备用;人参粉碎,过80目筛,60Co辐照灭菌,辐照剂量3kGy,备用;
(2)称量:按配方比例称取刺五加、益智仁、五味子及人参粉,备用;
(3)提取:将称量好的刺五加、益智仁、五味子,加水提取3次,每次1小时,第一次加9倍水,第二、三次分别加8倍水,提取液滤过,合并,备用;
(4)浓缩:提取液减压浓缩,浓缩温度60~80℃,真空度为0.04~0.08MPa,浓缩至至60℃热测相对密度1.05~1.10的清膏;
(5)真空干燥:采用真空烘箱干燥,温度55~70℃,真空度为0Mpa,先烘干2小时,然后打开真空阀门进行真空干燥,温度55~70℃,真空度为0.04~0.08Mpa,收集干膏,水分应控制在4%以内,备用;
(6)干膏粉碎:将干膏粉碎,过80目筛网,收集细粉,备用;
(7)将干膏粉、人参灭菌粉混合均匀,加入玉米淀粉干法制粒,整粒、总混后,按常规方法搓丸即得丸剂。
Claims (9)
1.一种辅助改善记忆的组合物,其特征在于该组合物由如下重量份的原料药制成:
刺五加640-960份;人参214-320份;益智仁214-320份;五味子142-214份,
所述组合物的活性组分制备包括以下步骤:
(1)原料处理:取刺五加、益智仁、五味子饮片,洗净备用;人参,粉碎,过80目筛;
(2)称量:按配方比例称取刺五加、益智仁、五味子及人参粉,备用;
(3)提取:将称取的的刺五加、益智仁、五味子加水提取,提取液备用;
(4)浓缩:提取液浓缩成稠膏;
(5)干燥 :稠膏干燥,所得干膏备用;
(6)粉碎:干膏进行粉碎,得干膏粉;
干膏粉和人参粉共同构成了所述组合物的活性组分。
2.如权利要求1所述的组合物,其特征在于该组合物由如下重量份的原料药制成:
刺五加640份;人参320份;益智仁214份;五味子214份。
3.如权利要求1所述的组合物,其特征在于该组合物由如下重量份的原料药制成:
刺五加960份;人参214份;益智仁320份;五味子142份。
4.如权利要求1所述的组合物,其特征在于该组合物由如下重量份的原料药制成:
刺五加800份;人参267份;益智仁267份;五味子178份。
5.如权利要求1所述的组合物,其特征在于该组合物由如下重量份的原料药制成:
刺五加700份;人参250份;益智仁280份;五味子200份。
6.如权利要求1-5中任一项所述的组合物,其特征在于该组合物可制备成药品或保健食品。
7.如权利要求6所述的组合物,其特征在于所述药品或保健食品的制剂剂型为胶囊剂、片剂、丸剂、散剂或膏剂。
8.如权利要求7所述的组合物,其特征在于所述胶囊剂制备方法为:
(1)原料处理:取刺五加、益智仁、五味子饮片,洗净备用;人参粉碎,过80目筛, 60 Co辐照灭菌,辐照剂量3kGy,备用;
(2)称量:按配方比例称取刺五加、益智仁、五味子及人参粉,备用;
(3) 提取:将称量好的刺五加、益智仁、五味子,加水提取3次,每次1小时,第一次加9倍水,第二、三次分别加8倍水,提取液滤过,合并,备用;
(4) 浓缩:提取液减压浓缩,浓缩温度60~80℃,真空度为0.04~0.08MPa,浓缩至60℃热测相对密度1.05~1.10的清膏;
(5) 真空干燥:采用真空烘箱干燥,温度55~70℃,真空度为0Mpa,先烘干2小时,然后打开真空阀门进行真空干燥,温度55~70℃,真空度为0.04~0.08Mpa,收集干膏,水分控制在4%以内,备用;
(6) 干膏粉碎:将干膏粉碎,过80目筛网,收集细粉,备用;
(7) 将干膏粉、人参灭菌粉混合均匀,加入玉米淀粉干法制粒,整粒、总混后,填充胶囊即得。
9.如权利要求6所述的药品或保健食品在制备辅助改善记忆的组合物中的应用。
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