CN106309847B - 一种益智的中药组合物及其制备方法 - Google Patents
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Abstract
本发明属于保健品领域,具体涉及一种益智的中药组合物及其制备方法。本发明所述的中药组合物包括以下重量份的制备原料:核桃仁4~10份、黑芝麻2~8份、桂圆2~8份、牛磺酸0.03~0.05份、山药2~8份、枸杞子1~6份、大枣1~6份、谷氨酸γ‑乙基酰胺4~10份、表没食子儿茶素没食子酸酯磷脂复合物2~8份和辅料10~70份。该中药组合物营养成分丰富,且安全有效,服用方便,益智效果明显,可有效促进儿童智力发展,适宜儿童长期服用,并能有效缓解退行性及劳损性大脑损伤引起的智力下降。
Description
技术领域
本发明属于保健品领域,具体涉及一种益智的中药组合物及其制备方法。
背景技术
智力是一种综合能力,是众多认知的综合体现,包括记忆、判断、理解、推理和学习等能力。智力发展与生理因素和外界环境因素密切相关,其中生理因素包括遗传因素、营养状况和生长过程中的药物、射线及孕期感染等影响,而外界环境因素包括社会大环境因素和家庭微环境因素。
儿童是家庭和社会的未来,而儿童智力是其生长发育中最重要的要素之一,是每个家庭最为关注的事情。智力低下不但是严重危害儿童身心健康的一类世界性疾患,更是一个严重的社会问题。此外,随着社会老龄化的到来和社会生活节奏的加快,大脑的生理压力日趋增加,引发脑白质退行性变性或劳损性变性的风险大幅上升,退行性及劳损性大脑损伤已成为智力下降的两大主因,使人群中特别是中老年人群中的脑源性失智、失能患者不断增多,给社会及患者家庭带来沉重的负担。
中医认为智力不足或智力减退多与心脾两虚、阴虚火旺、心肾不交、痰饮淤血等因素有关,故多以具有补虚益气、益脾补肾、祛痰开窍、活血去瘀、安神益智等功效的中药,如人参、黄芪、三七、灵芝、远志、益智仁、山药等进行复配以发挥益智作用,但往往在辨证施治上靶向缺失较为明显,入方中药协同机制不清,且质量控制及成本控制困难加大,如公开号为CN 102552625 B的中国专利公开了一种抗衰老益智中药及其制备方法,该中药组方由以下原料组成:人参、制首乌、黄芪、三七、刺五加、灵芝、枸杞子、远志、红薯干、芝麻油和怀山药。西医对因大脑损伤所至失智、失能患者的治疗,主要在降脂降压、扩张血管、改善循环、促进代谢以及神经能因子诱导等方法着手,但疗效总体欠佳,在治疗手段上有较为明显的局限性。因此,急需开发一种疗效确切,成本相宜,能有效促进儿童智力发育,缓解退行性及劳损性大脑损伤引起的智力下降的组方,以满足市场的需求。
谷氨酸γ-乙基酰胺是茶叶中特有的游离氨基酸,具有降压、镇静、保护神经细胞、抗癌、抗抑郁等作用,为新型绿色健康食品添加剂,安全性高,没有摄取量限制,能有效改善儿童多动症,对更年期综合征具有明显的治疗作用。
表没食子儿茶素没食子酸酯磷脂复合物为表没食子儿茶素没食子酸酯与大豆卵磷脂形成的络合物,脂溶性较佳,可显著提高表没食子儿茶素没食子酸酯在体内的稳定性,所述的表没食子儿茶素没食子酸酯具有抗菌、抗病毒、抗氧化、抗血栓形成、抗癌等作用,在食品工业多作为保鲜、祛臭剂使用。
目前没有关于谷氨酸γ-乙基酰胺和表没食子儿茶素没食子酸酯磷脂复合物两者合用在益智方面的研究报道。
发明内容
为解决现有技术存在的问题,本发明的目的在于提供一种益智的中药组合物及其制备方法,该中药组合物营养成分丰富,且安全有效,服用方便,益智效果明显,可有效促进儿童智力发展,适宜儿童长期服用,并能有效缓解退行性及劳损性大脑损伤引起的智力下降。
本发明提供一种益智的中药组合物,其包括以下重量份的制备原料:核桃仁4~10份、黑芝麻2~8份、桂圆2~8份、牛磺酸0.03~0.05份、山药2~8份、枸杞子1~6份、大枣1~6份和辅料10~70份。
优选地,所述的中药组合物包括以下重量份的制备原料:核桃仁8份、黑芝麻5份、桂圆6份、牛磺酸0.03份、山药5份、枸杞子3份、大枣3份和辅料70份。
进一步地,所述的中药组合物还包括以下重量份的制备原料:谷氨酸γ-乙基酰胺4~10份和表没食子儿茶素没食子酸酯磷脂复合物2~8份。
进一步地,所述的表没食子儿茶素没食子酸酯磷脂复合物的制备方法包括以下步骤:
取大豆卵磷脂,加入无水乙醇,配成质量浓度为1%的溶液,然后进行超声处理20~30min,超声频率为30~35kHz,再加入表没食子儿茶素没食子酸酯,搅拌均匀,缓慢升温至40~60℃,在持续搅拌的条件下保温反应3h,减压干燥,将干燥物与氯仿按照1:5的质量比混合进行复溶,在2000rpm/min条件下离心5min除去不溶物,将上清液用0.45μm的非水滤膜过滤后进行减压干燥除去氯仿,即得表没食子儿茶素没食子酸酯磷脂复合物。
进一步地,所述的表没食子儿茶素没食子酸酯磷脂复合物的制备方法中大豆卵磷脂与表没食子儿茶素没食子酸酯的用量为1:1~2摩尔比。
优选地,所述的中药组合物包括以下重量份的制备原料:核桃仁8份、黑芝麻5份、桂圆6份、牛磺酸0.03份、山药5份、枸杞子3份、大枣3份、谷氨酸γ-乙基酰胺8份、表没食子儿茶素没食子酸酯磷脂复合物6份和辅料70份。
进一步地,所述的辅料为甜味剂、矫味剂和填充剂中的至少一种;
所述的甜味剂为白砂糖、葡萄糖、低聚异麦芽糖、冰糖、乳糖中的至少一种;
所述矫味剂为柠檬酸;
所述填充剂为环糊精、淀粉、微晶纤维素、甘露醇中的至少一种。
此外,本发明还提供一种所述中药组合物的制备方法,其包括以下步骤:
(1)取新鲜山药,洗净,按料液比为1:8的比例加入水,进行匀浆处理,加入0.05%wt混合酶,搅拌均匀,于45~50℃保温进行酶解60min,加入2%wt稳定剂,在85℃条件下回流提取2次,过滤,合并滤液,往滤液中加入乙醇直至含醇量为90%,静置12h后,在10000r/min,4℃条件下离心15min得沉淀,将沉淀冷冻干燥得到山药萃取物;
(2)取核桃仁、黑芝麻、桂圆、枸杞子、大枣,洗净,干燥后粉碎,过80目筛,加入药材总重量8~10倍量的水浸泡1~2h,回流提取2~3次,每次3~4小时,过滤并保留滤渣,合并滤液,得水提液;然后往滤渣中加入药材总重量8~10倍量体积分数为60~70%的乙醇,回流提取2~3次,每次3~4小时,过滤,合并滤液,得醇提液;将水提液和醇提液合并,减压干燥,粉碎,过100目筛,得粉末;
(3)将山药萃取物、步骤(2)得到的粉末、谷氨酸γ-乙基酰胺、表没食子儿茶素没食子酸酯磷脂复合物和辅料混合均匀,即得中药组合物。
其中,所述步骤(1)中的混合酶为纤维素酶和甘露聚糖酶以3:1的质量比组成;稳定剂为β-环糊精和海藻糖以1:4的质量比组成。
进一步地,所述的中药组合物可进一步制成颗粒剂、胶囊剂、口服液或固体饮料。
山药萃取物含有丰富的胆碱和卵磷脂,但由于其块茎肥厚,且黏度较高,其有效成分的萃取效率往往比较低。纤维素酶可以分解山药的细胞壁纤维,使有效成分易于从胞内扩散出来,从而有效地被萃取,而甘露聚糖酶可作用于山药黏液中多糖的糖苷键,使复杂的多糖降解为低分子糖类,进而降低黏度,当纤维素酶和甘露聚糖酶以3:1的质量比组成时,提高山药萃取物的萃取效果最佳。
此外,在萃取过程中添加β-环糊精和海藻糖作为稳定剂,利用β-环糊精的孔腔结构可进一步降低山药萃取液的黏度,并防止回流萃取过程中有效成分形成凝胶,发生絮凝现象,而海藻糖具有优异的生物学保护特性,可有效地防止蛋白质变性,保护山药萃取物各种活性成分。
本发明先将山药单独制备成萃取物,再将其与核桃仁、黑芝麻等其他中药材料经水提和醇提得到的提取混合物、谷氨酸γ-乙基酰胺和表没食子儿茶素没食子酸酯磷脂复合物进行复配,营养成分丰富,且易于消化和吸收,具有显著的益智效果。动物实验表明,中药组合物添加谷氨酸γ-乙基酰胺可进一步促进小鼠脑部发育,增强学习记忆力,延长小鼠跳台试验的跳下潜伏期,减少错误次数,而添加表没食子儿茶素没食子酸酯磷脂复合物对改善中药组合物的益智效果并不明显,并且以表没食子儿茶素没食子酸酯替换表没食子儿茶素没食子酸酯磷脂复合物,不能改善谷氨酸γ-乙基酰胺增强小鼠学习记忆力的效果,仅且当表没食子儿茶素没食子酸酯磷脂复合物与谷氨酸γ-乙基酰胺合用时,中药组合物物的益智效果达到最佳。此外,临床试验意外发现,本发明提供的中药组合物对退行性大脑损伤引起的老年性痴呆症具有显著的疗效,痊愈率达21.7%,显效率达86.7%,总进步率达93.3%,且安全性好。因此本发明取得了预料不到的技术效果。
与现有技术相比,本发明的优势在于:
(1)本发明通过大量的试验证明,本发明提供的中药组合物可促进脑部发育,显著增强学习记忆能力,对退行性大脑损伤引起的老年性痴呆症具有显著疗效,痊愈率达21.7%,显效率达86.7%,总进步率达93.3%,尤其当中药组合物与谷氨酸γ-乙基酰胺、表没食子儿茶素没食子酸酯磷脂复合物合用时效果更佳。
(2)本发明提供的中药组合物各组分相互协同,相互增益,益智效果好,营养成分丰富,口感较好,适宜儿童长期服用,且安全有效,服用方便。
具体实施方式
以下通过具体实施方式进一步描述本发明,但本发明不仅仅限于以下实施例。
实施例1表没食子儿茶素没食子酸酯磷脂复合物制备
分别准确称取大豆卵磷脂32.529g,表没食子儿茶素没食子酸酯45.838g(大豆卵磷脂与表没食子儿茶素没食子酸酯的用量为1:1摩尔比)。往大豆卵磷脂中加入无水乙醇,配成质量浓度为1%的溶液,然后进行超声处理25min,超声频率为35kHz,再加入表没食子儿茶素没食子酸酯,搅拌均匀,缓慢升温至45℃,在持续搅拌的条件下保温反应3h,减压干燥,将干燥物与氯仿按照1:5的质量比混合进行复溶,在2000rpm/min条件下离心5min除去不溶物,将上清液用0.45μm的非水滤膜过滤后进行减压干燥除去氯仿,即得表没食子儿茶素没食子酸酯磷脂复合物,所述的表没食子儿茶素没食子酸酯磷脂复合物的收率为94.26%。
实施例2-5和对比例1-4益智中药组合物的制备
本发明实施例2-5和对比例1-4所述的益智中药组合物包括下表所述的重量份制备原料:
实施例5益智中药组合物的制备方法为:
(1)取新鲜山药,洗净,按料液比为1:8的比例加入水,进行匀浆处理,加入0.05%wt混合酶,搅拌均匀,于45℃保温进行酶解60min,加入2%wt稳定剂,在85℃条件下回流提取2次,过滤,合并滤液,往滤液中加入乙醇直至含醇量为90%,静置12h后,在10000r/min,4℃条件下离心15min得沉淀,将沉淀冷冻干燥得到山药萃取物;
(2)取核桃仁、黑芝麻、桂圆、枸杞子、大枣,洗净,干燥后粉碎,过80目筛,加入药材总重量10倍量的水浸泡2h,回流提取2次,每次3小时,过滤并保留滤渣,合并滤液,得水提液;然后往滤渣中加入药材总重量8倍量体积分数为70%的乙醇,回流提取2次,每次3小时,过滤,合并滤液,得醇提液;将水提液和醇提液合并,减压干燥,粉碎,过100目筛,得粉末;
(3)将山药萃取物、步骤(2)得到的粉末、谷氨酸γ-乙基酰胺、表没食子儿茶素没食子酸酯磷脂复合物和辅料混合均匀,即得中药组合物。
其中,所述步骤(1)中的混合酶为纤维素酶和甘露聚糖酶以3:1的质量比组成;稳定剂为β-环糊精和海藻糖以1:4的质量比组成。
实施例2、3、4和对比例1-3益智中药组合物的制备方法参考实施例5。
对比例4的制备方法与实施例5基本相同,区别在于,步骤(1)不添加稳定剂,即不添加β-环糊精和海藻糖。
实施例2-5和对比例1-4益智中药组合物的颗粒剂制备
分别取实施例2-5和对比例1-4制备的益智中药组合物,粉碎,过150目筛,得粗粉,加入适量的质量分数为20%的聚维酮K30溶液,制软材,将软材过16目筛制粒,置于60℃的恒温干燥箱进行干燥,将干燥后的颗粒过16目筛进行整粒,即得颗粒剂。
实施例2-5和对比例1-4益智中药组合物的胶囊剂制备
分别取实施例2-5和对比例1-4制备的益智中药组合物,粉碎,过150目筛,得粗粉,将粗粉填充于1号胶囊壳中,即得胶囊剂。
实施例2-5和对比例1-4益智中药组合物的口服液制备
分别取实施例2-5和对比例1-4制备的益智中药组合物,粉碎,过200目筛,加入纯化水溶解,加入适量的防腐剂,灭菌,灌装,即得口服液。
试验例一、安全性试验
将实施例2-5和对比例1-4制得的益智中药组合物分别进行急性毒性试验、30天喂养试验和90天喂养试验,结果显示,本发明提供的益智中药组合物安全无毒,经喂养的动物生长情况良好,血液学检查,生化学检查,主要脏体和组织学检查均未发现异常,且未出现便秘的现象。因此,本发明提供的益智中药组合物安全无毒,适宜长期服用。
试验例二、本发明提供的益智中药组合物对小鼠学习记忆的影响试验
用跳台法预选合格的SPF级昆明小鼠100只,体重25~30g,雌雄各半,将小鼠随机分为10组,每组10只,分别为实施例2组、实施例3组、实施例4组、实施例5组、对比例1-4组、空白对照组和阳性对照组。其中,空白对照组灌胃给蒸馏水,实施例2、3、4、5组和对比例1-4组分别灌胃给实施例2、3、4、5和对比例1-4制得的中药组合物,每次灌胃剂量为600mg/kg,每日灌胃2次。阳性对照组灌胃给市售欧立建益智胶囊,每次灌胃剂量为600mg/kg,每日灌胃2次。各组大鼠连续灌胃21天。第20天以跳台法分别训练每只小鼠1次,24h后开始测试并记录每组小鼠的跳下潜伏期(自跳台上跳下的时间)和5min内错误次数。结果见下表1。
表1本发明中药组合物对正常小鼠学习和记忆获得能力的影响
注:与空白对照组比较,*P<0.05,**P<0.01;与阳性对照组比较,#P<0.05。
结果显示,本发明实施例2-5制得的中药组合物可显著增强小鼠的学习记忆能力,尤其以实施例5的效果最佳。由对比例1和2可知,中药组合物添加谷氨酸γ-乙基酰胺可进一步促进小鼠脑部发育,增强学习记忆力,延长小鼠跳台试验的跳下潜伏期,减少错误次数,而添加表没食子儿茶素没食子酸酯磷脂复合物对改善中药组合物的益智效果并不明显;由对比例3可知,以表没食子儿茶素没食子酸酯替换表没食子儿茶素没食子酸酯磷脂复合物,效果与对比例1相当,表明表没食子儿茶素没食子酸酯不能改善谷氨酸γ-乙基酰胺增强小鼠学习记忆力,仅且当表没食子儿茶素没食子酸酯磷脂复合物与谷氨酸γ-乙基酰胺合用时,中药组合物物的益智效果达到最佳(实施例5)。由对比例4可知,山药萃取物制备过程中不添加稳定剂,即不添加β-环糊精和海藻糖,使山药萃取物活性成分降低,进而使中药组合物的益智效果稍减弱。
试验例三、本发明提供的中药组合物对退行性大脑损伤引起的老年性痴呆症的治疗效果
筛选420例经确诊为退行性大脑损伤引起的老年性痴呆症志愿患者,其中男性220例,女性200例,随机分为7组,每组60例,分别为实施例2组、实施例5组、对比例1-4组和对照组。实施例2、5组和对比例1-4组的志愿患者分别服用实施例2、5和对比例1-4制得的颗粒剂,每次冲服1袋(5g/袋),每日2次。对照组志愿患者服用市售欧立建益智胶囊,每次2~3粒(300mg/粒),每日3次。各组志愿患者连续服用3个月为1疗程,共服用2个疗程,采用阿尔茨海默病评定量表-认知部分(ADAS-cog)对志愿患者的智能变化进行评价,具体为:
疗效指数=(治疗前积分-治疗后积分)/治疗后积分╳100%;
显效:疗效指数≥20%,进步:20%>疗效指数≥10%;无退步:10%>疗效指数≥0%;无效:疗效指数<0%。
并对进行中医证候疗效评价,标准为:
疗效指数=(治疗前积分-治疗后积分)/治疗后积分╳100%;
临床痊愈:患者的症状、体征消失或基本消失,疗效指数>80%;
显效:症状、体征明显改善,疗效指数>50%;
进步:症状、体征均有好转,疗效指数>20%;
无退步:症状、体征无明显变化,疗效指数<20%;
无效:症状、体征加重,疗效指数<0%。结果见表2-3。
表2 ADAS-cog临床疗效比较(2个疗程)
组别 | 例数 | 显效 | 进步 | 无退步 | 无效 | 显效率(%) | 总进步率(%) |
对照组 | 60 | 39 | 6 | 11 | 4 | 65.0 | 75.0 |
实施例2组 | 60 | 41 | 6 | 10 | 3 | 68.3 | 78.3 |
实施例5组 | 60 | 52 | 4 | 4 | 0 | 86.7 | 93.3 |
对比例1组 | 60 | 47 | 4 | 8 | 1 | 78.3 | 85.0 |
对比例2组 | 60 | 40 | 6 | 12 | 2 | 66.7 | 76.7 |
对比例3组 | 60 | 47 | 3 | 7 | 3 | 78.3 | 83.3 |
对比例4组 | 60 | 50 | 4 | 5 | 1 | 83.3 | 90.0 |
表3中医证候疗效评价结果(2个疗程)
由表2和3可知,本发明实施例2制得的中药组合物对退行性大脑损伤引起的老年性痴呆症具有一定的治疗效果,并以实施例5制得的中药组合物疗效最佳,其志愿患者连续服用6个月(2个疗程)后,ADAS-cog临床疗效评价的显效率为86.7%,总进步率为93.3%,显著优于对照药欧立建益智胶囊的效果(显效率为65.0%,总进步率为75.0%),中医证候疗效评价的痊愈率为21.7%,总显效率为86.7%,显著优于对照药欧立建益智胶囊的效果(痊愈率为10.0%,总显效率为70.0%)。对比例1仅添加谷氨酸γ-乙基酰胺而不添加表没食子儿茶素没食子酸酯磷脂复合物,使中药组合物的疗效增强;对比例2添加表没食子儿茶素没食子酸酯磷脂复合物而不添加谷氨酸γ-乙基酰胺,没有使中药组合物的疗效增强;对比例3以表没食子儿茶素没食子酸酯替换表没食子儿茶素没食子酸酯磷脂复合物,效果与对比例1相当;对比例4山药萃取物制备过程中不添加稳定剂,即不添加β-环糊精和海藻糖,使山药萃取物活性成分降低,进而使中药组合物的益智效果稍减弱。
以上结果表明,中药组合物添加谷氨酸γ-乙基酰胺可进一步改善其对退行性大脑损伤引起的老年性痴呆症的疗效,而添加表没食子儿茶素没食子酸酯磷脂复合物对改善中药组合物的疗效并不明显;此外,表没食子儿茶素没食子酸酯不能改善谷氨酸γ-乙基酰胺对退行性大脑损伤引起的老年性痴呆症的疗效,仅且当表没食子儿茶素没食子酸酯磷脂复合物与谷氨酸γ-乙基酰胺合用时,中药组合物物的疗效达到最佳。
以上仅是本发明的优选实施方式,应当指出的是,上述优选实施方式不应视为对本发明的限制,本发明的保护范围应当以权利要求所限定的范围为准。对于本技术领域的普通技术人员来说,在不脱离本发明的精神和范围内,还可以做出若干改进和润饰,这些改进和润饰也应视为本发明的保护范围。
Claims (7)
1.一种益智的中药组合物,其特征在于,所述的中药组合物由以下重量份的制备原料制备而成:核桃仁4~10份、黑芝麻2~8份、桂圆2~8份、牛磺酸0.03~0.05份、山药2~8份、枸杞子1~6份、大枣1~6份、谷氨酸γ-乙基酰胺4~10份和表没食子儿茶素没食子酸酯磷脂复合物2~8份和辅料10~70份;
其中,山药经以下步骤进行制备:
取新鲜山药,洗净,按料液比为1:8的比例加入水,进行匀浆处理,加入0.05%wt混合酶,所述的混合酶为纤维素酶和甘露聚糖酶以3:1的质量比组成,搅拌均匀,于45~50℃保温进行酶解60min,加入2%wt稳定剂,所述的稳定剂为β-环糊精和海藻糖以1:4的质量比组成,在85℃条件下回流提取2次,过滤,合并滤液,往滤液中加入乙醇直至含醇量为90%,静置12h后,在10000r/min,4℃条件下离心15min得沉淀,将沉淀冷冻干燥得到山药萃取物。
2.根据权利要求1所述的益智的中药组合物,其特征在于,所述的表没食子儿茶素没食子酸酯磷脂复合物的制备方法包括以下步骤:
取大豆卵磷脂,加入无水乙醇,配成质量浓度为1%的溶液,然后进行超声处理20~30min,超声频率为30~35kHz,再加入表没食子儿茶素没食子酸酯,搅拌均匀,缓慢升温至40~60℃,在持续搅拌的条件下保温反应3h,减压干燥,将干燥物与氯仿按照1:5的质量比混合进行复溶,在2000rpm/min条件下离心5min除去不溶物,将上清液用0.45μm的非水滤膜过滤后进行减压干燥除去氯仿,即得表没食子儿茶素没食子酸酯磷脂复合物。
3.根据权利要求2所述的益智的中药组合物,其特征在于,所述的表没食子儿茶素没食子酸酯磷脂复合物的制备方法中大豆卵磷脂与表没食子儿茶素没食子酸酯的用量为1:1~2摩尔比。
4.根据权利要求1所述的益智的中药组合物,其特征在于,所述的中药组合物由以下重量份的制备原料制备而成:核桃仁8份、黑芝麻5份、桂圆6份、牛磺酸0.03份、山药5份、枸杞子3份、大枣3份、谷氨酸γ-乙基酰胺8份、表没食子儿茶素没食子酸酯磷脂复合物6份和辅料70份。
5.根据权利要求1所述的益智的中药组合物,其特征在于,所述的辅料为甜味剂、矫味剂和填充剂中的至少一种;
所述的甜味剂为白砂糖、葡萄糖、低聚异麦芽糖、冰糖、乳糖中的至少一种;
所述矫味剂为柠檬酸;
所述填充剂为环糊精、淀粉、微晶纤维素、甘露醇中的至少一种。
6.一种制备如权利要求1所述的益智的中药组合物的方法,其特征在于,包括以下步骤:
(1)取新鲜山药,洗净,按料液比为1:8的比例加入水,进行匀浆处理,加入0.05%wt混合酶,搅拌均匀,于45~50℃保温进行酶解60min,加入2%wt稳定剂,在85℃条件下回流提取2次,过滤,合并滤液,往滤液中加入乙醇直至含醇量为90%,静置12h后,在10000r/min,4℃条件下离心15min得沉淀,将沉淀冷冻干燥得到山药萃取物;
(2)取核桃仁、黑芝麻、桂圆、枸杞子、大枣,洗净,干燥后粉碎,过80目筛,加入药材总重量8~10倍量的水浸泡1~2h,回流提取2~3次,每次3~4小时,过滤并保留滤渣,合并滤液,得水提液;然后往滤渣中加入药材总重量8~10倍量体积分数为60~70%的乙醇,回流提取2~3次,每次3~4小时,过滤,合并滤液,得醇提液;将水提液和醇提液合并,减压干燥,粉碎,过100目筛,得粉末;
(3)将山药萃取物、步骤(2)得到的粉末、谷氨酸γ-乙基酰胺、表没食子儿茶素没食子酸酯磷脂复合物和辅料混合均匀,即得中药组合物;
所述步骤(1)中的混合酶为纤维素酶和甘露聚糖酶以3:1的质量比组成;稳定剂为β-环糊精和海藻糖以1:4的质量比组成。
7.根据权利要求1-5任一所述的益智的中药组合物的应用,其特征在于,所述的中药组合物可进一步制成颗粒剂、胶囊剂、口服液或固体饮料。
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