CN115414448B - 一种具有神经保护作用的中药组合物、制备方法及应用 - Google Patents
一种具有神经保护作用的中药组合物、制备方法及应用 Download PDFInfo
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Abstract
本发明公开了一种具有神经保护作用的中药组合物、制备方法及应用。所述中药组合物,包括百合、甘草、小麦、大枣和富含神经酸的植物油。本发明在原有古方甘麦大枣汤的基础上进行加减化裁,联合功效油品,得到了中药组合物,经实验证明该中药组合物降低血清皮质酮含量、提高血清中5‑HT/5‑HIAA水平、降低氧化应激和下调炎症因子综合作用发挥干预神经系统,起到保护神经的功能,抗抑郁效果显著。
Description
技术领域
本发明涉及中药技术领域,具体来说,涉及一种具有神经保护作用的中药组合物、制备方法及应用。
背景技术
甘麦大枣汤出自于汉代名医张仲景的《金匮要略》,由炙甘草、大枣、小麦三味药材组成。主治情志不舒,肝郁化火伤阴,思虑过度,心脾两伤导致的脏阴不足,心神失养,躁扰不宁的脏躁症,是古今医家用来治疗精神类疾病的主要方剂。
炙甘草甘温,益气和中,调和诸药。炙甘草的作用真谛为“甘缓”缓急,缓心之急,是缓心神之急而缓急止悸,以治“心动悸”之标急。同时指出了炙甘草“甘缓”缓急,不止于缓心之急,更在于缓众病之急而“主五脏六腑寒热邪气”。
小麦性凉,味甘咸,入心、脾、肾经。具有益气、除热、止汗之功效,但止汗是其主要功能,阳虚自汗、骨蒸劳热、阴虚盗汗均可应用。小麦还有益气养阴功效,可用于阴虚发热、骨蒸劳热等,常与玄参、麦冬、生地、地骨皮等同用,起到养阴清热、敛汗除蒸的作用。
大枣的应用始载于《神农本草经》,列为上品。称其为“性甘、平,主心腹邪气,安中养神,助十二经,平胃气,通九窍,补少气、少精液、身中不足、大惊、四肢重,和百药作为中医临床常用补益药,味甘、性温,归脾、胃经,具有补中益气,养血安神之功。也是国家公布的药食同源之品,古今均将其作为健脾专药,益气养血佳品。
CN108888722A公开了一种具有安神治疗失眠的药食同源中药大枣怡神颗粒,是由以下重量计的原料药物:大枣5-7g、玫瑰花2.5-3.5g、桔梗2.5-3.5g、莲子4-5g、浮小麦2.5-3.5g、甘草2.5-3.5g、莱菔子3.5-5.5g、炒山楂2.5-3.5g和陈皮2-3g制成,该发明原料丰富,制备方法简单,组分配伍科学合理,组分间互相支持,具有宁心安神,治疗失眠之功效。
CN105614548A公开了一种可宁心安神的小麦百合汤,其包含以下重量份的原材料:小麦30-50份、甘草20-40份、百合20-40份、生地10-30份、黄精10-30份、生龙骨10-30份、大枣20-50份、茯苓10-30份、水300-600份。该发明配方科学,原料易得,重点突出,能清热滋阴、宁心安神,无毒副作用,对肝肾阴亏、腰软无力、头晕失眠者有很好的疗效。
百合地黄汤,由百合、生地黄组成,具有养阴清热、补益心肺等功效。目前广泛应用于神经病学与精神病学、中医内科学等研究领域,常用于抑郁症、失眠、妇女更年期综合征等临床治疗。文冠果油具有抗炎、改善记忆、改善心血管等功效。经检索,目前尚未发现文冠果油与甘草、小麦和大枣联合的研究。
发明内容
本发明的目的在于提供一种具有神经保护作用的中药组合物及其制备方法,该中药组合物富含神经酸的植物油与百合、甘草、小麦和大枣进行复配,具有较好的营养神经、调节情绪的功效。
为了实现上述目的,本发明采用以下技术方案:
一种具有保护神经作用的中药组合物,包括百合、甘草、小麦、大枣和植物油。
优选地,所述植物油为富含神经酸的植物油;进一步优选为文冠果油。
优选地,所述中药组合物,包括百合25-35份、甘草8-12份、小麦20-40份、大枣25-35份和植物油15-50份,最优选地,所述中药组合物,包括百合30份、甘草10份、小麦30份、大枣30份和植物油20份。
本发明中,当中药组合物中百合、甘草、小麦和大枣的重量份为g,则对应所述植物油的重量份为mL,当百合、甘草、小麦和大枣的重量份为kg,则对应所述植物油的重量份为L。
本发明还提供了上述中药组合物的制备方法,包括以下步骤:
S1、将配方量的百合、甘草、小麦和大枣混合粉碎,水煎煮,过滤得到滤液,浓缩干燥,得到混合提取物;
S2、将配方量的文冠果油与β-环糊精水溶液包合,过滤,低温干燥,得到文冠果油中间体;
S3、将步骤S1得到的混合提取物、步骤S2得到的文冠果油中间体混合均匀,得到所述中药组合物。
优选地,步骤S1中所述浓缩干燥为:55-60℃真空浓缩5-8h后,采用低温冻干技术冻干至粉末或喷雾干燥至粉末。
优选地,步骤S2中所述文冠果油与β-环糊精水溶液的体积比为1:29-58。
进一步优选地,所述β-环糊精水溶液的质量百分数为4-12%。
优选地,步骤S2中所述包合的条件为:35-40℃搅拌2-2.5h,转速1380-1500rpm。
优选地,步骤S2中所述干燥为35±2℃下鼓风干燥6-10h;或40℃下真空干燥8-12h。
优选地,所述神经保护作用为通过降低血清皮质酮含量、提高血清中5-HT/5-HIAA水平、降低氧化应激和下调炎症因子综合作用发挥干预神经系统,起到保护神经的功能。
进一步优选地,所述炎症因子包括前额皮质层的IL-6和TNF-α。
本发明的有益效果为:
本发明在原有古方甘麦大枣汤的基础上进行加减化裁,服用功效油品,得到了本发明的中药组合物,经实验证明该中药组合物具有降低血清皮质酮含量、提高血清中5-HT/5-HIAA水平、降低氧化应激和下调炎症因子等功能,协同发挥保护和营养神经的功能。相比现有技术,本发明中药组合物的抗抑郁效果更佳。
具体实施方式
以下实施例的说明只是用于帮助理解本发明的方法及其核心思想。应当指出,对于本技术领域的普通技术人员来说,在不脱离本发明原理的前提下,还可以对本发明进行若干改进和修饰,这些改进和修饰也落入本发明权利要求的保护范围内。对所公开的实施例的下述说明,使本领域专业技术人员能够实现或使用本发明。对这些实施例的多种修改对本领域的专业技术人员来说将是显而易见的,本文中所定义的一般原理可以在不脱离本发明的精神或范围的情况下,在其它实施例中实现。因此,本发明将不会被限制于本文所示的这些实施例中,而是可以应用于符合与本文所公开的原理和新颖特点相一致的更宽的范围。虽然在本发明的实施或测试中可以使用与本发明中所述相似或等价的任何方法和材料,本文在此处列举优选的方法和材料。
除非另外定义,本文中使用的所有技术和科学术语具有与本发明所属技术领域的普通技术人员通常理解的相同意义。
本发明实施例中的文冠果油由文冠果压榨或超临界萃取而得。
实施例1
一种具有保护神经作用的中药组合物,含百合25g、甘草8g、小麦20g、大枣35g和文冠果油15mL。
上述中药组合物的制备方法为:
S1、将配方量的百合、甘草、小麦和大枣混合粉碎,水煎煮1次,时间2h,过滤得到滤液,在60℃下浓缩干燥8h后低温冻干24h,得到混合提取物;
S2、将20gβ-环糊精水溶解到250ml水中,加入5ml文冠果油,在40℃搅拌2h,转速1380rpm,过滤,35℃下鼓风干燥8h,得到文冠果油中间体; S3、将步骤S1得到的混合提取物、步骤S2得到的文冠果油中间体混合均匀,得到所述中药组合物。
实施例2
一种具有保护神经作用的中药组合物,含百合35g、甘草12g、小麦40g、大枣25g和文冠果油50mL。
上述中药组合物的制备方法为:
S1、将配方量的百合、甘草、小麦和大枣混合粉碎,水煎煮1次,时间2h,过滤得到滤液,在60℃下浓缩干燥4h后喷雾干燥,得到混合提取物;
S2、将50gβ-环糊精水溶解到500ml水中,加入50ml文冠果油,在35℃搅拌2.5h,转速1500rpm,过滤,40℃下真空干燥12h,得到文冠果油中间体;
S3、将步骤S1得到的混合提取物、步骤S2得到的文冠果油中间体混合均匀,得到所述中药组合物。
实施例3
一种具有保护神经作用的中药组合物,含百合30g、甘草10g、小麦30g、大枣30g和文冠果油20mL。
上述中药组合物的制备方法为:
S1、将配方量的百合、甘草、小麦和大枣混合粉碎,水煎煮1次,时间2h,过滤得到滤液,在55℃下浓缩干燥6h后低温冻干30h,得到混合提取物;
S2、将配方量的文冠果油与β-环糊精水溶液包合,过滤,35℃下鼓风干燥8h,得到文冠果油中间体;
S2、将100gβ-环糊精水溶解到1000ml水中,加入20ml文冠果油,在37℃搅拌2.5h,转速1400rpm,过滤,35℃下鼓风干燥20h,得到文冠果油中间体;
S3、将步骤S1得到的混合提取物、步骤S2得到的文冠果油中间体混合均匀,得到所述中药组合物。
对比例1
一种具有保护神经作用的中药组合物,含百合30g、甘草10g、小麦30g和大枣30g。
上述中药组合物的制备方法为:
将配方量的百合、甘草、小麦和大枣混合粉碎,水煎煮1次,时间2h,过滤得到滤液,在55℃下浓缩干燥6h后低温冻干30h,得到混合提取物;即为所述中药组合物。
对比例2
一种具有保护神经作用的中药组合物,含百合10g、甘草30g、小麦10g、大枣40g和文冠果油20mL。
上述中药组合物的制备方法为:
S1、将配方量的百合、甘草、小麦和大枣混合粉碎,水煎煮1次,时间2h,过滤得到滤液,在55℃下浓缩干燥6h后低温冻干30h,得到混合提取物;
S2、将100gβ-环糊精水溶解到1000ml水中,加入20ml文冠果油,在37℃搅拌2.5h,转速1400rpm,过滤,35℃下鼓风干燥20h,得到文冠果油中间体;
S3、将步骤S1得到的混合提取物、步骤S2得到的文冠果油中间体混合均匀,得到所述中药组合物。
为了进一步理解本发明的技术方案及其效果,下面结合动物实验考察其在抗抑郁以及降低血清皮质酮含量、提高血清中5-HT/5-HIAA水平、降低氧化应激和下调炎症因子四个方面所能达到的技术效果。
1.实验动物
SD大鼠,雄性,8周。
2、抑郁症动物模型建模方法
采用慢性不可预知温和刺激(CUMS)结合孤养模型进行建模。
应激方法包括:①禁食24h;②禁水24h;③4℃冰水游泳5min;④夹尾1min;⑤束缚4h;⑥潮湿垫料及倾斜45°;⑦昼夜颠倒。每天给予一种刺激,顺序随机,使动物不能预料刺激的发生。单笼喂养的造模动物以出现下列情况作为模型成功的指标:活动量减少,摄食减少,体重下降,快感缺乏和兴趣退化等现象。
3、实验分组和给药
将抑郁症动物模型大鼠随机分为7组,分别为给药组S1、S2、S3、D1和D2以及正常组和模型组,每组6只。其中,给药组S1、S2和S3分别灌胃实施例1-3制备的中药组合物,给药组D1和D2分别灌胃对比例1-2制备的中药组合物,每日灌胃一次,每日给药剂量为3mg/kg,连续给药5周;正常组和模型组每日灌胃等体积生理盐水。
同时,给药期间,给药组和模型组继续进行造模饲养,正常组正常饲养。
4、行为学评价
(1)糖水偏好度实验:实验前各个实验组大鼠进行糖水适应性训练。在测试时,每个笼子分别放入两瓶等体积的1%(w/v)蔗糖水溶液和纯水,大鼠24小时自由饮水,测试期间交换两个水瓶位置,避免记忆影响。记录实验期间的总液体消耗,糖水消耗和纯水消耗。
糖水偏爱度=蔗糖水溶液消耗量/(蔗糖水溶液+纯水消耗总量)*100%。
(2)强迫游泳实验:实验于直径30 cm,高60 cm、水深 40 cm的玻璃圆形桶中进行,水温25±1℃。实验前一天,将大鼠置于桶内进行15 min强迫游泳以适应环境。24 h后进行正式实验,记录大鼠5min内的不动时间。不动状态定义为大鼠在水中停止挣扎、呈漂浮状态,或仅有细小肢体动作以保持身体不下沉漂浮于水面。
5、生化指标
采用ELISA试剂盒测定血清中皮质酮、5-羟色胺、5-羟基吲哚乙酸及炎症因子IL-6、TNF-α含量,前额皮质层的炎症因子 IL-6、TNF-α及氧化应激指标MDA、NO(上海酶联生物科技有限公司)。
6、实验结果
6.1抗抑郁行为评价
糖水偏爱实验和强迫游泳实验是检测动物抑郁行为的经典方法。通过行为学检测评估各组大鼠的行为差异,如表1所示,研究发现与正常组大鼠相比,抑郁症模型组大鼠糖水偏好指数明显降低,游泳不动时间明显增加,表明模型组大鼠出现快感缺乏及行为绝望等精神障碍行为。
相比模型组,灌胃本发明中药组合物的给药组S1-S3均能增加大鼠对于糖水的偏好度,且明显降低游泳不动时间(P<0.05),具有良好的抗抑郁作用,而给药组D1-D2对增加大鼠对糖水的偏好度,降低游泳不动时间均无明显改善。
表1 大鼠的糖水偏好度及游泳不动时间(平均值±方差)
6.2 生化指标检测
(一)降低血清皮质酮含量
下丘脑-垂体-肾上腺(HPA)轴功能亢进是抑郁症的发病机制之一,也是抑郁症患者常见的神经生物学异常表现之一。皮质酮是由肾上腺皮质分泌的一种皮质激素类二十一碳甾体激素,对机体发育生长、生理代谢以及免疫功能有直接的影响。皮质酮通过与两类胞内受体,糖皮质激素受体和盐皮质激素受体结合蛋白影响神经元的功能。在应激及衰老等情况下,皮质酮水平升高,可导致海马形态与功能损伤,包括CA3区椎体神经元顶树突的萎缩,海马神经元长时程增强的抑制、学习与记忆功能的损伤等。
如表2所示,研究表明模型组抑郁症大鼠血清皮质酮水平与正常大鼠相比呈上升趋势(P<0.01),而与模型组相比,给药组S1-S3大鼠的皮质醇水平均明显下降(P<0.05,P<0.01),且给药组S3对于皮质酮的抑制效果优于其他组,同时,与模型组相比,给药组D1和D2大鼠的皮质醇水平无显著性差异(P>0.05)。
表2大鼠的血清皮质酮含量(μg/L)(平均值±方差)
(二)提高血清中5-HT/5-HIAA水平
5-羟色胺(5-HT)是机体内的一种吲哚衍生物,广泛存在于哺乳动物组织中,特别在大脑皮层质及神经突触内含量很高,可作为神经递质在整个神经元之间传递信号。5-HT的合成是色氨酸在色氨酸羟化酶作用下生成5-羟色氨酸,再经5-羟色氨酸脱羧酶在中枢神经元及动物(包含人类)消化道之肠嗜铬细胞中合成。在单胺氧化酶作用下,5-HT经肝脏代谢降解为5-羟基吲哚乙酸(5-HIAA)。5-HT/5-HIAA水平涉及多个生理系统,包括调节心情、食欲和睡眠以及认知功能。
如表3所示,与正常组相比,模型组大鼠的5-HT/5-HIAA水平显著升高(P<0.05),而与模型组相比,给药组S1-S3大鼠的5-HT/5-HIAA水平显著降低,表明本发明的中药组合物能够降低血清中5-HT/5-HIAA比值(P<0.05),说明本发明的中药组合物可通过对5-HT代谢调节发挥效应。
表3大鼠5-HT/5-HIAA水平(平均值±方差)
(三)降低氧化应激
氧化应激,尤其是长期的氧化应激是引起抑郁最重要因素之一。氧化应激水平增高可能造成严重的神经元损伤,进而加重疾病严重程度。大量研究显示,抑郁症患者脑中脂质过氧化物丙二醛(MDA)、一氧化氮(NO)含量较正常对照组的明显增高。在本发明中,采用ELISA试剂盒对前额皮质层中的MDA和NO含量进行检测。
如表4所示,结果表明模型组大鼠,相比正常组大鼠,其前额皮质层MDA和NO含量显著增加(P<0.01),同时,相比模型组,给药组S1-3的抑郁症大鼠接受给药治疗后,其MDA和NO水平显著下降(P<0.05,P<0.01),表明本发明的中药组合物可以减轻机体氧化应激反应。
同时,相比模型组,给药组D1和D2的抑郁症大鼠接受给药治疗后,其MDA和NO水平物下降水平无显著性差异(P>0.05)。
表4大鼠前额皮质层MDA含量(nmol/L)和NO含量(μmol/L)(平均值±方差)
(四)下调炎症因子
炎症反应是免疫系统为清除有害刺激或病源体,促进组织修复的保护措施,各种促炎性因子会引发人体组织发炎。抑郁症患者炎性细胞因子释放和炎症反应都较正常人显著活跃。炎症因子在外周的效应是产生炎症反应,在中枢的作用是启动抑郁样行为。本发明对前额皮质层的促炎因子IL-6和TNF-α进行检测。
如表5所示,研究发现模型组大鼠促炎因子IL-6、TNF-α较正常组明显升高(P<0.05,P<0.01),相比模型组,给药组S1-S2大鼠促炎因子IL-6、TNF-α在中药组合物给药后显著下降(P<0.05,P<0.01),而给药组D1-D2大鼠促炎因子IL-6、TNF-α与模型组相比无显著性差异。
结果表明本发明的中药组合物能够抑郁症大脑神经炎症介质水平的升高,发挥其抗炎作用。
表5大鼠前额皮质层Il-6(pg/mL)和INT-α(ng/L)(平均值±方差)
综上所述,经实验证明,本发明的中药组合物,利用富含神经酸的文冠果油与百合、甘草、小麦和大枣进行复配,通过降低血清皮质酮含量、提高血清中5-HT/5-HIAA水平、降低氧化应激和下调炎症因子的综合作用发挥干预神经系统,起到保护神经的功能,抗抑郁效果显著。
以上是结合具体实施例对本发明进一步的描述,但这些实施例仅仅是范例性的,并不对本发明的范围构成任何限制。本领域技术人员应该理解的是,在不偏离本发明的精神和范围下可以对本发明技术方案的细节和形式进行修改或替换,但这些修改和替换均落入本发明的保护范围内。
Claims (5)
1.一种具有保护神经作用的中药组合物,其特征在于,由以下重量份的组分制成:百合25-35份、甘草8-12份、小麦20-40份、大枣25-35份和植物油15-50份;
所述植物油为文冠果油;
所述的中药组合物的制备方法,包括以下步骤:
S1、将配方量的百合、甘草、小麦和大枣混合粉碎,水煎煮,过滤得到滤液,浓缩干燥,得到混合提取物;
S2、将配方量的文冠果油与β-环糊精水溶液包合,过滤,低温干燥,得到文冠果油中间体;
S3、将步骤S1得到的混合提取物、步骤S2得到的文冠果油中间体混合均匀,得到所述中药组合物。
2.根据权利要求1所述的中药组合物,其特征在于,由以下重量份的组分制成:百合30份、甘草10份、小麦30份、大枣30份和植物油20份。
3.权利要求1-2任一项所述的中药组合物的制备方法,其特征在于,包括以下步骤:
S1、将配方量的百合、甘草、小麦和大枣混合粉碎,水煎煮,过滤得到滤液,浓缩干燥,得到混合提取物;
S2、将配方量的文冠果油与β-环糊精水溶液包合,过滤,低温干燥,得到文冠果油中间体;
S3、将步骤S1得到的混合提取物、步骤S2得到的文冠果油中间体混合均匀,得到所述中药组合物。
4.根据权利要求3所述的制备方法,其特征在于,步骤S2中所述文冠果油与β-环糊精水溶液的体积比为1:29-58。
5.根据权利要求3所述的制备方法,其特征在于,所述β-环糊精水溶液的质量百分数为4-12%。
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