CN109432181A - 缓解抑郁症的组合物及其制备方法与应用 - Google Patents
缓解抑郁症的组合物及其制备方法与应用 Download PDFInfo
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Abstract
本发明属于保健产品技术领域,公开了一种缓解抑郁症的组合物及其制备方法与应用,组合物包括NMN、NADPH、人参皂苷PPD、人参皂苷Rh2、枸杞多糖、远志和活性成分,活性成分为牛磺酸、磷脂酰丝氨酸、硫酸软骨素、熊去氧胆酸、燕窝酸、s‑腺苷蛋氨酸、γ‑氨基丁酸、虾青素、焦谷氨酸酯中的至少一种。上述各组分协同发挥作用,提供了一种全方位、针对多个环节的缓解抑郁症的保健组合物,该组合物对提高细胞供氧量、加速大脑神经细胞再生、促进大脑对养分的吸收、调节抗抑郁激素的分泌平衡具有很大功效,对缓解抑郁症具有明显的治疗效果,临床观察,其治疗效果可达98%以上,组合物的原生药材均为植物药,为药物的安全性提供了最佳的保障。
Description
技术领域
本发明属于保健产品技术领域,具体地说涉及一种用于缓解抑郁症的组合物、制剂及其制备方法与应用。
背景技术
抑郁症又称抑郁障碍,以显著而持久的心境低落为主要临床特征,是心理障碍的主要类型,近些年来已逐渐成为危害人们身心健康的常见多发并,全过抑郁症患者估计有3000万以上,而在患有高血压、冠心病、糖尿病甚至癌症等疾病的人群中,抑郁症发病率更是高达50%,而严重的抑郁症患者存在自杀倾向,由此引发一系列重大家庭、社会问题和经济损失。
目前,抗抑郁药物普遍为西药,如基于单胺假说的抗抑郁药物:单胺氧化酶抑制剂、丙咪嗪、帕罗西汀、氟西汀、艾司西酞普兰;基于HPA轴功能异常的抗抑郁药物:Antalarmin、R121919、地昔帕明;基于氨基酸、肽类的抗抑郁药物:拉莫三嗪、依利罗地;上述抗抑郁西药药物疗效确切,但同时也存在毒副作用大、容易产生药物依赖、病情易反复等问题。
这些化学药物或多或少都有人们接受不了的不良反应,无法对普遍的抑郁症下降人群用药。目前国内市场上也有一些中成药的产品,但是大多数存在效果不佳或成份复杂的缺陷。
发明内容
为此,本发明正是要解决上述技术问题,从而提出一种安全、无毒副作用的缓解抑郁症的组合物及其制备方法与应用。
为解决上述技术问题,本发明的技术方案为:
本发明提供一种缓解抑郁症的组合物,其包括NMN、NADPH、人参皂苷PPD、人参皂苷Rh2、枸杞多糖、远志和活性成分,所述活性成分为牛磺酸、磷脂酰丝氨酸、硫酸软骨素、熊去氧胆酸、燕窝酸、s-腺苷蛋氨酸、γ-氨基丁酸、虾青素、焦谷氨酸酯中的至少一种;
优选的,所述活性成分为牛磺酸、磷脂酰丝氨酸、硫酸软骨素、熊去氧胆酸、燕窝酸、s-腺苷蛋氨酸、γ-氨基丁酸、虾青素、焦谷氨酸酯中的至少五种。
作为优选,以重量份计,所述组合物包括如下组分:NMN 1-10份、NADPH 1-10份、人参皂苷PPD1-10份、人参皂苷Rh2 1-10份、枸杞多糖1-10份、远志1-10份、活性成分1-10份;
优选的,以重量份计,所述组合物包括如下组分:NMN 2-8份、NADPH 2-9份、人参皂苷PPD 2.5-8份、人参皂苷Rh2 2-8.5份、枸杞多糖2-8份、远志2-9份、活性成分2-8份;
优选的,以重量份计,所述组合物包括如下组分:NMN 5份、NADPH 5.5份、人参皂苷PPD 5份、人参皂苷Rh2 5份、枸杞多糖5.5份、远志6份、活性成分6份。
作为优选,以重量份计,所述组合物包括如下组分:NMN 3-7份、NADPH 2.5-8份、人参皂苷PPD 3-7份、人参皂苷Rh2 3-7份、枸杞多糖3-7.5份、远志3-7份、牛磺酸0.2-0.7份、磷脂酰丝氨酸0.3-1.1份、硫酸软骨素0.2-1份、熊去氧胆酸0.2-1.5份、燕窝酸0.3-1.3份、s-腺苷蛋氨酸0.1-0.7份、γ-氨基丁酸0.2-1份、虾青素0.2-0.8份、焦谷氨酸酯0.2-0.8份;
优选的所述组合物包括如下组分:NMN 5份、NADPH 6份、人参皂苷PPD 5.5份、人参皂苷Rh2 5.7份、枸杞多糖4.8份、远志5份、牛磺酸0.5份、磷脂酰丝氨酸0.8份、硫酸软骨素0.6份、熊去氧胆酸0.8份、燕窝酸0.9份、s-腺苷蛋氨酸0.5份、γ-氨基丁酸0.7份、虾青素0.6份、焦谷氨酸酯0.5份。
本发明还提供一种制备所述的组合物的方法,将所述缓解抑郁症的组合物各组分按照配比混合均匀,即得。
本发明还提供一种缓解抑郁症的组合物的应用,将所述组合物用于制备药物制剂或保健食品。
本发明还提供一种缓解抑郁症的药物制剂,其包括所述的组合物和辅料。
作为优选,所述辅料为尼泊金复合酯、富马酸、磷酸盐、木糖醇、微晶纤维素、失水山梨醇脂肪酸酯、硬脂酸镁、交联羧甲基纤维素钠、氢氧化镁、预胶化淀粉、硫酸钙、气相二氧化硅、乳糖中的至少一种;
优选的,所述辅料的重量份数为1-10份。
作为优选,所述辅料为尼泊金复合酯、富马酸、磷酸盐、木糖醇、微晶纤维素、失水山梨醇脂肪酸酯、硬脂酸镁、交联羧甲基纤维素钠、氢氧化镁、预胶化淀粉、硫酸钙、气相二氧化硅、乳糖中的三种。
作为优选,所述辅料由尼泊金复合酯、富马酸、磷酸盐、木糖醇、微晶纤维素、失水山梨醇脂肪酸酯、硬脂酸镁、交联羧甲基纤维素钠、氢氧化镁、预胶化淀粉、硫酸钙、气相二氧化硅、乳糖组成。
作为优选,所述药物制剂为片剂、口服液剂、胶囊剂、颗粒剂、注射剂、酊剂、栓剂、贴剂、丸剂、糖浆剂、合剂、散剂、膜剂、滴丸中的一种。
本发明的上述技术方案相比现有技术具有以下优点:
(1)本发明所述的缓解抑郁症的组合物,包括NMN、NADPH、人参皂苷PPD、人参皂苷Rh2、枸杞多糖、远志和活性成分,所述活性成分为牛磺酸、磷脂酰丝氨酸、硫酸软骨素、熊去氧胆酸、燕窝酸、s-腺苷蛋氨酸、γ-氨基丁酸、虾青素、焦谷氨酸酯中的至少一种。上述各组分协同发挥作用,提供了一种全方位、针对多个环节的缓解抑郁症的保健组合物,该组合物对提高细胞供氧量、加速大脑神经细胞再生、促进大脑对养分的吸收、调节抗抑郁激素的分泌平衡具有很大功效,该组合物是发明人在长期的实践中对中医方术结合现代工艺精心研制的结果,对缓解抑郁症具有明显的治疗效果,临床观察,其治疗效果可达98%以上,组合物的原生药材均为植物药,为药物的安全性提供了最佳的保障,也为中药治疗抑郁症的药物研发开辟了新天地。
(2)在传统配方的基础上,首次加用NMN(烟酰胺单核苷酸)、NADPH(还原型辅酶Ⅱ,学名还原型烟酰胺腺嘌呤二核苷酸磷酸)、人参皂苷PPD、人参皂苷Rh2等明确有效的成分,现有技术中,NMN、NADPH、人参皂苷PPD、人参皂苷Rh2仅作为原料被单独使用,尚无将四者共同使用以缓解抑郁症的报道,所述组合物中西医理论相呼应,通过加入各类特定的活性成分,能够显著提高对抑郁症的缓解效果,以上组分产生了协同增效作用,通过调配使得各个组分的功效得到了1+1>2的技术效果。
(3)本发明所述的缓解抑郁症的组合物可用于制备药物制剂或保健食品。填补了目前食品行业中缓解抑郁症食品的空缺和替代药物缓解抑郁症的保健药品的空缺。
具体实施方式
为了使本发明的内容更容易被清楚的理解,下面根据本发明的具体实施例并对本发明作进一步详细的说明。
实施例1
本实施例提供一种缓解抑郁症的组合物,其包括NMN、NADPH、人参皂苷PPD、人参皂苷Rh2、枸杞多糖、远志和活性成分,所述活性成分为牛磺酸、磷脂酰丝氨酸、硫酸软骨素、熊去氧胆酸、燕窝酸、s-腺苷蛋氨酸、γ-氨基丁酸、虾青素、焦谷氨酸酯中的至少一种。
所述活性成分可以为牛磺酸、磷脂酰丝氨酸、硫酸软骨素、熊去氧胆酸、燕窝酸、s-腺苷蛋氨酸、γ-氨基丁酸、虾青素、焦谷氨酸酯中的一种;或者所述活性成份为牛磺酸、磷脂酰丝氨酸、硫酸软骨素、熊去氧胆酸、燕窝酸、s-腺苷蛋氨酸、γ-氨基丁酸、虾青素、焦谷氨酸酯中的几种,优选为至少五种,优选的,至少四种;优选的,至少三种,优选的,至少两种。或者所述活性成分包括牛磺酸、磷脂酰丝氨酸、硫酸软骨素、熊去氧胆酸、燕窝酸、s-腺苷蛋氨酸、γ-氨基丁酸、虾青素、焦谷氨酸酯。
本实施例中,所述活性成分为牛磺酸。以重量份计,所述缓解抑郁症的组合物包括NMN 1份、NADPH 10份、人参皂苷PPD 1份、人参皂苷Rh2 10份、枸杞多糖1份、远志10份、牛磺酸1份。
本实施例还提供制备所述组合物的方法:将上述组分按照比例混合均匀,即得缓解抑郁症的组合物。
所述缓解抑郁症的组合物可用于制备药物制剂或保健食品,其中药物制剂可为片剂、胶囊剂、颗粒剂、注射剂、酊剂、栓剂、贴剂、丸剂、糖浆剂、合剂、散剂、膜剂、滴丸中的一种。
对于药物制剂,其包括所述改善骨质疏松的组合物和辅料,所述辅料为尼泊金复合酯、富马酸、磷酸盐、木糖醇、微晶纤维素、失水山梨醇脂肪酸酯、硬脂酸镁、交联羧甲基纤维素钠、氢氧化镁、预胶化淀、硫酸钙、气相二氧化硅、乳糖中的至少一种,本实施例中,所述辅料为交联羧甲基纤维素钠,其重量份为1份。
本实施例中,所述药物制剂为口服液剂,所述口服液剂通过如下方法制备:将干燥好的组合物和辅料分别过30-80目筛,使粒度分布均匀,流动性更好,组合物和辅料保持干燥,然后进行配比称重,加水在25-40℃下充分搅拌均匀后,升温至50℃,搅拌1h,即得。
本实施例还提供一种保健食品,所述保健食品包括所述组合物和适量可接受的食品辅料,所述食品辅料包括山梨糖醇、麦芽糊精、柠檬酸、麦芽糖、磷脂、羟丙基淀粉中的至少一种或其它常规食品辅料。
实施例2
本实施例提供一种缓解抑郁症的组合物,以重量份计,所述组合物包括:NMN 10份、NADPH 1份、人参皂苷PPD 10份、人参皂苷Rh2 1份、枸杞多糖10份、远志1份、磷脂酰丝氨酸6份、硫酸软骨素4份,所述组合物采用实施例1所述的方法制备。
本实施例还提供一种药物制剂,所述药物制剂包括所述组合物和辅料,所述辅料以重量份计,包括5份交联羧甲基纤维素钠、4份富马酸、1份木糖醇。本实施例中,所述药物制剂为颗粒剂,其通过如下方法制备:将干燥好的组合物和辅料分别过60目筛,使颗粒粒度分布均匀,流动性更好,所述组合物和辅料保持干燥,然后将组合物和辅料配比称重后,搅拌均匀,并在制粒机中进行制粒,即得颗粒剂。
实施例3
本实施例提供一种缓解抑郁症的组合物,以重量份计,所述组合物包括:NMN 2份、NADPH 9份、人参皂苷PPD 2.5份、人参皂苷Rh2 8.5份、枸杞多糖2份、远志9份、活性成分2份,所述活性成分包括熊去氧胆酸、燕窝酸、s-腺苷蛋氨酸、γ-氨基丁酸、虾青素,所述活性成分中各组分的质量比为1:1:2:1:2。所述组合物采用实施例1所述的方法制备。
本实施例还提供一种药物制剂,所述药物制剂包括所述组合物和辅料,所述辅料的重量份为7份,所述辅料包括木糖醇、失水山梨醇脂肪酸酯、硬脂酸镁、交联羧甲基纤维素钠、氢氧化镁、预胶化淀粉,上述辅料组分的质量比为1:2:1:2:3:1。所述药物制剂为片剂,其通过如下方法制备:首先由实施例2所述的方法制得颗粒,然后将颗粒放入压片机,调节压片机参数进行压片,理论片重为500mg,最后进行薄膜包衣、检验和包装。
实施例4
本实施例提供一种缓解抑郁症的组合物,以重量份计,所述组合物包括:NMN 8份、NADPH 2份、人参皂苷PPD 8份、人参皂苷Rh2 2份、枸杞多糖8份、远志2份、活性成分8份,所述活性成分包括牛磺酸、燕窝酸、s-腺苷蛋氨酸、γ-氨基丁酸、焦谷氨酸酯,所述活性成分中各组分的质量比为1:2:1:3:1。所述组合物采用实施例1所述的方法制备。
本实施例还提供一种药物制剂,所述药物制剂包括所述组合物和辅料,所述辅料的重量份为6份,所述辅料包括预胶化淀粉、富马酸、磷酸盐、木糖醇、硫酸钙、气相二氧化硅,上述辅料组分的质量比为1:2:1:2:1:1。
所述药物制剂为胶囊剂中的软胶囊,其通过如下方法制备:
(1)配制内容物:首先将干燥好的组合物和辅料分别过60目筛并保持干燥,然后将组合物和辅料配比称重,均和均匀。
(2)软胶囊体制备:先将甘油和水加入溶胶罐中,随后分别加入明胶和相关辅料,搅拌,真空脱气,制得软胶囊体。
(3)制备软胶囊:将所述内容物和软胶囊体经过压丸、定型干燥、洗丸、晾丸、捡丸和包装等步骤,制得软胶囊。
实施例5
本实施例提供一种缓解抑郁症的组合物,以重量份计,所述组合物包括:NMN 5份、NADPH 5.5份、人参皂苷PPD 5份、人参皂苷Rh2 5份、枸杞多糖5.5份、远志6份、活性成分6份,所述活性成分包括磷脂酰丝氨酸、燕窝酸、s-腺苷蛋氨酸、γ-氨基丁酸、虾青素、焦谷氨酸酯,所述活性成分中各组分的质量比为1:1.3:3:1:2:1.5。所述组合物采用实施例1所述的方法制备。
本实施例还提供一种药物制剂,所述药物制剂包括所述组合物和辅料,所述辅料的重量份为5.5份,所述辅料由尼泊金复合酯、富马酸、磷酸盐、木糖醇、微晶纤维素、失水山梨醇脂肪酸酯、硬脂酸镁、交联羧甲基纤维素钠、氢氧化镁、预胶化淀粉、硫酸钙、气相二氧化硅、乳糖组成,上述辅料中各组分的质量比为1:1:2:3:1:2:3:1.5:2:1:1:1.5:3。
所述药物制剂为胶囊剂中的硬胶囊,其通过如下方法制备:
S1:取活性成分碎成粗颗粒,加5倍量70%的乙醇加热回流提取2h,滤过;药渣再加3倍量70%的乙醇加热回流提取1h,滤过,滤液合并,回收乙醇并减压浓缩至60℃下相对密度为1.35~1.40的稠膏,备用。
S2:将步骤1所得的产物加7倍量的水,加热回流提取挥发油4h,分取分层的挥发油,备用;药渣和药液粗滤,滤液离心分离,上清液和药渣分别保存备用。
S3:取NMN、NADPH、人参皂苷PPD、人参皂苷Rh2、硫酸软骨素、牛磺酸与S2步骤得到的挥发油后药渣合并,加水煎煮提取二次,第一次加18倍量水提取2h,第二次加12倍量水提取1h,粗滤,滤液离心分离,两次提取的上清液与S2步骤得到的提取挥发油后的上清液合并,减压浓缩至60℃下相对密度为1.35~1.40的稠膏,备用。
S4:取糊精、微粉硅胶,混匀,加入到上述S1步骤得到的水提浓缩稠膏与S3步骤得到的醇提浓缩稠膏中,充分搅拌均匀,铺层,真空干燥,粉碎,加入糊精,喷入S2步骤得到的挥发油,过筛,混匀,装入胶囊。
实施例6
本实施例提供一种缓解抑郁症的组合物,以重量份计,所述组合物包括:NMN 3份、NADPH 8份、人参皂苷PPD 3份、人参皂苷Rh2 7份、枸杞多糖3份、远志7份、牛磺酸0.2份、磷脂酰丝氨酸1.1份、硫酸软骨素0.2份、熊去氧胆酸1.5份、燕窝酸0.3份、s-腺苷蛋氨酸0.7份、γ-氨基丁酸0.2份、虾青素0.8份、焦谷氨酸酯0.2份。所述组合物采用实施例1所述的方法制备。
本实施例还提供一种药物制剂,所述药物制剂包括所述组合物和辅料,所述辅料的重量份为5份,所述辅料包括交联羧甲基纤维素钠、氢氧化镁、预胶化淀粉、微晶纤维素、乳糖,上述辅料中各组分等量加入,所述药物制剂为片剂,其采用实施例3所述的方法制备。
实施例7
本实施例提供一种缓解抑郁症的组合物,以重量份计,所述组合物包括:NMN 7份、NADPH 2.5份、人参皂苷PPD 7份、人参皂苷Rh2 3份、枸杞多糖7.5份、远志3份、牛磺酸0.7份、磷脂酰丝氨酸0.3份、硫酸软骨素1份、熊去氧胆酸0.2份、燕窝酸1.3份、s-腺苷蛋氨酸0.1份、γ-氨基丁酸1份、虾青素0.2份、焦谷氨酸酯0.8份。所述组合物采用实施例1所述的方法制备。
本实施例还提供一种药物制剂,所述药物制剂包括所述组合物和辅料,所述辅料的重量份为6.2份,所述辅料由尼泊金复合酯、富马酸、磷酸盐、木糖醇、微晶纤维素、失水山梨醇脂肪酸酯、硬脂酸镁、交联羧甲基纤维素钠、氢氧化镁、预胶化淀粉、硫酸钙、气相二氧化硅、乳糖组成,上述辅料组分等质量,所述药物制剂为软胶囊剂,其采用实施例4所述的方法制备。
实施例8
本实施例提供一种缓解抑郁症的组合物,以重量份计,所述组合物包括如下组分:NMN 5份、NADPH 6份、人参皂苷PPD 5.5份、人参皂苷Rh2 5.7份、枸杞多糖4.8份、远志5份、牛磺酸0.5份、磷脂酰丝氨酸0.8份、硫酸软骨素0.6份、熊去氧胆酸0.8份、燕窝酸0.9份、s-腺苷蛋氨酸0.5份、γ-氨基丁酸0.7份、虾青素0.6份、焦谷氨酸酯0.5份。所述组合物采用实施例1所述的方法制备。
本实施例还提供一种药物制剂,所述药物制剂包括所述组合物和辅料,所述辅料的重量份为4份,所述辅料由尼泊金复合酯、富马酸、磷酸盐、木糖醇、微晶纤维素、失水山梨醇脂肪酸酯、硬脂酸镁、交联羧甲基纤维素钠、氢氧化镁、预胶化淀粉、硫酸钙、气相二氧化硅、乳糖组成,上述辅料组分的质量比为1:0.5:0.8:2:1.5:1:3:1.2:2:1:1:1:2,所述药物制剂为颗粒剂,其采用实施例2所述的方法制备。
实验例
1、动物试验
大鼠实验前适应性饲养1周,以适应环境。用敞箱实验进行行为学评分,选择得分相近的大鼠110只,随机分为11组,每组10只,分别为实施例1-7组、抑郁组(盐水组)、氟西汀组、正常组。
其中,正常组:分两笼群居饲养,每笼5只,与其他组别大鼠在相互隔离的环境下饲养,按照需要正常给与饲料及饮水,不接受任何刺激。
抑郁组:实验的56天内,该组大鼠均分别单笼喂养,并接受各种不同的慢性应激刺激,每天安排1种,平均每种刺激被采用8次,同种刺激不连续出现,使大鼠不能预料将发生的刺激,28天后每日给与生理盐水1ml灌胃。
各种刺激方法具体如下:
(1)冰水游泳:将动物放入盛有4℃水的水桶中(水深15厘米),大鼠的后足尖刚能触及桶底,5分钟后将动物取出放回笼中。
(2)悬尾:手持大鼠尾巴,使大鼠头部朝下,旋转大鼠。
(3)禁水:24小时断水。
(4)电击:巧妙运用电针仪,用铁丝延长正负极探针长度,两探针置于大鼠身体不同部位,打开开关,电压36V,电流强度1m A,每次持续15s,关闭开关0.5分钟,重复20次,将大鼠放回饲养笼。
(5)夹尾:将大鼠放入固定笼中,露出尾巴,用止血钳夹住距尾根1cm处,用力不要过大,使大鼠发出哀叫声即可,持续1分钟,将大鼠放回饲养笼。
(6)通宵照明:天黑时将日光灯打开,使大鼠在夜间处于光照状态。
(7)禁食:24小时内不提供饲料。
氟西汀组:饲养环境及刺激方式同抑郁组,28天后每日按照2.5mg/Kg剂量灌胃给药。
实施例1-7组:饲养环境及刺激方式同抑郁组,28天后每日按照10mg/Kg剂量灌胃给实施例1-7所述的药,给药期间仍持续刺激;对比例1给枳壳提取物。
旷野实验(open-field)评分:
敞箱长、宽、高各80厘米,箱的内壁和底面均漆成黑色,底面分成面积相等的25个方格,将大鼠置于敞箱中间,以穿越底面的方格数为水平运动的得分,穿越一格得1分,以双足离地的直立次数为垂直得分,双足离地一次得1分,测定时间为3min。于实验第3天、28天、56天的各测量1次,最终比较各组得分差异。该指标可以反映大鼠活动度及对新鲜环境的好奇度,其中水平运动反映大鼠运动活动度水平,垂直运动多少反映其对外界新鲜环境的好奇探知欲望程度。
测试结果如表1所示:
表1
组别 | 3d | 28d | 56d |
正常组 | 58.2±4.3 | 55.4±2.4 | 56.3±2.8 |
抑郁组 | 55.9±2.9 | 30.1±3.2** | 29.1±2.1** |
氟西汀组 | 57.6±4.1 | 30.5±2.5** | 49.5±2.5 |
实施例1 | 56.3±3.3 | 34.7±3.2** | 43.7±1.9* |
实施例2 | 56.9±3.1 | 30.8±2.7** | 42.2±2.2* |
实施例3 | 57.1±3.5 | 31.5±3.2** | 43.8±2.8* |
实施例4 | 56.5±2.3 | 30.8±3.1** | 42.8±2.5* |
实施例5 | 57.1±2.5 | 31.4±3.4** | 42.5±2.9* |
实施例6 | 57.2±3.2 | 32.2±2.9** | 42.6±2.6* |
实施例7 | 56.8±3.6 | 32.3±2.8** | 42.1±2.3* |
对比例1 | 56.6±4.1 | 30.8±2.2** | 28.9±2.3* |
注:*代表P<0.05,**代表P<0.01。
由表1可以看出,实验第3天各组open-field水平运动评分无明显差异,第28d抑郁症组、氟西汀组、实施例1-7及对比例1明显评分下降,第56天,抑郁症组评分继续下降,而氟西汀组上升接近至正常组水平,实施例1-7显著上升,证明本发明的药物起到了抗抑郁的功效,而对比例1没有明显提升,反而有所下降,证明枳壳提取物单独使用没有抗抑郁的功效。
游泳不动时间测定:
水桶长、宽各25厘米、高40厘米,将大鼠放入水桶内,大鼠首先挣扎试图逃跑,随后处于一种不动状态,不动状态是指大鼠在水中停止挣扎,处于一种漂浮不动的状态,偶尔以肢体活动以保证头部浮在水面,这种状态被称为“行为绝望”,累计各大鼠5min内的游泳不动时间。于实验的第3天、28天、56天的各测量一次,该指标可以反映大鼠绝望情绪的程度。测试结果如表2所示。
表2
组别 | 3d | 28d | 56d |
正常组 | 44.1±2.2 | 66.2±3.8 | 54.5±2.4 |
抑郁组 | 44.7±3.3 | 65.1±2.5* | 43.2±3.1** |
氟西汀组 | 44.9±2.1 | 64.9±2.4** | 50.9±2.7 |
实施例1 | 44.3±2.8 | 63.8±3.1** | 51.1±3.8 |
实施例2 | 45.1±3.4 | 65.9±2.6** | 51.7±3.5 |
实施例3 | 44.2±3.1 | 62.3±2.9** | 52.2±2.1 |
实施例4 | 45.5±2.1 | 64.1±3.8** | 52.2±2.6 |
实施例5 | 46.1±2.6 | 65.2±3.2** | 51.3±2.7 |
实施例6 | 46.4±3.1 | 65.8±3.2** | 51.6±2.9 |
实施例7 | 44.8±3.1 | 64.2±2.8** | 50.6±2.8 |
对比例1 | 44.9±3.1 | 65.2±2.1** | 89.8±2.1** |
注:*代表P<0.05,**代表P<0.01。
由表2可以看出,实验第3天各组大鼠游泳不动时间无明显差异,第28d抑郁症组、氟西汀组、实施例1-7及对比例1大鼠游泳不动时间显著升高(P<0.01),第56天,抑郁症组大鼠游泳不动时间上升,氟西汀组下降接近至正常组水平,实施例1-7显著下降,证明本发明的药物起到了抗抑郁的功效,而对比例1没有明显下降,证明枳壳提取物单独使用没有抗抑郁的功效。
2、临床实验
(1)李某,女,50岁。情绪低落,焦虑,失眠,对任何事不感兴趣,轻生念头强烈。口服实施例2中制得的治疗抑郁症的中药组合物,一天1次,每次口服5g,连续治疗6个月。症状基本消失,心境及情绪正常,思维敏捷,饮食、睡眠正常,躯体症状消失,能完全适应日常生活工作。
(2)张某,男,53岁。情绪低落,易悲伤,悲忧时欲哭泣,生活热情兴趣下降,喜怒无常,疲乏无力,有轻生念头。口服实施例7中制得的治疗抑郁症的中药组合物,一天1次,每次口服5g,连续治疗6个月。症状基本消失,心境及情绪正常,思维敏捷,饮食、睡眠正常,躯体症状消失,能完全适应日常生活工作。
显然,上述实施例仅仅是为清楚地说明所作的举例,而并非对实施方式的限定。对于所属领域的普通技术人员来说,在上述说明的基础上还可以做出其它不同形式的变化或变动。这里无需也无法对所有的实施方式予以穷举。而由此所引伸出的显而易见的变化或变动仍处于本发明创造的保护范围之中。
Claims (10)
1.一种缓解抑郁症的组合物,其特征在于,包括NMN、NADPH、人参皂苷PPD、人参皂苷Rh2、枸杞多糖、远志和活性成分,所述活性成分为牛磺酸、磷脂酰丝氨酸、硫酸软骨素、熊去氧胆酸、燕窝酸、s-腺苷蛋氨酸、γ-氨基丁酸、虾青素、焦谷氨酸酯中的至少一种;
优选的,所述活性成分为牛磺酸、磷脂酰丝氨酸、硫酸软骨素、熊去氧胆酸、燕窝酸、s-腺苷蛋氨酸、γ-氨基丁酸、虾青素、焦谷氨酸酯中的至少五种。
2.根据权利要求1所述的缓解抑郁症的组合物,其特征在于,以重量份计,所述组合物包括如下组分:NMN 1-10份、NADPH 1-10份、人参皂苷PPD1-10份、人参皂苷Rh2 1-10份、枸杞多糖1-10份、远志1-10份、活性成分1-10份;
优选的,以重量份计,所述组合物包括如下组分:NMN 2-8份、NADPH 2-9份、人参皂苷PPD 2.5-8份、人参皂苷Rh2 2-8.5份、枸杞多糖2-8份、远志2-9份、活性成分2-8份;
优选的,以重量份计,所述组合物包括如下组分:NMN 5份、NADPH 5.5份、人参皂苷PPD5份、人参皂苷Rh2 5份、枸杞多糖5.5份、远志6份、活性成分6份。
3.根据权利要求2所述的缓解抑郁症的组合物,其特征在于,以重量份计,所述组合物包括如下组分:NMN 3-7份、NADPH 2.5-8份、人参皂苷PPD 3-7份、人参皂苷Rh2 3-7份、枸杞多糖3-7.5份、远志3-7份、牛磺酸0.2-0.7份、磷脂酰丝氨酸0.3-1.1份、硫酸软骨素0.2-1份、熊去氧胆酸0.2-1.5份、燕窝酸0.3-1.3份、s-腺苷蛋氨酸0.1-0.7份、γ-氨基丁酸0.2-1份、虾青素0.2-0.8份、焦谷氨酸酯0.2-0.8份;
优选的所述组合物包括如下组分:NMN 5份、NADPH 6份、人参皂苷PPD 5.5份、人参皂苷Rh2 5.7份、枸杞多糖4.8份、远志5份、牛磺酸0.5份、磷脂酰丝氨酸0.8份、硫酸软骨素0.6份、熊去氧胆酸0.8份、燕窝酸0.9份、s-腺苷蛋氨酸0.5份、γ-氨基丁酸0.7份、虾青素0.6份、焦谷氨酸酯0.5份。
4.一种制备如权利要求1-3任一项所述的组合物的方法,其特征在于,将所述缓解抑郁症的组合物各组分按照配比混合均匀,即得。
5.一种缓解抑郁症的组合物的应用,其特征在于,将权利要求1所述的组合物用于制备药物制剂或保健食品。
6.一种缓解抑郁症的药物制剂,其特征在于,包括如权利要求1-3任一项所述的组合物和辅料。
7.根据权利要求6所述的药物制剂,其特征在于,所述辅料为尼泊金复合酯、磷酸盐、木糖醇、微晶纤维素、失水山梨醇脂肪酸酯、硬脂酸镁、交联羧甲基纤维素钠、氢氧化镁、预胶化淀粉、硫酸钙、气相二氧化硅、乳糖中的至少一种;
优选的,所述辅料的重量份数为1-10份。
8.根据权利要求7所述的药物制剂,其特征在于,所述辅料为尼泊金复合酯、富马酸、磷酸盐、木糖醇、微晶纤维素、失水山梨醇脂肪酸酯、硬脂酸镁、交联羧甲基纤维素钠、氢氧化镁、预胶化淀粉、硫酸钙、气相二氧化硅、乳糖中的三种。
9.根据权利要求8所述的药物制剂,其特征在于,所述辅料由尼泊金复合酯、富马酸、磷酸盐、木糖醇、微晶纤维素、失水山梨醇脂肪酸酯、硬脂酸镁、交联羧甲基纤维素钠、氢氧化镁、预胶化淀粉、硫酸钙、气相二氧化硅、乳糖组成。
10.根据权利要求6-9任一项所述的药物制剂,其特征在于,所述药物制剂为片剂、口服液剂、胶囊剂、颗粒剂、注射剂、酊剂、栓剂、贴剂、丸剂、糖浆剂、合剂、散剂、膜剂、滴丸中的一种。
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