CN116370583A - 一种抗抑郁症的中药组合物及其制备方法和应用 - Google Patents
一种抗抑郁症的中药组合物及其制备方法和应用 Download PDFInfo
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Abstract
本发明公开了一种抗抑郁症的中药组合物及其制备方法和应用。本发明抗抑郁症的中药组合物,包括如下重量份的原料:蒺藜5‑20份、藳木5‑20份、菟丝子5‑20份、藏红花20‑40份、牡丹皮20‑40份、花椒5‑20份、木香5‑20份、半夏5‑20份、薏苡仁20‑40份、鱼腥草20‑40份、柴胡20‑40份、知母10‑20份、远志10‑30份、白芍20‑40份、菊花5‑20份、叶下珠20‑40份、川芎5‑20份和麝香5‑20份。该中药组合物通过蒺藜、藳木、菟丝子、藏红花、牡丹皮、花椒、木香、半夏、薏苡仁、鱼腥草、柴胡、知母、远志、白芍、菊花、叶下珠、川芎和麝香的复配,可用于治疗抑郁症,并且无明显不良反应,应用顺应性好,利于抑郁症的治疗、巩固及维持;该中药组合物成本较低,还可大大减轻患者的经济压力。
Description
技术领域
本发明涉及医药技术领域,尤其涉及一种抗抑郁症的中药组合物及其制备方法和应用。
背景技术
目前药物治疗和心理治疗是控制抑郁症的主要措施。但是,一方面病耻感影响患者主动就诊,另一方面治疗时间长、经济压力大、药物的副作用等因素使患者治疗依从性较差,同时,还有65%~75%接受标准药物治疗的患者症状不能得到缓解。因此,抑郁症的治疗迫切需要新型手段。
中医学虽无抑郁症病名记载,但根据其症状,可将其归属于中医“郁症”、“百合病”、“脏躁”等范畴。因其初起多以气郁、痰阻等邪实为主,病久耗伤气血,损及心脾而成虚实夹杂之症。业已证实,中药复方多途径、多环节的抗抑郁症综合效应,是其中医药整体观念的优势体现,已经成为抑郁症防治研究的一种重要策略。
发明内容
本发明的其中一个目的是提出一种抗抑郁症的中药组合物及其制备方法和应用,解决了现有技术中针对抑郁症,采用药物治疗和心理治疗存在患者主动就诊性差、治疗时间长、经济压力大、药物副作用大、患者治疗依从性差以及治疗效果不佳的技术问题。本发明优选技术方案所能产生的诸多技术效果详见下文阐述。
为实现上述目的,本发明提供了以下技术方案:
本发明抗抑郁症的中药组合物,包括如下重量份的原料:蒺藜5-20份、藳木5-20份、菟丝子5-20份、藏红花20-40份、牡丹皮20-40份、花椒5-20份、木香5-20份、半夏5-20份、薏苡仁20-40份、鱼腥草20-40份、柴胡20-40份、知母10-20份、远志10-30份、白芍20-40份、菊花5-20份、叶下珠20-40份、川芎5-20份和麝香5-20份。
根据一个优选实施方式,所述的抗抑郁症的中药组合物包括如下重量份的原料:蒺藜10份、藳木5份、菟丝子10份、藏红花20份、牡丹皮15份、花椒10份、木香5份、半夏15份、薏苡仁20份、鱼腥草20份、柴胡40份、知母20份、远志10份、白芍20份、菊花10份、叶下珠15份、川芎10份、麝香10份。
本发明抗抑郁症的中药组合物的制备方法,利用溶剂提取本发明中任一项技术方案所述的抗抑郁症的中药组合物,提取完成后将提取液过滤,再浓缩滤液,回收溶剂并制得抗抑郁症的中药组合物。
根据一个优选实施方式,所述的抗抑郁症的中药组合物的制备方法,包括如下步骤:
按重量比称取蒺藜、藳木、菟丝子、藏红花、牡丹皮、花椒、木香、半夏、薏苡仁、鱼腥草干燥并粉碎,得中药混合物A;按重量比称取柴胡、知母、远志、白芍、菊花、叶下珠、川芎和麝香干燥并粉碎,得中药混合物B;
向中药混合物A中加入重量为中药混合物A重量6~10倍的乙醇,利用乙醇提取中药混合物30~180min,提取温度为80~100℃,提取完成后将提取液过滤;
向第一次提取中药混合物A所得的滤渣中加入重量为滤渣重量4~8倍的乙醇,利用乙醇提取滤渣30~120min,提取温度为80~100℃,提取完成后将提取液过滤;
将两次提取过程所得的滤液混合,将滤液浓缩,回收溶剂并制得中药组合物Aa;
向中药混合物B中加入重量为中药混合物B重量6~10倍的乙醇,利用乙醇提取中药混合物30~180min,提取温度为80~100℃,提取完成后将提取液过滤;
向第一次提取中药混合物B所得的滤渣中加入重量为滤渣重量4~8倍的乙醇,利用乙醇提取滤渣30~120min,提取温度为80~100℃,提取完成后将提取液过滤;
将两次提取过程所得的滤液混合,将滤液浓缩,回收溶剂并制得中药组合物Bb;
而后混合中药组合物Aa和Bb,既得抗抑郁症的中药组合物。
根据一个优选实施方式,制备中药组合物Aa时乙醇的浓度为10-40%,制备中药组合物Bb时,乙醇的浓度为60-80%。
根据一个优选实施方式,制备中药组合物Aa时乙醇的浓度为30%,制备中药组合物Bb时,乙醇的浓度为70%。
本发明中任一项技术方案所述的抗抑郁症的中药组合物在制备治疗抗抑郁症药物中的应用。
根据一个优选实施方式,所述治疗抗抑郁症药物为中药组合物与药学上接受的辅料或者辅助性成分制备而成的制剂。
根据一个优选实施方式,所述制剂为胶囊剂、片剂、颗粒剂、口服液、丸剂、散剂和丹剂中的一种或多种。
本发明提供的抗抑郁症的中药组合物及其制备方法和应用至少具有如下有益技术效果:
根据中医药理论,利用中药独特的药性,即蒺藜的平肝解郁、活血祛风作用,藁本的祛风散寒作用,菟丝子的补益肝肾作用,藏红花的活血化瘀、解郁安神作用,牡丹皮的活血化瘀作用,花椒的温中止痛作用,木香的行气止痛作用,半夏的燥湿化痰、消痞散结作用,薏苡仁的健脾利湿、除痹作用,鱼腥草的利尿通淋作用,柴胡的疏肝解郁作用,知母的滋阴润燥作用,远志的安神益智、祛痰消肿作用,白芍的温阳祛湿、补虚健脾作用,菊花的散风清热、平肝明目作用,叶下珠的利水消肿、消积作用,川芎的辛散温通、活血祛瘀作用,麝香的活血散结、消肿止痛作用,将蒺藜、藳木、菟丝子、藏红花、牡丹皮、花椒、木香、半夏、薏苡仁、鱼腥草、柴胡、知母、远志、白芍、菊花、叶下珠、川芎和麝香复配,制备出了抗抑郁症的中药组合物。具体的,本发明抗抑郁症的中药组合物,包括如下重量份的原料:蒺藜5-20份、藳木5-20份、菟丝子5-20份、藏红花20-40份、牡丹皮20-40份、花椒5-20份、木香5-20份、半夏5-20份、薏苡仁20-40份、鱼腥草20-40份、柴胡20-40份、知母10-20 份、远志10-30份、白芍20-40份、菊花5-20份、叶下珠20-40份、川芎5-20 份和麝香5-20份,通过蒺藜、藳木、菟丝子、藏红花、牡丹皮、花椒、木香、半夏、薏苡仁、鱼腥草、柴胡、知母、远志、白芍、菊花、叶下珠、川芎和麝香的复配,可用于治疗抑郁症,并且本发明抗抑郁症的中药组合物,无明显不良反应,应用顺应性好,利于抑郁症的治疗、巩固及维持;另一方面,本发明抗抑郁症的中药组合物,成本较低,还可大大减轻患者的经济压力。
本发明抗抑郁症的中药组合物的制备方法,利用溶剂提取本发明中任一项技术方案抗抑郁症的中药组合物,提取完成后将提取液过滤,再浓缩滤液,回收溶剂并制得抗抑郁症的中药组合物,本发明通过提取、过滤、浓缩的方式制得抗抑郁症的中药组合物,该制备方法具有工艺简单的优势。
本发明中任一项技术方案抗抑郁症的中药组合物在制备治疗抗抑郁症药物中的应用,通过该中药组合物的作用,可使该药物用于治疗抑郁症,并且该药物无明显不良反应,应用顺应性好,利于抑郁症的治疗、巩固及维持;另一方面,该药物成本较低,还可大大减轻患者的经济压力。
具体实施方式
为使本发明的目的、技术方案和优点更加清楚,下面将对本发明的技术方案进行详细的描述。显然,所描述的实施例仅仅是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动的前提下所得到的所有其它实施方式,都属于本发明所保护的范围。
下面结合实施例1和2对本发明抗抑郁症的中药组合物及其制备方法和应用进行详细说明。
实施例1
本实施例提供一种抗抑郁症的中药组合物以及利用该中药组合物制得的治疗抗抑郁症药物。
本实施例抗抑郁症的中药组合物,包括如下重量份的原料:蒺藜10份、藳木5份、菟丝子10份、藏红花20份、牡丹皮15份、花椒10份、木香5份、半夏15份、薏苡仁20份、鱼腥草20份、柴胡40份、知母20份、远志10份、白芍20份、菊花10份、叶下珠15份、川芎10份、麝香10份。
利用该中药组合物制备治疗抗抑郁症药物,并且治疗抗抑郁症药物为丸剂,具体包括如下步骤:
S1:按重量比称取蒺藜、藳木、菟丝子、藏红花、牡丹皮、花椒、木香、半夏、薏苡仁、鱼腥草干燥并粉碎,得中药混合物A。按重量比称取柴胡、知母、远志、白芍、菊花、叶下珠、川芎和麝香干燥并粉碎,得中药混合物B。
S2:向中药混合物A中加入重量为中药混合物A重量6~10倍的乙醇,利用乙醇提取中药混合物30~180min,提取温度为80~100℃,提取完成后将提取液过滤。
向第一次提取中药混合物A所得的滤渣中加入重量为滤渣重量4~8倍的乙醇,利用乙醇提取滤渣30~120min,提取温度为80~100℃,提取完成后将提取液过滤。
将两次提取过程所得的滤液混合,将滤液浓缩,回收溶剂并制得中药组合物Aa。
制备中药组合物Aa时乙醇的浓度为30%。
S3:向中药混合物B中加入重量为中药混合B物重量6~10倍的乙醇,利用乙醇提取中药混合物30~180min,提取温度为80~100℃,提取完成后将提取液过滤。
向第一次提取中药混合物B所得的滤渣中加入重量为滤渣重量4~8倍的乙醇,利用乙醇提取滤渣30~120min,提取温度为80~100℃,提取完成后将提取液过滤。
将两次提取过程所得的滤液混合,将滤液浓缩,回收溶剂并制得中药组合物Bb。
制备中药组合物Bb时乙醇的浓度为70%。
S4:而后混合中药组合物Aa和Bb,得到60℃时比重为1.17的流浸膏。
S5:将中药组合物的浸润膏与炼蜜按照重量比为1∶1的比例混合,充分混匀,制丸。炼蜜优选为中蜜。
不限于此,治疗抗抑郁症药物也可以是其它制剂。
本实施例治疗抗抑郁症药物制剂的制备方法可以采用制药领域的常规方法,使用常规的药用辅料进行。例如:采用常规方法将提取物与任意一种或一种以上药剂学上常用的载体或辅料混合,然后制成各种口服剂型。所述的载体为赋形剂、填料、稀释剂、润滑剂、湿润剂、崩解剂、表面活性剂、防腐剂、甜味剂、芳香剂等中的一种或多种。具体地,所述载体为淀粉、糊精、乳糖、微晶纤维素、羟丙甲基纤维素、聚乙二醇、硬脂酸镁、微粉硅胶、葡萄糖、甘露醇、木糖醇、甘氨酸等中的一种或多种。
由于各原料中活性成分的性质不同,本实施例的制备方法中,将各原料分为两组,两组原料分别提取其活性成分,有利于提高各原料中活性成分的提取率,增强中药组合物的药效。具体的,制备中药组合物Aa时,乙醇的浓度为 30%,有利于提高蒺藜、藳木、菟丝子、藏红花、牡丹皮、花椒、木香、半夏、薏苡仁和鱼腥草中活性成分的提取率;制备中药组合物Bb时,乙醇的浓度为 70%,有利于提高柴胡、知母、远志、白芍、菊花、叶下珠、川芎和麝香中活性成分的提取率。
实施例2
本实施例提供了抗抑郁症的中药组合物的药效学实验。
本实施例的目的在于观察本发明抗抑郁症的中药组合物对大鼠抑郁模型的治疗作用。具体实验过程如下。
材料:实验动物SD雄性大鼠,体重180g左右,由四川大学华西医院实验动物中心提供。药物利用本发明抗抑郁症的中药组合物制得的颗粒剂,颗粒剂使用时以纯净水配制所需浓度。阳性对照药物为马普替林,购置于诺华制药有限公司生产,用时以纯净水配制所需浓度。
动物模型:本实施例构建的是轻度慢性不可预见性应激SD大鼠抑郁模型。正常对照组每笼饲养6只,不给任何刺激,正常摄水饮食。其余老鼠均为每只单笼饲养,并接受连续21天随机给予不同的应激刺激。刺激方法为根据改进的 Katz方法,包括:2次持续48h的禁食,2次持续24h的禁水,2次通宵照明(12h), 2次4℃冰水游泳5分钟,2次45℃烘箱5分钟热烘,2次夹尾1分钟,2次高水平振荡(160Hz)10分钟,2次昼夜颠倒,2次24h潮湿(笼底放置水浸湿的木屑)饲养,1次闪光刺激(120次每秒)15分钟。刺激时保障每天随机给予一种刺激,使大鼠不能预见刺激的发生,以避免产生适应。
而后将造模后SD大鼠随机分为模型组、抗抑郁症的中药组合物组、马普替林组,每组大鼠10只。模型组、抗抑郁症的中药组合物组、马普替林组按照上述模型制备方案随机给予应激刺激21天。药物组按1mL/100g鼠重分别灌服相应的药物,每天1次,正常模型组给予相应量的饮用水灌胃。
检测指标:(1)Open-Field行为评分:在实验的第1天、第22天行Open-Field 行为学评分。(2)血清ACTH、COR浓度以及海马cAMP含量检测。
抗抑郁症的中药组合物对大鼠行为学的影响:抑郁症模型大鼠体质量增长缓慢,水平和垂直活动及糖水消耗量均明显减少(P<0.05,P<0.01)。而抗抑郁症的中药组合物能显著改善大鼠行为学指标,具有显著抗抑郁作用,为后续进行中药复方抗抑郁症的相关研究提供了科学的药效学依据。
表1 各组大鼠行为学评分的变化(d22,各值以均值表示)
实验第1天各组SD大鼠行为学评分均无显著性差异(P>0.05)。
如表1所示:实验第22天,与模型组比较,马普替林组组水平得分、垂直得分、修饰次数和大便颗粒数均明显减少(P<0.05);与模型组比较,中药组合物组能够提升水平得分、垂直得分、修饰次数和大便颗粒数(P<0.05),中央格停留时间马普替林组较各组有所延长。
表2 抗抑郁症的中药组合物对大鼠血清ACTH、COR和海马cAMP含量的影响(d22,各值以均值表示)
组别 | ACTH(pg/mL) | COR(ng/mL) | cAMP(pmol/mL) |
模型组 | 10.3 | 11.4 | 0.82 |
马普替林组 | 19.4 | 28.5 | 0.41 |
中药组合物组 | 14.2 | 17.2 | 0.67 |
抗抑郁症的中药组合物对大鼠血清ACTH、COR和海马cAMP含量的影响:实验第1天各组SD大鼠血清ACTH、COR和海马cAMP无显著性差异(P>0.05)。如表2所示,实验第22天,与模型组比较,马普替林组血清ACTH、COR水平均明显升高(P<0.05),与马普替林组比较,中药组合物组SD大鼠血清ACTH、 COR水平均明显降低(P<0.05),说明中药组合物对小鼠的抑郁症具有明显改善作用。
实施例3
本实施例提供了抗抑郁症的中药组合物的毒理学实验。
本实施例的目的在于评价本发明抗抑郁症的中药组合物对单味中药的毒理作用影响。具体实验过程如下。
材料:实验动物C57BL/6雄性小鼠,体重22g左右,由四川大学华西医院实验动物中心提供。药物利用本发明抗抑郁症的中药组合物制得的颗粒剂,颗粒剂使用时以纯净水配制所需浓度。蒺藜组、麝香组和花椒组药物为用中药组合物同样方法制成的颗粒剂。
给药干预:将C57BL/6雄性小鼠机分为五组,分别为空白对照组(给生理盐水)、蒺藜组、麝香组、花椒组和中药组合物组。除空白对照组外,药物组分别给予300g/kg的药物干预14天(蒺藜组、麝香组、花椒组的给药量分别与中药组合物组中蒺藜、麝香和花椒的用量相同)。14天给药干预后检测小鼠血清指标,评价肝毒性,检测结果如表3所示。
表3 14天给药干预后小鼠血清指标表
检测指标 | AST(u/l) | ALT(u/l) | ALP(u/l) | TBB(umol/l) |
空百对照组 | 161±12 | 43±5 | 190±20 | 2.6±0.3 |
蒺藜组 | 243±21 | 97±5 | 240±40 | 5.2±0.5 |
麝香组 | 271±30 | 103±6 | 253±32 | 6.1±0.4 |
花椒组 | 198±16 | 67±8 | 210±43 | 4.1±0.3 |
中药组合物组 | 161±12 | 43±5 | 190±20 | 2.6±0.3 |
结果显示本发明的中药组合物组可减少单味给药(蒺藜、麝香或花椒)时的药物毒性,说明本发明的中药组合物还有利于减低单味药物的毒性。
以上所述,仅为本发明的具体实施方式,但本发明的保护范围并不局限于此,任何熟悉本技术领域的技术人员在本发明揭露的技术范围内,可轻易想到变化或替换,都应涵盖在本发明的保护范围之内。因此,本发明的保护范围应以所述权利要求的保护范围为准。
Claims (9)
1.一种抗抑郁症的中药组合物,其特征在于,包括如下重量份的原料:蒺藜5-20份、藳木5-20份、菟丝子5-20份、藏红花20-40份、牡丹皮20-40份、花椒5-20份、木香5-20份、半夏5-20份、薏苡仁20-40份、鱼腥草20-40份、柴胡20-40份、知母10-20份、远志10-30份、白芍20-40份、菊花5-20份、叶下珠20-40份、川芎5-20份和麝香5-20份。
2.根据权利要求1所述的抗抑郁症的中药组合物,其特征在于,包括如下重量份的原料:蒺藜10份、藳木5份、菟丝子10份、藏红花20份、牡丹皮15份、花椒10份、木香5份、半夏15份、薏苡仁20份、鱼腥草20份、柴胡40份、知母20份、远志10份、白芍20份、菊花10份、叶下珠15份、川芎10份、麝香10份。
3.一种抗抑郁症的中药组合物的制备方法,其特征在于,利用溶剂提取权利要求1或2所述的抗抑郁症的中药组合物,提取完成后将提取液过滤,再浓缩滤液,回收溶剂并制得抗抑郁症的中药组合物。
4.根据权利要求3所述的抗抑郁症的中药组合物的制备方法,其特征在于,包括如下步骤:
按重量比称取蒺藜、藳木、菟丝子、藏红花、牡丹皮、花椒、木香、半夏、薏苡仁、鱼腥草干燥并粉碎,得中药混合物A;按重量比称取柴胡、知母、远志、白芍、菊花、叶下珠、川芎和麝香干燥并粉碎,得中药混合物B;
向中药混合物A中加入重量为中药混合物A重量6~10倍的乙醇,利用乙醇提取中药混合物30~180min,提取温度为80~100℃,提取完成后将提取液过滤;
向第一次提取中药混合物A所得的滤渣中加入重量为滤渣重量4~8倍的乙醇,利用乙醇提取滤渣30~120min,提取温度为80~100℃,提取完成后将提取液过滤;
将两次提取过程所得的滤液混合,将滤液浓缩,回收溶剂并制得中药组合物Aa;
向中药混合物B中加入重量为中药混合物B重量6~10倍的乙醇,利用乙醇提取中药混合物30~180min,提取温度为80~100℃,提取完成后将提取液过滤;
向第一次提取中药混合物B所得的滤渣中加入重量为滤渣重量4~8倍的乙醇,利用乙醇提取滤渣30~120min,提取温度为80~100℃,提取完成后将提取液过滤;
将两次提取过程所得的滤液混合,将滤液浓缩,回收溶剂并制得中药组合物Bb;
而后混合中药组合物Aa和Bb,既得抗抑郁症的中药组合物。
5.根据权利要求4所述的抗抑郁症的中药组合物的制备方法,其特征在于,制备中药组合物Aa时乙醇的浓度为10-40%,制备中药组合物Bb时,乙醇的浓度为60-80%。
6.根据权利要求4或5所述的抗抑郁症的中药组合物的制备方法,其特征在于,制备中药组合物Aa时乙醇的浓度为30%,制备中药组合物Bb时,乙醇的浓度为70%。
7.一种权利要求1或2所述的抗抑郁症的中药组合物在制备治疗抗抑郁症药物中的应用。
8.根据权利要求7所述的抗抑郁症的中药组合物在制备治疗抗抑郁症药物中的应用,其特征在于,所述治疗抗抑郁症药物为中药组合物与药学上接受的辅料或者辅助性成分制备而成的制剂。
9.根据权利要求8所述的抗抑郁症的中药组合物在制备治疗抗抑郁症药物中的应用,其特征在于,所述制剂为胶囊剂、片剂、颗粒剂、口服液、丸剂、散剂和丹剂中的一种或多种。
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