CN105963499A - 一种治疗神经衰弱的中药组合物及其制备方法和用途 - Google Patents
一种治疗神经衰弱的中药组合物及其制备方法和用途 Download PDFInfo
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- Medicines Containing Plant Substances (AREA)
Abstract
本发明公开了治疗神经衰弱的中药组合物及其制备方法和用途。所述的中药组合物包括:薤白、徐长卿、爵床、黄荆子和石刁柏。本发明中药组合物按照中药常规制剂方法可制备成任何一种临床上可接受的口服药物制剂。本发明中药组合物为纯中药制剂,各组分来源广泛,制备工艺简单,成本低廉;具有宁心安神、补肾固精、通经活络、活血行气的功效,对于神经衰弱标本兼治;临床疗效表明其对神经衰弱疗效确切可靠,安全,无任何毒副作用。
Description
技术领域
本发明涉及一种中药组合物,尤其涉及一种治疗神经衰弱的中药组合物及其制备方法和用途,属于神经衰弱的中药治疗领域。
背景技术
神经衰弱(neurasthenia)是以精神和躯体功能衰弱症状为主,精神易兴奋,脑力易疲劳,常伴情绪紧张、烦恼以及紧张性头痛和睡眠障碍等心理生理症状为特征的一类神经症性障碍。神经衰弱的发病原因是由多种因素互相影响相互作用的结果,大多是由于患者的神经活动受到急性或慢性刺激而处于持久和过度的紧张状态所导致。
中医认为本病多因情绪紧张,暴受惊骇,或素体虚弱,心虚胆怯,导致心神不安而形成有关。由于西药治疗副作用大,易产生耐药性,因此,研制一种能有效治疗神经衰弱的中药制剂具有重大意义。
发明内容
本发明的目的之一是克服现有的药物在治疗神经衰弱中存在的见效慢、疗效不持久、毒副作用大、容易复发等缺陷,提供一种见效快、疗效确切、无毒副作用的治疗神经衰弱的中药组合物;
本发明的目的之二是提供一种制备上述中药组合物的方法。
为达到上述目的,本发明所采取的技术方案是:
本发明首先公开了一种治疗神经衰弱的中药组合物,包括以下各组分:薤白、徐长卿、爵床、黄荆子和石刁柏;
优选的,各组分的重量份是:薤白30-36份、徐长卿30-36份、爵床25-30份、黄荆子15-25份、石刁柏3-9份。
最优选的,各组分的重量份是:薤白33份、徐长卿33份、爵床27份、黄荆子20份、石刁柏6份。
薤白为百合科植物小根蒜或薤的鳞茎。性味:辛苦,温。入手阳明经。功能主治:理气,宽胸,通阳,散结。治胸痹心痛彻背,脘痞不舒,干呕,泻痢后重,疮疖。
徐长卿为萝藦科植物徐长卿的根及根茎或带根全草。性味:辛,温。功能主治:镇痛,止咳,利水消肿,活血解毒。治胃痛,牙痛,风湿疼痛,经期腹痛,慢性气管炎,腹水,水肿,痢疾,肠炎,跌打损伤,湿疹,荨麻疹,毒蛇咬伤。
爵床为爵床科爵床属植物爵床Rostellularia procumbens(L.)Ness的全草。性味:咸辛,寒。入肝、胆二经。功能主治:清热解毒,利湿消滞,活血止痛。治感冒发热,咳嗽,喉痛,疟疾,痢疾,黄疸,肾炎浮肿,筋骨疼痛,小儿疳积,痈疽疔疮,跌打损伤。
黄荆子为马鞭草科植物黄荆的果实。性味:辛苦,温。功能主治:祛风,除痰,行气,止痛。治感冒,咳嗽,哮喘,风痹,疟疾,胃痛,疝气,痔漏。
石刁柏为百合科植物石刁柏Asparagus officinalis L.的块根。性味:性微温,昧苦、微辛。功能主治:润肺镇咳,祛痰杀虫。用于肺热咳嗽、杀疳虫;外治皮肤疥癣及寄生虫。
本发明进一步公开了一种治疗神经衰弱的中药组合物,包括以下各组分:薤白、徐长卿、爵床、黄荆子、石刁柏、五月霜和乌桕。
优选的,各组分的重量份是:薤白30-36份、徐长卿30-36份、爵床25-30份、黄荆子15-25份、五月霜15-25份、乌桕3-9份、石刁柏3-9份。
最优选的,各组分的重量份是:薤白33份、徐长卿33份、爵床27份、黄荆子20份、五月霜20份、乌桕6份、石刁柏6份。
五月霜为菊科植物稀毛香青的全草。性味:苦微辛,凉。功能主治:清热解毒,杀虫。治子宫炎,阴道滴虫。
乌桕为大戟科植物乌桕的种子。性味:甘,凉,有毒。功能主治:杀虫,利水,通便。治疥疮,湿疹,皮肤皲裂,水肿。便秘。
本发明由薤白、徐长卿、爵床、黄荆子和石刁柏制备的中药组合物对神经衰弱具有一定的治疗效果,有效率达68.8%。在薤白、徐长卿、爵床、黄荆子和石刁柏的基础上分别添加了以下几组药物(1)黄芩、山药(2)川芎、当归(3)人参、首乌(4)五月霜、山药(5)乌桕、山药(6)黄芩、五月霜(7)黄芩、乌桕(8)川芎、五月霜(9)川芎、山药(10)乌桕、当归(11)五月霜、当归(12)五月霜、乌桕;将上述12组药物组合物分别制备中药组合物,考察其对神经衰弱的治疗效果。实验结果表明,在薤白、徐长卿、爵床、黄荆子和石刁柏基础上添加五月霜、乌桕对病人的有效率高达100.0%,显著高于其它组合。说明薤白、徐长卿、爵床、黄荆子、石刁柏与五月霜、乌桕配伍在一起具有确切的协同增效功效,有效提高了治疗神经衰弱的有效率。相比之下,将薤白、徐长卿、爵床、黄荆子、石刁柏与其它几种药物配伍在一起后,对于提高神经衰弱治疗效果的作用不明显。
本发明中药组合物是基于发明人对神经衰弱的深层发病机理的研究及其治疗原则,同时依据发明人多年临床经验和药理学研究成果,筛选出具有补中益气、滋阴降火、补血的原料药,按照一定的重量配比组方而成。
本发明各药配伍在一起具有宁心安神、补肾固精、通经活络、活血行气的功效,对于神经衰弱标本兼治;临床疗效观察证实,本发明中药组合物对于神经衰弱的治疗确切可靠、真实。本发明中药组合物无毒无害,安全可靠,服用后无不良反应,临床使用安全。
本发明所用的各味原料药都可以在医药商店购买得到。
在本发明中药组合物的基础上,添加适宜的辅料或载体按照中药常规制剂方法将其制备成治疗神经衰弱的适宜的临床制剂;优选为口服制剂。
所述的口服制剂包括丸剂、散剂、颗粒剂、胶囊剂、冲剂、片剂、口服液或滴丸剂。
所述的载体或辅料是指药学领域常规的载体或辅料,例如:稀释剂、崩裂剂、润滑剂、赋形剂、粘合剂、助流剂、填充剂、表面活性剂等;另外,还可以在组合物中加入其它辅助剂,如香味剂和甜味剂。所述稀释剂可以是一种或几种增加片剂重量和体积的成分,常用的稀释剂包括乳糖、淀粉、预胶化淀粉、微晶纤维素、山梨醇、甘露醇以及无机钙盐等;其中最常用为乳糖、淀粉、微晶纤维素。所述崩解剂可以为交联聚乙烯吡咯烷酮,交联羧甲基纤维素钠、海藻酸、微晶纤维素中之一种或几种混合物;其中以交联聚乙烯吡咯烷酮,交联羧甲基纤维素钠为佳。所述的润滑剂包括硬脂酸,硬脂酸钠,硬脂酸镁,硬脂酸钙,聚乙二醇,滑石粉,氢化植物油中之一种或几种混合物;其中以硬脂酸镁最为适宜。所述的粘合剂可以是一种或几种有利于制粒的成分;可以是淀粉浆,羟丙基甲基纤维素,聚乙烯吡咯烷酮,以聚乙烯吡咯烷酮的乙醇水溶液为佳。所述助流剂可以为微粉硅胶、滑石粉、三硅酸镁中之一种或几种混合物。所述表面活性剂可以为一种或几种能够提高润湿性和增加药物溶出的成分,常用为十二烷基硫酸钠。
本发明中药组合物的一种制备方法,包括以下步骤:取本发明的各原料药,粉碎,过筛(例如可以是100-300目筛),即得。当然,也可以将各原料药粉碎后,加入制剂成型所需的辅料或赋型剂,按照常规方法制备成所需剂型。
本发明中药组合物的另一种制备方法:取各原料药;将各原料药用水煎煮,合并煎煮液,过滤,滤液浓缩成清膏,加入制剂成型的辅料或赋型剂,制剂成型,即得。
本发明中药组合物的用法与用量:本发明的用药量取决于具体剂型、病人的年龄、健康状况等因素。作为指导:用法用量:丸剂,每丸丸剂含0.4克生药,每次口服3至4丸,一日3次,10天为一个疗程,一般治疗6-7个疗程。
本发明技术方案与现有技术相比,具有以下有益效果:
本发明中药组合物的配伍合理,能够明显提高治疗神经衰弱的有效率,疗效确切。本发明中药组合物为纯中药制剂,标本兼治,无副作用,且各组分来源广泛,制备工艺简单,成本低廉,具有良好的应用前景。
具体实施方式
下面结合具体实施例来进一步描述本发明,这些实施例仅是范例性的,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。
实施例1 丸剂的制备
按以下重量称取各原料药:薤白3.0kg、徐长卿3.0kg、爵床2.5kg、黄荆子1.5kg、石刁柏0.3kg;将上述各原料药加水煎煮二次,第一次加4倍重量的水,煎煮2小时,第二次加5倍重量的水,煎煮1.5小时;将煎煮液合并,滤过,滤液浓缩至相对密度为1.17-1.19(60℃)的清膏;加适量炼蜜,混匀,制备成每粒6g的药丸。
实施例2 丸剂的制备
按以下重量称取各原料药:薤白3.6kg、徐长卿3.6kg、爵床3.0kg、黄荆子2.5kg、石刁柏0.9kg;将上述各原料药加水煎煮二次,第一次加4倍重量的水,煎煮2小时,第二次加5倍重量的水,煎煮1.5小时;将煎煮液合并,滤过,滤液浓缩至相对密度为1.17-1.19(60℃)的清膏;加适量炼蜜,混匀,制备成每粒6g的药丸。
实施例3 丸剂的制备
按以下重量称取各原料药:薤白3.3kg、徐长卿3.3kg、爵床2.7kg、黄荆子2.0kg、石刁柏0.6kg;将上述各原料药加水煎煮二次,第一次加4倍重量的水,煎煮2小时,第二次加5倍重量的水,煎煮1.5小时;将煎煮液合并,滤过,滤液浓缩至相对密度为1.17-1.19(60℃)的清膏;加适量炼蜜,混匀,制备成每粒6g的药丸。
实施例4 丸剂的制备
按以下重量称取各原料药:薤白3.0kg、徐长卿3.0kg、爵床2.5kg、黄荆子1.5kg、五月霜1.5kg、乌桕0.3kg、石刁柏0.3kg;将上述各原料药加水煎煮二次,第一次加4倍重量的水,煎煮2小时,第二次加5倍重量的水,煎煮1.5小时;将煎煮液合并,滤过,滤液浓缩至相对密度为1.17-1.19(60℃)的清膏;加适量炼蜜,混匀,制备成每粒6g的药丸。
实施例5 丸剂的制备
按以下重量称取各原料药:薤白3.6kg、徐长卿3.6kg、爵床3.0kg、黄荆子2.5kg、五月霜2.5kg、乌桕0.9kg、石刁柏0.9kg;将上述各原料药加水煎煮二次,第一次加4倍重量的水,煎煮2小时,第二次加5倍重量的水,煎煮1.5小时;将煎煮液合并,滤过,滤液浓缩至相对密度为1.17-1.19(60℃)的清膏;加适量炼蜜,混匀,制备成每粒6g的药丸。
实施例6 丸剂的制备
按以下重量称取各原料药;薤白3.3kg、徐长卿3.3kg、爵床2.7kg、黄荆子2.0kg、五月霜2.0kg、乌桕0.6kg、石刁柏0.6kg;将上述各原料药加水煎煮二次,第一次加4倍重量的水,煎煮2小时,第二次加5倍重量的水,煎煮1.5小时;将煎煮液合并,滤过,滤液浓缩至相对密度为1.17-1.19(60℃)的清膏;加适量炼蜜,混匀,制备成每粒6g的药丸。
实施例7 冲剂的制备
按以下重量称取各原料药:薤白3.3kg、徐长卿3.3kg、爵床2.7kg、黄荆子2.0kg、五月霜2.0kg、乌桕0.6kg、石刁柏0.6kg;将上述各原料药加水煎煮二次,第一次加4倍重量的水,煎煮2小时,第二次加5倍重量的水,煎煮1.5小时;将煎煮液合并,滤过,滤液浓缩至相对密度为1.17-1.19(60℃)的清膏;加入适量的白砂糖、糊精,混合均匀,再加乙醇适量制成颗粒,包装,即得。
实施例8 片剂的制备
按以下重量称取各原料药:薤白3.3kg、徐长卿3.3kg、爵床2.7kg、黄荆子2.0kg、五月霜2.0kg、乌桕0.6kg、石刁柏0.6kg;将上述各原料药加水煎煮二次,第一次加4倍重量的水,煎煮2小时,第二次加5倍重量的水,煎煮1.5小时;将煎煮液合并,滤过,滤液浓缩至相对密度为1.17-1.19(60℃)的清膏;加入适量淀粉,混合均匀,再与糊精混合均匀,加入乙醇(50%)适量制软材;通过16目尼龙筛制粒,在60℃干燥,干粒再过16目筛整粒,加入适量硬脂酸镁,混合均匀后压片。
实施例9 胶囊剂的制备
按以下重量称取各原料药:薤白3.3kg、徐长卿3.3kg、爵床2.7kg、黄荆子2.0kg、五月霜2.0kg、乌桕0.6kg、石刁柏0.6kg;将上述各原料药加水煎煮二次,第一次加4倍重量的水,煎煮2小时,第二次加5倍重量的水,煎煮1.5小时;将煎煮液合并,滤过,滤液浓缩至相对密度为1.17-1.19(60℃)的清膏;加入适量淀粉,混合均匀,加乙醇适量制成颗粒,干燥,整粒,填充胶囊,即得。
实验例1 应用本发明中药组合物治疗神经衰弱的临床疗效观察试验
一、一般资料
1040例患者均符合神经衰弱的诊断标准,将患者随机分成13组,每组80例;13组在性别、年龄、病程及病情严重程度上差异无显著性。根据《神经病学》中神经衰弱的诊断标准制定:
(1)衰弱症状:如精神疲乏、脑力迟钝,注意力难以集中,记忆困难,工作或学习不能持久、效率降低。(2)兴奋症状:工作或学习用脑均可引起精神兴奋;回忆及联想增多,控制不住;可对声光敏感;但并不表现为言语运动增多。(3)情绪症状:易烦恼、易激,也可表现在工作、学习效率下降或精力不足而焦急、苦恼,但无广泛的焦虑或原因不明的心境低沉。(4)紧张性疼痛:如紧张性头痛、紧张性肌肉疼痛。(5)睡眠障碍:如入睡困难、多梦、易醒、醒后不解乏等。
至少具备以上五项中的三项时,可诊断为神经衰弱。
二、药物制备
中药组合物1,按照以下重量称取各组分:薤白3.3kg、徐长卿3.3kg、爵床2.7kg、黄荆子2.0kg、石刁柏0.6kg;
将上述各原料药加水煎煮二次,第一次加4倍重量的水,煎煮2小时,第二次加5倍重量的水,煎煮1.5小时;将煎煮液合并,滤过,滤液浓缩至相对密度为1.17-1.19(60℃)的清膏;加适量炼蜜,混匀,制备成每粒6g的药丸。。
中药组合物2:在中药组合物1基础上添加黄芩2.0kg、山药0.6kg;
中药组合物3:在中药组合物1基础上添加川芎2.0kg、当归0.6kg;
中药组合物4:在中药组合物1基础上添加人参2.0kg、首乌0.6kg;
中药组合物5:在中药组合物1基础上添加五月霜2.0kg、山药0.6kg;
中药组合物6:在中药组合物1基础上添加乌桕2.0kg、山药0.6kg;
中药组合物7:在中药组合物1基础上添加黄芩2.0kg、五月霜0.6kg;
中药组合物8:在中药组合物1基础上添加黄芩2.0kg、乌桕0.6kg;
中药组合物9:在中药组合物1基础上添加川芎2.0kg、五月霜0.6kg;
中药组合物10:在中药组合物1基础上添加川芎2.0kg、山药0.6kg;
中药组合物11:在中药组合物1基础上添加乌桕2.0kg、当归0.6kg;
中药组合物12:在中药组合物1基础上添加五月霜2.0kg、当归0.6kg;
中药组合物13:在中药组合物1基础上添加五月霜2.0kg、乌桕0.6kg;
中药组合物2-13的制备方法同中药组合物1。
三、治疗方法
分别用上述中药组合物1-13的冲剂对上述13组神经衰弱患者进行治疗;口服,每次口服3至4丸,一日3次,10天为一个疗程,共治疗7个疗程;服药期间停服其它相关药物及其它治疗。
四、疗效评定标准
治愈:神经衰弱症状消失,体质恢复正常;
有效:神经衰弱症状减轻,体质逐步恢复;
无效:达不到好转标准者。
五、临床观察结果
临床观察结果见表1。
表1 不同中药组合物治疗神经衰弱的统计结果
结果表明,由薤白、徐长卿、爵床、黄荆子、石刁柏制备的中药组合物1对神经衰弱具有一定的治疗效果,有效率达68.8%。在薤白、徐长卿、爵床、黄荆子、石刁柏基础上,添加五月霜、乌桕,对治疗神经衰弱的有效率显著提高,达到100.0%。
以上结果说明,薤白、徐长卿、爵床、黄荆子、石刁柏与五月霜、乌桕之间具有显著的协同增效作用,将其配伍在一起能够显著提高治疗神经衰弱的有效率。相比之下,将薤白、徐长卿、爵床、黄荆子、石刁柏与其它几种药物配伍在一起后,对于提高神经衰弱治疗效果的作用不明显。安全性观察发现,没有观察到任何临床不良反应,表明本发明中药组合物临床应用安全、无毒副作用。
Claims (8)
1.一种治疗神经衰弱的中药组合物,其特征在于,由以下各组分组成:薤白、徐长卿、爵床、黄荆子和石刁柏。
2.按照权利要求1所述的中药组合物,其特征在于,各组分的重量份是:薤白30-36份、徐长卿30-36份、爵床25-30份、黄荆子15-25份、石刁柏3-9份。
3.按照权利要求2所述的中药组合物,其特征在于,各组分的重量份是:薤白33份、徐长卿33份、爵床27份、黄荆子20份、石刁柏6份。
4.一种治疗神经衰弱的中药组合物,其特征在于,由以下各组分组成:薤白、徐长卿、爵床、黄荆子、石刁柏、五月霜和乌桕。
5.按照权利要求4所述的中药组合物,其特征在于,各组分的重量份是:薤白30-36份、徐长卿30-36份、爵床25-30份、黄荆子15-25份、五月霜15-25份、乌桕3-9份、石刁柏3-9份。
6.按照权利要求5所述的中药组合物,其特征在于,各组分的重量份是:薤白33份、徐长卿33份、爵床27份、黄荆子20份、五月霜20份、乌桕6份、石刁柏6份。
7.一种制备权利要求1-6任何一项所述中药组合物的方法,包括以下步骤:取各组分,混合;用水煎煮,合并煎煮液,过滤,滤液浓缩成清膏,加入制剂成型的辅料或赋型剂,制剂成型,即得。
8.权利要求1-6任何一项所述中药组合物在制备治疗神经衰弱药物中的用途。
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