CN114949057A - 一种中药组合物在治疗老年痴呆中的用途 - Google Patents
一种中药组合物在治疗老年痴呆中的用途 Download PDFInfo
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Abstract
本发明属于中药技术领域,具体涉及一种具有改善或治疗来年痴呆作用的中药组合物。所述中药组合物主要由羌活、独活、茯苓、防风、荆芥、川芎、桔梗、柴胡、前胡、枳壳、甘草制备而成。药理实验证实,本发明中药组合物制备而成的荆防颗粒可以通过提高单胺类神经递质含量,起到改善老年痴呆小鼠学习记忆能力的作用。
Description
技术领域
本发明涉及一种组合物及其制备方法,具体涉及一种具有治疗老年痴呆的中药组合物,属于中药技术领域。
背景技术
广义上来说老年期(中国一般指60岁以上)出现痴呆症状都可称为老年痴呆,如血管性痴呆、额颞叶痴呆、路易体痴呆、帕金森病痴呆、阿尔茨海默病等。但医学上的老年痴呆通常特指阿尔茨海默病,该病是一种隐匿起病、进行性发展的神经系统退行性疾病。患者可有记忆障碍、失语、失用、失认、视空间能力损害、抽象思维和计算力受损、人格行为改变等临床表现,目前临床上用于治疗该病的药物种类繁多,但尚无确定能逆转认知缺损的药物。
世界卫生组织(WHO)估计全球65岁以上老年人群阿尔兹海默症的患病率为4%~7%。中国65岁及以上的阿尔茨海默病患病率在北方地区为4.2%,南方地区为2.8%。
老年痴呆典型症状主要为:
1、痴呆前阶段
该期患者可无认知障碍表现或仅有轻度损害。主要表现为记忆力轻度受损,学习和保存新知识的能力下降,其他认知域,如注意力、执行能力、语言能力和视空间能力也可出现轻度受损,但不影响基本日常生活能力,达不到痴呆的程度。
2、痴呆阶段
该阶段根据认知能力受损的程度可分为如下三度:
(1)轻度:主要表现是记忆障碍。首先出现的是近事记忆减退,常将日常所做的事和常用的一些物品遗忘。随着病情的发展,可出现远期记忆减退,即对发生己久的事情和人物的遗忘。部分患者出现视空间障碍,外出后找不到回家的路,不能精确地临摹立体图。面对生疏和复杂的事物容易出现疲乏、焦虑和消极情绪,还会表现出人格方面的障碍,如不爱清洁、不修边幅、暴躁、易怒、自私多疑。
(2)中度:除记忆障碍继续加重外,工作、学习新知识和社会接触能力减退,特别是原已掌握的知识和技巧出现明显的衰退。出现逻辑思维、综合分析能力减退,言语重复、计算力下降,明显的视空间障碍,如在家中找不到自己的房间,还可出现失语、失用、失认等,有些患者还可出现癫痫、强直-少动综合征。此时患者常有较明显的行为和精神异常,性格内向的患者变得易激惹、兴奋欣快、言语增多,而原来性格外向的患者则可变得沉默寡言,对任何事情提不起兴趣,出现明显的人格改变,甚至做出一些丧失羞耻感的行为(如随地大小便等)。
(3)重度:此期的患者除上述各项症状逐渐加重外,还有情感淡漠、哭笑无常、言语能力丧失、以致不能完成日常简单的生活事项如穿衣、进食。终日无语而卧床,与外界(包括亲友)逐渐丧失接触能力。四肢出现强直或屈曲瘫痪,括约肌功能障碍。此外,此期患者常可并发全身系统疾病的症状,如肺部及尿路感染、压疮以及全身性衰竭症状等,最终因并发症而死亡。
发明内容
本发明的主要目的在于提供一种具有改善或治疗老年痴呆功效的中药组合物,所述的中药组合物主要由羌活、独活、茯苓、防风、荆芥、川芎、桔梗、柴胡、前胡、枳壳、甘草制备而成。
本发明是在现有产品“荆防颗粒”的基础上所做的对其用途的进一步开发,荆防颗粒解酒的新用途来源于公司员工反馈,公司员工反馈,患老年痴呆家属长期服用荆防颗粒用于预防感冒,在服用荆防颗粒近半年后,员工发现其家属记忆能力较之前稍有提高。基于使用反馈,发明人对荆防颗粒及其组方进行了“改善或治疗老年痴呆”新用途的进一步研究与开发。
本发明目的之一在于提供上述中药组合物的具体组成,即所述中药组合物主要由以下原料制备而成:
优选的,所述中药组合物主要由以下原料制备而成:
进一步优选的,所述中药组合物主要由以下原料制备而成:
本发明目的之二在于提供上述中药组合物的制备方法,所述制备方法主要包括以下步骤:
步骤A:将荆芥、防风、羌活、独活、前胡、川芎、枳壳,蒸馏提取挥发油备用,蒸馏后的药渣、蒸馏后的川芎、枳壳水溶液备用;
步骤B:将步骤A所得蒸馏后的川芎、枳壳水溶液配制成10-40%的乙醇溶液,备用;
步骤C:将茯苓、步骤A所得蒸馏后的川芎、枳壳药渣混合,以步骤B所得乙醇溶液渗漉提取,渗漉液备用;
步骤D:将柴胡、桔梗、甘草、步骤A所得蒸馏后的荆芥、防风、羌活、独活、前胡药渣,加水煎煮,煎煮液浓缩后备用;
步骤E:将步骤C所得渗漉液、步骤D所得煎煮液混合,浓缩,加入步骤A所得挥发油,即得。
优选的,所述制备方法主要包括以下步骤:
步骤A:将荆芥、防风、羌活、独活、前胡、川芎、枳壳,蒸馏提取挥发油备用,蒸馏后的药渣、蒸馏后的川芎、枳壳水溶液备用;
步骤B:将步骤A所得蒸馏后的川芎、枳壳水溶液配制成15-30%的乙醇溶液,备用;
步骤C:将茯苓、步骤A所得蒸馏后的川芎、枳壳药渣混合,以步骤B所得乙醇溶液渗漉提取,渗漉液备用;
步骤D:将柴胡、桔梗、甘草、步骤A所得蒸馏后的荆芥、防风、羌活、独活、前胡药渣,加水煎煮,煎煮液浓缩成稠膏,备用;
步骤E:将步骤C所得渗漉液、步骤D所得稠膏混合,浓缩成清膏,加入步骤A所得挥发油,即得。
进一步优选的,所述制备方法主要包括以下步骤:
步骤A:将荆芥、防风、羌活、独活、前胡、川芎、枳壳,蒸馏提取挥发油备用,蒸馏后的药渣、蒸馏后的川芎、枳壳水溶液备用;
步骤B:将步骤A所得蒸馏后的川芎、枳壳水溶液配制成25%的乙醇溶液,备用;
步骤C:将茯苓、步骤A所得蒸馏后的川芎、枳壳药渣混合,以步骤B所得乙醇溶液渗漉提取,渗漉液备用;
步骤D:将柴胡、桔梗、甘草、步骤A所得蒸馏后的荆芥、防风、羌活、独活、前胡药渣,加水煎煮,煎煮液浓缩成稠膏,备用;
步骤E:将步骤C所得渗漉液、步骤D所得稠膏混合,浓缩成清膏,加入步骤A所得挥发油,即得。
本发明目的之三在于提供含有上述中药组合物或主要由上述中药组合物制备而成的中药制剂,所述的中药制剂可以是临床上可接受的口服制剂。
优选的,所述的口服制剂可以是固体制剂和/或液体制剂。
进一步优选的,所述液体制剂包括但不限于口服液、混悬液、糖浆剂、合剂,所述的固体包括包括但不限于片剂、丸剂、散剂、颗粒剂、胶囊剂,所述的气体制剂是气雾剂或者吸入剂;
更优选的,所述液体制剂为合剂,所述固体制剂为颗粒剂。
与现有技术相比,本发明取得了显著的技术效果:
药理实验证实,本发明中药组合物制备而成的荆防颗粒对三氯化铝造成的老年痴呆模型小鼠的学习记忆能力有明显改善,可显著提高模型小鼠脑组织中NE、DA、5-HT含量,提示荆防颗粒可以通过提高单胺类神经递质含量,起到改善老年痴呆小鼠学习记忆能力的作用。
具体实施方式
实施例1颗粒剂制备
处方:
荆芥75g、防风75g、羌活75g、独活75g、柴胡75g、前胡75g、川芎75g、枳壳75g、茯苓75g、桔梗75g、甘草25g;
制备方法:
步骤A:将荆芥、防风、羌活、独活、前胡、川芎、枳壳,分别蒸馏提取挥发油备用,蒸馏后的药渣、蒸馏后的川芎、枳壳水溶液备用;
步骤B:将步骤A所得蒸馏后的川芎、枳壳水溶液配制成25%的乙醇溶液,备用;
步骤C:将茯苓、步骤A所得蒸馏后的川芎、枳壳药渣混合,以步骤B所得乙醇溶液渗漉提取,渗漉液备用;
步骤D:将柴胡、桔梗、甘草、步骤A所得蒸馏后的荆芥、防风、羌活、独活、前胡药渣,加水煎煮两次,每次1.5小时,合并两次的煎煮液,过滤后浓缩成稠膏,备用;
步骤E:将步骤C所得渗漉液、步骤D所得稠膏混合,静置,过滤后浓缩成清膏,加蔗糖适量,混匀,制成颗粒,干燥,加入步骤A所得挥发油,混匀,即得。
实施例2颗粒剂制备
处方:
荆芥70g、防风85g、羌活60g、独活90g、柴胡70g、前胡90g、川芎70g、枳壳80g、茯苓50g、桔梗80g、甘草20g;
制备方法参考实施例1。
实施例3颗粒剂制备
处方:
荆芥60g、防风90g、羌活50g、独活110g、柴胡60g、前胡100g、川芎60g、枳壳100g、茯苓50g、桔梗80g甘草20g;
制备方法参考实施例1。
实施例4合剂制备
处方:
荆芥97g、防风97g、羌活97g、独活97g、柴胡97g、前胡97g、川芎97g、枳壳97g、茯苓97g、桔梗97g、甘草32.4g;
制备方法:
步骤A:将荆芥、防风、羌活、独活、前胡、川芎、枳壳,分别蒸馏提取挥发油备用,蒸馏后的药渣、蒸馏后的川芎、枳壳水溶液备用;
步骤B:将步骤A所得蒸馏后的川芎、枳壳水溶液配制成25%的乙醇溶液,备用;
步骤C:将茯苓、步骤A所得蒸馏后的川芎、枳壳药渣混合,以步骤B所得乙醇溶液渗漉提取,渗漉液备用;
步骤D:将柴胡、桔梗、甘草、步骤A所得蒸馏后的荆芥、防风、羌活、独活、前胡药渣,加水煎煮三次,合并煎煮液,过滤后浓缩至约1300ml,备用;
步骤E:将步骤C所得渗漉液、步骤D所得浓缩煎煮液混合,静置,过滤后浓缩至约1000ml,加入苯甲酸钠适量和步骤A所得挥发油,混匀,加水至1000ml,即得。
实施例5合剂制备
处方:
荆芥85g、防风70g、羌活90g、独活60g、柴胡90g、前胡70g、川芎90g、枳壳50g、茯苓80g、桔梗70g、甘草30g;
制备方法参考实施例4。
实施例6合剂制备
处方:
荆芥90g、防风60g、羌活110g、独活50g、柴胡100g前胡60g、川芎120g、枳壳50g、茯苓100g、桔梗70g、甘草30g;
制备方法参考实施例4。
实施例7糖浆剂制备
处方:
荆芥75g、防风75g、羌活75g、独活75g、柴胡75g、前胡75g、川芎75g、枳壳75g、茯苓75g、桔梗75g、甘草25g;
制备方法参考实施例4,按照常规工艺制备糖浆剂。
实施例8口服液制备
处方:
荆芥97g、防风97g、羌活97g、独活97g、柴胡97g、前胡97g、川芎97g、枳壳97g、茯苓97g、桔梗97g、甘草32.4g;
制备方法参考实施例4,按照常规工艺制备口服液。
实施例9片剂制备
处方:
荆芥75g、防风75g、羌活75g、独活75g、柴胡75g、前胡75g、川芎75g、枳壳75g、茯苓75g、桔梗75g、甘草25g;
制备方法参考实施例1,按照常规工艺制备片剂。
实施例10胶囊剂制备
处方:
荆芥75g、防风75g、羌活75g、独活75g、柴胡75g、前胡75g、川芎75g、枳壳75g、茯苓75g、桔梗75g、甘草25g;
制备方法参考实施例1,按照常规工艺制备胶囊剂。
实施例11丸剂制备
处方:
荆芥75g、防风75g、羌活75g、独活75g、柴胡75g、前胡75g、川芎75g、枳壳75g、茯苓75g、桔梗75g、甘草25g;
制备方法参考实施例1,按照常规工艺制备丸剂。
二、药理学实验
为验证本发明中药组合物的改善或治疗老年痴呆方面的功效,发明人开展了相关的药效学试验研究。需要说明的是,下述药效学试验所选取的药品为本发明具有代表性的配方及其制备方法所得的药品;本发明所包含的其它配方及制备方法所得药品,发明人同样进行了药效学实验,实验结果显示其他配方及制备方法所得药品具有相同或类似的效果,但由于篇幅限制,在此不一一穷举;此外,下述药效学实验仅以部分代表性的动物模型为例验证本发明的功效。
发明人要说明的是,以下实验研究均是在急性毒性试验、长期毒性试验证明药物安全性基础之上开展,实验研究中的给药剂量均在安全剂量范围之内。
本发明组合物对对三氧化铝诱导的老年痴呆小鼠学习记忆能力的改善作用
1材料
1.1动物:
昆明种小鼠,SPF级,30~35g,实验动物许可证号:SYXK(鲁)2018 0008,由鲁南制药集团股份有限公司提供,实验前适应性饲养一周。
1.2药物、试剂
1.2.1药物
本发明实施例1、2、3所得颗粒剂、实施例4所得合剂;
吡拉西坦片(国药准字H22023211)
1.2.3小鼠用药剂量
实施例1颗粒剂:2.925g/kg(低剂量)、5.85g/kg(中剂量)、11.7g/kg(高剂量);
实施例2颗粒剂:5.85g/kg;
实施例3颗粒剂:5.85g/kg;
实施例4合剂:8.0ml/kg;
吡拉西坦片:0.64g/kg。
2.实验过程
2.1动物分组、造模及给药
取小鼠90只,随机分为空白组、模型组、吡拉西坦片组、实施例1(高、中、低)三个剂量组、实施例2组、实施例3组、实施例4组,共计9组,每组10只。除空白组灌胃给予生理盐水外,其余各组小鼠每天灌胃给予三氯化铝(200mg/kg),建立老年痴呆模型,连续造模50天;小鼠灌胃给予三氯化铝后,各给药组小鼠分别灌胃给予相应的药物,模型组、空白组灌胃给予等量的生理盐水,连续给药60天。
2.2指标测定
2.2.1学习记忆能力测定
参考Morris水迷宫法测定,水深20cm,高于平台1cm,自给药第56天起,小鼠末次给药1小时后,放入水中,记录小鼠从入水至爬上平台所需的时间,连续训练测试4天,2次/天,每次测试60s,60s内未找到平台,逃避潜伏期记为60s,并引至平台停留20s,第5天将平台撤除,选相同入水点,记录小鼠在60s内的游泳轨迹和在原平台象限爹停留时间及穿越站台的次数。
2.2.2脑组织中NE(去甲肾上腺素)、DA(多巴胺)、5-HT(5-羟色胺)含量测定
小鼠记忆能力测试完成后,小鼠禁食24h,断头处死,剥离脑组织,高效液相色谱-电化学法测定脑组织中NE、DA、5-HT含量。
2.3统计学处理
3.结果及结论
3.1各组小鼠学习记忆能力检测
与空白组比较,模型组小鼠逃避潜伏期显著延长,穿越次数显著减少(P<0.01);与模型组比较,各给药组小鼠的逃避潜伏期均显著缩短,穿越次数显著增加(P<0.05或P<0.01);本发明个别实施例组小鼠逃避潜伏期、穿越次数与吡拉西坦片组无差异(P>0.05),结果见表1。
注:与空白组对比,*P<0.05,△P<0.01;
与模型组对比,#P<0.01;
与吡拉西坦片组对比,&P<0.05。
3.2各组小鼠脑组织中NE、DA、5-HT含量测定结果
与空白组比较,模型组小鼠的脑组织中NE、DA、5-HT含量显著减少(P<0.01);与模型组比较,各给药组小鼠脑组织NE、DA、5-HT的含量均显著增加(P<0.01);本发明个别实施例组小鼠脑组织NE、DA、5-HT的含量与吡拉西坦片组无差异(P>0.05),结果见表2。
注:与空白组对比,*P<0.05,△P<0.01;
与模型组对比,#P<0.01;
与吡拉西坦片组对比,&P<0.05。
Claims (9)
1.一种主要由羌活、独活、茯苓、防风、荆芥、川芎、桔梗、柴胡、前胡、枳壳、甘草制备而成的中药组合物在制备改善和/或治疗老年痴呆药物中的用途。
5.如权利要求1-4任一项所述的用途,其特征在于,所述的中药组合物可制备成临床上可接受的中药制剂。
6.如权利要求5所述的用途,其特征在于,所述中药制剂可以是口服制剂或其他制剂。
7.如权利要求6所述的用途,其特征在于,所述的口服制剂可以是固体制剂和/或液体制剂。
8.如权利要求7所述的用途,其特征在于,所述液体制剂包括但不限于口服液、混悬液、糖浆剂、合剂,所述的固体包括包括但不限于片剂、丸剂、散剂、颗粒剂、胶囊剂。
9.如权利要求8所述的用途,其特征在于,所述液体制剂为合剂,所述固体制剂为颗粒剂。
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