CN116832132B - 一种可减轻疼痛及麻木的中药组合物、制剂及其制备方法和应用 - Google Patents
一种可减轻疼痛及麻木的中药组合物、制剂及其制备方法和应用 Download PDFInfo
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Abstract
本发明属于中药技术领域,提供了一种可减轻疼痛及麻木的中药组合物、制剂及其制备方法和应用;所述的中药组合物,包括以下原料:鸡血藤、延胡索、青风藤、乳香、两面针、川芎、苏木及冰片;通过各原料活性组分的复配,具有活血、镇痛的作用,相比于现有技术,中药组合物组分更为精简,可以更好的减轻肢体疼痛和麻木,可用于糖尿病周围神经病变、风湿免疫相关疾病引起的肢体疼痛和麻木。
Description
技术领域
本发明属于中药技术领域,具体涉及一种可减轻疼痛及麻木的中药组合物、制剂及其制备方法和应用。
背景技术
肢体痛疼麻木是临床常见的症状之一,除跌打损伤外,其发病部位还有面部、口舌、四肢、指端、皮肤、肩背、胸腹等处。主要表现为患部麻木不仁、非痛非痒、肉内如有虫行,甚则痒痛不知、感觉消失、如木之厚,发病原因较为复杂。目前市场上治疗疼痛麻木的方法很多,包括西药、中药、针灸还有联合治疗,西药在应用过程中往往伴随着副作用,且部分药品如阿片类止疼药还易产生药物依赖性,对人体容易引起不良反应,中药治疗方法较多,但效果往往不确切。
CN106728955A公开了一种治疗肢体疼痛、麻木的热敷药,是由白芷、僵蚕、西红花、(制)穿山甲、地龙、(制)王不留行、血竭、千年健、桑寄生、川乌,草乌、独活、羌活、荆芥、防风、祖师麻、天麻、黑骨藤、伸筋草、钻地风、雪莲花、乳香、没药、当归、川芎、艾叶、五加皮、桂枝、葱白、小茴香、花椒、附子、肉桂、寻骨风、防己、苍术、桔梗、木瓜、靳蛇、泽兰、苏木、丹参、怀牛膝、益母草、马钱子、雷公藤、杜仲、续断、(制)猫骨、大风子、天仙子、凤仙根、蚕沙、藁本、鸡血藤、海风藤、蚂蚁等中药组成,经粉碎调入白酒和醋混合、拌匀、渗透,装入棉布袋中,置于微波炉中加热,敷于患处,对治疗肢体疼痛、麻木有显著的疗效。
CN107583000A一种治疗肢体麻木或疼痛的中药配方,属于中药技术领域。该中药配方中各药材配比为:桂皮20g;当归25克;甘草10克;芍药25克;川芎15克;熟地15克;陈皮10g;半夏10克;白术25克;茯苓10g;干姜10克;大枣10枚,用法:水煎服,分早晚温服;人参单煎同服。主治手足麻木感、运动麻痹、脑溢血所致的肢体麻痹和疼痛,颜面神经痉挛、三叉神经痛,颜面神经麻痹等。
肢体疼痛和麻木作为广泛存在于各种疾病与肢体损伤的症状,治疗肢体疼痛麻木的药物发展前景十分广阔,提供一种组方更为简练且效果显著的可减轻疼痛与麻木的中药组合物,对于减轻患者病痛,提高患者的生活质量,有着重要意义。
发明内容
本发明的术语和声明:
1、如本文所用,冠词"一个"、"一种"和"所述":除非以其它方式明确地限定到一个(种)对象,否则包括复数的对象。
2、如本文所用,数值范围:除非以其他方式明确指出,本文中公开的所有范围或比率将会被理解为包括其中包含的任何和所有的子范围或子比率。例如,声明的1至30的范围或比率应当被认为包含在最小值1和最大值30之间,并且包括断端点在内的任何子范围或子比率、整数、小数或由整数或小数构成的子范围或子比率。
3、如本文所用,术语“包含”、“包括”、“具有”、“可以”、“含有”及其变化形式的意义是不排除另外组成或结构的可能性的开放式连接词语或术语。
为了解决上述技术问题,本发明提供了一种可减轻疼痛与麻木的中药组合物,该中药组合物通过鸡血藤、延胡索、青风藤、乳香、两面针、川芎、苏木及冰片与姜黄、牛膝、辣椒及桂枝的协同作用,可以有效镇痛、活血,用于减轻肢体疼痛与麻木,使之满足临床需求。
为了实现上述目的,本发明采用的技术方案如下:
一种可减轻疼痛与麻木的中药组合物,包括鸡血藤、延胡索、青风藤、乳香、两面针、川芎、苏木及冰片。
所述鸡血藤包括但不限于山鸡血藤、网络鸡血藤、亮叶鸡血藤及常春油麻藤。
所述延胡索包括但不限于炒延胡索、醋延胡索及酒延胡索。
所述青风藤包括但不限于青藤、华防己及清风藤。
所述乳香包括但不限于生乳香、醋乳香及炒乳香。
所述两面针包括但不限于两面针及毛两面针。
所述川芎包括但不限于川芎、酒川芎、炒川芎及麸炒川芎。
所述冰片包括但不限于天然冰片、合成龙脑及艾片。
优选地,所述中药组合物,包括以下重量份的组分:
鸡血藤2-8份、延胡索3-10份、青风藤4-10份、乳香2-5份、两面针2-8份、川芎2-7份、苏木1-6份及冰片0.5-3份。
进一步优选地,所述中药组合物,包括以下重量份的组分:
鸡血藤3-7份、延胡索4-9份、青风藤5-9份、乳香3-4份、两面针3-7份、川芎3-6份、苏木2-5份及冰片1-2份。
更进一步优选地,所述中药组合物,包括以下重量份的组分:
鸡血藤4-6份、延胡索5-8份、青风藤6-8份、乳香3-4份、两面针4-6份、川芎4-5份、苏木2-4份及冰片1-2份。
最优选地,所述中药组合物,包括以下重量份的组分:
鸡血藤6份、延胡索5份、青风藤6份、乳香7份、两面针5份、川芎5份、苏木3份及冰片2份。
优选地,所述中药组合物,还包括姜黄、牛膝、辣椒及桂枝。
所述姜黄包括但不限于郁金及莪术。
所述牛膝包括但不限于川牛膝、怀牛膝、土牛膝、酒牛膝及盐牛膝。
所述辣椒包括但不限于指天椒、簇生椒及小指椒。
进一步优选地,所述中药组合物,还包括以下重量份的组分:
姜黄3-9份、牛膝1-7份、辣椒0.5-4份及桂枝1-5份。
更进一步优选地,所述中药组合物,还包括以下重量份的组分:
姜黄4-8份、牛膝2-6份、辣椒1-3份及桂枝2-4份。
再进一步优选地,所述中药组合物,还包括以下重量份的组分:
姜黄5-7份、牛膝3-5份、辣椒1-3份及桂枝2-4份。
最优选地,所述中药组合物,还包括以下重量份的组分:
姜黄6份、牛膝4份、辣椒2份及桂枝3份。
一种可减轻疼痛与麻木的中药组合物的制备方法,包括以下步骤:
S1、将配方量的鸡血藤、延胡索、青风藤、乳香、两面针、苏木及川芎混合醇提,得到提取液;
S2、将步骤S1中得到的提取液浓缩,静置分离,得到油脂层和水层;
S3、向步骤S2中得到的油脂层中加入辅料分散,得到油脂中间体;
S4、将步骤S2中得到的水层,醇沉并浓缩,得到浓缩膏;
S5、向步骤S3中得到的油脂中间体中加入步骤S4中得到的浓缩膏及配方量冰片,混合即得所述中药组合物。
优选地,步骤S1中所述醇提为:加入乙醇体积分数为30%-90%的乙醇溶液提取。
进一步优选地,所述乙醇溶液的用量为15-30倍于步骤S1所述鸡血藤、延胡索、青风藤、乳香、两面针、苏木及川芎重量的总和。
更进一步优选地,所述乙醇溶液中乙醇的体积分数为60-90%;所述乙醇溶液的用量为8-10倍于步骤S1所述鸡血藤、延胡索、青风藤、乳香、两面针、苏木及川芎重量的总和。
最优选地,所述提取的单次时间为2小时,提取的次数为2-3次。
优选地,步骤S2中所述浓缩到相对密度为1.10-1.30。
进一步优选地,步骤S2中所述浓缩到相对密度为1.20-1.30。
优选地,步骤S3中所述辅料为聚乙二醇。
进一步优选地,所述辅料的加入量为油脂层重量的0.5-3倍。
优选地,步骤S4中所述醇沉为:加入乙醇使所述水层中乙醇体积分数为30-90%,静置。
进一步优选地,所述醇沉为:加入乙醇使所述水层中乙醇体积分数为60-80%,静置。
优选地,步骤S4中所述浓缩到相对密度为1.10-1.30。
进一步优选地,步骤S4中所述浓缩到相对密度为1.20-1.30。
本发明还提供了上述可减轻疼痛与麻木的中药组合物在制备可减轻疼痛与麻木的制剂中的应用。
优选地,所述可减轻疼痛与麻木的制剂的剂型为软膏、乳膏、搽剂、凝胶剂、凝胶贴膏剂、涂膜剂。
本发明还提供了包含有按照上述可减轻疼痛与麻木的中药组合物的制备方法制备的中药组合物的制剂。
优选地,提供了一种可减轻疼痛与麻木的搽剂,包括以下重量份的组分:
本发明提供的制备方法制备的中药组合物40-60份、乙醇30-40份和水1-20份。
进一步优选地,所述搽剂包括以下重量份的组分:
本发明提供的制备方法制备的中药组合物45-55份、乙醇35-40份和水1-10份。
最优选地,所述搽剂包括以下重量份的组分:
本发明提供的制备方法制备的中药组合物50份、乙醇40份和水10份。
优选地,提供了一种可减轻疼痛与麻木的软膏,包括以下重量份的组分:
本发明提供的制备方法制备的中药组合物15-30份、聚乙二醇400 1-15份、凡士林50-70份、羊毛脂1-5份、单硬脂酸甘油酯0.1-2份和薄荷脑1-5份。
进一步优选地,所述软膏包括以下重量份的组分:
本发明提供的制备方法制备的中药组合物18-25份、聚乙二醇400 8-13份、凡士林60-70份、羊毛脂2-3份、单硬脂酸甘油酯1-2份和薄荷脑1-3份。
最优选地,所述软膏包括以下重量份的组分:
本发明提供的制备方法制备的中药组合物20份、聚乙二醇400 10份、凡士林65份、羊毛脂2份、单硬脂酸甘油酯2份和薄荷脑1份。
本发明还提供了上述搽剂和软膏在治疗糖尿病周围神经病变及风湿免疫疾病中的应用。
本发明所用中草药的药用功效:
延胡索具有活血,行气止痛之功效。抗焦虑、镇静、催眠、抗心肌缺血、抗脑缺血、抗胃溃疡作用、抗肿瘤、增强内分泌系统功能、抗血小板聚集、抗抑郁等药理作用。
鸡血藤具有活血补血,调经止痛,舒筋活络之功效。用于月经不调、痛经、经闭、风湿痹痛、麻木瘫痰、血虚萎黄等,药效成分主要为蒽醌类(如:大黄酸、芦荟大黄素、大黄素)。药理作用显示:具有抗氧化、抗炎、抗肿瘤、抗病毒、肝保护、药理作用。
姜黄具有破血行气、通经止痛之功效。用于胸胁刺痛、胸痹心痛、痛经、经闭、癥瘕、风湿肩臂疼痛、跌扑肿痛等症。主要活性成分为姜黄素、黄酮类以及挥发油类。药理实验显示:具有抗炎、抗菌、抗氧化、抗糖尿病、神经保护、抗肿瘤、保肝以及降血脂等药理作用。
青风藤具有祛风湿、通经络、利小便等。用于风湿痹痛、关节肿胀、麻痹瘙痒等症。主要活性成分为生物碱类化合物(如:清风藤碱)。药理实验显示:具有镇痛、抗炎,调节免疫、促组胺释放及抗肿瘤等药理作用。
牛膝具有逐瘀通经、补肝肾、强筋骨、利尿通淋、引血下行之功效。用于腰膝酸痛、筋骨无力、头痛、眩晕、牙痛、口疮、经闭、痛经、吐血及衄血等症。主要活性成分为甾酮类、三萜皂苷类。
川芎具有活血行气、祛风止痛之功效。用于胸痹心痛、胸胁刺痛、跌扑肿痛、月经不调、经闭痛经、癥瘕腹痛、头痛、风湿痹痛等症。主要活性成分为生物碱类(如:川芎嗪)和挥发油(如:藁本内脂)。药理实验显示:具有镇痛、抗炎、抗氧化、细胞保护、抗凝血、抗脑缺血、抗血管认知障碍、抗电离辐射损伤及抗抑郁等药理作用。
苏木具有活血祛瘀、消肿止痛之功效。用于瘀滞肿痛、跌打损伤、骨折筋伤、经闭痛经、产后瘀阻、胸腹刺痛、痈疽肿痛等症。主要活性成分为高异黄酮类。药理作用:抗菌、抗炎、舒张血管、免疫抑制以及抗肿瘤等药理作用。
乳香具有活血定痛、消肿生肌之功效。用于胸痹心痛、胃脘疼痛、痛经经闭、产后瘀阻、瘾瘕腹痛、风湿痹痛、筋脉拘挛、跌打损伤、痈肿疮疡等症。主要活性药效成分为挥发油。药理实验显示:具有抗菌、抗炎、抗氧化、抗溃疡、促进伤口愈合、促神经再生、镇痛、调节糖脂代谢、改善学习记忆、抗纤维化、抗哮喘、抗焦虑、抗抑郁、抗凝血等药理活性。
两面针具有活血化瘀、行气止痛、祛风通络、解毒消肿之功效。用于跌打损伤、胃痛、牙痛、风湿痹痛、毒蛇咬伤、烧烫伤等症。主要活性药效成分为生物碱类(如:氯化两面针碱、小檗碱、茵芋碱)。药理实验显示:具有抗菌、抗寄生虫及抗肿瘤等药理作用。
冰片具有开窍醒神、清热止痛之功效。用于热病神昏、惊厥、中风痰厥、气郁暴厥、中恶昏迷、胸痹心痛、目赤、口疮、咽喉肿痛、耳道流脓等症。
辣椒外用温中散寒,用于寒滞腹痛。呕吐,泻痢,冻疮。
桂枝具有发汗解肌,温通经脉,助阳化气,平冲降气之功效。用于风寒感冒,脘腹冷痛,血寒经闭,关节痹痛,痰饮,水肿,心悸,奔豚。
本发明的有益效果为:
本发明的可减轻疼痛与麻木的中药组合物,精选两面针、川芎、延胡索、清风藤、乳香、鸡血藤、苏木、姜黄、牛膝、辣椒、桂枝及冰片为原料,通过各原料活性组分的复配,具有活血、镇痛的作用,相比于现有技术,中药组合物组方更为简练;可以更好的减轻肢体疼痛和麻木,可用于糖尿病周围神经病变、风湿免疫相关疾病引起的肢体疼痛和麻木。
具体实施方式
下面通过实施例对本发明进行说明,以使本发明技术方案更易于理解、掌握,但本发明并不局限于此。下述实施例所述实验方法,如无特殊说明,均为常规方法;所述药材和试剂,如无特殊说明,均可从商业途径获得;且不同来源产品性能不具有显著性影响。
基础实施例
一种可减轻疼痛与麻木的中药组合物,包括以下重量份的组分:鸡血藤2-8份、延胡索3-10份、青风藤4-10份、乳香2-5份、两面针2-8份、川芎2-7份、苏木1-6份、姜黄3-9份、牛膝1-7份、辣椒0.5-4份、桂枝1-5份及冰片0.5-3份。
实施例1-3一种可减轻疼痛与麻木的中药组合物及其制剂和制备方法
实施例1-3中所述可减轻疼痛与麻木的中药组合物的原料及用量如表1所示,每份按1g计。
表1原料及用量表
表中“-”标记表明配方中未添加所对应的原料。
表中“*”标记表明将配方中的鸡血藤替换为等配方量的丹参。
上述实施例1-3的中药组合物,其制备方法如下:
S1、对配方量的鸡血藤、延胡索、青风藤、乳香、两面针、川芎及苏木进行提取,每次提取利用8倍于鸡血藤、延胡索、青风藤、乳香、两面针、川芎及苏木重量总和的体积分数为80%的乙醇溶液提取2小时,共提取3次;过滤并合并提取后的乙醇溶液得到提取液;
S2、将步骤S1中得到的提取液减压浓缩至相对密度为1.25,静置16小时,分离,得到油脂层和水层。
S3、向步骤S2中得到的油脂层中加入总质量为2倍于油脂层重量的聚乙二醇分散,得到油脂中间体;
S4、向步骤S2中得到的水层中加入乙醇,至乙醇的质量分数为80%,静置24小时以上并分离上清液,将上清液减压浓缩至相对密度为1.25,得到浓缩膏;
S5、向步骤S2中得到的油脂中间体中加入步骤S3中得到的浓缩膏及配方量冰片,混合均匀即得所述中药组合物。
实施例4-6一种可减轻疼痛与麻木的中药组合物及其制剂和制备方法
实施例4-6与实施例1-3的不同在于:制备方法中步骤S1不同,具体为:
S1、将配方量的鸡血藤、延胡索、青风藤、乳香、两面针、川芎、苏木、姜黄、牛膝、辣椒及桂枝混合醇提,得到提取液。
实施例4-6中所述可减轻疼痛与麻木的中药组合物的原料及用量如表1所示。
实施例7一种可减轻疼痛与麻木的中药组合物制剂的制备方法
本对比例与实施例4的区别在于:将实施例4中所得到的中药组合物进一步制备成搽剂,具体如下:
取实施例4制备得到的中药组合物50份,加入乙醇40份,水10份,混匀,过滤,即得。
实施例8一种可减轻疼痛与麻木的中药组合物制剂的制备方法
本对比例与实施例4的区别在于:将实施例4中所得到的中药组合物进一步制备成软膏,具体如下:
取实施例4制备得到的中药组合物20份,加入聚乙二醇400 10份,凡士林65份,羊毛脂2份,单硬脂酸甘油酯2份,薄荷脑1份,混匀,即得。
对比例1一种可减轻疼痛与麻木的中药组合物及其制剂和制备方法
本对比例与实施例1的不同在于:鸡血藤、延胡索、青风藤、乳香、两面针、川芎、苏木与冰片的用量不同,具体地,如表1所示。
对比例2一种可减轻疼痛与麻木的中药组合物及其制剂和制备方法
本对比例与实施例1的不同在于:鸡血藤、延胡索、青风藤、乳香、两面针、川芎、苏木与冰片的用量不同,具体地,如表1所示。
对比例3一种可减轻疼痛与麻木的中药组合物及其制剂和制备方法
本对比例与实施例1的不同在于:所述中药组合物中利用等重量的丹参代替鸡血藤,具体地,如表1所示。
对比例4一种可减轻疼痛与麻木的中药组合物及其制剂和制备方法
本对比例与实施例4的不同在于:鸡血藤、延胡索、青风藤、乳香、两面针、川芎、苏木、冰片、姜黄、牛膝、辣椒及桂枝的用量不同,具体地,如表1所示。
对比例5一种可减轻疼痛与麻木的中药组合物及其制剂和制备方法
本对比例与实施例1的不同在于:制备方法不同;具体为:
S1、对配方量的鸡血藤、延胡索、青风藤、乳香、两面针、川芎及苏木进行煎煮,每次加入8倍于鸡血藤、延胡索、青风藤、乳香、两面针、川芎及苏木重量总和的水煎煮2小时,共煎煮3次,过滤并合并煎煮液,得到提取液。
S2、将步骤S1中得到的提取液浓缩至相对密度1.25,加入配方量冰片混匀,即得所述中药组合物。
镇痛与活血功效评价
1.试验材料
SPF级ICR小鼠,雄性,体重13.4-19.4g,数量112只,购自广东维通利华实验动物技术有限公司,生产许可证号SCXK(粤)2022-0063,动物合格证号44829700009083,检疫3天。
2.试剂及阳性药
二甲苯、甲醛,均为国产分析纯;扶他林(双氯芬酸二乙胺乳胶剂,GSK ConsumerHealthcare S.A.);云南白药气雾剂(云南白药集团股份有限公司);空白对照样品为聚乙二醇。
3.分组及实验顺序
112只雄性ICR小鼠,先进行热刺痛实验,调整光照强度为45%,选择基础疼痛阈值在4.35-7.05s的小鼠,随机划分为14组,即模型对照组、阳性药对照1组、阳性药对照2组、受试物1组、受试物2组,受试物3组、受试物4组,受试物5组、受试物6组,受试物7组,受试物8组,受试物9组,受试物10组及受试物11组;每组8只。分组及剂量见表2。
表2分组及给药量表
4.给药
热刺痛实验(D1):各组取约30mg或0.3ml药膏或药液均匀涂抹于小鼠小腿和足部,揉搓约30s,等待完全干燥后,放回笼内,一天时间2次。
耳廓微循环观察实验(D2):各组取约20mg或0.2ml药膏或药液均匀涂抹于小鼠耳廓内侧。
甲醛致痛实验(D3):各组取约30mg或0.3ml药膏或药液均匀涂抹于小鼠小腿和足部,揉搓约30s,等待完全干燥后,放回笼内。
5.动物模型制备及检测
5.1热刺痛实验D1
小鼠检疫结束后D0进行热刺痛实验,测量分组前右足基础阈值,后根据上述分组方法进行分组。
D1末次给药后30min、60min、120min、240min检测热刺痛阈值。右足连续检测两次,取平均值。
检测方法:打开热刺痛仪电源,预热,调整光照强度为45%,把小鼠放进透气隔离箱中适应至少5min,待安静后,刺激红外十字点对准小鼠脚底位置进行热刺激,记录痛阈值,结果如表3所示。
5.2耳廓微循环观察实验D2
给药前及给药后一定时间(除阳性药对照1组是给药后1h外,其余组为给药后30min)用体式显微镜观察和拍摄小鼠耳廓的微循环情况,记录微血管较大主支管径,计算同一位置管径变化率,计算公式:微血管管径变化率(%)=(给药后微血管直径-给药前微血管直径)/给药前微血管直径100%,结果如表4所示。
5.3甲醛致痛实验(痛反应时间)D3
给药后一定时间(除阳性药对照1组是给药后1h外,其余组为给药后30min),在小鼠右足足底皮下注射2%甲醛生理盐水溶液25μL。造模后立即将小鼠放进大烧杯里观察,连续观察30min,每5min为1个时间段,采用计时器分别记录各时间段内痛反应累积时间,即小鼠右后足不接触烧杯底部,处于舔足、抖足或咬足状态的累积时间。计算30min内总痛反应时间,和Ⅰ相反应(0~5min,神经疼痛)和Ⅱ相反应(10~30min,神经疼痛和炎性疼痛)的累积痛反应时间,结果如表5所示。
6.实验结果及结论
表3给药后各组对小鼠热刺痛实验痛阈的影响(秒,)
注:#为各组给药后各时间点与给药前痛阈相比,两两T检验。#P<0.05,##P<0.01。*为各组各时间点与模型对照组痛阈相比,两两T检验。*P<0.05,**P<0.01。
由表3中数据可知,涂抹有本发明实施例1-6中中药组合物(受试物1-6)的小鼠在给药后30min时的热刺痛痛阈,与给药前痛阈或模型对照组相比,均显著提高了小鼠热刺痛的痛阈,相比于阳性药对照2组表现出了更为显著的提高小鼠热刺痛痛阈的作用,实施例4-6由于加入了可优选加入的姜黄、牛膝、辣椒及桂枝四味药材,相比于未加入这些原料的实施例1-3,表现出更好的提高小鼠热刺痛痛阈的作用;而对比例1和2中的中药组合物(受试物7和8)由于中药组合物中各组分的重量比在本发明所限定的保护范围鸡血藤2-8份、延胡索3-10份、青风藤4-10份、乳香2-5份、两面针2-8份、川芎2-7份、苏木1-6份及冰片0.5-3份外,而未表现出显著的提高小鼠热刺痛痛阈的作用;对比例3中的中药组合物(受试物9)由于将中药组合物中的鸡血藤替换为具有相近药效的丹参,而未表现出显著的提高小鼠热刺痛痛阈的作用;对比例4中的中药组合物(受试物10)由于中药组合物中各组分的重量比在本发明所限定的保护范围鸡血藤2-8份、延胡索3-10份、青风藤4-10份、乳香2-5份、两面针2-8份、川芎2-7份、苏木1-6份、冰片0.5-3份、姜黄3-9份、牛膝1-7份、辣椒0.5-4份及桂枝1-5份外,而未表现出显著的提高小鼠热刺痛痛阈的作用;对比例5中的中药组合物(受试物11)由于中药组合物的制备过程中采用水提而非醇提醇沉的方式,从而使得其未表现出显著的提高小鼠热刺痛痛阈的作用;综上所述,本发明所提供的中药组合物(实施例1-6)具有显著的提高小鼠热刺痛痛阈的作用,而非本发明的中药组合物(对比例1-5),则未有明显的提高小鼠热刺痛痛阈的效果。
表4给药后各组对小鼠耳廓微血管管径变化率的影响(百分比,)
注:*为与模型对照组相比,两两T检验。*P<0.05,**P<0.01。
由表4数据可知,耳廓涂抹有本发明实施例1-6中的中药组合物(受试物1-6)的小鼠,其耳廓微血管管径相比于模型对照组呈现显著扩张,与阳性药对照1组对比表现出几乎一致(受试物1-3)或更佳的(受试物4-6)血管管径扩张效果,表现出了显著的促进小鼠耳廓微血管管径扩张的作用,可以认为具有促进微循环及活血的功效;而本发明对比例1-5(受试物7-11)中的中药组合物,或由于其中药组合物的中药组分含量与本发明要求的不一致,或由于其中药组合物中中药组分与本发明要求的不一致,或由于其中药组合物的制备方法与本发明不一致,导致了本发明对比例1-5中的中药组合物并未显示出显著的促进小鼠耳廓微血管管径扩张的作用,即未体现出明显的促进微循环及活血的功效。
表5给药后各组对小鼠甲醛致痛实验痛反应时间的影响(秒,)
注:*为与模型对照组相比,两两T检验。*P<0.05,**P<0.01。
由表5数据可知,本发明实施例1-6中的中药组合物(受试物1-6),其对于小鼠甲醛致痛的Ⅰ相反应(0~5min,神经疼痛)的痛反应时间减少并未有显著的缓解作用,而对于II相反应(10~30min,神经疼痛和炎性疼痛)则表现出了显著的镇痛作用,具体体现为可以有效的减少小鼠炎性疼痛的痛反应时间,而实施例4-6(受试物4-6)通过中药组分的进一步复配,用药为实施例4-6中中药组合物的小鼠在甲醛致痛实验中的总痛时间相较于模型对照组表现出极显著的下降,表现出更佳的镇痛效果;结合上述小鼠热刺痛痛阈试验可以说明本发明实施例1-6中的中药组合物具有显著的镇痛作用。
综上所述,本发明实施例1-6中的中药组合物均表现出良好的镇痛与活血作用,可以有效的减轻疼痛和麻木。
最后应当说明的是,以上内容仅用以说明本发明的技术方案,而非对本发明保护范围的限制,本领域的普通技术人员对本发明的技术方案进行的简单修改或者等同替换,均不脱离本发明技术方案的实质和范围。
Claims (7)
1.一种减轻疼痛与麻木的中药组合物,其特征在于:采用以下重量份的组分制成:
鸡血藤2-8份、延胡索3-10份、青风藤4-10份、乳香2-5份、两面针2-8份、川芎2-7份、苏木1-6份、冰片0.5-3份、姜黄3-9份、牛膝1-7份、辣椒0.5-4份及桂枝1-5份。
2.根据权利要求1所述的中药组合物在制备减轻疼痛与麻木的制剂中的应用。
3.根据权利要求2所述的应用,其特征在于:所述减轻疼痛与麻木的制剂的剂型为软膏、搽剂、凝胶剂和涂膜剂。
4.根据权利要求3所述的应用,其特征在于:所述减轻疼痛与麻木的制剂的剂型为乳膏。
5.一种中药组合物的制备方法,其特征在于:包含以下步骤:
S1、将配方量的鸡血藤、延胡索、青风藤、乳香、两面针、苏木、川芎、姜黄、牛膝、辣椒及桂枝混合醇提,得到提取液;
S2、将步骤S1中得到的提取液浓缩,静置分离,得到油脂层和水层;
S3、向步骤S2中得到的油脂层中加入辅料分散,得到油脂中间体;
S4、将步骤S2中得到的水层,醇沉并浓缩,得到浓缩膏;
S5、向步骤S3中得到的油脂中间体中加入步骤S4中得到的浓缩膏及配方量冰片,混合即得所述中药组合物;
所述的中药组合物,采用以下重量份的组分制成:
鸡血藤2-8份、延胡索3-10份、青风藤4-10份、乳香2-5份、两面针2-8份、川芎2-7份、苏木1-6份、冰片0.5-3份、姜黄3-9份、牛膝1-7份、辣椒0.5-4份及桂枝1-5份;
步骤S1中所述醇提为:加入乙醇体积分数为30%-90%的乙醇溶液提取;
步骤S2中所述浓缩到相对密度为1.10-1.30;
所述乙醇溶液的用量为15-30倍于步骤S1所述鸡血藤、延胡索、青风藤、乳香、两面针、苏木及川芎重量的总和;
步骤S4中所述醇沉为:加入乙醇使所述水层中乙醇体积分数为30-90%,静置;
步骤S4中所述浓缩到相对密度为1.10-1.30。
6.采用权利要求5所述制备方法制备的中药组合物为原料制备的制剂,其特征在于:剂型为搽剂,由以下重量份的组分制成:
所述中药组合物40-60份,乙醇30-40份,水1-20份。
7.采用权利要求5所述制备方法制备的中药组合物为原料制备的制剂,其特征在于:剂型为软膏,由以下重量份的组分制成:
所述中药组合物15-30份,聚乙二醇400 1-15份,凡士林50-70份,羊毛脂1-5份,单硬脂酸甘油酯0.1-2份,薄荷脑1-5份。
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