CN110090285A - 一种治疗坐骨神经痛的膏药及其制备方法 - Google Patents
一种治疗坐骨神经痛的膏药及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种治疗坐骨神经痛的膏药组合物,按重量份计,其制备原料至少包含:皂角刺20~40份、独活5~15份、制附子5~15份、肉桂1~10份、姜黄10~20份、苍术10~20份、薏苡仁20~40份、防己5~15份、托玛琳130~170份;本发明对于由各种原因引起的坐骨神经痛均有良好的治疗效果,并且起效时间短,可及时减轻患者病痛。
Description
技术领域
本发明涉及中医药领域,尤其涉及一种治疗坐骨神经痛的膏药及其制备方法。
背景技术
坐骨神经痛为一综合征,是指坐骨神经通路及其分布区内的疼痛,其范围包含了人体大腿后部、小腿后外侧和足部,疼痛会严重影响患者的工作和生活,尤其疼痛剧烈的病人甚至难以行走,形体发生变化,如腰部屈曲、屈膝、脚尖着地等。引起坐骨神经痛的原因有多种,少数为原发性的坐骨神经炎,多数为继发性,即坐骨神经局部及周围结构的病变对坐骨神经造成刺激压迫与损害,最为常见的是由腰椎间盘突出引起的坐骨神经痛,其他原因可列举腰椎骨性关节病、骶髂关节炎等。
中医上将坐骨神经痛归为“痹症”范畴,病因多由风寒湿邪外袭经络,气血运行不畅所致,但针对不同的病患情况会有不同,中医辨证治疗本病时,又将坐骨神经痛细分为寒湿凝络、湿热侵络、瘀血阻络、肝肾不足等四种类型,而现有的技术中难以将这四种情况完全涵盖,实现一方多治的效果。此外,继发性坐骨神经痛的根源性问题多种多样,有些为绵延的慢性症状,难以根治,病患长期忍受病痛,非常需要一种见效快、效果好的治疗方案。
发明内容
为了解决上述技术问题,本发明的第一方面提供了一种治疗坐骨神经痛的膏药组合物,按重量份计,其制备原料至少包含:皂角刺20~40份、独活5~15份、制附子5~15份、肉桂1~10份、姜黄10~20份、苍术10~20份、薏苡仁20~40份、防己5~15份、托玛琳130~170份。
作为一种优选的技术方案,按重量份计,所述制备原料还包含熟地50~70份、麻黄20~40份、细辛20~40份。
作为一种优选的技术方案,按重量份计,所述制备原料还包含熟地50~70份、麻黄20~40份、细辛20~40份、毕波40~60份、花川50~70份。
本发明的第二方面提供了一种治疗坐骨神经痛的膏药,其制备原料至少包含上述的膏药组合物;所述制备原料还包含膏药基质,按重量份计,膏药基质的制备原料至少包含:羊毛脂270~330份、氮酮0.01~0.1份、冰片0.01~0.3份、薄荷脑0.01~0.2份、樟脑0.01~0.1份。
作为一种优选的实施方式,所述薄荷脑和樟脑的重量之和占羊毛脂重量的0.03~0.1wt%。
作为一种优选的实施方式,所述制备原料中皂角刺、苍术、羊毛脂、托玛琳的重量比为(1~3):1:(18~22):(8~12)。
作为一种优选的实施方式,按重量份计,所述膏药基质的制备原料还包含:沉香粉0.1~1份、麝香粉0.1~1份。
作为一种优选的实施方式,所述沉香粉和麝香粉的重量比为1:1。
作为一种优选的实施方式,所述沉香粉和麝香粉的重量之和占羊毛脂重量的0.2~0.5wt%。
本发明的第三方面提供了一种上述的治疗坐骨神经痛的膏药的制备方法,包括以下步骤:将膏药组合物混合打粉,粉末粒径为200目,再将粉末与膏药基质混合调成膏状,最后将药膏涂于无菌丝布上。
有益效果:本发明提供的一种治疗坐骨神经痛的膏药对于由各种原因引起的坐骨神经痛均有良好的治疗效果,并且起效时间短,可及时减轻患者病痛;此外,该膏药主治坐骨神经痛,还可对其他部位的病痛产生治疗效果,如颈、胸、腰椎、关节等,对于妇科疾病,如痛经、***同样有效。
具体实施方式
结合以下本发明的优选实施方法的详述以及包括的实施例可进一步地理解本发明的内容。除非另有说明,本文中使用的所有技术及科学术语均具有与本申请所属领域普通技术人员的通常理解相同的含义。如果现有技术中披露的具体术语的定义与本申请中提供的任何定义不一致,则以本申请中提供的术语定义为准。
在本文中使用的,除非上下文中明确地另有指示,否则没有限定单复数形式的特征也意在包括复数形式的特征。还应理解的是,如本文所用术语“由…制备”与“包含”同义,“包括”、“包括有”、“具有”、“包含”和/或“包含有”,当在本说明书中使用时表示所陈述的组合物、步骤、方法、制品或装置,但不排除存在或添加一个或多个其它组合物、步骤、方法、制品或装置。此外,当描述本申请的实施方式时,使用“优选的”、“优选地”、“更优选的”等是指,在某些情况下可提供某些有益效果的本发明实施方案。然而,在相同的情况下或其他情况下,其他实施方案也可能是优选的。除此之外,对一个或多个优选实施方案的表述并不暗示其他实施方案不可用,也并非旨在将其他实施方案排除在本发明的范围之外。
为了解决上述技术问题,本发明的第一方面提供了一种治疗坐骨神经痛的膏药组合物,按重量份计,其制备原料至少包含:皂角刺20~40份、独活5~15份、制附子5~15份、肉桂1~10份、姜黄10~20份、苍术10~20份、薏苡仁20~40份、防己5~15份、托玛琳130~170份。
在一些优选的实施方式中,按重量份计,其制备原料至少包含:皂角刺30份、独活9份、制附子9份、肉桂6份、姜黄16份、苍术15份、薏苡仁30份、防己9份、托玛琳150份。
皂角刺
皂角刺,性温,味辛,归肝经、胃经,具有消肿托毒、排脓杀虫之功效,其含有黄酮苷、酚类、氨基酸、槲皮素、非瑟素、黄颜木素、无色花青素、棕榈酸等成分,对金黄色葡萄球菌和卡他球菌有抑制作用。
独活
独活,性微温,味辛、苦,归肾经、膀胱经,具有祛风除湿、痛痹止痛之功效,其含有佛手烯、百里香酚等,还含二氢山芹醇、二氢山芹醇乙酸酯、当归酸、巴豆酸、蛇床子素、二氢欧山芹醇、当归酸酯、欧芹酚甲醚、毛当归醇、当归醇D、二氢山芹醇、异欧前胡内酯、二氢山芹醇-β-D-葡萄糖苷、佛手酚、橙花叔醇等成分。动物实验表明,独活的醇提物有抗血小板凝集和抗血栓作用,水煎剂或流浸膏对大鼠有镇静、催眠、镇痛、抗炎作用,此外还有降压、抗心律失常、抗肿瘤、抗菌、促进脂肪分解、兴奋呼吸等作用。
制附子
制附子,性大热,味辛、甘,归心经、肾经、脾经,具有回阳救逆,补火助阳,逐风寒湿邪之功效,生附子中含有剧毒的二萜双酯类生物碱,如乌头碱、次乌头碱、新乌头碱、塔拉弟胺、川乌碱甲、川乌碱乙(亦称卡米查林),还有毒性较弱的阿替新、氨基酚、去甲乌药碱等成分,经炮制后少部分有毒物质随水流失,大部分转变成毒性大大降低的二萜单酯类生物碱。制附子可以强心、抗心肌缺血、抗休克、抑制凝血功能和抗血栓形成,还具有抗炎、镇痛、局部麻醉、增强体液免疫的作用。
所述生附子的炮制方法可为本领域技术人员熟知的任意一种。
肉桂
肉桂,性大热,味辛、甘,归肾经、脾经、心经、肝经,具有补火助阳,引火归元,散寒止痛,温通经脉之功效,其含挥发油1.98%-2.06%,主要成分为桂皮醛,还有乙酸桂皮酯、苯甲酸苄酯、反式桂皮酸、桂皮酸钠、桂皮苷、肉桂醇、肉桂醇醋酸酯、香豆素等成分。药理研究表明,肉桂对肠胃有缓和的刺激作用,并能解除胃肠平滑肌痉挛,具有很强的抗溃疡作用;可拮抗血小板聚集,具有改善心血管***的作用,调节机体免疫功能;对中枢神经***,具有镇静、镇痛、解热、抗惊厥等作用;对阳虚、阴虚模型有预防和保护作用;具有一定的抗炎作用;具有很强的杀真菌作用;此外,还有抗肿瘤的功能。
姜黄
姜黄,性温,味苦、辛,归脾经、肝经,具有破血行气、通经止痛、活血化瘀之功效,其主要含挥发油及酚性物质,挥发油已鉴定出51种成分,以萜类化合物为主,主要有姜黄酮、姜油烯等,酚性成分主要有姜黄素等,另含姜黄新酮、3-谷固醇、3-谷固醇-3-O-胡萝卜苷、姜黄多糖等。药理研究表明,姜黄有保肝、利胆、抗菌、抗炎、抗肿瘤、抗艾滋病、抗生育、降血脂、抗病原微生物及抗病原虫、加快创伤愈合、抗突变等作用;对消化***有保护作用;增加心脏冠脉血流量;抗凝血和抑制血小板聚集。
苍术
苍术,性温,味辛、苦,归脾经、胃经、肝经,具有燥湿健脾,祛风散寒之功效,其主要成分为苍术醇、苍术酮、茅术醇及桉叶醇等。药理研究表明,苍术对结核杆菌、金黄色葡萄球菌、大肠、枯草及绿脓杆菌有显著的灭菌效果
薏苡仁
薏苡仁,性凉,味甘,归脾经、胃经、肺经,具有健脾渗湿,除痹止泻,清热排脓之功效,其化学成分含薏苡素、薏苡酯、三萜化合物、甾醇酯、亚油酸、棕榈酸、硬脂酸等,薏苡仁的药理作用有抗肿瘤、提高免疫力、降血糖、降血钙、降血压、抑制胰蛋白酶等。
防己
防己,性寒,味苦,归膀胱经、肺经,具有利水消肿、祛风止痛之功效,其化学成分主要为多种生物碱,如防己碱、防己醇灵碱、防己宾碱、门尼新碱、甲门尼萨任碱、去甲门尼萨任碱等,药理作用为镇痛、消炎、抗过敏、抗菌、抗虫、抗肿瘤等。
托玛琳
托玛琳,又称电气石,具有天然的热电和压电效应,由人体磁场形成共振共鸣,并通过人体自身能量可连续释放热能、负离子、远红外光波,长期使用,化瘀止痛,增加身体的承受能力,缓解关节过渡劳损、老化等现象。
本申请中的托玛琳购自河北灵寿县茂川矿产品加工厂。
在一些优选的实施方式中,按重量份计,所述制备原料还包含熟地50~70份、麻黄20~40份、细辛20~40份。
在一些优选的实施方式中,按重量份计,所述制备原料还包含熟地60份、麻黄30份、细辛30份。
熟地
熟地,为生地经过炮制后的药材,性微温,味甘,归肝经、肾经,具有滋阴补血、益精填髓之功效,其化学成分中含少量环烯醚匝类成分,如益母草甙、桃叶珊瑚甙、梓醇、地黄甙、美利妥双甙、地黄素、地黄氯化臭蚁醛甙等,还有单萜成分,如焦地黄素、焦地黄内酯、焦地黄呋喃、焦地黄内酯、焦地黄呋喃、地黄苦甙元等。药理研究表明,熟地有延缓衰老、止血补血等作用。
麻黄
麻黄,性温,味辛、微苦,归肺经、膀胱经,具有发汗散寒,宣肺平喘,利水消肿之功效,其化学成分主要为生物碱,如麻黄碱、伪麻黄碱、甲基麻黄碱、甲基伪麻黄碱、麻黄次碱,还包含儿茶鞣质,挥发油中含有松油醇。药理研究表明,麻黄对心血管***具有拟肾上腺能神经作用;对呼吸***有平喘、镇咳、祛痰作用;可使汗腺分泌增加;具有明显的利尿作用;具有抗***反应作用及一定的抗炎作用;具有解热作用及不同程度的抗病原微生物作用;可兴奋神经中枢,影响神经肌肉的传递;能抗过敏,对流感病毒有抑制作用;麻黄油乳剂有镇痛作用。
细辛
细辛,性温,味辛,归心经、肺经、肾经,具有祛风、散寒、通窍止痛、温肺祛痰之功效,其化学主要成分为甲基丁香酚、优香芹酮、黄樟醚、β-蒎烯、α-蒎烯、龙脑、异茴香醚、细辛酯素等。此外,尚含一种消旋-去钾乌药碱,微量元素有钾、钠、镁、钙、铁、锰、铜、锌等。细辛有局部麻醉作用,对关节炎有一定程度的抑制作用,还具有一定的抑菌作用,有增强脂质代谢及升高血糖的作用,调节机体平滑肌功能;挥发油能使麻醉动物血压下降,而煎剂则使血压上升;并具消炎和抗惊厥作用;还有镇痛、镇静、抑制发热、解热、抗组胺和抗***反应和兴奋呼吸作用。
通过在治疗坐骨神经痛的膏药组合物中添加熟地、麻黄、细辛三味中药,有助于治疗阳虚性慢性腰腿疼,其可能的原因是由于熟地、麻黄、细辛同属性温味辛/甘之药,可以补阳改善阳虚,而慢性症状绵延不宜用烈性药,此三味恰可温和调理疏解绵延症状。
在一些优选的实施方式中,所述制备原料还包含熟地50~70份、麻黄20~40份、细辛20~40份、毕波40~60份、花川50~70份。
在一些优选的实施方式中,所述制备原料还包含熟地60份、麻黄30份、细辛30份、毕波50份、花川60份。
毕波
毕波,又名荜茇,性热,味辛,归胃经、大肠经,具有温中散寒、下气止痛之功效,其化学成分主要含酰胺类化合物、木脂素、挥发油、胡椒碱、四氢胡椒酸、棕榈酸、荜茇明宁碱、长柄胡椒碱、荜茇明碱等成分。毕波的醇提物具有抗溃疡、抗心肌缺血作用;挥发油能抗心律失常、调血脂,并能抑制中枢神经;此外,其还有耐缺氧、镇静、镇痛、解热、广谱抗菌等作用。
花川
花川,即川花椒,性温,味辛,归脾经、胃经、肾经,具有温中止痛、杀虫止痒之功效,其挥发油中含有柠檬烯、枯醇、牻牛儿醇等,还含去1,8-桉叶素、月桂烯、香草木宁碱、七叶内酯、茴香脑、侧柏烯等成分。药理实验表明,花川可以抗实验性胃溃疡、对肠平滑肌运动有双向作用、抗腹泻、保肝、镇静抗炎、局部麻醉、抗凝血、杀疥螨;果皮注射液有止痛、麻醉作用;牻牛儿醇小量可引起离体肠管蠕动,大量则使之抑制;水煎剂对链球菌、葡萄球菌、肺炎球菌、炭疽杆菌、枯草杆菌、霍乱弧菌、副伤寒杆菌和绿脓杆菌均有抑制作用。
通过在治疗坐骨神经痛的膏药组合物中添加熟地、麻黄、细辛、毕波、花川,有助于温经散寒,其原因是由于这几味药均有温中之效,可以祛除寒气,还有止痛效果,而该膏药针对的治疗部位在于坐骨盆腔处,故对于女性痛经也有很好的治疗效果。
本发明的第二方面提供了一种治疗坐骨神经痛的膏药,其制备原料至少包含上述的膏药组合物;所述制备原料还包含膏药基质,按重量份计,膏药基质的制备原料至少包含:羊毛脂270~330份、氮酮0.01~0.1份、冰片0.01~0.3份、薄荷脑0.01~0.2份、樟脑0.01~0.1份。
在一些优选的实施方式中,按重量份计,所述膏药基质的制备原料至少包含:羊毛脂300份、氮酮0.05份、冰片0.2份、薄荷脑0.12份、樟脑0.06份。
羊毛脂
羊毛脂,为附着在羊毛上的一种分泌油脂,有微弱的臭味,主要成分是甾醇类、脂肪醇类和三萜烯醇类与大约等量的脂肪酸所生成的酯,约占95%,还含有游离醇4%,并有少量的游离脂肪酸和烃类物质。使用羊毛脂作为膏药基质,可以使主要迅速被粘膜及皮肤吸收,有附着力,性质稳定,不易酸败。
在一些优选的实施方式中,所述膏药的制备原料中皂角刺、苍术、羊毛脂、托玛琳的重量比为(1~3):1:(18~22):(8~12);进一步优选的,所述皂角刺、苍术、羊毛脂、托玛琳的重量比为2:1:20:10。
本申请中的羊毛脂购自河南鑫隆生物科技有限公司。
氮酮
氮酮,为常用的外用药物涂抹、按摩的促渗剂,其对亲油、亲水性药物和活性成分均有明显的透皮助渗作用,使皮肤角质层与脂质相互作用,降低了有效物质向角质层间隙中脂质的相转移温度,增加了流动性,使药物或活性添加剂在角质层中的扩散阻力减少,故起到很强的促渗作用。
本申请中的氮酮购自郑州六顺化工产品有限公司。
申请人发现通过对中药材料组分以及相应基质之间的配伍,并且对皂角刺、苍术、托玛琳及羊毛脂等之间的用量比例进行调控,能够加快被贴处的皮肤对膏药中有效成分的吸收,缩短膏药的起效时间,使其短时间内减少患者疼痛。其可能的原因是,膏药调和制备过程中,在羊毛脂、氮酮等的作用下能够破坏皂角刺、苍术等原料的内部细胞结构,并且在羊毛脂中甾醇、脂肪醇、三萜烯醇所形成的酯类有效成分的作用下能够促进皂角刺、苍术等原料中有效物质的溶出,而其中的黄酮苷、氨基酸、苍术素、β-桉油醇、茅术醇、羟基苍术酮等有效成分在彼此之间的相互作用之下促进向皮肤内部的渗透,增强内皮细胞的吸收,起到祛风消痛,活血祛湿的功效。同时由于托玛琳独特的内部结构和电热效应,经受皮肤传导的热量和膏药在使用过程中产生的压力作用下,托玛琳快速释放出大量的负氧离子,以及对人体有益的远红外线,在人体内皮产生微电流,促进人体新陈代谢,调节中枢神经***和大脑皮层的相关功能,镇痛镇静。此外,托玛琳产生的远红外线、微电流等能够通过羊毛脂中的甾醇、脂肪醇、三萜烯醇等成分渗透作用下,被具有共轭双键结构的苍术素等有效成分传递到苍术、皂角刺等中药组分内部结构中,进一步破坏其内部的致密结构和细胞,释放其中残留的有效成分,使中药组分中的有效成分充分溶出,进一步改善膏药的综合效果。
冰片
冰片,性寒,味辛、苦,归心经、脾经、肺经,具有开窍醒神、清热止痛之功效,其化学成分为龙脑,是一种萜类化合物。冰片可抑制中枢神经***,表现为明显的镇静镇痛作用,促进神经胶质细胞的生长和***;有抗炎、抗菌、抗生育作用,能与其他药物如四甲基吡嗪、水杨酸发生相互作用;局部应用对感觉神经具有轻微的刺激作用,有一定的止痛和防腐作用。
薄荷脑
薄荷,性凉,味辛,归肺经、肝经,有特殊香味,具有宣散风热、清头目、透疹之功效,薄荷脑为薄荷的提取物,作用于皮肤或粘膜,有清凉止痒作用,药理研究表明,薄荷具有发汗、解热、缓解胃肠平滑肌痉挛、兴奋中枢神经、促进呼吸道腺体分泌而具消炎及解痉等作用;还能刺激神经末梢冷感受器而产生冷感,并反向性地造成深部组织血管的变化而起到消炎、止痛、止痒作用;对革兰氏阻性、革兰氏阴性球菌、杆菌及多种病毒有一定的抑制作用;具有明显的解痉作用、保肝利胆作用、抗早孕及子宫的作用;对心血管,可麻痹心脏,扩张血管;对呼吸***,具有祛痰作用及良好的止咳作用;促进透皮吸收,可用于抗微生物。
樟脑
樟脑,性热,味辛,归心经、脾经,具有开窍辟秽、除湿杀虫、温散止痛之功效,其为一种莰类化合物,可兴奋中枢神经***,对于高级中枢尤为显著;对循环性虚脱或急性心功能衰竭有强心作用;其水溶性代谢产物有明显的强心、升压和兴奋呼吸的作用;对皮肤有温和的刺激及防腐作用;对胃肠道黏膜的刺激,小剂量使胃感到温暖及舒适,大量则能产生恶心呕吐;并有轻微的祛痰作用。
在一些优选的实施方式中,所述薄荷脑和樟脑的重量之和占羊毛脂重量的0.03~0.1wt%;进一步优选的,所述薄荷脑和樟脑的重量之和占羊毛脂重量的0.06wt%。
羊毛脂虽然能够将皂角刺、独活、制附子、肉桂、姜黄、苍术、薏苡仁、防己等组分很好地融合,使得其中的每个组分能够充分发挥其驱风除湿、活血镇痛等作用,但是由于羊毛脂实际为羊毛上的一种分泌油脂,其中的化学成分相对比较复杂,容易使患者皮肤产生过敏和刺激,而且羊毛脂载药量少,在贴敷使用过程中,尤其在夏天天气热的时候容易出汗而导致滑脱,从而影响膏药的广泛实用性。申请人发现通过对膏药基质中薄荷脑、樟脑、羊毛脂等用量的调控,再结合本发明中的特定用量的托玛琳,可以消除臭味,有效避免膏药对患者皮肤的过敏和刺激,避免将膏药贴伏患处后出现瘙痒、红肿等症状。
申请人预料不到地发现,通过合理调控膏药组合物中各个成分的用量,以及膏药基质中羊毛脂、薄荷脑、樟脑等成分的用量,可以有效避免因膏药致密不透气,热天使用过程中因出汗而使被贴处皮肤发白、褶皱等情况的出现。其可能的原因是皂角刺、独活、制附子、肉桂、姜黄、苍术等膏药组合物中的成分在羊毛脂等作用下充分混合,溶出有效成分,但是由于这些有效成分的溶出、被皮肤细胞吸收等速度均有差异,而且在将该中药组分涂覆在丝布上时的渗透性、成膜性等均有所不同,因此充分融合的各个组分在托玛琳、羊毛脂、薄荷脑等成分之间的相互作用之下,有效成分被皮肤吸收后,药膏内部留下了微孔,提高了药膏的透气透湿性,避免药膏因热天出汗而滑脱或对皮肤的其他伤害。
在一些优选的实施方式中,所述樟脑和薄荷脑的重量比例为1:2。
在一些优选的实施方式中,所述樟脑的用量占皂角刺用量的0.1~0.3wt%;进一步优选的,所述樟脑的用量占皂角刺用量的0.2wt%。
申请人发现通过对樟脑、皂角刺和托玛琳等组分用量的调控,会使膏药的抗刺激、抗过敏性能得到进一步的提高,甚至有助于伤口的愈合,治疗坐骨神经疼痛更加有效。其可能的原因是天然樟脑、薄荷脑可能促进皂角刺中有效成分的溶出与向皮肤内部的渗透,同时可能协同增效托玛琳的改善皮肤过敏等效果。此外,由于中药组分有效成分在羊毛脂、氮酮、冰片等作用下的溶出、被皮肤细胞吸收速度等之间的差异而造成的微孔,使得皮肤上,尤其是有伤口的皮肤能够传导湿气,避免伤口的皮肤因湿气过多而褶皱、受损,加快内皮细胞组织的生长,促进伤口愈合。
在一些优选的实施方式中,按重量份计,所述膏药基质的制备原料还包含:沉香粉0.1~1份、麝香粉0.1~1份;进一步优选的,按重量份计,所述膏药基质的制备原料还包含:沉香粉0.3~0.5份、麝香粉0.3~0.5份。
在一些优选的实施方式中,所述沉香粉和麝香粉的重量比为1:1。
在一些优选的实施方式中,按重量份计,所述膏药基质的制备原料还包含:沉香粉0.4份、麝香粉0.4份。
沉香
沉香,性微温,味辛、苦,归肾经、脾经、胃经,具有行气止痛、温中止呕、纳气平喘之功效,其挥发油中主要成分为沉香螺醇、白木香酸、白木香醛、白木香醇、去氢白木香醇、白木香呋喃醛、白木香呋喃醇、α-沉香呋喃、β-沉香呋喃、茴香酸等成分,沉香的药理研究表明,其可解除肠平滑肌痉挛,抑制中枢神经***,还具有镇静、镇痛、降压、抗菌的作用。
麝香
麝香,性温,味辛,归心经、脾经,具有开窍醒神、活血通经、消肿止痛之功效,其化学成分含麝香酮、麝吡啶、雄甾烷衍生物,胆甾醇类化合物等。药理研究表明,麝香有兴奋中枢神经和苏醒作用,可兴奋呼吸、加速心搏、升高血压;能增加肾上腺素对受体的作用,并有对儿茶酚胺的增加作用;此外,还有强心、抗炎及抑制血管通透性等作用。
在一些优选的实施方式中,所述沉香粉和麝香粉的重量之和占羊毛脂重量的0.2~0.5wt%;进一步优选的,所述沉香粉和麝香粉的重量之和占羊毛脂重量的0.3wt%。
在一些优选的实施方式中,所述沉香粉与托玛琳重量比例为(0.3~0.5):150;进一步优选的,所述沉香粉与托玛琳重量比例为0.4:150。
申请人发现在膏药中加入适量的沉香粉和麝香粉,会使膏药的抗刺激、抗过敏性能得到进一步的提高,甚至有助于伤口的愈合。其可能的原因是,沉香粉和麝香粉中的有效组分可能会与膏药中药组分中的一些对皮肤具有刺激性的化学成分相结合,阻碍上述成分对皮肤以及伤口中的细胞组织之间的作用,避免对皮肤中的正常细胞的破坏。
本发明的第三方面提供了一种上述的治疗坐骨神经痛的膏药的制备方法,包括以下步骤:将膏药组合物混合打粉,粉末粒径为200目,再将粉末与膏药基质混合调成膏状,最后将药膏涂于无菌丝布上。
本发明所用到的原料药材可从中药店和中药材市场购买得到,其规格符合国家中药材药典标准。
实施例
以下通过实施例对本发明技术方案进行详细说明,但是本发明的保护范围不局限于所述实施例。本申请中所用原料,如无特殊说明,均为市售。
实施例1
实施例1提供了一种治疗坐骨神经痛的膏药组合物,按重量份计,其制备原料至少包含:皂角刺30份、独活9份、制附子9份、肉桂6份、姜黄16份、苍术15份、薏苡仁30份、防己9份、托玛琳150份。
本例还提供了一种治疗坐骨神经痛的膏药,其制备原料至少包含上述的膏药组合物;所述制备原料还包含膏药基质,按重量份计,膏药基质的制备原料至少包含:羊毛脂300份、氮酮0.05份、冰片0.2份、薄荷脑0.12份、樟脑0.06份;
按重量份计,所述膏药基质的制备原料还包含:沉香粉0.4份、麝香粉0.4份。
本例还提供了上述治疗坐骨神经痛的膏药的制备方法,包括以下步骤:将膏药组合物混合打粉,粉末粒径为200目,再将粉末与膏药基质混合调成膏状,最后将药膏涂于无菌丝布上。
实施例2
实施例2提供了一种治疗坐骨神经痛的膏药组合物,其与实施例1的不同之处在于,按重量份计,所述制备原料还包含:熟地60份、麻黄30份、细辛30份。
本例还提供了一种治疗坐骨神经痛的膏药及其制备方法,其与实施例1类似。
实施例3
实施例3提供了一种治疗坐骨神经痛的膏药组合物,其与实施例2的不同之处在于,按重量份计,所述制备原料还包含:毕波50份、花川60份。
本例还提供了一种治疗坐骨神经痛的膏药及其制备方法,其与实施例2类似。
实施例4
实施例4提供了一种治疗坐骨神经痛的膏药组合物,其与实施例1的不同之处在于,所述皂角刺的重量份为10份。
本例还提供了一种治疗坐骨神经痛的膏药及其制备方法,其与实施例1类似。
实施例5
实施例5提供了一种治疗坐骨神经痛的膏药组合物,其与实施例1的不同之处在于,所述皂角刺的重量份为50份。
本例还提供了一种治疗坐骨神经痛的膏药及其制备方法,其与实施例1类似。
实施例6
实施例6提供了一种治疗坐骨神经痛的膏药组合物,其与实施例1类似。
本例还提供了一种治疗坐骨神经痛的膏药,其与实施例1的不同之处在于,所述羊毛脂的重量份为350份。
本例还提供了上述治疗坐骨神经痛的膏药的其制备方法,其与实施例1类似。
实施例7
实施例7提供了一种治疗坐骨神经痛的膏药组合物,其与实施例1类似。
本例还提供了一种治疗坐骨神经痛的膏药,其与实施例1的不同之处在于,所述羊毛脂的重量份为250份。
本例还提供了上述治疗坐骨神经痛的膏药的其制备方法,其与实施例1类似。
实施例8
实施例8提供了一种治疗坐骨神经痛的膏药组合物,其与实施例1的不同之处在于,所述托玛琳的重量份为100份。
本例还提供了一种治疗坐骨神经痛的膏药及其制备方法,其与实施例1类似。
实施例9
实施例9提供了一种治疗坐骨神经痛的膏药组合物,其与实施例1的不同之处在于,所述托玛琳的重量份为200份。
本例还提供了一种治疗坐骨神经痛的膏药及其制备方法,其与实施例1类似。
实施例10
实施例10提供了一种治疗坐骨神经痛的膏药组合物,其与实施例1类似。
本例还提供了一种治疗坐骨神经痛的膏药,其与实施例1的不同之处在于,所述薄荷脑的重量份为0.18份,樟脑的重量份为0.09份。
本例还提供了上述治疗坐骨神经痛的膏药的其制备方法,其与实施例1类似。
实施例11
实施例11提供了一种治疗坐骨神经痛的膏药组合物,其与实施例1类似。
本例还提供了一种治疗坐骨神经痛的膏药,其与实施例1的不同之处在于,所述薄荷脑的重量份为0.06份,樟脑的重量份为0.03份。
本例还提供了上述治疗坐骨神经痛的膏药的其制备方法,其与实施例1类似。
实施例12
实施例12提供了一种治疗坐骨神经痛的膏药组合物,其与实施例1类似。
本例还提供了一种治疗坐骨神经痛的膏药,其与实施例1的不同之处在于,所述薄荷脑的重量份为0.24份,樟脑的重量份为0.12份。
本例还提供了上述治疗坐骨神经痛的膏药的其制备方法,其与实施例1类似。
实施例13
实施例13提供了一种治疗坐骨神经痛的膏药组合物,其与实施例1类似。
本例还提供了一种治疗坐骨神经痛的膏药,其与实施例1的不同之处在于,所述薄荷脑的重量份为0.04份,樟脑的重量份为0.02份。
本例还提供了上述治疗坐骨神经痛的膏药的其制备方法,其与实施例1类似。
实施例14
实施例14提供了一种治疗坐骨神经痛的膏药组合物,其与实施例1类似。
本例还提供了一种治疗坐骨神经痛的膏药,其与实施例1的不同之处在于,所述薄荷脑的重量份为0.18份。
本例还提供了上述治疗坐骨神经痛的膏药的其制备方法,其与实施例1类似。
实施例15
实施例15提供了一种治疗坐骨神经痛的膏药组合物,其与实施例1类似。
本例还提供了一种治疗坐骨神经痛的膏药,其与实施例1的不同之处在于,所述薄荷脑的重量份为0.06份。
本例还提供了上述治疗坐骨神经痛的膏药的其制备方法,其与实施例1类似。
实施例16
实施例16提供了一种治疗坐骨神经痛的膏药组合物,其与实施例1类似。
本例还提供了一种治疗坐骨神经痛的膏药,其与实施例1的不同之处在于,所述沉香粉的重量份为0.6份,麝香粉的重量份为0.2份。
本例还提供了上述治疗坐骨神经痛的膏药的其制备方法,其与实施例1类似。
实施例17
实施例17提供了一种治疗坐骨神经痛的膏药组合物,其与实施例1类似。
本例还提供了一种治疗坐骨神经痛的膏药,其与实施例1的不同之处在于,所述沉香粉的重量份为0.1份,麝香粉的重量份为0.1份。
本例还提供了上述治疗坐骨神经痛的膏药的其制备方法,其与实施例1类似。
实施例18
实施例18提供了一种治疗坐骨神经痛的膏药组合物,其与实施例1类似。
本例还提供了一种治疗坐骨神经痛的膏药,其与实施例1的不同之处在于,所述沉香粉的重量份为1份,麝香粉的重量份为1份。
本例还提供了上述治疗坐骨神经痛的膏药的其制备方法,其与实施例1类似。
实施例19
实施例19提供了一种治疗坐骨神经痛的膏药组合物,其与实施例1类似。
本例还提供了一种治疗坐骨神经痛的膏药,其与实施例1的不同之处在于,所述沉香粉的重量份为0.2份,麝香粉的重量份为0.2份。
本例还提供了上述治疗坐骨神经痛的膏药的其制备方法,其与实施例1类似。
实施例20
实施例20提供了一种治疗坐骨神经痛的膏药组合物,其与实施例1类似。
本例还提供了一种治疗坐骨神经痛的膏药,其与实施例1的不同之处在于,所述沉香粉的重量份为0.6份,麝香粉的重量份为0.6份。
本例还提供了上述治疗坐骨神经痛的膏药的其制备方法,其与实施例1类似。
性能评价
一、对实施例1-20所得到的治疗坐骨神经痛的膏药进行疗效测试。
1.诊断标准
1.1中医辨证标准
中医辨证治疗本病,常见的有寒湿凝络、湿热侵络、瘀血阻络、肝肾不足等四型。
1.1.1寒湿凝络
证候:腰胯持续性钝痛,并向大腿后侧、小腿外侧及足背外侧放散,受寒加剧,得热痛缓,静卧时痛不减。苔白腻,脉沉而迟缓。
证候分析:因寒性收引,湿性凝滞,故疼痛呈持续性钝痛,常兼夹风邪,而有向下肢放散的特点。湿为阴邪,其性粘滞,静卧时湿邪易于停滞,故痛不减。苔白腻,脉沉而迟缓,均为寒湿停聚之象。
1.1.2湿热侵络
证候:腰腿痛呈烧灼样剧烈胀痛,口渴、心烦、尿赤,苔黄腻,脉濡数或弦数。
证候分析:湿热壅塞,经络阻滞,不通则痛,且感疼痛烧灼而剧烈。热邪偏盛则出现心烦、口渴,湿热下注膀胱则尿赤。苔黄腻,脉濡数,均为湿热之象。
1.1.3瘀血阻络
证候:腰腿痛持续剧烈,咳嗽、解便、行走均使疼痛加剧,坐卧屈膝则痛稍减,疼痛如刺,痛有定处,痛处拒按,下肢麻木,舌质暗紫,或有瘀斑,脉涩。
证候分析:由于腰部损伤,瘀血阻滞经脉,气血运行不畅,故见腰腿持续疼痛,患肢拘挛屈膝,痛有定处,剧烈如刺,动则痛剧且拒按。气血阻滞,故肢体麻木。舌质暗紫,或有瘀斑,脉涩,均为瘀血内停征象。
1.1.4肝肾不足:
证候:腰腿痛缠绵不愈,向下放射,遇劳更甚,卧则减轻,腿膝无力,舌淡,脉沉细,或舌红少苔,脉弦细数。
证候分析:腰为肾府,肾主骨,肝主筋,肝肾亏虚则筋骨失养,正虚邪入,其痛缠绵难愈,遇劳更甚,卧则减轻,腿膝无力均为虚证所见。舌淡,脉沉细为阳虚之象;舌红少苔,脉弦细数,为阴虚之征。
1.2西医诊断标准
1.2.1在某些致病原因的基础上,急性发病,也可见反复发作。
1.2.2临床多见起自腰、臀部、大腿后侧或大腿后侧向下放射的持续性或间歇性疼痛。
1.2.3站立、弯腰、咳嗽、打喷嚏时均可使疼痛加重,故患者常保持一种特殊姿势或***。
1.2.4检查感觉障碍常不明显,或仅在小腿外侧和足部腓神经分布区有感觉障碍。
1.2.5坐骨神经诸压痛点为阳性,拉塞格氏征及坐骨神经牵拉征阳性。
1.2.6腱反射减弱或消失、但急性期可稍活跃,足或足趾运动障碍。
1.2.7颏胸试验:即令患者仰卧,检查者将其头颈被动前屈使下颏触及胸壁,如激发或加剧下肢疼痛为颏胸试验阳性。
2.测试方法
2.1分组方法:选取400名患者,随机数字表法分为20组,各组之间在性别、年龄、病程、病情等方面比较,差异无统计学意义,每组患者试用同一个实施例中的治疗坐骨神经痛的膏药。
2.2给药方法:使用实施例1-20提供的膏药,每次贴12小时,每天换药一次,15天为一疗程,治疗一疗程。
2.3疗效判定:痊愈-临床症状和体征全部消失,功能恢复正常;显效-症状和体征基本恢复,能参加正常活动和工作;有效-症状和体征部分恢复,参加活动和工作的能力有改善;无效-未达到有效标准。
2.4起效时间判定:在观察症状中,某一症状减轻或改善的时间即定为该病例用药后的起效时间。
2.5测试结果:见表1。
表1
二、对实施例1-20所得到的治疗坐骨神经痛的膏药进行气味、皮肤刺激性、伤口皮肤刺激性、服帖程度、皮肤泛白、皮肤褶皱情况的主观评价,评价者为上述各组患者,结果为各组患者达成一致的意见,见表2。
表2
三、实施例的治疗病例
1.病例一:患者金某某,男,53岁。
诉:颈椎病史2年,近日加重。
现症:颈部疼痛伴僵硬,头晕,偶感头痛,右手指麻木,大小便正常,舌质红苔薄,脉滑,辨为肝肾亏虚,寒邪外袭。
按:颈椎病是常见病、多发病。其病因阳气虚弱,髓海不足,兼外感风、寒、湿,三邪致经脉壅滞不通,不通则痛。“上实下虚”从中医角度来总结就是“胃气不降,脾气不升,肾气不藏”,本质是脾肾阳虚,阳浮于上,不能温煦下身。上实下虚,引火归元是最佳方法,让气往下走。
治则:温补肝肾,通经活络。
用药:将实施例1得到的膏药贴敷于穴位中脘、关元、气海。
治疗效果:连续敷贴十天痊愈。
2.病例二:患者李某,男,49岁。
诉:之前CT确诊腰椎腰椎间盘突出症,多方求治效果时好时坏,近日天气渐凉,疼痛明显加重,已二月多了,被背入诊室。
现症:腰疼沿右腿到足疼如刀割,夜重,遇热减轻,遇冷则重,右侧肢体肌肉萎缩,皮温低,饮食尚可,二便如常,舌淡苔白,脉象沉缓无力,阳虚寒湿。
用药:将实施例1得到的膏药贴敷于穴位足三里、三阴交、涌泉。
治疗效果:腰痛愈,随访5年未反复。
3.病例三:王某,男,27岁,工人。
诉:2年前因过度用力而腰痛,CT检查确诊为腰椎间盘突出压迫神经,经治疗缓解,近日因受寒,病痛再次复发。
现症:全身困乏,关节疼痛,以左下肢沿坐骨神经区域放散,疼痛难忍,呻吟不止,昼轻夜重,遇热则轻,扶入诊室,经针灸、理疗等可短暂缓解,舌淡,太白腻,脉浮紧,虚寒湿在表。
用药:将实施例1得到的膏药贴敷于穴位足三里、三阴交、涌泉。
治疗效果:愈,4年随访未复发。
4.病例四:孔某,男,54岁,公务员。
诉:痛风多年。于2018年3月1日因进食牛排、红酒等半夜右膝关节突然痛疼肿胀,皮色未变,触痛,屈伸不利,行走困难,上下楼更明显。
现症:脉沉,舌淡苔薄白,齿痕。关节中卒,中痰证,痰湿。
用药:将实施例3得到的膏药贴敷于患处及脊柱夹脊穴、长强穴、膻中穴、涌泉贴敷。
治疗效果:三天症状明显减轻,又连续贴敷两个月并嘱咐忌酒海鲜嘌呤高的食物至今一年多无发病。
5.病例五:曹某,男,47岁。
诉:痛风8年,近2年加重左踝关节和双侧第一跗蹠关节常年肿痛,行走痛疼,穿鞋困难。
现症:反复发作,苦不堪言,形寒畏冷,肢凉腰酸,不渴,舌淡,苔白,胖润水滑,齿痕。脉沉细。尿酸706mmol/L,元阳不足,寒湿阻滞经脉,经气不利。
用药:将实施例3得到的膏药贴敷于患处及脊柱、长强穴、膻中、神阙、关元、三阴交、足三里、涌泉穴。
治疗效果:五天疼痛痊愈,行走自如,关节肿痛消失,尿酸将至正常。
6.病例六:毕某,女,34岁,教师。
诉:2018年5月8日初诊,经期疼痛,红糖红枣姜水缓解,经血有大量血块,食欲正常,饮水量少,不渴但喜冷饮水果,现已尽量避免冷饮,大小便规律,入睡有点难,近三月约12点左右入睡,浅睡多梦。正常情况不怕冷,仅经期怕冷,便溏。不易出汗,常感乏力,结婚两年多未孕。
现症:舌胖润痕,苔薄白,舌质略暗,少阴病胞宫虚寒。
用药:将实施例3得到的膏药贴敷于膻中穴,神阙穴,关元穴,三阴交,足三里,涌泉穴,八髎区连续三个月贴敷,又嘱咐避风寒忌食一切生冷食物。
治疗效果:5月底,来月经,无痛疼,经量中等,色鲜红,无血块;6月底,月经正常;8月中旬,确诊怀孕。
7.病例七:张某,女,17岁。
诉:2018年7月20日来诊,痛经,小腹冷痛拒按,量少,经色暗,平时小腹冷。
现症:舌淡脉沉。
用药:将实施例3得到的膏药贴敷于命门穴、长强穴、神阙穴、关元穴。
治疗效果:经前,经中贴敷五天疼痛缓解;继续经前、中贴敷两个月经血鲜红,量正常。小腹温。
从以上的测试结果和病例可以得知,本发明提供的一种治疗坐骨神经痛的膏药通过调节膏药组合物和膏药基质中各原料间的配比,使得起效时间和治疗效果均达到最佳,可快速减轻患者病痛并完全治愈;此外,本发明中的膏药没有异味,载药量高,对皮肤无刺激,可与皮肤良好地贴合在一起,舒适透气,不会引起皮肤泛白、褶皱等问题。本发明用于治疗坐骨神经痛之外,对其他病症同样有良好的治疗效果,如痛经、痛风等症。
最后指出,以上所述仅为本发明的较佳实施例而已,并不用以限制本发明,凡在本发明的精神和原则之内所作的任何修改、等同替换和改进等,均应包含在本发明的保护范围之内。
Claims (10)
1.一种治疗坐骨神经痛的膏药组合物,其特征在于,按重量份计,其制备原料至少包含:皂角刺20~40份、独活5~15份、制附子5~15份、肉桂1~10份、姜黄10~20份、苍术10~20份、薏苡仁20~40份、防己5~15份、托玛琳130~170份。
2.如权利要求1所述的治疗坐骨神经痛的膏药组合物,其特征在于,按重量份计,所述制备原料还包含熟地50~70份、麻黄20~40份、细辛20~40份。
3.如权利要求1所述的治疗坐骨神经痛的膏药组合物,其特征在于,按重量份计,所述制备原料还包含熟地50~70份、麻黄20~40份、细辛20~40份、毕波40~60份、花川50~70份。
4.一种治疗坐骨神经痛的膏药,其特征在于,其制备原料至少包含如权利要求1~3任一项所述的膏药组合物;所述制备原料还包含膏药基质,按重量份计,膏药基质的制备原料至少包含:羊毛脂270~330份、氮酮0.01~0.1份、冰片0.01~0.3份、薄荷脑0.01~0.2份、樟脑0.01~0.1份。
5.如权利要求4所述的治疗坐骨神经痛的膏药,其特征在于,所述薄荷脑和樟脑的重量之和占羊毛脂重量的0.03~0.1wt%。
6.如权利要求4所述的治疗坐骨神经痛的膏药,其特征在于,所述制备原料中皂角刺、苍术、羊毛脂、托玛琳的重量比为(1~3):1:(18~22):(8~12)。
7.如权利要求4所述的治疗坐骨神经痛的膏药,其特征在于,按重量份计,所述膏药基质的制备原料还包含:沉香粉0.1~1份、麝香粉0.1~1份。
8.如权利要求7所述的治疗坐骨神经痛的膏药,其特征在于,所述沉香粉和麝香粉的重量比为1:1。
9.如权利要求7所述的治疗坐骨神经痛的膏药,其特征在于,所述沉香粉和麝香粉的重量之和占羊毛脂重量的0.2~0.5wt%。
10.一种如权利要求4~9任一项所述的治疗坐骨神经痛的膏药的制备方法,其特征在于,包括以下步骤:将膏药组合物混合打粉,粉末粒径为200目,再将粉末与膏药基质混合调成膏状,最后将药膏涂于无菌丝布上。
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