CN115040483B - 治疗慢性疼痛的外用中药组合物及其制备方法 - Google Patents
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Abstract
本发明公开了一种治疗慢性疼痛的外用中药组合物及其制备方法,其包含羌活、独活、白芷、麻黄、桂枝、桑枝、木瓜、川牛膝、路路通、透骨草、海桐皮、青风藤、忍冬藤、当归、乳香、没药、五灵脂、大黄、苏木、延胡索、骨碎补、桑寄生、狗脊、肉桂、干姜、丁香、艾叶、薄荷。本发明具有祛风除湿、温阳散寒、行气活血、化瘀散结、通络止痛的作用,是一种安全无创、无肝肾代谢负担、操作简便、成本低廉、疗效确切的中医外治疗法,能有效地减轻腰椎间盘突出症、颈椎病、膝骨关节炎、肩关节周围炎、腰背肌筋膜炎等引起的慢性疼痛,改善由长期慢性疼痛而导致的抑郁、焦虑、恐惧等不良心理状况,提高患者的生活质量。
Description
技术领域
本发明涉及一种治疗慢性疼痛的外用中药组合物,具体而言,涉及一种治疗慢性疼痛的外用中药组合物及其制备方法和应用。
背景技术
疼痛为临床常见主诉,涉及生物学、心理学以及社会环境等多方面因素,根据疼痛持续时间及性质可分为急性疼痛和慢性疼痛,当疼痛持续3~6月及以上时,急性疼痛将向慢性疼痛转变。慢性疼痛是影响人群健康的最普遍问题之一,世界范围内约有11%~40%的人口遭受着慢性疼痛的困扰。慢性疼痛病因及发病机制复杂,其中肌肉骨骼疾病是临床常见原因,如腰椎间盘突出症、颈椎病、膝骨关节炎、肩关节周围炎、腰背肌筋膜炎等。慢性疼痛可导致机体各器官系统功能紊乱、免疫系统受损,增加恶性疾病发生的可能,增加焦虑、抑郁、睡眠障碍等精神疾病的罹患风险。此外,腰背痛、肌肉骨骼疾病和颈部疼痛引起的慢性疼痛是致残的主要原因,严重影响患者的生活质量,造成极大的经济和医疗负担。
目前慢性疼痛的治疗手段包括药物疗法、微创介入疗法及手术疗法等。药物治疗如非甾体类抗炎药、阿片类药物、肌松药物等,存在诱发消化道溃疡、损伤肝肾功能、成瘾性等不良反应,无法长期使用,且停药后易复发;微创介入疗法和手术疗法治疗慢性疼痛虽然取得一定的疗效,但因较高的技术水平要求、高昂的医疗成本,限制了临床的推广应用。中医治疗慢性疼痛有很大潜力,如针灸、推拿、拔罐等具有较好的疗效,但需要具有医疗资质的医师进行操作,技术难度较高。因此,寻求一种安全无创、操作简便、成本低廉、疗效确切的慢性疼痛外治疗法具有重要意义。
发明内容
为解决上述问题,本发明提供一种外用中药组合物及其制备方法和应用,所述中药组合物用于治疗慢性疼痛,所述慢性疼痛包括但不限于腰椎间盘突出症、颈椎病、膝骨关节炎、肩关节周围炎、腰背肌筋膜炎等疾病导致的疼痛。
本发明的技术方案是:一种治疗慢性疼痛的外用中药组合物,包括以下重量份的原料药物:
羌活10~30份,独活10~60份,白芷5~20份,生麻黄5~20份,桂枝5~20份,桑枝15~60份,木瓜15~60份,川牛膝10~30份,路路通10~30份,透骨草10~30份,海桐皮10~30份,青风藤10~30份,忍冬藤10~30份,当归5~20份,醋乳香10~30份,醋没药10~30份,醋五灵脂10~30份,生大黄10~30份,苏木15~60份,醋延胡索10~30份,骨碎补10~30份,桑寄生10~30份,狗脊10~30份,肉桂5~20份,干姜5~20份,丁香5~20份,生艾叶10~30份,薄荷5~20份。
作为优选的实施方案,所述中药组合物,基于重量份计,优选包含:羌活15份,独活15份,白芷10份,生麻黄10份,桂枝10份,桑枝30份,木瓜30份,川牛膝15份,路路通15份,透骨草15份,海桐皮15份,青风藤15份,忍冬藤15份,当归10份,醋乳香15份,醋没药15份,醋五灵脂15份,生大黄15份,苏木30份,醋延胡索15份,骨碎补15份,桑寄生15份,狗脊15份,肉桂10份,干姜10份,丁香10份,生艾叶15份,薄荷10份。
慢性疼痛病因繁杂,所属中医疾病范畴亦较广泛,根据临床表现可归于“痹证”、“腰痛”、“颈痹”、“膝痹”、“鹤膝风”等病,其基本病机为“不通则痛”和“不荣则痛”。风、寒、湿、热等外邪侵袭,痹阻经脉,凝滞气血;或劳作太过,闪挫跌仆,损伤筋脉气血,气机不畅,血脉瘀阻,致不通则痛。禀赋不足,久病体虚,或年老体衰,肾精不足,肝阴亏虚,筋脉失于濡养,致不荣则痛。本方中羌活、独活、白芷、麻黄祛风除湿,解表散寒,通痹止痛,可使风、寒、湿邪速去。慢性疼痛一般病程较长,久病入络,气血瘀滞,则肌肉紧张僵硬,关节活动受限,疼痛不已。桂枝、桑枝、木瓜、川牛膝、路路通、透骨草、海桐皮、青风藤、忍冬藤祛风活络,通利关节;当归、乳香、没药、五灵脂、大黄、苏木、延胡索活血祛瘀,行气止痛。肾主骨生髓,肝主身之筋膜,骨碎补、桑寄生、狗脊补肝肾,强筋骨。肉桂、干姜、丁香、艾叶温阳散寒,通经活络。薄荷味辛,其挥发油有促渗作用,可促进药物透皮吸收。诸药相合,共奏祛风除湿,温阳散寒,行气活血,化瘀散结,通络止痛之功,用于治疗风寒湿痹阻、气滞血瘀之慢性疼痛效果好。药理研究表明,此类药可抑制炎症介质的释放,改善局部血液循环,减轻筋膜粘连,缓解肌肉痉挛,减轻神经根周围水肿,从而缓解疼痛。
以下为各组分的作用和功效:
羌活:辛、苦,温。归膀胱、肾经。具有解表散寒、祛风除湿、止痛的作用。用于风寒感冒、头痛项强、风湿痹痛、肩背酸痛。研究表明羌活中的醋酸乙酯提取物具有镇痛作用。
独活:辛、苦,微温。归肾、膀胱经。具有祛风湿、止痛、解表的作用。用于治疗风寒湿痹、风寒挟湿表证、少阴头痛。研究表明其具有抗炎、镇痛、镇静、抑制血小板聚集的药理作用。
白芷:辛、温。归胃、大肠、肺经。功效解表散寒、祛风止痛、宣通鼻窍、燥湿止带、消肿排脓。可用于治疗风寒表证、头痛、牙痛、鼻渊鼻鼽等病症。研究表明,白芷中所含的白芷总香豆素和挥发油组合物具有止痛功效。
生麻黄:辛、微苦,温。归肺、膀胱经。功效发汗散寒、宣肺平喘、利水消肿。用于风寒感冒、胸闷喘咳、风水浮肿。其含有的麻黄碱能通过兴奋大脑皮层及皮层下中枢发挥镇痛作用。
桂枝:辛、甘,温。归心、肺、膀胱经。具有发汗解肌、温通经脉、助阳化气之功。用于胸阳不振、心脉痹阻引起的胸痹心痛、心动悸、脉结代者。研究表明,桂枝中所含的桂皮醛有一定程度的镇痛作用。
桑枝:微苦,平。归肝经。功效祛风湿、利关节。用于风湿痹证,新久、寒热均可应用,尤宜于肩臂、关节酸痛麻木者。研究表明,桑枝具有较强的抗炎活性和免疫调节作用。
木瓜:酸,温。归肝、脾经。功效舒筋活络、和胃化湿。用于湿痹拘挛、腰膝关节酸重疼痛、吐泻转筋、脚气水肿。研究发现,其有效成分木瓜苷可通过抑制外周炎症反应而达到镇痛效果。
川牛膝:甘、微苦,平。归肝、肾经。功效逐瘀通经、通利关节、利尿通淋。用于跌扑损伤、风湿痹痛、足痿筋挛、经闭癥瘕、胞衣不下、尿血血淋。其有效成分具有抗炎、镇痛、改善血流变学等作用。
路路通:苦,平。归肝、肾经。具有祛风活络、利水通经的作用。可用于治疗风湿痹痛、半身不遂、跌打损伤、经行不畅、经闭等病症。其含有的路路通酸和没食子酸能够降低毛细血管通透性,抑制炎性介质分泌,具有抗炎、消肿、镇痛的作用。
透骨草:辛、咸,温。入肾,膀胱经。具有祛风除湿、通络止痛的作用。可用于治疗风湿性关节炎、四肢麻木、拘挛疼痛等病症。研究表明,透骨草具有镇痛、抗炎、抗菌的药理作用。
海桐皮:苦、辛,平。归肝经。具有祛风湿、通经络的作用。可用于治疗风湿痹痛、四肢拘挛、腰膝疼痛。研究表明,海桐皮具有镇静、镇痛等药理活性。
青风藤:苦、辛,平。归肝、脾经。功效祛风湿、通经络、利小便。用于风湿痹证、关节肿胀、风湿麻木、水肿、脚气等病症。其有效成分青藤碱具有抗炎、镇痛、镇静、免疫抑制等作用。
忍冬藤:甘,寒。归肺、胃经。具有清热解毒、疏风通络的作用。用于温病发热、热毒血痢、痈肿疮疡、风湿热痹、关节红肿热痛。药理研究表明,忍冬藤具有抗炎、抗血小板聚集、抗氧化等作用。
当归:甘、辛,温。归心、肝、脾经。具有补血活血、调经止痛、润肠通便的作用。可用于治疗血虚证,月经不调、经闭痛经,及其他各种痛症。当归对于子宫具有双相反应,可调节子宫平滑肌收缩,解除痉挛而达到调经止痛的作用。
乳香:辛、苦,温。归心、肝、脾经。具有活血定痛、消肿生肌的作用。用于治疗胸痹心痛、痛经经闭、产后瘀阻、癥瘕腹痛、风湿痹痛、筋脉拘挛、跌打损伤等。研究表明,乳香具有抗炎、抗菌、抗肿瘤、抗溃疡等多种作用,常用于缓解炎症引起的疼痛。
没药:辛、苦,平。归心、肝、脾经。功效散瘀定痛、消肿生肌。用于风湿痹痛、跌打损伤、瘀滞肿痛、痈疽肿痛、胸腹诸痛等。其有效成分可作用于中枢神经系统阿片受体,有镇痛活性。
五灵脂:苦、咸、甘,温。归肝经。功效活血止痛、化瘀止血。用于治疗瘀血阻滞之骨折肿痛、胸痹心痛、脘腹胁痛等病症。研究发现,五灵脂具有抗炎、抗血小板聚集、改善血流变的作用。
生大黄:苦,寒。归脾、胃、大肠、肝、心包经。功效泻下攻积、清热泻火、凉血解毒、逐瘀通经、利湿退黄。用于实热积滞便秘、血热吐衄、目赤咽肿、痈肿疔疮、肠痈腹痛、瘀血经闭、产后瘀阻、跌打损伤、湿热痢疾等症。药理研究表明,其含有的大黄素可通过抑制钙离子信号及突触长时程增强等机制发挥镇痛作用。
苏木:甘、成、辛,平。归心、肝、脾经。功效活血祛瘀、消肿止痛。用于跌打损伤、骨折筋伤、瘀滞肿痛、经闭痛经、产后瘀阻、胸腹刺痛等。苏木及其所含化学成分具有抗炎、镇静、免疫抑制、舒张血管等多种生物活性。
醋延胡索:辛、苦,温。归肝、脾经。具有活血、行气、止痛的作用。可用于胸胁脘腹疼痛、胸痹心痛、经闭痛经、产后瘀阻、跌扑肿痛。延胡索能阻扰中枢多巴胺受体,抑制损伤神经元自主放电,从而缓解疼痛,镇痛程度可达吗啡的40%,尤其对慢性炎性疼痛效果好,而且还有抗焦虑、镇静催眠等作用。
骨碎补:苦,温。归肾、肝经。具有补肾强骨,续伤止痛。用于跌打损伤或创伤,筋骨损伤,瘀滞肿痛,肾虚腰痛,耳鸣耳聋,牙痛诸症。研究表明,骨碎补可促进骨折的愈合,有明显镇痛、镇静作用。
桑寄生:苦、甘,平。入肝、肾经。功效祛风湿、补肝肾、强筋骨、安胎。用于风湿腰痛、关节不利、筋骨酸痛等症。研究表明,桑寄生具有抗炎、镇痛作用。
狗脊:苦、甘,温。归肝、肾经。功效祛风湿、补肝肾、强腰膝。用于风湿痹痛、腰膝酸软、下肢无力等症。研究表明,狗脊具有镇痛、止血的药理作用。
肉桂:辛、甘,大热。归肾、脾、心、肝经。具有补火助阳、引火归元、散寒止痛、温通经脉的作用。可用于治疗阳痿宫冷、腰膝冷痛、心腹冷痛、寒疝腹痛、痛经经闭。药理研究表明,肉桂具有抗炎、抗菌、抗氧化、调节神经系统、保护心血管等作用。
干姜:辛,热。归脾、胃、肾、心、肺经。具有温中散寒、回阳通脉、温肺化饮的作用。用于脘腹冷痛、呕吐泄泻、肢冷脉微、寒饮喘咳等病症。研究表明,干姜有抗炎、抑菌、抗氧化等作用。
丁香:辛,温。归脾、胃、肺、肾经。功效温中降逆、补肾助阳。可用于脾胃虚寒、呃逆呕吐、食少吐泻、心腹冷痛、肾虚阳痿。研究表明,丁香在小鼠醋酸扭体、福尔马林以及热板实验中均表现出显著的镇痛作用。
艾叶:辛、苦,温;有小毒。归肝、脾、肾经。具有温经止血、散寒止痛的作用。用于治疗吐血、衄血、崩漏、月经过多、胎漏下血、少腹冷痛、经寒不调、宫冷不孕等。研究表明艾叶具有明显的镇痛抗炎作用。
薄荷:辛,凉。归肺、肝经。具有疏散风热、清利头目、利咽、透疹、疏肝行气的作用。用于风热感冒、风温初起、头痛、目赤、喉痹、风疹、麻疹、胸胁胀闷等症。研究表明,薄荷活性成分有促进渗透、抗炎、抗菌、抗病毒、改善精神疲劳等作用。
本发明中药组合物还可加上药学上可接受的赋形剂制成药学上的常规制剂,所述赋形剂包括崩解剂、润滑剂、黏合剂等,所述药学上的常规制剂优选包括散剂、凝胶贴膏、膏药。
本发明的另一目的在于,提供一种治疗慢性疼痛的外用中药组合物的制备方法,包括如下步骤:
散剂制备包括如下步骤:
(1)将上述原料药物按照重量比称重;
(2)将上述中药组分干燥后混匀;
(3)使用中药打粉机进行磨粉,药物粉末为60~100目为宜;
(4)将药物粉末分装,得到散剂。
凝胶贴膏制备包括如下步骤:
(1)将上述原料药物按照重量比称重;
(2)将上述中药组分干燥后加入8倍量70%的乙醇溶液提取2次,过滤2~3次后得到澄清液;
(3)将澄清液进行减压浓缩干燥成干浸膏,低温超微粉碎成干药粉:
(4)取增粘剂加入去离子水溶胀后为基质A相;
(5)取骨架材料、填充剂、凝胶交联剂充分混匀后加入保湿剂搅拌均匀为基质B相;
(6)取pH调节剂以去离子水溶解后为C相;
(7)将干药粉、促渗剂缓缓先加入A相,搅拌均匀;
(8)依次加入C相、B相,搅拌均匀;
(9)将混合物涂布,盖上防粘膜,固化成型后裁成21cm×14cm大小的药贴,塑封即得。
膏药制备包括如下步骤:
(1)将上述原料药物按照重量比称重;
(2)将上述中药组分干燥后混匀;
(3)使用中药打粉机进行磨粉,药物粉末为60~100目为宜;
(4)将上述药物粉末份放入锅内,加入2~5倍重量的芝麻油浸泡24小时;
(5)文火煎煮,并不断搅拌,熬至药枯,浮起为度,去药渣,继续熬至滴水成珠;
(6)每1000重量份芝麻油加入樟丹25-30重量份,不断搅拌,文火熬制成粘稠的膏体,捻之软硬适中、拉丝不断、不粘手时停火;
(7)搅之烟尽,倒入冷水中,浸泡7天,每24小时换一次水,以去火毒,捞出揉匀制成膏药团;
(8)取膏药团置于容器中,文火溶化,摊贴在膏药布或牛皮纸上,制成膏药。
本发明的优点:
1.本发明的一种治疗慢性疼痛的外用中药组合物具有祛风除湿、温阳散寒、行气活血、化瘀散结、通络止痛的功效,现代药理研究证明其有效成分可抑制炎症介质的释放,改善局部血液循环,减轻筋膜粘连,缓解肌肉痉挛,减轻神经根周围水肿,缓解疼痛。
2.本发明的一种治疗慢性疼痛的外用中药组合物直接作用于患处,不经过胃肠道,无药物首过效应,可通过透皮吸收而迅速起效。
3.本发明的一种治疗慢性疼痛的是一种绿色、安全、无创、无肝肾代谢负担、成本低廉、操作简便、疗效确切的中医外治疗法。
附图说明
图1为本发明中药组合物治疗慢性疼痛的例数和有效率。
具体实施方式
下面结合具体实施例对本发明作进一步详细描述,但不作为对本发明的限定。
实施例1:
羌活15份,独活15份,白芷10份,生麻黄10份,桂枝10份,桑枝30份,木瓜30份,川牛膝15份,路路通15份,透骨草15份,海桐皮15份,青风藤15份,忍冬藤15份,当归10份,醋乳香15份,醋没药15份,醋五灵脂15份,生大黄15份,苏木30份,醋延胡索15份,骨碎补15份,桑寄生15份,狗脊15份,肉桂10份,干姜10份,丁香10份,生艾叶15份,薄荷10份。
制作方法如下:
(1)将上述原料药物按照重量比称重;
(2)将上述中药组分干燥后混匀;
(3)使用中药打粉机进行磨粉,药物粉末为60~100目为宜;
(4)将药物粉末分装,得到散剂。
使用方法:治疗时,将中药粉末用温水调至糊状,均匀涂抹在患部,厚度0.2~0.3cm,停留1~2h。
实施例2:
羌活10份,独活15份,白芷9份,生麻黄12份,桂枝9份,桑枝15份,木瓜15份,川牛膝12份,路路通12份,透骨草12份,海桐皮15份,青风藤15份,忍冬藤15份,当归9份,醋乳香12份,醋没药12份,醋五灵脂15份,生大黄12份,苏木15份,醋延胡索15份,骨碎补12份,桑寄生15份,狗脊12份,肉桂9份,干姜12份,丁香9份,生艾叶15份,薄荷12份。
制作方法如下:
(1)将上述原料药物按照重量比称重;
(2)将上述中药组分干燥后加入8倍量70%的乙醇溶液提取2次,过滤2~3次后得到澄清液;
(3)将澄清液进行减压浓缩干燥成干浸膏,低温超微粉碎成干药粉;
(4)取增粘剂加入去离子水溶胀后为基质A相;
(5)取骨架材料、填充剂、凝胶交联剂充分混匀后加入保湿剂搅拌均匀为基质B相;
(6)取pH调节剂以去离子水溶解后为C相;
(7)将干药粉、促渗剂缓缓先加入A相,搅拌均匀;
(8)依次加入C相、B相,搅拌均匀;
(9)将混合物涂布,盖上防粘膜,固化成型后裁成21cm×14cm大小的药贴,塑封即得。
使用方法:治疗时,将凝胶贴膏热水浸泡至温热,揭开防粘膜后贴在患部,停留2~4h。
实施例3:
羌活12份,独活20份,白芷12份,生麻黄15份,桂枝12份,桑枝20份,木瓜20份,川牛膝15份,路路通15份,透骨草15份,海桐皮20份,青风藤20份,忍冬藤20份,当归12份,醋乳香15份,醋没药15份,醋五灵脂20份,生大黄15份,苏木20份,醋延胡索20份,骨碎补15份,桑寄生20份,狗脊15份,肉桂12份,干姜15份,丁香12份,生艾叶20份,薄荷15份。
制作方法如下:
(1)将上述原料药物按照重量比称重;
(2)将上述中药组分干燥后混匀;
(3)使用中药打粉机进行磨粉,药物粉末为60~100目为宜;
(4)将上述药物粉末份放入锅内,加入2~5倍重量的芝麻油浸泡24小时;
(5)文火煎煮,并不断搅拌,熬至药枯,浮起为度,去药渣,继续熬至滴水成珠;
(6)每1000重量份芝麻油加入樟丹25-30重量份,不断搅拌,文火熬制成粘稠的膏体,捻之软硬适中、拉丝不断、不粘手时停火;
(7)搅之烟尽,倒入冷水中,浸泡7天,每24小时换一次水,以去火毒,捞出揉匀制成膏药团;
(8)取膏药团置于容器中,文火溶化,摊贴在膏药布或牛皮纸上,制成膏药。
使用方法:治疗时,将膏药贴在患部,停留2~4h。
实施例4:
羌活20份,独活40份,白芷15份,生麻黄15份,桂枝15份,桑枝30份,木瓜40份,川牛膝25份,路路通20份,透骨草20份,海桐皮12份,青风藤15份,忍冬藤15份,当归15份,醋乳香20份,醋没药20份,醋五灵脂25份,生大黄25份,苏木40份,醋延胡索25份,骨碎补20份,桑寄生25份,狗脊25份,肉桂15份,干姜12份,丁香10份,生艾叶25份,薄荷20份。制备服用方法如实施例1。
实施例5:
羌活30份,独活60份,白芷20份,生麻黄20份,桂枝20份,桑枝60份,木瓜60份,川牛膝30份,路路通30份,透骨草30份,海桐皮30份,青风藤30份,忍冬藤30份,当归20份,醋乳香30份,醋没药30份,醋五灵脂30份,生大黄30份,苏木60份,醋延胡索30份,骨碎补30份,桑寄生30份,狗脊30份,肉桂20份,干姜20份,丁香20份,生艾叶30份,薄荷20份。制备服用方法如实施例2。
实施例6:
羌活15份,独活30份,白芷10份,生麻黄20份,桂枝10份,桑枝20份,木瓜20份,川牛膝20份,路路通15份,透骨草15份,海桐皮20份,青风藤15份,忍冬藤15份,当归15份,醋乳香20份,醋没药20份,醋五灵脂20份,生大黄20份,苏木20份,醋延胡索30份,骨碎补20份,桑寄生30份,狗脊30份,肉桂15份,干姜15份,丁香15份,生艾叶30份,薄荷20份。制备服用方法如实施例3。
实施例7:
羌活20份,独活45份,白芷20份,生麻黄10份,桂枝10份,桑枝45份,木瓜45份,川牛膝25份,路路通30份,透骨草30份,海桐皮25份,青风藤30份,忍冬藤30份,当归20份,醋乳香30份,醋没药20份,醋五灵脂30份,生大黄25份,苏木45份,醋延胡索20份,骨碎补20份,桑寄生25份,狗脊25份,肉桂20份,干姜10份,丁香20份,生艾叶25份,薄荷15份。制备服用方法如实施例1。
实施例8:
羌活18份,独活48份,白芷12份,生麻黄18份,桂枝18份,桑枝48份,木瓜42份,川牛膝24份,路路通24份,透骨草24份,海桐皮24份,青风藤18份,忍冬藤18份,当归12份,醋乳香24份,醋没药24份,醋五灵脂18份,生大黄18份,苏木48份,醋延胡索24份,骨碎补24份,桑寄生24份,狗脊24份,肉桂12份,干姜18份,丁香12份,生艾叶18份,薄荷18份。制备服用方法如实施例2。
实施例9:
羌活15份,独活60份,白芷15份,生麻黄20份,桂枝15份,桑枝50份,木瓜50份,川牛膝30份,路路通30份,透骨草25份,海桐皮25份,青风藤30份,忍冬藤30份,当归20份,醋乳香20份,醋没药20份,醋五灵脂20份,生大黄30份,苏木50份,醋延胡索30份,骨碎补30份,桑寄生30份,狗脊20份,肉桂10份,干姜20份,丁香10份,生艾叶20份,薄荷20份。制备服用方法如实施例3。
前期基础
本方中药组合物共累积治疗慢性疼痛患者927例,其中治疗腰椎间盘突出症352例,有效率为80%;腰背肌筋膜炎136例,有效率91%;颈椎病147例,有效率为83%;膝骨关节炎136例,有效率87%;腰痛130例,有效率90%。具体结果表1和图1所示,其中表1为中药组合物治疗慢性疼痛的例数和有效率。
表1:
案例
病例1
张某,女,54岁,主因“腰部疼痛1年余,加重1天”就诊。患者1年前因搬抬重物后出现腰部两侧疼痛剧烈,自行贴敷膏药后缓解,未系统治疗。1天前因搬重物加之受寒后腰痛复发,活动受限,俯仰转侧困难,动则痛甚,行走困难,影响睡眠、饮食。予本发明外用中药组合物:羌活15份,独活15份,白芷10份,生麻黄10份,桂枝10份,桑枝30份,木瓜30份,川牛膝15份,路路通15份,透骨草15份,海桐皮15份,青风藤15份,忍冬藤15份,当归10份,醋乳香15份,醋没药15份,醋五灵脂15份,生大黄15份,苏木30份,醋延胡索15份,骨碎补15份,桑寄生15份,狗脊15份,肉桂10份,干姜10份,丁香10份,生艾叶15份,薄荷10份。取适量上述原料药物制成的中药粉末,用温水调至糊状,均匀涂抹在患部,厚度0.2~0.3cm,停留1~2h。治疗2次后,患者腰部疼痛明显减轻,脊柱活动基本正常,疼痛视觉模拟量表VAS评分为由8分减为2分。
病例2
刘某,男,44岁,主因“腰骶部疼痛伴双下肢麻木、发凉1年余”就诊。患者腰骶部疼痛,久坐后易发,自觉双下肢麻木、发凉,平素怕冷。于宣武医院骨科,查腰椎MRI示:腰椎退行性改变;L2-S1椎间盘膨出。诊为“腰椎间盘突出症”,嘱静养,未予特殊处置。因疼痛影响正常工作,遂来我院就诊,寻求中医药治疗。予本发明外用中药组合物:羌活15份,独活15份,白芷10份,生麻黄10份,桂枝10份,桑枝30份,木瓜30份,川牛膝15份,路路通15份,透骨草15份,海桐皮15份,青风藤15份,忍冬藤15份,当归10份,醋乳香15份,醋没药15份,醋五灵脂15份,生大黄15份,苏木30份,醋延胡索15份,骨碎补15份,桑寄生15份,狗脊15份,肉桂10份,干姜10份,丁香10份,生艾叶15份,薄荷10份。膏药贴于患部,治疗5次后,患者腰骶部酸胀感、疼痛、双下肢麻木、发凉感未发,无明显怕冷;疼痛视觉模拟量表VAS评分由6分减至0分;腰椎JOA评分由15分增至28分,直腿抬高试验及加强试验(-)。
病例3
马某,女,75岁,主因“反复双膝关节疼痛5年”就诊。患者5年前外出受寒后出现双膝关节疼痛,伴僵硬,活动受限,遇寒加重,肢体沉重、乏力,上下楼梯时疼痛明显,反复发作,曾多次就诊于当地医院,诊断为“膝骨性关节炎”,口服中药汤剂治疗,效不佳。予本发明外用中药组合物:羌活15份,独活15份,白芷10份,生麻黄10份,桂枝10份,桑枝30份,木瓜30份,川牛膝15份,路路通15份,透骨草15份,海桐皮15份,青风藤15份,忍冬藤15份,当归10份,醋乳香15份,醋没药15份,醋五灵脂15份,生大黄15份,苏木30份,醋延胡索15份,骨碎补15份,桑寄生15份,狗脊15份,肉桂10份,干姜10份,丁香10份,生艾叶15份,薄荷10份。取适量上述原料药物制成的中药粉末,用温水调至糊状,均匀涂抹在患部,厚度0.2~0.3cm,停留1~2h。治疗5次后,双膝关节疼痛偶隐痛,僵硬基本消失,无明显沉重乏力,畏寒明显减轻。视觉模拟VAS评分由9分减至3分,WOMAC评分由37分减至5分,膝关节功能Lysholm评分由42分增至91分,JOA评分由55分增至90分。3个月后随访,患者膝关节疼痛、活动受限等症状基本消失。
病例4
Nava,女,45岁,非洲人,主因“双膝关节疼痛1月,加重3日”就诊。患者1月前外出受寒后出现双膝关节疼痛,沉重,乏软,畏寒,休息后稍有缓解,未予治疗。3日前,患者乘坐长途飞机时因机舱温度较低受凉,时感双膝关节疼痛加重,伴活动受限,影响生活质量,遂来我院就诊。刻下症见:双膝关节疼痛,遇寒加重,伴活动受限,肢体沉重乏软,双膝轻度肿胀。予本发明外用中药组合物:羌活15份,独活15份,白芷10份,生麻黄10份,桂枝10份,桑枝30份,木瓜30份,川牛膝15份,路路通15份,透骨草15份,海桐皮15份,青风藤15份,忍冬藤15份,当归10份,醋乳香15份,醋没药15份,醋五灵脂15份,生大黄15份,苏木30份,醋延胡索15份,骨碎补15份,桑寄生15份,狗脊15份,肉桂10份,干姜10份,于香10份,生艾叶15份,薄荷10份。凝胶膏贴贴于患部,治疗2次后,患者双膝关节疼痛症状明显缓解。视觉模拟VAS评分由5分减至1分,WOMAC评分由20分减至3分,膝关节功能Lysholm评分由73分增至93分,JOA评分由75分增至95分。
以上显示和描述了本发明的基本原理和主要特征及本发明的优点。应当指出,对于本技术领域的普通技术人员来说,在不脱离本发明基本原理的前提下,还可以做出若干改进和润饰,这些改进和润饰也视为本发明的保护范围。
Claims (9)
1.一种治疗慢性疼痛的外用中药组合物,其特征在于,基于重量份计,所述中药组合物由羌活10~30份,独活10~60份,白芷5~20份,生麻黄5~20份,桂枝5~20份,桑枝15~60份,木瓜15~60份,川牛膝10~30份,路路通10~30份,透骨草10~30份,海桐皮10~30份,青风藤10~30份,忍冬藤10~30份,当归5~20份,醋乳香10~30份,醋没药10~30份,醋五灵脂10~30份,生大黄10~30份,苏木15~60份,醋延胡索10~30份,骨碎补10~30份,桑寄生10~30份,狗脊10~30份,肉桂5~20份,干姜5~20份,丁香5~20份,生艾叶10~30份,薄荷5~20份制成。
2.根据权利要求1所述的一种治疗慢性疼痛的外用中药组合物,其特征在于,基于重量份计,由羌活15份,独活15份,白芷10份,生麻黄10份,桂枝10份,桑枝30份,木瓜30份,川牛膝15份,路路通15份,透骨草15份,海桐皮15份,青风藤15份,忍冬藤15份,当归10份,醋乳香15份,醋没药15份,醋五灵脂15份,生大黄15份,苏木30份,醋延胡索15份,骨碎补15份,桑寄生15份,狗脊15份,肉桂10份,干姜10份,丁香10份,生艾叶15份,薄荷10份制成。
3.根据权利要求1所述的一种治疗慢性疼痛的外用中药组合物,其特征在于,基于重量份计,由羌活10份,独活15份,白芷9份,生麻黄12份,桂枝9份,桑枝15份,木瓜15份,川牛膝12份,路路通12份,透骨草12份,海桐皮15份,青风藤15份,忍冬藤15份,当归9份,醋乳香12份,醋没药12份,醋五灵脂15份,生大黄12份,苏木15份,醋延胡索15份,骨碎补12份,桑寄生15份,狗脊12份,肉桂9份,干姜12份,丁香9份,生艾叶15份,薄荷12份制成。
4.根据权利要求1所述的一种治疗慢性疼痛的外用中药组合物,其特征在于,基于重量份计,由羌活12份,独活20份,白芷12份,生麻黄15份,桂枝12份,桑枝20份,木瓜20份,川牛膝15份,路路通15份,透骨草15份,海桐皮20份,青风藤20份,忍冬藤20份,当归12份,醋乳香15份,醋没药15份,醋五灵脂20份,生大黄15份,苏木20份,醋延胡索20份,骨碎补15份,桑寄生20份,狗脊15份,肉桂12份,干姜15份,丁香12份,生艾叶20份,薄荷15份制成。
5.根据权利要求1所述的一种治疗慢性疼痛的外用中药组合物,其特征在于,基于重量份计,由羌活20份,独活40份,白芷15份,生麻黄15份,桂枝15份,桑枝30份,木瓜40份,川牛膝25份,路路通20份,透骨草20份,海桐皮12份,青风藤15份,忍冬藤15份,当归15份,醋乳香20份,醋没药20份,醋五灵脂25份,生大黄25份,苏木40份,醋延胡索25份,骨碎补20份,桑寄生25份,狗脊25份,肉桂15份,干姜12份,丁香10份,生艾叶25份,薄荷20份制成。
6.根据权利要求1所述的一种治疗慢性疼痛的外用中药组合物,其特征在于,基于重量份计,由羌活30份,独活60份,白芷20份,生麻黄20份,桂枝20份,桑枝60份,木瓜60份,川牛膝30份,路路通30份,透骨草30份,海桐皮30份,青风藤30份,忍冬藤30份,当归20份,醋乳香30份,醋没药30份,醋五灵脂30份,生大黄30份,苏木60份,醋延胡索30份,骨碎补30份,桑寄生30份,狗脊30份,肉桂20份,干姜20份,丁香20份,生艾叶30份,薄荷20份制成。
7.根据权利要求1~6任一项所述的一种治疗慢性疼痛的外用中药组合物,其特征在于,还包含药学上可接受的赋形剂,并制成药学上的常规制剂。
8.根据权利要求7所述的一种治疗慢性疼痛的外用中药组合物,其特征在于,所述赋形剂为崩解剂、润滑剂或黏合剂中的一种或多种,所述药学上的常规制剂为散剂、凝胶贴膏或者膏药。
9.一种制备如权利要求7所述的一种治疗慢性疼痛的外用中药组合物的方法,其特征在于,包括如下步骤:
散剂制备包括如下步骤:
(1)将上述原料药物按照重量比称重;
(2)将上述中药组分干燥后混匀;
(3)使用中药打粉机进行磨粉,药物粉末为60~100目为宜;
(4)将药物粉末分装,得到散剂;
或者,凝胶贴膏制备包括如下步骤:
(1)将上述原料药物按照重量比称重;
(2)将上述中药组分干燥后加入8倍量70%的乙醇溶液提取2次,过滤2~3次后得到澄清液;
(3)将澄清液进行减压浓缩干燥成干浸膏,低温超微粉碎成干药粉;
(4)取增粘剂加入去离子水溶胀后为基质A相;
(5)取骨架材料、填充剂、凝胶交联剂充分混匀后加入保湿剂搅拌均匀为基质B相;
(6)取pH调节剂以去离子水溶解后为C相;
(7)将干药粉、促渗剂缓缓先加入A相,搅拌均匀;
(8)依次加入C相、B相,搅拌均匀;
(9)将混合物涂布,盖上防粘膜,固化成型后裁成21cm×14cm大小的药贴,塑封即得;
或者,膏药制备包括如下步骤:
(1)将上述原料药物按照重量比称重;
(2)将上述中药组分干燥后混匀;
(3)使用中药打粉机进行磨粉,药物粉末为60~100目为宜;
(4)将上述药物粉末放入锅内,加入2~5倍重量的芝麻油浸泡24小时;
(5)文火煎煮,并不断搅拌,熬至药枯,浮起为度,去药渣,继续熬至滴水成珠;
(6)每1000重量份芝麻油加入樟丹25-30重量份,不断搅拌,文火熬制成粘稠的膏体,捻之软硬适中、拉丝不断、不粘手时停火;
(7)搅之烟尽,倒入冷水中,浸泡7天,每24小时换一次水,以去火毒,捞出揉匀制成膏药团;
(8)取膏药团置于容器中,文火溶化,摊贴在膏药布或牛皮纸上,制成膏药。
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