CN110302336B - 预防脑卒中后肩手综合征的中药组合物及其制备方法与应用 - Google Patents
预防脑卒中后肩手综合征的中药组合物及其制备方法与应用 Download PDFInfo
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Abstract
本发明提供一种预防脑卒中后肩手综合征的中药组合物及其制备方法与应用。该中药组合物包括如下重量份的原料:细辛10‑30份、片姜黄10‑30份、元胡10‑30份、川椒10‑30份、川乌10‑30份、生南星10‑30份、红花10‑30份、青风藤10‑30份、丁香5‑15份、三七5‑15份、白芷5‑15份、山奈5‑15份。本发明中药组合物对于脑卒中后上肢功能障碍患者预可减少肩手综合征发生,改善患者关节活动度,减少疼痛,有效改善临床症状。
Description
技术领域
本发明涉及预防脑卒中后肩手综合征的药物,具体为一种中药组合物及其制备方法与应用。
背景技术
脑卒中具有发病率高、死亡率高、致残率高的特点,给家庭和社会造成严重生活负担,因此,临床上除积极脑血管病二级预防外,对卒中的相关并发症进行早期干预也可有效减少脑卒中的致残率。脑卒中偏瘫症状的患者常易出现肩部肿胀伴随剧烈疼痛,给患者的日常生活能力造成不便,增加了医疗费用,这类并发症为肩手综合征。
肩手综合征又称反射性交感神经营养不良,是脑卒中常见合并症,是指脑梗死或脑出血后患者上肢水肿、患侧肩手疼痛、肩关节活动受限等,严重可导致手部变形,甚至丧失手功能。脑卒中后,肩手综合征发生率约为12.5%~74.1%,一旦发生很难恢复。有一项随访5年的研究表明,肩手综合征I期的患者仍然存在肢体的病损、残疾以及日常生活能力的受损,26%的患者需要更换工作,接近30%的患者需要停止工作超过1年甚至以上。脑卒中后1-3个月是肩手综合征高发期,5个月后少见,因此,早期对脑卒中患者进行干预,预防肩手综合征的发生可降低致残率,提高患者ADL评分。
脑卒中后肩手综合征的发病机制尚不完全清楚,目前认为的发病机制可能与肩关节不当牵拉、血管运动神经麻痹、血管损伤等有关。目前的治疗主要集中在物理疗法和针灸推拿,传统抗抑郁药、阿片类药物、皮质类固醇药物、NMDA受体拮抗剂及肉毒素等药物治疗主要集中在针对该病的止痛治疗,且西药治疗该病的药物不良反应较多,中药外治法具有操作方便、不良反应小、相对安全的特点,针灸、拔罐、熏蒸、涂擦等疗法可有效改善临床症状。早期康复护理是促进脑卒中患者神经功能、运动功能恢复的重要环节,能够改善患者上肢功能,减少肩手综合征发生。因此对脑卒中患者进行早期康复护理,减少肩手综合征发生可提高患者生活质量,对减少致残率及医疗费用具有重要意义。
专利CN201510087531.3为一种口服治疗肩手综合征的中药,由附子8~12份、肉桂3~5份、熟地黄20~30份、山茱萸9~15份、楮实子6~10份、沙棘6~10份、薏苡仁25~35份、桔梗6~10份、桑白皮12~18份、豨签草9~15份、泽兰9~15份、萆薢12~18份、葛根12~18份、穿山甲1~2份、蜂房2~4份、全蝎0.5~1.5份组成,是一种口服治疗肩手综合征的专用药物。
专利CN107898884A公开了一种治疗脑卒中后肩手综合征手肿胀的中药组合物及康复手臂套,中药组分如下:红花12-18份、泽泻2-8份、艾叶5-15份、透骨草2-8份、丝瓜络10-20份、桂枝12-18份。手臂套结构如下:包括手臂套本体、手掌套、包裹带,手掌套和手臂套为一体式连接,包裹带设置在手臂套尾部,手臂套本体设有内层、中层、外层、凸点;手掌套为半指形手掌套,内层材料为无纺布,中层材料为海绵,外层材料为无纺布,在手掌套的内表面设有中药巴布剂。该手臂套结构简单,防水透气,长时间使用不会对病人产生负面影响,凸点的设置能够按摩肌肉,利于病人的康复,中药巴布剂显著改善患者手肿胀及手运动功能,对患者手部进行消肿治疗。
专利CN201610643971公开了一种配合针刺治疗中风后肩手综合征的中药喷剂及制备方法,该中药喷剂取下述重量配比的原料制备而成:雷公藤15-25份、白花菜子10-20份、刺楸茎10-20份、鸡血藤10-20份、白桂10-20份、老鹳草10-20份、豆瓣七8-16份、赤芍8-16份、刺葡萄根5-15份、川芎5-15份、大横纹5-15份、鬼箭羽5-15份、红木香4-12份、红花4-12份、姜黄4-12份、大独叶草2-8份、马鞭草2-8份、天仙藤2-8份。本发明的中药喷剂采用常见中药材作为原料,成本低廉,无副作用,具有活血通络、祛风散寒、消肿止痛的功效,配合针刺治疗中风后肩手综合征,作用更快、更全面,疗效更显著。
专利CN201510932382公开了一种治疗Ⅰ期肩手综合征的中药组合物,所述中药组合物由以下原料药制成:红芪、小雪人参、鬼箭羽、南丹参、八月札、凤冠草、红毛蛇、蒙自水芹、威灵仙、洋虫。本发明提供的治疗Ⅰ期肩手综合征的中药组合物,补充了现有康复技术治疗机制的不足,与现有技术相比具有疗效好、使用方便等优点。采用本发明提供的治疗Ⅰ期肩手综合征的中药组合物水煎剂治疗60例患者,经4周治疗,治疗组总有效率91.7%,对照组总有效率70.0%,治疗组总有效率明显优于对照组,组间差异具有统计学意义(P<0.05)。
专利CN201510390242公开了一种辅助治疗I期肩手综合征的中药组合物,所述中药组合物由以下原料药制成:凤尾参、刺人参、苏木、红牛毛刺根、鸡血莲、黑虎七、三加皮、桑寄生、细辛、乌梢蛇。本发明提供的辅助治疗I期肩手综合征的中药组合物,补充了现有康复技术治疗机制的不足,与现有技术相比具有疗效好、使用方便等优点。
专利CN201310055565公开了一种治疗肩手综合症的中药膏及其制备方法,可有效解决肩手综合症的治疗用药问题,方法是,采用以下重量计的原料药物制成:当归5-15g、川芎5-15g、赤芍12-20g、川乌7-15g、附子5-18g、桂枝7-20g、花椒6-18g、防风5-12g、丹参5-18g、独活8-18g、羌活6-18g、徐长卿5-15g、细辛1-3g和乳膏基质90-110g,本发明采用超临界萃取技术,将传统膏摩疗法与现代制剂技术相结合,绿色低碳环保,制备新型经皮给药制剂—康摩膏,为广大肩手综合征患者带来福音,该制剂具有疗效显著,病患无痛苦,使用方便,是治疗肩手综合症药物上的创新。
目前西医治疗肩手综合征仅为对症治疗,传统抗抑郁药、阿片类药物、皮质类固醇药物、NMDA受体拮抗剂及肉毒素等药物治疗主要集中在针对该病的止痛治疗,且西药治疗该病的药物不良反应较多,中药外治法具有操作方便、不良反应小、相对安全、有效改善临床症状的特点。
现有公开治疗肩手综合征的专利中口服汤药中多含有毒性药物或虫类药物,长期服用可能会有损伤肝肾功能等药物不良反应;针灸治疗需患者来医院就诊,而脑卒中后肩手综合征患者部分行动不便,就诊治疗给患者及家属带来不便;外用治疗专利多为药物后处理,加工成喷雾或膏剂等剂型,患者操作不便。本发明物采用的中药膏摩疗法是按摩与药物配合运用的一种形式,即以中药配制的膏剂涂抹于体表的治疗穴位上,再施以推拿按摩手法,以发挥推拿按摩和药物二者的综合作用来防治疾病。中药膏摩疗法减少药物不良反应的特点,直接作用于疼痛肿胀处,且膏摩制作操作便捷,方便患者出院后家庭治疗,较现有技术比,具有操作便捷、不良反应少的优点。
发明内容
本发明的目的是提供一种预防脑卒中后肩手综合征的中药组合物。本发明的技术方案是基于祖国医学对肩手综合征发病机理的认识及治疗原则,参考现代药理研究成就,根据温阳活血配以祛风化痰的组方原则而成。
具体而言,本发明预防脑卒中后肩手综合征的中药组合物,包括如下重量份的原料:细辛10-30份、片姜黄10-30份、元胡10-30份、川椒10-30份、川乌10-30份、生南星10-30份、红花10-30份、青风藤10-30份、丁香5-15份、三七5-15份、白芷5-15份、山奈5-15份。
优选地,所述预防脑卒中后肩手综合征的中药组合物,包括如下重量份的原料:细辛10-20份、片姜黄10-20份、元胡10-20份、川椒10-20份、川乌10-20份、生南星10-20份、红花10-20份、青风藤10-20份、丁香5-10份、三七5-10份、白芷5-10份、山奈5-10份。
较佳地,所述预防脑卒中后肩手综合征的中药组合物,包括如下重量份的原料:细辛15份、片姜黄15份、元胡20份、川椒10份、川乌10份、生南星15份、红花15份、青风藤30份、丁香5份、三七5份、白芷5份、山奈10份。
在本发明具体实施方式中,所述预防脑卒中后肩手综合征的中药组合物即是以上述中药细辛、片姜黄、元胡、川椒、川乌、生南星、红花、青风藤、丁香、三七、白芷、山奈为活性成分,按上述配比组成或制成。
上述中药组合物可按本领域常规方法制备。例如按照配比称取各成分,然后干燥、粉碎成细粉,过筛,混匀,即得。
进一步地,本发明还提供一种中药制剂,由上述预防脑卒中后肩手综合征的中药组合物单独制成,或由上述预防脑卒中后肩手综合征的中药组合物与药学上可用的载体或辅料制成。
进一步地,本发明所述中药制剂为外用制剂,优选为膏剂。
所述药学上可接受的载体是指药学领域常规的药物载体,选自填充剂、粘合剂、崩解剂、润滑剂、助悬剂、润湿剂、色素、香精、溶剂、表面活性剂或矫味剂中的一种或几种。
所述填充剂选自淀粉、蔗糖、乳糖、甘露醇、山梨醇、木糖醇、微晶纤维素或葡萄糖等;
所述粘合剂选自纤维素衍生物、藻酸盐、淀粉、水、糊精、明胶或聚乙烯吡咯烷酮等;
所述崩解剂选自微晶纤维素、羧甲基淀粉钠、交联聚乙烯吡咯烷酮、低取代羟丙基纤维素或交联羧甲基纤维素钠;
所述润滑剂选自硬脂酸、聚乙二醇、碳酸钙、碳酸氢钠、微粉硅胶、滑石粉或硬脂酸镁;
所述助悬剂选自微粉硅胶、蜂蜡、纤维素、固态聚乙二醇;
所述润湿剂选自甘油、吐温-80、乙氧基氢化蓖麻油或卵磷脂;
所述溶剂选自乙醇、液态聚乙二醇、异丙醇、吐温-80、甘油、丙二醇或植物油,所述植物油选自大豆油、蓖麻油、花生油、调和油等;
所述表面活性剂选自十二烷基苯磺酸钠、硬脂酸、聚氧乙烯-聚氧丙烯共聚物、脂肪酸山梨坦或聚山梨酯(吐温)等;
所述矫味剂选自阿斯巴甜、蔗糖素、香精、甜菊素、安赛蜜、柠檬酸或糖精钠。
上述中药制剂可按本领域常规方法制备。例如按照配比称取所述组合物各成分,然后干燥、粉碎成细粉,过筛,混匀,制得药物组合物;向所述药物组合物中加入药学上可接受的载体和/或辅料(赋形剂),采用现有技术方法可制成临床可接受的任何剂型。
在本发明一种具体实施方式中,所述制剂为膏剂,可按本领域常规方法制备。具体地,本发明还提供其制备方法:
1)按配比称取原料中药材;干燥、粉碎成细粉,过筛,备用;
2)用50-60℃的热水将经粉碎的原料中药材调制成膏状。
具体应用时,可将本发明中药组合物(膏剂)在体表穴位上均匀涂抹,正确取穴,将中药制剂涂抹于穴位处进行按摩1min。病变部位敷纱布,将剩余中药涂抹于患者病变部位,其上敷盖石膏后以红光照射30min。期间应注意询问患者感受,避免发生烫伤。
本发明所用原料均可市售购得,或按本领域常规方法制备。
在符合本领域常识的基础上,上述各优选条件,可以相互组合,即得本发明各较佳实例。
本发明还包括所述中药组合物或中药制剂在制备用于预防脑卒中后肩手综合征的药物中的应用。
本发明中药组合物中,片姜黄,辛苦温,可活血行气、通经止痛,善治风湿肩臂疼痛;三七,其性温、味辛,有活血化瘀、消肿定痛功效。三七得姜黄之助,瘀血去而新血生,一养一破,相反相成;姜黄得三七之助,活血通络、行气止痛之功更著。元胡又名延胡索,辛散、苦泄、温通,既入血分,又入气分,既能行血中之气,又能行气中之血,气畅血行,通则不痛,《本草纲目》中归纳元胡有“活血,理气,止痛,通小便”四大功效,并推崇元胡“能行血中气滞,气中血滞,故专治一身上下诸痛”,元胡含有多种生物碱,镇痛作用较佳。《本草求真》:姜黄,功用颇类延胡索,但延胡索则于心肝血分行气,气分行血;此则入脾,既治气中之血,复兼血中之气耳。三药配伍为君药,共奏活血止痛作用。方中细辛,辛温有小毒,可解表散寒,祛风止痛,用于治疗风湿痹痛,《药品化义》云“细辛,若寒邪入里,而在阴经者,以此从内托出”。丁香,性温、辛,归脾、胃、肺、肾经,外用可温中止痛;川椒辛、麻,温,归脾、胃、肾经,外用可温中止痛,两药与细辛相配共为臣药,加强细辛散寒之功,增强止痛之效。方中川乌辛、苦,热,有大毒,归心、肝、肾、脾经,可祛风除湿,温经止痛,用于风寒湿痹、关节疼痛;白芷辛,温,入肺、脾、胃经,可祛风,燥湿,消肿,止痛;山奈,辛,温,归脾、胃经,可温中化湿,行气止痛;生南星,苦、辛,温,有毒,可祛风止痉,散结消肿;红花活血散瘀止痛;青风藤苦、辛,平。归肝、脾经,可祛风湿,通经络,利小便,用于风湿痹痛,关节肿胀,麻痹瘙痒,《本草便读》:凡藤蔓之属,皆可通经入络,此物善治风疾,故一切历节麻痹皆治之,浸酒尤妙。以风气通于肝,故入肝,风胜湿,湿气又通于脾也。诸药合用,在活血温阳基础上,祛风除湿,加强止痛之功,共为佐使药。
本发明中药组合物是纯中药制剂,在传统中药外治法的基础上应用中医膏摩治疗方法,中药膏摩是中医常用外治疗法,通过按摩与中药配合,以中药调制药膏为介质,配合推拿按摩手法,有利于药物充分吸收,同时能够发挥推拿、手法按摩的独特作用,松解紧张的肌肉,改善局部血液循环,且外用法不良反应少,对于脑卒中后上肢功能障碍患者预可减少肩手综合征发生,改善患者关节活动度,减少疼痛,有效改善临床症状。
具体实施方式
以下实施例用于说明本发明,但不用来限制本发明的范围。实施例中未注明具体技术或条件者,按照本领域内的文献所描述的技术或条件,或者按照产品说明书进行。所用试剂或仪器未注明生产厂商者,均为可通过正规渠道商购买得到的常规产品。
实施例1
一种预防脑卒中后肩手综合征的中药组合物,配方:细辛15份、片姜黄15份、元胡20份、川椒10份、川乌10份、生南星15份、红花15份、青风藤30份、丁香5份、三七5份、白芷5份、山奈10份。
本实施例还提供一种膏剂,是由上述中药组合物制成,制备方法包括:
1)按照上述中药组合物配方称取原料中药材;
2)将原料中药材干燥、粉碎成细粉,过筛,备用;
3)在步骤2)的细粉中将中药粉末倒入治疗碗中,用50-60℃的热水将中药调制成膏状,即为膏剂。
实施例2
一种预防脑卒中后肩手综合征的中药组合物,配方:细辛10份、片姜黄10份、元胡10份、川椒10份、川乌10份、生南星20份、红花10份、青风藤30份、丁香10份、三七10份、白芷10份、山奈10份。
按照上述中药组合物配方称取各成分,然后干燥、粉碎成细粉,过筛,混匀,制得药物组合物;加入药学上可接受的载体和/或辅料(赋形剂),采用现有技术方法制成临床可接受的任何外用剂型。
实施例3
一种预防脑卒中后肩手综合征的中药组合物,配方:细辛20份、片姜黄20份、元胡20份、川椒20份、川乌20份、生南星20份、红花20份、青风藤20份、丁香10份、三七10份、白芷10份、山奈10份。
按照上述中药组合物配方称取各成分,然后干燥、粉碎成细粉,过筛,混匀,制得药物组合物;加入适量的荆花蜜,充分混匀,制成外用膏剂。
实验例
1.对象与方法
选取90例首次发作急性脑卒中患者,
纳入标准:符合急性脑卒中的诊断标准经影像学明确诊断且首次发作者;发病时间≤3天;合并有上肢活动障碍,上肢肌力检查≤Ⅲ级;入院时无肩手综合征。
排除标准:严重认知功能障碍及精神疾病患者;昏迷患者;此次发病合并严重感染者;既往因其他原因上肢畸形者;皮肤对外用药物易过敏者;对已知中药成分过敏者;正在参与其他课题研究的患者。
采用随机数字表法,以不透光的信封作为隐藏随机,将患者随机分为两组。治疗组45例;对照组45例。所有患者均于病情稳定后48h内予早期康复护理,对照组及治疗组两组患者均采取常规康复护理方案,治疗组在常规护理方案的基础上,联合使用实施例1制备的膏剂,治疗周期为3个月。常规护理方案:对患侧上肢肌力进行阶段性训练,第一阶段主要是进行肩胛带、腕关节、肘关节被动活动,并尽量使患者主动活动;第二阶段主要是进行肩胛带、腕关节被动活动,前臂屈伸、旋转,使用腋托,运用Bobath技术辅助训练;第三阶段主要进行翻身、坐起练习,辅助Bobath技术;第四阶段为坐位训练、转移训练,同时辅助滚筒及拔木钉训练、Bobath球操等。
以治疗组和对照组患者治疗3个月后的肩手综合征的发生率、肩关节活动度以及疼痛程度为评价指标。运用SPSS21.0软件进行数据分析,计量资料两样本正态分布比较采用t检验,非正态分布比较采用秩和检验,计数资料采用X2检验,P<0.05表示差异,有统计学意义。
2.结果
2.1一般资料
治疗组、对照组患者的年龄、性别无统计学差异(P>0.05);2组患者入组时的上肢FMA评分比较,无统计学差异(P>0.05)。
2.2肩手综合征发生率对比
治疗组患者肩手综合征发生率3例(占6.67%),对照组患者肩手综合征发生率10例(占22.22%),2组患者肩手综合征的发生率比较,有统计学差异(P<0.05),见表2。
表2两组患者肩手综合征发生率对比[n(%)]
观察组与对照组总发病率对比:X2=4.41,P<0.05。
2.3关节活动度对比
治疗组与对照组患者入组时均伴有一定程度的关节疼痛,2组比较无统计学差异(P>0.05);治疗后,由于对照组肩手综合征的发生率高于治疗组,其关节活动度较入组时也有所下降,且关节活动度明显小于治疗组,疼痛程度高于治疗组,有统计学差异(P<0.05),见表3。
3.结论
本发明中药组合物可减少肩手综合征发生,改善患者关节活动度,减少疼痛,有效改善临床症状,在临床上进一步值得推广。
虽然,上文中已经用一般性说明及具体实施方案对本发明作了详尽的描述,但在本发明基础上,可以对之作一些修改或改进,这对本领域技术人员而言是显而易见的。因此,在不偏离本发明精神的基础上所做的这些修改或改进,均属于本发明要求保护的范围。
Claims (3)
1.一种预防脑卒中后肩手综合征的中药制剂,其特征在于,由如下重量份的原料制成:细辛15份、片姜黄15份、元胡20份、川椒10份、川乌10份、生南星15份、红花15份、青风藤30份、丁香5份、三七5份、白芷5份、山奈10份;所述制剂为膏剂,制备方法包括:
1)按配比称取原料;干燥、粉碎成细粉,过筛,备用;
2)用50-60℃的热水将经粉碎的原料调制成膏状。
2.权利要求1所述中药制剂的制备方法,其特征在于,包括:
1)按配比称取原料;干燥、粉碎成细粉,过筛,备用;
2)用50-60℃的热水将经粉碎的原料调制成膏状。
3.权利要求1所述中药制剂在制备预防脑卒中后肩手综合征的药物中的应用。
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