CN114931611A - 一种治疗烧烫伤、创伤病症的中药组合物及其制备方法 - Google Patents
一种治疗烧烫伤、创伤病症的中药组合物及其制备方法 Download PDFInfo
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Abstract
本发明涉及一种治疗烧烫伤、创伤病症的中药组合物,该中药组合物由如下中药原料制备得到:鲜侧柏叶、地榆、茜草、白蔹、虎杖、葫芦壳、黄芪、猪苓、没药、乳香、白及、冰片。所述中药组合物可以制备为膏剂,用于治疗烧烫伤、皮肤创伤引起的皮肤外伤溃疡、溃烂及软组织挫裂伤等病症。
Description
技术领域
本发明涉及中医药技术领域,具体涉及一种治疗烧烫伤、创伤病症的中药组合物及其中药制剂,该中药制剂的制备方法,以及该中药组合物和该中药制剂在制备治疗烧烫伤、创伤引起的皮肤外伤溃疡、溃烂及软组织挫裂伤的制剂中的应用。
背景技术
烧烫伤系由灼热的气体、液体、固体或火焰、电、放射线及化学物质等作用于人体所造成的组织损害,人们在日常生活和工作中稍有疏忽,就有被烧烫伤的可能。烧烫伤是日常生活中一种常见的损伤,烧烫病人多为Ⅱ度烧烫伤,其中大部分是中小面积烧烫伤的患者。严重烧伤可引起机体各系统出现严重的反应和功能、代谢及形态变化,甚至导致休克、脓毒血症和多脏器功能衰竭等并发症,死亡率较高。
皮肤创伤一般指皮肤在各种因素的作用下,所造成的皮肤组织破坏以及可能发生的全身反应。外来伤害是创伤发生的直接原因。外来各种伤害如跌仆、坠堕、撞击、闪挫、压扎、负重、刀刃、劳损、虫兽咬伤等作用于人体或动物体,导致皮肉、筋骨、血脉、五脏六腑等破坏,损伤气血及经络,轻则局部功能障碍,致留残疾;重则危及生命,亦可造成巨大精神创伤。
发明内容
本发明的目的是为了克服现有技术存在的在治疗烧烫伤、创伤时西药不能治本以及现有中药效果不明显等问题,提供一种治疗烧烫伤、创伤的中药组合物及其中药制剂,该中药制剂的制备方法,以及该中药组合物和该中药制剂在制备治疗烧烫伤、皮肤创伤引起的皮肤外伤溃疡、溃烂及软组织挫裂伤的制剂中的应用。
为了实现上述目的,本发明第一方面提供一种中药组合物,该中药组合物由如下中药原料制备得到:鲜侧柏叶、地榆、茜草、白蔹、虎杖、葫芦壳、黄芪、猪苓、没药、乳香、白及、冰片;
所述中药组合物由如下重量份数的中药原料制备得到:鲜侧柏叶20-30份、地榆13-25份、茜草9-17份、白蔹8-15份、虎杖5-15份、葫芦壳9-15份、黄芪9-20份、猪苓5-10份、没药1-5份、乳香1-5份、白及6-15份、冰片0.15-0.3份。
优选的所述中药组合物由如下重量份数的中药原料制备得到:鲜侧柏叶23-27份、地榆20-23份、茜草12-15份、白蔹9-12份、虎杖7-11份、葫芦壳10-12份、黄芪11-17份、猪苓6-8份、没药3-5份、乳香3-5份、白及8-13份、冰片0.15-0.2份。
中医认为,烧烫伤是由热毒侵害人体,导致皮肉,甚至脏腑腐烂而成,轻者仅皮肉损伤,重者则因火毒炽盛,伤津耗液,损伤阳气,致气阴两伤,或因火毒侵入营血,内攻脏腑,导致脏腑失和,阴阳平衡失调,甚至死亡;其治则应以泻火解毒、清热凉血、散瘀止痛为原则。创伤多由外来伤害作用于人体,引起皮肉筋骨甚至内脏损伤,导致气血癖滞,经络阻塞,而气血不足,肌肉失养,则腐肉不易脱落,或津血亏损,阳气失散,阴阳失衡,壮火、少火偏盛偏衰,使人体气化功能失调,其修复是邪正相争,正胜邪退,经络复通,脏腑调和,津血正气恢复,气血流通的渐进过程,主要以消散,扶助正气、托毒外出,补气养血为治疗原则。综上,对于烧烫伤、创伤的治疗,应以泻火解毒、清热凉血、消肿生肌、活血化瘀定痛、补气升阳养血为原则。
方中侧柏叶性微寒,具有凉血止血、祛风解毒之效,善清血分之热,侧柏炭功偏收敛止血;地榆(炭)味苦,性微寒,苦寒泻火解毒,清热凉血,善入血分,可止血敛疮,为治水火烫伤之要药,两药合用,可增强血分清热解毒之功,共为君药。葫芦壳,清热解毒,利水消肿;茜草凉血活血、祛瘀;白蔹清热解毒、消痈散结;虎杖清热解毒,散瘀止痛,四药合用,可增强君药清热、凉血之功,同时兼有活血祛瘀、消肿止痛之效,共为臣药。猪苓性平,利水渗湿;乳香、没药散瘀定痛,消肿生肌;黄芪甘温,具有补气升阳,行滞通痹,托毒排脓,敛疮生肌之效;白及味苦性微寒,具有收敛止血,消肿生肌之效;冰片辛、苦性微寒,具有开窍醒神、清热凉血、消肿止痛,防腐生肌之功,可引药直达病所,佐助君臣对创面消肿生肌的治疗,促进药物在创面的渗透吸收,进而加快创面的愈合,共为佐使。诸药合用,共奏泻火解毒、清热凉血、散瘀止痛、消肿生肌、补气养血之功。
本发明添加的中药各组分功效如下.
侧柏叶:苦、涩,寒。归肺、肝、脾经。凉血止血,化痰止咳,生发乌发。用于吐血,衄血,咯血,便血,崩漏下血,肺热咳嗽,血热脱发,须发早白。
地榆:苦、酸、涩,微寒。归肝、大肠经。凉血止血,解毒敛疮。用于便血,痔血,血痢,崩漏,水火烫伤,痈肿疮毒。
茜草:苦,寒。归肝经。凉血,祛瘀,止血,通经。用于吐血,衄血,崩漏,外伤出血,瘀阻经闭,关节痹痛,跌扑肿痛。
白蔹:苦,微寒。归心、胃经。清热解毒,消痈散结,敛疮生肌。用于痈疽发背,疔疮,療痂,烧烫伤。
虎杖:微苦,微寒。归肝、胆、肺经。利湿退黄,清热解毒,散瘀止痛,止咳化痰。用于湿热黄疸,淋浊,带下,风湿痹痛,痈肿疮毒,水火烫伤,经闭,癥瘕,跌打损伤,肺热咳嗽。
葫芦壳:味甘,性平,能入心经和小肠经。利水消肿。
黄芪:甘,微温。归肺、脾经。补气升阳,固表止汗,利水消肿,生津养血,行滞通痹,托毒排脓,敛疮生肌。用于气虚乏力,食少便溏,中气下陷,久泻脱肛,便血崩漏,表虚自汗,气虚水肿,内热消渴,血虚萎黄,半身不遂,痹痛麻木,痈疽难溃,久溃不敛。
猪苓:甘、淡,平。归肾、膀胱经。具有利水渗湿的功效,主治小便不利、水肿、泄泻、淋浊、带下等症。
没药:辛、苦,平。归心、肝、脾经。散瘀定痛,消肿生肌。用于胸痹心痛,胃脘疼痛,痛经经闭,产后瘀阻,癥瘕腹痛,风湿痹痛,跌打损伤,痈肿疮疡。
乳香:辛、苦,温。归心、肝、脾经。活血定痛,消肿生肌。用于胸痹心痛,胃脘疼痛,痛经经闭,产后瘀阻,癥瘕腹痛,风湿痹痛,筋脉拘挛,跌打损伤,痈肿疮疡。
白及:苦、甘、涩,微寒。归肺、肝、胃经。收敛止血,消肿生肌。用于咯血,吐血,外伤出血,疮疡肿毒,皮肤皲裂。
冰片:辛、苦,凉。归心、脾、肺经。开窍醒神,清热止痛。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。
在没有特殊说明的情况下,上述中药为本领域常使用的方式。
本发明提供的中药组合物可以通过将所述各种原料混合而制得。混合的条件只要使各种原料混合均匀即可。
在本技术方案中,鲜侧柏叶、地榆、茜草、白蔹、葫芦壳炭化后粉碎入药,其他原料药粉碎后入药。
本发明提供的中药组合物能够用于治疗烧烫伤、皮肤创伤引起的皮肤外伤溃疡、溃烂及软组织挫裂伤等病症。
本发明第二方面提供一种中药制剂,所述中药制剂含有活性成分和辅料,所述活性成分为如上所述的中药组合物。
所述中药制剂由活性组分和辅料组分组成,其特征在于,所述活性成分为权利要求1或2所述的中药组合物。
以所述中药制剂的总重量为基准,所述活性成分的重量份为90-180份,所述辅料重量份为27-50份。所述辅料为药学上可接受的辅料,优选为中药制剂常用的辅料,本领域技术人员可以根据制剂的剂型进行选择。所述制剂的剂型可以为膏剂、散剂、洗剂、酊剂、搽剂、凝胶剂或贴剂。
所述的辅料包括壳聚糖,以及植物油和/或动物油,所述辅料的重量份数为:壳聚糖1-5份、植物油和/或动物油26-45份。
所述辅料的重量份数为:壳聚糖2-4份、植物油和/或动物油30-40份。
所述的植物油为芝麻油、麻油、油菜籽油、茶籽油、橄榄油、蓖麻籽油的一种或几种;所述的动物油为猪油、牛油、羊油、獾油中的一种或几种。
优选的,所述植物油为芝麻油。
优选地,上述中药原料的重量配比为:鲜侧柏叶20-30g、地榆13-25g、茜草9-17g、白蔹8-15g、虎杖5-15g、葫芦壳9-15g、黄芪9-20g、猪苓5-10g、没药1-5g、乳香1-5g、白及6-15g、冰片0.15-0.3g,其所使用的辅料重量配比为:壳聚糖1-5g、动植物油26-45g。
更优选地,所述中药原料的重量配比为:鲜侧柏叶23-27g、地榆20-23g、茜草12-15g、白蔹9-12g、虎杖7-11g、葫芦壳10-12g、黄芪11-17g、猪苓6-8g、没药3-5g、乳香3-5g、白及8-13g、冰片0.15-0.2g,其所使用的辅料重量配比为:壳聚糖2-4g、动植物油30-40g。
在没有特殊说明的情况下,上述物质均为商购可获得的用于药品领域的产品。
本发明第三方面提供如上所述的中药制剂的制备方法,该方法包括将活性成分与辅料混合,得到中药制剂。
优选地,所述中药制剂为膏剂。
优选的所述膏剂的配制方法如下:
(1)按重量称取鲜侧柏叶、地榆、茜草、白蔹、葫芦壳,炭化研粉、过80-120目筛;
(2)按重量称取虎杖、黄芪、猪苓、没药、乳香、白及、冰片研粉,过80-120目筛;
(3)按重量称取过筛后的冰片加入芝麻油中,搅拌使其完全溶解,将步骤(1)、(2)的药粉与按重量称取壳聚糖混合均匀,放入芝麻油中,调和成粥状即可。
应当理解的是,所述膏剂的制备方式不限于上述列举的方式,本领域技术人员可以根据物料的种类进一步调整制备的方式。
本发明第四方面提供如上所述的中药组合物或如上所述的中药制剂在制备治疗烧烫伤、皮肤创伤引起的皮肤外伤溃疡、溃烂及软组织挫裂伤的制剂中的应用;
还提供了所述的中药组合物或所述的中药制剂在制备治疗由烧烫伤、皮肤创伤引起的皮肤外伤溃疡、溃烂及软组织挫裂伤的制剂中的应用。
该中药制剂可以外用,涂抹于皮肤患处。
本发明具有如下显著的有益效果,但不限于如下有益效果。
1、本发明为中药复方制剂,辅料种类单一,涂抹后可在创伤表面迅速形成一层保护膜,创造创面湿润环境,有效隔绝空气,避免干燥性损伤,对烧烫伤创面无局部刺激性。
2、本药含有多种凉血止血、散瘀止痛中药,涂药后创面的灼痛感迅速转为清凉感,并以强渗透力释放至创面以下组织,阻断局部痉挛与神经末梢的致痛热源达到快速止痛,具有迅速、显著、持久的止痛效果。
3、本药处方所含中药,具有抑制金黄色葡萄球菌、绿脓杆菌、福氏痢疾杆菌、炭疽杆菌等多种微生物生长、繁殖的药理作用,杀菌效力显著,且相比抗生素,不易产生耐药性。此外,涂抹后可在创面形成一层保护油膜,既可促使坏死组织早期液化,自动引流排出,从而形成不利于细菌繁殖生存的环境;又可有效隔离细菌的侵入,减少感染,保护创面。
4、具有一定穿透痂皮和焦痂的能力,可促进伤口愈合,抑制瘢痕增生。
5、本处方中的中药有效成分能生肌敛疮,有化瘀消肿,消痈散结的作用。可改善微循环,降低毛细血管通透性,使烧伤坏死组织和代谢产物无损伤性地由表入里地液化、排除,使残存于皮下的毛囊汗腺以及毛细血管周围的间质细胞向干细胞方向转化,通过激活休眠于间质细胞中的干细胞,使之不断的有序分裂、增殖,产生生肌生发作用,抑制疤痕和色素沉淀的产生,实现深度烧伤创面的生理性愈合,可大大减轻病人的痛苦和后遗症的产生。
附图说明
图1是实验例1中皮肤烫伤模型的各实验组大鼠皮肤图。
图2是实验例2中皮肤创伤模型的各实验组大鼠皮肤图。
具体实施方式
在本文中所披露的范围的端点和任何值都不限于该精确的范围或值,这些范围或值应当理解为包含接近这些范围或值的值。对于数值范围来说,各个范围的端点值之间、各个范围的端点值和单独的点值之间,以及单独的点值之间可以彼此组合而得到一个或多个新的数值范围,这些数值范围应被视为在本文中具体公开。
以下将通过实施例对本发明进行详细描述。
实施例1-3
本实施例用于说明本发明所述的中药组合物的配方。
按照表1所述的用量(均以重量g计)将各原料混合,分别对应组合物A1-A3,其中实施例1为A1,实施例2为A2,实施例3为A3。
表1各实施例中药组合物配方
膏剂配制方法:
(1)按重量称取鲜侧柏叶、地榆、茜草、白蔹、葫芦壳,炭化研粉、过80-120目筛;
(2)按重量称取虎杖、黄芪、猪苓、没药、乳香、白及、冰片研粉,过80-120目筛;
(3)按重量称取过筛后的冰片加入芝麻油中,搅拌使其完全溶解,将步骤(1)、(2)的药粉与按重量称取壳聚糖混合均匀,放入芝麻油中,调和成粥状即可。
对比例1-3:
发明人在处方摸索过程中还曾实验多达几十种其他组方和其他重量配比方式,结果发现本申请的组方和重量配比时治疗效果是最优的,下面举出部分典型对比例进行说明。
表2各对比例中药组合物配方
实验例1
1 实验动物及造模方法。
1.1实验动物
SD大鼠40只,体重180-200g,雌雄各半,分笼饲养。随机分为4组,每组10只,为对照组、药物1组、药物2组、对比例组,其中药物1组使用的是按照实施例1配制的药膏,药物2组使用的是按照实施例2配制的药膏,对比例组使用的是按照对比例2配制的药膏。
1.2造模方法
1.2.1实验前,按照0.01ml/只速眠新的量将动物麻醉,将动物拟造模区脱毛,面积约5cm×5cm,脱毛区域应无损伤。
1.2.2使用电阻炉,在盛装2/3水量的不锈钢烧杯中放入一小玻璃烧杯,共同加热,直至将热水煮沸,并保持沸腾状态。
1.2.3待烫区(直径2.5cm)准备就绪后,用镊子夹出装满沸水的小烧杯,用纱布快速擦去烧杯底部水分,直接按压在待烫区,停留12s后快速拿开。
2 给药治疗
造模后,每天观察大鼠烫伤区域,记录其变化情况。从造模第3天开始药物组和对比例组给药,每天给药1次,与对照组对比观察愈合情况,每天记录。给药10天后停止给药。
3实验结果
表观指标是最直观的表现,是判定烧(烫)伤模型成功与否的关键指标。各阶段大鼠烫伤的愈合情况参见图1。
造模当天可见皮肤出现红肿、白色水疱,次日可观察到水疱内含血浆样黄色液体,水疱破裂后创面鲜红湿润、水肿明显,表面撕脱后可见创面湿润苍白;从图1中可以看出,给药前,创面上形成一层坏死组织。综合上述表现,参照三度四分法,认为该模型的烫伤程度介于浅Ⅱ度烧(烫)伤和深Ⅱ度烧(烫)伤之间,表明造模成功。
给药3天后,两药物组大鼠烫伤结痂快速硬化,便于脱落,对比例组烫伤部位也开始结痂;给药7天后,药物组和对比例组烫伤痂皮开始脱落,并在2天内退完,均较对照组修复程度高;给药10天后,药物1组伤口区域明显缩小,且较其他两组差异明显;药物2组伤口区域面积缩小程度优于对比例组,两个药物组伤口已基本完全愈合;对比例组虽然痂皮已脱落,但是伤口区域面积相对药物组较大,而对照组此时痂皮还未完全脱落,皮肤表面未恢复。表明药物对烫伤小鼠具有显著的治疗作用,而对比例药物对创伤小鼠的治疗效果差于药物组。
实验例2
实验动物及造模方法
1.1实验动物
SD大鼠40只,200-240g,雌雄各半,分笼饲养。随机分为4组,每组10只,分别对照组、药物1组、药物2组、对比例组,其中药物1组使用的是按照实施例1配制的药膏,药物2组使用的是按照实施例2配制的药膏,对比例组使用的是按照对比例3配制的药膏。
1.2造模方法
实验第1天,大鼠背部右侧剃毛,面积3cm×3cm,用温和脱毛膏对剃毛处部位进行脱毛,脱毛后皮肤表面光滑,无明显毛发。
除对照组外,各组大鼠进行舒泰(0.01ml/只)和速眠新(0.01ml/只)麻醉剂肌肉注射,裁剪脱毛处皮肤大小1.5cm×1.5cm,裁剪后可见筋膜,立即对创伤处进行包扎处理,观察大鼠麻醉后恢复情况,术后连续3天,各组大鼠每天一次庆大霉素肌肉注射(0.2ml/只),以防止感染。
2. 给药治疗
手术3天后,除对照组外,对2个药物组和对比例组分别取适量相应膏剂均匀涂抹于创伤部位,进行给药治疗,每天1次,连续给药10天,于给药2d、4d、7d和10d分别观察并记录创伤部位的皮损变化情况。
3. 实验结果
表观指标是最直观的表现,是判定创伤模型成功与否的关键指标。各阶段大鼠创伤的愈合情况参见图2:
手术后,各组大鼠背部创伤处皮肤均出现不同程度渗血、渗组织液等情况,表明造模成功。
给药2天后,各给药组大鼠均表现出一定程度的愈合情况,表明各给药组对大鼠创伤伤口愈合有一定的促进作用,而此时的对照组大鼠背部创伤处皮肤仍有渗血和渗组织液的情况出现;给药7d后,各组大鼠背部皮肤伤口面积明显收缩,药物1组和2组的伤口面积明显小于对比例和对照组,而对照组此时还有伤口裂开渗血的现象;给药10天后,各组伤口面积较给药前面积急剧减小,其中药物1组和2组大鼠表现最佳,伤口已基本愈合,对比例组大鼠的伤口收缩,呈不规则的四边形;对照组仍表现渗血,组织液渗出现象。表明药物对创伤小鼠具有显著的治疗作用,而对比例药物对创伤小鼠的治疗效果差于药物组。
上述两个实验例结果表明,本发明重量配比范围内的实施例1明显优于本发明重量配比范围之外的对比例,用于说明所选择的重量配比是优选的,发明人事实上还曾经使用过其他重量配比,但发现均不如请求保护范围内的重量配比更优;并且,猪苓的作用为利水渗湿,似乎与烧烫伤或创伤关系不大,但事实上发明人发现,猪苓由于化学成分和物理结构等方面的特殊性,在组合物中能够发挥重要的作用,在减少猪苓的情况下,即使等量增加君药用量,组合物的治疗效果明显降低;另外,猪苓和葫芦壳的作用均为利水作用,减少葫芦壳增加等量猪苓,理论上对组合物的作用应该影响较小,但事实上发明人发现,减少葫芦壳之后,即使增加猪苓,组合物的效果也显著降低,可见在组合物中猪苓和葫芦壳的组合能够发挥重要的作用,其具体原因有待进一步研究,但这不影响发明人采用猪苓和葫芦壳搭配的技术方案。
Claims (9)
1.一种治疗烧烫伤、创伤病症的中药组合物,其特征在于所述中药组合物由如下重量份数的中药原料制备得到:鲜侧柏叶20-30份、地榆13-25份、茜草9-17份、白蔹8-15份、虎杖5-15份、葫芦壳9-15份、黄芪9-20份、猪苓5-10份、没药1-5份、乳香1-5份、白及6-15份、冰片0.15-0.3份。
2.根据权利要求1所述的中药组合物,其特征在于所述中药组合物由如下重量份数的中药原料制备得到:鲜侧柏叶23-27份、地榆20-23份、茜草12-15份、白蔹9-12份、虎杖7-11份、葫芦壳10-12份、黄芪11-17份、猪苓6-8份、没药3-5份、乳香3-5份、白及8-13份、冰片0.15-0.2份。
3.一种治疗烧烫伤、创伤病症的中药制剂,所述中药制剂由活性组分和辅料组分组成,其特征在于,所述活性成分为权利要求1或2所述的中药组合物。
4.根据权利要求3所述的中药制剂,其特征在于以所述中药制剂的总重量为基准,所述活性成分的重量份为90-180份,所述辅料的重量份为27-50份。
5.根据权利要求3所述的中药制剂,其特征在于所述的辅料包括壳聚糖,以及植物油和/或动物油,所述辅料的重量份数为:壳聚糖1-5份、植物油和/或动物油26-45份。
6.根据权利要求5所述的中药制剂,其特征在于所述辅料的重量份数为:壳聚糖2-4份、植物油和/或动物油30-40份;
所述的植物油为芝麻油、麻油、油菜籽油、茶籽油、橄榄油、蓖麻籽油的一种或几种;所述的动物油为猪油、牛油、羊油、獾油中的一种或几种。
7.根据权利要求6所述的中药制剂,其特征在于所述植物油为芝麻油。
8.一种权利要求5或6所述的治疗烧烫伤、创伤病症的中药制剂的制备方法,其特征是采用如下方法步骤制得:
(1)按重量称取鲜侧柏叶、地榆、茜草、白蔹、葫芦壳,炭化、研粉、过80-120目筛,备用;
(2)按重量称取虎杖、黄芪、猪苓、没药、乳香、白及、冰片研粉,过80-120目筛,备用;
(3)按重量称取过筛后的冰片加入芝麻油中,搅拌使其完全溶解,将步骤(1)、(2)的药粉与按重量称取壳聚糖混合均匀,放入芝麻油中,调和成粥状即可。
9.权利要求1或2所述的中药组合物或权利要求3-7中任意一项所述的中药制剂在制备治疗由烧烫伤、皮肤创伤引起的皮肤外伤溃疡、溃烂及软组织挫裂伤的制剂中的应用。
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