CN105664053A - 一种治疗维持性血液透析患者动静脉内瘘穿刺处皮肤硬结的中药组合物 - Google Patents
一种治疗维持性血液透析患者动静脉内瘘穿刺处皮肤硬结的中药组合物 Download PDFInfo
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Abstract
本发明公开了一种治疗维持性血液透析患者动静脉内瘘穿刺处皮肤硬结的中药组合物,由以下重量份的原料药制成:积雪草10-20份,芦荟10-20份,凌霄花10-20份,桑白皮10-20份,柏子仁10-15份,黄芩10-15份,川芎10-15份,当归10-15份,瓜蒌皮10-15份,广枣8-12份,红参8-12份,莲子心5-10份,竹节参5-10份,酸枣仁5-10份,罗布麻叶3-6份,灯盏细辛3-6份,合欢皮3-6份,郁金4-8份,竹茹3-5份,冬凌草3-5份,川木通3-5份,紫苏叶3-5份。本发明的中药组合物具有修复皮肤组织,促进皮肤的新陈代谢,并改善皮肤弹性,从而实现软化硬皮、促进皮肤新生等作用,能够有效缓解皮肤硬化,延长血管通路的使用。
Description
技术领域
本发明涉及一种治疗维持性血液透析患者动静脉内瘘穿刺处皮肤硬结的中药组合物,属于药物制剂技术领域。
背景技术
自体动静脉内瘘被称为维持性血液透析患者的生命线,也是首选血管通路,在保证充分透析的过程中起到至关重要的作用。但是,在长期维持性血液透析治疗的过程中,反复穿刺不可避免的导致局部穿刺点的增生硬化,不仅影响了内瘘血流量,严重时甚至导致内瘘堵塞。
目前对该种皮肤硬结缺乏行之有效的治疗方法,临床常通过局部涂抹喜疗妥、肝素钠软膏等药物,或者进行扣眼穿刺方法以减少内瘘处的皮肤硬化。但上述各种方法的治疗效果有限。
发明内容
针对上述现有技术,本发明的目的是提供一种治疗维持性血液透析患者动静脉内瘘穿刺处皮肤硬结的中药组合物,该中药组合物具有修复皮肤组织,促进皮肤的新陈代谢,并改善皮肤弹性,从而实现软化硬皮、促进皮肤新生等作用,能够有效缓解皮肤硬化,延长血管通路的使用。
为实现上述目的,本发明采用下述技术方案:
一种治疗维持性血液透析患者动静脉内瘘穿刺处皮肤硬结的中药组合物,由以下重量份的原料药制成:
积雪草10-20份,芦荟10-20份,凌霄花10-20份,桑白皮10-20份,柏子仁10-15份,黄芩10-15份,川芎10-15份,当归10-15份,瓜蒌皮10-15份,广枣8-12份,红参8-12份,莲子心5-10份,竹节参5-10份,酸枣仁5-10份,罗布麻叶3-6份,灯盏细辛3-6份,合欢皮3-6份,郁金4-8份,竹茹3-5份,冬凌草3-5份,川木通3-5份,紫苏叶3-5份。
本发明的用于治疗心脑血管疾病的中药组合物,优选的药物组方为:
积雪草20份,芦荟20份,凌霄花15份,桑白皮15份,柏子仁12份,黄芩12份,川芎13份,当归12份,瓜蒌皮12份,广枣10份,红参10份,莲子心8份,竹节参8份,酸枣仁8份,罗布麻叶5份,灯盏细辛4份,合欢皮4份,郁金6份,竹茹4份,冬凌草4份,川木通4份,紫苏叶4份。
上述药物组方中,各味药均为《中国药典》2010年版(一部)收载的品种,其质量均符合各品种项下有关的各项规定。
中药的配伍讲究相须、相使、相畏、相杀、相恶、相反,由于不同的中药之间存在不同的配伍关系,因此在使用两味以上中药时,必须有所选择,充分发挥药物之间相须相使的配伍关系。本发明通过将多味中药进行配伍,药物之间共同发挥了软化硬皮、促进皮肤新生的作用,具有明显的增效作用,充分发挥了相须相使的配伍关系。药物组方中各味药的药理分析如下:
积雪草:苦、辛,寒。归肝、脾、肾经。清热利湿,解毒消肿。用于湿热黄疸,中暑腹泻,石淋血淋,痈肿疮毒,跌扑损伤。
芦荟:苦,寒。归肝、胃、大肠经。泻下通便,清肝泻火,杀虫疗疳。用于热结便秘,惊痫抽搐,小儿疳积,外治癣疮。
凌霄花:甘、酸,寒。归肝、心包经。活血通经,凉血祛风。用于月经不调,经闭癥瘕,产后乳肿,风疹发红,皮肤瘙痒,痤疮。
桑白皮:甘,寒。归肺经。泻肺平喘,利水消肿。用于肺热喘咳,水肿胀满尿少,面目肌肤浮肿。
柏子仁:甘,平。归心、肾、大肠经。养心安神,润肠通便,止汗。用于阴血不足,虚烦失眠,心悸怔忡,肠燥便秘,阴虚盗汗。
黄芩:苦,寒。归肺、胆、脾、大肠、小肠经。清热燥湿,泻火解毒,止血,安胎。用于湿温、暑湿,胸闷呕恶,湿热痞满,泻痢,黄疸,肺热咳嗽,高热烦渴,血热吐衄,痈肿疮毒,胎动不安。
川芎:辛,温。归肝、胆、心包经。活血行气,祛风止痛。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。
当归:甘、辛,温。归肝、心、脾经。补血活血,调经止痛,润肠通便。用于血虚萎黄,眩晕心悸,月经不调,经闭痛经,虚寒腹痛,风湿痹痛,跌扑损伤,痈疽疮疡,肠燥便秘。酒当归活血通经。用于经闭痛经,风湿痹痛,跌扑损伤。
瓜蒌皮:甘,寒。归肺、胃经。清热化痰,利气宽胸。用于痰热咳嗽,胸闷胁痛。
广枣:甘、酸,平。行气活血,养心,安神。用于气滞血瘀,胸痹作痛,心悸气短,心神不安。
红参:甘、微苦,温。归脾、肺、心、肾经。大补元气,复脉固脱,益气摄血。用于体虚欲脱,肢冷脉微,气不摄血,崩漏下血。
莲子心:苦,寒。归心、肾经。清心安神,交通心肾,涩精止血。用于热入心包,神昏谵语,心肾不交,失眠遗精,血热吐血。
竹节参:甘、微苦,温。归肝、脾、肺经。散瘀止血,消肿止痛,祛痰止咳,补虚强壮。用于痨嗽咯血,跌扑损伤,咳嗽痰多,病后虚弱。
酸枣仁:甘、酸,平。归肝、胆、心经。养心补肝,宁心安神,敛汗,生津。用于虚烦不眠,惊悸多梦,体虚多汗,津伤口渴。
罗布麻叶:甘、苦,凉。归肝经。平肝安神,清热利水。用于肝阳眩晕,心悸失眠,浮肿尿少。
灯盏细辛:辛、微苦,温。归心、肝经。活血通络止痛,祛风散寒。用于中风偏瘫,胸痹心痛,风湿痹痛,头痛,牙痛。
合欢皮:甘,平。归心、肝、肺经。解郁安神,活血消肿。用于心神不安,忧郁失眠,肺痈,疮肿,跌扑伤痛。
郁金:辛、苦,寒。归肝、心、肺经。活血止痛,行气解郁,清心凉血,利胆退黄。用于胸胁刺痛,胸痹心痛,经闭痛经,乳房胀痛,热病神昏,癫痫发狂,血热吐衄,黄疸尿赤。
竹茹:甘,微寒。归肺、胃、心、胆经。清热化痰,除烦,止呕。用于痰热咳嗽,胆火挟痰,惊悸不宁,心烦失眠,中风痰迷,舌强不语,胃热呕吐,妊娠恶阻,胎动不安。
冬凌草:苦、甘,微寒。归肺、胃、肝经。清热解毒,活血止痛。用于咽喉肿痛,癥瘕痞块,蛇虫咬伤。
川木通:苦,寒。归心、小肠、膀胱经。利尿通淋,清心除烦,通经下乳。用于淋证,水肿,心烦尿赤,口舌生疮,经闭乳少,湿热痹痛。
紫苏叶:辛,温。归肺、脾经。解表散寒,行气和胃。用于风寒感冒,咳嗽呕恶,妊娠呕吐,鱼蟹中毒。
本发明的中药组方从中医辩证角度出发,针对由动静脉内瘘穿刺引起的皮肤硬结进行辨证施治。其中,积雪草中含有积雪草苷生物活性成分,能够促进细胞再生,促进受损组织再生恢复,具有促进伤口愈合的作用;芦荟能够软化硬皮,促进皮肤新生;凌霄花和桑白皮配合使用,共同起到活血通经,缓解皮肤硬化的作用;川芎、当归、广枣、合欢皮和郁金养血活血,黄芩和罗布麻叶活血祛瘀,冬凌草活血止痛的功效,从而促进血行、通利血脉、消散淤血,以达到活血祛瘀的效果,促进皮肤的心声;然后,再配以柏子仁、莲子心、酸枣仁和川木通,养心安神,平肝清心;利用竹茹和紫苏叶,软化血管,清除体内有毒性作用的自由基,恢复血管弹性;诸药配伍,具有修复皮肤组织,促进皮肤的新陈代谢,并改善皮肤弹性,从而实现软化硬皮、促进皮肤新生的功效。
本发明还提供了该中药组合物的制备方法,步骤如下:
(1)将积雪草、芦荟、桑白皮、柏子仁、黄芩、川芎、当归、瓜蒌皮、广枣、红参、莲子心、竹节参、酸枣仁、灯盏细辛、郁金、竹茹、冬凌草和川木通,混合,加水煎煮两次,合并滤液,滤液浓缩至相对密度为1.1-1.3(50℃测),干燥,粉碎,过筛,得中药浸膏粉末;
(2)将凌霄花、合欢皮、罗布麻叶和紫苏叶粉碎,过筛,然后与中药浸膏粉末混合,即得;
步骤(1)中,水煎煮的具体操作为:加入8-10倍(g/ml)的水进行第一次煎煮,煎煮时间为1-2h,滤过,药渣中再加入6-8倍(g/ml)的水进行第二次煎煮,煎煮时间为1-2h。
步骤(1)中,干燥采用真空干燥或冷冻干燥。
步骤(1)中,粉碎后过100目筛。
本发明的中药组合物可以进一步的与药学上可接受的辅料混合,制成各种药物剂型,如外用膏剂、胶囊剂、片剂、颗粒剂、栓剂等。
药学上可接受的辅料为药物制剂中的常规辅料,如崩解剂、润滑剂、粘合剂等;但本发明中药学上可接受的辅料并不局限于此,本领域技术人员认为可行的常规辅料均在本发明的保护范围之内,本发明在此不做限定。
本发明的有益效果:
本发明的中药组合物充分发挥了各原料药自身特有的性能和功效,兼顾了彼此间的互补作用;配伍合理相宜,药效相辅相成,各原料药按配方比例组合后,具有协同增效的作用,可使中药组合物的疗效得以显著提高。可应用于血管通路-自体动静脉内瘘反复穿刺治疗后导致局部皮肤硬结的治疗,见效快、疗效好,且对患者身体无副作用。经药效学试验证明,使本发明的中药组合药物后,穿刺处皮肤硬化状况得到明显的改善,有效延长了血管通路的使用时间。
具体实施方式
下面通过具体实例对本发明进行进一步的阐述,应该说明的是,下述说明仅是为了解释本发明,并不对其内容进行限定。
实施例1:一种治疗维持性血液透析患者动静脉内瘘穿刺处皮肤硬结的中药组合物:
配方:积雪草20克,芦荟20克,凌霄花15克,桑白皮15克,柏子仁12克,黄芩15克,川芎13克,当归12克,瓜蒌皮12克,广枣10克,红参10克,莲子心8克,竹节参8克,酸枣仁8克,罗布麻叶5克,灯盏细辛4克,合欢皮4克,郁金6克,竹茹4克,冬凌草4克,川木通4克,紫苏叶4克。
制备方法:
(1)将积雪草、芦荟、桑白皮、柏子仁、黄芩、川芎、当归、瓜蒌皮、广枣、红参、莲子心、竹节参、酸枣仁、灯盏细辛、郁金、竹茹、冬凌草和川木通混合,加水煎煮两次,滤过(第一次加8倍量水,煎煮2小时;第二次加6倍量水,煎煮1.5小时),合并滤液,浓缩至相对密度为1.2(50℃)的浸膏,80℃减压干燥,粉碎,过100目筛,备用;
(2)将凌霄花、合欢皮、罗布麻叶和紫苏叶粉碎,过100目筛,然后与中药浸膏粉末混合,即得。
实施例2:一种治疗维持性血液透析患者动静脉内瘘穿刺处皮肤硬结的中药组合物:
配方:积雪草10克,芦荟20克,凌霄花10克,桑白皮20克,柏子仁10克,黄芩15克,川芎10克,当归15克,瓜蒌皮10克,广枣12克,红参8克,莲子心10克,竹节参5克,酸枣仁10克,罗布麻叶3克,灯盏细辛6克,合欢皮3克,郁金8克,竹茹3克,冬凌草5克,川木通3克,紫苏叶5克。
制备方法同实施例1。
实施例3:一种治疗维持性血液透析患者动静脉内瘘穿刺处皮肤硬结的中药组合物:
配方:积雪草20克,芦荟10克,凌霄花20克,桑白皮10克,柏子仁15克,黄芩10克,川芎15克,当归10克,瓜蒌皮15克,广枣8克,红参12克,莲子心5克,竹节参10克,酸枣仁5克,罗布麻叶6克,灯盏细辛3克,合欢皮6克,郁金4克,竹茹5克,冬凌草3克,川木通5克,紫苏叶3克。
制备方法同实施例1,不再赘述。
临床资料:
为验证本发明实施例制备的中药组合物对维持性血液透析患者动静脉内瘘穿刺处皮肤硬结的治疗效果,选择200例由于维持性血液透析患者动静脉内瘘穿刺处皮肤硬结的患者进行临床观察。
1.临床资料:
2012年至2014年来院就诊的维持性血液透析患者动静脉内瘘穿刺处皮肤硬结的患者200例,将其随机分为治疗1组、治疗2组、治疗3组和对照组,每组50例,四组的年龄、性别等无显著差异。
2.治疗方法:
试验组I:使用本发明实施例1制备的中药组合物,按常规方法制备成外用软膏剂,每日2次,每次2~3ml,患处直接给药。
试验组II:使用本发明实施例2制备的中药组合物,按常规方法制备成外用软膏剂,使用方法同试验组I。
试验组III:使用本发明实施例3制备的中药组合物,按常规方法制备成外用软膏剂,使用方法同试验组I。
对照组:患处涂敷喜疗妥,按说明书使用。
观察期间停用一切药物,嘱患者注意饮食,忌辛辣,四组均以15天为1疗程,治疗2个疗程后统计结果。
4.疗效评定标准:
有效:穿刺处皮肤硬结软化,恢复自然肤色,皮肤恢复弹性。
无效:穿刺处皮肤硬结无改变软化,甚至加重。
5.治疗结果:
经治疗观察后,结果见表1。
表1临床治疗结果
病例 | 病例数 | 有效 | 无效 | 总有效率(%) |
试验组I | 50 | 47 | 3 | 94 |
试验组II | 50 | 45 | 5 | 90 |
试验组III | 50 | 46 | 4 | 92 |
对照组 | 50 | 40 | 10 | 80 |
由表1可以看出,与现有药物相比,本发明的中药组合物对维持性血液透析患者动静脉内瘘穿刺处皮肤硬结的治疗效果更为显著。临床应用过程中,各治疗组均未出现毒、副作用,说明本发明的中药组合物安全有效。
以上所述,仅为本发明较佳的具体实施方式,但本发明的保护范围并不局限于此,任何熟悉本技术的技术人员在本发明批露的技术范围内,根据本发明的技术方案及其发明构思加以等同替换或改变,都应涵盖在本发明的保护范围之内。
Claims (8)
1.一种治疗维持性血液透析患者动静脉内瘘穿刺处皮肤硬结的中药组合物,其特征在于,由以下重量份的原料药制成:
积雪草10-20份,芦荟10-20份,凌霄花10-20份,桑白皮10-20份,柏子仁10-15份,黄芩10-15份,川芎10-15份,当归10-15份,瓜蒌皮10-15份,广枣8-12份,红参8-12份,莲子心5-10份,竹节参5-10份,酸枣仁5-10份,罗布麻叶3-6份,灯盏细辛3-6份,合欢皮3-6份,郁金4-8份,竹茹3-5份,冬凌草3-5份,川木通3-5份,紫苏叶3-5份。
2.如权利要求1所述的中药组合物,其特征在于,由以下重量份的原料药制成:
积雪草20份,芦荟20份,凌霄花15份,桑白皮15份,柏子仁12份,黄芩12份,川芎13份,当归12份,瓜蒌皮12份,广枣10份,红参10份,莲子心8份,竹节参8份,酸枣仁8份,罗布麻叶5份,灯盏细辛4份,合欢皮4份,郁金6份,竹茹4份,冬凌草4份,川木通4份,紫苏叶4份。
3.权利要求1或2所述的中药组合物在制备治疗维持性血液透析患者动静脉内瘘穿刺处皮肤硬结的药物制剂中的应用。
4.权利要求1或2所述的中药组合物的制备方法,其特征在于,步骤如下:
1)将积雪草、芦荟、桑白皮、柏子仁、黄芩、川芎、当归、瓜蒌皮、广枣、红参、莲子心、竹节参、酸枣仁、灯盏细辛、郁金、竹茹、冬凌草和川木通,混合,加水煎煮两次,合并滤液,滤液浓缩至相对密度为1.1-1.3(50℃测),干燥,粉碎,过筛,得中药浸膏粉末;
(2)将凌霄花、合欢皮、罗布麻叶和紫苏叶粉碎,过筛,然后与中药浸膏粉末混合,即得。
5.如权利要求4所述的制备方法,其特征在于,步骤(1)中,水煎煮的具体操作为:加入8-10倍(g/ml)的水进行第一次煎煮,煎煮时间为1-2h,滤过,药渣中再加入6-8倍(g/ml)的水进行第二次煎煮,煎煮时间为1-2h。
6.如权利要求4所述的制备方法,其特征在于,步骤(1)中,干燥采用真空干燥或冷冻干燥。
7.一种治疗维持性血液透析患者动静脉内瘘穿刺处皮肤硬结的药物制剂,其特征在于,该药物制剂以权利要求1或2所述的中药组合物为活性成分。
8.如权利要求7所述的药物制剂,其特征在于,该药物制剂的剂型为外用膏剂、胶囊剂、片剂、颗粒剂或栓剂。
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Application publication date: 20160615 |
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