CN117414398A - 一种中药组合物及其在治疗脉管炎中的用途 - Google Patents
一种中药组合物及其在治疗脉管炎中的用途 Download PDFInfo
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Abstract
本发明涉及一种中药组合物及其在治疗脉管炎中的用途,属于中药技术领域。本发明所述中药组合物,以重量份计,含有以下组分:鸡血藤30‑60份、花椒20‑50份、蜈蚣3‑10份、水蛭1‑5份、没药5‑15份、淮小麦5‑20份、黄芪5‑15份、黄柏5‑20份、金银花10‑30份、玄参5‑15份、海风藤5‑10份。本发明中药组合物对周围血管病,尤其是血栓闭塞性脉管炎具有较好的治疗作用,临床治疗有效率可达93%以上,可明显改善患者患肢麻木、疼痛等临床症状,减轻患者痛苦。
Description
技术领域
本发明属于中药技术领域,涉及一种中药组合物及其在治疗脉管炎中的用途。
背景技术
临床上将心脑血管病以外的血管疾病统称为周围血管病,包括动脉、静脉及淋巴三个系统的疾病。据世界卫生组织调查,周围血管疾病是一种危害性极强的高发病种,若长期不愈,病情将呈进行性发展,重者将导致截肢致残,甚至危及生命。
生活中常见的周围血管病有:血栓闭塞性脉管炎、动脉硬化闭塞症、血栓性静脉炎等。其中血栓闭塞性脉管炎简称脉管炎,发病年龄一般在20~45岁之间,多发于小腿及足部,发病初期患肢明显发凉、怕冷、麻木或针刺样疼痛,行走时足底有垫物感。肢体易疲劳,行走一段距离后被迫停止行走,休息片刻,才能继续行走,该症状在临床上叫间歇性跛行。中期患肢疼痛加重,动脉搏动消失、表面皮肤粗糙且成红紫或变白、汗毛脱落、趾甲增厚变形、肌肉萎缩。后期出现感染溃疡,指(趾)坏死,形成“脱骨疽”。
中医学认为血栓闭塞性脉管炎致病因素中,外因包括感受寒湿之邪,饮食不节,外伤染毒等,内因由于先天禀赋不足,脾肾阳衰,肝肾亏虚,情志内伤,使经脉痹阻不通而成。寒主收引,经脉受寒则痉挛收缩,血得寒则凝。受寒之后,阳气不能到达四肢,导致血液流通不畅而瘀滞不通,不通则痛,病久气血两虚,四肢气血失于濡养而致。《素问痹论》指出“痛者,寒气多也,有寒故痛也”。《素问举痛论》日:“寒气人经而稽迟,泣而不行,客于脉外则血少,客于脉中则气不通,故卒然而痛”。该病后期有损伤筋骨、气血两虚的病理的特点,病变发生主要在血脉,多见于青壮年男性患者。
本病的病理机制主要是气血凝滞,血脉阻塞。《灵枢·痈疽篇》提出:“营卫稽留于经脉之中,则血泣而不行,不行则卫气从之而不通,壅遏而不得行”。刘惠洁认为,血脉瘀阻在本病的发病过程中起主导作用。总之,其病理机制主要可归纳为:寒湿阻络、血脉瘀阻、湿热下注、热毒炽盛、气血两虚。
血栓闭塞性脉管炎起病急、进展快、病情重、预后相对差。西医治疗以缓解症状为目的,远期效果不太理想,患者截肢率较高。中医在辨证治疗方面,因针对不同患者正确分期论治,准确辨证选药,有虚者则补之,有邪者则祛之,值得临床借鉴。
发明内容
本发明的主要目的在于提供一种新的中药组合物,该中药组合物对周围血管病,尤其是血栓闭塞性脉管炎具有较好的治疗作用,临床治疗有效率较高,可明显改善患者临床症状,减轻患者痛苦。
本发明采用了以下技术方案来实现上述目的:
一种中药组合物,以重量份计,含有以下组分:
鸡血藤30-60份、花椒20-50份、蜈蚣3-10份、水蛭1-5份、没药5-15份、淮小麦5-20份、黄芪5-15份、黄柏5-20份、金银花10-30份、玄参5-15份、海风藤5-10份;
进一步的,所述的中药组合物以重量份计,含有以下组分:
鸡血藤45-55份、花椒30-45份、蜈蚣5-8份、水蛭1-5份、没药5-10份、淮小麦8-15份、黄芪10-15份、黄柏8-15份、金银花15-25份、玄参8-12份、海风藤5-8份;
具体的,所述的中药组合物以重量份计,含有以下组分:
鸡血藤50份、花椒40份、蜈蚣6份、水蛭3份、没药8份、淮小麦10份、黄芪10份、黄柏10份、金银花20份、玄参10份、海风藤6份。
本发明提供上述中药组合物的具体用途,即所述的中药组合物在制备治疗周围血管病药物中的用途;
进一步的,所述的周围血管病为血栓闭塞性脉管炎。
本发明提供了由上述中药组合物制备而成的中药制剂,所述的中药制剂是由上述中药组合物直接或加入辅料后制备而成。
进一步的,上述中药制剂可以是口服固体制剂和/或口服液体制剂。
更进一步的,上述口服固体制剂为片剂、胶囊剂、丸剂、颗粒剂等;口服液体制剂为汤剂、口服液、糖浆剂、合剂等。
本发明具有以下有益效果:
1.本发明中药组合物中鸡血藤舒筋活络、行气,花椒温中止痛,二者共为君药;蜈蚣息风镇痉、通络止痛,水蛭破血通经、逐瘀消癥,没药活血止痛、散血祛瘀,搭配淮小麦,工位臣药;黄芪利水消肿,行滞通痹,治疗痹痛麻木、痈疽难溃、久溃不敛,黄柏清热燥湿,解毒疗疮,金银花清热解毒,用于痈肿疔疮、热毒血痢,玄参清热凉血、解毒散结,用于热入营血、温毒发斑、痈肿疮毒,共为佐药;海风藤祛风湿、通经络、止痹痛,用于风寒湿痹、肢节疼痛,为方中之使药,各药味相互协作,共奏祛湿寒、通经络、止痛之功效。
2.本发明中药组合物为本院治疗周围血管病的临床经验方,对周围血管病,尤其是血栓闭塞性脉管炎具有较好的治疗作用,临床治疗有效率可达93%以上,可明显改善患者患肢麻木、疼痛等临床症状,减轻患者痛苦。
3.本发明中药组合物经药效学实验进一步证实,对血栓闭塞性脉管炎模型大鼠具有较好的治疗作用,可以明显改善大鼠患肢病变情况,调节炎症因子等含量。
附图说明
图1:药效试验中各组大鼠血浆中IL-6含量
图2:药效试验中各组大鼠血浆中TNF-α含量
图3:药效试验中各组大鼠血浆中CRP含量
图4:药效试验中各组大鼠血浆中NO含量
具体实施方式
下面结合具体实施例进一步阐明本发明,应理解这些实施例仅用于说明本发明而不用于限制本发明的范围,在阅读了本发明之后,本领域技术人员对本发明的各种等价形式的修改均落于本申请权利要求所保护的范围。
实施例1丸剂制备
处方:鸡血藤50g、花椒40g、蜈蚣6g、水蛭3g、没药8g、淮小麦10g、黄芪10、黄柏10g、金银花20g、玄参10g、海风藤6g。
以上11味,加水煎煮2次,每次1小时,合并煎煮液,过滤,滤液浓缩成清膏,干燥,粉碎,加入适量辅料,用乙醇和大豆油制作软材,制丸,干燥,即得丸剂,每丸重约1.5g。
实施例2丸剂制备
处方:鸡血藤55g、花椒30g、蜈蚣8g、水蛭1g、没药10g、淮小麦8g、黄芪15g、黄柏8g、金银花25g、玄参8g、海风藤8g;
以上11味,加水煎煮2次,每次1小时,合并煎煮液,过滤,滤液浓缩成清膏,干燥,粉碎,加入适量辅料,用乙醇和大豆油制作软材,制丸,干燥,即得丸剂,每丸重约1.5g。
实施例3丸剂制备
处方:鸡血藤30g、花椒50g、蜈蚣3g、水蛭5g、没药5g、淮小麦20g、黄芪5、黄柏20g、金银花10g、玄参15g、海风藤5g;
以上11味,加水煎煮2次,每次1小时,合并煎煮液,过滤,滤液浓缩成清膏,干燥,粉碎,加入适量辅料,用乙醇和大豆油制作软材,制丸,干燥,即得丸剂,每丸重约1.5g。
实施例4颗粒剂制备
处方:鸡血藤45g、花椒45g、蜈蚣5g、水蛭5g、没药5g、淮小麦15g、黄芪10g、黄柏15g、金银花15g、玄参12g、海风藤5g;
以上11味,加水煎煮2次,每次1小时,合并煎煮液,过滤,滤液浓缩至相对密度为1.10~1.30(60~65℃)的清膏,加入糊精、预胶化淀粉、甜菊素,流化床制粒,干燥,即得颗粒剂。
实施例5片剂制备
处方:鸡血藤60g、花椒20g、蜈蚣10g、水蛭1g、没药15g、淮小麦5g、黄芪15、黄柏5g、金银花30g、玄参5g、海风藤10g;
以上11味,加水煎煮2次,每次1小时,合并煎煮液,过滤,滤液浓缩至相对密度为1.10~1.20(60~65℃)的稠膏,干燥成干膏,加入适量蔗糖、淀粉混匀,制粒,干燥,加入1%的硬脂酸镁,混匀,压片,包薄膜衣,即得片剂。
实施例6胶囊剂制备
处方:鸡血藤50g、花椒40g、蜈蚣6g、水蛭3g、没药8g、淮小麦10g、黄芪10、黄柏10g、金银花20g、玄参10g、海风藤6g。
以上11味,加水煎煮2次,每次1小时,合并煎煮液,过滤,滤液浓缩至相对密度为1.10~1.30(60~65℃)的清膏,干燥,得干膏粉,加入适量淀粉,混匀,装入胶囊即得胶囊剂。
实施例7口服液制备
处方:鸡血藤55g、花椒30g、蜈蚣8g、水蛭1g、没药10g、淮小麦8g、黄芪15g、黄柏8g、金银花25g、玄参8g、海风藤8g;
以上11味,加水煎煮2次,每次1小时,合并煎煮液,过滤,滤液浓缩成清膏,干燥,粉碎,加入适量辅料,用乙醇和大豆油制作软材,制丸,干燥,即得丸剂。
实施例8汤剂制备
处方:鸡血藤30g、花椒50g、蜈蚣3g、水蛭5g、没药5g、淮小麦20g、黄芪5、黄柏20g、金银花10g、玄参15g、海风藤5g;
对比实施例1丸剂制备
处方:白藤50g、花椒40g、蜈蚣6g、水蛭3g、没药8g、淮小麦10g、黄芪10、黄柏10g、金银花20g、玄参10g、海风藤6g。
以上11味,加水煎煮2次,每次1小时,合并煎煮液,过滤,滤液浓缩成清膏,干燥,粉碎,加入适量辅料,用乙醇和大豆油制作软材,制丸,干燥,即得丸剂,每丸重约1.5g。
对比实施例2丸剂制备
处方:鸡血藤50g、花椒40g、蜈蚣6g、水蛭3g、没药8g、淮小麦10g、黄芪10、黄柏10g、金银花20g、玄参10g、枳实6g。
以上11味,加水煎煮2次,每次1小时,合并煎煮液,过滤,滤液浓缩成清膏,干燥,粉碎,加入适量辅料,用乙醇和大豆油制作软材,制丸,干燥,即得丸剂,每丸重约1.5g。
对比实施例3丸剂制备
处方:鸡血藤50g、花椒40g、全蝎9g、没药8g、淮小麦10g、黄芪10、黄柏10g、金银花20g、玄参10g、海风藤6g。
以上11味,加水煎煮2次,每次1小时,合并煎煮液,过滤,滤液浓缩成清膏,干燥,粉碎,加入适量辅料,用乙醇和大豆油制作软材,制丸,干燥,即得丸剂,每丸重约1.5g。
对比实施例4丸剂制备
处方:鸡血藤90g、蜈蚣6g、水蛭3g、没药8g、淮小麦10g、黄芪10、黄柏10g、金银花20g、玄参10g、海风藤6g。
以上11味,加水煎煮2次,每次1小时,合并煎煮液,过滤,滤液浓缩成清膏,干燥,粉碎,加入适量辅料,用乙醇和大豆油制作软材,制丸,干燥,即得丸剂,每丸重约1.5g。
临床应用
1资料与方法
1.1一般资料
病例来源于本院收治的患者62例,均以血管闭塞性脉管炎为临床诊断,随机分为试验组和对照组,每组31例,两组患者性别、年龄、病程等资料无差异性(P>0.05)。
1.2诊断标准
研究对象均符合《血栓闭塞性脉管炎的诊断标准》和《中药新药治疗血栓闭塞性脉管炎的研究指导原则》相关标准。
1.3治疗方法
对照组给予临床常规治疗,包括静脉推注前列地尔注射液、口服阿司匹林肠溶片和贝前列素钠片。
试验组在对照组治疗的基础上,给予本发明实施例1所制备的丸剂,一天服用2次,每次1丸。
1.4观察指标及疗效评定标准
1.4.1观察指标
观察2组患者治疗前后患者疼痛、发凉、麻木、疮面改善情况。
1.4.2疗效评定
显效:患肢疼痛消失,皮色、肤温恢复正常,疮口愈合,行走活动自如。
有效:患肢疼痛基本消失,皮色、肤温有好转,疮口范围缩小,行走活动不能持久。
无效:患肢疼痛不能控制,疮口未愈合或继续发展,行走活动受限。
总有效率(%)=(显效例数+有效例数)/患者总例数×100%
1.5统计学处理
对各组患者数据采用SPSS22.0进行统计学分析,计数资料使用卡方检验,计量资料使用t检验,以P<0.05为有显著性差异。
2结果分析
2.1治疗效果评定
两组患者的治疗效果显著,试验组和对照组治疗的总有效率分别为90.32%和83.87%,试验组明显高于对照组,可见本发明中药组合物对血栓闭塞性脉管炎具有较好的治疗效果。
表1两组患者治疗效果评定
组别 | 例数(例) | 显效(例) | 有效(例) | 无效(例) | 总有效率(%) |
对照组 | 31 | 8 | 18 | 5 | 83.87 |
试验组 | 31 | 15 | 13 | 3 | 90.32 |
2.2治疗前后症状变化
治疗后,两组患者疼痛、麻木、发凉、疮面等临床症状均得到明显的改善,其中,试验组患者整体治疗情况优于对照组。
表2两组患者患肢症状变化比较
临床使用结果显示,本发明中药组合物对血栓闭塞性脉管炎治疗效果确切,可有效改善患者患肢症状、加速疮面愈合,减轻患者临床症状,效果显著。
药效学实验
为进一步佐证本发明中药组合物治疗周围血管病,尤其是血栓闭塞性脉管炎的功效,发明人在临床使用的基础上特委托具有相关资质的第三方试验机构开展了相关的药效学试验研究。以下药效学实验中所采用的动物模型是在参考现有文献的技术上制备。
1材料
1.1动物:
Wistar大鼠,SPF级,180-220g,实验动物许可证号:SYXK(鲁)2022 0025青岛科创质量检测有限公司提供,实验前适应性饲养一周。
1.2药物、试剂
1.2.1药物
本发明实施例1、实施例2、实施例3所得丸剂
1.2.3用药剂量
0.27g/kg
2实验过程
取大鼠80只,随机分为模型组、实施例1组、实施例2组、实施例3组、对比实施例1组、对比实施例2组、对比实施例3组、对比实施例4组,每组10只。大鼠麻醉后仰卧位固定,以左下侧腹股沟为手术部位,备皮,消毒,在腹股沟中点处纵行切开,暴露股动脉鞘,游离腹壁浅动脉上端的股动脉,股动脉近心端用动脉夹阻断血流,动脉夹下方1cm处向远心端注入7g/L月硅酸钠溶液0.1mL,用医用胶封闭穿刺点,1min后股动脉无出血现象,缝合皮肤。术后消毒,防止感染。造模第二天,除模型组外,其余各组大鼠灌胃给予相应的药物,模型组灌胃给予蒸馏水,连续给药30d。
另取正常大鼠10只,股动脉注射生理盐水,灌胃给予蒸馏水,作为假手术组。
3检测指标
3.1大鼠患肢病变评分
大鼠造模后,每天观察大鼠左侧后腿变化,待药物治疗结束后进行整体评分,标准如下为:0度(整体外观没有变化);Ⅰ度(趾甲颜色出现变化);Ⅱ度(患肢出现颜色改变);Ⅲ度(患肢出现坏疽);Ⅳ度(患肢出现干化)。
3.2大鼠生化指标检测
大鼠给药治疗结束后,腹主动脉取血,测定血浆中白细胞介素-6(IL-6)、肿瘤坏死因子-α(TNF-α)、C反应蛋白(CRP)、一氧化氮(NO)含量。
4统计学处理
采用graphpadprism软件对所得数据进行统计分析,计量资料用表示。以P<0.05为差异有统计学意义。
5 结果分析
5.1 大鼠患肢病变情况
给药结束后,模型组大鼠患肢病变最为明显,80%以上大鼠出现Ⅲ度以上病变;各给药组大鼠病变程度较模型组明显减轻,其中实施例1组大鼠病变程度最轻,无大鼠出现Ⅲ度以上病变。
表3各组大鼠患肢病变情况比较(n=15)
5.2大鼠生化指标情况
与假手术组比较,模型组大鼠血浆中IL-6、TNF-α和CRP含量明显升高(P<0.05或P<0.01),NO含量明显降低(P<0.05);与模型组比较,各给药组大鼠血浆中IL-6、TNF-α和CRP含量降低,NO含量明显升高,差异有统计学意义(P<0.05或P<0.01)与对比实施例的比较具体见图1-4。
Claims (9)
1.一种中药组合物,以重量份计,含有以下组分:
鸡血藤30-60份、花椒20-50份、蜈蚣3-10份、水蛭1-5份、没药5-15份、淮小麦5-20份、黄芪5-15份、黄柏5-20份、金银花10-30份、玄参5-15份、海风藤5-10份。
2.如权利要求1所述的中药组合物,其特征在于,以重量份计,含有以下组分:
鸡血藤45-55份、花椒30-45份、蜈蚣5-8份、水蛭1-5份、没药5-10份、淮小麦8-15份、黄芪10-15份、黄柏8-15份、金银花15-25份、玄参8-12份、海风藤5-8份。
3.如权利要求1所述的中药组合物,其特征在于,以重量份计,含有以下组分:
鸡血藤50份、花椒40份、蜈蚣6份、水蛭3份、没药8份、淮小麦10份、黄芪10份、黄柏10份、金银花20份、玄参10份、海风藤6份。
4.一种权利要求1-3任一项权利要求所述的中药组合物在制备治疗周围血管病药物中的用途。
5.如权利要求4所述的用途,其特征在于,所述的周围血管病为血栓闭塞性脉管炎。
6.一种中药制剂,其特征在于,所述的中药制剂是由权利要求1-5任一项权利要求所述的中药组合物制备而成。
7.如权利要求6所述的中药制剂,其特征在于,所述的中药制剂为口服固体制剂和/或口服液体制剂。
8.如权利要求7所述的中药制剂,其特征在于,所述的口服固体制剂为片剂、胶囊剂、丸剂和颗粒剂中的一种或多种。
9.如权利要求8所述的中药制剂,其特征在于,所述的口服液体制剂为汤剂、口服液、糖浆剂和合剂中的一种或多种。
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CN101342356A (zh) * | 2008-08-29 | 2009-01-14 | 陕西东泰制药有限公司 | 一种用于淤血阻滞、脉管不通的中药制剂及其制备方法 |
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