CN114010704A - 用于治疗疮疡类疾病的外用中药组合物、药线及制备方法 - Google Patents
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Abstract
本发明属于外用医疗用品技术领域，具体涉及一种用于治疗疮疡类疾病的中药组合物、药线及制备方法。本发明的中药组合物是由如下重量份的组分组成的：芫花根1‑7份；羊蹄根1‑5份；木芙蓉叶1‑5份；琥珀1‑5份；壁钱炭0.1‑2份。本发明还进一步提供该中药组合物制成的中药药线。本发明的中药组合物及其制成的药线对疮疡类疾病(例如体表感染性疾病或体表包块)具有良好的治疗作用，应用前景良好。
Description
技术领域
本发明属于外用医疗用品技术领域，具体涉及一种用于治疗疮疡类疾病的外用中药组合物、药线及制备方法。
背景技术
体表感染性疾病是一种常见的感染性疾病，如肛周脓肿、肛瘘，藏毛窦、急慢性乳腺炎等，主要表现为红肿热痛，深部感染化脓可能表现为局部压痛和全身感染症状。目前国内外治疗方法包括保守抗菌治疗、手术切开引流等。临床结果表明，对于范围较小的浅部疮疡，手术切开后效果好。但是对于复杂性深部感染，单纯手术切开后常常存在引流不畅，形成慢性窦道、复发、不愈合、愈合后瘢痕巨大等并发症。现有的引流方法(如油纱引流、橡皮引流)存在效果差、功效单一等缺点。而一些抗菌或新型材料如藻酸盐等价格昂贵，使用成本高。因此目前本领域急需具有复合功效的用于体表感染性疾病的产品。
体表包块如疣、内痔等，目前治疗以切除为主，其中内痔结扎术是目前针对内痔、混合痔内痔部分的主流手术方式，但目前主要采用的是丝线结扎和胶圈套扎，胶圈套扎价格昂贵，且无论是胶圈套扎还是丝线结扎都存在痔疮脱落期大出血，脱落后创面感染，瘢痕形成过大，肛门直肠狭窄等。
针对上述体表感染性疾病或体表包块的治疗，中医药特别是中医外治在治疗这类疾病方面优势明显。通过将中药活性成分附着在用于引流或结扎的丝线上，能够有效发挥药物的药效，从而产生抗菌、促进愈合、防止感染和减小愈合后的瘀痕等效果。中国发明专利申请“CN112472762A一种疮疡类疾病治疗用中药药线及该药线制备方法”公开了一种用于治疗疮疡类疾病的药线，其采用如下药物组合物制备：芫花根8～4份、鸦胆子仁5～1份、巴豆仁5～1份、壁钱炭5～1份、荆芥炭5～1份、血竭8～4份。然而，该中药组合物中采用的芫花、鸦胆子、巴豆仁均具有一定腐蚀作用，全方腐蚀作用过强，临床应用中毒副作用偏大。另外该中药组合物缺少清热抗炎药物，对于感染性疾病疗效有待改进。采用该药物组合物治疗感染性疾病，切开引流后，遗留创面及瘢痕较大影响面部和体表的美观以及局部的功能。因此，针对体表感染性疾病或体表包块的治疗，仍然有必要开发其他种类的中药组合物及其制成的药线。
发明内容
针对现有技术的缺陷，本发明的目的在于提供一种用于体表感染性疾病或体表包块的治疗的中药组合物及其制成的药线。
一种用于治疗疮疡类疾病的外用中药组合物，它是由如下重量份的原料制成：芫花根1-7份、羊蹄根1-5份、木芙蓉叶1-5份、琥珀1-5份、壁钱炭0.1-2份。
优选的，它是由如下重量份的原料制成：芫花根2-6份、羊蹄根1-4份、木芙蓉叶1-4份、琥珀1-4份、壁钱炭0.1-1份。
优选的，它是由如下重量份的原料制成：芫花根4份、羊蹄根2份、木芙蓉叶2份、琥珀2份、壁钱炭0.5份。
本发明还提供上述中药组合物在制备用于治疗体表感染性疾病或体表包块的药线中的用途。
本发明还提供以上述中药组合物和丝线为原料制备的药线。
优选的，所述药线是将中药组合物或其活性成分附着在丝线上制成的。
本发明还提供上述药线的制备方法，包括如下步骤：
步骤1，将芫花根、羊蹄根、木芙蓉叶和丝线在水中浸泡、煎煮和浓缩，捞出丝线；
步骤2，将琥珀细末和壁钱炭细末附着在经过步骤1处理的丝线上，即得。
优选的，步骤1中，芫花根、羊蹄根和木芙蓉叶的总重量与水的体积比例为1g:10-12ml。
优选的，步骤1中，所述芫花根为醋制的芫花根。醋制的方法为：将芫花根、醋和清水按1：0.2～0.4：2～5的重量比例混合；文火熬干后，炒至微干。
优选的，步骤1中，所述羊蹄根为醋制的羊蹄根。醋制的方法为：将羊蹄根、醋和清水按1：0.2～0.4：2～5的重量比例混合；文火熬干后，炒至微干。
本发明提供的中药组合物及其制成的药线作外用，祛腐解毒，逐脓止血，收敛生肌(加快坏死组织液化、协助引流，减轻炎症和促进伤口愈合)功能，使其具备祛腐解毒，止血生肌，缩减瘢痕(加快坏死组织坏死液化、减轻炎症、引流止血和促进伤口愈合和减少瘢痕)功能，用于体表感染性疾病(如肛周脓肿、急慢性乳腺炎)和体表包块(如疣、痔)结扎。本发明的中药成分功效如下：
芫花根：辛、苦，温，逐水；解毒；散结，主治水肿、瘰疬、乳痈、痔痿、疥疮、治风湿筋骨痛、跌打损伤。芫花根散结，有一定腐蚀作用，加快坏死组织液化，逐水可引流瘘道里的脓液(分泌物)，解毒可减轻炎症为君药。芫花水提物可以有效减轻局部炎症反应，促进肛瘘创面愈合及镇痛。
羊蹄根：苦、寒，归经心、肝、大肠经，功能主治清热通便；凉血止血；杀虫止痒。《滇南本草图说》：晒干为末，敷马刀，石痈，疔毒，癣疮，疥癞，痈疽，瘘疬等症，用醋为使，破烂用油调搽。现代研究羊蹄中含有多种生物活性成份，起主要作用的是葱酮类，如大黄酸、大黄素、大黄酚、大黄素甲醚、大黄酚葱酮、大黄素葱酮等，主要具备比较强的抗菌活性和止血作用。
木芙蓉叶：辛，平；归肺、肝经。功能主治：凉血，解毒，消肿，止痛。治痈疽域肿，缠身蛇丹，烫伤，目赤肿痛，跌打损伤。《本草纲目》：“木芙蓉花并……其方治一切痈疽发背，乳痈恶疮，不拘已成未成，已穿未穿，并用芙蓉叶，初起者，即觉清凉，痛止肿消。已成者，即脓聚毒出。”本方用于体表感染性疾病，消肿解毒、止痛，无论是初期还是溃后均可使用。
琥珀：甘；平；无毒，归经心；肝；小肠经；膀胱；肺；脾经。功能主治镇惊安神；散瘀止血；利水通淋；去翳明目。主惊悸失眠；惊风癫痫；血淋血尿；血滞经闭；产后瘀滞腹痛；症瘕积聚；目生障翳；痈肿疮毒。外用：研末点、撒。《本经逢原》：琥珀，消磨渗利之性，又研细敷金疮，则无瘢痕，亦散血消瘀之验。”有研究发现琥珀敛疮膏对家兔皮肤慢性溃疡的溃疡缩小作用和溃疡面平均愈合时间优于西药对照组。琥珀具有促进伤口愈合和缩小瘢痕的作用。
壁钱炭：咸，平，清热解毒；定惊；止血，治喉痹，牙疳，鼻衄，痔疮下血，金疮出血，《日华子本事》："治小儿吐逆。敷瘘疮。"烧炭存性后止血药效更加。
全方以芫花根为君药，祛腐引流，抗炎促愈止痛，羊蹄根和木芙蓉叶加强抗炎效果，共为臣药，琥珀生肌促愈，缩减瘢痕，壁钱炭止血为佐使药。
5味药共凑祛腐解毒，止血生肌，缩减瘢痕的作用，对于体表感染性疾病急性期和慢性窦道形成的各个阶段具有良好的治疗效果。
显然，根据本发明的上述内容，按照本领域的普通技术知识和惯用手段，在不脱离本发明上述基本技术思想前提下，还可以做出其它多种形式的修改、替换或变更。
以下通过实施例形式的具体实施方式，对本发明的上述内容再作进一步的详细说明。但不应将此理解为本发明上述主题的范围仅限于以下的实例。凡基于本发明上述内容所实现的技术均属于本发明的范围。
具体实施方式
本发明实施例、实验例中所用试剂和材料无特别说明的均为市售品。
实施例1一种用于治疗体表感染性疾病或体表包块的药线
本实施例中采用如下原料制成药线：芫花根4g、羊蹄根2g、木芙蓉叶2g、琥珀2g、壁钱炭0.5g以及医用丝线0.8g。
具体制备方法为：
(1)药物的准备：芫花根醋制(将芫花根、醋和清水按1：0.3：4的重量比例混合；文火熬干后，炒至微干)；同法将羊蹄根醋制，琥珀、壁钱炭研细末备用；
(2)浸泡煎煮药线：将醋制的芫花根、醋制的羊蹄根、木芙蓉叶放入非金属容器中，按照1ml:10g(v:w)的比例加入蒸馏水，加入医用丝线，一起室温浸泡24小时后，文火煎煮至药液将干但仍有水液时将医用丝线捞出；
(3)将已经研磨好的琥珀、壁钱炭细末和上述处理后的医用丝线放入容器中，充分均匀搅拌，使药物粉末附着于医用丝线上，即得中药药线；
(4)中药药线经紫外线照射消毒后独立真空包装。
为了进一步说明本发明的技术方案，下面通过实验例对本发明的有益效果作进一步的说明。
实验例1应用实例
(1)肛周脓肿的治疗
中药药线组：采用实施例1制备的中药药线治疗肛周脓肿，共15例。
对照中药药线1组：采用对照组方(芫花根6g、鸦胆子仁3g、巴豆仁3g、壁钱炭3g、荆芥炭3g、血竭6g)按照实施例1的方法制成中药药线，将其用于治疗肛周脓肿，共15例。
对照中药药线2组：采用对照组方(芫花根2g、羊蹄根2g、木芙蓉叶2g、琥珀2g)按照实施例1的方法制成中药药线，将其用于治疗肛周脓肿，共15例。
药线使用方法：肛周脓肿多切口之间挂药线：多个间隙的肛周脓肿做多个放射状切口或弧形切口，切口之间若需引流，以弯钳自一个切口探入，自另一切口探出，轻柔将药线引入两切口之间，打结系上，作虚挂线，3-5天后引流物明显减少，肉芽新鲜既拆除丝线。对照组挂线方式相同，使用照中药药线1组或对照中药药线2组的药线挂线。创面愈合时间和VAS术后疼痛评分结果如表1所示。
表1：试验组的切口愈合时间
可以看出中药药线组术后切口愈合时间较对照中药药线1组和对照中药药线2组均明显缩短。而在术后疼痛评分中，中药药线组同样优于对照中药药线1组和对照中药药线2组。可见，采用本发明提供的中药组合物制成药线后，对肛周脓肿具有更好的治疗效果。
(2)采用实施例1制备的中药药线用于混合痔内痔部分结扎和单纯内痔结扎术。两组各20例，两组术前准备，手术操作及术后治疗护理均相同。药线使用方法：试验组使用本发明中药药线结扎内痔，对照组使用普通市售医用丝线结扎内痔。结果如表2所示。
表2：治疗结果
试验组可以有效缩短创面愈合时间，减少痔脱落期出血的发生率。
通过上述实施例和实验例可以看到，本发明提供的中药组合物及其制成的药线对疮疡类疾病(例如体表感染性疾病或体表包块)具有良好的治疗作用，应用前景良好。
Claims (10)
1.一种用于治疗疮疡类疾病的外用中药组合物，其特征在于，它是由如下重量份的原料制成：芫花根1-7份、羊蹄根1-5份、木芙蓉叶1-5份、琥珀1-5份、壁钱炭0.1-2份。
2.按照权利要求1所述的中药组合物，其特征在于，它是由如下重量份的原料制成：芫花根2-6份、羊蹄根1-4份、木芙蓉叶1-4份、琥珀1-4份、壁钱炭0.1-1份。
3.按照权利要求2所述的中药组合物，其特征在于，它是由如下重量份的原料制成：芫花根4份、羊蹄根2份、木芙蓉叶2份、琥珀2份、壁钱炭0.5份。
4.如权利要求1-3任一项所述的中药组合物在制备用于治疗体表感染性疾病或体表包块的药线中的用途。
5.以权利要求1-3任一项所述的中药组合物和丝线为原料制备的药线。
6.按照权利要求4所述的药线，其特征在于：所述药线是将中药组合物或其活性成分附着在丝线上制成的。
7.权利要求5或6所述的药线的制备方法，其特征在于，包括如下步骤：
步骤1，将芫花根、羊蹄根、木芙蓉叶和丝线在水中浸泡、煎煮和浓缩，捞出丝线；
步骤2，将琥珀细末和壁钱炭细末附着在经过步骤1处理的丝线上，即得。
8.按照权利要求7所述的制备方法，其特征在于：步骤1中，芫花根、羊蹄根和木芙蓉叶的总重量与水的体积比例为1g:10-12ml。
9.按照权利要求7所述的制备方法，其特征在于：步骤1中，所述芫花根为醋制的芫花根。
10.按照权利要求7所述的制备方法，其特征在于：步骤1中，所述羊蹄根为醋制的羊蹄根。
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