CN102698086B - 一种治疗褥疮蕴毒腐溃证的中药乳剂 - Google Patents
一种治疗褥疮蕴毒腐溃证的中药乳剂 Download PDFInfo
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Abstract
本发明公开了一种治疗褥疮蕴毒腐溃证的中药乳剂，属中药制剂，它是由以下重量份的中草药制成：(鲜)落地生根30-50份，(鲜)小蓟10-20份，益母草6-12份，黄芪8-16份，血竭2-4份，乳香2-4份，儿茶2-4份，白及2-4份，海螵蛸4-8份，甘草4-8份。本发明疗效好、见效快、使用方便、治疗成本低、愈后不留疤痕，是治疗褥疮的首选药物，适合医院及家庭治疗褥疮使用。
Description
技术领域
本发明涉及医药，特别是涉及中药制剂。
褥疮又称席疮，是局部软组织长期受压导致血液循环障碍，组织细胞缺血、缺氧引起的局部组织坏死、皮肤溃疡所致，是临床常见的并发症之一。本病愈合差，治疗时间长，护理难度大，至今仍是护理学领域的难题。目前治疗方法较多，如手术治疗常采用带蒂皮瓣移植术[1]，现代医学常以甲硝唑、碘酊、呋喃类抗炎药治疗为主[2]，但对于溃疡面积大、创面深、伴有微生物混合感染经综合抗炎治疗效果不佳的病例仍然多见。老年人或不宜手术的重度患者，易引起全身感染，甚至导致死亡。中成药治疗有膏剂、洗剂等，如湿润烧伤膏[3]、三黄浸泡液[4]等，公开号为CN1463740A的中国专利由蛋黄油、核桃油、芝麻油制成，该制剂对疮面有保护作用，有利于肉芽组织的生长，对轻度褥疮有一定疗效，但对褥疮已经溃烂，腐肉及脓水较多的蕴毒腐溃证病例疗效欠佳。
发明内容
本发明的目的在于提供一种疗效好、见效快、使用方便、治疗成本低、愈后不留疤痕的治疗褥疮蕴毒腐溃证的中药乳剂。
为达到以上目的，本发明所采用的技术方案是：该一种治疗褥疮蕴毒腐溃证的中药乳剂，其特征在于由以下重量份的中草药制成：(鲜)落地生根30-50份，(鲜)小蓟10-20份，益母草6-12份，黄芪8-16份，血竭2-4份，乳香2-4份，儿茶2-4份，白及2-4份，海螵蛸4-8份，甘草4-8份。
本发明的优选方案是：该一种治疗褥疮蕴毒腐溃证的中药乳剂，其特征在于由以下重量份的中草药制成：(鲜)落地生根40份，(鲜)小蓟15份，益母草9份，黄芪12份，血竭3份，乳香3份，儿茶3份，白及3份，海螵蛸6份，甘草6份。
生产方法：
称取上药，将血竭、乳香粉碎，过筛，细粉备用；将益母草、黄芪、白及、海螵蛸、甘草，用水煎法提取药液，滤过，滤液减压浓缩至在60℃下相对密度1.05-1.09，备用；将鲜落地生根和鲜小蓟压榨提取汁液，滤过，将该汁液与上述药液合并，加入儿茶、再加入上述细粉，搅拌，成为混合药液，再加入乳化剂和黑豆油，混合药液、乳化剂和黑豆油的重量比为1∶1∶2，再加入防腐剂，高速匀浆机匀浆1-3分钟，带喷雾机构的医用瓶分装，密封，即为本发明治疗褥疮蕴毒腐溃证的中药乳剂。
药物治疗作用分析：
落地生根：为景天科植物落地生根的全草或根。功用主治：凉血止血，消肿解毒；治吐血，刀伤出血，胃痛，关节炎，疮痈溃烂，烫伤。
小蓟：凉血，祛瘀，止血。治各种出血，疮疡痈肿。
益母草：活血祛瘀，消水解毒。治产后血瘀恶露，浮肿，疮疡。
黄芪：补气升阳，固表止汗，托疮排脓，利水消肿。治气虚血少，自汗，痈疽外证，久不溃脓，或溃而不收。
血竭：行瘀止痛，敛疮生肌。治外伤损扑，淤血凝滞作痛，疮疡久不收口。
乳香：活血，伸筋，消肿止痛，生肌。治血瘀胃痛，跌打损伤，疮疡久溃不收。
白及：收敛止血，消肿生肌，治咯血吐血，疮疡痈肿。
儿茶：清热收湿，敛疮止血，定痛。治疮溃久不敛，流眼，流黄水，外伤出血。
海螵蛸：止血止滞，固精，生肌祛湿。治血崩漏下，滑精早泄，胃痛吞酸，疮疡湿气。
甘草：清热解毒，调和诸药。治疮溃肿毒，调和药性。
临床报告：
1、临床资料：66例患者均符合褥疮蕴毒腐溃证辨证标准，随机分为两组，每组33例。观察组，男13例，女20例，平均年龄56.2岁；褥疮分布于枕部8处，骶尾28处，肩胛4处，平均面积为30.4cm2；对照组，男14例，女19例，平均年龄55.5岁；褥疮分布于枕部8处，骶尾29处，肩胛5处，平均面积为29.8cm2；两组患者性别、年龄、褥疮分期及溃疡面积等项指标，经统计学处理差异无显著性，具有可比性。
2.诊断依据：依据《中华人民共和国中医药行业标准——中医病证诊断疗效标准(YZ/T001.1-94)》褥疮的诊断依据，证候分类和疗效评定。
2.1.诊断依据：
2.1.1好发于尾骶、背脊、肘踝等骨突易受压迫及摩擦部位。
2.1.2初起皮肤上出现褐色红斑，微肿，继而紫暗水肿，坏死溃烂。
2.1.3继发染毒时组织坏死迅速，脓水淋漓，相应部位并发臖核疼痛。
2.1.4多见于昏迷、瘫痪、骨折、大面积烧伤等久病卧床的患者。
2.2证候分类
2.2.1蕴毒腐溃证：褥疮溃烂，腐肉及脓水较多，或有恶臭，重者溃烂可深及筋骨，四周漫肿。伴有发热或低热，口苦且干，形神萎靡，不思饮食等。舌红，苔少，脉细数。
3、治疗方法：两组均给予清创，碘伏消毒和抗生素静脉滴注。对照组合并给予局部涂抹湿润烧伤膏；观察组合并给予本发明均匀喷在疮面上，每天2-3次。
4、疗效评定：依据《中华人民共和国中医药行业标准——中医病证诊断疗效标准(YZ/T001.1-94)》褥疮的疗效评定标准。
4.1治愈：褐色红斑消退，或溃烂疮口愈合。
4.2好转：红斑未全消退，或溃烂疮面腐肉脱落，新肉生长，疮面逐渐缩小。
4.3未愈：疮口增大，溃烂不止。
5、治疗结果：观察组疗效显著优于对照组，详细情况见表1。
表1.两组患者治疗效果比较表 例(％)
| 组别 | 例数 | 治愈 | 好转 | 未愈 | 总有效 |
| 观察组 | 33 | 28(84.8) | 4(12.1) | 1(3.0) | 32(96.9) |
| 对照组 | 33 | 15(45.5) | 12(36.4) | 6(18.1) | 27(81.9) |
6、临床应用：我院应用本发明治疗褥疮蕴毒腐溃证284例，治愈241例，占84.9％，好转34例，占12.0％，总有效275例，占率96.8％。溃疡痊愈后不留疤痕或仅有严重患者留有少量轻微疤痕。治疗期间，未见与药物有关的不良反应。
本发明的有益效果
与现有技术相比具有以下优点：
1.疗效好，见效快。褥疮多因久病卧床，气血运行失畅，肌肤失养，每因摩擦皮破，染毒而成。故治疗宜以清热解毒、活血祛瘀、托疮排脓、祛湿生肌为治则。组方中落地生根、小蓟、甘草清热解毒，凉血止血；黄芪托疮排脓，利水消肿；益母草、血竭、乳香，活血祛瘀，行瘀止痛，敛疮生肌；儿茶、白及、海螵蛸敛疮，生肌祛湿，消肿定痛；甘草调和诸药药性。全方具有清热解毒、活血祛瘀、托疮排脓、祛湿生肌、消肿定痛之功效，因而疗效好、见效快。
2.使用方便。本发明为油乳制剂，只要轻轻向疮面一喷，即可完成治疗操作，避免了疮面上药给疮面带来的肉芽损伤。
3.治疗费用低。本发明所采用的中草药为常用药，市场容易采购，且药价不高，生产成本较低，可降低治疗费用。
4.疮面愈后不留疤痕。本发明由于具有活血祛瘀、排脓生肌作用，使表皮组织血供充足，促进了表皮细胞的生长。疮面痊愈后留下的疤痕主要是胶原成份异常生成和积累的结果，是纤维化形成的，黄芪具有显著的抑制成纤维细胞脱氧核糖核酸合成和细胞增生的作用，有效抑制纤维化过程，预防了疤痕的形成。
5.应用范围广。本发明适合治疗褥疮蕴毒腐溃证，也适合治疗褥疮其它证型，还适合治疗因气滞血瘀，细菌感染引起的臁疮的治疗，疮面愈合质量好，患者容易接受，适合医院及家庭治疗褥疮使用。
具体实施例
实施例1.
称取(鲜)落地生根50份，(鲜)小蓟20份，益母草6份，黄芪8份，血竭2份，乳香2份，儿茶2份，白及2份，海螵蛸4份，甘草4份。生产方法同上。用本处方生产的中药乳剂治疗褥疮蕴毒腐溃证患者80例，治愈65例，占81.3％，好转10例，占12.5％，未愈5例，占6.3％，总有效75例，占93.8％。
典型病例
刘xx，男，83岁。因脑溢血后遗症卧床并发褥疮。检查：尾骶部有4.5cm×6.0cm褥疮，呈开放性疮面。经换药，抗生素局部使用，给疮面吹氧等治疗，溃疡面改善缓慢，并有窦道形成。经彻底清创，暴露新鲜疮面，碘伏消毒后，给予本发明均匀喷在疮面上，每天2-3次。6周后疮口愈合。无疤痕形成。
实施例2.
称取(鲜)落地生根30份，(鲜)小蓟10份，益母草12份，黄芪16份，血竭4份，乳香4份，儿茶4份，白及4份，海螵蛸8份，甘草8份。生产方法同上。用本处方生产的中药乳剂治疗褥疮蕴毒腐溃证患者80例，治愈67例，占83.8％，好转9例，占11.3％，未愈4例，占5.0％，总有效76例，占95.0％。
典型病例
陈xx，女，75岁。脑梗阻后遗症并发褥疮，患者背脊部有5.0cm×6.8cm褥疮呈开放性疮面。经抗生素静脉滴注，疮面局部湿润烧伤膏治疗，疮面改善缓慢。经彻底清创，暴露新鲜疮面，碘伏消毒后，给予本发明均匀喷在疮面上，每天2-3次。5周后疮口愈合。无疤痕。
实施例3.
称取(鲜)落地生根40份，(鲜)小蓟15份，益母草9份，黄芪12份，血竭3份，乳香3份，儿茶3份，白及3份，海螵蛸6份，甘草6份。生 产方法同上。用本处方生产的中药乳剂治疗褥疮蕴毒腐溃证患者124例，治愈109例，占87.9％，好转15例，占12.1％，未愈0例，总有效124例，占100.0％。
典型病例
患者李xx，男，80岁。患者偏瘫卧床并发褥疮。检查右背部有7.5cm×6.5cm黑痣褥疮，周围红肿明显，黑痣按之有波动感，可挤压出少许脓性分泌物，褥疮面积大，坏死组织深及肌层。因患者年龄大，身体状况差，不宜行皮瓣移植术。我们对病人的状况进行了评估，调整病人的整体护理方案，对褥疮黑痣进行分次小范围的切痣清创，清除黑痣，坏死组织及液化脂肪，暴露新鲜疮面，碘伏消毒后，给予本发明均匀喷在疮面上，每天喷药2-3次。两周后疮面新生肉芽组织形成，5周后疮口愈合，无疤痕。
Claims (2)
1.一种治疗褥疮蕴毒腐溃证的中药乳剂，其特征在于由以下重量份的中草药制成：鲜落地生根30-50份，鲜小蓟10-20份，益母草6-12份，黄芪8-16份，血竭2-4份，乳香2-4份，儿茶2-4份，白及2-4份，海螵蛸4-8份，甘草4-8份。
2.权利要求1所述的一种治疗褥疮蕴毒腐溃证的中药乳剂，其特征在于由以下重量份的中草药制成：鲜落地生根40份，鲜小蓟15份，益母草9份，黄芪12份，血竭3份，乳香3份，儿茶3份，白及3份，海螵蛸6份，甘草6份。
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