CN116036168B - 一种用于治疗静脉炎的中药组合物及其应用 - Google Patents
一种用于治疗静脉炎的中药组合物及其应用 Download PDFInfo
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Abstract
本发明公开了一种用于治疗静脉炎的中药组合物及其应用，该中药组合物包含如下中药：黄芩20～40重量份、黄连20～40重量份、黄柏20～40重量份、大黄20～40重量份、紫草20～40重量份、丹参20～40重量份、地榆20～40重量份、地龙20～40重量份、冰片20～40重量份。该中药组合物具有清热、解毒、抗炎、凉血、祛瘀、消肿、排脓的功效，用于制备治疗静脉炎的药物可明显改善静脉炎患者的临床症状，具有较高的临床应用价值。
Description
技术领域
本发明涉及中医药技术领域，具体涉及一种用于治疗静脉炎的中药组合物及其应用。
背景技术
目前，对于浅静脉炎防治及治疗手段多样，大多采用的是中药外敷或涂擦。中医认为，静脉炎乃脉络因药石攻伐所伤，热邪湿毒外侵，以致气血瘀滞，脉络不畅，终致湿、热、瘀三者于脉道搏结，于肌肤凝聚，红、热、肿、痛诸症丛生所致，属恶脉脉痹之范畴，当以行气化瘀、活血通络为主。
现有技术中，邢菁菁等应用醋调金黄散外敷来预防化疗性静脉炎取得了良好的效果，金黄散可以祛毒解热，通络经脉，活血化瘀，止痛消肿，对血栓性静脉炎效果不错；闵燕丽等应用金黄膏防治华蟾素所致的化疗性静脉炎，金黄膏泻火解毒、凉血等，但对红肿、疼痛效果不太明显。此外，有报道应用红花注射液注射、芪柏塌渍以及复方紫草酊等中药防治静脉炎，效果都很明显，且不良反应较少；王艳芳等研究中药制剂中乳香、没药活血行气止痛、消肿生肌；冰片散热解毒、止痛生肌；大黄解毒止血、活血祛瘀；牡丹皮清热凉血、活血散瘀，此方旨在加强活血散瘀通脉，消肿定痛之功，改善血液循环，有利于静脉再通，通过外敷能显著降低静脉炎的发生率，同时降低疼痛。
但是，上述研究都针对的是静脉炎的某一体征，不会覆盖所有体征，可见中药对治疗静脉炎值得深入研究。
发明内容
针对现有技术中的上述问题，本发明的主要目的是提供一种用于治疗静脉炎的中药组合物，该中药组合物对静脉炎的发生及发展具有明显治疗作用，可以减少临床护士的工作量及医疗成本，减轻患者痛苦，提高患者的治疗质量与效果，在预防和治疗静脉炎方面具有较高的临床应用价值。
本发明的另一目的是提供上述用于治疗静脉炎的中药组合物在药物制备中的应用。
为了达到上述目的，本发明提供如下技术方案：
本发明第一方面提供一种用于治疗静脉炎的中药组合物，所述中药组合物包含如下中药：黄芩20～40重量份、黄连20～40重量份、黄柏20～40重量份、大黄20～40重量份、紫草20～40重量份、丹参20～40重量份、地榆20～40重量份、地龙20～40重量份、冰片20～40重量份。
作为优选，所述中药组合物包含如下中药：黄芩30重量份、黄连30重量份、黄柏30重量份、大黄30重量份、紫草30重量份、丹参30重量份、地榆30重量份、地龙30重量份、冰片30重量份。
本发明所用各味药材的入经、功能、主治和作用原理如下：
黄芩：黄芩又名腐肠，是多年生草本植物，具有抗菌、抗炎、抗病毒、清热燥湿、泻火清心、凉血活血的功效，对人体的作用功效多种多样。
黄连：性质偏寒，味道偏苦，可以清热解毒、除湿、活血，治疗脾胃湿热、感染性疾病，抑制反酸、治疗反流性食管炎等。
黄柏：具有燥湿清热、解毒泻火、去腐消肿的功效，其主要化学成分为黄酮类和生物碱类，具有抗菌、抗炎、抗氧化等多种药理作用。
大黄：具有泻下攻积、清热泻火、凉血解毒、逐瘀通经、利湿退黄的功效，现代药理研究表明，大黄还具有抗肿瘤、抗菌、保护心血管的作用，主要成分是蒽醌类衍生物，其能有效抑制细菌繁殖，有效清除血液和组织中的氧自由基，保护血管等。
紫草：是植物紫草的根，采收晒干即可入药，其性寒、味苦，具有清热解毒、凉血消肿、清热利湿及避孕等功效，由于紫草寒性，脾胃虚弱的病人不适合服用。
丹参：味苦，性微寒，入心、心包、肝经，有活血化瘀、调经止血、养血安神、凉血消痈的功效。
地榆：蔷薇科植物地榆或长叶地榆的干燥的根，味道苦、酸、涩，性微寒，归肝和大肠经，中医认为它有凉血止血、解毒敛疮的作用，治疗烧伤、烫伤、痈肿疮毒等。
地龙：地龙咸寒，善于清肝热，止风定惊，具有解热、镇静、抗惊厥、抗凝、抗血栓、降血压、抗炎、镇痛、平喘、增强免疫等作用。
冰片：龙脑香料植物龙脑香树的树脂中析出的天然结晶性化合物、人工合成的机制冰片以及艾纳香蒸馏结晶的加工品，性寒清热，外用具有清热、止痒、止痛、防腐、清热、生肌的作用。
综合疗效：黄芩主要功能是抗炎、抗菌、清热泻火、凉血活血；能够清热解毒、除湿活血；大黄主要功能就是泻火、凉血、解毒和祛瘀；黄柏能够泻火解毒、清热燥湿；辅以紫草凉血消肿止痛；丹参能够活血化瘀、凉血消痈；臣药中，地榆凉血止血，解毒敛疮使热毒从外而出，与君药合用，内外分消热毒之邪；佐以地龙、冰片清热止痒、止痛防腐、清热生肌、抗凝、抗炎、抗血栓、镇痛，诸药相合，共奏清热解毒、消肿止痛之功。
本发明立足于中医“治未病”理念，长期临床证明本发明前述中药组合物具有清热、解毒、抗炎、凉血、祛瘀、消肿、排脓的功效，适用于各类静脉炎的预防和治疗，中医外治成分安全，不会对患者造成不良影响。
本发明另一方面还提供上述用于治疗静脉炎的中药组合物在制备治疗静脉炎的药物中的应用。
作为优选，所述中药组合物的有效成分经过提取后的混合物制备为一种药学上可接受的药物制剂，所述药物制剂包含上述中药组合物的提取物和药学上可以接受的药物载体或赋形剂，所述药物制剂的剂型包括片剂、胶囊剂、软胶囊剂、颗粒剂、丸剂、粉剂、散剂、膏剂、混悬剂、口服液或注射剂。
作为优选，所述药物制剂为膏剂，按所述用于治疗静脉炎的中药组合物的配方称取中药，将中药药材混合搅拌在一起，用粉碎机粉碎成细粉，然后用蜂蜜水调拌均匀成膏状，即得。
作为优选，所述膏剂的使用方法包括：所述膏剂均匀涂覆在医用纱布上湿敷于患者穿刺点上方5cm，每次6～8小时，每日一次。
与现有技术相比，本发明提供的中药组合物具有清热、解毒、抗炎、凉血、祛瘀、消肿、排脓的功效，用于制备治疗静脉炎的药物可明显改善静脉炎患者的临床症状，在静脉炎治疗方面具有较高的临床应用价值。
具体实施方式
为使本发明实施例的目的、技术方案和优点更加清楚，下面将对本发明实施例的技术方案进行清楚、完整地描述。显然，所描述的实施例是本发明的一部分实施例，而不是全部的实施例。基于所描述的本发明的实施例，本领域普通技术人员在无需创造性劳动的前提下所获得的所有其它实施例，都属于本发明保护的范围。
以下实施例中采用的中药膏剂，其包含以下中药：黄芩30重量份、黄连30重量份、黄柏30重量份、大黄30重量份、紫草30重量份、丹参30重量份、地榆30重量份、地龙30重量份、冰片30重量份。
实施例1
以下实施例通过临床试验来观察和评价本发明的中药组合物在治疗静脉炎的临床疗效。
1.一般资料：选取上海市第七人民医院2021年9月—2022年2月住院进行静脉留置针输液的住院病人为研究对象，按随机数表法分为治疗组和对照组两组，每组各35例。
2.1评价标准：
(一)美国静脉输液协会对静脉炎分级
0级：没有症状；
1级：输液部位发红，伴或不伴疼痛；
2级：输液部位疼痛，伴有发红/或水肿；
3级：输液部位疼痛，伴有发红/或水肿，条索状物形成，可触摸到条索状静脉；
4级：输液部位疼痛，伴有发红/或水肿，可触摸到条索状静脉>2.5cm，可有脓液渗出。
(二)浅静脉血管评级标准
表1
(三)疼痛评估标准
选用美国国立卫生研究所制定的视觉模拟评估法(VAS)，于两次疗程结束时，测评患者在留置针留置过程中，皮肤局部及整体舒适度。用两端标有0和10的10cm长的尺表示疼痛由无痛到最痛的不同级别，患者在尺上标记出最能代表其疼痛强度的点，从0到标记点的距离即为疼痛强度评分值。
2.2纳入标准：①年龄18～65岁；②穿刺部位：手背或者前臂静脉；③血管条件：浅静脉血管评级为0级或1级；④患者因疾病需要输入刺激性液体；⑤每日输液量为1000～1500mL，输液速度为60d/min左右；⑥意识清楚自愿参加本次研究并签署知情同意书。
2.3排除标准：①对于本实验中中药成分存在过敏史；②患有皮疹等影响结果评估的皮肤性疾病；③已患有静脉损伤或原有静脉损伤史；④合并有长期慢性病或者其他血液系统相关疾病；⑤拒绝签署知情同意书。
3.方法：
对照组：静脉留置针输液时于穿刺点上方5cm使用50％硫酸镁软膏涂抹，每次30min，一次两次。
治疗组：输液过程中使用涂有中药膏剂的纱布湿敷穿刺点上方5cm，促进血液循环，用医用纸胶带固定，防止患者出现胶带过敏，每次6～8小时，每日一次，敷完用生理盐水棉球测试皮肤。
统计学方法：采用统计软件SPSS19.0对数据进行分析，正态分布的计量资料以均数±标准差表示，两组间比较采用t检验；计数资料以率表示，采用χ2检验，以P<0.05为差异有统计学意义。
4.结果：
4.1两组静脉炎发生情况比较:两组间Z＝-2.557，P<0.05，其结果有统计学意义，见表2。
表2：两组静脉炎发生情况比较(秩和)
4.2两组输液后预防效果比较：两组间χ2＝6.784，P<0.05，其结果有统计学意义，见表3。
表3：两组输液后预防效果(四格卡方)
5.结论：实验组(中药膏剂外敷组)在预防静脉炎发生、降低静脉炎发生程度以及提升患者输液时舒适度时其效果优于对照组(硫酸镁外敷组)，在临床应用及参考具有一定的价值。
下面结合典型病例具体地说明本发明的内容并对本发明作进一步阐述，但这些典型病例绝非对本发明有任何限制。
以下使用的中药膏剂：黄芩30重量份、黄连30重量份、黄柏30重量份、大黄30重量份、紫草30重量份、丹参30重量份、地榆30重量份、地龙30重量份、冰片30重量份，上述中药药材混合搅拌在一起，用粉碎机粉碎成细粉，然后用蜂蜜水调拌均匀成膏状，即得。
使用方法：上述中药膏剂均匀涂覆在医用纱布上湿敷于患者穿刺点上方5cm，每次8小时，每日一次。
病例1
张某某，42岁，男性，上海市第七人民医院，住院号：57**46
患者为年轻男性，经静脉留置针补液高浓度电解质后，右上臂局部红肿，患者主诉局部疼痛，皮温高，遵医嘱予中药膏剂外敷，第二日患者局部红肿稍退，仍有疼痛感，继续予中药膏剂外用，第三日痛感基本消失，第四日静脉炎完全治愈。
病例2
马某某，96岁，女性，上海市第七人民医院，住院号：57**26
患者营养差，身形瘦弱，静脉条件差，与右前臂进行留置针静脉补液后，右前臂发红，皮温升高，有轻度条索状静脉炎产生，遵医嘱予中药膏剂外敷，第二日患者前臂静脉炎发红稍退，但皮温仍高，条索状静脉炎仍有，继续予中药膏剂外用，第三日患者右前臂发红消退，皮温正常，条索状静脉炎好转，第五日，条索状静脉炎基本消失，第七日，右前臂条索状静脉炎完全消失。
以上所述，仅为本发明的具体实施方式，但本发明的保护范围并不局限于此，任何熟悉本技术领域的技术人员在本发明揭露的技术范围内，可轻易想到变化或替换，都应涵盖在本发明的保护范围之内。因此，本发明的保护范围应所述以权利要求的保护范围为准。
Claims (6)
1.一种用于治疗静脉炎的中药组合物，其特征在于，所述中药组合物由如下中药组分制成：黄芩20~40重量份、黄连20~40重量份、黄柏20~40重量份、大黄20~40重量份、紫草20~40重量份、丹参20~40重量份、地榆20~40重量份、地龙20~40重量份、冰片20~40重量份。
2.根据权利要求1所述的用于治疗静脉炎的中药组合物，其特征在于，所述中药组合物由如下中药组分制成：黄芩30重量份、黄连30重量份、黄柏30重量份、大黄30重量份、紫草30重量份、丹参30重量份、地榆30重量份、地龙30重量份、冰片30重量份。
3.权利要求1或2所述中药组合物在制备治疗静脉炎的药物中的应用。
4.根据权利要求3所述的应用，其特征在于，所述中药组合物的有效成分经过提取后的混合物制备为一种药学上可接受的药物制剂。
5.根据权利要求4所述的应用，其特征在于，所述药物制剂包含上述中药组合物的提取物和药学上可以接受的药物载体或赋形剂，剂型包括片剂、胶囊剂、颗粒剂、丸剂、散剂、膏剂、混悬剂或口服液。
6.根据权利要求5所述的应用，其特征在于，所述药物制剂为膏剂，按照权利要求1或2所述中药组合物称取中药，将中药药材混合搅拌在一起，用粉碎机粉碎成细粉，然后用蜂蜜水调拌均匀成膏状，即得。
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| 自制四黄膏外敷治疗外周性静脉炎的临床观察;马晓芬;;光明中医;-;第26卷(第05期);954 * |
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