CN114470056A - 一种治疗下肢静脉性溃疡的中药溻渍制剂组方及其制备和使用方法 - Google Patents
一种治疗下肢静脉性溃疡的中药溻渍制剂组方及其制备和使用方法 Download PDFInfo
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Abstract
本发明涉及一种治疗下肢静脉性溃疡的中药溻渍制剂组方及其制备和使用方法,属于中药制备方法应用技术领域。本发明的技术方案为:取黄柏、苍术、赤芍、当归、大黄、黄芩、生黄芪、川牛膝,将药物加入蒸馏水浸泡,煎煮滤渣后得到的药液即为治疗下肢静脉性溃疡的中药溻渍制剂,应用时先行冷溻30min,再行局部罨敷治疗,隔日换药1次。方制剂及治疗方法的优点是:该制剂可有效促进创面愈合并改善炎症反应,副作用小,疗程短,治愈率高。
Description
技术领域
本发明涉及一种治疗下肢静脉性溃疡的中药溻渍制剂组方及其制备和使用方法,属于外用中药复方制剂技术领域。
背景技术
下肢静脉性溃疡(venous leg ulcer,VLU)是下肢静脉功能不全的常见并发症,常继发于下肢深静脉血栓形成、下肢静脉曲张等疾病后期,占下肢溃疡的70%。该病临床多表现为小腿足靴区皮肤色素沉着、干燥脱屑、难愈性疮面、脓水淋漓等,易反复发作,严重影响着患者的生活质量。该病的病理机制为持续的静脉高压导致创面局部营养障碍,局部发生慢性炎症反应,并形成细菌生物膜,从而难以愈合。目前临床对于VLU的治疗尚无专用药物,一般采用局部应用抗生素湿敷、抑菌敷料(含银敷料、壳聚糖敷料)、重组牛碱性成纤维细胞生长因子敷料治疗。
1.临床常用湿敷抗生素为庆大霉素,庆大霉素是一种氨基糖苷类药。其作用机制是作用于细菌体内的核糖体,抑制细菌蛋白质合成,并破坏细菌细胞膜的完整性;然而庆大霉素有肾毒性和耳毒性等常见副作用,患者常出现听力减退、耳鸣或耳部饱满感(耳毒性)、血尿、排尿次数显著减少或尿量减少、食欲减退、极度口渴(肾毒性)、步履不稳、眩晕等表现,甚至会发生呼吸困难、嗜睡、极度软弱无力等,因此孕妇禁用庆大霉素。
2.目前市面上尚有非抗生素类的抑菌敷料,包括含银敷料、壳聚糖敷料等,多需要配合使用二次覆盖敷料在创面后形成透气保湿的可被肌体吸收的隔离膜,多具备良好的抑菌效果;然而含银敷料、壳聚糖敷料虽然有良好的抑菌作用,但是无法改善创面局部的营养障碍状态,并不能促进局部肉芽的生长。
3.重组牛碱性成纤维细胞生长因子敷料有良好的促进肉芽生长的作用,牛碱性成纤维细胞生长因子(rb-bFGF)对来源于中胚层和外胚层的细胞(如上皮细胞、真皮细胞、成纤维细胞、血管内皮细胞等)具有促进修复和再生作用;然而重组牛碱性成纤维细胞生长因子敷料有良好的促进肉芽生长的作用,可以促进创面愈合。但是无法解决VLU创面的局部感染。
临床中由于难以兼顾,常常需要先进行抗菌敷料,再应用促进生长的敷料交替使用。因此,临床亟需一种可以兼顾抗炎和促进生长的治疗下肢静脉性溃疡的外用药物制剂。
发明内容
本发明针对上述问题,提供了一种治疗下肢静脉性溃疡的中药溻渍制剂组方及其制备和使用方法,本发明中药溻渍制剂组方又称为三妙解毒液,其由黄柏、苍术、赤芍、当归、大黄、黄芩、生黄芪、川牛膝组成,功可清热燥湿、活血解毒。临床中采用冷溻续贯罨敷法用于治疗VLU创面,取得良好的疗效,且无明显毒副作用,价格低廉,使用方便,便于推广使用。中医溻渍治疗溃疡历史悠久,早在南朝·龚庆宣《刘涓子鬼遗方》就有中药药液溻渍治疗痈疮的记载。现代临床研究表明,中医外治法可以通过抑制炎症反应、抑制细菌生物膜形成等途径祛除疮面腐败组织,促进血管新生和肉芽生长,从而促使溃疡愈合。明代《医学正传》中的三妙丸是清热燥湿的代表方剂,本项目据其化裁而成外用方剂三妙解毒液。
本发明中中黄柏清热、燥湿、解毒,为君药。苍术可燥湿,常与黄柏相须为用;赤芍清热凉血,能制约苍术温性。二药合用,共为臣药。大黄、黄芩均可清热泻火解毒,配伍使用可治疗热毒壅滞;当归活血止痛,与黄芩配伍可清血热;生黄芪有补气之功,外科常用其托毒生肌之效,四药合用,共为佐药。川牛膝为使药,可活血通经、引火下行。诸药合用,共奏清热燥湿、活血解毒之功。现代药理研究表明,黄柏中的小檗碱、黄柏碱等主要成分均可有效降低溃疡组织TNF-α水平。苍术、黄芩均可降低脾胃湿热证大鼠血清TNF-α水平,当归-赤芍配伍可降低热毒血瘀型大鼠血清TNF-α水平。
本发明的技术方案如下:
一种治疗下肢静脉性溃疡的中药溻渍制剂组方,其药物组成:黄柏21份,苍术15份,赤芍15份,当归12份,大黄12份,黄芩12份,生黄芪12份,川牛膝12份。
上述中药溻渍制剂组方的制备方法为:将药物加入蒸馏水浸泡60min,用自动煎药机煎煮,将获得的药液室温保存,避免阳光直射。
进一步的,上述中药溻渍制剂组方的使用方法如下:
创周以75%乙醇棉球常规消毒3遍,用生理盐水蘸拭疮面,经冷溻和罨敷治疗后,无菌纱布包扎;隔日换药1次,治疗14天为1疗程。
(1)冷溻法:以浸药纱布(2层)冷溻创面及疮周30min。
(2)罨敷法:浸药纱布(6~8层)覆盖创面。
本发明与现有技术相比具有以下优点:
本发明中药溻渍制剂组方全方共8味中药,组方精炼,均可在药店买到,制成中药药液用于治疗下肢静脉性溃疡,同时兼顾了抗炎和促进肉芽生长的作用,取得良好的临床疗效,且无毒副作用和过敏反应。
既往临床研究证实,中药溻渍制剂组方可以有效缩小VLU创面面积,降低患者足背静脉血TNF-α、hs-CRP,提示该方剂可有效抑制VLU炎症反应,促进疮面愈合,值得临床推荐使用。
具体实施方式
下面结合具体实施例来进一步描述本发明,本发明的优点和特点将会随着描述而更为清楚。但实施例仅是范例性的,并不对本发明的范围构成任何限制。本领域技术人员应该理解的是,在不偏离本发明的精神和范围下可以对本发明技术方案的细节和形式进行修改或替换,但这些修改和替换均落入本发明的保护范围内。
实施例1:一种治疗下肢静脉性溃疡的中药溻渍制剂组方及其制备方法
药物组成:黄柏21g,苍术15g,赤芍15g,当归12g,大黄12g,黄芩12g,生黄芪12g,川牛膝12g。
制备方法为:将药物加入蒸馏水浸泡60min,第一次加水约400-500ml,倒出药液,再加水约300ml,均为水开后文火煎煮15分钟,将两次药液合在一起,再蒸发成100ml,无菌袋装药液,室温保存,避免阳光直射。
本发明的临床资料如下:
1.一般资料
选取2019年11月~2021年5月VLU湿热证患者共80例,按1:1随机数字表法分为治疗组和对照组。治疗组男21例,女19例,年龄47岁~80岁,平均(69.78±8.25)岁,病程0.05年~40年,平均(19.23±9.64)年;对照组男22例,女18例,年龄45岁~79岁,平均(68.49±8.52)岁,病程0.04年~38年,平均(20.37±11.87)年。两组一般资料经统计学处理无显著性差异(P>0.05),具有可比性。本研究已取得伦理委员会批准,且患者均已签署知情同意书[批件号:(2019)伦审第(055)号-KY]。
2.纳入标准
符合国家中医药管理局制定的《中医病证诊断疗效标准》下肢静脉性溃疡诊断标准。临床表现以小腿内侧较为多见。局部初起常先痒后痛,色红,糜烂,迅速转为溃疡。溃疡大小不等,呈灰白或暗红色,表面或附有黄色脓苔,脓水秽臭难闻。病久溃疡边缘变厚高起,四周皮色黢黑,漫肿或伴有湿疹,收口后易反复发作。多见于下肢患有筋脉横解(静脉曲张)的患者。18岁<年龄≤80岁者。溃疡面积≤20cm2。属于CEAP临床分级C6级别者。
辨证分型属湿热证者。小腿青筋扩张,局部瘙痒、红肿、疼痛,继而破溃,脓水浸淫,疮面腐暗,四周漫肿灼热;伴口渴,便秘,小便黄赤;苔黄腻,脉滑数。
3.排除标准
合并严重心、脑、肝、肾系统及恶性肿瘤、血液系统疾病、结缔组织疾病和精神类疾病者;排除非下肢静脉性溃疡者(包括但不限于下肢动脉硬化闭塞症、糖尿病足、血管炎溃疡、神经性溃疡、放射性溃疡、结核性溃疡等);排除合并严重化脓性感染,出现全身症状者;排除对本研究药物有过敏史者;排除入组前1周内下肢溃疡局部应用中药及生长因子类药物治疗者。
4.治疗方法
4.1对照组
患者疮周予以75%乙醇棉球常规消毒3遍,用生理盐水蘸拭去除疮面脓腐组织,室温环境,外敷疮面等面积凡士林油纱。无菌纱布包扎,隔日换药1次,治疗14d。
4.2治疗组
患者疮面处理同对照组,并在室温环境下以三妙解毒液浸药纱布2层冷溻疮面及疮周30min,再以浸药纱布8层罨敷疮面,外敷等面积凡士林油纱。无菌纱布包扎后隔日换药1次,治疗14d。
药物组成:黄柏21g,苍术15g,赤芍15g,当归12g,大黄12g,黄芩12g,生黄芪12g,川牛膝12g。生药加入蒸馏水浸泡60min,用自动煎药机煎煮成100ml无菌袋装药液,室温保存,避免阳光直射。
5.疗效分析
5.1观察指标
3.1.1疮面面积:于治疗前、治疗第15天观察疮面颜色、渗液及肉芽情况,对疮面进行拍照并采用Image-J软件测量计算疮面面积。
5.1.2炎症因子
于治疗第1、15天清晨,患者仰卧位,抽取足背静脉血4ml,置于枸橼酸钠凝血实验管中存放,应用酶联免疫吸附实验(ELISA)法检测TNF-α、hs-CRP的表达。
5.1.3安全性
观察两组患者患肢治疗过程中,疮周有无红肿、瘙痒、渗出、创周皮肤丘疹等过敏反应,以及是否出现肝肾功能损害。
5.2统计学方法
5.3研究结果
5.3.1疮面面积
治疗前,两组患者疮面面积比较差异无统计学意义(P>0.05)。治疗14天后,两组患者疮面面积均较治疗前降低,且治疗组患者疮面面积较对照组低,差异有统计学意义(P<0.05),见表1。
注:与治疗前比较,aP<0.05;与对照组比较,bP<0.05。
5.3.2炎症因子
治疗前,两组患者各炎症因子比较差异无统计学意义(P>0.05)。治疗14d后,两组患者TNF-α、hs-CRP均较治疗前降低,且治疗组低于对照组,差异有统计学意义(P<0.05),见表2。
表2治疗组与对照组患者血清炎症因子比较
注:与治疗前比较,aP<0.05;与对照组比较,bP<0.05。
5.3.3安全性观察
两组患者在治疗过程中均未出现肝肾功能损害以及皮肤过敏情况。
Claims (5)
1.一种治疗下肢静脉性溃疡的中药溻渍制剂组方,其特征在于,中药溻渍制剂组方的组成为:黄柏21份,苍术15份,赤芍15份,当归12份,大黄12份,黄芩12份,生黄芪12份,川牛膝12份。
2.制备如权利要求1所述的中药溻渍制剂组方的方法,其特征在于,将药物加入蒸馏水浸泡60min,用自动煎药机煎煮,将获得的药液室温保存,避免阳光直射。
3.如权利要求1所述中药溻渍制剂组方的使用方法,步骤如下:
创周以75%乙醇棉球常规消毒3遍,用生理盐水蘸拭疮面,经冷溻法和罨敷法治疗后,无菌纱布包扎;隔日换药1次,治疗14天为1疗程。
4.根据权利要求3所述的使用方法,其特征在于,所述冷溻法为:以2层浸药纱布冷溻创面及疮周30min。
5.根据权利要求3所述的使用方法,其特征在于,所述罨敷法为:6~8层浸药纱布覆盖创面。
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