CN117281854A - 疤痕软散液及其制备方法 - Google Patents
疤痕软散液及其制备方法 Download PDFInfo
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- CN117281854A CN117281854A CN202311501488.1A CN202311501488A CN117281854A CN 117281854 A CN117281854 A CN 117281854A CN 202311501488 A CN202311501488 A CN 202311501488A CN 117281854 A CN117281854 A CN 117281854A
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Abstract
本申请公开了一种疤痕软散液及其制备方法,其原料包括以重量份计的下列各组分:桂枝18~36份,白芍18~36份,大黄18~36份,苦参36~72份,花椒36~72份,艾叶36~72份,白鲜皮12~24份,炒蒺藜12~24份。上述疤痕软散液使用中草药为原料制作而成,可以通过外敷使用,即使用中医外治法改善疤痕增生的情况;外敷使用时中草药可以深入至疤痕组织内抑制疤痕的增生,进而促进疤痕软化、消散,高效治疗和抑制疤痕的发生发展。上述疤痕软散液无毒,不刺激,对皮肤温和,呈黄褐色,黏度适中,擦拭后无残留。
Description
技术领域
本申请涉及中医中药治疗疤痕技术领域,特别是涉及一种疤痕软散液及其制备方法。
背景技术
疤痕是指伤口愈合过程中创面表面形态和内部组织变化的统称,一般分为浅表性疤痕、增生性疤痕、萎缩性疤痕和疤痕疙瘩。日常生活中,灼伤、切割伤、感染等造成真皮层创伤后,胶原蛋白合成加速进行,导致纤维细胞增殖,易生成增生性疤痕,表现为该组织颜色红紫、高于正常皮肤,且伴随瘙痒肿痛等症状,短时间内极难平复,给患者造成严重的外表和精神影响。
目前常见的疤痕修复手段包括手术、药物、加压、放射、激光、物理康复等多种方法综合治疗。在众多治疗手段中,疤痕外用药物因其使用简单方便、效果良好的特点,近年来已经成为了疤痕修复中的重要手段。目前市面上的疤痕外用药物种类繁多,各种疤痕外用药物的原理也存在差异。国外疤痕外用药物的价格均较高,国产疤痕药物价格相对较低,但对于疤痕修复效果欠佳,因此对于疤痕外用药物的研发,国内仍存在巨大的市场潜力。
发明内容
本发明提供了一种疤痕软散液及其制备方法,以解决现有技术中疤痕外用药修复效果欠佳的技术问题。
为达到上述目的,本发明提供的技术方案如下:
本发明的第一方面,提供了一种疤痕软散液,其原料包括以重量份计的下列各组分:桂枝18~36份,白芍18~36份,大黄18~36份,苦参36~72份,花椒36~72份,艾叶36~72份,白鲜皮12~24份,炒蒺藜12~24份。
进一步地,其原料包括以重量份计的下列各组分:桂枝27份,白芍27份,大黄27份,苦参54份,花椒54份,艾叶54份,白鲜皮18份,炒蒺藜18份。
本发明的第二方面,提供了上述疤痕软散液的制备方法,包括以下步骤:按照重量份配比分别称取原料中的各组分,并置入容器内用水浸泡,然后煎制,即得到疤痕软散液。
进一步地,所述用水浸泡的步骤中,浸泡时间为15min~25min,用水量高于所述原料5cm~10cm。
进一步地,所述煎制的步骤中,煎制的次数为2次~3次,每次煎制的时间为25min~40min。
进一步地,所述步骤还包括所述煎制的步骤之后使用紫外线灭菌的步骤。
本申请的疤痕软散液使用时需要借助纱布,具体为:用疤痕软散液将双层医用脱脂纱布浸湿制作疤痕贴,外敷于疤痕处,每20mL/100cm2,每日两次,每次外敷30min。
本发明提供的疤痕软散液使用中草药为原料制作而成,可以通过外敷使用,即使用中医外治法改善疤痕增生的情况;外敷使用时中草药可以深入至疤痕组织内抑制疤痕的增生,进而促进疤痕软化、消散,高效治疗和抑制疤痕的发生发展。上述疤痕软散液无毒,不刺激,对皮肤温和,呈黄褐色,黏度适中,擦拭后无残留。
具体实施方式
为了使本领域的技术人员更好地理解本申请中的技术方案,下面将对本申请实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例仅仅是本申请的一部分实施例,而不是全部的实施例。基于本申请中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例,都属于本申请保护的范围。
本申请实施例的第一方面,提供一种疤痕软散液,其原料包括以重量份计的下列各组分:桂枝18~36份,白芍18~36份,大黄18~36份,苦参36~72份,花椒36~72份,艾叶36~72份,白鲜皮12~24份,炒蒺藜12~24份。
桂枝具有发汗解肌、温通经脉、助阳化气、平冲降气的功效。桂枝具有扩血管、抗氧化、降血脂等方面的药理活性。其中桂枝挥发油对金黄色葡萄球菌、大肠杆菌具有较好的抑菌效果。其所含肉桂酸具有抗菌、升高白细胞等药理作用,3,4-二羟基苯甲酸是植物中抗炎、抗菌的活性成分,桂皮醛有明显的镇静、镇痛、改善外周循环的作用。
白芍《别录》谓其:“通顺血脉,缓中,散恶血,逐贼血,去水气,利膀胱、大小肠,消痈肿”,其化学成分主要为挥发油类、单萜类、三萜类及黄酮类化合物等,药理作用广泛,具有镇痛、抗炎、抗菌、免疫调节及扩血管、抗血小板凝集、改善缺血再灌注等作用,毒副作用小,临床应用广。
大黄始载于《神农本草经》,“大黄,味苦寒,归胃肝大肠经,主下瘀血,血闭寒热,破症,积聚。”近年来,国内外对大黄的化学成分进行了大量研究,主要包括蒽醌类、蒽酮类、二苯乙烯类、苯丁酮类、色原酮类、黄酮类、鞣质类、多糖类等成分,还有挥发油、甾醇类、有机酸类及微量元素等化合物,具有抗炎、镇痛、抑菌、消除氧自由基等作用。
苦参味苦、性寒,具有清热、燥湿、杀虫的功效。苦参中的化学成分主要包括生物碱和黄酮类化合物,其中黄酮类化合物的药理作用主要有抗炎、抗病毒以及抑制血管生成的作用。
花椒具有温中止痛、杀虫止痒的功效,花椒中的活性物质α-山椒素对细胞有潜在的镇痛作用。花椒油素所含的二磷酸腺苷(ADP)、花生四烯酸(AA)和凝血酶对血小板的聚集均有明显的抑制作用,花椒多酚类化合物有较强的还原能力,能有效地清除活性氧自由基,花椒挥发油渍能抑制G-菌及G+菌,同时对霉菌、真菌也有抑制作用,尤其对青霉和黑曲霉的抑菌效果最好。花椒的多种生理活性,包括抗炎、镇痛、局部麻醉、抗氧化、抗肿瘤、抑菌、杀虫、抗皱等,在医药领域有着广阔的应用前景。
艾叶是我国常用的传统中药,味苦、辛,性温,其主要含有挥发油、黄酮类、苯丙素类、萜类等成分,具有抗菌、抗病毒、止血、镇痛、抗炎、抗氧化等多种药理作用。
白鲜皮其味苦、寒,具有清热燥湿、祛风解毒的功效,其具有广泛的药理作用,包括抗炎、抗真菌、抗动脉粥样硬化、止血、神经保护以及抗氧化等。含有多种化学成分,包括生物碱、柠檬苦素、黄酮、倍半萜及其苷类、甾体等。白鲜皮的化学成分是其发挥药效的重要物质基础。
炒蒺藜具平肝解郁、活血祛风、祛痰止咳、明目、利尿、止痒之功效。现代药理研究表明,其具有抗动脉粥样硬化和血小板聚集等作用,可抑制金黄色葡萄球菌、大肠杆菌等的生长,显示出一定的抗菌作用,增强机体免疫力,提高机体清除氧自由基的能力。
本申请实施例在中草药制剂中创新性组合使用桂枝、白芍、大黄、苦参、花椒、艾叶、白鲜皮、炒蒺藜,并通过调配各成分比例而制成上述疤痕软散液,结合不同中药属性抑制疤痕增生,使其在疤痕修复过程中效果更强;并能在疤痕生成之前就发挥作用,完美契合疤痕防治动态疗的治疗策略。中草药制剂的疤痕软散液不但适合于已形成的疤痕防治,而且适合于各种手术和创伤疤痕的早期处理。在疤痕治疗这样一个中长期、慢性过程的背景下,中草药制剂的疤痕软散液将因其简单方便且效果良好的特点而成为疤痕修复中的重要手段,大大推进疤痕的动态、长期、慢性治疗节奏。
本申请实施例中草药制作的疤痕软散液不论在创新上或者作用效果上均有较大优势,可广泛应用于烧伤科、整形外科、普外科等科室术后增生性疤痕的修复,以及用于疤痕疙瘩的治疗。上述疤痕软散液能够清热利湿,外敷利于疤痕湿润和清洁,从而有助于疤痕整体情况的改善;也使疤痕面积减小,颜色退浅,起到治疗作用;也可与其它疤痕治疗方法配合使用,增强治疗效果;另外,对于刚愈合的初期伤口可以起到减少疤痕形成的作用,并抑制疤痕增生,促进组织恢复。
本申请实施例的疤痕软散液使用中草药为原料制作而成,可以通过外敷使用,即使用中医外治法改善疤痕增生的情况;外敷使用时中草药可以深入至疤痕组织内抑制疤痕的增生,进而促进疤痕软化、消散,高效治疗和抑制疤痕的发生发展。上述疤痕软散液无毒,不刺激,对皮肤温和,呈黄褐色,黏度适中,擦拭后无残留。
本申请实施例的疤痕软散液使用时需要借助纱布,具体为:用疤痕软散液将双层医用脱脂纱布浸湿制作疤痕贴,外敷于疤痕处,每20mL/100cm2,每日两次,每次外敷30min。
上述疤痕贴的使用方法具体如下:
首先应进行致敏性测试,即在自己的正常易观察皮肤处(例如腕内侧)试敷5min,观察是否有过敏现象出现,若出现红肿、瘙痒等局部轻微过敏反应,应立即停止外敷;若出现大范围皮疹、呼吸困难等严重过敏反应,应及时就医。症状较轻可考虑脱敏疗法进行渐进性敷贴,操作方法为:每疗程15日,每日一次,首日外敷时间为5min,每次递增2min,若出现局部不适则不相应延长外敷时间。疤痕软散液的最大使用面积视疤痕范围情况而定,每袋药剂使用时限建议最长不超过7天。
除了疤痕外用膏剂,目前市场上存在的疤痕贴、疤痕凝胶等制剂的祛疤效果一般,硅酮凝胶易残留,透气性偏差,清除时容易损伤伤口粘膜新生上皮及周围皮肤,有痛感,缺少使用舒适度;单支剂量小,较大面积的疤痕患者使用成本高。通过美容手术、药物治疗及激光祛疤来改善疤痕的方式具有风险性且费用较高,会给患者带来新的心理负担。
本申请实施例利用中草药的优势,针对疤痕患者局部多因伤后湿热蕴于疤痕处的皮肤,进而出现瘙痒疼痛、湿性黏滞、流于关节等症状,利用上述多种中草药组方组合制作消散液,具有清热利湿,软坚散结之功效,对疤痕的修复效果更好。
外用中草药治疗疤痕的优势:疤痕患者多因伤后湿热蕴于皮肤上创面疤痕处,导致瘙痒疼痛、湿性黏滞,流于关节,关节屈伸不利,肌肤体表外治易佳,治宜清热利湿;上述原料中各组分的中药属性相结合,促使疤痕软化消散,色素变浅,减轻瘙痒疼痛。
本申请实施例的第二方面,还提供了上述疤痕消散液的制备方法,包括以下步骤:按照重量份配比分别称取原料中的各组分,并置入容器内用水浸泡,然后煎制,即得到疤痕软散液。
上述制备方法为在常温条件下加工,使得有效组分不被破坏;且成本低廉,经济实惠,设备成熟,工艺简单;载药量大,剂量准确,血药浓度平衡,无峰谷现象。本申请实施例采用绿色原材料,在工业生产中无有机溶媒,对环境无污染,绿色环保,适合大量推广。
以下通过具体的实施例来对本申请做进一步的说明。下列各实施例中各试剂均为市售。
实施例1
疤痕软散液,其原料包括以重量份计的下列各组分:桂枝18份,白芍18份,大黄18份,苦参36份,花椒36份,艾叶36份,白鲜皮12份,炒蒺藜12份。
上述疤痕软散液的制备方法,包括以下步骤:
1、按桂枝18份、白芍18份、大黄18份、苦参36份、花椒36份、艾叶36份、白鲜皮12份、炒蒺藜12份的每剂重量份比计,取1剂。
2、取步骤1中的中药成分置入砂锅内,也可用自动煎药机,用水浸泡药物20min左右,可用自来水、井水、泉水,用水量浸过药面5cm。
3、将步骤2浸泡后的药液进行煎制,煎制3次,先用猛火烧开,再用小火煎煮30min后冷却,煎制成600mL药液。
4、用封装机将步骤3冷却后的药液分装在200mL医用密封袋中,然后转移至灭菌室中于紫外线辐照下灭菌30min,常温保存。
实施例2
疤痕软散液,其原料包括以重量份计的下列各组分:桂枝36份,白芍36份,大黄36份,苦参72份,花椒72份,艾叶72份,白鲜皮24份,炒蒺藜24份。
本实施例的疤痕软散液的制备方法,除各组分重量份与实施例1不同,其它步骤均相同。
实施例3
疤痕软散液,其原料包括以重量份计的下列各组分:桂枝27份,白芍27份,大黄27份,苦参54份,花椒54份,艾叶54份,白鲜皮18份,炒蒺藜18份。
本实施例的疤痕软散液的制备方法,除各组分重量份与实施例1不同,其它步骤均相同。
利用实施例1至3的疤痕软散液进行临床试验,如下:
典型病例1:
王某,女22岁,河南南阳邓州人,因在家中不慎被液化气烧伤3月余,面部及颈部皮肤出现瘢痕,质地较硬,充血反应明显,面积最大约4.5×5cm,高出皮肤0.1~0.3cm,诊断为面部外伤后瘢痕增生伴溃疡。用实施例1的疤痕软散液外敷,每日20分钟,3天后瘢痕出现软化,质地变软,充血反应较前出现明显好转。继续坚持2周治疗,基本痊愈,出院后仍继续外涂。半年后回访,局部皮肤无瘢痕,无功能障碍,可见疤痕处有少许色素沉着。
典型病例2:
张某,男,25岁,河南南阳市人,因额部外伤后流血3小时入院,行面部皮肤清创术,术后一周愈合出院,一月后为求进一步防疤治疗,遂来我院,患者额部可见长约5cm疤痕,质地较硬,高出皮肤0.1~0.3cm,充血反应明显,与局部组织无粘连。外敷实施例2的疤痕软散液1周后,其表面皮肤红肿减退,继续使用本制剂外敷,3周后基本痊愈,局部皮肤未见明显瘢痕,有少许色素沉着。出院后继续使用本制剂外敷,1月后,电话回访,患者自诉局部表面看不出瘢痕,无色素沉着。
典型病例3:
陈某,男12岁,河南郑州人,因不慎被机器烫伤半年余,右手及腕部出现瘢痕,质地较硬,充血反应明显,手部面积最大约4.5×3cm,高出皮肤0.1~0.2cm,诊断为手部外伤后瘢痕增生伴溃疡。用本实施例3的疤痕软散液外敷,每日20分钟,2天后瘢痕出现软化,质地变软,充血反应较前好转;继续坚持3周治疗,基本痊愈,局部皮肤无瘢痕,无功能障碍,疤痕处有少许色素沉着。
由上述典型病例来看,外敷本申请实施例的疤痕软散液,对于疤痕的修复效果更好。
根据多年本申请疤痕软散液的临床统计,共120例患者,男70人,女50人,平均年龄30岁,患处疤痕、痘印统计,如表1所示;自感使用状况结果参照表2。
表1本申请疤痕软散液的临床统计表
表2病例自感使用状况表
经临床试验证明,本申请疤痕软散液去疤痕的有效率为90%,治愈率为87%,比其它外用药水有效率高60%,治愈率高77%;比其他外用软膏,有效率高45%,治愈率高67%;使用本申请疤痕软散液,能起到软坚散结、活血化瘀、清热滋阴等功效,治疗烧烫伤后留下的增生性疤痕,疤痕疙瘩,萎缩性疤痕,手术后留下的疤痕疙瘩、烧烫伤后期的治疗、创伤后留下的疤痕以及青春痘,痤疮、粉刺留下的痘印疤痕等症,并能加速皮肤新陈代谢,有效祛除痘印疤痕,使皮肤光洁、明亮。疗效好、见效快,有效率达90%以上,且有标本兼治的效果,能达愈后不易复发的目标。
对所公开的实施例的上述说明,使本领域专业技术人员能够实现或使用本发明。对这些实施例的多种修改对本领域的专业技术人员来说将是显而易见的,本文中所定义的一般原理可以在不脱离本发明的精神或范围的情况下,在其它实施例中实现。因此,本发明将不会被限制于本文所示的这些实施例,而是要符合与本文所公开的原理和新颖特点相一致的最宽的范围。
Claims (6)
1.一种疤痕软散液,其特征在于,其原料包括以重量份计的下列各组分:
桂枝18~36份,白芍18~36份,大黄18~36份,苦参36~72份,花椒36~72份,艾叶36~72份,白鲜皮12~24份,炒蒺藜12~24份。
2.根据权利要求1所述的疤痕软散液,其特征在于,其原料包括以重量份计的下列各组分:桂枝27份,白芍27份,大黄27份,苦参54份,花椒54份,艾叶54份,白鲜皮18份,炒蒺藜18份。
3.权利要求1或2所述的疤痕软散液的制备方法,其特征在于,包括以下步骤:
按照重量份配比分别称取原料中的各组分,并置入容器内用水浸泡,然后煎制,即得到所述疤痕软散液。
4.根据权利要求3所述的疤痕软散液的制备方法,其特征在于,所述用水浸泡的步骤中,浸泡时间为15min~25min,用水量高于所述原料5cm~10cm。
5.根据权利要求3所述的疤痕软散液,其特征在于,所述煎制的步骤中,煎制的次数为2次~3次,每次煎制的时间为25min~40min。
6.根据权利要求3所述的疤痕软散液,其特征在于,所述步骤还包括所述煎制的步骤之后使用紫外线灭菌的步骤。
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