CN108815341A - 一种治疗烧伤和瘢痕的凝胶 - Google Patents

一种治疗烧伤和瘢痕的凝胶 Download PDF

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CN108815341A
CN108815341A CN201810971098.3A CN201810971098A CN108815341A CN 108815341 A CN108815341 A CN 108815341A CN 201810971098 A CN201810971098 A CN 201810971098A CN 108815341 A CN108815341 A CN 108815341A
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夏忠锐
陈舒玲
高晨曦
唐钰彬
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First People's Hospital Of Guiyang (guiyang First Aid Center)
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Abstract

一种治疗烧伤和瘢痕的凝胶,该凝胶由中药提取物和辅料组合而成,所述中药提取物是用以下质量配比的药材提取的:丹参40,生蒲黄15,当归1,虎杖15,黄药子15,黄柏15,五倍子30,苦参30,血竭5,山茶油15,冰片5,甘草10,所述辅料是甘油、丙二醇、纤维素衍生物、卡波母、海藻酸盐、西黄蓍胶、明胶、聚乙二醇400~聚乙二醇6000,交联型聚丙烯酸钠、液状石蜡、聚氧乙烯或脂肪酸与胶体硅或铝皂、锌皂中的一种或几种。制法包括提取有效成分、制备浓缩物或细粉,包装。本凝胶是半固体制剂,重量轻,患者便于携带、使用;本凝胶药材易得,加工方便,疗效明显。主要适用于治疗烧伤和瘢痕,也用于治疗其它原因产生的瘢痕。

Description

一种治疗烧伤和瘢痕的凝胶
技术领域
本发明涉及医用配制品,具体而言,涉及用中草药提取的药物,进一步来说,涉及治疗烧伤和瘢痕的药物。
背景技术
烧伤及烧伤后瘢痕是目前所有疾病中痛苦最大、治疗难度最高的疾病之一。烧伤原因主要有硝火烧伤、瓦斯烧伤、生活中沸水、热液、暖水袋烫伤,还有热渣烧伤、电弧烧伤、化学品烧伤、汽柴油火焰烧伤等。大面积烧伤死亡率高, 深度烧伤病残率高,医疗费用高昂是烧伤治疗的三大特点;创面疼痛、行性坏死、感染、愈合后瘢痕增生是烧伤治疗过程中的四大难题,是烧伤治疗的现状。烧伤病人治愈后,创面虽然愈合,在病人皮肤上却留下累累瘢痕,面部烧伤容易毁容,病人心灵创伤难以抚平。烧伤外科认为,感染是烧伤死亡的重要原因,创面渗出和坏死组织的存在为细胞繁殖提供了良好的条件, 防治感染必须保持创面干燥,因而采取促进创面干燥结痂, 再进行切痂植皮的局部治疗, 结合抗感染、营养支持。现代烧伤学常将烧伤与整形密切联系在一起,这就意味着一旦发生烧伤必将留有瘢痕,必经整形康复。与其瘢痕形成之后整形,不如在瘢痕生成之先治疗。
近年来有不少治疗烧伤瘢痕药物的中国专利申请,如2007101209156号《一种治疗瘢痕疙瘩的中药制剂》、2011101662138号《一种治疗瘢痕增生的中药配方》、2014103717232号《用于治疗瘢痕的中药及其制备方法》、2015100424855号《一种治疗烧伤不留瘢痕的药膏》、2016104507870号《一种治疗瘢痕疙瘩的中药制剂及其制备方法》、2016105934204号《一种治疗皮肤瘢痕的药物》等。这些药物疗效究竟如何尚无从了解,故而人们仍然在探索更有效治疗烧伤的药物,为人们的健康服务。
发明内容
本发明旨在提供一种治疗烧伤和烧伤后瘢痕的凝胶,增加治疗的药物品种,消除患者的痛苦,更好地服务于人民健康。
本发明的又一目的是提供该凝胶的制法,使其能够批量生产。
本发明的治疗烧伤的凝胶由中药提取物和辅料组合而成,所述中药提取物是用以下质量配比的药材提取的:
丹参40,生蒲黄15,当归1,虎杖15,黄药子15,黄柏15,五倍子30,苦参30, 血竭5,山茶油15,冰片5,甘草10;
所述辅料是甘油、丙二醇、纤维素衍生物、卡波母、海藻酸盐、西黄蓍胶、明胶、聚乙二醇400~聚乙二醇6000,交联型聚丙烯酸钠、液状石蜡、聚氧乙烯或脂肪酸与胶体硅或铝皂、锌皂中的一种或几种。
上述配方中,苦参、五倍子,活血化瘀,清热燥湿抗菌、收湿敛疮止血,是为君药;生蒲黄、当归、虎杖、黄药子、黄柏是为臣药,活血祛瘀,清热燥湿解毒止痛,增强君药的作用;佐以冰片散结、血竭化瘀生肌抗菌、山茶油清热解毒,抗菌保健护肤,且作为凝胶基质;甘草为使药,调和药性。诸药合用,可达到活血散结祛癖生新,消除瘢痕,恢复功能的目的。
配方中的药材,丹参为唇形科植物丹参(Salvia miltiorrhiza Bge.)的干燥根及根茎,味微苦涩,味苦,性微寒,能活血祛瘀,通经止痛,清心除烦,凉血消痈(见《中华人民共和国药典》2010版一部70页);生蒲黄为香蒲科植物长苞香蒲(Typha angustata) 、狭叶香蒲(Typha angustifolia)、宽叶香蒲(Typha latifolia)等的花粉,味甘辛、性凉,能凉血止血,活性消瘀(见江苏新医学院编《中药大辞典》2457页);当归为伞形科植物当归(Angelica sinensis (Oliv.) Diels) 的干燥根,味甘辛、微苦,性温;能补血活血,调经止痛,润肠通便(见《中华人民共和国药典》2010版一部124页);虎杖,为蓼科植物虎杖(Reynoutriajaponica)的根茎,味苦,性平,能祛风、利湿,破瘀、通经(见《中药大辞典》1329页);黄药子为薯蓣植物黄独(Dioscorea bulbifera)的块茎,味苦,性寒,有小毒,能散结消瘘,清热解毒,凉血止血(见《中药大辞典》第二版2858页);黄柏为芸香科植物黄柏(Phellodendron amurense)的树皮,味苦,性寒,可清热、燥湿、泻火、解毒(见《中药大辞典》2013页);五倍子为倍蚜科昆虫角倍蚜(Melaphis chinensis)或倍蛋蚜(Melaphis peitan)在其寄主盐肤木上形成的虫瘿,味酸,性平,有敛肺、涩肠,止痛,解毒功效(见《中药大辞典》361页);苦参,为豆科植物苦参(Sophora flavescens)的根,味苦,性寒,能清热燥湿,杀虫利尿(见《中药大辞典》1283页);血竭,为棕榈科植物麒麟竭(Daemonrops draco) 的果实及树脂,性平,味甘咸,有散瘀定痛,止血生肌的功效(见《中药大辞典》927页);山茶油,即茶油,为山茶科植物油茶(Camellia oleifera)种子的脂肪油,味甘,性凉,能清热化湿、杀虫解毒(见《中药大辞典》1663页);冰片为龙脑香科植物龙脑香树脂(Dryobalanops aromatica)的加工品,味苦辛、性凉,能通诸窍,散郁火,祛翳明目,消肿止痛(见《中药大辞典》951页);甘草为豆科植物甘草(Glycyrrhiza uralensis)的根茎,味甘、性平,有和中缓急、润肺、解毒,补脾益气功效(见《中药大辞典》567页)。
上述药材应符合《中华人民共和国药典》2015年版中各药材项下的规定。
发明人提供的治疗烧伤瘢痕的凝胶的制法如下:
(1)有效成分的提取
1) 按照配方比例取药材丹参、生蒲黄、当归、虎杖、黄药子、黄柏、五倍子、苦参、血竭、甘草,煎煮两次,合并煎煮液,备用;另按照配方比例取冰片粉碎成细粉备用,取山茶油备用;
2)将以上煎煮液可采用以下4种情况之一进行提取物的处理:
a.减压浓缩至相对密度1.05~1.10,加乙醇至60%,过夜,减压回收乙醇,浓缩至相对密度1.05~1.30,浓缩物备用;
b. 减压浓缩至相对密度1.10~1.30,浓缩物备用;
c. 减压浓缩至相对密度1.05~1.10,加乙醇至60%,过夜,减压回收乙醇,浓缩至相对密度1.05~1.15,喷雾干燥得提取物细粉;
d. 减压浓缩至相对密度1.05~1.15,喷雾干燥得提取物细粉;
所述相对密度都是在60℃下测量的数据;
(2)取凝胶基质及辅料加热溶解,加入备用的浓缩物或细粉混匀,加入冰片、山茶油和辅料,调节PH,搅拌混匀成凝胶剂。
(3)装瓶或装铝塑管,包装,检验合格即得到丹冰烧伤祛痕凝胶。
上述方法的第(1)步中,所述煎煮两次,第一次煎煮2h,加水量为药材质量的10倍;第二次煎煮时间为1.5h,加水量为药材质量的8倍。
上述方法的第(2)步中,所述加热溶解的温度为40℃~75℃;所述辅料为甘油、丙二醇、纤维素衍生物、卡波母、海藻酸盐、西黄蓍胶、明胶、聚乙二醇400~聚乙二醇6000,交联型聚丙烯酸钠、液状石蜡、聚氧乙烯或脂肪酸与胶体硅或铝皂、锌皂中的一种或几种。
上述方法的第(3)步中,所述装瓶是玻璃瓶或PV瓶。
制得的凝胶产品质量标准应符合中国药典对凝胶剂产品的规定。
本发明的治疗烧伤瘢痕的凝胶的用法是外用,涂于创面,每天1~2次,用药前须洗净创面。本品应在遮光、密闭、低温条件下保存。
本发明的治疗烧伤及瘢痕的凝胶是半固体制剂,重量轻,患者便于携带、使用;本凝胶药材易得,加工方便,疗效明显。主要适用于烧伤瘢痕的治疗,也可用于其它原因产生的瘢痕。
本发明的治疗烧伤瘢痕的凝胶是在长期医疗实践得出的配方,已经在临床应用,治愈率高于68.00%,且无副作用,95人有疗效,有效率95.00%以上,5人无效。典型的病例如下:
病例1:患者 女 62岁, 热汤烫伤面颈前胸及双上肢,面积18%, 创面为浅Ⅱº深Ⅱº,用药方法:创面以碘伏消毒彻底清洁创面,生理盐水清洗后, 将本发明的凝胶均匀涂于创面,厚度约0.5~ 1.0mm, 先以单层纱布覆盖, 行半暴露或包扎疗法均可。创面用药之初, 渗出较多, 2~ 3d,渗出随即明显减少,注意每日换药清除液化坏死组织,创面干净干燥, 创面炎症反应也明显消退。用药始终患者无痛感或较轻, 亦未见过敏或其他不良反应,10天后部分创面开始痂下愈合,21天创面全部愈合,创面愈合后继续坚持用清洗,并每日外涂本发明的凝胶至创面愈合后6月,患者疤痕瘙痒,瘢痕增生较对照组明显减轻,瘢痕软化时间缩短。
病例2:某男 35岁,火焰烧伤面颈及四肢,面积20 % 创面为浅Ⅱº深Ⅱº,用药方法:创面以碘伏消毒彻底清洁创面,生理盐水清洗后, 将本发明的凝胶均匀涂于创面, 厚度约0.5~1.0mm , 先以单层纱布覆盖, 行半暴露或包扎疗法均可。创面用药之初, 渗出较多, 2~3d,渗出随即明显减少,注意每日换药清除液化坏死组织,创面干净干燥, 创周炎症反应也明显消退。用药始终患者无痛感, 亦未见过敏或其他不良反应,9天部分创面开始痂下愈合,20天创面全部愈合。创面愈合后继续坚持用清洗,并每日外涂该凝胶至创面愈合后6月,患者疤痕瘙痒,瘢痕增生较对照组明显减轻,瘢痕软化时间缩短。
病例3:某男 20岁,火焰烧伤面颈及四肢,面积20% 创面为浅Ⅱº深Ⅱº,用药方法:创面以碘伏消毒彻底清洁创面,生理盐水清洗后, 将本发明的凝胶均匀涂于创面, 厚度约0.5~1.0mm , 先以单层纱布覆盖, 行半暴露或包扎疗法均可。创面用药之初, 渗出较多, 2~3d,渗出随即明显减少,注意每日换药清除液化坏死组织, 创面干净干燥, 创周炎症反应也明显消退。用药始终患者无痛感, 亦未见过敏或其他不良反应, 9天部分创面开始痂下愈合,20天创面全部愈合。创面愈合后继续坚持用清洗,并每日外涂该凝胶至创面愈合后6月,患者疤痕瘙痒,瘢痕增生较对照组明显减轻,瘢痕软化时间缩短。
病例4:某男 35岁,火焰烧伤面颈及四肢,创面愈合后未作抗瘢痕治疗,创面愈合后一个月开始出现颈部及双上肢散在瘢痕增生,瘢痕发红,质硬,瘢痕周围皮肤色素沉着,伴疼痛瘙痒,面积5% 用药方法: 彻底清洁瘢痕后,将本发明的凝胶均匀涂于创面, 厚度约0.5~1.0mm , 其中颈部瘢痕暴露治疗,双上肢外加弹力绷带均匀加压包扎,创面用药后30分钟瘢痕疼痛瘙痒改善,双上肢 1个月瘢痕质地开始变软.瘢痕充血减轻(双上肢配合压力治疗),颈部瘢痕50天瘢痕质地开始变软,瘢痕充血减轻。连续治疗3个月瘢痕软化变平,瘢痕开始消退,瘢痕周围色素明显消退。用药始终患者无痛感, 亦未见过敏。
具体实施方式
实施例1:首先取丹参400g,生蒲黄150g,当归150g ,虎杖150g,黄药子150g,黄柏150g,五倍子300g,苦参300g, 血竭50g,甘草100g ,混合煎煮两次,第一次煎煮时间为2h,加水量为药材的10倍量,第二次煎煮时间为1.5h,加水量为药材的8倍量,合并煎煮液,减压浓缩至相对密度1.10~1.20(60℃),加乙醇至60%,过夜,减压回收乙醇,浓缩至相对密度1.10~1.20(60℃),取凝胶基质及辅料加热至40℃~75℃溶解;加入提取的有效成分中间体混匀,冷却至40℃加入冰片50g、山茶油150g和保湿剂甘油30、防腐剂尼铂金甲酯和尼铂金丙酯(总量的1.5%),调节物料pH,搅拌混匀,即得。
实施例2:首先取丹参400g,生蒲黄150g,当归150g ,虎杖150g,黄药子150g,黄柏150g,五倍子300g,苦参300g, 血竭50g,甘草100g ,混合煎煮两次,第一次煎煮时间为2h,加水量为药材的10倍量,第二次煎煮时间为1.5h,加水量为药材的8倍量,合并煎煮液,减压浓缩至相对密度1.10~1.20(60℃),加乙醇至60%,过夜,减压回收乙醇,浓缩至相对密度1.10~1.20(60℃),喷雾干燥得提取物细粉。取凝胶基质及辅料加热至40℃~75℃溶解;将提取的有效成分细粉用山茶油吸收过胶体磨混匀,加入冰片50g、山茶油150g和保湿剂丙二醇25g、防腐剂尼铂金乙酯和尼铂金丙酯(总量的1.5%),调节物料pH值,搅拌混匀,即得。
实施例3:首先取丹参400g,生蒲黄150g,当归150g ,虎杖150g,黄药子150g,黄柏150g,五倍子300g,苦参300g, 血竭50g,甘草100g ,混合煎煮两次,第一次煎煮时间为2h,加水量为药材的10倍量,第二次煎煮时间为1.5h,加水量为药材的8倍量,合并煎煮液,减压浓缩至相对密度1.10~1.20(60℃),加乙醇至60%,过夜,减压回收乙醇,浓缩至相对密度1.25~1.30(60℃),备用。取凝胶基质及辅料加热至40℃~75℃溶解;将以上提取的有效成分浸膏用山茶油吸收过胶体磨混匀,加入冰片50g、山茶油150g和保湿剂甘油25g,防腐剂尼铂金甲酯和尼铂金丙酯(总量的1.5%),调节物料pH值,搅拌混匀,即得。

Claims (5)

1.一种治疗烧伤瘢痕的凝胶,其特征在于该凝胶由中药提取物和辅料组合而成,所述中药提取物是用以下质量配比的药材提取的:
丹参40,生蒲黄15,当归1,虎杖15,黄药子15,黄柏15,五倍子30,苦参30, 血竭5,山茶油15,冰片5,甘草10;
所述辅料是甘油、丙二醇、纤维素衍生物、卡波母、海藻酸盐、西黄蓍胶、明胶、聚乙二醇400~聚乙二醇6000,交联型聚丙烯酸钠、液状石蜡、聚氧乙烯或脂肪酸与胶体硅或铝皂、锌皂中的一种或几种。
2.制造权利要求1所述凝胶的方法,其特征包括以下步骤:
(1)有效成分的提取
① 按照配方比例取药材丹参、生蒲黄、当归、虎杖、黄药子、黄柏、五倍子、苦参、血竭、甘草,煎煮两次,合并煎煮液,备用;另按照配方比例取冰片粉碎成细粉备用,取山茶油备用;
② 将以上煎煮液可采用以下4种情况之一进行提取物的处理:
a.减压浓缩至相对密度1.05~1.10,加乙醇至60%,过夜,减压回收乙醇,浓缩至相对密度1.05~1.30,浓缩物备用;
b. 减压浓缩至相对密度1.10~1.30,浓缩物备用;
c. 减压浓缩至相对密度1.05~1.10,加乙醇至60%,过夜,减压回收乙醇,浓缩至相对密度1.05~1.15,喷雾干燥得提取物细粉;
d. 减压浓缩至相对密度1.05~1.15,喷雾干燥得提取物细粉;
所述相对密度都是在60℃下测量的数据;
(2)取凝胶基质及辅料加热溶解,加入备用的浓缩物或细粉混匀,加入冰片、山茶油和辅料,调节PH,搅拌混匀成凝胶剂;
(3) 包装,装瓶或装铝塑管,检验合格即得到丹冰烧伤祛痕凝胶。
3.制备权利要求2所述凝胶的方法,其特征在于方法的第(1)步中,所述煎煮两次,第一次煎煮2h,加水量为药材质量的10倍;第二次煎煮时间为1.5h,加水量为药材质量的8倍。
4.制备权利要求2所述凝胶的方法,其特征在于方法的第(2)步中,所述加热溶解的温度为40℃~75℃;所述辅料为甘油、丙二醇、纤维素衍生物、卡波母、海藻酸盐、西黄蓍胶、明胶、聚乙二醇400~聚乙二醇6000,交联型聚丙烯酸钠、液状石蜡、聚氧乙烯或脂肪酸与胶体硅或铝皂、锌皂中的一种或几种。
5.制备权利要求2所述凝胶的方法,其特征在于方法的第(3)步中,所述装瓶是采用玻璃瓶或PV瓶。
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CN109481559A (zh) * 2018-11-08 2019-03-19 贵阳护理职业学院(贵阳市卫生学校) 一种治疗烧伤和瘢痕的凝胶

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109481559A (zh) * 2018-11-08 2019-03-19 贵阳护理职业学院(贵阳市卫生学校) 一种治疗烧伤和瘢痕的凝胶

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