CN106421392A - 一种治疗褥疮的中药凝胶剂及其制备方法 - Google Patents
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Abstract
本发明公开了一种治疗褥疮的中药凝胶剂及其制备方法,组成原料包括中药组合物和凝胶成型剂组成,本发明的中药组方依据中医基础理论,协同作用强,具有清热解毒、活血生肌、消毒祛腐的功效,药物与凝胶剂基质组合在一起,使其药理活性及优势充分发挥,在清除腐毒的同时疏通血脉经络同时能促进皮肤新陈代谢及创口愈合,增强对细菌、真菌的抵抗力,促进伤口愈合,避免伤口愈合后再度感染,本品涂抹于创伤表面,使用方便,顺应性强,治疗效果良好。
Description
技术领域
本发明属于中药及中药制剂领域,尤其涉及一种治疗褥疮的中药凝胶剂及其制备方法。
背景技术
褥疮(decubitus)(又称压疮,压力性溃疡)是由于局部组织长期受压,发生持续缺血、缺氧、营养不良而致皮肤及皮下组织缺血而发生水疱、溃疡或坏疽。其形成过程分为红斑期、水泡期和溃疡期三期。中医称为“席疮”,乃因久病气血大亏,长期卧床,局部受压以致血气运行失常,经络阻塞,无以荣肤所致。一般来说,长期卧床、体质衰弱、翻身不便及肢体感觉迟钝者易患褥疮,临床上多见于以下三类患者:1.昏迷及瘫痪病人。2.卧床不起,体质衰弱的病人。3.骨折后长期固定或卧床的病人。据有关文献报道每年约有6万人死于褥疮及引起合并症。
与中成药相比,传统的西医换药时多应用消毒剂或抗生素,虽然能够有效的控制细菌,但也不可避免的抑制了创面细胞的健康再生,从而导致创面愈合非常慢,病情迁延不愈,影响患者的生活和工作。
中医认为,褥疮是由于久卧伤气,气虚而血行不畅;外因为躯体局部连续长期受到压迫及摩擦,导致气虚血瘀,局部肌肤失养,皮肉坏死而成。中药治疗褥疮的主要原则是清热解毒、活血祛瘀、去腐生肌,促进坏死组织排出,加快组织生长愈合,促进创面周围组织的微循环,祛腐生肌,自动修复,对正常组织无副作用,填充伤口窦道及腔隙,防止伤口塌陷感染,减轻患者精神及肉体疼痛。
中国专利申请 201510675028.X 公开了一种用于治疗褥疮的中药组合及其制备方法,该中药组合物包括以下重量份数的制备原料 :艾叶 20-30、牡荆 18-30、桉叶 16-25、积雪草 15-20、孩儿茶 12-20、川芎 10-20、当归 10-15、高良姜 8-16、白蔹 5-12、地榆5-15以及甘草5-12。该药膏在治疗褥疮方面具有一定的疗效,但是该药物治疗褥疮疗程长,痊愈率只有78.5%,效果不是太优越,本发明也未提供确定的制剂应用形式的制备方法,不利于临床使用。对于有的褥疮发生腐臭异味未能明显掩盖。
发明内容
为了解决现有技术中治疗褥疮的药物存在愈合慢、治疗时间长和未能掩盖褥疮腐臭异味,本发明的目的在于提供一种治疗褥疮的中药凝胶剂及其制备方法,以解决上述问题。
为了实现上述目的,本发明采用如下技术方案:
治疗褥疮的中药凝胶剂,其组成原料由7%-9%中药组合物和91%-93%凝胶成型剂组成,中药组合物的组成原料重量份为:蜂房 20-30、紫锥菊15-30、血竭 15-30、三七 15-25、积雪草 15-20、白芨 15-20、蒲黄10-20、珍珠 10-15、冰片 5-15、锻石膏 5-15、天花粉5-15、皂角刺5-15、黎辣根5-15、穿山甲5-10以及黄连 5-10;凝胶成型剂的组成原料重量百分比为:卡波姆 1.0-1.5%、丙二醇 15-20%、氢氧化钠 0.5-0.7%、吐温-80 0.8-1.2%、透明质酸1.8-2.2%、聚硅酮 4-6%、异鲸蜡醇聚醚-20 1-3%、乙内酰脲 0.1-0.3%、苯扎氯铵0.013-0.018%、薰衣草精油0.04-0.06%、沉香精油0.04-0.06%,其余为纯化水组成。
所述中药组合物的组成原料重量份为:蜂房 20、紫锥菊15、血竭 15、三七 15、积雪草 15、白芨 15、蒲黄10、珍珠 10、冰片 5、锻石膏 5、天花粉5、皂角刺5、黎辣根5、穿山甲5以及黄连 5。
所述中药组合物的组成原料重量份为:蜂房15、紫锥菊25、血竭 25、三七 20、积雪草 18、白芨 18、蒲黄15、珍珠13、冰片 12、锻石膏12、天花粉12、皂角刺12、黎辣根12、穿山甲8以及黄连8。
所述中药组合物的组成原料重量份为:蜂房 30、紫锥菊25、血竭 30、三七 25、积雪草 20、白芨 20、蒲黄20、珍珠 15、冰片 15、锻石膏 15、天花粉15、皂角刺15、黎辣根15、穿山甲10以及黄连 10 。
所述的凝胶成型剂的组成原料重量百分比为:卡波姆 1.2%、丙二醇 18%、氢氧化钠 0.6%、吐温-80 1.0%、透明质酸 2%、聚硅酮 5%、异鲸蜡醇聚醚-20 2%、乙内酰脲 0.2%、苯扎氯铵0.015 %、薰衣草精油0.05%、沉香精油0.05%,其余为纯化水组成。
本发明的组成原料优选由8%中药组合物和92%凝胶成型剂组成。
所述的中药组合物制备方法如下述步骤:
步骤1:按中药组方分别称取各味药材,洗去杂质,干燥后分别粉碎,过 60-80 目筛,备用;
步骤2:取蜂房、紫锥菊、积雪草、白芨、三七、冰片、蒲黄、锻石膏、天花粉、皂角刺、黎辣根、黄连粗粉,加入粗粉重量的30-45% 体积分数为60-80% 的乙醇,回流提取2-3 次,过滤,合并滤液,滤液真空减压浓缩至 60℃条件下测相对密度为 1.25-1.35 的浓缩液,得醇提浓缩液;保留残渣;
步骤3:在上述步骤2的残渣中加入总量8-13倍量的水浸泡0.5-1小时,然后煎煮2-3次,每次1-2 小时,过滤并保留滤渣,合并滤液,滤液真空减压浓缩至 60℃条件下测相对密度为1.25-1.35 的浓缩液,得水提浓缩液;
步骤4:取血竭、珍珠、穿山甲打成极细粉,过150目-200目筛,得混合极细粉,备用;
步骤5:将上述步骤4所得的极细粉、步骤3的水提浓缩液和步骤2的醇提浓缩液合并混匀,在 60℃温度下进行真空干燥,干燥后将干浸膏粉碎,过 120-200 目筛,即得。
治疗褥疮的中药凝胶剂的制备方法,包括以下内容:
步骤1,称取1.2%卡波姆,加处方量85%纯化水,浸泡溶胀,过40目筛,用氢氧化钠调配pH值至6.80,得卡波姆胶体组分;
步骤2,称取8%中药组合物、18%丙二醇、1.0%吐温-80、2% 透明质酸、5% 聚硅酮、2% 异鲸蜡醇聚醚-20、0.2%乙内酰脲、0.015 % 苯扎氯铵及剩余纯化水,60℃混合搅拌均匀,用氢氧化钠调pH至6.80,得主药组分;
步骤3,将卡波姆胶体缓慢组分倒入主药组分中,60℃加热,并高速剪切,过程中不断搅拌并脱气,最后加入0.05%薰衣草精油、0.05%沉香精油,搅拌均匀、脱气,灌装。
本发明中药组合物中所用组分的来源、性味、归经及功效:
蜂房:本品为胡蜂科昆虫果马蜂Polistes olivaceous (DeGeer)、日本长脚胡蜂Polistes japonicus Saussure 或异腹胡蜂 Parapolybia varia Fabricius的巢。甘,平,归胃经。具有祛风,攻毒,杀虫,止痛,抗过敏的作用。主治疮疡肿毒,乳痈,瘰疬,皮肤顽癣,鹅掌风等。
紫锥菊:产于北美和加拿大南部的一种松果菊属植物,目前作为药物开发的主要有3个品种:紫松果菊(Echinacea purpurea,即通常所说的紫锥菊),狭叶紫锥菊(Echinacea augustifolia)和白色紫锥菊(Echinacen pallida)。在历史上用于治疗猩红热、梅毒、疟疾、败血症和白喉。 具有天然抗生素的作用。
血竭:为棕榈科植物麒麟竭果实及树干中的树脂。多为百合科剑叶龙血树或柬埔寨龙血树树脂。甘咸,平。入心、肝、脾经。具有活血散瘀,定痛,止血生肌,敛疮。用于治跌打肿痛,内伤瘀痛;外伤出血不止,瘰疬,臁疮溃久不合。
三七:为五加科植物三七Panax notoginseng(Burk.) F.H.Chen的根。性温,味甘、微苦。具有散瘀止血,消肿定痛。用于各种内、外出血,胸腹刺痛,跌扑肿痛。
积雪草:为双子叶植物伞形科 Umbelliferae 积雪草 Centella asiatica (L.)Urban 的干燥全草或带根全草。性寒,味苦辛。入肝,脾,肾经。功效为清热解毒,利湿消肿。主治病症有痈肿疮毒、跌扑损伤、湿热黄疸、中暑腹泻、砂淋血淋。积雪草可以使皮肤变柔软,帮助促进真皮层中胶原蛋白形成,有令肌肤紧致的效果。还可帮助受损的组织愈合及紧实肌肤。既能促进表皮与真皮之间的密切连接,又能抑制脂肪细胞的增加,防止皮肤水肿、出现肥胖。
白芨:为兰科植物白及Bletilla striata(Thunb.) Reichb. f.的干燥块茎。苦、甘、涩,微寒。归肺、肝、胃经。具有收敛止血,消肿生肌。用于外伤出血,疮疡肿毒,皮肤皲裂;肺结核咳血,咳血吐血,溃疡病出血。
蒲黄:为香蒲科植物水浊香蒲Typha angustifolia L. 、东方香蒲Typhaorientalis Presl、或同属植物的干燥花粉。甘,平,归肝、心包经。具有止血,化瘀,通淋。用于吐血,衄血,咯血,崩漏,外伤出血,经闭痛经,脘腹刺痛,跌扑肿痛,血淋涩痛。
珍珠:为珍珠贝科动物马氏珍珠贝Pteria martensii (Dunker)、蚌科动物三角帆蚌Hyriopsis cumingii (Lea)或褶纹冠蚌Cristaria plicata (Leach)等双壳类动物受刺激形成的珍珠。甘、咸,寒。归心、肝经。具有安神定惊,明目消翳,解毒生肌。用于惊悸失眠,疮疡不敛,惊风癫痫,目生云翳。
冰片:分机制冰片与艾片两类。机制冰片以松节油、樟脑等为原料经化学方法合成的龙脑;辛、苦,微寒。归心、脾、肺经。具有开窍醒神,清热止痛。用于热病神昏、痉厥,中风痰厥,气郁暴厥,中恶昏迷,目赤,口疮,咽喉肿痛,耳道流脓。
(锻)石膏:为硫酸盐类矿物硬石膏族石膏,主含含水硫酸钙(CaSO4·2H2O)。味辛、甘,性寒。功效为:生石膏清热降温,生津止渴;熟石膏清热、收敛、生肌。
天花粉:为葫芦科植物栝楼Trichosanthes kirilowii Maxim.或双边栝楼Trichosan-thes rosthornii Herms 的干燥根。甘、微苦,微寒。归肺,胃经。具有清热生津,消肿排脓。用于热病烦渴,肺热燥咳,内热消渴,疮疡肿毒。
皂角刺:为豆科植物皂荚Gleditsia sinensis Lam. 的干燥棘刺。味辛,温,归肝、胃经。具有消肿托毒,排脓,杀虫。用于痈疽初起或脓成不溃;外治疥癣麻风。
穿山甲:为鲮鲤科动物穿山甲Manis pentadactyla Linnaeus的鳞甲。味咸,微寒,归肝、胃经。具有通经下乳,消肿排脓,搜风通络。用于经闭癓瘕,乳汁不通,痈肿疮毒,关节痹痛,麻木拘挛。
黎辣根: 为鼠李科植物长叶冻绿的根或根皮。性味苦,平,有毒,入肝经。具有清热解毒;杀虫利湿。主治疥疮,顽癣疮疖,湿疹,荨麻疹,癞痢头,跌打损伤。
黄连:为毛茛科植物黄连Coptis chinensis Franch.、三角叶黄连Coptisdeltoidea C. Y. Cheng et Hsiao或云连Coptis teeta Wall.的干燥根茎。味苦,寒,归心、脾、胃、肝、胆、大肠经。具有清热燥湿,泻火解毒。用于湿热痞满,呕吐吞酸,泻痢,黄疸,高热神昏,心火亢盛,心烦不寐,血热吐衄,目赤,牙痛,消渴,痈肿疔疮;外治湿疹,湿疮,耳道流脓。
沉香:为瑞香科植物白木香Aquilaria sinensis (Lour.) Gilg 含有树脂的木材。味辛、苦,微温。具有行气止痛,温中止呕,纳气平喘。用于胸腹胀闷疼痛,胃寒呕吐呃逆,肾虚气逆喘急,挥发油成分有麻醉、镇静、止痛、肌松作用。
薰衣草:为唇形花科(Labiatae),薰衣草属(Lavandula)之多年生常绿小灌木。具有清热解毒,散风止痒,可驱风、镇静、消除肠胃胀气、腹泻、安定神经、纾解压力,可令紧张情绪快速松弛,解除焦虑,帮助入眠,具促进食欲、养颜美肤的功效。
本发明中药组方的组方分析 :本发明中药组方是以蜂房、紫锥菊、血竭、三七为君药,活血散瘀、止血生肌、定痛敛疮;以积雪草、白芨、珍珠、锻石膏、天花粉、黎辣根和皂角刺为臣药,清热解毒,利湿消肿、消肿排脓;以穿山甲、黄连为佐药,消肿排脓,搜风通络,痈肿疮毒,清热燥湿,泻火解毒 ;以薰衣草、沉香为使药,镇静、止痛、肌松、安神作用,使诸药协同配合,相辅相成,共同达到解毒消肿、活血祛瘀、生肌安神、芳香祛腐等功效,对褥疮有十分显著的治疗效果。
本发明的有益效果:
与现有技术相比,本发明的中药组合物在治疗褥疮方面具有清热解毒、活血消肿、祛腐生肌和定疼安神的功效,在清除腐毒的同时疏通血脉经络,可以促进创伤皮肤的自身生理代谢,同时进一步增强机体免疫力,增强对细菌、真菌的抵抗力,避免伤口愈合后再度感染,并对疤痕进行修复。本发明提供的其药物凝胶剂组合制备方法,适用范围广、顺应性强。
具体实施方式
中药及中药制剂领域相关人员应理解,以下实施例中所公开的技术代表本发明人发现的在本发明的实践中发挥良好作用的技术,然而,在所公开的具体实施方案中可以做出许多组合的改变,并仍然获得相同或相似的结果,而不脱离本发明的精神、范围和意义。
实施例 1:
本发明实施例 1 中药组合物包括以下重量份数的制备原料 :蜂房 20、紫锥菊15、血竭 15、三七 15、积雪草 15、白芨 15、蒲黄10、珍珠 10、冰片 5、锻石膏 5、天花粉5、皂角刺5、黎辣根5、穿山甲5、黄连 5。
凝胶成型剂由卡波姆 1.2%、丙二醇 18%、氢氧化钠 0.6%、吐温-80 1.0%、透明质酸 2%、聚硅酮 5%、异鲸蜡醇聚醚-20 2%、乙内酰脲 0.2%、苯扎氯铵0.015 %、薰衣草精油0.05%、沉香精油0.05%,其余为水组成。
A.中药组合物的制备方法包含下述步骤:
步骤1:按中药组方分别称取各味药材,洗去杂质,干燥后分别粉碎,过 60-80 目筛,备用;
步骤2:取蜂房、紫锥菊、积雪草、白芨、三七、冰片、蒲黄、锻石膏、天花粉、皂角刺、黎辣根、黄连 粗粉,加入粗粉重量的 30-45% 体积分数为 60-80% 的乙醇,回流提取2-3 次,过滤,合并滤液,滤液真空减压浓缩至 60℃条件下测相对密度为 1.25-1.35 的浓缩液,得醇提浓缩液;保留残渣。
步骤3:所述的残渣,加入总量 8-13 倍量的水浸泡 0.5-1 小时,然后煎煮 2-3次,每次 1-2 小时,过滤并保留滤渣,合并滤液,滤液真空减压浓缩至 60℃条件下测相对密度为1.25-1.35 的浓缩液,得水提浓缩液;
步骤4:取血竭、珍珠、穿山甲打成极细粉,过150目-200目筛,得混合极细粉,备用;
步骤5:将所述的极细粉、水提浓缩液和醇提浓缩液合并混匀,在 60℃温度下进行真空干燥,干燥后将干浸膏粉碎,过 120-200 目筛,即得本发明中药组合物。
B.中药组合物的凝胶剂制备方法:
步骤1,称取1.2%卡波姆,加处方量85%纯化水,浸泡溶胀,过40目筛,用氢氧化钠调配pH值至6.80,得卡波姆胶体组分;
步骤2,取8%中药组合物、18%丙二醇、1.0%吐温-80、2% 透明质酸、5% 聚硅酮、2% 异鲸蜡醇聚醚-20、0.2%乙内酰脲、0.015 % 苯扎氯铵及剩余纯化水,60℃混合搅拌均匀,用氢氧化钠调pH至6.80,得主药组分;
步骤3,将卡波姆胶体缓慢组分倒入主药组分中,60℃加热,并高速剪切,过程中不断搅拌并脱气,最后加入0.05%薰衣草精油、0.05%沉香精油,搅拌均匀、脱气,灌装。
实施例 2
本发明实施例 2 中药组合物包括以下重量份数的制备原料:蜂房15、紫锥菊25、血竭25、三七 20、积雪草 18、白芨 18、蒲黄15、珍珠13、冰片 12、锻石膏12、天花粉12、皂角刺12、黎辣根12、穿山甲8以及黄连8。
凝胶成型剂由卡波姆 1.2%、丙二醇 18%、氢氧化钠 0.6%、吐温-80 1.0%、透明质酸 2%、聚硅酮 5%、异鲸蜡醇聚醚-20 2%、乙内酰脲 0.2%、苯扎氯铵0.015 %、薰衣草精油0.05%、沉香精油0.05%,其余为水组成。
中药组合物的制备方法和中药组合物的凝胶剂制备方法如实施例 1 类似,中药组合制成凝胶剂。
实施例 3
本发明实施例 2 中药组合物包括以下重量份数的制备原料 :蜂房 30、紫锥菊25、血竭 30、三七 25、积雪草 20、白芨 20、蒲黄20、珍珠 15、冰片 15、锻石膏 15、天花粉15、皂角刺15、黎辣根15、穿山甲10以及黄连10。
凝胶成型剂由卡波姆 1.2%、丙二醇 18%、氢氧化钠 0.6%、吐温-80 1.0%、透明质酸 2%、聚硅酮 5%、异鲸蜡醇聚醚-20 2%、乙内酰脲 0.2%、苯扎氯铵0.015 %、薰衣草精油0.05%、沉香精油0.05%,其余为水组成。
中药组合物的制备方法和中药组合物的凝胶剂制备方法如实施例 1 类似,中药组合制成凝胶剂。
本发明中药组合物的凝胶制剂临床试验:
1. 临床研究对象
选取200例患有褥疮的临床志愿患者,其中男95 例,女 105 例,年龄 35-88 岁,患者在治疗前疮面直径 1-30cm,溃疡期 120 例,深度溃疡期80 例 ;将 200 例患者随机分为2 组,分别为治疗组和对照组,每组 100人。两组患者性别、年龄、身体状况、病情程度及临床表现经统计学处理差异无显著性,具有可比性(P>0.5)。
2. 试验药物及试验方法
治疗组:涂抹本发明实施例 2 制备的本发明中药组合物凝胶剂,折合生药含量为8.0%生药/管,每天睡前换药1次,加强基础护理2H翻身1次,防止创面受压,凝胶剂涂抹于已清洁的创面上,再用塑料薄膜覆盖、胶布固定,连续观察 10天。
对照组:创面周围皮肤用75%酒精消毒,创面用0.1%新洁尔灭清洁,尽量剪除坏死组织,然后敷以紫草油纱布,以无菌纱布覆盖包扎,其他与观察组相同。
3. 疗效标准
参照中医药管理局实施的《中医病证诊断疗效标准》并结合本研究的具体情况拟定观察内容。
痊愈:创口愈合,无炎性渗出,疮面缩小,有新生肉芽组织生成及上皮组织覆盖或创面结痂并脱落;
有效:创口感染控制,疮面缩小,无分泌物,有肉芽组织生成,但创口未完全愈合;
无效:治疗前后创口对比无明显改善,未见肉芽生长,创面缩小或创面未愈合。
4. 试验结果
表 1 两组临床疗效比较 (% )
组别 | N | 痊愈(率) | 有效(率) | 无效(率) | 总有效率(%) |
治疗组 | 100 | 84(84.0%) | 10(10.0%) | 6(6.0%) | 94.0% |
对照组 | 100 | 17(17.0%) | 53(53.0%) | 30(30.0%) | 70.0% |
5. 试验结论
试验结果显示,本发明制备的一种治疗褥疮的中药组合物及其凝胶制剂在治疗褥疮方面具有显著的效果,痊愈率达到84.0%,总有效率达到 94.0%,明显优于对照组的效果,临床试验结果表明,本发明制备的治疗褥疮的中药组合物及其凝胶剂在治疗褥疮方面具有显著的技术优势及临床疗效,可以作为治疗褥疮临床药物应用。
Claims (8)
1.一种治疗褥疮的中药凝胶剂,其特征在于,其组成原料由7%-9%中药组合物和91%-93%凝胶成型剂组成,中药组合物的组成原料重量份为:蜂房 20-30、紫锥菊15-30、血竭15-30、三七 15-25、积雪草 15-20、白芨 15-20、蒲黄10-20、珍珠 10-15、冰片 5-15、锻石膏 5-15、天花粉5-15、皂角刺5-15、黎辣根5-15、穿山甲5-10以及黄连 5-10;凝胶成型剂的组成原料重量百分比为:卡波姆 1.0-1.5%、丙二醇 15-20%、氢氧化钠 0.5-0.7%、吐温-800.8-1.2%、透明质酸 1.8-2.2%、聚硅酮 4-6%、异鲸蜡醇聚醚-20 1-3%、乙内酰脲 0.1-0.3%、苯扎氯铵0.013-0.018%、薰衣草精油0.04-0.06%、沉香精油0.04-0.06%,其余为纯化水组成。
2.根据权利要求 1 所述的治疗褥疮的中药凝胶剂,其特征在于,所述中药组合物的组成原料重量份为:蜂房 20、紫锥菊15、血竭 15、三七 15、积雪草 15、白芨 15、蒲黄10、珍珠10、冰片 5、锻石膏 5、天花粉5、皂角刺5、黎辣根5、穿山甲5以及黄连 5。
3. 根据权利要求 1 所述的治疗褥疮的中药凝胶剂,其特征在于,所述中药组合物的组成原料重量份为:蜂房15、紫锥菊25、血竭 25、三七 20、积雪草 18、白芨 18、蒲黄15、珍珠13、冰片 12、锻石膏12、天花粉12、皂角刺12、黎辣根12、穿山甲8以及黄连8。
4. 根据权利要求 1 所述的治疗褥疮的中药凝胶剂,其特征在于,所述中药组合物的组成原料重量份为:蜂房 30、紫锥菊25、血竭 30、三七 25、积雪草 20、白芨 20、蒲黄20、珍珠 15、冰片 15、锻石膏 15、天花粉15、皂角刺15、黎辣根15、穿山甲10以及黄连 10。
5. 根据权利要求 1 所述的治疗褥疮的中药凝胶剂,其特征在于,所述的凝胶成型剂的组成原料重量百分比为:卡波姆 1.2%、丙二醇 18%、氢氧化钠 0.6%、吐温-80 1.0%、透明质酸 2%、聚硅酮 5%、异鲸蜡醇聚醚-20 2%、乙内酰脲 0.2%、苯扎氯铵0.015 %、薰衣草精油0.05%、沉香精油0.05%,其余为纯化水组成。
6.根据权利要求1所述的治疗褥疮的中药凝胶剂,其特征在于,其组成原料优选由8%中药组合物和92%凝胶成型剂组成。
7.根据权利要求1-4任一所述的治疗褥疮的中药凝胶剂,其特征在于,所述的中药组合物制备方法如下述步骤:
步骤1:按中药组方分别称取各味药材,洗去杂质,干燥后分别粉碎,过 60-80 目筛,备用;
步骤2:取蜂房、紫锥菊、积雪草、白芨、三七、冰片、蒲黄、锻石膏、天花粉、皂角刺、黎辣根、黄连粗粉,加入粗粉重量的30-45% 体积分数为60-80% 的乙醇,回流提取2-3 次,过滤,合并滤液,滤液真空减压浓缩至 60℃条件下测相对密度为 1.25-1.35 的浓缩液,得醇提浓缩液;保留残渣;
步骤3:在上述步骤2的残渣中加入总量8-13倍量的水浸泡0.5-1小时,然后煎煮2-3次,每次1-2 小时,过滤并保留滤渣,合并滤液,滤液真空减压浓缩至 60℃条件下测相对密度为1.25-1.35的浓缩液,得水提浓缩液;
步骤4:取血竭、珍珠、穿山甲打成极细粉,过150目-200目筛,得混合极细粉,备用;
步骤5:将上述步骤4所得的极细粉、步骤3的水提浓缩液和步骤2的醇提浓缩液合并混匀,在 60℃温度下进行真空干燥,干燥后将干浸膏粉碎,过 120-200 目筛,即得。
8.如权利要求1所述的治疗褥疮的中药凝胶剂的制备方法,其特征在于,包括以下内容:
步骤1,称取1.2%卡波姆,加处方量85%纯化水,浸泡溶胀,过40目筛,用氢氧化钠调配pH值至6.80,得卡波姆胶体组分;
步骤2,称取8%中药组合物、18%丙二醇、1.0%吐温-80、2% 透明质酸、5% 聚硅酮、2% 异鲸蜡醇聚醚-20、0.2%乙内酰脲、0.015 % 苯扎氯铵及剩余纯化水,60℃混合搅拌均匀,用氢氧化钠调pH至6.80,得主药组分;
步骤3,将卡波姆胶体缓慢组分倒入主药组分中,60℃加热,并高速剪切,过程中不断搅拌并脱气,最后加入0.05%薰衣草精油、0.05%沉香精油,搅拌均匀、脱气,灌装。
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