CN113082089A - 一种治疗皮肤过敏的中药膏剂及其制备方法 - Google Patents
一种治疗皮肤过敏的中药膏剂及其制备方法 Download PDFInfo
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Abstract
本发明涉及一种治疗皮肤过敏的中药膏剂及其制备方法,其中制备方法包括如下步骤:1)准备以下各原料药材:土槿皮20‑25份;石榴皮10‑15份;白头翁3‑6份;毛茛3‑6份;松花粉5‑10份;当归2‑5份;川芎2‑5份;甘草4‑8份;2)将土槿皮、石榴皮、当归、川芎和甘草粉碎混合后,以水为溶剂进行超声浸提处理得第一中药浸膏;然后将滤渣与粉碎后的白头翁及毛茛混合,以乙醇为溶剂进行超声浸提处理,得第二中药浸膏;3)将第一中药浸膏、第二中药浸膏和松花粉混合得膏状物,然后添加适量的凡士林并充分搅拌混匀,即得。优点为,其内各味药主次分明,配伍关系合理,经验证其对皮肤过敏症引起的瘙痒有显著疗效。
Description
技术领域
本发明属于皮肤病中医治疗领域,具体涉及一种治疗皮肤过敏的中药膏剂及其制备方法。
背景技术
皮肤过敏是一种变态反应,由变应原进入机体后,促使机体产生相应的抗体,引发抗原抗体反应,表现为红斑、丘疹、风团等临床客观体征,常伴瘙痒。皮肤过敏是一种很常见的过敏形式,有20%的人有皮肤过敏现象。从医学角度讲皮肤过敏主要是指当皮肤受到各种刺激如不良反应的化妆品、化学制剂、花粉、某些食品、污染的空气等等,导致皮肤出现红肿、发痒、脱皮及过敏性皮炎等皮肤过敏症状。对于过敏,西医学认为是免疫反应过度,是一种机体的过度敏感,但从中医角度看,任何免疫反应,都是人体自愈能力的一种自我调整,也即中医所言的人体正气的调节作用。《黄帝内经》中言明“邪之所凑,其气发虚”,就皮肤过敏而言,其病因通常认为主要是外感风邪(风疹),同时又常伴有湿邪(湿疹),风气强盛则皮肤斑疹必奇痒难耐,湿气过盛则易出现疱疹发痒。因此,中医治疗皮肤过敏,以祛风除湿为主。
目前,使用化妆品导致的皮肤过敏最为常见,其中又以女性居多。治疗皮肤过敏通常采用糖皮类激素,但其长期使用容易导致皮肤萎缩、毛细血管扩张、痤疮色素异常和光过敏等副作用,且激素类药物停用后过敏易复发,治标不治本。因此如何找到安全有效的治疗皮肤过敏的方法,取得标本兼治的效果,显得越来越重要。
发明内容
本发明所要解决的技术问题是提供一种治疗皮肤过敏的中药膏剂及其制备方法,旨在克服现有技术存在的不足。
本发明解决上述技术问题的技术方案如下:一种治疗皮肤过敏的中药膏剂的制备方法,其包括如下步骤:
1)以同一重量单位计准备以下各原料药材:土槿皮20-25份;石榴皮10-15份;白头翁3-6份;毛茛3-6份;松花粉5-10份;当归2-5份;川芎2-5份;甘草4-8份;
2)将土槿皮、石榴皮、当归、川芎和甘草粉碎混合后,以水为溶剂进行超声浸提处理,过滤,滤液减压浓缩得相对密度在1.25-1.35的第一中药浸膏;然后将滤渣与粉碎后的白头翁及毛茛混合,以75-85vol%的乙醇为溶剂进行超声浸提处理,过滤,滤液减压浓缩得相对密度在1.15-1.25的第二中药浸膏;
3)将第一中药浸膏、第二中药浸膏和松花粉混合得膏状物,然后添加0.2-0.5倍膏状物质量的凡士林并充分搅拌混匀,即得所述治疗皮肤过敏的中药膏剂。
在上述技术方案的基础上,本发明还可以有如下进一步的具体或更优选择。
具体的,步骤2)中在进行超声浸提处理前相应的原料药材粉碎后过25目筛。
具体的,步骤2)中以水为溶剂进行超声浸提处理的条件为:先用水浸泡粉碎的后的药粉1h以上,然后在超声提取设备中分别以45-50kHz和55-60kHz各提取一次,每次45-60min,随后进行真空抽滤,滤液在65-75℃及真空度0.75-0.85Mpa下减压浓缩至室温下相对密度为1.25-1.35后结束,即得第一中药浸膏。
具体的,步骤2)中以75-85vol%的乙醇为溶剂进行超声浸提处理的条件为:先用75-85vol%的乙醇水溶液浸泡粉碎后的药粉和制备第一中药浸膏时过滤产生的滤渣1h以上,然后超声提取设备中分别以35-40kHz和45-50kHz各提取一次,每次45-60min,随后进行真空抽滤,滤液在65-75℃及真空度0.75-0.85Mpa下减压浓缩至室温下相对密度为1.15-1.25后结束,即得第二中药浸膏。
具体的,步骤2)中以水为溶剂进行超声浸提处理时的料液比为1g:8-10mL,以75-85vol%的乙醇为溶剂进行超声浸提处理时的料液比为1g:6-8mL。
本发明还提供了一种治疗皮肤过敏的中药膏剂,其通过上述的方法制备得到。
本发明使用到的各味中药材的性味及主要功效简述如下:
土槿皮,味辛、苦,性温,入脾经;具有祛风除湿,杀虫止痒的效果,目前主要用于治疗疥癣,湿疹和神经性皮炎等。
石榴皮,味酸、涩,性温,入大肠经;具有涩肠止泻,止血,驱虫的效果,目前主要用于久泻,久痢,便血,脱肛,崩漏,带下,虫积腹痛等,同时煮水后具有消炎杀菌、止痒、收敛的效果,可治疗皮肤疾病。
当归,味甘、辛,性温,归肝、心、脾经,具有补血活血,调经止痛,润肠通便的效果,外用可促进血液循环,延缓皮肤衰老,去除色斑,具有美容养颜的作用。
川芎,味辛,性温,入肝、胆经,行气开郁,祛除风燥湿,活血止痛,外敷具有祛风、活血、润肤、止痒、祛班、美容养颜的功效。
白头翁,苦,寒,归胃,大肠经,清热解毒,凉血止痢,能祛风除湿且止痛,主治热毒血痢,阴痒带下,其含有白头翁素,有显著的抗菌、镇痛作用。
毛茛,辛,温,有毒,归肝、胆、心、胃经,主治风湿关节痛、黄疸、牙痛和痈疮肿毒等,含有原白头翁素,对皮肤、黏膜有强烈刺激性,有很强的抗菌作用,一般其用于发泡拔脓排毒。
松花粉为松科植物马尾松Pinus massoniana Lamb.、油松Pinus tabuli formisCarr.或同属数种植物的干燥花粉,天然无刺激,外用具有祛风、收敛、止血、爽身消炎作用,用于外伤出血、湿疹、黄水疮、皮肤糜烂、脓水淋漓等。
甘草,味甘,性平,归心、肺、脾、胃经,补脾益气,清热解毒,缓急止痛,调和诸药。
与现有技术相比,本发明的有益效果是:
本发明以土槿皮和石榴皮为君药,主要利用前者祛风除湿和后者的杀菌止痒配合,消除病因,缓解症状,达到快速缓解和从根本上治疗皮肤过敏的作用;以白头翁和毛茛为臣药,其分别含有白头翁素和原白头翁素,均有较强的抗真菌作用,同时毛茛具有发泡作用,适量的毛茛能有效刺激皮肤毛孔张开而又不致起泡,毛孔张开后,君药的祛风除湿效果能有效增强,同时臣药本身具有很强的抗菌镇痛效果,确保快速止痒的效果,另外臣药中的白头翁为本方中唯一一味寒性药,可适当调和药性,使本方更中正平和;以当归、苍芎和松花粉为佐药,臣药中的毛茛因含有原白头翁素而对皮肤刺激发泡作用较强,故以松花粉的收敛性来适当中和毛茛的药性,从而避免过强刺激产生副作用,当归及苍芎可加强局部血液循环的能力,其兼具臣药和佐药效果(作为臣药加速君药的吸收,作为佐药加快臣药的作用),同时佐药中的松花粉还具有爽身作用,外用可增强药膏涂抹后的舒适性,当归及苍芎外用还兼具淡化色斑、美容养颜的功效,即佐药具有一定的护肤作用;以甘草为使药,其清热解毒,和中缓急,具有调和诸药,能够缓解药物的毒性、烈性。本发明提供的中药膏剂中各味药主次分明,配伍关系合理,经验证其对缓解和治疗皮肤过敏症(风疹、湿疹)引起的瘙痒有显著疗效。
另外,本发明在制备方法上合理使用水超声提取和乙醇超声提取配后,针对不同的中药选用适宜的提取方法能够增强提取效率,乙醇超声提取时针对水超声提取后的药渣进行再次提取,能够保证提取更充分,避免有效成份浪费;纯中药制剂,不含西药化学成份,纯天然,可有效避免使用糖皮类激素治疗皮肤过敏带来的诸多问题。
具体实施方式
以下结合具体实施例对本发明作进一步的详细描述,所举实例只用于解释本发明,并非用于限定本发明的范围。
实施例1
一种治疗皮肤过敏的中药膏剂,其制备方法包括如下步骤:
1)以同一重量单位计准备以下各原料药材:土槿皮23份;石榴皮12份;白头翁5份;毛茛4份;松花粉8份;当归4份;川芎3份;甘草6份;
2)将土槿皮、石榴皮、当归、川芎和甘草粉碎(过25目筛),粉料混合后,以水为溶剂进行超声浸提处理,先用水浸泡药粉1h,料液比为1g:9mL(药粉质量与所用溶剂体积的比),然后在超声提取设备中分别以45-50kHz和55-60kHz各提取一次,每次45min,随后进行真空抽滤,滤液在65-75℃及真空度0.75-0.85Mpa下减压浓缩至室温下相对密度为1.25-1.30后结束,即得第一中药浸膏;然后将滤渣与粉碎后的白头翁及毛茛(过25目筛)混合,先用75vol%的乙醇水溶液浸泡药粉和制备第一中药浸膏时过滤产生的滤渣1h,料液比为1g:7mL然后超声提取设备中分别以35-40kHz和45-50kHz各提取一次,每次45min,随后进行真空抽滤,滤液在65-75℃及真空度0.75-0.85Mpa下减压浓缩至室温下相对密度为1.15-1.20后结束,即得第二中药浸膏;
3)将第一中药浸膏、第二中药浸膏和松花粉混合得膏状物,然后添加0.3倍膏状物质量的凡士林并充分搅拌混匀,即得所述治疗皮肤过敏的中药膏剂。
实施例2
一种治疗皮肤过敏的中药膏剂,其制备方法包括如下步骤:
1)以同一重量单位计准备以下各原料药材:土槿皮20份;石榴皮10份;白头翁3份;毛茛3份;松花粉5份;当归2份;川芎2份;甘草4份;
2)将土槿皮、石榴皮、当归、川芎和甘草粉碎(过25目筛),粉料混合后,以水为溶剂进行超声浸提处理,先用水浸泡药粉1.2h,料液比为1g:8mL(药粉质量与所用溶剂体积的比),然后在超声提取设备中分别以45-50kHz和55-60kHz各提取一次,每次60min,随后进行真空抽滤,滤液在65-75℃及真空度0.75-0.85Mpa下减压浓缩至室温下相对密度为1.25-1.30后结束,即得第一中药浸膏;然后将滤渣与粉碎后的白头翁及毛茛(过25目筛)混合,先用80vol%的乙醇水溶液浸泡药粉和制备第一中药浸膏时过滤产生的滤渣1.2h,料液比为1g:6mL然后超声提取设备中分别以35-40kHz和45-50kHz各提取一次,每次60min,随后进行真空抽滤,滤液在65-75℃及真空度0.75-0.85Mpa下减压浓缩至室温下相对密度为1.15-1.20后结束,即得第二中药浸膏;
3)将第一中药浸膏、第二中药浸膏和松花粉混合得膏状物,然后添加0.2倍膏状物质量的凡士林并充分搅拌混匀,即得所述治疗皮肤过敏的中药膏剂。
实施例3
一种治疗皮肤过敏的中药膏剂,其制备方法包括如下步骤:
1)以同一重量单位计准备以下各原料药材:土槿皮25份;石榴皮15份;白头翁6份;毛茛6份;松花粉10份;当归5份;川芎5份;甘草8份;
2)将土槿皮、石榴皮、当归、川芎和甘草粉碎(过25目筛),粉料混合后,以水为溶剂进行超声浸提处理,先用水浸泡粉碎后的药粉1h,料液比为1g:10mL(药粉质量与所用溶剂体积的比),然后在超声提取设备中分别以45-50kHz和55-60kHz各提取一次,每次50min,随后进行真空抽滤,滤液在65-75℃及真空度0.75-0.85Mpa下减压浓缩至室温下相对密度为1.30-1.35后结束,即得第一中药浸膏;然后将滤渣与粉碎后的白头翁及毛茛(过25目筛)混合,先用85vol%的乙醇水溶液浸泡粉碎后的药粉和制备第一中药浸膏时过滤产生的滤渣1h,料液比为1g:8mL然后超声提取设备中分别以35-40kHz和45-50kHz各提取一次,每次50min,随后进行真空抽滤,滤液在65-75℃及真空度0.75-0.85Mpa下减压浓缩至室温下相对密度为1.20-1.25后结束,即得第二中药浸膏;
3)将第一中药浸膏、第二中药浸膏和松花粉混合得膏状物,然后添加0.5倍膏状物质量的凡士林并充分搅拌混匀,即得所述治疗皮肤过敏的中药膏剂。
对比例1
与实施例1的制备方法相同,本对比例在选择组方时与实施例1相比仅未使用毛茛和白头翁,其余相同。
对比例2
实施例1的制备方法相同,本对比例在选择组方时与实施例1相比仅未使用当归、苍芎及松花粉,其余相同。
为验证本发明提供的治疗皮肤过敏的中药膏剂的安全性和药效,进行了动物皮肤涂抹试验和志愿者临床试验,具体如下:
动物试验:取健康豚鼠20只,分成5组,每组4只,鼠背部剃毛露出皮肤,大小约3cm×5cm,5组豚鼠分别一一对应均匀涂抹实施例1至3和对比例1和2的中药膏剂,早晚各一次,每只鼠一次涂药量约为1.2g,连续一周后,观察鼠背皮肤情况,记录如下:
动物试验表明,本发明提供的中药药膏各组份配伍合理,使用后对皮肤无明显刺激,较为温和且安全,对比例2因缺少佐药成份当归、苍芎和松花粉,不能有效中和毛茛的毒副作用,导致皮肤出现损伤。
临床资料:以实施例1和对比例1对应的中药膏剂为代表,对40例有皮肤过敏症且正处于发作期的志愿者进行涂药治疗,志愿者年龄在6-65岁之间,皮肤过敏症包括风疹、湿疹、神经性皮炎和老年性皮肤瘙痒等,症状以有明显的皮肤红斑和/或瘙痒为特征,均分成两组,每组20例分别施用实施例1和对比例1的中药膏剂,涂药时以约0.1g/cm2为基准,早中晚各一次,持续使用一至两周,统计结果表明,本发明实施例1提供的中药膏剂对及时缓解瘙痒有奇效,见效快,一般涂抹后5min左右即可明显缓解瘙痒且药效可持续4h以上,对缓解瘙痒的有效率在90%以上(约18例有效,2例无明显变化),85%以上的病患三天左右皮肤上红斑即可明显出现消退,85%以上的病患(17例治愈,1例症状有明显缓解,2例无明显变化)在一至两周即可治愈且停药一月未见复发,未观察到用药后症状明显加重病例;对比例1对应的中药膏使用后也有缓解瘙痒效果,但见效慢,一般涂药后30min左右可明显缓解瘙痒,药效持续4h左右,对缓解瘙痒的有效率在85%以上,75%以上的病患七天左右皮肤上红斑明显开始消退,持续用药两周后65%以上的病患得以治愈,同样未观察到用药后加重病例。本发明提供的中药膏剂广泛适用于一般人群,婴幼儿及孕妇慎用。
以上所述仅为本发明的较佳实施例,并不用以限制本发明,凡在本发明的精神和原则之内,所作的任何修改、等同替换、改进等,均应包含在本发明的保护范围之内。
Claims (6)
1.一种治疗皮肤过敏的中药膏剂的制备方法,其特征在于,包括如下步骤:
1)以同一重量单位计准备以下各原料药材:土槿皮20-25份;石榴皮10-15份;白头翁3-6份;毛茛3-6份;松花粉5-10份;当归2-5份;川芎2-5份;甘草4-8份;
2)将土槿皮、石榴皮、当归、川芎和甘草粉碎混合后,以水为溶剂进行超声浸提处理,过滤,滤液减压浓缩得相对密度在1.25-1.35的第一中药浸膏;然后将滤渣与粉碎后的白头翁及毛茛混合,以75-85vol%的乙醇为溶剂进行超声浸提处理,过滤,滤液减压浓缩得相对密度在1.15-1.25的第二中药浸膏;
3)将第一中药浸膏、第二中药浸膏和松花粉混合得膏状物,然后添加0.2-0.5倍膏状物质量的凡士林并充分搅拌混匀,即得所述治疗皮肤过敏的中药膏剂。
2.根据权利要求1所述的一种治疗皮肤过敏的中药膏剂的制备方法,其特征在于,步骤2)中在进行超声浸提处理前相应的原料药材粉碎后过25目筛。
3.根据权利要求1所述的一种治疗皮肤过敏的中药膏剂的制备方法,其特征在于,步骤2)中以水为溶剂进行超声浸提处理的条件为:先用水浸泡粉碎的后的药粉1h以上,然后在超声提取设备中分别以45-50kHz和55-60kHz各提取一次,每次45-60min,随后进行真空抽滤,滤液在65-75℃及真空度0.75-0.85Mpa下减压浓缩至室温下相对密度为1.25-1.35后结束,即得第一中药浸膏。
4.根据权利要求1所述的一种治疗皮肤过敏的中药膏剂的制备方法,其特征在于,步骤2)中以75-85vol%的乙醇为溶剂进行超声浸提处理的条件为:先用75-85vol%的乙醇水溶液浸泡粉碎后的药粉和制备第一中药浸膏时过滤产生的滤渣1h以上,然后超声提取设备中分别以35-40kHz和45-50kHz各提取一次,每次45-60min,随后进行真空抽滤,滤液在65-75℃及真空度0.75-0.85Mpa下减压浓缩至室温下相对密度为1.15-1.25后结束,即得第二中药浸膏。
5.根据权利要求1所述的一种治疗皮肤过敏的中药膏剂的制备方法,其特征在于,步骤2)中以水为溶剂进行超声浸提处理时的料液比为1g:8-10mL,以75-85vol%的乙醇为溶剂进行超声浸提处理时的料液比为1g:6-8mL。
6.一种治疗皮肤过敏的中药膏剂,其特征在于,通过权利要求1至5任一项所述的方法制备得到。
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