CN104398796B - 一种渗出性皮肤病用湿敷剂及其制备方法 - Google Patents
一种渗出性皮肤病用湿敷剂及其制备方法 Download PDFInfo
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Abstract
本发明涉及一种渗出性皮肤病用湿敷剂及其制备方法,其有效原料药及重量份比为:地肤子3份、黄柏3份、何首乌2份、金银花2份、杜仲炭1.5份、蛇床子1.5份、穿心莲1份、明矾1.5份、黄精1份、细辛1份和甘草1.5份,所述湿敷剂还可包括杠板归1份、血竭0.2份、水溶性红没药醇0.1份、水溶性蜂胶0.1份、竹茹2份和石榴皮1份,其制备方法采用浸泡、两次加热后药液混合的方式获得,工艺简单,易操作,本发明得到的湿敷剂采用冷湿敷疗法起到清热解毒燥湿、散瘀消肿止痛、止渗止痒敛疮的功效,具有愈合快、见效快的优点,抑菌效果好且温和无刺激性,不易引起皮肤过敏反应,湿敷剂清澈不粘稠且不宜结晶,易于喷洒。
Description
技术领域
本发明涉及一种治疗皮肤病的药物,适用于渗出性皮肤病,具体地说,涉及一种渗出性皮肤病用湿敷剂、制备方法及湿敷剂用治疗仪,属于中医药领域。
背景技术
渗出性皮肤病是皮肤科常见的临床病症,病因多种多样,如接触性皮炎、急性及亚急性湿疹、多种药疹、脓疱疮、各种免疫性大疱病及浅表的烧烫伤等,均可出现皮肤渗出,可伴有红斑、水疱、糜烂、结痂,甚至出现脓疱及脓液渗出等。以上情况会让病人无法正常工作生活,如不立即处理,可以导致严重感染、溃疡形成等并发症。
冷湿敷有抑制渗出、解毒消肿、收敛止痒、控制感染、软痂脱腐、清洁疮面、促进皮损愈合的功能,是处理渗出性皮肤病的常用方法。湿敷溶液常用的有硼酸溶液、生理盐水及多种中药汤剂等。
授权公告号为 CN102119976B,发明名称为“一种治疗急性炎性渗出性皮肤病的外用制剂”的发明专利公开了一种制剂,该制剂由以下重量份的原料药制成:苦参2-6,地榆2-4,五倍子1-3,黄柏2-5,地肤子2-5,威灵仙2-5,透骨草2-5,枯矾1-3。其制备方法为称取苦参60g、地榆40g、五倍子30g、黄柏50g、地肤子50g、威灵仙30g、透骨草30g和枯矾10g,粉碎成粗粉,加入70%乙醇1000ml,密封浸渍20天,每2天振摇1次,滤过,再加入70%乙醇定容至1000ml。称取苦参60g、地榆40g、五倍子30g、黄柏50g、地肤子50g、威灵仙30g、透骨草30g和枯矾10g,粉碎成粗粉,加入70%乙醇1000ml,密封浸渍20天,每2天振摇1次,滤过,再加入70%乙醇定容至1000ml。
该发明所述的外用制剂可以是洗剂、搽剂、喷雾剂或酊剂,将其施于急性炎性渗出性皮肤病的患处具有清热燥湿、敛湿止痒之功,故风、热、毒、湿皆可除,可敛,功效显著,但见效慢,创面愈合慢,且该外用制剂中含有大量乙醇,刺激性强,易引起皮肤过敏。
发明内容
本发明要解决的技术问题是针对以上不足,提供一种渗出性皮肤病用湿敷剂,克服了现有技术中愈合慢、见效慢的缺陷,采用本发明的药物后,具有愈合快、见效快的优点,抑菌效果好且温和无刺激性,不易引起皮肤过敏反应,湿敷剂清澈不粘稠且不易结晶,易于喷洒。
本发明的目的之二在于提供一种渗出性皮肤病用湿敷剂的制备方法,具有工艺简单、易操作的优点,制备效率高。
为解决以上技术问题,本发明采用以下技术方案:一种渗出性皮肤病用湿敷剂,其有效原料药及重量份比为:地肤子3份、黄柏3份、何首乌2份、金银花2份、杜仲炭1.5份、蛇床子1.5份、穿心莲1份、明矾1.5份、黄精1份、细辛1份和甘草1.5份。
采用该技术方案获得的湿敷剂用于治疗渗出性皮肤病时,有效率达到99.2%,一年复发率仅为0.8%,使用三天后患处停止渗出,皮损明显减少,温和无刺激性。
一种优化方案,所述湿敷剂包括地肤子3份、黄柏3份、何首乌2份、金银花2份、杜仲炭1.5份、蛇床子1.5份、穿心莲1份、明矾1.5份、黄精1份、细辛1份、甘草1.5份、杠板归1份、血竭0.2份、水溶性红没药醇0.1份、水溶性蜂胶0.1份、竹茹2份和石榴皮1份。
采用该技术方案获得的湿敷剂用于治疗渗出性皮肤病时,有效率达到100%,且一年复发率为0,显效时间快,使用一天后患处停止渗出,皮损明显减少,温和无刺激性。
另一种优化方案,所述湿敷剂的制备方法包括以下步骤:
1)取药:按照上述分量取原料药;
2)炒石榴皮:将石榴皮置热锅内,用文火加热炒至色略深,筛去灰渣,加入水溶性红没药醇和水溶性蜂胶,加水至没石榴皮,浸泡10天后过滤分离出滤液;
3)初步混合:将地肤子、黄柏、何首乌、金银花、杜仲炭、蛇床子、穿心莲、黄精、细辛、甘草、杠板归、血竭和竹茹混合均匀,得到原料药初步混合物;
4)浸泡:在原料药初步混合物中加入体积比为原料药初步混合物10倍量的水浸泡20分钟;
5)加热:文火煮15分钟;
6)过滤:收集滤液得第一次药液和药渣;
7)二次加热:在药渣中加入体积比为药渣8倍量的水进行二次加热,二次加热时间为10分钟;
8)加入明矾;
9)继续加热:继续加热5分钟;
10)过滤:收集滤液得第二次药液和药渣;
11)混合:将步骤2)中得到的滤液、步骤6)中得到的第一次药液和步骤10)中得到的第二次药液混合均匀。
经过大量试验验证,采用该技术方案,保证了原料药中的药效成分最大限度地溶解在水中,且有利于快速高效地促进原料药中的药效成分溶解,既保证了湿敷剂的快速制备,又能保证药效成分的浓度,且使得湿敷剂清澈不粘稠且不易结晶,易于喷洒,药效成分保持活性。
采用上述制备方法,工艺简单、易操作,获得的湿敷剂药效成分浓度高、清澈不粘稠且不易结晶,易于喷洒。
本发明采用以上技术方案后,与现有技术相比,具有以下优点:清热解毒、补肝益肾利湿、祛风止痒、补益气血功效,消除炎症水肿,抑菌抗炎止血,抗***反应,改善微循环,促进伤口愈合。君、臣药物科学组方,君药为黄柏、金银花和地肤子,具有清热解毒、利湿止痒的功效,但其作用相对单一,故配以臣药作为补充,臣药为杜仲炭、何首乌、蛇床子、穿心莲、黄精、细辛、甘草和明矾,除了加强抗微生物的作用外,杜仲炭、何首乌、黄精补肝益肾、止血祛风,蛇床子、穿心莲、甘草、细辛镇痛抗炎,抗***反应,减少毛细血管通透性;明矾有较强的收敛消肿作用,再配以杠板归、血竭、水溶性红没药醇、水溶性蜂胶、竹茹和石榴皮,各种药物取长补短,相互作用,迅速起到抗菌、控制局部炎症、水肿及渗出,促进创面愈合的作用。本发明制得的湿敷剂采用冷湿敷疗法起到清热解毒燥湿、散瘀消肿止痛、止渗止痒敛疮的功效,具有愈合快、见效快的优点,抑菌效果好且温和无刺激性,不易引起皮肤过敏反应,湿敷剂清澈不粘稠且不易结晶,易于喷洒。
下面结合实施例对本发明进行详细说明。
具体实施方式
实施例1,一种渗出性皮肤病用湿敷剂,其有效原料药及重量份比为:地肤子3份、黄柏3份、何首乌2份、金银花2份、杜仲炭1.5份、蛇床子1.5份、穿心莲1份、明矾1.5份、黄精1份、细辛1份、甘草1.5份、杠板归1份、血竭0.2份、水溶性红没药醇0.1份、水溶性蜂胶0.1份、竹茹2份和石榴皮1份。
本实施例中以1份原料药10g为例进行说明:所述湿敷剂的制备方法包括以下步骤:
1)取药:按照上述分量取原料药;
2)炒石榴皮:将石榴皮置热锅内,用文火加热炒至色略深,筛去灰渣,加入水溶性红没药醇和水溶性蜂胶,加水至没石榴皮,浸泡10天后过滤分离出滤液;
3)初步混合:将地肤子、黄柏、何首乌、金银花、杜仲炭、蛇床子、穿心莲、黄精、细辛、甘草、杠板归、血竭和竹茹混合均匀,得到原料药初步混合物;
4)浸泡:在原料药初步混合物中加入体积比为原料药初步混合物10倍量的水浸泡20分钟;
5)加热:文火煮15分钟;
6)过滤:收集滤液得第一次药液和药渣;
7)二次加热:在药渣中加入体积比为药渣8倍量的水进行二次加热,二次加热时间为10分钟;
8)加入明矾;
9)继续加热:继续加热5分钟;
10)过滤:收集滤液得第二次药液和药渣;
11)混合:将步骤2)中得到的滤液、步骤6)中得到的第一次药液和步骤10)中得到的第二次药液混合均匀,即可获得湿敷剂。
实施例2,一种渗出性皮肤病用湿敷剂,其有效原料药及重量份比为:地肤子3份、黄柏3份、何首乌2份、金银花2份、杜仲炭1.5份、蛇床子1.5份、穿心莲1份、明矾1.5份、黄精1份、细辛1份和甘草1.5份。
本实施例中以1份原料药10g为例进行说明:所述湿敷剂的制备方法包括以下步骤:
1)取药:按照上述分量取原料药;
2)混合:将地肤子、黄柏、何首乌、金银花、杜仲炭、蛇床子、穿心莲、黄精、细辛和甘草混合均匀,得到原料药初步混合物;
3)浸泡:在原料药初步混合物中加入体积比为原料药初步混合物10倍量的水浸泡20分钟;
4)加热:文火煮15分钟;
5)过滤:收集滤液得第一次药液和药渣;
6)二次加热:在药渣中加入体积比为药渣8倍量的水进行二次加热,二次加热时间为10分钟;
7)加入明矾;
8)继续加热:加入明矾后继续加热5分钟;
9)过滤:收集滤液得第二次药液和药渣;
10)混合:将步骤5)中得到的第一次药液和步骤9)中得到的第二次药液混合均匀,即可获得湿敷剂。
使用方法:局部冷湿敷,将6层无菌纱布覆盖在患有渗出性皮肤病的皮损上,将湿敷剂均匀地喷洒在纱布上,15分钟更换纱布,一天湿敷两次,一个疗程7天。
将所述湿敷剂用于治疗渗出性皮肤病的试验,治疗效果的评定标准为:1)治愈:患处停止渗出,皮损消失;2)好转:患处停止渗出,皮损减少;3)无效:患处的渗出及皮损均未减轻。
对比试验:选取360例渗出性皮肤病患者,其中包含急性湿疹150例、接触性皮炎80例、带状疱疹50例、脓疱疮50例和手足癣合并感染30例,将360例患者随机分成3组,每组120例,分别作为试验组1、试验组2和对照组,试验组1采用本发明实施例1制备的湿敷剂,实施例2采用本发明实施例2制备的湿敷剂,对照组采用康复新液治疗,各组别分别治疗一个疗程,试验结束后跟踪随访一年,记录复发情况,试验治疗过程中同时记录显效时间,并根据患者反馈记录是否具有刺激性。
在对比试验过程中,急性湿疹及接触性皮炎患者湿敷治疗同时给予抗组胺药物及小剂量强的松口服,带状疱疹、脓疱疮及手足癣合并感染患者治疗同时给予相应抗病毒药物或抗生素口服。
一个疗程后的治疗结果对比情况如表1所示。
从以上数据可以看出,使用本发明2个实施例制备的药物治疗渗出性皮肤病,本发明2个实施例制备的湿敷剂的有效率均比对照组常规治疗的有效率高,其中实施例1制备的湿敷剂的效果最好,总有效率达到100%,且一年复发率为0,显效时间快,使用一天后患处停止渗出,皮损明显减少,温和无刺激性。
实施例2制备的湿敷剂与对照组相比,治疗效果也有大幅提升,有效率达到99.2%,一年复发率仅为0.8%,使用三天后患处停止渗出,皮损明显减少,温和无刺激性。
为了进一步判断原料药中杠板归、血竭、水溶性红没药醇、水溶性蜂胶、竹茹和石榴皮对湿敷剂治疗效果的影响,通过随机、双盲、阳性对照临床试验方法,客观评价本发明湿敷剂对渗出性皮肤病的临床治疗效果和安全性,试验方案如表2所示,基础方案为本发明实施例1中的湿敷剂,其余方案中杠板归、血竭、水溶性红没药醇、水溶性蜂胶、竹茹和石榴皮的重量份比发生变化,其余原料药(未在表2中逐一列出)的重量份比与实施例1中保持不变。
将表2中所述的方案采用实施例中1的制备方法制备湿敷剂,观察所获得的湿敷剂的外观,其结果如表3所示。
将表2中所述的方案采用实施例中1的制备方法制备湿敷剂,应用于临床实践,经过长期大量临床试验得到统计结果如表4所示,治疗有效率为治愈病例与好转病例的总和占总病例数的比例。
综上所述,实施例1获得的湿敷剂治疗效果最佳,且清澈、不粘稠、室温下不结晶、喷洒均匀度高,尤其适合配合药液喷洒装置对患者进行护理,提高护理效率,利于推广使用。
通过上述对本发明湿敷剂的临床疗效和安全性的试验研究,证明本发明实施例中的湿敷剂对接触性皮炎、急性湿疹、脓疱疮、带状疱疹和手足癣合并感染等渗出性皮肤病具有良好地治疗效果,并可消除患者的临床症状以及体征,清除致病菌,此外据临床观察发现,本发明实施例中的湿敷剂对各种有水疱渗出的药疹、自身免疫性大疱病、间擦疹及浅表烫伤也有很好的治疗效果。可见,本发明溶液剂的临床疗效确切,安全性高,使用方便且适应症广泛,是一种安全有效的湿敷用中药制剂。
以上所述为本发明最佳实施方式的举例,其中未详细述及的部分均为本领域普通技术人员的公知常识。本发明的保护范围以权利要求的内容为准,任何基于本发明的技术启示而进行的等效替代,也在本发明的保护范围之内。
Claims (3)
1.一种渗出性皮肤病用湿敷剂,其特征在于:所述湿敷剂的有效原料药及重量份比为:地肤子3份、黄柏3份、何首乌2份、金银花2份、杜仲炭1.5份、蛇床子1.5份、穿心莲1份、明矾1.5份、黄精1份、细辛1份和甘草1.5份。
2.一种渗出性皮肤病用湿敷剂,其特征在于:所述湿敷剂的有效原料药及重量份比为:地肤子3份、黄柏3份、何首乌2份、金银花2份、杜仲炭1.5份、蛇床子1.5份、穿心莲1份、明矾1.5份、黄精1份、细辛1份、甘草1.5份、杠板归1份、血竭0.2份、水溶性红没药醇0.1份、水溶性蜂胶0.1份、竹茹2份和石榴皮1份。
3.如权利要求2所述的一种渗出性皮肤病用湿敷剂的制备方法,其特征在于:所述制备方法包括以下步骤:
1)取药:按照上述份量取原料药;
2)炒石榴皮:将石榴皮置热锅内,用文火加热炒至色略深,筛去灰渣,加入水溶性红没药醇和水溶性蜂胶,加水至没石榴皮,浸泡10天后过滤分离出滤液;
3)初步混合:将地肤子、黄柏、何首乌、金银花、杜仲炭、蛇床子、穿心莲、黄精、细辛、甘草、杠板归、血竭和竹茹混合均匀,得到原料药初步混合物;
4)浸泡:在原料药初步混合物中加入体积比为原料药初步混合物10倍量的水浸泡20分钟;
5)加热:文火煮15分钟;
6)过滤:收集滤液得第一次药液和药渣;
7)二次加热:在药渣中加入体积比为药渣8倍量的水进行二次加热,二次加热时间为10分钟;
8)加入明矾;
9)继续加热:继续加热5分钟;
10)过滤:收集滤液得第二次药液和药渣;
11)混合:将步骤2)中得到的滤液、步骤6)中得到的第一次药液和步骤10)中得到的第二次药液混合均匀;
采用所述制备方法制得的湿敷剂清澈不粘稠且不易结晶。
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