CN110179871A - 一种治疗湿疹的外用中药组合物及其制备方法 - Google Patents
一种治疗湿疹的外用中药组合物及其制备方法 Download PDFInfo
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Abstract
本发明提供了一种治疗湿疹的外用中药组合物及其制备方法,属于外用中药组合物技术领域。一种治疗湿疹的外用中药组合物,按重量份数计,包括以下组分及配比:蟾酥3‑5重量份、陈艾33‑38重量份、蛇床子28‑32重量份、天然冰片3‑5重量份、苦参28‑30份、荆芥25‑30重量份、黄芩11‑13重量份、黄连11‑13重量份、雪见草11‑13重量份。本发明制备的所述的外用中药组合物可应用于临床治疗湿疹,疗效显著。
Description
技术领域
本发明属于外用中药组合物技术领域,具体涉及一种治疗湿疹的外用中药组合物及其制备方法。
背景技术
湿疹是由多种内外因素引起的多形性、具有渗出倾向的炎症性皮肤疾病,属于变态反应性皮肤病,表现为瘙痒剧烈,根据临床表现的不同分为急性湿疹和亚急性湿疹以及慢性湿疹。湿疹是目前的成人及儿童都易患有的常见皮肤病。中医称湿疹为“浸淫疮、血风疮、粟疮、旋耳疮、窝疮、肾囊风、脐疮、四弯风、乳头风”等,中医学认为,湿疹缘于禀赋不足,饮食失节或过食辛辣刺激荤腥之物,脾胃受损,失其健运,湿热内生,又兼外受风邪,内外两邪相博,风湿热邪浸淫肌肤所致。现代医学对湿疹的发病机制中的真正病因尚未探清。国家中医药管理局发布的《中医常见病症诊疗常规》中,将湿疹辩证分为湿热浸淫、脾虚湿蕴、血虚风噪三型。
目前,对于湿疹的治疗主要是使用糖皮质激素、免疫调节剂或者外加抗生素制剂,虽然可以缓解湿疹症状,但无法根除,且容易产生耐药性和多种不良反应等。
发明内容
本发明针对上述情况,提出了一种治疗湿疹的外用中药组合物,能够有效地治疗湿疹,疗效显著。
本发明通过如下技术方案实现上述目的:
一种治疗湿疹的外用中药组合物,按重量份数计,包括以下组分及配比:
蟾酥3-5重量份、陈艾33-38重量份、蛇床子28-32重量份、天然冰片3-5重量份、苦参28-30份、荆芥25-30重量份、黄芩11-13重量份、黄连11-13重量份、雪见草11-13重量份。
优选的,所述外用中药组合物,按重量份数计,包括以下组分及配比:蟾酥3重量份、陈艾34重量份、蛇床子30重量份、天然冰片3重量份、苦参28重量份、荆芥27重量份、黄芩11重量份、黄连11重量份、雪见草12重量份。
本发明中所述的外用中药组合物的制备方法包括以下步骤:
(1)称取配方比的陈艾、苦参、荆芥、黄芩、黄连、雪见草全草,加入6-10倍质量的水浸泡20-30min,之后,将原料和浸泡液一并移入挥发油提取器中,蒸馏1-2h,获得挥发油,备用;
(2)称取配方比的蛇床子,蛇床子加入步骤(1)蒸馏后剩下的含料渣的水液中,再加入4-6倍质量的水后,一并煎煮1-1.5h,过滤,滤渣再加入4-6倍质量的水煎煮0.5h,过滤,合并两次滤液;
(3)向步骤(1)中的滤液内边搅拌边加入乙醇并使溶液的醇含量达到55%-65%,静置24-48h,过滤,取滤液,回收乙醇,浓缩成稠膏,向稠膏中加入配方比的蟾酥,混匀,干燥成粉,将粉与冰片研匀后喷入挥发油,混匀即可。
进一步的,所述外用中药组合物还可根据实际需要,添加药物制剂上允许添加的任意辅助成分制成任意剂型,优选剂型为乳剂、搽剂、洗剂剂型。
本发明的外用中药组合物或制成的剂型直接涂抹在患处,应用于临床治疗湿疹,还可应用于治疗各种皮肤炎症。
本发明相对于现有技术,其有益效果在于:
本发明提供的外用中药组合物用于临床治疗湿疹,起效快,疗效显著,治愈率高,同时能够克服激素类药物治疗湿疹过程中造成的病情反复和耐药性等问题,具有明显的优势。
具体实施方式
下面结合具体实施例,对本发明作进一步地说明。
实施例一 配方及制剂制备
例1
配方1:蟾酥3重量份、陈艾33重量份、蛇床子28重量份、天然冰片3重量份、苦参28份、荆芥25重量份、黄芩11重量份、黄连11重量份、雪见草11重量份。
外用中药组合物1制备过程:
(1)称取配方比的陈艾、苦参、荆芥、黄芩、黄连、雪见草全草,加入10倍质量的水浸泡30min,之后,将原料和浸泡液一并移入挥发油提取器中,加热至100℃,蒸馏2h,获得挥发油,备用;
(2)称取配方比的蛇床子,蛇床子加入步骤(1)蒸馏后剩下的含料渣的水液中,再加入4倍质量的水后,一并煎煮1h,过滤,滤渣再加入6倍质量的水煎煮0.5h,过滤,合并两次滤液;
(3)向步骤(1)中的滤液内边搅拌边加入乙醇并使溶液的醇含量达到60%,静置24-48h,过滤,取滤液,回收乙醇,浓缩成稠膏,向稠膏中加入配方比的蟾酥,混匀,干燥成粉,将粉与冰片研匀后喷入挥发油,混匀即可,制得外用中药组合物1。
制剂1制备:
取上述制得的外用中药组合物1,加入适量生理盐水至含药浓度为1g/ml,制得外用中药组合物洗剂1,密封阴凉保存。
例2
配方2:蟾酥5重量份、陈艾38重量份、蛇床子32重量份、天然冰片5重量份、苦参30份、荆芥30重量份、黄芩13重量份、黄连13重量份、雪见草13重量份。
外用中药组合物2制备过程:
(1)称取配方比的陈艾、苦参、荆芥、黄芩、黄连、雪见草全草,加入6倍质量的水浸泡20min,之后,将原料和浸泡液一并移入挥发油提取器中,加热至100℃,蒸馏2h,获得挥发油,备用;
(2)称取配方比的蛇床子,蛇床子加入步骤(1)蒸馏后剩下的含料渣的水液中,再加入5倍质量的水后,一并煎煮1h,过滤,滤渣再加入4倍质量的水煎煮0.5h,过滤,合并两次滤液;
(3)向步骤(1)中的滤液内边搅拌边加入乙醇并使溶液的醇含量达到55%,静置24-48h,过滤,取滤液,回收乙醇,浓缩成稠膏,向稠膏中加入配方比的蟾酥,混匀,干燥成粉,将粉与冰片研匀后喷入挥发油,混匀即可。
例3
配方3:蟾酥3重量份、陈艾34重量份、蛇床子30重量份、天然冰片3重量份、苦参28重量份、荆芥27重量份、黄芩11重量份、黄连11重量份、雪见草12重量份。
外用中药组合物3制备过程:
(1)称取配方比的陈艾、苦参、荆芥、黄芩、黄连、雪见草全草,加入8倍质量的水浸泡30min,之后,将原料和浸泡液一并移入挥发油提取器中,加热至100℃,蒸馏1.5h,获得挥发油,备用;
(2)称取配方比的蛇床子,蛇床子加入步骤(1)蒸馏后剩下的含料渣的水液中,再加入5倍质量的水后,一并煎煮1h,过滤,滤渣再加入6倍质量的水煎煮0.5h,过滤,合并两次滤液;
(3)向步骤(1)中的滤液内边搅拌边加入乙醇并使溶液的醇含量达到60%,静置24-48h,过滤,取滤液,回收乙醇,浓缩成稠膏,向稠膏中加入配方比的蟾酥,混匀,干燥成粉,将粉与冰片研匀后喷入挥发油,混匀即可。
例4
配方4:蟾酥3重量份、陈艾36重量份、蛇床子30重量份、天然冰片3重量份、苦参28份、荆芥27重量份、黄芩12重量份、黄连11重量份、雪见草13重量份。
外用中药组合物4制备过程:
(1)称取配方比的陈艾、苦参、荆芥、黄芩、黄连、雪见草全草,加入7倍质量的水浸泡25min,之后,将原料和浸泡液一并移入挥发油提取器中,加热至100℃,蒸馏1h,获得挥发油,备用;
(2)称取配方比的蛇床子,蛇床子加入步骤(1)蒸馏后剩下的含料渣的水液中,再加入5倍质量的水后,一并煎煮1h,过滤,滤渣再加入5倍质量的水煎煮0.5h,过滤,合并两次滤液;
(3)向步骤(1)中的滤液内边搅拌边加入乙醇并使溶液的醇含量达到65%,静置24-48h,过滤,取滤液,回收乙醇,浓缩成稠膏,向稠膏中加入配方比的蟾酥,混匀,干燥成粉,将粉与冰片研匀后喷入挥发油,混匀即可。
对比例1
例1中不加入雪见草,其余与例1的制备步骤相同,制得不含雪见草的对比制剂1。向对比制剂1中加入适量生理盐水至含药浓度为1g/ml,制得不含雪见草的对比洗剂1,密封阴凉保存。
对比例2
例1中不加入蟾酥,步骤(3)中的浓缩稠膏直接干燥成粉,其余与例1的制备步骤相同,制得不含蟾酥的对比制剂2。向对比制剂2中加入适量生理盐水至含药浓度为1g/ml,制得不含雪见草的对比洗剂2,密封阴凉保存。
对比例3
例1中不加入冰片,步骤(3)中的干粉直接喷入挥发油混匀,其余与例1的制备步骤相同,制得不含冰片的对比制剂3。向对比制剂3中加入适量生理盐水至含药浓度为1g/ml,制得不含雪见草的对比洗剂3,密封阴凉保存。
对比例4
例1中不加入雪见草、蟾酥、冰片,步骤(3)中的浓缩稠膏不加入蟾酥后直接干燥成粉并喷入挥发油混匀,其余与例1的制备步骤相同,制得不含雪见草的对比制剂4。向对比制剂4中加入适量生理盐水至含药浓度为1g/ml,制得不含雪见草、蟾酥、冰片的对比洗剂4,密封阴凉保存。
实施例二 药效评价
例1动物实验
选取体重相近的清洁级昆明种小鼠72只,随机分为9组,雌雄各半,每组8只,分别为高剂量组(用生理盐水稀释洗剂1至含药0.5g/ml的洗剂+模型组鼠)、中剂量组(用生理盐水稀释洗剂1至含药0.25g/ml的洗剂+模型组鼠)、低剂量组(用生理盐水稀释洗剂1至含药0.15g/ml的洗剂+模型组鼠)、阳性对照组(丁酸氢化可的松软膏+模型组鼠)、对比1组(用生理盐水稀释对比洗剂1至含药0.25g/ml的洗剂+模型组鼠)、对比2组(用生理盐水稀释对比洗剂2至含药0.25g/ml的洗剂+模型组鼠)、对比3组(用生理盐水稀释对比洗剂3至含药0.25g/ml的洗剂+模型组鼠)、对比4组(用生理盐水稀释对比洗剂4至含药0.25g/ml的洗剂+模型组鼠)、空白模型组(生理盐水+模型组鼠)。按照文献方法,建立72只小鼠耳廓急性湿疹模型。各组的每只小鼠腹部剪毛,面积2cm×2cm大小,并抹适量脱毛膏脱毛8min后用温水洗净脱毛膏,每只小鼠在脱毛后第1天用5%二硝基氯苯丙酮(DNCB)溶液25ul外涂腹部致敏,致敏1h后,高剂量组、中剂量组、低剂量组、阳性对照组、对比1组、对比2组、对比3组、空白模型组的每只小鼠右耳内侧分别外用0.8ml的用生理盐水稀释洗剂1至含药0.5g/ml的洗剂、0.8ml的用生理盐水稀释洗剂1至含药0.25g/ml的洗剂、0.8ml的用生理盐水稀释洗剂1至含药0.15g/ml的洗剂、0.12g丁酸氢化可的松软膏、0.8ml生理盐水,每天2次,连续7天。洗剂和生理盐水的给药方法为:用医药纱布浸湿洗剂或生理盐水后湿敷于皮损处30min。丁酸氢化可的松软膏直接均匀涂抹皮损处给药。第7天于末次给药2h后,各组的每只小鼠右耳内侧涂1%DNCB溶液0.1ml作为激发,每周1次,连续激发2次,激发期间照常给药,在激发完成后的末次给药24h后,测评:(1)测耳肿胀度:用螺旋测微器测定每只小鼠两耳中部厚度(每只耳朵测两次,取平均值),计算其差值。(2)将小鼠麻醉处死,立即用直径12mm打孔器分别在左右耳对称处取下圆形耳片,称重,计算双耳的重量差。(3)真皮炎性细胞计数:取小块右耳组织,石蜡包埋切片,苏木精一伊红(HE)染色,分别计数10个高倍视野(HPF)真皮炎性细胞数,取其平均值。结果见表1。
表1不同药物外用对DNCB诱导小鼠耳廓慢性湿疹模型的影响
从表1可以看出,高、中、低剂量组与阳性对照组在对DNCB诱导小鼠耳廓慢性湿疹模型上相比,不同剂量的本发明的中药组合物在DNCB诱导小鼠耳廓慢性湿疹模型上具有治疗作用,且治疗效果优于丁酸氢化可的松。
例2临床实验
(一)、材料与方法
1、受试品:按本发明实施例1生产得到的外用中药组合物洗剂1。
2、受试对象:有急性和亚急性湿疹患者自愿者46例(按照《中国临床皮肤病学》所列湿疹诊断标准而入选),年龄在16~65岁,男女各半,病程为1-10天,其急性或亚急性湿疹皮疹表现为:皮损处红肿、丘疹及丘疱疹、渗出或糜烂等。
3、使用方法:用医药纱布浸湿中药组合物洗剂1后湿敷于皮损出30min,每日2次,连续14天,于实验期进行疗效评价。
4、观察主要症状:患者治疗前后的湿疹面积的EASI积分变化,根据用药2周后患者的皮损表现来确定疗效。即根据:改善率=(治疗前EASI总分-治疗后EASI总分)/治疗前EASI总分*100%。
1.痊愈;症状消失或明显减轻(改善率>90%)。
2.显效:症状明显减轻(60%<改善率<89%)。
3.有效:症状减轻(20%<改善率<59%)。
4.无效:症状体征无明显变化(改善率<20%)。
(二)结果
表2主要症状改善情况
由上述实验及数据表明,本发明的组合物对急性和亚急性湿疹患者的病情改善有效。
Claims (5)
1.一种治疗湿疹的外用中药组合物,其特征在于,按重量份数计,包括以下组分及配比:
蟾酥3-5重量份、陈艾33-38重量份、蛇床子28-32重量份、天然冰片3-5重量份、苦参28-30份、荆芥25-30重量份、黄芩11-13重量份、黄连11-13重量份、雪见草11-13重量份。
2.根据权利要求1所述的一种治疗湿疹的外用中药组合物,其特征在于,按重量份数计,所述外用中药组合物包括以下组分及配比:
蟾酥3重量份、陈艾34重量份、蛇床子30重量份、天然冰片3重量份、苦参28重量份、荆芥27重量份、黄芩11重量份、黄连11重量份、雪见草12重量份。
3.一种治疗湿疹的的外用中药组合物的制备方法,其特征在于,包括以下步骤:
(1)称取配方比的陈艾、苦参、荆芥、黄芩、黄连、雪见草全草,加入6-10倍质量的水浸泡20-30min,之后,将原料和浸泡液一并移入挥发油提取器中,蒸馏1-2h,获得挥发油,备用;
(2)称取配方比的蛇床子,蛇床子加入步骤(1)蒸馏后剩下的含料渣的水液中,再加入4-6倍质量的水后,一并煎煮1-1.5h,过滤,滤渣再加入4-6倍质量的水煎煮0.5h,过滤,合并两次滤液;
(3)向步骤(1)中的滤液内边搅拌边加入乙醇并使溶液的醇含量达到55%-65%,静置24-48h,过滤,取滤液,回收乙醇,浓缩成稠膏,向稠膏中加入配方比的蟾酥,混匀,干燥成粉,将粉与冰片研匀后喷入挥发油,混匀即可。
4.根据权利要求3所述的一种治疗湿疹的外用中药组合物,其特征在于,外用中药组合物还可根据实际需要,添加药物制剂上允许添加的任意辅助成分制成任意剂型。
5.根据权利要求4所述的一种治疗湿疹的外用中药组合物,其特征在于,所述剂型为乳剂、搽剂、洗剂剂型。
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