CN109125641A - 复方白鲜皮软膏及其制备方法 - Google Patents
复方白鲜皮软膏及其制备方法 Download PDFInfo
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- CN109125641A CN109125641A CN201811101469.9A CN201811101469A CN109125641A CN 109125641 A CN109125641 A CN 109125641A CN 201811101469 A CN201811101469 A CN 201811101469A CN 109125641 A CN109125641 A CN 109125641A
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Abstract
本发明公开了一种复方白鲜皮软膏,按重量组份计,包括:白鲜皮15‑40份、地肤子5‑10份、苍耳子4‑8份、木槿皮5‑12份、白蒺藜10‑14份、蝉衣5‑10份、防风10‑15份、蛇床子15‑25份、川黄柏8‑14份、荆芥4‑10份、野菊花8‑15份、浮萍5‑8份、及花椒3‑10份。本发明公开了一种复方白鲜皮软膏的制备方法。本发明渗透性好,作用安全,通过增强防御功能和抑制致病因素协同完成对痤疮的治疗,且有效减缓痤疮愈后色素沉淀、及瘢痕残留,具有活血化瘀、脱敏、滋阴养颜的有益效果。
Description
技术领域
本发明涉及中药制备领域。更具体地说,本发明涉及一种复方白鲜皮软膏及其制备方法。
背景技术
痤疮,发生在毛囊皮脂腺的慢性皮肤炎症,座疮的发生原因较复杂,主要诱因是青春期发育成熟,体内雄性激素水平升高,而刺激皮脂及毛囊脱落的上皮细胞聚集成黄白色物质栓塞在毛孔中,即形成粉刺,皮脂难以排出则形成灰白色小丘疹,即为白头粉刺,暴露在毛囊口外面的粉刺遇空气灰尘污染,变成黑色的黑头粉刺,此外毛囊管腔内还存在着大量痤疮丙酸杆菌,将皮脂分解成不饱和脂肪酸,造成毛囊及其周围发生不同等程度的炎症,而出现化脓,结节,囊肿或粉瘤等,长期反复的炎症会在脸上留下难愈的瘢痕,使皮肤不平,粗糙难看,而皮脂的分泌不畅,和反复炎症,又加重刺激皮脂的分泌形成恶性循环。根据痤疮皮损性质及严重程度可将痤疮分为四级:1级(轻度):粉刺为主,少量丘疹、脓疱,总皮损数少于30个;2级(中度):粉刺+中等量炎性丘疹、脓疱,总皮损数为31-50个;3级(中度):粉刺+大量炎性丘疹+脓疱,总皮损数51-100个,结节数小于3个;4级(重度):粉刺+炎性丘疹+脓疱+结节、囊肿或瘢痕,即结节/囊肿、聚合性痤疮,总皮损数大于100个,结节/囊肿数大于3个。好发于青春男女脸部、颈部、胸背部等,对青少年的心理、社交、生活质量影响很大。痤疮在临床上主要表现为点状痤疮、丘疹性痤疮、脓疱性痤疮、结节性痤疮、萎缩性痤疮、囊肿性痤疮、聚合性痤疮、恶病性痤疮等。其中,痤疮为4级(重度)痤疮,除粉刺、丘疹、炎症性结节外,其还具有脓肿、和囊肿性皮损,目前对于痤疮的治疗药物主要是市场的化学药物和激素类药物,病情反复,且愈后也多存在色素沉淀、及瘢痕症状,鲜有纯天然的中药或中药提取药物。
发明内容
本发明的一个目的是解决至少上述问题,并提供至少后面将说明的优点。
本发明还有一个目的是提供一种复方白鲜皮软膏,其渗透性好,作用安全,通过增强防御功能和抑制致病因素协同完成对痤疮的治疗,且有效减缓痤疮愈后色素沉淀、及瘢痕残留,具有活血化瘀、脱敏、滋阴养颜的有益效果。
本发明还有一个目的是提供一种复方白鲜皮软膏的制备方法,其采用水回流提取配合醇沉法,实现物料功效的同时,操作简单。
为了实现根据本发明的这些目的和其它优点,提供了一种活复方白鲜皮软膏,包括:
白鲜皮15-40份、地肤子5-10份、苍耳子4-8份、木槿皮5-12份、白蒺藜10-14份、蝉衣5-10份、防风10-15份、蛇床子15-25份、川黄柏8-14份、荆芥4-10份、野菊花8-15份、浮萍5-8份、及花椒3-10份。
优选的是,所述的复方白鲜皮软膏,按重量组份计,还包括:柴胡3-4份、生薏仁4-5份、白芨2-3份、蛇倒退4-5份、紫草2-3份、及薄荷2-4份。
一种活复方白鲜皮软膏的制备方法,包括以下步骤:
步骤一、按重量组份计,将白鲜皮、蛇床子、地肤子、及防风的分别采用水回流提取,得白鲜皮滤液和白鲜皮滤渣、蛇床子滤液和蛇床子滤渣、地肤子滤液和地肤子滤渣、及防风滤液和防风滤渣,白鲜皮滤液、蛇床子滤液、地肤子滤液、及防风滤液分别浓缩后醇沉得白鲜皮多糖、蛇床子多糖、地肤子多糖、及防风多糖,
步骤二、按重量组分计,取苍耳子、木槿皮、白蒺藜、蝉衣、川黄柏、荆芥、野菊花、浮萍、花椒、白鲜皮滤渣、蛇床子滤渣、地肤子滤渣、及防风滤渣混匀后得第一混合物,第一混合物进行水回流提取,得第一滤液,第一滤液浓缩后醇沉去除沉淀后浓缩得混合提取物;
步骤三、将步骤一中的白鲜皮多糖、蛇床子多糖、地肤子多糖、防风多糖、及步骤二中的混合提取物混合,得总提取物,向总提取物中加入润滑固形剂,搅拌均匀至膏状,即得膏状物,将膏状物灭菌包装即可。
优选的是,步骤一中白鲜皮、蛇床子、地肤子、及防风在进行水回流提取前分别用8-10倍量的有机溶剂浸提后过滤干燥,其中,有机溶剂为乙酸乙酯、乙醇、或甲醇中的一种。
优选的是,步骤一中水回流提取具体为:向原料中加入水,调控温度为89℃,提取3h,其中,水与原料的质量比为20-22:1;
步骤一中浓缩后醇沉具体为:将待处理物料浓缩为比重为1.3-1.6的浓缩液,向浓缩液中边搅拌边加入浓缩液体积50倍量的体积分数为52%的乙醇溶液进行一次醇沉,过滤得精制液,向精制液中边搅拌边加入浓缩液体积80倍量的体积分数为85%的乙醇溶液进行二次醇沉,过滤得沉淀即为对应的多糖;
步骤二中的水回流提取具体为:向原料中加入水,调控温度为89℃,提取3h,其中,水与原料的质量比为20-22:1;
步骤二中浓缩后醇沉去除沉淀具体为:将待处理物料浓缩为比重为1.3-1.6的浓缩液,向浓缩液中边搅拌边加入浓缩液体积50倍量的体积分数为52%的乙醇溶液进行一次醇沉,过滤得精制液,向精制液中边搅拌边加入浓缩液体积80倍量的体积分数为85%的乙醇溶液进行二次醇沉,过滤去沉淀得滤液,即可。
优选的是,步骤三中润滑固形剂为凡士林、大油、聚乙二醇、甘油、或羊毛脂中的一种,总提取物与润滑固形剂的用料比为1g:3-5g。
优选的是,步骤三中将膏状物灭菌包装具体为:将膏状物加温至100-110℃下进行热化灭菌处理10-15min,按剂量装入包装袋即可。
优选的是,步骤一中的蛇床子在使用有机溶剂浸提前,取一半重量份的蛇床子采用水蒸馏法得蛇床子精油及第一滤渣,第一滤渣和剩余一半重量份的蛇床子进行有机溶剂浸提;
步骤二还包括:按重量组分计,取薄荷2-4份,通过水蒸馏法制备薄荷精油;
取柴胡3-4份、生薏仁4-5份、白芨2-3份、蛇倒退4-5份、及紫草2-3份、及步骤二中水回流提取中过滤得到滤渣混合均匀后得第二混合物,第二混合物进行水回流提取,过滤得第二滤液,将第一滤液和第二滤液混合,浓缩后醇沉去除沉淀后浓缩得混合提取物;
步骤三中将总提取物还包括蛇床子精油、及薄荷精油。
优选的是,步骤一中水回流提取具体为:向原料中加入水,进行三次回流超声处理,每次回流超声处理具体为调控温度为65℃,提取40min后,调控超声功率为250W,超声3min,每次水与原料的质量比为7:1;
步骤二中第一混合物进行水回流提取具体为:向原料中加入水,进行三次回流超声处理,每次回流超声处理具体为调控温度为75℃,提取40min后,调控超声功率为250W,超声3min,每次水与原料的质量比为7:1;
步骤二中第二混合物进行水回流提取具体为:向原料中加入水,进行三次回流超声处理,每次回流超声处理具体为调控温度为85℃,提取40min后,调控超声功率为250W,超声3min,每次水与原料的质量比为7:1。
本发明至少包括以下有益效果:
第一、本发明通过各原料的合理用量配比、及各原料间理化性质产生配伍协同作用,复方白鲜皮软膏对皮肤无刺激性,其pH值与人体皮肤的pH值5.0-7.0接近,具有活血化瘀、脱敏、滋阴养颜的效果,且渗透性好,作用安全,通过增强防御功能和抑制致病因素协同完成对痤疮的治疗,且有效减缓痤疮愈后色素沉淀、及瘢痕残留的问题;
第二、蝉衣为蝉科昆虫黑蚱的弱虫羽化时脱落的皮壳,其含有大量的甲壳质、角蛋白、及氨基酸,花椒为芸香科植物花椒的干燥成熟果皮,其具有温中止痛,止痒功效的同时,能够促进毛孔扩张,利于药物进入以促进药物吸收,蝉衣与紫草(紫草中含有红草素、牡荆素)、薄荷共用,能够有效减缓毛孔栓塞,配合花椒促进毛孔扩张,由源头缓解痤疮初起透发不畅的问题,减少粉刺形成;
野菊花配合花椒使用,能够有效减缓花椒促进的毛孔扩张导致皮肤油脂分泌过多的问题;皮脂主要由角鲨烯、蜡酯、三酰甘油和少量固醇、胆固醇酯组成,痤疮患者的皮脂中蜡酯的含量较高,而亚油酸的含量较低,亚油酸含量的降低使毛囊周围的必须脂肪酸减少,促进毛囊上皮的角化,而蛇床子的使用能有效缓解皮脂中亚油酸含量降低的问题,进而减缓毛囊上皮的角化;
荆芥为唇形科植物荆芥的干燥地上部分,其具有解表散风,透疹,消疮之功效,且配合蛇倒退、地肤子及蛇床子中含有的蛇床子素,能够有效缓解痤疮引起的皮肤瘙痒,提高用户体验效果;地肤子为藜科植物地肤的干燥成熟果实,其具有清热利湿,祛风止痒,可用于小便涩痛,阴痒带下,风疹,湿疹,皮肤瘙痒;
白鲜皮、蛇床子、地肤子、及防风对应制得的白鲜皮多糖、蛇床子多糖、地肤子多糖、及防风多糖均为具有生物活性的药物,苍耳子为菊科植物苍耳的干燥成熟带总苞的果实,其具有散风寒,通鼻窍,祛风湿,可用于风寒头痛,鼻塞流涕,鼻鼽,鼻渊,风疹瘙痒,湿痹拘挛;苍耳子配合柴胡、及芸香科植物黄皮树的干燥树皮川黄柏,能够有效抑制痤疮丙酸杆菌酯酶活性,避免大量痤疮丙酸杆菌将皮脂分解成不饱和脂肪酸,效缓解炎症介质的释放,抑制结缔组织增生作用,而化脓,结节,囊肿或粉瘤等的出现,进而降低瘢痕产生;
第三、水回流提取具体为进行三次回流超声处理,相对于常规的浸提有效缩短提取时间的同时,避免传统高温提取对提取成分的影响,同时相对于常规超声波提取,可适当降低料液比,以减缓后期浓缩难度。
本发明的其它优点、目标和特征将部分通过下面的说明体现,部分还将通过对本发明的研究和实践而为本领域的技术人员所理解。
具体实施方式
下面结合实施例对本发明做进一步的详细说明,以令本领域技术人员参照说明书文字能够据以实施。
<实施例1>
复方白鲜皮软膏,按重量组份计,包括:白鲜皮15份、地肤子5份、苍耳子4份、木槿皮5份、白蒺藜10份、蝉衣5份、防风10份、蛇床子15份、川黄柏8份、荆芥4份、野菊花8份、浮萍5份、及花椒3份;
复方白鲜皮软膏的制备方法,包括以下步骤:
步骤一、按重量组份计,将白鲜皮、蛇床子、地肤子、及防风的分别采用水回流提取,得白鲜皮滤液和白鲜皮滤渣、蛇床子滤液和蛇床子滤渣、地肤子滤液和地肤子滤渣、及防风滤液和防风滤渣,白鲜皮滤液、蛇床子滤液、地肤子滤液、及防风滤液分别浓缩后醇沉得白鲜皮多糖、蛇床子多糖、地肤子多糖、及防风多糖,
步骤二、按重量组分计,取苍耳子、木槿皮、白蒺藜、蝉衣、川黄柏、荆芥、野菊花、浮萍、花椒、白鲜皮滤渣、蛇床子滤渣、地肤子滤渣、及防风滤渣混匀后得第一混合物,第一混合物进行水回流提取,得第一滤液,第一滤液浓缩后醇沉去除沉淀后浓缩至稀膏状,得混合提取物;
步骤三、将步骤一中的白鲜皮多糖、蛇床子多糖、地肤子多糖、防风多糖、及步骤二中的混合提取物混合,得总提取物,向总提取物中加入润滑固形剂,搅拌均匀至膏状,即得膏状物,将膏状物灭菌包装即可;
步骤一中白鲜皮、蛇床子、地肤子、及防风在进行水回流提取前分别用8倍量的有机溶剂浸提后过滤干燥,其中,有机溶剂为乙酸乙酯;
步骤一中水回流提取具体为:向原料中加入水,调控温度为89℃,提取3h,其中,水与原料的质量比为20:1;
步骤一中浓缩后醇沉具体为:将待处理物料浓缩为比重为1.36的浓缩液,向浓缩液中边搅拌边加入浓缩液体积50倍量的体积分数为52%的乙醇溶液进行一次醇沉,过滤得精制液,向精制液中边搅拌边加入浓缩液体积80倍量的体积分数为85%的乙醇溶液进行二次醇沉,过滤得沉淀即为对应的多糖;
步骤二中的水回流提取具体为:向原料中加入水,调控温度为89℃,提取3h,其中,水与原料的质量比为22:1;
步骤二中浓缩后醇沉去除沉淀具体为:将待处理物料浓缩为比重为1.45的浓缩液,向浓缩液中边搅拌边加入浓缩液体积50倍量的体积分数为52%的乙醇溶液进行一次醇沉,过滤得精制液,向精制液中边搅拌边加入浓缩液体积80倍量的体积分数为85%的乙醇溶液进行二次醇沉,过滤去沉淀得滤液,即可;
步骤三中润滑固形剂为凡士林,总提取物与润滑固形剂的用料比为1g:3.9g;
步骤三中将膏状物灭菌包装具体为:将膏状物加温至100-110℃范围内进行热化灭菌处理10min,按剂量装入包装袋即可。
<实施例2>
复方白鲜皮软膏,按重量组份计,包括:白鲜皮30份、地肤子7份、苍耳子6份、木槿皮8份、白蒺藜12份、蝉衣8份、防风13份、蛇床子20份、川黄柏11份、荆芥7份、野菊花11份、浮萍7份、及花椒7份;
复方白鲜皮软膏的制备方法,包括以下步骤:
步骤一、按重量组份计,将白鲜皮、蛇床子、地肤子、及防风的分别采用水回流提取,得白鲜皮滤液和白鲜皮滤渣、蛇床子滤液和蛇床子滤渣、地肤子滤液和地肤子滤渣、及防风滤液和防风滤渣,白鲜皮滤液、蛇床子滤液、地肤子滤液、及防风滤液分别浓缩后醇沉得白鲜皮多糖、蛇床子多糖、地肤子多糖、及防风多糖,
步骤二、按重量组分计,取苍耳子、木槿皮、白蒺藜、蝉衣、川黄柏、荆芥、野菊花、浮萍、花椒、白鲜皮滤渣、蛇床子滤渣、地肤子滤渣、及防风滤渣混匀后得第一混合物,第一混合物进行水回流提取,得第一滤液,第一滤液浓缩后醇沉去除沉淀后浓缩至稀膏状,得混合提取物;
步骤三、将步骤一中的白鲜皮多糖、蛇床子多糖、地肤子多糖、防风多糖、及步骤二中的混合提取物混合,得总提取物,向总提取物中加入润滑固形剂,搅拌均匀至膏状,即得膏状物,将膏状物灭菌包装即可;
步骤一中白鲜皮、蛇床子、地肤子、及防风在进行水回流提取前分别用9倍量的有机溶剂浸提后过滤干燥,其中,有机溶剂为乙醇;
步骤一中水回流提取具体为:向原料中加入水,调控温度为89℃,提取3h,其中,水与原料的质量比为21:1;
步骤一中浓缩后醇沉具体为:将待处理物料浓缩为比重为1.47的浓缩液,向浓缩液中边搅拌边加入浓缩液体积50倍量的体积分数为52%的乙醇溶液进行一次醇沉,过滤得精制液,向精制液中边搅拌边加入浓缩液体积80倍量的体积分数为85%的乙醇溶液进行二次醇沉,过滤得沉淀即为对应的多糖;
步骤二中的水回流提取具体为:向原料中加入水,调控温度为89℃,提取3h,其中,水与原料的质量比为21:1;
步骤二中浓缩后醇沉去除沉淀具体为:将待处理物料浓缩为比重为1.53的浓缩液,向浓缩液中边搅拌边加入浓缩液体积50倍量的体积分数为52%的乙醇溶液进行一次醇沉,过滤得精制液,向精制液中边搅拌边加入浓缩液体积80倍量的体积分数为85%的乙醇溶液进行二次醇沉,过滤去沉淀得滤液,即可;
步骤三中润滑固形剂为大油,总提取物与润滑固形剂的用料比为1g:4.2g;
步骤三中将膏状物灭菌包装具体为:将膏状物加温至100-110℃范围内进行热化灭菌处理13min,按剂量装入包装袋即可;
其中,大油又称猪油或荤油,一种饱和高级脂肪酸甘油脂,分子中不含有碳碳双键,常温下为白色或浅黄色固体,猪油味甘、性凉、无毒,有补虚、润燥、解毒的作用,主要营养成分蛋白质,脂肪酸。
<实施例3>
复方白鲜皮软膏,按重量组份计,包括:白鲜皮40份、地肤子10份、苍耳子8份、木槿皮12份、白蒺藜14份、蝉衣10份、防风15份、蛇床子25份、川黄柏14份、荆芥10份、野菊花15份、浮萍8份、及花椒10份;
复方白鲜皮软膏的制备方法,包括以下步骤:
步骤一、按重量组份计,将白鲜皮、蛇床子、地肤子、及防风的分别采用水回流提取,得白鲜皮滤液和白鲜皮滤渣、蛇床子滤液和蛇床子滤渣、地肤子滤液和地肤子滤渣、及防风滤液和防风滤渣,白鲜皮滤液、蛇床子滤液、地肤子滤液、及防风滤液分别浓缩后醇沉得白鲜皮多糖、蛇床子多糖、地肤子多糖、及防风多糖,
步骤二、按重量组分计,取苍耳子、木槿皮、白蒺藜、蝉衣、川黄柏、荆芥、野菊花、浮萍、花椒、白鲜皮滤渣、蛇床子滤渣、地肤子滤渣、及防风滤渣混匀后得第一混合物,第一混合物进行水回流提取,得第一滤液,第一滤液浓缩后醇沉去除沉淀后浓缩至稀膏状,得混合提取物;
步骤三、将步骤一中的白鲜皮多糖、蛇床子多糖、地肤子多糖、防风多糖、及步骤二中的混合提取物混合,得总提取物,向总提取物中加入润滑固形剂,搅拌均匀至膏状,即得膏状物,将膏状物灭菌包装即可;
步骤一中白鲜皮、蛇床子、地肤子、及防风在进行水回流提取前分别用10倍量的有机溶剂浸提后过滤干燥,其中,有机溶剂为甲醇;
步骤一中水回流提取具体为:向原料中加入水,调控温度为89℃,提取3h,其中,水与原料的质量比为22:1;
步骤一中浓缩后醇沉具体为:将待处理物料浓缩为比重为1.56的浓缩液,向浓缩液中边搅拌边加入浓缩液体积50倍量的体积分数为52%的乙醇溶液进行一次醇沉,过滤得精制液,向精制液中边搅拌边加入浓缩液体积80倍量的体积分数为85%的乙醇溶液进行二次醇沉,过滤得沉淀即为对应的多糖;
步骤二中的水回流提取具体为:向原料中加入水,调控温度为89℃,提取3h,其中,水与原料的质量比为22:1;
步骤二中浓缩后醇沉去除沉淀具体为:将待处理物料浓缩为比重为1.41的浓缩液,向浓缩液中边搅拌边加入浓缩液体积50倍量的体积分数为52%的乙醇溶液进行一次醇沉,过滤得精制液,向精制液中边搅拌边加入浓缩液体积80倍量的体积分数为85%的乙醇溶液进行二次醇沉,过滤去沉淀得滤液,即可;
步骤三中润滑固形剂为聚乙二醇,总提取物与润滑固形剂的用料比为1g:4.7g;
步骤三中将膏状物灭菌包装具体为:将膏状物加温至100-110℃范围内进行热化灭菌处理15min,按剂量装入包装袋即可。
<实施例4>
复方白鲜皮软膏,按重量组份计,包括:白鲜皮30份、地肤子7份、苍耳子6份、木槿皮12份、白蒺藜12份、蝉衣8份、防风13份、蛇床子20份、川黄柏11份、荆芥7份、野菊花11份、浮萍7份、花椒77份、柴胡3.5份、生薏仁4.5份、白芨2.5份、蛇倒退4.5份、紫草2.5份、及薄荷3份。
复方白鲜皮软膏的制备方法,包括以下步骤:
步骤一、按重量组份计,取一半重量份的蛇床子采用水蒸馏法得蛇床子精油及第一滤渣,第一滤渣和剩余一半重量份的蛇床子混合后用9倍量的有机溶剂进行有机溶剂浸提后过滤干燥得浸提干燥后的蛇床子,白鲜皮、地肤子、及防风用9倍量的有机溶剂浸提后过滤干燥,将浸提干燥后的白鲜皮、蛇床子、地肤子、及防风的分别采用水回流提取,得白鲜皮滤液和白鲜皮滤渣、蛇床子滤液和蛇床子滤渣、地肤子滤液和地肤子滤渣、及防风滤液和防风滤渣,白鲜皮滤液、蛇床子滤液、地肤子滤液、及防风滤液分别浓缩后醇沉得白鲜皮多糖、蛇床子多糖、地肤子多糖、及防风多糖,其中,有机溶剂为乙醇;
步骤二、按重量组分计,取薄荷3份,通过水蒸馏法制备薄荷精油;
按重量组分计,取苍耳子、木槿皮、白蒺藜、蝉衣、川黄柏、荆芥、野菊花、浮萍、花椒、白鲜皮滤渣、蛇床子滤渣、地肤子滤渣、及防风滤渣混匀后得第一混合物,第一混合物进行水回流提取,得第一滤液;
取柴胡3.5份、生薏仁4.5份、白芨2.5份、蛇倒退4.5份、紫草2.5份、及步骤二中水回流提取中过滤得到滤渣混合均匀后得第二混合物,第二混合物进行水回流提取,过滤得第二滤液,将第一滤液和第二滤液混合浓缩后醇沉去除沉淀后浓缩至稀膏状,得混合提取物;
步骤三、将步骤一中的白鲜皮多糖、蛇床子多糖、地肤子多糖、防风多糖、步骤二中的混合提取物、蛇床子精油、及薄荷精油混合,得总提取物,向总提取物中加入润滑固形剂,搅拌均匀至膏状,即得膏状物,将膏状物灭菌包装即可。
步骤一中水回流提取具体为:向原料中加入水,进行三次回流超声处理,每次回流超声处理具体为调控温度为65℃,提取40min后,调控超声功率为250W,超声3min,每次水与原料的质量比为7:1;
步骤一中浓缩后醇沉具体为:将待处理物料浓缩为比重为1.48的浓缩液,向浓缩液中边搅拌边加入浓缩液体积50倍量的体积分数为52%的乙醇溶液进行一次醇沉,过滤得精制液,向精制液中边搅拌边加入浓缩液体积80倍量的体积分数为85%的乙醇溶液进行二次醇沉,过滤得沉淀即为对应的多糖;
步骤二中第一混合物进行水回流提取具体为:向原料中加入水,进行三次回流超声处理,每次回流超声处理具体为调控温度为75℃,提取40min后,调控超声功率为250W,超声3min,每次水与原料的质量比为7:1;
步骤二中第二混合物进行水回流提取具体为:向原料中加入水,进行三次回流超声处理,每次回流超声处理具体为调控温度为85℃,提取40min后,调控超声功率为250W,超声3min,每次水与原料的质量比为7:1;
步骤二中浓缩后醇沉去除沉淀具体为:将待处理物料浓缩为比重为1.35的浓缩液,向浓缩液中边搅拌边加入浓缩液体积50倍量的体积分数为52%的乙醇溶液进行一次醇沉,过滤得精制液,向精制液中边搅拌边加入浓缩液体积80倍量的体积分数为85%的乙醇溶液进行二次醇沉,过滤去沉淀得滤液,即可;
步骤三中润滑固形剂为甘油,总提取物与润滑固形剂的用料比为1g:3.9g;
步骤三中将膏状物灭菌包装具体为:将膏状物加温至100-110℃范围内进行热化灭菌处理14min,按剂量装入包装袋即可。
1临床资料
2级(中度)痤疮患者28人,年龄17-22岁,随机等分为两组,分别为实验1-1组,和实验1-2组;
3级(中度)痤疮患者26人,年龄18-23岁,随机等分为两组,分别为实验2-1组,和实验2-2组;
4级(重度)痤疮患者34人,年龄18-25岁,随机等分为两组,分别为实验3-1组,和实验3-2组;
其中,实验1-1组、实验2-1组、实验3-1组采用实施例2制备的复方白鲜皮软膏进行治疗,实验1-2组、实验2-2组、实验3-2组采用实施例4制备的复方白鲜皮软膏进行治疗;
实验1-1组、及实验1-2组的治疗以1个月为一个疗程,每天早晚两次,每两周复诊一次,用药量随症加减,一个疗程结束后,每天晚一次,每两周复诊一次,用药量随症加减,为期两个疗程,疗效评估在停药20天后进行;
实验2-1组、及实验2-2组的治疗以1.5个月为一个疗程,每天早晚两次,每两周复诊一次,用药量随症加减,一个疗程结束后,每天晚一次,每两周复诊一次,用药量随症加减,为期两个疗程,疗效评估在停药20天后进行;
实验3-1组、及实验3-2组的治疗以2个月为1个疗程,每天早中晚各一次,每两周复诊一次,用药量随症加减,一个疗程结束后,每天早晚各一次,每两周复诊一次,用药量随症加减,为期两个疗程,疗效评估在停药20天后进行;
所有患者均为自愿受试者,治疗前4周内未服用抗生素或者其他系统性治疗痤疮药物;
1.1注意事项:所有典型病例患者每次涂抹药膏前用清水清洗,去除皮肤表面油脂、皮屑等,治疗疗程中,患者均禁食高糖、高脂肪、酒、辛辣等刺激性食物,多食豆芽、青菜、蓬蒿菜、冬瓜、丝瓜、苦瓜等蔬菜、含长纤维食品、及水果;
1.2判断标准:以皮损改善程度判定疗程,皮损改善程度=(治疗前皮损数-治疗后皮损数)/治疗前皮损数*100%,分为以下四个等级:
治愈:治愈后皮损总数减少≥90%;
显效:治疗后总皮损数减少60-89%;
有效:治疗后总皮损数减少20-59%;
无效:治疗后皮损总数减少<20%,或反见增多;
1.3疗效评估
组别/实施例 | 例数/例 | 治愈/例 | 显效/例 | 有效/例 | 无效/例 |
实验1-1组/实施例2 | 14 | 12 | 2 | / | / |
实验1-2组/实施例4 | 14 | 13 | 1 | / | / |
实验2-1组/实施例2 | 13 | 9 | 3 | 1 | / |
实验2-2组/实施例4 | 13 | 10 | 3 | / | / |
实验3-1组/实施例2 | 17 | 8 | 6 | 2 | 1 |
实验3-2组/实施例4 | 17 | 10 | 7 | / | / |
根据表1可知,实施例2和实施例4制备的复方白鲜皮软膏对于中度痤疮患者均具有较好的疗效,对于2级(中度)痤疮患者的治疗均全部达到显效结果,对于4级(重度)痤疮患者实施例2出现1例无效,其主要原因在于患者在治疗期间未能与实验计划很好配合,中断治疗,其余有14例达到显效及以上的治疗效果;
典型病例
1:吴某,男,22岁,患者前额部、及前脸部2年前长红色丘疹、及小脓疱,症状不重,患者自行手挤处理,症状加重,诊断为2级(中度)痤疮患者,使用本品实施例2方法制备的复方白鲜皮软膏,以1个月为一个疗程,每天早晚两次,每两周复诊一次,用药量随症加减,一个疗程结束后,不痛不痒了,脓疱也没有了,嘱咐患者只需每天晚一次,每两周复诊一次,用药量随症加减,再一个疗程结束后,达到治愈的效果,且脸部未见明显的痘印残留;
2:刘某,女,24岁,患者前额部、及前脸部4年前开始出现痤疮,曾与多家医院就诊,虽略能控制,但停药后痤疮随即复发,且有越来越严重的趋势,症状:面颊、额头、下巴部位现大量的丘疹、脓疱、结节,诊断为4级(重度)痤疮患者,使用本品实施例4方法制备的复方白鲜皮软膏,以2个月为一个疗程,每天早中晚各一次,每两周复诊一次,用药量随症加减,第一次复诊时发现新增痤疮少,原有痤疮结节变软,颜色变淡,第二次复诊时发现无新增痤疮,痤疮结节性状进一步减轻,一个疗程结束后凸出的结节、丘疹基本消失,嘱咐患者只需每天早晚一次,每两周复诊一次,用药量随症加减,再一个疗程结束后,达到治愈的效果,且脸部痘印、瘢痕残留少,基本未见;
3:肖某,女,23岁,自述既往脸部痤疮,曾经到多家医院治疗效果不佳,2个月前饮食加作息不规律导致面部症状加重,症状:面颊、额头部位现粉刺、及大量炎性丘疹、脓疱,诊断为3级(中度)痤疮患者,使用本品实施例4方法制备的复方白鲜皮软膏,以1.5个月为一个疗程,每天早晚各一次,每两周复诊一次,用药量随症加减,一个疗程结束后嘱咐患者只需每天晚一次,每两周复诊一次,用药量随症加减,再一个疗程结束后,达到治愈的效果;
尽管本发明的实施方案已公开如上,但其并不仅仅限于说明书和实施方式中所列运用,它完全可以被适用于各种适合本发明的领域,对于熟悉本领域的人员而言,可容易地实现另外的修改,因此在不背离权利要求及等同范围所限定的一般概念下,本发明并不限于特定的细节和这里示出与描述的实施例。
Claims (9)
1.复方白鲜皮软膏,其特征在于,按重量组份计,包括:白鲜皮15-40份、地肤子5-10份、苍耳子4-8份、木槿皮5-12份、白蒺藜10-14份、蝉衣5-10份、防风10-15份、蛇床子15-25份、川黄柏8-14份、荆芥4-10份、野菊花8-15份、浮萍5-8份、及花椒3-10份。
2.如权利要求1所述的复方白鲜皮软膏,其特征在于,按重量组份计,还包括:柴胡3-4份、生薏仁4-5份、白芨2-3份、蛇倒退4-5份、紫草2-3份、及薄荷2-4份。
3.如权利要求1所述的复方白鲜皮软膏的制备方法,其特征在于,包括以下步骤:
步骤一、按重量组份计,将白鲜皮、蛇床子、地肤子、及防风的分别采用水回流提取,得白鲜皮滤液和白鲜皮滤渣、蛇床子滤液和蛇床子滤渣、地肤子滤液和地肤子滤渣、及防风滤液和防风滤渣,白鲜皮滤液、蛇床子滤液、地肤子滤液、及防风滤液分别浓缩后醇沉得白鲜皮多糖、蛇床子多糖、地肤子多糖、及防风多糖,
步骤二、按重量组分计,取苍耳子、木槿皮、白蒺藜、蝉衣、川黄柏、荆芥、野菊花、浮萍、花椒、白鲜皮滤渣、蛇床子滤渣、地肤子滤渣、及防风滤渣混匀后得第一混合物,第一混合物进行水回流提取,得第一滤液,第一滤液浓缩后醇沉去除沉淀后浓缩得混合提取物;
步骤三、将步骤一中的白鲜皮多糖、蛇床子多糖、地肤子多糖、防风多糖、及步骤二中的混合提取物混合,得总提取物,向总提取物中加入润滑固形剂,搅拌均匀至膏状,即得膏状物,将膏状物灭菌包装即可。
4.如权利要求3所述的复方白鲜皮软膏及其制备方法,其特征在于,步骤一中白鲜皮、蛇床子、地肤子、及防风在进行水回流提取前分别用8-10倍量的有机溶剂浸提后过滤干燥,其中,有机溶剂为乙酸乙酯、乙醇、或甲醇中的一种。
5.如权利要求3所述的复方白鲜皮软膏及其制备方法,其特征在于,步骤一中水回流提取具体为:向原料中加入水,调控温度为89℃,提取3h,其中,水与原料的质量比为20-22:1;
步骤一中浓缩后醇沉具体为:将待处理物料浓缩为比重为1.3-1.6的浓缩液,向浓缩液中边搅拌边加入浓缩液体积50倍量的体积分数为52%的乙醇溶液进行一次醇沉,过滤得精制液,向精制液中边搅拌边加入浓缩液体积80倍量的体积分数为85%的乙醇溶液进行二次醇沉,过滤得沉淀即为对应的多糖;
步骤二中的水回流提取具体为:向原料中加入水,调控温度为89℃,提取3h,其中,水与原料的质量比为20-22:1;
步骤二中浓缩后醇沉去除沉淀具体为:将待处理物料浓缩为比重为1.3-1.6的浓缩液,向浓缩液中边搅拌边加入浓缩液体积50倍量的体积分数为52%的乙醇溶液进行一次醇沉,过滤得精制液,向精制液中边搅拌边加入浓缩液体积80倍量的体积分数为85%的乙醇溶液进行二次醇沉,过滤去沉淀得滤液,即可。
6.如权利要求3所述的复方白鲜皮软膏及其制备方法,其特征在于,步骤三中润滑固形剂为凡士林、大油、聚乙二醇、甘油、或羊毛脂中的一种,总提取物与润滑固形剂的用料比为1g:3-5g。
7.如权利要求3所述的复方白鲜皮软膏及其制备方法,其特征在于,步骤三中将膏状物灭菌包装具体为:将膏状物加温至100-110℃下进行热化灭菌处理10-15min,按剂量装入包装袋即可。
8.如权利要求4所述的复方白鲜皮软膏及其制备方法,其特征在于,步骤一中的蛇床子在使用有机溶剂浸提前,取一半重量份的蛇床子采用水蒸馏法得蛇床子精油及第一滤渣,第一滤渣和剩余一半重量份的蛇床子进行有机溶剂浸提;
步骤二还包括:按重量组分计,取薄荷2-4份,通过水蒸馏法制备薄荷精油;
取柴胡3-4份、生薏仁4-5份、白芨2-3份、蛇倒退4-5份、紫草2-3份、及步骤二中水回流提取中过滤得到滤渣混合均匀后得第二混合物,第二混合物进行水回流提取,过滤得第二滤液,将第一滤液和第二滤液混合,浓缩后醇沉去除沉淀后浓缩得混合提取物;
步骤三中将总提取物还包括蛇床子精油、及薄荷精油。
9.如权利要求8所述的复方白鲜皮软膏及其制备方法,其特征在于,步骤一中水回流提取具体为:向原料中加入水,进行三次回流超声处理,每次回流超声处理具体为调控温度为65℃,提取40min后,调控超声功率为250W,超声3min,每次水与原料的质量比为7:1;
步骤二中第一混合物进行水回流提取具体为:向原料中加入水,进行三次回流超声处理,每次回流超声处理具体为调控温度为75℃,提取40min后,调控超声功率为250W,超声3min,每次水与原料的质量比为7:1;
步骤二中第二混合物进行水回流提取具体为:向原料中加入水,进行三次回流超声处理,每次回流超声处理具体为调控温度为85℃,提取40min后,调控超声功率为250W,超声3min,每次水与原料的质量比为7:1。
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