CN114010733A - 一种防治脚气的组合物及其制备方法 - Google Patents
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Abstract
本发明属于药物领域,尤其涉及一种防治脚气的组合物及其制备方法;所述组合物包含以下重量份的原料制成:薏苡仁10~20份,苦参10~20份,甘草6~14份,桔梗10~20份,莲子心6~14份。本发明用于治疗脚气的中药代茶饮,以天然食材、药食两用的物品和可用保健食品的物品为主要原料,本发明配方以清热解毒、强肾健脾,使得五脏六腑阴阳趋于平衡。
Description
技术领域
本发明属于药物领域,尤其涉及一种防治脚气的组合物及其制备方法。
背景技术
脚气是由致病性真菌引起的足部皮肤病,具有传染性,在全世界范围内广为流行,在热带和亚热带地区更为普遍;在我国,脚气的发病率也相当高,成人中70-80%的人有脚气。由于人的足底和趾间的皮肤汗腺很丰富,且出汗比较多,空气流通性差、局部潮湿温暖,适宜丝状真菌的生长,但此处皮肤没有皮脂腺,继而缺乏抑制皮肤丝状真菌的脂肪酸,生理防御机能较差,故易于发生真菌感染。此外,足底部位皮肤角质层较厚,角质层中的角蛋白是真菌的丰富营养物质,有利于真菌的生长。脚气发病时脚趾间起水疱、脱皮或皮肤发白湿软,也可出现糜烂或皮肤增厚、粗糙、开裂,并可蔓延至足跖及边缘,剧痒难忍,给脚气患者带来极大的痛苦。现代医学研究认为,真菌感染主要与细胞免疫功能密切相关。部分中草药复方可通过提高感染真菌动物模型的机体免疫功能,而起到辅助治疗作用。
目前,针对脚气的治疗,市场上主要分为西药和中药两大类,西药治疗脚气的针对性强,主要从杀菌止痒角度出发,疗程短、起效快,受到广大脚气患者的欢迎。但西药多具有毒副作用,且治标不治本,对于顽固性脚气的治疗极易复发。相较于西药,中药具有毒副作用小的优势,中药治疗脚气多从患病的内因出发,注重调理,受到越来越多的脚气患者的关注。
发明内容
本发明的第一个目的在于提供一种用于防治脚气的组合物,其具有提升免疫能力的功效。
本发明的第二目的在于提供一种用于防治脚气的组合物的制备方法,其具有激发药物药性、简化饮用过程的优点。
一种防治脚气的组合物,所述组合物包含以下重量份的原料制成:薏苡仁10~20份,苦参10~20份,甘草6~14份,桔梗10~20份,莲子心6~14份。
所述薏苡仁为13~17份。
所述薏苡仁为未经炒制的薏苡仁。
所述苦参为13~17份。
所述甘草为生甘草。
一种防治脚气的组合物的制备方法,包括如下步骤:
步骤1,选用薏苡仁、苦参、甘草、桔梗、莲子心,备用;
步骤2,将步骤1中的药材分别通过微波杀菌设备进行杀菌烘干操作,备用;
步骤3,将薏苡仁、苦参、甘草、桔梗、莲子心分别进行粉碎;
步骤4,分别对薏苡仁、苦参、甘草、桔梗、莲子心的破碎后原料进行筛分,除去粉料,筛分出药材颗粒;
步骤5,称重,并按重量份数配比各原料,搅拌混合均匀后,装入茶叶包中,即得。
本品配方基于中医药理论与现代药理研究相结合而设计的配方,选用薏苡仁,苦参,甘草,桔梗,莲子心为主要原料制成的对脚气患者具有辅助保护功能的保健食品。配方中,苦参有清热燥湿,利尿之功,为君;桔梗为臣,增强苦参清热燥湿功效,具有宣肺、排脓作用。佐以薏苡仁,莲子心,莲子心清心火,薏苡仁有除痹,排脓,解毒散结的作用。以甘草补脾益气,调和诸味,为本方之使,本方能广泛地刺激机体免疫反应,通过多种途径提高机体的免疫功能。
综上所述,本发明具有以下有益效果:
1.本发明用于治疗脚气的中药代茶饮,以天然食材、药食两用的物品和可用保健食品的物品为主要原料,本发明配方以清热解毒、强肾健脾,使得五脏六腑阴阳趋于平衡。
2.本发明用于治疗脚气的中药代茶饮的制备方法中包括粉碎药材,筛分除杂等步骤,于茶叶包中加入粉碎筛分后的各类药材颗粒,易激发药性,且饮用过程简单。
具体实施方式
实施例1
配方:薏苡仁200g、苦参100g、甘草140g、桔梗100g、莲子心140g。
制备方法:将薏苡仁、苦参、甘草、桔梗、莲子心分别放置于内部真空的微波杀菌设备中;启动设备,采用微波加热方式,使各组分药材在35℃的低温环境下脱水130min,实现快速脱水,并完成杀菌烘干,分别粉碎至药材颗粒小于40目,进行筛分,除去粉料,筛分出药材颗粒,称重,并按重量份数配比各原料,搅拌混合均匀后,装入茶叶包中,即得。
实施例2
配方:薏苡仁170g、苦参130g、甘草120g、桔梗130g、莲子心120g。
制备方法:将薏苡仁、苦参、甘草、桔梗、莲子心分别放置于内部真空的微波杀菌设备中;启动设备,采用微波加热方式,使各组分药材在35℃的低温环境下脱水130min,实现快速脱水,并完成杀菌烘干,分别粉碎至药材颗粒小于40目,进行筛分,除去粉料,筛分出药材颗粒,称重,并按重量份数配比各原料,搅拌混合均匀后,装入茶叶包中,即得。
实施例3
配方:薏苡仁150g、苦参150g、甘草100g、桔梗150g、莲子心100g。
制备方法:将薏苡仁、苦参、甘草、桔梗、莲子心分别放置于内部真空的微波杀菌设备中;启动设备,采用微波加热方式,使各组分药材在35℃的低温环境下脱水130min,实现快速脱水,并完成杀菌烘干,分别粉碎至药材颗粒小于40目,进行筛分,除去粉料,筛分出药材颗粒,称重,并按重量份数配比各原料,搅拌混合均匀后,装入茶叶包中,即得。
实施例4
配方:薏苡仁130g、苦参170g、甘草80g、桔梗170g、莲子心80g。
制备方法:将薏苡仁、苦参、甘草、桔梗、莲子心分别放置于内部真空的微波杀菌设备中;启动设备,采用微波加热方式,使各组分药材在35℃的低温环境下脱水130min,实现快速脱水,并完成杀菌烘干,分别粉碎至药材颗粒小于40目,进行筛分,除去粉料,筛分出药材颗粒,称重,并按重量份数配比各原料,搅拌混合均匀后,装入茶叶包中,即得。
实施例5
配方:薏苡仁100g、苦参200g、甘草60g、桔梗200g、莲子心60g。
制备方法:将薏苡仁、苦参、甘草、桔梗、莲子心分别放置于内部真空的微波杀菌设备中;启动设备,采用微波加热方式,使各组分药材在35℃的低温环境下脱水130min,实现快速脱水,并完成杀菌烘干,分别粉碎至药材颗粒小于40目,进行筛分,除去粉料,筛分出药材颗粒,称重,并按重量份数配比各原料,搅拌混合均匀后,装入茶叶包中,即得。
实验例1(组方筛选试验)
对本发明涉及药物进行体外抗真菌试验,测量其最小抑菌浓度(MIC)值。
方法:采用美国临床实验室标准化委员会推荐的《产孢丝状真菌的液基稀释抗真菌药敏试验参考方案》。在此方案的基础上测定本发明药物组合物对临床常见皮肤癣菌以的MIC值。
菌种活化:将来自菌种保藏库的菌株挑取直径约3mm菌丝体,以点接种法接种于新制备的马铃薯培养基(PDA)试管斜面中央,温度28℃培养7-14d后进行药敏实验。所需菌株:红色毛癣菌6株,石膏样毛癣菌6株,须发毛癣菌6株。
抗真菌药物储备液、稀释液的制备:分别称取表1所述样品的浸膏50mg,用1mlDMSO溶解,制成浓度为50000μg/ml的储备液,存于温度-70℃冰箱备用;称取氟康唑8mg,用1mlDMSO溶解,制成浓度为80000μg/ml的储备液,存于温度-70℃冰箱备用;临用前将上述储备液,分别用RPMI-1640培养基倍比稀释成2倍试验终浓度。
表1各药物组组方(单位:g)
制备方法:将薏苡仁、苦参、甘草、桔梗、莲子心分别放置于内部真空的微波杀菌设备中;启动设备,采用微波加热方式,使各组分药材在35℃的低温环境下脱水130min,实现快速脱水,并完成杀菌烘干,分别粉碎至药材颗粒小于40目,进行筛分,除去粉料,筛分出药材颗粒,称重,并按重量份数配比各原料,搅拌混合均匀后,装入茶叶包中,即得。将所得产物加入100ml的80℃以上的水中浸泡30min,滤液,浓缩得浸膏。
将受试的皮肤癣菌接种于马铃薯培养基斜面上,温度28℃培养7-14d,吸取2ml无菌的0.85%%的NaCl溶液,轻轻冲洗菌落表面的菌丝和孢子,吸取菌液转移至无菌试管中,振荡器上振荡15s,将含有菌丝和孢子的冲洗器用血细胞计数板计数,将其浓度调至0.4×106-0.5×106cfu/ml之间,用RPMI-1640培养基稀释50倍至2倍终浓度。
接种:将100μl的2倍终浓度的药液,由第1孔至第10孔分别由高浓度到低浓度加入96孔细胞培养板中;第11孔为省长对照孔(仅加菌接种液100μl和RPMI-1640培养基100μl);第12孔为空白对照孔(只加RPMI-1640培养基200μl);将调好的菌接种液100μl,分别加入相应的微孔内,这将使每一梯度的抗真菌药物和菌接种液(2倍终浓度)分别被1:1稀释至终浓度。
于28℃孵育7-14天读取MIC值,取完全不生长管最低药物浓度为最低抑菌浓度(MIC),结果如表2所示。
表2本发明药物对真菌的药物敏感性
结果:本发明药物组合物(药物E组)对皮肤癣菌中不同菌种的MIC值范围为17.5-50μg/ml,体外具有显著抗真菌作用。
实验例2
对豚鼠皮肤红色癣菌感染模型的治疗作用
红色毛癣菌是一种人源的皮癣菌,引起常见的皮肤浅部真菌病,如手癣、足癣、头癣等。普通短毛的豚鼠是著名的实验动物,对红色毛癣菌较其它动物敏感,故选择豚鼠进行皮肤癣菌造模实验。
动物:健康豚鼠,体质量250-300g,雌雄各半。
药物:实施例1-5所得药物。
方法:健康豚鼠,随机分为8组,每组10只,即空白组、模型对照组、阳性药组、实施例1药物组、实施例2药物组、实施例3药物组、实施例4药物组、实施例5药物组。
实验动物的预处理:除空白组外,接种前3d开始,每天注射1次股部肌肉注射曲安奈德注射液20mg/kg·d。
接种用真菌悬液制备:将红色毛癣菌菌株接种于马铃薯培养基培养基,10d后轻轻刮取表面菌落,移至无菌的PBS,无菌研钵内研磨成菌丝段(含分生孢子)悬液,调整菌丝段/孢子浓度为1×108cfu/mL待用。
接种:实验前24h剪除实验动物背部毛发,面积2.5cm×2.5cm。无菌生理盐水冲洗,电吹风吹干。24h后用75%酒精擦拭脱毛部位,待脱毛部位残余酒精挥发干燥后,用无菌粗砂纸轻轻磨破豚鼠背部皮肤,以观察到点状渗血为宜,涂布菌悬液,空白对照组涂无菌生理盐水。
接种后处理:除空白对照组外的各组动物马上腹腔注射给予地塞米松注射液7.5mg/kg,隔日重复注射1次,共3-4次。每日观察实验动物接种处皮肤红肿、渗出、鳞片样改变、脱屑、结痂和毛发生长变化。
真菌镜检:接种后第4d开始刮取少许动物背部接种处皮屑进行10%氢氧化钾常规镜检,隔日进行1次,至接种后第8天,同时接种于含氯霉素和放线菌酮的马铃薯培养基培养基,以镜检和培养阳性为造模成功。造模后一般观察造模前各组豚鼠一切活动正常,造模后,豚鼠性情暴躁,时常相互间厮打,四肢及头部常见被抓伤,精神萎靡,毛发粗糙无光,反应迟钝,造模部位皮肤第四天大量脱白色鳞屑,后续几天陆续出现蔓延、红肿、渗出,病变逐渐向四周扩散,真菌镜检结果逐渐显阳性,至造模第七天菌丝和孢子浓度为0.4×106-5×106cfu/ml之间可用于后续试验。
造模成功后48h内开始实验治疗,试验药物组,分别灌胃给予实施例1-5组(2.5g/kg),每日一次,同时,盐酸特比奈芬乳膏组每次用药量为0.05g/cm2,每日一次。结果见表3。
表3本发明药物对豚鼠皮肤癣菌感染模型治愈率
结论:从上表可知,给药起各组皮屑均明显减少,并且皮肤逐渐恢复了平整,且到给药第7天,实施例1-5组中有部分豚鼠镜检基本成阴性并且皮屑培养也基本上呈现阴性,提示本发明药物作用效果良好。
本具体实施例仅仅是对本发明的解释,其并不是对本发明的限制,本领域技术人员在阅读完本说明书后可以根据需要对本实施例做出没有创造性贡献的修改,但只要在本发明的权利要求范围内都受到专利法的保护。
Claims (6)
1.一种防治脚气的组合物,其特征在于,所述组合物包含以下重量份的原料制成:薏苡仁10~20份,苦参10~20份,甘草6~14份,桔梗10~20份,莲子心6~14份。
2.根据权利要求1所述组合物,其特征在于,所述薏苡仁为13~17份。
3.根据权利要求1所述组合物,其特征在于,所述薏苡仁为未经炒制的薏苡仁。
4.根据权利要求1所述组合物,其特征在于,所述苦参为13~17份。
5.根据权利要求1所述组合物,其特征在于,所述甘草为生甘草。
6.一种防治脚气的组合物的制备方法,其特征在于,包括如下步骤:
步骤1,选用薏苡仁、苦参、甘草、桔梗、莲子心,备用;步骤2,将步骤1中的药材分别通过微波杀菌设备进行杀菌烘干操作,备用;
步骤3,将薏苡仁、苦参、甘草、桔梗、莲子心分别进行粉碎;
步骤4,分别对薏苡仁、苦参、甘草、桔梗、莲子心的破碎后原料进行筛分,除去粉料,筛分出药材颗粒;
步骤5,称重,并按重量份数配比各原料,搅拌混合均匀后,装入茶叶包中,即得。
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