CN105663759A - 一种治疗白癜风的中药制剂及其制备方法 - Google Patents
一种治疗白癜风的中药制剂及其制备方法 Download PDFInfo
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Abstract
本发明提供了一种治疗白癜风的中药制剂及其制备方法,中药制剂中包括以下原料药材:白石英、白花菜、苦木、白珠树、钗子股、补血草、原蚕蛾、刺血红、牛抄藤、柘树茎叶、半截叶、邪蒿、绵毛金腰、八月瓜、沙枣、苏铁蕨、红簕钩、三叶铜钱草、刺黄柏、韭菜子和枇杷核。本发明的有益效果:本发明的中药制剂能够联合西药治疗白癜风,提高西药的治疗效果,无毒副作用和不良反应,制备工艺简单。
Description
技术领域
本发明涉及中医药工程技术领域,尤其涉及一种治疗白癜风的中药制剂及其制备方法。
背景技术
白癜风(vitiligo)是一种常见多发的色素性皮肤病。该病以局部或泛发性色素脱失形成白斑为特征,是一种获得性局限性或泛发性皮肤色素脱失症,是一影响美容的常见皮肤病,易诊断,治疗难。白癜风是后天性因皮肤色素脱失而发生的局限性白色斑片,使得局部皮肤呈白斑样。医学上通常把这种病变叫色素脱失。此病世界各地均有发生,印度发病率最高,我国约有万人发病,可以累及所有种族,男女发病无显著差别。白癜风是一种常见的后天性色素脱失性皮肤粘膜病,我国人群患病率约0.17%~1.0%。目前白癜风发病原因尚不明确,近年来研究认为自身免疫是最主要的发病机制。白癜风患者血清中存在抗黑素细胞自身抗体,而且抗体滴度与病变活动性、皮损面积呈正相关,此外还可检出多种自身抗体,白斑边缘部分朗格汉斯细胞数目增多等。
白癜风相当于中医白癜、白驳风,祖国医学认为,该疾病与机体风邪入侵、肝肾不足及阻与肌肤等因素具有重要关系。如《诸病源候论》白癜记载:“白癜者,面及颈项身体皮肉色变白,与肉不同,亦不痒痛,谓之白癜”。又如《医宗金鉴·外科心示》白驳风记载:“白驳风生面颈间,风邪相搏白点斑,甚至遍身无痛痒,治宜消风涂脂痊”。中医学对本病的认识很早,《五十二病方》中已有治疗“白处”的记载,并有二则方剂。隋唐时代的《诸病源候论》、《备急千金要方》始称“白癜”、“白癜风”或“白疙”,并指出其病机为“风邪博于皮肤,血气不和”。
发明内容
本发明所要解决的技术问题在于,利用我国传统的中医理论,提供一种疗效确切且无毒性作用的治疗白癜风的中药制剂及其制备方法。
为了解决上述技术问题,本发明提供了一种治疗白癜风的中药制剂,所述中药制剂包括以下原料药材:白石英、白花菜、苦木、白珠树、钗子股、补血草、原蚕蛾、刺血红、牛抄藤、柘树茎叶、半截叶、邪蒿、绵毛金腰、八月瓜、沙枣、苏铁蕨、红簕钩、三叶铜钱草、刺黄柏、韭菜子和枇杷核。
所述中药制剂中的各种原料药材的重量份数比可以优选为:白石英20~30份、白花菜15~25份、苦木10~20份、白珠树30~40份、钗子股15~30份、补血草10~25份、原蚕蛾20~30份、刺血红25~35份、牛抄藤15~25份、柘树茎叶10~20份、半截叶20~35份、邪蒿30~40份、绵毛金腰15~25份、八月瓜20~30份、沙枣10~25份、苏铁蕨5~15份、红簕钩15~25份、三叶铜钱草10~25份、刺黄柏20~30份、韭菜子10~20份和枇杷核10~20份。
所述中药制剂中的各种原料药材的重量份数比还可以进一步优选为:白石英20~25份、白花菜15~20份、苦木10~15份、白珠树30~35份、钗子股20~25份、补血草15~20份、原蚕蛾25~30份、刺血红30~35份、牛抄藤15~20份、柘树茎叶10~15份、半截叶25~30份、邪蒿35~40份、绵毛金腰20~25份、八月瓜25~30份、沙枣15~20份、苏铁蕨5~10份、红簕钩15~20份、三叶铜钱草20~25份、刺黄柏25~30份、韭菜子15~20份和枇杷核10~15份。
所述中药制剂中的各种原料药材的重量份数比也可以进一步优选为:白石英21份、白花菜20份、苦木12份、白珠树35份、钗子股21份、补血草19份、原蚕蛾26份、刺血红35份、牛抄藤16份、柘树茎叶15份、半截叶26份、邪蒿39份、绵毛金腰22份、八月瓜28份、沙枣16份、苏铁蕨10份、红簕钩16份、三叶铜钱草24份、刺黄柏26份、韭菜子18份和枇杷核12份。
当所述中药制剂的剂型为散剂时,其制备方法包括以下步骤:
第一步,将白石英、白花菜、苦木、白珠树、钗子股、补血草、原蚕蛾、刺血红、牛抄藤、柘树茎叶和半截叶按所述比例混合,用相对于获得的混合物质量的3~5倍的醇浓度为85%~95%的乙醇溶解,加热回流2~4小时后提取,过滤,得第一过滤液;将滤渣再次用相对于获得的混合物质量的2~3倍的醇浓度85%~95%的乙醇溶解,加热回流1~2小时后提取,过滤,得第二过滤液;合并第一过滤液和第二过滤液,减压回收乙醇并浓缩至药液浓度为1.2~1.5g生药/mL,经体积为5L的大孔吸附树脂柱洗脱,先用5倍树脂柱体积的去离子水或蒸馏水洗脱,再用3倍树脂柱体积的醇浓度为90%~95%乙醇洗脱,收集乙醇洗脱液,减压浓缩除去乙醇,干燥并粉碎成粉末;
第二步,将剩余原料药材按所述比例混合,加相对于获得的混合物质量的3~6倍的水溶解,加热煎煮2~4小时,过滤;将滤渣再次用相对于获得的混合物质量的2~4倍的水溶解,再次加热煎煮1~3小时,过滤;合并两次的过滤液,减压浓缩除去水分,干燥并粉碎成粉末;
第三步,将第一步和第二步获得的粉末混合,随后过筛成100~200目的细粉,将获得的细粉和相对于细粉质量0.2~0.4倍的淀粉一起投入混合搅拌机中搅拌,即获得所述中药制剂的散剂。
当所述中药制剂的剂型为胶囊剂时,其制备方法包括以下步骤:
第一步,将白石英、白花菜、苦木、白珠树、钗子股、补血草、原蚕蛾和刺血红按比例混合,加相对于混合物4~6倍的水提取挥发油,将获得的挥发油用β-环糊精包合,挥发油与β-环糊精的比例为1∶3~6,搅拌75分钟~90分钟,温度30℃~50℃,得挥发油包合物,备用;另将水提取液浓缩至60℃时相对密度为1.15~1.17的清膏;
第二步,将牛抄藤、柘树茎叶、半截叶、绵毛金腰、八月瓜、沙枣和红簕钩按所述比例混合,加相对于混合物6~8倍量醇浓度为80%~90%的乙醇回流提取3~5次,每次2~3小时,过滤,滤液合并,回收乙醇,浓缩至60℃时相对密度为1.20~1.22的清膏,备用;
第三步,将剩余所述原料药材按所述比例混合,加相对于混合物8~10倍量水,煮沸6~8小时,过滤,浓缩至65℃时相对密度为1.28~1.30的清膏;
第四步,将第一步、第二步、第三步的清膏混合,60℃~70℃减压真空干燥,得干膏粉;
第五步,将第一步所述挥发油包合物和第四步所述干膏粉充分混合,随后加入相对于100重量份所述挥发油包合物和干膏粉的混合物,5~8重量份羧甲基淀粉钠、10~50重量份淀粉混合均匀,加入150~200重量份醇浓度为80%~90%乙醇制粒,干燥,整粒,随后加入相对于100重量份所述挥发油包合物和干膏粉的混合物,3~5重量份硬脂酸镁,然后装入明胶胶囊中。
本发明的有益效果:本发明的中药制剂能够联合西药治疗白癜风,提高西药的治疗效果,无毒副作用和不良反应,制备工艺简单。
具体实施方式
本发明提供了一种治疗白癜风的中药制剂,中药制剂中包括以下原料药材:白石英、白花菜、苦木、白珠树、钗子股、补血草、原蚕蛾、刺血红、牛抄藤、柘树茎叶、半截叶、邪蒿、绵毛金腰、八月瓜、沙枣、苏铁蕨、红簕钩、三叶铜钱草、刺黄柏、韭菜子和枇杷核。
各种原料药材的药理如下:
白石英:【来源】药材基源:为氧化物类矿物石英的矿石。【性味】甘;辛;温;无毒。【归经】肺;肾;心经。【功能主治】温肺肾;安心神;利小便。主肺寒咳喘;阳痿;消渴;心神不安;惊悸善忘;小便不利;黄疸;石水;风寒湿痹。【各家论述】《本经》:主消渴,阴痿不足,咳逆(一作呕逆),胸膈间久寒,益气,除风湿痹。【摘录】《中华本草》《中药大辞典》
白花菜:【别名】羊角菜、屡析草、臭花菜、臭豆角、猪屎草、五梅草、白花仔草。【来源】药材基源:为白花菜科植物白花菜的全草。【性味】辛;甘;平。【归经】肝;脾经。【功能主治】祛风除湿;清热解毒。主风湿痹痛;跌打损伤;淋浊;白带;疟疾;痢疾;痔疮;蛇虫咬伤。【各家论述】汪颖《食物本草》:下气。【摘录】《中华本草》
苦木:【别名】苦皮树、苦树皮、苦皮子、苦胆木、赶狗木、熊胆树、土樗子。【来源】本品为苦木科植物苦木干燥枝及叶。夏、秋二季采收,干燥。【性味】苦,寒;有小毒。【归经】归肺、大肠经。【功能主治】清热,祛湿,解毒。用于风热感冒,咽喉肿痛,腹泻下痢,湿疹,疮疖,毒蛇咬伤。【摘录】《中国药典》
白珠树:【别名】老虎尿、老虎面、满山香、牛头药药。【来源】药材基源:为杜鹃花科植物白珠树的根或茎叶。【性味】辛;性温。【功能主治】祛风除湿;通络止痛。主风湿痹痛;跌打损伤。【摘录】《中华本草》
钗子股:【别名】金钗股、三十根、松寄生、虫寄生、金环草、大羊角、老鼠尾、肖羊耳兰、圆柱兰、石珊瑚、石鹿角、龙须草。【出处】出自《本草纲目拾遗》。1.出自《本草纲目拾遗》》:金钗股,生岭南山谷。根如细辛,三、四十茎,岭南人用之。2.《海药本草》:钗子股,谨按陈氏云:生岭南及南海诸山,每茎三十根,状似细辛。忠、万州者佳。草茎功力相似,以水煎服。缘岭南多毒,家家贮之。【来源】药材基源:为兰科植物钗子股的根或全草。采收和储藏:夏、秋季采收,鲜用或晒干。【性味】苦;辛;性凉;小毒。【归经】肺;心;肝;肾经。【功能主治】清热解毒;祛风利湿。主疟疾;痈疽;咽喉肿痛;风湿痹痛;水肿;白浊;白带过多;跌打损伤;药物或食物中毒。【摘录】《中华本草》
补血草:【别名】匙叶草、海赤芍、海罗卜、海金花、土地榆。【来源】药材基源:为白花丹科植物补血草的根。【性味】苦;微咸;性凉。【功能主治】清热;利湿;止血;解毒。主湿热便血;脱肛;血淋;月经过多,白带;痈肿疮毒。【各家论述】《新疆中草药手册》:止血散瘀。治功能性子宫出血,宫颈癌及其他出血。【摘录】《中华本草》
原蚕蛾:【别名】蚕蛾、晚蚕蛾、魏蚕蛾、天蛾。【出处】出自《名医别录》。【来源】药材基源:为蚕蛾科动物家蚕蛾雄虫的全体。采收和储藏:夏季取雄性蚕蛾,以沸水烫死,晒干。【性味】味咸;性温。【归经】肝;肾经。【功能主治】补肾壮阳;涩精;止血;解毒消肿。主阳痿遗精;白浊;血淋;金疮出血;咽喉肿痛;口舌生疮;痈肿毒;冻疮;蛇伤。【摘录】《中华本草》
刺血红:【别名】七星剑、血路草。【来源】药材基源:为爵床科植物花叶假杜鹃的全株。【性味】味辛;苦;性平。【功能主治】通经络;续筋骨;解毒消肿。主跌打肿痛;骨折;外伤出血;痈肿疮毒;毒蛇咬伤。【摘录】《中华本草》
牛抄藤:【别名】长叶海金沙、驳筋藤、介指藤、缠藤、柳叶海金沙、海金沙、左壮藤、坐转藤、加吊藤、戒指藤。【来源】药材基源:为海金沙科植物曲轴海金沙的全草。【性味】甘;微苦;寒。【归经】肾;肝;大肠经。【功能主治】舒筋活络;清热利湿;止血。主风湿麻木;跌打损伤;尿路感染;泌尿系结石;水肿;痢疾;疮痈肿毒;小儿口疮;火眼;癣疾;外伤出血。【各家论述】1.《广西药植名录》:治痢疾,霍乱抽筋,止血,消炎。2.《云南中草药选》:舒筋活络,清热,利尿,消肿。治风湿麻木,尿路感染,泌尿系结石,肾炎水肿,跌打损伤。【摘录】《中华本草》《中药大辞典》
柘树茎叶:【来源】药材基源:为桑科植物柘树的枝及叶。【性味】甘;微苦;性凉。【功能主治】清热解毒;祛风活络。主痄腮;痈肿;隐疹;湿疹;跌打损伤;腰腿痛。【各家论述】《云南中草药选》:消炎止痛,祛风活血。治流行性腮腺炎,肺结核,慢性腰腿痛,跌打痨伤,疖肿,急性关节扭伤。【摘录】《中华本草》
半截叶:【别名】锅铲叶、金边莲、半节叶、半节观音、铲叶西番莲。【来源】药材基源:为西番莲科植物镰叶西番莲的全草。【性味】味微苦;性温。【功能主治】祛风湿;补肝肾;活血调经,杀虫截疟。主风温滑痛;腰酸背痛;肝炎;肝硬化;月经不调;跌打损伤;骨折;疟疾;蛔虫病。【各家论述】1.《云南中草药选》:燥湿,止血,消炎,生肌。治风湿腰痛,肝炎,肝硬化,肿瘤,跌打损伤,骨折。2.《云南思茅中草药选》:舒筋活络,散瘀活血,止咳化痰,驱虫。治风湿骨痛,关节炎,疟疾,痰阻,蛔虫症。【摘录】《中华本草》
邪蒿:【来源】药材基源:为伞形科植物香芹的根。【性味】味辛;性平;归脾;胃经。【功能主治】化浊;醒脾;通脉。主湿阻痞满;胃呆食少;痢疾;疮肿。【各家论述】孟诜:通血脉,续不足气。【摘录】《中华本草》
绵毛金腰:【出处】始载于《中国高等植物图鉴》。【来源】药材基源:为虎耳草科植物绵毛金腰的全草。【性味】甘;寒。【归经】肺、胃二经。【功能主治】清热解毒、生肌收敛、活血通络。主用于臁疮,烫火伤,跌打损伤。【摘录】《中华本草》
八月瓜:【别名】牛腰子果、六月瓜、小八瓜、哪瓜、黄狗肾、木王瓜、八月果、野人瓜、刺藤果、牛懒袋果。【来源】药材基源:为木通科植物五风藤、宽叶八月瓜和小花八月瓜的果实。采收和储藏:秋季果熟时采摘,晒干。【性味】苦;凉。【归经】膀胱;心;肝经。【功能主治】清热利湿;活血通脉;行气止痛。主小便短赤;淋浊;水肿;风湿痹痛;跌打损伤;乳汁不通;疝气痛;子宫脱垂;睾丸炎。【摘录】《中华本草》
沙枣:【别名】四味果、红豆、吉格达。【出处】出自《新疆中草药手册》。【来源】药材基源:为胡颓子科植物沙枣、东方沙枣和尖果沙枣的成熟果实。采收和储藏:果实成熟时分批采摘,鲜用或烘干。【性味】味酸;微甘;性凉。【归经】肺;肝;脾;胃;肾经。【功能主治】养肝益肾;健脾调经。主肝虚目眩;肾虚腰痛;脾虚腹泻;消化不良;带下;月经不调。【各家论述】《新疆中草药手册》:强壮,镇静,固精,健胃,止泻,调经,利尿。治胃痛,腹泻,身体虚弱,肺热咳嗽。【摘录】《中华本草》
苏铁蕨:【别名】贯众。【来源】药材基源:为乌毛蕨科植物苏铁蕨的根茎。采收和储藏:全年均可采收,洗净,晒干或鲜用。【性味】微涩;凉。【功能主治】清热解毒;活血止血;驱虫。主感冒;烧伤;外伤出血;蛔虫病。【摘录】《中华本草》
红簕钩:【来源】药材基源:为蔷薇科植物梨叶悬钩子的根。【性味】酸;涩;凉。【归经】肺;肝经。【功能主治】清肺止咳;行气解郁。主肺热咳嗽,气滞胁痛,脘腹胀痛。【各家论述】《新华本草纲要》:根:味酸、涩、性凉。有清肺凉血、解郁的功能。用于肺热咳嗽、胸闷。【摘录】《中华本草》
三叶铜钱草:【别名】山酢浆草。【来源】药材基源:为酢浆草科植物白花酢浆草的全草。采收和储藏:夏、秋季采集全草,鲜用或晒干。【性味】味酸;微辛;性平。【归经】心;肝;膀胱经。【功能主治】活血化瘀;清热解毒;利尿通淋。主劳伤疼痛;跌打损伤;麻疯;无名肿毒;疥癣;小儿口疮;烫火伤;淋浊带下;尿闭。【摘录】《中华本草》
刺黄柏:【别名】老鼠刺、木黄连、刺黄芩、山黄芩、野黄芩。【出处】出自《四川省药志》。【来源】药材基源:为小檗科植物密叶十大功劳、细梗十大功劳、滇刺黄柏和长阳十大功劳的根和茎。采收和储藏:夏、秋采挖,洗净,晒干。【性味】苦;性寒。【归经】肝;肾经。【功能主治】清热燥湿,泻火解毒。主湿热痢疾;腹泻;目赤肿痛;除;劳热骨蒸;咯血;头晕;风湿痹痛;痈肿疮疡。【摘录】《中华本草》
韭菜子:【来源】本品为百合科植物韭菜的干燥成熟种子。【性味】辛、甘,温。【归经】归肝、肾经。【功能主治】温补肝肾,壮阳固精。用于阳痿遗精,腰膝酸痛,遗尿尿频,白浊带下。【摘录】《中国药典》
枇杷核:【来源】药材基源:为蔷薇科植物枇杷的种子。【性味】苦;平;无毒。【归经】肾经。【功能主治】化痰止咳;疏肝行气;利水消肿。主咳嗽痰多;疝气;水肿;瘰疬。【各家论述】1.《本草纲目拾遗》:治肝有余诸症,气实者可用。2.《四川中药志》:疏肝理气。【摘录】《中华本草》
所述中药制剂中的各种原料药材的重量份数比可以优选为:白石英20~30份、白花菜15~25份、苦木10~20份、白珠树30~40份、钗子股15~30份、补血草10~25份、原蚕蛾20~30份、刺血红25~35份、牛抄藤15~25份、柘树茎叶10~20份、半截叶20~35份、邪蒿30~40份、绵毛金腰15~25份、八月瓜20~30份、沙枣10~25份、苏铁蕨5~15份、红簕钩15~25份、三叶铜钱草10~25份、刺黄柏20~30份、韭菜子10~20份和枇杷核10~20份。
所述中药制剂中的各种原料药材的重量份数比还可以进一步优选为:白石英20~25份、白花菜15~20份、苦木10~15份、白珠树30~35份、钗子股20~25份、补血草15~20份、原蚕蛾25~30份、刺血红30~35份、牛抄藤15~20份、柘树茎叶10~15份、半截叶25~30份、邪蒿35~40份、绵毛金腰20~25份、八月瓜25~30份、沙枣15~20份、苏铁蕨5~10份、红簕钩15~20份、三叶铜钱草20~25份、刺黄柏25~30份、韭菜子15~20份和枇杷核10~15份。
所述中药制剂中的各种原料药材的重量份数比也可以进一步优选为:白石英21份、白花菜20份、苦木12份、白珠树35份、钗子股21份、补血草19份、原蚕蛾26份、刺血红35份、牛抄藤16份、柘树茎叶15份、半截叶26份、邪蒿39份、绵毛金腰22份、八月瓜28份、沙枣16份、苏铁蕨10份、红簕钩16份、三叶铜钱草24份、刺黄柏26份、韭菜子18份和枇杷核12份。
当所述中药制剂的剂型为散剂时,其制备方法包括以下步骤:
第一步,将白石英、白花菜、苦木、白珠树、钗子股、补血草、原蚕蛾、刺血红、牛抄藤、柘树茎叶和半截叶按所述比例混合,用相对于获得的混合物质量的3~5倍的醇浓度为85%~95%的乙醇溶解,加热回流2~4小时后提取,过滤,得第一过滤液;将滤渣再次用相对于获得的混合物质量的2~3倍的醇浓度85%~95%的乙醇溶解,加热回流1~2小时后提取,过滤,得第二过滤液;合并第一过滤液和第二过滤液,减压回收乙醇并浓缩至药液浓度为1.2~1.5g生药/mL,经体积为5L的大孔吸附树脂柱洗脱,先用5倍树脂柱体积的去离子水或蒸馏水洗脱,再用3倍树脂柱体积的醇浓度为90%~95%乙醇洗脱,收集乙醇洗脱液,减压浓缩除去乙醇,干燥并粉碎成粉末;
第二步,将剩余原料药材按所述比例混合,加相对于获得的混合物质量的3~6倍的水溶解,加热煎煮2~4小时,过滤;将滤渣再次用相对于获得的混合物质量的2~4倍的水溶解,再次加热煎煮1~3小时,过滤;合并两次的过滤液,减压浓缩除去水分,干燥并粉碎成粉末;
第三步,将第一步和第二步获得的粉末混合,随后过筛成100~200目的细粉,将获得的细粉和相对于细粉质量0.2~0.4倍的淀粉一起投入混合搅拌机中搅拌,即获得所述中药制剂的散剂。
当所述中药制剂的剂型为胶囊剂,其包括以下步骤:
第一步,将白石英、白花菜、苦木、白珠树、钗子股、补血草、原蚕蛾和刺血红按比例混合,加相对于混合物4~6倍的水提取挥发油,将获得的挥发油用β-环糊精包合,挥发油与β-环糊精的比例为1∶3~6,搅拌75分钟~90分钟,温度30℃~50℃,得挥发油包合物,备用;另将水提取液浓缩至60℃时相对密度为1.15~1.17的清膏;
第二步,将牛抄藤、柘树茎叶、半截叶、绵毛金腰、八月瓜、沙枣和红簕钩按所述比例混合,加相对于混合物6~8倍量醇浓度为80%~90%的乙醇回流提取3~5次,每次2~3小时,过滤,滤液合并,回收乙醇,浓缩至60℃时相对密度为1.20~1.22的清膏,备用;
第三步,将剩余所述原料药材按所述比例混合,加相对于混合物8~10倍量水,煮沸6~8小时,过滤,浓缩至65℃时相对密度为1.28~1.30的清膏;
第四步,将第一步、第二步、第三步的清膏混合,60℃~70℃减压真空干燥,得干膏粉;
第五步,将第一步所述挥发油包合物和第四步所述干膏粉充分混合,随后加入相对于100重量份所述挥发油包合物和干膏粉的混合物,5~8重量份羧甲基淀粉钠、10~50重量份淀粉混合均匀,加入150~200重量份醇浓度为80%~90%乙醇制粒,干燥,整粒,随后加入相对于100重量份所述挥发油包合物和干膏粉的混合物,3~5重量份硬脂酸镁,然后装入明胶胶囊中。
以下采用实施例来详细说明本发明的实施方式,借此对本发明如何应用技术手段来解决技术问题,并达成技术效果的实现过程能充分理解并据以实施。
实施例1:本发明制备的散剂
取白石英210g、白花菜200g、苦木120g、白珠树350g、钗子股210g、补血草190g、原蚕蛾260g、刺血红350g、牛抄藤160g、柘树茎叶150g、半截叶260g、邪蒿390g、绵毛金腰220g、八月瓜280g、沙枣160g、苏铁蕨100g、红簕钩160g、三叶铜钱草240g、刺黄柏260g、韭菜子180g和枇杷核120g。
其制备方法包括以下步骤:
第一步,将白石英、白花菜、苦木、白珠树、钗子股、补血草、原蚕蛾、刺血红、牛抄藤、柘树茎叶和半截叶按所述比例混合,用相对于获得的混合物质量的5倍的醇浓度为85%的乙醇溶解,加热回流4小时后提取,过滤,得第一过滤液;将滤渣再次用相对于获得的混合物质量的2倍的醇浓度95%的乙醇溶解,加热回流2小时后提取,过滤,得第二过滤液;合并第一过滤液和第二过滤液,减压回收乙醇并浓缩至药液浓度为1.2~1.5g生药/mL,经体积为5L的大孔吸附树脂柱洗脱,先用5倍树脂柱体积的去离子水或蒸馏水洗脱,再用3倍树脂柱体积的醇浓度为95%乙醇洗脱,收集乙醇洗脱液,减压浓缩除去乙醇,干燥并粉碎成粉末;
第二步,将剩余原料药材按所述比例混合,加相对于获得的混合物质量的5倍的水溶解,加热煎煮4小时,过滤;将滤渣再次用相对于获得的混合物质量的3倍的水溶解,再次加热煎煮3小时,过滤;合并两次的过滤液,减压浓缩除去水分,干燥并粉碎成粉末;
第三步,将第一步和第二步获得的粉末混合,随后过筛成170目的细粉,将获得的细粉和相对于细粉质量0.25倍的淀粉一起投入混合搅拌机中搅拌,即获得所述中药制剂的散剂。
实施例2:本发明制备的胶囊剂
取白石英230g、白花菜160g、苦木150g、白珠树320g、钗子股250g、补血草160g、原蚕蛾290g、刺血红320g、牛抄藤180g、柘树茎叶120g、半截叶280g、邪蒿360g、绵毛金腰250g、八月瓜260g、沙枣190g、苏铁蕨70g、红簕钩180g、三叶铜钱草220g、刺黄柏280g、韭菜子160g和枇杷核150g。
其制备方法包括以下步骤:
第一步,将白石英、白花菜、苦木、白珠树、钗子股、补血草、原蚕蛾和刺血红按比例混合,加相对于混合物5倍的水提取挥发油,将获得的挥发油用β-环糊精包合,挥发油与β-环糊精的比例为1∶4,搅拌80分钟,温度40℃,得挥发油包合物,备用;另将水提取液浓缩至60℃时相对密度为1.16的清膏;
第二步,将牛抄藤、柘树茎叶、半截叶、绵毛金腰、八月瓜、沙枣和红簕钩按所述比例混合,加相对于混合物6倍量醇浓度为85%的乙醇回流提取4次,每次3小时,过滤,滤液合并,回收乙醇,浓缩至60℃时相对密度为1.20的清膏,备用;
第三步,将剩余所述原料药材按所述比例混合,加相对于混合物9倍量水,煮沸8小时,过滤,浓缩至65℃时相对密度为1.28的清膏;
第四步,将第一步、第二步、第三步的清膏混合,65℃减压真空干燥,得干膏粉;
第五步,将第一步所述挥发油包合物和第四步所述干膏粉充分混合,随后相对于100重量份所述挥发油包合物和干膏粉的混合物,加入6重量份羧甲基淀粉钠、30重量份淀粉混合均匀,加入160重量份醇浓度为85%乙醇制粒,干燥,整粒,随后相对于100重量份所述挥发油包合物和干膏粉的混合物,加入4重量份硬脂酸镁,然后装入明胶胶囊中。
毒性实验:
急性毒性实验:应用小鼠60只,雌雄各半,体重20~38g,进行急性毒性试验。小鼠随机分为两组,即对照组和给药组,实验前禁食12小时,将本发明的实施例1制备的中药散剂溶解在水中,(浓度为8.87g生药/ml,最高浓度)灌胃,灌胃容积为5ml/kg(即单次给药剂量为44.35生药/kg),对照组给予等量生理盐水,一天给药2次,给药间隔时间6小时,给药后连续观察14天,并记录小鼠的的毒性反应及死亡数。实验结果表明:与对照组比较,给药后小鼠未见明显差异,实验连续观察14天,小鼠全身状况、饮食、饮水、体重增长均正常。小鼠口服灌胃本发明的散剂LD50>44.35生药/kg,每日最大给药量为88.7生药/kg/日。本发明的中药临床用药量为8.35g生药/日/人,成人体重以60KG计,平均用药剂量为0.139g生药/kg/日。按体重计:小鼠(平均体重以29g计)口服灌胃本发明的中药的耐受量为临床用量的638倍。因此本发明的中药急性毒性极低,临床用药安全。
长期毒性实验:本发明中药实施例1散剂对三组小鼠(每组20只)按13.27、25.45和42.36g生药/kg连续用药15周(1.0ml/100g体重,每天2次)及停药3周后,结果表明:本发明中药对小鼠的毛发、行为、大小便、体重、脏器重量、血象、肝肾功能、血糖、血脂等指标均无明显影响,脏器肉眼没有发现异样变化和组织学检查结果表明,用药15周及停药3周后,小鼠各脏器均无明显改变。说明本发明中药对小鼠长期用药后毒性小,停药后也没有异样反应,应用安全。
临床资料:
病例选择:所有105例病例均来源于本院门诊及住院的白癜风患者,其中,男58例,女47例;年龄15~66岁;病程3个月~9年;寻常型98例,节段型7例。随机分为两组,治疗组与对照组各105例患者。治疗组55例患者中,男30例,女25例;年龄15~66岁;病程3个月~9年;寻常型51例,节段型4例。对照组50例患者中,男28例,女22例;年龄15~65岁;病程3个月~8年;寻常型47例,节段型3例。治疗组与对照组在性别、年龄、病程和临床表现等方面比较无明显差异,具有可比性。
诊断标准:根据湖南省医院协会编写的《临床疾病诊断与疗效判断标准》制定。
一、任何年龄均可发展,以青壮年多见,50%患者20岁以前发病。
二、好发于暴露及摩擦部位,如颜面部、颈部、手背、腕部及腰骶部。
三、皮损初发时为一片或几片色素减退斑,境界不清,逐渐扩大为境界清楚的色素脱失斑,呈乳白色。
四、多数患者无自觉症状,病程慢性迁延,有时可自行好转或消退。
五、组织病理:活动期皮损内黑素细胞密度降低,周围黑素细胞异常增大;后期脱色皮损内无黑素细胞,多巴染色阴性。真皮浅层可有淋巴细胞浸润。
分型标准:根据中国中西医结合学会皮肤性病专业委员会色素病学组1994年制定的《白癜风临床分型及疗效标准(草案)》制定。
1、寻常型:
(1)局限性:单片或多片白斑,局限于某一部位。
(2)散在性:散在、多发白斑,常呈对称分布。
(3)泛发性:多由散在性发展而来,白斑多互相融合成不规则大片,有时仅残留小片岛屿状正常肤色。
(4)肢端性:白斑初发于人体的肢端,而且主要分布在这些部位。
2、节段型:白斑为一片或数片,沿某一皮神经节段支配的皮肤区域走向分布,一般为单侧。
治疗方法:
对照组:采用常规西药治疗,给予泼尼松片,每日15mg,晨顿服,每月递减5mg;疗程3个月。
治疗组:在对照组常规西药治疗基础上,同时口服本发明中药实施例1散剂,每次30g,每天3次;疗程3个月。
疗效判断标准:(1)治愈:皮损完全消退,恢复正常肤色。(2)显效:白斑部分消退或缩小,恢复正常肤色的面积≥50%皮损面积。(3)有效:白斑部分消退或缩小,恢复正常肤色的面积≥10%而<50%皮损面积。(4)无效:白斑无变化或增多,恢复正常肤色的面积<10%。
治疗结果:两组分别治疗3个月后,统计结果参见表1。
表1两组分别治疗3个月后临床疗效比较(单位:例)
组别 | 例数 | 治愈 | 显效 | 有效 | 无效 | 总有效率 |
治疗组 | 55 | 30 | 16 | 6 | 3 | 52(94.55%) |
对照组 | 50 | 18 | 14 | 8 | 10 | 40(80%) |
从表1可以看出,治疗组采用本发明的中药,配合西药治疗白癜风,相对于对照组,在治疗效果上,具有显著的改进。
不良反应:治疗期间,两组患者均未出现肝肾功能损害或其他明显不良反应。
具体病例:赵某,女,30岁,患者约三年半之前发现脸部耳际张了许多小白点,不痛不痒,置之不理,几周后发现小斑点变大,开始连成片,并呈扩张趋势,医院就诊临床确诊为白癜风(寻常型)。曾用外用涂抹剂治疗,效果不明显,后因短期内出现更多新的白斑,至本院求诊。给予泼尼松片,每日15mg,晨顿服,每月递减5mg;同时口服本发明中药实施例1散剂,每次30g,每天3次;治疗3个月,皮损完全消退,恢复正常肤色,治愈,随访6个月无复发。
所有上述的首要实施这一知识产权,并没有设定限制其他形式的实施这种新产品或新方法。本领域技术人员将利用这一重要信息,上述内容修改,以实现类似的执行情况。但是,所有修改或改造基于本发明新产品属于保留的权利。
以上所述,仅是本发明的较佳实施例而已,并非是对本发明作其它形式的限制,任何熟悉本专业的技术人员可能利用上述揭示的技术内容加以变更或改型为等同变化的等效实施例。但是凡是未脱离本发明技术方案内容,依据本发明的技术实质对以上实施例所作的任何简单修改、等同变化与改型,仍属于本发明技术方案的保护范围。
Claims (8)
1.一种治疗白癜风的中药制剂,其特征在于,所述中药制剂包括以下原料药材:白石英、白花菜、苦木、白珠树、钗子股、补血草、原蚕蛾、刺血红、牛抄藤、柘树茎叶、半截叶、邪蒿、绵毛金腰、八月瓜、沙枣、苏铁蕨、红簕钩、三叶铜钱草、刺黄柏、韭菜子和枇杷核。
2.如权利要求1所述的中药制剂,其特征在于,所述原料药材的重量份数比为:白石英20~30份、白花菜15~25份、苦木10~20份、白珠树30~40份、钗子股15~30份、补血草10~25份、原蚕蛾20~30份、刺血红25~35份、牛抄藤15~25份、柘树茎叶10~20份、半截叶20~35份、邪蒿30~40份、绵毛金腰15~25份、八月瓜20~30份、沙枣10~25份、苏铁蕨5~15份、红簕钩15~25份、三叶铜钱草10~25份、刺黄柏20~30份、韭菜子10~20份和枇杷核10~20份。
3.如权利要求1或2所述的中药制剂,其特征在于,所述原料药材的重量份数比为:白石英20~25份、白花菜15~20份、苦木10~15份、白珠树30~35份、钗子股20~25份、补血草15~20份、原蚕蛾25~30份、刺血红30~35份、牛抄藤15~20份、柘树茎叶10~15份、半截叶25~30份、邪蒿35~40份、绵毛金腰20~25份、八月瓜25~30份、沙枣15~20份、苏铁蕨5~10份、红簕钩15~20份、三叶铜钱草20~25份、刺黄柏25~30份、韭菜子15~20份和枇杷核10~15份。
4.如权利要求1至3所述的中药制剂,其特征在于,所述原料药材的重量份数比为:白石英21份、白花菜20份、苦木12份、白珠树35份、钗子股21份、补血草19份、原蚕蛾26份、刺血红35份、牛抄藤16份、柘树茎叶15份、半截叶26份、邪蒿39份、绵毛金腰22份、八月瓜28份、沙枣16份、苏铁蕨10份、红簕钩16份、三叶铜钱草24份、刺黄柏26份、韭菜子18份和枇杷核12份。
5.如权利要求1至4所述的中药制剂,其特征在于,所述中药制剂的剂型为散剂,其制备方法包括以下步骤:
第一步,将白石英、白花菜、苦木、白珠树、钗子股、补血草、原蚕蛾、刺血红、牛抄藤、柘树茎叶和半截叶按所述比例混合,用相对于获得的混合物质量的3~5倍的醇浓度为85%~95%的乙醇溶解,加热回流2~4小时后提取,过滤,得第一过滤液;将滤渣再次用相对于获得的混合物质量的2~3倍的醇浓度85%~95%的乙醇溶解,加热回流1~2小时后提取,过滤,得第二过滤液;合并第一过滤液和第二过滤液,减压回收乙醇并浓缩至药液浓度为1.2~1.5g生药/mL,经体积为5L的大孔吸附树脂柱洗脱,先用5倍树脂柱体积的去离子水或蒸馏水洗脱,再用3倍树脂柱体积的醇浓度为90%~95%乙醇洗脱,收集乙醇洗脱液,减压浓缩除去乙醇,干燥并粉碎成粉末;
第二步,将剩余原料药材按所述比例混合,加相对于获得的混合物质量的3~6倍的水溶解,加热煎煮2~4小时,过滤;将滤渣再次用相对于获得的混合物质量的2~4倍的水溶解,再次加热煎煮1~3小时,过滤;合并两次的过滤液,减压浓缩除去水分,干燥并粉碎成粉末;
第三步,将第一步和第二步获得的粉末混合,随后过筛成100~200目的细粉,将获得的细粉和相对于细粉质量0.2~0.4倍的淀粉一起投入混合搅拌机中搅拌,即获得所述中药制剂的散剂。
6.如权利要求1至4所述的中药制剂,其特征在于,所述中药制剂的剂型为胶囊剂,其制备方法包括以下步骤:
第一步,将白石英、白花菜、苦木、白珠树、钗子股、补血草、原蚕蛾和刺血红按比例混合,加相对于混合物4~6倍的水提取挥发油,将获得的挥发油用β-环糊精包合,挥发油与β-环糊精的比例为1∶3~6,搅拌75分钟~90分钟,温度30℃~50℃,得挥发油包合物,备用;另将水提取液浓缩至60℃时相对密度为1.15~1.17的清膏;
第二步,将牛抄藤、柘树茎叶、半截叶、绵毛金腰、八月瓜、沙枣和红簕钩按所述比例混合,加相对于混合物6~8倍量醇浓度为80%~90%的乙醇回流提取3~5次,每次2~3小时,过滤,滤液合并,回收乙醇,浓缩至60℃时相对密度为1.20~1.22的清膏,备用;
第三步,将剩余所述原料药材按所述比例混合,加相对于混合物8~10倍量水,煮沸6~8小时,过滤,浓缩至65℃时相对密度为1.28~1.30的清膏;
第四步,将第一步、第二步、第三步的清膏混合,60℃~70℃减压真空干燥,得干膏粉;
第五步,将第一步所述挥发油包合物和第四步所述干膏粉充分混合,随后加入相对于100重量份所述挥发油包合物和干膏粉的混合物,5~8重量份羧甲基淀粉钠、10~50重量份淀粉混合均匀,加入150~200重量份醇浓度为80%~90%乙醇制粒,干燥,整粒,随后加入相对于100重量份所述挥发油包合物和干膏粉的混合物,3~5重量份硬脂酸镁,然后装入明胶胶囊中。
7.一种权利要求1至4所述的中药制剂的制备方法,其特征在于,所述中药制剂的剂型为散剂,其包括以下步骤:
第一步,将白石英、白花菜、苦木、白珠树、钗子股、补血草、原蚕蛾、刺血红、牛抄藤、柘树茎叶和半截叶按所述比例混合,用相对于获得的混合物质量的3~5倍的醇浓度为85%~95%的乙醇溶解,加热回流2~4小时后提取,过滤,得第一过滤液;将滤渣再次用相对于获得的混合物质量的2~3倍的醇浓度85%~95%的乙醇溶解,加热回流1~2小时后提取,过滤,得第二过滤液;合并第一过滤液和第二过滤液,减压回收乙醇并浓缩至药液浓度为1.2~1.5g生药/mL,经体积为5L的大孔吸附树脂柱洗脱,先用5倍树脂柱体积的去离子水或蒸馏水洗脱,再用3倍树脂柱体积的醇浓度为90%~95%乙醇洗脱,收集乙醇洗脱液,减压浓缩除去乙醇,干燥并粉碎成粉末;
第二步,将剩余原料药材按所述比例混合,加相对于获得的混合物质量的3~6倍的水溶解,加热煎煮2~4小时,过滤;将滤渣再次用相对于获得的混合物质量的2~4倍的水溶解,再次加热煎煮1~3小时,过滤;合并两次的过滤液,减压浓缩除去水分,干燥并粉碎成粉末;
第三步,将第一步和第二步获得的粉末混合,随后过筛成100~200目的细粉,将获得的细粉和相对于细粉质量0.2~0.4倍的淀粉一起投入混合搅拌机中搅拌,即获得所述中药制剂的散剂。
8.一种权利要求1至4所述的中药制剂的制备方法,其特征在于,所述中药制剂的剂型为胶囊剂,其制备方法包括以下步骤:
第一步,将白石英、白花菜、苦木、白珠树、钗子股、补血草、原蚕蛾和刺血红按比例混合,加相对于混合物4~6倍的水提取挥发油,将获得的挥发油用β-环糊精包合,挥发油与β-环糊精的比例为1∶3~6,搅拌75分钟~90分钟,温度30℃~50℃,得挥发油包合物,备用;另将水提取液浓缩至60℃时相对密度为1.15~1.17的清膏;
第二步,将牛抄藤、柘树茎叶、半截叶、绵毛金腰、八月瓜、沙枣和红簕钩按所述比例混合,加相对于混合物6~8倍量醇浓度为80%~90%的乙醇回流提取3~5次,每次2~3小时,过滤,滤液合并,回收乙醇,浓缩至60℃时相对密度为1.20~1.22的清膏,备用;
第三步,将剩余所述原料药材按所述比例混合,加相对于混合物8~10倍量水,煮沸6~8小时,过滤,浓缩至65℃时相对密度为1.28~1.30的清膏;
第四步,将第一步、第二步、第三步的清膏混合,60℃~70℃减压真空干燥,得干膏粉;
第五步,将第一步所述挥发油包合物和第四步所述干膏粉充分混合,随后加入相对于100重量份所述挥发油包合物和干膏粉的混合物,5~8重量份羧甲基淀粉钠、10~50重量份淀粉混合均匀,加入150~200重量份醇浓度为80%~90%乙醇制粒,干燥,整粒,随后加入相对于100重量份所述挥发油包合物和干膏粉的混合物,3~5重量份硬脂酸镁,然后装入明胶胶囊中。
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CN104940524A (zh) * | 2015-06-16 | 2015-09-30 | 上海应用技术学院 | 一种用于治疗白癜风的药物及其制备方法 |
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CN104337901A (zh) * | 2014-11-05 | 2015-02-11 | 于晓红 | 一种治疗非特异性膀胱炎的中药制剂及其制备方法 |
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