CN115040600B - 一种治疗头皮银屑病的中药组合物 - Google Patents
一种治疗头皮银屑病的中药组合物 Download PDFInfo
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Abstract
本发明属于中药领域,具体涉及一种治疗头皮银屑病的中药组合物,包括如下组分:土茯苓、茵陈、大黄、野菊花、枳壳、苦参、麻黄、苦地丁、甘草。该中药组合物在制备治疗头皮银屑病的药物制剂中的应用。
Description
技术领域
本发明属于中药领域,具体涉及一种治疗头皮银屑病的中药组合物。
背景技术
银屑病是一种非传染性慢性疾病,会影响皮肤和关节。银屑病表现为红斑、丘疹、肥厚、鳞屑,病理上表现为角化过度,棘层增厚,毛细血管迂曲、扩张充血。头皮银屑病有轻微的细鳞屑,整个头皮上覆盖着厚厚的结皮斑块也很严重,通常会导致脱发,甚至可以超出发际线延伸到前额,脖子后部和耳朵周围等区域。
银屑病外观不雅,导致患者具有自卑倾向,同时还影响其生活质量,长期以来,因该病顽固难治,仍被列为当今世界皮肤科领域的重要研究课题,也是全世界皮肤科重点防治疾病之一,如何治愈银屑病已是世界医学领域的一大难题。多数学者认为,银屑病是由刺激T淋巴细胞活化,增殖和细胞因子释放的未知因素引起的,从而导致角质形成细胞过度增殖。一些因素被认为会加剧头皮银屑病,这些包括压力,过量饮酒和吸烟。
银屑病在临床上诊断较容易,目前治疗方法主要包括外用药、系统治疗和物理治疗三大类。现有针对银屑病的治疗,西医用常采用维生素类、抗生素类、抗肿瘤类、重金属类、免疫调节剂或激动剂、作用于神经系统的药物等内服药或用激素、角质形成剂、细胞毒制剂等外用药,同时配合紫外线照射、光化学方法等综合治疗。但临床实践证明,上述药物及疗法缓解期短、长期使用副作用大、不良反应多、治疗费用高。那么,就如何找到一种可有效治疗银屑病的中药组合物,是我们目前急需要解决的问题。
中医认为银屑病的病因主要是体内血燥、血热、血虚、血瘀等内因招致外来风毒邪气侵入而发病。该病的康复治疗临床上有内治法:荡涤癣毒,逐邪外出,透毒外出,调和营卫;外治法:杀灭癣毒,坚壁清野。当今临床上内服的中药制剂较多,如汤剂作为口服制剂,服用后成分复杂,往往存在不同程度的脏器损伤,需要进一步的精制和成分筛选,以减少对治疗无用的成分。而在临床上很少见到外用中药制剂。发掘研制符合中医药对银屑病病因病机理论的中药外用治疗药物应为当务之急。
专利CN104800361A公开了一种中药处方:由苦参50-150份、皂角20-80份、地肤子20-80份、黄柏50-100份、桑白皮50-150份、麻黄根50-150份、苦楝皮50-150份、白矾50-150份组成,制成洗剂,但其研究的疾病是脂溢性皮炎,且使用的洗剂操作耗费时间长,每次需要20min,还需要冲洗头发,使用不方便。此外,该专利没有涉及用于预防,治疗或减轻与头皮银屑病有关的特定制剂。所以对用于预防和治疗与头皮银屑病有关的症状的中药组合物和方法的医学需求仍未得到满足。
综上所述,研制一款能够外用治疗头皮银屑病、且治愈率高的中药组合物及使用便捷、生物利用度高的外用制剂,特别是凝胶剂是本领域技术人员尚未解决的技术难题。
发明内容
鉴于以上现有技术难题,本发明的目的在于:
提供一种治疗头皮银屑病的中药组合物,包括如下组分:土茯苓、茵陈、大黄、野菊花、枳壳、苦参、麻黄、苦地丁、甘草;按质量比计,土茯苓:茵陈:大黄:野菊花:枳壳:苦参:麻黄:苦地丁:甘草为1:(0.5-2):1:1:(0.3-1.8):(1-2):1:1:1。
优选的,按质量比计,土茯苓:茵陈:大黄:野菊花:枳壳:苦参:麻黄:苦地丁:甘草为1:(0.8-1.2):1:1:(0.4-1.0):(1.5-2):1:1:1。
进一步优选的,按质量比计,土茯苓:茵陈:大黄:野菊花:枳壳:苦参:麻黄:苦地丁:甘草为1:1:1;1:0.68:2:1:1:1。
提供一种治疗头皮银屑病的中药组合物的制备方法:按上述处方量,称取各组分适量,加蒸馏水,浸泡20-40min后煎煮,煎煮2-3次,合并药液,静置至药液与沉淀物分层,过滤上层药液,于110-130℃下浓缩药液后即得中药组合物提取液,密封后置阴凉处备用。
提供一种治疗头皮银屑病的中药组合物在制备治疗头皮银屑病的药物制剂中的应用。
提供一种治疗头皮银屑病的外用制剂,外用制剂由中药组合物和医学上可接受的辅料组成。
优选的,外用制剂为凝胶剂。
提供一种凝胶剂的制备方法:称取凝胶基质,加入水中,得到凝胶基质溶液,随后加入保湿剂和防腐剂,搅拌均匀,静置过夜,放入90-100℃的水浴中加热,用pH调节剂调节pH值至7.0,再加入中药组合物提取液,搅拌均匀,即得凝胶剂。
优选的,凝胶基质选自卡波姆940、卡波姆980、羟丙基甲基纤维素、羧甲基纤维素钠中的一种或多种组合;防腐剂为羟苯乙酯;保湿剂为甘油;pH调节剂为三乙醇胺。
进一步优选的,凝胶基质选自波姆940,卡波姆940溶液的质量浓度为2%。
优选的,中药组合物提取液与卡波姆940溶液的容积比为1:4。
治疗头皮银屑病中药组合物中以苦参清热燥湿祛风、大黄清热活血、苦地丁、野菊花清热解毒共为君药,以麻黄解表祛邪、枳壳祛风行气止痒、茵陈、土茯苓清热利湿共为臣药,甘草清热解毒、调和诸药。全方围绕凉血活血为核心,凉血、活血、清热、燥湿、祛风五法并用,使血热消退,气血通畅,风邪易去,湿邪随泄。在抑制细胞增殖上可以调节细胞周期,从而抑制银屑病患者角质形成细胞的过度增殖,减轻皮损的肥厚程度;在血管生成上可以抑制细胞的增殖、迁移、黏附及管样结构形成和血管生成相关因子的分泌从而抑制血管生成。
有益效果:
本发明的中药组合物优点在于:
1、治疗银屑病疗效显著,总有效率高达95%;
2、毒副作用小,安全性高,易于被患者接受;
3、凝胶剂操作方便,涂抹给药每次耗费时间短,缓慢的释放其三维网状结构包裹的药物,使药物在局部作用较长的时间,生物利用度高;
4、涂抹在皮肤上时能创造局部的湿润环境,保护皮肤屏障,具有良好的透气性和抗菌性,抑制微生物的滋生,能够促进组织修复;
5、通过本技术方案,明确治疗头皮银屑病的机制,为更好推广中药组合物的凝胶剂在临床应用及治疗头皮银屑病的新药研究奠定基础。
附图说明:
图1为共聚焦激光扫描显微镜下观察真皮浅层毛细血管数量。
具体实施方式
在一种实施方式中,卡波姆940作为凝胶基质,加水,搅拌均匀,静置过夜,使其充分溶胀,加热,配制成质量浓度为1%、2%、3%的卡波姆940溶液,1%的卡波姆940溶液过稀,性状无法达到要求,3%的卡波姆940溶液加热后无法形成均匀液体,所以本技术方案中卡波姆940溶液的质量浓度为2%。
在一种实施方式中,医学上可接受的辅料包括凝胶基质、防腐剂、保湿剂等。
术语“头皮银屑病”典型皮疹表现为边界清楚、覆有薄厚不等鳞屑性红斑,可融合成片,较薄的鳞屑呈银白色或污黄色,可见束状发。组织病理学表现为角化过度伴角化不全,颗粒层明显减少或消失,棘层增厚,表皮突向下延伸呈钉突状;真皮乳头顶部呈杵状,其上方棘层变薄,毛细血管迂曲、扩张充血,周围可见淋巴细胞、中性粒细胞等浸润。
术语“约””左右”是指指定的量的正负10%。
以下是本发明的具体实施例,对本发明的技术方案做进一步的描述,但是本发明的保护范围并不限于这些实施例。凡是不背离本发明构思的改变或等同替代包括在本发明的保护范围之内。
第一部分:中药组合物及凝胶剂
中药材由天津市中医药研究院附属医院中药房提供。
实施例1治疗头皮银屑病中药组合物及凝胶剂制备工艺
中药组合物处方如下:
土茯苓400份、茵陈400份、大黄400份、野菊花400份、枳壳270份、苦参800份、麻黄400份、苦地丁400份、甘草400份;
凝胶剂的制备工艺如下:
(1)中药组合物提取液的制备
按处方量称取上述药材,加10倍水,浸泡30min后煎煮,煎煮2次,合并药液,静置至药液与沉淀物分层,时间约72h,使用滤纸、玻璃漏斗过滤上层药液至烧杯中,过滤完毕后于120℃下浓缩药液,浓缩过程中防止煮沸,浓缩至1.5L,即得中药组合物提取液,随后使用保鲜膜密封置阴凉处备用。
(2)凝胶剂的制备
称取质量浓度为2%的卡波姆940溶液,加入甘油35ml和羟苯乙酯0.1g,搅拌均匀,静置过夜,使其充分溶胀,溶胀充分后放入水浴锅中加热,水浴99℃至变为均一液体,涂抹至皮肤上时无颗粒感即可,加入三乙醇胺调节pH值至7.0左右,使用玻璃棒沿顺时针方向搅拌,出现先稠后稀的状态,随后加入步骤(1)中备用的中药组合物提取液,顺时针搅拌使提取液分散均匀,即得凝胶剂。
所述中药组合物提取液加入量与卡波姆940溶液的容积比为1:4;
实施例2治疗头皮银屑病中药组合物处方及凝胶剂制备工艺
中药组合物处方如下:
土茯苓400份、茵陈200份、大黄400份、野菊花400份、枳壳120份、苦参400份、麻黄400份、苦地丁400份、甘草400份;
制备方法同实施例1,仅将上述处方量进行替换。
实施例3治疗头皮银屑病中药组合物处方及凝胶剂制备工艺
中药组合物处方如下:
土茯苓400份、茵陈320份、大黄400份、野菊花400份、枳壳160份、苦参600份、麻黄400份、苦地丁400份、甘草400份;
制备方法同实施例1,仅将上述处方量进行替换。
实施例4治疗头皮银屑病中药组合物处方及凝胶剂制备工艺
中药组合物处方如下:
土茯苓400份、茵陈480份、大黄400份、野菊花400份、枳壳400份、苦参800份、麻黄400份、苦地丁400份、甘草400份;
制备方法同实施例1,仅将上述处方量进行替换。
实施例5治疗头皮银屑病中药组合物处方及凝胶剂制备工艺
中药组合物处方如下:
土茯苓400份、茵陈800份、大黄400份、野菊花400份、枳壳720份、苦参1000份、麻黄400份、苦地丁400份、甘草400份;
制备方法同实施例1,仅将上述处方量进行替换。
实施例6中药组合物提取液的加入量对凝胶剂成型指标的影响
以实施例1的处方为基础,仅将凝胶剂制备方法中步骤2的中药组合物提取液含量进行替换,中药组合物提取液不同加入量对凝胶剂成型指标的影响。
参照2020年版《中国药典》四部通则中0114凝胶剂项下的有关规定,检查如下成型指标:外观、均匀性、延展性、黏稠度和室温存放一个月后的稳定性。
中药组合物提取液不同加入量对成型指标的影响结果如表1所示:
表1:提取液不同加入量对成型指标的影响结果
从表1可看出,只有当中药组合物提取液加入量为质量浓度为2%卡波姆940溶液的1/4时,制备得到的凝胶剂外观为半透明、半固体、深棕色,均匀性为整体均匀细致,无较大气泡、团块、颗粒,光泽度为表面光滑有光泽,延展性为有弹性、易于涂抹,储存稳定性为室温存放1月后无明显分层现象,外观状态、均匀性、光泽度、涂展性无明显变化。
第二部分:凝胶剂治疗头皮银屑病的临床疗效及机制研究
实施例7:人体试验
病例来源:天津市中医药研究院附属医院皮肤科银屑病专科门诊银屑病病人,皮损以头部皮损为主的病人。
实验分组方法:按照药物临床实验随机、对照、平行的原则,合格的寻常型银屑病患者随机分为3组,每组病人40例。
①卡泊三醇倍他米松组(阳性药物对照组):外用卡泊三醇倍他米松凝胶治疗,每日一次,治疗周期为30天。
②凝胶剂组:外用实施例1中的凝胶剂治疗,外用,每日一次,治疗周期为30天;
③洗剂组:外用本方制成的洗剂(将实施例1中的中药组合物提取液置于容器中,将其和洗发水潘婷(选用无硅油氨基酸款,适用于任何发质)调和,搅拌均匀,涂抹于头皮,并用指腹轻揉2min,静待5min后用温水洗涤干净)治疗,两日一次,治疗周期为30天。
患者无口服药物,除头部外,其他部位可以外用其他治疗银屑病的药物。
基础指标
①人口学指标:出生日期、年龄、性别、民族、国籍、婚姻状态、文化程度、身高、体重、职业、长期居住地等。
②生命体征:体温、呼吸、心率、血压。
③过敏史:药物、食品或接触过敏史。
④疾病史及治疗史:银屑病发病、家族史、既往治疗史及其他疾病史。
1、临床疗效研究
观察对照组、凝胶剂组和洗剂组使用前后头皮银屑病评分(PSSI)、头皮生活质量评分(Scalpdex量表)变化,判定临床疗效。
统计分析:实验数据以表示。采用SPSS 25.0统计软件储存和分析数据。计量资料以平均值±标准差/>表示,计量资料服从正态分布、方差齐的,采用t检验,反之用非参数秩和检验;计数资料用卡方检验。P值大于0.05时,检验结果无统计学差异,P值小于0.05时,检验结果有显著统计学差异。
①头皮银屑病严重程度评分(PSSI),详见表2,分别以头皮银屑病皮损的面积、红斑、肥厚、鳞屑判定头皮银屑病皮损严重程度。治疗期间第0、4周记录PSSI评分。
表2:头皮银屑病严重程度评分
(1)PSSI评分改善率=[(治疗前积分-治疗后积分)/治疗前积分]×100%。对照组与凝胶剂组PSSI评分改善率对比结果见表3,凝胶剂组与洗剂组PSSI评分改善率对比结果见表4:
表3:对照组与凝胶剂组PSSI评分改善率对比表
组别 | n | PSSI评分改善率 | z | Ρ |
对照组 | 40 | 0.719±0.210 | ||
凝胶剂组 | 40 | 0.575±0.184 | ||
合计 | 80 | -3.854 | 0.000 |
通过表3数据可知:对照组和凝胶剂组PSSI评分改善率不满足正态性,采用非参数秩和检验,其结果为z=-3.854,P=0.000<0.05,有显著统计学差异,对照组的PSSI评分改善率为71.9%±21%,凝胶剂组的PSSI评分改善率为57.5%±18.4%,对照组PSSI评分改善率高于凝胶剂组。
表4:凝胶剂组与洗剂组PSSI评分改善率对比表
组别 | n | PSSI评分改善率 | z | Ρ |
凝胶剂组 | 40 | 0.575±0.184 | ||
洗剂组 | 40 | 0.468±0.157 | ||
合计 | 80 | -3.061 | 0.002 |
通过表4数据可知:凝胶剂组与洗剂组PSSI清除率不满足正态性,采用非参数秩和检验,其结果为z=-3.061,P=0.002<0.05,有显著统计学差异,洗剂组PSSI评分改善率为46.8%±15.7%,凝胶剂组PSSI评分改善率高于洗剂组。
(2)根据疗效指数将对照组和治疗组分为如下四个等级:
痊愈:PSSI积分下降>90%。
显效:PSSI积分下降60%—89%。
有效:PSSI积分下降25%—59%。
无效:PSSI积分下降<25%。
总有效率=(痊愈例数+显效例数+有效例数)/总病例数×100%,对照组与凝胶剂组总有效率对比结果见表5,凝胶剂组与洗剂组总有效率对比结果见表6:
表5:对照组与凝胶剂组总有效率对比表
组别 | n | 痊愈 | 显效 | 有效 | 无效 | 总有效率 | X2 | Ρ |
对照组 | 40 | 5 | 28 | 5 | 2 | 95% | ||
凝胶剂组 | 40 | 1 | 19 | 18 | 2 | 95% | ||
合计 | 80 | 0.000 | 1.000 |
通过表5数据可知:凝胶剂组总有效率与对照组相同,两组总有效率采用卡方检验,X2=0.000,P=1.000>0.05,无统计学差异。
表6:凝胶剂组与洗剂组总有效率对比表
组别 | n | 痊愈 | 显效 | 有效 | 无效 | 总有效率 | X2 | Ρ |
凝胶剂组 | 40 | 1 | 19 | 18 | 2 | 95% | ||
洗剂组 | 40 | 0 | 7 | 29 | 4 | 90% | ||
合计 | 80 | 4.114 | 0.043 |
通过表6数据可知:凝胶剂组与洗剂组总有效率采用卡方检验,结果为X2=-4.114,P=0.043<0.05,有显著统计学差异,凝胶剂组总有效率高于洗剂组。
②头皮银屑病生活质量评分(Scalpdex量表),详见表7。
表7:头皮银屑病生活质量评分
治疗期间第0、4周记录Scalpdex量表,计算治疗前后头皮银屑病生活质量评分的变化。
生活质量评分改善率=[(治疗前Scalpdex评分-治疗后Scalpdex评分)/治疗前Scalpdex评分]×100%,对照组与凝胶剂组生活质量评分改善率对比结果见表8,凝胶剂组与洗剂组生活质量评分改善率对比结果见表9:
表8:对照组与凝胶剂组生活质量评分改善率对比表
组别 | n | 生活质量评分改善率 | z | Ρ |
对照组 | 40 | 0.649±0.271 | ||
凝胶剂组 | 40 | 0.529±0.176 | ||
合计 | 80 | -3.008 | 0.003 |
通过表8数据可知:对照组和凝胶剂组生活质量评分改善率不符合正态性,采用非参数秩和检验,结果为z=-3.008,P=0.003<0.05,有显著统计学差异,对照组生活质量评分改善率为64.9%±27.1%,凝胶剂组的生活质量评分改善率为52.9%±17.6%,对照组生活质量改善率高于凝胶剂组。
表9:凝胶剂组与洗剂组生活质量评分改善率对比表
组别 | n | 生活质量评分改善率 | t | Ρ |
凝胶剂组 | 40 | 0.529±0.176 | ||
洗剂组 | 40 | 0.439±0.178 | ||
合计 | 80 | 2.261 | 0.027 |
通过表9数据可知:凝胶剂组和洗剂组生活质量评分改善率不符合正态性,采用非参数秩和检验,结果为t=2.261,P=0.027<0.05,有显著统计学差异,洗剂组的生活质量评分改善率为43.9%±17.8%,凝胶剂组生活质量改善率高于洗剂组。
2、机制研究
通过共聚焦激光扫描显微镜下毛细血管数量评价凝胶剂对头皮银屑病患者真皮浅层毛细血管增生的影响。详见图1。
图1证明凝胶剂能减少皮损部位毛细血管数量,可能通过抑制毛细血管生成,参与头皮银屑病发病进程中的新血管生成过程,进而抑制银屑病的炎症。
综上,本发明的中药组合物制备成凝胶剂后治疗头皮银屑病的总有效率高达95%,与目前公认疗效最好的外用药卡泊三醇倍他米松总有效率相同,治愈效果显著高于其他剂型(如洗剂),生物利用度高。另外通过机制研究,其疗效确切,值得临床推广。
Claims (1)
1.治疗头皮银屑病的中药组合物在制备治疗头皮银屑病的药物制剂中的应用,其特征在于,所述治疗头皮银屑病的中药组合物的原料药按质量比计,土茯苓:茵陈:大黄:野菊花:枳壳:苦参:麻黄:苦地丁:甘草为1:(0.8-1.2):1:1:(0.4-1.0):(1.5-2):1:1:1;所述药物制剂为凝胶剂,由治疗头皮银屑病的中药组合物和医学上可接受的辅料组成;所述治疗头皮银屑病的中药组合物的制备方法如下:按处方量称取各原料药,加蒸馏水,浸泡20-40min后煎煮,煎煮2-3次,合并药液,静置至药液与沉淀物分层,过滤上层药液,于110-130℃下浓缩药液后即得中药组合物提取液;所述凝胶剂的制备方法如下:称取凝胶基质,加入水中,得到凝胶基质溶液,随后加入甘油和羟苯乙酯,搅拌均匀,静置过夜,放入90-100℃的水浴中加热,用三乙醇胺调节pH值至7.0,再加入中药组合物提取液,搅拌,即得凝胶剂;所述凝胶基质选自波姆940,卡波姆940溶液的质量浓度为2%;所述中药组合物提取液与卡波姆940溶液的容积比为1:4。
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