CN110393752B - 一种改善银屑病皮肤症状的外用复方制剂及其用途 - Google Patents
一种改善银屑病皮肤症状的外用复方制剂及其用途 Download PDFInfo
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Abstract
本发明属于外用药物领域,具体发明了一种改善银屑病皮肤症状的外用复方制剂及其用途。改善银屑病皮肤症状的外用复方制剂由荆芥、防风、羌活、威灵仙、当归、川芎、白鲜皮制成,可以加入黄零草、和筋草等其他药物。其中羌活、威灵仙、白鲜皮、黄零草采用乙醇回流法提取有效部位;荆芥、防风、当归、川芎、和筋草采用水蒸气蒸馏法提取活性部位。改善银屑病皮肤症状的外用复方制剂的剂型可以是外用软膏、外用凝胶或者外用洗剂,涂布在皮肤患处。该改善银屑病皮肤症状的外用复方制剂对银屑病具有改善作用,而且使用方便。
Description
技术领域
本发明属于外用药物领域,具体发明了一种改善银屑病皮肤症状的外用复方制剂及其用途。
背景技术
银屑病也称为牛皮癣,是一种易复发的慢性皮肤疾病,由于皮肤细胞过度增殖,表皮细胞核分裂速度加快,皮肤出现红斑和鳞屑。西医对银屑病的发病原因与发病机制还没研究清楚,认为可能与遗传、代谢障碍、感染、免疫功能障碍等有关,季节变化、潮湿、精神创伤等也可能诱发银屑病。维甲酸和一些单抗类药物是西医常用的银屑病治疗药物,其中维甲酸通过抑制角质形成细胞增生发挥作用,容易引起皮肤干燥、瘙痒和唇炎。单抗类药物多数是白介素和肿瘤坏死因子,以减轻皮损部位的炎症损伤。
中药复方在临床治疗中对银屑病具有良好的缓解作用。但因为组方复杂,成分不明,相互作用不清楚,确切的治疗机制并不清楚。即使血清药化研究的开展,仍无法完全揭示其中的道理。在临床治疗中,不同的中医大夫往往根据经验采用不同的治疗方法和选用不同的药材和复方。例如,银屑病的治疗中,有从血论治的,又可以细分为补血、养血、活血、凉血,其中凉血之法贯穿始终;有从肝论治的,也有从脾论治的。总之是各有各法,各有各方,缺乏可遵循的一致原则和用药规律。我单位对银屑病用药规律进行了分析(李杨, 裴丽. 基于古代文献的中医治疗银屑病用药规律研究. 中国医药导报. 2018 年1 月第15卷第1 期),发现医学文献中银屑病治疗涉及药物294 味,其中高频药物51 味。294 味药物的种类以清热药、解表药、解毒杀虫燥湿止痒药和补虚药为主,占全部药物的50%。
在临床实践中,我单位名老中医独创了祛风败毒汤,方中荆芥祛风解表,防风祛风胜湿,共为君药。羌活、独活解表散风寒、祛风胜湿; 苍术祛风燥湿; 威灵仙祛风除湿通络;白鲜皮祛风除湿止痒,驱邪外出,共祛外风; 乌梢蛇搜风通络;蜈蚣以毒攻毒、熄风止痒共除内风为臣。当归、川芎养血活血、和营润燥,体现“治风先治血”之旨为佐。甘草解毒和中为使。临床应用本方治疗银屑病患者取得满意疗效。
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。外用制剂安全性高,用药方便。但是中药外用治疗银屑病的研究较少,对活性部位的研究更少。
发明内容
在针对上述问题,本发明的目的是,提供一种改善银屑病皮肤症状的外用复方制剂。
本发明具体内容如下:
一种改善银屑病皮肤症状的外用复方制剂,用于制备所述外用复方制剂的中药材包括:荆芥、防风、羌活、威灵仙、当归、川芎、白鲜皮;制备所述外用复方制剂的中药材的重量份配比为:荆芥7~11重量份、防风7~11重量份、羌活7~11重量份、威灵仙12~17重量份、当归9~15重量份、川芎7~11重量份、白鲜皮12~17重量份。其中羌活、威灵仙、白鲜皮采用乙醇回流法提取有效部位;荆芥、防风、当归、川芎采用水蒸气蒸馏法提取活性部位。所述外用复方制剂中可以加入黄零草、和筋草、大枫子等中药。所述外用复方制剂为外用复方软膏、外用复方凝胶、外用复方洗剂中的一种。
优选的,所述外用复方制剂由以下中药材制成:荆芥、防风、羌活、威灵仙、当归、川芎、白鲜皮、黄零草、和筋草;制备所述外用复方制剂的中药材的重量份配比为:荆芥7~11重量份、防风7~11重量份、羌活7~11重量份、威灵仙12~17重量份、当归9~15重量份、川芎7~11重量份、白鲜皮12~17重量份、黄零草7~15重量份、和筋草10~19重量份。
优选的,制备所述外用复方制剂的中药材的重量份配比为:荆芥10重量份、防风10重量份、羌活10重量份、威灵仙15重量份、当归12重量份、川芎10重量份、白鲜皮15重量份、黄零草12重量份、和筋草17重量份。
优选的,制备所述外用复方制剂的中药材的重量份配比为:荆芥10重量份、防风10重量份、羌活10重量份、威灵仙15重量份、当归12重量份、川芎10重量份、白鲜皮15重量份、黄零草15重量份、和筋草13重量份。
上述外用复方制剂中,羌活、威灵仙、白鲜皮、黄零草采用乙醇回流法提取有效部位;荆芥、防风、当归、川芎、和筋草采用水蒸气蒸馏法提取活性部位。所述外用复方制剂的制备方法包括以下步骤:
步骤1:按重量份称取羌活、威灵仙、白鲜皮、黄零草药材,将药材分别粉碎过40目筛子后混合;向所得药材粉碎产物中加入8~11倍重量的浓度为72%~80%的乙醇浸泡0.5~1小时,70℃~80℃下回流提取2~3次,每次提取1~3小时,合并滤液,回收乙醇得干膏,干膏粉碎备用;
步骤2:按重量份称取荆芥、防风、当归、川芎、和筋草,将药材分别粉碎过30目筛子后混合;向所得药材粉碎产物中加入8~11倍重量的水浸泡0.5~1小时,70℃~80℃下水蒸气蒸馏提取7~9小时,馏出液脱水备用。
优选的,所述外用复方制剂的制备方法包括以下步骤:
步骤1:按重量份称取羌活、威灵仙、白鲜皮、黄零草药材,将药材分别粉碎过40目筛子后混合;向所得药材粉碎产物中加入10倍重量的浓度为80%的乙醇浸泡1小时,80℃下回流提取3次,每次提取2小时,合并滤液,回收乙醇得干膏,干膏粉碎备用;
步骤2:按重量份称取荆芥、防风、当归、川芎、和筋草,将药材分别粉碎过30目筛子后混合;向所得药材粉碎产物中加入10倍重量的水浸泡1小时,75℃下水蒸气蒸馏提取9小时,馏出液脱水备用。
作为改善银屑病皮肤症状的外用复方软膏剂,可以采用的辅料包括白凡士林、液体石蜡、羊毛脂、硬脂酸、单硬脂酸甘油酯、氮酮、三乙醇胺、蒸馏水。上述辅料满足软膏剂的使用要求,也可以加入甘油等进一步提高效果。所述外用复方制剂中辅料的重量份比为:白凡士林100重量份、液体石蜡600重量份、羊毛脂500重量份、硬脂酸1200重量份、单硬脂酸甘油酯350重量份、氮酮640重量份、三乙醇胺15重量份、蒸馏水10000重量份;所述外用复方制剂的制备方法包括如下步骤:
步骤1:按重量份称取羌活、威灵仙、白鲜皮、黄零草药材,将药材分别粉碎过40目筛子后混合;向所得药材粉碎产物中加入8~11倍重量的浓度为72%~80%的乙醇浸泡0.5~1小时,70℃~80℃下回流提取2~3次,每次提取1~3小时,合并滤液,回收乙醇得干膏,干膏粉碎备用;
步骤2:按重量份称取荆芥、防风、当归、川芎、和筋草,将药材分别粉碎过30目筛子后混合;向所得药材粉碎产物中加入8~11倍重量的水浸泡0.5~1小时,70℃~80℃下水蒸气蒸馏提取7~9小时,馏出液脱水备用;
步骤3:称取氮酮、三乙醇胺、蒸馏水和步骤1所得干膏粉碎产物混合作为水相,过滤保温;称取白凡士林、液体石蜡、羊毛脂、硬脂酸、单硬脂酸甘油酯加热融化混合作为油相,保温;将水相缓慢加入油相搅拌均匀,冷却后加入步骤2所得馏出液脱水产物搅拌或研磨混合均匀。
作为改善银屑病皮肤症状的外用复方凝胶剂;所述外用复方制剂的辅料为:卡波姆940、乙醇、丙二醇、三乙醇胺、氮酮、甘油、蒸馏水;上述辅料满足外用凝胶剂的使用要求,也可以加入对羟基苯甲酸乙酯等辅料。所述外用复方制剂中辅料的重量份比为:卡波姆94010重量份、乙醇180重量份、丙二醇100重量份、甘油50重量份、氮酮20重量份、三乙醇胺15重量份、蒸馏水625重量份;所述外用复方制剂的制备方法包括如下步骤:
步骤1:按重量份称取羌活、威灵仙、白鲜皮、黄零草药材,将药材分别粉碎过40目筛子后混合;向所得药材粉碎产物中加入8~11倍重量的浓度为72%~80%的乙醇浸泡0.5~1小时,70℃~80℃下回流提取2~3次,每次提取1~3小时,合并滤液,回收乙醇得干膏,干膏粉碎备用;
步骤2:按重量份称取荆芥、防风、当归、川芎、和筋草,将药材分别粉碎过30目筛子后混合;向所得药材粉碎产物中加入8~11倍重量的水浸泡0.5~1小时,70℃~80℃下水蒸气蒸馏提取7~9小时,馏出液脱水备用;
步骤3:称取卡波姆940在蒸馏水中充分溶胀,加入甘油搅匀,滴加三乙醇胺,搅拌均匀;称取乙醇、丙二醇加入蒸馏水中搅匀,加入步骤1所得干膏粉碎产物混合均匀过滤后加入透明凝胶中,然后加入氮酮、步骤2所得馏出液脱水产物和余量蒸馏水,搅匀。
作为改善银屑病皮肤症状的外用复方洗剂;所述外用复方制剂的辅料为聚山梨酯80、甘油、乙醇和水;所述外用复方制剂中辅料的重量份比为:聚山梨酯80 2重量份、甘油 2重量份、乙醇20重量份、水 90重量份;
所述外用复方制剂的制备方法包括如下步骤:
步骤1:按重量份称取羌活、威灵仙、白鲜皮、黄零草药材,将药材分别粉碎过40目筛子后混合;向所得药材粉碎产物中加入8~11倍重量的浓度为72%~80%的乙醇浸泡0.5~1小时,70℃~80℃下回流提取2~3次,每次提取1~3小时,合并滤液,回收乙醇得干膏,干膏粉碎备用;
步骤2:按重量份称取荆芥、防风、当归、川芎、和筋草,将药材分别粉碎过30目筛子后混合;向所得药材粉碎产物中加入8~11倍重量的水浸泡0.5~1小时,70℃~80℃下水蒸气蒸馏提取7~9小时,馏出液脱水备用;
步骤3:称取聚山梨酯80、甘油、乙醇和水混合,加入步骤1所得干膏粉碎产物搅拌混合均匀后加入步骤2所得馏出液脱水产物搅拌混合均匀。
本发明还提供了,前述外用复方制剂在制备改善银屑病皮肤症状药物中的用途。尤其是前述外用复方制剂在制备改善寻常型银屑病皮肤症状药物中的用途。
复方制剂中荆芥为唇形科植物荆芥Schizonepeta tenuifolia Briq. 的干燥地上部分;有解表散风、透疹功效。防风为伞形科植物防风Saposhnikovia divaricata(Turcz.) Schischk. 的干燥根;有解表祛风、胜湿、止痉功效。羌活为伞形科植物羌活(背翅芹)Notopterygium incisum Ting ex H. T. Chang 或宽叶羌活Notopterygiumforbesii Boiss. 的干燥根茎及根;有散寒、祛风、除湿、止痛功效。威灵仙为毛茛科植物威灵仙Clematis chinensis Osbeck 、棉团铁线莲(山蓼)Clematis hexapetala Pall.或东北铁线莲(黑薇)Clematis manshurica Rupr.的干燥根及根茎;有祛风除湿、通络止痛功效。当归为伞形科植物当归Angelica sinensis (Oliv.)Diels 的干燥根;有补血活血、调经止痛、润肠通便功效。川芎为伞形科植物川芎Ligusticum chuanxiong Hort.(或Ligusticum wallichii Franch.)的干燥根茎;有活血行气、祛风止痛功效。白鲜皮为芸香科植物白鲜Dictamnus dasycarpus Turcz.的干燥根皮;有清热燥湿,祛风解毒功效。黄零草为报春花科植物灵香草的带根全草;有祛风寒、辟秽浊功效。和筋草为石竹科植物日本狗筋蔓的全草,有利尿通淋、免疫调节、抗微生物、抗肿瘤等功效。
前述复方制剂外用给药以可经皮肤吸收的成分发挥对银屑病的改善作用,克服了传统汤剂的服用和携带困难,以及口服的不良反应。在对抗银屑病中药有效部位的筛选中发现,黄零草醇提物、和筋草水蒸气蒸馏提取物对银屑病有一定的缓解作用,遂用于对本单位祛风败毒汤的改进中,研究显示前述复方的提取物外用给药对银屑病皮肤症状具有改善作用。
具体实施方式
下面通过具体实施方式,对本发明进行说明。
实施例1 抗银屑病软膏剂及制备
组方:荆芥100g、防风100g、羌活100g、威灵仙150g、当归120g、川芎100g、白鲜皮150g。
制备:
(1)按重量称取羌活、威灵仙、白鲜皮,药材粉碎过40目筛子,混合药粉;向药粉中加入4000g浓度为80%的乙醇浸泡1小时,80℃下回流提取3次,每次提取2小时,合并滤液,回收乙醇收干膏,干膏粉碎过120目筛子。
(2)按重量称取荆芥、防风、当归、川芎,药材粉碎过30目筛子,混合药粉;向药粉中加入4200g水浸泡1小时,75℃下水蒸气蒸馏提取9小时,馏出液脱水收集挥发油。
(3)按照白凡士林、液体石蜡、羊毛脂、硬脂酸、单硬脂酸甘油酯、氮酮、三乙醇胺、蒸馏水重量比为20:120:100:240:70:128:3:2000的比例称取辅料;取氮酮、三乙醇胺、蒸馏水和步骤(1)所得干膏粉混合作为水相,过滤、保温70℃;称取白凡士林、液体石蜡、羊毛脂、硬脂酸、单硬脂酸甘油酯加热融化混合作为油相,保温70℃;将水相缓慢加入油相搅拌均匀,冷却后加入步骤(2)所得挥发油研磨混合均匀制成软膏。
按照需要配制成1g干膏粉/100g软膏、5g干膏粉/100g软膏、10g干膏粉/100g软膏等规格。
实施例2抗银屑病软膏剂及制备
组方:荆芥100g、防风100g、羌活100g、威灵仙150g、当归120g、川芎100g、白鲜皮150g、黄零草120g、和筋草170g。
制备:
(1)按重量称取羌活、威灵仙、白鲜皮、黄零草,药材粉碎过40目筛子,混合药粉;向药粉中加入5200g浓度为80%的乙醇浸泡1小时,80℃下回流提取3次,每次提取2小时,合并滤液,回收乙醇收干膏,干膏粉碎过120目筛子。
(2)按重量称取荆芥、防风、当归、川芎、和筋草,药材粉碎过30目筛子,混合药粉;向药粉中加入5900g水浸泡1小时,75℃下水蒸气蒸馏提取9小时,馏出液脱水收集挥发油。
(3)按照白凡士林、液体石蜡、羊毛脂、硬脂酸、单硬脂酸甘油酯、氮酮、三乙醇胺、蒸馏水重量比为20:120:100:240:70:128:3:2000的比例称取辅料;取氮酮、三乙醇胺、蒸馏水和步骤(1)所得干膏粉混合作为水相,过滤、保温70℃;称取白凡士林、液体石蜡、羊毛脂、硬脂酸、单硬脂酸甘油酯加热融化混合作为油相,保温70℃;将水相缓慢加入油相搅拌均匀,冷却后加入步骤(2)所得挥发油研磨混合均匀制成软膏。
按照需要配制成1g干膏粉/100g软膏、5g干膏粉/100g软膏、10g干膏粉/100g软膏等规格。
实施例3抗银屑病凝胶剂及制备
组方:荆芥100g、防风100 g、羌活100g、威灵仙150g、当归120g、川芎100g、白鲜皮150g、黄零草150g、和筋草130g。
制备:
(1)按重量称取羌活、威灵仙、白鲜皮、黄零草,药材粉碎过40目筛子,混合药粉;向药粉中加入5500g浓度为80%的乙醇浸泡1小时,80℃下回流提取3次,每次提取2小时,合并滤液,回收乙醇收干膏,干膏粉碎过120目筛子。
(2)按重量称取荆芥、防风、当归、川芎、和筋草,药材粉碎过30目筛子,混合药粉;向药粉中加入5500g水浸泡1小时,75℃下水蒸气蒸馏提取9小时,馏出液脱水收集挥发油。
(3)按照卡波姆940、乙醇、丙二醇、三乙醇胺、氮酮、甘油、蒸馏水重量比为2:36:20:10:4:3:125的比例称取辅料;取卡波姆940加蒸馏水配成浓度为4%的溶液,过夜充分溶胀,加入甘油搅匀,滴加三乙醇胺,搅拌均匀;取乙醇、丙二醇混合,加入乙醇、丙二醇混合液等重量的蒸馏水搅匀,加入步骤(1)所得干膏粉混合均匀过滤后加入凝胶中,然后加入氮酮、步骤(2)所得挥发油和余量蒸馏水,搅匀。
按照需要配制成1g干膏粉/100g凝胶、2g干膏粉/100g凝胶、10g干膏粉/100g凝胶等规格。
实施例4抗银屑病洗剂及制备
组方:荆芥100g、防风100g、羌活100g、威灵仙150g、当归120g、川芎100g、白鲜皮150g、黄零草120g、和筋草170g。
制备:
(1)按重量称取羌活、威灵仙、白鲜皮、黄零草,药材粉碎过40目筛子,混合药粉;向药粉中加入5200g浓度为80%的乙醇浸泡1小时,80℃下回流提取3次,每次提取2小时,合并滤液,回收乙醇收干膏,干膏粉碎过120目筛子。
(2)按重量称取荆芥、防风、当归、川芎、和筋草,药材粉碎过30目筛子,混合药粉;向药粉中加入5900g水浸泡1小时,75℃下水蒸气蒸馏提取9小时,馏出液脱水收集挥发油。
(3)按照聚山梨酯80、甘油、乙醇、水重量比为1:1:10:45的比例称取辅料;将辅料混合均匀,加入步骤(1)的干膏粉和步骤(2)的挥发油,混合均匀。
实施例5中药活性部位不同给药途径的抗银屑病效果的考察
药物制备:
药11:黄零草醇提取物:取黄零草粉碎过40目筛子,向药粉中加入10倍重量浓度为80%的乙醇浸泡1小时,80℃下回流提取3次,每次提取2小时,合并滤液,回收乙醇收干膏,干膏粉碎过120目筛子,收集黄零草干膏粉。
药12:黄零草水蒸气蒸馏提取物:取黄零草粉碎过30目筛子;向药粉加入10倍重量的水浸泡1小时,75℃下水蒸气蒸馏提取9小时,馏出液脱水,收集黄零草挥发油。
药21:和筋草醇提取物:取和筋草粉碎过40目筛子,向药粉中加入10倍重量浓度为80%的乙醇浸泡1小时,80℃下回流提取3次,每次提取2小时,合并滤液,回收乙醇收干膏,干膏粉碎过120目筛子,收集和筋草干膏粉。
药22:和筋草水蒸气蒸馏提取物:取和筋草粉碎过30目筛子;向药粉加入10倍重量的水浸泡1小时,75℃下水蒸气蒸馏提取9小时,馏出液脱水,收集和筋草挥发油。
造模和给药:
豚鼠,体重300~400g,雌雄兼用。应用50g/L心得安乳剂均匀外涂双耳背皮肤,每日3次,连续涂2周,诱导建立银屑病模型。造模后第15天进行检查。
取造模成功豚鼠45只,随机分为9组,每组5只。
模型组灌胃饮用水。药11灌胃组将干膏粉加入饮用水中,灌胃干膏6mg/只/日;药11外用组,将干膏粉加入二甲基亚砜,涂抹于耳朵内外两侧皮肤,涂抹干膏1mg/耳/日。药12灌胃组灌胃挥发油1mL/只/日;药12外用组,将挥发油涂抹于耳朵内外两侧皮肤,涂抹挥发油0.2mL耳/日。药21灌胃组将干膏粉加入饮用水中,灌胃干膏6mg/只/日;药21外用组,将干膏粉加入二甲基亚砜,涂抹于耳朵内外两侧皮肤,涂抹干膏1mg/耳/日。 药22灌胃组灌胃挥发油1mL/只/日;药22外用组,将挥发油涂抹于耳朵内外两侧皮肤,涂抹挥发油0.2mL耳/日。各组豚鼠连续给药15日。
给药完毕第2日处死豚鼠,对双耳造模部位进行大体观察,取双耳,常规制备石蜡切片,HE染色,显微镜下按照表1的评分标准进行评分,每耳总分0~9分。
表1银屑病皮肤组织病理评分标准
结果和统计分析:
给药15日后,各组豚鼠耳背造模部位大体观察以及病理组织显微观察结果见表2。其中大体观察皮肤组织脱落皮屑和水肿情况,表中大体观察项下为存活动物中,出现皮肤组织脱落皮屑和水肿的耳数。
表2 不同中药提取物不同给药途径的抗银屑病效果
*与模型组相比p<0.05。
给药期间黄零草水蒸气蒸馏提取物组各死亡一只,和筋草水蒸气蒸馏提取物灌胃组死亡1只。死亡动物不纳入病理评分统计。统计比较表明,黄零草醇提取物灌胃或外用给药以及和筋草水蒸气蒸馏提取物外用给药对银屑病皮肤病变具有抑制作用。
实施例6 复方中药外用的抗银屑病研究
药物制备:
药1:取荆芥100g、防风100g、羌活100g、独活150g、苍术90g、威灵仙150g、当归120g、川芎100g、乌梢蛇150g、蜈蚣20 条、白鲜皮150g、甘草60g。药材粉碎过30目筛,加入药材10倍重量的水,煎煮2次,每次1.5小时,过滤,收集、合并滤液,冷却作为药1的灌胃液体制剂,模拟祛风解毒汤给药。
药2:按照实施例1的配比和方法制备药2的软膏剂,10g干膏粉/100g软膏,外用给药。
药3:按照实施例2的配比和方法制备药3的软膏剂,10g干膏粉/100g软膏,外用给药。
造模和给药:豚鼠,体重300~320g,雄性。应用50g/L心得安乳剂均匀外涂双耳背皮肤,每日3次,连续涂2周,诱导建立银屑病模型。造模后第15天进行检查。
取造模成功豚鼠24只,随机分为4组,每组6只。
模型组外用动物饮用水;药1组灌胃药1的水煎液,6mL/只/日,每日早晚各灌胃1次;药2组软膏涂抹于耳朵内外两侧皮肤,涂抹软膏0.2 mL耳/日,每日分4个时间段涂抹,间隔2小时。药3组软膏涂抹于耳朵内外两侧皮肤,涂抹软膏0.2 mL耳/日,每日分4个时间段涂抹,间隔2小时。各组豚鼠连续给药15日。
第16日处死豚鼠,取左耳加入磷酸盐缓冲液匀浆,离心分离ELISA法测定TNF-a的含量;右耳常规制备石蜡切片,HE染色,显微镜下按照表1的评分标准进行评分,每耳总分0~9分。
表3 不同组方药物的抗银屑病效果
*与模型组相比p<0.05。#与药1组相比p<0.05。
统计比较表明,药1灌胃、药2、药3外用可降低银屑病部位皮肤组织的TNF-a水平,其中药1、药3可降低银屑病部位皮肤组织的病理评分,药3组病理评分显著低于药1组。
以上实施例是本发明外用复方制剂的部分实施例,仅用于解释和展示本发明的实施和效果,不用于限制本发明的保护范围。在本发明的内容展示下,利用常规手段或者进行常规研究后对药材组方配比的调整或制剂辅料的调整应视为本发明的保护范围。
Claims (8)
1.一种改善银屑病皮肤症状的外用复方制剂,其特征在于,制备所述外用复方制剂的中药材为:荆芥、防风、羌活、威灵仙、当归、川芎、白鲜皮、黄零草、和筋草;制备所述外用复方制剂的中药材的重量份配比为荆芥7~11重量份、防风7~11重量份、羌活7~11重量份、威灵仙12~17重量份、当归9~15重量份、川芎7~11重量份、白鲜皮12~17重量份、黄零草7~15重量份、和筋草10~19重量份;制备所述外用复方制剂的中药材中,羌活、威灵仙、白鲜皮、黄零草采用乙醇回流法提取有效部位;荆芥、防风、当归、川芎、和筋草采用水蒸气蒸馏法提取有效部位。
2.根据权利要求1所述的外用复方制剂,其特征在于,制备所述外用复方制剂的中药材的重量份配比为荆芥10重量份、防风10重量份、羌活10重量份、威灵仙15重量份、当归12重量份、川芎10重量份、白鲜皮15重量份、黄零草12重量份、和筋草17重量份。
3.根据权利要求1所述的外用复方制剂,其特征在于,制备所述外用复方制剂的中药材的重量份配比为荆芥10重量份、防风10重量份、羌活10重量份、威灵仙15重量份、当归12重量份、川芎10重量份、白鲜皮15重量份、黄零草15重量份、和筋草13重量份。
4.根据权利要求1所述的外用复方制剂,其特征在于,所述外用复方制剂的制备方法包括以下步骤:
步骤1:按重量份称取羌活、威灵仙、白鲜皮、黄零草药材,将药材分别粉碎过40目筛子后混合;向所得药材粉碎产物中加入8~11倍重量的浓度为72%~80%的乙醇浸泡0.5~1小时,70℃~80℃下回流提取2~3次,每次提取1~3小时,合并滤液,回收乙醇得干膏,干膏粉碎备用;
步骤2:按重量份称取荆芥、防风、当归、川芎、和筋草,将药材分别粉碎过30目筛子后混合;向所得药材粉碎产物中加入8~11倍重量的水浸泡0.5~1小时,70℃~80℃下水蒸气蒸馏提取7~9小时,馏出液脱水备用。
5.根据权利要求1所述的外用复方制剂,其特征在于,所述外用复方制剂为外用复方软膏剂;所述外用复方制剂的辅料为:白凡士林、液体石蜡、羊毛脂、硬脂酸、单硬脂酸甘油酯、氮酮、三乙醇胺、蒸馏水;所述外用复方制剂的制备方法包括如下步骤:
步骤1:按重量份称取羌活、威灵仙、白鲜皮、黄零草药材,将药材分别粉碎过40目筛子后混合;向所得药材粉碎产物中加入8~11倍重量的浓度为72%~80%的乙醇浸泡0.5~1小时,70℃~80℃下回流提取2~3次,每次提取1~3小时,合并滤液,回收乙醇得干膏,干膏粉碎备用;
步骤2:按重量份称取荆芥、防风、当归、川芎、和筋草,将药材分别粉碎过30目筛子后混合;向所得药材粉碎产物中加入8~11倍重量的水浸泡0.5~1小时,70℃~80℃下水蒸气蒸馏提取7~9小时,馏出液脱水备用;
步骤3:称取氮酮、三乙醇胺、蒸馏水和步骤1所得干膏粉碎产物混合作为水相,过滤保温;称取白凡士林、液体石蜡、羊毛脂、硬脂酸、单硬脂酸甘油酯加热融化混合作为油相,保温;将水相缓慢加入油相搅拌均匀,加入步骤2所得馏出液脱水产物搅拌混合均匀。
6.根据权利要求1所述的外用复方制剂,其特征在于,所述外用复方制剂为外用复方凝胶剂;所述外用复方制剂的辅料为:卡波姆940、乙醇、丙二醇、三乙醇胺、氮酮、甘油、蒸馏水;所述外用复方制剂的制备方法包括如下步骤:
步骤1:按重量份称取羌活、威灵仙、白鲜皮、黄零草药材,将药材分别粉碎过40目筛子后混合;向所得药材粉碎产物中加入8~11倍重量的浓度为72%~80%的乙醇浸泡0.5~1小时,70℃~80℃下回流提取2~3次,每次提取1~3小时,合并滤液,回收乙醇得干膏,干膏粉碎备用;
步骤2:按重量份称取荆芥、防风、当归、川芎、和筋草,将药材分别粉碎过30目筛子后混合;向所得药材粉碎产物中加入8~11倍重量的水浸泡0.5~1小时,70℃~80℃下水蒸气蒸馏提取7~9小时,馏出液脱水备用;
步骤3:称取卡波姆940在蒸馏水中充分溶胀,加入甘油搅匀,滴加三乙醇胺,搅拌均匀;称取乙醇、丙二醇加入蒸馏水中搅匀,加入步骤1所得干膏粉碎产物混合均匀过滤后加入透明凝胶中,然后加入氮酮、步骤2所得馏出液脱水产物和余量蒸馏水,搅匀。
7.根据权利要求1所述的外用复方制剂,其特征在于,所述外用复方制剂为外用复方洗剂;所述外用复方制剂的辅料为聚山梨酯80、甘油、乙醇和水;所述外用复方制剂的制备方法包括如下步骤:
步骤1:按重量份称取羌活、威灵仙、白鲜皮、黄零草药材,将药材分别粉碎过40目筛子后混合;向所得药材粉碎产物中加入8~11倍重量的浓度为72%~80%的乙醇浸泡0.5~1小时,70℃~80℃下回流提取2~3次,每次提取1~3小时,合并滤液,回收乙醇得干膏,干膏粉碎备用;
步骤2:按重量份称取荆芥、防风、当归、川芎、和筋草,将药材分别粉碎过30目筛子后混合;向所得药材粉碎产物中加入8~11倍重量的水浸泡0.5~1小时,70℃~80℃下水蒸气蒸馏提取7~9小时,馏出液脱水备用;
步骤3:称取聚山梨酯80、甘油、乙醇和水混合,加入步骤1所得干膏粉碎产物搅拌混合均匀后加入步骤2所得馏出液脱水产物搅拌混合均匀。
8.权利要求1所述的外用复方制剂在制备改善银屑病皮肤症状药物中的用途。
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