CN108635530B - 一种治疗银屑病的外用药物 - Google Patents
一种治疗银屑病的外用药物 Download PDFInfo
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Abstract
本发明涉及一种治疗银屑病的外用药物，该外用药物由有效成份和医学上可接受的辅料组成，其中所述的有效成份由以下重量百分比的原料药制成：徐长卿12～18％，白鲜皮12～18％，蛇床子8～12％，土茯苓12～18％，熟地黄12～18％，当归8～12％，石榴皮12～18％。本发明所述的外用药物具有扶正化湿、和肤止痒之功效，能够有效改善银屑病症状。
Description
技术领域
本发明涉及一种医用配制品，具体涉及一种治疗银屑病的药物。
背景技术
银屑病是一种免疫介导的、多基因相关的、具有遗传倾向的、系统性的慢性炎症性皮肤病，属于祖国医学“白疕”的范畴，发病率呈逐年升高趋势，是人类十大顽疾之一。作为一种毁容性疾病，大部分银屑病患者因被歧视存在工作、社交障碍，常伴有焦虑、抑郁，自杀率高达5.6％-7.2％。银屑病不仅有严重的身心损害，也可导致严重危害人类健康的并发症，影响患者生存质量，对社会、个人均造成相当大的经济负担。
现代医学对银屑病治疗主要采取口服阿维A、甲氨蝶呤等药物，局部外用糖皮质激素、维生素D3衍生物等，或者注射生物制剂。外用激素和维生素D3衍生物复合制剂是目前临床运用最广的治疗方式，典型代表药物为倍他米松和卡泊三醇复合制剂。两种药物有机结合，既减少了各自的副反应，又增强了疗效，更加高效的缓解寻常型银屑病病人的疾病严重程度，但也存在治疗价格昂贵，停药后复发或反跳等副作用；阿维A、甲氨蝶呤以及环孢素是传统上用于银屑病系统治疗的药物，也出现了一些不良反应，长期服用阿维A会导致皮肤黏膜干燥损害，甲氨蝶呤最常见副作用为骨髓抑制和肝毒性，而环孢素则会引起肝肾损伤、胃肠道反应等副作用。寻求安全、有效，价格合适的外用治疗银屑病的药物及其重要。
公开号为CN101632827A公开了一种治疗银屑病的中药组合物，由肿节风、莪术、乌梅、土茯苓、赤芍、紫草和甘草7味药材组成，具有活血化瘀消斑，祛风除湿止痒功效，但外用疗效有限，寻找疗效更佳的外用治疗银屑病的药物是目前亟需解决的问题。
发明内容：
本发明主要解决的技术问题是提供一种治疗银屑病的外用药物，该外用药物能够有效改善银屑病症状，治疗银屑病效果显著。
本发明解决上述问题的技术方案如下：
一种治疗银屑病的外用药物，该外用药物由有效成份和医学上可接受的辅料组成，其中所述的有效成份由以下重量百分比的原料药制成：
徐长卿12～18％，白鲜皮12～18％，蛇床子8～12％，土茯苓12～18％，熟地黄12～18％，当归8～12％，石榴皮12～18％。
本发明所述的外用药物，其中所述的原料药的最佳配比为：徐长卿15.8％，白鲜皮15.8％，蛇床子10.5％，土茯苓15.8％，熟地黄15.8％，当归10.5％，石榴皮15.8％。
本发明所述的外用药物，其特征在于，所述的有效成分由以下方法制得：取原料药，加水煎煮3次，每次加水8～12倍量，武火煮沸后，文火煎30～60分钟，合并水煎液，过滤，滤液减压浓缩至25℃下相对密度为1.30的稠膏，即得。
本发明所述的外用药物，其特征在于，将所述的有效成分加入适量医学上可接受的辅料，按照常规方法制成洗剂、搽剂、软膏剂或凝胶剂。
本发明所述的外用药物中，徐长卿和白鲜皮共为君药，蛇床子和土茯苓共为臣药，熟地和当归共为佐药，石榴皮为使药。徐长卿性味辛温而归肝胃经，善于祛风湿而通经络性温而不燥，故能祛邪而不伤正，滋补而不碍邪，长于扶正化湿止痒；白鲜皮性味苦寒而归脾胃膀胱经，利湿热的同时兼能祛风。一温一寒，辛温能祛风湿，苦寒能降湿热，既专于止痒，又寓意扶正。臣药为化湿药对，其中蛇床子性味辛苦温而归肾经，能温肾阳而祛风湿，又善止痒。土茯苓性味甘平而入肝胃经，有入经络而渗水湿之功效，引水湿下行排出。两药一升一降，使湿邪得以上下分消，配合君药加强化湿解毒之功。熟地黄色黑入肾水，当归活血补血，两者相配，阴血双补又补中有通，以佐君臣药发挥润燥止痒功效。石榴皮作为使药，有“以皮走皮”之意，既引药达皮肤病所，又加强补血活血、润燥止痒之用。全方共奏扶正化湿、和肤止痒之功，治疗银屑病效果显著。
本发明药物能有效改善银屑病症状，本发明药物对银屑病的治疗效果，可通过下述实验研究得到进一步证实。
动物实验
1药物与试剂
专利方：本发明实施例1的洗剂；
报道方：公开号为CN101632827A专利申请的实施例5：取肿节风15g，莪术9g，乌梅30g，土茯苓15g，赤芍9g，紫草50g，甘草6g，上述中药原料粉碎成粗粉以10倍重量70％乙醇提取两次，合并提取液，减压浓缩，回收乙醇至含乙醇为3％，加入总重量10％的冰片、2％苯甲酸钠配置为搽剂；
咪喹莫特软膏，购于四川明欣药业有限责任公司；
实验动物：BalB/C小鼠40只，雄性，体重18-22g，购于广东省医学动物实验中心；
2实验方法
2.1实验分组及给药
取BalB/C小鼠40只，雄性，体重18-22g，随机分成4组，每组10只，即空白对照组、模型对照组、专利方组以及报道方组。实验前一天剃除小鼠背部2cm×3cm面积的毛发。除空白对照组外，其他组别每天上午在小鼠剃毛处涂抹5％咪喹莫特软膏62.5㎎；此外，空白对照组和模型对照组每天下午在小鼠剃毛处外涂生理盐水0.5mL，专利方组涂专利方洗剂0.5mL，报道方组涂报道方搽剂0.5mL。连续涂抹6天，第7天停止给药，脱颈椎处死小鼠后，取背部剃毛处皮损皮肤0.5cm×0.5cm大小面积，4％的多聚甲醛固定，石蜡包埋，备用。
2.2小鼠银屑病样皮损面积和疾病严重程度评分：
于末次给药后，采用数码相机照相方法记录，并依照银屑病皮损严重程度指数(Psoriasis Area and Severity Index，PASI)评分标准，给予小鼠皮损处红斑、鳞屑及浸润增厚程度0-4的积分，将三者积分相加得到总积分。PASI评分标准如下：0：无；1：轻度；2：中度；3：重度；4：极重度。
2.3小鼠皮损组织病理组织学观察：
HE染色是在不同染液的作用下将切片中的不同物质染成不同颜色而显示出来，再通过光学显微镜观察组织中的各种结构，它是最为常规的染色，可以有助于对皮损程度做出诊断。
皮损组织中病理组织学操作包括取材固定、脱水透明、浸蜡包埋、切片与贴片、脱蜡染色、HE染色、脱水透明和封固几个步骤。
2.4统计方法：
结果以均数±标准误(Mean±S.E.M.)表示，并采用SPSS 17.0统计软件进行分析，各组间差异比较用单因素方差分析(One-way ANOVA)(不假定方差齐性Dunnett's T3)。P<0.05表示差异具有统计学意义。
3结果：
3.1专利方和报道方对咪喹莫特诱导小鼠银屑病模型皮损情况的影响
末次给药后，小鼠背部皮损情况如图1所示，PASI评分结果如图2所示。其中空白组小鼠背部光滑，无红斑，表明无鳞屑，且无增厚现象；与空白组相比，模型组小鼠背部皮损增多，皮肤浸润增厚，皮损颜色呈现鲜红色至紫红色，皮损表明有鳞屑覆盖，鳞屑厚，成层，且有少量脱落现象；与模型组相比，专利方和报道方给药组小鼠皮损仍有鳞屑，但鳞屑与模型相比有减少趋势，皮损增厚情况也有所改善，说明专利方和报道方对咪喹莫特诱导银屑病小鼠都具有保护作用。PASI评分显示，专利方组评分(平均总积分)低于报道方组(P<0.01)，说明专利方外用治疗银屑病疗效优于报道方。
3.2专利方和报道方对咪喹莫特诱导小鼠皮损组织形态学的影响
HE染色显示结构如图3所示。空白组小鼠背部皮肤完整，表皮薄，无增厚现象；与空白组比较，模型组角化不全，表皮棘细胞数量增加，棘细胞层增厚，类似银屑病样病理变化，说明本模型造模成功；经专利方和报道方治疗一周后，表皮皮层较为平整，角化不全细胞明显减少，增厚情况低于模型组，说明专利方和报道方均能够改善咪喹莫特诱导的小鼠银屑病样作用；与报道方，专利方表皮皮层较为平整，角化不全细胞明显减少，增厚情况低于报道方，说明专利方外用治疗银屑病疗效优于报道方。
4结论
本研究采用咪喹莫特诱导银屑病小鼠模型评价专利方和报道方的保护作用，结果显示，专利方和报道方均能够显著性降低小鼠背部皮损情况及PASI评分，改善皮损组织形态学情况，但是专利方与报道方相比，专利方效果更优，说明专利方和报道方均有治疗银屑病作用，而专利方外用治疗银屑病疗效优于报道方。
附图说明
图1为不同药物对咪喹莫特诱导小鼠皮损结果的图。
图2为不同药物对咪喹莫特诱导小鼠PASI评分结果的条形图，图中标注符号的意思分别为：模型组与空白对照组比较##P<0.01；专利方组、报道方组与模型对照组比较**P<0.01；专利方组与报道方组比较$$P<0.01。
图3为不同药物对咪喹莫特诱导小鼠皮损组织形态学结果的图。
具体实施方式
实施例1(洗剂)
1、处方：
徐长卿160g，白鲜皮140g，蛇床子110g，土茯苓160g，熟地黄160g，当归110g，石榴皮160g，合计：1000g。
2、制备方法：
(1)取原料药，加水煎煮3次，每次加水8倍量，武火煮沸后，文火煎40分钟，合并煎液，滤过，滤液减压浓缩至至25℃下相对密度为1.30的稠膏
(2)稠膏加水稀释至1000mL，加入尼泊金乙酯1g，制得洗剂。
实施例2(洗剂)
1、处方：
徐长卿300g，白鲜皮180g，蛇床子80g，土茯苓120g，熟地黄120g，当归80g，石榴皮120g，合计：1000g。
2、制备方法：
与实施例1相同。
实施例3(洗剂)
1、处方：
徐长卿120g，白鲜皮260g，蛇床子120g，土茯苓120g，熟地黄120g，当归80g，石榴皮180g，合计：1000g。
2、制备方法：
与实施例1相同。
实施例4(洗剂)
1、处方：
徐长卿120g，白鲜皮300g，蛇床子80g，土茯苓120g，熟地黄120g，当归80g，石榴皮180g，合计：1000g。
2、制备方法：
与实施例1相同。
实施例5(洗剂)
1、处方：
徐长卿120g，白鲜皮320g，蛇床子120g，土茯苓120g，熟地黄120g，当归80g，石榴皮120g，合计：1000g。
2、制备方法：
与实施例1相同。
实施例6(软膏剂)
1、处方：
徐长卿160g，白鲜皮140g，蛇床子110g，土茯苓160g，熟地黄160g，当归110g，石榴皮160g，合计：1000g。
2、制备方法：
(1)取原料药，加水煎煮3次，每次加水10倍量，武火煮沸后，文火煎50分钟，合并水煎液，滤过，滤液减压浓缩至至25℃下相对密度为1.30的稠膏；
(2)稠膏加水稀释至500mL；取硬脂酸120g、单硬脂酸甘油酯35g、液状石蜡60g、凡士林10g、羊毛脂50g置于容器内，水浴至75℃，充分搅匀；取药液加入三乙醇胺4g、尼泊金乙酯1g，加入蒸馏水至725g，水浴至75℃，充分搅匀，缓慢倒入硬脂酸等油相中，充分搅拌至乳化完全，放冷，即得软膏剂。
实施例7(搽剂)
1、处方：
徐长卿160g，白鲜皮140g，蛇床子110g，土茯苓160g，熟地黄160g，当归110g，石榴皮160g，合计：1000g。
2、制备方法：
(1)按照配比称取原料药，加水煎煮3次，每次加水12倍量，武火煮沸后，文火煎60分钟，合并水煎液，滤过，滤液减压浓缩至25℃下相对密度为1.30的稠膏；
(2)稠膏加75％乙醇稀释至1000mL，即得搽剂。
实施例8(凝胶剂)
1、处方：
徐长卿160g，蛇床子110g，白鲜皮140g，土茯苓160g，熟地黄160g，当归110g，石榴皮160g，合计：1000g。
2、制备方法：
(1)按照配比称取原料药，加水煎煮3次，每次加水10倍量，武火煮沸后，文火煎60分钟，合并水煎液，滤过，滤液减压浓缩至25℃下相对密度为1.30的稠膏；
(2)稠膏加水稀释至500mL，加入卡波姆10g混匀，加蒸馏水至1000g，浸泡过夜，充分搅拌后加入三乙醇胺调节pH值至10左右，即得凝胶剂。
Claims (4)
1.一种治疗银屑病的外用药物，该外用药物由有效成份和医学上可接受的辅料组成，其中所述的有效成份由以下重量百分比的原料药制成：
徐长卿12～18％，白鲜皮12～18％，蛇床子8～12％，土茯苓12～18％，熟地黄12～18％，当归8～12％，石榴皮12～18％。
2.根据权利要求1所述的一种治疗银屑病的外用药物，其特征在于，所述的有效成份由以下重量百分比的原料药制成：
徐长卿15.8％，白鲜皮15.8％，蛇床子10.5％，土茯苓15.8％，熟地黄15.8％，当归10.5％，石榴皮15.8％。
3.根据权利要求1或2所述的一种治疗银屑病的外用药物，其特征在于，所述的有效成分由以下方法制得：取原料药，加水煎煮3次，每次加水8～12倍量，武火煮沸后，文火煎30～60分钟，合并水煎液，过滤，滤液减压浓缩至25℃下相对密度为1.30的稠膏，即得。
4.根据权利要求3所述的一种治疗银屑病的外用药物，其特征在于，将所述的有效成分加入适量医学上可接受的辅料，按照常规方法制成洗剂、搽剂、软膏剂或凝胶剂。
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