CN112773786B - 淫羊藿苷元在制备治疗银屑病药物中的应用 - Google Patents
淫羊藿苷元在制备治疗银屑病药物中的应用 Download PDFInfo
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Abstract
本发明属于医药领域,具体涉及淫羊藿苷元的用途,即淫羊藿苷元在用于制备治疗银屑病药物的用途。动物试验显示,其对于银屑病具有显著的防治作用,可显著改善银屑病皮损PASI评分、组织形态变化,证实淫羊藿苷元具有治疗银屑病的用途。本发明新用途方法和已有治疗银屑病的药物、方法相比可以取得意想不到的疗效,治愈率高,这种新用途方法对治疗银屑病是一个创新。
Description
技术领域
本发明属于医药领域,涉及一种淫羊藿苷元的医药用途,具体涉及淫羊藿苷元在制备治疗银屑病药物中的医药用途。
背景技术
银屑病是一种常见的慢性复发性炎症性皮肤病。该病病程相对较长,目前尚不能完全治愈。作为一种红斑鳞屑性皮肤病,常常造成患者外观损害,且严重影响患者的生活质量甚至身心健康。疾病后期还极有可能损害患者的关节及多个内脏器官,对患者的生命健康造成极大威胁。
目前文献显示银屑病的病因尚不明确,通常认为主要由免疫介导,是一种“自身免疫系统失调性疾病”。多数学者认为该病是由于患者的多基因遗传造成的一种由T淋巴细胞介导的免疫疾病,同时学者们认为该病也可能因为患者严重创伤而致的感染、不合理用药、过度吸烟饮酒以及其他合并疾病等原因引发。
银屑病按照其临床特征进行分类,主要分为寻常型、关节型、脓疱型及红皮病型,而90%以上的银屑病均属于寻常型。寻常型银屑病多出现于头皮膝、肘和躯干、四肢等部位,并且呈现出对称分布的特点,其中基本皮损多以红色丘疹的斑块为主,其表面附着银白色鳞屑,若将其刮除则会有点状出血现象发生。而面部皮损则为点滴状浸润性红斑和皮疹;头皮皮损则为明显的束状发生;腋下及乳房等多摩擦的部位皮损呈现为鳞屑减少而出现渗出和糜烂的症状。关节型银屑病的皮损状况同寻常型银屑病,但其一般先有皮损,后出现关节症状,亦可同时出现。任何关节均可受累,并增加了关节畸形的发生率。红皮病型银屑病的临床表现多为全身皮肤潮红同时伴有肿胀的发生,皮损处则出现大量糠状鳞屑,另外可能会有发热等全身症状的发生。脓疱型银屑病:分为局限性或泛发性。①局限性脓疱性银屑病皮损局限于手掌及足跖,对称分布,皮损为红斑基础上的小脓疱。②泛发性脓疱性银屑病常急性发病,在寻常性银屑病皮损或无皮损的正常皮肤上迅速出现大小不等黄白色浅表无菌性小脓疱,密集分布,可融合,迅及全身,可有寒战、高热等全身症状。部分病例有发热、头痛、关节疼痛及浅表淋巴结肿大等表现。
银屑病为皮肤科常见的疾病,1984年流行病学调查我国银屑病患者为0.123%,2010年通过六省市银屑病调查发病率为0.47%,具有反复发作,迁延难愈的特点,病理机制仍不清楚。轻症者以外用药物为主,重症者可根据病情选用全身治疗。新发的面积不大的皮损,外用药作为首选。内服药物可以选用甲氨蝶呤、维A酸类、糖皮质激素、抗生素等药物进行治疗。另外,可应用紫外线,光化学疗法(PUMA),宽谱中波紫外线(BB-UVB)疗法,窄谱中波紫外线(NB-UVB)疗法,水疗。银屑病病程较长,有易复发倾向,严重危害患者的身心健康。
我国尽管医药学博大精深,但是至今经国家食品药品审评中心批准的用于治疗银屑病的“准”字号中药的制剂仍然极少,临床上使用的多为医院药房制剂。当务之急应重点开发治疗银屑病的中药良品。
淫羊藿为小檗科植物淫羊藿、箭叶淫羊藿、粗毛淫羊藿、巫山淫羊藿或朝鲜淫羊藿的干燥地上部分。淫羊藿含多种黄酮类成分,如淫羊藿苷、淫羊藿次苷、淫羊藿苷元(Icaritin,ICT)等。中医认为其味辛、甘,性温,归肝、肾经,主治功能:补肾阳,强筋骨,祛风湿。淫羊藿苷元属黄酮醇类化合物,少量存在于淫羊藿药材中,其化学结构式如下:
淫羊藿苷元可以从淫羊藿药材中分离得到(孙朋悦,徐颖,文晔等,朝鲜淫羊藿的化学成分,中国植物化学杂志,1998,8(2):122-125),或将淫羊藿苷经酶解分离得到(叶海涌,刘健,楼宜嘉,淫羊藿苷衍生物的制备及其雌激素样作用研究,浙江大学学报,2005,34(2):131-136)。
有文献报道淫羊藿苷元具有抗Aβ肽致大鼠原代培养神经细胞凋亡的作用(张翔南,王欢欢,王志强等,淫羊藿苷元抗Aβ肽致大鼠原代培养神经细胞凋亡的作用,浙江大学学报,2007,36(3):224-226)。中国专利CN101836976A公开了淫羊藿苷元具有抗肿瘤血管生成的作用。中国专利CN101428015A公开了淫羊藿苷元具有抗内毒素血症的作用。中国专利CN101284000A公开了淫羊藿苷元具有防治肥胖症或脂肪肝的作用。中国专利CN1869204A公开了淫羊藿苷元在诱导干细胞体外定向分化方面的用途。中国专利CN1194701C公开了淫羊藿苷元或去甲基淫羊藿苷元具有在制备雌激素受体调节剂中的应用。
目前,从未见淫羊藿苷元可以用于治疗银屑病的报道。本发明人经过多年研究,发现淫羊藿苷元能够对银屑病具有显著疗效,从而完成了本发明。
发明内容
为了解决现有技术中银屑病难以治疗的问题,本发明人经过长期深入研究,发现淫羊藿苷元在银屑病治疗中的显著疗效,由此完成了本发明。
本发明提供了一种新的治疗银屑病的药物,该药物以淫羊藿苷元为药物活性成分,即本发明涉及淫羊藿苷元在制备治疗银屑病药物中的用途。
优选地,所述银屑病选自寻常型银屑病、关节型银屑病、红皮病型银屑病、脓疱型银屑病中的一种或几种。
上述所述的医药用途中,淫羊藿苷元可以与药学上可接受的载体或者辅料制备成合适的药物剂型口服给药或注射给药,其适用对象可以为人或其他恒温动物。当适用对象为人时,淫羊藿苷元的用量优选为0.001mg/kg·d~50mg/kg·d,进一步优选为0.01mg/kg·d~10mg/kg·d。对于本发明预防或治疗银屑病的药物的给药时间和给药次数需要根据病情的具体诊断结果而定,这在本领域技术人员掌握的技术范围之内。例如,将对小鼠预防或治疗银屑病的治疗方案应用于人身上,所用药物对人的有效剂量可以通过该药物对小鼠的有效剂量进行换算,这对于本领域的普通技术人员来说是显而易见的。
上述所述的医药用途中,根据动物病情以及用药部位可以将淫羊藿苷元与药学上可接受的载体或者辅料制备成合适的药物制剂以方便用药,如淫羊藿苷元可以开发成口服制剂、舌下含服制剂或注射制剂方便患者的使用,其中所述口服制剂可以为片剂、胶囊剂或微乳制剂,优选为片剂;所述舌下含服制剂为含有淫羊藿苷元并适用舌下给药的药物制剂,优选为其舌下片;所述注射制剂可以为其注射液、注射微乳等,优选为注射液。当淫羊藿苷元制备成注射液时,药物可接受的载体可以为注射用水、氯化钠、柠檬酸钠、柠檬酸、甘油、乙醇、丙二醇等。上述所述淫羊藿苷元注射液还可以根据药物的性质加入适宜的附加剂,如渗透压调节剂、pH值调节剂、增溶剂、抑菌剂、乳化剂、助悬剂等,其中所述增溶剂为聚乙二醇400、吐温-80中的任意一种或两种。
上述药物制剂的制备方法均可采用本领域技术人员制备该种剂型常规使用制备方法制得。上述药物制剂中,每一制剂单位中含有淫羊藿苷元的含量为0.001mg~50mg。
与现有技术相比,本发明的优势在于:
1、本发明采用淫羊藿苷元治疗银屑病的用途,且和已有治疗药物、方法相比可以取得意想不到的疗效,这种新用途对治疗银屑病是一个创新。
2、本发明所述的淫羊藿苷元具有显著的预防或治疗银屑病的作用。本发明实施例10显示本发明的淫羊藿苷元能够明显改善银屑病皮损PASI评分、组织形态变化,角化不全现象得到改善,表皮厚度明显薄于模型对照组,银屑病的症状得到明显改善,证实淫羊藿苷元具有治疗银屑病的用途。
本发明实施例11显示淫羊藿苷元联合窄谱UVB照射治疗银屑病较单纯使用淫羊藿苷元治疗效果更佳,淫羊藿苷元联合窄谱UVB照射治疗银屑病较单纯窄谱UVB照射治疗效果更佳。
3、淫羊藿苷元治疗银屑病范围广泛,可用于治疗寻常型银屑病、关节型银屑病、红皮病型银屑病、脓疱型银屑病、各型银屑病引发的合并症,如心脑血管、代谢等,还可治疗各种肿瘤、皮炎湿疹等。
4、本发明所述淫羊藿苷元是从传统中药淫羊藿中提取得到的天然中药单体,其对人体毒副作用低,可以显著提高患者的用药安全性和用药依从性,进而大幅度改善了银屑病患者的治疗效果和生活质量。
具体实施方式
为使本发明实施例的目的、技术方案和优点更加清楚,下面将结合本发明实施例中的附图,对本发明实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例是本发明的一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动的前提下所获得的所有其他实施例,都属于本发明保护的范围。
实施例1淫羊藿苷元注射液
制备工艺:将处方量的丙二醇和乙醇混合均匀,加入淫羊藿苷元,搅拌溶解,加入处方量的0.9%氯化钠溶液,搅拌均匀,加入0.5%针用活性炭,搅拌,脱炭,即得。
实施例2淫羊藿苷元注射液
制备工艺:向处方量的PEG-400加入淫羊藿苷元,搅拌溶解,加入0.9%氯化钠溶液至10L,搅拌均匀,加入0.5%针用活性炭,搅拌,脱炭,即得。
实施例3淫羊藿苷元注射液
制备工艺:将处方量的乙醇和吐温-80混合均匀,加入淫羊藿苷元,搅拌溶解,加入注射用水至10L,搅拌均匀,加入0.5%针用活性炭,搅拌,脱炭,即得。
实施例4淫羊藿苷元注射液
淫羊藿苷元 0.01g
乙醇 3.3L
注射用水 加至10L
制备工艺:将处方量的乙醇加入淫羊藿苷元,搅拌溶解,加入注射用水至10L,搅拌均匀,加入0.5%针用活性炭,搅拌,脱炭,即得。
实施例5片剂的制备
制备工艺:将淫羊藿苷元和辅料微晶纤维素、羧甲基淀粉钠混合均匀,加入适量的淀粉浆制软材,然后过16目筛制粒。湿颗粒在60℃干燥,干颗粒过20目筛整粒,筛出干粒中的细粉,与硬脂酸镁混匀,然后再与干颗粒混匀,压片,每片约200mg,即得。
实施例6淫羊藿苷元舌下片
制备工艺:上述组分烘干、粉碎过筛预处理后混匀直接压片制得。
实施例7淫羊藿苷元舌下片
制备工艺:将主药及各辅料成分烘干、粉碎过筛预处理,将主药与乳糖、羧甲基纤维素钠混匀,以纯水作为粘合剂将混匀的物料制备软材,过20目筛制粒并于60℃下干燥制备干颗粒,将硬脂酸镁加入到上述干颗粒总混,压片即得。
实施例8微乳浓缩物
制备工艺:称取处方量中链脂肪酸甘油酯、聚氧乙烯蓖麻油EL-40、1,2-丙二醇、无水乙醇,混合后搅拌均匀,然后加入淫羊藿苷元溶解,也可以超声波处理以加速溶解,得澄清浓缩液,即为淫羊藿苷元微乳浓缩物。上述微乳浓缩物可进一步稀释用于注射或口服。
实施例9微乳浓缩物
制备工艺:称取处方量PEG-2-硬脂酸酯、吐温-20、1-己醇、PEG3350混合后搅拌均匀,然后加入淫羊藿苷元溶解,也可以超声波处理以加速溶解,得澄清浓缩液,即为淫羊藿苷元微乳浓缩物。上述微乳浓缩物可以根据用药需要进行进一步稀释用于患者注射给药或口服给药。
实施例10淫羊藿苷元对咪喹莫特诱导的小鼠银屑病的作用研究
本实验中咪喹莫特诱导的动物模型BALB/c小鼠背部皮肤出现红斑,表皮肥厚,鳞屑成层等现象,使用淫羊藿苷元治疗小鼠模型,银屑病的症状得到明显改善,银屑病样皮损减轻PASI评分降低,角化不全现象得到改善,表皮厚度明显薄于模型对照组,各给药组症状改善明显。
1.动物造模、分组及给药
将70只BALB/c小鼠用戊巴比妥钠腹腔注射麻醉后,去毛,形成约2cm×4cm大小的区域。小鼠随机分为7组,每组10只,分别为空白对照组、模型对照组、淫羊藿苷元低剂量组、淫羊藿苷元中剂量组、淫羊藿苷元高剂量组、照射组、联合治疗组。
除空白对照组外,其余各组小鼠背部去毛处均涂抹5%咪喹莫特(IMQ)62.5mg,空白对照组小鼠背部去毛处涂抹等量凡士林,连续涂抹6d。造模同时给予相应治疗,每只0.4mL,每日1次。
各组动物治疗方案如下:
淫羊藿苷元低剂量组:灌胃给予1mg/kg淫羊藿苷元;
淫羊藿苷元中剂量组:灌胃给予5mg/kg淫羊藿苷元;
淫羊藿苷元高剂量组:灌胃给予10mg/kg淫羊藿苷元;
照射组:于脱毛处照射紫外线,初始照射时间分别为2s、4s、6s、8s、10s(相应的剂量分别为90J/m2、180J/m2、270J/m2、、360J/m2、450J/m2,每周在原有剂量上增加1s(约45J/m2),每周3次;
联合治疗组:灌胃给予5mg/kg淫羊藿苷元,同时采用上述照射组治疗方法。
淫羊藿苷元用0.5%羧甲基纤维素钠混悬。
正常对照组:灌胃给予等体积的羧甲基纤维素钠;
模型对照组:灌胃给予等体积的羧甲基纤维素钠。
造模结束后,各组动物再继续治疗15天,末次治疗24h后处死,取背部去毛处皮肤(2×2)cm2,4%甲醛固定,测定银屑病样皮损面积和疾病严重程度(PASI)评分。
2.实验方法及数据处理
2.1银屑病样皮损面积和疾病严重程度评分
采用数码照相的方法每天记录,并依据PASI评分标准(Kerkhof P C M V D.ThePsoriasis Area and Severity Index and alternative approaches for theassessment of severity;persisting areas of confusion[J].British Journal ofDermatology,1997,137(4):661-662),给予小鼠皮损处红斑(eryhema)、鳞屑(scales)及浸润增厚程度(hickness)0~4的积分,将三者积分相加得到总积分。PAIS评分标准如下:0无;1轻度;2中度;3重度;4极重度。对各组小鼠积分取平均值后绘制趋势线,观察各组小鼠皮损的变化情况。评分标准见表1。
表1 PAIS评分标准
2.2组织形态学检测
采用苏木精-伊红(HE)染色观察。剪取各组小鼠裸露皮肤,经HE染色观察皮肤组织学改变,并测量表皮厚度以反应表皮增厚情况。
3.结果与讨论
3.1PASI的结果:模型对照组与正常对照组比较,模型对照组咪喹莫特乳膏涂抹一天后皮肤立即出现红斑,2d~3d出现鳞屑,6d最严重,且皮肤持续增厚,红斑由淡粉色斑点变为大面积深红色斑块,鳞屑增厚增多,皮肤增厚浸润明显,形成类似银屑病样皮损。
淫羊藿苷元各给药组与模型对照组比较,淫羊藿苷元低剂量组、淫羊藿苷元中剂量组、淫羊藿苷元高剂量组组皮损症状明显减轻,鳞屑稀少,肥厚较轻。
照射组与模型对照组比较,皮损症状明显减轻,鳞屑稀少,肥厚较轻。
联合治疗组与淫羊藿苷元单用、照射组相比,其皮损症状减轻更明显,鳞屑更稀少,肥厚程度更轻。
结果见表2~5。
表2各组对咪喹莫特致小鼠银屑病样皮损红斑的影响
表3各组对咪喹莫特致小鼠银屑病样皮损肥厚的影响
表4各组对咪喹莫特致小鼠银屑病样皮损鳞屑的影响
表5各组对咪喹莫特致小鼠银屑病样皮损变化程度的影响
与模型对照组相比,#P<0.05,##P<0.01;
3.2对皮肤组织形态学的影响
正常对照组小鼠皮损处皮肤表皮为角化的复层扁平上皮,较薄,细胞为1~3层;模型对照组表皮与正常对照组比较明显增生、增厚,细胞达8层以上,并且颗粒层细胞、棘层细胞较多、表皮突向下延伸。
淫羊藿苷元各给药组、照射组与模型对照组相比,表皮更薄,细胞降到3~4层,颗粒层细胞、棘层细胞明显变少。
联合治疗组较淫羊藿苷元单用组、照射组,表皮更薄,细胞降到2~3层,颗粒层细胞、棘层细胞更少。
淫羊藿苷元各给药组、淫羊藿苷元联合窄谱UVB照射治疗对咪喹莫特诱导的小鼠银屑病样皮损具有明显的抑制作用。淫羊藿苷元联合窄谱UVB照射治疗银屑病效果更佳。
Claims (10)
1.淫羊藿苷元作为唯一活性成分在制备治疗银屑病药物中的用途,所述淫羊藿苷元的化学结构式如下:
。
2.如权利要求1所述的用途,其特征在于所述药物是治疗寻常型银屑病、关节型银屑病、红皮病型银屑病、或脓疱型银屑病中的一种或多种疾病的药物。
3.如权利要求1所述的用途,其特征在于所述淫羊藿苷元的给药剂量为0 .001mg/kg·d~50mg/kg·d。
4.如权利要求3所述的用途,其特征在于所述淫羊藿苷元的给药剂量为0 .01mg/kg·d~10mg/kg·d。
5.如权利要求1-4任一项所述的用途,其特征在于所述药物还包含有药学上可接受的载体或者辅料。
6.如权利要求1-4任一项所述的用途,其特征在于所述淫羊藿苷元可制备成口服制剂、舌下含服制剂或注射制剂中的一种或多种。
7.如权利要求6所述的用途,其特征在于所述口服制剂为其片剂、胶囊剂或微乳制剂中的一种或多种。
8.如权利要求6所述的用途,其特征在于所述注射制剂为其注射液或注射微乳中的一种或多种。
9.如权利要求6所述的用途,其特征在于每一制剂单位中淫羊藿苷元的含量为0.001mg~50mg。
10.淫羊藿苷元作为唯一活性成分在制备与窄谱UVB照射联合治疗银屑病的药物中的应用,所述淫羊藿苷元的化学结构式如下:。
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魏敏杰主编.《药物代谢动力学》.上海科学技术出版社,2011,(第1版),第306"黄酮类药物的代谢动力学特点". * |
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