CN104491311A - 一种治疗眼睑湿疹的药物及其应用 - Google Patents

一种治疗眼睑湿疹的药物及其应用 Download PDF

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CN104491311A
CN104491311A CN201410791609.5A CN201410791609A CN104491311A CN 104491311 A CN104491311 A CN 104491311A CN 201410791609 A CN201410791609 A CN 201410791609A CN 104491311 A CN104491311 A CN 104491311A
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崔合芳
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Abstract

本发明公开了一种治疗眼睑湿疹的药物，属于中医药技术领域。其由以下原料药制得：丰花草、番红花、红天葵、掌叶榕、营实、淮通、一枝蒿、爬山虎、泽兰、小粘药、徐长卿、金银花、茜草、紫河车、何首乌。本发明中药诸药配合，共健活瘀凉血、清热解毒、祛风除湿、养血润燥之功效；使病情得到有效治疗和治愈。与现有技术相比，本发明药物具有见效快、标本兼治、兼顾调理、不易复发的效果，治愈后不复发，患者用药方便。

Description

一种治疗眼睑湿疹的药物及其应用
技术领域
本发明属于中医药技术领域，具体涉及一种治疗眼睑湿疹的药物。
背景技术
眼睑湿疹（palpebral ecgema）是一种过敏性皮肤病，分急性、亚急性和慢性三种表现。可单发于眼睑部，亦可为全身、面部湿疹的一部分。其中急性症状表现为：①睑部有明显的刺痒感和烧灼感；②眼睑皮肤红肿，出现红斑、丘疹、水疱（如有继发感染则为脓疱、溃疡）、结盟痂等；③血嗜酸粒细胞增多。慢性症状：湿疹长期不愈，眼睑皮肤粗糙呈鳞屑样，组织肥厚。一般具有一定程度的规律性。主觉症状：在与致敏物质的接触后出现，病变部位热奇痒感。病变表现：起初眼睑皮肤红肿，局部见大量血疹、水泡、糜烂、结痂。当继发感染时则形成脓泡。脱痂而痊愈。范围亦可扩大至面部、额部等。但亦可由急性演变为亚急性和慢性。睑部皮肤粗糙肥厚、呈苔癣状，表面有鳞屑脱落，亦可有色素沉着等。倘若继续接触致敏物质或药物，尚可发生渗出性结膜炎、角膜表层浸润、水肿等并发症。
中医学认为本病系风湿热邪客于泡睑，或久病耗血、生风化燥所致。中医疗法：内服活瘀凉血、清热、除湿、解毒之药。
发明内容
发明人在中医理论指导下，经多年研究获得本发明一种安全可靠、疗效显著的治疗眼睑湿疹的中药。
为实现上述目的本发明采用以下技术方案。
一种治疗眼睑湿疹的药物，由以下原料药制得：丰花草、番红花、红天葵、掌叶榕、营实、淮通、一枝蒿、爬山虎、泽兰、小粘药、徐长卿、金银花、茜草、紫河车、何首乌。
优选地，上述治疗眼睑湿疹的药物，由以下重量份原料药制得：丰花草28-31份、番红花33-36份、红天葵34-37份、掌叶榕17-20份、营实10-14份、淮通21-25份、一枝蒿10-15份、爬山虎9-12份、泽兰7-10份、小粘药5-8份、徐长卿12-15份、金银花20-23份、茜草11-14份、紫河车5-8份、何首乌10-13份。
进一步优选地，上述治疗眼睑湿疹的药物，由以下重量份原料药制得：丰花草30份、番红花34份、红天葵35份、掌叶榕18份、营实13份、淮通23份、一枝蒿13份、爬山虎10份、泽兰8份、小粘药7份、徐长卿14份、金银花21份、茜草12份、紫河车6份、何首乌11份。
上述治疗眼睑湿疹的药物的制备方法采用以下步骤：
（1）取处方量的丰花草、番红花、红天葵、掌叶榕、营实、淮通、一枝蒿、爬山虎、泽兰、小粘药、徐长卿、金银花、茜草、紫河车、何首乌，加入所述药材总重量的5-10 倍量水煎煮二次，第一次煎煮2-3 小时，第二次煎煮1-2 小时，合并煎液，滤过，滤液减压浓缩，加入乙醇使得溶液的含乙醇量为50-70%，溶液放置12-24小时，滤过，滤液回收乙醇，浓缩得稠膏；
（2）将上述所得稠膏干燥后粉碎成细粉，过筛，加入辅料制备得到临床上常用中药药物剂型。
优选的，上述药物剂型是丸剂、片剂、颗粒剂、口服液、胶囊剂、膏剂、乳剂、咀嚼剂当中的任何一种。
本发明的另一个目的是提供一种医药用途，即上述药物在制备治疗眼睑湿疹症药物中的应用。
根据中医药史料记载，上述各种药材的药理活性和功能主治如下：
丰花草，活血祛瘀；消肿解毒。主跌打损伤；骨折；痈疽肿毒；毒蛇咬伤。
小粘药，行气止痛；活血化瘀；祛风除湿。主气滞腹胀；风湿骨痛；跌打损伤；乳痈；疮疖肿毒；刀伤出血。
掌叶榕，祛风利湿，活血祛瘀。用于风湿骨痛，闭经，产后瘀血腹痛，白带，睾丸炎，跌打损伤。
番红花，活血化瘀，凉血解毒，解郁安神。用于经闭症瘕、产后瘀阻、温毒发斑、忧郁痞闷、惊悸发狂。
红天葵，清热凉血，活血解毒。治暑热高烧，肺热咳嗽，咯血，跌打扭伤，血瘀疼痛，疮毒疥癣，水火烫伤。
徐长卿，镇痛，止咳，利水消肿，活血解毒。治胃痛，牙痛，风湿疼痛，经期腹痛，慢性气管炎，腹水，水肿，痢疾，肠炎，跌打损伤，湿疹，荨麻疹，毒蛇咬伤。
营实，清热解毒，祛风活血，利水消肿。主疮痈肿毒，风湿痹痛，关节不利，月经不调，水肿，小便不利。
金银花，清热，解毒。治温病发热，热毒血痢，痈疡，肿毒，瘰疬，痔漏。《重庆堂随笔》："清络中风火湿热，解温疫秽恶浊邪，息肝胆浮越风阳，治痉厥癫痫诸症。"
淮通，清热利湿，行水下乳，排脓止痛。用于小便不利，水肿，尿路感染，阴道滴虫，风湿关节痛，湿疹，荨麻疹，痈肿。
何首乌，养血滋阴；润肠通便；截疟；祛风；解毒。主血虚头昏目眩；心悸；失眠；肝肾阴虚之腰膝酸软；须发早白；耳鸣；遗精；肠燥便秘；久疟体虚；风疹瘙痒；疮痈；瘰疬；痔疮。
一枝蒿，活血，祛风，止痛，解毒。治跌打损伤，风湿疼痛，痞块，痈肿。
《纲目》："蓍叶主治痞疾。"《纲目拾遣》："活血解毒，去一切积滞、沉痼阴寒等疾，驱风理怯。"《分类草药性》："治一切热毒，涂疮生肌。"
爬山虎，祛风通络，活血解毒。
茜草，凉血，止血，祛瘀，通经。用于吐血，衄血，崩漏，外伤出血，经闭瘀阻，关节痹痛，跌扑肿痛。
泽兰，活血化瘀，行水消肿。用于月经不调，经闭，痛经，产后瘀血腹痛，水肿。《日华子本草》："通九窍，利关脉，养血气，破宿血，消症瘕，产前产后百病，通小肠，长肉生肌，消扑损瘀血，治鼻洪吐血，头风目痛，妇人劳瘦，丈夫面黄。"
紫河车，补气，养血，益精。治虚损，羸瘦，劳热骨蒸，咳喘，咯血，盗汗，遗精，阳痿，妇女血气不足，不孕或乳少。
方中丰花草、番红花、红天葵具有活血化瘀，清热解毒之功效，共为君药。掌叶榕、营实、淮通、一枝蒿、爬山虎、和泽兰协君药祛风利湿，行水消肿，诸为臣药。佐以小粘药、徐长卿、金银花、茜草协君行气止痛，凉血解毒。紫河车、何首乌补气养血，引方中诸药以达病灶，为使药。诸药配合，共健活瘀凉血、清热解毒、祛风除湿、养血润燥之功效；使病情得到有效治疗和治愈。与现有技术相比，本发明药物具有见效快、标本兼治、兼顾调理、不易复发的效果，治愈后不复发，患者用药方便。
具体实施方式
下面结合具体实施例对本发明作进一步说明，但并不限制本发明。
实施例1、本发明中药口服液的制备
为了给急慢性毒性试验和临床试验提供药品，同时验证本发明制备工艺，按本发明中药配方实践生产中药口服液，所述口服液分别编号为A、B、C、D，其中，A为最优选配比，B为组方最小范围配比，C为组方最大范围配比，D为组方范围内任意配比。各配比的中药材数量如表1所示。
表1 各配比中药材数量表（单位：kg）
制备方法采用以下步骤：
（1）取处方量的丰花草、番红花、红天葵、掌叶榕、营实、淮通、一枝蒿、爬山虎、泽兰、小粘药、徐长卿、金银花、茜草、紫河车、何首乌，加入所述药材总重量的7 倍量水煎煮二次，第一次煎煮2 小时，第二次煎煮1小时，合并煎液，滤过，滤液减压浓缩，加入乙醇使得溶液的含乙醇量为65%，溶液放置24小时，滤过，滤液回收乙醇，浓缩得稠膏；
（2）将上述所得稠膏干燥后粉碎成细粉，过筛，按照传统工艺制备成口服液，生药含量约为0.28g生药/ml。
实施例2、本发明药物的动物毒性试验
（一）、急性毒性试验
1、试验药品：本发明实施例1所制得中药口服液编号为A-D。试验所用动物：普通级NIH小鼠，体重21g±6g，雌雄各半，雌性小鼠均无孕；
2、应用小鼠进行急性毒性实验表明：小鼠灌胃实施例1的中药口服液，在784.9g生药/kg剂量下，给药后小鼠出现轻微活动减少，1小时左右恢复正常，给药后连续观察7天，无一小鼠死亡，且全身状况、饮食、摄水、小便和体重增长均正常。实验结果表明：小鼠灌胃实施例1的中药口服液的最大给药量为784.9g生药/kg/d（LD50＞784.9g生药/kg）。本发明的中药制剂每日临床用药总量为0.18g生药/kg/d；按体重计，小鼠灌胃本发明中药制剂的耐受量为临床病人的4360.6倍。提示该药急性毒性极低，临床用药安全。
（二）、动物长期毒性试验
1、药物：本发明实施例1所得中药口服液。
2、动物：普通级SD大鼠，初始体重217±6g，雌雄各半，雌性大鼠均无孕。
3、方法与结果：
（1）4种中药口服液：均分为高、中、低三个剂量组，单位体重给药量分别为患者服用量的180、60、20倍；
（2）将实验鼠随机分成13组，其中12组分别灌胃4种三个剂量的口服液，剩余一组灌胃生理盐水（患者服用量的40倍）；所有13组均连续灌胃180天，观察动物全身毒性反应及严重程度，处死后按操作规程检查各部位，并进行血液学，ALT、BUN及心、肝、脾、肺、肾、胃等主要脏器的病理学检查；
（3）经过长期喂食，13组大鼠均未出现毒性反应。发育良好。肉眼外观及主要脏器未见异常。外周血象及血清ALT、BUN与对照组比较无病理性改变。病理报告心、肝、脾、肺、肾、胃等均未有意义的改变，因此，认为经病理证实，4种中药口服液对动物无慢性毒性表现。
通过以上两个毒性实验，证明本发明按实施例1制作的中药口服液是安全的，无毒副作用的，可以被患者服用。
实施例3、临床药效试验
1、病例选择：选择医院确诊的眼睑湿疹患者88例，其中男53例，女35例，年龄19-47岁，随机分成4组，每组22人，编号A、B、C、D。
2、治疗方法：四组患者依次对应服用本发明实施例1制备的A-D口服液，每次3.6g生药量，每天3次，10天一疗程，治疗一个疗程。
3、疗效判定
痊愈：症状完全消失，无任何不舒适感。
好转：症状减轻，仍有不适感。
无效：症状同治疗前无明显差异。
4、治疗结果
以上结果显示，本发明药物治疗眼睑湿疹疗效确切，治愈率高，平均总有效率达98.48%。特别是A组药物疗效最好。
典型病例
赵某某，男，36岁，睑部有明显的刺痒感和烧灼感。2个月前出现眼睑皮肤红肿，出现红斑，诊断为进行眼睑湿疹。服用本发明实施例1制备的编号为A的口服液，连续服用一个疗程，症状完全消失，至今未复发。
孙某，女，43岁，湿疹长期不愈，眼睑皮肤粗糙呈鳞屑样，组织肥厚，久治不愈。后服用本发明实施例1制备的编号为A的口服液，连续服用3个疗程，症状完全消失，至今未复发。

Claims (6)

1.一种治疗眼睑湿疹的药物，其特征在于由以下原料药制得：丰花草、番红花、红天葵、掌叶榕、营实、淮通、一枝蒿、爬山虎、泽兰、小粘药、徐长卿、金银花、茜草、紫河车、何首乌。
2.如权利要求1所述的治疗眼睑湿疹的药物，其特征在于由以下重量份原料药制得：丰花草28-31份、番红花33-36份、红天葵34-37份、掌叶榕17-20份、营实10-14份、淮通21-25份、一枝蒿10-15份、爬山虎9-12份、泽兰7-10份、小粘药5-8份、徐长卿12-15份、金银花20-23份、茜草11-14份、紫河车5-8份、何首乌10-13份。
3.如权利要求2所述的治疗眼睑湿疹的药物，其特征在于由以下重量份原料药制得：丰花草30份、番红花34份、红天葵35份、掌叶榕18份、营实13份、淮通23份、一枝蒿13份、爬山虎10份、泽兰8份、小粘药7份、徐长卿14份、金银花21份、茜草12份、紫河车6份、何首乌11份。
4.一种如权利要求1-3任一所述的治疗眼睑湿疹的药物的制备方法，其特征在于包括以下步骤：
（1）取处方量的丰花草、番红花、红天葵、掌叶榕、营实、淮通、一枝蒿、爬山虎、泽兰、小粘药、徐长卿、金银花、茜草、紫河车、何首乌，加入所述药材总重量的5-10 倍量水煎煮二次，第一次煎煮2-3 小时，第二次煎煮1-2 小时，合并煎液，滤过，滤液减压浓缩，加入乙醇使得溶液的含乙醇量为50-70%，溶液放置12-24小时，滤过，滤液回收乙醇，浓缩得稠膏；
（2）将上述所得稠膏干燥后粉碎成细粉，过筛，加入辅料制备得到临床上常用中药药物剂型。
5.如权利要求1-3任一所述的治疗眼睑湿疹的药物，其特征在于：所述药物为丸剂、片剂、颗粒剂、口服液、胶囊剂、膏剂、乳剂、咀嚼剂当中的任何一种。
6.如权利要求1-3任一所述治疗眼睑湿疹的药物在制备治疗眼睑湿疹症药物中的应用。
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