CN108992544A - 一种防治眼病的中药组合物 - Google Patents
一种防治眼病的中药组合物 Download PDFInfo
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Abstract
本发明属于医药保健技术领域,特别涉及一种防治眼病的中药组合物,包含有组分A和组分B,其中组分B的含量不超过总质量的15%;提供一种能够标本兼治各种眼病的中药组合物,毒副作用小,使用更加安全,而且质量可控,对眼部疾病具有防护和理疗作用,可以缓解视疲劳,预防或治疗火眼症、白内障、青光眼、青盲症、夜盲症、干眼症等病症。
Description
技术领域
本发明属于医药保健技术领域,特别涉及一种防治眼病的中药组合物。
背景技术
中医理论认为:目为肝窍,肝主目;眼为五脏之精,肝为五脏之长;肝主疏泄,调畅情志;肝生血气,藏血藏魂;肝生“相火”,萌发元阳;肝为将军之官,主攘外安内;肝主筋膜,罴极之本;肝为泪。强调眼病从肝治。现在中医理论分析认为:引起眼病的病因病机主要分别以下五个方面:(1)郁:根据辩证朱丹溪《丹溪心法六郁》云:“气血冲和,万病不生,一有拂郁,诸病生焉。”五脏六腑的气血均循经络上行于目窍,脏腑功能失调导致的痰浊瘀滞均可上行害目。内外障眼病虽然种类繁多,病因病机各有不同,但其根源可总归为脏腑经络郁滞。因此,眼病治疗中开“郁”,肝郁为先。(2)火:目为火窍,“火热”是眼科重要致病因素;风为百病之长,善行而数变,头目最易外受风邪侵袭,内遭肝风上扰;(3)淤:目受血而能视,目窍血络丰富,而在外感六淫中,风邪常与其他邪气相博,郁滞于目,寒性收引,湿性黏滞,热邪煎破血分,均可导致血瘀。目窍位高而精血难上,故血淤常与血亏并存,相互为患,因此开瘀不仅仅活血,亦常结合养血、理气、通络、化痰、散结等。(4)气:目受十二经气血而得视,肝又开窍于目,故肝气郁滞、湿阻气机都能导致血气不能上注于目,因此疏肝理气、行气化湿、芳香开窍类药也为眼病常用药。(5)虚:肝开窍于目,目得肝血而能视,瞳神为水轮属肾,肾精充足则精采光明;脾胃气虚:年老体弱,脾胃气虚,运化失司,气血生化匮乏,目失濡养。
现代药理研究表明:自由基损伤、视细胞营养物质损耗、视网膜损伤、视网膜色素上皮细胞衰老等也是导致眼病产生的主要原因。
目前,临床上治疗上述病症多对症治疗,所用药物多为滴眼剂。但是,目前市售的滴眼剂大多含有防腐剂,长期应用对眼表具有毒副作用。因此,寻求一种纯天然不含防腐剂,且能够显著预防或治疗上述多种症状的药物或保健品成为目前研究的重点。我国天然药材资源丰富,运用历史悠久,几千年来形成了以中医理论为指导原则的中药学。中药材是人类最早运用的纯天然有机物,且其中很大一部分药材被作为食材有长期的食用历史,使用中药材制备成既具有治疗功效又兼备食用价值的制剂,非常符合现代的养生观念。
发明内容
本发明的目的之一就是提供一种能够标本兼治各种眼病的中药组合物,相对西药来说,毒副作用小,使用更加安全,而且质量可控,对眼部疾病具有防护和理疗作用,可以作为缓解视疲劳,预防或治疗火眼症、白内障、青光眼、青盲症、夜盲症、干眼症等病症的药物或保健品的有效成分。
本发明所采用的技术方案是:
一种防治眼病的中药组合物,其包含有组分A和组分B,其中组分B的含量不超过总质量的15%;
组分A包括:蒺藜6~10份、丹参3~10g、黄芪9~15g、菊花5~10份、决明子9~15份、枸杞子6~12份、桑葚5~10份以及陈皮3~10份、叶黄素0.003~0.012份、元宝枫籽油1~3份、玉米黄质0.001~0.0044份、乳汁20~50份、蛋液5~20份以及植物汁液2~5份;
组分B为疏肝解郁降逆理气组分或疏风清热组分或活血化瘀组分或开窍明目组分或滋阴潜阳补益肝肾组分或健脾益气的组分或滋阴润肺的组分或其任意组合。
进一步限定,所述乳汁为人乳、狗乳、驴乳或各种乳加工产品中的一种或者几种;所述蛋液为鸭蛋、鸡蛋、鹌鹑蛋、鹅蛋或者蛋液加工产品中的一种或者几种;所述植物汁液为马齿苋汁、枸杞汁、桑叶汁、榕树胶汁、败酱草汁、榄李树汁中任意一种或其任意组合。
进一步限定,所述疏肝解郁降逆理气组分为羚羊角、香附、青皮、柴胡、芍药、郁金等中的任意一种或其任意组合。
进一步限定,所述疏风清热组分为防风、黄芩、土荆芥、柴胡、连翘、夏枯草、金银花、薄荷、木贼、牛蒡子、草决明、青葙子、谷精草、蔓荆子、桑叶、密蒙花、鱼腥草中的任意一种或其任意组合。
进一步限定,所述活血化瘀组分为川芎、桃仁、红花、当归、赤芍、蒲黄、乳香、没药、延胡索、莪术、泽兰中的任意一种或其任意组合;所述开窍明目组分为麝香和/或冰片。
进一步限定,所述滋阴潜阳补益肝肾组分为生地黄、覆盆子、磁石、制首乌、女贞子、山茱萸、山药、菟丝子、沙苑子、五味子中任意一种或其任意组合。
进一步限定,所述健脾益气组分为党参、茯苓、山药、人参、黄精、白术中任意一种或其任意组合。
进一步限定,所述滋阴润肺组分为铁皮石斛、玉竹、黄精、西洋参、百合、女贞子、麦冬、墨旱莲、沙参等中任意一种或其任意组合。
进一步说明,所述中药组合物中还包含有维生素A或β-胡萝卜素或其两者的组合,其维生素A含量不超过总质量的0.02‰。
上述的护眼功能的中药组合物可作为缓解视疲劳和防治火眼症、白内障、青光眼、青盲症、夜盲症、干眼症的药物或者食品有效成分的用途。
本发明的防治眼病的中药组合物主要是将具有清热散风、活血祛瘀、平肝解郁、健脾理气、滋补肝肾等作用的中药材与叶黄素、元宝枫籽油、玉米黄质、奶及奶制品、蛋及蛋制品、植物汁液等视细胞营养物质以及富含视细胞营养物质的原料配伍使用,能够标本兼治,从根本上预防或治疗各种眼疾不适症状等,主要有以下特点:
(1)中草药成分:
蒺藜:辛、苦,微温。归肝经。平肝解郁,活血祛风,明目,止痒。
丹参:苦,微寒。归心、肝经。活血祛瘀,通经止痛,清心除烦,凉血消痈。
黄芪:甘,微温。归肺、脾经。补气升阳,固表止汗,利水消肿,生津养血,行滞通痹,托毒排脓,敛疮生肌。
菊花:甘、苦,微寒。归肺、肝经。散风清热,平肝明目,清热解毒。
决明子:甘、苦、咸,微寒。归肝、大肠经。清热明目,润肠通便。
枸杞子:甘、平。归肝、肾经。滋补肝肾,益精明目。
桑葚:甘、咸,平。归肝、肾经。固精缩尿,补肾助阳,滋阴补血。
陈皮:苦、辛,温。归肺、脾经。理气健脾,燥湿化痰。
山楂:酸、甘,微温。归脾、胃、肝经。消食健胃、行气散瘀、化浊降脂。
(2)叶黄素:以高浓度沉积于人眼底黄斑中,具有保护视网膜,防治紫外线损伤,预防老年性眼球视网膜黄斑退化引起的视力下降与失明的作用。
(3)玉米黄质:主要集中在视网膜的黄斑区中心,可特异性吸收对视网膜最具损伤性的蓝色光线,从而保护视网膜中央凹的视锥细胞。有11个共轭双键,并且尾端集团上有羟基,该结构使它具有较强的抗氧化能力,防止膜脂过氧化,减少脂褐素生成,进而防止白内障的形成。
(4)元宝枫籽油:含有5.8%的功能性脂肪酸——神经酸,是各国科学家公认的大脑神经纤维和神经细胞的核心天然成分,也是唯一一个能修复疏通受损大脑神经纤维并促进神经细胞再生的双效神奇物质。因此,神经酸具有促进视神经发育和修复的作用。而且,元宝枫籽油中还含有丰富的维生素E(含量高达125mg/100g)以及不饱和脂肪酸。
(5)奶、蛋、植物汁液等不仅含有丰富的营养物质,如各种维生素和矿物质,在蛋黄中还含有较多的磷脂,其中约一半是卵磷脂,这些成分对人的脑及神经组织(包括视神经)的发育有重大作用;而且很多在传统使用习惯中对眼部疾病和预防也有很广泛的用途。
上述各成分之间能够协同增效,对视疲劳、火眼症、白内障、青光眼、青盲症、夜盲症、干眼症等各种眼病能够从根本上调节,保护视网膜,防治紫外线损伤,预防老年性眼球视网膜黄斑退化引起的视力下降与失明,防止膜脂过氧化,促进视神经发育和修复,具有平肝解郁,活血祛风,疏风清热,补益肝肾,滋阴明目等功效,标本兼治,此外,本发明的各原料取自天然中草药和动植物成分,相对西药来说,更加安全,毒副作用小。
根据中医辨证疗法,在上述主要成分的基础上还可以根据不同眼病的特点,通过添加下述辅助中草药成分进一步强化,对各种眼部疾病起到很好的预防和治疗效果,具体为:
1、火眼:以双眼突发红赤疼痛,沙涩羞明,眵多泪热为主要表现的眼病。主要由风热上攻眼目所致。因此,可添加疏风清热组分,如防风、黄芩、土荆芥、柴胡、连翘、夏枯草、金银花、薄荷、木贼、牛蒡子、草决明、青葙子、谷精草、蔓荆子、桑叶、密蒙花、鱼腥草中任意一种或其任意组合,但是疏风清热组分的含量不超过整体中药组合物的15%。
2、白内障:由各种原因如老化、遗传、局部营养障碍、免疫与代谢异常、外伤、中毒、辐射等,引起的晶状体代谢紊乱,导致晶状体蛋白质变性而发生混浊,称为白内障。中医认为主要病因为肝肾阴虚,脾胃气虚和血淤。
(1)肝肾阴虚:可添加滋阴潜阳、补益肝肾组分,如生地黄、覆盆子、磁石、制首乌、女贞子、山茱萸、山药、菟丝子、沙苑子、五味子中任意一种或其任意组合;但是滋阴潜阳、补益肝肾组分的含量不超过整体中药组合物的15%。
(2)脾胃气虚:可添加健脾益气组分,如党参、茯苓、山药、人参、黄精、白术中任意一种或其任意组合,但是健脾益气组分的含量不超过整体中药组合物的15%。
(3)血瘀型:可添加活血化瘀组分,如川芎、桃仁、红花、当归、赤芍、蒲黄、乳香、没药、延胡索、莪术、泽兰中的任意一种或其任意组合,但是活血化瘀组分的含量不超过整体中药组合物的15%。
3、青光眼:一组威胁和损害视神经视觉功能,主要与病理性眼压升高有关的眼病。中医认为主要病因包括风热上扰,肝邪气逆,肝肾阴虚,气虚血瘀,肝邪脾虚等。
(1)肝经风热,可添加疏风清热组分,如防风、黄芩、土荆芥、柴胡、连翘、夏枯草、金银花、薄荷、木贼、牛蒡子、草决明、青葙子、谷精草、蔓荆子、桑叶、密蒙花、鱼腥草中的任意一种或其任意组合,但是疏风清热组分的含量不超过整体中药组合物的15%。
(2)肝郁气逆,可添加疏肝解郁、降逆理气组分,如羚羊角、香附、青皮、柴胡、芍药、郁金等中的任意一种或其任意组合。但是疏肝解郁、降逆理气组分的含量不超过整体中药组合物的15%。
(3)肝肾阴虚:可添加滋阴潜阳、补益肝肾组分,如生地黄、覆盆子、磁石、制首乌、女贞子、山茱萸、山药、菟丝子、沙苑子、五味子中任意一种或其任意组合。但是滋阴潜阳、补益肝肾组分的含量不超过整体中药组合物的15%。
(4)血瘀:可添加活血化瘀组分,如川芎、桃仁、红花、当归、赤芍、蒲黄、乳香、没药、延胡索、莪术、泽兰中的任意一种或其任意组合,但是活血化瘀组分的含量不超过整体中药组合物的15%。
(5)脾胃气虚:可添加健脾益气组分,如党参、茯苓、山药、人参、黄精、白术中任意一种或其任意组合,但是健脾益气组分的含量不超过整体中药组合物的15%。
4、青盲:眼外观端好,而视力渐降至失明为主要表现的眼病。主要由肝肾阴亏、虚火上升、气滞血瘀等导致目失涵养而成。可添加滋阴潜阳、补益肝肾组分或开窍名目组分,如生地黄、覆盆子、磁石、制首乌、女贞子、山茱萸、山药、菟丝子、沙苑子、五味子中任意一种或其任意组合。但是滋阴潜阳、补益肝肾组分的含量不超过整体中药组合物的15%;开窍明目组分为麝香、冰片的一种或两种。
5、夜盲:对弱光敏感度下降,暗适应时间延长的重症表现,多因VA缺乏所致。因此可添加维生素A、β-胡萝卜素中的一种或两种的组合,但是维生素A含量不超过总质量的0.02‰。
6、干眼:指任何原因造成的泪液质或量异常或动力学异常,导致泪膜稳定性下降,并伴有眼部不适(或)眼表组织病变特征的多种疾病的总称。多由肺阴不足或肝肾阴虚,虚火上炎所致;亦可因湿热蕴结,火伏气分而发。可添加滋阴润肺组分,如铁皮石斛、玉竹、黄精、西洋参、百合、女贞子、麦冬、墨旱莲、沙参等中任意一种或其任意组合,但是滋阴润肺组分的含量不超过整体中药组合物的15%;以及滋阴潜阳、补益肝肾组分,如生地黄、覆盆子、磁石、制首乌、女贞子、山茱萸、山药、菟丝子、沙苑子、五味子中的任意一种或其任意组合,但是补益肝肾、滋阴养血组分的含量不超过整体中药组合物的15%。
具体实施方式
本发明防治眼病的中药组合物既可以内服也可以外用,通过以下实施例的不同剂型为例进行说明。
实施例1:
(1)蒺藜9g、丹参6g、黄芪9g、菊花6g、决明子9g、枸杞子9g、桑葚6g、陈皮6g,加12倍水浸泡1.5个小时,煎煮2次,每次提取2小时,每次煎煮后分离药液,滤过,合并两次煎煮滤液,静止后分取上清液;
(2)将得到的上清液减压浓缩(-0.06MPa,温度为55℃)至50℃时相对密度为1.22,向浓缩液中加入相对浓缩液质量2.5倍体积浓度为95%的乙醇,充分搅拌,静置48h滤过,得滤液,药渣用体积浓度为60%的乙醇洗涤,洗液与滤液合并,减压浓缩(-0.06MPa,温度为55℃)除乙醇,加入人乳汁31g,榕树胶汁5g、鸡蛋液10g、叶黄素0.01g、玉米黄质0.003g以及元宝枫籽油3g(其中元宝枫籽油中神经酸的含量≥5%),搅拌、均质,制成均匀的药液。
(3)将得到的均匀药液减压浓缩(-0.06MPa,温度为55℃)至50℃时相对密度为1.35的清膏;清膏减压干燥(-0.085Mpa,60℃),粉碎至干膏粉,过80目筛,加入60%(w/w)乙醇制粒;将制好的湿颗粒55℃干燥至水分5%以下,整粒,得干颗粒,装入胶囊,即得成品。
实施例2:
(1)蒺藜10g、丹参3g、黄芪12g、菊花10g、决明子12g、枸杞子12g、桑葚6g、陈皮6g,木贼9g,加12倍水浸泡2个小时,煎煮2次,每次提取2小时,每次煎煮后分离药液,滤过,合并两次煎煮滤液,静止后分取上清液;
(2)将得到的上清液减压浓缩(-0.07MPa,温度为60℃)至50℃时相对密度为1.22,向浓缩液中加入相对浓缩液质量3倍体积浓度为95%的乙醇,充分搅拌,静置后(静置时间48h)滤过,得滤液,药渣用体积浓度为60%的乙醇洗涤,洗液与滤液合并,减压浓缩(-0.07MPa,温度为60℃)除乙醇,加入人乳汁20g,马齿苋汁4g、鸡蛋液5g、叶黄素0.01g、玉米黄质0.003g以及元宝枫籽油2g、锉研成细粉的羚羊角3g,搅拌、均质,制成均匀的药液。
(3)将得到的均匀药液,减压浓缩(-0.07MPa,温度为60℃)至50℃时相对密度为1.35的清膏;清膏减压干燥(-0.085Mpa,60℃),粉碎至干膏粉,过80目筛,加入干膏粉量的1%的羧甲基纤维素钠和2%的羧甲基淀粉钠,混合均匀,加入60%(w/w)乙醇制粒;将制好的湿颗粒55℃干燥至水分5%以下,整粒,得干颗粒;加入干颗粒总量1%的硬脂酸镁,混合,得总混物经压片制成片剂。
实施例3:
(1)蒺藜9g、丹参9g、黄芪9g、菊花6g、决明子6g、枸杞子6g、桑葚6g、陈皮6g,防风3g、荆芥5g、谷精草5g、薄荷3g,加12倍水浸泡2个小时,煎煮2次,每次提取2小时,每次煎煮后分离药液,滤过,合并两次煎煮滤液,静止后分取上清液;
(2)将得到的上清液减压浓缩(-0.06MPa,温度为55℃)至50℃时相对密度为1.22,向浓缩液中加入相对浓缩液质量2.5倍体积浓度为95%的乙醇,充分搅拌,静置后(静置时间36h)滤过,得滤液,药渣用体积浓度为60%的乙醇洗涤,洗液与滤液合并,减压浓缩(-0.06MPa,温度为55℃)除乙醇,加入驴乳汁40g,败酱草汁5g、鸭蛋液5g、叶黄素0.01g、玉米黄质0.004g以及元宝枫籽油3g,搅拌、均质,制成均匀的药液。
(3)将上述均匀药液减压浓缩(-0.06MPa,温度为55℃)至体积为30ml时,冷却至常温后,加入透明质酸5g和用乙醇溶解后的天然冰片(0.3g),混合均匀,取购买的眼贴膜布浸没在药液中,使充分吸收药液,之后沥去余液,装入复合膜袋中,每袋装两片。包装后两天内及时采用辐照灭菌。
实施例4
(1)蒺藜8g、丹参6g、黄芪12g、菊花6g、决明子6g、枸杞子6g、桑葚6g、陈皮6g、熟地黄6g、菟丝子3g、五味子3g,加12倍水浸泡2个小时,煎煮2次,每次提取2小时,每次煎煮后分离药液,滤过,合并两次煎煮滤液,静止后分取上清液;
(2)将得到的上清液减压浓缩(-0.06MPa,温度为55℃)至50℃时相对密度为1.22,向浓缩液中加入相对浓缩液质量3倍体积浓度为95%的乙醇,充分搅拌,静置后(静置时间36h)滤过,得滤液,药渣用体积浓度为60%的乙醇洗涤,洗液与滤液合并,减压浓缩(-0.06MPa,温度为55℃)除乙醇,加入人乳汁20g,榕树胶汁2g、蛋黄液5g、叶黄素0.01g、玉米黄质0.004g以及元宝枫籽油3g,搅拌、均质,制成均匀的药液。
(3)将得到的均匀药液,减压浓缩(-0.06MPa,温度为55℃)至50℃时相对密度为1.35的清膏;清膏减压干燥(-0.085Mpa,55~70℃),粉碎至干膏粉,过80目筛,备用。将干膏粉、抗性糊精混合均匀,用14目筛制粒,55-60℃干燥,12、20目双筛选粒,分装,检验,包装,即得成品(每袋装3g)。
实施例5
(1)蒺藜10g、丹参3g、黄芪9g、菊花5g、决明子9g、枸杞子6g、桑葚8g、陈皮8g、覆盆子9g,女贞子9g,加12倍水浸泡2个小时,煎煮2次,每次提取2小时,每次煎煮后分离药液,滤过,合并两次煎煮滤液,静止后分取上清液;
(2)将得到的上清液减压浓缩(-0.06MPa,温度为55℃)至50℃时相对密度为1.22,向浓缩液中加入相对浓缩液质量3倍体积浓度为95%的乙醇,充分搅拌,静置后(静置时间36h)滤过,得滤液,药渣用体积浓度为60%的乙醇洗涤,洗液与滤液合并,减压浓缩(-0.06MPa,温度为55℃)除乙醇,加入人乳汁35g,鹅蛋液15g、枸杞汁4g、叶黄素0.005g、元宝枫籽油1g、玉米黄质0.002g,搅拌、均质,制成均匀的药液。
(3)将得到的均匀药液,减压干燥(-0.085Mpa,55~70℃),粉碎至100目~300目的细膏粉,备用。将医用凡士林置于不锈钢器皿中,加热到70~110℃,使其完全融化,待温度降至30~60℃后加入混合细粉,充分搅拌均匀,冷却后制成膏剂。
实施例6
本实施例的防治眼病的中药组合物,可用于治疗脾胃气虚型白内障,即可添加健脾益气组分,筛选原料称取:蒺藜7g、丹参3g、黄芪9g、菊花6g、决明子12g、枸杞子10g、桑葚8g、陈皮7g、叶黄素0.009g、元宝枫籽油1g、玉米黄质0.003g、狗乳40g、鸭蛋液15g、枸杞汁4g,黄芪9g,党参6g,白术6g。
参照前述的方法可以制成颗粒剂、胶囊、片剂、膏剂或眼贴,能够健脾益气,保健预防脾胃气虚型白内障。此外,还可以添加党参、茯苓、山药、人参、黄精和白术中的任意一种,对于上述健脾益气组分也可以任意组合使用,但是其整体含量不超过中药组合物的15%,以使各组分药效相容。
实施例7
本实施例的防治眼病的中药组合物,可用于治疗血淤型白内障,即可添加活血化瘀组分,筛选原料称取:蒺藜10g、丹参9g、黄芪9g、菊花8g、决明子9g、枸杞子10g、桑葚6g、陈皮6g、叶黄素0.012g、元宝枫籽油2g、玉米黄质0.003g、狗乳40g、鸭蛋液40g、桑叶汁4g、川穹3g、赤芍6g。
参照前述的方法可以制成颗粒剂、胶囊、片剂、膏剂或眼贴,能够活血化瘀,祛障明目,保健预防白内障。此外,还可以添加其他活血组分如:川芎、桃仁、红花、当归、赤芍、蒲黄、乳香、没药、延胡索、莪术、泽兰,对于上述活血组分也可以任意组合使用,但是其整体含量不超过中药组合物的15%,以使各组分药效相容。
实施例8
本实施例的防治眼病的中药组合物,可用于治疗青盲眼,即可添加滋阴潜阳、补益肝肾组分,筛选原料称取:蒺藜8g、丹参3g、黄芪12g、菊花5g、决明子15g、枸杞子7g、桑葚10g、陈皮10g、叶黄素0.01g、元宝枫籽油1g、玉米黄质0.002g、狗乳45g、鸭蛋液35g、榄李树汁5g,制首乌9g,沙苑子9g。
参照前述的方法可以制成颗粒剂、胶囊、片剂、膏剂或眼贴,能够滋阴潜阳、补益肝肾。此外,还可以添加生地黄、覆盆子、磁石、制首乌、女贞子、山茱萸、山药、菟丝子、沙苑子、五味子等的中药组合物或者前述成分的其他任意组合,但是其整体含量不超过中药组合物的15%,还可以添加开窍明目组分如麝香或冰片,以使各组分药效相容。
实施例9
本实施例的防治眼病的中药组合物,可用于治疗肝郁气逆型青光眼,即可添加疏肝解郁、降逆理气组分,筛选原料称取:蒺藜10g、丹参6g、黄芪9g、菊花6g、决明子10g、枸杞子10g、桑葚5g、陈皮5g、叶黄素0.004g、元宝枫籽油2g、玉米黄质0.001g、人乳50g、鸭蛋液5g、败酱草汁3g,柴胡9g。其中疏肝解郁、降逆理气组分是羚羊角、香附、青皮、柴胡、芍药、郁金等中的任意一种或其任意组合,但是其整体含量不超过中药组合物的15%,以使各组分药效相容。
实施例10
本实施例的防治眼病的中药组合物,可用于治疗脾胃气虚型青光眼,即可添加健脾益气组分,筛选原料称取:蒺藜6g、丹参3g、黄芪12g、菊花10g、决明子10g、枸杞子10g、桑葚6g、陈皮6g、叶黄素0.006g、元宝枫籽油2g、玉米黄质0.001g、人乳汁20g、鹅蛋液20g、榄李树汁3g、山药9g、党参12g。其中健脾益气组分是党参、茯苓、山药、人参、黄精、白术中任意一种或其任意组合,但是健脾益气组分的含量不超过整体中药组合物的15%,以使各组分药效相容。
实施例11
本实施例的防治眼病的中药组合物,可用于治疗血淤型青光眼,即可添加活血化瘀组分,筛选原料称取:蒺藜10g、丹参9g、黄芪9g、菊花10g、决明子6g、枸杞子10g、桑葚8g、陈皮8g、叶黄素0.005g、元宝枫籽油3g、玉米黄质0.003g、狗乳40g、鸭蛋液20g、马齿苋汁3g,红花3g、桃仁6g,其中活血化瘀组分是由川芎、桃仁、红花、当归、赤芍、蒲黄、乳香、没药、延胡索、莪术、泽兰中的任意一种或其任意组合,但是活血化瘀组分的含量不超过整体中药组合物的15%,以使各组分药效相容。
实施例12
本实施例的防治眼病的中药组合物,可用于夜盲眼,即可添加维生素A或β-胡萝卜素或其两者的组合,其维生素A含量不超过0.02‰,以使各组分药效相容。
实施例13
本实施例的防治眼病的中药组合物,可用于治疗干眼,即同时添加滋阴润肺和滋阴潜阳、补益肝肾组分,筛选原料称取:蒺藜8g、丹参3g、黄芪9g、菊花5g、决明子10g、枸杞子8g、桑葚8g、陈皮6g、叶黄素0.01g、元宝枫籽油1g、玉米黄质0.002g、驴乳30g、鹌鹑蛋20g、桑叶汁3g,滋阴润肺组分为铁皮石斛6g、玉竹6g以及滋阴潜阳、补益肝肾组分为沙苑子9g、磁石9g,其中滋阴润肺组分还可以为铁皮石斛、玉竹、黄精、西洋参、百合、女贞子、麦冬、墨旱莲、沙参中任意一种或其任意组合;滋阴潜阳、补益肝肾组分还可以为生地黄、覆盆子、磁石、制首乌、女贞子、山茱萸、山药、菟丝子、沙苑子、五味子中任意一种或其任意组合;但是滋阴润肺组分的含量不超过整体中药组合物的15%;但是滋阴潜阳、补益肝肾组分的含量不超过整体中药组合物的15%,以使各组分药效相容。
进一步说明,上述实施例1~13的人乳汁、狗乳或驴乳可以相互替换或者也可用人乳加工产品如乳粉、乳酪等、狗乳加工产品如乳粉、酸狗乳等或者驴乳加工产品乳粉、驴炼乳等来替换,其配方量(其他乳制品的配方量以换算成乳汁计算)可以在20~50g之间选择。
进一步说明,上述实施例1~13的鸡蛋液、鸭蛋、鹌鹑蛋以及鹅蛋可以相互替代或组合使用,可以用其中任一种的蛋液或者蛋液加工产品等其他蛋液来替换,其配方量可以在5~20g之间选择。
进一步说明,上述实施例1~13的榕树胶汁、马齿苋汁、枸杞叶汁、桑叶汁、榕树胶汁、败酱草汁、榄李树汁可以相互替换,也可以将其任意组合来替换,对于植物汁液的用量可以在2~5g之间调整。
本发明所提供的中药组合物可以制成胶囊型、片剂、颗粒粉剂或眼贴、膏脂等,还可以加工成茶品或冲调制剂等,可以作为药物成分,也可以制备成食品或者保健品。
为了验证本发明的产品对眼病的防治效果,发明人通过大量的实验室研究和临床试验进行验证,以下述试验为例进行说明,具体为:
试验例1
用实施例1中得到的产品进行缓解视疲劳的人体试食试验,试验方法参考《保健食品检验与评价技术规范》(2003版)中的缓解视疲劳功能检验方法进行。材料与方法
样品
实施例1的缓解视疲劳的复合中药组合物制成的胶囊剂;安慰剂的外观、规格与样品相同,人体推荐食用量为:每次2粒,每日3次。
受试对象:按自愿原则选择18~60岁,具有是帕劳症状的受试者100例
纳入者标准:长期用眼,视力易疲劳者。
排除标准:
患有感染性眼部疾病者,角膜云翳、圆锥角膜等内外眼疾患者。
患有眼底疾病或合并有心血管、脑血管、肝、肾、造血系统等疾病。
短期内服用与受试功能有关的物品,影响到对结果的判断者。
长期服用其他有关治疗视力的药物或使用其他治疗方法,未能终止者。
不合符纳入标准,未按规定服用,或资料不全等影响功效或安全性判断者。
实验设计与分组:采用资深和组建两种对照涉及,100组受试者随机分为试食者和对照者,试食组服用该保健食品胶囊,对照组服用相同形状无功效安慰剂。
服用剂量及时间:每次2粒,每日2次,连续服用30天,受试者在试食期间停止服用有关改善视力的药物或其他保健食品。
观察指标:以下观察指标实验前后各检查一次。
1、功效性观察
一般情况:详细询问病史,了解受试者眼痛、眼胀、畏光、视物模糊、干涩等主要临床症状。观察该保健食品对受试者是否有不良影响。
视疲劳症状检查:眼胀、眼酸痛、畏光、视物模糊、眼干涩。
注:“偶感”是指1-2次/2天;“时有”是指1-3次/天;“经常”是指>3次/天
明视持久度检测:在检查表上绘制“品”字形立体方块图,方块没边长一厘米,局部照明100-150LX。检查表与眼睛的举例应按照受试者视物习惯保持在适当距离不动,规定受试者看到“品”字图像视为明视,倒“品”字时为不明视,测试时间为3分钟。明视持久度=(明视时间/注视总时间)×100%。
2、安全性观察:
血液、尿常规及便常规检查
肝肾功能检查
腹部B超,心电图,X线胸部透视。
数据处理和统计分析:计量资料用t检验进行分析。自身对照采用配对t检验,两组均数比较采用成组t检验。对非正态分布或方差不齐的数据进行适当的变量转换,待满足正态方差齐后,用转换的数据进行t检验;若转换数据仍不能满足正态方差齐要求,改用t’检验或秩和检验。在试食前组间比较差异无显著性的前提下,可进行试验后组间比较。改善率为计数资料,用卡方检验。四格表总例数小于40,或总例数等于或大于40但出现理论频数等于或小于1时,改用确切概率法。
3、功效判定
有效:症状改善且明视持久度前后相差大于等于10%
无效:症状和明视持久度无明显变化。
4、实验结果
4.1一般情况:纳入受试者106例,随机分为试食组和对照组。排除受试者6例,有效受试者100例,试食组和对照组各50例,受试者试验前血常规、尿常规、大便常规、肝肾功能、胸透、心电图、B超等检查均在正常范围,分组情况见表2试食前两组受试者年龄、性别、明视持久度、视力均无明显差异(P>0.05),具有可比性。试食者试食前后精神、睡眠、饮食、大小便等无明显变化。
表2试食前一般资料比较
试食组和对照组间P>0.05
4.2安全性观察指标
4.2.1一般状况:试验期间,两组受试者的精神正常,饮食、睡眠和大小便均未见异常。试食前后,受试者的血压测定结果差异均无显著性(P>0.05),见表3。
表3两组受试者试食前后血压测试结果
组内、组间P<0.05
4.2.2尿常规、大便常规检查
试食前后,试食组和对照组人群的尿液酸碱度、透明度、颜色等均未见异常;两组人群的粪便颜色、性状和镜检均未见异常。
4.2.3血常规检查
试食组自身前后比较及与对照组的组间比较红细胞、白细胞、血红蛋白、血小板测定值均无显著性差异(P>0.05),见表4。
表4两组受试者试食前后血常规检验结果
4.2.4试食前后血生化指标检验
试食组自身前后比较及与对照组的组间比较各个生化指标测定值均无显著性(P>0.05),见表5。
表5两组受试者试食前后生化指标检验结果
4.2.5心电图、胸透和腹部B超检查
试食前两组受试者的心电图、胸部X线透视和腹部B超等检查均未见异常。
4.3功能性指标测定
4.3.1实施例对受试者明视持久度的影响
试食后试食组受试者的明视持久度平均升高11.00%,与对照组比较差异有显著性(P<0.01),试食组试食前后组内自身比较差异有显著性(P<0.01);试食后试食组与对照组明视持久度组间比较差异有显著性(P<0.01),对照组试食前后明视持久度自身比较差异无显著性(P>0.05),见表6。
表6实施例对受试者明视持久度的影响
4.3.2实施例受试者临床症状改善率的比较
试食后试食组受试者眼胀、眼痛、视物模糊、畏光、眼干涩的症状改善有效率明显高与对照组(P<0.01,P<0.05),试食组与对照组症状改善总有效率比较差异有显著性(P<0.01),见表7。
表7实施例受试者临床症状改善率比较
4.3.3实施例对受试者症状总积分的影响
试食后试食组受试者的症状总积分平均降低3.23,与对照组比较差异有显著性(P<0.01),试食组试食前后组内自身比较差异有显著性(P<0.01);试食后两组间受试者的症状总积分比较差异有显著性(P<0.01),对照组受试者试食前后症状总积分自身比较差异无显著性(P>0.05),见表8。
表8实施例对受试者症状总积分的影响
病例脱失率:试食组和对照组各为53例,其中试食组结束时有3例未在规定时间按时复查,对照组有3例未在规定时间内按时复查。试食组和对照组各有3例符合受试者排除标准,有效病例每组50例,病例脱失率为5.67%。
综上所述,100例符合要求的视疲劳患者,随机分为试食组和对照组,试食组按要求服用该保健食品,对照组给予安慰剂,30天后,在用眼时间无明显变化的前提下,试食后试食组受试者的明视持久度平均提高了11.00%,与对照组比较差异有显著性(P<0.01),试食组试验前后组内自身比较,差异有显著性(P<0.01),而对照组受试者试食前后的明视持久度比较差异无显著性(P>0.05);试食后试食组受试者的症状总积分平均降低3.23,与对照组比较差异有显著性(P<0.01),试食组试食前后组内自身比较,差异有显著性(P<0.01);试食组两组间受试者的症状总积分比较差异有显著性(P<0.01),而对照组受试者试食前后的症状总积分比较差异无显著性(P>0.05);试食后试食组受试者眼胀、眼痛、畏光、视物模糊、眼干涩等症状改善有效率与对照组比较差异有显著性(P<0.01)。试食前后受试者的红细胞、白细胞、血红蛋白、血小板、血清总蛋白、血清白蛋白、谷草转氨酶、谷丙转氨酶、肌酐、尿素氮、总胆固醇、甘油三酯、血糖及尿常规、大便常规、心电图、胸部X线透视和腹部B超等各项检查均无明显变化,说明本品对受试者健康无不良影响。在试食过程中未观察到过敏及其它不良反应。
试验例2
用实施例2制得的片剂进行肝经风热型青光眼治疗效果的实验。人体食用量为:每次2片,每日3次,连续服用30天。
诊断标准:视物模糊或视力下降、眼部干涩、常伴有头痛,眼珠胀痛,白睛混赤,抱轮红赤尤甚,黑睛混浊,瞳神散大,伴恶心呕吐,面红口苦,恶寒发热。舌苔薄白或黄,脉弦数或弦硬。
治疗标准:
显效:视力提高3行以上,眼压下降10毫米汞柱或以上,其他症状消失。
有效:视力提高1~3行,或从光感、手动提高到0.04以上,眼压下降5毫米汞柱或以上,症状改善。
无效:视力、眼压治疗后未见明显变化或未达到有效标准,症状未见改善。
共有32例肝经风热型青光眼患者服用本发明药物,显效9人、有效22人、无效1例,有效率达到96.88%。
试验例3
用实施例3制得的眼贴进行火眼治疗效果的实验。每天早晚各一贴,连续使用30天。
诊断标准:起病较急,暴发目赤肿痛,沙涩畏光羞明,眵多流泪等,可兼发热头痛等。
治疗标准:(1)显效:患者眼部刺痒、如有异物、眼睑沉重、畏光流泪、灼热感、视物不清、目垢增多、眼睛充血、眼睛水肿等症状完全消失;(3)有效:患者眼部刺痒、如有异物、眼睑沉重、畏光流泪、灼热感、视物不清、目垢增多、眼睛充血、眼睛水肿等症状基本消失;(3)无效:主要症状、体征无明显改善。
共有50例火眼病患者使用本发明眼贴,显效31人、有效19人、无效0例,有效率达到100%,治疗过程中,患者未见不良反应。
试验例4
用实施例4得到的颗粒剂进行白内障治疗效果的实验。每天3次,每次1袋,持续服用30天。
诊断标准:晶状体发生变性和混浊,变为不透明,以至影响视力,而矫正视力在0.7或以下。
治疗标准:(1)显效:经治疗,用国际标准视力表检查,视力提高3行及3行以上;(2)有效:治疗后,视力提高1~2行;(3)无效:经治疗,视力无变化或下降。
共有42例白内障患者服用本发明药物,显效30人、有效10人、无效2例,有效率达到95.24%。
Claims (10)
1.一种防治眼病的中药组合物,其特征在于包含有组分A和组分B,其中组分B的含量不超过总质量的15%;
组分A包括:蒺藜6~10份、丹参3~10g、黄芪9~15g、菊花5~10份、决明子9~15份、枸杞子6~12份、桑葚5~10份以及陈皮3~10份、叶黄素0.003~0.012份、元宝枫籽油1~3份、玉米黄质0.001~0.0044份、乳汁20~50份、蛋液5~20份以及植物汁液2~5份;
组分B为疏肝解郁降逆理气组分或疏风清热组分或活血化瘀组分或开窍明目组分或滋阴潜阳补益肝肾组分或健脾益气组分或滋阴润肺组分或其任意组合。
2.根据权利要求1所述的防治眼病的中药组合物,其特征在于:所述乳汁为人乳、狗乳、驴乳或各种乳加工产品中的一种或者几种;所述蛋液为鸭蛋、鸡蛋、鹌鹑蛋、鹅蛋或者蛋液加工产品中的一种或者几种;所述植物汁液为马齿苋汁、枸杞汁、桑叶汁、榕树胶汁、败酱草汁、榄李树汁中任意一种或其任意组合。
3.根据权利要求1所述的防治眼病的中药组合物,其特征在于:所述疏肝解郁降逆理气组分为羚羊角、香附、青皮、柴胡、芍药、郁金等中的任意一种或其任意组合。
4.根据权利要求1所述的防治眼病的中药组合物,其特征在于:所述疏风清热组分为防风、黄芩、土荆芥、柴胡、连翘、夏枯草、金银花、薄荷、木贼、牛蒡子、草决明、青葙子、谷精草、蔓荆子、桑叶、密蒙花、鱼腥草中的任意一种或其任意组合。
5.根据权利要求1所述的防治眼病的中药组合物,其特征在于:所述活血化瘀组分为川芎、桃仁、红花、当归、赤芍、蒲黄、乳香、没药、延胡索、莪术、泽兰中的任意一种或其任意组合;所述开窍明目组分为麝香和/或冰片。
6.根据权利要求1所述的防治眼病的中药组合物,其特征在于:所述滋阴潜阳补益肝肾组分为生地黄、覆盆子、磁石、制首乌、女贞子、山茱萸、山药、菟丝子、沙苑子、五味子中任意一种或其任意组合。
7.根据权利要求1所述的防治眼病的中药组合物,其特征在于:所述健脾益气组分为党参、茯苓、山药、人参、黄精、白术中任意一种或其任意组合。
8.根据权利要求1所述的防治眼病的中药组合物,其特征在于:所述滋阴润肺组分为铁皮石斛、玉竹、黄精、西洋参、百合、女贞子、麦冬、墨旱莲、沙参等中任意一种或其任意组合。
9.根据权利要求1~8任一项所述的防治眼病的中药组合物,其特征在于:所述中药组合物中还包含有维生素A或β-胡萝卜素或其两者的组合,其中维生素A含量不超过总质量的0.02‰。
10.权利要求1所述的防治眼病的中药组合物可作为缓解视疲劳和防治火眼症、白内障、青光眼、青盲症、夜盲症、干眼症的药物或者食品有效成分的用途。
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