CN109288970A - 一种具有滋补肝肾、清肝明目、滋阴生津功能的药食同源组合物及其制备方法 - Google Patents
一种具有滋补肝肾、清肝明目、滋阴生津功能的药食同源组合物及其制备方法 Download PDFInfo
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- CN109288970A CN109288970A CN201811364846.8A CN201811364846A CN109288970A CN 109288970 A CN109288970 A CN 109288970A CN 201811364846 A CN201811364846 A CN 201811364846A CN 109288970 A CN109288970 A CN 109288970A
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Abstract
本发明涉及一种具有滋补肝肾、清肝明目、滋阴生津功能的药食同源组合物及其制备方法,该组合物包括覆盆子3~18重量份、枸杞子3~18重量份、决明子4~24重量份、山药4~45重量份、玫瑰花1~9重量份、菊花2~15重量份、石斛2~15重量份,其余为常用固体或液体制剂所需的辅料。可以制成固体制剂如片剂、胶囊剂、颗粒剂、丸剂、散剂;可以制成液体制剂如饮料、糖浆剂、合剂。本发明具有滋补肝肾、清肝明目、滋阴生津的功效,主要用于肝肾不足,阴虚火旺或用眼过度所致的视物模糊、眼睛干涩、眼睛红痒痛、有异物感、分泌物黏稠、见风流泪、眼睛干痒、眼睛易疲劳等症,可用于干眼症的辅助治疗,通过调节阴虚、肝肾不足的体质,达到缓解视疲劳和干眼症、润养保护眼睛的作用。
Description
技术领域
本发明涉及一种具有滋补肝肾、清肝明目、滋阴生津功能的组合物,是以食品(同时也是中药材)为原料制备的食品或药品,属于食品、保健品和药品领域。
背景技术
眼睛是人类收集外界信息最多的器官,是生活、工作中最为疲惫的器官。眼疾对人类的生活和工作的影响极大。随着科技发展,可视化的工具越来越多,人们对眼睛的过度使用和不卫生使用,导致了干眼症、视疲劳、眼部不适等眼疾频发,对人们的生活和工作造成极大的影响。
干眼症又称角结膜干燥症,是指泪液质或量异常或动力学异常,导致泪膜稳定性下降,并伴有眼部不适和(或)眼表组织病变特征的多种疾病的总称。据文献报道,干眼症是常见的眼科疾病之一,在我国20岁以上人群发生率高达30%左右,每天在电脑前工作3小时以上以及长时间戴隐形眼镜的人中,90%的人都患有干眼症,而且随着智能手机普及、从事电脑工作的人越来越多,干眼症患者人数以每年10%以上的速度上升。
由于许多干眼症患者不知道平时应如何进行患眼护理,常使病变发展加速,病变程度加重,加之此类患者常被误诊,经常得不到及时正确的诊治,甚至被给予错误的治疗,导致病情加重或恶化,这也为日后疾病的健康埋下隐患。
干眼症的症状多为刺激感、流泪、烧灼感、针刺感、干燥或异物感、轻度发痒、充血、疼痛、黏丝状分泌物、畏光、视物模糊、易疲劳等。
中医认为,肝开窍于目,而瞳神属肾,故治目病,关系肝肾两脏。中医将干眼症首次作为病名提出,即“白涩症”,见于明·傅仁宇《审视瑶函》,是古代医家根据其临床表现提出来的:“不肿不赤,爽快不得,沙涩昏朦,名曰白涩”。认为本病多由肝肾阴虚,虚火上炎所致。具体治则,宜养阴清热。故,滋补肝肾、清肝明目、滋阴生津的疗法可治疗肝肾阴虚引起的眼疾。
东汉《针经》曰:“五脏六腑精气,皆上于目,而为之精。故夫目之精明者,阴阳合传而为精明者也。若肾肝虚,则阴弱不能敛精以升养神水于内;脾肺虚,则阳衰不能摄阴而浮散神光于外,以致神水宽大,睹物成二。此其治法,其营在肝,其主在肾,其合在脾,能合肾脾之阴而使肝达之,则必能归经于两眸,而继明如昼夜矣。”
干眼症属于内障,多为虚证,不宜长期服用苦寒的清火泻肝药和含矿物的镇坠药,否则久服伤及脾胃、肝肾,宜采用补上治下,通过缓和作用和长期滋补来改善整体体质。
干眼症的现代医学治疗方法,最常采用的方法是人工泪液滴眼(含多种添加剂的人工泪液、润滑液)、刺激泪液分泌药物(溴苄环己胺类、胆碱能类、章鱼唾腺精类等),但是该方法只能治标,没有对病因进行治疗。病因治疗药包括抗生素类药物、免疫调节剂、激素类药物、补充维生素类药物,但是这类药物多为化学药,副作用大,不能长期使用。手术治疗包括隐静脉移植行腮腺管结膜成形术、泪腺造瘘术、泪小点封闭术等,但均为创伤性的治疗方法。
现已公布的技术,如中国发明专利公开号CN103336036A所公布的纯天然人工泪液及其制备方法,组分为盐湖卤水,功能单一,不含有PH缓冲溶液,保存过程不稳定,容易引起PH的变化,以及微生物滋生等问题。中国发明专利公开号CN102824547A公开了“治疗干眼症的中药超声波雾化剂及其制备方法”,该中药雾化剂的中药原料包括麦冬、沙参、柴胡、白芷、菊花、枸杞、石斛、桑叶、防风、蔓荆子、薄荷组成;中国发明专利公开号CN10102973842A公开了“一种治疗干眼症的中药薰洗液”,该中药薰洗液的中药原料包括千里光、青黛、小画眉草、寸金草、赤芍、土千年健、王不留行、玉竹、女贞子、菟丝子、薏苡仁组成;都是通过外用雾化或熏蒸给药途径达到治疗效果。中国发明专利公开号CN102688479A公开了“预防干眼症的组合物、包括其的眼贴膜及该眼贴膜的制备方法”,该组合物包括γ-聚谷氨酸和细胞生长因子;中国发明专利公开号CN103007284A公开了“HMGCoA还原酶抑制剂在制备治疗干眼症药物中的用途”;中国发明专利公开号CN101721358A公开了“一种含有重组人角质细胞生长因子-2滴眼液及其在干眼症治疗中的应用”;中国发明专利公开号CN101780076A公开了“一种含有他克莫司的药物组合物用于干眼症治疗的用途”。上述公开的专利文献包括生物、化学药物原料通过外用贴膜、滴眼和口服几种给药途径,但药物本身存在较大副作用。
2002年国家卫生部公布的《关于进一步规范保健食品原料管理的通知》中规定了既是食品又是药品的物品名单,简称为药食同源物品名单,这是中华民族传承千年的“医食同源,药膳同功”养生方式,指导着人们自我养生保健。该类物品可作为食品原料,同时具有中药功效,亦可作为药品原料。
目前市场上大多治疗干眼症的产品为保健食品、药品,具有同等功效但具有食品属性的产品却很少。而本发明组合物主治肝肾不足、阴虚火旺之病症。根据中医理论,在本方中,君药为覆盆子、枸杞子,起到滋补肝肾,益肾固精的作用;臣药为决明子、菊花,具有平肝潜阳、清肝热、明目的作用;佐药为山药、石斛,健脾益肺、滋阴生津、培补中宫,合肾脾之阴;使药为玫瑰花,行气达肝、和血祛瘀;诸药共同达到滋补肝肾、清肝明目、滋阴生津、健脾生津,使肾脾之阴精血充盈于肝的作用。作用缓和、安全有效,可作为人们自我眼保健用,亦可开发为普通食品、保健品、药品。
发明内容
本发明的目的是提供一种组成简单,具有滋补肝肾、清肝明目、滋阴生津功能的药食同源组合物,该组合物具有滋补肝肾、清肝明目、滋阴生津的功效,主要用于肝肾不足,阴虚火旺或用眼过度所致的视物模糊、眼睛干涩、眼睛红痒痛、有异物感、分泌物黏稠、见风流泪、眼睛干痒、眼睛易疲劳等症,可用于干眼症的辅助治疗。
本发明是根据中医理论,利用中药独特的药性,制备本发明组合物的原料药组成及配比如下:覆盆子 3~18份、枸杞子3~18份、决明子4~24份、山药4~45份、玫瑰花1~9份、菊花2~15份、石斛2~15份。
一种含有覆盆子、枸杞子、决明子、山药、玫瑰花、菊花、石斛的制品,由以下方法制成:
方法一:对原料覆盆子、枸杞子、决明子、山药、玫瑰花、菊花、石斛参分别用粉碎机粉碎并过30-120 目筛,将原料投入混合机中混匀5-90分钟,混合均匀后过30-120目筛,加入适合的辅料制得相应的固体制剂;
方法二:将原料覆盆子、枸杞子、决明子、山药、玫瑰花、菊花、石斛分别用粉碎机粉碎并过10-40 目筛,加3-20倍量的水,煎煮提取15-180分钟,过滤,滤渣加3-20倍量的水,煎煮提取15-180分钟,过滤,合并两次滤液,干燥,备用;将所有的提取物粉碎,过40-200目筛,混合机混合5-90分钟,混合均匀后,按常规制剂成型方法制备成固体或液体制剂。
方法三:将原料覆盆子、枸杞子、决明子、山药、玫瑰花、菊花、石斛分别用粉碎机粉碎并过10-40 目筛,按份称取后,混合,加3-20倍量的水提取15-180分钟,滤过,滤渣加3-20倍量的水,煎煮提取15-180 分钟,过滤,合并两次滤液,浓缩,按常规制剂成型方法制备成固体或液体制剂。
本发明的药食同源组合物具有滋补肝肾、清肝明目、滋阴生津的功效,主要用于肝肾不足,阴虚火旺或用眼过度所致的视物模糊、眼睛干涩、眼睛红痒痛、有异物感、分泌物黏稠、见风流泪、眼睛干痒、眼睛易疲劳等症,可用于干眼症的辅助治疗。
本发明以覆盆子、枸杞子、决明子、山药、玫瑰花、菊花、石斛干粉直接制成固体制剂或者提取后制成固体制剂或液体制剂,完全地保存了原料的有效成分,更好地发挥其功效。
将本发明进行了动物急性毒性试验,结果表明无明显毒性反应及其它异常;开展了对家兔干眼症模型的影响实验,结果表明本发明对实验性干眼症有改善作用;开展试食研究,结果表明本发明具有缓解视疲劳、提高明视持久度的作用。
1.小鼠灌胃给药急性毒性试验
选择SPF级KM种小鼠24h内两次灌胃给予本发明组合物,观察给药后产生的急性毒性反应和死亡情况。将40只小鼠随机分为2组,即溶媒对照组和本发明组合物组,每组雌雄各10只。禁食不禁水约12 小时后,小鼠以灌胃最大容量40ml/kg.bw给予浓度为1.7g生药/ml的本发明组合物,共两次(间隔约4h),折合生药剂量为136g生药/kg.bw,是临床拟用剂量的120倍;对照组给予同容积的纯水。给药当天连续4 小时观察动物出现的各种反应及症状、死亡情况;以后每天观察1次,连续观察14天,并于给药后第3、 7、14天称量体重;观察结束处死动物,大体解剖观察各动物组织器官、脏器的体积、颜色、质地等有无明显异常。
结果显示:本发明组合物组(相当于136g生药/kg.bw),给药后4-6小时先后有6只小鼠出现腹泻症状,发生率为30%,该症状次日有所减轻,第3天即无腹泻;试验期间,无动物死亡,各组动物体重均正常增长,本发明组合物组(相当于136g生药/kg.bw)小鼠体重增长幅度比溶媒对照组大;试验结束,对所有动物大体解剖,观察主要脏器、器官均无明显异常。
2.对家兔干眼症模型的影响实验
动物:日本大耳白家兔30只,雌雄各半,共60只眼,体重1.8-2.2kg。
造模:除空白对照组外,其余动物采用氯霉素滴眼液每次每眼3滴,每天2次,连续天,适应性喂养 3天后,麻醉,摘除兔眼泪腺、Harder腺和全部瞬膜,用细棉签蘸三氯醋酸涂抹距角膜缘3mm以外球结膜 1周,待球结膜颜色变白时用生理盐水缓慢冲洗,术后每天涂四环素眼膏预防感染,连续7天,形成兔眼形成干眼症模型。手术后第7天进行兔泪液分泌量检测,造模各组比空白对照组显著减少,说明造模成功。
分组与给药:随机分为空白对照组、模型对照组、本发明组合物低剂量组、中剂量组、高剂量组、阳性对照组,每组5只共10只眼。手术后第8天起,各组开始给药,低剂量组、中剂量组、高剂量组分别每天灌胃给予本发明组合物相当于21g生药/kg.bw、42g生药/kg.bw、84g生药/kg.bw,空白对照组和模型对照组每天灌胃给予等体积蒸馏水,阳性对照组每天灌胃给予毛果芸香碱0.56mg//kg.bw,连续4周。
观察及指标检侧:给药同时,各组每周进行1次SchirmerⅠ试验、泪膜破裂时间记录及角膜结膜虎红染色情况观察。
结果评价:本发明组合物中剂量组、高剂量组动物SchirmerⅠ试验滤纸湿长度、泪膜破裂时间分别在用药3周及4周后与模型对照组比较增加(P<0.05,P<0.01),本发明组合物高剂量组在用药2周后、其他给药组在用药3周及4周后与模型组比较减少(P<0.05,P<0.01)。详见表1、表2、表3。
结论:本发明组合物对实验性干眼症有改善作用。
表1各组泪液分泌量变化情况(n=10,mm)
注:与空白对照组比较,△P<0.01;与模型对照组比较,*P<0.05,**P<0.01
表2各组不同时间泪膜破裂时间变化情况(n=10,s)
注:与空白对照组比较,△P<0.01;与模型对照组比较,*P<0.05,**P<0.01
表3各组不同时间角结膜染色评分结果变化情况(n=10,分)
注:与空白对照组比较,△P<0.01;与模型对照组比较,*P<0.05,**P<0.01
3.缓解视疲劳症状的试验
对本发明所制成片剂进行了186例成年人为期60天的试吃观察,受试者为长期用眼且视力易疲劳者,且无眼部其他疾患,年龄25-60岁,其中男性85例,女性101例,试吃后缓解视疲劳的总有效率达96.24%。具体如下:
以下表计算每位受试者试食前后的症状积分。
表4视疲劳症状判定方法
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
表5缓解视疲劳症状的疗效判定方法表
表6 186例缓解视疲劳症状总有效率情况表
4.明视持久度的测定
在检查表上绘制“品”字形立体方块图。测定时,检查表与眼睛的距离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。测定时间为3min。检查时让受试者手持能断续计时的秒表,检查者发出开始的口令后,受试者立即注视方块中的图案(或打开灯箱开关),同时开动手中的秒表计时。在注视过程中看到倒“品”字时立即按下秒表的暂停开关;看到又呈“品”字图像时再开动秒表,如此反复进行。测定到规定时间3min结束时受试者听到检查者的口令立即停止秒表,这段时间内秒表走过的读数就是受试者看成“品”字图像的总时间,即明视时间。明视持久度=(明视时间/注视总时间)×100%,受试者测定3次取平均值。
表7 186例治疗前后明视持久度比较表
与治疗前比较,受试者的明视持久度值显著升高(P<0.01)。说明本发明有提高明视持久度的作用。
附图说明
图1明视持久度测定用“品”字图。
具体实施方式
以下通过实施例进一步说明本发明,但不作为对本发明的限制。
实施例1:
称取覆盆子18g、枸杞子18g、决明子18g、山药18g、玫瑰花18g、菊花18g、石斛12g,将全部药材拣选洗净干燥后,按量称取后,分别用粉碎机粉碎并过30目筛,将原料投入混合机中混匀5分钟,混合均匀后过30目筛,加入18g微晶纤维素,10.5g淀粉,3g微粉硅胶,1g硬脂酸镁,混合均匀,填装胶囊,即可。本品具有滋补肝肾、清肝明目、滋阴生津的功效,主要用于肝肾不足,阴虚火旺或用眼过度所致的视物模糊、眼睛干涩、眼睛红痒痛、有异物感、分泌物黏稠、见风流泪、眼睛干痒、眼睛易疲劳等症,可用于干眼症的辅助治疗。
实施例2:
称取覆盆子10g、枸杞子10g、决明子10g、山药10g、玫瑰花5g、菊花10g、石斛10g,将全部药材拣选洗净干燥后,按量称取后,分别用粉碎机粉碎并过120目筛,将原料投入混合机中混匀90分钟,混合均匀后过120目筛,加入18g微晶纤维素,10.5g淀粉,3g微粉硅胶,1g硬脂酸镁,混合均匀,填装胶囊,即可。本品具有滋补肝肾、清肝明目、滋阴生津的功效,主要用于肝肾不足,阴虚火旺或用眼过度所致的视物模糊、眼睛干涩、眼睛红痒痛、有异物感、分泌物黏稠、见风流泪、眼睛干痒、眼睛易疲劳等症,可用于干眼症的辅助治疗。
实施例3:
称取覆盆子3g、枸杞子3g、决明子4g、山药4g、玫瑰花1g、菊花2g、石斛2g,将全部药材拣选洗净干燥后,按量称取后,分别用粉碎机粉碎并过10目筛,加20倍量的水,煎煮提取180分钟,过滤,滤渣加20倍量的水,煎煮提取180分钟,过滤,合并两次滤液,干燥,备用;将所有的提取物粉碎,过200 目筛,混合机混合90分钟,混合均匀后,加入蔗糖粉8g、糊精2g,混匀,制成颗粒,干燥,过筛,分装,即得颗粒剂。本品具有滋补肝肾、清肝明目、滋阴生津的功效,主要用于肝肾不足,阴虚火旺或用眼过度所致的视物模糊、眼睛干涩、眼睛红痒痛、有异物感、分泌物黏稠、见风流泪、眼睛干痒、眼睛易疲劳等症,可用于干眼症的辅助治疗。
实施例4:
称取覆盆子10g、枸杞子8g、决明子12g、山药40g、玫瑰花8g、菊花8g、石斛8g,将全部药材拣选洗净干燥后,按量称取后,分别用粉碎机粉碎并过10目筛,加3倍量的水,煎煮提取15分钟,过滤,滤渣加3倍量的水,煎煮提取15分钟,过滤,合并两次滤液,干燥,备用;将所有的提取物粉碎,过40目筛,混合机混合5分钟,混合均匀后,加入淀粉5g,加乙醇适量制丸,干燥,分装,即得丸剂。本品具有滋补肝肾、清肝明目、滋阴生津的功效,主要用于肝肾不足,阴虚火旺或用眼过度所致的视物模糊、眼睛干涩、眼睛红痒痛、有异物感、分泌物黏稠、见风流泪、眼睛干痒、眼睛易疲劳等症,可用于干眼症的辅助治疗。
实施例5:
称取覆盆子15g、枸杞子16g、决明子24g、山药45g、玫瑰花9g、菊花15g、石斛15g,将全部药材拣选洗净干燥后,按量称取后,分别用粉碎机粉碎并过20目筛,加10倍量的水,煎煮提取150分钟,过滤,滤渣加10倍量的水,煎煮提取150分钟,过滤,合并两次滤液,干燥,备用;将所有的提取物粉碎,过150目筛,混合机混合60分钟,混合均匀后,加入50g的微晶纤维素,5g淀粉,6g滑石粉,以80%乙醇,过16目筛制粒,80℃鼓风干燥,14目筛整粒,加入0.5g硬脂酸镁,压片,即可。本品具有滋补肝肾、清肝明目、滋阴生津的功效,主要用于肝肾不足,阴虚火旺或用眼过度所致的视物模糊、眼睛干涩、眼睛红痒痛、有异物感、分泌物黏稠、见风流泪、眼睛干痒、眼睛易疲劳等症,可用于干眼症的辅助治疗。
实施例6:
称取覆盆子10g、枸杞子10g、决明子20g、山药40g、玫瑰花8g、菊花10g、石斛10g,将全部药材拣选洗净干燥后,按量称取后,分别用粉碎机粉碎并过40目筛,加10倍量的水,煎煮提取100分钟,过滤,滤渣加10倍量的水,煎煮提取120分钟,过滤,合并两次滤液,滤液减压浓缩至相对密度为1.1,加入甜菊素2g,,苯甲酸钠3g,搅匀,滤过,灭菌制成合剂。本品具有滋补肝肾、清肝明目、滋阴生津的功效,主要用于肝肾不足,阴虚火旺或用眼过度所致的视物模糊、眼睛干涩、眼睛红痒痛、有异物感、分泌物黏稠、见风流泪、眼睛干痒、眼睛易疲劳等症,可用于干眼症的辅助治疗。
Claims (4)
1.一种具有滋补肝肾、清肝明目、滋阴生津功能的药食同源组合物,其特征在于该组合物含有下述重量份的组分:覆盆子3~18份、枸杞子3~18份、决明子4~24份、山药4~45份、玫瑰花1~9份、菊花2~15份、石斛2~15份。
2.根据权利要求1所述的一种具有滋补肝肾、清肝明目、滋阴生津功能的药食同源组合物,其特征在于由以下方法制成:
方法一:对原料覆盆子、枸杞子、决明子、山药、玫瑰花、菊花、石斛参分别用粉碎机粉碎并过30-120目筛,将原料投入混合机中混匀5-90分钟,混合均匀后过30-120目筛,加入适合的辅料制得相应的固体制剂;
方法二:将原料覆盆子、枸杞子、决明子、山药、玫瑰花、菊花、石斛分别用粉碎机粉碎并过10-40目筛,加3-20倍量的水,煎煮提取15-180分钟,过滤,滤渣加3-20倍量的水,煎煮提取15-180分钟,过滤,合并两次滤液,干燥,备用;将所有的提取物粉碎,过40-200目筛,混合机混合5-90分钟,混合均匀后,加入适合的辅料按常规制剂成型方法制备成固体或液体制剂;
方法三:将原料覆盆子、枸杞子、决明子、山药、玫瑰花、菊花、石斛分别用粉碎机粉碎并过10-40目筛,按份称取后,混合,加3-20倍量的水提取15-180分钟,滤过,滤渣加3-20倍量的水,煎煮提取15-180分钟,过滤,合并两次滤液,浓缩,加入适合的辅料按常规制剂成型方法制备成固体或液体制剂。
3.根据权利要求1或2所述的药食同源组合物,其特征在于该组合物具有滋补肝肾、清肝明目、滋阴生津的功效,用于肝肾不足,阴虚火旺或用眼过度所致的视物模糊、眼睛干涩、眼睛红痒痛、有异物感、分泌物黏稠、见风流泪、眼睛干痒、眼睛易疲劳等症,可用于干眼症的辅助治疗,该组合物中的各味药材均为既是食品又是药材的药食同源品种,可长期食用。
4.根据权利要求1或2所述的药食同源组合物,其特征在于:可以制成固体制剂如片剂、胶囊剂、颗粒剂、丸剂、散剂的剂型;可以制成液体制剂如饮料、糖浆剂、合剂。
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