CN107334868A - 一种治疗干眼症的中药组合物、制剂及其制备方法 - Google Patents
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Abstract
本发明涉及一种治疗干眼症的中药组合物、制剂及其制备方法,它是以枸杞、青葙子、决明子、五味子、桑椹、菊花、西洋参、黄芪、桑叶、冰片为原料,经过各种制备工艺制成制剂。本发明的中药组合物具有补益肝肾、清肝明目、清热解毒、滋阴润燥、补益气血、活血健脾,增加眼睛润泽,改善眼睛干涩、畏光、视力模糊的作用,对干眼症有良好的疗效。临床和药理实验观察未发现毒副作用,具有广泛的推广应用前景。
Description
技术领域
本发明属于中医药技术领域,是一种治疗干眼症的中医药技术,特别是指一种治疗干眼症的中药组合物、制剂及其制备方法。
背景技术
干眼症是现代人眼科最常见的疾病之一,指的是泪液层不稳定,患者会有异物感、干涩、畏光或疼痛感的症状出现。因为现代人长期待在有中央空调的空间当中,空气干燥、湿度降低、泪液蒸发快,再加上计算机的普及、隐形眼镜的风行、药物的滥用等等,的确让干眼症成为一种现代人的流行文明病。干眼症易导致眼睑、结膜发炎及角膜发炎,造成生活工作上的不便;严重者可能会导致角膜破损受伤或感染,甚至不可逆的视力损伤;而针对睑板腺功能异常的患者,若不及早治疗也会造成管腺萎缩甚至完全消失,一旦严重萎缩时再积极治疗也不可逆了。因此干眼症的治疗方法越来越受到各界的关注和重视,但目前为止尚无满意的治疗手段。传统的西医治疗效果不佳,且反复复发,而中医中药对干眼症治疗上有其特有的优势。
现代的人工作压力大,工作时间长,熬夜,喜欢吃烧烤油炸辣物,还有许多人沉溺在电视、计算机、手机等3C产品,导致眼球老化退化、泪腺萎缩、内分泌失调、停经、失眠等,进而引发干眼症。干眼症可分为原发性及续发性两种:原发性指的是先天泪腺功能不足及年纪大、泪腺功能降低;续发性则是病人本身可能有其他原因引发干眼症,譬如自体免疫疾病引起的干燥症,泪腺肿瘤、外伤及慢性结膜炎等。但大部分病人属于原发性,简单的说,就是泪液分泌不足。
干眼症的治疗目的主要在于改善眼睛干涩,容易疲劳,眼睛红、痒、酸,有异物感、灼热感、刺痛,感受到刺激(如风、烟、光线)时会有短暂视力模糊,眼内角或四周有黏稠的分泌物的状况。
目前常被用于治疗干眼症的西医疗法大多是给予人工泪液或在角膜表面使用外用药物,不过这些治疗方式只能改善部分干眼症症状,使干涩的眼睛得到暂时的舒缓,药一停又复发,很多患者还是不断出现眼睛痛或其他部位疼痛症状,治标不治本,反而增加眼睛的负担。并且许多眼药水中含有“可的松”成分,长期使用会造成“青光眼”或“白内障”。至于泪小管手术,则可能造成泪管不通,且泪小管或泪囊内易因细菌囤积而引起泪囊炎,以致于需动手术做泪囊蓄脓之引流,增加感染的风险。
尽管西医在干眼症治疗上取得了重要进展,但因为症状容易反复发作或有副作用,中医界主动开始了对干眼症发生因素的探索。
目前大部分研究者都认为干眼症是由老化或起居饮食压力环境诸因素,造成肺、脾、胃、肝、肾等脏腑亏虚,甚至免疫失调,导致泪腺机能失常或邪毒留恋体内而发生的。因此治疗之道,唯有透过恢复脏腑功能或调整免疫机制之药物,才能有效地缓解或改善它的症状。
中医认为干眼症易发生于风热外袭、肺火壅盛、阴虚火旺、脾失健运等等,以及常常发生的眼疾如慢性结膜炎、结膜干燥症、视疲劳、泪腺萎缩、浅层点状角膜炎等情形。
中医药在干眼症的防治中,除了具有改善症状等作用外,对于因自体免疫疾病引起的干眼症治疗已经得到公认。对于改善症状和生活质量,更是优势明显。西医药疗法已经不能满足患者的需要,而中医药治疗干眼症却具有其独特的优势和方法,并且具有广阔的发展前景。
中医药治疗干眼症有其自身的优势,主要体现在以下几个方面:
1、调养脏腑的作用,包括改善症状,改善眼睛功能,调整患者的自体免疫功能,缓解双眼干涩少泪和灼热异物感,以及防止角膜受损导致视力渐减等。
2、西医认为不宜或治疗失败的干眼症患者,如续发性患者由其它原因引发的干眼症,药物治疗失败者,或因自体免疫疾病引起的干眼症患者等,采用中医药治疗能收到一定效果。
3、副作用相对较少,患者依从性和耐受性较好。
4、医疗费用相对较低。
总之,中药在治疗干眼症方面有较大的潜力。在长期的临床治疗中,中药汤剂治疗干眼症疗效好,但因其携带不方便,患者难以坚持服用。鉴于以上情况,寻找一种吸收快、起效迅速、并让患者容易坚持服用的剂型,是本领域迫切研究的方向。
发明内容
本发明的目的是提供一种治疗干眼症的中药组合物,以补益肝肾、清肝明目、清热解毒、滋阴润燥、益气生津为基本治疗法的治疗干眼症的中药复方制剂。
本发明是通过以下技术方案实现的:
一种治疗慢性干眼症的中药组合物,其原料由枸杞、青葙子、决明子、五味子、桑椹、菊花、西洋参、黄芪、桑叶及冰片组成;且其原料按重量份数配比分别为:枸杞10-30份、青葙子6-25份、决明子6-30份、五味子8-25份、桑椹10-30份、菊花6-30份、西洋参6-10份、黄芪15-20份、桑叶10-30份及冰片0.01-0.05份。
进一步的,所述菊花为白菊花;所述黄芪为炙黄芪。
进一步的,所述治疗干眼症的中药组合物,其原料按重量份数配比优选为:枸杞15-25份、青葙子10-20份、决明子10-23份、五味子10-25份、桑椹12-25份、菊花10-23份、西洋参8-10份、黄芪15-25份、桑叶10-20份及冰片0.02-0.05份。
进一步的,所述治疗干眼症的中药组合物,其原料按重量份数配比更优选为:枸杞20份、青葙子15份、决明子15份、五味子12份、桑椹20份、菊花15份、西洋参6份、黄芪20份、桑叶12份及冰片0.05份。
一种治疗干眼症的中药制剂,采用如上述任一项中药组合物,将其制成任何一种药剂学上的剂型的药剂;或在加入辅料后将其制成任何一种药剂学上的剂型的药剂。
一种治疗干眼症的中药制剂,采用如上述任一项中药组合物,将其提取剂制成任何一种药剂学上的剂型的药剂;或提取剂在加入辅料后将其制成任何一种药剂学上的剂型的药剂。
所述药剂是丸剂、散剂、片剂、膏剂、水剂、针剂、口服液、颗粒或胶囊。
一种治疗干眼症的中药制剂的制备方法,包括以下步骤:
(1)取决明子、西洋参混合,喷入75%酒精适量,密闭闷润灭菌12小时,置鼓风干燥箱中,烘干,粉碎成细粉,过100目筛,得到备用细粉;
(2)取冰片以适量95%乙醇溶解,备用;
(3)将枸杞、青葙子、五味子、桑葚、菊花、黄芪及桑叶加水煎煮后得到煎煮液;煎煮液过滤,合并滤液,减压浓缩;
(4)所述煎煮液浓缩至稠膏;将所述稠膏与所述备用细粉混合,经过干燥、过筛后得到筛上部分及筛下部分;将所述筛下部分喷入所述冰片乙醇溶液后混匀,再与所述筛上物混匀,密闭30分钟,得到复方制剂。
进一步的,所述水煎煮共分为三次煎煮,其中第一次煎煮时间与第二次煎煮时间相同,但大于第三次煎煮时间;三次煎煮所得到的煎煮液混合;干燥温度控制在60~80℃。
本发明的技术方案是基于祖国医学对“白涩症”、“干涩昏花症”、“神水枯瘁”及“神水将枯症”辨证施治的理论。中医理论认为,黑睛属风轮,在脏为肝,肝开窍于目,泪为肝之液;肝藏血,津血同源,生理上相互补充,病理上相互影响,阴血不足则津液无以化生,故两目干涩。隋·巢元方《诸病源侯论》专设“目涩候”,分析了其致病原因,“目,肝之外候也……上液之道……其液竭者,则目涩。”提出目涩与泪液不足相关。明·王肯堂《证治准绳》在目疾的分类中提出白眼痛、干涩昏花症和神水将枯症,与现代干眼症的症状描述基本接近。
“白涩症”,指的是白睛无红赤,但觉干涩不适,病因大致可分为素体阴虚劳倦、湿热内蕴或风热外袭等。如《审视瑶函·神水将枯症》曰:“此症视珠外神水枯涩而不润莹。”本病的形成多因年老体衰,肝肾亏损,阴精不足;或脾虚,气血生化不足,目失濡养所致。此外,邪毒客于睑络,灼伤络脉,或外伤酸咸烧伤等,使组织受损,津液不生也是形成本病的主因之一。
《黄帝内经》中有许多肝之机能与眼睛相关的记载、《金匮真言论》所言:“开窍于目、藏精于肝”,亦指眼睛所需的能量主要来自于肝。《灵枢·五癃津液别》:“五脏六腑之津液尽上渗于目。”《灵枢·大惑论》言:“五脏六腑之精气皆上注于目而为之精。”
中医认为本病与肺、肝、肾关系密切,肝、肾阴虚,肝之阴液不足是其发病主因,肺失宣降、燥伤肺阴而不能上荣于目是其发病的重要诱发因素。从肺、肝、肾辨证施治入手,全身调节加局部强化,内服外用相结合,以滋阴润燥、益气生津、提高免疫功能为目的。
《素问·五脏生成》又曰:“肝受血而能视”。认为目是肝与外界相通的窍道,目以血为本,肝血的盛衰直接影响视觉功能状态,所谓“肝受血而能视”。
《素问·宣明五气》云:“五脏化液,肝为泪”;《银海精微》云:“泪乃肝之液”。此外,肝主疏泄,调畅气机,气机条达,则经脉通利,气血精微上达,目得所养,实现“肝气通于目,肝气和则目能辨五色矣”。
肝肾不足、风热外袭、肝血不足所致眼干涩,异物感,时有羞明畏光,白睛隐隐淡红,刺痛,视物模糊,久视则诸症加重。干眼症后期视力锐减,角膜受损,甚至失明。从临床上看,肝肾亏损,阴血不足,必然目失濡养。中医有所谓五脏六腑之精气,皆上注于目而为之精,其中以肝肾最为重要。肾主津液,主全身体液的代谢和分布;肝开窍于目且泪为肝之液,眼睛需要肝血的濡养才能正常运作。
蒸散过多和现代人长时间使用3C产品有关,眨眼次数减少,泪液自然来不及敷布眼球。用眼过度会影响眼周的血液循环,代谢废物增加也会使眼睛产生干涩感。
肝开窍于目,泪为肝之液;阴血不足则津液无以化生,故两目干涩,这是导致干眼症的最重要的病机。而且阴津枯竭,气阴亏虚,则干燥导致反复炎症,角膜遭到破坏,角膜透明度逐渐降低,最终导致失明。
参考现代药理研究成就,采用了有补益肝肾、清肝明目、清热解毒、滋阴润燥、补益气血法、活血健脾之法,科学配伍,筛选出以下复方。处方以枸杞、青葙子、决明子、菊花清肝泻火,补肝肾,养血明目为君药,抗炎、改善眼睛干涩、眼睛痒和角膜炎的作用,防止角膜破损受伤,继而影响视力。辅以五味子、桑椹、黄芪为臣药,增强补肝益肾、益气健脾、平肝明目之功效。西洋参、桑叶、冰片益气养阴,疏风清热止痛为辅佐药,减轻红、酸、痒,感觉有异物感、刺痛感、灼热感。增加眼睛润泽功能。使以改善眼睛干涩,眵黏稠微黄,畏光,视力模糊。
干眼症病情反复复发、迁延不愈,方中重用清肝泻火,益气养阴,补肝益肾,养血明目药物。可抑制眼干涩畏光,双目频眨,可抑制刺痛感、灼热感;有利于调整体质,使人体的泪腺恢复正常分泌的功能;可增加眼部新陈代谢,促进血液循环,能有利于明目益视。全方贯穿清肝泻火,补肝肾,袪风明目、益气健脾、益气养阴、疏风清热之法,以防止病情加速恶化。
本发明的治疗干眼症的药物中,以枸杞养阴补血,益精明目,用于肝血不足、肾阴亏虚之患者,《药性论》载:"补益精诸不足,明目安神。"今之药理研究,枸杞富含胡萝卜素(玉米质素Zeaxanthin)、维生素B1、B2、D、E,其中胡萝卜素的含量最高,具有保护眼睛的功能。
决明子苦寒泻热、甘咸益阴,既能清泻肝火、又兼益肾阴。肝开窍于目,瞳子属肾,故为明目佳品。《神农本草经》中即有记载:“决明子治青盲目淫,眼赤泪出,久服益精光。”是我国药学史上最早的眼科专用药之一,历代医家都把它作为明目的要药。现代药理研究证明,决明子所含的有效成分具有调节免疫、抑菌及明目通便等作用。
青葙子,又名草决明,味苦、性凉,入肝经,具有清肝明目、清热燥湿、祛除风热的功效,临床用于治疗眩晕、目赤、目干涩等。《本经逢原》:“青葙子,治风热目疾,与决明子功同……其治风瘙身痒,皮肤中热,以能散厥阴经中血脉之风热也。”《本草正义》:“青葙,即鸡冠花之同类。其子苦寒滑利,善涤郁热,故目科风热肝火诸症统以治之。”
五味子具有敛肺滋肾,涩精止泻,生津敛汗,宁心安神之功效。五味子性味酸、温,酸能收敛、性温而润,归肺、肾、心三经。
菊花味辛清香质轻,性能发散。其性味苦寒,长于清热,入于肝经能清肝明目,用于多种目疾。治疗肝经风热或肝火上攻目赤肿痛。《本草纲目》中对菊花茶的药效也有详细的记载:性甘、微寒,具有散风热、平肝明目之功效。
桑叶味甘,苦,性寒,归肺,肝经。能疏散风热,清肺润燥,平抑肝阳,清肝明目。《本草衍义》:“清肺泻胃,凉血燥湿,去风明目。”《神农本草经》称桑叶为“神仙叶”,具有滋阴补血,疏散风热,益肝通气,降压利尿之功效。《本草纲目》记载:桑叶乃手足阳明之药,汁煎代苦,能止消渴,明目长发。桑叶不仅能降低眼部的发炎反应,最重要的是,还有调理肝脾的效果。而肝经与眼睛功能有关,对于眼睛周遭血管神经也有一定的保护作用。
桑葚味甘酸,性微寒,入心、肝、肾经,具有补益肝肾,滋阴养血,清肝明目,改善睡眠,提高人体免疫力。《滇南本草》:“桑葚益肾而固精,久服黑发明日。”《本草疏经》载“桑葚,甘寒益血而除热,为凉血补血益阴之药”。中医认为,桑葚性味甘寒,具有补肝益肾、生津润肠、乌发明目等功效。《随息居饮食谱》载桑葚“滋肝肾,充血液,祛风湿,健步履,息虚风,清虚火。”用于治肝肾阴亏之眩晕、目暗耳鸣、须发早白、津伤口渴、肠燥便秘。
西洋参、黄芪,可补气养阴、清火、养胃生津,升提清气等。西洋参益精养血与促进造血,中医认为,肾藏精,精能生随,精随可以化而为血。《读医随笔.气血精神论》:“夫血者,水谷之精微,得命门真火蒸化。”故有血之源头在于肾之说。中医认为,气者,人之根本也。《医权初编》:“人之生死,全赖乎气。气聚则生,气壮则康,气衰则弱,气散则死。”气是维持人体生命活动的物质基础,能激发和促进各脏腑,经络等组织器官的生理功能。《医编.气》:“气根于肾,亦归于肾,故曰肾纳气,其息深深。”西洋参大补元气,肾气充沛,摄纳正常,正气存内,邪不可干。西洋参最主要的功能在于调整免疫系统,黄芪本身具有养血的功效,而且通过补气的作用又有助于生血。中医曰:气能生血,气能行血。气能生血是指气的运动变化是血液生成的动力,气的运动变化能力旺盛,则脏腑的功能活动旺盛,化生血液的功能亦强;气的运动变化能力减弱,则脏腑功能活动衰退。气能行血指气的推动作用是血液循行的动力,又可促进脏腑的功能活动,通过脏腑的功能活动推动血液运行。故在治疗干眼症方药中配合补气药,以补益生血的动力,改善血虚弱证候而达到明目作用的治法。
冰片味辛、苦,入心、脾、肺经。性微寒,具有清热止痛、消肿之功,以改善目赤肿痛。《新修本草》:“主心腹邪气,风湿积聚,耳聋,明目,去目赤肤翳。”《唐本草》:“主心腹邪气,风湿积聚,耳聋。明目,去目赤肤翳。”《海药本草》:“主内外障眼,三虫,治五痔,明目,镇心,秘精。”
患病日久,眼球過度乾燥,角膜容易受傷,故以补肝益肾,滋阴养血,疏风清热,以防止病情加速恶化。
本发明所有原料的来源没有特殊限制,为市售即可。其中,枸杞、青葙子、决明子、五味子、桑椹、菊花、西洋参、黄芪、桑叶及冰片均同上所述,在此不再赘述。
本发明治疗干眼症的中药复方制剂各原料功能主治如下:
一、枸杞
本品为茄科植物宁夏枸杞Lycium barbarum L.的干燥成熟果实。夏、秋二季果实呈红色时采收,热风烘干,除去果梗。或晾至皮皱后,晒干,除去果梗。味甘,性平。归肝、肾经。具有滋补肝肾,益精明目的功效。用于虚劳精亏,腰膝酸痛,眩晕耳鸣,内热消渴,血虚萎黄,目昏不明。宁夏枸杞的成熟果实含甜菜碱(betane),阿托品(aTCMLIBopine),天仙子胺(gyoscyamine),又含玉蜀黍黄质,酸浆果红素,隐黄质(cryptosxanthin),东莨菪素(scopo-letin),胡萝卜素,硫胺素,核黄素,烟酸,维生素C。
药理作用:
对脾脏的作用
枸杞多糖(LBP)在5.20mg/(kg/天)×7天可显着增高脾PFC数,5mg/kg剂量可使PFC数达正常免疫对照组的1.4倍。而25.50mg/kg时,则见PFC数明显降低,其中25mg/kg组PFC数为正常对照组的43%。表明LBP对抗体形成细胞数的增强效果有适宜的剂量范围。采用超适量SRBC免疫(SOI)诱导Ts细胞法观察到,供体小鼠脾细胞中Ts细胞可使正常免疫小鼠的PFC数抑制63%,表明SOI法可以诱导出对抗体生成细胞产生显着抑制作用的Ts细胞。给予供体鼠LBP5mg/(kg.天)×7天后,受体鼠PFC数比SOI对照组显着下降,说明此剂量对Ts细胞功能有增强作用。当剂量增加到25、50mg/kg时,LBP对Ts细胞功能的增强作用明显下降。
二、黄芪
本品为豆科植物蒙古黄芪Astragalus membranaceus(Fisch.)Bge.var.mongholicus(Bge.)Hsiao或膜荚黄芪Astragalus membranaceus(Fisch.)Bge.的干燥根。春、秋二季采挖,除去须根及根头,晒干。味甘,性温。归肺、脾经。具有补气固表,利尿托毒,排脓,敛疮生肌的功效。用于气虚乏力,食少便溏,中气下陷,久泻脱肛,便血崩漏,表虚自汗,气虚水肿,痈疽难溃,久溃不敛,血虚痿黄,内热消渴;慢性肾炎蛋白尿,糖尿病。膜荚黄芪根含2’,4’二羟基-5,6-二甲氧基异黄酮(2’,4’-dihydroxy-5,6-dimethoxyisoflavone)、胆碱(choline)、甜菜碱(betaine)、氨基酸、蔗糖、葡萄糖醛酸及微量的叶酸。内蒙古黄芪根含β-谷甾醇、亚油酸及亚麻酸。
药理作用:
对脾胃的作用
黄芪能改善脾虚型IBS模型大鼠的胃肠推进功能,增加大鼠十二指肠最大收缩力和最小舒张力,使收缩幅度减少,频率减慢。黄芪对大鼠胃肠动力异常有调节作用。黄芪多糖粉针剂(APS-P)能够有效地促进化疗后小鼠免疫系统功能的恢复,增加化疗后BALB/c小鼠脾细胞分泌细胞因子的能力,对正常小鼠分泌细胞因子有一定的调节作用,并能增进S-180荷瘤小鼠NK细胞的杀伤能力。黄芪多糖(100μg/mL)能引起小鼠脾淋巴细胞蛋白激酶C(PKC)活性明显升高,提示APS的免疫增强作用与升高脾淋巴细胞蛋白激酶活性有关。黄芪多糖对丝裂霉素C(MMC)引起骨髓抑制小鼠有促进骨髓和脾脏造血祖细胞的增殖和成熟的作用。黄芪对脾脏的损伤有修复和促再生作用。黄芪95%乙醇提取物较其不同极性提取部位具有较强的抗胃溃疡作用,通过HPLC指纹图谱与药效相关性分析可知黄芪抗胃溃疡作用与其所含的多种成分有关。对于胃癌前病变患者,黄芪治疗疗效显著,并且复发率低,值得临床广泛推广。黄芪治疗胃溃疡的作用机理可能是通过促进EGF、EGFR的表达,使胃黏膜上皮组织、腺体结构较好地修复和重建,从而促进溃疡愈合并且提高溃疡愈合质量。
三、青葙子
本品为苋科青葙属植物青葙Celosia argentea L.的种子,其茎、叶、花序亦入药。味苦,微寒。入肝经,具有清肝明目,清热燥湿,祛除风热的功效等。临床用于治疗眩晕、目赤、目干涩等。青葙子含β-谷甾醇、棕榈酸胆甾烯酯(cholesterylpalmitatie)、对羟基苯甲酸(p-hydroxylbenzoic acid)、3,4-二羟基苯甲醛(3,4-dihydroxylbenzaldehyde)、3,4-二羟基苯甲酸(3,4-dihydroxybenzoicacid)、正丁基-β-D-果糖苷(n-butyl-β-D-frucoseglycoside)及蔗糖。种子含脂肪油为青葙子油脂(celosiaol),并含烟酸及硝酸钾等。
药理作用:
对眼睛的作用
增强晶状体的抗氧化能力,防护晶状体的氧化损伤,黄秀榕等将由Fenton反应所引起新西兰白兔晶状体氧化损伤模型与青葙子水提液孵育后,晶状体的混浊程度明显减轻且效果明显优于传统抗白内障药物吡诺克辛钠(PS)滴眼液;且青葙子SOD、GSH-Px和GSH含量显著高于Fenton模型组及PS组。表明其能增强晶状体的抗氧化能力,防护晶状体的氧化损伤。
四、决明子
本品为为豆科草本植物決明或小決明的成熟种子,味苦、甘、咸,微寒,入肝、肾、大肠经。有清肝火、祛风湿、益肾明目,利水通便等作用。主治目赤肿痛,羞明泪多,青盲,雀目,头痛头晕,视物昏暗,肝硬化腹水,小便不利,习惯性便秘,外治肿毒、癣疾等。现代研究表明,决明子除含有糖类、蛋白质、脂肪外,还含甾体化合物、蒽醌类化合物如大黄酚、大黄素等,还有人体必需的微量元素铁、锌、锰、铜、镍、钴、钼等。有平喘、利胆、保肝、降压、降脂等作用,并有一定抗菌、消炎,降血压和强心作用。对人体新陈代谢、中枢神经和血液循环也都有影响。
药理作用:
对免疫功能的影响
煎醇沉剂15g/kg皮下注射可使小鼠胸腺萎缩,外周血淋巴细胞ANAE染色阴性率明显降低,使2,4-二硝基氯苯(DNCB)所致小鼠皮肤迟发型超敏反应受抑,但对血清溶血素形成无明显影响。另外决明子水煎醇沉剂可使小鼠腹腔巨噬细胞吞噬鸡红细胞百分率和吞噬指数明显增高,溶菌酶水平也明显高于对照组。
五、五味子
本品为木兰科多年生落叶木质藤本植物北五味子Schisandra chinensis(Turcz)Baill.和南五味子Schisandra sphenanthera Rehd.Et Wils.的成熟果实。北五味子为传统使用的正品。味酸,温。归肺、肾、心经。具有敛肺滋肾,涩精止泻,生津敛汗,宁心安神。本品酸能收敛,性温而润,归肺、肾、心三经。果实种子内含挥发油,五味子素,去羟基五味子素,五味子醇,苹果酸,柠檬酸,酒石酸,糖类,树脂,维生素C。
药理作用:
对中枢神经系统的作用
五味子素有广泛的中枢抑制作用,并且有安定作用的特点。五味子醇提取物5-10mg/kg灌胃可减少小鼠自发活动,协同戊巴比妥钠对小鼠的睡眠作用,对抗苯丙胺引起的小鼠兴奋,对抗咖啡因、烟碱引起的小鼠惊厥。五味子素(五味子醇甲)10~100mg/kg腹腔注射,随剂量的增加而减少小鼠自发活动,10mg/kg腹腔注射对抗咖啡因、苯丙胺引起的小鼠兴奋;60~120mg/kg腹腔注射明显延长小鼠巴比妥钠及戊巴比妥钠引起的小鼠睡眠时间;对抗电休克、戊四唑等引起的惊厥。五味子素有广泛的中枢抑制作用,并且有安定作用的特点。
对免疫功能的作用
能增强机体对非特异性刺激的防御能力。
六、桑葚
本品为桑科落叶乔木桑树的成熟果实,于果实红熟时采收,晒干或生用、或加蜜熬膏用。桑葚味甘、酸,性寒。能滋补肝肾、补血养颜、生津止渴。可用于肝肾阴亏、腰膝酸软、目暗耳鸣、关节不利、津亏血少、口渴烦热、肠燥便秘等症。它含有丰富的活性蛋白、维生素、氨基酸、胡萝卜素、矿物质、葡萄糖、蔗糖、果糖、鞣质、苹果酸、钙、维生素B1、维生素B2、维生素C、尼克酸等成分。
药理作用:
1.桑葚有中度促进淋巴细胞转化的作用,可促使T淋巴细胞成熟,从而使衰老的T细胞得到恢复;2.桑葚对体液免疫功能有促进作用;3.桑葚能降低细胞膜上Na-K-ATP酶活性,可能是其滋阴作用机制。
七、菊花
本品为菊科植物菊(Chrysanthemun morifolium Ra-mat)的干燥头状花序,为多年生草本,性味甘苦,凉。具有疏风、清热、明目、解毒的功效,主治头痛、眩晕、目赤、心胸烦热、疔疮、肿毒。现代药理分析表明,菊花里含有丰富的维生素A,是维护眼睛健康的重要物质。
白菊花:味甘、清热力稍弱,常用于平肝明目,含氨基酸等成分,有抗病毒、增强毛细血管抵抗力的作用,对于视力下降和头昏头痛有很好的效果。
现代医学研究证明,菊花含菊甙、腺嘌呤、氨基酸、胆碱、水苏碱、黄酮类及维生素B1,对葡萄球菌、绿脓杆菌、结核杆菌、痢疾杆菌、流感病毒及皮肤真菌等均有抑制作用。
八、桑叶
桑叶始载于《神农本草经》,为桑科植物Morus alba L.的干燥叶.本品性寒、味甘苦,归肺、肝经,具有疏散风热、清肺润燥、清肝明目的功能,是常用中药之一。
现代药理研究证明桑叶具有降血糖、降血压、抗菌和抗病毒等多种药理活性。
九、西洋参
本品为五加科植物西洋参Panax quinquefoliumL的根。又名美国参、花旗参、洋参、广东参。主产于美国、加拿大。其味甘、微苦、性凉。为气血双补清凉之品。归肺、心、肾、脾经。具有补气养阴、清热生津、宁神益智的功效。西洋参成分有皂苷类、挥发油类、氨基酸类、聚炔类、脂肪酸类、糖类、酶类、黄酮类等,经研究证明西洋参的主要活性成分是人参皂苷。可提高免疫力,可以促进血清蛋白合成、骨髓蛋白合成,器官蛋白合成,提高机体免疫力,抑制癌细胞生长。
十、冰片
本品为龙脑香料乔木植物龙脑香Dryobalanops aromatica Gaertn.f.树脂的加工品,或龙脑香的树干经蒸馏冷却而得的结晶,称“龙脑冰片”,亦称“梅片”。由菊科多年生草本植物艾纳香(大风艾)Blumea balsamifera DC.的叶,经蒸馏、升华劈削而成的加工品,称“艾纳香”、“艾片”。现多用松节油、樟脑等用化学合成法加工所得物,称“机制冰片”。冰片性微寒;味辛、苦;归心、脾、肺经。有清热止痛、消肿之功,为五官科常用药。龙脑冰片含右旋龙脑,又含葎草烯、β-榄香烯、石竹烯等倍半萜,以及齐墩果酸、麦珠子酸、龙脑香醇等。现代研究它局部用有凉爽感,且能抑菌、防腐、消炎、有清热效果,有良好的止痛效果。
药理作用:
1.透皮吸收作用。龙脑是一种有效的透皮促进剂,可促进外用皮质激素、双氯灭痛等药的透皮吸收;2.药物透过眼角膜,提高眼部用药的生物利用度;3.药物透过鼻黏膜,提高药物经鼻腔吸收入脑的速度,增加了脑组织药物的吸收量,是治疗缺血性脑血管机能不全急性期的一种速效途径。
本申请治疗干眼症的中药组合物在制备方法上,可以依据传统中药的制备方法,也可以采用现技术的制备方法,通过上述任一种方法制备的药剂的剂型均具有治疗干眼症的作用,具体到采用何种制备方法,需要综合考虑生产规模,及最终用药人群的需要,并重点考虑到用药人群的用药习惯及是否便利性。药剂的类型可以包括药剂学上的任何一种剂型,比如丸剂、散剂、片剂、膏剂、颗粒或胶囊等,还或者该中药组合物的提取物制备的水剂、针剂及口服液等。
具体实施方式
以下通过实施例来详细说明本发明的技术方案,以下的实施例仅是示例性的,仅能用来解释和说明本发明的技术方案,而不能解释为是对本发明技术方案的限制。
实施例1
一种治疗干眼症的中药组合物,其原料按重量份数配比分别为:枸杞10份、青葙子6份、决明子6份、五味子8份、桑椹10份、菊花6份、西洋参6份、黄芪15份、桑叶10份及冰片0.01份。
在本实施例中,以制备胶囊为例以说明具体制备方法:
取决明子、西洋参混合,喷入75%酒精适量,密闭闷润灭菌12小时,置鼓风干燥箱中,60℃烘干,粉碎成细粉,过100目筛,得到备用细粉;
取冰片以适量95%乙醇溶解,备用;
将枸杞、青葙子、五味子、桑葚、菊花、黄芪及桑叶加水煎煮后得到煎煮液;本实施例中,加水煎煮三次,第一次煎煮和第二次煎煮均为2小时,第三次煎煮1小时,将三次煎煮的药液合并然后过滤。
所述煎煮液减压浓缩至相对密度为1.15~1.20(60℃)的稠膏;将所述稠膏与所述备用细粉混合,经过干燥、过筛后得到筛上部分及筛下部分;将所述筛下部分喷入所述冰片乙醇溶液后混匀,再与所述筛上物混匀,密封30分钟,得到复方制剂,然后装入胶囊。
实施例2
一种治疗干眼症的中药组合物,其原料按重量份数配比分别为:枸杞30份、青葙子25份、决明子30份、五味子25份、桑椹30份、菊花30份、西洋参10份、黄芪20份、桑叶30份及冰片0.05份。
在本实施例中,以制备胶囊为例以说明具体制备方法:
取决明子、西洋参混合,喷入75%酒精适量,密闭闷润灭菌12小时,置鼓风干燥箱中,60℃烘干,粉碎成细粉,过100目筛,得到备用细粉;
取冰片以适量95%乙醇溶解,备用;
将枸杞、青葙子、五味子、桑葚、菊花、黄芪及桑叶加水煎煮后得到煎煮液;本实施例中,加水煎煮三次,第一次煎煮和第二次煎煮均为2小时,第三次煎煮1小时,将三次煎煮的药液合并然后过滤。
所述煎煮液减压浓缩至相对密度为1.15~1.20(60℃)的稠膏;将所述稠膏与所述备用细粉混合,经过干燥、过筛后得到筛上部分及筛下部分;将所述筛下部分喷入所述冰片乙醇溶液后混匀,再与所述筛上物混匀,密封30分钟,得到复方制剂,然后装入胶囊。
实施例3
一种治疗干眼症的中药组合物,其原料按重量份数配比分别为:枸杞15份、青葙子10份、决明子15份、五味子12份、桑椹15份、菊花20份、西洋参8份、黄芪15份、桑叶18份及冰片0.02份。
在本实施例中,以制备胶囊为例以说明具体制备方法:
取决明子、西洋参混合,喷入75%酒精适量,密闭闷润灭菌12小时,置鼓风干燥箱中,60℃烘干,粉碎成细粉,过100目筛,得到备用细粉;
取冰片以适量95%乙醇溶解,备用;
将枸杞、青葙子、五味子、桑葚、菊花、黄芪及桑叶加水煎煮后得到煎煮液;本实施例中,加水煎煮三次,第一次煎煮和第二次煎煮均为2小时,第三次煎煮1小时,将三次煎煮的药液合并然后过滤。
所述煎煮液减压浓缩至相对密度为1.15~1.20(60℃)的稠膏;将所述稠膏与所述备用细粉混合,经过干燥、过筛后得到筛上部分及筛下部分;将所述筛下部分喷入所述冰片乙醇溶液后混匀,再与所述筛上物混匀,密封30分钟,得到复方制剂,然后装入胶囊。
实施例4
一种治疗干眼症的中药组合物,其原料按重量份数配比分别为:枸杞20份、青葙子15份、决明子15份、五味子12份、桑椹20份、菊花15份、西洋参6份、黄芪20份、桑叶12份及冰片0.05份。
在本实施例中,以制备胶囊为例以说明具体制备方法:
取决明子、西洋参混合,喷入75%酒精适量,密闭闷润灭菌12小时,置鼓风干燥箱中,60℃烘干,粉碎成细粉,过100目筛,得到备用细粉;
取冰片以适量95%乙醇溶解,备用;
将枸杞、青葙子、五味子、桑葚、菊花、黄芪及桑叶加水煎煮后得到煎煮液;本实施例中,加水煎煮三次,第一次煎煮和第二次煎煮均为2小时,第三次煎煮1小时,将三次煎煮的药液合并然后过滤。
所述煎煮液减压浓缩至相对密度为1.15~1.20(60℃)的稠膏;将所述稠膏与所述备用细粉混合,经过干燥、过筛后得到筛上部分及筛下部分;将所述筛下部分喷入所述冰片乙醇溶液后混匀,再与所述筛上物混匀,密封30分钟,得到复方制剂,然后装入胶囊。
实施例5
一种治疗干眼症的中药组合物,其原料按重量份数配比分别为:枸杞20份、青葙子15份、决明子20份、五味子15份、桑椹20份、菊花15份、西洋参6份、黄芪20份、桑叶20份及冰片0.02份。
在本实施例中,将上述各组份经过二次水煎煮,第一次煎煮入第二次煎煮时间为2-4小时,第三次煎煮时间为1-2小时,合并三次煎煮液加入辅料经过浓缩、干燥后,根据需要制备成散剂或粉剂。在本实施例中,辅料使用的焦糖或糊精。
实施例6
一种治疗干眼症的中药组合物,其原料按重量份数配比分别为:枸杞18份、青葙子12份、决明子15份、五味子15份、桑椹15份、菊花15份、西洋参6份、黄芪16份、桑叶15份及冰片0.01份。
在本实施例中,将取决明子、西洋参混合,喷入75%酒精适量,密闭闷润灭菌12小时,置鼓风干燥箱中,烘干,粉碎成细粉,过100目筛,得到备用细粉;
将余下组份经过三次水煎煮,第一次煎煮入第二次煎煮时间为2-4小时,第三次煎煮时间为1-2小时,合并三次煎煮液加入辅料经过浓缩、混入备用细粉及辅料,制备成颗粒,干燥后,根据需要制备成颗粒、散剂或粉剂。在本实施例中,辅料使用的焦糖或糊精。
实施例7
一种治疗干眼症的中药组合物,其原料按重量份数配比分别为:枸杞20份、青葙子15份、决明子15份、五味子12份、桑椹20份、菊花15份、西洋参6份、黄芪20份、桑叶12份及冰片0.05份。
本申请的中药组合物在其制备方法上,可以依据传统中药的制备方法,也可以采用现技术的制备方法;具体到采用何种制备方法,需要综合考虑生产规模,及最终用药人群的需要,并重点考虑到用药人群的用药习惯及是否便利。药剂的类型可以包括药剂学上的任何一种剂型,比如丸剂、散剂、片剂、膏剂、颗粒或胶囊等,还或者该中药组合物的提取物制备的水剂、针剂及口服液等。
本中药组合物或者提取物均可以加入辅料后再制备成丸剂、散剂、片剂、膏剂、颗粒或胶囊以及水剂、针剂及口服液。
在本申请中药组合物的各实施例中,辅料为现用药剂所常用的辅料,还可以根据需要使用无糖型辅料或有糖型辅料。
本实施例以制备提及剂为例进行说明,将上述各组份通过溶剂提及得到提取液,再将各提取液经过萃取等步骤得到萃取液,再将各萃取液混合,得到水剂或针剂,或者将混合后的萃取液加入辅料,比如葡萄糖溶液或氯化钠溶液等制备相应的水剂、针剂或口服液。在本实施例中,通过溶液萃取的方式为现有技术,因此,申请人不进行详细的描述。
对于本中药组合物,各组份的比例变化是准许的,均能起到治疗效果,均属于本发明的保护范围。
Claims (9)
1.一种治疗干眼症的中药组合物,由枸杞、青葙子、决明子、五味子、桑椹、菊花、西洋参、黄芪、桑叶及冰片组成,其特征在于:其原料按重量份数配比分别为:枸杞10-30份、青葙子6-25份、决明子6-30份、五味子8-25份、桑椹10-30份、菊花6-30份、西洋参6-10份、黄芪15-20份、桑叶10-30份及冰片0.01-0.05份。
2.根据权利要求1所述的一种治疗干眼症的中药组合物,其特征在于:所述菊花为白菊花,所述黄芪为炙黄芪。
3.根据权利要求2所述的治疗干眼症的中药组合物,其特征在于:其原料按重量份数配比分别为:枸杞15-25份、青葙子10-20份、决明子10-23份、五味子10-25份、桑椹12-25份、菊花10-23份、西洋参8-10份、黄芪15-25份、桑叶10-20份及冰片0.02-0.05份。
4.根据权利要求3所述的治疗干眼症的中药组合物,其特征在于:其原料按重量份数配比分别为:枸杞20份、青葙子15份、决明子15份、五味子12份、桑椹20份、菊花15份、西洋参6份、黄芪20份、桑叶12份及冰片0.05份。
5.一种治疗干眼症的中药制剂,采用如权利要求1至4中任一项中药组合物,其特征在于:将其制成任何一种药剂学上的剂型的药剂;或将其在加入辅料后制成任何一种药剂学上的剂型的药剂。
6.一种治疗干眼症的中药制剂,采用如权利要求1至4中任一项中药组合物,其特征在于:将其提取剂制成任何一种药剂学上的剂型的药剂;或将其提取剂在加入辅料后制成任何一种药剂学上的剂型的药剂。
7.根据权利要求5或6所述的治疗干眼症的中药制剂,其特征在于:所述药剂是丸剂、散剂、片剂、膏剂、水剂、针剂、口服液、颗粒或胶囊。
8.一种治疗干眼症的中药制剂的制备方法,包括以下步骤:
(1)取决明子、西洋参混合,喷入75%酒精适量,密闭闷润灭菌12小时,置鼓风干燥箱中,烘干,粉碎成细粉,过100目筛,得到备用细粉;
(2)取冰片以适量95%乙醇溶解,备用;
(3)将枸杞、青葙子、五味子、桑葚、菊花、黄芪及桑叶加水煎煮后得到煎煮液;煎煮液过滤,合并滤液,减压浓缩;
(4)所述煎煮液浓缩至稠膏;将所述稠膏与所述备用细粉混合,经过干燥、过筛后得到筛上部分及筛下部分;将所述筛下部分喷入所述冰片乙醇溶液后混匀,再与所述筛上物混匀,密闭30分钟,得到复方制剂。
9.根据权利要求8所述的治疗干眼症的中药制剂的制备方法,其特征在于:所述水煎煮共分为三次煎煮,其中第一次煎煮时间与第二次煎煮时间相同,但大于第三次煎煮时间;三次煎煮所得到的煎煮液混合;干燥温度控制在60~80℃。
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CN110960605A (zh) * | 2019-12-27 | 2020-04-07 | 河南爱视力药业有限公司 | 一种护眼中药组合物 |
WO2020143646A1 (en) * | 2019-01-08 | 2020-07-16 | Yunnan Baiaotaike Biotechnology Co, Ltd | Composition for treating dry eye disorders, preparation method and pharmaceutical use thereof |
US10933111B2 (en) | 2019-01-08 | 2021-03-02 | Boston Biotechnology US CORP | Treating dry eye disorders |
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WO2020143646A1 (en) * | 2019-01-08 | 2020-07-16 | Yunnan Baiaotaike Biotechnology Co, Ltd | Composition for treating dry eye disorders, preparation method and pharmaceutical use thereof |
CN112040966A (zh) * | 2019-01-08 | 2020-12-04 | 云南拜奥泰克生物技术有限责任公司 | 治疗干眼症 |
US10933111B2 (en) | 2019-01-08 | 2021-03-02 | Boston Biotechnology US CORP | Treating dry eye disorders |
CN110960605A (zh) * | 2019-12-27 | 2020-04-07 | 河南爱视力药业有限公司 | 一种护眼中药组合物 |
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