CN107837343A - 一种缓解眼疲劳、治疗近视的复方中药组合物及其丸剂的制备方法 - Google Patents
一种缓解眼疲劳、治疗近视的复方中药组合物及其丸剂的制备方法 Download PDFInfo
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Abstract
本发明公开了一种缓解眼疲劳、治疗近视的复方中药组合物及其丸剂的制备方法,所述复方中药组合物由如下重量份的原料组成,50‑55%中药提取物,35‑40%的辅料,5‑10%的复合维生素和1‑3%的微量元素。本发明以中药组合物结合微量元素和维生素,从护肝、强肾、健脾、和胃、养心出发,达到缓解眼疲劳、治疗近视的目的。综合运用中医的协调观、整体观遣方用药,调动五脏的活性,以五脏的活力确保血液供给的充沛,则肝的营养充足,保证眼部的活力充足,即在协调机体全身功能的基础上达到治疗效果,达到缓解眼疲劳、治疗近视的目的。
Description
技术领域
本发明涉及中药领域,特别一种缓解眼疲劳、治疗近视的复方中药组合物及其丸剂的制备方法。
背景技术
随着现代人的工作、学习、生活压力的增大,特别是网络的发达,使大批网民眼睛疲劳不堪、干涩难当,造成视疲劳。视疲劳是目前眼科常见的一种疾病,患者的症状多种多样,常见的有近距离工作不能持久,出现眼及眼眶周围疼痛、视物模糊、眼睛干涩、流泪等,严重者头痛、恶心、眩晕。注意力不集中、记忆力下降、食欲不振、以及颈肩腰背酸痛和指关节麻木等全身症候群,少数患者可出现复视、立体视觉功能障碍、眼压升高、角膜损害等,青少年还可以出现近视眼或加深原有近视程度。有青光眼、眼表面或眼前节疾患者还可因眼的过度疲劳而引发或加重原有眼病。医生一般建议看电脑每一小时休息5分钟,每天两遍做眼保健操。但是,几乎没有年轻网民能做到每小时提醒自己休息远眺。加之生活作息不规律和饮食结构的改变容易导致上火失眠、肝脏负担加重,出现肝血失养、眼睛干涩肿胀、视力下降、视物模糊等眼部不适症状。中医认为肝主目“肝气通于目,肝和则目能辨五色矣”。肝脏的病变往往影响到眼睛。如肝血不足,则双目干涩,视物不清或者夜盲:肝经风热,可见目赤痒痛:肝火上炎,可见目赤生翳;肝阳上亢,则头目眩晕;肝风内动,可见目斜上视等。因此目与肝息息相关。
滴眼液是治疗眼睛最常用的物品之一,但是滴眼液毕竟含有过多的化学成分,如果长时间使用会导致眼内被感染,使得眼内细胞无法正常的进行新陈代谢作用,使得眼睛出现视物模糊不清等现象。中医针对这一症状进行了广泛的研究,申请号2006100461465的中国专利公开了一种治疗眼疲劳的中药制剂,主要是由紫金龙总生物碱1-10g、眼用凝胶基质0.1-20g和适量的水混合,搅拌,用PH调节剂调节PH值至4-9,加注射用水至1000ml,搅拌均匀制备成凝胶即得,该发明采用抗眼疲劳药物紫金龙总生物碱为活性成分,采用水溶性凝胶为基质,形成了具有眼部缓释作用和良好的生物相容性凝胶,具有缓释、舒适、刺激相对较小的优点。但是,依然存在对眼部的刺激作用。申请号2016107557848的中国专利公开了一种清肝明目中药组合物,包括决明子5-12份、菊花4-10份、山楂2-6份和甘草1-4份,还可以进一步包括佛手4-7份、百合3-6份、马齿苋2-5份和生姜1-4份能够较好的缓解视力疲劳,治疗青少年假性近视,但是疗效相对比较单一。
发明内容
有鉴于此,本发明的目的是针对现有技术的不足,提供一种缓解眼疲劳、治疗近视的复方中药组合物,从中药整体观和协调观出发,从养肝、护肝出发进而达到缓解眼疲劳、治疗近视的效果。
为达到上述目的,本发明采用以下技术方案:
一种缓解眼疲劳、治疗近视的复方中药组合物,由如下重量份的原料组成,50-55%中药提取物,35-40%的辅料,5-10%的复合维生素和1-3%的微量元素;
所述中药原料的组成及其重量份数如下,薄荷100-150份、黑米100-120份、川穹100-120份、冰片100-120份、楮实子100-120份、功劳木100-120份、百脉根80-100份、枸杞子80-100份、决明子80-100份、金银花80-100份、白芍80-100份、桑叶60-80份、花生叶60-80份、鱼眼睛60-80份、莲子60-80份、榴莲30-50份、黄芪30-50份、三七30-50份、蝉蜕30-50份、蚂蚁30-50份、藏红花30-50份、山茱萸30-50份和甘草10-15份。
进一步地,所述缓解眼疲劳、治疗近视的复方中药组合物,由如下重量份的原料组成,50-55%中药提取物,35-40%的辅料,5-10%的复合维生素和1-3%的微量元素;
所述中药原料的组成及其重量份数如下,薄荷120-130份、黑米105-115份、川穹105-115份、冰片105-115份、楮实子105-115份、功劳木105-115份、百脉根85-95份、枸杞子85-95份、决明子85-95份、金银花85-95份、白芍85-95份、桑叶65-75份、花生叶65-75份、鱼眼睛65-75份、莲子65-75份、榴莲35-45份、黄芪35-45份、三七35-45份、蝉蜕35-45份、蚂蚁35-45份、藏红花35-45份、山茱萸35-45份和甘草12-15份。
进一步地,所述缓解眼疲劳、治疗近视的复方中药组合物,由如下重量份的原料组成,50-55%中药提取物,35-40%的辅料,5-10%的复合维生素和1-3%的微量元素;
所述中药原料的组成及其重量份数如下,薄荷125份、黑米110份、川穹110份、冰片110份、楮实子110份、功劳木110份、百脉根90份、枸杞子90份、决明子90份、金银花90份、白芍90份、桑叶70份、花生叶70份、鱼眼睛70份、莲子70份、榴莲40份、黄芪40份、三七40份、蝉蜕40份、蚂蚁40份、藏红花40份、山茱萸40份和甘草15份。
进一步地,所述辅料的组成及其重量份数如下,蜂蜜40-60份、淀粉30-40份、羧甲基纤维素钠10-15份和壳聚糖10-15份。
进一步地,所述复合维生素的组成及其重量份数如下,维生素A 10-15份、维生素B8-10份、维生素C 3-5份和β-胡萝卜素6-8份。
进一步地,所述微量元素的组成及其重量份数如下,锌8-10份、铁6-8份、锰6-8份、钙5-8份和硒3-5份。
本发明还提供了一种缓解眼疲劳、治疗近视的复方中药组合物丸剂的制备方法,包括如下步骤,
S1:将所述薄荷、川穹、黄芪和冰片,粉碎超微粉,CO2超临界萃取,以乙醇作为夹带剂,萃取物浓缩干燥、备用;
S2:将所述黑米、桑叶、花生叶和榴莲粉碎,加入体积分数35-45%的乙醇水溶液,35-45℃超声提取30-40min,功率1000-2000W,提取物浓缩干燥、备用;
S3:将所述枸杞子、决明子、金银花、白芍、藏红花、山茱萸、楮实子、功劳木、百脉根和甘草粉碎、浸泡,回流提取,回收回流液,合并,浓缩、干燥备用;
S4:将所述鱼眼、蝉蜕、蚂蚁、三七和莲子焙烤,碾碎成粉末状;
S5:将S1、S2、S3和S4所得产物混合,加入辅料、维生素和微量元素制成丸剂。
进一步地,S1中萃取压力:25-30Mpa,乙醇浓度95%,固液比:5-5.5:1,萃取温度为500C,萃取时间为4h流体流速为35kg/h;
进一步地,S3中的回流提取具体的是,加入2-3倍重量份的体积份数75-85%乙醇浸泡,回流提取20-30分钟,分离馏份和滤渣;将滤渣加入2-3倍重量份的清水,并滴入体积分数为1%的醋酸,搅拌、浸泡,回流提取20-30分钟,回收回流液,合并,浓缩、干燥备用。
所述缓解眼疲劳、治疗近视的复方中药组合物在制备缓解眼疲劳、治疗近视类药物中的应用。
中药组分的药理药效如下:
薄荷
性味归经:味辛,性凉;归肺,肝经。
功效主治:功效:辛凉解表中药薄荷有发散风热、清利头目,利咽,透疹。主治:用于风热表证,头痛目赤,咽喉肿痛,麻疹不透,风疹瘙痒。
黑米,
性味归经:性平,味甘;归肝、肾、脾、胃经。
功效:黑米有开胃益中、健脾活血、明目的功效。可抗衰老;补充人体需要的蛋白质、锰、锌等多种矿物资。
黑米的营养价值
1.黑米含蛋白质、碳水化合物、B族维生素、维生素E、钙、磷、钾、镁、铁、锌等营养元素,营养丰富。
2.黑米所含锰、锌、铜等无机盐大都比大米高1~3倍;更含有大米所缺乏的维生素C、叶绿素、花青素、胡萝卜素及强心甙等特殊成分,因而黑米比普通大米更具营养。
川穹
性味归经:辛,温。归肝、胆、心包经。
功效主治:活血行气,祛风止痛。用于安抚神经,正头风头痛,症瘕腹痛,胸胁刺痛,跌扑肿痛,头痛,风湿痹痛。川芎能扩张平滑肌,改善微循环,并有抗凝、抗聚集作用,并通过扩张末梢血管而降压。
冰片
性味归经:性寒、味辛、苦;归心经、脾经、肺经。
功效,通诸窍,散郁火,去翳明目,消肿止痛。
主治,治中风口噤,热病神昏,惊痫痰迷,气闭耳聋,喉痹,口疮,中耳炎,痈肿,痔疮,目亦翳膜,蛲虫病。
楮实子
性味归经:味甘,性寒;入肝,脾、肾经。
功能主治:补肾清肝,明目,利尿。用于腰膝酸软、虚劳骨蒸、砂晕目昏、目生翳膜、水肿胀满。
功劳木
性味归经:性寒,味苦。归肝经、胃经、大肠经。
功效与作用:清热燥湿、泻火解毒。
百脉根
性味归经:甘、苦;微寒;归肺经。
功效:补虚;清热;止渴。
主治:虚劳;阴虚发热;口渴、可以止咳平喘。百脉根对于风热咳嗽和咽炎有很好的作用。
枸杞子
性味归经:性平味甘;归肝,肾经。
功效主治:滋补肝肾,益精明目。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。
决明子
性味归经:味甘、苦,性微寒;归大肠经。
功效主治:1.清热明目,用治肝火上炎所致目赤肿痛,常与夏枯草、钩藤、菊花等同用;风热上冲所致目赤肿痛、羞明多泪,常与青葙子、茺蔚子、菊花等同用;热毒上攻所致目赤涩痛,可与黄芩、赤芍、木贼等同用。2.润肠通便用治内热肠燥所致大便秘结,常与火麻仁、瓜蒌仁等同用。
金银花
性味归经:味甘,性寒;归肺、心、胃、大肠经。
功效主治:1.清热解毒,用治温病初起,身热、口渴、脉数,常与连翘、板蓝根等同用;疮痈初起,红肿热痛,常与蒲公英、野菊花、紫花地丁等同用。2.疏散风热,用治外感风热表证,常与连翘、薄荷、马勃等同用。3.凉血止痢,用治热毒血痢,可配马齿苋、白头翁等同用。
白芍
性味归经:味苦、酸,性微寒;归肝、脾经。
功效主治:功效:养血敛阴,柔肝止痛,平抑肝阳。主治:用于***,崩漏,虚汗,脘腹急痛,胁肋疼痛,四肢挛痛,头痛眩晕。
桑叶
性味归经:味苦、甘,性寒;归肺、肝经。
功效主治:功效:疏散风热,清肝明目。主治:用于风热表证,温病初起,燥热咳嗽,目赤肿痛,目暗昏花等。
花生叶
性味归经:性甘淡;味平;归肝经。
功能主治:清热解毒,宁神降压。主跌打损伤,痈肿疮毒,失眠,高血压。
鱼眼睛
鱼眼睛当中含有比较多的dha以及epa,这是属于一种不饱和脂肪酸,对于人体的大脑的记忆力及思维能力都是有着非常好的增强的作用的,而且可以帮助预防出现胆固醇过高以及高血压的情况,尤其是对于孩子来说,现在的小孩子用眼是非常大的,这个时候应该多给孩子吃一些鱼眼睛,这样的话就会有着比较好的缓解视力的作用,同时也要注意多吃一些水果和蔬菜。
莲子
性味归经:味甘、涩,性平;归脾、肾、心经。
功效主治:功效:补脾止泻,益肾固精,养心安神。主治:主治脾虚久泻、久痢,肾虚遗精、滑泄、小便不禁,崩漏带下,心神不宁,惊悸不眠。
榴莲
性味归经:辛、甘,热。入肝、肾、肺三经。
功效,滋阴强壮、疏风清热、利胆退黄、杀虫止痒、补身体。
主治,可用于精血亏虚须发早白、衰老等症。可用于风热等症。可用治黄疸。可用治疥癣、皮肤瘙痒等症。
黄芪
性味归经:味甘,性微温;归脾、肺经。
功效主治:1.补气升阳,用治中气下陷,常与人参、白术、升麻、柴胡等同用;胸中大气下陷,常配柴胡、升麻、桔梗同用。2.益气固表,用治气虚不固的自汗,常与牡蛎、浮小麦、麻黄根等同用;卫表不固,易感外邪者,常与白术、防风等配伍。3.益气利水,用治气虚水肿,常配白术、陈皮、茯苓等同用。4.益气摄血,用治气不摄血的吐衄、崩漏、便血、紫癜,常与人参、白术等同用。5.益气活血,用治气虚血瘀所致肌肤麻木不仁,常与桃仁、当归、川芎等配伍;中风偏瘫,常配地龙、红花、川芎等同用;胸痹心痛,常与丹参、瓜蒌壳等同用。6.托毒排脓,用治气血不足,脓成不溃者,常与当归、川芎、穿山甲、皂角刺等同用;疮疡溃后久不收口,常与白芍、丹参、天花粉等同用。
三七
性味归经:味辛、甘、微涩,微苦,性温;归肝、心、胃经。
功效主治:功效:止血,活血化瘀,化瘀止痛时止血不留瘀,适合瘀血引起的出血证。1、化瘀止血,用于各种内外出血证,尤以有瘀者为宜。三七既能止血,又能散瘀,有止血而不留瘀,化瘀而不伤正之特点,诚为血证良药。常用治咳血、吐血、便血、尿血崩漏及外伤出血等,单味研末内服或外用即可奏效。亦可配花蕊石、血余炭同用,如《医学衷中参西录》化血丹。2、活血定痛,用于跌打损伤,瘀滞疼痛。三七能活血化瘀而消肿定痛,为伤科要药。可单味内服或外敷,或配活血行气药同用。如以疗伤止血著名的“云南白药”中,三七是主要组成药。3、近年来以其化瘀之功,用治冠心病心绞痛,缺血性脑血管病、脑出血后遗症等,均有较好疗效。
蝉蜕
性味归经:味甘,性寒;归肺、肝经。
功效主治:功效:发散风热,透疹止痒,明目退翳,熄风止痉。主治:用于外感风热,温病初起,麻疹不透,风疹瘙痒,目赤,目翳,小儿夜啼,破伤风。
蚂蚁
性味归经:味咸、酸,性平;归肝经,肾经。
功效主治:功效:补肾益精,通经活络,解毒消肿。主治:主治肾虚头昏耳鸣,失眠多梦,阳痿遗精,风湿痹痛,中风偏瘫,手足麻木,红斑性狼疮,硬皮病,皮肌炎,痈肿疔疮,毒蛇咬伤。
藏红花
性味归经:性平味甘;归心,肝经。
功能主治:活血化瘀通经,凉血解毒。用于:经闭瘕瘕,产后瘀阻,温毒发斑,忧郁痞闷,惊悸发狂。
山茱萸
性味归经:味酸,性微温;归肝、肾经。
功效主治:1.收敛固涩,用治遗精滑精、遗尿尿频,常与补骨脂、桑螵蛸等同用;崩漏下血、月经过多,常与当归、白芍等同用;大汗虚脱,常与人参、附子同用。2.补益肝肾,用治肝肾不足,腰膝酸软,常与熟地黄、杜仲、淫羊藿同用。
甘草
性味归经:性味,味甘,性平。归经,归心、肺、脾、胃经。
功效,补脾益气,清热解毒,祛痰止咳,缓急止痛,调和诸药。
主治,用于脾胃虚弱,倦怠乏力,心悸气短,咳嗽痰多,脘腹、四肢挛急疼痛,痈肿疮毒,缓解药物毒性、烈性。
中医理论认为:肺开窍于鼻、肝开窍于目、肾开窍于耳。也就是说,通过观察五官的异常情况,就能了解心、肝、脾、肺、肾可能存在的病变。视力的好坏有赖于肝气的疏泄和营养。中医讲,肝藏血,而血又是眼睛活动最直接的物质基础,所以,肝血的盛衰会直接影响到视觉功能。若肝血不足,目失所养,则两眼昏花、视物不明,出现如夜盲等问题;若肝经火盛,可见眼红肿痛;肝阴虚,可致眼糊干涩,或也可见眼珠不灵活、斜视等;肝气郁结过久,则能导致口苦目眩。即护目需先护肝,护肝则要养血,中医理论上血与五脏紧密相连。(1)血与心,血液具有营养作用,脉是血行的隧道,心脏则是血行的动力。心脏和血脉相互联系,互相贯通,互相配合,共同完成血液的正常运行。血液循着脉管运行不息,从而将血液中的营养物质不断地输送到全身,以供给机体生理活动的需要。虽然血液循环是心与血脉共同的活动,但心脏是起主导的、主要的作用。《内经》云:“心主身之血脉”,“诸血者皆属于心”。(2)血与肺血与肺关系也颇为密切。由中焦脾胃吸收转化而成的精微物质,需“上注于肺脉乃化为血”,说明肺脏亦参与血的生成。中医有“肺朝百脉”之说,意思是说人体所有血脉都会集于肺脏,血液在流经肺脏时,将其中残存的废物通过肺的呼吸而排出体外,又通过肺的作用将新鲜空气吸入体内,汇入血中。可见,肺的吐故纳新作用保持着血液的清新,新鲜的血液在宗气的推动下,再循行于血脉,温养着五脏六腑、四肢百骸。(3)血与肝中医认为,肝藏血。唐代王冰解释说:“肝藏血,心行之。人动则血运于诸经,人静则血归于肝。何者?肝主血海故也。”意思是说,肝脏具有贮藏血液和调节血量的功能。当人体在劳作或情绪激动时,机体各部的需血量增加,循环血量也须相应增加,这时肝脏就把贮藏的血液排出来,以供机体活动的需要;当人在休息或情绪安定时,全身活动量减少,机体所需血量亦减少,部分血液便贮存于肝脏。如果肝脏有病,藏血的功能失常,既影响人体的正常活动,亦可出现血液方面的病变。若肝血不足(肝血虚),不能滋养于目,则两目昏花、干涩、夜盲;不能濡养于筋,则筋肉拘急,屈伸不利;不能充盈血海,则妇女月经量少,甚至闭经;若是肝失疏泄而肝气逆乱,则藏血不固,易引起出血病变,如吐血、呕血、衄血,妇女月经过多或崩漏等。肝主疏泄,又主藏血。血的运行有赖于气的推动。当肝脏疏泄功能正常时,则气机条达舒畅,血随气行亦通畅无阻。若疏泄不及,肝郁气滞,可导致血瘀,出现胸胁刺痛等证。若疏泄太过,气机逆乱,则藏血不固而引起出血病变。(4)血与脾,中医认为,脾为后天之本,能纳谷受气,取水谷之精微化生为血液。血的生成与脾脏的关系最为密切。脾脏不但与血生成有密切的关系,而且脾能统血。所谓统血,是指脾有统摄血液在脉管中正常运行而不溢出脉外的功能。我国早期的医学著作《难经》指出:“脾裹血,温五脏”,裹的意思就是统摄。而脾的统血功能,全赖脾气的作用。清代沈目南说:“五脏六腑之血,全赖脾气统摄。”后来唐容川也说:“经云脾统血,血之运行上下,全赖于脾,脾阳虚,则不能统血”,“人身之生,总是以气统血”。可见,血液的运行,除依赖于心脏的推动、肝脏的调节之外,还必须有脾脏的统摄。明代武之望《济阴纲目》说:“血生于脾,故曰脾统血。”说明脾脏的统摄作用,与脾为气血生化之源有密切关系。(5)血与肾,中医认为,肾藏精,精生髓,髓化血。同时,肾中命门为原气之所系,十二经之根,生化之源,也是温煦、促进血液生化的原动力之所在。可见,肾是形成血液的主要脏器之一,故中医有“生血根本在于肾”的说法。而血之精华又可化为肾精。如隋代巢元方《诸病源候论》说:“肾藏精,精者血之所成也”。清代唐容川说:“肾藏精,然精虽以肾为主,而合心血之所化”。意思是说,精血同源,是可以互相转化的。因此,治疗上常精血并补。如再生障碍性贫血,用健脾补肾法往往能取得较好的生血效果。同样,肾精亏虚者在用补肾药的同时,亦给以补气血之品,有助生精补髓。
本发明的有益效果是:
本发明以中药组合物结合微量元素和维生素,从护肝、强肾、健脾、和胃、养心出发,达到缓解眼疲劳、治疗近视的目的。综合运用中医的协调观、整体观遣方用药,调动五脏的活性,以五脏的活力确保血液供给的充沛,则肝的营养充足,保证眼部的活力充足,即在协调机体全身功能的基础上达到治疗效果,达到缓解眼疲劳、治疗近视的目的。
方中薄荷清利头目,利咽,透疹,黑米开胃益中、健脾活血、明目、同时补充人体需要的蛋白质、锰、锌等多种矿物资;川穹活血行气,祛风止痛,冰片通诸窍,散郁火,去翳明目,消肿止痛、楮实子补肾清肝,明目,利尿共为君药;功劳木清热燥湿、泻火解毒、百脉根补虚;清热;止渴;、枸杞子滋补肝肾,益精明目、决明子清热明目、治肝火、金银花清热解毒,白芍养血敛阴,柔肝止痛,平抑肝阳,桑叶疏散风热,清肝明目、花生叶清热解毒,宁神降压、莲子补脾止泻,益肾固精,养心安神共为臣药;榴莲滋阴强壮、疏风清热、利胆退黄,黄芪补气升阳、益气固表、益气利水、益气摄血、益气活血,三七活血化瘀,化瘀止痛时止血不留瘀、蝉蜕明目退翳,熄风止痉,蚂蚁补肾益精,通经活络,解毒消肿;藏红花活血化瘀通经,凉血解毒,山茱萸补益肝肾,鱼眼睛具有补益视力功能共为佐药;
方中以独特的君臣佐使理论指导用药,君药统筹利目、补益肝肾、清肺、健脾和胃、活血行气之功效;臣药枸杞子滋补肝肾,益精明目、白芍养血敛阴,柔肝止痛,平抑肝阳,决明子治肝火,金银花清热解毒共同协调肝功能、肺功能;花生叶宁神降压,莲子补脾,养心安神增益君药心功能之不足;佐药榴莲滋阴强壮、黄芪补气升阳、三七活血化瘀、藏红花活血化瘀通经,凉血解毒、蝉蜕明目退翳、蚂蚁补肾益精,通经活络,山茱萸补益肝肾,以补益肝肾、活血通络、补气升阳、明目退翳全方位呼应君药、臣药的功能,以甘草补脾益气,清热解毒,祛痰止咳,清咽利肺、缓急止痛,调和诸药;心安宁则血脉畅通,肺清则血脉得养,肝功能强则藏血足,双目能够得到滋养,脾能统血,肾藏精,精者血之所成也,用健脾补肾法往往能取得较好的生血效果,五脏血脉通畅,视力问题自然得到解决,同时以鱼眼补给大脑和眼睛所必须的不饱和脂肪酸,与维生素和微量元素共同补充机体所需营养。
本发明提供的中药组合物的制备方法,以超临界萃取、微波和回流提取有机结合,在综合考虑本发明配方中各原料药药物性质的基础上,充分利用不同提取工艺的特点,更为高效的提取有效成分。
具体实施方式
实施例1
一种缓解眼疲劳、治疗近视的复方中药组合物,由如下重量份的原料组成,50%中药提取物,40%的辅料,9%的复合维生素和1%的微量元素;
所述中药原料的组成及其重量份数如下,薄荷100份、黑米100份、川穹100份、冰片100份、楮实子100份、功劳木100份、百脉根80份、枸杞子80份、决明子80份、金银花80份、白芍80份;桑叶60份、花生叶60份、鱼眼睛60份、莲子60份、榴莲30份、黄芪30份、三七30份、蝉蜕30份;蚂蚁30份;藏红花30份、山茱萸30份和甘草10份。
所述辅料的组成及其重量份数如下,蜂蜜40份、淀粉30份、羧甲基纤维素钠10份和壳聚糖10份。
所述复合维生素的组成及其重量份数如下,维生素A 10份、维生素B 8份、维生素C3份和β-胡萝卜素6份。
所述微量元素的组成及其重量份数如下,锌8份、铁6份、锰6份、钙5份和硒3份。
其丸剂的制备方法,包括如下步骤,
S1:将所述薄荷、川穹、黄芪和冰片,粉碎超微粉,CO2超临界萃取,以乙醇作为夹带剂,萃取物浓缩干燥、备用;萃取压力:25Mpa,乙醇浓度95%,固液比:5-5.5:1,萃取温度为500C,萃取时间为4h流体流速为35kg/h;
S2:将所述黑米、桑叶、花生叶和榴莲粉碎,加入体积分数35-45%的乙醇水溶液,35℃超声提取30-40min,功率1000W,提取物浓缩干燥、备用;
S3:将所述枸杞子、决明子、金银花、白芍、藏红花、山茱萸、楮实子、功劳木、百脉根和甘草粉碎、浸泡,加入2倍重量份的体积份数75%乙醇浸泡,回流提取20分钟,分离馏份和滤渣;将滤渣加入2倍重量份的清水,并滴入体积分数为1%的醋酸,搅拌、浸泡,回流提取20分钟,回收回流液,合并,浓缩、干燥备用。回流提取,回收回流液,合并,浓缩、干燥备用;
S4:将所述鱼眼、蝉蜕、蚂蚁、三七和莲子焙烤,碾碎成粉末状;
S5:将S1、S2、S3和S4所得产物混合,加入辅料、维生素和微量元素制成丸剂。
实施例2
一种缓解眼疲劳、治疗近视的复方中药组合物,由如下重量份的原料组成,55%中药提取物,37%的辅料,5%的复合维生素和3%的微量元素;
所述中药原料的组成及其重量份数如下,薄荷150份、黑米120份、川穹120份、冰片120份、楮实子120份、功劳木120份、百脉根100份、枸杞子100份、决明子100份、金银花100份、白芍100份;桑叶80份、花生叶80份、鱼眼睛80份、莲子80份、榴莲50份、黄芪50份、三七50份、蝉蜕50份;蚂蚁50份;藏红花50份、山茱萸50份和甘草15份。
所述辅料的组成及其重量份数如下,蜂蜜60份、淀粉40份、羧甲基纤维素钠15份和壳聚糖15份。
所述复合维生素的组成及其重量份数如下,维生素A 15份、维生素B 10份、维生素C 5份和β-胡萝卜素8份。
所述微量元素的组成及其重量份数如下,锌10份、铁8份、锰8份、钙8份和硒5份。
其丸剂的制备方法,包括如下步骤,
S1:将所述薄荷、川穹、黄芪和冰片,粉碎超微粉,CO2超临界萃取,以乙醇作为夹带剂,萃取物浓缩干燥、备用;萃取压力:30Mpa,乙醇浓度95%,固液比:5.5:1,萃取温度为500C,萃取时间为4h流体流速为35kg/h;
S2:将所述黑米、桑叶、花生叶和榴莲粉碎,加入体积分数45%的乙醇水溶液,45℃超声提取40min,功率2000W,提取物浓缩干燥、备用;
S3:将所述枸杞子、决明子、金银花、白芍、藏红花、山茱萸、楮实子、功劳木、百脉根和甘草粉碎、浸泡,加入2-3倍重量份的体积份数75-85%乙醇浸泡,回流提取20-30分钟,分离馏份和滤渣;将滤渣加入2-3倍重量份的清水,并滴入体积分数为1%的醋酸,搅拌、浸泡,回流提取20-30分钟,回收回流液,合并,浓缩、干燥备用;
S4:将所述鱼眼、蝉蜕、蚂蚁、三七和莲子焙烤,碾碎成粉末状;
S5:将S1、S2、S3和S4所得产物混合,加入辅料、维生素和微量元素制成丸剂。
实施例3
一种缓解眼疲劳、治疗近视的复方中药组合物,由如下重量份的原料组成,52%中药提取物,38%的辅料,8%的复合维生素和2%的微量元素;
所述中药原料的组成及其重量份数如下,薄荷125份、黑米110份、川穹110份、冰片110份、楮实子110份、功劳木110份、百脉根90份、枸杞子90份、决明子90份、金银花90份、白芍90份;桑叶70份、花生叶70份、鱼眼睛70份、莲子70份、榴莲40份、黄芪40份、三七40份、蝉蜕40份;蚂蚁40份;藏红花40份、山茱萸40份和甘草15份。
所述辅料的组成及其重量份数如下,蜂蜜50份、淀粉35份、羧甲基纤维素钠12份和壳聚糖13份。
所述复合维生素的组成及其重量份数如下,维生素A 12份、维生素B 9份、维生素C4份和β-胡萝卜素7份。
所述微量元素的组成及其重量份数如下,锌9份、铁7份、锰7份、钙6份和硒4份。
其丸剂的制备方法,包括如下步骤,
S1:将所述薄荷、川穹、黄芪和冰片,粉碎超微粉,CO2超临界萃取,以乙醇作为夹带剂,萃取物浓缩干燥、备用;萃取压力:28Mpa,乙醇浓度95%,固液比:5.3:1,萃取温度为500C,萃取时间为4h流体流速为35kg/h;
S2:将所述黑米、桑叶、花生叶和榴莲粉碎,加入体积分数40%的乙醇水溶液,40℃超声提取35min,功率1500W,提取物浓缩干燥、备用;
S3:将所述枸杞子、决明子、金银花、白芍、藏红花、山茱萸、楮实子、功劳木、百脉根和甘草粉碎、浸泡,加入2.5倍重量份的体积份数80%乙醇浸泡,回流提取25分钟,分离馏份和滤渣;将滤渣加入2.5倍重量份的清水,并滴入体积分数为1%的醋酸,搅拌、浸泡,回流提取25分钟,回收回流液,合并,浓缩、干燥备用;
S4:将所述鱼眼、蝉蜕、蚂蚁、三七和莲子焙烤,碾碎成粉末状;
S5:将S1、S2、S3和S4所得产物混合,加入辅料、维生素和微量元素制成丸剂。
实施例4
一种缓解眼疲劳、治疗近视的复方中药组合物,由如下重量份的原料组成,53%中药提取物,35%的辅料,10%的复合维生素和2%的微量元素;
所述中药原料的组成及其重量份数如下,薄荷120份、黑米105份、川穹105份、冰片105份、楮实子105份、功劳木105份、百脉根85份、枸杞子85份、决明子85份、金银花85份、白芍85份;桑叶65份、花生叶65份、鱼眼睛65份、莲子65份、榴莲35份、黄芪35份、三七35份、蝉蜕35份、蚂蚁35份、藏红花35份、山茱萸35份和甘草12份。
所述辅料的组成及其重量份数如下,蜂蜜45份、淀粉32份、羧甲基纤维素钠11份和壳聚糖11份;
所述复合维生素的组成及其重量份数如下,维生素A 10份、维生素B 8份、维生素C3份和β-胡萝卜素6份。
所述微量元素的组成及其重量份数如下,锌8份、铁6-8份、锰6份、钙6份和硒4份。
其丸剂的制备方法见实施例3。
实施例5
一种缓解眼疲劳、治疗近视的复方中药组合物,由如下重量份的原料组成,51%中药提取物,39%的辅料,8%的复合维生素和2%的微量元素;
所述中药原料的组成及其重量份数如下,薄荷130份、黑米115份、川穹115份、冰片115份、楮实子115份、功劳木115份、百脉根95份、枸杞子95份、决明子95份、金银花95份、白芍95份;桑叶75份、花生叶75份、鱼眼睛75份、莲子75份、榴莲45份、黄芪45份、三七45份、蝉蜕45份;蚂蚁45份;藏红花45份、山茱萸45份和甘草15份。
所述辅料的组成及其重量份数如下,蜂蜜55份、淀粉38份、羧甲基纤维素钠14份和壳聚糖14份。
所述复合维生素的组成及其重量份数如下,维生素A 14份、维生素B 9份、维生素C5份和β-胡萝卜素8份。
所述微量元素的组成及其重量份数如下,锌10份、铁8份、锰8份、钙7份和硒5份。
其丸剂的制备方法见实施例3。
实施例6
一种缓解眼疲劳、治疗近视的复方中药组合物,由如下重量份的原料组成,53%中药提取物,38%的辅料,7%的复合维生素和2%的微量元素;
所述中药原料的组成及其重量份数如下,薄荷126份、黑米112份、川穹108份、冰片111份、楮实子114份、功劳木113份、百脉根88份、枸杞子86份、决明子94份、金银花87份、白芍93份;桑叶66份、花生叶73份、鱼眼睛72份、莲子71份、榴莲42份、黄芪36份、三七37份、蝉蜕38份;蚂蚁39份;藏红花41份、山茱萸42份和甘草13份。
所述辅料的组成及其重量份数如下,蜂蜜40-60份、淀粉30-40份、羧甲基纤维素钠10-15份和壳聚糖10-15份。
所述复合维生素的组成及其重量份数如下,维生素A 10份、维生素B 10份、维生素C 3份和β-胡萝卜素8份。
所述微量元素的组成及其重量份数如下,锌8份、铁7份、锰6份、钙5份和硒4份。
其丸剂的制备方法见实施例3。
实施例7
一种缓解眼疲劳、治疗近视的复方中药组合物,由如下重量份的原料组成,54%中药提取物,36%的辅料,7%的复合维生素和3%的微量元素;
所述中药原料的组成及其重量份数如下,薄荷101份、黑米102份、川穹103份、冰片118份、楮实子117份、功劳木116份、百脉根82份、枸杞子98份、决明子96份、金银花99份、白芍97份、桑叶61份、花生叶63份、鱼眼睛78份、莲子76份、榴莲31份、黄芪32份、三七33份、蝉蜕48份;蚂蚁47份;藏红花46份、山茱萸49份和甘草11份。
所述辅料的组成及其重量份数如实施例3。
所述复合维生素的组成及其重量份数如如实施例3。
所述微量元素的组成及其重量份数如如实施例3。
其丸剂的制备方法见实施例3。
实施例8
一种缓解眼疲劳、治疗近视的复方中药组合物,由如下重量份的原料组成,53%中药提取物,39%的辅料,6%的复合维生素和2%的微量元素;
所述中药原料的组成及其重量份数如下,薄荷148份、黑米101份、川穹118份、冰片100份、楮实子120份、功劳木104份、百脉根81份、枸杞子82份、决明子83份、金银花84份、白芍95份;桑叶62份、花生叶65份、鱼眼睛70份、莲子72份、榴莲35份、黄芪45份、三七38份、蝉蜕44份;蚂蚁30份;藏红花50份、山茱萸40份和甘草13份。
所述辅料的组成及其重量份数如如实施例3。
所述复合维生素的组成及其重量份数如如实施例3。
所述微量元素的组成及其重量份数如如实施例3。
其丸剂的制备方法见实施例3。
对比例1
对比例1与实施例3基本相同,其不同之处在于,删除蚂蚁组分。
对比例2
对比例2与实施例3基本相同,其不同之处在于,将黑米以等重量份的黑豆取代。
黑豆:
性味归经:味甘,性微寒,性平、入脾、肾经。
功效主治:功效:补肾益阴,健脾利湿,除热解毒。主治目盲,翳膜。
对比例3
对比例3与实施例3基本相同,其不同之处在于,增加中药组分当归40份。
当归
性味归经:当归味甘、辛,性温;归肝经、心经、脾经。
功效主治:1.补血调经,用治血虚所致面色苍白、***等,常与熟地黄、黄芪、白芍等同用2.活血止痛,用治跌打损伤,瘀血肿痛,常与乳香、没药、桃仁等同用;寒滞经络之痹痛,常与川芎、桂枝、细辛等同用。3.润肠通便,用治血虚津亏所致肠燥便秘,常与肉苁蓉、郁李仁、枳壳同用。
对比例4
对比例4与实施例3基本相同,其不同之处在于,将薄荷组分的重量份变为70份。
对比例5
对比例5与实施例3基本相同,其不同之处在于,删除微量元素。
对比例6
对比例6与实施例3基本相同,其不同之处在于,删除维生素。
对比例7
对比例7与实施例3基本相同,其不同之处在于,删除羧甲基纤维素钠。
对比例8
对比例8与实施例3基本相同,其不同之处在于,制备方法步骤中,删除醋酸。
药理实验
1、对兔眼虹膜-睫状体肌中乳酸脱氢酶活性的影响:15只家兔,随机分成3组,每组5只,10只眼。分别给予生理盐水、本发明的丸剂和珍视明滴眼液,生理盐水和珍视明滴眼液均每眼0.1ml,滴眼3次/天,本发明的丸剂为口服,1粒/次,3次/天;连续给药2周。末次给药后30min,处死动物,摘除虹膜-睫状体肌,按微量比色法测虹膜-睫状体肌中乳酸脱氢酶(LDH)活性。结果见表1。
表1对兔眼虹膜-睫状体肌中乳酸脱氢酶活性的影响
组别 | 乳酸脱氢酶活性 | P值 |
生理盐水组 | 0.43±0.24 | |
治疗组 | 0.74±0.17 | P<0.01 |
对照组 | 0.58±0.25 | P<0.05 |
统计结果表明,本发明眼用凝胶能显著提高兔眼虹膜-睫状体肌中乳酸脱氢酶活性(P<0.01)疗效显著优于对照组。
2、对兔眼组织中锌微量元素的影响:15只家兔,随机分成3组,每组5只,10只眼。分别给予生理盐水、本发明的丸剂和珍视明滴眼液,生理盐水和珍视明滴眼液均每眼0.1ml,滴眼3次/天,本发明的丸剂为口服,1粒/次,3次/天;连续给药2周。末次给药后30min,处死动物,摘取眼球,并以生理盐水冲洗。抽取房水。剖取角膜、虹膜-睫状体肌和晶体。用等离子发射光谱法测定上述组织中锌元素的含量(μg/g组织)。结果见表2。
表2对兔眼组织中锌微量元素的影响(μg/g组织)
分组 | 眼球数 | 角膜 | 房水 | 晶体 | 虹膜-睫状体肌 |
生理盐水组 | 10 | 161±32 | 74±22 | 73±15 | 397±56 |
对照组 | 10 | 171±25 | 85±22 | 76±15 | 420±68 |
治疗组 | 10 | 200±38※ | 137±33※※ | 93±17 | 498±61※ |
注:与生理盐水组比较:※P<0.05※※P<0.01
乳酸脱氢酶是人体的重要酶之一,广泛分布于各种组织之中,其主要功能是参与糖的无氧酵解,产生ATP。ATP除提供能量外,并能扩张末梢血管,促进血液循环,从而改善视网膜及视神经的功能,近年来均有利有ATP治疗近视眼的报道,本发明眼用凝胶能够提高眼组织中乳酸脱氢酶活性。元素锌参加一些重要金属酶的活动,对房水有重要影响的碳酸酐酶就是一种含锌酶,该酶的抑制剂可以减少50-60%房水的形成。锌还参与视网膜中乙醇脱氢酶和视黄醇还原酶的活性。使视黄醛再生,并作用于视网膜神经细胞。
临床实验
1、临床病例:治疗组166例,320眼,男84例,女82例,年龄17-68岁,左眼6例,右眼6例,其余为双眼患者:对照组182例,360眼,男85例,女97例,年龄18-66岁,右眼2例,左眼2例,其余均为双眼患者。
2、治疗方法:实验组用法:口服实施例1-8所得丸剂,一次3-4粒/3-4g,一日3次;当视力达到1.0以上时可酌量减少,疗程30天。对照组:对照组1为滴珍视明滴眼液,用法:每日4-6次,每次1-2滴,疗程30天。对照组2-9为口服对比例1-8所得丸剂,一次3-4粒/3-4g,一日3次;当视力达到0.8以上时可酌量减少,疗程30天。
3、临床治疗结果
1)疗效判定标准
治愈:能坚持阅读或者注视精细工作1小时以上,眼睛症状及全身症状消失者。
显效:能坚持阅读或者注视精细工作30-60分钟(短暂性视力减退者,重症闭目休息10分钟后视力恢复,轻度及中度症失),眼部症状及全身症状各有2项明显改善者。
有效:阅读或者注视精细工作较治疗前延长10分钟以上(短暂性视力减退者,重症闭目休息20分钟后视力恢复,重症闭目休息10分钟后视力恢复,轻度症失),眼部症状及全身症状各有2项明显改善者。或各有一项明显改善者。
无效:治疗前后眼部症状及全身症状均无改善者。
(2)治疗结果
治疗组320眼,有效320眼,有效率100%;对照组360眼,有效295眼,有效率81.94%。两组之间的个体差异可以忽略不计。结果见表3。
表3治疗组与对照组疗效统计分析
(3)典型病例:
吴某某,男,17岁,河南某高中学生,2010年8月初视物模糊,精神萎靡、注意力不集中、记忆力下降症状,2010年8月底开始服用本发明药物,服用两天后注意力集中,精神变好,继续服用两天,记忆力、视力恢复,停药,至今未复发。
刘某,男,40岁,山东菏泽人,工作压力大,2012年开始出现眼胀痛及眼部充血,未进行治疗,随后出现颈肩腰背酸痛症状,随之开始服用本发明中药,两天后症状消失,精神恢复,继续服用4天后停药。
林某某,女,29岁,河南郑州人,从事文案工作多年,2012年开始出现畏光流泪、眼胀痛及眼部充血等状况,有时还伴有头痛、恶心症状,随服用本发明中药,1天后,眼睛干涩、流泪症状消失,继续服用3天后停药,至今未复发。
最后说明的是,以上实施例仅用以说明本发明的技术方案而非限制,本领域普通技术人员对本发明的技术方案所做的其他修改或者等同替换,只要不脱离本发明技术方案的精神和范围,均应涵盖在本发明的权利要求范围当中。
Claims (10)
1.一种缓解眼疲劳、治疗近视的复方中药组合物,其特征在于,由如下重量份的原料组成,50-55%中药提取物,35-40%的辅料,5-10%的复合维生素和1-3%的微量元素;
所述中药原料的组成及其重量份数如下,薄荷100-150份、黑米100-120份、川穹100-120份、冰片100-120份、楮实子100-120份、功劳木100-120 份、百脉根80-100份、枸杞子80-100份、决明子80-100份、金银花80-100份、白芍80-100份、桑叶60-80份、花生叶60-80份、鱼眼睛60-80份、莲子60-80份、榴莲30-50份、黄芪30-50份、三七30-50份、蝉蜕30-50份、蚂蚁30-50份、藏红花30-50份、山茱萸30-50份和甘草10-15份。
2.根据权利要求1所述的缓解眼疲劳、治疗近视的复方中药组合物,其特征在于,由如下重量份的原料组成,50-55%中药提取物,35-40%的辅料,5-10%的复合维生素和1-3%的微量元素;
所述中药原料的组成及其重量份数如下,薄荷120-130份、黑米105-115份、川穹105-115份、冰片105-115份、楮实子105-115份、功劳木105-115 份、百脉根85-95份、枸杞子85-95份、决明子85-95份、金银花85-95份、白芍85-95份、桑叶65-75份、花生叶65-75份、鱼眼睛65-75份、莲子65-75份、榴莲35-45份、黄芪35-45份、三七35-45份、蝉蜕35-45份、蚂蚁35-45份、藏红花35-45份、山茱萸35-45份和甘草12-15份。
3.根据权利要求1所述的缓解眼疲劳、治疗近视的复方中药组合物,其特征在于,由如下重量份的原料组成,50-55%中药提取物,35-40%的辅料,5-10%的复合维生素和1-3%的微量元素;
所述中药原料的组成及其重量份数如下,薄荷125份、黑米110份、川穹110份、冰片110份、楮实子110份、功劳木110份、百脉根90份、枸杞子90份、决明子90份、金银花90份、白芍90份、桑叶70份、花生叶70份、鱼眼睛70份、莲子70份、榴莲40份、黄芪40份、三七40份、蝉蜕40份、蚂蚁40份、藏红花40份、山茱萸40份和甘草15份。
4.根据权利要求1-3任一项所述的缓解眼疲劳、治疗近视的复方中药组合物,其特征在于,所述辅料的组成及其重量份数如下,蜂蜜40-60份、淀粉30-40份、羧甲基纤维素钠10-15份和壳聚糖10-15份。
5.根据权利要求1-3任一项所述的缓解眼疲劳、治疗近视的复方中药组合物,其特征在于,所述复合维生素的组成及其重量份数如下,维生素A 10-15份、维生素B 8-10份、维生素C 3-5份和β-胡萝卜素6-8份。
6.根据权利要求1-3任一项所述的缓解眼疲劳、治疗近视的复方中药组合物,其特征在于,所述微量元素的组成及其重量份数如下,锌8-10份、铁6-8份、锰6-8份、钙5-8份和硒3-5份。
7.一种根据权利要求1-6任一项所述缓解眼疲劳、治疗近视的复方中药组合物丸剂的制备方法,其特征在于,包括如下步骤,
S1:将所述薄荷、川穹、黄芪和冰片,粉碎超微粉, CO2超临界萃取,以乙醇作为夹带剂,萃取物浓缩干燥、备用;
S2:将所述黑米、桑叶、花生叶和榴莲粉碎,加入体积分数35-45%的乙醇水溶液,35-45℃超声提取30-40min,功率1000-2000W,提取物浓缩干燥、备用;
S3:将所述枸杞子、决明子、金银花、白芍、藏红花、山茱萸、楮实子、功劳木、百脉根和甘草粉碎、浸泡,回流提取,回收回流液,合并,浓缩、干燥备用;
S4:将所述鱼眼、蝉蜕、蚂蚁、三七和莲子焙烤,碾碎成粉末状;
S5:将S1、S2、S3和S4所得产物混合,加入辅料、维生素和微量元素制成丸剂。
8.根据权利要求7所述的制备方法,其特征在于,S1中萃取压力:25-30Mpa,乙醇浓度95%,固液比:5-5.5:1,萃取温度为500C,萃取时间为4h流体流速为35kg/h。
9.根据权利要求7所述的制备方法,S3中的回流提取具体的是,加入2-3倍重量份的体积份数75-85%乙醇浸泡,回流提取20-30分钟,分离馏份和滤渣;将滤渣加入2-3倍重量份的清水,并滴入体积分数为1%的醋酸,搅拌、浸泡,回流提取20-30分钟,回收回流液,合并,浓缩、干燥备用。
10.所述缓解眼疲劳、治疗近视的复方中药组合物在制备缓解眼疲劳、治疗近视类药物中的应用。
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CN113952437A (zh) * | 2021-12-06 | 2022-01-21 | 王光辉 | 一种预防近视、缓解用眼疲劳的中药组合物及其制备方法 |
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CN113952437A (zh) * | 2021-12-06 | 2022-01-21 | 王光辉 | 一种预防近视、缓解用眼疲劳的中药组合物及其制备方法 |
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